Imagine the result - IFV Human health risk assessment 123 5.13.4 Environmental effects 124 ......

Imagine the result

European Commission Health & Consumers DG Contract number 17.020200/09/549040 Identification and evaluation of data on flame retardants in consumer products FINAL REPORT

Project number 11/005409

17.020200/09/549040-Evaluation of data on flame retardants in consumer products – Final report - 2|402

Client Contact

EC – DG Health and Consumers B232 6/116 1049 Brussel Jürgen Vogelgesang

Contract number Date

17.020200/09/549040 26/04/2011

Contractor ARCADIS Belgium Posthofbrug 12 2600 Berchem

Contact Tel Fax E-mail Website

Karen Callebaut +32 3 328 62 76 +32 3 328 62 87 [email protected] www.arcadisbelgium.be


Table of contents Table of contents 3

List of tables 13

List of figures 20

List of annexes 21

Glossary and abbreviations 23

Executive summary 26

Identification of relevant flame retardants and their applications 26

Risk assessment 27

Grouping of substances 27

1 Background and first considerations 39

2 Objectives and scope 43

3 Identification of substances 45

3.1 Literature search 45

3.2 Organisation of data 45

3.2.1 Preparation of overview matrix 45

3.2.2 Selection of a core set of flame retardant applications 48

3.2.3 Core set identification 53

3.2.4 Conclusions 56

4 Assessment methodology 57

4.1 Physico-chemical data 57

4.2 Effect data 58

4.2.1 Human health effect data 58

4.2.2 Environmental effect data 61

4.3 Consumer exposure assessment 62

4.3.1 Prioritisation criteria for the exposure route of relevance 62

4.3.2 First tier assessment 64

4.3.3 Refinements 65

4.4 Environmental exposure assessment 67

4.4.1 Service life 67

4.4.2 Disposal phase 68

4.4.3 Data gaps 70

5 Health and environmental assessment of substances 71

5.1 Physico-chemical data 76

5.2 Decabromodiphenyl ether (CAS 1163-19-5) 76

5.2.1 Human health effects 76

5.2.2 Consumer exposure 76

5.2.3 Human health risk assessment 77


5.2.4 Environmental effects 77

5.2.5 Environmental exposure 78

5.2.6 Environmental risk assessment 78

5.3 Tris(tribromoneopentyl)phosphate (CAS 19186-97-1) 79







5.4 Tetrabromobisphenol A bis (2,3-dibromopropyl ether)/TBBPA-DBPE (CAS 21850-44-2) 82







5.5 Hexabromocyclododecane (CAS 25637-99-4) 87







5.6 Tri (2,4,6 tribromophenoxy) triazine (CAS 25713-60-4) 91







5.7 Bis-(2-ethylhexyl)tetrabromophthalate (CAS 26040-51-7) 94







5.8 Ethylene bis(tetrabromophtalimide) (CAS 32588-76-4) 95








5.9 1,2-bis(2,4,6-tribromophenoxy)ethane (CAS 37853-59-1) 101







5.10 Decabromodiphenylethane (CAS 84852-53-9) 107







5.11 Chloroparaffins (SCCP) (CAS 85535-84-8) 111







5.12 Chloroparaffins (MCCP) (CAS 85535-85-9) 114







5.13 Magnesium hydroxide (CAS 1309-42-8 and 13760-51-5) 119








5.14 Boehmite (aluminium hydroxideoxide) (CAS 1318-23-6) 124







5.15 Aluminium hydroxide (CAS 1318-23-7 and 21645-51-2) 128







5.16 Triphenyl phosphate (CAS 115-86-6) 134







5.17 Tris (2-chloroethyl)phosphate (CAS 115-96-8) 140







5.18 2-ethylhexyl diphenyl phosphate (CAS 1241-94-7) 143







5.19 Tricresyl phosphate (CAS 1330-78-5) 150








5.20 Tris(2-chloro-1-methylethyl)phosphate (CAS 13674-84-5) 159







5.21 Tris(2-chloro-1-(chloromethyl)ethyl)phosphate (CAS 13674-87-8) 163







5.22 Dimethyl propane phosphonate (CAS 18755-43-6) 166







5.23 Diethylphosphinate, aluminium salt (CAS 225789-38-8) 168







5.24 Trixylyl phosphate (CAS 25155-23-1) 171







5.25 Cresyl diphenyl phosphate (CAS 26444-49-5) 176








5.26 Isopropylated triphenyl phosphates (CAS 28108-99-8, 26967-76-0 and 68937-41-7)) 183







5.27 Bis-(isopropylphenyl) phenylphosphate (CAS 28109-00-4) 191







5.28 Tris-(tert-butylphenyl)phosphate (CAS 28777-70-0 and 78-33-1) 193







5.29 Isodecyl diphenyl phosphate (CAS 29761-21-5) 195







5.30 Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) (CAS 38051-10-4) 202







5.31 Guanidine phosphate (CAS 5423-23-4) 205








5.32 Isodecylphosphate (CAS 56572-86-2) 209







5.33 Tert-butylphenyl diphenyl phosphate (CAS 56803-37-3) 211







5.34 Resorcinol bis-diphenylphosphate (CAS 57583-54-7) 217







5.35 Bisphenol A-bis(diphenylphosphate) (CAS 5945-33-5 and 181028-79-5) 223







5.36 Bis-(tert-butylphenyl)phenylphosphate (CAS 65652-41-7) 228








5.37 Hypophosphite, aluminium salt (CAS 7784-22-7) 230







5.38 Hypophosphite, calcium salt (CAS 7789-79-9) 232







5.39 Diethyl ethylphosphonate (CAS 78-38-6) 234







5.40 Triethyl phosphate (CAS 78-40-0) 236







5.41 Melamine phosphate (CAS 415836-09-9, 20208-95-1) 241







5.42 Tetrabromobisphenol A (CAS 79-94-7) 246


5.42.2 Consumer exposure assessment 246

5.42.3 Human health risk characterisation 246





5.43 Uncertainties in the human risk assessment 247

6 Grouping of flame retardants used in consumer products 250

6.1.1 Methodology 250

6.1.2 Results 253

7 Fire incidents and human intoxication and/or burning 269

7.1 Approach 269

7.2 Collection of data from specific organisations 269

7.2.1 World Fire Statistics Centre (WFSC) 270

7.2.2 Centre of Fire Statistics of the International Association of Fire and Rescue Services (CTIF)270

7.2.3 World Health Organisation (WHO) 270

7.2.4 The insurance sector 272

7.2.5 European associations dealing with fire prevention 272

7.2.6 Conclusions on data from specific organisations 272

7.3 Collection of data from Member States (questionnaire) 272

7.3.1 Approach 272

7.3.2 Conclusions on data from Member States (questionnaire) 273

8 European and national requirements on the flammability and use of flame retardants in consumer products 277

8.1 Approach 277

8.2 Enquiry of the Member States by means of a questionnaire 277

8.3 Results on the regulatory and non-regulatory requirements on the non-flammability of consumer products 278

8.3.1 Regulations on EU level 278

8.3.2 Regulations at Member State level 280

8.3.3 Fire safety standards 285

8.4 Results on the use of flame retardants in consumer products 290

8.4.1 European legislation 290

8.4.2 National legislation 293

8.4.3 Ecolabels 293

8.4.4 Voluntary industry agreements 295

9 Non-flammability requirements and fire accidents 297

9.1.1 Evolution of the yearly number of domestic fire deaths per million inhabitants per Member State 297

9.1.2 Analysis of the stringency of the non-flammability requirements of consumer products in the different Member Sates 307

9.1.3 Impact of non-flammability requirements on the number of domestic fire deaths 308

10 Conclusions and recommendations 312

10.1 Conclusions 312


10.2 Recommendations 313

10.3 Added value of the study 314

11 Literature references 315

12 Annexes 327


List of tables Table 3-1: Description of article and product categories (REACH) ................................... 46

Table 3-2 : Substances included in the core set, defined for the purpose of this study .... 49

Table 3-3: Emissions of TBBPA at disposal phase (landfill and incinerator) .................... 52

Table 3-4: Relative importance of substance/application subsets .................................... 56

Table 4-1: Default exposure route of relevance in accordance with ECETOC-TRA......... 62

Table 4-2: Default exposure route of relevance ................................................................ 63

Table 4-3: Model used to assess exposure to articles not explicitly stated in the ECETOC-TRA tool ............................................................................................................................. 64

Table 4-4: Quantitative literature data on brominated flame retardant emissions............. 69

Table 5-1: Overview of assessed substances ................................................................... 72

Table 5-2: Summary of human health effect data for decabromodiphenyl ether from the EU-RAR (ECB, 2002) brought forward to the risk characterisation................................... 76

Table 5-3: Summary of effects of decabromdiphenyl ether brought forward to the risk characterisation:................................................................................................................. 77

Table 5-4: Deca-BDE and PBDE concentrations at incinerator sites................................ 78

Table 5-5: Human health effect data for tris(tribromoneopentyl)phosphate as given by Fisk et al. (2003)........................................................................................................................ 79

Table 5-6: Consumer exposure estimations to tris(tribromoneopentyl)phosphate............ 80

Table 5-7: Tentative qualitative risk assessment of tris(tribromoneopentyl) phosphate for consumers ......................................................................................................................... 81

Table 5-8: Environmental effect data for Tris(tribromoneopentyl) phosphate retrieved through a literature search................................................................................................. 81

Table 5-9: Summary of human health effect data for TBBPA-DBPE brought forward to the risk characterisation. .......................................................................................................... 85

Table 5-10: Consumer exposure estimations to TBBPA-DBPE........................................ 85

Table 5-11: Tentative risk assessment of TBBPA-DBPE for consumers. ......................... 86

Table 5-12: Summary of human health effect data for HBCDD from the EU-RAR (ECB, 2008) brought forward to the risk characterisation. ........................................................... 88

Table 5-13: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on HBCDD. ............................................................................................................................. 88

Table 5-14: Risk characterisation for consumers and conclusions according to the EU-RAR (ECB, 2008) on HBCDD............................................................................................ 89

Table 5-15: Summary of environmental effects of HBCDD brought forward to the risk characterisation.................................................................................................................. 89

Table 5-16: Concentrations of HBCDD in MSW landfill leachate...................................... 90


Table 5-17: Human health effect data for tri(2,4,6 tribromophenoxy) triazine as given by Fisk et al. (2003). ............................................................................................................... 92

Table 5-18: Consumer exposure estimates to tris (2,4,6 tribromophenoxy)triazine.......... 92

Table 5-19: Tentative qualitative risk assessment of tris (2,4,6 tribromophenoxy)triazine for consumers. ................................................................................................................... 93

Table 5-20: Environmental effect data for tris (2,4,6 tribromophenoxy)triazine ................ 93

Table 5-21: Matrices relevant for additive integration of bis-(2-ethylhexyl)tetrabromophthalate ......................................................................................... 94

Table 5-22: Environmental effect data for bis-(2-ethylhexyl)tetrabromophthalate ............ 95

Table 5-23: Summary of human health effect data for ethylene bis(tetrabromo phthalimide) brought forward to the risk characterisation:................................................. 98

Table 5-24: Consumer exposure estimates to ethylene bis(tetrabromo phthalimide)....... 99

Table 5-25: Tentative risk assessment of ethylene bis(tetrabromo phthalimide) for consumers. ...................................................................................................................... 100

Table 5-26: Environmental effect data for ethylene bis (tetrabromophthalimide)............ 100

Table 5-27: Summary of human health effects for 1,2-bis(2,4,6-tribromophenoxy)ethane brought forward to the risk characterisation. ................................................................... 105

Table 5-28: Consumer exposure estimates to 1,2-bis(2,4,6-tribromophenoxy)ethane ... 105

Table 5-29: Tentative risk assessment to 1,2-bis(2,4,6-tribromophenoxy)ethane for consumers. ...................................................................................................................... 105

Table 5-30: Environmental effect data for 1,2-bis (2,4,6-tribromophenoxy)ethane......... 106

Table 5-31: Summary of human health effects for DBDPE brought forward to the risk characterisation................................................................................................................ 109

Table 5-32: Consumer exposure estimations to DBDPE. ............................................... 110

Table 5-33: Tentative risk assessment to DBDPE for consumers. ................................. 110

Table 5-34: Summary of human health effect data for SCCP from the EU-RAR (ECB, 2000) brought forward to the risk characterisation. ......................................................... 112

Table 5-35: Summary of effects of SCCP brought forward to the risk characterisation:. 112

Table 5-36: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on MCCP. ............................................................................................................................. 117

Table 5-37: Summary of effects of MCCP brought forward to the risk characterisation: 118

Table 5-38: Summary of human health effect data for magnesium hydroxide brought forward to the risk characterisation:................................................................................. 122

Table 5-39: Consumer exposure estimates to magnesium hydroxide. ........................... 122

Table 5-40: Tentative risk assessment to magnesium hydroxide for consumers. .......... 123

Table 5-41: Summary of human health effect data for aluminium hydroxide oxide brought forward to the risk characterisation.................................................................................. 126

Table 5-42: Consumer exposure estimates to aluminium hydroxide oxide..................... 126


Table 5-43: Tentative risk assessment of aluminium hydroxide oxide for consumers. ... 127

Table 5-44: Summary of human health effect data for aluminium hydroxide brought forward to the risk characterisation:................................................................................. 131

Table 5-45: Exposure estimates to aluminium hydroxide................................................ 131

Table 5-46: Tentative risk assessment to aluminium hydroxide for consumers.............. 132

Table 5-47: Summary of human health effects data for triphenyl phosphate brought forward to the risk characterisation:................................................................................. 136

Table 5-48: Consumer exposure estimates to triphenyl phosphate ................................ 136

Table 5-49: Tentative risk assessment to triphenyl phosphate for consumers. .............. 137

Table 5-50: Environmental effects for triphenyl phosphate, as reported by Brookes et al. (2009):.............................................................................................................................. 138

Table 5-51: PEC/PNEC ratios for triphenyl phosphate calculated in the UK RAR (Brooke et al., 2009) ...................................................................................................................... 139

Table 5-52: Summary of human health effect data for tri(2-chloroethyl)phosphate from the EU-RAR (ECB, 2009) brought forward to the risk characterisation................................. 140

Table 5-53: Consumer exposure estimations according to the EU-RAR (2009) on TCEP.......................................................................................................................................... 141

Table 5-54: Risk characterisation to TCEP for consumers and conclusions according to the EU-RAR (ECB, 2009). ............................................................................................... 142

Table 5-55: Environmental effects compiled in the EU RAR report of TCEP (ECB, 2009)......................................................................................................................................... 142

Table 5-56: Summary of human health effect data for 2-ethylhexyl diphenyl phosphate brought forward to the risk characterisation .................................................................... 146

Table 5-57: Consumer exposure estimations to 2-ethylhexyl diphenyl phosphate. ........ 147

Table 5-58: Tentative risk assessment to 2-ethylhexyl diphenyl phosphate for consumers......................................................................................................................................... 147

Table 5-59: Tentative risk assessment for consumers using the DNELs reported in the CSR on 2-ethylhexyl diphenyl phosphate (provided in 01-2011 by ICL-IP). ................... 148

Table 5-60: Environmental effect data for 2-ethylhexyl diphenyl phosphate (Brooke et al., 2009)................................................................................................................................ 148

Table 5-61: PEC/PNEC ratios for 2-ethylhexyl diphenyl phosphate calculated in the UK RAR (Brooke et al., 2009)................................................................................................ 150

Table 5-62: Summary of human health effect data for tricresyl phosphate brought forward to the risk characterisation............................................................................................... 154

Table 5-63: Consumer exposure estimations to tricresyl phosphate. ............................. 154

Table 5-64: Tentative risk assessment to tricresyl phosphate for consumers. ............... 155

Table 5-65: Environmental effect data for tricresyl phosphate complied from Brooke et al. (2009)............................................................................................................................... 156

Table 5-66: PEC/PNEC ratios for tricresyl phosphate calculated in the UK RAR (Brooke et al., 2009) .......................................................................................................................... 158


Table 5-67: Summary of human health effect data for TCPP from the EU-RAR (ECB, 2008) brought forward to the risk characterisation. ......................................................... 160

Table 5-68: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on TCPP. .............................................................................................................................. 160

Table 5-69: Risk assessment to TCPP for consumers according to the EU-RAR (ECB, 2008)................................................................................................................................ 161

Table 5-70: Environmental effects of TCPP brought forward to the risk characterisation (European Chemicals Bureau, 2008) .............................................................................. 162

Table 5-71: Summary of human health effect data for TDCP from the EU-RAR (ECB, 2008) brought forward to the risk characterisation .......................................................... 163

Table 5-72: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on TDCP. .............................................................................................................................. 164

Table 5-73: Risk assessment to TDCP for consumers according to the EU-RAR (ECB, 2008)................................................................................................................................ 164

Table 5-74: Environmental effects of TDCP brought forward to the risk characterisation (ECB, 2008) ..................................................................................................................... 165

Table 5-75: Consumer exposure estimations to dimethyl propane phosphonate ........... 167

Table 5-76: Tentative qualitative risk assessment to dimethyl propane phosphonate for consumers. ...................................................................................................................... 167

Table 5-77: Environmental effect data for dimethyl propane phosphonate found in the literature consulted within this project.............................................................................. 168

Table 5-78: Consumer exposure estimations to DEEP. .................................................. 170

Table 5-79: Summary of health effect data for trixylyl phosphate brought forward to the risk characterisation. ........................................................................................................ 173

Table 5-80: Consumer exposure estimates to trixylyl phosphate.................................... 174

Table 5-81: Tentative risk assessment to trixylyl phosphate for consumers. .................. 174

Table 5-82: Environmental effect data for trixylyl phosphate, summarized from Brooke et al. (2009).......................................................................................................................... 175

Table 5-83: Summary of human health effect data for cresyl diphenyl phosphate brought forward to the risk characterisation.................................................................................. 179

Table 5-84: Consumer exposure estimates to cresyl diphenyl phosphate...................... 180

Table 5-85: Tentative risk assessment to cresyl diphenyl phosphate for consumers. .... 181

Table 5-86: Environmental effect data for cresyl diphenyl phosphate (Brooke et al., 2009)......................................................................................................................................... 181

Table 5-87: PEC/PNEC ratios for cresyl diphenyl phosphate (Brooke et al., 2009) ....... 183

Table 5-88: Summary of human health effect data for isopropylated triphenyl phosphates brought forward to the risk characterisation .................................................................... 186

Table 5-89: Consumer exposure estimations to isopropylated triphenyl phosphates..... 186

Table 5-90: Tentative risk assessment to isopropylated triphenyl phosphates for consumers. ...................................................................................................................... 187


Table 5-91: Effect data for isopropylated triphenyl phosphates (Brooke et al., 2009) .... 188

Table 5-92: share of consumer use related emissions in the total emissions (life cycle) of isopropylated triphenyl phosphates ................................................................................. 189

Table 5-93: PEC/PNEC ratio’s for isopropylated triphenyl phosphates ( Brooke et al., 2009)................................................................................................................................ 190

Table 5-94: Consumer exposure estimations to bis-(isopropylphenyl) phenylphosphate191

Table 5-95: Tentative qualitative risk assessment to bis-(isopropylphenyl) phenylphosphate for consumers...................................................................................... 192

Table 5-96: Summary of human health effect data for tris-(tert-butylphenyl) phosphate brought forward to the risk characterisation .................................................................... 193

Table 5-97: Consumer exposure estimations to tris-(tert-butylphenyl) phosphate.......... 194

Table 5-98: Tentative risk assessment to tris-(tert-butylphenyl) phosphate for consumers.......................................................................................................................................... 194

Table 5-99: Summary of human health effect data for isodecyl diphenyl phosphate brought forward to the risk characterisation .................................................................... 197

Table 5-100: Consumer exposure estimations to isodecyl diphenyl phosphate. ............ 198

Table 5-101: Tentative risk assessment to isodecyl diphenyl phosphate for consumers.......................................................................................................................................... 198

Table 5-102: Tentative risk assessment for consumers using the DNELs reported in the CSR on isodecyl diphenyl phosphate (provided in 01-2011 by ICL-IP). ......................... 199

Table 5-103: Environmental effects for isodecyl diphenyl phosphate (Brooke et al., 2009)......................................................................................................................................... 199

Table 5-104: PEC/PNEC ratios for isodecyl diphenyl phosphate (Brooke et al., 2009).. 201

Table 5-105: Summary of human health effect data for V6 from the EU-RAR (ECB, 2008) brought forward to the risk characterisation. ................................................................... 202

Table 5-106: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on V6..................................................................................................................................... 203

Table 5-107: Risk assessment to V6 for consumers according to the EU-RAR (ECB, 2008)................................................................................................................................ 203

Table 5-108: Environmental effect data for V6 brought forward to the risk characterisation (ECB, 2008) ..................................................................................................................... 204

Table 5-109: Summary of human health effect data for guanidine phosphate brought forward to the risk characterisation.................................................................................. 207

Table 5-110: Consumer exposure estimations to guanidine phosphate. ........................ 208

Table 5-111: Tentative risk assessment to guanidine phosphate for consumers. .......... 208

Table 5-112: Consumer exposure estimation to isodecylphosphate............................... 210

Table 5-113: Tentative qualitative risk assessment to isodecylphosphate for consumers.......................................................................................................................................... 210

Table 5-114: Summary of human health effects for tertbutylphenyl diphenyl phosphate brought forward to the risk characterisation .................................................................... 213


Table 5-115: Consumer exposure estimations to tertbutylphenyl diphenyl phosphate... 214

Table 5-116: Tentative risk assessment to tertbutylphenyl diphenyl phosphate for consumers. ...................................................................................................................... 214

Table 5-117: Tentative risk assessment for consumers using the DNELs reported in the CSR on tertbutylphenyl diphenyl phosphate (provided in 01-2011 by ICL-IP). ............... 215

Table 5-118: Environmental effect data for tert-butylphenyl-diphenyl phosphate complied from Brooke et al. (2009). ................................................................................................ 215

Table 5-119: PEC/PNEC ratios for tertbutylphenyl diphenyl phosphate (Brooke et al., 2009)................................................................................................................................ 217

Table 5-120: Summary of human health effect data for resorcinol bis-diphenyl phosphate brought forward to the risk characterisation. ................................................................... 220

Table 5-121: Consumer exposure estimations to resorcinol bis-diphenyl phosphate..... 220

Table 5-122: Tentative risk assessment to resorcinol bis-diphenylphosphate for consumers. ...................................................................................................................... 220

Table 5-123: Environmental effect data for resorcinol bis-diphenylphosphate (Brooke et al., 2009) .......................................................................................................................... 221

Table 5-124: PEC/PNEC ratios for resorcinol bis-diphenylphosphate (Brooke et al., 2009)......................................................................................................................................... 222

Table 5-125: Summary of human health effect data for bisphenol A-bis(diphenylphosphate) brought forward to the risk characterisation .............................. 224

Table 5-126: Consumer exposure estimations to bisphenol A-bis(diphenylphosphate) . 225

Table 5-127: Tentative risk assessment to bisphenol A-bis(diphenylphosphate) for consumers. ...................................................................................................................... 226

Table 5-128: Environmental effects of bisphenol A-bis(diphenylphosphate) gathered from the literature consulted within this project........................................................................ 227

Table 5-129: Summary of human health effect data for bis-(tert-butylphenyl) phenyl phosphate brought forward to the risk characterisation................................................... 228

Table 5-130: Consumer esposue estimations to bis-(tert-butylphenyl)phenylphosphate.......................................................................................................................................... 229

Table 5-131: Tentative risk assessment to bis-(tert-butylphenyl)phenylphosphate for consumers. ...................................................................................................................... 229

Table 5-132: Consumer exposure estimations to hypophosphite, aluminium salt. ......... 231

Table 5-133: Tentative qualitative risk assessment to hypophosphite, aluminium salt for consumers. ...................................................................................................................... 232

Table 5-134: Consumer exposure estimations to hypophosphite, calcium salt. ............. 233

Table 5-135: Tentative qualitative risk assessment to hypophosphite, calcium salt for consumers. ...................................................................................................................... 233

Table 5-136: Human health effect data for diethyl ethylphosphoate gathered by Fisk et al. (2003)............................................................................................................................... 235

Table 5-137: Consumer exposure estimations to diethyl ethylposphonate..................... 235


Table 5-138: Tentative qualitative risk assessment to diethyl ethylposphonate for consumers. ...................................................................................................................... 235

Table 5-139: Summary of human health effect data for triethyl phosphate brought forward to the risk characterisation............................................................................................... 239

Table 5-140: Consumer exposure estimations to triethyl phosphate. ............................. 239

Table 5-141: Tentative risk assessment to triethyl phosphate for consumers. ............... 240

Table 5-142: Summary of human health effect data for melamine phosphate brought forward to the risk characterisation.................................................................................. 243

Table 5-143: Consumer exposure estimations to melamine phosphate. ........................ 244

Table 5-144: Tentative risk assessment to melamine phosphate for consumers. .......... 245

Table 5-145: Environmental effects of melamine phosphate, compiled from the literature consulted in this project ................................................................................................... 245

Table 6-1: Prioritisation based on flame retardant inherent properties ........................... 252

Table 6-2 : Criteria for identification of PBT and vPvB substances (REACH Regulation (EC) n°1907/2006)........................................................................................................... 253

Table 6-3: Group: 'no need for immediate risk management, based on the approach of this study' ' .............................................................................................................................. 255

Table 6-4 : Group: 'no need for immediate risk management -with concerns' ................ 255

Table 6-5: Group: ‘inconclusive’ ..................................................................................... 258

Table 6-6: Group: ‘risk’ .................................................................................................... 262

Table 6-7: ‘Data gap’ list .................................................................................................. 264

Table 8-1 Overview of national fire safety regulations for furniture and textiles in some Member States................................................................................................................. 281

Table 8-2 Overview of the fire safety regulations for furniture and textiles in public buildings in some Member States.................................................................................... 284

Table 8-3 European standards addressing fire safety of consumer products ................. 287

• Table 8-4 Overview of the restrictions on the use of flame retardants emanating from European legislation ........................................................................................................ 292

Table 8-5 Overview of national/regional ecolabelling schemes ...................................... 294

Table 8-6 Overview of ecololabelling schemes that impose limitations to the use of flame retardants for specific product categories........................................................................ 295

Table 9-1 Ranking of the Member States according to the number of domestic fire deaths......................................................................................................................................... 307


List of figures Figure 1-1: Volume consumption of flame retardants in the USA, Europe and Asia (DEFRA, 2010) .................................................................................................................. 40

Figure 1-2: Types and proportions of flame retardants used in the EU-25 in 2006 (DEFRA, 2010).................................................................................................................................. 41

Figure 1-3: Halogenated flame retardants used in electronic and electrical products in the EU (DEFRA, 2010) ............................................................................................................ 41

Figure 3-1: Selection of a core set of flame retardant applications ................................... 50

Figure 5-1: measured concentrations of aluminium as a function of pH (left) and different equilibration times (right, expressed as relative concentration, C = concentration at different equilibration times, Cmax = maximum concentration); gibb = gibbsite, ett = ettringite. .......................................................................................................................... 133

Figure 9-1 Evolution domestic fire deaths per 1,000,000 inhabitants in the Czech Republic......................................................................................................................................... 297

Figure 9-2 Evolution domestic fire deaths per 1,000,000 inhabitants in Denmark.......... 298

Figure 9-3 Evolution domestic fire deaths per 1,000,000 inhabitants in Estonia ............ 298

Figure 9-4 Evolution domestic fire deaths per 1,000,000 inhabitants in Finland............. 299

Figure 9-5 Evolution domestic fire deaths per 1,000,000 inhabitants in Germany.......... 299

Figure 9-6 Evolution domestic fire deaths per 1,000,000 inhabitants in Hungary........... 300

Figure 9-7 Evolution domestic fire deaths per 1,000,000 inhabitants in Ireland ............. 300

Figure 9-8 Evolution domestic fire deaths per 1,000,000 inhabitants in the Netherlands301

Figure 9-9 Evolution domestic fire deaths per 1,000,000 inhabitants in Poland ............. 301

Figure 9-10 Evolution domestic fire deaths per 1,000,000 inhabitants in Slovenia......... 302

Figure 9-11 Evolution domestic fire deaths per 1,000,000 inhabitants in Sweden ......... 302

Figure 9-12 Evolution domestic fire deaths per 1,000,000 inhabitants in the United Kingdom........................................................................................................................... 303

Figure 9-13 Evolution domestic fire deaths per 1,000,000 inhabitants in Austria ........... 304

Figure 9-14 Evolution domestic fire deaths per 1,000,000 inhabitants in France ........... 304

Figure 9-15 Evolution domestic fire deaths per 1,000,000 inhabitants in Latvia............. 305

Figure 9-16 Evolution domestic fire deaths per 1,000,000 inhabitants in Lithuania........ 305

Figure 9-17 Evolution domestic fire deaths per 1,000,000 inhabitants in Romania ........ 305

Figure 9-18 Evolution domestic fire deaths per 1,000,000 inhabitants in Slovakia......... 306

Figure 9-19 Evolution domestic fire deaths per 1,000,000 inhabitants in Spain ............. 306

Figure 12-1 : Landfilling of flooring waste in the UK........................................................ 365


List of annexes Annex 1: Overview of NGO’s and their relevance for this study ..................................... 329

Annex 2: List of consulted stakeholders .......................................................................... 331

Annex 3: Substances banned, polymeric, reactive mode of integration.......................... 335

Annex 4: Substances/applications not relevant for a domestic environment or no longer used ................................................................................................................................. 337

Annex 5: Substances assessed under existing legislation.............................................. 339

Annex 6: EU RAR and UK RAR summary ...................................................................... 341

Annex 7: Consumer exposure assessment..................................................................... 343

Annex 8: Environmental core set of applications............................................................. 345

Annex 9: Overview physic-chemical data........................................................................ 347

Annex 10: DNEL derivation ............................................................................................. 349

Annex 11: Overview of available data on effects for each flame retardant in the environmental core set of applications ............................................................................ 351

Annex 12: Default parameters for estimating exposure in different product/article categories acc. to ECETOC-TRA .................................................................................... 353

Annex 13: Overview of available data for each flame retardant in the consumer core set of applications ...................................................................................................................... 355

Annex 14: Operational landfill and incineration techniques compliant with EU requirements......................................................................................................................................... 358

Annex 15: Disposal options per polymer ......................................................................... 367

Annex 16: Literature disposal phase: summary .............................................................. 369

Annex 17: Data gaps environmental relevance............................................................... 371

Annex 18: Inherent properties of substances on ‘inconclusive’ list ................................. 373

Annex 19: Overview WFSC statistics on fire deaths ....................................................... 379

Annex 20: Overview CTIF statistics on fire deaths.......................................................... 381

Annex 21: Overview WHO statistics on domestic fire deaths ......................................... 383

Annex 22: Questionnaire about fire statistics (example of Austria) ................................. 387

Annex 23: Overview contacts questionnaire about fire statistics + response rate .......... 389

Annex 24: Overview of the domestic fire deaths documented by the Members States in response to questionnaire on fire statistics ..................................................................... 391

Annex 25: Overview of the number of domestic fire deaths per million inhabitants per year, documented by the Members States in response to questionnaire on fire statistics and EUROSTAT population statistics..................................................................................... 393

Annex 26: Overview contacts questionnaire about flammability requirements and the use of flame retardants........................................................................................................... 395


Annex 27: Questionnaire about flammability requirements and the use of flame retardants......................................................................................................................................... 397

Annex 28: Contact details of the national focal points of the WHO................................. 401


Glossary and abbreviations ACx Article category x

ASTM American Society for Testing and Materials

BEUC European Consumers’ Organisation

BfR Federal Institute for Risk Assessment of Germany

BP Boiling point

BSEF Bromine Science and Environmental Forum

CAS Chemical Abstracts Service

CEN European Committee for Standardisation

CENELEC European Committee for Electrotechnical Standardisation

Substances and applications that were selected as a candidate for tentative risk assessment Core set substances/applications

Danish EPA Danish Environmental Protection Agency

DIY Do it yourself

DNEL Derived No Effect Level

DWTI Belgian Service for Scientific and Technical Information

E&E Electric and electronic equipment

EBFRIP European Brominated Flame Retardant Industry Panel

ECETOC-TRA European Centre for Ecotoxicology and Toxicology of Chemicals – Targeted Risk Assessment

ECHA European Chemicals Agency

ECOTOX Ecological toxicology

EEC European Economic Community

EFRA European Flame Retardant Association

EU European Union

FR Flame retardant

GDP Gross Domestic Product

GHG Greenhouse gas

HSDB Hazardous Substances Database

INERIS Institut National de l’Environnement Industriel et des Risques

IPCS International Programme on Chemical Safety

IPPC Integrated Pollution Prevention and Control

IUCLID International Uniform Chemical Information Database

Kow Partition coefficient octanol – water

Monomer A relatively small molecule which can be covalently bonded to other monomers to form a polymer


MP Melting point

MSDS Material Safety Data Sheet

MW Molecular weight

NGO Non-governmental organisation

NICNAS National Industrial Chemicals Notification and Assessment Scheme of Australia

OECD Organisation for Economic Co-operation and Development

Oligomer A compound intermediate between a monomer and a polymer, normally having a specified number of units between about five and a hundred

Pa Pascal (unit of pressure)

PBT Persistence, Bio accumulation, Toxicity

PCB Polychorobiphenyl

PCDD/F Polychlorinated dibenzodioxins/furanes

PCx Product category x

pH measure of the acidity or basicity of a solution

PINFA Non-halogenated Phosphorus, Inorganic and Nitrogen Flame Retardants Association

PIR Polyisocyanurate

Polymer A naturally occurring or synthetic compound consisting of large molecules made up of a linked series of repeated simple monomers

PUR Polyurethane

PVC Polyvinylchloride

QSAR Quantitative structure – activity relationship

RAR Risk assessment report

REACH Registration, Evaluation, Authorisation and restriction of CHemicals

RIVM National Institute for Public Health and the Environment of the Netherlands

Substance Information Exchange Forum SIEF

STP Sewage treatment plant

SVC Saturated vapour concentration

TBBPA Tetrabromobisphenol A

Tpa Tonnes per annum

UK United Kingdom

VLIZ Flemish Institute for the Sea

VOC Volatile Organic Carbon

VP Vapour pressure

WEEE Waste from electric and electronic equipment

WHO World Health Organisation

WWF World Wide Fund for Nature


Executive summary In the EU, fire safety has been an issue of public and political concern during the past years and Member States have taken different approaches to the flammability of consumer products used in domestic environments. While some Member States have put in place very stringent flammability requirements which have led to the generalised use of flame retardants, other Member States, especially in continental Europe, preferred to limit such very stringent requirements to professional or public areas due to concerns about the possible negative impact of flame retardants on human health and the environment. This divergence of views about the use of flame retardants has persisted throughout the years.

The aim of this study was therefore to acquire an up-to-date knowledge about flame retardants currently applied in consumer products used in dwellings, and thus to provide a contribution to move forward the debate.

Identification of relevant flame retardants and their applications

Over 700 applications of bromine, chlorine, inorganic, phosphorus and nitrogen flame retardants were identified in consumer products used in domestic environments. Information was collected from the scientific literature and from websites of flame retardant manufacturers and NGOs. Applications included construction material, electric and electronic equipment, fabrics, textile and apparel, leather, paper, rubber, wood and plastic articles, adhesives and sealants, coatings and paints, filler and putty. Each application was characterised in detail by naming the flame retardant, its CAS number, the chemical group to which it belonged (bromine, chlorine, etc.), the matrix in which the flame retardant was included and the mode of inclusion into the matrix (additive, i.e., mixed with the matrix, or reactive, i.e., chemically linked into the matrix), the flame retardant concentration range in the matrix, and the REACH registration deadline where applicable.

This first identification was fine-tuned in consultation with flame retardant manufacturers and their European associations, and downstream users such as plastic and textile manufacturers. This fine-tuning allowed to identify those flame retardants and their applications which were relevant for the European market and the European domestic environment.

In addition, manufacturers, associations and downstream users were asked to identify future flame retardants and/or future applications. The answers indicated a general trend towards larger, macromolecular (oligomeric/polymeric) and reactive flame retardants as opposed to monomeric or additive flame retardant (which may leach from the matrix). There is also a trend towards flame retardants without PBT (persistent, bio-accumulative and toxic) properties.

Eventually, 42 flame retardants were addressed in detail, in 121 applications. For the purpose of risk assessment the latter could be grouped in to 64 subcategories, since e.g. different polymeric matrices did not affect the assessment.

The identification exercise and its results are addressed in detail in chapter 3 of this report.


Risk assessment

Of the 42 flame retardants addressed in this study, 19 have already been assessed under existing legislation: 9 in EU risk assessment reports (RAR) developed under the “Existing Substances Regulation” No 793/93, of which 8 assessing both the risks for human health and the environment and 1 EU RAR assessing human health only. 10 flame retardants were assessed in 9 RAR’s prepared by the UK (1 RAR covering 2 flame retardants), assessing the risks for the environment only.

To further add up to risk assessment, tentative risk assessments were prepared for relevant flame retardants using the REACH first tier approach (ECETOC TRA) wherever sufficient data were available.

Consumer risk assessment

For 32 flame retardants relevant for consumer exposure, toxicological data (e.g. on acute, chronic, reproduction or developmental toxicity) were available for 16 substances; for further 8 substances a read-across approach was used to identify toxicological data. For the remaining 8 substances data were either insufficient or not at all available. Thus, 24 flame retardants could be assessed regarding consumer health through a first tier assessment using the REACH first tier approach ECETOC TRA.

Environmental risk assessment

Regarding possible risks for the environment, 20 flame retardants were identified for a possible assessment (8 during service life, all 20 during disposal). However, due to the lack of data about the use volume, not even a first tier risk assessment could be carried out.

Link to REACH

For 34 out of the 42 flame retardants addressed in this study, a REACH registration deadline was identified based on registration information from the European Chemicals Agency (ECHA) and feedback from industry. Detailed information on consumer and environmental risk of flame retardants should therefore become available under REACH. For 24 of them by December 2010, for 9 in June 2013, and for a further 1 in June 2018. Further 5 flame retardants counted as REACH registered due to their earlier notification as 'new substances' under the notification scheme of Directive 67/548/EEC (resp. Directive 92/32/EEC), and for 3 substances no registration deadline could be identified.

Following close consultation with manufacturers the REACH chemical safety reports (CSRs) were made available for 6 flame retardants due for registration in 2010, and for 1 due in 2013. This allowed refining the first tier assessments for consumer risk (human health) for 2 substances (due in 2010). Exposure data shared for further 1 flame retardant allowed for a refinement with respect to consumer exposure but not for environmental exposure.

Grouping of substances

The flame retardants addressed in this study were eventually grouped according to their risks from the use in consumer products used in a domestic environment, the risks being identified either through the first tier assessments in this study, or as described in available risk assessment reports.

Details on the grouping of the flame retardants can be found in chapter 6 of this report.


The group with 'no need for immediate risk management, based on the approach of this study' included flame retardants for which no risk was identified according to the approach used in this study, neither for consumer health nor for the environment. The group consisted of 5 substances which had a REACH registration deadline in 2010, and 1 substance which counts as REACH registered due to its notification as a ‘new substance’ under the EU notification scheme preceding REACH (Directive 67/548/EEC resp. Directive 92/32/EEC). For 3 of these flame retardants a EU RAR exists, for a further 1 a EU RAR exists for the human health.

The applications of these flame retardants included plastic articles, upholstery, housings of large electric and electronic equipment, textiles, paints, sealants and adhesives, rubber products, rubber in building applications, polyurethane (PUR) foam in furniture and for do-it-yourself fillings, indoor insulation and wire and cable of electric and electronic equipment.

The following table displays the group with 'no need for immediate risk management, based on the approach of this study'.


Group: 'no need for immediate risk management, based on the approach of this study' Chapter report Flame Retardant CAS No. Existing

legislation REACH deadline

Read-across approach used

CSR excerpts received from industry

CSR excerpts used for risk assessment refinement

5.10 decabromodiphenylethane 84852-53-9 2010

5.12 Chloroparaffins (MCCP) 85535-85-9 EU RAR 2010

5.20 Tris (2-chloro-1-methylethyl)phosphate

13674-84-5 EU RAR 2010

5.23 Diethylphosphinate, aluminium salt

225789-38-8 2010

5.30 Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

38051-10-4 EU RAR Already registered

5.42 Tetrabromobisphenol A 79-94-7 EU RAR (human health only)

2010 x

-(HH)

Important: Check current REACH status of substances (Authorisation, Restriction) at http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp http://echa.europa.eu/chem_data/reg_int_tables/reg_int_en.asp?substance_state=submitted

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

http://echa.europa.eu/chem_data/reg_int_tables/reg_int_en.asp?substance_state=submitted


Note that 3 substances, which in principle belong to the group with 'no need for immediate risk management, based on the approach of this study' if only consumer products and the possibly ensuing risks were considered, have raised serious concerns due to their secondary poisoning, their POP (Persistent Organic Pollutant) or PBT (persistent, bio-accumulative and toxic) effects. They are therefore displayed separately in the following table. For all 3 substances an EU RAR exists.

The following table displays the group with 'no need for immediate risk management, based on the approach of this study, but with concerns'.


Group: 'no need for immediate risk management, based on the approach of this study, but with concerns' Chapter report Flame Retardant CAS No. Existing

legislation REACH deadline




Concern

5.2 Decabromodiphenyl ether

1163-19-5 EU RAR 2010 Secondary poisoning effects

5.5 Hexabromocyclodo-decane

25637-99-4 EU RAR 2010 PBT (article 57d of REACH). Subject to REACH Authorisation (sunset date 21 August 2015)

5.11 Short Chain Chlorinated Paraffins (SCCP)

85535-84-8 EU RAR 2010 Listed in the POPs Protocol of LRTAP (long range transport air pollution) Convention, PBT and vPvB (articles 57d and 57e of REACH). Is a REACH candidate for Authorisation.





The ‘inconclusive’ group included flame retardants for which a risk was identified, either for (some routes of) consumer exposure or for the environment, whilst indicating no risk for the other relevant aspects, of course always under the approach used in this study. All 10 flame retardants in this group had REACH registration deadlines, 8 in 2010, 1 in 2013, 1 in 2018. For 9 of them risk assessments were carried out under existing legislation, namely 1 in a EU RAR and 8 in 7 UK RAR (1 RAR covered 2 flame retardants: n° 5.26). For 5 substances additional information was provided by industry, this allowed to refine the consumer risk assessments for 2 of them.

Risks for consumers were related to dermal exposure from furniture (sofas), the environmental risk was related to in-service-losses from adhesives, lubricants and pigment dispersions and to waste from plastics, textile coating, paints, coatings and pigment dispersions remaining in the environment. The risk was only identified for sediment and soil.

The following table displays the ‘inconclusive’ group.


Group: ‘inconclusive’ Chapter report

Flame Retardant CAS No. Existing legislation

REACH deadline




Inconclusive

5.19 tricresylphosphate 1330-78-5 UK RAR (environment)

2010 X - (HH) High concern

5.26 Isopropylphenyl diphenyl phosphate (IPP) 28108-99-8 UK RAR (environment)

2010 X - (HH) Data gap

5.34 Resorcinol bis-diphenylphosphate (RDP) 57583-54-7 UK RAR (environment)

2010 Low concern

5.4 tetrabromobisphenol A bis (2,3-dibromopropyl ether)

21850-44-2 2013 X Human health: inconclusive Environment: data gap

5.16 triphenylphosphate 115-86-6 UK RAR (environment)

2010 Data gap

5.17 Tris (2-chloroethyl)phosphate 115-96-8 EU RAR 2010 Data gap

5.18 2-Ethylhexyldiphenyl phosphate 1241-94-7 UK RAR (environment)

2010 X + (HH) Data gap

5.25 cresyl diphenyl phosphate 26444-49-5 UK RAR (environment)

2018 Data gap

5.26 Tris-(isopropylphenyl)phosphate 26967-76-0 and 68937-41-7

UK RAR (environment)

2010 X - (HH) High concern

5.33 tert-Butylphenyl diphenyl phosphate (BDP) 56803-37-3 UK RAR (environment)

2010 X + (HH) Data gap





The ‘risk’ group included one flame retardant for which risks were identified for both consumer health and the environment. It should be noted, however, that the CSR indicated no risk for the consumer regarding inhalation. If this were confirmed the substance would join the ‘inconclusive’ group.

Group: 'risk' Chapter report

Flame Retardant

CAS No.

Existing legislation

REACH deadline




5.29 Isodecyl diphenyl phosphate

29761-21-5


2013 X + (HH)


The ‘data gap’ group included 22 flame retardants for which too little data were available, mainly regarding environmental risks, but also regarding human health risks. The following 4 sub-groups could be identified:

• No risk for human health, but data gaps for the environment: 5 substances

• Data gaps for human health, no risk for the environment: 1 substance

• Risk for human health for some exposure routes, but data gaps for environment: 7 substances.

• Data gaps for human health and the environment: 9 substances

The following table displays the ‘data gaps’ group.





Group: 'data gaps' Chapter report


REACH deadline




Data gap

No risk for human health, data gaps for environment

5.8 ethylene bis(tetrabromophtalimide) 32588-76-4 2013 Human health: no risk Environment: data gap

5.9 1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 2013 Human health: no risk Environment: data gap

5.13 magnesium hydroxide 1309-42-8 and 13760-51-5

2010 X Human health: no risk Environment: data gap

5.15 aluminium hydroxide 21645-51-2 2010 X Human health: no risk Environment: data gap

5.40 triethyl phosphate 78-40-0 2010 Human health: no risk Environment: data gap

Data gaps for human health, no risk for the environment 5.21 Tris (2-chloro-1-

(chloromethyl)ethyl)phosphate 13674-87-8 EU RAR 2010 Human health: effects on female

fertility Risk for human health for some exposure routes, data gaps for environment

5.14 boehmite (aluminium hydroxideoxide) 1318-23-6 2010 X Human health: inconclusive Environment: data gap

5.24 trixylyl phosphate 25155-23-1 UK RAR 2010 Human health: risk Environment: data gap

5.28 tris-(tert-Butylphenyl)phosphate (TBDP) 28777-70-0 and 78-33-1

2013 X Human health: inconclusive Environment: data gap

5.31 guanidine phosphate 5423-23-4 ? X Human health: inconclusive Environment: data gap

5.35 bisphenol A-bis(diphenylphosphate) 5945-33-5 and 181028-79-5

Already registered

Human health: inconclusive Environment: data gap

5.36 bis-(tert-Butylphenyl)phenylphosphate (BBDP)

65652-41-7 2010 X Human health: inconclusive Environment: data gap

5.41 melamine phosphate 20208-95-1 ? X Human health: inconclusive Environment: data gap

Data gaps for human health and for environment 5.3 tris(tribromoneopentyl)phosphate 19186-97-1 Already

registered Human health: data gap

Environment: data gap

5.6 tris(2,4,6 tribromophenoxy)triazine 25713-60-4 Already registered

Human health: data gap Environment: data gap

5.7 bis(2-ethylhexyl)tetrabromophthalate 26040-51-7 2013 Human health: not in core set = data gap Environment: data gap


Chapter report


REACH deadline




Data gap

5.22 dimethyl propane phosphonate 18755-43-6 2013 Human health: data gap Environment: data gap

5.27 bis-(Isopropylphenyl) phenylphosphate (BIPP)

28109-00-4 ? Human health: data gap Environment: data gap

5.32 Isodecylphosphate (IDP) 56572-86-2 2010 Human health: data gap Environment: data gap

5.37 Hypophosphite, aluminium salt 7784-22-7 Already registered

Human health: data gap Environment: data gap

5.38 Hypophosphite, calcium salt 7789-79-9 2013 Human health: data gap Environment: data gap

5.39 diethyl ethylphosphonate 78-38-6 2013 Human health: data gap Environment: data gap





Potential impacts of non-flammability requirements

In the EU several Member States, in particular the UK and Ireland, are known to have more stringent non-flammability requirements for products used in consumer homes (such as upholstered furniture) than others. In order to assess the possible impacts of individual Member States’ non-flammability requirements on the number of fire fatalities, information was collected from the Member States about related legislation and the number of fire fatalities over the years. Where no data on the fatalities were available, relevant WHO statistics were consulted.

It turned out that 7 Member States, namely the Czech Republic, France, Ireland, the Netherlands, Finland, Sweden and the UK, had non-flammability requirements for specific consumer products. These were furniture, such as sofas or mattresses, and textiles, such as nightwear or curtains. The requirements were considered more stringent the larger the ignition source was that the product should resist to in a (non-) flammability test, and the larger the range of consumer products was to which the non-flammability requirements applied. - Note that the non-flammability requirements laid down in EU legislation, in voluntary EU schemes such as the Ecolabel or in EN standards apply to all Member States alike and were therefore not relevant in this exercise.

The annual number of fire deaths in the different Member States was difficult to compare, because data were gathered differently in different Member States, and this over different time periods. Also, where fatality numbers from consumer product fires were not available for certain years, those numbers were extrapolated from other years where such fatality numbers could be calculated as ‘fraction of the total number of fire deaths’. Furthermore, the WHO statistics rarely corresponded exactly to the fatality numbers reported by Member States, the best matches ranging from 55% to 113% (with 100% being the fatality numbers reported by the Member States). All these inconsistencies put some limitation on the assessment of the possible impacts of non-flammability requirements.

The number of fire fatalities per million inhabitants varied considerably between Member States, from 2.5 in the Netherlands to 31 in Estonia, for the year 2009. Also their evolution over time differed considerably, from a spectacular decrease in Estonia (on average -5.6 fatalities per million inhabitants per year) over a nearly stable average in the Netherlands (-0.04) and Slovakia (+0.03) to a noteworthy increase in Latvia (+1.3 on average). Fluctuations in the number of fatalities over the years made the picture even more complex. Overall, however, particular drops in the numbers upon entry-into-force of specific(ally stringent) non-flammability requirements, whether or not with a time delay, could not be identified consistently. Also, fatality decreases were observed in countries where no specific non-flammability requirements were adopted.

In conclusion, it was impossible to correlate the number of fire fatalities to the non-flammability requirements for consumer products at home. Reasons for this were certainly the multiple factors that influence the outbreak of fires at home, but also the insufficient specificity of statistics or the long lifetime of consumer products such as furniture which are not immediately replaced when non-flammability requirements enter into force.


Outlook

This study has shown, as its main result, that for a selection of flame retardants, namely those used in consumer products in domestic environments, risk assessment was possible to a limited extent only, because data publicly available were either insufficient or missing in the majority of cases. The study should therefore be seen as a starter for more in-depth assessments, to be carried out as soon as the relevant data become available.


1 Background and first considerations

The total estimated loss of life in Europe amounted up to 2,926 due to residential fires in the years 2000-2001 (Emsley et al., 2005). In economic terms, this is equivalent to about €12.6 bn or 0.17% of GDP.

According to statistics1, residential fires originate in well identified areas: the living room, the bedroom and the kitchen. Statistics also indicate that consumer products (e.g. upholstered furniture, mattresses, beddings, furnishings, textiles, candles, white goods, luminaries, electrical and electronic devices, etc) are the main cause of residential fires, followed by arson, smoking and use of fireworks.

In the EU, fire safety has been an issue of serious public and political concern during the past years, and Member States have taken different approaches to deal with this matter. In the case of mattresses, beddings, furnishings, nightwear and upholstered furniture, some Member States have put in place very stringent requirements which include a generalised use of fire resistant chemical substances, or flame retardants. In other Member States, especially in continental Europe, the use of such substances is limited only to professional or public areas. In the course of the years, concerns about the negative impact of flame retardants on human health and the environmental have emerged.

Measures for reducing fire incidents are among others fire safety standards. Fire safety standards and regulations require that products offer a certain level of safety in use. Fire safety standards are defined by standardisation organisations, industrial associations or fire organisations. Conformity to standards can be obligatory (required by law or by, for example, building regulations), may be required by insurers, or can offer producers a marketing advantage. In the EU, fire safety standards are issued by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC). Standards are for example available for textiles, electronic and electrical appliances, and cigarettes2.

Flame retardants can be added to materials to achieve the necessary safety level. They are used in a wide range of consumer products, such as electric & electronic equipment, textiles, mattresses, upholstered furniture, etc. to reduce the risk of catching fire and to prolong escape times. According to a survey carried out by SRI Consulting, the total market for flame retardants in the United States, Europe and Asia in 2007 amounted to about 1.8 million metric tons. This market was expected to grow at an average annual rate of about 3.7% per year on a volume basis over the period 2007-2012 (DEFRA, 2010).

1 "Domestic Fire Safety – fatal fires and consumer products" - NIBRA research 2 EN 16156:2010 "Cigarettes – Assessment of the ignition propensity – Safety requirement"


Figure 1-1: Volume consumption of flame retardants in the USA, Europe and Asia (DEFRA, 2010)

ATH: alumina trihydrate


A wide variety of FR is used in consumer products, ranging from halogenated FRs, over phosphorous or nitrogen-based FRs to inorganic FRs. With regard to the European Union (EU-25), an EFRA members survey carried out in 2007 gave an estimated consumption of flame retardants for 2006 of about 465,000 tonnes. The breakdown of flame retardant types is shown in Figure 1-2.

Figure 1-2: Types and proportions of flame retardants used in the EU-25 in 2006 (DEFRA, 2010)

A study by TN SOFRES Consulting with parts published by EFRA the quantity of plastics used in electronic and electrical products in the EU totalled 1.45 million tonnes in 2004. Of this, 30% (450,000 tonnes) had some form of fire retardancy applied. The proportion of this group that was halogenated FRs was estimated at 41% or 186,000 tones, as shown in Figure 1-3 (DEFRA, 2010).

Figure 1-3: Halogenated flame retardants used in electronic and electrical products in the EU (DEFRA, 2010)


Since many years, concerns on the human health and environmental impact, fate and toxicology of certain flame retardants have been voiced.

Due to the widespread application of flame retardants in plastic and textile products used in the domestic environment, there is potential for long-lasting consumer exposure. Flame retardants encapsulated in extrusions or mouldings are embedded in an inert, plastic matrix of high molecular weight. However, inhalation and dermal exposure to some types of flame retardants in these products via ‘blooming’ and emissions still persist, even though little data to assess exposure from these processes are available.

Dermal exposure to flame retardants may occur on surface contact and dispersion into the atmosphere may lead to inhalation exposure. The exposure level will be influenced by factors such as flame retardant concentrations in the finished product, ambient temperatures, the operating temperature of flame retardants-containing appliances, the extent of ventilation and the dermal absorption potential (e.g. molecular weights/size and solubility) for the individual flame retardants. There is also potential for oral exposure especially for children sucking on flame retardant treated textiles or toys.

In case the exposure level exceeds the hazard safety level of the substance (i.e. the derived no effect level - DNEL), a significant risk can be expected. In order to reduce a risk from an application, two alternatives exist:

• use a less hazardous substances

• reduce the emission of chemicals from the finished articles

Due to the persistence and bioaccumulation that characterise certain flame retardants, they can be found in sediment and dust, birds of prey and their eggs, seals, foxes, etc. Some flame retardants are even found in polar bears, as global airstreams carry flame retardant emissions to distant areas such as the polar regions. As such, flame retardants can also have an impact on the environment.

Currently, there is no conclusive picture on the risks and the benefits associated with the use of flame retardants in consumer products. Therefore this study aims to provide up-to-date knowledge for further debate on the issue.


2 Objectives and scope

The aim of this study is to acquire an up-to-date knowledge on flame retardant substances currently applied in consumer products largely used at home. This involves:

• Identification of flame retardants in consumer products

• Assessment of exposure and hazard properties of flame retardants in relevant consumer product applications

• Assessing the effects of legislation on non-flammability requirements and restricted use on number and relevance of fire incidents. Note: a comprehensive risk/benefit analysis for individual FRs is however outside the scope of this study.

• In the scope of this study ‘consumer products’ are defined as ‘Products used at home or in a domestic environment’.

The following aspects are therefore not included in the scope of this study:

• The manufacturing phase of consumer products

• Transport applications (e.g. flame retardants in cars, tarpaulin)

• Packaging material

• Personal protective equipment

• Recreational items (e.g. tent, sailing clothes)

• Degradation/transformation products (e.g. brominated flame retardants transforming to dioxins under uncontrolled thermal conditions). Degradation/transformation will be flagged, however, if considered relevant by readily available data

The results of this study should enable an independent Scientific Committee to provide an opinion on the safety of these flame retardants, covering both human health and environment aspects.

The identification and evaluation of available data on flame retardants in consumer products comprises two key tasks:

1. A first step involves the identification of relevant substances (chapter 3)

2. Subsequently data on effects, exposure and risk are gathered and evaluated by substance in a risk assessment framework (chapter 0)

All decisions taken throughout the study are substantiated. Uncertainty issues are clearly stated (e.g. response rate with regard to fire statistics, waiving of endpoints, reliability of risk assessment, etc.).


3 Identification of substances

3.1 Literature search

Taking into account the vast amount of literature available on flame retardants used in consumer products, a tiered approach was followed to collect the relevant data.

The fact sheets of the European Flame Retardant Association (EFRA) were used as a starting point for data collection. These fact sheets cover 35 substances, grouped in the categories ‘bromine’, ‘phosphorus’, ‘nitrogen’, ‘inorganic’ and ‘chlorine’. Subsequently, additional data was retrieved from the relevant links mentioned in the fact sheets. Those referred to:

• European Risk Assessment Reports (RAR), established in the framework of the Existing Substances Regulation (EEC) 793/93

• Environmental Health Criteria of the World Health Organisation (WHO)

For the bromine group, additional data were retrieved from the Bromine Science and Environmental Forum (BSEF) fact sheets. Publications from the European Brominated Flame Retardant Industry Panel (EBFRIP) were also screened for additional information.

Subsequently additional data were gathered from the most relevant literature sources. These included international initiatives on flame retardants, initiatives on a European level, national initiatives and others.

The product information, available from the website of the EFRA members was checked. In particular, the product application tools of Albemarle3 and ICL-IP Europe4 proved to be very useful.

Finally, data available from different NGOs such as WWF or BEUC (see Annex 1), focussing on the consumer exposure, environmental fate and effects of flame retardants and their alternatives is integrated in the appropriate sections of this report.

All consulted literature references are listed in chapter 11 of this report.

All collected data on the identification of flame retardants and their uses were systematically introduced in Excel documents (Annex 3

Annex 3

, Annex 4

Annex 4

, Annex 5

Annex 5

, Annex 7

Annex 7

, Annex 8

Annex 8

). The approach of the data organisation is discussed hereafter.

3.2 Organisation of data

3.2.1 Preparation of overview matrix

The data collected during the literature search concerned flame retardants that are currently used or intended to be used in the near future in consumer products. They were organised in Excel documents ( , , , , ). The

3 http://www.albemarle.com/Products_and_services/Polymer_additives/Flame_retardants/Flame_retardants_application_selector/ 4 http://www.iclfr.com/brome/brome.nsf/entry?readform&mf=viewFramesetSearchByGlobalCode/Pbu22?OpenDocument&ws=Pbu22


format of the document already takes into account most of the parameters that are needed to carry out a first tier exposure assessment. In particular it concerns:

• Flame retardant group: in accordance with the fact sheets available from EFRA, a distinction was made between bromine, phosphorus, nitrogen, inorganic and chlorine flame retardants

• Flame retardant: name of the flame retardant

• CAS number: CAS number of the flame retardant

• Matrix: material into which the flame retardant is integrated (e.g. high impact polystyrene)

• Matrix relevance: approximate market share of the matrix with the specific flame retardant

• Use: category of articles in which the flame retardant is used (e.g. ‘Electric and electronic equipment’’)

• Use relevance: approximate market share of the article category with the specific flame retardant/matrix combination

• Product examples: examples of articles in which the specific matrix/flame retardant combination is used (e.g. ‘television cabinet’)

• Article category/product category under REACH: each application was assigned to the most appropriate article or product (for preparations) category defined under REACH, if enough information was available. Each application was assigned to one of the following article categories, as indicated in Table 3-1

Table 3-1: Description of article and product categories (REACH) Article or product category Description

AC 0 Construction material

AC 2 Machinery, mechanical appliances, electrical/electronic articles

AC 5 Fabrics, textiles and apparel

AC6 Leather articles

AC8 Paper articles

AC 10 Rubber articles

AC11 Wood articles

AC 13 Plastic articles

PC 1 Adhesives, sealants

PC 9a Coatings and paints, thinners, paint removers

PC9b Filler and putty

Mode of integration: a flame retardant can be ‘additively’ or ‘reactively’ integrated in a matrix. In the scope of this study 'additive' means that the flame retardant in the matrix does not chemically react with that matrix. ‘Reactive’ is considered as ‘chemically reacting with the matrix during the production phase, thus being chemically bound to the matrix which prevents release of the flame retardant from the matrix’

Minimum concentration of the flame retardant in the matrix

Maximum concentration of the flame retardant in the matrix


REACH registration deadline: several of the identified flame retardants have to be registered under REACH. Knowledge of the registration deadline will give an indication of data availability for risk assessment

Over 700 applications were identified from literature. This list was finetuned in consultation with the relevant stakeholders (see Annex 2 for contact details), in order to fill the data gaps and to introduce a quality check. This involved consultation of the most relevant manufacturers (Albemarle, Chemtura, ICL-IP) and European flame retardant associations (EFRA, PINFA), as well as the relevant downstream users, who were asked to:

• Verify whether the most relevant applications are covered

• Review/complete:

o The article category (under REACH)

o The matrix

o The mode of integration

o The minimum and maximum concentration of the flame retardant in the matrix

• Indicate the REACH registration deadline of the substance (when applicable)

All manufacturers and European flame retardant associations mentioned above as well as some downstream users (POLYNT GmbH, Fretwork, Centexbel, Plastics Europe, TEGEWA, contact details see Annex 2) provided input, which was fine tuned through bilateral discussions by e-mail or telephone. Adaptations to the data compilation were carried out accordingly, if needed. This resulted in a refined data set, which was used as a basis for the selection of core set applications (see 3.2.2).

Furthermore, the stakeholders were asked to identify future flame retardants and/or applications. The response was limited to general statements: the general philosophy is towards larger, macromolecular (oligomer/polymer) and reactive flame retardants as opposed to monomeric additive flame retardants. There is also a focus on improved PBT profiles.

A project commissioned by DEFRA concluded that there is significant scope to move towards design-based and inherent flame retarded material approaches for the considered consumer products5, which can avoid the use of chemical flame retardant technologies. However, adoption of these may not in all cases offer the best whole life environmental performance as judged by formal life cycle assessment and this could exclude chemical flame retardant technologies that are good environmental performers. While adoption of inherent flame retardant technologies is to be encouraged, it may take some time for this to occur and it may be constrained by costs and other technical, environmental and market factors (DEFRA, 2010).

5 Products covered by the Furniture and Furnishings (Fire) (Safety) Regulations 1988: "items which contain upholstery: beds, headboards, mattresses, sofa-beds, nursery furniture"; clothing textiles – nightwear, personal protective equipment and any other relevant categories; Electronic and electrical equipment: specifically including televisions and computers (both personal or office computers and portable computers including laptops, notebook and notebook)


3.2.2 Selection of a core set of flame retardant applications

The health and environmental impact of flame retardants will be assessed for a "core set" of applications. These were selected from all the identified flame retardant applications by means of a stepwise elimination procedure, which is illustrated in Figure 3-1 and outlined hereafter.

In summary, the core set of applications results from excluding banned, reactively integrated and polymeric flame retardants from the overview; as well as applications that are not likely in a domestic environment and substances that are no longer on the market. Substances for which an EU RAR or UK RAR (environment only) exists were also excluded6, as well as applications which did not fulfil the exposure criteria. For human health this criterion relates to the availability of information in which applications it is used as well as the concentration range in the matrix. For environment this relates to the liability to wear during service life (core set service life) and the concentration range in the matrix (core set disposal).

An overview of the substances included in the core set is given in Table 3-2.

6 The applications listed in the EU RAR and UK RAR were not checked with the stakeholders. All were included in this report


Table 3-2 : Substances included in the core set, defined for the purpose of this study Flame Retardant CAS No. Consumer

core set Environmental

core set - service life

Environmental core set - disposal

Tris(tribromoneopentyl)phosphate 19186-97-1 X X X Tetrabromobisphenol A bis (2,3-dibromopropyl ether)

21850-44-2 X

Tris(2,4,6 tribromophenoxy)triazine 25713-60-4 X X Bis(2-ethylhexyl)tetrabromophthalate 26040-51-7 X Ethylene bis(tetrabromophtalimide) 32588-76-4 X X 1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 X X

Decabromodiphenylethane 84852-53-9 X

Magnesium hydroxide 1309-42-8 and 13760-51-5

X X

Boehmite (aluminium hydroxideoxide) 1318-23-6 X X Aluminium hydroxide 21645-51-2 X X Triphenylphosphate 115-86-6 X 2-Ethylhexyldiphenyl phosphate 1241-94-7 X Tricresylphosphate 1330-78-5 X

Dimethyl propane phosphonate 18755-43-6 X X

Diethylphosphinate, aluminium salt 225789-38-8 X Trixylyl phosphate 25155-23-1 X Cresyl diphenyl phosphate 26444-49-5 X Tris-(isopropylphenyl)phosphate 26967-76-0

and 68937-41-7

X

Isopropylphenyl diphenyl phosphate (IPP)

28108-99-8 X

Bis-(Isopropylphenyl) phenylphosphate (BIPP)

28109-00-4 X X X

Tris-(tert-Butylphenyl)phosphate (TBDP) 28777-70-0 and 78-33-1

X X X

Isodecyl diphenyl phosphate 29761-21-5 X Guanidine phosphate 5423-23-4 X X X Isodecylphosphate (IDP) 56572-86-2 X X X Tert-Butylphenyl diphenyl phosphate (BDP)

56803-37-3 X

Resorcinol bis-diphenylphosphate (RDP) 57583-54-7 X Bisphenol A-bis(diphenylphosphate) 5945-33-5

and 181028-79-5

X X X

Bis-(tert-Butylphenyl)phenylphosphate (BBDP)

65652-41-7 X X X

Hypophosphite, aluminium salt 7784-22-7 X X Hypophosphite, calcium salt 7789-79-9 X X Diethyl ethylphosphonate 78-38-6 X X Triethyl phosphate 78-40-0 X X

Melamine phosphate 20208-95-1 X X X

17.020200/09/549040-Evaluation of data on flame retardants

Figure 3-1: Selection of a core set of flame retardant applications


3.2.2.1 Exposure potential

Since risk is determined by both exposure and hazardous effect, only the applications that can induce exposure were retained for further evaluation. Thus all banned substances/applications (see Annex 3), were not taken into further consideration. Substances subject to ban but already on the market before the ban commencement date can still pose a risk. This is especially the case for products with a long lifetime, these are flagged in Annex 3.

Applications where the flame retardant is reactively integrated into the matrix were neither taken into further consideration since they should normally not pose any exposure. Manufacturers were consulted to verify whether excess addition of reactively integrated flame retardants occurs and - if so - to comment on the leaching potential of the flame retardant:

• According to Albemarle, the only relevant reactive flame retardant for them is diester/ether diol of tetrabromophthalic anhydride. It is used in rigid polyurethane foams (PUR and PIR). Formulators always use an excess of isocyanate to give more strength to the matrix, irrespective of the fact whether or not a flame retardant is added. While there is always an excess of isocyanate, there is no excess of the flame retardant. The flame retardant is completely bound into the polymer matrix. Furthermore, the size of the molecules of this flame retardant is sufficiently large and bulky that one cannot expect to see a substantial degree of migration or any emission or leaching from the foam matrix (Albemarle, pers. comm.)

• According to Chemtura, the only reactive flame retardant relevant for them is the use of TBBPA in epoxy resin. The unreacted levels of TBBPA in epoxy resin are very low. Probably >99.9% is reacted into the resin to make the TBBPA-epoxy resin. Next, the resin is mixed with curing agents and other materials to make the formulation, which is then cured to form the fully cross-linked polymer. The amount of epoxy resin ‘prepolymer’ used relative to curing agent is usually in excess because there is a certain amount of homopolymerization that occurs with the epoxy that needs to be accounted for (i.e. some of it reacts with itself to cure and some reacts with the curing agent and/or both). At the end, it is fully cured regardless of the path. The reactivity is optimized so the epoxy resin is fully utilized (Chemtura, pers. comm.)

• According to ICL-IP, in practice only stoechiometric amounts of TBBPA are added to the reactor. Potential leftovers of TBBPA will be left in the solvent/water and ending up in the sludge of the waste water treatment or solvent treatment, and the sludge is disposed to controlled landfill or incineration. This type of process is valid for reactive intermediate use of TBBPA and for other flame retardants as well. Analysis in the end product assured levels of below 5 mg/kg as residue (ICL-IP, pers. comm.)

According to a report by US EPA (2008), TBBPA is most commonly used as a reactive flame retardant in printed circuit boards (PCBs) and is incorporated through chemical reactions with the epoxy resin. Since TBBPA is reacted with an epoxy resin to form D.E.R. 538, which is then reacted with a hardener to form a crosslinked polymer, low levels of unreacted TBBPA and D.E.R. 538 may remain in trace concentrations in PCBs. Although its water solubility is low under neutral conditions, free TBBPA could be released from PCBs in landfills that come in contact with basic leachate. A literature search on the


emissions of flame retardants in the disposal phase revealed some quantitative data for TBBPA, as illustrated in Table 3-3. This confirms the trace level concentrations, indicated by both US EPA (2008) and the manufacturers (Chemtura, ICL-IP).

Table 3-3: Emissions of TBBPA at disposal phase (landfill and incinerator)

Substance Phase Reference Environmental exposure

Tetrabromobisphenol A (TBBPA) Landfill leachate sediment

Borgnes & Rikheim (2004)

0.001 – 0.44 µg/g

Tetrabromobisphenol A (TBBPA) MSW incinerator air emissions: co-incineration of plastic waste (Japan)


8 ng/Nm³

Tetrabromobisphenol A (TBBPA) Incinerator: bottom ash (Japan)


0.02 µg/g

Tetrabromobisphenol A (TBBPA) Incinerator: fly ash (Japan)


0.0013 µg/g

According to US EPA (2008), there is a potential for emissions of brominated dioxins and furans or other byproducts when products containing TBBPA are combusted during end-of-life processes. However, Lundstedt (in prep.) states that emissions of chlorinated, brominated and mixed brominated-chlorinated dioxins from brominated flame retardants (amongst others TBBPA) in electronic waste occurs under controlled conditions and as such impose no risk to the environment7 (see Annex 16).

From the manufacturers’ answers it can be concluded that excess addition of reactively integrated flame retardants seldom occurs. Potential excess is disposed to controlled landfill or incineration; as such there is no leaching from the product during service life.

Finally, polymeric flame retardants were also not taken into further consideration, since their release potential was considered as being as minor as for the reactively integrated substances, if at all existing.

It was checked with PINFA whether the more hazardous yellow / white phosphorus (P4) present in polymeric red phosphorus might pose a risk. According to PINFA (pers. comm.) there are residual quantities of yellow / white phosphorus (P4) in the polymeric red phosphorus. However, the levels of P4 in existing products is less than 50 mg/kg (= 0.005% w/w) and even < 0.002% w/w. This amount of P4 can be extracted with CS2, the most suitable solvent. P4 is chemically very reactive; it will even spontaneously ignite when exposed to air. Therefore, even if trace quantities of P4 are released, they will be oxidised rather quickly. As such, it was concluded that polymeric red phosphorus can be safely omitted from the core set.

The substances/applications not taken into further consideration are given in Annex 3.

7 The post combustion steps and flue gas treatment systems, that exist in modern incineration facilities, will remove or decompose most of these compounds before the flue gases are emitted to the environment


3.2.2.2 Applications’ relevance

Several applications were deemed irrelevant by the most relevant manufacturers (Albemarle, Chemtura, ICL-IP) and European associations (EFRA, PINFA), due to the fact that:

• The application is unlikely to be used in a domestic environment

• The substance is a legacy product, no longer in use since several years

An overview of those substances and applications is given in Annex 4.

The European Tyre & Rubber Manufacturers Association, indicated that the flame-retardant-issue in consumer product applications as defined for the purpose of this study seems not to be relevant for the rubber industry; except for latex mattresses for the UK and Irish market because of the national fire regulation. Specifically for latex foam mattresses, the following technologies can be used:

• Addition of a graphite compound

• Addition of a compound based on antimony trioxide

• Additives based on ammonium chloride

3.2.2.3 Available assessments under existing legislation

A lot of work has already been carried out with regard to detailed risk assessment of flame retardants. The assessments made under Council Regulation (EEC) 793/93 on Existing Substances (human health and environment) and on behalf of the U.K. Environment Agency (environment only) will be considered to provide state-of-the-art information and can therefore be included in this study as such or with minor additions.

Indeed, several substances have been assessed according to the methodology of the European Technical Guidance Document on Risk Assessment. The uses in the overview matrix that were identified from literature, and identified in these assessments, were flagged in Annex 5. A short summary on the use of these flame retardants in consumer products, their releases and their share in the assessed risk (where available) is provided in Annex 6.

A targeted literature search, focussing on the Member States and Norway8 where the availability of peer-reviewed risk assessment reports is to be expected, revealed no other RAR than those published by the U.K.

3.2.3 Core set identification

This study aims at assessing risks for both human health and the environment. Since the exposure assessment involves a different approach for each of these targets, it was decided to identify a core set of applications for each of them. This is outlined hereafter.

8 The Netherlands – RIVM (www.rivm.nl), Sweden – KemI (www.kemi.se), Denmark – Danish EPA (www.mst.dk), Germany - Umweltbundesamt (www.umweltbundesamt.de), Norway – Norwegian Pollution Control Authority (www.klif.no), France – Ministère de l’écologie, de l’énergie, du développement durable et de la mer (http://www.developpement-durable.gouv.fr/), Institut National de l’environnement industriel et des risqué (http://www.ineris.fr/)

http://www.rivm.nl/

http://www.kemi.se/

http://www.mst.dk/

http://www.umweltbundesamt.de/

http://www.klif.no/

http://www.developpement-durable.gouv.fr/

http://www.ineris.fr/


3.2.3.1 Consumer exposure

To assess consumer exposure, information on the material, where it is used as well as the concentration range of flame retardant in the matrix is relevant. For a first tier assessment the assignment to an article category (AC) or product category (PC) and a specific subcategory are mandatory. Furthermore, the input of the concentration in the matrix is highly recommended. This resulted in the identification of 3 groups of applications:

• Core set (Annex 7):

• Core set: all applications, where the category and subcategory as well as the concentration range is available. A 1st tier exposure assessment will be carried out

• Core set with uncertainties: applications for which information on the concentration range is available, however the assignment to the category and/or subcategory was done by assumptions. Therefore, the defined relevant exposure route and outcome of the 1st tier assessment will be based on uncertainties

• Relevant exposure route assignable (Annex 7):

• all applications where only the category and subcategory but no information on the concentration range is available, solely the relevant exposure routes can be assigned, no 1st tier exposure assessment can be carried out

• Data gaps (Annex 7):

• in some cases, only the polymer matrix and the concentration range was provided. As one polymer matrix can be used for different applications a category and subcategory could not be assigned. Due to these high uncertainties an assessment of the route of exposure could not be carried out

• in several cases only the polymer matrix was provided and information on concentration as well as category/subcategory and use where missing. Therefore, these applications were not further assessed

• in some cases only a broad description of the matrix (e.g. thermosets) was provided and information on concentration as well as the specific use were missing. Therefore these applications were not further assessed

3.2.3.2 Environmental exposure

Within the scope of this study, environmental exposure is considered during service life and during disposal (incineration and landfill).

The likelihood of environmental exposure during service life was assessed by means of liability to wear and tear of the consumer product (use category), on a case by case basis. In general, electrical & electronic equipment and building & construction material covered after application were considered not to be subject to wear during service life. Relevant applications were grouped as the environmental core set of applications (Annex 8).

The likelihood of environmental exposure during the disposal phase was assessed by means of the maximal flame retardant concentration in the matrix. Assuming that all flame retardant in the matrix can be emitted into the environment during incineration and/or landfill is a worst case scenario. Taking into account other parameters such as matrix


relevance9 and use relevance10 was not feasible, since few data is available to accurately quantify these criteria. All applications with a possible flame retardant concentration >10% wt. of the matrix (i.e. at least maximum concentration of flame retardant >10% wt. of matrix) were added to the environmental core set of applications (Annex 8).

Applications for which data were lacking to decide whether they belong to the environmental core set are given in Annex 9.

3.2.3.3 Refinement of core set data

15 of the core set substances are to be registered under Regulation No 1907/2006 (REACH) by December 2010 (see Table 1). By means of a risk assessment, the registrant has to show that each use indicated in the registration dossier is safe. In order to provide a summary of the risk assessment as to refine the core set data, the consortia and/or lead registrants were asked to provide registration data on identified uses, exposure scenarios for consumer and for service life, DNEL and PNEC data and conclusions on risk characterisation for the substances of potential concern (i.e. excluding the polymeric substances). The consortia, lead registrants and/or SIEF members were somewhat reluctant to provide any information in the framework of this report. The overall opinion is that companies are reticent to share any data from the dossiers before they are submitted to the European Chemicals Agency (ECHA). This is due to the fact that some data may still change (work in progress) and that data are generally owned by the SIEF and not by single companies. As such, solely CSR information from ICL-IP and Chemtura on some REACH 2010 substances was shared in the framework of this report. However, it should be noted that information from registration dossiers submitted from 1 December 2010 or updated after this date will be published on ECHA’s website without further communication with the registrant. Information from dossiers submitted before 1 December 2010 will be automatically added to the Dissemination Portal as of 1 March 2011. Exceptions to these arrangements are dossiers containing testing proposals. ECHA aims to publish information from these dossiers as soon as possible after they have been accepted as complete, to ensure that a maximum amount of scientifically valid information on the substance can be gathered during the public consultation. In addition, information from dossiers that have already been reviewed or updated by registrants with a view to publication will also be made publicly available as soon as possible11.

The uses which are not identified in the 2010 registration dossiers can be assumed to be historical or minor uses, which might be phased out (no registration = no market) or will be registered at a later date Substances manufactured or imported in quantities between 100 tpa and 1000 tpa have a REACH registration deadline of 2013, those manufactured or imported in quantities between 1 tpa and 100 tpa have a REACH registration deadline of 2018. Relevant uses of substances with a 2013 or 2018 registration deadline are assumed to be incorporated in the core set of applications by means of the exposure-based criteria (see 3.2.3.1 and 3.2.3.2).

9 a flame retardant may be used in various matrices. It can be assumed that exposure and consequently the risk from rarely used matrices will be minor 10 a flame retardant/matrix combination may be used in various applications. It can be assumed that exposure and consequently the risk from less frequently used flame retardant/matrix combinations will be minor 11 http://echa.europa.eu/news/na/201010/na_10_59_dissemination_20101018_en.asp


3.2.4 Conclusions

Hereafter, an overview is given of the relative importance of the various subsets of substances/applications. It should be noted that a substance can appear in several subsets, in particular when the subset delimitation criteria are application-based.

Table 3-4: Relative importance of substance/application subsets

Subset Number of substances

Bromine Phosphorus

Inorganic Nitrogen Chlorine

Substances considered in this study

EU RAR exists (Annex 5) 3 4 0 0 2

UK RAR exists (environment only) (Annex 5)

0 12 0 0 0

Substances with potential relevant consumer exposure (Annex 7)

6 23 3 0 0

Substances with potential relevant environmental exposure (Annex 8) - During service life

1 5 0 1 0

Substances with potential relevant environmental exposure (Annex 8) - During disposal phase

6 14 3 1 0

Substances not considered in this study

Banned substances (Annex 3) 2* 0 0 0 0

Reactive mode of integration (Annex 3)

11 5 0 0 0

Polymeric substances (Annex 3) 6 4 0 1 0

Unlikely in domestic environment (Annex 4)12

5 9 3 2 0

Not relevant or no longer used (Annex 4)

3 2 0 0 0

* Decabromodiphenyl ether only banned in electrical and electronic equipment if >0.1 % by weight

(RoHS+European Court of justice C�14/06)

12 In other applications, these substances may be relevant for domestic environment


4 Assessment methodology

A health and environmental risk assessment was carried out for the identified core set applications. With regard to human health, the "assessment" was limited to the assignment of the relevant exposure route for those applications for which no concentration range was available (and for which thus no 1st tier exposure assessment could be carried out). Environmental impact at disposal phase was also assessed for the substances with a REACH 2010 registration deadline, since the disposal phase is not explicitly assessed under REACH.

The methodology for the assessment is outlined hereafter. The actual assessment by substance is given in chapter 5.

4.1 Physico-chemical data

Physico-chemical data (such as water solubility, vapour pressure and octanol-water partition coefficient, which are used in models for exposure predictions) were gathered for the flame retardants belonging to the core set of applications (consumer + environment) and for the flame retardants where solely the relevant consumer exposure route was assignable. This was done by means of a literature search, starting with the Fisk et al. (2003) database.

In Fisk et al. (2003) an overview is provided of the use of flame-retardant substances in the UK, with a particular view on the impact to the environment. From this exercise an Access database with information on physicochemical properties (such as water solubility, vapour pressure and octanol-water partition coefficient) was available. Fisk et al. (2003) searched the following publicly available data sources for each substance:

• Hazardous substances data bank (HSDB)

• IUCLID database (confidential version)

• Elsevier ECOTOX database

• Syracuse Research Corporation PhysProp and ChemFate databases

• Danish brominated flame retardant report (Danish EPA, 1999)

• Company web site MSDSs

• Published Existing Substances Regulation reports and drafts

• IPCS Environmental Health Criteria series

The data obtained by Fisk et al. (2003) were treated as priority information, since these were checked by Fisk et al. (2003) for consistency. Where conflicting measurements were available for the same substance, they used expert judgement to select a preferred value, taking the following considerations into account when assessing the validity and quality of the data:

• Evidence from other properties (e.g. the relationship between vapour pressure, melting and boiling points)

• Any possible ionization effects/variations caused by pH (e.g. does a difference in log Kow imply that the test was conducted at a different pH?)


• Whether values are sourced by full reference, the date of the test is given, and whether it was conducted using a recognized test method. However, according to the author these criteria are very rarely fulfilled, even for the information received from industry sources.

Where no information was provided within the Fisk database, the following publicly available data sources were consulted:

• On-line databases : OECD e-chem portal, NICNAS, HSDB (http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB), INERIS – Environnement (http://chimie.ineris.fr/fr/index.php), Environmental Health Criteria Monographs (http://www.inchem.org/pages/ehc.html), VLIZ (http://www.vliz.be/vmdcdata/ecotox/index.php), Akron University (http://ull.chemistry.uakron.edu/erd/), Databank Gevaarlijke Stoffen (http://www.gevaarlijkestoffen.be/)

• Handbooks: Merck Index, CRC Handbook of Chemistry and Physics, Kirk-Othmer encyclopedia of chemical technology, Verschueren, Beilstein

Furthermore, a QSAR calculation was performed for organic substances where no information could be provided. To that aim, the EPIWEB4.0 program was used, which includes several models to calculate physico-chemical properties like melting and boiling point, vapour pressure, partition coefficient and water solubility. This program requires the input of the chemical structure using SMILES. The models within EPIWEB 4.0 belong to the recommended software programs by the REACH guidance on information requirements R.7a if no measured data are available. However, it should be noted that the prediction errors within this program are well in excess of the error on experimental measurements. But in view of lack of the information on physico-chemical properties the QSAR calculation was used.

The overview of the available physico-chemical data is given in Annex 9.

4.2 Effect data

4.2.1 Human health effect data

4.2.1.1 Literature search

For the substances assessed under Council Regulation (EEC) 793/93 on Existing Substances the risk assessments were considered to be state-of-the art and no further search was conducted. This approach allows focusing on those substances which have not yet been discussed in detail.

All substances of the consumer exposure core set were considered for a comprehensive literature search of publicly available literature. The data search focussed on documents, which covered predetermined toxicological endpoints (e.g. Acute toxicity, oral / dermal / inhalative or Development toxicity studies) to compile as far as possible a complete toxicological profile of each flame retardant.

For that reason, a tiered approach in the conduct of the literature search was performed to obtain the most relevant publicly available information on the effect data and to close potential data gaps.

http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB

http://chimie.ineris.fr/fr/index.php

http://www.inchem.org/pages/ehc.html

http://www.vliz.be/vmdcdata/ecotox/index.php

http://ull.chemistry.uakron.edu/erd/

http://www.gevaarlijkestoffen.be/


In order to handle the abundant information on flame retardants the following prioritisation criteria were defined at the beginning of the literature search (in order of priority):

• CAS No. versus Substance Name. To conduct a practically and efficiently literature search the CAS No. were used as several names exist for most of the flame retardants within the framework of this project. In cases where several CAS No. exist all numbers were integrated in the search. Only in few cases where the search by CAS No. did not reveal relevant information the search was extended to the use of the substance name as given in the report.

• Peer-reviewed versus non-peer-reviewed documents. The literature search focussed on international accepted peer-reviewed documents to ensure that the information has been evaluated and critically assessed by researchers and experts.

• Newer versus older reviews. Newer reviews were preferred, also on the assumption that newer reviews integrated or amended the information of older ones.

The search was performed in the time period June 2010 till August 2010. The main database chosen to search for peer-reviewed documents was OECD eChemPortal (http://www.echemportal.org/echemportal/page.action?pageID=0), since following important databases are participating:

• CESAR (Canada’s Existing Substances Assessment Repository)

• ESIS (European Chemical Substances Information System)

• HPVIS (High Production Volume Information System)

• INCHEM (Chemical Safety Information from Intergovernmental Organizations)

• NICNAS PEC (Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Priority Existing Chemical Assessment Reports)

• SIDS UNEP (OECD Initial Assessment Reports for HPV Chemicals including Screening Information Data Sets (SIDS) as maintained by United Nations Environment Programme (UNEP) Chemicals)

• UK CCRMP Outputs (UK Coordinated Chemicals Risk Management Programme Publications)

• US EPA IRIS (United States Environmental Protection Agency Integrated Risk Information System)

Additionally, data were gathered from national authorities, institutions on a European level, and others (in alphabetical order):

• Advisory Committee on Existing Chemicals (BUA) Report by German Chemical Society (GDCh) (http://www.gdch.de/fowi/archiv/bua/berichte/bua_stoffecas.htm)

• Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles (http://www.atsdr.cdc.gov/substances/index.asp)

• Committee for Risk Assessment on proposals for harmonised classification and labelling (http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp)

http://www.echemportal.org/echemportal/page.action?pageID=0

http://www.gdch.de/fowi/archiv/bua/berichte/bua_stoffecas.htm

http://www.atsdr.cdc.gov/substances/index.asp

http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp

http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp


• Danish Environment Protection Agency (Danish EPA) (http://www.mst.dk/English/)

• Federal Institute for Occupational Safety and Health (BAuA) (http://www.baua.de/cln_135/en/Homepage.htm)

• Federal Environment Agency (UBA) (http://www.umweltbundesamt.de/index-e.htm)

• National Toxicology Program (US NTP) (http://ntpsearch.niehs.nih.gov/index.html?col=010stat)

• The Climate and Pollution Agency (the former SFT) (http://www.klif.no/no/english/english/)

• United States Consumer Product Safety Commission (http://www.cpsc.gov/)

After this comprehensive data search, for some of the flame retardants data were still lacking. In these cases a data search using databases of minor relevance (e.g. non-peer-reviewed documents, summary of endpoints only) were conducted in the time period September 2010 till November 2010 (in alphabetical order):

• Database of Fisk et al. (2003)

• GESTIS-Stoffdatenbank (http://biade.itrust.de/biade/lpext.dll?f=templates&fn=main-h.htm)

• HSNO CCID (New Zealand Hazardous Substances and New Organisms Chemical Classification Information Database) (http://www.ermanz.govt.nz/hs/compliance/chemicals.html)

• IUCLID & OECD Chemical Data Sheets and Export Files Information

• Toxicology Data Network (TOXNET) (http://toxnet.nlm.nih.gov/)

It should be noted that besides SCCPs and MCCPs none of the substances of the core set were listed as a substances suspected of interfering with the hormone systems of humans and wildlife within the framework of the Community strategy for endocrine disrupters COM(1999) 706. As such, this effect parameter has not been further mentioned in chapter 5.

All consulted literature references are listed in chapter 11 of this report.

4.2.1.2 DNEL derivation

The derivation of DN(M)ELs (derived no(minimal) effect level) is based on the following step-wise procedure as laid down in the document “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose (concentration)-response for human health (ECHA, May 2008):

• Selection of the relevant dose-descriptor for the endpoint

• Modification, when necessary, of the relevant dose descriptor to the correct starting point,

• Application, when necessary, of assessment factors to the correct starting point to obtain an endpoint-specific DN(M)EL for the relevant exposure pattern (exposed human population, route, duration and frequency).

http://www.mst.dk/English/

http://www.baua.de/cln_135/en/Homepage.htm

http://www.umweltbundesamt.de/index-e.htm

http://ntpsearch.niehs.nih.gov/index.html?col=010stat

http://www.klif.no/no/english/english/

http://www.cpsc.gov/

http://biade.itrust.de/biade/lpext.dll?f=templates&fn=main-h.htm

http://www.ermanz.govt.nz/hs/compliance/chemicals.html

http://toxnet.nlm.nih.gov/


Based on the available data, the decision needs to be taken whether the mode of action for the critical endpoint follows a threshold or a non-threshold principle. As no non-threshold endpoint has been identified from the toxicological data available, only DNELs have been derived.

The uses were assessed on a chronic basis as this is based on a protective approach: Chronic DNELs/DMELs are lower than the acute DNELs/DMELs and as exposure during one event is the same whether it is considered as an acute or as a chronic event, a chronic risk assessment is considered as a worst case compared to an acute risk assessment.

Long-term DNELs for systemic effects or for local effects have been assessed for the general population for the oral, dermal and/or inhalation route depending on the outcome of the exposure assessment.

The scope of the project was to derive a tentative risk assessment. Therefore, derived no effect levels (DNELs) have only been calculated for those routes of exposure (oral, dermal or inhalation) that are considered relevant for the given applications of each flame retardant.

It should be noted that the DNELs for flame retarding substances have been derived on the basis of secondary information published in peer-reviewed publications or risk assessment documents. The primary literature was not available for evaluation. Thus, modifications of the relevant dose descriptors and the application of assessment factors were made by using the default values as given in the “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008). Deviations from such default values are only justifiable by detailed knowledge on the experimental conditions, e.g. availability of the full study report, which was not the case in this study.

For a detailed description on the DNEL derivation per substance please refer to Annex 10.

4.2.2 Environmental effect data

Effect data of the flame retardants belonging to the environmental core set of applications were collected by means of a literature search, starting with Fisk et al. (2003) and followed by comprehensive literature such as review documents and databases (e.g. OECD eChemPortal). All consulted literature references are listed in chapter 11 of this report. Effect and environmental fate data collected from NGO websites should be interpreted with care, since often the origin and thus the scientific quality of the data is not given. It should be noted that the flame retardants under consideration were not listed in the ED-North database on endocrine disruption potential. Thus, this effect parameter is not mentioned in chapter 5.

Data collection for environmental effects was restricted to the endpoints which are related to the relevant exposure pathways. Priority was given to endpoints which provide the most reliable environmental effect assessment (e.g. chronic data instead of acute data). An overview of the available data on effects for each flame retardant in the environmental core set of applications is given in Annex 11.


4.3 Consumer exposure assessment

4.3.1 Prioritisation criteria for the exposure route of relevance

As a first step in the assessment of human exposure, the likelihood of exposure via the different exposure routes (oral, dermal, inhalation) was identified. This was done by means of application characteristics as described hereafter.

The main product and article categories identified for flame retardants are sealants and adhesives (PC1), paints (PC9a), filler and putty (PC9b) electric and electronic equipment (AC2), textiles (AC5), paper articles (AC8), rubber articles (AC10), wood articles (AC11), plastic articles (AC13) and construction material (AC0).

The default exposure route of relevance was assessed based on application characteristics using the ECETOC-TRA Consumer tool as a basis. ECETOC-TRA is a reference 1st tier model at European level and in line with the “Guidance on information requirements and chemical safety assessment. Chapter R.15: Consumer exposure estimations version: 2 (ECHA, April 2010). In the Technical report No 107 (ECETOC, 2009), Appendix E-2, the default routes assessed by the ECETOC-TRA Consumer tool for some categories and subcategories are provided. These default routes originate from expert discussions within an ECHA consumer expert group (comprised of representatives of ECHA, ECETOC, RIVM, BfR, INERIS and the Danish EPA). The categories/subcategories relevant for consumer exposure within the scope of this project have been summarised in Table 4-1

Table 4-1: Default exposure route of relevance in accordance with ECETOC-TRA

below.

Descriptor (AC/PC) Subcategory Dermal oral Inhalation1

Glues DIY-use (carpet glue, tile glue, od parquet glue) wo y n0 y PC1

Adhesives and sealants Sealants y n0 y

Waterborne latex wall paint y n0 y

Solvent rich, high solid, waterborne paint y n0 y PC9a Coatings, paints, thinners, removers

Aerosol spray can n n0 y

PC9b Fillers, putties, plasters

Fillers and putty y n0 y

Clothing (all kind of material), towel y y (child) y

Bedding, mattress y y (child) y AC5 Fabrics, textiles and apparel

Car seats, chair, flooring y n0 y

AC6 Leather articles2 Furniture (sofa) y n0 y

AC11 wood articles

Walls and flooring (also applicable to non-wood materials) y n0 y

Plastic, larger articles (plastic chair, PVC-flooring) y n0 y

n3 Toys (doll, car, animals, teething rings) y (child) y (child) AC13 Plastic articles

Plastic small articles (ball pen, mobile phone) y y y

0 Oral exposures do not occur as part of the intended product use 1 for vapour pressure < 10-4 Pa inhalation exposure predictions will be highly overestimated, therefore higher tier assessments are recommended using SVC or measured indoor air data. 2 Even though no leather articles have been identified besides artificial leather made out of PVC, this category/subcategory combination from the ECETOC-TRA Consumer tool will be used for the first tier assessment of flame retardants in furniture like sofas.


3 Formulations contain negligible amounts of volatiles or particulate matter – no inhalation exposure

For categories/subcategories that are not included in the ECETOC-TRA Consumer tool, default routes have been added according to the "General considerations" given below. The categories/subcategories together with the additional default exposure routes are summarised in Table 4-2

Table 4-2: Default exposure route of relevance

.

General considerations on articles to address exposure

• The flame retardant is uniformly distributed within the matrix. Release of the flame retardant from the matrix is not foreseen, however, migration into a medium like air, sweat or saliva, cannot be excluded in general

• For dermal exposure a prolonged contact is required for migration of the substance into sweat. As such, uptake of chemicals is unlikely from short term dermal contact with these articles. Therefore, the dermal route will only be considered as relevant if a high contact potential and appropriate contact time can be assumed

• Inhalation exposure highly depends on the vapour pressure of the substance or if wear can occur during normal use of the article. Furthermore, inhalation exposure to construction articles which will be enclosed after installation is highly unlikely, since the vapour pressure of the flame retardants within this project is rather low (all < 100Pa), and it can therefore be safely assumed that no relevant amount will be penetrating the covering

• Oral exposure will be assessed mainly with regard to the mouthing behaviour of children. Therefore, the size and availability of the article to children will be considered

Descriptor Subcategory Dermal oral Inhalation1

Interior part of the article n4 n0 y

Wire & cable (cable jacket)3 n4 n0 y

Housing, large articles n4 n0 y

Exterior part (buttons etc.) n4 n0 y

AC2 electric and electronic equipment

Housing, small articles (mobile phone) Y n0 y

enclosed after installation n2 n2 n AC0 construction material small parts indoor n4 n0 y

No adequate information on the use of flame retardant paper by consumers or in domestic settings has been provided. It was therefore assumed that it would be used as electrical insulation paper. Due to these uncertainties no default route of relevance could be assigned.

AC 8 paper article

AC10 rubber articles latex mattresses n2 n y 0 Oral exposures do not occur as part of the intended product use 1 for vapour pressure < 10-4 Pa inhalation exposure predictions will be highly overestimated, therefore higher tier assessments are recommended using SVC or measured indoor air data. 2 enclosed in article 3 From the available information it is not clear whether the flame retardant is used in the insulation or the cable jacket, therefore as a worst case consideration it was always assumed to be the cable jacket. 4 dermal exposure is not expected due to the short contact time and the nature of the product.


The default exposure routes of relevance as given in Table 4-1 Table 4-2 and , will be used as a starting point to assess consumer exposure. For every exposure route of relevance, further considerations will be made based on the physic-chemical properties of the substance.

4.3.2 First tier assessment

The consumer exposure has been assessed using the ECETOC-TRA Consumer tool 2010 version, which combines the conservatism of a first tier assessment tool using first tier algorisms with default values from expert knowledge taken from the ConsExpo fact sheets (http://www.rivm.nl/en/healthanddisease/productsafety/ConsExpo.jsp#Fact_sheets).

The model requires data on the following input parameters:

• Vapour pressure

• Article category and subcategory

• Concentration of the substance in article or product

The default parameters for contact surface area, ‘mouthed’ surface area, amount of product used, and exposure time and body weight were used as given in ECETOC-TRA unless otherwise stated. For those categories/subcategories (E&E and construction), which are not explicitly assessed by the ECETOC-TRA Consumer tool, cross reference to categories/subcategories assessed within the ECETOC-TRA Consumer tool have been proposed as far as applicable or the calculation of the saturated vapour pressure concentration has been proposed for one application as stated in Table 4-3 below. The default parameters used per category/subcategory by the ECETOC-TRA Consumer tool relevant for the scope of this project are given in Annex 12.

Table 4-3: Model used to assess exposure to articles not explicitly stated in the ECETOC-TRA tool Descriptor Subcategory Dermal Oral Inhalation 1

E&E (interior part of the article) n n0 SVC2

AC13, small articles3 Wire & cable (cable jacket) n n0

Housing, large articles n n0 AC13, large articles3

Exterior part (buttons etc.) n n0 AC13 small articles3

AC2 electric and electronic equipment

Housing, small articles (mobile phone)

AC13, small articles3 n0 AC13, small

articles3

enclosed after installation n n n AC0 Construction material small parts indoor n n AC13, small

articles3 0 Oral exposures do not occur as part of the intended product use 1 for vapour pressure < 10-4 Pa inhalation exposure predictions will be highly overestimated, therefore higher tier assessments are recommended using SVC or measured indoor air data. 2 SVC = saturated vapour concentration 3 ECETOC-TRA


It has to be kept in mind, that ECETOC-TRA Consumer tool is a very conservative assessment tool due to the following reasons:

• One algorithm per exposure route is used to calculate the exposure for all product and article categories.

• Dermal exposure:

• Duration factor is not accounted for

• 100% transfer of substance from product or article to the skin assumed, without applying any transfer factor

• Oral exposure:

• Relevance is reduced to accidental ingestion and special situations of foreseeable product misuse and addresses mouthing by children

• 100% of the substance present in the surface layer of an article is transferred and available for ingestion without considering transfer factor

• Inhalation exposure:

• Fraction of release to air based on vapour pressure only

• Only four bands of vapour pressure values are considered (between ≥ 10 Pa - < 0.1 Pa)

Altogether, ECETOC-TRA was deemed appropriate for a first tier assessment.

4.3.3 Refinements

A Tier 1 exposure calculation by ECETOC TRA requires only very few parameters and is sufficient for a screening purpose.

In some cases further information was available to provide a more realistic exposure estimate. However, no specific literature search neither on substance specific nor application specific data was performed to gather information for providing higher tier exposure assessments, which would be beyond the scope of a tentative risk assessment.

An overview of the available data for each flame retardant in the consumer core set of applications is given in Annex 13.

4.3.3.1 General considerations in refining exposure estimations from ECETOC TRA

4.3.3.1.1 Inhalation exposure

In several scenarios, using the most conservative assumptions (small room size and high use volume) results in combinations of input values that are rather conservative. Furthermore, air change rates were not taken into account. Even in homes with closed doors and windows and no active ventilation a certain low level of air exchange occurs. Mean values for Air Changes per Hour (ACH) include 0.6 (RIVM General Fact Sheet, Bremmer et al., 2006) and 0.45 ACH (US EPA, 1997).

4.3.3.1.2 Dermal exposure

The most critical point in the dermal Tier 1 exposure calculation may be the 100% transfer of the substance from the article to the skin. A refinement should include considerations of


time dependent processes of migration and release of the substance from the matrix to a liquid phase (e.g. artificial sweat). It can be assumed that an external liquid phase facilitates the transfer of flame retardant chemical from the surface of the article to the skin. During normal use, perspiration would be assumed to be the liquid phase.

Also input of sector specific additional data on operational conditions such as duration of use or amount of product per use should be considered.

4.3.3.1.3 Oral exposure

Also for oral exposure the most critical point in the Tier 1 exposure calculation may be the 100% transfer of the substance from the article. A refinement should include considerations of time dependent processes of migration and release of the substance from the matrix to artificial saliva or gastric fluids.

Also a refinement of the duration of e.g. mouthing or amount of product swallowed should be considered.

4.3.3.2 Refinement of inhalation exposure performed

With respect to inhalation exposure a differentiation should be made between the inhalation of vapour and airborne particles. Inhalation of vapour is relevant for substances with a high vapour pressure, whereas especially for non volatile substances the release from products by mechanical abrasion (e.g. elements, flame retardants) may be an important path for inhalation exposure. These substances can be found in house dust. The refinements performed are summarized below.

4.3.3.2.1 Use of saturated vapour concentration (SVC) as a limit on exposure

For substance with vapour pressure ≥10 Pa instantaneous release of 100% is assumed, for non-aerosol products. This assumption can result in concentrations that exceed the upper bound saturated vapour concentration for many scenarios in the ECETOC TRA tool.

Furthermore substances with vapour pressure below 10-4 Pa are regarded as non-volatiles and ECETOC TRA tends to significantly overestimate vapour concentrations.

Therefore calculation of saturated vapour concentration has been applied to non-spray products as an upper bound vapour concentration. The ideal gas equation has been used to calculate the SVC for the pure substances as a conservative approach.

4.3.3.2.2 Measured data of flame retardants in house dust

It is assumed that non-volatiles occurring in any products used in private households may contribute to accumulation in house dust. The most realistic exposure estimation can be obtained from measured data. Therefore, where measured data on flame retardants in the dust of domestic environments was available this was used to perform a higher tier exposure assessment.


4.3.3.3 Refinement on the textile applications

For textile products, the minimum and maximum concentrations in the product used by the consumer cannot be provided. In most cases the flame retardant finished fabric is tailored by the textile industry to produce the textile product which is marketable to the private consumer. As a rule the marketable product is produced using different matrixes. Solely indicative minimum and maximum concentrations of the flame retardant in the matrix can be given. It is not possible to indicate more detailed figures, because the concentration depends very much on the kind of fabric, the kind of textile consumer product and on the wishes of the customer in the textile industry (TEGEWA, pers. comm.).

To account for this uncertainty on the final concentration in the textile product besides the worst case scenario assumption (100% of flame retardant fibre being used for the product), different percentages of flame retardant fibre being used in the end product (e.g. 100%, 50% and 10%) were assumed. This will allow performing a sensitivity analysis.

4.4 Environmental exposure assessment

4.4.1 Service life

Environmental exposure in service life should be assessed for the applications subject to wear and tear during service life (Annex 8). ECETOC TRA, a first tier exposure assessment tool described in the guidelines of ECHA, is suggested to be used to quantify exposure. The model results in environmental concentrations for STP, freshwater, freshwater sediment and soil.

The main bottleneck to run the ECETOC TRA model is the availability of the EU tonnage of a flame retardant used for a specific application. To obtain accurate figures is difficult, if not impossible. It requires an in-depth knowledge of the market share of the consumer product on a sector specific (in our case domestic) and country specific basis. Indeed, the amount of flame retardant used can differ according to the non-flammability requirements set on both levels (see Table 8.1 and and Table 8-2). This is especially the case for upholstered furniture, an application which is most relevant for in service losses. Manufacturers and relevant downstream users (Annex 2) were contacted to obtain data on the EU tonnage. However, no input on this parameter was received.

Alternatively, the total amount of flame retardant present on the EU market in the specific application could be calculated from the wt% of flame retardant in the consumer product, the weight of the consumer product, the number of products sold in EU and the lifetime of the product. However, all applications with potential exposure during service life relate to textile products, for which the minimum and maximum concentrations in the product used by the consumer cannot be provided. TEGEWA (pers. comm.) states that in most cases the flame retardant finished fabric is tailored by the textile industry to produce the textile product which is marketable to the private consumer. As a rule the marketable product is produced using different matrices. Solely indicative minimum and maximum concentrations of the flame retardant in the matrix can be given. It is not possible to indicate more detailed figures, because the concentration depends very much on the type of fabric, the type of textile consumer product and on the requirements provided by the customer in the textile industry. Thus, the environmental exposure during service life cannot be calculated based on the data available in this report. However, it can be assumed that the most relevant transport pathway for environmental exposure during


service life is the cleaning water, which usually ends up in the soil adjacent to the home or in the public sewage system. Since the sewage system is evolving to a separate system for wastewater and rainwater, the cleaning water disposed of on the street might directly enter the surface water. This is especially relevant for persistent flame retardants, which will not be subject to degradation during their transport period in the sewage system.

4.4.2 Disposal phase

4.4.2.1 Potential exposure pathways

Landfill is the most important practice for disposal of waste in the European Union. It is mainly regulated by the Landfill Directive13.

Article 14 of the Landfill Directive states that ‘any existing landfill shall comply with the requirements of the Directive (Annex 14) with the exception of the requirements on location, before 16.07.2009’. The Waste Incineration Directive (Directive 2000/76/EC on the incineration of waste) aims to prevent or to reduce as far as possible negative effects on the environment caused by the incineration and co-incineration of waste. From 28 December 2002 on new incinerators had to comply with the provisions of the Directive. The deadline to bring existing plants into compliance was 28 December 2005.

From the operational requirements it can be concluded that flame retardants under consideration enclosed in an EU compliant landfill may enter the environment via the water treatment effluent and via fugitive emissions of the landfill gas phase. Furthermore, it can be concluded that flame retardants under consideration may enter the environment via the effluent of the water treatment plant and the fly ashes of an EU compliant incinerator. Other exposure pathways, and as such risks, might occur at landfills and incinerators that are non compliant with EU requirements. Quantification of those emissions would require a case by case assessment, which is out of the scope of this study.

Major waste streams to consider when evaluating the impact of flame retardants in the disposal phase of post-consume wastes are (Annex 14) cable scrap, upholstered furniture, building and construction wastes, floor coverings and backcoated carpets, textiles, electrical and electronic equipment, remains of paints, coatings, sealants, adhesives and plastic wastes. Especially plastic wastes as the main matrix for flame retardants are important. Both primary post-consumer wastes and secondary wastes like wastes and recycling residues from waste treatment are important.

For all waste streams examined, and thus for all flame retardants that can be found in them, recycling techniques exist either in an operational commercial context or in a experimental phase. However, for none of the waste streams, landfilling and incineration can be excluded. Distinction solely has to be made between controlled high standard treatment in EU Member States and treatment in sometimes non-controlled conditions in non-OECD countries.

13 Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste, as amended


4.4.2.2 Quantification of emissions from landfill and/or incinerators

Literature has been retrieved from sources available in the public domain and from a selection of scientific literature, to quantify environmental exposure from landfills and incinerators. The selection criteria for the scientific articles were:

• Key words: ‘incineration’, ‘landfill’, ‘flame retardants’, one of the CAS numbers of the disposal core set flame retardants, ‘municipal solid waste’, ‘post consumer waste’, ‘emissions’, ‘leachate’, ‘fly ash’, ‘flue gas’, ‘buttom ash’, ‘sludge’, ‘effluent’…

• Publications limited to European or American studies, excluding patents and excluding studies prior to 2006

This has lead to a long-list of 282 publications, which has been limited to a short-list of 26 publications that are potentially interesting. They are all screened on the presence of emission data for flame from landfills and incinerators. A summary of each relevant publication is given in Annex 16. The selection has been realised in cooperation with the DWTI – scientific and technical information service from the department of Federal Science Policy of Belgium.

Substance-specific information encountered in these publications was included in chapter 5. General statements from these publications on flame retardants in the disposal phase are given hereafter.

The risk of emissions of toxics from sanitary landfills is usually considered limited, but the consulted sources pointed out that emissions of flame retardants did occur. The emissions from well managed landfills are found in leachate, as no dispersion through volatilization occurs. For electric and electronic equipment or printed circuit boards, no completely safe end-of-life solution can be found through landfilling. Leaking of flame retardants from landfilled products or equipment depends upon physical and chemical conditions, mainly based on the solubility of the used product or on the pH conditions.

Incineration is considered largely to nearly completely break down the structure of the flame retardants. Some flame retardant emissions are found in bottom ashes, filter dust, scrubber water and air emission, but below emission thresholds. However, immissions of PBDE are sometimes linked to an incinerator. While a Norvegian study could not make the link between immissions and incinerator, a US study identified an incinerator as the source of PBDE emission.

Quantitative literature data on brominated flame retardant emissions are given in Table 4-4.

Table 4-4: Quantitative literature data on brominated flame retardant emissions


Brominated flame retardants

Waste incinerator equipped with modern flue gas cleaning systems (addition of bromine containing plastics) (Norway):


- flue gas 14 – 20 ng/Nm (Olso); <5 ng/Nm (Ranheim)

- bottom ash 0.034 – 0.1 mg/kg (Oslo); <0.016 mg/kg (Ranheim)



- filter dust 0.04 mg/kg (Oslo); ND (Ranheim)

- scrubber water (untreated) 0.01 mg/L (Oslo); ND (Ranheim)

The major problem with incineration is however not caused by the flame retardants but with the breakdown products, like bromine. In an experimental setup bromine emissions from incineration can be recycled, but usually they are captured or emitted. Breakdown products are out of scope of this study.

When properly recycled, the emissions of flame retardants especially from plastic recycling can be limited due to the fact that the flame retardants used remain stable throughout the recycling process. Recycling of brominated flame retardants does not lead to generation of dioxins or lower brominated diphenylethers, if recycling is done properly.

The major problem with flame retardants in the waste phase is caused by substandard recycling or treatment activities, usually performed in non-OECD countries. The case of e-waste is well examined in China. Flame retardant emissions are not an isolated problem, but often linked to POPs, heavy metals, plasticizers and other emissions. The most important pathways are dust from shredding and recycling activities, leachate from stored or dumped material and breakdown products of incomplete combustion (a.o. dioxins).

Flame retardant immissions can be found at places at long distance from the source of pollution, as shown in Italy, but usually a close link to waste treatment industry can be made. A Swiss study showed that prevention at the source, or the ban on the use of certain flame retardants, has a considerable effect on the presence of these products in the environment.

4.4.3 Data gaps

The remaining data gaps with regard to environmental assessment are overviewed in Annex 17.


5 Health and environmental assessment of substances

In Table 5-1 an overview is given of the substances assessed in the framework of this report. More detailed information is given in the subsequent sections of this chapter. The REACH registration deadlines were either provided by the key manufacturers or found at ECHA’s website14 (2010 deadlines only).

Besides the REACH registration deadlines, Table 5-1 includes the following information:

• No: the chapter of this report that contains details on the responding substance.

• Flame retardant: name of the flame retardant.

• CAS No.: CAS Registry Numbers are unique numerical identifiers assigned by the "Chemical Abstracts Service" to every chemical described in the open scientific literature.

• EC No.: The European Commission number, or EC number, also known as EC-No and EC#, is the seven-digit code that is assigned to chemical substances that are commercially available within the European Union. This number is assigned by the Commission of the European Union; the EC number is the official number of a substance in the European Union.

• Existing legislation: this column indicates whether or not, the flame retardant is already assessed under existing legislation. Substances might be assessed under EU RAR (risk assessment reports) or UK RAR.

• Read-across approach used: this column indicates the substances for which a read-across approach was used to identify toxicological data.

• CSR excerpts received from industry: This column indicates the substances for which a chemical safety report was received from industry.

• CSR excerpts used for risk assessment refinement: this column indicates wheter the chemical safety report was used for risk assessment refinement.

• Consumer core set: this column indicates whether the substance belongs to the consumer core set (x) or not.

• Environmental core set: this column indicates whether the substance belongs to the environmental –service life core set, the environmental – disposal core set or not to the environmental core set.

It should be noted that all conclusions drawn in this report on exposure and risk only refer to the applications considered in this report, i.e. consumer products largely used at home or in a domestic environment.

14 Publishable Phase-in Substances Registered 17/01/2011: http://apps.echa.europa.eu/registered/registered-sub.aspx

http://en.wikipedia.org/wiki/Identifier

http://en.wikipedia.org/wiki/Chemical_Abstracts_Service

http://en.wikipedia.org/wiki/European_Union

http://en.wikipedia.org/wiki/Commission_of_the_European_Union


Table 5-1: Overview of assessed substances

No Flame Retardant CAS No. EC No Existing legislation

REACH deadline




Consumer core set

Environmental core set

BROMINE

5.2 Decabromodiphenyl ether 1163-19-5 214-604-9 EU RAR 2010

5.3 tris(tribromoneopentyl)phosphate 19186-97-1 N - Already

registered x Service life Disposal

5.4 tetrabromobisphenol A bis (2,3-dibromopropyl ether)* 21850-44-2 244-617-5 - 2013 x x

5.5 Hexabromocyclodecane 25637-99-4 25637-99-4 EU RAR 2010

5.6 tris(2,4,6 tribromophenoxy)triazine 25713-60-4 426-040-2 - Already

registered x isposal D

5.7 bis(2-ethylhexyl)tetrabromophthalate

26040-51-7 247-426-5 - 2013 Disposal

ethylene bis(tetrabromophtalimide) 5.8 32588-76-4 251-118-6 - 2013 x Disposal

5.9 1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 253-692-3 - 2013 x Disposal

5.10 decabromodiphenylethane 84852-53-9 284-366-9 - 2010 x

CHLORINE

5.11 Chloroparaffins (SCCP) 85535-84-8 284-366-9 EU RAR 2010

5.12 Chloroparaffins (MCCP) 85535-85-9 287-477-0 EU RAR 2010

INORGANIC



REACH deadline




Consumer core set


5.13 magnesium hydroxide* 1309-42-8 and 13760-51-5 215-170-3 - 2010 x x Disposal

5.14 boehmite (aluminium hydroxideoxide)* 1318-23-6 215-284-3 - 2010 x x Disposal

5.15 aluminium hydroxide* 21645-51-2 244-492-7 - 2010 x x Disposal

PHOSPHORUS

5.16 triphenylphosphate 115-86-6 204-112-2 UK RAR (environment) 2010 x

5.17 Tris (2-chloroethyl)phosphate 115-96-8 204-118-5 EU RAR

2010

5.18 2-Ethylhexyldiphenyl phosphate 1241-94-7 214-987-2 UK RAR

(environment) 2010 x +(HH) x

5.19 tricresylphosphate 1330-78-5 215-548-8 UK RAR (environment) 2010 x -(HH) x

5.20 Tris (2-chloro-1-methylethyl)phosphate 13674-84-5 237-158-7 EU RAR 2010

5.21 Tris (2-chloro-1-(chloromethyl)ethyl)phosphate

13674-87-8 237-159-2 EU RAR 2010

5.22 dimethyl propane phosphonate 18755-43-6 242-555-3 - 2013 x Disposal

5.23 diethylphosphinate, aluminium salt 225789-38-8 N - 2010 x

5.24 trixylyl phosphate 25155-23-1 246-677-8 UK RAR (environment) 2010 x

5.25 cresyl diphenyl phosphate 26444-49-5 247-693-8 UK RAR (environment) 2018 x

5.26 Isopropylphenyl diphenyl phosphate (IPP) 28108-99-8 / 248-848-2 UK RAR

(environment) 2010 x -(HH) x



REACH deadline




Consumer core set


5.26 tris-(isopropylphenyl)phosphate

26967-76-0 and 68937-41-7 248-848-2 UK RAR

(environment) 2010 x -(HH) x

5.27 bis-(Isopropylphenyl) phenylphosphate (BIPP) 28109-00-4 248-849-8 - ?15 x Service life

Disposal

5.28 tris-(tert-Butylphenyl)phosphate (TBDP)*

28777-70-0 and 78-33-1 201-106-1 - 2013 x x Service life

Disposal

5.29 Isodecyl diphenyl phosphate 29761-21-5 249-828-6 UK RAR (environment) 2013 x x

5.30 Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

38051-10-4 253-760-2 EU RAR Already registered

5.31 guanidine phosphate* 5423-23-4 226-552-4 - ? x x Service life Disposal

5.32 Isodecylphosphate (IDP) 56572-86-2 260-263-4 - 2010 x Service life Disposal

5.33 tert-Butylphenyl diphenyl phosphate (BDP) 56803-37-3 260-391-0 UK RAR

(environment) 2010 x +(HH) x

5.34 Resorcinol bis-diphenylphosphate (RDP) 57583-54-7 260-830-6 UK RAR

(environment) 2010 x

5.35 bisphenol A-bis(diphenylphosphate)

5945-33-5 and 181028-79-5

425-220-8 and N Already

registered x Service life Disposal

5.36 bis-(tert-Butylphenyl)phenylphosphate (BBDP)*

65652-41-7 265-859-8 - 2010 x x Service life Disposal

5.37 Hypophosphite, aluminium salt 7784-22-7 N - Already

registered16 x isposal D

5.38 Hypophosphite, calcium salt 7789-79-9 232-190-8 - 2013 x Disposal

5.39 diethyl ethylphosphonate 78-38-6 201-111-9 - 2013 x Disposal

15 No a flame retardant in itself, but a component in isopropylated TPP (CAS 68937-41-7) (ICL-IP, pers. comm.) 16 Already REACH registered via ELINCS, till now registration is up to 10 MT/year, but notification of going to band 100 MT/year has been already given to ECHA in late 2010, and dossier preparations for the new band are underway (Italmatch Chemicals Spa, pers. comm.)



REACH deadline




Consumer core set


5.40 triethyl phosphate 78-40-0 201-114-5 - 2010 x Disposal

5.41 melamine phosphate* 20208-95-1 243-601-5 - ? x x Service life

Disposal

5.42 Tetrabromobisphenol A 79-94-7 201-236-9 EU RAR (human health only)

2010 x -(HH)

*: read-across principle used to determine human health effect data


5.1 Physico-chemical data

An overview of physico-chemical data for the substances under consideration is given in Annex 9.

5.2 Decabromodiphenyl ether (CAS 1163-19-5)

Decabromdiphenyl ether (DBDPO) was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2002) is provided hereafter.

Decabromdiphenyl ether is mainly used in polymers for electrical and electronic equipment and as a minor use in textile backcoating and fibers. DBDPO is additively integrated in the matrix. A detailed list is provided in Annex 6 - chapter 1. Under the RoHS Directive, DBDPO is banned in electric and electronic equipment when exceeding 0.1% by weight.

5.2.1 Human health effects

Current classification

Currently, the substance is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP with respect to human health.

Table 5-2: Summary of human health effect data for decabromodiphenyl ether from the EU-RAR (ECB, 2002) brought forward to the risk characterisation.

Endpoint Internal body burden (mg/kg/day) Effects observed MOS

Repeated dose toxicity 67.2 Oral NOAEL of 1,120 mg/kg/bw for systemic toxicity using an oral absorption rate of 6%

NG

Carcinogenicity 67.2 Oral NOAEL of 1,120 mg/kg/bw for systemic toxicity using an oral absorption rate of 6%

NG

NG: not given

5.2.2 Consumer exposure

Two qualitative exposure scenarios for consumers to DBDPO are presented in the EU-RAR:

• Use of DBDPO in plastic

• Use of DBDPO in upholstery

A detailed description of the exposure assessment is provided in Annex 6 – chapter 1. In summary, based on scattered pieces of evidence and in agreement with previous risk assessment conducted under the auspices of International Programme on chemical Safety (IPCS) (WHO, 1994), consumer exposure to DBDPO is likely to be negligible.


Combined (multiple) consumer exposure: consumer exposures are negligible and therefore calculation of the combined exposure is not considered necessary.

5.2.3 Human health risk assessment

Due to the lack of detailed information about consumer exposure to DBDPO, it is not possible to conduct a sound risk assessment for the consumer. However, based on scattered pieces of evidence, and in agreement with the previous risk assessment conducted under the auspices of IPCS (WHO, 1994), it was concluded in the EU-RAR that consumer exposure to DBDPO is likely to be negligible, with no resulting risk for consumers.

The EU RAR report (ECB, 2002) concludes that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already for consumer applications addressed in the risk assessment report.

5.2.4 Environmental effects

Table 5-3: Summary of effects of decabromdiphenyl ether brought forward to the risk characterisation:

Compartment PNEC Argumentation

Surface water >1 µg/l17 Lowest effect concentration: 72h-EC50 for growth of marine algae Skeletonema costatum and Thalassiosira pseudonana and 96h-EC50 for marine algae Chlorella sp. >1 mg/L Assessment factor 1000: acute test results for 3 throphic levels

STP ≥1.5 mg/L Lowest effect concentration: NOEC activated sludge respiration inhibition test (OECD 209) ≥15 mg/L Assessment factor 10: deriving a PNEC for micro-organisms from a NOEC value

Sediment ≥384 mg/kg dwt

Lowest effect concentration: 28d-NOEC (flow-through). Lumbriculus variegatus (measured) ≥ 3,841 mg/kg dwt Assessment factor 10: studies on three sediment species with the substance pentabromodiphenyl ether (published EU risk assessment report (ECB, 2000)) suggest that other available test species are unlikely to be more sensitive to decabromodiphenyl ether than Lumbriculus. An assessment factor of 10 is therefore appropriate to derive the PNEC from the lowest NOEC from the two different sediments used

Terrestrial ≥89 mg/kg dwt Lowes effect concentration: 56d-NOEC survival/reproduction Eisenia fetida ≥4,910 mg/kg dwt Assessment factor 50: NOECs available for 2 species

Atmosphere NR Direct emissions of decabromodiphenyl ether to the atmosphere are likely to be very low. No biotic or abiotic effects are likely because of the limited release and the low volatility of decabromodiphenyl ether. Very low concentrations of decabromodiphenyl ether are predicted for the atmospheric compartment

17 This value should be treated as a minimum value for the PNEC since no clear effects of decabromodiphenyl ether have been demonstrated in any of the acute toxicity tests reported so far


5.2.5 Environmental exposure

A detailed description of the exposure assessment during service life and from waste and during waste management taken from the EU-RAR (European Chemicals Bureau, 2002) is provided in Annex 6 – chapter 1. In summary, the use of consumer products treated with decabromodiphenyl ether results in emissions to air, waste water and surface water which represent almost all (88% - 97%) emissions during the entire life cycle of decabromodiphenyl ether (including production, formulation, processing, industrial use, consumer use and waste phase). The emissions to industrial/urban soil are entirely related to the waste of polymers and textiles remaining in the environment, which is due to consumer product use. Emissions from landfilling and incineration are assumed to be minimal or near zero.

Table 5-4 shows literature data on deca-BDE in incinerator flue gas and fly ash. The publication dates from after the year 2002 and can as such be considered complementary to the EU-RAR. However, these data have not been taken forward to the risk assessment, since the emissions cannot be related to consumer products. Furthermore, the data refer to a Japanese incinerator, whose operating conditions might differ from EU compliant incinerators.

Table 5-4: Deca-BDE and PBDE concentrations at incinerator sites


Deca-BDE Rotary kiln furnace combined with a secondary cylindrical furnace, burning plastics (Japan):

Miyake et al. (2008)

15 ng/m3N, - flue gas

8.3 ng/m3N - fly ash

It can be noted that packaging waste containing residues is identified by the Voluntary Emissions Control Action programme (VECAP) as the main contributor to potential land emissions of Deca-BDE at users’ sites due to uncontrolled landfill or composting, to recycling of empty paper packaging, to the packaging waste going to unknown destinations or to the unprotected storage of packaging. The implementation of VECAP best practices for disposal of used packaging in 2009 has led to a substantial reduction in total emissions in the period 2008 – 2009 (VECAP, 2009). However, these emissions refer to the manufacturing phase and are as such out of the scope of this report.

5.2.6 Environmental risk assessment

The EU RAR report (European Chemicals Bureau, 2002) concludes that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already. This applies to the environmental assessment of risks to the aquatic (surface water, sediment and wastewater treatment plants), terrestrial and atmospheric compartments by the conventional PEC/PNEC


approach for decabromodiphenyl ether itself from all sources. As such, the considered consumer product uses can be considered to be safe for the environment.

There is however a need for further information and/or testing of the risk of secondary poisoning from all sources of decabromodiphenyl ether. Although the current PEC/PNEC approach indicates that there is no risk of secondary poisoning, it is possible that this approach may not be appropriate for secondary poisoning in terms of both the PEC and the PNEC, and could underestimate the risk. Further information should be gathered in order to refine the risk assessment, in light of:

• the persistence of the substance

• the time it would take to gather the information and

• the fact that there is no guarantee that the studies would provide unequivocal answers

• consideration should be given at a policy level of the need to investigate risk management options now in the absence of adequate scientific knowledge (European Chemicals Bureau, 2002). Since the use of consumer products treated with decabromodiphenyl ether largely contributes to the emissions to air, waste water, surface water and industrial/urban soil, this conclusion is of concern to the applications mentioned in this report (see Annex 6 – chapter 1).

5.3 Tris(tribromoneopentyl)phosphate (CAS 19186-97-1)

Tris(tribromoneopentyl) phosphate is used as a flame retardant in polyurethane, styrene, polypropylene and high impact polystyrene and is additively integrated into the matrix. The uses known are in housings of electric and electronic equipment as well as in textiles.

According to the manufacturers, this substance is already registered under past legislation (New and Existing Substances Regulation) and as such already registered under REACH.


No toxicological data are available from consulted publisched literature sources and according to Harju et al. (2009). However, the effect data provided in Table 5-5 were gathered from the manufacturer´s MSDS (Dead Sea Bromine Group) by Fisk et al. (2003).

Table 5-5: Human health effect data for tris(tribromoneopentyl)phosphate as given by Fisk et al. (2003).

Toxicological information Endpoint Effect level Reference

Acute oral toxicity, rat LD50 > 5000 mg/kg manufacturers MSDS

Acute dermal toxicity, rat LD50 > 2000 mg/kg manufacturers MSDS

Acute inhalative toxicity, rat LC50(4h) > 1.81 mg/L manufacturers MSDS

Long-term oral toxicity, rat NOEL(4 wk) 20 000 ppm manufacturers MSDS

Long-term oral toxicity, rat NOEL(13 wk) 20 000 ppm manufacturers MSDS

In vitro mutagenicity Non-clastogenic in Chinese hamster cells manufacturers MSDS



In vitro mutagenicity Non-mutagenic in Ames test manufacturers MSDS

In vitro mutagenicity Non-mutagenic in mouse lymphoma assay manufacturers MSDS

Toxicokinetics, absorption, metabolism and distribution

Based on physico-chemical information i.e. molecular mass and lipophilicity the absorption via the skin can be assumed to be ≤ 10% (ECHA guidance chapter R.7c, section R.7.12 (ECHA, 2008)).

However, the quality of the data available is not sufficient for a risk characterisation.


Currently, the substance is not classified according to regulation (EC) 1272/2008 and its 1st ATP.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to tris(tribromoneopentyl)phosphate were calculated for two consumer applications:

• Service life of electric and electronic equipment containing tris(tribromoneopentyl)phosphate

• Service life of textiles used in furniture cover or carpets containing tris(tribromoneopentyl)phosphate.

The exposure estimates, the model and the parameters used for the estimations are provided in Table 5-6.

Table 5-6: Consumer exposure estimations to tris(tribromoneopentyl)phosphate.

Route of exposure Exposure estimate (external) Comment

Service life of electric and electronic equipment

Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as an upper bound vapour concentration.

Inhalation 3.89 * 10-11 mg/m³ (SVC)

Service life of textiles used in furniture cover or carpets

Dermal

292 mg/kg bw/day (20%) 146 mg/kg bw/day (10%) 72.9 mg/kg bw/day (5%) 14.6 mg/kg bw/day (1%)

1.Tier assessment using ECETOC-TRA (AC5, subcategory furniture, flooring) and different concentration in the final product: 20%, 10%, 5% and 1%.

Inhalation 8 - 160 mg/m³ (1%-20%) (SVC + airborne particulates)

1.Tier assessment using ECETOC-TRA (AC5, subcategory furniture, flooring) and different concentration in the final product: 20%, 10%, 5% and 1%. To account for abrasion (dust particles) resulting from wear of furniture covering or carpets the ECETOC-TRA value has been



used. However, the value may be seen as highly overestimated.


No toxicological data are available from consulted public literature sources and according to Harju et al. (2009). Some toxicological endpoints were gathered from the manufacturer´s MSDS by Fisk et al. (2003). However, the quality of the data available is not sufficient for quantitative risk assessment and therefore only a qualitative risk assessment could be performed, given in Table 5-7.

Table 5-7: Tentative qualitative risk assessment of tris(tribromoneopentyl) phosphate for consumers

Exposure scenario Route of exposure Qualitative risk assessment

Service life of electric and electronic equipment Inhalation The inhalation exposure can be regarded as negligible.


Dermal

The dermal exposure has been assessed for different concentrations in the textile product resulting in rather high estimates due to the conservative assumption of the tool used. The uptake via the skin (≤ 10%) can be regarded as rather low.


Inhalation A highly conservative exposure estimation has been performed and no toxicological data are available therefore no conclusion can be drawn.

First tier exposure assessments to tris(tribromoneopentyl) phosphate using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized by Fisk et al. (2003). However, as the quality of the toxicological data available for tris(tribromoneopentyl) phosphate is not sufficient for a DNEL derivation, a firm conclusion on the risk cannot be drawn.


Table 5-8: Environmental effect data for Tris(tribromoneopentyl) phosphate retrieved through a literature search

Effect Endpoint Value Unit Reference Reliability

Bio accumulation BCF 3.2E+05 L/kg STN CAS Registry

predicted value; 25°C, pH 1 to 10

Short-term toxicity testing on fish

LC50(96h) >0.0156 mg/L Fisk et al. (2003) From MSDS

Short-term toxicity testing on aquatic invertebrates

EC50(48h) >0.0156 mg/L Fisk et al. (2003) From MSDS

Short-term toxicity testing on algae

EC50(72h) >0.0156 mg/L Fisk et al. (2003) From MSDS


From the data available in this study, environmental exposure during service life could not be assessed.


No substance specific information was found through a literature search on emissions from disposal (landfill and incineration). As such, environmental exposure at disposal phase could not be assessed in this report.


Since environmental exposure could not be assessed, no risk assessment could be carried out in this study.

5.4 Tetrabromobisphenol A bis (2,3-dibromopropyl ether)/TBBPA-DBPE (CAS 21850-44-2)

Tetrabromobisphenol A bis(2,3-dibromopropylether) is used in flame retardant articles made of polypropylene, polyethylene, polystyrene and high impact polystyrene and is additively integrated into the matrix. The applications known are in electric and electronic equipment, textiles and construction materials available to consumers or in the domestic environment.

This substance is intended to be registered under REACH by 2013.


In light of the lack of information for the time being, read-across to Tetrabrombisphenol A was considered appropriate and toxicological key information from an EU Risk assessment report (EU-RAR Volume 63, Tetrabromobisphenol-A (TBBP-A), CAS No: 79-94-7) (ECB, 2006) was used as the basis for hazard identification for the endpoints repeated dose toxicity, carcinogenicity and toxicity to reproduction.

Toxicokinetics, metabolism and distribution

Absorption, distribution, metabolism and excretion were studied by oral and i.v. administration in rats. TBBPA-DBPE was shown to be largely excreted in faeces (95 %). The conclusion was that TBBPA-DBPE is poorly absorbed through the gastrointestinal tract and the amount that is absorbed accumulates in the liver and is slowly metabolized and eliminated in the faeces (Knudsen et al., 2007) (cited from Harju et al., 2009).

Based on physico-chemical information i.e. molecular mass and lipophilicity the absorption via the skin can be assumed to be ≤ 10% (ECHA guidance chapter R.7c, section R.7.12, ECHA, 2008).

Acute toxicity

TBBPA-DBPE has a low acute oral and dermal toxicity in mice with LD50 > 20 g/kg (NICNAS, 2001). No data are reported for an acute inhalation toxicity study (NICNAS, 2001; Harju et al., 2009).

Irritation / Corrosivity / Sensitisation

TBBPA-DBPE is not skin irritating, however slight eye irritation in rabbits was observed. It did not induce dermal sensitisation in guinea pigs (Safepharm Laboratories Ltd, 1997) (cited from NICNAS, 2001).

Repeated dose toxicity

Tetrabromobisphenol A bis (2,3-dibromopropyl ether)


Oral

The toxicological data base is very weak for TBBPA-DBPE. However, the substance is under the investigation of the US NTP (2006), and some information about results of the 13-week study could be obtained online. The results demonstrate that body weights and survival of mice and rats under study are not adversely affected by treatment, but based on the information available for non-neoplastic lesions, it is not feasible to define effect levels (LOAEL/NOAEL) without more detailed information on study results.

In a 90-day study mice were administered TBBPA-DBPE at dose levels of 200 or 2000 mg/kg per day in the diet. No deaths occurred at either dose level. No abnormal symptoms were observed in the gross pathological examination (Great Lakes Chemical Corporation, 1987, summary report) (cited from WHO, 1995 and NICNAS, 2001).

No data are reported addressing repeated dose toxicity for the dermal or inhalation route (NICNAS, 2001; Harju et al., 2009).

Additional information

TBBPA-DBPE did not show any immunotoxic effect, in vitro, on the splenocytes of C57BL/6 mice (Pullen et al., 2003) (cited from Harju et al., 2009).

Tetrabromobisphenol A

In total six studies with TBBP-A were identified as appropriate for human health hazard assessment, of which four were conducted via the oral route, one via dermal and one via inhalation route (ECB, 2006).

Oral

Taking all information presented above together, a NOAEL for systemic oral toxicity of 1000 mg/kg bw/d can safely be assumed. This represents a conservative approach, because no critical effects on different toxiciological endpoints were observed in these studies, and the true NOAEL was always expected to be above the highest dose.

Dermal

In a short-term dermal toxicity study with treatment of the abraded skin of rabbits with TBBP-A up to a dose level of 2500 mg/kg bw/d no systemic or local effects were observed in the animals, thus will be used as NOAEL.

Inhalation

In a 14-day inhalation repeated dose toxicity study with whole-body exposure of rats with TBBP-A up to a dose level of 18 mg/L no systemic effects were observed in the animals and the highest dose level of 18 mg/L (18 000 mg/m3), thus will be used as NOAEL(systemic). Local effects in the respiratory tract were observed which were related to mechanical irritation at 6 and 18 mg/L, thau a NOAEL(local) of 2 mg/L will be used.

Mutagenicity

In vitro gene mutation

Three bacterial reverse mutation assays were carried out with TBBPA-DBPE with and without metabolic activation. The test item was positive in 2 of these tests (Brusick, 1982) (cited from WHO, 1995).

In vitro clastogenicity


CHO K-1 cells were exposed to TBBPA-DBPE in the presence and absence of metabolic activation at doses of 5, 17, 50, 170, and 500 mg/ml, limited by solubility. No statistically significant increases in the number of exchanges per chromosome or the number of exchanges per cell were seen at any of the levels tested (Cavagnaro and Cortina, 1984) (cited from WHO, 1995).

In vivo clastogenicity

An in vivo micronucleus test in the peripheral blood of mice was conducted as an additional experiment during a 90-day oral repeated dose toxicity study with TBBPA-DBPE. No statistical increase of polynucleated erythrocytes was observed (US NTP, 2006).

Additional information: DNA damage

TBBPA-DBPE was tested in a rat (Sprague-Dawley) unscheduled DNA Synthesis Assay in duplicate doses of 10, 50, 100, 500, and 1000 mg/ml, limited by solubility. No significant increase in the nuclear grain count was observed at any dose level (Cavagnaro and Sernau, 1984) (cited from WHO, 1995).

Carcinogenicity


Testing in a 90-day repeated dose toxicity study via oral route in rats and mice is currently ongoing in the US National Toxicology Program. Preliminary histological results are made available in a tabulated form through the NTP database search. There are currently no indications of neoplastic lesions in rats and mice up to the highest dose (US NTP, 2006).

Tetrabromobisphenol A

There is no evidence from in-vitro mutagenicity and repeated dose toxicity studies with TBBP-A of concerns for carcinogenicity (ECB, 2006).

Toxicity for reproduction


Effects on fertility

No data available. However during the conduct of a 90-day repeated dose toxicity study via the oral route, histological examination of the reproductive organs of some animals was conducted. There are no histological indications on effects on reproductive organs, however additional information are lacking. No NOAEL can be derived at the currents stage without more detailed information on study results (US NTP 2006).

Developmental toxicity

No data are reported in NICNAS (2001) and Harju et al. (2009)


Currently, the substance is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.


Table 5-9: Summary of human health effect data for TBBPA-DBPE brought forward to the risk characterisation.

Route Endpoint Species/treatment period/Dose regimen Point of departure DNEL*

Dermal Repeated dose toxicity – animal data

Rabbit / 0, 100, 500, 2500 mg/kg bw/day

NOAEL > 2500 mg/kg bw/d 3.6 mg/kg/d

Inhalation Repeated dose toxicity – animal data

Rat / 14 days / 0, 2, 6, 18 mg/L (whole body exposure)

NOAEL (local) = 2mg/L NOAEL (systemic) > 18mg/L

Local: 28.9 mg/m³ Systemic: 104.1 mg/m³

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. A conversion from Tetrabrombisphenol A to Tetrabrombisphenol A bis (2,3-dibromopropyl ether) has been done based on the molecular weight.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to tetrabromobisphenol A bis(2,3-dibromopropylether) (TBBPA-DBPE) could be provided for three consumer applications:

• Service life of exterior parts of electric and electronic equipment containing TBBPA-DBPE

• Service life of textiles used for carpets containing TBBPA-DBPE

• Service life of construction material containing TBBPA-DBPE

Besides the exposure estimates, the model and the parameters used for the estimations are provided in Table 5-10.

Table 5-10: Consumer exposure estimations to TBBPA-DBPE


Service life of exterior parts of electric and electronic equipment

Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration.


Service life of textiles used for carpets

1.Tier assessment using ECETOC-TRA (AC5, subcategory furniture, flooring) and different concentration in the final product: 3%, 2% and 1%.

Dermal 43.8 mg/kg bw/day (3%) 29.2 mg/kg bw/day (2%) 14.6 mg/kg bw/day (1%)

Inhalation 8 - 24 mg/m³ (1 – 3%)

1.Tier assessment using ECETOC-TRA (AC5, subcategory furniture, flooring) and different concentration in the final product: 3%, 2% and 1%. To account for abrasion (dust particles) resulting from wear of furniture covering or carpets the ECETOC-TRA value has been used. However, the value may be seen as highly overestimated.

Service life of construction material

Inhalation 3.24 * 10-10 mg/m³ (SVC) No exposure considerations where made for construction material enclosed after



installation. However, inconclusive information was provided for PE in construction materials, therefore, inhalation exposure has been assessed. Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration.


Three sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-11: Tentative risk assessment of TBBPA-DBPE for consumers.

Exposure scenario Route of exposure Exposure estimate DNEL RCR*

SVC (saturated vapour concentration) Inhalation 3.24 * 10-10 mg/m³ Local: 28.9 mg/m³ 1.1 * 10-9

Service life of textiles used for carpets Dermal 14.6 - 43.8 mg/kg bw/d 3.6 mg/kg/d 4.1 – 12.2

Service life of textiles used for carpets Inhalation 8 - 24 mg/m³ Local: 28.9 mg/m³ 0.3 – 0.8

*The risk characterisation ratio (RCR) is the quotient of the exposure estimate and the respective DNEL (derived no-effect level). If the RCR is < 1 the use can be regarded as safe.

First tier exposure assessments to TBBPA-DBPE have been performed using the ECETOC TRA Consumer tool with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment.

Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized. The lack of evidence of any organ specific toxicity up to the limit dose of 1000 mg/kg bw/d in repeated dose toxicity, reproduction and developmental toxicity studies makes it not necessary to consider endpoint specific DNELs. In addition, although Tetrabromobisphenol A bis (2,3-dibromopropyl ether) is under evaluation of the NTP for potential carcinogenic effect, there is no evidence from in-vitro mutagenicity and repeated dose toxicity studies with Tetrabromobisphenol A of concerns for carcinogenicity. In view of the lack of route specific data for inhalation exposure, route-to-route extrapolation was conducted based on the starting point of an oral NOAEL for systemic toxicity of 1000 mg/kg bw/d. This represents a conservative approach, because no critical effects on different toxicological endpoints were observed in these studies, and the true NOAEL was always expected to be above the highest dose. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal exposure to textiles used for carpets. I should be noted that this application was questioned as being relevant for the domestic environment and would


therefore be out of the scope of this project (personal communication 01-2011 Chemtura and ICL-IP). No risk has been identified for the inhalation of vapour or airborne particulates.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. Tetrabromobisphenol A bis(2,3-dibromopropylether) is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental effects were not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. Tetrabromobisphenol A bis(2,3-dibromopropylether) is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental exposure was not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. Tetrabromobisphenol A bis(2,3-dibromopropylether) is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental risk was not assessed.

5.5 Hexabromocyclododecane (CAS 25637-99-4)

Hexabromocyclododecane (HBCDD) was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2008) is provided hereafter.

Hexabromocyclododecane (HBCDD) is mainly used in insulation boards in building constructions e.g. houses’ walls, cellars and indoor ceilings and ”inverted roofs” as well as in transport vehicles and road and railway embankments. A minor use is in electrical and electronic equipment and textile backcoating. HBCDD is additively integrated in the matrix. A detailed list is provided in Annex 6 - chapter 2.



Currently, the substance is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP. However, the Risk Assessment Committee (RAC) of ECHA agreed in


December 2010 on a harmonised classification with respect to the effects on human health with (ECHA RAC, 2010):

• Repr. 2 - H361 (Suspected of damaging fertility or the unborn child.) and Lact. - H362 (Suspected of damaging fertility or the unborn child.)

• Repr. Cat 3; R63 (Possible risk of harm to the unborn child) and R64 (Possible risk of harm to the unborn child)

Table 5-12: Summary of human health effect data for HBCDD from the EU-RAR (ECB, 2008) brought forward to the risk characterisation.

Endpoint Internal body burden (mg/kg/day) Effects observed MOS

Repeated dose toxicity 22.9

NOAEL of 22.9 mg/kg/d, due to increased liver weight, thyroid weight increase (and decreased serum T4 levels), and increased pituitary weight

40

Reproductive toxicity/fertility 10

NOAEL of 10 mg/kg/d Dose-dependent decrease in fertility index and a reduced number of primordial follicles

100


The following scenarios for consumer exposure to HBCDD were presented in the EU-RAR:

Textile in furniture (and curtains):

• Subscenario: Oral exposure to dust

• Subscenario: Inhalation exposure

• Subscenario: Oral exposure by mouthing of textile

Indoor air: Inhalation exposure from XPS construction boards

Mattress ticking: Dermal exposure from lying down on a mattress with flame-retarded ticking

A detailed description of the exposure assessment is provided in Annex 6 – chapter 2 whereas the outcome of the exposure assessment is summarised in Table 5-13 below.

Table 5-13: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on HBCDD.

Exposure scenario Internal exposure (mg/kg/day) Remarks

Considering the rather unrealistic worst case exposure scenario, the exposure is considered insignificant and was not brought forward to the risk characterisation

ES1: Inhalation exposure to dust generated from wear of a sofa

1.5 * 10-3


ES1: Oral exposure to dust generated from wear of a sofa

1.2 * 10-3

ES1: Oral exposure, mouthing of textile (only textile side)

3 * 10-3 Taken forward to risk characterisation


Internal exposure Exposure scenario Remarks (mg/kg/day)

ES1: Oral exposure, mouthing of textile (both sides)

0.03 Taken forward to risk characterisation

ES2: Indoor air, Inhalation exposure

1.9 * 10-4 (0.05% release during life-time, TGD) or 2 * 10-6 (measured emission factor)


ES3: Ticking in furniture, Dermal exposure

1 * 10-5 The exposure level is considered insignificant and therefore not brought forward to the risk characterisation

Combined (multiple) consumer exposure: this scenario applies for a person exposed to HBCDD or HBCDD-containing dust from building material in houses, from HBCDD-treated mattresses and textile in furniture. It also includes children’s mouthing of HBCDD-treated textiles. However, there is no concern for the mouthing scenario as given in Table 5-14 below, and the other exposure routes are considered to be insignificant and were thus not taken forward to the risk characterisation.


Two sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, Margins of Safety (MOS) and conclusions are compiled in the table below.

Table 5-14: Risk characterisation for consumers and conclusions according to the EU-RAR (ECB, 2008) on HBCDD

Exposure scenario Exposure (mg/kg/day)

MOS (repeated) MOS (repro) Conclusion

ES1: subscenario mouthing (only textile side)

0.003 7600 3300 No concern for repeated dose toxicity or reproductive toxicity

ES1: subscenario mouthing (both sides)

0.03 760 330 No concern for repeated dose toxicity or reproductive toxicity

The EU-RAR report (ECB, 2008) concludes that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already for consumer products addressed in the risk assessment report.


Table 5-15: Summary of environmental effects of HBCDD brought forward to the risk characterisation




Surface water 0.31 μg/L Lowest effect concentration: 21d-NOEC for Daphnia = 3.1 μg/L Assessment factor 10: reliable NOEC values are available for three trophic levels

STP 0.15 mg/L Lowest effect concentration: EC30 micro-organisms respiration inhibition test = 15 mg/L Assessment factor 100: deriving a PNEC for micro-organisms from an EC50 value

Sediment 0.86 mg/kg dwt

Lowest effect concentration: 28d-NOEC (static) L. variegatus (normalized to standard organic carbon content, i.e. 5 %) = 8.6 mg/kg dwt Assessment factor 10: chronic results from three species with different feeding regimes

Terrestrial 5.9 mg/kg dry soil

Lowest effect concentration: normalized 56d-NOEC reproduction Eisenia fetida = 59 mg/kg dry soil Assessment factor 10: studies on terrestrial organisms from three trophic levels available

Atmosphere NC There are no effect data available for the atmospheric environment and therefore it is not possible to calculate a PNECair


A detailed description of the exposure assessment during professional and private use, during service life and from waste and during waste management is provided in Annex 6 – chapter 2. In summary, the emissions of HBCDD from the use of consumer products is near to zero, whilst total emissions during the complete life cycle equal 441 kg/year to air, 3253 kg/year to waste water and 1058 kg/year to surface water. It should be noted that the emission of HBCDD during service life of HIPS-treated electric and electronic equipment was not quantified in the exposure assessment. This is no explained in the EU RAR.

According to the EU-RAR (European Chemicals Bureau, 2008), emissions from landfills may prevail for a very long time, often thousands of years or longer. Polymer end-products containing HBCDD will accumulate on landfill sites. Degradation of the matrix will sooner or later cause release of the substance from the matrix. Besides this, biodegradation of HBCDD that occur in the landfill will limit potential future emissions. For example, polystyrene is degraded in the landfill due to UV-light, micro-organisms and physical impact. Some 1-10 % of polystyrene will be degraded in the landfill.

A literature search revealed some quantitative data on HBCDD at landfills, as illustrated in Table 5-16: .

Table 5-16: Concentrations of HBCDD in MSW landfill leachate


Hexabromocyclododecane (HBCDD) MSW landfill leachate (Norway)

Haarstad & Borch (2008)

1 – 7.5 µg/L

Hexabromocyclododecane (HBCDD) Landfill leachate

Borgnes & Rikheim

<0.0001 – 0.08 µg/g


sediment (2004)

The EU-RAR (European Chemicals Bureau, 2008) further indicates that HBCDD containing waste can be treated in an acceptable way in well-functioning MSW incinerators. This is indicated by the low concentrations of PBDD and PBDF, found by Vehlow & Mark (1995, 1996) (in European Chemicals Bureau, 2008) at co-combustion of building insulation foams with MSW at well-functioning incinerator:

• Polybrominated dibenzodioxins (PBDD): levels of pg/m³

• Polybrominated dibenzofurans (PBDF): < 1 ng/m³

According to the EU-RAR (European Chemicals Bureau, 2008) emissions to air, wastewater and surface water are either not reported (landfilling) or zero (incineration).


According to the EU RAR (European Chemicals Bureau, 2008) there is at present no need for further information and/or testing and no need for risk reduction measures beyond those, which are being applied already. For some local sites there is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. However, since this refers to local sites, this does not involve releases from consumer product use. Furthermore, it was concluded that there is no concern at the regional level.

HBCDD is ubiquitous in the environment, being also found in remote areas far away from point sources. The highest concentrations of HBCDD are detected in marine top-predators such as porpoise and seals showing that HBCDD bioaccumulates up the food chain (European Chemcials Bureau, 2008). It can be assumed that the releases of HBCDD from the use of consumer products do not significantly contribute to this accumulation, since these emissions are near to zero (see Annex 6 – chapter 2). As such, the considered consumer product uses can be considered to be safe for the environment.

Based on an overall assessment the TCNES subgroup on identification of PBT and vPvB substances have concluded that HBCDD has PBT properties according to the PBT criteria of the TGD (European Chemicals Bureau, 2008).

5.6 Tri (2,4,6 tribromophenoxy) triazine (CAS 25713-60-4)

Tris (2,4,6 tribromophenoxy)triazine is used in flame retardant articles made of high impact polystyrene or acrylonitrile butadiene styrene and is additively integrated into the matrix. The applications known are in the housings of small and large electric and electronic equipment (e.g. monitor or mobile phone).




No toxicological data are available from consulted public literature sources and according to Harju et al. (2009). However, effect data where gathered from the manufacturer´s MSDS (Dead Sea Bromine Group) by Fisk et al. (2003).

Table 5-17: Human health effect data for tri(2,4,6 tribromophenoxy) triazine as given by Fisk et al. (2003).


Acute oral toxicity, rat LD 50 > 2000 mg/kg manufacturers MSDS

Acute dermal toxicity, rat LD 50 > 2000 mg/kg manufacturers MSDS

Long-term oral toxicity, rat NOEL(4 wk) 1000 mg/kg manufacturers MSDS

In vitro mutagenicity Non-clastogenic in Chinese hamster cells and human lymphocytes manufacturers MSDS

In vitro mutagenicity Non-mutagenic in Ames test with Salmonella and E.coli manufacturers MSDS

However, the quality of the data available is not sufficient for a risk characterisation.




Based on the data compiled within the framework of this study (chapter 3) exposure estimates to tris (2,4,6 tribromophenoxy)triazine have been provided for one consumer application:

• Service life of housings for large electric and electronic equipment containing tris (2,4,6 tribromophenoxy)triazine in their housing.

• Service life of housings and exterior parts of small electric and electronic equipment containing tris (2,4,6 tribromophenoxy)triazine.


Table 5-18: Consumer exposure estimates to tris (2,4,6 tribromophenoxy)triazine


Service life of housings for large electric and electronic equipment



Service life of housings and exterior parts of small electric and electronic equipment

Dermal 6.55 * 10-2 mg/kg bw/d

1.Tier assessment using ECETOC-TRA (AC13, subcategory small articles and a concentration of 11% (max. conc. from other application)






No toxicological data are available from consulted public literature sources and according to Harju et al. (2009). Some toxicological endpoints (acute oral and dermal, 4 week oral and in vitro mutagenicity) where gathered from the manufacturer´s MSDS by Fisk et al. (2003). However, the quality of the data available is not sufficient for a quantitative risk assessment, therefore only a tentative qualitative risk assessment could be performed, as illustrated in Table 5-19: .

Table 5-19: Tentative qualitative risk assessment of tris (2,4,6 tribromophenoxy)triazine for consumers.

Exposure scenario Route of exposure Qualitative risk assessment

SVC (saturated vapour concentration) Inhalation The inhalation exposure can be regarded as negligible.

Service life of housings and exterior parts of small electric and electronic equipment

Dermal

The dermal exposure assessed is low even though the exposure estimate is based on conservative assumption used by the tool. However, uncertainties on the concentration exist.

First tier exposure assessments to tris (2,4,6 tribromophenoxy)triazine using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized by Fisk et al. (2003). However, as the quality of the toxicological data available for tris (2,4,6 tribromophenoxy)triazine is not sufficient for a DNEL derivation, thus a firm conclusion on the risk cannot be drawn.


Environmental effect data for tris (2,4,6 tribromophenoxy)triazine, gathered through a literature search, are given in Table 5-20.

Table 5-20: Environmental effect data for tris (2,4,6 tribromophenoxy)triazine




Long-term toxicity testing fish

NOEC <0.001

mg/L Fisk et al. (2003) ECOSAR


LC50(96h) >0.013

mg/L Fisk et al. (2003) MSDS


LC50(?h) <0.001


Toxicity to microorganisms (activated sludge)

EC50(3h) >100


Short-term toxicity algae EC50(96h) >0.013 mg/L Fisk et al. (2003) MSDS Short-term toxicity testing on aquatic invertebrates

EC50(48h) >0.013




The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. As such, environmental exposure during that phase was not assessed.

According to a downstream user, tris(2,4,6 tribromophenoxy)triazine is present in high impact polystyrene used for the production of electric and electronic equipment in concentrations ranging from 5% by weight to 11% by weight, thus possibly in concentrations > 10% wt. in the applications under consideration. This implies that tris(2,4,6 tribromophenoxy)triazine belongs to the environmental core set – disposal. However, this information was provided in too short notice to include this substance in the literature search on disposal emissions. As such, exposure via landfill or incineration was not assessed.


Since environmental exposure was not assessed at disposal phase, no environmental risk assessment was carried out in this study.

5.7 Bis-(2-ethylhexyl)tetrabromophthalate (CAS 26040-51-7)

Bis-(2-ethylhexyl)tetrabromophthalate is additively integrated in various matrices, as given in Table 5-21.

Table 5-21: Matrices relevant for additive integration of bis-(2-ethylhexyl)tetrabromophthalate

Matrix Use Remark

PVC Building and construction -

PVC Furniture: imitation leather Minor use (not domestic)

PUR foam Building and construction: sealants & adhesives Minor use (not domestic)

TPU Sealants Minor use

EPDM No data Minor use



Not a substance from the core set of applications for consumer exposure, therefore no human health assessment has been performed.


From the data available in this study, consumer exposure could not be assessed.



Since consumer exposure could not be assessed, no risk assessment could be carried out in this study.


Environmental effect data for bis-(2-ethylhexyl)tetrabromophthalate, gathered through a literature search, are given in Table 5-22.

Table 5-22: Environmental effect data for bis-(2-ethylhexyl)tetrabromophthalate





NOEC <0.001


Growth inhibition study on aquatic algae and cyanobacteria

EC50(96h)

5.83E-05

mg/L OECD ChemPortal

ECOSAR v0.99 Short-term toxicity testing on fish

LC50(?h) 2.04E-06

mg/L OECD ChemPortal ECOSAR v0.99


LC50(96h)

>1000

mg/L Pennwalt Corporation (1989)

not valid due to insolubility of test compound


LC50(?h) 0.000508



LC50(48h) 4.95E-07



EC50(48h)

0.3

mg/L Pennwalt Corporation (1989) valid with restrictions


LC50 <0.001



The application relevant for the scope of this study is not subject to wear and as such do not belong to the environmental core set for service life. As such, environmental exposure during that phase was not assessed.



Since environmental exposure at disposal phase was not assessed, no risk assessment could be carried out in this study.

5.8 Ethylene bis(tetrabromophtalimide) (CAS 32588-76-4)

Ethylene bis(tetrabromophthalimide) is used in flame retardant articles made of a variety of plastics like polypropylene, polyethylene, polycarbonate and high impact polystyrene and is additively integrated into the matrix. The applications known are in electric and electronic equipment, wire and cable, construction materials and possibly textiles available


to consumers or in the domestic environment. Furthermore, it is added to preparations which need flame retardancy like foams used for construction.

The substance is intended to be registered under REACH by 2013.



Following oral administration to rats 85% of the total dose administered over a 14 day period was recovered in the faeces and urine with a short half-life of < 17-20 days, suggesting that test substance is not able to bioaccumulate (Toxnet, 2008) (cited from Harju et al., 2009).

Based on physico-chemical information i.e. molecular mass and lipophilicity the absorption via the skin can be assumed to be ≤ 10% (ECHA guidance chapter R.7c, section R.7.12, ECHA, 2008).

Acute toxicity

Ethylene bis(tetrabromo phthalimide) is of low acute oral toxicity in rats with LD50 > 7.5 g/kg (Biosearch, Inc., 1976c) (cited from Raymond, 1999). In an acute dermal toxicity test with albino rabbits no mortalities were observed up to 2.0 g/kg (Biosearch, Inc., 1976b) (cited from Raymond, 1999).

The acute inhalation toxicity of ethylene bis (tetrabromo phthalimide) in albino Sprague-Dawley rats was tested at a dose of 4.5 (±3.0) g/m³ for 1 hour (IRDC, 1981). Dyspnoea was seen in all of the rats during the exposure and persisted for 1 to 5 days following the exposure. The occurrence of 1-mm red foci in the lungs of 2 male and 2 female rats was the principal lesion observed at necropsy (cited from Raymond, 1999).

An inhalation study on rat gave a LC >203 g/kg/m³/1 hour, with effects on sense organs (olfaction) and the respiratory system (dyspnoea and pulmonary emboli) (cited from Harju et al., 2009).


Dermal

Ethylene bis(tetrabromo phthalimide) is not irritating to the skin (Biosearch, Inc., 1976a) (cited from Raymond, 1999).

Eye

In an acute eye irritation test in male and female albino New Zealand rabbits (Pharmakon Research International, 1983) ethylene bis (tetrabromo phthalimide) received a Draize score of 3.0 at 1 hour, indicating that it is considered to be a mild eye irritant. The Draize score was 0.3 at 72 hours and at 7 days after exposure (cited from Raymond, 1999).

Ethylene bis(tetrabromo phthalimide) was instilled in the right eye of six albino rabbits. No effects were observed at any time point in any animal with respect to the cornea, iris, or conjunctiva. The test article was not an eye irritant (Biosearch, Inc., 1976) (cited from Albemarle Corporation, 2004).

Sensitisation

No data available (Stuer-Lauridsen et al., 2007; Albermale Corporation, 2004 and Harju et al., 2009).



Oral

Ethylene bis(tetrabromo phthalimide) was fed to Sprague-Dawley rats (15 of each sex per dose level) at doses of 0.01%, 0.1%, or 1.0% in the diet for 90 days. No mortalities, clinical signs of toxicity or alterations in chemical or histopathological parameters were observed, thus the NOAEL is > 1% in the diet (1000 mg/kg bw, based on body weight of 250 g and food consumption of 25 g/d). (Cannon Laboratories, 1978b) (cited from Raymond, 1999) (Cannon Laboratories, 1978) (cited from HPVIS, 2010).

Ethylene bis(tetrabromo phthalimide) was fed to weanling Sprague-Dawley male rats at doses of 0.01%, 0.1%, and 1.0% in the diet for 28 days. Animals received the test diets from initiation of the experiment until their sacrifice. No mortalities, clinical signs of toxicity or alterations in chemical or histopathological parameters were observed, thus the NOAEL is > 1% in the diet (1000 mg/kg bw, based on body weight of 250 g and food consumption of 25 g/d) (Warf Institute, 1976) (cited from Raymond, 1999 and cited from HPVIS, 2010).

Dermal


Inhalation


Mutagenicity


Ethylene bis (tetrabromo phthalimide) was tested in an bacterial reverse mutation assay at 10, 50, 100, 500, 1,000, and 5,000 μg/plate. No mutagenic activity was detected, either with or without metabolic activation (Chemical Inspection and Testing Institute, 1982) (cited from Raymond, 1999).

Ethylene bis(tetrabromo phthalimide) was tested in an bacterial reverse mutation assay at 1, 10, 100, 500, and 1,000 μg/plate. No mutagenic activity was detected, either with or without metabolic activation (Cannon Laboratories, 1978c) (cited from Raymond, 1999).

Ethylene bis(tetrabromo phthalimide) was tested in an bacterial reverse mutation assay. No mutagenic activity was detected, either with or without metabolic activation (Zeiger et al., 1985) (cited from Raymond, 1999).


No data available (Albermale Corporation, 2004)

Carcinogenicity

No data found (cited from Stuer-Lauridsen et al., 2007)



There were no specific reproductive toxicity studies of ethylene bis(tetrabromo phtalimide). Therefore, the evaluation of reproductive organs reported in the repeated dose toxicity studies via oral route cited above was used to address the reproductive toxicity endpoint.


There was no indication of toxicity to reproductive organs examined in repeated-dose studies in rats.


A teratology study was conducted with ethylene bis(tetrabromo phthalimide) in Sprague-Dawley rats at doses of 0, 100, 500, 1000 mg/kg bw/day via gavage. The test item was administered by gavage daily from gestation day 6 to gestation day 15. All animals in this study survived until the termination of the experiment on gestation day 20. No abortions, resorptions, or premature deliveries were reported and the pregnancy rate was 100% in all groups. The observed malformations among all groups were known to occur in this strain of rat. The NOAEL (maternal and developmental) is > 1000 mg/kg bw/day (Springborn Life Sciences, 1988a) (cited from Raymond, 1999) (Rodwell, 1988) (cited from HPVIS, 2010).

A teratology study was conducted with ethylene bis(tetrabromo phthalimide) in New Zealand white rabbits at a limit dose of 1000 mg/kg bw/day via gavage. The animals were dosed from gestation day 7 through gestation day 19. All rabbits were sacrificed on gestation day 29. No mortalities and abortions or premature deliveries were observed. The pregnancy rate was 90% in the control group and 95% in the test group. The observed malformations among all groups were known to occur in this strain of rat. The NOAEL (maternal and developmental) is > 1000 mg/kg bw/day (Springborn Life Sciences, 1988c) (cited from Raymond, 1999) (Rodwell, 1988) (cited from HPVIS, 2010).



Table 5-23: Summary of human health effect data for ethylene bis(tetrabromo phthalimide) brought forward to the risk characterisation:



Rat / 90-days oral / 0.01%, 0.1%, or 1.0% in the diet

NOAEL > 1000 mg/kg bw/day (=1.0% in the diet)

12.5 mg/kg/day


Rat / 90-days oral / 0.01%, 0.1%, or 1.0% in the diet

NOAEL > 1000 mg/kg bw/day (=1.0% in the diet)

4.4 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to ethylene bis(tetrabromo phthalimide) have been provided for four consumer applications:

• Service life of electric and electronic equipment containing ethylene bis (tetrabromophthalimide) in exterior parts and housings

• Service life of electric and electronic equipment containing ethylene bis (tetrabromophthalimide) in the interior part


• Service life of wire and cable containing ethylene bis (tetrabromophthalimide).

• Use of ethylene bis (tetrabromophthalimide) in foams for construction


Table 5-24: Consumer exposure estimates to ethylene bis(tetrabromo phthalimide)


Service life of electric and electronic equipment (exterior parts and housings)

1.Tier assessment using ECETOC-TRA (AC13, subcategory: small articles) and a max concentration of 15%.

Dermal 8.93 * 10-2 mg/kg bw/day



Service life of electric and electronic equipment (interior part)

Even under the assumption that the temperature inside electric and electronic equipment will be above RT, the SVC will be low. Due to the lack of VP at elevated temperature the saturated vapour concentration at RT has been used as upper bound vapour concentration.


Service life of wire and cable



Service life of construction materials


No exposure considerations where made for construction material enclosed after installation. However, PP may be used in injection moulded parts, therefore, inhalation exposure had been assessed. Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration.

Use in foams for construction

1.Tier assessment using ECETOC-TRA (PC9b) and the highest concentration stated: 12%

Dermal 0.715 mg/ kg bw /d




Three sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including


reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-25: Tentative risk assessment of ethylene bis(tetrabromo phthalimide) for consumers.


SVC (saturated vapour concentration) Inhalation 1.15 * 10-17 mg/m³ 4.4 mg/m³ 2.6 * 10-18

Service life of electric and electronic equipment (exterior parts and housings)

Dermal 0.0893 mg/ kg bw /d 12.5 mg/kg/d 7.1 * 10-3

Use in foams for construction Dermal 0.715 mg/ kg bw /d 12.5 mg/kg/d 5.7 * 10-2


First tier exposure assessments to ethylene bis(tetrabromo phthalimide) using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment.

Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized. The lack of evidence of any organ specific toxicity up to the limit dose of 1000 mg/kg bw/d makes it not necessary to consider endpoint specific DNELs, e.g. for reproduction or development. No effects on reproductive organs were reported in RDT studies and no developmental toxicity was observed up to 1000 mg/kg bw/d. However, no information on a carcinogenic potential is available. Taking all information presented together, a NOAEL for systemic oral toxicity of 1000 mg/kg bw/d can safely be assumed. This represents a conservative approach, because no critical effects on different toxicological endpoints were observed in these studies, and the true NOAEL was always expected to be above the highest dose. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

Altogether a rather conservative tentative risk assessment to ethylene bis(tetrabromo phthalimide) from consumer applications has been performed showing no risk for all the applications and routes considered.


Environmental effect data for ethylene bis (tetrabromophthalimide), gathered through a literature search, are given in Table 5-26.

Table 5-26: Environmental effect data for ethylene bis (tetrabromophthalimide)


Bio accumulation BCF 64518.79 L/kg STN CAS Registry



LC50(96h)

0.000612

mg/L Syracuse Research Corporation on OECD ChemPortal

EPI Win Suite v.304

LC40(48h)

>500

ppm Chemicals Inspection & Testing Institute Japan on OECD

study performed by experienced lab as part of fish BC study


Effect Endpoint Value Unit Reference Reliability ChemPortal

LC50(48h)

>500

mg/L Fisk el al. (2003) HSDB IOM Consulting et al. (2009)

IUCLID EPA – HPV -

LC50

<0.001 mg/L Fisk et al.

(2003) ECOSAR


The application relevant for the scope of this study is not subject to wear and as such does not belong to the environmental core set for service life.. As such, environmental exposure during that phase was not assessed.




5.9 1,2-bis(2,4,6-tribromophenoxy)ethane (CAS 37853-59-1)

1,2-bis(2,4,6-tribromophenoxy)ethane is used in flame retardant articles made of a variety of plastics like acrylonitrile butadiene styrene, polycarbonate and high impact polystyrene and is additively integrated into the matrix. The applications known are in electric and electronic equipment and construction materials (sealant around window frames) available to consumers or in the domestic environment. Furthermore, it is available to consumer in preparations which need flame retardancy like adhesives used for construction. However, not enough information was provided to estimate exposure from this use.




A study of the metabolism and depuration of 14C 1,2-bis(2,4,6-tribromophenoxy)ethane (Flame retardant: FF-680) in rats by gavage was performed. Results showed that 99% of the total excreted 14C was via the faecal route and 1 % was recovered in the urine. In rats dosed for 10 days only trace levels of radioactivity were found in all tissues except the brain of some animals. The adipose tissue contained the highest levels (excluding the gastrointestinal tract) followed by kidney, skin and thymus and lowest concentrations in brain, testes and spleen. The data indicated that FF-680 where very poorly absorbed through the GI (Nomeir et al., 1993) (cited from Harju et al., 2009).

A metabolism and fate study of 1,2-bis(2,4,6-tribromophenoxy)ethane on rats resulted in >94% of 1,2-bis(2,4,6-tribromophenoxy)ethane excreted in faeces with a minimal retention in tissues. Tissues retaining the highest concentrations were thymus, adipose tissue,


adrenals, lung and skin. They concluded that limited absorption and metabolism of 1,2-bis(2,4,6-tribromophenoxy)ethane would occur by ingestion in animals (Hakk and Letcher, 2003; Hakk et al., 2004) (cited from Harju et al., 2009).

Acute toxicity

Oral

Sprague-Dawley rats (5/sex/dose) were administered a commercial product Firemaster 680 (1,2-bis(2,4,6-tribromophenoxy)ethane suspended in 0.5 % Methocel) via gavage at 10,000 mg/kg-bw. None of the animals died during the study. LD50 oral > 10,000 mg/kg-bw (US EPA, 2009) (Wazeter and Goldenthal, 1974) (cited from HPVIS, 2010).

Beagle dogs were administered 1,2-bis(2,4,6-tribromophenoxy)ethane via gavage at 10,000 mg/kg-bw. None of the animals died. No adverse effects on body weight were found. LD50 oral > 10,000 mg/kg-bw (US EPA, 2009) (Wazeter and Goldenthal, 1974) (cited from HPVIS, 2010).

Dermal

Albino rabbits were administered a single dermal dose of 1,2-bis(2,4,6-tribromophenoxy)ethane at a concentration of 10,000 mg/kg-bw under a sleeve of rubber fastened about the clipped trunk for 24 hours and observed for 14 days. Neither animal died during the study. There was no mention of any clinical signs of toxicity. LD50 dermal > 10,000 mg/kg-bw (US EPA, 2009) (WARF Institute, 1973) (cited from HPVIS, 2010).

Inhalation

Sprague-Dawley rats (5/sex) were exposed to 1,2-bis(2,4,6-tribromophenoxy)ethane dust (micronized commercial product, Firemaster 680) at 36.68 mg/L for 4 hours. No rats died during exposure or the 14 days observation period. Signs of toxicity during the exposure included eye squint, erythema, slight dyspnea, slight bradypnea, salivation, nasal porphyrin discharge and increased, then decreased motor activity. LC50 inhalation > 36.68 mg/L (US EPA, 2009) (Wazeter and Goldenthal, 1974) (cited from HPVIS, 2010).


Skin

Administration of 1,2-bis(2,4,6-tribromophenoxy)ethane onto the skin of rabbits using the standard draize test showed a mild response (RTECS, 2008) (cited from Harju et al., 2009).

Eye

1,2-bis(2,4,6-tribromophenoxy)ethane was not primary skin and eye irritating to rabbits (EPA/OTS; Doc#88-7800184) (cited from TOXNET, http://toxnet.nlm.nih.gov, 2010).

Sensitisation

The test item produced no significant irritation and gave no evidence of contact sensitization in 45 human subjects (Wazeter and Goldenthal, 1974) (cited from HPVIS, 2010).


Oral

In a 14-day range-finding study, Sprague-Dawley (Charles River, CD) rats (5/sex/dose) were fed 1,2-bis(2,4,6-tribromophenoxy)ethane in the diet at concentrations of 0, 0.5, 1.0,



5.0 or 10.0% (0, 50, 1000, 5000 or 10,000 mg/kg-bw/day, respectively). One male rat in the 5000 mg/kg-bw/day group died; cause of death unknown. No mortalities were observed at 10,000 mg/kg-bw/day. There were no differences in general behavior and appearance, body weights, food consumption or gross pathology between treated and control animals. NOAEL = 10,000 mg/kg-bw/day (based on no effects at the highest dose tested) (US EPA, 2009) (Wazeter and Goldenthal, 1975) (cited from HPVIS, 2010).

In a 28-day study, Sprague-Dawley rats (25/sex/dose) were fed 1,2-bis(2,4,6-tribromophenoxy)ethane in the diet at concentrations of 0 or 1000 ppm (0 or 75.2 mg/kg-bw/day for males and 89.4 mg/kg-bw/day for females, respectively). There were no deaths during this study. There were no treatment-related changes in general behavior, appearance, body weight, food consumption or survival. NOAEL = 75.2/89.4 (m/f) mg/kg-bw/day (based on no effects at the only dose tested) (US EPA, 2009) (Wazeter and Goldenthal, 1975) (cited from HPVIS, 2010).

Charles River rats (15/sex/dose) were fed 1,2-bis(2,4,6-tribromophenoxy)ethane in the diet at concentrations of 0, 0.1, 1.0 or 10.0% (approximately 0, 71.7, 729, and 8329 mg/kg-bw/day for males and 0, 84.6, 874, and 9364 mg/kg-bw/day for females, respectively) for 106 days. There were no clinical signs of toxicity and no treatment-related effects on body weights, body weight gains and food consumption. Changes in hematology and clinical chemistry were all in the range of historical controls and not considered treatment-related. Gross pathological findings were similar among control and treated animals. Histopathologic examination revealed hepatic changes among most animals in the high dose group. The lesions consisted of either focal or multifocal enlargement of hepatocytes located within the centrilobular to midzonal regions of affected liver lobules. The severity of these liver lesions was graded as minimal in all animals. LOAEL = 8329/9364 (m/f) mg/kg-bw/day (based on lesions in the liver), NOAEL = 729/874 (m/f) mg/kg-bw/day (US EPA, 2009) (Marias, 1977) (cited from HPVIS, 2010).

Dermal

In a four-week study, New Zealand white rabbits (3/sex/dose) were administered 1,2-bis(2,4,6-tribromophenoxy)ethane dermally at 0, 50, 500 and 5000 mg/kg-bw/day, 6 hours/day, 5 days/week. There were no treatment-related mortalities or clinical signs of toxicity. Most rabbits in the control and treated groups exhibited slight erythema during the study. There were no changes in hematology, clinical chemistry, organ weights or histopathology attributed to the test substance. NOAEL = 5000 mg/kg-bw/day (based on no effects at the highest does tested) (US EPA, 2009) (Wazeter and Goldenthal, 1975) (cited from HPVIS, 2010).

Inhalation

In a 21-day study, Sprague-Dawley rats were exposed to 1,2-bis(2,4,6-tribromophenoxy)ethane dust via inhalation at concentrations of 0, 5 or 20 mg/L for 4 hours/day, 5 days/week. There were no deaths during the study. No treatment-related effects on body weight or food consumption were observed. Changes in hematology and clinical chemistry were not considered treatment-related. There was a dose-related increase in absolute lung weight in males. No gross lesions or changes were seen in treated rats. Excepting one rat, all treated rats exhibited scattered foci of foamy alveolar macrophages in their lungs. LOAEC = 5 mg/L/day (based on the histopathological changes in the lung), NOAEC = Not established (US EPA, 2009) (Wazeter and Goldenthal, 1975) (cited from HPVIS, 2010).

Mutagenicity



In a bacterial reverse mutation assay 1,2-bis(2,4,6-tribromophenoxy)ethane was tested at concentrations of 100, 333, 1000, 3333 and 10,000 μg/plate in the presence and absence of metabolic activation. None of the concentrations caused an increase in the number of mutants in the presence or absence of metabolic activation (US EPA, 2009) (US NTP, 1982) (Zeiger et al., 1987) (cited from HPVIS, 2010).

In a bacterial reverse mutation assay 1,2-bis(2,4,6-tribromophenoxy)ethane was tested at concentrations of 0.25, 0.5, 5.0 and 50 μg/plate in the presence and absence of metabolic activation. The test substance did not show dose-dependent mutagenic activity in the presence or absence of metabolic activation (US EPA, 2009) (Brusick, 1976) (cited from HPVIS, 2010 and Harju et al., 2009).


No data available (US EPA, 2009).

Carcinogenicity

No data available (US EPA, 2009).



There were no specific reproductive toxicity studies of 1,2-bis(2,4,6-tribromophenoxy)ethane. Therefore, the evaluation of reproductive organs reported in the repeated dose toxicity studies via oral, dermal and inhalation route cited above was used to address the reproductive toxicity endpoint. There was no indication of toxicity to reproductive organs examined in repeated-dose studies in rats or rabbits.


Sprague-Dawley (Charles River CD) pregnant rats (5/dose) were administered 1,2-bis(2,4,6-tribromophenoxy)ethane via gavage at 0, 30, 100, 300, 1000, 3000 and 10,000 mg/kg-bw/day during 6 to 15 days of gestation. Survival in all groups of dams was 100 %. There was no maternal or developmental toxicity reported. NOAEL (maternal and developmental toxicity) = 10,000 mg/kg-bw/day (based on no effects at the highest dose tested) (US EPA, 2009) (Goldenthal, 1978) (cited from HPVIS, 2010).

Sprague-Dawley (Charles River CD) pregnant rats (25/dose) were administered 1,2-bis(2,4,6-tribromophenoxy)ethane via gavage at 0, 100, 1000 and 10,000 mg/kg bw/ day during 6 to 15 days of gestation. There were no maternal deaths. There was no biologically significant maternal or developmental toxicity reported. NOAEL (maternal and developmental toxicity) = 10,000 mg/kg-bw/day (based on no effects at the highest dose tested) (US EPA, 2009) (Goldenthal. 1979) (cited from HPVIS, 2010).

Additional information: Endocrine effects in vitro

In vitro tests of BFRs for the porfyrinogenic action on chick embryo liver cultures showed no effect from DecaBDE while BTBPE was slightly porfyrinogenic but only after pretreatment with betanaphtoflavone (Koster et al., 1980) (cited from Harju et al., 2009).




Table 5-27: Summary of human health effects for 1,2-bis(2,4,6-tribromophenoxy)ethane brought forward to the risk characterisation.



Rat / 21-days inhalation / 0, 5, 20 mg/L

LOAEC: 5 mg/L (based on histopathological findings in lungs)

11 mg/m3



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to 1,2-bis (2,4,6-tribromophenoxy)ethane have been provided for two consumer applications:

• Service life of electric and electronic equipment containing 1,2-bis(2,4,6-tribromophenoxy)ethane in exterior parts and housings.

• Service life of adhesives/sealants used for construction containing 1,2-bis(2,4,6-tribromophenoxy)ethane.


Table 5-28: Consumer exposure estimates to 1,2-bis(2,4,6-tribromophenoxy)ethane


Service life of housings of large electric and electronic equipment



Service life of adhesives/sealants used for construction




One sub-scenario has been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-29: Tentative risk assessment to 1,2-bis(2,4,6-tribromophenoxy)ethane for consumers.

Exposure scenario Route of Exposure estimate DNEL RCR*


exposure

SVC (saturated vapour concentration) Inhalation 1.39 * 10-5 mg/m³ 11 mg/m³ 1.26 * 10-6


Inhalation exposure to 1,2-bis(2,4,6-tribromophenoxy)ethane for two consumer application has been assessed by using the saturated vapour concentration for an upper inhalation exposure. Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized.

The lack of evidence of organ specific toxicity up to high exposure levels in repeated dose toxicity and developmental toxicity studies makes it not necessary to consider endpoint specific DNELs for reproduction or development. No effects on reproductive organs were reported in RDT studies and no developmental toxicity was seen up to 10000 mg/kg bw/d. However, no information on a carcinogenic potential is available. The results of a sub-chronic oral toxicity study indicate a NOAEL of 729 or 874 mg/kg bw/day for male or female rats, respectively. In addition, the results of a short-term dermal toxicity study indicate a NOAEL above the highest dose level of 5000 mg/kg bw/d. Thus, systemic toxicity resulting from the oral or dermal route of exposure is not of concern. A NOAEC for systemic inhalation toxicity of 20,000 mg/m³ was used as a starting point. This represents a conservative approach, because in this short-term study, no evidence of systemic effects was observed in the animals at the high dose level of 20 mg/L. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

Altogether a rather conservative tentative risk assessment to 1,2-bis(2,4,6-tribromophenoxy)ethane from consumer applications has been performed showing no risk for all the applications and routes considered.


Environmental effect data for 1,2-bis (2,4,6-tribromophenoxy)ethane, gathered through a literature search, are given in Table 5-30.

Table 5-30: Environmental effect data for 1,2-bis (2,4,6-tribromophenoxy)ethane



predicted value; 25°C; pH 1 to 10

Growth inhibition study on aquatic algae and cyanobacteria

EC50(96h)

33.66

mg/L OECD Chemportal: EPIWIN ECOSAR (v0.99g)

valid with restrictions: data obtained by modelling


LC50(96h)

1531

mg/L Wazeter FX and Goldenthal EI. (1974)

valid with restrictions: purity of test substance not verified


LC50(96h)

43.509




LC50(96h)

1410

mg/L Wazeter FX and Goldenthal EI. (1974)



Effect Endpoint Value Unit Reference Reliability Short-term toxicity testing on fish

LC50(48h)

230

mg/L Chemicals Inspection and Testing Institute, Japan (CITI) (1976)



LC50(48h)

50.43




LC50(96h)

5.573

not reported, mg/L can be assumed

OECD Chemportal: EPIWIN ECOSAR (v0.99g)



The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. As such, exposure in that phase was not assessed.



Since environmental exposure at disposal phase was not assessed, no environmental risk assessment for that phase could be carried out in this study.

5.10 Decabromodiphenylethane (CAS 84852-53-9)

Decabromodiphenylethane is used in flame retardant articles made of a variety of plastics like polyethylene, polypropylene, epoxy and phenolic resin and polybutylene terephthalate. It is assumed that the mode of integration is ‘additive’18. The applications known are in electric and electronic equipment, wire and cable, flooring and construction material.




Absorption is “not significant”. There is no data available on metabolism and half-life values. Accumulation in fat tissue is ruled out although the structure and the octanol/water-coefficient offer reason to believe the opposite (Leisewitz et al., 2001).

Acute toxicity

18 No information on the mode of integration, therefore it was assumed to be additive as worst case, as substances with an reactive mode of integration will not be assessed.


Oral

Single dose oral administration of Decabromodiphenylethane in rats resulted in high LD50 values > 5000 mg/kg body wt (cited from Harju et al., 2009).

Dermal

The dermal acute toxicity (LD50) in rabbits was > 2000 mg/kg bw (RTECS, 2008) (cited from Harju et al., 2009).

Inhalation

Acute inhalation toxicity testing in rats resulted in a LC50 = 50 mg/L (1 hour) (Li et al., 2004) (cited from Harju et al., 2009).


Skin

Decabromodiphenylethane is not suspected to be a skin irritant (TOXNET, 2008) (cited from Harju et al., 2009). The substance has no irritating effect on mucous membranes. Possible allergic reactions were not analysed (Leisewitz et al., 2001).

Eye

Decabromodiphenylethane is not suspected to be an eye irritant (TOXNET, 2008) (cited from Harju et al., 2009).

Sensitisation

No evidence of skin sensitization properties was observed on 200 professional workers during a repeated application of Decabromodiphenylethane in petrolatum during three weeks (Li et al., 2004) (cited from Harju et al., 2009).


Oral

NOEL (28-days, oral, rat) = 1250 mg/kg/day (Manufacturer´s Info 5) (cited from Fisk et al., 2003).

Ethane, 1,2-bis(pentabromophenyl) dose levels of 0, 100, 320 and 1000 mg/kg/day administered to rats via gavage for 90 consecutive days produced no compound-related clinical signs of systemic toxicity, ocular lesions, or alterations in urinalysis, clinical chemistry, and hematology values in the treated or recovery groups. No biologically or toxicologically significant differences were observed in body weights, body weight gains, and food consumption. The 90-day Ethane, 1,2-bis(pentabromophenyl) no-adverse-effect level (NOAEL) in the rat was 1000 mg/kg/day, and was consistent with that of the preceding 28-day study (no-effect level 1250 mg/kg/day) (Hardy et al., 2002) (cited from Leisewitz et al., 2001).

Dermal

No data available in the cited literature.

Inhalation

No data available in the cited literature.

Mutagenicity


Based on structurally similar analogues The EPA have determined that this material may cause cancer (TOXNET, 2008) (cited from Harju et al., 2009).


Non-mutagenic with or without metabolic activation in a bacterial reverse mutation assay (Manufacturer´s Info 5) (cited from Fisk et al., 2003).


Non-clastogenic (+/- S9) to CHL cells in vitro (Manufacturer´s Info 5) (cited from Fisk et al., 2003).

Carcinogenicity

No data available (Leisewitz et al., 2001).



There were no specific reproductive toxicity studies of decabromodiphenylethane. Therefore, the evaluation of reproductive organs reported in the repeated dose toxicity studies via oral route cited above was used to address the reproductive toxicity endpoint. There was no indication of toxicity to reproductive organs examined in repeated-dose studies in rats.


In a prenatal developmental study was performed in rats and rabbits, animals were administered decabromodiphenylethane via gavage at dosage levels of 0, 125, 400, and 1,250 mg/kg-day from gestation day (GD) 6 through 15 for rats and GD 6 through 18 for rabbits. All female rats and rabbits were sacrificed on GD 20 and GD 29, respectively. No treatment-related mortality, abortions, or clinical signs of toxicity were observed during the study. Body weights, body weight gain, and food consumption were not affected. No significant internal abnormalities were observed in either species on necropsy. No treatment-induced malformations or developmental variations occurred. NOAEL > 1,250 mg/kg-day (Hardy et al., 2010) (cited from TOXNET, 2010).



Table 5-31: Summary of human health effects for DBDPE brought forward to the risk characterisation



Rat / 90-days oral / 1000 mg/kg bw/day

NOAEL > 1000 mg/kg bw/day 2.9 mg/m3




Based on the data compiled exposure estimates to decabromodiphenylethane have been provided for one consumer application:

• Service life of electric and electronic equipment containing DBDPE in the housing.


Table 5-32: Consumer exposure estimations to DBDPE.


Service life of electric and electronic equipment (housing large articles)


Inhalation 7.84 * 10 -9 mg/m³ (SVC)



Table 5-33: Tentative risk assessment to DBDPE for consumers.


SVC (saturated vapour concentration) Inhalation 7.84 * 10 -9 mg/m³ 2.9 mg/m³ 2.7 * 10 -9


Inhalation exposure to DBDPE for one consumer application has been assessed by using the saturated vapour concentration as an upper inhalation exposure. Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized.

However, no information on reproduction toxicity is available based on the limited data set. No effects were observed up to a dose level of 1250 mg/kg bw/d regarding developmental toxicity. No information on a carcinogenic potential are available. Limited information was made available by the manufacturer without any details and indicates a sub-chronic NOAEL for systemic oral toxicity of 1000 mg/kg bw/d. In view of the lack of route specific data for inhalation exposure, route-to-route extrapolation was conducted based on this NOAEL.

Altogether a tentative risk assessment to DBDPE from consumer applications has been performed showing no risk for the application and route considered.



The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. DBPE is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental effects were not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. DBPE is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental exposure was not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. DBPE is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental risk was not assessed.

5.11 Chloroparaffins (SCCP) (CAS 85535-84-8)

SCCP were assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2000) is provided hereafter.

SCCP is used as flame retardant, additively integrated in rubber, paints, sealants and adhesives. However, SCCP are practically not used in consumer products. A detailed list is provided in Annex 6 - chapter 4.



SCCPs are currently classified according to regulation (EC) 1272/2008 with respect to their effects on human health as follows (Index No. 602-080-00-8):

• Carc. 2, H351 (Suspected of causing cancer)

• Carc Cat 3, R40 (Limited evidence of a carcinogenic effect) and R66 (Repeated exposure may cause skin dryness or cracking).


Table 5-34: Summary of human health effect data for SCCP from the EU-RAR (ECB, 2000) brought forward to the risk characterisation.

Endpoint Study NOAEL (mg/kg/day) Effects observed MOS

Repeated dose toxicity 100 NOAEL of 100 mg/kg/d due to kidney toxicity in rats from a repeated dose toxicity study

Not derived

Carcinogenicity 100 NOAEL of 100 mg/kg/d due to kidney carcinogenicity in rats from a repeated dose toxicity study

Not derived

Developmental effects 500 NOAEL of 500 mg/kg/d due to developmental effect in rats from a 13 week study

Not derived


The following scenarios for consumer’s exposure to SCCP as flame retardant were presented in the EU-RAR:

• Use in textile

• Use in paints, sealants and adhesives

• Use in rubber products

A detailed description of the exposure assessment is provided in Annex 6 – chapter 4. The consumer exposure from SCCP as flame retardant is considered to be negligible. Indeed, these uses are mainly professional uses (see Annex 6 – chapter 4).


Consumer exposure due to the use of SCCP as flame retardant is considered to be negligible. Therefore no risk characterisation has been performed.

The EU RAR report (ECB, 2000) concludes that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already for consumer applications addressed in this risk assessment report.


Table 5-35: Summary of effects of SCCP brought forward to the risk characterisation:


Surface water 0.5 μg/L Lowest effect concentration: 21d-NOEC for Daphnia = 0.005 mg/L Assessment factor 10: reliable NOEC values are available for three trophic levels

STP 6 mg/L Lowest effect concentration: 24h-EC50 anaerobic sludge digestion inhibition = 600 mg/L Assessment factor 100: deriving a PNEC for micro-organisms from an EC50 value



Sediment 0.88 mg/kg dwt19

There are no studies available on sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms * 1000 where Ksed-water = sediment/water partition coefficient = 2,281 m³/m³ (log Kow = 6) Psed = bulk density of wet sediment = 1,300 kg/m³

Terrestrial 0.8 mg/kg dry soil20

There are no studies available on plants, earthworms or other soil-dwelling organisms. In the absence of any ecotoxicological data for soil-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method with the PNEC for aquatic organisms and the soil/water partition coefficient: PNECsoil = Ksoil-water / Psoil * PNECaquatic organisms * 1000 where Ksoil-water = soil/water partition coefficient = 2,736 m³/m³ (log Kow = 6) Psoil = density of soil = 1,700 kg/m³

Atmosphere NR Direct emissions of chlorinated paraffins to the atmosphere are likely to be very low. Predicted levels reflect the small but measurable volatility of this group of substances. Therefore, neither biotic nor abiotic effects are likely because of the limited release and low volatility of chlorinated short chain paraffins


A detailed description of the exposure assessment during service life and from waste and during waste management is provided in Annex 6 - chapter 4. In summary, the contribution of emissions from consumer product use to total emissions of SCCP during its life cycle can be considered to be negligible. Total emissions throughout the complete life cycle of SCCP equal 390 kg/year to air and 1,784 tonnes/year to wastewater.


According to the EU RAR (European Chemicals Bureau, 2000) there is a need for further information and/or testing for the sediment and soil compartment for production of short chain length chlorinated paraffins (sediment only), formulation and use of metal working fluids and leather finishing products, use in rubber formulations (sediment only), and also at the regional level.

Furthermore, there is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account for the aquatic compartment and for secondary poisoning. A risk to aquatic organisms exists arising from the local emission of short chain length chlorinated paraffins from metal working and leather finishing

19 The ingestion of the sediment-bound substance by sediment-dwelling organisms may not be sufficiently explained by this relationship for substances with a log Kow greater than 5. The Technical Guidance Document suggests that in such cases the PEC/PNEC ratio is increased by a factor of 10 20 The reported log Kow for short chain length chlorinated paraffins range from 4.39-8.69 and sothe equilibrium partitioning method is not really applicable to these substances. However, in the absence of any other data a tentative PNEC for soil can be calculated assuming a Ksoil-water of 2,736 m³/m³


applications, and also from the formulation of products for these uses. This conclusion also applies to secondary poisoning arising from formulation and use in leather finishing, and use in metal working applications.

Both conclusions from the EU RAR (European Chemicals Bureau, 2000) on secondary poisoning do not refer to consumer product use. As such, no conclusion can be drawn with regard to the environmental risk from such use. However, since SCCP are practically not used in consumer products (Annex 6 – chapter 4), it can be expected that environmental risk from that use is negligible.

5.12 Chloroparaffins (MCCP) (CAS 85535-85-9)

MCCPs were assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections is provided hereafter. Wereas a final risk assessment report is available for the environmental part (European Chemicals Bureau, 2005) only a draft risk assessment report is publicly available for the human health part (ECB, 2008).

Chlorinated paraffins are used as flame retardants in some applications like flooring, coatiungs, insulation of cable sheating and are additively integrated in the matrix. However, when used primarily as a flame retardant, chlorinated paraffins with high chlorine content (e.g. 70% wt. Cl) are used. As medium-chain chlorinated paraffins are not produced with these high chlorine contents, they are not considered primarily as flame retardants. However, some applications make use of both their plasticising and flame retardant properties. A detailed list is provided in Annex 6 – chapter 5.


Chlorinated paraffins are complex mixtures that are expected to differ with respect to their chemical content between “batches” or “runs” and between manufacturers. Chlorinated paraffins may differ in the number of carbons in the chain, chlorine content, and trace contaminants. Therefore, any toxicological risk assessment should be based on toxicological data generated for the specific commercial chlorinated paraffin to be used as a flame retardant in residential applications.

Toxicokinetics, absorption, metabolism and distribution

C14–17, 52% chlorine, was not absorbed through human skin in vitro at any detectable level after 56 hr of continuous contact (Scott, 1989) (cited from ECB, 2008).

Absorption following oral exposure in animals has been demonstrated to be significant (probably at least 50% of the total administered dose). There is no specific information for the inhalation route of exposure; however, given that the data indicate 50% absorption by the oral route and only 1% by the dermal route, and in view of the very high log Pow and the very low water solubility of MCCPs, it reasonable to assume that inhalation absorption is also unlikely to be higher than 50%.

In relation to metabolism, one study with a 65% chlorinated MCCP indicated conjugation with glutathione. The production of CO2 from MCCPs has also been demonstrated; metabolism to CO2 was quite extensive with MCCPs of lower chlorination, but appeared to be much more limited with more heavily chlorinated MCCPs (e.g. 69% chlorination).


Elimination of MCCPs and/or their metabolites occurs via the faeces, via exhaled CO2 with lower chlorinated MCCPs (e.g. 34% chlorination), and to a limited extent in the urine (ECB, 2008).

Acute toxicity

Oral

A number of unpublished studies are available in which rats received single oral gavage doses of up to 15 000 mg/kg MCCPs (Kuhnert, 1986a; Kuhnert, 1986b; Chater, 1978). No deaths occurred in any of these studies, thus MCCPs are not acutely toxic (cited from ECB, 2008).

Dermal

No animal studies are available in relation to MCCPs. However, data are available on SCCPs which indicate that no signs of local or systemic toxicity were seen in rats following dermal administration of 2800 mg/kg.

Inhalation

No data available. However, EU-RAR concludes that acute inhalation toxicity is expected to be low (ECB, 2008).


Skin

Based upon two standard animal studies, C14-17 chlorinated paraffins have been shown to cause only slight skin irritation on single exposure (ECB, 2008).

Eye

Several studies are cited in the Draft EU-RAR. Overall, these studies indicate that MCCPs have low eye irritation potential (ECB, 2008).

Sensitisation

No evidence of skin sensitisation was produced in guinea pig maximisation tests using C14-17 MCCPs (ECB, 2008).


No data relating to repeated inhalation or dermal exposure are available.

A number of oral studies in several rodent species are available which have investigated the repeated dose toxicity of C14-17, 40% or 52% chlorinated paraffins. A 90-day oral feeding study in rats was identified as key study. Rats (Fischer 344) were fed doses of: 2.38, 9.34, 23.0 and 222 mg/kg bw/day males and 2.51, 9.70, 24.6 and 242 mg/kg bw/day for females via diet. Overall, a NOAEL of 23 mg/kg bw/day is identified for repeated dose toxicity based upon effects seen in rat kidney (increased weight at the next dose level of 222 mg/kg bw/day and ‘chronic nephritis’ and tubular pigmentation at 625 mg/kg bw/day) (CXR, 2005) (cited from ECB, 2008).

Mutagenicity

MCCPs (40-52% chlorination) are not mutagenic to bacteria. No in vitro cytogenetic or gene mutation studies are available but negative results were obtained for SCCPs in a gene mutation assay. Three in vivo bone marrow studies demonstrate that MCCPs are not


mutagenic towards this target tissue. Negative results for in vivo genotoxicity tests in somatic and germ cells have been obtained for SCCPs.

Overall, the available data on MCCPs and SCCPs indicate that MCCPs do not possess genotoxic activity (ECB, 2008).

Carcinogenicity

Although no direct information is available, MCCPs are are generally unreactive and not mutagenic. In the absence of experimental carcinogenicity data on MCCPs, given the similarities between MCCPs and SCCPs in physicochemical properties and in the results obtained in relation to other toxicological endpoints, particularly the effects seen on the liver, thyroid and kidneys on repeated exposure, it seems reasonable to presume that the carcinogenic potential of MCCPs will be similar, at least in qualitative terms, to that of SCCPs. Overall, SCCPs, and by analogy MCCPs, should be considered not to pose a carcinogenic hazard to humans (ECB, 2008).



The two available animal studies showed that administration of up to approximately 100 and 400 mg/kg/day respectively in the diet had no apparent effect upon fertility.


No adverse effects occurring during gestation were produced in rats or rabbits in two conventional teratology studies using doses up to 5000 and 100 mg/kg/day respectively. Haemorrhaging was seen in one study at the time of parturition in 16% of dams given 538 mg/kg/day (6250 ppm) MCCPs, but not up to 100 mg/kg (1200 ppm) in other studies. The NOAEL of 100 mg/kg/day (1200 ppm) is therefore selected for the risk characterisation of haemorrhaging effects potentially occurring in pregnant women at the time of parturition (ECB, 2008).


MCCPs are currently classified according to regulation (EC) 1272/2008 with respect to their effects on human health as follows (Index No. 602-095-00-X):

• Lact. H362 (Suspected of damaging fertility or the unborn child.)

• R64 (May cause harm to breast-fed babies) and R66 (Repeated exposure may cause skin dryness or cracking).


The following scenarios for consumer exposure to MCCPs were presented in the draft EU-RAR for human health:

• Use of adhesives/sealants containing MCCPs

• Service life of rubber in building applications containing MCCPs

• Service life of plastic goods containing MCCPs

• Use of paints containing MCCPs


The outcome of the exposure assessment is summarised in the tabular format below, including short explanations:

Table 5-36: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on MCCP.

Route of exposure Exposure estimate (external) Comment taken from draft EU-RAR

Use of adhesives/sealants

The sealants are likely to be applied by a caulking gun in larger applications which would lead to limited dermal exposure.

Dermal negligible

Given the infrequency and short duration of use by a consumer (fitting a window frame for example), that they form a small proportion of the final product, and the physicochemical properties of very low volatility (around 2.2 x 10-3 Pa), the inhalation exposure will be negligible.

Inhalation negligible

Service life of rubber in building application

Exposure from the building applications of MCCPs is not applicable for the consumer because consumers do not come into contact with these products.

Not applicable Not applicable

Service life of plastic goods (PVC flooring or garden hoses)

Dermal negligible

Inhalation

Leaching rates are likely to be minimal due to the amounts used and the physicochemical properties of MCCPs, including low volatility and low solubility in water.

negligible

Use of paints

Dermal negligible

Inhalation

The main areas of application are mainly for industrial and commercial use and not in the kinds of paints or coatings commonly purchased by consumers. One exception is in the use of some paints used for coating swimming pools. The exposure from this source has not been measured but is thought to be negligible (personal communication).

negligible

Combined (multiple) consumer exposure: not applicable


Most applications of MCCP are not designed for consumer contact, and therefore exposures are clearly negligible. Hence, there are no exposure values from the use as flame retardant plasticiser to be taken forward to the risk characterisation.




Table 5-37: Summary of effects of MCCP brought forward to the risk characterisation:


Surface water 1 μg/L Lowest effect concentration: 21d-NOEC for Daphnia = 10 µg/l Assessment factor 10: reliable NOEC values are available for two trophic levels and considerable body of information available for other chlorinated paraffins (e.g. short-chain) that indicates that invertebrates, and Daphnia in particular, are more sensitive to long-term exposure to chlorinated paraffins than fish

STP 80 mg/L Lowest effect concentration: LOEC bacteria = 800 mg/L Assessment factor 10: deriving a PNEC for micro-organisms from approximates to a NOEC/LOEC value

Sediment 5 mg/kg dwt21 Lowest effect concentration: NOEC Lumbriculus variegatus and Hyalella azteca = 50 mg/kg wet wt. An assessment factor of 10 is appropriate for this data set

Terrestrial 0.8 mg/kg dry soil22

Lowest effect concentration: NOEC earthworm = 248 mg/kg wet wt. Assessment factor 10: reliable NOEC values are available for three trophic levels

Atmosphere23 NR No data are available on possible effects of the substance on the atmosphere. However, given the low volatility of the substance, neither biotic nor abiotic effects are likely

NR = not reported


A detailed description of the exposure assessment during service life and from waste and during waste management is provided in Annex 6 - chapter 5. In summary, the contribution of emissions from consumer product use to total emissions of MCCP during its life cycle can be considered to be negligible. Total emissions of MCCP throughout the complete life cycle equal 171.321 – 171.503 tonnes/year to air, 1,262.77 – 1,308.97 tonnes/year to waste water, 816.22 – 885.02 tonnes/year to surface water and finally 826 – 973 tonnes/year to urban/industrial soil.

21 As this PNEC is derived from actual sediment data using a sediment with a similar organic carbon content to the TGD default value (4.9%-5.0% compared with the TGD default of 5%), there is no need to normalise the value to the default organic carbon content and there is no need to increase the resulting PEC/PNEC ratios by a factor of 10 to take into account direct ingestion, i.e. the organisms in the test would have been exposed via both pore water and sediment-bound substance and so if direct ingestion was important it would be already taken account of in the toxicity results obtained. 22 The reported log Kow for short chain length chlorinated paraffins range from 4.39-8.69 and sothe equilibrium partitioning method is not really applicable to these substances. However, in the absence of any other data a tentative PNEC for soil can be calculated assuming a Ksoil-water of 2,736 m³/m³ 23 The potential for long-range transport (and subsequent accumulation) of the medium-chain chlorinated paraffins appears to be less than that for the short-chain. This is because the medium-chain chlorinated paraffins generally have lower vapour pressures, and are likely to adsorb more strongly to soil and sediment. However, the substance is a complex mixture with components exhibiting a range of physico-chemical properties. Some components of the commercial products might have properties that may mean that long-range transport via the atmosphere is a possibility. This issue should be considered further in the appropriate international fora



The EU RAR (European Chemicals Bureau, 2005) concluded that there is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already with regard to safeguarding the aquatic compartment, the sediment, the terrestrial compartment, the sewage treatment processes and the atmosphere. This conclusion applies to most industrial sources of MCCP. For a couple of industrial uses and for the formulation of metal cutting fluids, there is a need for limiting the risks to the aquatic compartment, the sediment (industrial uses only) and the terrestrial compartment (industrial uses only).

For secondary poisoning via the fish food chain from formulation and use of sealants and domestic applications of paints, there is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. This also applies to the assessment of secondary poisoning via the earthworm food chain for production (sites where no sewage sludge is applied to land), formulation and use of sealants, and domestic applications of paints. There is a need for limiting the risks: risk reduction measures wich are already being applied shall be taken into account. For the fish food chain this applies to production sites and several industrial uses. For the earthworm food chain, this conclusion applies to all the uses of medium-chain chlorinated paraffin, with the exception of production (sites where no sewage sludge is applied to land), formulation and use of sealants, and domestic applications of paints.

As such, it can be concluded that the consumer uses do not represent an environmental risk.

5.13 Magnesium hydroxide (CAS 1309-42-8 and 13760-51-5)

Magnesium hydroxide is used in flame retardant articles made of different plastic matrices (e.g. polypropylene, polystyrene and acrylnitril-butadiene-styrene), in which it is additively integrated. The applications known are in electric and electronic equipment, textiles, toys and construction materials available to consumers or in the domestic environment. Furthermore, it is added to preparations which need flame retardancy like certain paints, adhesives and sealants.



Very few information on magnesium hydroxide are available in the public domain. However, the toxicological effects of other inorganic magnesium compounds is based on the concentration of dissolved magnesium cations and therefore on the solubility. For the purpose of human health hazard assessment, read-across from other magnesium compounds with similar or higher water solubility to magnesium hydroxide is justified.


Magnesium hydroxide is emptied slowly from the stomach, prolonging its antacid action. About 5-15% of ingested magnesium is absorbed and this is readily excreted in the urine if kidney function is normal (Miller et al., 1979) (cited from ECB, 2000). Following the HERAG guidance for metals and metal salts, a dermal absorption rate in the range of


max. 0.1-1.0 % can be anticipated (EBRC, 2007). Dermal absorption in this order of magnitude is not considered to be “significant”.

Acute toxicity

Magnesium hydroxide has an acute oral toxicity in rat and mice of LD50: 8,500 mg/kg (RTECS, 1999) (cited from Stuer-Lauridsen et al., 2000).

No relevant experimental toxicity data via the dermal route or inhalation is reported for magnesium hydroxide.


For Magnesium hydroxide no relevant experimental data on skin or eye irritation are reported in the public domain. However, according to suppliers of the substance it is indicated that it may irritate or injure the eye and that repeated or prolonged contact may cause skin irritation (Supplier MSDS: http://www.sealers.com/msds/thio.htm) (cited from Stuer-Lauridsen et al., 2000).

An aqueous solution of magnesium hydroxide has a pH value of 9.5 to 10.5, thus a pH-dependant skin and eye irritation potential cannot be excluded (O'Neil, 2001).

No data on sensitisation are available. However, magnesium is abundantly distributed throughout the human body. Thus, sensitising properties of that substance can safely be excluded.


Oral

Male and female rats (Fischer 344) were treated with magnesium chloride hexahydrate in a 90-days oral, feed study at doses of 2.5%, 0.5% and 0.1% test substance (nominal in diet). A NOAEL of 308 mg/kg bw/day (male) was set, based on transient soft stool in the 2.5% group and suppression of body weight gain. A NOAEL of 299 mg/kg bw/day (female) based on transient soft stool in the 2.5% group (Takizawa et al., 2000).

Male and female rats (Wistar) were treated with magnesium distearate in a 90-days oral, feed study at doses of 20%, 10% and 5% test substance (nominal in diet). A NOAEL of 2500 mg/kg bw/day (male and female) was set, based on reduction in relative liver weight at 10 and 20% magnesium sterarate in the diet (Sondergaard, 1990).

Male and female mice (B6C3F1) were treated with magnesium chloride hexahydrate in a 90-days oral, feed study at doses of 5%, 2.5%, 1.25%, 0.6% and 0.3% test substance (nominal in diet). A NOAEL of 2690 mg/kg bw/day (male and female) was set, based on effects on kidney weights and minimal renal tubular changes in male mice at 2.5% and 5 % in the diet (Tanaka et al., 1994).

Male and female mice (B6C3F1) were treated with magnesium chloride hexahydrate in a 96-weeks oral, feed study at doses of 2% and 0.5% test substance (nominal in diet). A NOAEL of 730 mg/kg bw/day (female) was set, based on decresaed body weight at 2% magnesium chloride in the diet (Kurata et al., 1989).

Dermal

No relevant experimental dermal repeated dose toxicity data is reported for magnesium hydroxide.

Inhalation


No relevant experimental animal inhalation repeated dose toxicity data is reported for magnesium hydroxide, human data is reported further below.

Mutagenicity

No relevant experimental genetic toxicity data is reported for magnesium hydroxide.

However, regarding the genetic toxicity of magnesium compounds, the following comments are put forward:

• - the German federal institute for risk assessment (BfR) has conducted a comprehensive risk assessment on health effects associated with either magnesium deficiency (hypomagnesaemia) or increased systemic magnesium levels (hypermagnesaemia). It was concluded that the only adverse effect following overdosage (>250mg per day in a single dose) is an osmosis-related reversible diarrhoea (Domke et al., 2006)

• - magnesium is abundantly distributed throughout the human body, with the highest concentration in muscle (270mM) and bone (530mM). Further blood concentrations are reported as 27.1-43.9mg/L. The majority of the systemic magnesium is present intracellularly, since over 300 enzymes are magnesium depended for the correct functioning of the catalytic reactions (Swaminathan, 2003; Iyengar et al., 1978)

• - in vitro genotoxicity tests are conducted with mammalians cells in standard cell culture media such as DMEM, Ham’s F12 and RPMI1640 which are supplemented with magnesium salts at concentrations ranging from 0.6 to 0.85mM.

Carcinogenicity

No evidence of a carcinogenic potential was found in male and female B6C3F1 mice fed diets containing up to 2% magnesium chloride hexahydrate corresponding to 2810 and 3930 mg/kg bw/d (Kurata et al., 1989).


No relevant experimental data on reproductive toxicity is reported for magnesium hydroxide. However, based on human experience, reproductive toxicity for magnesium hydroxide can safely be excluded.

Human data

Kuschner (1997) reports that inhalation of fine and ultrafine magnesium oxide particles to humans at concentrations up to 230 mg/m³ over 15 minutes or 143 mg/m³ over 45 minutes did not result in any adverse effects (inflammation markers, or subjective symptoms). This result suggests that inhalation of magnesium oxide dust does not produce adverse effects up to these concentrations. In consequence, local effects are not anticipated for this substance.

In a comprehensive evaluation of possible adverse health effects of individual nutrients at intakes in excess of dietary requirements presented in the scientific opinions of the Scientific Committee on Food, the sources, properties and effects of magnesium on animals as well as on different subgroups of the human population have been re-evaluated and a tolerable upper intake level for magnesium has been defined. The SCF decided to base the derivation of an UL for magnesium on the evidence of different interventional studies of long duration in adults, some of which were placebo-controlled and in which total daily magnesium intakes of 250 mg from both the diet and supplements


were tolerated without any adverse effects. Based on the findings, a tolerable upper intake level of 250 mg of magnesium per day for magnesium intake from all sources is proposed for adults, corresponding to a dose of about 3.6 mg magnesium/kg bw/d taking into account an average body weight of 70 kg/person. The UL is considered to also cover any potential systemic repeated dose toxicity effects (Scientific Committee on Food, 2001).



Table 5-38: Summary of human health effect data for magnesium hydroxide brought forward to the risk characterisation:


Inhalation Repeated dose toxicity – human data Humans / lifetime

250 mg/person(=3.6 mg Mg/kg bw/d at an average bw of 70 kg/person)

4.56 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. A conversion from magnesium to magnesium hydroxide has been done based on the molecular weight


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to magnesium hydroxide have been provided for three consumer applications:

• Service life of electric and electronic equipment containing magnesium hydroxide in housings or small exterior parts

• Service life of wire and cable containing magnesium hydroxide

• Service life of textiles used for furniture or flooring containing magnesium hydroxide.


Table 5-39: Consumer exposure estimates to magnesium hydroxide.


Service life of electric and electronic equipment (housing, exterior parts)

Due to the very low vapour pressure of magnesium hydroxide and the task involved, no inhalation exposure needs to be considered.

Inhalation -


Due to the very low vapour pressure of magnesium hydroxide and the task involved, no inhalation exposure needs to be considered.

Inhalation -

Service life of textiles for carpets or furniture

Dermal -

Qualitative assessment Due to the possible skin irritating properties of magnesium hydroxide repeated or prolonged contact needs to be avoided. However, after



inclusion into a polymeric matrix it is unlikely that magnesium hydroxide still exists as such and may migrate out of the matrix. It is most likely that instead magnesium ions migrate out of the matrix if any. Due to the negligible dermal absorption of magnesium (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for magnesium cations following exposure to skin, the dermal route is not a relevant exposure path from the toxicological point. Thus, dermal exposure has not been assessed.

Flame retardants might be worn away during everyday use of the upholstery or carpet and some of the particles might be small enough to be entrained into the air of the room and be inhaled. Gardner et al. (2000) provided an exposure estimate for a room airborne particle concentration of magnesium hydroxide resulting from abrasion of upholstery.

Inhalation 1.5 µg/m³ (airborne particle concentration)


One sub-scenario has been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-40: Tentative risk assessment to magnesium hydroxide for consumers.

Exposure scenario Route of exposure Exposure estimate DNEL RCR

Service life of textiles for carpets or furniture Inhalation 1.5 µg/m³ 4.56 mg Mg(OH)2/m³ 3.3 * 10-4


Inhalation exposure to airborne particulates has been assessed by the use of a higher tier exposure assessment provided in Gardner et al. (2000). The dermal exposure has not been assessed, due to the negligible dermal absorption of magnesium (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for magnesium cations following exposure to skin. The dermal route was thus considered not to be a relevant exposure path.

Regarding the hazard assessment, very few information on magnesium hydroxide are available in the public domain. However, the toxicological effects of other inorganic magnesium compounds are used for read across. In view of the lack of route specific data for inhalation exposure, route-to-route extrapolation was conducted based on the tolerable upper intake level for magnesium of 250 mg/ person/day as the starting point.

Altogether this tentative risk assessment to magnesium hydroxide from consumer applications beeing performed showed no risk for the applications considered.



The substance is intended to be registered under REACH by 2010. As such, no environmental effect data were collected in the framework of this study.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. . As such, no environmental exposure data for the service life phase were collected in the framework of this study.

The disposal phase as considered in this study (landfill, incineration) is not covered by REACH. No substance specific information was found through a literature search on emissions from disposal (landfill and incineration). As such, environmental exposure at disposal phase could not be assessed in this report.


Since environmental exposure was not assessed at disposal phase, no environmental risk assessment for that phase was carried out in this study.

5.14 Boehmite (aluminium hydroxideoxide) (CAS 1318-23-6)

Boehmite is additively integrated in various matrices. Available data on its use refer to electric and electronic equipment, such as printed circuits boards and wire & cable.



The database on human health effects data for aluminium hydroxide oxide is poor. However, a read-across to aluminium hydroxide is proposed based on the following information: During precipitation of readily soluble aluminium slats, a cloudy precipitate of aluminium tri hydroxide is observed. Technically this precipitate is referred as aluminium oxide hydrates or alum earth, which converts slowly (quicker upon heating) to aluminium hydroxide oxide upon water elimination. Based on these physico-chemical properties of aluminium hydroxide oxide, a read-across to human health hazard data of aluminium hydroxide is justified without restriction.


No data available. However, following the HERAG guidance for metals and metal salts, a dermal absorption rate in the range of max. 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant” (EBRC, 2007).

Acute toxicity

Oral

Boehmite has a LD50 (oral) in rat of > 5050 mg/kg bw (Catapal, 1990) (Vista Catapal Fines, 1990) (cited from ECB, 2000).


Dermal

No data available (ECB, 2000). However, a dermal absorption rate in the range of 0.1 % can be anticipated for aluminium hydroxide oxide, which is not considered to be “significant”.

Inhalation

Following 4 hours exposure the LC50 (rat) for acute inhalation toxicity is > 5.09 mg/L (Vista Catapal Fines, 1990) (cited from ECB, 2000).


Skin

In two separate tests Boehmite was not skin irritating (Catapal, 1990; Vista Catapal Fines, 1990) (cited from ECB, 2000).

Eye

In two separate tests Boehmite was not eye irritating (Catapal, 1990; Vista Catapal Fines, 1990) (cited from ECB, 2000).

Sensitisation

In a Buehler test Boehmite was not sensitizing (Vista Catapal Fines, 1990) (cited from ECB, 2000).


Oral

No data available (ECB, 2000).

Dermal

No data available (ECB, 2000). However, a dermal absorption rate in the range of 0.1 % can be anticipated for aluminium hydroxide oxide, which is not considered to be “significant”.

Inhalation

One experimental inhalation study in guinea pig was conducted over 6 month with, at a dosage of 40-120 mg/m³, 48 hours per week. The NOAEL was determined to be > 120 mg/m³ (Dinman, 1988) (cited from ECB, 2000).

Mutagenicity


Carcinogenicity

No relevant data on carcinogenicity is available. Two studies with an unphysiological route of exposure were identified- references are considered inadequate for hazard assessment.

30 rats per sex were i.p. administered at a dose of 25 mg pseudoboehmite (in saline) over an exposure period of 105-110 weeks. Two mesotheliomas were observed in the male rats. None were observed in the female rats (Mobil Research and Development Corporation, 1990) (cited from ECB, 2000).

30 rats per sex were s.c. administered at a dose of 25 mg pseudoboehmite (in saline) over an exposure period of 105-110 weeks. One anaplastic sarcoma was observed in one male


rat. None were observed in female rats (Mobil Research and Development Corporation, 1990) (cited from ECB, 2000).





Table 5-41: Summary of human health effect data for aluminium hydroxide oxide brought forward to the risk characterisation.


Oral Repeated dose toxicity – animal data

Rat / 28-days oral/ 0, 302 mg/kg/d

NOAEL: 302 mg Al(OH)3/kg/d

0.015 mg/kg/d

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. A conversion from aluminium hydroxide to aluminium hydroxide oxide has been done based on the molecular weight.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to aluminium hydroxide oxide have been provided for three consumer applications:

• Service life of electric and electronic equipment containing aluminium hydroxide oxide in the housing or small exterior parts.

• Service life of wires and cables containing aluminium hydroxide oxide.

• Service life of toys containing aluminium hydroxide oxide in the outer part (assumed, due to inconclusive information).


Table 5-42: Consumer exposure estimates to aluminium hydroxide oxide


Service life of electric and electronic equipment (interior part)

Due to the very low vapour pressure of the ionic substance aluminium hydroxide oxide even at elevated temperature which will occur in the internal part of electric and electronic equipment, no inhalation exposure needs to be considered.

Inhalation -


Inhalation - Due to the very low vapour pressure of the ionic substance aluminium hydroxide oxide and the task involved, no inhalation exposure needs to



be considered.

Service life of toys

1.Tier assessment using ECETOC-TRA (AC13, toys and a max concentration of 60%) Oral 0.6 mg/kg bw/d (child)

Due to the negligible dermal absorption of aluminium hydroxie oxide (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for aluminium cations following exposure to skin, the dermal route is not a relevant exposure path. Thus, dermal exposure has not been assessed.

Dermal -


One sub-scenario has been identified for which a quantitative risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-43: Tentative risk assessment of aluminium hydroxide oxide for consumers.


Service life of toys oral 0.6 mg/kg bw/d (child) 0.015 mg/kg bw/d 40


A first tier oral exposure assessment to aluminium hydroxide oxide using the ECETOC TRA Consumer tool has been performed. The inhalative exposure to aluminium hydroxide oxide vapour has been considered not relevant due to the ionic nature of the substance. The dermal exposure has not been assessed, due to the negligible dermal absorption of aluminium (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for aluminium cations following exposure to skin. The dermal route was thus considered not to be a relevant exposure pathway.

Regarding the hazard assessment, very few information on aluminium hydroxide oxide are available in the public domain. However, the toxicological effects of other inorganic aluminium compounds are used for read across. A NOAEL for systemic oral toxicity of 302 mg/kg bw/d from a dietary 28-day toxicity study with aluminium hydroxide in rats was used. This represents a conservative approach, because no systemic effects were observed in this study and the true NOAEL is expected to be above the highest dose. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

However, this conservative, tentative risk assessment using conservative exposure estimations (1. Tier) and an upper limit DNEL showed a risk with respect to the scenario sucking on toys containing aluminium hydroxide oxide. The exposure for the dermal and inhalation route has been considered to be not relevant.





The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. As such, no environmental exposure data for the service life phase were collected in the framework of this study.




5.15 Aluminium hydroxide (CAS 1318-23-7 and 21645-51-2)

Aluminium hydroxide is used in flame retardant articles made of different plastic matrices (e.g. PVC, acrylnitrile-butadiene-styrene or polyethylene), in which it is assumed to be additively integrated. The applications known are mainly wire and cable but also electric and electronic equipment, textiles, furniture, toys and construction materials available to consumers or in the domestic environment.



Very few information on aluminium hydroxide are available in the public domain. However, the toxicological effects of other inorganic aluminium compounds is based on the concentration of dissolved aluminium cations and therefore on the solubility. For the purpose of human health hazard assessment, read-across from other aluminium compounds with similar or higher water solubility to aluminium hydroxide is justified.


Aluminum is poorly absorbed following either oral or inhalation exposure and is essentially not absorbed dermally. Approximately 0.1–0.6 % of ingested aluminum is usually absorbed, although absorption of less bioavailable forms, such as aluminum hydroxide, can be in the order of 0.1%. The unabsorbed aluminum is excreted in the feces. The toxicokinetics of aluminum can vary, depending on the nature of these complexes. For example, aluminum bound in a low-molecular-weight complex could be filtered at the renal glomeruli and excreted, while aluminum in a high-molecular-weight complex (aluminum transferrin) would not (ATSDR, 2008).

Acute toxicity

Oral


The acute toxicity of metallic aluminium and aluminium compounds is low, the reported oral LD50 values being in the range of several hundred to 1000 mg aluminium/kg body weight per day.

Because aluminium is only sparingly absorbed from the gut, the oral LD50 values for aluminium ingestion are unavailable, since death occurs from intestinal blockage due to precipitated aluminium species rather than systemic aluminium toxicity (HSDB, 1999) (cited from Stuer-Lauridsen et al. 2000). The only LD50 value (>5000 mg/kg bw) found supports this (ECB, 1996) (cited from Stuer-Lauridsen et al., 2000) (Martinswerk GmbH, 1989) (cited from ECB, 2000).

Dermal

No relevant experimental toxicity data via the dermal route is reported for aluminium hydroxide.

Inhalation

No deaths were reported following an acute 4-hour exposure to up to 1,000 mg/m³ of aluminium oxide in groups of 12–18 male Fischer 344 rats (Thomson et al., 1986) (cited from ATSDR, 2008).


Skin

Not a skin irritant (ECB, 1996) (cited from Stuer-Lauridsen et al., 2000). Aluminium hydroxide (powder) was not irritating on rabbit skin (Martinswerk GmbH, 1989) (cited from ECB, 2000).

Eye

One study indicates that aluminium hydroxide is not an eye irritant (ECB, 1996) (cited from Stuer-Lauridsen et al., 2000) (Martinswerk GmbH, 1989) (cited from ECB, 2000).

Sensitisation

No data available. However, aluminium hydroxide and other aluminium compounds have a wide dispersive use as additive in cosmetic products (e.g. as antiperspirants). Thus, skin sensitising properties can safely be excluded.


Oral

No aluminium-related deaths in healthy humans have been reported after oral exposure. No mortality was observed in male Sprague-Dawley rats (7–10 per group) orally exposed to 70 mg Al/kg/day as aluminium chloride in water for 30, 60, or 90 days (Dixon et al., 1979), or up to 158 mg Al/kg/day as aluminium hydroxide in the feed for 16 days (Greger, Donnaubauer, 1986); these doses do not include aluminium in the base diet (cited from ATSDR, 2008).

Dietary administration of aluminium hydroxide was examined in male Sprague-Dawley rats. 25 Rats were fed a diet containing 14,470 ppm aluminium hydroxide for 28 days. The mean daily aluminium dose was calculated as 302 mg/kg body weight/day. Dietary administration of aluminium hydroxide did not induce any signs of toxicity. Clinical observations were similar in control and treated rats. There were no significant changes in haematology, clinical chemistry parameters, or organ weights. Histopathological examination of tissues revealed no treatment related changes. Ingestion of aluminium


hydroxide caused no significant deposition of Al in bone samples (HSDB, 1999) (cited from Stuer-Lauridsen et al., 2000).

Dermal

No relevant experimental toxicity data via the dermal route is reported for aluminium hydroxide. However, a dermal absorption rate in the range of 0.1 % can be anticipated for aluminium hydroxide, which is not considered to be “significant”.

Inhalation

Pigott et al. (1981) did not find evidence of lung fibrosis in rats exposed to 2.18 or 2.45 mg/m³ for 86 weeks, 5 days per week, 6 hours per day. Exposure was towards manufactured or aged Saffil alumina fibers, being a refractory material containing aluminium oxide and about 4% silica. Exposed was followed by a 42-week observation period. A NOAEL of 2.45 mg/m³ will be used for hazard assessment (ATSDR, 2008).

Mutagenicity

Aluminium compounds have been evaluated as non-mutagenic by most standard methods of mutagenic assays (HSDB, 1999) (cited from Stuer-Lauridsen et al., 2000).

Carcinogenicity

No studies were identified regarding cancer effects in humans following acute- or intermediate-duration inhalation exposure to various forms of aluminium. An increase in cancer was not observed in male and female Wistar rats exposed via whole-body inhalation to atmospheres containing 2.18–2.45 mg Al/m3 as alumina fibers (≈96% aluminium oxide) for 86 weeks (Pigott et al., 1981) (ATSDR, 2008).


Aluminium hydroxide did not produce either maternal or developmental toxicity when it was administered by gavage during embryogenesis to rats (Gómez et al., 1990) or mice (Domingo et al., 1989) (cited from WHO, 1997).


Chronic studies showed no histological changes in the testes or ovaries of male and female Wistar rats fed a diet containing unspecified levels of aluminium phosphide/ammonium carbamate for 24 months (Hackenberg, 1972), or in B6C3F1 mice that ingested 979 mg Al/kg/day as dietary aluminium potassium sulfate for 20 months (Oneda et al., 1994). The doses in the latter study do not include aluminum in the base diet. Neither mouse study assessed reproductive function (cited from ATSDR, 2008).

Mating success (numbers of litters and offspring) was not affected in a three-generation study with Dobra Voda mice that were exposed to 49 mg Al/kg/day as aluminium chloride in drinking water and base diet over a period of 180–390 days (Ondreicka et al., 1966) (cited from ATSDR, 2008).


In one study, concentrations of aluminium ranging from 500 to 1,000 ug/g body weight were added to the diets of pregnant rats from day 6 to day 19 of gestation, when the foetuses were removed by Caesarean section. Aluminium in the diet did not affect embryo or foetal mortality rate, litter size, foetal body weight, or length (HSDB, 1999) (cited from Stuer-Lauridsen et al., 2000). 5-16 days’ exposure of mice did not lead to material toxicity,


embryo/foetal toxicity or teratogenicity (ECB, 1996) (cited from Stuer-Lauridsen et al., 2000).

One teratogenicity study on mice (dosage: 0, 66.5, 133, 266 mg/kg, gavage), duration of test from gestation days 6-18 and exposure from days 6-15 showed no evidence of maternal toxicity, embryo/foetal toxicity or teratogenicity (Domingo et al., 1989) (cited from ECB, 2000; cited from ATSDR, 2008).

Human data

Aluminium hydroxide is one of the main sources to aluminium in the body. The implications of previous reports of elevated aluminium concentration in patients with Alzheimer's disease for the treatment of the disease are discussed. At the present time there is no conclusive evidence that active attempt to alter aluminium concentration in diet or medicines produce any beneficial effect in Alzheimer's disease (HSDB, 1999) (cited from Stuer-Lauridsen et al., 2000).



Table 5-44: Summary of human health effect data for aluminium hydroxide brought forward to the risk characterisation:



Rat / 28-days inhalation/ 0, 2.15, 2.45 mg/m³ NOAEC: 2.45 mg Al/m³ 0.14 mg/m³

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. A conversion from aluminium to aluminium hydroxide has been done based on the molecular weight.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to aluminium hydroxide could be provided for two consumer applications:

• Service life of wire and cable containing aluminium hydroxide.

• Service life of PVC flooring containing aluminium hydroxide.

Besides the exposure estimates, the model and the parameters used for the estimations are provided inTable 5-45.

Table 5-45: Exposure estimates to aluminium hydroxide



Due to the very low vapour pressure of aluminium hydroxide and the task involved, no inhalation exposure needs to be considered.

Inhalation -

Service life of PVC flooring



Due to the negligible dermal absorption of aluminium hydroxide and aluminium (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected following exposure to skin, the dermal route is not a relevant exposure path. Thus, dermal exposure has not been assessed.

Dermal -

Inhalation - (vapour) 52.5 μg/m3 (airborne particulates)

(i) Vapour: Due to the very low vapour pressure of the ionic substance aluminium hydroxide the inhalation exposure to vapour can be regarded as negligible. (ii) Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g aluminium hydroxide per g dust as a unrealistic worst case assumption, due to the lack of measured data.



Table 5-46: Tentative risk assessment to aluminium hydroxide for consumers.


Airborne particles inhalation 0.052 mg/m³ 0.14 mg/m³ 0.37


Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions. The inhalation exposure to aluminium hydroxide vapour has been considered not relevant due to the ionic nature of the substance. The dermal exposure has not been assessed, due to the negligible dermal absorption of aluminium (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for aluminium cations following exposure to skin. The dermal route was thus considered not to be a relevant exposure pathway.

Regarding the hazard assessment, very few information on aluminium hydroxide are available in the public domain. However, the toxicological effects of other inorganic aluminium compounds are used for read across. There is only limited information available on systemic toxicity resulting from inhalation exposure in animals. Due to the limitations of the data base, the lower NOAEC of 2.45 mg/m3 from a chronic inhalation toxicity/cancerogenicity study with aluminium oxide in rats is used for DNEL derivation. Therefore, the DNEL derived can be regarded being of conservative nature.


Altogether a rather conservative tentative risk assessment to aluminium hydroxide from consumer applications has been performed showing no risk for all the applications and routes considered.




The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. As such, no environmental exposure data for the service life phase were collected in the framework of this study.

The disposal phase as considered in this study (landfill, incineration) is not covered by REACH.

Dijkstra et al. (2005) investigated the leaching of major, amongst others aluminium, and trace elements from MSWI bottom ash as a function of pH and time. The risks associated with the presence of potentially hazardous constituents in waste materials, with respect to their mobility and ecotoxicological significance, are determined by their leaching potential rather than their total content (van der Sloot et al. 1997, Kosson et al. 2002; in Dijkstra et al., 2005). The evaluation of the pH dependency of leaching is an important tool in the assessment of the expected long-term leaching behavior of materials in utilization/disposal scenarios (van der Sloot et al., 1997).

Figure 5-1: measured concentrations of aluminium as a function of pH (left) and different equilibration times (right, expressed as relative concentration, C = concentration at different equilibration times, Cmax = maximum concentration); gibb = gibbsite, ett = ettringite.

Figure 5-1 gives the measured concentrations of aluminium as a function of pH and different equilibration times. In the concentration–pH diagram, clear time trends are indicated with arrows. For clarity, equilibrium model curves are only shown for the situation after 168 h.





5.16 Triphenyl phosphate (CAS 115-86-6)

Triphenyl phosphate is used in flame retardant articles made of PVC, in which it is additively integrated. The applications known are wire and cable and furniture made of artificial leather (PVC) available to consumers.

An environmental risk assessment on this substance was carried out by the U.K. Environmental Agency (Brooke et al., 2009). A summary of the relevant chapters is given in Annex 6 – chapter 15. Although no consumer risk assessment was carried out, the toxicological information mentioned in Brooke et al. (2009a) was cited hereafter.




There are no valid in vivo data on the absorption, distribution and elimination of triphenyl phosphate in mammals, including humans. There is only one valid in vitro study, showing that triphenyl phosphate is metabolised by hydrolysis (in rat liver homogenate) to the major metabolite diphenyl phosphate (Sasaki et al., 1984, cited in OECD, 2002, 2005) (cited from Brooke et al., 2009a).

Acute toxicity

Oral

No studies conducted to current test guidelines are available for acute oral toxicity. However, the many limited studies allow adoption of a weight of evidence approach. After oral administration to rats, mice, rabbits, guinea pigs and hens, LD50 values are all in a range from 3,000 to above 20,000 mg/kg bodyweight.

Dermal

The toxicity of triphenyl phosphate after dermal application is LD50 of above 7,900 mg/kg bodyweight in rabbits (cited from Brooke et al., 2009a).

Inhalation

No reliable, valid data are available (cited from Brooke et al., 2009a)


Skin

In one OECD TG 404 study and two other reasonable quality, valid studies there was no evidence to suggest that triphenyl phosphate has skin irritation potential (cited from Brooke et al., 2009a).

Eye


There is evidence from a study conducted to OECD TG 405 and other adequate studies that triphenyl phosphate causes mild reversible irritation to the eye, primarily to the conjunctiva. However, this initial irritation was thought to be mechanically induced. Thus, it was concluded that the test substance did not have a significant potential to cause eye irritation (cited from Brooke et al., 2009a).

Sensitisation

There are a few human case reports showing evidence of skin sensitisation. However, the incidence of skin sensitisation is low, and the causative agent is often uncertain. Triphenyl phosphate was negative for skin sensitisation in a good quality guinea pig study conducted to OECD test guideline 406 and GLP (cited from Brooke et al., 2009a).


Oral

Overall, general well being, immune and nervous systems were not affected by exposure to triphenyl phosphate. The NOAEL for repeated dose toxicity is 70 mg/kg bw/day, based on decreased bodyweight and increased liver weight following administration of triphenyl phosphate at a higher dose of around 350 mg/kg bw/day to rats for 35 days (cited from Brooke et al., 2009a).

Dermal

The low general toxicity was confirmed after dermal exposure of 100 or 1,000 mg/kg bodyweight in rabbits for 15 days without any apparent sign of toxicity besides an unquantified depression of acetylcholinesterase as the only dose-related effect (cited from Brooke et al., 2009a).

Inhalation

No data available (cited from Brooke et al., 2009a)

Mutagenicity

Tests for gene mutations in bacterial reverse mutation test, mammalian cells and yeast did not reveal any sign of mutagenicity (OECD, 2002; WHO, 1991). In addition, triphenyl phosphate does not appear to induce unscheduled DNA synthesis based on the results of a UDS test (cited from Brooke et al., 2009a).

Carcinogenicity

No long-term carcinogenicity bioassays are available for triphenyl phosphate (cited from Brooke et al., 2009a).


In a study conducted by Welsh et al. (1987), there were no significant differences in the number of corpora lutea, implants, implantation efficiency, viable foetuses and number of early or late resorptions following dietary exposure to triphenyl phosphate up to 1.0 per cent (approximately 690 mg/kg bw/day) for 91 days prior to mating, and during mating and gestation. There was also no effect on litter size, thus providing evidence that triphenyl phosphate does not affect fertility in the rat. There were also no treatment-related effects on fetal development. Hence, the NOAEL for fertility and developmental toxicity was greater than the highest dose of 690 mg/kg bw/day (cited from Brooke et al., 2009a).

Human data


There are no human data on the potential for triphenyl phosphate to cause adverse health effects following repeated exposure by any route (cited from Brooke et al., 2009a).


Triphenyl phosphate is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-47: Summary of human health effects data for triphenyl phosphate brought forward to the risk characterisation:

Species/treatment Route Endpoint period/Dose regimen Point of departure DNEL*


Rat / 3 weeks dermal/ 0, 100, 1000 mg/kg/d NOAEL> 1000 mg /kg/d 1.7 mg/kg/d


Rat / 35-days oral/ 0, 0.1, 0.5% in diet

NOEL: 70 mg/kg/d 0.2 mg/m³

(30 mg/m³)**

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. ** Corrected point of departure, derived from route to route extrapolation.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to triphenyl phosphate have been provided for two consumer applications:

• Service life of wire and cable containing triphenyl phosphate

• Service life of furniture e.g sofa containing triphenyl phosphate in the artificial leather


Table 5-48: Consumer exposure estimates to triphenyl phosphate



Inhalation < 0.1 * 10-4 mg/m³ Please refer to the monitoring data given below.

Service life of furniture

Dermal 36.5 mg/kg bw/day 1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of 25%)

Inhalation < 0.1 * 10-4 mg/m³ 94.5 * 10-6 mg/m³ (airborne particulates)

Please refer to the monitoring data given below.

Monitoring data

< 0.1 * 10-4 mg/m³ Inhalation (indoor air) Monitoring data of indoor air sampling at residential and public buildings showed triphenyl phosphate concentrations of 0.1



μg/m³ at maximum in Sweden (Carlsson et al., 1997), Germany (Hansen et al., 2001), and Japan (Otake et al., 2001) (cited from OECD, 2006).

Inhalation (airborne particulates) 94.5 * 10-6 mg/m³

Higher tier assessment: Due to the absence of measured data or realistic models on the release of TPP as debris from furniture measured data of house dust has been used. TPP was detected in house dust by Becker et al. (2004). When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) 1.8μg TPP /g dust (95th percentile) corresponds to 94.5 ng TPP /m3 (read-across from EU-RAR on Diantimony trioxide) (cited from ECB, 2008).



Table 5-49: Tentative risk assessment to triphenyl phosphate for consumers.


Indoor air (monitoring data) Inhalation < 0.1 * 10-4 mg/m³ 0.2 mg/m³ <0.5 * 10-4

Service life of furniture Dermal 36.5 mg/kg bw/d 1.7 mg/kg bw/d 21.5

Airborne particulates (monitoring data) Inhalation 94.5 * 10-6 mg/m³ 0.2 mg/m³ 4.7 * 10-4


A first tier dermal exposure assessment to triphenyl phosphate using the ECETOC TRA Consumer tool has been performed; whereas the inhalation exposure assessment is based on monitoring data.

During a second industry consultation period it was explained by industry that the concentration of the flame retardant in the final matrix (artificial leather) used for the dermal exposure assessment refers to a mixture of flame retardants, whereas triphenyl phosphate is only present to a small extent in this mixture (confidential personal communication 01-2011 Albermale). Taking the new figure given by industry a reduction in the dermal exposure estimate leads to a RCR < 1.

Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized. No evidence of specific organ toxicity (neurotoxicity or immunotoxicity) as well as effects on the reproduction and development are given. Based on the available studies in rats or rabbits, the toxicity after oral and dermal repeated administration with triphenyl phosphate is low. Overall, general wellbeing, immune and nervous systems were


not affected by exposure to triphenyl phosphate. There are no appropriate studies on carcinogenicity available, but negative information is available based on in-vitro mutagenicity studies and an UDS test. However, it is not possible to fully evaluate the genotoxic potential of triphenyl phosphate. In view of the lack of route specific data for inhalation exposure, route-to-route extrapolation was conducted based on the starting point of an oral NOEL of 70 mg/kg bw/d based on a 35 day sub-chronic toxicity study in rats. A NOAEL of > 1000 mg/kg bw/d was selected as starting point for the dermal DNEL derivation. This represents a conservative approach, because no systemic effects were observed in this study, and the true NOAEL was expected to be above the highest dose. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

The first tier tentative risk assessment performed for the dermal route using conservative exposure estimations and an upper limit DNEL showed a risk with respect to exposure to furniture. Using new confidential information from industry the exposure was reduced and thus resulting in no risk for the dermal route. No risk has been identified for the inhalation route using measured exposure data.


Table 5-50: Environmental effects for triphenyl phosphate, as reported by Brookes et al. (2009):


Surface water 0.74 μg/L Alternative: 3.2 µg/L

Lowest effect concentration: 30d-EC10 growth of rainbow trout sac fry = 0.037 mg/L Assessment factor 50: reliable NOEC values are available for two trophic levels Alternative: estimated NOEC for invertebrates using log(measured NOEC) = -0.2279*log(EPI estimated Kow) – 5.9317 = 0.032 mg/L Assessment factor: 10

STP 0.51 mg/L Lowest effect concentration: IC50 for Tetrahymena pyriformis = 5.05 mg/L Assessment factor 10 A NOEC of 100 mg/L could be inferred from the positive results in a MITI I test. This would give a PNEC of 10 mg/L. This is considered in the risk characterisation section

Sediment 0.16 mg/kg wwt

There are no studies available on sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms * 1000 where Ksed-water = sediment/water partition coefficient = 251 m³/m³ Psed = bulk density of wet sediment = 1,150 kg/m³

Terrestrial 0.13 mg/kg wwt

A contact study with insects is reported, but the results are not suitable for PNEC derivation. The PNECsoil was obtained by the equilibrium partitioning method: PNECsoil = Ksoil-water / Psed * PNECaquatic organisms * 1000 where Ksoil-water = soil/water partition coefficient = 300 m³/m³ Psed = bulk density of wet sediment = 1,700 kg/m³ An additional factor of ten is applied to PEC/PNEC ratios in view of the high sorption coefficient to organic carbon and



consequent potential for uptake via the solid phase

Atmosphere NR No information is available on the toxicity of triphenyl phosphate to plants and other organisms exposed via air. The low vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be low. The possibility of triphenyl phosphate contributing to atmospheric effects such as global warming and acid rain is thus likely to be small. In addition, as the substance does not contain halogen atoms, it will not contribute to ozone depletion


The major current areas of use of triphenyl phosphate include printed circuit boards, thermoplastic/styrenic polymers, thermosets and epoxy resins, and photographic film. Triphenyl phosphate is additively integrated in the matrix. Environmental exposure during service life and from waste and during waste management was assessed. In summary, releases of triphenyl phosphate during service life and disposal of consumer products contribute to a minor extent to the total environmental emissions of that substance to air (5%). Consumer use is almost entirely accountable for total releases to soil (99.9%). Consumer use contributes around 50% to the total releases to water (wastewater + surface water).

A detailed overview of the uses and the exposure assessment is given in Annex 6 – chapter 15.


The PEC/PNEC ratios calculated in the UK RAR (Brooke et al., 2009) are given in Table 5-51.

Table 5-51: PEC/PNEC ratios for triphenyl phosphate calculated in the UK RAR (Brooke et al., 2009)

Compartment Source(s) PEC/PNEC

Surface water Regional 0.01

STP Only available for production phase -

Sediment Regional 0.15

Terrestrial Regional: Agricultural soil Natural soil Industrial soil

<0.01 <0.01 0.39

From the above mentioned PEC/PNEC ratios it can be concluded that no risks are to be expected from the consumer use of triphenyl phosphate for the environmental compartments under consideration.

As noted, triphenyl phosphate is present in most of the other aryl phosphate flame retardants assessed in this series. PECs in this assessment are based on emissions from


the use of triphenyl phosphate itself, and so do not include releases from the use of other substances. To consider these possible sources, the fraction of other substances which may be triphenyl phosphate was applied to overall emissions estimated for other substances in their respective assessments. This does not take any account of the different properties, which may mean that triphenyl phosphate has higher or lower releases than the other substance, but is intended to provide an order of magnitude estimate. The result is that air emissions would increase by 35 per cent, while emissions to water and soil would be trebled. The resulting PEC for regional water is still only a small fraction of the PEC values, and would have no influence on the results. None of the regional concentrations (water, soil or sediment) give rise to PEC/PNEC ratios above one. So although the additional release is significant in terms of quantity, it is not significant in terms of the resulting concentrations.

The alternative PNEC for STP considered above is higher, and so this too would not show any risks.

5.17 Tris (2-chloroethyl)phosphate (CAS 115-96-8)

Tris(2-chloroethyl)phosphate (TCEP) was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2009) is provided hereafter.

Tris(2-chloroethyl)phosphate (TCEP) is mainly used in the building industry e.g. roofing. A minor use is as PUR foam in furniture. TCEP is additively integrated in the matrix. A detailed list is provided in Annex 6 – chapter 6.



TCEP is classified according to regulation (EC) 1272/2008 with respect to its effects on human health as follows (Index No. 015-102-00-0):

• Carc. 2, H351 (Suspected of causing cancer), Repr. 1B, H360F (May damage fertility) and Acute Tox. 4, H302 (Harmful if swallowed)

• Carc Cat. 3, R40 (Limited evidence of a carcinogenic effect.), Repr. Cat. 2; R60 (May impair fertility.) and Xn, R22 (Harmful if swallowed).

Table 5-52: Summary of human health effect data for tri(2-chloroethyl)phosphate from the EU-RAR (ECB, 2009) brought forward to the risk characterisation.

Endpoint Study NOAEL (mg/kg/day) Effects observed/comments MOS

Repeated dose toxicity 12 LOAEL of 12 mg/kg/d based on kidney lesions in Scl:ddY mice, 100% absorption by the oral route assumed

-

Carcinogenicity 12

LOAEL of 12 mg/kg/d based on kidney lesions in Scl:ddY mice after 18 months was used as a surrogate LOAEL for carcinogenicity, 100% absorption by the oral route assumed

-


Endpoint Study NOAEL Effects observed/comments MOS (mg/kg/day)

Reproductive toxicity -fertility 5

NOAEL of 175 mg/kg bw/d due to significant impairment of reproductive capacity and fertility in mice.

-

Developmental toxicity 100 NOAEL of 100 mg/kg/d for developmental effects at maternal toxic dose, therefore no relevant endpoint

-


The following scenarios for consumer’s exposure to TCEP were presented in the EU-RAR (ECB, 2009):

• Exposure to TCEP containing house dust

• Inhalation of airborne particles

• Dermal exposure to house dust (child)

• Oral exposure due to hand to mouth contact (child)

• Textiles (upholstered furniture)

• Dermal exposure

• Use of cuddly toys

• Oral exposure by sucking on toys (child)

• A detailed description of the exposure assessment is provided in Annex 6 – chapter 6 whereas the outcome of the exposure assessment is summarised in the tabular format below.

Table 5-53: Consumer exposure estimations according to the EU-RAR (2009) on TCEP.

Exposure scenario Internal exposure (mg/kg bw/d)

Indoor air: Inhalation exposure

4 * 10-4 adults 9.6 * 10-4 child

House dust: Dermal exposure to house dust (child)

1.8 * 10-5 child

House dust: Oral exposure (hand to mouth contact)

3.3 * 10-6 adults 0.2 * 10-3 child

Upholstery furniture: Dermal exposure

~ 3.9 * 10-3 adult 10 * 10-3 child

Cuddly toys: Oral exposure (sucking by child)

0.24 (RWC)

Combined (multiple) consumer exposure: for female adults, a body burden would account for ~ 4.5 μg/kg bw/d, under reasonable worst case conditions and taking all paths into consideration. The respective value for 1 - 3 year-old children is 11 μg/kg bw/d. For babies of about 3 months a body burden would account up to 240 μg/kg bw/d by sucking on toys, the other paths can be neglected.



Five sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, Margins of Safety (MOS) and conclusions are compiled in the table below.

Table 5-54: Risk characterisation to TCEP for consumers and conclusions according to the EU-RAR (ECB, 2009).

Exposure scenario Internal exposure (mg/kg bw/d)

MOS (repeat)

MOS (carc)

MOS (repro)

Conclusion

Indoor air: Inhalation exposure

4 * 10-4 adults 9.6 * 10-4 child

30,000 12,500

- - No concern

House dust: Dermal exposure

1.8 * 10-5 child - - - No concern

House dust: Oral exposure (hand to mouth contact)

3.3 * 10-6 adults 0.2 * 10-3 child

> 3 *106

60,000 - - No concern

Upholstery furniture: Dermal exposure

~ 3.9 * 10-3 adult 10 * 10-3 child

3,000 1,200

- - No concern

Cuddly toys: Oral exposure (sucking by child)

0.24 (RWC) 50 - - concern

Combined (adult) 4.5 * 10-3 - 2,660 39,000 No concern

Combined (child) 11 * 10-3 - 1,090 16,000 No concern

Combined (baby) 0.24 - 50 730 concern

The EU RAR report (ECB, 2009) concludes that risk reduction measures are required for babies with respect to the scenario sucking on toys taking into consideration the carcinogenic properties of the substance and the effects after repeated oral administration. With respect to the other consumer applications considered in this risk assessment report it was concluded that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already (ECB, 2009).


Environmental effects brought forward to the risk characterisation in the EU RAR report (ECB, 2009) of TCEP are given in Table 5-55.

Table 5-55: Environmental effects compiled in the EU RAR report of TCEP (ECB, 2009)


Surface water 65 µg/L Lowest effect concentration: 48h-ErC10 = 0.65 mg/L for Scenedesmus subspicatus Assessment factor of 10: long-term stets with species from two trophic levels are available; however algae are the most sensitive species to TCEP (EC50-value is a factor of 18 to 90 lower than EC50/LC50 values from fish and daphnids found in short-term tests), and it is therefore not expected that in a long-



term test with fish an effect value below 0.65 mg/L will be found, an assessment factor of 10 is justified according to the TGD

STP 32 mg/L Lowest effect concentration: EC50 from OECD209 respiration inhibition test = 3.2 g/L Assessment factor: 100

Sediment NA No ecotoxicological data are available for this environmental compartment

Terrestrial 0.386 mg/kg dw.

Lowest effect value: 28d LC10 (assumed to represent a NOEC) for Folsomia = 19.3 mg/kg dw. Assessment factor: 50; since long-term tests are available for springtails and soil microorganisms

Atmosphere NR NR

NA: not available

NR: not reported


A detailed description of the exposure assessment during service life and from waste and during waste management is provided in Annex 6 – chapter 6. In summary, emissions of TCEP during waste management (landfilling, incineration) are either not reported or equal to zero. Emissions of TCEP during service life occur to air and waste water. These emissions are however minimal, compared to the emissions during the complete life cycle (including processing, formulation, industrial use, use as an intermediate and consumer use). Emissions of TCEP to surface water are however almost entirely attributable to leaching of outdoor used polymers (99%). No direct release to soil is identified; release is therefore to be expected as a result of deposition from air and sludge application on land.


The EU RAR (European Chemicals Bureau, 2009) concludes that there is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. This conclusion applies to all life cycle steps to all environmental compartments, to the function of waste water treatment plants and to secondary poisoning via the food chain (as such including the use of consumer products).

The EU RAR (European Chemicals Bureau, 2009) concludes that TCEP does not meet the PBT criteria.

5.18 2-ethylhexyl diphenyl phosphate (CAS 1241-94-7)

2-ethylhexyl diphenyl phosphate is used in flame retardant articles made of PVC, in which it is additively integrated. The applications known are wire and cable and furniture made of artificial leather (PVC) available to consumers.

The environmental impact of 2-ethylhexyl diphenyl phosphate was assessed on behalf of the U.K. Environment Agency (Brooke et al., 2009). Relevant sections from this


assessment are summarized hereafter. Even though no human health risk assessment for the use of consumer products containing 2-ethylhexyl diphenyl phosphate has been provided by Brooke et al. (2009b), the toxicological information gathered are summarised below.




There are no available in vivo or in vitro data on the absorption, distribution or elimination of 2-ethylhexyl diphenyl phosphate in mammals, including humans (cited from Brooke et al., 2009b).

Acute toxicity

Oral

The LD50 by the oral route in the rat is greater than 15,800 mg/kg bodyweight (cited from Brooke et al., 2009b).

Dermal

The LD50 by the dermal route in the rabbit is greater than 7,940 mg/kg bodyweight (cited from Brooke et al., 2009b).

Inhalation

For inhalation exposure, a GLP-compliant study in rats gave a 4-hour LD50 in rats greater than 4.8 mg/L (cited from Brooke et al., 2009b).


Skin and eye

Two poorly reported studies from secondary sources are available on the irritancy of 2-ethylhexyl diphenyl phosphate to human skin. One of the studies suggests very slight irritation but the information provided is too limited to draw a confident conclusion. A single study in three rabbits indicates a slight potential for irritation, and a further study of irritant effects to the eye in three rabbits also reports slight irritation. Given the reports that only slight irritation was observed for both skin and eye, it is considered that the irritant potential of 2-ethylhexyl diphenyl phosphate may be low (cited from Brooke et al., 2009b).

Sensitisation

The two human studies of skin sensitisation reported present only limited information. Exploration of the primary sources may provide more informative study descriptions. However, the information that is available does not suggest that 2-ethylhexyl diphenyl phosphate has sensitising potential (cited from Brooke et al., 2009b).


Oral

In a 12-day oral (gavage) study rats received either 5 or 10 g/kg for 12 consecutive days. Only general observations were made in the summary report in the USEPA HPV test plan and it is considered uninformative in establishing a toxicity profile for this substance (cited from Brooke et al., 2009b). Similarly, the summary of the 26-month oral (capsule) study in


six dogs given is considered too limited for useful evaluation (Treon et al., 1953) (cited from Brooke et al., 2009b).

Two GLP-compliant 90-day oral (feeding) studies are described in IUCLID (2000a). Both used a mixture of two commercial products containing a high proportion (greater than 92 per cent) of 2-ethylhexyl diphenyl phosphate. The results of both studies were consistent in that effects on blood and liver enzyme and liver and adrenal pathology were similar. The study in which rats were fed diets containing 0.001, 0.005, 0.010, 0.025 and 0.625 per cent test material (equivalent to 0.6, 3, 6, 15, and 375 mg/kg bodyweight) a NOAEL at 6 mg/kg bodyweight was identified. In the second study, using diets containing 0, 0.2, 0.4, and 0.8 per cent test material (stated as equivalent to 0, 120, 240 and 480 mg/kg bw/day), no NOAEL was identified, although the dose-related effects were similar to those seen in the first study (Monsanto, 1992a,b) (cited from Brooke et al., 2009b).

A third 90-day feeding study in rats used concentrations in the feed of 0.2, 0.4 and 0.8 per cent 2-ethylhexyl diphenyl phosphate (commercial product: Santicizer 141). The changes seen in the blood, liver enzymes and pathological changes in the liver and adrenals were dose related and similar to those seen in the other two 90-day studies. In addition, this study reported weight increases in the kidney, brain and testes and some hyperplasia of the interstitial gland cells in the ovaries in the females receiving the 0.8 per cent test material (high dose). A NOAEL was not identified in this study and it was thus reported to be less than 0.2 per cent 2-ethylhexyl diphenyl phosphate in the diet (BIBRA, 1990) (cited from Brooke et al., 2009b).

A 24-month oral study in rats is considered unreliable (Treon et al., 1953) (cited from Brooke et al., 2009b).

Dermal

No data reported by Brooke et al. (2009b).

Inhalation

There are no data on repeated inhalation exposure to 2-ethylhexyl diphenyl phosphate (cited from Brooke et al., 2009b).

Additional information: Neurotoxicity

In a 21-day study by Johannsen et al. (1977) on adult hens given a total dose of 120 g/kg, no treatment-related effects were reported in any of the hens treated with 2-ethylhexyl diphenyl phosphate. Although it appears that no positive control was included in the study design, evidence of neurotoxicity was reported in this paper for a number of other aryl phosphates tested suggesting that the test method was capable of detecting neurotoxic agents; in addition, the hen is a well established model for the detection of delayed neuropathy. Given these results it is likely that any neurotoxic potential of 2-ethylhexyl diphenyl phosphate is very low (cited from Brooke et al., 2009b).

Mutagenicity

Tests for gene mutation in S. typhimurium, and mammalian and yeast cells as well as an in vivo bone marrow chromosome aberration study in rats did not reveal any evidence of mutagenicity or clastogenicity, thus 2-ethylhexyl diphenyl phosphate can be considered not to be genotoxic in the presence or absence of metabolic activation, under the test conditions (cited from Brooke et al., 2009b).

Carcinogenicity


There are no data available on the carcinogenicity of 2-ethylhexyl diphenyl phosphate. However, the negative in vitro and in vivo studies reported above indicating a low genotoxic potential and the absence of proliferative lesions in the repeat-dose toxicity studies suggest that any potential for carcinogenicity would be also be low (cited from Brooke et al., 2009b).


One study on fertility and reproductive performance and two studies that address developmental effects are available for evaluation of effects on reproduction.


On the basis of the available information, it would seem that, in a reliable fertility study, the parental and F1 NOAEL was estimated to be 144 mg/kg/day of 2-ethylhexyl diphenyl phosphate (cited from Brooke et al., 2009b).


In the developmental studies, no clearly treatment-related developmental effects were seen at doses of up to 3,000 mg/kg bw/day of 2-ethylhexyl diphenyl phosphate. The NOAEL was thus considered to be greater than 3,000 mg/kg bw/day (cited from Brooke et al., 2009b).


2-Ethylhexyl diphenyl phosphate is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-56: Summary of human health effect data for 2-ethylhexyl diphenyl phosphate brought forward to the risk characterisation



Rat / 90-days oral/ 0, 0.6, 3, 6, 15, 375 mg/kg/d

NOAEL: 6 mg/kg/d (based on liver enzyme changes)

0.03 mg/kg/d


Rat / 90-days oral/ 0, 0.6, 3, 6, 15, 375 mg/kg/d

NOAEL: 6 mg/kg/d (2.6 mg/m³)**

0.052 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. **Corrected point of departure, derived from route to route extrapolation.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to 2-ethylhexyl diphenyl phosphate have been provided for two consumer applications:

• Service life of wire and cable containing 2-ethylhexyl diphenyl phosphate

• Service life of furniture e.g sofa containing 2-ethylhexyl diphenyl phosphate in the artificial leather



Table 5-57: Consumer exposure estimations to 2-ethylhexyl diphenyl phosphate.



Due to the very low vapour pressure (3.4 * 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration.

Inhalation 0.0506 mg/m³ (SVC)


1.Tier assessment using ECETOC-TRA (AC6, furniture and a concentration of 25%) Dermal 36.5 mg/kg bw/day


Inhalation 0.0506 mg/m³ (SVC)

Inhalation 0.0525 mg/m³ (airborne particulates)

Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g 2-ethylhexyl diphenyl phosphate per g dust as a unrealistic worst case assumption, due to the lack of measured data.



Table 5-58: Tentative risk assessment to 2-ethylhexyl diphenyl phosphate for consumers


SVC (saturated vapour concentration) Inhalation 0.0506 mg/m³ 0.052 mg/m³ 0.97

Service life of furniture (artificial leather) Dermal 36.5 mg/kg /d 0.03 mg/kg/d 1217

Service life of furniture (artificial leather)

Inhalation of airborne particulates

0.0525 mg/m³ 0.052 mg/m³ 1


First tier exposure assessments to 2-ethylhexyl diphenyl phosphate using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions.


Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized. Although there are no studies available on carcinogenicity, the available negative information on in vitro and in vivo mutagenicity and chromosome effects does not suggest that 2-ethylhexyl diphenyl phosphate is likely to possess a carcinogenic potential to exposed humans. The studies available on fertility and reproductive performance and the information on potential teratogenicity suggest that there were no adverse developmental effects at up to 3000 mg/kg bw/day. Although somewhat limited, the studies do not suggest that 2-ethylhexyl diphenyl phosphate has a neurotoxic potential. A number of 90-day repeat dose studies in the rat are available and the effects seen in these studies were generally consistent. Information from the most informative and reliable study gives a NOAEL of 6 mg/kg bw/d based on liver enzyme perturbations which was used for DNEL derivation.

This tentative risk assessment for the inhalation (airborne particulates) and dermal route using conservative exposure estimations showed a risk with respect to exposure to artificial leather used in furniture. No risk has been identified for the inhalation route to vapour (SVC).

However, it should be noted that this substance is not legally classified and no classification was proposed by industry in the REACH 2010 registration dossier provided by ICL-IP to the authors in January 2011. Therefore, no chemical safety assessment had to be performed in the framework of the REACH registration.

The DNELS derived in the CSR (chapter 5.11. in CSR on 2-ethylhexyl diphenyl phosphate, provided in 01-2011 by ICL-IP) on 2-ethylhexyl diphenyl phosphate are slightly different from the once derived in the framework of this report, even though the same study has been used as a starting point for the DNEL derivation. The RCRs calculated with these DNELs are provided in Table 5-59 below. The outcome of this tentative risk assessment would show no risk with respect to the inhalation route and risk with respect to the dermal route.

Table 5-59: Tentative risk assessment for consumers using the DNELs reported in the CSR on 2-ethylhexyl diphenyl phosphate (provided in 01-2011 by ICL-IP).


SVC (saturated vapour concentration) Inhalation 0.0506 mg/m³ 0.19 mg/m³ 0.27

Service life of furniture (artificial leather) Dermal 36.5 mg/kg /d 0.0365 mg/kg/d 1000


Inhalation of airborne particulates

0.0525 mg/m³ 0.19 mg/m³ 0.28



Environmental effect data complied from Brooke et al. (2009) are given in Table 5-60.

Table 5-60: Environmental effect data for 2-ethylhexyl diphenyl phosphate (Brooke et al., 2009)


Surface water 1.8 µg/L Lowest effect concentration: 21d NOEC for Daphnia magna =



0.018 mg/L Assessment factor: 10

STP >100 mg/L Lowest effect concentration: IC50 activated sludge respiration inhibition test >10,000 mg/L Assessment factor: 100

Sediment 0.0373 mg/kg wwt.24


Terrestrial 0.0302 mg/kg wwt.24

Since only one short-term test result is available, the PNECsoil was obtained by the equilibrium partitioning method: PNECsoil = Ksoil-water / Psed * PNECaquatic organisms * 1000 where Ksoil-water = soil/water partition coefficient = 285 m³/m³ Psed = bulk density of wet sediment = 1,700 kg/m³

Atmosphere NR No information is available on the toxicity of 2-ethylhexyl diphenyl phosphate to plants and other organisms exposed via air. The very low vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be very low. Thus, the possibility of 2-ethylhexyl diphenyl phosphate contributing to atmospheric effects such as global warming and acid rain is likely to be very small. In addition, as the substance does not contain halogen atoms it will not contribute to ozone depletion.

NR: not reported


2-ethylhexyl diphenyl phosphate is mainly used in wire and cables, foams and paints. 2-ethylhexyl diphenyl phosphate is additively integrated in the matrix. Environmental exposure during service life and from waste and during waste management was assessed. In summary, releases of 2-ethylhexyl diphenyl phosphate during service life and disposal of consumer products contribute to a very large extent to the total environmental emissions of that substance to air (97.5%) and to soil (99.9%). However, it is unclear to which extend the PVC applications and the category ‘Miscellaneous’ refer to domestic use. As a worst case, it was assumed that all releases from PVC applications and from the ‘miscellaneous’ category can be attributed to domestic use. The processes ‘In service losses’ and ‘Waste remaining in the environment’ were assumed to be entirely attributable to the use of the consumer product. As a worst case scenario, all consumer uses were assumed to be domestic. The release category ‘Miscellaneous’ includes losses from production, processing and during lifetime of products. Since no distinction was made between these three use areas, the emissions were entirely attributed to the lifetime of products (worst case scenario) (Brooke et al., 2009).

24 As the log Kow of this substance is above five, according to the TGD the resulting PEC/PNEC ratios should be increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance.


The contribution of consumer uses to the total releases to waste water and surface water during the complete life cycle could not be calculated, due to the lack of total release figures for those compartments (confidential data). The releases from consumer use to waste water amount to 1870.8 kg/year, almost entirely due to ‘miscellaneous’ sources. The releases from consumer use to surface water amount to a total of 91335.23 kg/year.




Table 5-61: PEC/PNEC ratios for 2-ethylhexyl diphenyl phosphate calculated in the UK RAR (Brooke et al., 2009)



STP All uses <0.01


Terrestrial Regional sources: Agricultural soil Industrial soil Natural soil

0.01 0.66 <0.01

From the above mentioned PEC/PNEC ratios it can be concluded that no risks are to be expected from the consumer use of 2-ethylhexyl diphenyl phosphate for the environmental compartments under consideration.

5.19 Tricresyl phosphate (CAS 1330-78-5)

Tricresyl phosphate is used in flame retardant articles made of PVC, in which it is additively integrated. The applications known are wire and cable and furniture made of artificial leather (PVC) available to consumers.

The environmental impact of tricresyl phosphate was assessed on behalf of the U.K. Environment Agency (Brooke et al., 2009). Even though no human health risk assessment for the use of consumer products containing tricresyl phosphate has been provided by Brooke et al. 2009c, the toxicological information gathered are summarised below.

This substance is intended to be registered under REACH by 2010. A CSR was made available by ICL-IP in January 2011. A CSR is also available at Chemtura. However, the information can only be exchanged on a confidential basis and is therefore not included in this report.



It should be noted that the commercial product of tricresyl phosphate is a relatively pure mixture of meta- and para-isomers (Weil, 1993; Saeger et al., 1979). Bayer (2002) reported an ortho-isomer content below 0.05 per cent in the commercial tricresyl phosphate (cited from Brooke et al., 2009c). Therefore, read across to the ortho-isomer should be taken with care.


There appear to be significant interspecies differences in dermal absorption of tri-o-cresyl phosphate, with absorption being greater in humans and cats, than in dogs. It appears that tri-o-cresyl phosphate is readily absorbed via the gut in rabbits, but TCP is mostly excreted unchanged when given orally to rats (cited from Brooke et al., 2009c).

Studies generally indicate that, once absorbed, tri-o-cresyl phosphate is widely distributed throughout the body, and may be metabolized via three pathways: 1) hydroxylation of one or more of the methyl groups which results in formation of mono- and di-hydroxymethyl tri-o-cresyl phosphate and o-hydroxybenzyl alcohol; 2) dearylation of the o-cresyl groups, resulting in the formation of o-cresyl, di-o-cresyl phosphate, o-cresyl phosphate and phosphoric acid; and 3) further oxidation of the hydroxymethyl to aldehyde and carboxylic acid (cited from Brooke et al., 2009c).

Tri-o-cresyl phosphate and its metabolites are eliminated mainly via the urine and faeces, together with small amounts in the expired air. The estimated half-lives (in days) of tri-o-cresyl phosphate and its metabolites range from approximately one to 14 days (cited from Brooke et al., 2009c).

Acute toxicity

Oral

The oral LD50 of tricresyl phosphate and its isomers in experimental animals ranges from 100-200 mg/kg (tri-o-cresyl phosphate; chicken) to above 15,800 mg/kg (tricresyl phosphate mixed isomers; rat) (cited from Brooke et al., 2009c).

Dermal

Dermal studies indicate that tricresyl phosphate is more toxic in the cat (LD50= 1,500 mg/kg) than in the rabbit (LD50= >7,900 mg/kg) (IPCS, 1990) (cited from Brooke et al., 2009c).

Inhalation

Inhalation LC50 values for the rat ranging from above 3.53 (six-hour exposure) to more than 200 mg/ml (one-hour exposure) have been reported (IUCLID, 1998) (cited from Brooke et al., 2009c).


Skin

Eight sources of limited reliability are available addressing the endpoint for skin irritation (IUCLID, 1998). All but one gave a negative result for skin irritation. The IUCLID (2001) document lists one study in rabbits considered valid without restriction though not conducted to GLP, which concluded that tricresyl phosphate did not cause skin irritation when tricresyl phosphate was applied undiluted to abraded or unabraded skin under semi-


occlusive conditions. The balance of evidence suggests that tricresyl phosphate is not irritating to the skin (cited from Brooke et al., 2009c).

Eye

Five sources of limited reliability are available addressing the endpoint for eye irritation (IUCLID, 1998). All but one gave a negative result for eye irritation. IUCLID (2001) lists one study in rabbits considered valid without restriction though not conducted to GLP, which concluded that tricresyl phosphate is not an eye irritant when applied as 0.1 ml of undiluted material. The balance of evidence suggests that tricresyl phosphate is not irritating to the eye (cited from Brooke et al., 2009c).

Sensitisation

A number of human patch test studies are listed in the IUCLID (1998) data set and indicate that tricresyl phosphate has skin sensitization potential (cited from Brooke et al., 2009c).

No animal studies on skin sensitization were identified, and no human or animal information on respiratory tract sensitisation is available (cited from Brooke et al., 2009c).


It is well established that tricresyl phosphate is toxic. In particular, there is evidence to suggest that tri-o-cresyl phosphate, rather than the other isomers of tricresyl phosphate, is neurotoxic to humans and animals after repeated oral or dermal (and potentially also inhalation) exposure (cited from Brooke et al., 2009c).

Oral

A number of pathological changes have been observed following repeat dose exposure to tricresyl phosphate mixed isomers, including effects in the liver, lymph nodes, spleen and thymus, testis, seminiferous tubules, ovaries, adrenal, kidney, gall bladder, sciatic nerve and spinal cord. The LOAEL for any treatment-related effect (cytoplasmic vacuolation of the adrenal cortex) in the 13-week studies was 250 ppm in the feed (in mice; equivalent to 45 mg/kg/bw or 65 mg/kg/bw for males and females respectively) (cited from Brooke et al., 2009c).

In a two-year feeding study, the LOAEL for any treatment-related effect (pigmentation of the adrenal cortex) was 60 ppm in the feed (in mice; equivalent to 7 mg/kg/bw or 8 mg/kg/bw for males and females respectively) (NTP, 1994) (cited from Brooke et al., 2009c).

Dermal

No data reported by Brooke et al. (2009c).

Inhalation

No data reported by Brooke et al. (2009c).


With regard to neurotoxicity and neurobehavioral changes, reduced hindlimb grip strength was seen in male mice receiving 200 mg/kg or more, in a 13-week gavage study with multifocal degeneration of the sciatic nerve observed in males receiving 200 mg/kg or more and in females dosed with 100 mg/kg or more. Axonal degeneration occurred in male and female mice exposed to 2,100 and 4,200 ppm (equivalent to 380 and 900 mg/kg bodyweight in males and 530 and 1050 mg/kg bodyweight in females) and in females


exposed to 1,000 ppm (equivalent to 230 mg/kg bw) in a 13-week feeding study. The lowest observed effect level (LOEL) for neurotoxicity (multifocal degeneration of the sciatic nerve) is therefore 100 mg/kg bw and the NOAEL is 50 mg/kg bw (cited from Brooke et al., 2009c).

Mutagenicity

There is no indication from the studies available (i.e. three bacterial reverse mutation assays, one in vitro chromosome aberration assay, three in vitro gene mutation tests and one in vivo UDS in male rats) that tricresyl phosphate is mutagenic (cited from Brooke et al., 2009c).

Carcinogenicity

Two-year feeding studies were conducted in F344/N rats and B6C3F1 mice using a mixed isomer preparation of tricresyl phosphate esters. Survival of the exposed rats and mice was similar to that of control animals and the final mean bodyweights of all exposed groups of male and female rats were also similar to controls. There were no chemical-related increased incidences of neoplasms in rats and mice (NTP, 1994) (cited from Brooke et al., 2009c).



A high quality reproductive toxicity study on tricresyl phosphate (mixed isomers) has been performed on Swiss (SD-1) mice using a continuous breeding protocol. Effects on fertility were noted at doses of 0.1 per cent or more in the feed. Observed male gonad pathologies included seminiferous tubule atrophy and decreased testis and epididymal weights at 0.05 per cent (35 mg/kg bw/day) and above, with sperm motility reduced in both the 0.05 per cent and 0.1 per cent tricresyl phosphate groups compared to controls (Chapin et al., 1988) (cited from Brooke et al., 2009c).


A number of studies are available for this endpoint. Apart from effects on numbers of live born pups (probably related to maternal toxicity), no treatment-related developmental effects have been observed in any of the reproductive toxicity studies (cited from Brooke et al., 2009c).

Human data

Information is available from human studies which indicate that initial symptoms of acute tricresyl phosphate poisoning are gastrointestinal, ranging from slight to severe nausea and vomiting, sometimes accompanied by abdominal pain and diarrhoea. These symptoms are usually transient, lasting from a few hours to a few days (IPCS, 1990). Symptoms of delayed neurotoxicity may then appear after a three to 28-day lag. Initial neurological symptoms are sharp cramp-like pains in the calves, and numbness and tingling in the feet and sometimes the hands (Staehelin, 1941, cited in IPCS, 1990) (cited from Brooke et al., 2009c).


Tricresyl phosphate (CAS 1330-78-5) is currently not legally classified according to regulation (EC) 1272/2008 and its 1st ATP. However, it should be noted that two of the individual (non-commercial) isomers of tricresyl phosphate are classified with respect to human health effects as follows:


• Tri-o-cresyl phosphate CAS No: 78-30-8:

• STOT SE 1, H370 (Causes damage to organs)

• T, R39/23/24/25 (Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.)

• Tri-p-cresyl phosphate CAS No: 78-32-0

• Acute Tox. 4, H312 (Harmful in contact with skin)

• Xn, R21/22 (Harmful in contact with skin and if swallowed)

Table 5-62: Summary of human health effect data for tricresyl phosphate brought forward to the risk characterisation


Oral Sub-chronic reproduction toxicity study – animal data

Mice / 98 days oral/ 0, 0.05, 0.1, 0.2% in diet NOAEL: 35 mg/kg/d -

Dermal See above See above NOAEL: 35 mg/kg/d

(35mg/kg/d)** 0.2 mg/kg/d

Inhalation See above See above NOAEL: 35 mg/kg/d (15mg/m³)**

0.3 mg/m³



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to tricresyl phosphate have been provided for two consumer applications based on the data compiled:

• Service life of wire and cable containing tricresyl phosphate

• Service life of furniture e.g sofa containing tricresyl phosphate in the artificial leather


Table 5-63: Consumer exposure estimations to tricresyl phosphate.




Inhalation 5.29* 10-3 mg/m³ (SVC)


Dermal 36.5 mg/kg bw/day 1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of



25%)



Inhalation 21 * 10-6 mg/m³ (airborne particulates)

Higher tier assessment: Due to the absence of measured data or realistic models on the release of TCP as debris from furniture measured data of house dust has been used. TCP was detected in house dust by Becker et al. (2004). When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) 0.4μg TCP/g dust (95th percentile) corresponds to 21 ng TCP/m3 (read-across from EU-RAR on Diantimony trioxide) (cited from ECB, 2008).



Table 5-64: Tentative risk assessment to tricresyl phosphate for consumers.


SVC (saturated vapour pressure) Inhalation 5.29* 10-3 mg/m³ 0.3 mg/m³ 0.018

Service life of furniture Dermal 36.5 mg/kg bw/d 0.2 mg/kg bw/d 183

Service life of furniture Dermal 36.5 mg/kg bw/d - Sensitising potential

- Dermal exposure to sensitising substances should be avoided

Service life of furniture Inhalation of airborne particulates

21 * 10-6 mg/m³ 0.3 mg/m³ 7 * 10-4


First tier exposure assessments to tricresyl phosphate have been performed using the ECETOC TRA Consumer tool with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and measured data.

Regarding the hazard assessment, it should be noted that tricresyl phosphate has a skin sensitizing potential. With regard to neurotoxicity and neurobehavioural changes, the


lowest no observed adverse effect level (NOAEL) for neurotoxicity was established at 50 mg/kg bw/d in a 13-week feeding study. There is no indication from the studies available that tricresyl phosphate is mutagenic, and no chemical-related increased incidences of neoplasm were observed in rats and mice. Apart from effects on numbers of live born pups (probably related to maternal toxicity), no treatment-related developmental effects have been observed in any of the reproductive toxicity studies. Thus, no end-point specific DNELs are considered. A number of pathological changes have been observed following repeat dose exposure to tricresyl phosphate mixed isomers. The LOAEL for any treatment-related effect (cytoplasmic vacuolation of the adrenal cortex) in the 13-week oral toxicity studies was 45/65 (M/F) mg/kg bw/d, and in a two-year feeding study, the LOAEL for any treatment-related effect (pigmentation of the adrenal cortex) was 7/8 mg/kg bw/d for males and females. However, because this finding is considered to probably represent a minor effect of uncertain significance to human health, the more conservative result (LOAEL of 35 mg/kg bw/d) from a sub-chronic reproduction toxicity study is used as starting point for DNEL derivation of long-term systemic effects.

This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal exposure to furniture. No risk has been identified for the inhalation of vapour or airborne particulates.

The CSR for the REACH registration of tricresyl phosphate was made available by ICL-IP. New toxicological information was provided leading to a different point of departure for DNEL derivation. A full evaluation of the effect data presented, the DNEL derived and the exposure estimations is outside the scope of this project.

The exposure scenarios used for the REACH registration was also made available by Chemtura shortly before finalization of the report. The information provided is somewhat scattered and exposure estimations were not provided. However, the concentration stated for leather articles (typical 0.001% in the product) is far below the concentration used in this study. To avoid misinterpretation the information was not used for refining the dermal exposure estimation to furniture.


Table 5-65: Environmental effect data for tricresyl phosphate complied from Brooke et al. (2009).


Surface water 0.032 µg/L Lowest effect concentration: 6w NOEC embryo-larval mortality, growth and development with Gasterosteus aculeatus = 0.32 µg/L Assessment factor: 10



There are no studies available on sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and




the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms *

119 1000 where Ksed-water = sediment/water partition coefficient =m³/m³ Psed = bulk density of wet sediment = 1,150 kg/m³


are reported in WHO l,

ECsoil was obtained by the equilibrium partitioning

oil = Ksoil-water / Psed * PNECaquatic organisms *

where Ksoil-water = soil/water partition coefficient = 142 m³/m³

A number of contact studies with insects (1990), however these cannot be used to dereive a PNECsoithe PNmethod: PNECs1000

Psed = bulk density of wet sediment = 1,700 kg/m³

Atmosphere NR hate nd other organisms exposed via air. The low vapour

phere is likely to be limited and the resulting

global warming and acid rain is likely to be small. In addition,

No information is available on the toxicity of tricresyl phospto plants apressure of the substance means that volatilisation to the atmosconcentrations are likely to be low. Thus, the possibility of tricresyl phosphate contributing to atmospheric effects such as

as the substance does not contain halogen atoms it will not contribute to ozone depletion.

According to Brooke et al. (2009) tric considered equivalent to a half-life he substance does not meet the P criter elected from the available

ata, hence the substance does not meet the B criterion. The lowest NOEC value from the available tests is 0,0032 mg/L; it may also be classifiable as a Category 2 reprotoxin. The

5.19.5

tal exposure during service life and from waste and during waste management was assessed. The processes ‘In service losses’ and ‘Waste remaining in the

nvironment’ were assumed to be entirely attributable to the use of the consumer product. r uses were assumed to be domestic. A detailed

ssment is given in Annex 6 - chapter 14.

The releases of tricresyl phosphate to soil however, are almost entirely attributable to losses

releases from PVC and polyurethane applications and from the ‘miscellaneous’ category

resyl phosphate is readily biodegradable, which isof less than 40 days in freshwater. Hence tion. A value of 800 is s

d

substance therefore meets the T criterion. The overall conclusion is that the substance meets the T criterion but does not meet the other two criteria, and so is not a PBT substance.

Environmental exposure

Environmen

eAs a worst case scenario, all consumeoverview of the uses and the exposure asse

In summary, releases of tricresyl phosphate during service life and disposal of consumer products contribute to a minor extent to the total environmental emissions of that substance to air (5%) and surface water (4%). Contributions to the releases to waste water are somewhat more significant (24%), mainly resulting from the use in PVC.

from consumer products (99.9%). This is mainly due to waste in the environment from PVC and polyurethane applications and to releases from miscellaneous sources. However, it is unclear to which extend the PVC and polyurethane applications and the category ‘Miscellaneous’ refer to domestic use. As a worst case, it was assumed that all

can be attributed to domestic use.




Table 5-66: PEC/PNEC ratios for tricresyl phosphate calculated in the UK RAR (Brooke et al., 2009)

5.19.6



STP All uses <0.01


Terrestrial Regional sources: Agricultural soil

0.09

Industrial sNatural soil

oil 1.41 0.34

From the above mention ratios it can be con that the risks from the r use of tricr sphate (regional sources) for surface water and natural and

agri ste water treatment plants would be expecte d o case assessment ving increased the risk characterisation ratio 10 to take into account the possibility of direct ingestion of sediment-bound sub ere is a risk to the sedime nal sources, in

hich consumer use probably only has a small share (based on the 4% share in surface

Cs) are observed, exposures are not

ed PEC/PNEC cludedconsume esyl pho

cultural soil apped. Base

ars to be low. No risk to wa n the worst - ha

s by a factorstance – th nt from regio

wwater emissions). Toxicity data for sediment organisms would allow the PNEC to be derived directly, and remove the need for the additional factor. It is likely that three long-term tests on sediment organisms would be required. Such testing would remove the risk that has been identified. A risk to industrial soil from regional sources (consumer use) has been identified. Since the PNEC for soil is based on the equilibrium partitioning approach, the PEC/PNEC ratios have been increased by a factor 10 to take into account the possibility of direct ingestion of sediment-bound substance. Analoguous to the sediment compartment, additional testing with sediment organisms would remove the need for the additional factor the risk that has been identified.

The lead registrant proposed various long term terrestrial environmental tests in the dossier per agreement with ECHA (Chemtura, pers. comm.). This suggests that when test results become available, this would remove the need for using an additional safety factor and as such remove the risk for both sediment and industrial soil. The exposure scenarios used for the REACH registration were made available by Chemtura shortly before finalization of the report. These conclude that when the recommended risk management measures (RMMs) and operational conditions (Oexpected to exceed the predicted PNECs and the resulting risk characterisation ratios are expected to be less than 1. The RMMs and OCs are not specified. The PNEC is not provided. This does not allow for a refinement of the risk assessment provided in this report.

The CSR provided by ICL-IP (January 2011), considered consumer use of sealants and adhesives, paints and coatings, photochemicals, polymer products and lubricants. The risk characterization for each of these applications resulted in a RCR < 1 for regional effects in sediment and soil, even when using an extra safety factor of 10. An in-depth


analysis of the CSR could refine the risk assessment. However, this is out of the scope of this report.

No information is available on the toxicity of tricresyl phosphate to plants and other

he risk characterisation ratios, no risk from secondary poisoning would be

, airplanes), thus

5.20

ris(2-chloro-1-methylethyl)phosphate (TCPP) is mainly used in construction application in igid PUR foam and in flexible PUR foam in upholstery and bedding. TCPP is additively

5.20.1

(EC) 1272/2008 st repared by Ireland to

22 (harmful if swallowed).

uman health effect data for TCPP from the EU-RAR (ECB, 2008) brought risation.

organisms exposed via air. The low vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be low. The possibility of tricresyl phosphate contributing to atmospheric effects such as global warming and acid rain is likely to be small. In addition, as the substance does not contain halogen atoms, it will not contribute to ozone depletion.

Based on texpected from the production and use of tricresyl phosphate. However, the PNEC for secondary poisoning is considered provisional in the absence of reliable data on neurotoxicity.

Lanxess (pers. comm.) stated that the use of tricresyl phosphate in adhesives is not a relevant market in Europe. According to ICL-IP (pers. comm.), tricresyl phosphate is not used in polyurethane and is mainly used in functional fluids (power plantsnot consumer nor domestic. If used, volumes should be extremely low. Both comments imply that the contribution of consumer product use to the environmental risk for tricresyl phosphate is overestimated.

Tris(2-chloro-1-methylethyl)phosphate (CAS 13674-84-5)

Tris(2-chloro-1-methylethyl)phosphate (TCPP) was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections is provided hereafter (European Chemicals Bureau, 2008).

Trintegrated in the matrix. A detailed list is provided in Annex 6 – chapter 7.


Human health effects


Currently, the substance is not legally classified according to regulation and its 1 ATP. However, an Annex XV C&L dossier has been padopt the Industry self classification as

R

Table 5-67: Summary of hforward to the risk characte


Acute toxicity 160 NOAEL of 200 mg/kg from acute oral toxicity, 80% absorption by the oral route assumed 100

Repeated dose toxicity 42 LOAEL of 52 mg/kg/d due to increased liver weights, 80% absorption by the oral route assumed

100



Carcinogenicity 42

LOAEL of 52 mg/kg/d from 90 day study, only ty, reasonable

worst case approach initial concern for carcinogenici

80% absorption by the oral route assumed

100

Reproductive toxicity/fertility and developmental

79 LOAEL of 99 mg/kg/d for effects on fertility, 80% absorption by the oral route assumed 300

5.20.2 posure

The following scenarios for consumer’s exposure to TCPP were presented in the EU-RAR

tial exposure from flexible PU foam/furniture:

• Subscenario. Inhalation exposure

re

al exposure to consumers from the use of 1-K foam/spray foam

ell rigid foam used for insulation

Annex 6 – the exposure assessment is summarised in the

n TCPP.

Consumer ex

(ECB, 2008):

• Poten

• Subscenario. Dermal exposu

• Subscenario. Oral exposure due to hand to mouth contact (child)

• Potenti


• Subscenario. Dermal exposure

• Potential exposure from closed-c


• A detailed description of the exposure assessment is provided in chapter 7 whereas the outcome oftabular format below.

Table 5-68: Consumer exposure estimations according to the EU-RAR (ECB, 2008) o

Internal exposure Exposure scenario Remarks

(mg/kg bw/d)

PUR foaInhalatio 0.8 * 10 (typical) change the outcome as only the RWC is

taken to risk characterisation

m in furniture: n exposure

1 * 10-3 (RWC) -3

0.6µg/kg/d is given as the typical value in the EU-RAR (taken the reduced time (18h) into account twice), however, this does not

PUR foam in furniture: Dermal exposure

0.0011 (RWC) It is not stated how this value was derived.

PUR foam in furniture: Oral exposure (hand to mouth 0.2 * 10-3 Taken over from TCEP EU-RAR (ECB,

2009) contact, child)

DIY one-component PUR foam: 1.4 * 10-3 (RWC) )

the unit changed from workers (µg/m³) to

factor of 10-3 and therefore negligible.

It is stated that the same value as for workers was used, however,

consumers (mg/m³), therefore the exposureto consumers should be even less by a

Inhalation exposure 2.5 * 10-3 (typical

DIY one-component PUR foam: Dermal exposure . However, the it is in the same

range as for workers and will not change the 0.24

It is irreproducible how this value was derived



(mg/kg bw/d)

outcome.

Will not be taken over to the risk characterisation. Indoor insulation Negligible

5.20.3 sm

Five sub-scenarios have been identified for whic characterisation has been ata used for th risk charact

reasonable worst case exposure concentrations Safety (MOS) and onclusions are compiled in the table below.

for consumers according to the EU-RAR (ECB, 2008).

Human health risk asses ent

h a risk performed. The d e erisation for consumers, including

, Margins ofc

Table 5-69: Risk assessment to TCPP

Internal

Exposure scenario exposure (mg/kg bw/d)

MOS (acute)

MOS (repeat)

MOS (carc)

MOS (repro)

Conclusion

PUR foam in furniture: 1 * 10-3 - 42,0(RWC) 00 42,000 79,000 No concern Inhalation exposure

PUR foam in furniture:

Dermal exposure 0.0011 - 38,182 38,182 71,818 No concern

PUR foam in

sure (hand t,

child)

furniture: Oral expoto mouth contac

0.2 * 10-3 - 210,000 210,000 395,000 No concern

DIY one-component PUR foam: Inhalation exposure

0-3 (RWC) 114,286 - No concern 1.4 * 1

DIY one-component 7 PUR foam:

Dermal exposure 0.24 66 - No concern

The EU RAR reinformation and/or te

por 0 cludes that th e is at present no n rther sting or for risk reduction measures beyond those which are being

onsumer applications addressed in the risk assessment report.


ean hemicals Bureau, 2008)

t (ECB, 2 08) con er eed for fu

applied already for c

The environmental effects brought forward to the risk characterisation in the EU RAR report (European Chemicals Bureau, 2008) for TCPP are given in Table 5-70.

Table 5-70: Environmental effects of TCPP brought forward to the risk characterisation (EuropC


Surface water 0.64 mg/L Lowest effect concentration: NOEC for reproduction of



Daphnia magna = 32 mg/L Assesment factor: 50

STP 7.84 mg/L Lowest effect concentration: IC50 = 784 mg/L Assessment factor: 100

Sediment 2.92 mgwwt.

/kg dies available on sediment-dwelling sed via sediment. In the absence of any

ium PNEC for aquatic organisms and

tition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms *

ment/water partition coefficient = 5.25 m³/m³

There are no stuorganisms expoecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrpartitioning method from thethe sediment/water par

1000 where Ksed-water = sedi


Terrestrial 1.7 mg/kg soil dw.

Lowest effect concentration: NOEC emergence of L. sativa seedlings = 17 mg/kg dwt. Assessment factor: 10, since long-term tests with species from at least three trophic levels available

Atmosphere NA

level of ty of TCPP

contributing to atmospheric effects such as global warming,

No data are available on the toxicity of TCPP to plants or other organisms exposed via air. Based on its structure, TCPP is not expected to have ozone depleting effects and the lowexposure makes other effects unlikely. The possibili

ozone depletion and acid rain is likely to be very small.

NA: not available


A detailed description of the exposure se, during service life and from waste and ex 6 –

ry, the use of consumer products contributes to some extent (≥38.64% of complete life cycle emissions) to the release of TCPP to air. The main source

the release of TCPP during outdoor use of furniture, containing TCPP-treated PUR the other environmental compartments from

ble.

5.20.6

already. This conclusion applies to all compartments for all local life cycle stages, and at the regional scale in all compartments

nd as such including the use of consumer products).

g, the available effects data mean that PNEC is based

assessment during professional and private uduring waste management is provided in Ann

chapter 7. In summa

isfoam. The contribution of TCPP emissions to the use of consumer products is negligi


The EU RAR (European Chemicals Bureau, 2008) concludes that there is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied

(a

With regard to secondary poisoninon a limit value. This means that all PEC/PNEC ratios are presented as ‘greater-than’ values, which could be interpreted as potential concerns. However, due to the low ratios and lack of any significant bioaccumulation potential of TCPP, it is reasonable to conclude that there are no risks (European Chemicals Bureau, 2008).


TCPP does not meet all of the PBT criteria, it meets the screening criteria for P or vP (European Chemicals Bureau, 2008).

Tris(2-chloro-1-(chloromethyl)ethyl)phosphate (5.21 CAS 13674-87-8)

mary of the relevant EU-RAR sections (European hemcials Bureau, 2008) is provided hereafter.

uction g. A

REACH by 2010.

5.21.1

ation (EC) 1272/2008. owever, the Risk Assessment Committee (RAC) of ECHA agreed in September 2010 on

with respect to the effects on human health with:

cted of causing cancer)

2008) brought

Tris[2-chloro-1-chloromethyl)ethyl]phosphate (TDCP) was assessed under the Existing Substances Directive. As such, a sumC

Tris[2-chloro-1-chloromethyl)ethyl]phosphate (TDCP) is mainly used in constrapplication in rigid PUR foam and in flexible PUR foam in upholstery and beddinfurther main use will be in textile adhesive coatings. TDCP is additively integrated in the matrix. A detailed list is provided in Annex 6 – chapter 8.

The substance is intended to be registered under



Currently the substance is not legally classified according to regulHa harmonised classification

• Carc. 2, H 351 (Suspe

• Carc. Cat 3, R40 (Limited evidence of a carcinogenic effect.)

Table 5-71: Summary of human health effect data for TDCP from the EU-RAR (ECB, forward to the risk characterisation


Repeated dose toxicity 5 the testicular effects, 100% absorption by the 300

LOAEL of 5 mg/kg/d based on hyperplasia of the kidney convoluted tubule epithelium and

oral route assumed

Carcinogenicity 5

rom 2 year crease in the

incidence of renal cortical tumours and 300

LOAEL of 5 mg/kg/d fcarcinogenicity study, due to in

testicular interstitial cell tumours, 100% absorption by the oral route assumed

Reproductive tfertility (female)

oxicity -

thin the risk characterisation for repeated dose toxicity

5

With respect to effects on female fertility, there are no data available (data gap). It is considered that the endpoint for female fertility is likely to be already covered by the low LOAEL of 5 mg/kg derived from the chronic toxicity study with TDCP and any risk for female fertility will be addressed wi

and carcinogenicity.

-

Developmental toxicity 100 0 NOAEL of 100 mg/kg/d for developmental effects, 100% absorption by the oral route assumed

10


5.21.2 er exposure

The following scenarios for consumer’s the EU-RAR (ECB, 2008):

• Potential exposure from flexible

• Subscenario: Inhalation exposu

• Subscenario: Dermal exposure

due to hand to mouth contact (child)

r 8 whereas the outcome of the exposure assessment is summarised in the tabular format below.

Table 5-72: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on TDCP.

Consum

exposure to TDCP are presented in

PU foam/furniture:

re

• Subscenario: Oral exposure

• A detailed description of the exposure assessment is provided in Annex 6 – chapte


(mg/kg bw/d)

PolyInhalatio

P EU-RAR (ECB,

change the outcome as only the RWC is taken to risk characterisation

Taken over from TCP2008)

urethan foam: n exposure

1 * 10-3 (RWC) 0.8 * 10-3 (typical)

0.6µg/kg/d is given as the typical value in the EU-RAR (taken the reduced time (18h) into account twice), however, this does not

Polyurethan foam: CB, 2008)

ted how this value was derived. Dermal exposure 0.0011 (RWC)

Taken over from TCPP EU-RAR (E

It is not sta

Polyurethan foam: Oral exposure (hand to mouth 0.2 * 10-3 contact, child)

Taken over from TCEP EU-RAR (ECB, 2009)


arios have b for whic sk characterisation has been e data used for the risk charact g rst case exposure concentrations, Margins of Safety (MOS) and

low.

Table 5-73: Risk assessment to TDCP for consumers according to the EU-RAR (ECB, 2008).

Three sub-scen een identified h a riperformed. Th erisation for consumers, includinreasonable woconclusions are compiled in the table be

Internal

Exposure scenario exposure MOS MOS MOS MOS

Conclusion (mg/kg bw/d)

(repeat) (carc) (repro) (develop)

PUR foam in furniture: Inhalation exposure

1 * 10-3 (RWC) 5,000 5,000 - 100,000 No concern

PUR foam in furniture: 0.0011 4,545 4,545 - 90,909 No concDermal exposure

ern

PUR foam in furniture: Oral exposure (hand to mouth contact, child)

25,000 25,000 - - No concern 0.2 * 10-3


The EU RAR report (ECB, 20 clu t th t pr nee r information and/or testing or for risk reduction measures beyond those which are being

er applications addressed in the risk assessment report. r, the con ‘o d’ w pect to effects ale fe ll

s (ECB, 2008).


ironmental effects brought forward to the risk characterisation in the EU RAR d in 5-74

nvironmental effects of TDCP brought forward to the risk characterisation (ECB, 2008)

08) con des tha ere is a esent no d for furthe

applied already for Howeve

consumclusion is n hol ith res on fem rtility for a

consumer exposure

The envreport (ECB, 2008)

Table 5-74: E

are liste Table .


Surface water 0.01 mg/L Lowest effect concentration: NOEC reproduction of Daphnia magna = 0.5 mg/L Assessment factor: 50

STP ≥100 mg/L Lowest effect concentration: NOEC activated sludge respiration inhibition test ≥ 1000 mg/L Assessment factor: 10

Sediment 0.18 mg/kg Lowest effect concentration: 28d NOEC Chironomus riparius = 8.8 mg/kg dwt. in sediment containing 5.3% total organic carbon. The NOEC was based on the geometric mean exposure concentrations over the first 3 days of the test and is

ment factor: 10

wwt.

equivalent to a NOEC of 8.3 mg/kg dwt or 1.8 mg/kg wwt in a standard test system. Assess

Terrestrial 0.32 Lowest effect concentration: 57d NOEC reproduction of Eisenia foetida = 3.3 mg/kg dAssessment fac

w. tor: 10 since data set that includes acceptable

results from long-term tests with species from at least three trophic levels

Atmosphere NA the toxicity of TDCP to plants or other organisms exposed via air. Based on its structure, TDCP is not

The possibility of TDCP eric effects such as global warming,

ozone depletion and acid rain is likely to be very small

No data are available on

expected to have ozone depleting effects and the low level of exposure makes other effects unlikely. contributing to atmosph

NA: not available

TDCP does not meet all of the PBT e screening criteria for P or vP (European Chemicals Bureau, 2008).


description of the exposure during service life and from waste and chapter 8. In summary, the contribution to the environmental emissions durin ot quantified but considered to be minima TDCP

r to air, 737 kg/year to waste water and 186 kg/year to surface water.

criteria, it meets th

A detailed assessment during professional and private use,during waste management is provided in Annex 6 - of the use of consumer products containing TDCP

g the complete life cycle of the substance is nl. Total emissions throughout the life cycle of

equal 6,504 kg/yea


5.21.6

According to the EU RAR (European Chemicals Bureau, 2008) there is at present no need r further information and/or testing and no need for risk reduction measures beyond

This conclusion applies at the regional scale in all cycle stages and as such to the use of consumer

5.22

n nd unsaturated polyester, in which it is assumed to be additively integrated. No

applications are known for these matrices. Furthermore, it is added to preparations which used for construction which will be enclosed after

5.22.1

cal data are available from consulted public literature sources. Also no effect ata were gathered by Fisk et al. (2003).

gulation (EC) 1272/2008

5.22.2

n the framework of this study (chapter 3) exposure d for two consumer

propane phosphonate (subcategorie and mode shing, spraying) not further specified, highest exposure estimate A for paints used)

esides the exposure estimates, the model and the parameters used for the estimations re provided in Table 5-75.

tions to dimethyl propane phosphonate


fothose which are being applied already. compartments and to all current local lifeproducts.

Dimethyl propane phosphonate (CAS 18755-43-6)

Dimethyl propane phosphonate is used in flame retardant articles made of epoxy resia

need flame retardancy like foamsinstallation or special paints.



No toxicologid


Currently, the substance is not legally classified according to reand its 1st ATP.

Consumer exposure

Based on the data compiled withiestimates to dimethyl propane phosphonate have been provideapplications:

• Use of foams for construction containing dimethyl propane phosphonate

• Use of paints containing dimethyl of application (bruform ECETOC TR

Ba

Table 5-75: Consumer exposure estima


Use of foams for construction

Dermal 1.149 mg/kg bw/day 1.Tier assessment using ECETOC(PC9b) and the highest concentration

-TRA

stated: 20%


te of exposure Exposure estimate (external) Comment Rou

Inhalatio (PC9b) and the highest concentration stated: 20%

n 10,000 mg/m³ (ECETOC) 1.Tier assessment using ECETOC-TRA

Use of paints

Dermal 7.15 mg/kg bw/day 1.Tier assessment using ECETOC-TRA (PC9a, paint and a max concentration of 10%).

Inhalation/ spray 1,500 mg/m³ (ECETOC)

ation ent using ECETOC-TRA

(PC9a, spray can and a max concentration of 10%).

Spray applic1.Tier assessm

application

1.Tier assessment using ECETOC-TRA (PC9a, wall paint and a max concentration of 10%).

Inhalation/brushing painting ETOC) 1.88 * 104 mg/m³ (EC

5.22.3 alth risk assessment

No toxicological data are available for dimethyl prso effect data we

Therefore only a tentative qualitative risk assessment be performed.

itative risk assessment to dimeth honate for consumers.

Human he

opane phosphonate from consulted re gathered by Fisk et al. (2003). could

public literature urces. Also no

Table 5-76: Tentative qual yl propane phosp

Route of exposure Qualitative risk assessment

Inhalation

The substance has a VP of about 64.6 Pa and rding pa

as well asassumed. However, inhalation exposure can be regarded as a dominant route of exposure.

will be used in preparations like foams ints the application technique and the kind of the application of high amounts has been

for construction and paints. Regapaints is unknown. Spraying

Dermal The dermal exposure has been assessed using 1 Tier assumptions.

First tier exposure assessments to dimethyl propane phosphonate using the ECETOC TRA Consumer tool have been performed. However, as no toxicological data are publicly

5.22.4 Environmental effe

iew of en project is given in T .

Table 5-77: Environmental effect data for dimethyl propane phosphonate found in the literature within this proj

available for dimethyl propane phosphonate a conclusion on the risk cannot be drawn.

cts

vironmental effect data found in the literature consulted within thisable 5-77

An overv

consulted ect


Bio accumulation BCF 1 L/kg STN CAS Registry Predicted; 25°C; pH 1 to 10


LC0(96h) >99

mg/L Bayer MSDS for Levagard VP SP 5100 no data



The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. As such, environmental

ormation was found through a literature search on emissions disposal (landfi cine . uch, ental expo disposal

phase could not be assessed in this report.

5.22.6 nvironmental risk assessment

al phase was not assessed, no environmental risk ut in this study.

5.23 AS 225789-38-8)

is assumed to be additively integrated. The applications knonw are wire and cable and printed wiring boards.


5.23.1

is stated on the NICNAS website (http://www.nicnas.gov.au/Industry/AICS/Search.asp) that this substance has been assessed by NICNAS, however, no report was publicly

ological information as follows:

e urine within 12 hours

cute toxicity

exposure during that phase was not assessed.

No substance specific inffrom ll and in ration) As s environm sure at

E

Since environmental exposure at disposassessment for that phase was carried o

Diethylphosphinate, aluminium salt (C

Diethylphosphinate, aluminium salt is used in flame retardant articles made of epoxy resin and thermoplastic polyurethane, in which it


It

available (NICNAS, 2010). However, the Danish EPA summarised the toxic


Diethyl phosphinic acid was excreted almost quantitatively via thafter oral application (cited from Stuer-Lauridsen et al., 2007).

A

Oral

The acute oral toxicity in rats is greater than 2,000 mg/kg bodyweight (cited from Stuer-Lauridsen et al., 2007)

Dermal

The acute dermal toxicity in rats is greater than 2,000 mg/kg bodyweight (cited from Stuer-Lauridsen et al., 2007).

Inhalation

No data available (Stuer-Lauridsen et al., 2007).


nd eyeSkin a


Diethylphosphinic acid, aluminium salt does not seem to be of concern with regard to skin irritation, but slight eye irritation was observed. No information on respiratory irritation

m Stuer-Lauridsen et al., 2007). (cited fro

Sensitisation

Diethylphosphinic acid, aluminium salt does not seem to be of concern with regard to skin n (cited from Stuer-Lauridsen et al., 2007) sensitisatio


Oral

A subchronic gavage dosin

oral toxicity study was performed in groups of 5 male and female rats by g (0, 62.5, 250 or 1000 mg/kg bw/day) for 28 days. No treatment-related

eight. No alterations were observed in the gross pic examination of tissues. The study was performed in accordance with

OECD guideline 407. Based on the results a NOAEL > 1000 mg/kg/day was established

Dermal

abnormal behaviour or appearance was observed, including neurotoxicological measurement. No toxicological significant changes were observed in body weight, food consumption, blood chemistry or organ wand microsco

(cited from Stuer-Lauridsen et al., 2007).


Inhalation

available (Stuer-Lauridsen et al., 2007).

ailable (Stuer-Lauridsen et al., 2007).

fication

5.23.2 Cons e

Based on the data compiled within the framework of this study (chapter 3) exposure n provided for two consumer applications:

EEP

• Service life of electric and electronic equipment containing DEEP in the interior wiring board)


Mutagenicity

No mutagenic activity was observed when diethylphosphinic acid, aluminium salt was tested in the Ames test and in the cytogenetic Chromosome Aberration Test with and without metabolic activation (cited from Stuer-Lauridsen et al., 2007).

Carcinogenicity

No data


No data av

Current classi


umer exposur

estimates to DEEP have bee

• Service life of wire and cable containing D

part (e.g. printed


Besides the exposure estimates and the parameters used for the estimations are provided Table 5-78.

tions to DEEP.

in




Inha

ue to the very low vapour pressure of the ionic substance DEEP and the task D

lation - involved, no inhalation exposure needs to be considered.


Inhalation

Due to the very low vapour pressure of the ionic substance DEEP even at elevated

- temperature which will occur in the internal part of electric and electronic equipment, no inhalation exposure needs to be considered.


n application considerations, the inhalatiorelevant for consumer exposure. However, taking th e of the substance into

n be regarded as negligible and thus no risk

Regarding the hazard assessment, the substance smarized. wever, as no exposure to die

been identified for the consumer applications undeassumed for all the applications considered.

environmental core set for disposal. Since none of


The applications relevant for the scope of this study are not subject to wear and as such al core set for service life. DEEP is present in

Based o n route has been identified to be e ionic natur

account the inhalation exposure cacharacterisation has been performed.

eems to be of low toxicity from the thylphosphinate, aluminium salt hasr consideration a safe use can be

data sum Ho


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. DEEP is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the the applications belong to the environmental core set environmental effects were not assessed.

do not belong to the environmentconcentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental exposure was not assessed.


5.23.6

tions relevant for the scope of this study are not subject to wear and as such o not belong to the environmental core set for service life. DEEP is present in

cations under consideration. As such nvironmental core set for disposal. Since none of

5.24

rixylyl phosphate is used in flame retardant articles made of PVC, in which it is additively tegrated. The applications known are wire and cable and furniture made of artificial

rs.

5.24.1

oxicokinetics, metabolism and distribution


The applicadconcentrations equal to or below 10% wt. in the applithe applications do not belong to the ethe applications belong to the environmental core set, environmental risk was not assessed.

Trixylyl phosphate (CAS 25155-23-1)

Tinleather (PVC) available to consume

An environmental risk assessment was carried out by the U.K. Environmental Agency (Brookes et al., 2009). The relevant information is summarised below.



T

No data reported by US EPA (2010).

Acute toxicity

Oral

Sprague-Dawley rats (5/sex) were administered a single dose of trixylenyl phosphate

010).

trixylenyl phosphate yrquel EHC) via oral gavage at 5000 mg/kg-bw. The animals were fasted 24 hours after

dosing and monitored for 14 days. No mortality was reported: LD50 > 5000 mg/kg-bw 0).

(Phosflex TXP) via oral gavage at 20,000 mg/kg-bw and monitored for 14 days. No mortality was reported: LD50 > 20,000 mg/kg-bw (cited from US EPA, 2

Sprague-Dawley rats (10/sex) were administered a single dose of(F

(cited from US EPA, 201

Dermal

New Zealand White rabbits (5/sex) were semi-occlusive administered trixylenyl phosphate via the dermal route at a dose of 2000 mg/kg-bw to clipped, intact or

y was reported. No treatment-related lesions were observed necropsy: LD50 > 2000 mg/kg-bw (cited from US EPA, 2010).

(Fyrquel EHC) abraded skin. No mortalitduring

Inhalation

No data available (cited from Brooke et al., 2009i).


Skin

New Zealand White rabbits were administered 0.5 mL of trixylenyl phosphate All animals showed mild erythema through 24 hours. No edema was observed. At 72 hours, two animals continued to show very mild erythema (cited from US EPA, 2010).


Eye

New Zealand white rabbits were administered 0.1 mL trixylenyl phosphate to the left eye. Mild to moderate irritation was observed at 1 hour in both washed and unwashed eyes of all nine animals. Irritation consisted of redness of the conjunctiva. There were no effects

ea or iris. The irritation resolved by the 24-hour observation period (cited from on the cornUS EPA, 2010).

Sensitisation



Oral

In a combined repeated-dose/reproductive/developmental toxicity screening study, gue- Dawley rats were administered trixylenyl phosphate (Phosflex TXP) via oral

c/males and females) was 25 mg/kg/day (Experimur, om US EPA, 2010 and ECHA RAC, 2010).

ion assays in S. typhiomurium were identified, ing that trixylenyl phosphate was not mutagenic in these assays. Trixylenyl

phosphate did not induce chromosomal aberrations in Chinese hamster ovary (CHO) cells

imilar across all dose groups, ctive outcome was significantly decreased in the 200 and 1000 mg/kg-

parturition was 100% in controls and 25 mg/kg-day dose groups,

n of the m of the testes with corollary findings of sloughed epithelial cells in the

lumen of the epididymis (all three dose levels). Findings in the ovaries consisted of distinct ose levels). A LOAEL (reproductive) of

generative changes in testes and ovaries was identified. The

Spragavage at 0, 25, 200 or 1000 mg/kg/day for 2 weeks prior to mating, during mating, and through gestation and lactation until sacrifice, for a total of approximately 33 days of dosing for males and 48 days for females. The LOAEL (systemic/males and females) was identified at 200 mg/kg/day, based on changes in clinical chemistry parameters, increases in organ weight, and histopathology, all consistent with toxicity of the liver and adrenal gland. Thus the NOAEL (systemi2004) (cited fr

Mutagenicity

Two negative bacterial reverse mutatshow

in the presence and absence of metabolic activation (cited from US EPA, 2010).

Carcinogenicity



In a combined repeated-dose/reproductive/developmental toxicity screening study described above, reproductive and developmental parameters were also evaluated. The number of successful matings (sperm positive) was showever, reproduday groups. Successful and 18% and 0% in the 200 and 1000 mg/kg-day groups. Absolute testes and epididymides weights and their ratios were significantly reduced in the 1000 mg/kg-day group. Ovarian weights and ratios were significantly increased in the 200 and 1000 mg/kg-day group. Histopathology of the reproductive organs consisted of degeneratiogerminal epitheliu

mild diffuse hyperplasia of the interstitial cells (all d25 mg/kg-day, based on deLOAEL for maternal toxicity was 200 mg/kg-day, based on changes in clinical chemistry parameters and histopathology consistent with toxicity of the liver and adrenal gland. The maternal NOAEL was 25 mg/kg-day. A LOAEL/NOAEL (developmental) was not established, based on only a single dose tested and on limited evaluations in offspring


during the recovery period of the study (Experimur, 2004) (cited from US EPA, 2010 and ECHA RAC, 2010).

According to the opinion of the ECHA RAC, this study provides supporting evidence for a proposed classification based on effects on fertility.


Trixylenyl phosphate is currently not legally classified according to regulation (EC) 1272/2008 and its 1st ATP. However, the Risk Assessment Committee (RAC) of ECHA agreed in January 2010 on a harmonised classification with respect to the effects on human health with:

• Repr. 1B - H360F (May damage fertility)

• Repr. Cat 2; R60 (May impair fertility.)

Table 5-79: Summary of health effect data for trixylyl phosphate brought forward to the risk haracterisation. c

Route Endpoint Species/treatment Point of departure DNEL* period/Dose regimen

Oral

Combined repeated-dose/ reproductive/ developmental toxicity screening study – animal data

Rat / 33/48-days oral/ 0, 25, 200, 1000 mg/kg/d

LOAEL: 25 mg/kg/d (based on dose-related systemic toxicity and effects on reproductive

-

organs in male and female animals)

Dermal See above See above LOAEL: 25 mg/kg/d (25 mg/kg/d)**

0.007 mg/kg/d

Inhalation See above See above LOAEL: 25 mg/kg/d (10.9 mg/m³)**

0.012 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. **Corrected point of departure, derived from route to route extrapolation


Based on 3) exposure ates fo ns:

• Service life of wire and cable containing trixyly

Service life of furniture e ntaining trix the ar

th e estimate del and the sed for th ns

Table 5-80: Consumer exposure estimates to trixylyl phosphate

the data compiled to trixylyl phosphate h

within the frameworkave been provided

of this study (chapter r two consumer applicat

l phosphate

estim io

• .g sofa co ylyl phosphate in tificial leather

Besides e exposur s, the mo parameters u e estimatioare provided in Table 5-80.



Inhalation 1.43* 10-2 mg/m³ (SVC) Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has



been used as upper bound vapour concentration.


Dermal 36.5 mg/kg1.Tier assessment using ECETOC-TRA

bw/day (AC6, furniture and a max concentration of 25%)


Due to the verPa), the sat

y low vapour pressure (< 10-4 urated vapour concentration has


0.0525 mg/m³ (airborne particulates) er (dust) in indoor air of 52.5

μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g

Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matt

Inhalation

TXP per g dust as a unrealistic worst case assumption, due to the lack of measured data.


Three sub-scenarios have been identified for whic risation has been performed. The data used for the risk charact reasonable worst case exposure concentrations, der

cterisation e t

Table 5-81: Tentative risk assessment to trixylyl phosphate

h a risk characteerisation for consumers, includingived no effect levels (DNELs) and theable below.

for consumers.

risk chara ratio (RCR) are compiled in th

Exposure scenario Route of Exposure estimate DNEL RCR* exposure

SVC Inhalation 0.014 mg/m³ 0.012 mg/m³ 1.2

Service life of furniture Dermal 36.5 mg/kg /d 0.007 mg/kg/d 5214

Service life of furniture (airborne particulates) Inhalation 0.0525 mg/m³ 0.012 mg/m³ 4.4


A first tier exposure assessment to trixylyl phosphate has been performed using the nsum som le refineme e the

saturated vapour concentration for a more plausible inhalation exposure assessment. ation exposure to rtic been asse e use simple

SOIL nservative assumptions.

nt, the is classifie c with pect to ts of a combined repeated-dose/reproductive/developmental toxicity

and female animals, however no OAEL could be established. The effects on fertility and on the reproductive organs were

seen at dose levels also inducing limited general toxicity. However, the effects observed in the low dose group were not considered as severe generalised toxicity or severe inanition,

ECETOC TRA Co er tool have been performed with e simp nts lik

Inhal airborne pa ulates has ssed by th ofparameters from C and co

Regarding the hazard afertility. The resul

ssessme substance d to be toxi res

screening study (OECD 422) with oral administration indicate dose-related systemic toxicity and effects on reproductive organs in maleN


and the lowest dose level of 25 mg/kg bw/day is considered as a LOAEL. Although there are no studies on carcinogenicity, the available negative information on in vitro mutagenicity and chromosome effects does not suggest that trixylyl phosphate is likely to possess a carcinogenic potential to exposed humans. In view of the lack of route specific data, route-to-route extrapolation was conducted based on the starting point of the oral

5.24.4

LOAEL of 25 mg/kg bw/d as given above.

Altogether this tentative risk assessment to trixylyl phosphate for one consumer application showed a risk for the applications and all routes considered.

Environmental effects

Table 5-82: Environmental effect data for trixylyl phosphate, summarized from Brooke et al. (2009)


Surface water 1.9 µg/L 0.7 µg/L

Lowest effect concentration: 96h EC50 marine invertebrate = 1.9 mg/L Assessment factor: 1000 Lowest effect concentration: 21d-NOEC invertebrates = 0.007 mg/L (read-across from available toxicity data for all triaryl phosphates) Assessment factor: 10

STP 160 mg/L Lowest effect concentration: 24h- EC50 Tetrahymena pyriformis >160 mg/L No assessment factor used

Sediment 0.130 mg/kg There are no studies available on sediment-dwelling

isionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and

water partition coefficient = 213

wwt26 organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may prov

the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms * 1000

here Ksed-water = sediment/wm³/m³ Psed = bulk density of wet sediment = 1,150 kg/m³

Terrestrial 0.105 mg/kg wwt26

ta are suitable for determining a PNEC for trixylenyl phosphate. In the absence of data, the equilibrium

: s *

r partition coefficient = 255 m³/m³

No terrestrial toxicity da

partitioning method can be used to estimate the PNECPNECsoil = Ksoil-water / Psed * PNECaquatic organism1000 where Ksoil-water = soil/watePsoil = bulk density of wet soil = 1,700 kg/m³

Atmosphere e

l

NR No information is available on the toxicity of trixylenyl phosphate to plants and other organisms exposed via air. Thlow vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be low. The possibility of trixylenyphosphate contributing to atmospheric effects such as globalwarming and acid rain is thus likely to be small. In addition, as the substance does not contain halogen atoms, it will not contribute to ozone depletion.

26 As the log Kow of this substance is above five, according to the TGD, the resulting PEC/PNEC ratios should be increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance


Trixylenyl phosphate is ered to biodegradable but it is not possible to determine if the specific criteria are met. Hence the substance meets the first stage screening criteria for P and vP. A valu in the assessment. Hence the substance owly fails to meet the B criterion. The lowest estimated NOEC value is 0.007 mg/L,

conclusion is t the subs basis of screening data, and only narrowly m candidate for further investigation. P r environmentally relevant conditions sh


o data are given with regard to releases from sources within the scope of this report. As

5.24.6

cope of this

5.25

syl diphenyl phosphate is used in flame retardant articles made of PVC, in which it is known are wire and cable and furniture made of

on behalf of the .K. Environment Agency (Brooke et al., 2009). Relevant sections from this assessment re summarized hereafter. Even though no human health risk assessment for the use of

yl diphenyl phosphate has been provided by Brooke et

/25E) in olive oil at doses of 75, 150 or 300

was, however, -day post-treatment

consid be inherently

e of 1,900 l/kg for bioconcentration is estimated narr

which would meet the toxicity criterion.

The overall tha tance meets two of the PBT criteria on the isses the third. It is therefore considered to be aersistence testing to determine a half-life unde

ould be considered.

Nsuch, no conclusions on environmental exposure can be drawn.


No exposure data are given with regard to releases from sources within the sreport. As such, no conclusions on environmental risk can be drawn.

Cresyl diphenyl phosphate (CAS 26444-49-5)

Creadditively integrated. The applications artificial leather (PVC) available to consumers.

The environmental impact of cresyl diphenyl phosphate was assessed Uaconsumer products containing cresal. (2009d), the toxicological information gathered are summarised below.




After a single intraperitoneal injection of technical grade cresyl diphenyl phosphate (45 per cent cresyl diphenyl phosphate; Disflamoll DPKmg/kg bodyweight, to five rats, it appears that cresyl diphenyl phosphate is rapidly eliminated from the body. In addition, liver activities of cytochrome P450, cytochrome b5, ethoxycoumarin O-deethylase and ethoxyresorufin O-deethylase were significantly increased within 24 hours of treatment. The activities of these enzymes were reported to return to initial values by seven days post-treatment, although it is not clear at which of the dose levels these changes occurred. Cytochrome c reductase activity significantly reduced at the highest dose throughout the 14


observation period (Vainiotalo et al.,1987; cited in BG Chemie 2000) (cited from Brooke et al., 2009d).

There are no publicly available studies on the metabolism of cresyl diphenyl phosphate. However, it is assumed that, based on the known biotransformation of substances such as tri-ortho-cresyl phosphate, the ortho-isomer can undergo cyclisation to neurotoxic phenyl saligenin phosphate, whereas this type of metabolism could not occur with the meta- and para-isomers due to steric hindrance involving the alkyl group (cited from Brooke et al., 2009d)

Acute toxicity

Oral

No studies conducted to test guidelines are available for acute oral toxicity. However, the many limited studies allow a weight of evidence approach. After oral administration in rats, mice, rabbits, guinea pigs and hens, LD50 values are in the range 893 (rabbits) to approximately 20,000 mg/kg bodyweight (rats), falling generally above the current limit dose (2,000 mg/kg bodyweight) applied in modern studies, which shows the compound to be of low toxicity after oral administration (cited from Brooke et al., 2009d).

Dermal

The toxicity of cresyl diphenyl phosphate following dermal application is very low, with 00 mg/kg bodyweight in rabbits (cited from Brooke et al., 2009d).

tion

LD50s above 2,0

Inhala

eye

Transient, minor mucous membrane irritation was the only treatment-related symptom observed following inhalation of cresyl diphenyl phosphate as an aerosol or vapour. Although high concentrations were tested, no information on achieved concentration was given in one study while, in the other, no deaths were observed following exposure to concentrations of 0.35 mg/L for one hour (cited from Brooke et al., 2009d).


Skin and

alance from several studies in rabbits from which only limited data is available is that

Cresyl diphenyl phosphate was not irritating to the skin of 90 per cent of human volunteers in a limited study; the remaining ten per cent showed signs of slight irritation. The bof evidencecresyl diphenyl phosphate is not irritating to intact skin but is mildly irritating to the eye (cited from Brooke et al., 2009d).

Sensitisation

One study reports extremely limited methodological details; therefore it is not possible to judge how the protocols used in the study compare with modern study designs. Thus,

ess the sensitizing potential of cresyl diphenyl ed from Brooke et al., 2009d).

there is inadequate information to assphosphate (cit


Oral

There are adequate data from studies conducted to OECD test guidelines to characterise the toxicity of cresyl diphenyl phosphate following repeated oral gavage exposure at doses up to 1,000 mg/kg bw/day. Evidence of repeated dose toxicity included increased

ppression in bodyweight gain and increases in water intake and food salivation, su


consumption. Haematological examination of males has shown anaemia and an increase of leukocytes. Blood chemical examination showed a decrease of cholinesterase activities in the brain, serum and erythrocytes, increases in GPT, γ-GTP, total cholesterol and calcium, and decreases in GOT, albumin, A/G ratio and triglycerides in the 300 mg/kg

urinalysis, decreases in pH and specific gravity and an increase en reported. Histopathological examination showed changes in

renals, liver, kidneys, stomach, testes, thymus and ovaries. The overall NOAEL for

bw/day group of males. Atin urine volume have bethe adrepeated dose toxicity is considered to be 12 mg/kg bw/day (Pharmaco LSR, 1995; MHW Japan, 1993) (cited from Brooke et al., 2009d).

Dermal

Cresyl diphenyl phosphate (purity not known, but thought to contain the ortho-isomer) in olive oil was applied to the shaved skin of groups of four guinea pigs daily for 73 days. Administered doses were equivalent to approximately 0, 120, 240, 480, 720 or 960 mg/kg bw/day. Two animals from each of the two highest dose groups died during the last week of treatment. All guinea pigs, including those in the control group, showed slight erythema with scale formation; this was attributed to the presence of the vehicle, olive oil. There was a dose-dependent increase in alopecia from 240 mg/kg bw/day, and bodyweight gains were reduced in the two highest doses. At 480 mg/kg bw/day, hind limb paralysis was observed in two animals. At doses greater than 480 mg/kg bw/day, paralysis of the hind limbs and lower portions of the back muscles were observed in all animals. At examination

inal cord at necropsy of those guinea pigs with paralysis, the most prominent of the spchange was oedema of the white matter, particularly in the ventral funiculus, and bleeding in the grey zone. Effects on the liver were apparent from 480 mg/kg bw/day, and included excess blood flow, an increase in collagen fibres in the sinusoids, disseminated large drop-like lipid infiltration and moderate glycogen depletion. At 720 mg/kg bw/day, the severity of hepatic effects increased, with changes including massive terminal hyperaemia with intralobular bleeding, considerable glycogen depletion and medium to large drop-like central intermediary fatty infiltration. The highest dose caused all of these effects plus necrosis of hepatocytes and complete glycogen depletion. At doses of 480 mg/kg bw/day or above, hyperplasia, formation of fatty cysts, lipid vacuoles in the cortex and hyperaemia in the cortex and medulla of the adrenal glands were noted. The NOAEL for this study was considered to be the lowest dose tested; 120 mg/kg bw/day (Geffke et al. 1970, cited in BG Chemie 2000, UNEP 2002)(cited from Brooke et al. 2009d).

Inhalation

There are no experimental animal data for effects following repeated inhalation of cresyl diphenyl phosphate (Brooke et al., 2009d).


Although the identified neurotoxicity studies were not conducted in accordance with OECD test guidelines and acetylcholinesterase and neuropathy target esterase (NTE) enzyme activities were not measured, the evidence suggests that neither isomer will cause delayed neuropathy at doses below those at which other effects (overall NOAEL 12 mg/kg bw/day) are observed (cited from Brooke et al., 2009d).

Mutagenicity

ng cells, cresyl diphenyl phosphate caused

Based on several valid gene mutation assays using S. Typhimurium, cresyl diphenyl phosphate is not a bacterial gene mutagen. In an in vitro mammalian chromosomal aberration test using Chinese hamster lu


structural chromosomal damage with metabolic activation (MHW Japan, 1995) (cited from

in vitro gene mutation assays, and two negative in vivo chromosomal

from Brooke et al., 2009d).

ed inhibition of spermatogenesis and, consequently,

erse effects on development of the offspring at any 93) (cited from Brooke et al., 2009d).

ere no adverse effects on fetal untingdon Life Sciences, 1996) (cited

yl phosphate brought forward to

Brooke et al., 2009d).

Cresyl diphenyl phosphate did not cause chromosomal aberrations in two in vivo mammalian erythrocyte micronucleus tests. On the basis of these results, cresyl diphenyl phosphate is not expected to be an in vivo mutagen (MHW Japan, 1996 and CCR, 1993) (cited from Brooke et al., 2009d).

The negative aberration studies, provide reassurance that, despite the positive result in one in vitro chromosomal aberration study, cresyl diphenyl phosphate is not likely to be a mutagen in vivo (cited from Brooke et al., 2009d).

Carcinogenicity

No data available (cited


Effects on fertility and developmental toxicity

Cresyl diphenyl phosphate causdecreased fertility, implantation rates, and lower delivery rates at the highest dose tested (300 mg/kg bw/day). However, these effects were only observed in the presence of systemic toxicity. No adverse effects on parameters relating to the neonates were reported. In addition, there were no advdose (MHW Japan, 19

In a prenatal developmental toxicity study, there wdevelopment up to doses of 900 mg/kg bw/day (Hfrom Brooke et al., 2009d).


Cresyl diphenyl phosphate is currently not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-83: Summary of human health effect data for cresyl diphenthe risk characterisation



Guinea pigs / 73 days dermal/ 0, 120, 240, 480, 720, 960 mg/kg/d

NOAEL = 120 mg /kg/d 0.2 mg/kg/d

Inhalation

Combined repeated-dose/ reproductive/ developmental toxicityscreening study –

Rat / 45-days oral/ 0,12, NOAEL: 12 mg/kg/d

animal data

60, 300 mg/kg/d (5.2 mg/m³)** 0.03 mg/m³



5.25.2 re

Based on the data compiled withi study (chapter 3) exposure es e two r

application

• Ser ble containing cresyl diphenyl phosphate

er aining cre l phosphate in alea

esides the exposure estimates, the model and the parameters used for the estimations are provided in Table 5-84.

tes to cresyl diphenyl phosphate.

Consumer exposu

n the framework of this l phosphate have bestimat to cresyl dipheny

s: en provided for consume

vice life of wire and ca

vice life of furniture ther

• S e.g sofa cont syl dipheny rtificial

B




Inhalation

r pressure (< 10-4 oncentration has 4.61 * 10 mg/m³ (SVC) been used as upper bound vapour

concentration.

-3

Due to the very low vapouPa), the saturated vapour c


Dermal 36.5 mg/kg bw/day (AC6, furniture and a max concentration of 25%)

1.Tier assessment using ECETOC-TRA

Inhalation 4.61 * 10 mg/m³ (SVC) 125 mg/m³ (including vapou

-3

r and rne particulates)

low vapour pressure (< 10-4 d vapour concentration has

d vapour n.

1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of

Due to the veryPa), the saturatebeen used as upper bounconcentratio

airbo

25%)

5.25.3 ssment

Three sub-scenarios have been identified for whiced. The d he risk charact

reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the t

Table 5-85: Tentative syl diphenyl ph

Human health risk asse

h a risk characterisation has been erisation for consumers, including perform ata used for t

able below.

osphate for consumers. risk assessment to cre

Exposure scenario Route of exposure ate DNEL RCR* Exposure estim

SCV (saturated vapour pressure) Inhalation 4.61 * 10-3mg/m³ 0.03 mg/m³ 0.15


Service life of furniture Inhalation 125 mg/m³ 0.03 mg/m³ 4167



First tier exposure assessments to cresyl diphenyl phosphate have been performed using Cons ents li saturat ur

a more inhal

t, no cific org (neuro ity) as well as effects on the reproduction (only in the presence of systemic effects) and

ven. h the id xicity s t c cted in ECD ideline idence sugg neither isomer of

bserved. The NOAELs of 12 mg/kg w/d (oral) and 120 mg/kg bw/d (dermal) were selected as starting points for DNEL

The negative in vitro gene mutation assays, and two negative in vivo

5.25.4

the ECETOC TRA concentration for

umer tool with som plausible

e simple refinemation exposure assessme

ke thent to vapour.

ed vapo

Regarding the hazard assessmen evidence of spe an toxicity toxic

development are gi Althoug entified neuroto tudies were no onduaccordance with O test gu s, the ev ests that cresyl diphenyl phosphate will cause delayed neuropathy at doses below those at which other effects (overall NOAEL 12 mg/kg bw/day) are obderivation.chromosomal aberration studies, provide reassurance that, despite the positive result in one in vitro chromosomal aberration study, cresyl diphenyl phosphate is not likely to be a mutagen in vivo. There are no appropriate studies on carcinogenicity available.

This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal and inhalation exposure to artificial leather in furniture. No risk has been identified for the inhalation of vapour.


An overview of environmental effect data complied from Brooke et al. (2009) is given in Table 5-86.

Table 5-86: Environmental effect data for cresyl diphenyl phosphate (Brooke et al., 2009)


Surface water 1.4 µg/L27 Lowest effect concentration: NOEC for fish = 14 µg/L Assessment factor: 10


Sediment 0.074 mg/kg wwt.28 organisms exposed via sediment. In the absence of any

ecotoxicological data for sediment-dwelling organisms, the

There are no studies available on sediment-dwelling

PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and

er = sediment/water partition coefficient = 61

the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms * 1000 where Ksed-watm³/m³ Psed = bulk density of wet sediment = 1,150 kg/m³

Terrestrial

nisms * 1000

2 m³/m³

0.059 mg/kgwwt.24

None of the terrestrial toxicity data are suitable for determining a PNEC. In the absence of data, the equilibrium partitioning method can be used: PNECsoil = Ksoil-water / Psed * PNECaquatic orga

where Ksoil-water = soil/water partition coefficient = 7

27 There are some uncertainties in this approach, relating to the read across from other substances and to the composition of the substance tested in many studies. If only the measured results were used, the PNEC would be higher at 2.4 μg/l (based on the lowest NOEC of 0.12 mg/l and an assessment factor of 50)

e 28 As the log Kow of this substance is above five, according to the TGD the resulting PEC/PNEC ratios should bincreased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance.




Atmosphere NR e

likely to be very small. In addition, as the substance does not

No information is available on the toxicity of cresyl diphenyl phosphate to plants and other organisms exposed via air. Thvery low vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be very low. Thus, the possibility of cresyl diphenyl phosphate contributing to atmospheric effects such as global warming and acid rain is

contain halogen atoms it will not contribute to ozone depletion.

NR: not reported


Cresyl diphenyl phosphate is mainly thermoplastic polyurethane. Cresyl d he matrix. Exposure was assessed duri ste management. In summary, releases te water + surface water) and soil are (a e during service life and disposal of cons

s amount to resp. 97.3% and 98.8% of the total emissions throughout he life cycle. However, it is unclear to which extend the PVC applications and the ategory ‘Miscellaneous’ refer to domestic use. As a worst case, it was assumed that all

om ‘Miscellaneous’ can be attributed to domestic use.

5.25.6

used in hot melts, paints, latex/adhesives andiphenyl phosphate is additively integrated in tng service life and from waste and during waof cresyl diphenyl phosphate to air, water (waslmost) entirely due to emissions of that substancumer products. With regard to emissions to air and

soil, these fractiontcreleases from PVC applications and fr

The processes ‘In service losses’ and ‘Waste remaining in the environment’ were assumed to be entirely attributable to the use of the consumer product. As a worst case scenario, all consumer uses were assumed to be domestic. The release category ‘Miscellaneous’ includes losses from production, processing and during lifetime of products. Since no distinction was made between these three use areas, the emissions were entirely attributed to the lifetime of products (worst case scenario) (Brooke et al., 2009). A detailled overview of the uses and the exposure assessment is given in Annex 6 – chapter 11.



Table 5-87: PEC/PNEC ratios for cresyl diphenyl phosphate (Brooke et al., 2009)



STP All uses <0.01


Terrestrial Regional sources: Agricultural soil Industrial soil

<0.01 0.08



Natural soil <0.01

From the above mentioned PEC/PNEC ratios it can be concluded that no risks are to be m the c use of cresyl diphenyl ph r the environmental ts under ation.

5.26 ylated tri sphates (CAS 28108-99-8, 26967-76-0 and 1-7))

The environmental im ropylated triphenyl phos s was assessed on behalf of the U.K. Enviro ency (Brooke et al., 20 Since this covers both

is(isopropylphenyl) phosphate (CAS 26967-76-0 and 68937-41-7) and isopropylphenyl

ovided by Brooke et al. 2009e, the toxicological formation gathered are summarised below.

nt ratios of isopropylated phenols to phenol. The same isomers are

ssumed to be out of scope of this study.

osphate (CAS 2967-76-0 and

5.26.1

ata available on the absorption, distribution and metabolism of isopropylated triphenyl phosphates in experimental animals or humans (cited from Brooke

expected fro onsumer osphate focompartmen consider

Isoprop phenyl pho68937-4

pact of isop phatenment Ag 09).

trdiphenyl phosphate (CAS 28108-99-8), these substances are discussed together hereafter by means of the data available from Brooke et al. (2009). Even though no human health risk assessment for the use of consumer products containing isopropylated triphenyl phosphates has been prin

The commercial products are complex isomeric mixtures of phosphate esters derived from phenol and isopropyl phenol. The various products are manufactured from feedstocks containing differecontained in all members of the range but at different ratios, reflecting the different degrees of isopropylation (cited from Brooke et al., 2009e).

The main area of use for all types of isopropylated triphenyl phosphates is in a range of PVC products. Both high and low alkylated products are also used in polyurethanes, textile coatings, adhesives, paints and pigment dispersions. Lower alkylated products are used in thermoplastics. Both types are used in lubricants, the lower alkylated products as additives, the higher alkylated products as both additives and base fluids. Lubricants, hydraulic fluid and power generation fluid are a

Isopropylated triphenyl phosphate is additively integrated in the matrix.

Isopropylphenyl diphenyl phosphate (CAS 28108-99-8) is intended to be registered under REACH by 2010.

Tris(isopropylphenyl) phosphate/isopropylphenyl triphenyl ph68937-41-7) is intended to be registered under REACH by 2010. A CSR was made available by ICL-IP in Jnauary 2011. A CSR is also available at Chemtura. However, the information can only be exchanged on a confidential basis and is therefore not included in this report.



There are no d


et al., 2009e). Two in vitro dermal absorption studies have been reported, however, it is not clear which substances have been tested (Brooke et al., 2009e).

Acute toxicity

Oral

Data from a number of studies of limited quality may be used for a weight-of-evidence approach to establishing the acute toxic profile and determining an LD50. For rats and

n single oral doses of isopropylated triphenyl phosphates, LD50 ight to above 20,000 mg/kg bodyweight,

Chinese hamsters givevalues ranged from above 5,000 mg/kg bodywewhich are above the limit value of 2,000 mg/kg bodyweight applied in modern studies (cited from Brooke et al., 2009e).

Dermal

The acute toxicity of isopropylated triphenyl phosphates following dermal application to ith a LD50 of greater than 2,000 mg/kg bodyweight (cited from Brooke et rabbits is low, w

al., 2009e).

Inhalation

No data from reliable studies are available (cited from Brooke et al., 2009e).


Skin

In two studies an isopropylated triphenyl phosphate preparation (Reofos 50) was found irritant to the skin of rabbits. In one study the skin of one of four rabbits exposed

to a isopropylated triphenyl phosphate preparation (Reolube HYD 46) showed slight,

Eye

not to be

transient erythema for up to 72 hours after the end of the exposure period (cited from Brooke et al., 2009e).

Due to the inconclusive results from three in vivo eye irritation tests it is not possible to s (cited from

tisation

fully assess the ocular irritant potential of isopropylated triphenyl phosphateBrooke et al., 2009e).

Sensi

Oral

Based on the information available from two studies, isopropylated triphenyl phosphate does not appear to be a skin sensitizer. No information on respiratory tract sensitisation is available (cited from Brooke et al., 2009e).


In two similar 28-day oral diet studies rats were treated with a isopropylated triphenyl

the findings, a NOAEL of 0.1 per cent is proposed (Foster, Snell, om Brooke et al., 2009e).

phosphate preparation (Kronitex K-100) at 0.1, 0.5, or 1.0 per cent. Unspecified abnormal haematology and blood chemistry was noted in high- and mid/high-dose animals, respectively. Based on1976) (cited fr

Dermal

In two briefly reported repeated dose studies with isopropylated triphenyl phosphate preparations (Kronitex 50 and Reolube HYD 46) rats were applied to shaved skin, doses


of 100, 500 or 2,000 mg/kg bodyweight and 40, 200 or 1,000 mg/kg bodyweight ctively (five/sex/group), for six hours per day, five days a week, for four weeks. A

100 mg/kg bw/d was established for Kronitex 50 and of 200 mg/kg bw/d for respeNOAEL of Reolube HYD 46 (Kobel, 1984a,b) (cited from Brooke et al., 2009e).

Inhalation

No data reported by (Brooke et al., 2009e).


A repeat dermal exposure study reported no signs of neurotoxicity in hens treated with a

ration (Reofos 50) at or 270 mg/kg/day by oral gavage, birds from the two highest doses showed

of the spinal cord and peripheral nerves, which correlated with signs of se-related. No clinical signs of neurotoxicity

ower doses, and the NOEL for neurotoxicity was established at 20 mg/kg/day (cited from Brooke et al., 2009e).

m Brooke et al., 2009e).

Table 5-88: Summary of human health effect data for isopropylated triphenyl phosphates brought aracterisation

isopropylated triphenyl phosphate preparation (Reofos 65) at 50 mg/kg bw/day, five days a week for four months. In a sub-acute study, five of six hens given a isopropylated triphenyl phosphate preparation (Reofos 50) at 5,000 mg/kg/day for five days showed signs of ataxia and evidence of delayed organophosphate neurotoxicity (axonal degeneration) and, in a 91-day, GLP-compliant, sub-chronic study in which adult White Leghorn hens were given a isopropylated triphenyl phosphate prepa10, 20, 90,degenerationataxia; both severity and incidence was dowere reported in birds given the two l

Mutagenicity

A number of genotoxicity test were conducted in vitro and in vivo on various commercial preparations of isopropylated triphenyl phosphate, a few of which gave positive or equivocal results. Nevertheless, using a weight-of evidence approach, overall the available information suggests that isopropylated triphenyl phosphate compounds may not be genotoxic (cited from Brooke et al., 2009e).

Carcinogenicity

No experimental data available (cited from Brooke et al., 2009e).


No data available (cited fro


Isopropylated triphenyl phosphates are currently not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

forward to the risk ch


Dermal toxicity – animal data 100, 500, 2000 mg/kg/d Repeated dose Rat / 4 weeks dermal/ 0, NOAEL = 100 mg /kg/d 0.08 mg/kg/d


Rat / 28-days oral/ 0, 0.1, 0.5, 1.0% in diet

NOAEL= 50 mg/kg/d (based on unspecified haematology and clinical chemistry findings) (22mg/m³)**

0.07 mg/m³



5.26.2 Cons

ithin the framework of this study (chapter 3) exposure estimates to isopropylated trip s have been provided for two consumer

Ser ph

• Service life of furniture e.g sofa containing iso yl phosphates in the artificial le

Besides the exposure estimates, the model and the para sed for the estimations

tions to isopropylated triphenyl phosphates

umer exposure

Based on the data compiled whenyl phosphate

applications:

• vice life of wire and cable containing isopropylated triphenyl phos ates

propylated triphenather

meters uare provided in Table 5-89.




Inhalation ~ 1.6 * 10-2 mg/m³ (SVC) Pa) of isopropylated triphenyl phospthe saturated vapour concentration

Due to the very low vapour pressure (< 10-4 hates, has



Dermal 36.5 mg/kg bw/day (AC6, furniture and a max concentration of 25%)

1.Tier assessment using ECETOC-TRA

Inhalation ~ 1.6 * 10-2 mg/m³ (SVC) 0.0525 mg/m³ (airborne particulates)

(i) Due to the very low vapour pressure lated triphenyl rated vapour

n has been used as upper concentration.

(ii) Airborne particulates: When taking the CSOIL (parameter set for

isopropylated triphenyl phosphates per g dust as a unrealistic worst case assumption, due to the lack of measured data.

(< 10-4 Pa) of isopropyphosphates, the satuconcentratiobound vapour

human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g


Three sub-scenarios have been identified for whicperformed. The data used for the risk charactreasonable worst case expo re concentrations, der s) and the

cterisation e t

Table 5-90: Tentative risk assessment to isopropylated triph

h a risk characterisation has been erisation for consumers, including

su ratio (RCR) are com

ived no effect levels (DNELrisk chara piled in th able below.

enyl phosphates for consumers.

Route of Exposure scenario Exposure estimexposure ate DNEL RCR*


Exposure scenario Route of ate DNEL Exposure estim RCR* exposure

SVC (saturated vapour oncentration) Inhalation ~ 1.6 * 10-2 mg/m³ (SVC) 0.07 mg/m³ 0.29 c


Service life of furniture Inhalation 0.0525 mg/m³ 0.07 mg/m³ 0.75


First tier exposure assessments to isopropylated triphenyl phosphates have performed using the ECETOC TRA Consumer tool with a simple refinement for a

been more

ion ex satur vapour co ation. Inhalation exposure to ai particulates has been assessed by the use of simple

ervat

indu nsultatio as exp st at the concentration of the flame retardant in the final matrix (artificial leather) used for the

assessment refers ture of rdants, whereas

ale). Even though this leads to a duction in the dermal exposure estimate it does not change the overall outcome (RCR >

udies suggest that isopropylated

cted as starting points for DNEL derivation.

ct) is far below the concentration used in this study. To avoid misinterpretation the information was not used for refining the dermal exposure estimation to furniture.

plausible inhalat posure assessrborne

ment using the ated ncentr

parameters from CSOIL and cons ive assumptions.

During a second stry co n period it w lained by indu ry th

dermal exposure to a mix flame retaisopropylated triphenyl phosphate is only present to a small extent in this mixture (confidential personal communication 01-2011 Albermre1).

Regarding the hazard assessment, the substance seems to be of low acute toxicity from the data summarized. No experimental data are available on the potential for isopropylated triphenyl phosphates to cause reproductive and developmental toxicity or carcinogenicity. The in vitro and in vivo genotoxicity sttriphenyl phosphates are not genotoxic. Based on the unspecified abnormal haematology and blood chemistry findings observed in a 28-day oral study with Kronitex K-100 in rats, a NOAEL of 0.1 per cent (1,000 ppm) is proposed. In rats treated dermally with Kronitex 50 for four weeks, a dose level of 100 mg/kg bw/d was established as lowest NOAEL. No neurotoxicity studies on mammals are available. Studies on hens gave a NOAEL of 20 mg/kg bw/ day for neurotoxic effects. This result is not suitable for deriving a DNEL for human health effects, and thus the oral and dermal NOAELs from rat studies were sele

This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal exposure to artificial leather in furniture. No risk has been identified for the inhalation route.

The CSR for the REACH registration of isopropylated triphenyl phosphates was made available by ICL-IP. New toxicological information was provided leading to a different point of departure for DNEL derivation. A full evaluation of the effect data presented, the DNEL derived and the exposure estimations is outside the scope of this project.

The exposure scenarios used for the REACH registration was also made available by Chemtura shortly before finalization of the report. The information provided is somewhat scattered and exposure estimations were not provided. However, the concentration stated for leather articles (typical 0.001% in the produ


Environmental effects 5.26.4

An overview of effect data complied by Brooke et al. (2009) is given in Table 5-91.

Table 5-91: Effect data for isopropylated triphenyl phosphates (Brooke et al., 2009)


Surface water 0.6 µg/L Lowest effect concentration: 21d-NOEC reproduction test for Daphnia magna = 0.006 mg/L Assessment factor: 10

29

STP >1 mg/L29 Lowest effect concentration: IC50 activated sludge respiration inhibition test = >100 mg/L Assessment factor: 100

Sediment 0.077 mg/k30

g wwt (isopropylphenyl diphenyl

phosphate)

There are no studies available on sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and the sediment/water partition coefficient:

sms *

cient = 147 361 m³/m³

(isopropylphenyl triphenyl phosphate) sity of wet sediment = 1,150 kg/m³

phosphate) 0.019 mg/kg wwt31

PNECsed = Ksed-water / Psed * PNECaquatic organi1000

(isopropylphenyl triphenyl

where Ksed-water = sediment/water partition coeffim³/m³ (isopropylphenyl diphenyl phosphate),

Psed = bulk den

Terrestrial >0.43 mg/k26

g wwt

g

(isopropylphenyl diphenyl

enyl

In the case where terrestrial toxicity data are available for

nisms *

³/m³

0.062 mg/kwwt26

phosphate) 0.153 mg/kg wwt26 (isopropylphriphenyl t

phosphate)

Lowest effect concentration: 19d-EC50 plants = >486 mg/kg Assessment factor 1000

plants only, the TGD indicates the assessment should also consider a PNEC derived from the equilibrium partitioning method: PNECsoil = Ksoil-water / Psed * PNECaquatic orga1000 where Ksoil-water = soil/water partition coefficient = 176 m(isopropylphenyl diphenyl phosphate), 433 m³/m³ (isopropylphenyl triphenyl phosphate) Psoil = bulk density of wet soil = 1,700 kg/m³ An additional factor of ten is applied to PEC/PNEC ratios in view of the high sorption coefficient to organic carbon and consequent potential for uptake via the solid phase

Atmosphere

eans that and the

rming and acid rain is likely to be en

NR No information is available on the toxicity of isopropylated triphenyl phosphates to plants and other organisms exposed via air. The low vapour pressure of the substance mvolatilisation to the atmosphere is likely to be limitedresulting concentrations are likely to be low. The possibility of

osphate contributing to atmosphericisopropylated triphenyl phffects such as global wae

small. In addition, as the substance does not contain halogatoms, it will not contribute to ozone depletion.

29 This value is assumed to hold for both isopropylphenyl diphenyl phosphate and isopropylphenyl triphenyl phosphate 30 As the log Kow of this substance is above five, according to the TGD, the resulting PEC/PNEC ratios should be increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance 31 As the log Kow of this substance is above five, according to the TGD, the resulting PEC/PNEC ratios should be increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance


The overall conclusion i sopropylp yl phosphate does not meet the P or B criteria, and so is not a PBT substance. Isopropylphenyl triphenyl phosphate meets the P, B and T criteria (P o of sfurther investigation. Tes n persiste ironmental half-life should be considered.

5.26.5 ntal exposu

Environmental exposure during service was assessed. The share of consumer u summarized as follows:

Table 5-92: share of consumer use rela isopropylated triphenyl phosphates

s that i henyl diphen

n the basis ting o

creening data only). It is therefore a candidate for nce to determine a relevant env

Environme re

life and from waste and during waste managementse related emissions in the total emissions can be

ted emissions in the total emissions (life cycle) of

Substance Air (%) Water (waste water Soil (%) + surface water) (%)

Isopropylphenyl triphenyl phosphate

81.6 76.3 51.4

Idisopropylphenyl phenyl phosphate

94.1 41.5 85.2


5.26.6

C ratio’s ed in the o l. (2009) is given in Table 5-93.

Table 5-93: PEC/PNEC ratio’s for isopropylated triphenyl phosphates ( Brooke et al., 2009)


PEC/PNE calculat UK RAR by Bro ke et a

Compartment Source(s) PEC/PNEC PEC/PNEC isopropylphenyl isopropylphenyl diphenyl triphenyl phosphate phosphate

Surface water Regional 0.56 0.11

STP Only available for production phase and - - industrial use

Sediment Regional 8.11 1.95

Terrestrial Agricultural soil Natural soil

0.36 0.03 20.97

0.03 <0.01 5.23 Industrial soil

The PEC/PNEC ratio’s indicate no risk for the surface water and natural and agricultural soil. A risk is indicated for sediment and industrial soil. However, it should be noted that an additional factor of 10 was applied to take into account the possibility of direct ingestion of sediment- and soil-bound substance. Toxicity data for sediment and soil organisms would


allow a sediment and soil PNEC to be derived directly, and remove the need for the ctor and remove the risk (it is like ee l ests on

sediment and soil organisms would be required), excep enyl diphenyl phosphate - industrial soil..

noted th ny uses, the regional conc tion contributes significantly to the predicted local concentrations. The main contributions to the regional emissions

from in service n t environment from some PVC applications, paints, pri rds, textiles and lubricant applications. A suitable

g program ht be able to establish ore rel background con for use in th t. However, for a nu r of local narios (just unde ), the PEC/ would still be above one if the region tribution was ignored. The same ho centra

he lead registrant proposed various long term terrestrial environmental tests in the

refinement of the risk assessment provided in this

than data from sediment

5.27

5.27.1

additional fa as such ly that thrt in the case

ong-term tof isopropylph

It should be at for ma entra

come losses and/or waste remaining inted circuit boa

he

monitorin me mig a m iablecentration

r halfe assessmen

s mbe sce

PNEC ratio al conlds for the local sediment con tions.

Tdossier per agreement with ECHA (Chemtura, pers. comm.). This suggests that when test results become available, this would remove the need for using an additional safety factor and as such remove the risk for both sediment and industrial soil. The exposure scenarios used for the REACH registration were made available by Chemtura shortly before finalization of the report. These conclude that when the recommended risk management measures (RMMs) and operational conditions (OCs) are observed, exposures are not expected to exceed the predicted PNECs and the resulting risk characterisation ratios are expected to be less than 1. The RMMs and OCs are not specified. The PNEC is not provided. This does not allow for a report.The CSR provided by ICL-IP (January 2011), considered consumer use of sealants and adhesives, paints and coatings, photochemicals, polymer products and lubricants. The risk characterization for each of these applications resulted in a RCR < 1 for regional effects in sediment and soil, even when using an extra safety factor of 10. Although there is no concern for regional effects form the use of polymer products and the use of lubricants, full containment of the substance to avoid exposure to the environment is considered essential for both applications. This is due to the fact that the PNEC for sediment and soil has been calculated by extrapolation, ratherand soil dwelling organisms. An in-depth analysis of the CSR could refine the risk assessment. However, this is out of the scope of this report.

Bis-(isopropylphenyl) phenylphosphate (CAS 28109-00-4)

Bis-(isopropylphenyl) phenylphosphate is used in flame retardant articles made of PVC, in which it is additively integrated. The applications known are wire and cable and furniture made of artificial leather (PVC) available to consumers.


No toxicological data are available from consulted public literature sources. Also no effect data were gathered by Fisk et al. (2003).





Based on the data compiled within the framework of this study (chapter 3) exposure two consumer

applications:

sopropylphenyl) phenylphosphate in artificial leather

ure estimations to bis-(isopropylphenyl) phenylphosphate

estimates to bis-(isopropylphenyl) phenylphosphate have been provided for

• Service life of wire and cable containing bis-(isopropylphenyl) phenylphosphate

• Service life of furniture e.g sofa containing bis-(i


Table 5-94: Consumer expos



Inhalation 4.54 * 10-4mg/m³ (SVC)



Dermal 1.Tier assessment using ECETOC-TRA

36.5 mg/kg bw/day (AC6, furniture and a max concentration of 25%)

(i) Due to the very low vapour pressur

Inhalation 4.54 * 10-4mg/m³ (SVC) 52.5 μg/m3 (airborne particulates)

human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5

e

bound vapour concentration. (ii) Airborne particulates: When taking the CSOIL (parameter set for

μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide,

tration of 1g sphate per

s a unrealistic worst case ck of measured

data.

(< 10-4 Pa), the saturated vapour concentration has been used as upper

ECB, 2008) and using a concenbis-(isopropylphenyl) phenylphog dust aassumption, due to the la


ta are available bis-(isopropylphenyl) phenylphosphate from consulted public literature sources. Also no effect data were gathered by Fisk et al. (2003).

re only a ten risk assessment

Table 5-95: Tentative qualitative risk assessment to bi ropylphenyl) phenylphosphate for consumers.

No toxicological da

Therefo tative qualitative could be performed.

s-(isop

nario Route of exposure QualiExposure sce tative risk assessment

SVC (saturated vapour concentration) Inhalation The inhalation exposure to vapour is very low.


Exposure scenario Route of Qualitative risk assessmentexposure

Service life of furniture Dermal The dermal exptransfer factor Therefore, it can

osure has been assessed using a 100% from article to the skin (ECETOC-TRA). be assumed that it will be lower in reality.

Service life of furniture Inhalation The inhalation exposure to airborne particulates is low.

irst tier exposure assessments to bis-(isopropylphenyl) phenylphosphate using the en performed with some simple refinements like the

or a more plausible inhalation exposure assessment.

5.27.4 En

nd on bio accumulation or aquatic toxicity in the consulted literature.

5.27.5 En e

ta available in this study, environmental exposure during service life could not be assessed.

No substance specific information wa ns dfill eratio posal

phase could not be assessed in this report.

5.27.6

5.28 Tris-(tert-butylphenyl)phosphate (CAS 28777-70-0 and 78-33-1)

ris-(tert-butylphenyl)phosphate is used in flame retardant articles made of PVC, in which integrated. The applications known are wire and cable and furniture made of

mers.

5.28.1

yl) phosphate are available from consulted ublic literature sources. However, as the UK assessment (Brooke et al., 2009g) for (tert-utylphenyl)phenylphosphate (CAS 56803-37-3) (see chapter 5.33.1) also covers phenol,

no. 68937-40-6), read-across to tris-(tert-butylphenyl)


FECETOC TRA Consumer tool have besaturated vapour concentration fRegarding the hazard assessment, no toxicological data are publicly available for bis-(isopropylphenyl) phenylphosphate, thus a firm conclusion on the risk cannot be drawn.

vironmental effects

No data fou

vironmental exposur

From the da

s found through a literature search on emissiofrom disposal (lan and incin n). As such, environmental exposure at dis



Tit is additivelyartificial leather (PVC) available to consu



No toxicological data for tri (tert-butylphenpbisobutylated, phosphate (3:1)’ (CASphosphate should be admissible.


Tris-(tert-butylphenyl) phosphate is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-96: Summary of human health effect data for tris-(tert-butylphenyl) phosphate brought forward to the risk characterisation



Rat / 90-days oral/ 0, 100, 400, 1600 ppm NOEL = 30 mg/kg/d -

Dermal See above See above (30 mg/kg/d)**

0.19mg/kg/d NOEL = 30 mg/kg/d

Inhalation See above See above NOEL = 30 mg/kg/d (13 mg/m³)**

0.34 mg/m3

*A detailed description of the DNEL derivation for (tert-butylphenyl)phenylphosphate is provided in Annex 10 of this report. A conversion from (tert-butylphenyl)phenylphosphate to tris-(tert-butylphenyl) phosphate has been done based on the molecular weight.

Corrected point of departure, derived from route to route extrapolation

5.28.2

Based on the data compiled within the framework of this study (chapter 3) exposure stimates to tris-(tert-butylphenyl) phosphate have been provided for two consumer

ble containing tris-(tert-butylphenyl) phosphate

Service life of furnitur ng nyl) ate in the artificial leath

Besides the exposure estimates, the model and th r the estimations vid e 5-97.

xposure estimati to tris-(tert-b te.

**

Consumer exposure

eapplications:

• Service life of wire and ca

• e e.g sofa containi tris-(tert-butylphe phospher

e parameters used foare pro ed in Tabl

Table 5-97: Consumer e ons utylphenyl) phospha



halation 5.47 * 10-4 mg/m³ (SVC)

the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration.

Due to

In


Dermal 36.5 mg/kg bw/day 1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of 25%)


Due to the very low vapour pressPa), the saturated vapour concentration has

ure (< 10-4


Inhalation 0.0525 mg/m³ (airborne particulates) Airborne particulates: When taking the CSOIL (parameter set for



human exposure modelling) estimate for n indoor air of 52.5 (Otte et al., 2001)

-RAR on Diantimony trioxide, and using a concentration of 1g

tris (tertbutylphenyl) phosphate per g dust as a unrealistic worst case assumption, due

particulate matter (dust) iμg/m3 into consideration(cited in EUECB, 2008)

to the lack of measured data.


Three sub-scenarios have been identified for whiced. The d he risk charact

reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the t

8: Tentative ylphen

h a risk characterisation has been erisation for consumers, including perform ata used for t

able below.

yl) phosphate for consumers. Table 5-9 risk assessment to tris-(tert-but



Service life of furniture /d Dermal 36.5 mg/kg bw 0.19 mg/kg bw/d 192


0.0525 mg/m³ 0.34 mg/m³ 0.15

*The risk characterisation ratio (RCR) is the quotient of the exposure estimate and the respective DNEL (derived o-effect level). If the RCR is < 1 the use can be regarded as safe.

hazard assessment, no owever,

(ter CAS 3-37-3) (s apter 5.33.1) had been perfo view of the lack of route specific data for dermal and

te ex ndu d on ing ral NOEL of 30 mg/kg bw/d based on a 90 day sub-chronic toxicity study in

This tentative risk asse nservative exposure estimations showed a risk e de ure . No risk identified for the


n

First tier exposure assessments to tris-(tert-butylphenyl) phosphate using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions. Regarding the information on tris-(tert-butylphenyl) phosphate was found in the public domain. Hread across from t-butylphenyl)ph

rmed. In enylphosphate ( 5680 ee ch

inhalation exposure, ropoint of an o

ute-to-rou trapolation was co cted base the start

rats.

ssment using cormal exposwith respect to th to furniture has been

inhalation of vapour or airborne particulates.



5.28.5

isposal phase as considered in this study (landfill, incineration) is not covered by

AS 29761-21-5)

ilable to consumers.

sphate has been provided by Brooke (2009f), the toxicological information gathered are summarised below.


5.29.1


Acute toxicity


The substance is intended to be registered under REACH by 2010. As such, no environmental exposure data for the service life phase were collected in the framework of this study.

The dREACH. No substance specific information was found through a literature search on emissions from disposal (landfill and incineration). As such, environmental exposure at disposal phase could not be assessed in this report.


Since no exposure assessment at disposal phase was carried out, risk during that phase was not assessed in the framework of this study.

5.29 Isodecyl diphenyl phosphate (C

Isodecyl diphenyl phosphate is mainly used in flame retardant articles made of flexible PVC, in which it is assumed to be additively integrated. The applications known are cord carpets ava

The environmental impact of isodecyl diphenyl phosphate was assessed on behalf of the U.K. Environment Agency (Brooke et al., 2009). Relevent sections from this assessment are summarized hereafter. Even though no human health risk assessment for the use of consumer products containing isodecyl diphenyl phoet al.


T

No data available (cited from Brooke et al., 2009f).

Oral

In two reports it was found that the LD50 by the oral route in the rat is greater than 15,800 mg/kg bodyweight (cited from Brooke et al., 2009f).

Dermal

The acute dermal toxicity in rabbits is greater than 7,940 mg/kg bodyweight (Johannsen et al., 1977) (cited from Brooke et al., 2009f).

Inhalation

Twa

here are two acute inhalation studies in rats. Following treatment for 4 hours, the LC50 s stated to be greater than 6.3 mg/L (Monsanto, 1983a). In an older study following

e LC50 was stated as greater than 2.2 mg/L (Monsanto, 1979b) exposure for 6 hours, th(cited from Brooke et al., 2009f).



Skin and eye

Limited information is available on the irritant potential of isodecyl diphenyl phosphate to the skin and eye. Nonetheless, given the reports that only slight irritation was observed for both skin and eye, the irritant potential of isodecyl diphenyl phosphate may be considered low (cited from Brooke et al., 2009f).

Sensitisation

reporting deficiencies, the study indicated that al to not sensitizing (Monsanto, 1968) (cited from Brooke et al., 2009f).

One poorly reported dermal study on human volunteers was identified but no experimental animal data are available. Despite some the chemic


Oral

One 28-day feeding study showed clear evidence of liver toxicity at 10,000 ppm and a of unknown extent at 1,000 or 10,000 ppm

m (30 mg/kg/day) was iven the limited information available, the toxicological significance of the

though subject to some uncertainty, these of potential toxicological significance and suggestive of at least hepatic

involvement, and, hence, it was not possible to define a NOAEL. On this basis, 140 ppm

decrease in serum cholinesterase activity (equivalent to 90 and 900 mg/kg/day). A NOAEL of 330 ppestablished. Geffect on serum cholinesterase is unknown (cited from Brooke et al., 2009f).

A 90-day oral study in rats also demonstrated changes in some urine parameters and in blood chemistry and associated liver pathology, with effects extending in some instances to the lowest dose. It was concluded that, alchanges were

(equivalent to an achieved dose of 9.3 mg/kg bw/day in males and 11 mg/kg bw/day in females) was considered to be the LOAEL for this study (Monsanto, 1983b) (cited from Brooke et al., 2009f).

Dermal

No data reported by Brooke et al. (2009f).

Inhalation

No data available (cited from Brooke et al. 2009f).


In a study by Johannsen et al. (1977) on adult hens (strain unspecified) given a total dose

n in Salmonella bacteria, mammalian and yeast cells did not reveal s of mutagenicity. The robustness of these studies could not, however, be verified

nimal level of reporting in IUCLID (2000) (cited from Brooke et al., 2009f). r statement on the genetic toxicity of isodecyl

osphate can be made.

of 120 g/kg over a 21-day period, no treatment-related effects were reported in any of the hens treated with isodecyl diphenyl phosphate. Given the uncertainties in studies that have investigated endpoints relevant to neurotoxicity, it is not possible to reach a conclusion on the neurotoxic potential of isodecyl diphenyl phosphate (cited from Brooke et al., 2009f).

Mutagenicity

Tests for gene mutatioany signdue to the miBased on the existing information no cleadiphenyl ph


Carcinogenicity






A number of papers have been identified that report on the teratogenic potential of yl phosphate in the rat. While there is some question as to whether these

phosphate is not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-99: Summary of human health effect data for isodecyl diphenyl phosphate brought forward sation

isodecyl diphenrelate to the same or different experiments, there is no evidence from any of the papers of any developmental effects at doses of up to 3,000 mg/kg bw/day.


Isodecyl diphenyl

to the risk characteri


Oral toxicity – animal data 500, 1000 mg/kg/d (males and females) - Repeated dose Rat / 90-days oral/ 0, 250, LOAEL 9.3/11.1 mg/kg/d

Dermal See above See above LOAEL ~10 mg/kg/d** 0.013 mg/kg/d

Inhalation See above See above LOAEL ~10 mg/kg/d (4.3 mg/m³)**

0.02 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. **Corrected point of o route extrapolation

5.29.2

ased on the data compiled within the framework of this study (chapter 3) exposure

data compiled:

Service life of PVC floor cyl te

Besides the d the para r the estimations vide 5-100.

Table 5-100: Consumer exposure estimations to isodecyl dip

departure, derived from route t

Consumer exposure

Bestimates to isodecyl diphenyl phosphate have been provided for one consumer applications based on the

• ing containing isode diphenyl phospha

exposure estimates, the model an meters used foare pro d in Table

henyl phosphate.

Route of exposure Exposure esti l) mate (externa Comment


Dermal 36.5 mg/kg/d 1.Tier assessment using ECETOC-TRA (AC13, flooring and a max concentration of



25%)

(i) Vapour:

Inhalation 5.77 * 10 mg/m³ (SVC) 52.5 * 10-3 mg/m³ (Airborne particulates

When taking the CSOIL (parameter set for human exposure modelling) estimate for

-3

)

Due to the very low vapour pressure (< 10-4 oncentration has bound vapour

concentration. (ii) Airborne particulates:

particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001)

Diantimony trioxide, ECB, 2008) and using a concentration of 1g

henyl phosphate per g dust as a unrealistic worst case assumption, due to the lack of measured data.

Pa), the saturated vapour cbeen used as upper

(cited in EU-RAR on

isodecyl dip


Three sub-scenarios have been identified for whic performed. The data used for the risk charact reasonable worst case exposure concentrations, derrisk characterisation ratio (RCR) are compiled in the t

01: Tentative

h a risk characterisation has beenerisation for consumers, includingived no effect levels (DNELs) and the able below.

Table 5-1 risk assessment to isodecyl diphenyl phosphate for consumers.

Exposure scenario Route of ate DNEL RCR* Exposure estimexposure

Service life of PVC flooring Dermal 36.5 mg/kg/d 0.013 mg/kg/d 2808

Service life of PVC flooring Inhalation 5.77 * 10-3 mg/m³ (SVC) 0.02 mg/m³ 0.29

Service life of PVC flooring Inhalation 0.0525 mg/m³ (Airborne particulates) 0.02 mg/m³ 2.6

*The risk characterisation ratio (RCR) is theno-effect level). If the RCR is < 1 the use ca

quotient of the exposure estimate and the respective DNEL (derived n be regarded as safe.

ents like the saturated vapour concentration for a more plausible inhalation exposure assessment. Inhalation

parameters onser

assessment, the city from the wev studie able on carci r effects on nform y, statem n the

genotoxic potential can be made. Ther neurotoxic potential, but it is L forma ntial teratog gests dverse

nd suitable for consideration in the sk assessment for humans. In this study, the lowest dose of 140 ppm (equivalent to

First tier exposure assessments to isodecyl diphenyl phosphate using the ECETOC TRA Consumer tool have been performed with some simple refinem

exposure to airborne particulates has been assessed by the use of simple from CSOIL and c vative assumptions.

Regarding the hazard data summarized. Ho

substance seems to bs are avail

e of low toxinogenicity oer, no

fertility. Based on the existing i ation on mutagenicit no clear ent oe is no indication of a tion on potenot well characterised. imited in enicity sug no a

developmental effects at up to 3000 mg/kg bw/day. A 90-day repeat dose oral toxicity study in the rat was selected as the most sensitive ari9.3/11.1 mg/kg bw/d in males and females) was considered to be the LOAEL. In view of the lack of route specific data for dermal and inhalation exposure, route-to-route extrapolation was conducted based on the starting point of the given LOAEL.


This tentative risk assessment for the inhalation (airborne particulates) and dermal route using conservative exposure estimations showed a risk with respect to exposure to PVC flooring. No risk has been identified for the inhalation route to vapour (SVC).

However, it should be noted that this substance is not legally classified and no classification was proposed by industry in the REACH 2010 registration dossier provided by ICL-IP to the authors in January 2011. Therefore, no chemical safety assessment had to be performed in the framework of the REACH registration.

The DNELS derived in the CSR (chapter 5.11. in CSR on isodecyl diphenyl phosphate, provided in 01-2011 by ICL-IP) on isodecyl diphenyl phosphate are slightly different from the once derived in the framework of this report, even though the same starting point for the DNEL derivation was used. The RCRs calculated with these DNELs are provided in Table 5-102 below. The outcome of this tentative risk assessment would show no risk with respect to the inhalation route and risk with respect to the dermal route.

Table 5-102: Tentative risk assessment for consumers using the DNELs reported in the CSR on isodecyl diphenyl phosphate (provided in 01-2011 by ICL-IP).


Service life of PVC flooring Dermal 36.5 mg/kg/d 0.017 mg/kg/d 2147

Service life of PVC flooring Inhalation 5.77 * 10-3 mg/m³ (SVC) 0.088 mg/m³ 0.07

Service life of PVC flooring Inhalation 0.0525 mg/m³ (Airborne particulates) 0.088 mg/m³ 0.6


vironmental effects 5.29.4 En

ntal effect data complied from Brooke et al. (2009) are given in Table 5-103. Environme

Table 5-103: Environmental effects for isodecyl diphenyl phosphate (Brooke et al., 2009)

PNEC ArgumCompartment entation

Surface water 0.4 µg/L Lo

Assessment factor: 10

west effect concentration: Nµg/L

OEC for Daphnia magna = 4

STP 3 mg/L Lowest effect concentration: 24w-NOEC activated sludge

ctor: 1, since ther de ation respiration simulation test = Assessment fa

3 mg/L there are two o grad

studies showing high degradation at higher concentrations

Sediment 0.059 mg/kg There are no studies available onwwt.32

sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the PNEC may provisionally be calculated using the equilibrium partitioning method from the PNEC for aquatic organisms and the sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms *

of this substance GD the resulting PEC/PNEC ratios should be

increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance.

32 As the log Kow is above five, according to the T



1000 where Ksed-water = sediment/water partition coefficient = 171

Psed = bulk density of wet sediment = 1,150 kg/m³ m³/m³


re suitable for determining

PNECsoil = Ksoil-water / Psed * PNECaquatic organisms *

³/m³

None of the terrestrial toxicity data aa PNEC. In the absence of data, the equilibrium partitioning method can be used:

1000 where Ksoil-water = soil/water partition coefficient = 206 mPsed = bulk density of wet sediment = 1,700 kg/m³

Atmosphere NR exposed via air. The

sation to the atmosphere is likely to be limited and the

ity of cresyl diphenyl phosphate contributing to

likely to be very small. In addition, as the substance does not

No information is available on the toxicity of cresyl diphenyl phosphate to plants and other organismsvery low vapour pressure of the substance means that volatiliresulting concentrations are likely to be very low. Thus, the possibilatmospheric effects such as global warming and acid rain is

contain halogen atoms it will not contribute to ozone depletion.

NR: not reported

In the CSR, made available by ICL-I d on the of two long-t and three he

lowest NOEC found in these tests is (freshwater) is 0.076 µg/L. This value i K RAR, being 0.4 µg/L. The PNECsedim not be compared with the values stated i ry weight (resp. 0.85 mg/kg sediment dw.


sodecyl diphenyl phosphate is mainly used in flexible PVC. Isodecyl diphenyl phosphate xposure was assessed during service life, from

applications and the category ‘Miscellaneous’ refer to domestic use. As a worst case, it

P, a PNECfreshwater was derived baseavailability erm short-term results (assessment factor = 50). T

3.8 µg/L (for Daphnia), therefore the PNECaquas substantially lower than the one derived in the Uent and PNECsoil derived in the UK RAR can n the CSR, since the latter are expressed as d and 0.251 mg/kg soil dw.).

The processes ‘In service losses’ and ‘Waste remaining in the environment’ were assumed to be entirely attributable to the use of the consumer product. As a worst case scenario, all consumer uses were assumed to be domestic. The release category ‘Miscellaneous’ includes losses from production, processing and during lifetime of products. Since no distinction was made between these three use areas, the emissions were entirely attributed to the lifetime of products (worst case scenario) (Brooke et al., 2009). A detailled overview of the uses and the exposure assessment is given in Annex 6 – chapter 12.

Iis additively integrated in the matrix. Ewaste and during waste management. In summary, releases of isodecyl diphenyl phosphate to air and soil are almost entirely due to emissions of that substance during service life and disposal of consumer products. Emissions during these life stages are responsible for some 70% of the total environmental emissions to water (waste water + surface water) of that substance. However, it is unclear to which extend the PVC

was assumed that all releases from PVC applications and from ‘Miscellaneous’ can be attributed to domestic use.




Table 5-104: PEC/PNEC ratios for isodecyl diphenyl phosphate (Brooke et al., 2009)



STP Application of paints (no regional sources reported)

<0.01


Terrestrial Regional sources: Agricultural soil IndustriNatural soil

0.2

al soil 16.67 0.29

From the above mentioned PEC/PNEC ratios it can be concluded that no risks are to be expected from the consumer use of isodecyl diphenyl phosphate for the environmental

soil.

ity analy ests that a faster hydroly an assumed in this asse could have a ant effect on the local an gional sediment PECs. It may therefore be possi carrying out further testing to investigate

ctual degradatio en er relevant environmental conditions. The PNE diment is based on the equilibrium partitioning approach.

aquatic PN hich this is based is not likely to be revised, toxicity data for sediment organisms would allow a PNEC to be derived directly, and remove the need for

onal factor y that three long-term sts on sediment organisms would be required. conclusion was drawn f terrestrial compartment (Brooke et al., 2009) diment, no application of an additional factor of 10 would

move the risk. Various test have been planned by Ferro and submitted as a request in

5.30

flexible PUR foam in upholstery and

compartments under consideration, except for the sediment and for industrial

The sensitiv sis sugg sis rate thssment signific

ble to refine the PECs by d re

the a n (mineralization) half-life in sedimC for se

t und

Since the EC on w

the additi of 10. It is likel teThe same or the. For the se

rethe registration dossier to ECHA (ICL-IP, pers. comm.). This suggests that when test results become available, this would remove the need for using an additional safety factor and as such remove the risk for sediment and soil.

The PNECsediment and PNECsoil in the CSR provided by ICL-IP, were also calculated from PNECwater by means of the partitioning method. As such, the risk for sediment and soil could not be refined based on the additional information from the CSR. Furthermore, environmental exposure from consumer use was not assessed in the CSR.

Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) (CAS 38051-10-4)

2,2-Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate (V6) was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2008) is provided hereafter.

2,2-Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate (V6) is mainly used in construction application in rigid PUR foam and in


bedding. A further main use will be in textile adhesive coatings. V6 is additively integrated in the matrix. A detailed list is provided in Annex 6 – chapter 9.


U-RAR (ECB, 2008) brought




Furthermore, based on the data presented in this risk assessment report, it is proposed not to classify V6 for human health effects, if the TCEP content is below 1%.

Table 5-105: Summary of human health effect data for V6 from the Eforward to the risk characterisation.

Endpoint Internal body

Effects observed/comments MOS burden (mg/kg/day)

15

NOAEL of 15 mg/kg/d from 28 day study in rats based on increased liver weight with correlating histopathological changes, 100% absorption by the oral route assumed

200 Repeated dose toxicity

Developmental toxicity 29

effects based on a treatment related increase in the number of runts and a decrease in pup 100

NOAEL of 29 mg/kg/d for developmental

body weight observed at the mid and high dose groups, 100% absorption by the oral route assumed

5.30.2

The following scenarios fo exposure to V6 are presented in the EU-RAR:

otential exposu ible

• Subscenario. Inhalation exposu

sure

• Subscenario. Oral exposure due to hand to mouth contact (child)

• A detailed description of the Annex 6 – her the outcom m rised in

Table 5-106 below.

Table 5-106: Consumer exposure estimations according to the EU-RAR (ECB, 2008) on V6.

Consumer exposure

r consumer’s

re from flex• P PU foam/furniture:

re

• Subscenario. Dermal expo

exposure assessment is provided ine of the exposure assessment is suchapter 9 w eas ma


(mg/kg bw/d)

PUR foam in furniture: 1 * 10-3 (RWC) Taken over from TCPP EU-RAR (EC2008)

Inhalation exposure 0.8 * 10-3 (typical) 0.6 µg/the EU

B,

kg/d is given as the typical value in -RAR (taken the reduced time (18h)

into account twice), however, this does not


change the outcome as only the RWC is taken to risk characterisation

PUR foam in furDermal e

AR (ECB, niture: xposure

0.0011 (RWC) 2008) It is not stated how this value was derived.

Taken over from TCPP EU-R

PUR foaOral exposure (hand to mouth 0.2 * 10-3 Taken over from TCEP EU-RAR (ECB,

m in furniture:

contact, child) 2009)


os have b for whic data used charact

reasonable worst case exposure concentrations conclusions are compiled in the table below.

essment to V6 for cons di

Three sub-scenari een identified h a risk characterisation has beenerisation for consumers, including, Margins of Safety (MOS) and

performed. The for the risk

Table 5-107: Risk ass umers accor ng to the EU-RAR (ECB, 2008).

Exposure scenario Internal body MOS MOS burden Conclusion (mg/kg bw/d) (repeat) (develop)

PUR foam in furniture: Inhalation exposure

1 * 10-3 (RWC) 15,000 29,000 No concern

PUR foam in furniture: 26,364 No concern

Dermal exposure 0.0011 13,636

PUR foam in furniture: Oral exposure (hand to mouth contact, child)

0.2 * 10-3 75,000 145,000 No concern

The EU RAR report (ECB, 2008) concludes that there is at present no need for further information and/or tes tion measures beyond those which are being

r con pplication essed in this risk asses rt.

5.30.4 cts

effe brought fo e ri racterisa EU RAR 08) is given in Table 5-108.

ata for V6 ght forw e risk ch (ECB,

ting or for risk reducsumer aapplied already fo s addr sment repo

Environmental effe

The environmental ct data rward to th sk cha tion in thereport (ECB, 20

Table 5-108: Environmental effect d brou ard to th aracterisation2008)


Surface water 0.0736 mg/L Lowest effect concentration: 21d NOEC for Daphnia magna = 3.68 mg/L Assessment factor: 50

STP >10 mg/L Lowest effect concentration: EC50 micro-organisms >1000 mg/L Assessment factor: 100

Sediment 0.45 mg/kg wwt.

There are no studies available on sediment-dwelling organisms exposed via sediment. In the absence of any ecotoxicological data for sediment-dwelling organisms, the



PNEC may provisionally be calculated using the equilibrium partitiothe sediment/

ning method from the PNEC for aquatic organisms and water partition coefficient:

PNECsed = Ksed-water / Psed * PNECaquatic organisms * 1000 where Ksed-water = sediment/water partition coefficient = 7.03 m³/m³

sity of wet sediment = 1,150 kg/m³ Psed = bulk den

Terrestrial 0.37 mg/kg soil dwt. (0.327 mg/kg soil wwt.)

d by the equilibrium partitioning method:

/ Psed * PNECaquatic organisms * 1000

m³

Since only one short-term test result is available, the PNECsoilwas obtainePNECsoil = Ksoil-water

where Ksoil-water = soil/water partition coefficient = 7.55 m³/Psed = bulk density of wet sediment = 1,700 kg/m³

5.30.5 Environmental exposu

A detailed description of the exposure d during waste management is provided mary, volatilisation from small particles, associated with p b’ furniture, will contribute to a significan V6 during the complete life cycle. The he use of consumer products to the total emissions to waste water and surface water is negligible

ssions equal 1 an not be calculated for ind

5.30.6 nvironmental risk assessment

According to the EU RAR (European Chemicals Bureau, 2008), there is at present no sting and no need for risk reduction measures

5.31

The identified use of guanidine phosphate is in textiles. No information on matrices was additively integrated in the matrix.

5.31.1

n that once the substance becomes

sessment will be conducted by considering the ounds separately. The most critical DNEL will then be taken forward to the risk

ssessment.

re

assessment during service life and from waste an in Annex 6 – chapter 9. In sumhysical erosion of the polymer from ‘loose crum

t extend (48.65% – 77.84%) to the air emissions of contribution of emissions resulting from t

(total emi 07 kg/year d 27 kg/year respectively). Such contribution couldustrial soil.

E

need for further information and/or tebeyond those which are being applied already. This conclusion applies to all compartments for all local life cycle stages, and at the regional scale in all compartments and as such also to the use of consumer products.

V6 does not meet all of the PBT criteria, it meets the screening criteria for P or vP (European Chemicals Bureau, 2008).

Guanidine phosphate (CAS 5423-23-4)

available; however it is known to be


Guanidine phosphate is an inorganic substance, which consist of two moieties guanidine and one moiety phosphate. Under the assumptiobioavailable either via oral or inhalation routes it dissociates in guanidine and phosphate. Thus, the human health hazard ascompa


Phosphate

Phosphorus as phosphate is an essential nutrient involved in many physiological rocesses, such as the cell’s energy cycle, regulation of the whole body acid-base

balance, as a component of the cell structure (as phospholipids), in cell regulation and eralisation of bones and teeth (as part of the hydroxyapatite).

intakes >750 mg phosphorus per day. There is no evidence of adverse ffects associated with the current dietary intakes of phosphorus in EU countries (cited

n Food Safety Authority, 2006).

p

signalling, and in the min

Estimates of habitual dietary intakes in European countries are on average around 1000-1500 mg/day, ranging up to about 2600 mg/day.

The available data indicate that normal healthy individuals can tolerate phosphorus (phosphate) intakes up to at least 3000 mg/day without adverse systemic effects. In some individuals, however, mild gastrointestinal symptoms have been reported if exposed to supplementalefrom Europea

Guanidine


There is limited evidence that guanidine is not absorbed to any significant degree through the skin in animals (cited from Ertell, 2006).

Acute toxicity

Oral

Based on the available toxicity data, guanidine and guanidine hydrochloride both fall into the category of toxic compounds, based on oral (ingestion) data. There is almost no data on guanidine, and minimal data for guanidine hydrochloride, but the test results for each compound are relatively consistent, and when the results for guanidine and guanidine

ydrochloride are compared, they are also similar. For this reason, it is reasonable to dine hydrochloride is similar to that of guanidine. Two

ues are available for guanidine hydrochloride: LD50 rat = 475 mg/kg, LD50

hconsider that the toxicity of guanioral LD50 valmouse = 571 mg/kg (cited from Ertell, 2006).

Dermal

One acute dermal toxicity study is available for guanidine hydrochloride: LD50 dermal, /kg (cited from Ertell, 2006).

tion

rabbit > 2000 mg

Inhala

No data available (cited from Ertell, 2006)


Skin and eye

Guanidine hydrochloride is very irritating to the skin and eyes. Since guanidine hydrochloride is irritating to the skin and eyes, it is also likely to be irritating to the lungs if inhaled (cited from Ertell, 2006).

Sensitisation


Guanidine hydrochloride was not skin sensitising in a test according to Buehler in guinea pig (cited from Ertell, 2006).


Oral

No animal data available, human data are reported further below.

Dermal

No data reported from Ertell (2006).

Inhalation

No data reported from Ertell (2006).

ndicate that guanidine or guanidine hydrochloride have any ed from Ertell, 2006).

ogenicity

for reproduction

Mutagenicity

Limited evidence does not imutagenic (damage to DNA) effects (cit

Carcin

No data available (cited from Ertell, 2006).

Toxicity





Human data

Guanidine is indicated for the reduction of the symptoms of muscle weakness and easy the myasthenic syndrome of Eaton-Lambert. It is not indicated

henia gravis. The Eaton-Lambert syndrome is ordinarily differentiated ssociation of the syndrome with small cell

myography may be necessary to make the diagnosis. Initial 10 and 15 mg/kg of body weight per day in 3 or 4 divided

e may be gradually increased to a total daily dosage of 35 mg/kg of ent of side effects. As individual tolerance is

highly variable, the dosage must be carefully titrated. Overdosage is characterised by mild s, such as anorexia, increased peristalsis, or diarrhoea are early

These symptoms may be relieved by atropine, less note should be taken of these symptoms and dosage reductions light numbness or tingling of the lips and fingertips shortly after taking a

fatigability associated withfor treating myastfrom myasthenia gravis by the usual acarcinoma of the lung, but dosage is usually betweendoses. This dosagbody weight per day or up to the developm

gastrointestinal disorderwarnings that tolerance is being exceeded. but nevertheconsidered. Sdose of guanidine has been reported. This per se is not an indication to discontinue treatment and/or reduce dosage. Severe guanidine intoxication is characterized by nervous hyperirritability, fibrillary tremors and convulsive contractions of muscle, salivation, vomiting, diarrhea, hypoglycemia, and circulatory disturbances. Administration of intravenous calcium gluconate may control the neuromuscular and convulsive symptoms and provide some relief of other toxic manifestations. (Information taken from the FDA label, available under: http://dailymed.nlm.nih.gov/dailymed/) (Daily Med, 2010).

http://dailymed.nlm.nih.gov/dailymed/


When used as medical treatment, the therapeutic dose of guanidine hydrochloride is from 10-15 mg/kg of body weight per day, not to exceed a daily dose of 30 mg/kg. Drug literature indicates that individual tolerance is highly variable for this drug and side effects on the neurological, gastrointestinal, skin, renal, hepatic, and cardiac systems are common, with the gastrointestinal and neurological effects of nausea/ diarrhea and nervousness/mood changes/irritability being the most frequently observed. Fatal cases of bone-marrow suppression have been reported in patients who took high doses of the drug (cited from Ertell, 2006).


Currently, guanidine phosphate is not legally classified according to regulation (ECst

) 1272/2008 and its 1 ATP.

Table 5-109: Summary of human health effect data for guanidine phosphate brought forward to the risk characterisation


Oral therapeutic dose Human data/ therapeutic dose of guanidine hydrochloride

15 mg/kg bw/d 0.2 mg/kg bw/d

Dermal See above See above 15 mg/kg bw/d** bw/d 0.2 mg/kg

Inhalation See above See above 26 mg/m3** 0.35 mg/m3


5.31.2 re

Based on the data compiled withi study (chapter 3) exposure ates ospha er app

• Service life of textiles and fibre containing guanidine phosphate (the subcategory clot een assume rst case as no tion

ations

able 5-110: Consumer exposure estimations to guanidine phosphate.

Consumer exposu

n the framework of this te have been provided forestim to guanidine ph one consum lications:

hes has b d as a wo further informa was provided)

Besides the exposure estimates, the model and the parameters used for the estimare provided in Table 5-110.

T


Service life of clothes

Oral

1 mg/kg bw/day (10%) 0.2 mg/kg bw/day (2%)

clothes and different concentrations in the final product of 20, 10 and 2%).

2 mg/kg bw/day (20%) 1.Tier assessment using ECETOC-TRA (AC5,

Dermal 477 mg/kg bw/day (20%) 239 mg/kg bw/day (10%)

1.Tier assessment using ECETOC-TRA (AC5, clothes and different concentrations in the final

47.7 mg/kg bw/day (2%) product of 20, 10 and 2%).

Inhalation - (vapour) 0.0525 mg/m³ (airborne

(i) Vapour: Due to the very low vapour pressure of the ionic



particulates) substance guanidine phosphate the inhalation exposure to vapour can be regarded as negligible. (ii) Airborne particulates:

indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited

When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in

in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g guanidine phosphate per g dust as a unrealistic worst case assumption, due to the lack of measured data.


Three sub-scenario een identified for terisation has been d. The d

reasonable worst ca concentrations,risk characterisation ratio (RCR) are compiled in

Table 5-111: Tentative risk assessment to guanidine p

s have b which a risk characperforme ata used for the risk cha

se exposureracterisation for consumers, including

derived no effect levels (DNELs) and the the table below.

hosphate for consumers.

Exposure scenario Route of mate DNEL RCR* Exposure estiexposure

Airborne particulates Inhalation 0.0525 mg/m³ 0.35 mg/m³ 0.15

Service life of clothes Oral 1 mg/kg bw/day (10%) 0.2 mg/kg bw/day (2%)

0.2 mg/kg/d 1-10 2 mg/kg bw/day (20%)

Service life of clothes Dermal 477 mg/kg bw/day (20%) 239 mg/kg bw/day (10%) 47.7 mg/kg bw/day (2%)

0.2 mg/kg/d 239 - 2385

*The risk characterisation ratio (RCR) is the quotient of the exposure estimate and the respective DNEL (derived no-effect level). If the RCR is garded as safe.

derm re a to guanidine ph clothes using the ECETOC TRA Consumer tool ed. It should be noted that the

is app on (text nd the s y clothes was chosen as a conservative approach final concentration in the textile product is not known. Therefore, diffe lame retardant fibre being used

(e.g. 50% a ed. T n exvapour has been considered not r ionic nature of the substance.

s.

arding the hazard assessment, no information on guanidine phosphate was found in

< 1 the use can be re

First tier oral and al exposu ssessments osphate inhave been perform

information on th licati iles) was scarce a ubcategor. Furthermore, the rent percentages of f

in the end product 100%, nd 10%) were assum he inhalatio posure to elevant due to the

Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumption

Regthe public domain. However, the moieties phosphate and guanidine have been assessed separately. For DNEL derivation the tolerable upper intake level of 3000 mg/day for phosphorus (phosphates), corresponding to 43 mg/kg bw/d (based on an average body weight of 70 kg), and the upper limit of the therapeutic range of 15 mg/kg bw/d for guanidine is taken forward. In view of the lack of route specific data for dermal and inhalation exposure, route-to-route extrapolation was conducted.


This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal and oral exposure to clothes.


No data available in the literature sources consulted in the framework of this study.


5.31.4

5.31.5

o substance specific information was found through a literature search on emissions ion). As such, environmental exposure at disposal eport.


t be assessed and no effect data were found in the

5.32

cles made of PVC, in which it is additively tegrated. The applications known are wire and cable and furniture made of artificial

rs.

5.32.1 uman health effects

d public literature sources. Also no effect data were gathered by Fisk et al. (2003).

classified according to regulation (EC) 1272/2008

e and cable containing isodecylphosphate


Nfrom disposal (landfill and incineratphase could not be assessed in this r

Since environmental exposure could noconsulted literature, no risk assessment could be carried out in this study.

Isodecylphosphate (CAS 56572-86-2)

Isodecylphosphate is used in flame retardant artiinleather (PVC) available to consume


H

No toxicological data are available from consulte


Currently, the substance is not legally and its 1st ATP.


Based on the data compiled within the framework of this study (chapter 3) exposure estimates to isodecylphosphate have been provided for two consumer applications:

• Service life of wir

• Service life of furniture e.g sofa containing isodecylphosphate in the artificial leather



Table 5-112: Consumer exposure estimation to isodecylphosphate.



halation 1.33 * 10-3 mg/m³ (SVC)

Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour In

concentration.


Dermal 36.5 mg/kg bw/day 1.Tier as(AC6, furn

sessment using ECETOC-TRA iture and a max concentration of

25%)

Inhalation 1.33 * 10-3 mg/m³ (SVC) 0.0525 mg/m3 (airborne particulates)

(i) Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour

e CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001)

orst case assumption, due to

concentration has been used as upper bound vapour concentration. (ii) Airborne particulates: When taking th

(cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g isodecylphosphate per g dust as a unrealistic wthe lack of measured data.


logical da odliterature sources, therefore only a tentative qua performed.

Table 5-113: Tentative qualitative risk assessment to isode

No toxico ta are publicly available for is ecylphosphate from consulted public litative risk assessment could be

cylphosphate for consumers.

Route of Exposure scenario Qualitative risk assessment exposure

SVC (saturated vapour Inhalation The inhalation exposure to vapour is low. concentration)

Service life of furniture Dermal The dermal exposure has been assessed using a 100% transfer factor from article to the skin (ECETOC-TRA). Therefore, it can be assumed that it will be lower in reality.

Service life of furniture Inhalation The inhalation exposure to airborne particulates is low.

First tier exposure assessments to isod ECETOC TRA Consumer ed with some simple refinements like the saturated vapour

n for a mor a rding the hazard assessment, no data are publicly avail

ecylphosphate using the tool have been performconcentratio e plausible inh lation exposure assessment. Rega

able, thus a firm conclusion on the risk cannot bedrawn.



5.32.5 mental exposure

rom the data available in this study, environmental exposure during service life could not

ental exposure at isposal phase could not be assessed in this report.

5.32.6

mental exposure could not be assessed, no risk assessment could be

5.33 S 56803-37-3)

ert-butylphenyl-diphenyl phosphate is used in flame retardant articles made of PVC, in e applications known are wire and cable and furniture

he environmental impact of tertbutylphenyl diphenyl phosphate was assessed on behalf f the U.K. Environment Agency (Brooke et al., 2009). Relevent sections from this

sk assessment for has been

5.33.1

oxicity


Environ

Fbe assessed.

The disposal phase as considered in this study (landfill, incineration) is not covered by REACH. No substance specific information was found through a literature search on emissions from disposal (landfill and incineration). As such, environmd


Since environcarried out in this study.

Tert-butylphenyl diphenyl phosphate (CA

Twhich it is additively integrated. Thmade of artificial leather (PVC) available to consumers. Tertbutylphenyl diphenyl phosphate is additively integrated in the matrix.

Toassessment are summarized hereafter. Even though no human health rithe use of consumer products containing tertbutylphenyl diphenyl phosphateprovided by Brooke et al. 2009g, the toxicological information gathered are summarised below.




No data available (cited from Brooke et al., 2009g).

Acute t

Oral

The toxicity of a tertbutylphenyl diphenyl phosphate preparation (Phosflex 51B) following > 5,000 mg/kg bodyweight in rats (Stauffer Chemical Company,

et al., 2009g). oral exposure is LD50 1979) (cited from Brooke

Dermal


The toxicity of tertbutylphenyl diphenyl phosphate following dermal exposure is > 2,000 mg/kg bodyweight in rabbits (ECB, 2001) (cited from Brooke et al., 2009g). LD50

Inhalation

The single study available for acute inhalation of tertbutylphenyl diphenyl phosphate was carried out at a single low exposure concentration. The LC50 for inhalation was above 3.1

four hours in rats (cited from Brooke et al., 2009g). mg/L for


Skin and eye

The two available studies on the irritant properties of tertbutylphenyl diphenyl phosphate suggest that the substance is mildly irritating to the skin and eyes. In both cases, irritation was reversed after several days (cited from Brooke et al., 2009g).

Sensitisation

No data available (cited from Brooke et al., 2009g).

ty Repeated dose toxici

Oral

One 90-day oral repeated dose toxicity study is available in which male and female Sprague-Dawley rats were fed 0, 100, 400 or 1,600 ppm (0, 6.6, 26.7 and 107.5

enyl diphenyl phosphate preparation (Phosflex 51B) via diet. The absolute and/or relative weights of pathological changes were observed

hanges in some haematological (platelet and leukocyte counts), ical parameters (serum phosphorous, total bilirubin, total serum protein,

lactate dehydrogenase, calcium, glutamic oxaloacetic transaminase and urinary protein)

mg/kg/day) a tertbutylphhighest dose group showed significant increases inlivers, kidney and adrenal glands, although no histoin any of these organs. Cclinical chem

and cholinesterase activity were noted in some treatment groups. However, the authors did not consider these to be biologically relevant. The NOEL is 26.7 mg/kg bodyweight/day in male rats or 30.0 mg/kg bodyweight/day in female rats (equivalent to 400 ppm) (Freudenthal et al., 2001) (cited from Brooke et al., 2009g).

Dermal

No data reported by Brooke et al. (2009g).

Inhalation

No data reported by Brooke et al. (2009g).

Mutagenicity

Tertbutylphstudies,

enyl diphenyl phosphate did not induce mutations in two in vitro mutagenicity a bacterial reverse gene mutation assay and a mouse lymphoma gene mutation

errations or sister chromosome exchanges in phoma L5178Y cells (cited from Brooke et al., 2009g).

le (cited from Brooke et al., 2009g).

assay, and did not induce chromosomal abmouse lym

Carcinogenicity

No data availab


Effects on fertility and developmental toxicity


In a reproduction/developmental toxicity screening test Sprague-Dawley rats received 0, 50, 250 or 1,000 mg/kg bw/day a tertbutylphenyl diphenyl phosphate preparation

gavage. No evidence of toxicity to fertility and reproduction of male and g mating, gestation and lactation from exposure to tertbutylphenyl

the number of live pups at gestation d. In addition, there were no treatment-related effects on

foetal development, except a reduction in mean foetal weights at 1,000 mg/kg bw/day, ams of this treatment group. Based on the

ulation (EC)

114: Summary of human health effects for tertbutylphenyl diphenyl phosphate brought rward to the risk characterisation

(Phosflex 61B) viafemale rats durindiphenyl phosphate, or any effects on litter size and day zero and four was observe

which was attributed to maternal toxicity in dlack of parental and foetal toxicity, the no observed adverse effects level (NOAEL) for this study was greater than 1,000 mg/kg bw/day (cited from Brooke et al., 2009g).

In addition, no effects on the development or teratogenicity were observed in a developmental toxicity study up to a dose level of 1000 mg/kg bw/d administered by gavage to pregnant female rats from day 6 to 20 of gestation (cited from Brooke et al., 2009g)


Tertbutylphenyl diphenyl phosphate is not legally classified according to reg1272/2008 and its 1st ATP.

Table 5-fo




Dermal See above See above NOEL = 30 mg/kg/d (30 mg/kg/d)**

0.15 mg/kg/d

Inhalation See above See above NOEL = 30 mg/kg/d

0.26 mg/m3 (13 mg/m³)**

*A detaildepartu

ed d the DNEL derivation is provided in Annex 1 rected pre, de oute to route


Based on the data compiled within the framework o (chapter 3) exposure s to yl diphenyl p have for tw er

• Service life of furniture e.g sofa containing tertbutylphenyl diphenyl phosphate in the artificial leather

escription ofrived from r

0 of this report. **Cor oint of extrapolation

f this study estimateapplication

tertbutylphens:

hosphate been provided o consum

• Service life of wire and cable containing tertbutylphenyl diphenyl phosphate



Table 5-115: Consumer exposure estimations to tertbutylphenyl diphenyl phosphate.

f exposure ExposurRoute o e estimate (external) Comment


Inhalation 1.22 * 10-2 m

Due to the very low vapour pressure (< 10-4

g/m³ (SVC) Pa), the saturated vapour concentration has been used as upper bound vapour concentration.


w/day 1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of Dermal 36.5 mg/kg b25%)

Inhalation 1.22 * 10-2 mg/m³ (SVC) d vapour concentration.

Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper boun

Inhalation 0.0525 mg/m³ (airborne particulates) r (dust) in indoor air of 52.5

dust as a unrealistic worst case assumption, ured data.

Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matteμg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g tertbutylphenyl diphenyl phosphate per g

due to the lack of meas

5.33.3 ealth risk

Three sub-scenarios have been identified for whicperformed. The data used for the risk charact reasonable worst case exposure concentrations, der ) and the sk characterisation ratio (RCR) are compiled in the table below.

t to tertbutylphenyl diphenyl phosphate for consumers.

Human h assessment

h a risk characterisation has been erisation for consumers, includingived no effect levels (DNELs

ri

Table 5-116: Tentative risk assessmen





0.0525 mg/m³ 0.26 mg/m³ 0.2

*The risk characterisation ratio (Rno-effect level). If the RCR is <

CR) is the quotient of the exposure estimate and the respective DNEL (derived can be

First tier exposure assessments to tert phenyl phosphate using the ECETOC l hav e simple r like th turated

vapour concentration f plausible inhalation exposure assessment. Inhalation

arding the hazard assessment, the substance seems to be of low toxicity from the data summarized. However, data gaps exist for in vivo genotoxicity and carcinogenicity

1 the use regarded as safe.

butylphenyl die been perform

or a more TRA Consumer too ed with som efinements e sa

exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions.

Reg


from the cited literature, but available data suggest that tertbutylphenyl diphenyl phosphate does not cause genotoxicity, neurotoxicity, toxicity to reproduction or development (up to 1000 mg/kg bw/d). However, the currently available neurotoxicity tests were not considered as appropriate for human risk assessment purposes. A valid three-month oral feeding study in rats revealed a NOEL for repeated dietary exposure of 26.7/30

idered. The DNELs derived in this CSR (chapter 5.11.

on, the results were interpreted differently. As

mg/kg bw/day in male/female rats based on increased organ weights and was selected as starting point for DNEL derivation.

The tentative risk assessment performed using conservative exposure estimations showed a risk with respect to dermal exposure to artificial leather used in furniture. No risk has been identified for the inhalation route.

It should be noted that the CSR on tertbutylphenyl diphenyl phosphate was provided by industry (ICL-IP) to the authors in January 2011. The consumer uses are considered to be safe, but do not include the application of artificial leather used for furniture. Furthermore, no dermal exposure has been consin CSR on tertbutylphenyl diphenyl phosphate) on tertbutylphenyl diphenyl phosphate are different from the once derived in the framework of this report, even though the same study has been used for the DNEL derivatithe primary literature was not evaluated by the authors themselves (use of secondary literature) no firm conclusion can be drawn. The RCRs calculated with these DNELs are provided in Table 5-117 below. The outcome of this tentative risk assessment would show no risk with respect to the inhalation route and risk with respect to the dermal route.

Table 5-117: Tentative risk assessment for consumers using the DNELs reported in the CSR on tertbutylphenyl diphenyl phosphate (provided in 01-2011 by ICL-IP).



Service life of furniture Dermal 36.5 mg/kg bw/d 5.375 mg/kg bw/d 6.8


0.0525 mg/m³ 1.87 mg/m³ 0.028

*The risk characterisation ratio timateno-effect level). If the RCR is can be regarded as safe.

5.33.4 ects

Table 5-118: Environmen r tert-butylphenyl-diphenyl phosphate complied from

(RCR) is the quoti< 1 the use

ent of the exposure es and the respective DNEL (derived

Environmental eff

tal effect data foBrooke et al. (2009).


Surface water 1 µg/L Lowest effect concentration: 21d-NOEC reproduction test for Daphnia magna = 0.010 mg/L Assessment factor = 10

STP NA -




n sediment-dwelling ediment. In the absence of any

ecotoxicological data for sediment-dwelling organisms, the EC may provisionally be calculated using the equilibrium

od from the PNEC for aquatic organisms and

*

0

There are no studies available oorganisms exposed via s

PNpartitioning meththe sediment/water partition coefficient: PNECsed = Ksed-water / Psed * PNECaquatic organisms1000 where Ksed-water = sediment/water partition coefficient = 12m³/m³ Psed = bulk density of wet sediment = 1,150 kg/m³


No terrestrial toiciy data are available suitable for determining a PNEC. In the absence of data, the equilibrium partitioning method can be used to estimate the PNEC: PNECsoil = Ksoil-water / Psed * PNECaquatic organisms * 1000 where Ksoil-water = soil/water partition coefficient = 143 m³/m³Psoil = bulk density of wet soil = 1,700 kg/m³

Atmosphere NA

possibility of ric

No information is available on the toxicity of tertbutylphenyl diphenyl phosphate to plants and other organisms exposed via air. The low vapour pressure of the substance means that

mited and the volatilisation to the atmosphere is likely to be liresulting concentrations are likely to be low. Thetertbutylphenyl diphenyl phosphate contributing to atmospheeffects such as global warming and acid rain is thus likely to be small. In addition, as the substance does not contain halogen atoms, it will not contribute to ozone depletion.

NA: not available

5.33.5 En e

ertbutylphenyl diphenyl phosphate is mainly used in flexible PVC. Exposure was ssessed during service life, from waste and during waste management. In summary,

phosphate during service life and disposal of

5.33.6

he PEC/PNEC ratios calculated in the UK RAR (Brooke et al., 2009) are given in Table -119.

utylphenyl diphenyl phosphate (Brooke et al., 2009)

vironmental exposur

Tareleases of tertbutylphenyl diphenyl consumer products contribute to a major extent to the total environmental emissions of that substance to air (92%) and to about half of the total releases to soil (58.6%). Consumer use contributes around 50% to the total releases to water (wastewater + surface water).

A detailled overview of the uses and the exposure assessment is given in Annex 6 – chapter 13.


T5

Table 5-119: PEC/PNEC ratios for tertb


Surface water Regional sources 0.02




STP - NA

Sediment Regional sources 0.2

Terrestrial gional sources: ReAgricultural soil

Industrial soil

<0.01 1

0.21 Natural soil

<0.0

NA: not available

water, sediment and soil from regional sources appear to be low. No NEC for waste water treatment processes could be derived for tertbutylphenyl diphenyl

phosphate and so no risk characterisation can be carried out. Based on the conclusions

5.34 Resorcino sphate (CAS 57583-54-7)

Resorcinol bis-diphenylphosphate is used in flame retardant articles made of engineering plications known are

computers. Therefore it was assumed that it is used in the exterior parts e.g. housing.

lf of ns from this

assessment are summarized hereafter. Even though no human health risk assessment for

5.34.1 health effects


investigated the metabolism and toxicokinetics of tetraphenyl s. Groups of animals were given a single

dose of 100 g/kg C-tetraphenyl resorcinol diphosphate by intravenous injection, nose-

The risk to surfaceP

found for this endpoint in the risk assessments carried out for other triaryl phosphates as part of this project, the risks to waste water treatment processes from tertbutylphenyl diphenyl phosphate would be expected to be low.

The overall conclusion is that tertbutylphenyl diphenyl phosphate is not a PBT substance; it does not meet the P or B criteria.

l bis-diphenylpho

resin, in which it is assumed to be additively integrated. The ap


The environmental impact of resorcinol bis-diphenylphosphate was assessed on behathe U.K. Environment Agency (Brooke et al., 2009). Relevent sectio

the use of consumer products containing resorcinol bis-diphenylphosphate has been provided by Brooke et al. (2009h), the toxicological information gathered are summarised below.

Human

T

A good quality study resorcinol diphosphate in rats, mice and monkey

14

only inhalation, oral gavage or dermal exposure. Dermal absorption of tetraphenyl resorcinol diphosphate in rats was approximately 20 per cent while, in monkeys, the amount absorbed was less than ten per cent. In rats, around 83 per cent of the tetraphenyl resorcinol diphosphate administered by oral gavage was absorbed. Approximately 80 per cent of the administered dose was excreted in the faeces and seven per cent excreted in urine by the end of day one; approximately five per cent was excreted as CO2 in expired air. In rats, following inhalation, the majority was excreted in the faeces (60 per cent in


males; 52 per cent in females), with a lesser amount excreted in the urine (ten per cent in males, seven per cent in females). The primary route of elimination was via the faeces, followed by urine. Tetraphenyl resorcinol diphosphate was found un-metabolised in the faeces only after oral exposure. Four major metabolites were found in the faeces: hydroxy-tetraphenyl resorcinol diphosphate, dihydroxy-tetraphenyl resorcinol diphosphate, resorcinol diphenylphosphate half-ester and hydroxyl-resorcinol diphenylphosphate half-ester. Three metabolites were identified in the urine: resorcinol, resorcinyl glucuronide, and resorcinyl sulfate (Freudenthal et al., 2000) (cited from Brooke et al., 2009h).

Acute toxicity

Three good quality, thoughoral, inhalation

briefly reported, rat studies investigated acute toxicity following or dermal administration of a tetraphenyl resorcinol diphosphate

preparation (Fyrolflex RDP). No mortality was observed in any of the studies. Based on the absence of mortality, oral and dermal LD50s were above 5,000 mg/kg bodyweight and above 2,000 mg/kg, respectively, which are above the limit doses applied in modern studies. The LC50 for inhalation was greater than highest attainable concentration of 4.14 mg/L (cited from Brooke et al., 2009h).


Skin and Eye

In two EC guskin but was f

ideline studies, tetraphenyl resorcinol diphosphate was not irritating to the ound to cause mild reversible irritation to the eye of one of three rabbits

tested (cited from Brooke et al., 2009h).

Sensitisation

No reliable d2009h).

ata available to assess the sensitising potential (cited from Brooke et al.,


Oral

In a 28-dat dos

ay mouse (B6C3F1) oral study, treatment with tetraphenyl resorcinol diphosphate es of 500, 1,500 or 5,000 mg/kg bw/day no treatment-related changes suggestive of

general toxicity or immunotoxicity up to 5,000 mg/kg bw/day were observed, thus this level was considered to be the oral NOAEL in mice (Sherwood et al., 2000) (cited from Brooke et al., 2009h).

Dermal

No data reported by Brooke et al. (2009h).

Inhalation

In a 28-daytetraphenyl

repeated dose toxicity study via nose-only inhalation, rats received a resorcinol diphosphate preparation (Fyrolflex RDP) at a concentration of 0,

0.1, 0.5 and 2.0 mg/L. Significantly lower bodyweight and food consumption values were noted in males given the test item at 2.0 mg/L, and evidence of liver enlargement was noted in rats of both sexes exposed at 0.5 or 2.0 mg/L. Pathological changes considered typical of the response of rodent lungs to high-level exposure to non-cytotoxic, water insoluble, foreign material were also noted in these treated groups, but this effect was not considered to reflect a specific toxic response per se. The NOEL for general toxicity endpoints in this study was 0.1 mg/L (Henrich et al., 2000) (cited from Brooke et al., 2009h).


Mutagenicity

Three OECD guideline studies assessed the mutagenicity and genotoxic potential of orcinol diphosphate in vitro and in vivo. The level of reporting of these

h).

duction

tetraphenyl resstudies in the secondary literature is not sufficient to determine the quality of the studies and results. Nonetheless, all three studies gave negative results, which indicate, on a weight-of-evidence basis, that tetraphenyl resorcinol diphosphate is unlikely to be an in vivo mutagen (cited from Brooke et al., 2009h).

Carcinogenicity

No data available (cited from Brooke et al., 2009

Toxicity for repro


In a two-generation study male and female Sprague-Dawley rats were given diet aphenyl resorcinol diphosphate preparation (Fyrolflex RDP) at a

spring in rats and rabbits were noted. Some

containing a tetrconcentration of 1,000, 10,000 or 20,000 ppm (equivalent to achieved doses of 0, 49, 520 or 995 mg/kg bw/day for males and 0, 59, 602 or 1,199 mg/kg bw/day for females). selected pups (at least one/sex/litter) were housed and fed the same dose levels as the parent animals through mating, gestation, lactation and weaning, until sacrifice (0, 55, 602 or 1,260 mg/kg bw/day for F1 males and 0, 63, 683 or 1,411 mg/kg bw/day for F1 females) (cited from Brooke et al., 2009h).

No treatment-related effects on reproductive performance or fertility of F0 rats or on the reproduction of rats or development of offchanges were noted, including changes in food consumption, bodyweights and the weight of adrenal glands in treated animals (considered to be a result of food aversion) and hepatic periportal hypertrophy in high-dose rats (attributed to an adaptive response to metabolism of tetraphenyl resorcinol diphosphate). Based on the lack of reproductive toxicity, the NOAEL for tetraphenyl resorcinol diphosphate administered in the diet is greater than 20,000 ppm (equivalent, in the F0 generation, to 995 mg/kg bw/day for male rats and 1,199 mg/kg bw/day for female rats and, in the F1 generation, to 1,260 mg/kg bw/day for males and 1,411 mg/kg bw/day for females) (Henrich et al., 2000) (cited from Brooke et al., 2009h).


In the developmental study on rabbits, no treatment-related effects were observed in e NOAEL for developmental toxicity for tetraphenyl resorcinol

sification

etraphenyl resorcinol diphosphate is not legally classified according to regulation (EC) P.

dams or fetuses. Thus, thdiphosphate is greater than 1,000 mg/kg bw/day (Ryan et al., 2000) (cited from Brooke et al., 2009h).

Current clas

T1272/2008 and its 1st AT


Table 5-120: Summary of human health effect data for resorcinol bis-diphenyl phosphate brought forward to the risk characterisation.



Rat / 28-days inhalation/ 0, 0.1, 0.5, 2.0 mg/L

NOEC: 100 mg/m³ (based on effects on body/organ weights and unspecific lung findings)

0.7 mg/m³



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to resorcinol bis-diphenylphosphate have been provided for one consumer applications based on the data compiled:

• Service life of electric and electronic equipment like computers containing resorcinol bis-diphenylphosphate


Table 5-121: Consumer exposure estimations to resorcinol bis-diphenyl phosphate.







Table 5-122: Tentative risk assessment to resorcinol bis-diphenylphosphate for consumers.


Service life of electric and electronic equipment (SVC)

Inhalation 2.0 * 10-2 mg/m³ 0.7 mg/m³ 2.9 * 10-2


Inhalation exposure to resorcinol bis-diphenylphosphate for one consumer application has been assessed by using the saturated vapour concentration as an upper inhalation exposure.

Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized.


Although there are no studies available on carcinogenicity, the available negative information on the in vitro and in vivo mutagenicity and genotoxic potential indicate that tetraphenyl resorcinol diphosphate is unlikely to possess a carcinogenic potential to exposed humans. The studies available on fertility and reproductive performance and the information on potential developmental toxicity/teratogenicity suggest that there were no adverse effects up to about 1000 mg/kg bw/day. Although somewhat limited, the repeated dose toxicity studies do not suggest that tetraphenyl resorcinol diphosphate has a neurotoxic potential. A NOEC for systemic inhalation toxicity of 100 mg/m³ was defined for systemic and local effects in the lungs and was thus used as the starting point for DNEL derivation of long-term systemic effects.

Altogether this tentative risk assessment to resorcinol bis-diphenylphosphate from consumer applications beeing performed showed no risk for the application considered.


Environmental effect data complied from Brooke et al. (2009) are given in Table 5-123.

Table 5-123: Environmental effect data for resorcinol bis-diphenylphosphate (Brooke et al., 2009)


Surface water 2.1 µg/L 0.42 µg/L

Lowest effect concentration: 21d-NOEC reproduction test for Daphnia magna = 0.021 mg/L Assessment factor = 10 Assessment factor 50, when taking into account extra NOEC value for algae, based onread-across from toxicity data for all triaryl phosphates assessed in U.K. RAR

STP 122 mg/L EC10 bacteria = >121.6 mg/L No assessment factor34

Sediment 0.336 mg/kg wwt. 35


Terrestrial 0.272 mg/kg wwt. 35

No terrestrial toxicity data are available suitable for determining a PNEC. In the absence of data, the equilibrium partitioning method can be used to estimate the PNEC: PNECsoil = Ksoil-water / Psed * PNECaquatic organisms * 1000 where Ksoil-water = soil/water partition coefficient = 220 m³/m³ Psoil = bulk density of wet soil = 1,700 kg/m³

34 The solubility of the test substance was exceeded in this test and so the results are best interpreted in terms of no effects at solubility. According to the TGD, the NOEC/EC10 from such a study can be used directly as the PNECmicroorganisms, and so the PNECmicroorganisms could be taken as 0.69 mg/l (the water solubility of the substance). However, this approach may overestimate the actual toxicity of the substance to sewage treatment processes since actual solubility in pure water may not be relevant to exposure of microorganisms during waste water treatment. In this respect, no significant effects would be seen at 122 mg/l and this is used as the PNECmicroorganisms in this case. 35 As the log Kow of this substance is above five, according to the TGD the resulting PEC/PNEC ratios should be increased by a factor of 10 when using this PNEC to take into account the possibility of direct ingestion of sediment-bound substance.



Atmosphere NA No information is available on the toxicity of tertbutylphenyl diphenyl phosphate to plants and other organisms exposed via air. The low vapour pressure of the substance means that volatilisation to the atmosphere is likely to be limited and the resulting concentrations are likely to be low. The possibility of tertbutylphenyl diphenyl phosphate contributing to atmospheric effects such as global warming and acid rain is thus likely to be small. In addition, as the substance does not contain halogen atoms, it will not contribute to ozone depletion.

NA: not available


From the data by Brooke et al. (2009), it can be deducted that releases of tetraphenyl resorcinol diphosphate during service life and disposal of consumer products contribute to about half of the total environmental emissions of that substance to air (61.5%) and represent almost all releases to soil (99.9%). Consumer use contributes largely (91%) to the total releases to water (wastewater + surface water).

A detailled overview of the uses and the exposure assessment is given in Annex 6 – chapter 17.



Table 5-124: PEC/PNEC ratios for resorcinol bis-diphenylphosphate (Brooke et al., 2009)


Surface water Regional sources 0.03

STP All uses 0.01

Sediment Regional sources 0.44

Terrestrial Regional sources: Agricultural soil Natural soil Industrial soil

<0.01 <0.01 5.15

NA: not available

The risk to surface water, sediment and agricultural and natural soil from regional sources appear to be low. Based on the PEC/PNEC ratios, no risk to waste water treatment plants would be expected from the production and use of tetraphenyl resorcinol diphosphate.

The PEC/PNEC ratio is above one for for regional industrial soil. Further information is needed on emissions from the processes to refine the PECs for this scenario. Furthermore, a sensitivity analysis suggests that a faster hydrolysis rate than assumed here could have a significant effect on regional soil PEC. It may therefore be possible to refine the PEC by carrying out further testing to investigate the actual degradation (mineralization) half-life in soil under relevant environmental conditions. The PNEC for soil


is based on the equilibrium partitioning approach, and the PEC/PNEC ratio has been increased by a factor of 10 to take into account the possibility of direct ingestion of soil-bound substance. Toxicity tests with soil organisms would allow the PNEC for this endpoint to be refined. Testing on three species in long-term tests would probably be required.

ICL-IP (pers. comm.) states that thermoplastics and styrenics would not end up in the environment at disposal. Since these plastics are used in electric and electronic equipment, they will be collected and/or recycled. As such, the share of resorcinol bis-diphenylphosphate used in consumer products that contributes to the regional risk for industrial soil would be reduced from 99.9% to 6%. According to ICL-IP (pers. comm.), resorcinol bis-diphenylphosphate is not classified, and thus no long term environmental tests are required in the framework of REACH and thus not planned. From the CSR provided by ICL-IP, a PNEC soil of 0.154 mg/kg dw is available. This PNECsoil is lower than the value used in the UK RAR. However, exposure assessment - and as such risk characterisation - was not available, implying no possible risk refinement.

Tetraphenyl resorcinol diphosphate is considered to meet the first stage screening criteria for P and vP. The substance does not meet the B criterion. The substance does not meet the T criterion. The overall conclusion is that the substance meets one of the criteria on the basis of screening data, but does not meet the other two criteria and so is not a PBT/vPvB substance.

5.35 Bisphenol A-bis(diphenylphosphate) (CAS 5945-33-5 and 181028-79-5)

Bisphenol A-bis(diphenylphosphate) is used in flame retardant articles made of e.g. high impact polystyrene, polycarbonate, thermoplastic polyurethane or textile fibres, in which it is additively integrated. The applications known are wire and cable, housings of electric and electronic equipment, textiles, furniture and flooring available to consumers.



Bisphenol A-bis(diphenylphosphate) (BAPP or BPADP) is a mixtures of chemicals. The major component comprises of > = 85%.


No data reported by NICNAS (2005).

Acute toxicity

Bisphenol A-bis(diphenylphosphate) was of very low acute oral toxicity (LD50 >2 000 mg/kg) (Donald & Edgar, 1999) and low acute dermal toxicity (LD50 >2 000 mg/kg) in the rat (Edgar, 1999a) (cited from NICNAS, 2005). An inhalation study was not provided (cited from NICNAS, 2005).


Skin and eye


Bisphenol A-bis(diphenylphosphate) was slightly irritating in an in vivo rabbit skin and eye irritation test (Edgar, 1999b,c) (cited from NICNAS, 2005). However, the substance is not to be classified as skin or eye irritant in the EU.

Sensitisation

Bisphenol A-bis(diphenylphosphate) was non-sensitising in a guinea pig maximisation test (Edgar, 1999d) (cited from NICNAS, 2005).


In a 28-day repeat dose study, rats were given Bisphenol A-bis(diphenylphosphate) by oral gavage at doses of 0, 250, 500 and 1000 mg/kg bw/day. A NOAEL of 1000 mg/kg bw/day was established, due to the lack of toxicological significant effects (Rusty & Rush, 2000) (cited from NICNAS, 2005).

Mutagenicity

In genotoxicity studies, Bisphenol A-bis(diphenylphosphate) was negative in a bacterial reverse mutation assay (Cattanach, 1999), and did not induce an increased incidence of chromosomal aberrations in Chinese hamster ovary cells in vitro (Murie, 2000) (cited from NICNAS, 2005). Bisphenol A-bis(diphenylphosphate) was non-clastogenic in an in vivo micronucleus assay in mice (Watson & Innes, 2000) (NICNAS, 2005).

Carcinogenicity





The substance is currently not classified according to regulation (EC) 1272/2008 and its 1st ATP with respect to effects on human health.

Table 5-125: Summary of human health effect data for bisphenol A-bis(diphenylphosphate) brought forward to the risk characterisation



Rat / 28-days oral/ 0, 250, 500, 1000 mg/kg/d NOAEL> 1000 mg/kg/d 0.6 mg/kg/d


Rat / 28-days oral/ 0, 250, 500, 1000 mg/kg/d

NOAEL> 1000 mg/kg/d (5000 mg/kg/d)**

4.2 mg/kg/d



NOAEL> 1000 mg/kg/d (435 mg/m³)**

1.5 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. **Corrected point of departure, derived from route to route extrapolation



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to bisphenol A-bis(diphenylphosphate) have been provided for five consumer applications:

• Service life of wire and cable containing bisphenol A-bis(diphenylphosphate)

• Service life of small and large electric and electronic equipment containing bisphenol A-bis(diphenylphosphate) in the housing

• Service life of textiles and fibre containing bisphenol A-bis(diphenylphosphate) (clothes have been assumed as a worst case as no further information was provided)

• Service life of PVC flooring containing bisphenol A-bis(diphenylphosphate)

• Service life of furniture e.g sofa containing bisphenol A-bis(diphenylphosphate) in the artificial leather


Table 5-126: Consumer exposure estimations to bisphenol A-bis(diphenylphosphate)






1.Tier assessment using ECETOC-TRA (AC13, small articles and a max concentration of 25%) Dermal 0.149 mg/kg bw/day



Service life of clothes

Oral 2.5 mg/kg bw/day (25%) 1.25 mg/kg bw/day (12.5%) 0.25 mg/kg bw/day (2.5%)

1.Tier assessment using ECETOC-TRA (AC5, clothes and different concentrations in the final product of 25, 12.5 and 2.5%).

Dermal 596 mg/kg bw/day (25%) 298 mg/kg bw/day (12.5%) 59.6 mg/kg bw/day (2.5%)

1.Tier assessment using ECETOC-TRA (AC5, clothes and different concentrations in the final product of 25, 12.5 and 2.5%).

Inhalation 3.35 * 10-4 mg/m³ (SVC) 0.0525 mg/m³ (airborne particulates)

(i) Due to the very low vapour pressure (< 10-4 Pa), the saturated vapour concentration has been used as upper bound vapour concentration. (ii) Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g bisphenol A-bis(diphenylphosphate) per g dust as a unrealistic worst case assumption, due to the lack of measured data.




1.Tier assessment using ECETOC-TRA (AC13, flooring and a max concentration of 20%) Dermal 29.2 mg/kg bw/day




1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of 20%) Dermal 29.2 mg/kg bw/day




Seven sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-127: Tentative risk assessment to bisphenol A-bis(diphenylphosphate) for consumers.



Airborne particulates Inhalation 0.0525 mg/m³ 1.5 mg/m³ 0.035

Service life of electric and electronic equipment Dermal 0.149 mg/kg /d 4.2 mg/kg/d 0.035

Service life of clothes Oral 2.5 mg/kg bw/day (25%) 1.25 mg/kg bw/day (12.5%) 0.25 mg/kg bw/day (2.5%)

0.6 mg/kg/d 4.2 2.1 0.4

Service life of clothes Dermal 596 mg/kg bw/day (25%) 298 mg/kg bw/day (12.5%)

4.2 mg/kg/d 142 – 14.2



59.6 mg/kg bw/day (2.5%)

Service life of PVC flooring Dermal 29.2 mg/kg bw/day 4.2 mg/kg/d 7

Service life of furniture Dermal 29.2 mg/kg bw/day 4.2 mg/kg/d 7


First tier exposure assessments to bisphenol A-bis(diphenylphosphate) have been performed using the ECETOC TRA Consumer tool with a simple refinement for a more plausible inhalation exposure assessment using the saturated vapour concentration. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions.

Regarding the hazard assessment, the substance seems to be of low toxicity from the data summarized. However, no information on reproductive function, developmental toxicity or carcinogenicity is available. The standard battery of genotoxicity studies revealed negative results, and the compound is not considered mutagenic or clastogenic. Therefore, derivation of end-point specific DNELs is not considered; only results from a 28-day oral toxicity study were available for bisphenol A-bis(diphenylphosphate). The results of the study did not indicate specific organ toxicity or effects on reproductive organs up to a dose level of 1000 mg/kg bw/d. Therefore, the DNEL derived can be regarded as an upper limit DNEL with the view to conducting a screening risk assessment.

This tentative risk assessment using conservative exposure estimations showed a risk with respect to the dermal and oral exposure to textiles and the dermal exposure to PVC flooring and furniture. It was stated by industry (personal communication 01-2011 Chemtura and ICL-IP) that the later two applications are not relevant for the domestic environment and would therefore be out of the scope of this project. The use in textiles was confirmed as being a niche application (personal communication 01-2011 ICL-IP). No risk has been identified for the other applications and routes considered.


An overview of the environmental effects of bisphenol A-bis(diphenylphosphate) gathered from the literature consulted within this project is given in Table 5-128.

Table 5-128: Environmental effects of bisphenol A-bis(diphenylphosphate) gathered from the literature consulted within this project

Effect Endpoint Value Unit Reference Reliability Bio accumulation

BCF 1.00E+06 L/kg STN CAS Registry

Predicted; 25°C; pH 1 to 10


NOEC(21d) >1

mg/L Muir, (1984) no data


LC50(96h) >1



EC50(48h) >1








5.36 Bis-(tert-butylphenyl)phenylphosphate (CAS 65652-41-7)

Bis-(tert-butylphenyl)phenyl phosphate is used in flame retardant articles made of PVC, in which it is additively integrated. The applications known are wire and cable and furniture made of artificial leather (PVC) available to consumers.



No toxicological data for bis (tert-butylphenyl) phenylphosphate are available from consulted public literature sources. However, as the UK assessment (Brooke et al., 2009g) for (tert-butylphenyl)phenylphosphate (CAS 56803-37-3) (see chapter 5.33.1) also covers phenol, isobutylated, phosphate (3:1)’ (CAS no. 68937-40-6), read-across to bis-(tert-butylphenyl) phenyl phosphate should be admissible.


Bis-(tert-butylphenyl)phenylphosphate is currently not legally classified according to regulation (EC) 1272/2008 and its 1st ATP.

Table 5-129: Summary of human health effect data for bis-(tert-butylphenyl) phenyl phosphate brought forward to the risk characterisation




Dermal See above See above NOEL = 30 mg/kg/d (30 mg/kg/d)**

0.17 mg/kg/d

Inhalation See above See above NOEL = 30 mg/kg/d (13 mg/m³)**

0.30 mg/m3

*A detailed description of the DNEL derivation for (tert-butylphenyl)phenylphosphate is provided in Annex 10 of this report. A conversion from (tert-butylphenyl)phenylphosphate to bis-(tert-butylphenyl)phenylphosphate has been done based on the molecular weight. ** Corrected point of departure, derived from route to route extrapolation



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to bis-(tert-butylphenyl)phenylphosphate have been provided for two consumer applications:

• Service life of wire and cable containing bis-(tert-butylphenyl)phenylphosphate

• Service life of furniture e.g sofa containing bis-(tert-butylphenyl)phenylphosphate in the artificial leather


Table 5-130: Consumer esposue estimations to bis-(tert-butylphenyl)phenylphosphate.






1.Tier assessment using ECETOC-TRA (AC6, furniture and a max concentration of 25%)

Dermal 36.5 mg/kg bw/day



Inhalation 0.0525 mg/m³ (airborne particulates)

Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g tertbutylphenyl diphenyl phosphate per g dust as a unrealistic worst case assumption, due to the lack of measured data.



Table 5-131: Tentative risk assessment to bis-(tert-butylphenyl)phenylphosphate for consumers.






0.0525 mg/m³ 0.30 mg/m³ 0.175


First tier exposure assessments to bis-(tert-butylphenyl)phenylphosphate using the ECETOC TRA Consumer tool have been performed with some simple refinements like the saturated vapour concentration for a more plausible inhalation exposure assessment. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions.

Regarding the hazard assessment, no information on bis-(tert-butylphenyl)phenylphosphate was found in the public domain. However, read across from (tert-butylphenyl)phenylphosphate (CAS 56803-37-3) (see chapter 5.33.1) had been performed. In view of the lack of route specific data for dermal and inhalation exposure, route-to-route extrapolation was conducted based on the starting point of an oral NOEL of 30 mg/kg bw/d based on a 90 day sub-chronic toxicity study in rats.

The tentative risk assessment performed using conservative exposure estimations showed a risk with respect to dermal exposure to artificial leather used in furniture. No risk has been identified for the inhalation route.







Since environmental exposure during disposal phase was not assessed, no environmental risk assessment for that phase was carried out in this study.

5.37 Hypophosphite, aluminium salt (CAS 7784-22-7)

Hypophosphite, aluminium salt is used in flame retardant articles made of high impact polystyrene, polybutylene terephtalate or polypropylene, in which it is assumed to be


additively integrated. The applications known are wire and cable and electric and electronic equipment available to consumers.

This substance is already registered via ELINCS and as such registered under REACH.






Based on the data compiled within the framework of this study (chapter 3) exposure estimates to hypophosphite, aluminium salt have been provided for two consumer applications:

• Service life of wire and cable containing hypophosphite, aluminium salt

• Service life of electric and electronic equipment containing hypophosphite, aluminium salt in the outer part (housing of small articles, assumed)


Table 5-132: Consumer exposure estimations to hypophosphite, aluminium salt.



Due to the very low vapour pressure of hypophosphite, aluminium salt and the task involved, no inhalation exposure needs to be considered.

Inhalation -


1.Tier assessment using ECETOC-TRA (AC13, small article and a max concentration of 15%)


Due to the very low vapour pressure of hypophosphite, aluminium salt and the task involved, no inhalation exposure needs to be considered.

Inhalation -


No toxicological data are available for hypophosphite, aluminium salt, from consulted public literature sources , therefore only a tentative qualitative risk assessment could be performed.


Table 5-133: Tentative qualitative risk assessment to hypophosphite, aluminium salt for consumers.


Dermal

The dermal exposure has been assessed to be rather low based on a conservative 100% transfer factor from article to the skin (ECETOC-TRA). Therefore, it can be assumed that it will be even lower in reality. Furthermore, dermal absorption of hypophosphite, aluminium salt can be regarded as negligible (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for aluminium cations following exposure to skin, the dermal route is not a relevant exposure path.

A first tier dermal exposure assessment to hypophosphite, aluminium salt using the ECETOC TRA Consumer tool has been performed. The inhalative exposure to hypophosphite, aluminium salt vapour has been considered not relevant due to the ionic nature of the substance. Regarding the hazard assessment, no toxicological information is publicly available, thus a firm conclusion on the risk cannot be drawn. However, with respect to the ionic nature of the substance and with respect to HERAG (EBRC, 2007) no systemic/local effects are expected for aluminium cations following exposure to skin.


No data found on bio accumulation or aquatic toxicity in the consulted literature.





Since environmental exposure during disoposal phase was not assessed, no environmental risk assessment for that phase was carried out in this study.

5.38 Hypophosphite, calcium salt (CAS 7789-79-9)

Hypophosphite, calcium salt is used in flame retardant articles made of high impact polystyrene, polybutylene terephtalate, polycarbonate or polypropylene, in which it is assumed to be additively integrated. The applications known are wire and cable and electric and electronic equipment (no further information provided) available to consumers.

It should be noted that this is a new substance in this market with an actually small market share. An estimation of the future relevance is not available.








Based on the data compiled within the framework of this study (chapter 3) exposure estimates to hypophosphite, calcium salt have been provided for one consumer application:

• Service life of electric and electronic equipment containing hypophosphite, calcium salt in the exterior part (assumed)


Table 5-134: Consumer exposure estimations to hypophosphite, calcium salt.



1.Tier assessment using ECETOC-TRA (AC13, small articles and a max concentration of 15%)


Due to the very low vapour pressure of the ionic substance hypophosphite, calcium salt and the task involved, no inhalation exposure needs to be considered.

Inhalation -


No toxicological data are available for hypophosphite, calcium salt, from consulted public literature sources , therefore only a tentative qualitative risk assessment could be performed.

Table 5-135: Tentative qualitative risk assessment to hypophosphite, calcium salt for consumers.


Dermal

The dermal exposure has been assessed to be rather low based on a 100% transfer factor from article to the skin (ECETOC-TRA). Therefore, it can be assumed that it will be even lower in reality. Furthermore, dermal absorption of hypophosphite, calcium salt can be regarded as negligible (1%; based on HERAG) (EBRC, 2007) and no systemic/local effects are expected for calcium cations following exposure to skin, the dermal route is not a relevant exposure path.


A first tier dermal exposure assessment to hypophosphite, calcium salt using the ECETOC TRA Consumer tool has been performed. The inhalative exposure to hypophosphite, aluminium salt vapour has been considered not relevant due to the ionic nature of the substance. Regarding the hazard assessment, no toxicological information is publicly available, thus a firm conclusion on the risk cannot be drawn. However, with respect to the ionic nature of the substance and with respect to HERAG (EBRC, 2007) no systemic/local effects are expected for calcium cations following exposure to skin.


No data found on bio accumulation or aquatic toxicity in the consulted literature.





Since environmental exposure during disposal phase was not assessed, no environmental risk assessment for that phase was carried out in this study.

5.39 Diethyl ethylphosphonate (CAS 78-38-6)

Diethyl ethylphosphonate is added to preparations which need flame retardancy like foams used for construction which will be enclosed after installation or special paints.



Publicly available toxicological data are scare.

Diethyl ethylphosphonate is of low acute oral toxicity with an LD50 > 2000mg/kg in mouse and rat (Spravochnik po Toksokologii i Gigienicheskim Normativam, 1999) (cited from ChemIDplusLite, 2010).

The outcome of an AMES test conducted by US NTP in 1981 is negative (cited from US NTP, 1981). No signs of neurotoxicity were observed in hens treated repeatedly by intraperitoneal injection (BIBRA working group, 1999) (cited from TOXNET, 2010).

Furthermore, effect data where gathered by Fisk et al. (2003) as given in Table 5-136.


Table 5-136: Human health effect data for diethyl ethylphosphoate gathered by Fisk et al. (2003).


Acute oral toxicity, rat LD 50 785 mg/kg manufacturers MSDS

Acute dermal toxicity, rat LD 50 > 2000 mg/kg manufacturers MSDS

In vitro mutagenicity Non-mutagenic in Ames test manufacturers MSDS

In vitro mutagenicity Non-mutagenic in human lymphocytes and L5178Y mouse lymphoma cells manufacturers MSDS

However, the data available are not sufficient for a risk characterisation.




Based on the data compiled within the framework of this study (chapter 3) exposure estimates to diethyl ethylposphonate have been provided for one consumer application:

• Use of foams for construction containing diethyl ethylposphonate


Table 5-137: Consumer exposure estimations to diethyl ethylposphonate.


Use of foams for construction




Inhalation 10,000 mg/m³ (ECETOC)


The toxicological data available for diethyl ethylphosphonate from the consulted public literature is scares and concentrates on acute endpoints and mutagenicity only, therefore only a tentative qualitative risk assessment could be performed.

Table 5-138: Tentative qualitative risk assessment to diethyl ethylposphonate for consumers.


Dermal The dermal exposure has been assessed using rather conservative assumptions.

Inhalation

The substance has a VP of about 42 Pa and will be used in preparations like paints and foams for construction. Therefore inhalation exposure can be regarded as a dominant route of exposure. The inhalation exposure has been assessed using rather conservative assumptions.


First tier exposure assessments to diethyl ethylposphonate using the ECETOC TRA Consumer tool have been performed without any further refinements. Regarding the hazard assessment, the substance seems to be of moderate toxicity from the data summarized. However, as the toxicological data available for diethyl ethylposphonate is not sufficient for a DNEL derivation, thus a firm conclusion on the risk cannot be drawn.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. Diethyl ethylposphonate is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set , environmental effects were not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life.



Since environmental exposure could not be assessed for the disposal phase, no risk assessment could be carried out in this study.

5.40 Triethyl phosphate (CAS 78-40-0)

Triethyl phosphate is added to polyurethane foam used for construction which will be enclosed after installation. Furthermore, it is used in unsaturated polyester resin. Triethyl phosphate is assumed to be additively integrated in the matrix.




Single oral or i.p. injection to rats and mice at a dose of 100 or 1000 mg/kg bw of 32P-triethyl phosphate was recovered by 90% of radio-active material in urine within 16 hours. The excreted metabolite was diethyl phosphate, no mono-ethyl phosphate or phosphoric acid was detected. Nearly complete recovery over 96 hours. The very low acute dermal toxicity indicates a markedly lower adsorption than with oral administration (OECD, 1998) (Jones, 1970) (cited from ECB, 2000).

Acute toxicity


Oral

Triethyl phosphate has an acute oral toxicity in rats of LD50 = 1.1 - 1.6 g/kg bw (Deichmann, Gerarde, 1969; Eastman Kodak Co., 1984) (cited from ECB, 2000).

Dermal

Triethyl phosphate has an acute dermal toxicity in guinea pig of LD50> 21.4 g/kg bw (Eastman Kodak Co., 1984) (cited from ECB, 2000)

Inhalation

Triethyl phosphate has an acute inhalation toxicity in rats of LC50 > 8817 mg/m3 (Bayer AG, 1990) (cited from ECB, 2000) (OECD, 1998).


Skin

Triethyl phosphate is not irritant to rabbit skin (Bayer AG data, 1991; Pyatlin et al., 1968) (cited from ECB, 2000). Two studies with guinea pig showed slightly irritating properties of triethyl phosphate to the skin (Sandmeyer, Kirwin, 1981; Fassett, 1963; Eastman Kodak, 1984) (cited from ECB, 2000).

Eye

Triethyl phosphate showed moderate eye irritation in 1 of 3 animals. No to be classified as eye irritant (OECD, 1998). This finding was confirmed by a supporting study (Eastman Kodak Co., 1984) (cited from ECB, 2000).

Sensitisation

In sensitization studies on guinea pigs triethyl phosphate showed no sensitising properties (Deichmann, Gerarde, 1969; Eastman Kodak Co., 1984) (cited from BUA, 1989).


Oral

In a 92-days oral feeding study in Sprague-Dawley rat, the animals received doses of 0.1, 0.5, 5 and 10% triethyl phosphate in food. Food consumption and growth were reduced at 10% in diet, and growth was retarded in the 10 and 5% groups. Liver weight was increased, being detectable in the males at 0.1% or more and in the females at 5% in the diet. Adrenal enlargement occurred at the highest levels (10%), especially in males. A small transient elevation of blood cholinesterase was seen on day 50, followed by slight depression in the females receiving 0.5% triethyl phosphate or more. Hepatocellular enlargement was evident in female (1%) and male (5%) rats. No validated NO(A)EL is given, but an approx. NOEL is stated to be 670 mg/kg bw/d. (Gumbmann, 1968) (cited from OECD, 1998 and ECB, 2000).

In a subacute 28-day oral study, male/female Wistar rats received doses of 10, 100 and 1000 mg/kg bw/day triethyl phosphate via gavage. No adverse effects were observed in all doses. At a dose of 1000 mg/kg, an increase of metabolic activity in the liver as a sign of adaptation of liver function was observed. Because this adaption was not considered as adverse a NOEL is given with 100 mg/kg bw/d and a NOAEL of 1000 mg/kg bw. (Bayer, 1992) (cited from OECD, 1998 and ECB, 2000).


In a 1 month oral toxicity study, mice received one dose level of 274 mg/kg bw/day. Since no toxic effects were observed, the dose was identified as NOAEL (Pyatlin, 1968) (cited from OECD, 1998 and ECB, 2000).

Dermal

No data reported (ECB, 2000).

Inhalation

In a 12-day study, rats received doses of 366 and 1786 mg/m³ via inhalation. Lethargy, decreased aural response, unsteady gait, porphyrin-like nasal discharge was observed in the 1786 mg/m³ group. Weight gain, clinical chemistry and hematology were unaffected by exposure. Organ weights and histopathology showed no treatment related changes. Based on these findings, a NOEL of 366 mg/m3 was determined (Eastman Kodak, 1984) (cited from OECD, 1998 and ECB, 2000).

Mutagenicity

in vitro gene mutation

A bacterial reverse mutation assay (4 strains) with and without metabolic activation at a dose range of 0, 333, 1000, 3333 and 10000 µg/plate was negative (US NTP, 1982).

Various additional bacterial tests were identified with an equivocal outcome.

Negative results were obtained in an in vitro gene mutation test (HPRT test in V79) in mammalian cells with and without metabolic activation (Bayer, 1996) (cited from OECD, 1998).

DNA damage

In an in vitro UDS test on rat hepatocytes triethyl phosphate showed no DNA-damaging effect (Bayer AG, 1992) (cited from OECD, 1998).

In vivo studies

In vivo studies on the bone marrow of male mice following a single i.p. injection of 300 mg/kg bw Triethyl phosphate was negative.

A dominant lethal assay in mice following a single i.p. injection of 300 and 660 mg/kg bw Triethyl phosphate was negative (Degraeve et al., 1986; 1984; Epstein et al., 1972) (cited from OECD, 1998).

Carcinogenicity

Carcinogenicity studies are not available. An in vitro cell transformation test was negative (Balb/c-3T3) (Eastman Kodak Co., 1984) (cited from OECD, 1998; ECB, 2000).



In an study using a small number of animals the litter size was reduced after repeated feeding to both sexes (rat) beginning at 670 mg/kg bw, although no symptoms of poisoning in the parent animals were described for the 670 mg/kg bw dose. The NOEL for effects on the litter size was 335 mg/kg bw/day. Neither testicular weights nor the histological investigation of the testes revealed remarkable findings in this study (max. dose 6700 mg/kg bw/day) (OECD, 1998).


A recent 28-day study with doses up to 1000 mg/kg bw also showed no effect on the testicular weight (Bayer, 1992) (OECD, 1998).


A teratogenicity study in rats showed no evidence of a teratogenic potential up to the highest dose of 625 mg/kg bw/day (NOEL developmental toxicity). In the highest dose there was reduction of body weight gain, food intake and feces excretion as a sign of maternal toxicity (NOEL 125 mg/kg bw/day) (OECD, 1998).

Neurotoxicity

In the chicken triethyl phosphate gave no indication of neurotoxicity. After single administration of high doses (rat, mouse, i.p. ≥ 300 mg/kg; dog oral 250 mg/kg) TEP causes narcosis and a cholinesterase inhibition which is slight compared to other phosphoric esters. Choline esterase inhibition was detectable in in vitro studies.


Triethyl phosphate is legally classified according to regulation (EC) 1272/2008 (Index No. 015-013-00-7) with respect to the effects on human health with:

Xn; R22 (Harmful if swallowed)

Acute Tox. 4, H302 (Harmful if swallowed)

Table 5-139: Summary of human health effect data for triethyl phosphate brought forward to the risk characterisation




NOAEL: 1000 mg/kg/d (1000 mg/kg/d)**

1.7 mg/kg/d


Rat / 16-days inhalation / 0, 366, 1786 mg/m³

NOEC: 366 mg/m³ (based on lethargy, decreased aural response, unsteady gait, porphyrin-like nasal discharge)

2.4 mg/m3



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to triethyl phosphate have been provided for one consumer application:

• Use of polyurethane foam for construction containing triethyl phosphate


Table 5-140: Consumer exposure estimations to triethyl phosphate.


Use of polyurethane foam for construction



1.Tier assessment using ECETOC-TRA (PC9b) and the highest concentration stated: 20 % Dermal 1.19 mg/kg bw/day

Inhalation 60 * 10-3 mg/m³ (initial value, decreasing over time)

Measured data from Kemmlein et al. (2003). were used: chamber measurement, trying to imitate real use conditions (foam filled area = 0.324 m² ( 1 door, 2 windows) , room volume 30m³, ventilation rate 0.5h-1), however, the concentration of TEP in the foam was not stated.


Two sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.

Table 5-141: Tentative risk assessment to triethyl phosphate for consumers.


Use of foams for construction Dermal 1.19 mg/kg /d 1.7 mg/kg/d 0.7

Use of foams for construction Inhalation 60 * 10-3 mg/m³ 2.4 mg/m³ 2.5 * 10-2


A first tier exposure assessment to triethyl phosphate via the dermal route has been performed using the ECETOC TRA Consumer tool. The exposure via the inhalation route has been assessed using experimental chamber measurements trying to imitate real use conditions.

Regarding the hazard assessment, the substance is classified as harmful if swallowed. The results of repeated dose toxicity studies did not indicate specific organ toxicity up to a dose level of 1000 mg/kg bw/d, or effects on reproductive organs up to and including a high dose level of 6700 mg/kg bw/d. No indications of developmental toxicity/teratogenicity were observed in rats up to 625 mg/kg bw/d. However, no information on carcinogenicity is available, but overall the results of genotoxicity studies did not indicate a mutagenic potential. Due to the lack of route specific data for dermal exposure, route-to-route extrapolation was conducted based on the starting point of an oral NOAEL of 1000 mg/kg bw/d based on a sub-chronic toxicity study in rats. A NOEC was established at the dose level of 366 mg/m3 from a short-term inhalation toxicity study in rats based on effects above this concentration.

Altogether this tentative risk assessment to triethyl phosphate for consumer applications has been performed showing no risk for the application and routes considered.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. Triethyl phosphate is present


in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental effects were not assessed.


The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life.



Since environmental exposure could not be assessed for the disposal phase, no risk assessment could be carried out in this study.

5.41 Melamine phosphate (CAS 415836-09-9, 20208-95-1)

Melamine phosphate is used in flame retardant articles made of a variety of plastics like polyethylene, polypropylene, epoxy resin and phenolic resin and is assumed to be additively integrated into the matrix. Furthermore, it is used in textile backcoating, within viscose fibres and in paper used for applications which need flame retardancy. It is also available to consumer in preparations which need flame retardancy like paints.


Melamine phosphates contain melamine in an equimolar ratio with a phosphate ion. Under the assumption that once the substance becomes bioavailable either via oral or inhalation routes it dissociates in melamine and phosphate. Thus, the human health hazard assessment will be conducted by considering the compounds separately. The most critical DNEL will then be taken forward to the risk assessment.

Phosphate

Phosphorus as phosphate is an essential nutrient involved in many physiological processes, such as the cell’s energy cycle, regulation of the whole body acid-base balance, as a component of the cell structure (as phospholipids), in cell regulation and signalling, and in the mineralisation of bones and teeth (as part of the hydroxyapatite).

Estimates of habitual dietary intakes in European countries are on average around 1000-1500 mg/day, ranging up to about 2600 mg/day.

The available data indicate that normal healthy individuals can tolerate phosphorus (phosphate) intakes up to at least 3000 mg/day without adverse systemic effects. In some individuals, however, mild gastrointestinal symptoms have been reported if exposed to supplemental intakes >750 mg phosphorus per day. There is no evidence of adverse effects associated with the current dietary intakes of phosphorus in EU countries (cited from European Food Safety Authority, 2006).


Melamine


Melamine is not metabolized and is rapidly eliminated via urine in a study with oral application to rats. The elimination half-life in plasma is about 3 hours (cited from OECD, 2002)

Acute toxicity

Oral

The acute oral toxicity was investigated in four studies. Two studies in mice resulted in (i) LD50 (male) = 3296 mg/kg bw, LD50 (female) = 7014 mg/kg bw and (ii) LD50 (combined) = 4550 mg/kg bw. Two studies in rats resulted in (i) LD50 (male) = 3161 mg/kg bw, LD50 (female) = 3828 mg/kg bw and (ii) LD50 (combined) > 6400 mg/kg bw (cited from OECD, 2002).

Dermal

An acute dermal toxicity test in rabbits resulted in a LD50 of > 1000 mg/L (cited from OECD, 2002).

Inhalation

An acute inhalation toxicity test in rats resulted in a LD50 of 3248 mg/L (cited from OECD, 2002).


Melamine is not irritating to the skin or the eyes of rabbits (cited from OECD, 2002). Furthermore, melamine is not a sensitizer in a human patch test and in a study with guinea pigs (cited from OECD, 2002).


Oral

Six studies with rats, oral administration of melamine with the feed and dosing periods of 14 days to 105 weeks are available (cited from OECD, 2002).

Summarising the results of different toxicological studies with subchronic and chronic exposure of rats and mice to melamine revealed the urinary tract as target organ of toxicity with the occurrence of bladder stones (urolothiasis), hyperplastic epithelial changes in the urinary bladder and calcerous deposits in the proximal kidney tubules. Male rats appeared to be the most sensitive individuals. Based on these findings, the dose level of 63 mg/kg bw/d from the 13-week study in rats represents the lowest NOEL, although in a chronic toxicity study, a NOEL of 126 mg/kg bw/d was established based on bladder stones and increased incidences of transitional cell carcinomas in high dose males (263 mg/kg bw/d).

Dermal

No data reported by OECD (2002).

Inhalation

No data reported by OECD (2002).

Mutagenicity


A number of studies with different endpoints (point mutation, chromosome aberration, DNA damage, cell transformation) and with different organisms and cells were performed. The studies included the usually performed assays as Ames test (6 studies), micronucleus test (2 studies), cytogenetics in vitro, HGPRT assay, etc. but also some not as common assays as e.g. a bioluminescence assay.

20 out of the 22 available studies were negative. 1 sister chromatid exchange test with CHO cells was equivocal as 1 of 2 trials without metabolic activation was positive. Another sister chromatid exchange test was negative.

Altogether melamine is considered to be not genotoxic and not mutagenic (cited from OECD, 2002)

Carcinogenicity

Based on the available data on carcinogenicity and chronic toxicity, the formation of bladder stones and the resulting irritation of the bladder epithelium are necessary for the induction of tumours, and thus melamine is only indirectly responsible for the occurrence of bladder tumours, and a non-genotoixc threshold mechanism can therefore be established with a NOEL of 126 mg/kg bw/d. (European Food Safety Authority, 2007).



There were no specific reproductive toxicity studies of melamine. Therefore, the evaluation of reproductive organs reported in the repeated dose toxicity studies was used. There were no indications of effects on reproductive organs in sub-chronic or chronic toxicity studies.


Melamine is not teratogenic in an investigation with rats. The NOEL for the foetuses is ca. 1060 mg/kg bw/day based on no findings in the high dose used. A NOEL of ca. 400 mg/kg bw/day (the medium dose in this study) is based on the maternal toxicity. Decreased body weight and feed consumption and haematuria of the dams were signs of maternal toxicity (Hellwig, 1996) (cited from OECD, 2002).



Table 5-142: Summary of human health effect data for melamine phosphate brought forward to the risk characterisation



Rat / 90-days oral / 0, 750, 1500, 3000, 6000, 12000 ppm in the diet

NOEL = 63 mg/kg bw/day

1.12 mg/kg bw/day


Rat / 90-days oral / 0, 750, 1500, 3000, 6000, 12000 ppm in the diet

NOEL = 63 mg/kg bw/day

1.96 mg/m3

*A detailed description of the DNEL derivation is provided in Annex 10 of this report. A conversion from melamine to melamine phosphate (C3H6N6 *H3O4P) has been done based on the molecular weight.



Based on the data compiled within the framework of this study (chapter 3) exposure estimates to melamine phosphate have been provided for two consumer applications:

• Service life of furniture containing melamine phosphate in the textile back coating.

• Use of paints containing melamine phosphate (subcategorie and mode of application (brushing, spraying) not further specified, highest exposure estimate form ECETOC TRA for paints used).


Table 5-143: Consumer exposure estimations to melamine phosphate.


Service life of furniture (textile back coating)

1. Tier assessment using ECETOC-TRA (AC6, subcategory furniture (sofa)) and a max. concentration of 25% in the back coating.

Dermal 36.5 mg/kg bw/d

Inhalation - (vapour) 0.0525 mg/m³ (airborne particulates)

(i) Vapour: Due to the ionic nature of the substance melamine phosphate the inhalation exposure to vapour can be regarded as negligible. (ii) Airborne particulates: When taking the CSOIL (parameter set for human exposure modelling) estimate for particulate matter (dust) in indoor air of 52.5 μg/m3 into consideration (Otte et al., 2001) (cited in EU-RAR on Diantimony trioxide, ECB, 2008) and using a concentration of 1g melamine phosphate per g dust as a unrealistic worst case assumption, due to the lack of measured data.

Use of paints

1. Tier assessment using ECETOC-TRA (PC9a, subcategory solvent rich, water born paint) and a max. concentration of 25% in the paint.

Dermal 17.9 mg/kg bw/d

1. Tier assessment using ECETOC-TRA (PC9a, subcategory aerosol spray can) and a max. concentration of 25% in the paint. As no information on the application technique is available, the subcategory with the highest inhalation exposure potential has been used.

Inhalation 375 mg/m³


Four sub-scenarios have been identified for which a risk characterisation has been performed. The data used for the risk characterisation for consumers, including reasonable worst case exposure concentrations, derived no effect levels (DNELs) and the risk characterisation ratio (RCR) are compiled in the table below.


Table 5-144: Tentative risk assessment to melamine phosphate for consumers.


Service life of furniture (textile back coating) Dermal 36.5 mg/kg bw/d 1.12 mg/kg bw/d 32.6

Service life of furniture (textile back coating) Inhalation 0.0525 mg/m³ 1.96 mg/m³ 0.03

Use of paints Dermal 17.9 mg/kg bw/d 1.12 mg/kg bw/d 16

Use of paints Inhalation 375 mg/m³ 1.96 mg/m³ 191


First tier exposure assessments to melamine phosphate using the ECETOC TRA Consumer tool have been performed. The inhalation exposure to vapour has been considered not relevant due to the ionic nature of the substance. Inhalation exposure to airborne particulates has been assessed by the use of simple parameters from CSOIL and conservative assumptions.

Regarding the hazard assessment, no information on melamine phosphate was found in the public domain. However, the moieties phosphate and melamine have been assessed separately. In view of the lack of route specific data for dermal and inhalation exposure, route-to-route extrapolation was conducted using an oral NOEL of 63 mg/kg bw/d as starting point based on a 90-day toxicity study in rats.

This tentative risk assessment using conservative exposure estimations showed a risk with respect to dermal exposure to textiles and dermal and inhalation exposure to the use of paints by consumers.


An overview of environmental effects of melamine phosphate, compiled from the literature consulted in this project, is given in Table 5-145.

Table 5-145: Environmental effects of melamine phosphate, compiled from the literature consulted in this project

Effect Endpoint Value Unit Reference Reliability Short-term toxicity testing on aquatic invertebrates

LC50 4

mg/L ECOSAR no data







5.42 Tetrabromobisphenol A (CAS 79-94-7)

In most applications (90%) Tetrabromobisphenol A is integrated as reactive flame retardant into the matrix. Only for a minor fraction will the mode of integration be as additive. Relevant applications will be in refrigarators, telephones, electrical and electronic equipment, furniture and building and construction material.

Tetrabromobisphenol A was assessed under the Existing Substances Directive. As such, a summary of the relevant EU-RAR sections (European Chemicals Bureau, 2006) is provided hereafter. More detailed information is provided in Annex 6 – chapter 3.



No health effects of potential concern to adults have been identified.


Currently, Tetrabromobisphenol A is not legally classified with regard to human health according to regulation (EC) 1272/2008 and its 1st ATP.

5.42.2 Consumer exposure assessment

According to the EU-RAR on TBBP-A there is no evidence that TBBP-A is used in textiles worn by consumers. It has been shown that TBBP-A was used predominantly in electronic data processing equipment. The only potential exposure occurs where consumers inhale, ingest or contact dust containing TBBP-A or inhale TBBP-A vapour or dust from hot consumer equipment like TVs or computers. A screening of published literature on measured TBBP-A air levels were provided in the EU-RAR and showed that the concentration in air was either negligible or not measurable.

According to the EU-RAR on TBBP-A the consumer exposure to TBBP-A is likely to be insignificant. Any attempt at quantitative assessments will result in disproportionately high errors because of the small exposures anticipated.

5.42.3 Human health risk characterisation

No health effects of potential concern to adults have been identified and given that consumer exposures are negligible, there are no concerns in relation to any endpoint.

Combined (multiple) consumer exposure: consumer exposures are negligible and therefore calculation of the combined exposure is not considered necessary and no risk characterisation has been performed.




No environmental part in the EU-RAR (European Chemicals Bureau, 2006) publicly available.

The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. TBBP-A is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set environmental effects were not assessed.



The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. TBBP-A is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental exposure was not assessed.



The applications relevant for the scope of this study are not subject to wear and as such do not belong to the environmental core set for service life. TBBP-A is present in concentrations equal to or below 10% wt. in the applications under consideration. As such the applications do not belong to the environmental core set for disposal. Since none of the applications belong to the environmental core set, environmental risk was not assessed.

5.43 Uncertainties in the human risk assessment

The consumer risk assessments performed were based solely on the substances itself. Degradation products which may arise during service life or the fact that the substance may be available in an altered form (e.g. oxidised or physically absorbed to the matrix) could not be taken into account. Furthermore, there are uncertainties involved in the measurement and selection of hazard data, and in the data, models and scenarios used in the exposure assessment. Any use of the risk characterization should therefore include consideration of these uncertainties.


Uncertainties in the human exposure assessment include the following:

• A 1 Tier model for screening purposes generating rather conservative exposure estimates has been used

• Modelled data were used due to the lack of measured data

• Parameter value uncertainty, including the use of default values derived from expert judgement in the absence of secured values and the use of high transfer factors (100%) from matrix to skin/sweat, air or saliva/gastric fluids.

• When using the saturated vapour concentration as an upper bound concentration, it was assumed that the pure and unmodified chemical is available in the matrix, but the chemical might be in an altered form (e.g. oxidized, physically absorbed to the matrix).

• Conservative assumptions were made in the dermal-exposure parameters relating to the body-surface area exposed, especially for exposure estimates to furniture textiles and flooring, e.g. wearing of fabrics would not present a barrier to movement of flame retardants.

• Conservative assumptions were made in the oral exposure scenario relating to the surface area sucked, and the timing.

• Further conservative assumptions in the calculation of exposure are constant release rates.

• Insufficient information on some of the applications leading to worst case assumptions e.g. textiles (use of clothes leading to high dermal exposure and oral exposure due to mouthing assumed for bisphenol A-bis(diphenylphosphate) and guanidine phosphate), toys (available to toddlers for mouthing assumed for boehmite).

Key assumptions made in the exposure assessment are provided in Section 4.3.

Uncertainties in the hazard assessment include the following:

• Using data from short-term studies to predict the effects of long-term exposures. To account for this uncertainty default assessment factors of 2 or 6 have been introduced.

• Using dose-response data from laboratory animals to predict effects in humans. To account for this uncertainty default assessment factors for allometric scaling and/or remaining differences in toxicodynamic/-kinetics have been introduced.

• Using data from homogeneous populations of laboratory animals or healthy human populations to predict the effects on the general human population, with a wide range of sensitivities. (This uncertainty is due to natural variations in human populations.) Therefore, a default assessment factor of 10 was introduced for consumers.

• Using LOAELs instead of NOAELs was necessary in a few cases, and for these purposes a default assessment factor of 3 was introduced.

• Limitations in the toxicological data base were considered by applying additional assessment factors of 2 or 3.

• Possible end point effects not evaluated because of a lack of carcinogenicity or reproduction toxicity data.


• Possible effects of substances not evaluated because of a lack of chronic/subchronic toxicity data.

• DNELs have been derived on the basis of secondary information published in peer-reviewed publications or risk assessment documents. The primary literature was not obtained for evaluation. Thus, modifications of the relevant dose descriptors and the application of assessment factors were made by using the default values as given in the guidance Chapter R.8 (ECHA, May 2008).

Another source of uncertainty comes from use of read-across and grouping of substances for estimating human health hazards in the absence of experimental toxicity data.

Specifically, this was done for: Tetrabromobisphenol A bis(2,3-dibromopropylether (read-across from Tetrabromobisphenol A), melamine phosphate, aluminium hydroxide, aluminium hydroxide oxide, and guanidine phosphate

Uncertainties in assessing risk from inhalation and dermal exposure come from the use of toxicological potency factors from studies with a different route of exposure than the one under evaluation (i.e. using oral toxicity measures to estimate inhalation or dermal risk). Specifically, this was done for magnesium hydroxide, ethylene bis (tetrabromophtalimide), decabromodiphenylethane, melamine phosphate, triethyl phosphate, triphenyl phosphate, 2-ethylhexyl diphenyl phosphate, tricresyl phosphate, trixylyl phosphate, cresyl diphenyl phosphate, isopropylated triphenyl phosphate, tertbutylphenyl diphenyl phosphate, bisphenol A-bis(diphenylphosphate), guanidine phosphate and isodecyl diphenyl phosphate.

Uncertainties in route to route extrapolation due to the use of default values for missing gastrointestinal, dermal and inhalation absorption data. Specifically, this was done for magnesium hydroxide, ethylene bis (tetrabromophtalimide), decabromodiphenylethane, melamine phosphate, triethyl phosphate, triphenyl phosphate, 2-ethylhexyl diphenyl phosphate, tricresyl phosphate, trixylyl phosphate, cresyl diphenyl phosphate, isopropylated triphenyl phosphate, tertbutylphenyl diphenyl phosphate, bisphenol A-bis(diphenylphosphate), guanidine phosphate and isodecyl diphenyl phosphate.


6 Grouping of flame retardants used in consumer products

According to the WHO (1997), there is a need for further evaluation of flame retardants. Useful criteria for setting priorities are volume of use, intrinsic toxic effects on human health and the environment, exposure assessments, and persistence and bioaccumulation/biomagnification of flame retardants or their breakdown products.

Hereafter, the methodology and grouping criteria used in this report are given, as well as the results.

6.1.1 Methodology

6.1.1.1 Grouping of substances/applications

Flame retardants in consumer products identified in this report were grouped into 4 lists depending on the results of risk assessments:

• The risk assessment (either tentative or other) shows no risk that would merit an immediate risk management: substances or applications for which the risk assessment is available for BOTH human health and the environment and indicates no risk to human health AND the environment from their use in consumer products. Hereafter referred to as the group with 'no need for immediate risk management'

• Inconclusive: substances or applications for which the risk assessment (either tentative or other) indicated a risk for some consumer exposure routes and/or for the environment, whilst indicating no risk for others. Hereafter referred to as ‘inconclusive' group’

• The risk assessment (either tentative or other) shows risk: substances or applications for which the risk assessment is available for BOTH for human health and the environment and indicates a risk to both human health AND the environment from their use in consumer products. Hereafter referred to as ‘risk' group’

• Inconclusive: substances or applications for which the risk assessment (either tentative or other) indicated a risk for some consumer exposure routes and/or for the environment, whilst indicating no risk for others. Hereafter referred to as ‘inconclusive list’

• Data gap group: substances or applications for which available data were insufficient to carry out a risk assessment for human health and/or the environment. Hereafter referred to as ‘data gap' group’

It should be noted that, as described in chapter 2, this study focused on flame retardants additively integrated in consumer products largely used at home, because such flame retardants may lead to consumer exposure. The study did not address banned, reactively integrated and polymeric substances. Neither did it address other identified applications which are not relevant for a domestic environment. Within the selected applications, the manufacturing phase, transport applications, packaging material and recreational items were not included, since they are outside the domestic environment. Substances assessed under existing legislation (EU RAR and UK RAR) were a priori assessed (UK


RAR only environment). Within the remaining relevant set of applications, core set applications were selected for consumer and for environment. Consumer core set applications were selected based on the availability of information on the articles/products used by consumers that it mandatory to assign article category (AC) or product category (PC) and a specific subcategory. Furthermore, the input of the concentration in the matrix and the vapour pressure of the substance was needed. Environmental core set applications were selected by means of their exposure potential during service life (represented by liability to wear and tear) and disposal (substance concentration in matrix > 10% wt.). This resulted in a core set of flame retardants and applications, including:

• Substances for which the relevant consumer exposure (route) was identified

• Substances with relevant environmental exposure potential

• Service life: subject to wear and tear (AC5, AC13)

• Disposal phase: potential flame retardant concentration of 10% wt. or more in the matrix (AC2, AC4, AC5, AC13, PC1 and PC9a)

A schematic overview of the selection of applications under consideration is given in Figure 3-1. The definition of the acrticle categories under REACH (AC) are given in Table 3-1.

The applications per substance, mentioned in the 4 lists below, may differ for human health and for the environment. For substances with an existing EU RAR, this is due to the fact that different exposure scenarios were assessed for human health and for the environment. For the other substances (UK RAR and not assessed under existing legislation) this is due to the different methodology by which core set substances were identified for human health and for environment. This implies that an application may be relevant for consumer exposure, but may not be relevant for environmental exposure.

6.1.1.2 Prioritisation of substances

Several methodologies exist for the relative assessment of chemicals by chemical grouping and scoring:

• Fisk et al. (2003): use, acute and chronic ecotoxicity, persistence, bio-accumulation

• COMMPS (1998): measured or modelled environmental concentrations, ecotoxicity, bio-accumulation, R-phrases, CMR, chronic toxicity

• Gjos et al. (1989): acute toxicity, sensitization, irritation

• Foran & Glenn (1993): carcinogenicity

• ARET: acute and (sub)chronic (eco)toxicity, CMR

• US EPA (2009) methodology for risk-based prioritization under ChAMP: persistence, bio-accumulation, acute and chronic (eco)toxicity, irritation, sensitization, carcinogenicity, neurotoxicity, immunotoxicity


• European Dangerous Substances Directive Annex VI36: acute ecotoxicity, persistence, bio-accumulation

In summary, these methodologies refer to the following criteria:

• Effect, inherent property: carcinogenicity, mutagenicity, teratorgenocity, acute effects, chronic effects, sensitization, bio-accumulation, persistence

• Exposure: use, monitoring data

Some methodologies assign a weight to these criteria and combine them into one score.

In the framework of this study, it was decided to prioritise the substances within the 'inconclusive' and the 'data gaps' groups in order to identify further research needs and priorities where appropriate.

Substances were prioritised, based on the data gathered and assessed in this study. Except for the substances assessed under existing legislation (i.e. EU RAR and UK RAR), the data were collected by a screening approach and interpreted according to a first tier risk assessment (‘tentative’ risk assessment). The tentative risk assessments are based on conservative assumptions and should not be the basis for an absolute ranking as this would pretend comparability and accuracy. E.g. different information levels are available with regard to the toxicological endpoints. For some substances a lot of information is available, some have a medium set of information publicly available and others none. Furthermore, primary literature has not been evaluated, this might lead to a reduction in the assessment factor for DNEL derivation and thus the DNEL would be higher, which can influence the outcome of the risk assessment. For the same reasons of incomparability and accuracy, the grouping criteria were neither weighted nor combined into a single score.

The prioritisation was done based on the assessment of inherent properties such as acute and local effects, carcinogenicity (C), genetic toxicity (M), reproductive toxicity (R), sensitisation, persistence, bioaccumulation and aquatic toxicity. These properties are considered in Annex VI of the European Dangerous Substances Directive: a guide to the classification and labelling of dangerous substances and preparations by means of criteria for the choice of phrases indicating special risks (R phrases) and safety advice (S phrases). This approach was also used by the Danish EPA in the ‘Environmental and Health Assessment of Alternatives to Phthalates and to flexible PVC’ (2001). The inherent properties for each substance of the ‘inconclusive list’ are given in Annex 18.

Based on the values for the distinct inherent properties, the substances are prioritised as ‘High concern’, ‘Low concern’ or ‘Data gap’, as shown in Table 6-1. It should be noted that the definition of ‘data gap’ in this prioritisation procedure differs from the definition of ‘data gap’ in the grouping procedure (‘substances or applications for which available data were insufficient to carry out a risk assessment for human health and/or the environment’).

Table 6-1: Prioritisation based on flame retardant inherent properties Group Criteria human health Criteria environment High concern CMR or sensitization skin/respiratory PBT or vPvB Low concern Not CMR and not sensitization skin/respiratory Not PBT and not vPvB Data gap No data/inconclusive on carcinogenicity,

mutagenicity, reproductive toxicity or sensitization skin/respiratory

No data/inconclusive on persistence, bio-accumulation or toxicity

36 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances - Annex VI: General classification and labeling requirements for dangerous substances and preparations


The criteria for identification of PBT and vPvB substances are those set in Annex XIII of the REACH Regulation (EC) n° 1907/200637, als given in Table 6-2.

Table 6-2 : Criteria for identification of PBT and vPvB substances (REACH Regulation (EC) n°1907/2006) Criterion PBT vPvB Persistent Half-life above 60 days in marine water or above 40

days in freshwater or half-life above 180 days in marine sediment or above 120 days in freshwater sediment or the half-life in soil is higher than 120 days

Half-life above 60 days in marine water or freshwater or above 180 days in marine or freshwater sediment or the half-life in soil is higher than 180 days

Bio-acumulation

BCF above 2,000 BCF above 5,000

Toxicity Chronic NOEC below 0.01 mg/L Not applicable

6.1.2 Results

Hereafter, the four lists of flame retardants compiled from the data available in the framework of this report are given. The following legend was used:

• No exp: not considered to be a relevant exposure route based on application specifications, as given in chapter 4.3.1

• No exp-pc: not a relevant exposure route due to physico chemical properties of the substance

• No risk: no risk expected: According to the EU- risk assessment report for that respective substance the exposure was considered to be negligible and no further risk characterisation was performed

• y: exposure has been assessed, but no risk characterisation could be performed

It should be noted that all conclusions drawn in this report on exposure and risk only refer to the core set applications and the substances for which an EU RAR or UK RAR exists, considered in this report. This implies: only consumer products largely used at home or in a domestic environment.

6.1.2.1 Risk assessment shows no need for immediate risk management

Several substances that have been assessed under existing legislation, i.e. by EU RAR or UK RAR, for which no need for immediate risk management was seen, based on the approach of this study. These substances entered the 'no need for immediate risk management, based on the approach of this study' group.

The same should hold for substances with a 2010 REACH registration deadline (see Table 5-1), where the specific application was identified as a use in the registration dossier and where ‘safe use’ should be demonstrated in the exposure scenarios (under REACH, ‘safe use’ needs to be demonstrated in the exposure scenarios, otherwise the use or article use has to be advised against). However such an ‘automatic’ consideration to be safe was not carried out in this study because, despite close contact with the

37 Regulation (EC) n° 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union, 30.12.2006, L396/1-849.


manufacturers, registration dossier data were not shared in due time by the lead registrants (ICL-IP shared CSRs for some substances by the end of January 2011).

The 'no need for immediate risk management, based on the approach of this study' group is displayed in Table 6-3.

It should be noted that 3 substances of this group, namely decabromodiphenylethane (5.10), diethylphosphinate aluminium salt (5.23) and tetrabromobisphenol A (5.42) are not subject to wear during service life; furthermore their minimal content in the matrix is less than 10% wt, thus no environmental exposure was expected during the disposal phase. Therefore no risk assessment for the environment was carried out.

Table 6-4 shows the group: 'no need for immediate risk management - with concerns'. This group consists of 3 substances, for which there is no need for immediate risk assessment, although, there is some reason for concern. For decabromodiphenyl ether, the reason of concern is related to the risk for secondary poisoning, for dexabromocyclododcane, the reason for concern is related to the PBT properties and for SCCP, the reason for concern is because it is listed in the POPs Protocol of LRTAP Convention and because of its PBT and vPvB properties.


Table 6-3: Group: 'no need for immediate risk management, based on the approach of this study' ' Human health risk assessment Environmental risk assessment

Result Chapter 5.x

Flame retardant CAS number EU RAR/UK RAR

REACH Registration deadline

Applications Dermal exps

Oral exp

Inhalation exp

Applications Result

No risk expected38 10 decabromodiphenylethane

84852-53-9 2010 AC2: housing large articles No exp No exp No risk Not included in core set

12 chloroparaffins (MCCP) 85535-85-9 EU RAR 2010 PC1: adhesives/sealants AC10: rubber in building applications AC13: plastic goods PC9a: paints

No risk No exp No risk No risk

No exp No exp No exp No exp

No risk No exp No risk No risk

AC2; AC5; AC10; AC13; PC9a

No risk

20 tris(2-chloro-1-(methylethyl)phosphate

13674-84-5 EU RAR 2010 AC5: PUR foam in furniture PC9b: PUR foam for DIY fillings AC13: Indoor insulation

No risk No risk No exp

No risk No exp No exp

No risk No exp No risk

AC2; AC5; AC13 No risk

No risk expected38 23 diethylphosphinate, aluminium salt

225789-38-8 2010 AC2: wire & cable AC5 : interior part

No exp No exp

No exp No exp

No exp-pcNo exp-pc

Not included in core set

30 bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

38051-10-4 EU RAR 2010 AC5: PUR foam in furniture No risk No risk No risk AC5; AC13 No risk

No risk expected38 42 tetrabromobisphenol A 79-94-7 EU RAR 2010 AC2: electronic data processing equipment

No risk No risk No risk EU RAR environment not publicly available Not included in core set


Table 6-4 : Group: 'no need for immediate risk management -with concerns' Human health risk assessment Environmental risk assessment

Result Chapter 5.x



Applications Dermal Oral Inhalation

Applications Result Concern

2 decabromodiphenyl ether

1163-19-5 EU RAR 2010 AC13, plastic products AC5, upholstery

No exp No risk

No exp No exp

No risk No exp

No risk Risk for secondary poisoning might be underestimated

38 Within the framework of this study, the environmental core set covers substances of which the exposure potential is higher compared to the other substances identified in this study. As such, no/low exposure and consequently no risk is expected for these substances




Human health risk assessment Environmental risk assessment Result

Chapter 5.x



Applications Dermal Oral Inhalation

Applications Result Concern

5 Hexabromocyclodo-decane

25637-99-4 EU RAR 010 AC5: upholstery AC13: construction boards AC5: mattress

No exp No exp No risk



AC2, AC5, AC13 No risk PBT (article 57d of REACH). Subject to REACH Authorisation (sunset date 21 August 2015)

11 Short Chain Chlorinated Paraffins (SCCP)

85535-84-8 EU RAR 2010 AC5: textiles PC1/PC9a: paints, sealants and adhesives AC10: rubber products

No risk No risk No risk

No exp No exp No exp


AC2; AC5; AC10; AC13

No risk Listed in the POPs Protocol of LRTAP (long range transport air pollution) Convention, PBT and vPvB (articles 57d and 57e of REACH). Is a REACH candidate for Authorisation.39


39 Candidate List of Substances of Very High Concern for authorization: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp




6.1.2.2 Inconclusive

Substances which have a risk for certain routes and/or applications are mentioned in Table 6-1. These are prioritised according to the criteria discussed in 6.1.1, to indicate a priority for future research policy.


Table 6-5: Group: ‘inconclusive’

Human health risk assessment Environmental risk assessment

Result

Chapter 5.x

Flame retardant CAS number

EU RAR/UK RAR

REACH Registration

Applications

Dermal Oral Inhalation

Applications Result

Concern

High concern

19 tricresyl phosphate40 1330-78-5 UK RAR 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

No risk No risk

PC1, PC9a, AC13 Risk In service losses from adhesives, waste in the environment (PVC, polyurethane) and miscellaneous sources41 contribute to the regional risk for industrial soil, since these emissions are almost entirely accountable for the total releases to soil (99.9%). Additional testing would remove the need for using an additional safety factor and as such remove the risk for both sediment and industrial soil.

26 Tris-(isopropylphenyl)phosphate

26967-76-0 and 68937-41-7

UK RAR 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

No risk No risk

PC1, PC9a, AC5, AC13

Risk In service losses from lubricant additives, waste remaining in the environment from textile/fabric coating, in service losses and waste remaining in the environment from pigment dispersions contribute to the regional risk for sediment (share of 76.3% in emissions to surface water) and industrial soil (share of 51.4% in emissions to soil). Additional testing would remove the need for using an additional safety factor, and as such removing the risk for sediment. However not for industrial soil

40 Additional information from industry is provided in 5.19 41 Worst case scenario: all uses considered domestic



Result

Chapter 5.x


EU RAR/UK RAR

REACH Registration

Applications


Applications

Concern

Result

Low concern

34 resorcinol bis-diphenylphosphate42

57583-54-7 UK RAR 2010 AC2; E & E No exp No exp No risk PC9a, AC13 Risk Waste remaining in the environment from thermoplastics and styrenics contributes to the regional risk for industrial soil (share of 99% in total emissions to soil). Risk might be removed by PEC refinement and/or hydrolysis rate refinement. Additional testing would remove the need for using an additional safety factor and as such remove the risk for regional industrial soil.

Data gap for prioritisation

HH data gap for prioritisation: sensitisation respiratory

4 tetrabromobisphenol A bis(2,3-dibromopropylether)

21850-44-2 2013 AC2, exterior parts E&E AC5, flooring AC0, construction material

No exp Risk No exp



Not included in core set

No risk expected43

16 triphenyl phosphate44

115-86-6 UK RAR 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

No risk No risk

AC2, AC13 No risk HH data gap for prioritisation: sensitisation respiratory, carcinogenicity

17 tris(2-chloroethyl)phosphate

115-96-8 EU RAR 2010 House dust AC5: upholstery AC5. Cuddly toys


No risk No exp Risk


AC13 No risk HH data gap for prioritisation: sensitisation respiratory

18 2-ethylhexyl diphenyl phosphate45


No exp Risk

No exp No exp

No risk No risk

PC1, PC9a, AC5, AC10, AC13

No risk HH data gap for prioritisation: sensitisation respiratory

42 Additional information from industry is provided in 5.34 43 Within the framework of this study, the environmental core set covers substances of which the exposure potential is higher compared to the other substances identified in this study. As such, no/low exposure and consequently no risk is expected for these substances 44 Additional information from industry is provided in 5.16



Result

Chapter 5.x


EU RAR/UK RAR

REACH Registration

Applications


Applications Result

Concern

25 cresyl diphenyl phosphate


No exp Risk

No exp No exp

No risk Risk

PC1, AC5, AC13 No risk HH data gap for prioritisation: sensitisation skin/respiratory, carcinogenicity

26 Isopropylphenyl diphenyl phosphate46


No exp Risk

No exp No exp

No risk No risk

PC1, PC9a, AC5, AC13

Risk HH data gap for prioritisation: sensitisation respiratory, carcinogenicity, reproductive toxicity In service losses/waste remaining in the environment (PVC) and waste remaining in the environment from paints&coatings and textile/fabric coating contribute to the regional risk for sediment (share of 41.5% in emissions to surface water) and industrial soil (share of 85.2% in emissions to soil)47.

33 tert-butylphenyl)phenylphosphate


No exp Risk

No exp No exp

No risk No risk

AC5, AC13 No risk HH data gap for prioritisation: sensitisation skin/respiratory, carcinogenicity


45 Additional information from industry is provided in 5.18 46 Additional information from industry is provided in 5.26 47 Additional information from industry is provided in 5.26




6.1.2.3 Risk assessment shows risk

The substances for which the EU RAR, the UK RAR or the tentative risk assessment showed a risk for both human health and the environment is given in Table 6-6.

Only one substance, isodecyl diphenyl phosphate, entered the risk list according to the tentative risk assessment carried out within this study. A further tentative risk assessment for consumers using the DNELs reported in the CSR on isodecyl diphenyl phosphate, which was made available by industry (ICL-IP), indicated no risk for the inhalation exposure route. Based on this CSR, this substance would move to the ‘inconclusive’ list.


Table 6-6: Group: ‘risk’


Result

Chapter 5.x Flame retardant CAS number EU RAR/ UK RAR

REACH Registration

Applications


Applications Results Concern

29 isodecyl diphenyl phosphate48

29761-21-5 UK RAR 2013 AC5, flooring (PVC)

Risk No exp Risk PC9a, AC10, AC5, AC13

Risk Waste remaining in the environment from PVC applications49, paints contributes to the regional risk for sediment (share of 70% in total emissions to wastewater and surface water) and industrial soil (share of 99.76% in total emissions to soil). Additional testing would remove the need for using an additional safety factor and as such remove the risk for sediment and soil


48 Additional information from industry is provided in 5.29 49 Worst case scenario: all uses assumed to be domestic




6.1.2.4 Data gaps

Substances for which the available data are insufficient to assess exposure, effect and/or risk entered the data gap list. More data are needed to asses the safety of these substances. These data can either be provided through exchange by industry (e.g. REACH2010 substances, substances which are already registered under past legislation (New Substances Directive)) or by additional monitoring and testing. Data gaps for substances registered under REACH or already assessed under existing legislation may be considered to be less relevant for additional monitoring and testing. It should be noted that industry was asked within this study to fill the data gaps, however, several data gaps (as indicated in Table 6-7) remained.

Substances for which not enough data are available for risk assessment are mentioned in the ‘data gap’ list, shown in Table 6-7. Since the situation may differ for human health and for environment, some subcategories of substances were identified. The same definitions hold as for the lists, mentioned in section 6.1.1:

• Subcategory A: no risk for human health, data gaps for environment

• Subcategory B: data gaps for human health, no risk for environment

• Subcategory C: risk for human health for some exposure routes, data gaps for environment

• Subcategory D: data gaps for human health and for environment


Table 6-7: ‘Data gap’ list


Result

Chapter 5.x


REACH Registration Applications


Applications Result

Concern50

Subcategory A: no risk for human health, data gaps for environment

8 ethylene bis(tetrabromophtalimide)

32588-76-4 2013 PC9b; construction foam AC2; exterior parts and housing, AC2: wire & cable, interior E&E parts AC0; construction material (small exterior parts)

No risk No risk No exp No exp

No exp No exp No exp No exp

No risk No risk No risk No risk

PC9a, AC2, AC13 Not assessed Emissions at disposal phase

9 1,2-bis(2,4,6-tribromophenoxy)ethane

37853-59-1 2013 AC2, housing large articles AC0, construction material (adhesives, sealants)

No exp No exp

No exp No exp

No risk No risk

AC2 Not assessed Emissions at disposal phase

13 magnesium hydroxide 1309-42-8, 13760-51-5

2010 AC2; wire & cable, interior part, housing AC5; flooring, furniture sofa

No exp NR

No exp No exp

NR No risk

PC1, AC2, AC13 Not assessed Emissions at disposal phase

15 aluminium hydroxide 1318-23-7 21645-51-2

2010 AC2; wire & cable AC13; flooring (PVC flex)

No exp NR

No exp No exp

NR No risk

PC1, PC9a, AC2, AC5, AC13

Not assessed Emissions at disposal phase

40 triethyl phosphate 78-40-0 2010 PC9b: construction foam No risk No exp No risk AC13 Not assessed Emissions at disposal phase

Subcategory B: data gaps for human health, no risk for environment

21 tris(2-chloro-1-(chloromethyl)ethyl)phosphate51

13674-87-8 EU RAR 2010 AC5: PUR foam in furniture

No risk No risk No risk AC5; AC13 No risk Data gap with respect to reproductive toxicity -fertility (female)

Subcategory C: risk for human health for some exposure routes, data gaps for environment

14 boehmite (aluminium hydroxideoxide)

1318-23-6 2010 AC2; wire & cable, interior part AC13; toys

No exp NR

No exp Risk

NR No exp

AC2 Not assessed Emissions at disposal phase

50 If the data gap refers to a specific application, the application is mentioned between brackets 51 See 5.21.3 for further details



Result

Chapter 5.x




Applications

Concern50

Result

24 trixylyl phosphate 25155-23-1 UK RAR 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

Risk Risk

No data Not assessed No exposure data

28 tris-(tert-butylphenyl)phosphate 28777-70-0, 78-33-1

2013 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

No risk No risk

AC2, AC13 Not assessed Emissions at disposal phase

31 guanidine phosphate 5423-23-4 AC5; textile (no data, clothes assumed)

Risk Risk No risk AC5 Not assessed Ecotoxological data; EU tonnage by application; Emissions at disposal phase

35 bisphenol A-bis(diphenylphosphate)

181028-79-5 5945-33-5

Already registered under past legislation (New and Existing Substances Regulation) and as such already registered under REACH

AC2; wire & cable, housing large and small articles AC5; clothes (assumed) AC13; flooring AC6; furniture sofa (PVC & TAC)

No risk Risk Risk Risk

No exp Risk No exp No exp

No risk No risk No risk No risk

AC2, AC5 Not assessed EU tonnage by application (AC5, AC6, AC13); Emissions at disposal phase

36 bis-(tert-butylphenyl)phenylphosphate

65652-41-7 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp Risk

No exp No exp

No risk No risk

AC2, AC13 Not assessed Emissions at disposal phase

41 melamine phosphate 20208-95-1, 41583-09-9

PC9a; paints AC6; furniture sofa (textile back-coating)

Risk Risk

No exp No exp

Risk No risk

PC9a, AC5 Not assessed Vapor pressure EU tonnage by application; Emissions at disposal phase

Subcategory D: data gaps for human health and for environment



Result

Chapter 5.x




Applications

Concern50

Result

3 tris (tribromoneopentyl) phosphate

19186-97-1 Already registered under past legislation (New and Existing Substances Regulation) and as such already registered under REACH

AC2; E & E AC5; textiles, furniture, carpets

No exp y

No exp No exp

y y

AC5 Not assessed No toxicological data; EU tonnage by relevant application service life (AC5); Emissions at disposal phase

6 tris(2,4,6 tribromophenoxy)triazine

25713-60-4 Already registered under past legislation (New and Existing Substances Regulation) and as such already registered under REACH

AC2; housing, large articles AC2; housing, small articles

No exp y

No exp No exp

y y

AC2 Not assessed No toxicological data; Emissions at disposal phase

7 bis-(2-ethylhexyl)tetrabromophthalate

26040-51-7 2013 AC6 No exp52 No exp52 No exp52 AC2, AC5, AC13 Not assessed Emissions at disposal phase

22 dimethyl propane phosphonate 18755-43-6 2013 PC9a; paints PC9b; construction foam AC0; construction material (enclosed)

y y No exp


y y No exp

AC13 Not assessed No toxicological data Emissions at disposal phase

52 Not included in core set human health



Result

Chapter 5.x




Applications Result

Concern50

27 bis-(isopropylphenyl) phenylphosphate

28109-00-4 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp y

No exp No exp

y y

AC2, AC13 Not assessed No toxicological data; EU tonnage by relevant application service life (AC6); Emissions at disposal phase

32 isodecylphosphate 56572-86-2 2010 AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

No exp y

No exp No exp

y y

AC2, AC13 Not assessed No toxicological data; EU tonnage by relevant application service life (AC6); Emissions at disposal phase

37 hypophosphite, aluminium salt 7784-22-7 Already registered under past legislation (New and Existing Substances Regulation) and as such already registered under REACH

AC2; wire & cable, housing E&E

y No exp NR AC2 Not assessed No toxicological data; Emissions at disposal phase

38 hypophosphite, calcium salt 7789-79-9 2013 AC2; E & E exterior part y No exp NR AC2 Not assessed No toxicological data; Emissions at disposal phase

39 diethyl ethylphosphonate 78-38-6 2013 PC9b; construction foam AC0; construction material (enclosed after installation)

y No exp

No exp No exp

y No exp

AC13 Not assessed No toxicological data





7 Fire incidents and human intoxication and/or burning

7.1 Approach

Available statistical information on fire incidents and cases of human intoxication and/or burning will be used to assess the effects of non-flammability requirements for consumer products (see chapter 9). Ideally, the statistical data should document the number of domestic fires and its consequences at a Member State level for as many years as possible. Consequences of domestic fires should be expressed as number of deaths and injured people per year.

For this study the data collection followed a two-step approach:

• a number of specific organisations have been contacted that have been working on fire statistics. This allowed for the compilation of statistical information on the number of fire deaths from the World Fire Statistics Centre (WFSC), the Centre of Fire Statistics of the International Association of Fire and Rescue Services (CTIF) and the World Health Organisation (WHO) at Member State level

• a questionnaire was prepared and sent to all Member States (except Bulgaria, Lithuania, Malta and Slovakia since no relevant contact (point) was identified/established for these countries, see also Annex 22); including any available data from the organisations mentioned above

This was the best possible data collection, although probably somewhat incomplete because:

• there is no Agency at the European Union that collates information on the impact from fires in the Member States. Eurostat, the statistical office of the European Union, does not provide any statics on the consequences of fires on its website

• from reference studies on the effectiveness of non-flammability regulations like Emsely et al. (2005), from the section about fire statistics on the website of the European Flame Retardants Association (EFRA) and from bilateral contacts with key actors from the European Fire Academy (EFA) and the European Burn Casualties Association (EBCA) it became clear that the data on the causes and consequences of (domestic) fires differs very much between Members States with regard to their availability, level of detail (e.g. distinction of domestic fires), quality and collection and statistical treatment methods. Some countries do not even collect information on the number of fire deaths

The data collection is discussed in detail hereafter.

7.2 Collection of data from specific organisations

Ideally, there should be an organisation that systematically collects uniform data on the number of deaths from domestic fires for the different Member States. This is not the case, but there are some organisations that do collect valuable statistical information. The information that is available at these organisations is discussed below.


7.2.1 World Fire Statistics Centre (WFSC)

The WFSC collects, analyses and disseminates internationally comparable fire cost statistics. With this it aims to persuade governments to adopt coherent fire strategies aimed at reducing national fire costs. The WFSC is supported by the Geneva Association, an international insurance ‘think tank’ for strategically important insurance and risk management issues set up by major international insurance companies.

Each year the Centre collects and collates fire statistics from its national respondents in participating countries. The number of countries that take part in the yearly enquiry is steadily increasing. The majority of respondents are European countries. Besides, the centre also makes use of relevant data published by the WHO.

The WFSC collects information on the number of fire deaths, the number of people injured and the fire costs. The data of the WFSC on the consequences of fires can, however, not be put in relation to the causes (domestic fires by consumers products). In addition to this it is noteworthy that although the national respondents to the WFSC enquiry complete and return the questionnaire to the best of their ability, lack of data generally means that few countries can complete all sections of the questionnaire and may make informed estimates. The WFSC applies a number of adjustments to the raw data to calculate adjusted figures for each country, aiming at making the data as internationally comparable as possible.

The WFSC provides statistics for 16 different Member States: Austria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Poland, Slovenia, Spain, Sweden and the United Kingdom. For Austria, Denmark, Finland, France, Tthe Netherlands, Sweden and the United Kingdom statistics are available from the early eighties onwards. For the other countries, the data only cover more recent years starting from the late nineties or even after the turn of the century. An overview of the WFSC statistics on the number of fire deaths per Member State is presented in Annex 19.

7.2.2 Centre of Fire Statistics of the International Association of Fire and Rescue Services (CTIF)

The CTIF Statistics Centre annually publishes a statistical report containing fire statistics for many countries and major cities in the world. The data are mostly derived from fire services’ raw data, gathered in fire incident reports.

The data on the number of fire deaths that is reported can, however, not be attributed to specific causes relevant for this study. The data reported are not adjusted for incomplete coverage or variations in definitions between countries.

The CTIF provides statistics for all but two Members States (Cyprus en Malta). For some other Member States like Belgium, Luxemburg and Portugal the number of years for which data are available is very limited. The first year that is covered by the CTIF statistics is 1993. An overview of the CTIF statistics on the number of fire deaths per Member State is presented in Annex 20.

7.2.3 World Health Organisation (WHO)

On its website the WHO provides detailed data files of the WHO Mortality Database. These are the raw mortality data files, which can be further detailed with regard to causes, gender, age, etc. The data of the WHO mortality database should be the same as the


mortality data held by Eurostat. The only difference is that Eurostat also collects data at the regional level.

The WHO data comprise deaths registered in national registration systems, with underlying cause of death as coded by the relevant national authority. The underlying cause of death is defined as ‘the disease or injury which initiated the train of morbid events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury’, in accordance with the rules of the International Classification of Diseases. These data are official national statistics in the sense that they have been transmitted to the World Health Organization by the competent authority of the country concerned. Data come from Ministries of Health, statistical offices, National Boards of Health, etc., depending on the institutions responsible of these data collections in each country. A list with the contact details of the national focal points providing these data for each Member State can be found in Annex 23. Each Member State reports population data along with their mortality data, for the population covered by the death registration system (i.e. the death registration system might not be established throughout the whole country). Where this is a subset of the national population, the data are labelled accordingly in the WHO Mortality Database. However, the completeness of death registration may also be less than 100% for the specified registration population. For Member States with incomplete registration systems, demographic techniques have been used by WHO to estimate the level of completeness of death recording for the specified population to allow the calculation of death rates.

One of the causes of death in the WHO Mortality Database is labelled ‘exposure to smoke, fire and flames’. The database further details this category on the basis of the underlying reasons having triggered the fire:

• Exposure to uncontrolled fire in building or structure (e.g. from furniture catching fire)

• Exposure to uncontrolled fire, not in building or structure (e.g. forest fire)

• Exposure to controlled fire in building or structure (e.g. fire in fireplace or stove)

• Exposure to controlled fire, not in building or structure (e.g. campfire)

• Exposure to ignition of highly flammable material (e.g. ignition of gasoline, kerosene and petrol)

• Exposure to ignition or melting of nightwear

• Exposure to ignition or melting of other clothing and apparel (e.g. ignition or melting of plastic jewellery)

• Exposure to other specified smoke, fire and flames

• Exposure to unspecified smoke, fire and flames

The WHO Mortality Database provides a very good framework for deriving the number of people who died from domestic fires or, even more specifically, from consumer products catching fire. In the framework of this study, the following categories were taken into account: ‘Exposure to uncontrolled fire in building or structure (e.g. from furniture catching fire)’, ‘Exposure to controlled fire in building or structure (e.g. fire in fireplace or stove)’, ‘Exposure to ignition or melting of nightwear’ and ‘Exposure to ignition or melting of other clothing and apparel (e.g. ignition or melting of plastic jewellery)’. This is an


underestimate, since ‘Exposure to other specified smoke, fire and flames’ and ‘Exposure to unspecified smoke, fire and flames’ possibly also contain deaths from domestic fires.

Using the WHO Mortality Database it was possible to document the domestic fire deaths for all but three Member States. For some Member States data are available for a few years only. The first year for which the number of domestic fire deaths was available for some countries is 1994. An overview of the WHO statistics on the number of domestic fire deaths per Member State is presented in Annex 21.

7.2.4 The insurance sector

The European insurance and reinsurance federation (CEA) was contacted to check what data on fire statistics they have available. At the European level the insurance industry does not dispose of data on the consequences of domestic fires. The member bodies of the CEA, the national insurance associations, may however have some information. To this end the Belgian national insurance association, Assuralia, was contacted. Assuralia does not possess statistical data on the number of fire deaths. They, however, do have information on the amounts of money the insurers receive and pay in relation to fire insurance. There is not much information on domestic fires. As a result it is not really feasible to document the amounts of money paid out for domestic fires.

7.2.5 European associations dealing with fire prevention

Neither the European Fire Academy (EFA) nor the European Burn Casualties Association (EBCA) have statistics on the number of deaths from domestic fires. Both organisations recognise that there is a lack of statistics in Europe on both the causes and consequences of fires. Not every country keeps a record on fire statistics and if countries do so the statistics for one country are not comparable to those of another country. The EFA and EBCA are now trying to come up with a standardised format, to be used by all Member States, for registering fire statistics.

7.2.6 Conclusions on data from specific organisations

With the exception of the data of the WHO no organisation could provide data on the number of deaths from domestic fires for all or several European Member States. In addition, the WHO data are likely to be more official than the WFSC and CTIF data as it is based on national statistics that have been transmitted to the World Health Organisation by the competent authorities of the countries involved. With regard to the analysis of the effects of non-flammability requirements for consumer products, the WHO data alone are not satisfactory. This is because for some Member States the WHO database does not contain any or only very little data on the number of fire related deaths. In addition the number of years for which the data are available may be too few for a sound qualitative trend analysis. The collection of additional data from the Member States on the number of domestic fire deaths (e.g. by means of a questionnaire) is therefore advisable.

The WFSC and CTIF data will be used to identify the share of domestic fire deaths (from WHO or Member States by means of questionnaire) in the total number of fire deaths.

7.3 Collection of data from Member States (questionnaire)

7.3.1 Approach

In order to overcome the lack of data on deaths from domestic fires, the individual Member States were contacted. This has some drawbacks since not all Member States


have been gathering the necessary information. In addition the data from the different Member States may not always be perfectly comparable. For some Members States e.g. Austria, Ireland, Czech Republic, Lithuania, the Netherlands and the United Kingdom, statistics on the total number of fire deaths can be found on the internet. This, however, is not the case for the number of domestic fire deaths. Therefore a questionnaire was developed and sent to the Members States, the example for Austria is given in Annex 22.

The European Commission provided a list with the members of the EU Fire Safety Network, which was used as a starting point to identify the national contact points. The contact details of these 23 organisations were gathered via an internet search. All organisations were contacted by telephone in order to first identify who is responsible for fire statistics and second to find out whether these organisations possess statistics on the number of domestic fires for their country. In some cases we were directed to another organisation. For those Member States for which no contact could be established with anyone having statistical data on the deaths from domestic fires available, including the 4 Member States that were not on the list with the members of the EU Fire Safety Network, an internet search was carried out in order to identify any other organisations that could possibly provide information on domestic fire deaths. Having done this, there were still about half of the Member States for which no competent authority could be identified or contacted. In order to overcome this situation, WFSC was asked to provide their contact details for the countries which were not covered yet. As such, two more Member States could be contacted and provided with a questionnaire. None of the remaining countries could be contacted through the EFA, since these countries are not members of EFA. On EFA’s advice (pers. comm.), the Member State delegates of the Federation of the European Union Fire Officer Associations (FEU) were contacted. As such, all Member States but Bulgaria, Lithuania, Malta and Slovakia (no contact points available) could be contacted.

The persons contacted were asked to complete the questionnaire with the number of deaths from domestic fires for as many years as possible (preferably from 1980 to 2009) and to provide the source of the data. For each Member State, statistical data from international organisations on the number of deaths from (domestic) fires were added to the questionnaire for the information of the respondents. The respondents were also asked to add any remarks about e.g. the quality of the data provided, specific assumptions, etc. The questionnaire was kept simple in order to get good quality answers and to obtain a high response rate.

Annex 23 provides an overview of the contacts per Member State, which were provided with the questionnaire about fire statistics.

7.3.2 Conclusions on data from Member States (questionnaire)

Fifteen Members States filled out the questionnaire on fire statistics. Of these, 12 contained useful statistical data on the number of domestic fire deaths, one questionnaire was returned but included too little information for statistical analyses, the two remaining answers indicated the Member States concerned do not have information on the number of domestic fire deaths. The data on the number of domestic fire deaths for Finland and Slovenia is only available for recent years. For both countries the number of domestic fire deaths was extrapolated to previous years using the average percentage of domestic fire deaths with regard to all fire deaths (= 100%), calculated for the recent years. Annex 23 provides an overview of the responses of the various Member States to the questionnaire


on fire statistics. For those Member States which have not responded, WHO data will be used. Data from WFSC and CTIF will not be used, since they refer to the total number of deaths by fire without differentiating between domestic fires and others.

An overview of the domestic fire deaths documented by the Member States in response to the questionnaire on fire statistics is presented in Annex 24. In order to analyse the evolution of the number of fire deaths from domestic fires, the absolute data were normalised to the corresponding number of domestic fire deaths per 1,000,000 inhabitants by using official Eurostat population statistics. These statistics describe the total population at the first of January of each year. An overview of the number of deaths per 1,000,000 inhabitants per year by Member State is given in Annex 25.

The annual number of domestic fire deaths per million and its evolution differs very much from country to country. In the year 2009, this number was as low as 2.5 persons per million inhabitants in the Netherlands while in Estonia this number equalled 31.

The data provided by the Members States seldom accurately corresponds to the data on the domestic fire deaths gathered from the WHO Mortality database. The number of domestic fire deaths from the WHO data is a fraction of the number of domestic fire deaths provided by the Member States in the framework of our questionnaire. The countries where the WHO data matched best with the data from the questionnaire (set as 100%) are Estonia (113%), the Netherlands (79%), the United kingdom (75%), Poland (64%), Germany (64%) and Hungary (55%). As indicated by several people working with fire (death) statistics, there is still quite some margin for improving the quality and the international comparability of fire statistics.

The useful statistical data on the number of domestic fire deaths in their country were asked to:

• Explain the differences in the number of domestic fire deaths per million inhabitants in their country and the other Members States that provided information

• Explain the evolution in the number of domestic fire deaths per million in their country

• Provide more detail on the way the data are collected in their country

Answers to these questions were received from Denmark, the Czech Republic, Finland, Sweden, Slovenia, the Netherlands and the United Kingdom. With the exception of the answer to the latter question (on how the data on domestic fire deaths are collected) the Member states generally did not really have an explanation.

Member States use different methods for gathering data on the number of domestic fire deaths. Some use the vital registration system while others use a combination of (sometimes secondary) sources like newspapers. The fire and rescue services are often involved, but not always and not to the same extent. Some registration systems are fully electronic, the different agencies involved follow predefined procedures while other systems require ad hoc investigations.

Concerning the differences in the number of fire deaths per million inhabitants per Member State, the Netherlands and Finland point at the influence of alcohol consumption in relation to smoking. The type of heating (open fire) is likely to also play a role in this respect. The fact that the number of domestic fire deaths in the Nordic and Eastern Member States is higher than average might be due to the combination of alcohol consumption, smoking and open fire. Some Member States also point at the type of


houses (construction material used) while others explicitly think this has only a marginal influence on the differences between the number of fire deaths per Member State. The flammability of the household inventory is believed to be more important than the characteristics of the building materials itself. With regard to the differences in the number of fire deaths per million inhabitants the (lack of) quality and comparability of the available data is also believed to partly explain the differences between the Member States.

The evolution of the number of domestic fire deaths per million inhabitants differs very much from country to country. From those countries for which we got data for a sufficient period of time Germany, Hungary and the United Kingdom have a consistent decrease in the number of domestic fire deaths per million inhabitants per year over the period considered.

With the exception of the United Kingdom, the reasons behind the evolution in the number of domestic fire deaths are largely unknown. Some Member States point out that the actual number of domestic fire deaths is so low that the year on year changes in the number of domestic fire deaths per million inhabitants are insignificant. The case of the United Kingdom is discussed more in-depth in section 9, where the effect of the non-flammability requirements on the number of fire accidents is assessed.


8 European and national requirements on the flammability and use of flame retardants in consumer products

8.1 Approach

The data collected on the non-flammability requirements for consumer products will be used to make a qualitative assessment of the impacts of these requirements on the number of fire incidents (see 9). To this end an overview was made of the European and national non-flammability requirements, documenting the evolution over time of the minimum requirements in the different Member States. The collected requirements cover both official legislation as well as voluntary actions. First a general literature review was carried out and websites of Member States and key stakeholders like industry organisations were consulted. Additionally, a questionnaire was sent to the Member States to identify Member State specific requirements.

The overview of the non-flammability requirements is complemented by an overview of the restrictions on the use of flame retardants in consumer products. This overview documents the European and national legislation in this respect. European ecolabelling schemes were also covered as well as restrictions on the use of flame retardants set by voluntary industry agreements.

8.2 Enquiry of the Member States by means of a questionnaire

A questionnaire on the fire safety requirements that apply to consumer products on the one hand and limitations on the use of flame retardants in consumer products on the other hand was established. Since both aspects of the questionnaire are somehow covered by the General Product Safety Directive 2001/95/EC (GPSD), the questionnaire was sent to the RAPEX contact points of every Member State. The RAPEX is the EU rapid alert system for the exchange of information on dangerous consumer products, set up in the framework of the GPSD. The national contact points are specifically dealing with consumer safety and should have a sound overview of the other experts and responsible bodies in their countries, which is necessary for forwarding the questionnaire to the competent persons and bodies if needed.

Shortly after the questionnaire had been send, the RAPEX contact points were contacted. The questionnaire was introduced and clarified. In case the questionnaire needed forwarding, arrangements were made on who would coordinate this process to make sure the questionnaire would be filled out. Annex 26 provides an overview of the contacts per Member State for the questionnaire about the non-flammability requirements and the use of flame retardants. The people in the list have either already sent an answer or may still provide input. The organisations and people that have been contacted but could not help us and/or forwarded the questionnaire are not in the list.

The questionnaire which was sent to the Members States is given in Annex 27. The persons contacted were asked to document the fire safety standards that apply in their country to the various types of consumer products (textiles, (upholstered) furniture, mattresses, electric and electronic equipment, etc.) used at home by completing the corresponding table. Next, they were also asked to document the restrictions on the use of


flame retardants in consumer products that apply in their country by completing the corresponding table.

Some countries that provided an answer to the questionnaire impose Member State specific requirements on the non-flammability of consumer products. This is not the case for restrictions on the use of flame retardants in consumer products. No country indicated to impose any restrictions on top of the European regulations.

8.3 Results on the regulatory and non-regulatory requirements on the non-flammability of consumer products

Laws and regulations define the necessary minimum requirements of fire safety for consumer products by making reference to specific standards. Standards translate fire safety requirements in an objective manner by making reference to specific fire tests; these fire tests specify what parameters are to be measured (e.g. time to ignition, heat release, .etc.) and how the measurements have to be carried out. The standards referred to in laws and regulations may be developed specifically for the purpose of the regulatory action; on the demand of European, national or regional rule makers. Regulations can, however, also make use of existing standards. The use of standards goes far beyond the purpose of rulemaking. The fact is that most standards are developed on the demand of industry, but standards may also be initiated by standardisation organisations and specific associations (e.g. fire safety organisations).

Fire safety requirements can address the fire safety of both materials used in products and of the end products themselves. Where fire safety requirements may simply require products to achieve a minimum safety level they could also encompass very specific provisions for achieving the predefined safety level (e.g. by prescribing the use of flame retardants).

Conformity to fire safety regulations is tested by product manufacturers, officially recognised testing institutes and independent experts, according to the methods referred to in the fire safety requirements or laid down in the standards.

8.3.1 Regulations on EU level

At a European level, Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (GPSD) imposes a general safety requirement on any product put on the market for consumers or likely to be used by them.

The GPSD places a general duty on all suppliers of consumer goods to supply products that are safe with regard to their normal or reasonably foreseeable use. The GPSD intends to ensure a high level of product safety throughout the EU for consumer products that are not covered by specific sector legislation. It, however, does not provide specific requirements for determining safety or ‘acceptable risk’. In general, a product is presumed to conform to the general safety requirement when

• in the absence of specific Community provisions, it conforms to national legislation setting out specific safety requirements, or

• it conforms to a voluntary national standard which gives effect to a European standard, the reference to which has been published in the Official Journal in accordance with Article 4 of the GPSD


In case that neither of the above two provisions do not exists, the safety of a product will be assessed taking into account:

• any voluntary standard applied in a Member State giving effect to a EU standard

• other national standards

• recommendation of the European Commission setting guidelines on product safety assessment

• product safety codes of good practice

• state of the art and technology

• reasonable consumer expectations concerning safety

The fire safety of furniture and textiles is not regulated by specific European legislation. Because of this, the GPSD applies to these products. In the early nineties the European Commission issued a mandate to the Committee for European Standardization (CEN) to produce standards for testing the fire resistance of upholstered furniture. This resulted in the European standards EN 1021-1:1993 and EN 1021-2:1993, both replaced in 2006, setting out the procedure to assess the fire resistance of upholstered furniture to cigarette and match ignition. Alongside the mandate to CEN, the Commission gave the onset to a Directive that should address both ignition resistance of upholstered furniture and control of the behavior of upholstered furniture after ignition has taken place. The Directive was, however, never finalised. Other actions in this respect have not yet led to more concrete results. European rulemaking has so far been very limited in this area.

The safety aspects concerning other consumer products like electrical and electronic articles, toys, construction material etc. are covered by sectoral directives. The most important directives which amongst others include non-flammability requirements for consumer products are:

• Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys. Soon to be replaced by the Toys Safety Directive 2009/48/EC;

• Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits;

• Directive 1999/5/EC of 9 March 1999 of the European Parliament and of the Council on Radio Equipment and Telecommunications Terminal Equipment and the mutual recognition of their conformity;

• Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC;

• Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products. Soon to be replaced by the new Construction Products Regulation (EU) No 305/2011.

These directives are all so-called ‘New Approach’ sectoral directives. Under this New Approach, product legislation is restricted to the requirements necessary to protect the public goals of health and safety. The directives that follow this approach define mandatory essential requirements. The European rule makers then refer to European


Standards, produced by one of the European Standardisation Organisations, for meeting the essential requirements.

In general, the New Approach sectoral directives contain comprehensive safety provisions. However, even in these cases the relationship between a sectoral directive and the revised GPSD will depend on the precise mechanisms which each sectoral directive uses in respect of each relevant safety provision set out in the revised GPSD. Some provisions of the GPSD mentioned above, may thus still apply to safety issues concerning consumer products that are covered by such New Approach sectoral directives.

8.3.2 Regulations at Member State level

In the absence of much European rulemaking concerning the fire safety of furniture and textiles some Member State have been active in drafting country specific fire safety regulations and standards for (upholstered) furniture, bed basses, bedding, mattresses, nightwear etc.

Table 8-1 provides an overview of national fire safety regulations for furniture and textiles in some Member States. This overview is a compilation of information gathered through the questionnaire sentd to the individual Member States as well consulting the following sources:

• Steen-Hansen A. and Kristoffersen B. (2007). Assessment of fire safety requirements to upholstered Furniture and mattresses

• Guillaume E., Chivas C. and Sainrat A. (2008). Regulatory issues and flame retardant usage in upholstered furniture in Europe

• Christian D. (n.d.). Safety standards. Report commissioned by EFRA

• Consultation of Member State specific legislation

No reference to consumer products other than furniture and textiles was encountered in the literature or reported by Member States.

As it is the objective to assess the effect of non-flammability requirements for consumer products on the number of fire incidents one should particularly look at the strictness of the non-flammability requirements on the one hand and the date these requirements entered into force on the other hand. Looking at the national fire safety regulations it is clear that furniture and textiles are required to respect strict fire safety regulations in the United Kingdom and Ireland, but not in the rest of Europe. The number of products that are covered by the regulations in the United Kingdom and Ireland is generally larger than in other countries. The non-flammability requirements are also stricter in the sense that the ignition sources used for testing the non-flammability are generally larger. The United Kingdom and Ireland also have a long tradition of regulating fire safety of consumer products compared to the other Member States that have only some requirements in this respect. Most Member States, however, do not have any fire safety regulations for furniture and textiles at all.


Table 8-1 Overview of national fire safety regulations for furniture and textiles in some Member States

Country Entry into force Regulation Scope Requirement Standard

Czech Republic 2008 Statutory Instrument N°23 - Notice on technical requirement fire safeguard building

Upholstered seating furniture, bed bases, carpets, curtains and other interior textiles for building

No ignition by match flame and no ignition by small flame. Testing by heating panel

EN 1101 EN ISO 6940 EN 1021-2 EN ISO 9239-1

Finland 1991 Regulation N° 743/1990 Regulation N° 479/1996

Seats No ignition by smouldering source (cigarette) EN 1021-1

Finland 1992 Regulation N° 57/1991 Mattresses No ignition by smouldering source (cigarette) EN 597-1

France 2001 Decree N° 2000-164 Bedding No ignition by smouldering source (cigarette) EN ISO 12952-1 and 2

Ireland 1996 Statutory Instrument N° 316/1995 Furniture No ignition by smouldering source (cigarette) and match flame

EN 1021-1 and 2

Ireland 1979 Statutory Instrument N° 215/1979 replacing the requirements in Statutory Instrument N° 5/1967

Children’s nightwear

- IS 148

The Netherlands 1997 Covenant fire safety Nightwear Nightwear Children’s nightwear: marker thread (520 mm) not severed in less then 17 s, no ignition of filter paper by flaming debris in less then 17 s. Adult nightwear: marker thread (520 mm) not severed in less then 10 s and no ignition of filter paper by flaming debris in less then 10 s

EN 1103

Netherlands 2008 Agreement fire safety clothing in accordance with the product law

Clothing Marker thread (127mm) not severed in less then 4 seconds

ASTM D1230

Sweden - Recommendations from the Swedish Consumer Agency only

Seats and mattresses

No ignition by smouldering source (cigarette) EN 1021-1 EN 597-1

United Kingdom progressively 1988-1990

Statutory Instrument N°1324/1988, amended in 1989 and 1993 by Statutory Instruments N° 2358/1989 and 207/1993

Furniture, divans, beds, mattresses, and bedding

No ignition by smouldering source (cigarette) and match flame. Cellular foam fillings testes with Crib 5 and mass loss measured

BS 5852: Part 1 and 2 BS 6807

United Kingdom 1987 Statutory Instrument N° 286/1987, replacing the Nightdresses (Safety) Regulations 1967 and 1968

Nightwear - BS 5722 BS 5438 BS 5651


Table 8-2 provides an overview of the fire safety regulations for furniture and textiles in public areas in some Member States. This overview is based on information gathered through the questionnaire, literature and the consultation of regulations. As a general conclusion we conclude that most countries have higher fire safety requirements for furniture and textiles in public buildings than they do for a domestic environment. The ignition sources used for testing the non-flammability requirements for furniture and textiles to be used in public buildings are generally larger than those prescribed for testing the flammability of these products in a domestic environment.


Table 8-2 Overview of the fire safety regulations for furniture and textiles in public buildings in some Member States

Country Entry into force Regulation Scope Requirement Standard

Finland 1988 Guidelines for public buildings Seats No ignition by smouldering source (cigarette) and match flame

EN 1021-1 and 2

France 2005, replacing a regulation from 1980

Fire safety regulation in healthcare - U23 Bedding No ignition by smouldering source (cigarette) EN ISO 12952-1 and 2


Fire safety regulation in public buildings – AM18

Bedding No ignition by smouldering source (cigarette) EN 597-1


Fire safety regulation in public buildings – AM18

Seats No ignition by 20g paper cushion NF 60013 NF P92 501 NF P92 507

France - GPEM DI 90 for prisons Mattresses No ignition by smouldering source (cigarette), match flame and higher ignition source

EN 597-1 and 2 GPEM DI 90

Denmark 2008 Public buildings Seats No ignition by smouldering source (cigarette) EN 1021-1

United Kingdom

Existing places entertainment

Guidance issued by The Home Office Furniture No ignition by smouldering source (cigarette), match flame and Crib 5.

BS 5852

United Kingdom

- Guidance for hotels and boarding houses issued by The Home Office

Furniture, mattresses and bed bases

No ignition by smouldering source (cigarette), match flame and Crib 5.

BS 5852 BS 7176

United Kingdom

2006 Guidance for healthcare issued by The Department of health


No ignition by smouldering source (cigarette), match flame and Crib 5 or Crib 7

BS 5852 BS 7176 BS 7177

United Kingdom

- Guidance for residential care homes issued by The British Standards Institution


No ignition by smouldering source (cigarette), match flame and Crib 5

EN 597-1 and 2 EN 1021-1 and 2 BS 5852 BS 7176 BS 7177 BS 6807


8.3.3 Fire safety standards

A standard is a technical document designed to be used as a rule, guideline or definition. It is a consensus-built, repeatable way of doing something. A fire safety standard generally prescribes the procedure for testing the flammability and/or burning behaviour of products.

8.3.3.1 EU level

At a European level standards are issued by the Committee for European Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI). These European standardisation organisations have been recognized by Directive 98/34/EC as competent in the area of voluntary technical standardization; each covering specific subject areas.

A European Standard (EN) automatically becomes a national standard in the member countries. European Standards need to be taken over by the national member organisations and translated into identical national standards, withdrawing any conflicting national standards.

As in Europe, there is also a clear trend towards the harmonisation of standards at a global scale. Global harmonisation of standards is being undertaken by the International Electrical Commission (IEC) for electrical equipment and by the International Organisation for Standardisation (ISO) for almost all other technical fields. IEC and ISO standards can respectively be taken over by the European standardisation organisations as EN-IEC and EN-ISO standards. Besides standardisation efforts by international organisations, standards are also issued by national bodies, industry bodies and specific organisations.

Most standards are initiated by industry, but also consumers, associations and governments can ask for the development of a standard. To an increasing extent standards are developed to support European legislation. The New Approach directives perfectly illustrate this trend. Making reference to standards within a legislative text is viewed as an effective means of ensuring that products meet the essential requirements of legislation. As such, no detailed laws have to be written. The application of standards is in principle voluntary. However, laws and regulations may refer to standards and even make compliance with them compulsory.

The overviews of the fire safety regulations for furniture and textiles in domestic and public buildings, presented in Table 8-1 and Table 8-2, make reference to standards for testing the flammability and/or burning behavior of products. An overview of the European standards with respect to fire safety is presented in Table 8-3. This overview includes specific standards for furniture and textiles and makes reference to the series of standards that have been drafted following the relevant New Approach directives. For each standard or series of standards it is indicated whether reference to these standards has been published in the Official Journal of the European Union (OJEU) or not and which directives do refer to it. For drafting this overview the databases of CEN and CENELEC have been screened.


Table 8-3 European standards addressing fire safety of consumer products

Standard53 Description of the standard Reference published in the OJEU?

Directives referring to the standard

EN 597-1:1994 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source: Smouldering cigarette No No

EN 597-2:1994 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -Part 2: Ignition source: Match flame equivalent

No No

EN 1021-1:2006 Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette No No

EN 1021-2:2006 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent No No

EN ISO 12952-1:1998 Textiles - Burning behaviour of bedding items - Part 1: General test methods for the ignitability by a smouldering cigarette (ISO 12952-1:1998)

No No

EN ISO 12952-2:1998 Textiles - Burning behaviour of bedding items - Part 2: Specific test methods for the ignitability by a smouldering cigarette (ISO 12952-2:1998)

No No

EN ISO 12952-3:1998 Textiles - Burning behaviour of bedding items - Part 3: General test methods for the ignitability by a small open flame (ISO 12952-3:1998)

No No

EN ISO 12952-4:1998 Textiles - Burning behaviour of bedding items - Part 4: Specific test methods for the ignitability by a small open flame (ISO 12952-4:1998)

No No

EN 13772:2003 Textiles and textile products - Burning behaviour - Curtains and drapes - Measurement of flame spread of vertically oriented specimens with large ignition source

No No

EN 13773:2003 Textiles and textile products - Burning behaviour - Curtains and drapes - Classification scheme No No

EN 1101:1995 Textiles and textile products - Burning behaviour - Curtains and drapes - Detailed procedure to determine the ignitability of vertically oriented specimens (small flame)

No No

EN 1101:1995/A1:2005

Textiles and textile products - Burning behaviour - Curtains and drapes - Detailed procedure to determine the ignitability of vertically oriented specimens (small flame)

No No

EN 1102:1995 Textiles and textile products - Burning behaviour - Curtains and drapes - Detailed procedure to determine the flame spread of vertically oriented specimens

No No

EN 1103:2005 Textiles - Fabrics for apparel - Detailed procedure to determine the burning behaviour No No

53 Standards produced in the framework of specific regulations may consist of many sub standards. We have chosen to refer to standards that comprise many more relevant sub standards as a ‘series’ of standards.


Reference Directives referring to the standard Standard53 Description of the standard published in

the OJEU?

EN ISO 6940:2004 Textile fabrics - Burning behaviour - Determination of ease of ignition of vertically oriented specimens (ISO 6940:2004) No No

EN ISO 6941:2003 Textile fabrics - Burning behaviour - Measurement of flame spread properties of vertically oriented specimens (ISO 6941:2003) No No

EN 14878:2007 Textiles - Burning behaviour of children's nightwear - Specification No No

EN 14878:2007/AC:2009 Textiles - Burning behaviour of children's nightwear - Specification No No

EN 71-2:2006+A1:2007 Safety of toys - Part 2: Flammability Expected 88/378/EEC

EN IEC 60695 series Fire hazard testing Yes 2006/95/EC

EN IEC 60332 series Tests on electric and optical fibre cables under fire conditions Yes 2006/95/EC

2006/95/EC, 1999/5/EC EN IEC 60065 series Audio, video and similar electronic apparatus - Safety requirements Yes

2006/95/EC, 1999/5/EC EN IEC 60950 series Information technology equipment - Safety Yes

2006/95/EC, 2006/42/EC EN IEC 60335 series Household and similar electrical appliances - Safety Yes

EN IEC 60598 series Luminaries Yes 2006/95/EC

ENV 13381 series Test methods for determining the contribution to the fire resistance of structural members No 89/106/EEC

EN 13238:2010 Reaction to fire tests for building products - Conditioning procedures and general rules for selection of substrates No 89/106/EEC

EN 1363 Series Fire resistance tests No 89/106/EEC

EN 1364 Series Fire resistance tests for non-loadbearing elements No 89/106/EEC

EN 1365 Series Fire resistance tests for loadbearing elements No 89/106/EEC

EN 13823:2002 Reaction to fire tests for building products - Building products excluding floorings exposed to the thermal attack by a single burning item No 89/106/EEC

EN 14135:2004 Coverings - Determination of fire protection ability No 89/106/EEC

EN 14390:2007-8 Fire test - Large-scale room reference test for surface products No 89/106/EEC


Standard53 Description of the standard Reference published in the OJEU?

Directives referring to the standard

EN 15254 Series Extended application of results from fire resistance tests - Non-loadbearing walls No 89/106/EEC

EN 15269 Series Extended application of test results for fire resistance and/or smoke control for door, shutter and openable window assemblies, including their elements of building hardware No 89/106/EEC

EN 1634 Series Fire resistance and smoke control tests for door and shutter assemblies, openable windows and elements of building hardware No 89/106/EEC

EN ISO 1182:2002 Reaction to fire tests for building products - Non-combustibility test (ISO 1182:2002) No 89/106/EEC

EN ISO 11925-2:2002 Reaction to fire tests - Ignitability of building products subjected to direct impingement of flame - Part 2: Single-flame source test (ISO 11925-2:2002) No 89/106/EEC

EN ISO 1716:2002 Reaction to fire tests for building products - Determination of the heat of combustion (ISO 1716:2002) No 89/106/EEC

EN ISO 9239-1:2002 Reaction to fire tests for floorings - Part 1: Determination of the burning behaviour using a radiant heat source (ISO 9239-1:2002) No 89/106/EEC

ENV 1187:2002 Test methods for external fire exposure to roofs No No

EN 1399 series Resilient Floor Coverings - Determination of Resistance to Stubbed and Burning Cigarettes-Ratified European Text No No

EN ISO 4589 series Plastics - Determination of burning behaviour by oxygen index No No


8.3.3.2 Member State level

Standardisation activities also take place at Member State level. Member States may, e.g. in the absence of satisfactory international standards, develop their own standards. The United Kingdom has done this in the framework of its Furniture and Furnishings (Fire) (Safety) Regulations 1988 and its Nightwear (Safety) Regulations 1985. The British Standards Institution developed a number of standards for these regulations, shown in Table 8-2.

8.3.3.3 Industry level

Action with respect to the flammability of consumer products can also be initiated by industry. Relevant voluntary action at industry level has been inventoried by means of an internet search; combing websites of relevant European sector and consumer organisations.

One such initiative concerns the fire safety of television sets. Television sets sold in Europe are manufactured to meet the safety requirements of EN IEC 60065 series. While this standard ensures that the TVs are intrinsically safe, it only imposes low fire protection levels against external ignition sources. The need to apply higher fire safety levels to the plastic enclosures has resulted in 2004 in a voluntary commitment of some of the leading TV manufacturers. With this commitment, Philips, Sony, Panasonic and Finlux agree to apply V1 ignition resistance level to the full enclosures of all their CRT models sold in Europe as of January 2006 (ACFSE, 2010).

The UFAC (Upholstered Furniture Action Council) was founded in 1978 to make upholstered furniture more resistant to ignition from smoldering cigarettes, which are the leading cause of upholstery fires at home. To do so, the UFAC developed a voluntary action program as well as specific standards. The test methods are published on the UFAC-website.54.

Contacts with the representatives of industry as well as the relevant downstream users did not reveal any other important initiatives.

8.4 Results on the use of flame retardants in consumer products

Hereafter, an overview is given of the European and national requirements with regard to the use of flame retardants in consumer products. Furthermore, requirements set by ecolabels and voluntary industry agreements are also discussed.

8.4.1 European legislation

Rulemaking by European institutions imposes restrictions on the use of certain flame retardants in consumer products. The following European Regulations and Directives particularly touch the production and use of flame retardants:

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and

54 www.UFAC.org


Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC and its amendments

• Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations and its amendments (now taken over into Annex XVII of REACH)

• Directive 2002/95/EC of the European Parliament and of the Council for the purpose of establishing the maximum concentration values for certain hazardous substances in electrical and electronic equipment and its amendments

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC and its amendments

• Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy and its amendments

Directives 76/769/EEC and 2002/95/EC and their amendments have placed concrete restrictions on the use of flame retardants in consumers products. Table 8-4 outlines the uses for which the above Directives, and their amendments, restrict the use of specific flame retardants as well as the date by which the Member States have to apply the provisions listed in the different regulations. As of June 2009, the Directive 76/769/EEC on the marketing and use of certain dangerous substances and preparations is fully incorporated under the REACH legislation.


• Table 8-4 Overview of the restrictions on the use of flame retardants emanating from European legislation

Flame retardant Regulation Date entry into force

Scope

tris (2,3 dibromopropyl)-phosphate

Council Directive 79/663/EEC of 24 July 1979 supplementing the Annex to Council Directive 76/769/EEC. Now REACH Annex XVII July 1980 textile applications

tris-(aziridinyl)-phosphinoxide

Council Directive 83/264/EEC of 16 May 1983 amending for the fourth time Directive 76/769/EEC. Now REACH Annex XVII

November 1984 textile applications

PBB Council Directive 83/264/EEC of 16 May 1983 amending for the fourth time Directive 76/769/EEC. Now REACH Annex XVII


PentaBDE Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003 amending for the 24th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations

15 August 2004

articles may not be placed on the EU market if they, or flame-retarded parts thereof, contain this substance in concentrations higher than 0,1 % by mass

OctaBDE Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003 amending for the 24th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations

15 August 2004

articles may not be placed on the EU market if they, or flame-retarded parts thereof, contain this substance in concentrations higher than 0,1 % by mass

PBB55 2005/618/EC: Commission Decision of 18 August 2005 amending Directive 2002/95/EC of the European Parliament and of the Council for the purpose of establishing the maximum concentration values for certain hazardous substances in electrical and electronic equipment

1 July 2006

maximum concentration value of 0,1 % by weight in homogeneous materials in new electrical and electronic equipment (EEE) put on the EU market

PBDE56 2005/618/EC: Commission Decision of 18 August 2005 amending Directive 2002/95/EC of the European Parliament and of the Council for the purpose of establishing the maximum concentration values for certain hazardous substances in electrical and electronic equipment electronic equipment

1 July 2006 max.conc. value of 0,1 % by weight in homogeneous materials in new EEE put on the EU market

DecaBDE57 (2008/C 116/04): Judgment of the Court (Grand Chamber) of 1 April 2008 — European Parliament (C-14/06), Kingdom of Denmark (C-295/06) v Commission of the European Communities 1 July 2008

max. conc. value of 0,1 % by weight in homogeneous materials in new EEE put on the EU market

55 Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment first stipulated PBB could not be used in new electronic equipment put on the EU market from 1 July 2006 onwards. This has been revised whereas it is evident that a total avoidance of brominated flame retardants is in some instances impossible to achieve 56 Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment first stipulated PBDE could not be used in new electronic equipment put on the EU market from 1 July 2006 onwards. This has been revised whereas it is evident that a total avoidance of brominated flame retardants is in some instances impossible to achieve 57 Annulment by the European Court of Justice of the exemption for DecaBDE as stipulated by 2005/717/EC: Commission Decision of 13 October 2005 amending for the purposes of adapting to the technical progress the Annex to Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment


Hexabromocyclododecane (HBCDD) and Tris(2-chloroethyl)phosphate are on the candidate List of Substances of Very High Concern for authorisation in the framework of the REACH legislation. This means that the registrant needs to prepare an application for authorisation, in order to be able (to continue) to use it or place it on the market (unless an exemption applies).

The Water Framework Directive (WFD) (2000/60/EC), which entered into force in December 2000, establishes a Community framework for water protection and management in order to prevent and reduce pollution, promote sustainable water use, protect the aquatic environment, improve the status of aquatic ecosystems and mitigate the effects of floods and droughts. The Directive identified a priority list of 33 substances in the field of Water Policy. This aims at ensuring a high level of protection against risks to the aquatic environment coming from these 33 priority substances by establishing environmental quality standards. These standards aim at limiting the quantity of certain chemical substances that pose a significant risk to the environment or to health in surface water in the EU. These standards would be coupled with an inventory of discharges, emissions and losses in order to ascertain whether the goals of reducing or eliminating such pollution have been achieved. Out of the 33 substances included in the WFD some will be monitored or reviewed for identification as potentially hazardous substances, while others were identified as hazardous substances to be phased out in 20 years. According to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council:

• OctaBDE and DecaBDE are listed among the substances to be monitored

• PentaBDE is listed as a hazardous substance to be phased out by 2020

8.4.2 National legislation

Specific national legislation with regard to the use of flame retardants in consumer products is very limited. The questionnaire sentd to the Member States sought to identify any national restrictions on the use of flame retardants in consumer products on top of those stemming from Community legislation. None of the respondents, however, indicated national regulations to be more severe in this respect than the European legislation.

An internet search revealed that Sweden introduced a partial national restriction on DecaBDE on 1 January 2007, covering the use in textiles, furniture and some cables, but exempting electrical and electronic equipment. The European Commission officially started an infringement procedure against Sweden concerning its ban on the use of DecaBDE in textiles, furniture and some cables. Faced with a legal challenge from the EU, Sweden lifted its national ban on the use of DecaBDE flame retardant in May 2008. (EBFRIP, 2009)

8.4.3 Ecolabels

Manufacturers promote the compliance with environmental standards of their products in two ways: via indication on the label or packaging material (self-declaration) or via the use of ecolabels. Although the framework for the operation of ecolabel schemes is governed


by regulation, their actual use is voluntary. The schemes develop and publish environmental performance criteria for certain product groups (for example televisions, furniture etc.), which have to be fulfilled by a manufacturer in order to qualify for an ecolabel.

The most widespread ecolabel scheme is the voluntary European Ecolabel, established in 1992 to encourage businesses to market products and services that are more environmental-friendly. When technically possible the EU ecolabel aims, amongst others, at substituting hazardous substances by safer ones. Today the EU ecolabel covers a wide range of products and services, with further groups being continuously added. Product groups include cleaning products, appliances, paper products, textile and home and garden products, lubricants and services such as tourist accommodation. For example (European Environment Bureau, 2009b), the European Ecolobel requests to prohibit the use of flame retardants in Ecolabelled textiles and bed mattresses, or at the very least those substances which are banned in electronic appliances including deca-BDE.

Next to the European Ecolabel there are a number of regional or national ecolabel schemes in Europe, see Table 8-5 for an overview. The EU Ecolabel Regulation requests Member States and the European Commission to ensure coordination between the EU Ecolabel and other national schemes, particularly in the selection of product groups and the development and revision of the criteria. The EU Ecolabelling scheme and these labels are developing a policy of cooperation and coordination.

Table 8-5 Overview of national/regional ecolabelling schemes

Ecolabel Countries / regions involved Start date

Internet source

Nordic Swan Denmark, Finland, Iceland, Norway and Sweden

1989 http://www.svanen.nu/Default.aspx?tabName=StartPage

AENOR Medio Ambiente Spain 1994 http://www.aenor.es/desarrollo/certificacion/productos/tipo.asp?tipop=2

El Destintiu Catalonia 1994 http://mediambient.gencat.net/cat/empreses/ecoproductes_i_ecoserveis/distintiu.jsp

Milieukeur The Netherlands 1995 http://www.smk.nl/nl/s357/SMK/Programma-s/Milieukeur/c324-Milieukeur

Blaue Engel Germany 1978 http://www.blauer-engel.de/en/index.php

Umweltzeichen Austria 1990 http://www.umweltzeichen.at/

NF Environnement France 1992 http://www.marque-nf.com/

Ekologicky Setrany Vyrobek Czech Republic 1994 http://www.ekoznacka.cz/

Környezetbarát Termék Hungary 1993 http://okocimke.kvvm.hu/public_eng/?ppid=2200000

EKO Znak Poland http://www.pcbc.gov.pl/index.php?page=ekoznak/ekoznak

Environmentálne Vhodný Výrobok

Slovakia 1996 http://www.enviro.gov.sk/servlets/page

http://www.svanen.nu/Default.aspx?tabName=StartPage

http://www.aenor.es/desarrollo/certificacion/productos/tipo.asp?tipop=2

http://www.aenor.es/desarrollo/certificacion/productos/tipo.asp?tipop=2

http://mediambient.gencat.net/cat/empreses/ecoproductes_i_ecoserveis/distintiu.jsp

http://mediambient.gencat.net/cat/empreses/ecoproductes_i_ecoserveis/distintiu.jsp

http://www.smk.nl/nl/s357/SMK/Programma-s/Milieukeur/c324-Milieukeur

http://www.smk.nl/nl/s357/SMK/Programma-s/Milieukeur/c324-Milieukeur

http://www.blauer-engel.de/en/index.php

http://www.umweltzeichen.at/

http://www.marque-nf.com/

http://www.ekoznacka.cz/

http://okocimke.kvvm.hu/public_eng/?ppid=2200000

http://www.pcbc.gov.pl/index.php?page=ekoznak/ekoznak

http://www.enviro.gov.sk/servlets/page


The criteria of the EU ecolabel, Blaue Engel, Nordic Schwan, Milieukeur and Umweltzeichen are available from the websites of these schemes and have been scanned with respect to the flammability of the products covered by these schemes. No non-flammability requirements were encountered. The ecolabelling schemes considered, however, do formulate specific requirements concerning the use of flame retardants in certain products. The use of (certain) flame redardants (in a specific concentration) is prohibited for certain product (categories). Table 8-6 provides an overview of those ecolabelling schemes that impose limitations to the use of flame retardants for specific product categories.

Table 8-6 Overview of ecololabelling schemes that impose limitations to the use of flame retardants for specific product categories

Product categories Ecolabel schemes

Mattresses EU ecolabel, Blaue Engel, Umweltzeichen

Textile products EU ecolabel, Nordic Schwan, Milieukeur

Textile floor coverings EU ecolabel, Blaue Engel

Office equipment (personal computers, printers, etc.) EU ecolabel, Blaue Engel, Nordic Swan, Umweltzeichen

Audivisual equipment (televisions, digital projectors, etc.) EU ecolabel, Blaue Engel, Nordic Swan

(Mobile) phones Blaue Engel

Domestic appliances (espresso machines, washing machines, refrigerators, freezers, etc.) Blaue Engel, Nordic Swan, Umweltzeichen

(Wooden) furniture EU ecolabel, Nordic Swan, Milieukeur, Umweltzeichen

Office chairs Umweltzeichen

(Low emission upholstered) leather Blaue Engel, Nordic Swan

Low emission wood products and wood based products Blaue Engel

Products made of recycled plastics (fences, composters, etc.) Blaue Engel

(Elastic) floor coverings Blaue Engel, Nordic Swan, Umweltzeichen

Low-noise and low emission garden tools Blaue Engel

Low emission thermal insulation material and suspended ceilings for use in buildings Blaue Engel

(Wooden) toys Blaue Engel, Nordic Schwan

8.4.4 Voluntary industry agreements

A European voluntary code of practice has been drawn up in cooperation between the brominated flame retardant industry and the Bromine Science and Environmental Forum (BSEF), the British Plastics Federation (BPF) and the Textile Finishers Association to monitor and reduce emissions of DecaBDE to the environment during use (application) of the product. This is now being implemented with industrial downstream users in these sectors, who are invited to sign up to this code of practice (EFRA, 2010).


In 1986 the association of the German chemical industry (VCI) introduced a voluntary agreement to discontinue the use of DecaBDE as flame retardant in polymers because of the potential of forming dioxins/ furans in uncontrolled thermal processes (EFRA, 2010).

Representatives of the relevant downstream users were contacted to identify other voluntary agreements. However, no voluntary industry agreements were identified by them.


9 Non-flammability requirements and fire accidents

The objective of the analysis presented in this section is to assess the effect of non-flammability requirements on the number of domestic fire deaths. The assessment was carried out as a stepwise approach:

• Analysis of the evolution of the yearly number of domestic fire deaths per million inhabitants per Member State

• Analysis of the stringency of the non-flammability requirements of consumer products in the different Member Sates

• Assessment of the evolution of the yearly number of domestic fire deaths per million inhabitants per Member State on the basis of the date of entry into force of non-flammability requirements as well as their stringency

• Formulation of general conclusions

9.1.1 Evolution of the yearly number of domestic fire deaths per million inhabitants per Member State

Below, the evolution of the domestic fire deaths is presented for those countries that documented the number of domestic fire deaths in response to the questionnaire on fire statistics. A linear trend line has been added in order to provide a more or less quantified indication of the likely evolution of the number of fire deaths.

Figure 9-1 illustrates that the number of domestic fire deaths in the Czech Republic per million inhabitants remained fairly stable over the last 25 years.

Czech Republic

y = 0.0089x + 5.7944

0

1

2

3

4

5

6

7

8

9

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

Year

Num

ber

of d

eath

s pe

r 1,0

00,0

00

Domestic firesLineair (Domestic fires) Linear trend

Figure 9-1 Evolution domestic fire deaths per 1,000,000 inhabitants in the Czech Republic

Figure 9-2 shows that the number of domestic fire deaths per million inhabitants in Denmark has been increasing since the middle of the nineties by on average 0.16 deaths per million per year. Fire deaths include people who die due to damage from fire (either


smoke damage or burns), either at the scene of fire or after hospitalation. The death must occur within 30 days after the fire.

Denmark

y = 0.1608x + 12.119

0

2

4

6

8

10

12

14

16

18

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Year

Num

ber

of d

eath

s pe

r 1,0

00,0

00


Figure 9-2 Evolution domestic fire deaths per 1,000,000 inhabitants in Denmark

Figure 9-3 shows that the number of domestic fire deaths per million inhabitants in Estonia is very high compared to the other Member States (see Annex 25). The data of the WHO confirm this. Since 2006 the number of domestic fire deaths has been decreasing by 2/3.

Estonia

y = -5.6333x + 102.98

0

20

40

60

80

100

120

2001 2002 2003 2004 2005 2006 2007 2008 2009

Year

Num

ber

of d

eath

s pe

r 1,0

00,0

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Domestic firesLineair (Domestic fires)

Linear trend Linear trend

Figure 9-3 Evolution domestic fire deaths per 1,000,000 inhabitants in Estonia

Figure 9-4 shows that the number of domestic fire deaths per million inhabitants in Finland has been decreasing progressively since the mid eighties, followed by an upwards trend since 2001. Nevertheless the number of domestic fire deaths has been decreasing on average with 0.22 deaths per million per year over the considered period.


In Finland the number of domestic fire deaths has only been recorded since 2006. For the period 2006-2008 the share of domestic fire deaths has been estimated to be about 91 % of all accidental fire deaths in Finland. This percentage was used by the competent authority to extrapolate from the total number of fire deaths to the number of domestic fire deaths for the years 1985-2005.

Finland

y = -0.2191x + 18.137

0

5

10

15

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25

1985

1986

1987

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2004

2005

2006

2007

2008

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Figure 9-4 Evolution domestic fire deaths per 1,000,000 inhabitants in Finland

Figure 9-5 shows that the number of domestic fire deaths per million inhabitants in Germany has been decreasing since the early nineties. Today the number of domestic fire deaths per million inhabitants is low compared to the other Member States.

Germany

y = -0.0474x + 5.9899

0

1

2

3

4

5

6

7

8

9

1985

1986

1987

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1990

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2000

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2003

2004

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2006

2007

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Figure 9-5 Evolution domestic fire deaths per 1,000,000 inhabitants in Germany


Figure 9-6 shows that in Hungary the number of domestic fire deaths has dropped on average by 1.3 inhabitants per million per year since the first half of the nineties. For the regression analysis the lacking numbers for 2003 and 2004 for Hungary have been interpolated. A closer look reveals that the decrease mainly took place in the period 1993 - 2000.

Hungary

y = -1.2864x + 29.95

0

5

10

15

20

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30

35

40

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Year

Num

ber

of d

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s pe

r 1,0

00,0

00


Figure 9-6 Evolution domestic fire deaths per 1,000,000 inhabitants in Hungary

Figure 9-7 shows that the number of domestic fire deaths per million inhabitants in Ireland is marked by a clear decrease over the past 25 years. The number of domestic fire deaths per million inhabitants has been decreasing by about 0.3 deaths per million inhabitants per year over the period considered.

y = -0,2838x + 16,585

0

2

4

6

8

10

12

14

16

18

20

Num

ber

of d

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Ireland

Domestic fires

Lineair (Domestic fires) Linear trend

Figure 9-7 Evolution domestic fire deaths per 1,000,000 inhabitants in Ireland

Figure 9-8 illustrates that the number of domestic fire deaths per million inhabitants in the Netherlands is very low compared to the other Member States (and similar to Germany). The overall trend reveals a small decrease in the number of domestic fire deaths over the


last 20 years. Since 2001 the data on domestic fires has been recorded by the Dutch fire fighters documentation centre. Because of the way the data are registered, they should be more accurate than before.

Netherlands

y = -0.0419x + 3.5321

0

1

2

3

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5

6

1988

1989

1990

1991

1992

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1995

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2001

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2003

2004

2005

2006

2007

2008

2009

Year

Num

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per 1

,000

,000


Linear trend

Figure 9-8 Evolution domestic fire deaths per 1,000,000 inhabitants in the Netherlands

Figure 9-9 reveals that the number of domestic fire deaths per million inhabitants in Poland has been increasing the last few years since 2004 after a slight decline before the turn of the century.

Poland

y = 0.1229x + 9.1648

0

2

4

6

8

10

12

14

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Year

Num

ber o

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0,00

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Linear trend

Figure 9-9 Evolution domestic fire deaths per 1,000,000 inhabitants in Poland

Figure 9-10 shows that in Slovenia the number of domestic fire deaths per million inhabitants has been increasing. Only from 2005 onwards there are data on the number of


domestic fire deaths. The number of domestic fire deaths amounts to about 67% of the total number of fire deaths, which is available for earlier years. This percentage was used to estimate the number of domestic fire deaths for the period 1993-2004.

Slovenia

y = 0.0564x + 4.6115

0

1

2

3

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7

8

9

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Year

Num

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Linear trend

Figure 9-10 Evolution domestic fire deaths per 1,000,000 inhabitants in Slovenia

According to Figure 9-11, on average the number of domestic fire deaths per million inhabitants in Sweden slightly decreased over the last 20 years. Harrami et al. (2006) conclude that ‘carelessness when smoking’ is the most commonly identified fire cause in Sweden. The houses where fatal fires occur are rarely protected by smoke detectors.

Sweden

y = -0.2441x + 10.584

0

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14

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Year

Num

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Linear trend

Figure 9-11 Evolution domestic fire deaths per 1,000,000 inhabitants in Sweden

Figure 9-12 shows that the number of domestic fire deaths per million inhabitants in the U.K. is marked by a consistent decrease over the last 25 years. The number of domestic


fire deaths per million inhabitants has been decreasing by about 0.3 deaths per million inhabitants per year during that period.

United Kingdom

y = -0.3091x + 14.413

0

2

4

6

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12

14

16

1980

1982

1984

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1994

1996

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2002

2004

2006

2008

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Linear trend

Figure 9-12 Evolution domestic fire deaths per 1,000,000 inhabitants in the United Kingdom

The evolution of the number of domestic fire deaths per million inhabitants differs a lot from country to country. Among those countries that provided data on the domestic fire deaths for a long period of time, Finland, Ireland and the United Kingdom have a noticeable decrease in the number of domestic fire deaths per million inhabitants per year over that period. In Germany and the Netherlands the decline is much more moderate. In Estonia the decline of the number of domestic fire deaths is spectacular, and Hungary showed a strong decrease, but the absolute level is still very high compared to the other Member States.

An increase in the number of domestic fire deaths was observed in Denmark, Poland and Slovenia, and since 2004 also in Sweden.

The evolution of the number of domestic fire deaths for those Member States that did not provide (sufficient) statistical data is assessed using the data from the WHO mortability database. We have seen that the data provided by the Members States seldom accurately correspond to the data on the domestic fire deaths gathered from the WHO Mortality database. The number of domestic fire deaths from the WHO data is only a fraction of the number of domestic fire deaths provided by the Member States in the framework of our questionnaire. Because of this we can not make any judgement on the absolute level of fire deaths.

The WHO data were used to asses the evolution of the domestic fire deaths for Austria, France, Latvia, Lithuania, Romania, Slovakia and Spain. Figure 9-13 to Figure 9-19 map the evolution of the domestic fire deaths in those countries using the WHO data. A linear trend line was added in order to provide an approximation of the likely evolution of the number of fire deaths. For the time periods considered, there is a decreasing trend in the


number of fire deaths in Austria, France, Lituania and Romania, however, only the decrease in Romania seems to be really consistent.

y = -0,1548x + 3,7606

0

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2002 2003 2004 2005 2006 2007 2008

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Austria

Domestic fires

Lineair (Domestic fires)

Linear trend

Figure 9-13 Evolution domestic fire deaths per 1,000,000 inhabitants in Austria

y = -0,1432x + 2,832

0

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3

4

2000 2001 2002 2003 2004 2005 2006 2007

Num

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France

Domestic fires


Linear trend

Figure 9-14 Evolution domestic fire deaths per 1,000,000 inhabitants in France


y = 1,2996x + 64,496

0

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60

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90

100

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

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Latvia

Domestic fires


Figure 9-15 Evolution domestic fire deaths per 1,000,000 inhabitants in Latvia

y = -0,5294x + 32,892

0

5

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35

40

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Num

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f dea

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Lithuania

Domestic fires


Linear trend

Figure 9-16 Evolution domestic fire deaths per 1,000,000 inhabitants in Lithuania

y = -0,1432x + 2,9453

0

1

2

3

4

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Num

ber

of d

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Romania

Domestic fires


Linear trend

Figure 9-17 Evolution domestic fire deaths per 1,000,000 inhabitants in Romania


y = 0,0349x + 2,9336

0

1

2

3

4

5

6

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Num

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Slovakia

Domestic fires


Linear trend

Figure 9-18 Evolution domestic fire deaths per 1,000,000 inhabitants in Slovakia

y = 0,1569x + 0,5778

0

1

2

1999 2000 2001 2002 2003 2004 2005

Num

ber

of d

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Spain

Domestic fires


Linear trend

Figure 9-19 Evolution domestic fire deaths per 1,000,000 inhabitants in Spain

was increasing.

he absolute number of domestic fire deaths was relatively high in Latvia (similarly to

s. It should be borne in mind that the WHO data are

In Spain and, particularly, in Latvia the number of domestic fire deaths

TEstonia), but also in Lithuania.

The numbers of domestic fire deaths per 1,000,000 inhabitants presented in the figures above are summarized in Table 9-1. In this table the Member States are ranked according to the number of domestic fire deathlikely to underestimate the actual number of domestic fire deaths.


Table 9-1 Ranking of the Member States according to the number of domestic fire deaths

High period Low period Evolution over period

Mean last 3 years period

Spain WHO 1999-2005 1.87 0.73 0.1569 1.55Romania WHO 1999-2008 3.25 1.29 -0.1432 1.84France WHO 2000-2007 3.14 1.43 -0.1432 2.05Austria WHO 2002-2008 4.67 1.93 -0.1548 2.37Netherlands Questionnaire 1988-2009 5.40 1.53 -0.0419 2.60Slovakia WHO 1994-2005 4.83 1.67 0.0349 2.85Germany Questionnaire 1985-2007 7.84 3.77 -0.0474 4.30Slovenia Questionnaire 1993-2007 8.01 3.02 0.0561 5.66United Kingdom Questionnaire 1980-2008 14.60 5.45 -0.3091 5.69Czech Republic Questionnaire 1983-2009 8.04 4.25 0.0089 6.01Ireland Questionnaire 1980-2008 18.29 7.04 -0.2838 8.06Sweden Questionnaire 1999-2008 12.46 5.57 -0.2441 8.37Poland Questionnaire 1995-2009 12.83 8.45 0.1229 11.74Hungary Questionnaire 1993-2009 35.21 10.17 -1.2864 12.24Denmark Questionnaire 1996-2008 15.71 8.57 0.1608 13.08Finland Questionnaire 1985-2008 20.03 9.07 -0.2191 15.67Lithuania WHO 1998-2007 36.49 19.20 -0.5294 30.12Estonia Questionnaire 2001-2009 98.16 31.33 -5.6333 53.42Latvia WHO 1996-2007 93.36 46.22 1.2996 75.84

Domestic fire deaths per million inhabitantsCountry Source Period

9.1.2 Analysis of the stringency of the non-flammability requirements of consumer products in the different Member Sates

Amongst all the non-flammability requirements that have been identified, only the Member States' specific non-flammability requirements for furniture and textiles can be classified into stringent and less stringent requirements, because such requirements are different in the different Member States. The non-flammability requirements for electrical and electronic articles, toys, construction material, etc. are covered by EU (sectoral) directives, therefore they apply in all Member States with the same stringency.

Within this study the stringency of the non-flammability requirements for furniture and textiles is determined on the basis of both

• the ignition source used to test the non-flammability of furniture and textiles: The larger the ignition source these products should be able to resist the more stringent the requirements;

• the scope: The larger the range of products covered the more stringent the requirements.

The United Kingdom, Ireland and the Czech Republic have the most stringent requirements in place for what concers the non-flammability of furniture and textiles. This is valid for both the scope of the requirements as well as the size of the ignition source. The ignition source commonly used to test the non-flammability of furniture and textiles is a smouldering source (cigarette) or equivalent. In the Czech Republic, Ireland and the United Kingdom, also larger flaming sources like a match flame or Crib 5 (an even more demanding test) are used. In the Czech Republic the requirements apply to upholstered seating furniture, bed bases, carpets, curtains and other interior textiles. The requirements in Ireland cover different kinds of furniture and children’s nightwear. In the United Kingdom


the requirements extend to furniture, divans, beds, mattresses and bedding on the one hand and nightwear on the other hand. The scope of the non-flammability requirements in these Member States is clearly broader than the scope in the other Member States that have requirements in place.

The non-flammebility requirements for furniture and textiles are less stringent in Finland, France and the Netherlands. In Finland, the scope of the non-flammability requirements only covers seats and mattresses. In France the scope of the non-flammability requirements only involves bedding. In the Netherlands the flammability of nightwear and clothing is regulated, but furniture is not.

In Sweden there are only recommendations from the Swedish Consumer Agency concerning the non-flammability for furniture (seats and mattresses).

For all other countries, no information is available on any non-flammability requirements for furniture or textiles.

9.1.3 Impact of non-flammability requirements on the number of domestic fire deaths

Harrami et al. (2006) advise that information and education on the risk of fire are deemed very important. Increased awareness should affect behaviour and lead to greater care. Other important measures are the reduction of smoking and reducing the flammability and improving the safety of electrical products. Early detection by smoke detectors is a very effective measure to deal with fires in the initial stage of development and to reduce the number of fire deaths.

The assessment of the effect of non-flammability requirements in the Member States on the yearly number of domestic fire deaths is complicated by several factors. The most important bottlenecks are:

• The statistical data on the yearly number of domestic fire deaths per million inhabitants (which is used in this study as indicator for assessing the benefits of non-flammability requirements for consumer products) should be interpreted carefully. Data may be of relatively poor quality. Data for the different Member States is seldom comparable, as the collection of data is not harmonised at a supranational level. Both observations may hamper a sound analysis;

• To assess the effectiveness of a consumer product-related non-flammability requirement, the number of domestic fire deaths should be related to the consumer product that caused the fire. Since such statistics are not available, it is difficult to accurately determine the effectiveness of a product or product category specific non-flammability requirement;

• The assessment of the effect of the non-flammability requirements is complicated by competing factors (e.g. smoke detectors), which complicates a qualitative assessment substantially;

• Fire safety regulations impose requirements from their entry into force onwards. Since the products that are covered generally do have a relatively long lifetime, non-compliant products may still be on the market after the implementation of the fire safety regulation. This will pose a lag on the effectiveness of the non-flammability requirements under consideration, making it more difficult to accurately identify impacts on trends in the number of domestic fire deaths;


• With regard to the assessment of the impact of non-flammability requirements on the number of domestic fire deaths, it is essential to know when new non-flammability requirements have been introduced. This is not always evident:

• the Member State specific non-flammabilty requirements for furniture and textiles are well documented in terms of the dates when these have been introduced. This information is provided in section 8.3.2

• in the preceding section 9.1.2 it was argued that it is not feasible to qualitalively assess the benefits of the non-flammability requirements for consumer products like electrical and electronic articles, toys, construction material, etc. that are covered by sectoral directives. The reasons for this is that the European rule makers refer to European standards for defining the essential (non-flammability) requirements for the products covered by these Directives. The fire safety standards referred to in the framework of these directives have been progressively adopted since the adoption of the Directives. Consequently, it will not be possible to discern any shift in the number of domestic fires as the fire safety of consumer products clearly is a very gradual process which can not be observed from the statistical data we have available

Taking into account

• the above mentioned considerations concerning the stringency of the non-flammability requirements

• the above mentioned considerations concerning the date when the various non-flammability requirements have been introduced

• the above mentioned bottlenecks

it is very difficult to assess the effects of the specific furniture and textiles fire safety regulations that exist in some countries. Nevertheless, although furniture and textiles are only a part of all domestic consumer products, they may have a noticeable influence, since the flammability of furniture and textiles is believed to be an important factor in domestic fire risk.58 The assessment is presented hereafter.

Countries with stringent requirements

The United Kingdom, which has stringent non-flammability in place for furniture and textiles, shows a consistent decrease in the number of domestic fire deaths per million inhabitants from 1980 to 2008 (fig. 9-12). In the middle of the eighties the number of domestic fire deaths per million inhabitants seemed to remain stable (at 12 to 13 deaths) and started to decrease remarcably in the 2 years after the introduction of the Furniture and Furnishings flammability regulations in 1988 and the requirements for nightwear (1987) onwards. A similar stagnation as in the mid-80s was observed from about 1995 to 1997, although at a lower level (about 10 deaths), which was again followed by a consistent decrease until 2007. It is however not clear to whether the latter decrease was due to any fire-reducing measures taken in the mid-nineties.

Several in-depth analyses (Emsley et al., 2005 and Greenstreet Berman Ltd, 2009) have seen an impact of the 1988 Furniture and Furnishings regulations on the reduction in the number of domestic fire deaths per million inhabitants. The non-flammability requirements,

58 In Sweden most fatal fires occur in homes, often starting in a bed, sofa, otter loose fittings or clothing. Over the period 2000-2004 more than 60% of the fatal domestic fires in Sweden, for which the object of origin was known, started in bed, sofa, armchair, clothing or curtains. (Harrami et al., 2006)


however, are not considered responsible for the entire reduction, as also the presence and effectiveness of smoke alarms has increased remarkably since then. The analysis by Emsley et al. (2005) considers that by the turn of the century about half of the reduction in the number of fire deaths in the United Kingdom could be ascribed to the United Kingdom’s furniture and furnishings regulations (1988) and half to the increased presence and effectiveness of smoke alarms. The analysis by Greenstreet Berman Ltd. (2009) suggests that the United Kingdom’s furniture and furnishings regulations (1988) account in the period 2002-2007 for 54 less deaths per year, 780 less non-fatal casualties per year and 1,065 less fires each year.

Ireland, which has very similar non-flammability regulations in place as the United Kingdom, has also realised a consistent decrease in its number of domestic fire deaths per million inhabitants (fig. 9-7). The link with the introduction of the non-flammability requirements for furniture in 1996, however, does not provide for the start of a steeper decrease since the number of fire deaths per million inhabitants was already decreasing since the early eighties, with oscillations between 10 and 14 deaths between about 1990 and 2002. There should be other reasons for the decline before the introduction of the non-flammability requirements for furniture in 1996. - The marked decline in the 1983-1990 period may be linked to the introduction of stringent non-flammability requirements for children’s nightwear in 1979, but this may also be a coincidence since there was no reinforced decrease upon the introduction of the non-flammability requirements for furniture in 1996.

The Czech non-flammability requirements for furniture and textiles, which can also be considered as stringent, have only been issued in 2008. The effect of this is not yet visible in the statistics (fig. 9-1). The number of domestic fire deaths per million remained fairly stable over the considered period 1983-2009.

Countries with less stringent requirements

Finland, France and the Netherlands have less stringent non-flammability requirements in place for furniture and textiles. In Sweden there are only recommendations from the Swedish Consumer Agency concerning the non-flammability for furniture (seats and mattresses). Over the period considered, the number of domestic fire deaths per million inhabitants per year has been decreasing in these four countries. The decrease, however, was not as consistent and marked as the decrease in the United Kingdom and Ireland.

The introduction of requirements for seats (1991) and mattresses (1992) in Finland (fig. 9-4) coincides with a drop of the number of domestic fire deaths per million inhabitants per year. The decrease has, however, been halted (and even inverted) in 2001. According to the Finnish Consumer Safety Agency (pers. comm.) the further increase after 2003 may have to do with the cut in taxes on alcohol in 2003. This tax reduction may have resulted in an increased alcohol consumption and consequently also a less responsible behavior with regard to flaming sources (e.g. cigarettes).

The introduction of requirements for bedding (2001) in France (fig. 9-14) is marked by a simultaneous drop in the number of domestic fire deaths per million inhabitants per year. In the subsequent years, the level of domestic fire deaths remained fairly stable, but at a lower level than during the period preceding 2001.

The Netherlands (fig. 9-8) introduced non-flammability requirements for nightwear (1997) and clothing (2008). The introduction of requirements for nightwear in 1997 did not


coincide with a decrease in the number of domestic fire deaths, and it is probably too early to draw any conclusions about the effect of the requirements for clothing. As can be seen (fig. 9-8) the number of domestic fire deaths per million inhabitants per year was oscillating between 2 and 3 from 1992-2001, and increased its variability from 1 to 4 until the end of the observation period in 2009.

The promulgation date of the recommendations for seats and mattresses in Sweden is unknown. It is therefore not possible to assess their effect.

Countries without requirements

For all other Member States, no information is available on possible non-flammability requirements for furniture or textiles. Estonia (fig. 9-3) and Hungary (fig. 9-6) show a very remarkable year on year decrease in the number of fire deaths per million inhabitants. These Member States did no provide any particular reason for this decrease. According to some other Member States the combination of alcohol consumption, smoking and open fire may be an important reason for the much higher level of domestic fire deaths in Nordic and Eastern countries. It may therefore be speculated that the steep decline may partly be due to a changing trend in the domestic alcohol consumption and smoking patterns or, perhaps, an increased awareness for the problem.

A country that does not have non-flammability requirements in place, but does show a consistent decrease in the number of domestic fire deaths per million inhabitants per year over the period considered is Germany (fig. 9-5). The reasons for this decrease are unknown.

Conclusion

The above evaluations of the numbers of domestic fire deaths per million inhabitants per year show that in some instances, drops in the number of fire deaths coincide with the introduction of non-flammability requirements for domestic consumer products. In other instances, however, there is no change in the ongoing trend of fire deaths. This suggests that these numbers do not reflect the stringency of non-flammability requirements, respectively that non-flammability requirements do not visibly decrease the number of fire deaths. This may indeed be due to the many factors that can influence the outbreak of fires and ensuing deaths, as outlined at the beginning of this section.


10 Conclusions and recommendations

10.1 Conclusions

This study has shown that, from the over 700 applications of flame retardants identified in consumer products in a domestic environment, 42 flame retardants in little more than 60 applications (resp. application groups) were relevant for risk assessment for consumer health and the environment. Regarding consumer health 9 of these flame retardants had already been assessed at EU level prior to this study, for the environment the assessments covered 8 flame retardants at EU level and 10 in a Member State (the UK). Thus, some risk assessment work had already been undertaken prior to this study.

To identify possible risks of flame retardants further, the recommended REACH first tier approach (ECETOC TRA) was considered to be appropriate for this study.

It turned out that for 16 of the 32 flame retardants relevant for consumer exposure data were available for such first tier assessment, for 8 further a read-across exercise enabled the first tier assessment, for the remaining 8 the toxicological data were either not sufficient for such an assessment or not available at all. For the 8 'read-across flame retardants' REACH should partially provide the data necessary for risk assessment: 4 substances had their REACH registration deadline in 2010 and 2 in 2013; the remaining 2 may however not be registered. For the 8 substances with too little or no data available, 1 had a 2010 deadline, 3 will have it in 2013, and 3 counted as REACH registered since notified as 'new substances' under Directive 67/548/EEC (resp. Directive 92/32/EEC).

Regarding possible environmental risks, 20 flame retardants were considered relevant in this study, in addition to the 18 already assessed previously. Lack of available data however impeded a first tier assessment. REACH should provide the missing data in the coming months (6 substances with REACH registration deadline 2010) or by 2013 (7 substances) and thus allow the environmental assessments. 4 further substances containing data gaps count as already registered under existing legislation and for 3 substances the REACH registration deadline remains unknown.

This study has thus shown that, under the current availability of data and by taking account of available risk assessments, 6 flame retardants used in consumer products in a domestic environment could be considered not to need risk management measures based on the assessment of the data within the approach of this study, either those publicly available or those obtained through a read-across exercise. A further 3 flame retardants would also belong to this group, but there are concerns about these three due to their secondary poisoning effects, their POP (Persistent Organic Pollutant) or their PBT (persistent, bio-accumulative and toxic) effects. For 10 others, either the human health or the environmental assessments identified a risk in this study. One flame retardant (namely isodecyl diphenyl phosphate) was identified as posing a risk for both human health and the environment. Finally, for 22 flame retardants too little data were available to carry out a human health and/or an environmental risk assessment. For further details see chapter 6.

Thus, quite some work to assess the risks of flame retardants used in consumer products in domestic environments remains to be done. It is hoped that REACH will provide a substantial amount of the data which are not publicly available today.

With regard to the impact of specific non-flammability requirements in 7 Member States on the number of fire deaths from consumer product fires, this study could not identify a


correlation between such requirements and the number of fire deaths. This was possibly due to the many factors that influence fire outbreaks in dwellings, and to the insufficient specificity of fire death statistics.

10.2 Recommendations

To achieve further progress with regard to flame retardants in consumer products used in domestic environments, the following recommendations can be made.

With regard to toxicological data:

• Replace modeled data by measured data in the human exposure assessment

• Refine the use of default values derived from expert judgment and the use of high transfer factors from matrix to skin/sweat, air or saliva/gastric fluids

With regard to consumer exposure:

• Generate more detailed information on some of the applications in order to refine current worst case assumptions

• Omit the use of conservative assumptions made in the dermal-exposure parameters relating to the body-surface area exposed, especially for exposure estimates to furniture, textiles and flooring (e.g. wearing of fabrics does not present a barrier to the migration of flame retardants)

• Refine the oral exposure by more detailed information on the uses: oral exposure was based on conservative assumptions according to the first tier assessment (surface area sucked, and the timing) and worst case assumptions were made with regard to the uses (textiles = clothes, toys = toys for toddlers) due to lack of detailed information

• Replace constant release rates used in the calculation of exposure by more realistic values

• Refine inhalation exposure: simple refinements of the exposure estimates were possible in most cases by e.g. using the saturated vapour concentration as an upper bound vapour concentration. The use of measured data would eliminate remaining uncertainties

With regard to environmental exposure and effects:

• Eliminate the existing data gaps impeding environmental risk assessment: knowledge of ecotoxicological data, EU tonnage by application and/or emissions from landfills and incinerators for the substances mentioned in the ‘data gap’ list. The relevant applications are mentioned in Annex 8 of this report. Several of these substances have a REACH 2010 registration deadline, which implies that accurate information on these aspects should be available.

With regard to fire statistics:

• Improve the quality and the international comparability of fire statistics

• Fine-tune the explanation of the trend in number of fire deaths by taking into account information on requirements on smoke detectors, fire extinguishers, etc.


10.3 Added value of the study

This study increases our knowledge about risk assessment of flame retardants in consumer products used in a domestic environment:

• It provides a detailed compilation of risk assessments, for human health as well as for environment, of flame retardants in all relevant consumer applications largely used at home

• It indicates where further work is needed, namely which substances should be considered in more detail for their toxicological properties, and which applications should be checked in more detail for their exposure potential

• It provides a timeline for data availability under REACH, and it indicates where REACH may not provide the data necessary for risk assessment

• It shows that the stringency of non-flammability requirements for consumer products in a domestic environment does not have a statistically noticeable impact on the number of fatalities from fires in dwellings. It thus supports the assumption that fire outbreaks and ensuing fatalities depend on many factors, and not only on the stringency of non-flammability requirements

In conclusion this study will hopefully be taken as a solid representation of the state-of-play on risk assessment of flame retardants in consumer products in a domestic environment, and thus enable the fire safety community to move their work forward in a target-oriented way.


11 Literature references

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Stuer-Lauridsen, F., Havelund, S., Birkved, M. (2000): Alternatives to brominated flame retardants. Screening for environmental and health data. Working report No. 17, Danish EPA

Swaminathan, R. (2003): Magnesium Metabolism and its Disorders. Clin Biochem Rev. 2003 May, 24(2): 47–66

Swanson, M.B. & Socha, A.C. (1997). Chemical ranking and scoring: guidelines for relative assessments of chemicals. SETAC, 1997.

Takizawa, T., Yasuhara, K., Mitsumori, K., Onodera, H., Koujitani, T., Tamura, T., Takagi, H., Hirose, M. (2000): A 90-day repeated dose oral toxicity study of magnesium chloride in F344 rats. Bull. Natl. Inst. Health Sci. 2000, 118, 63-70

Tamade, Y. et al. (Dioxin 2003). In: Borgnes, D. & Rikheim, B. (2004). Emission measurements during incineration of waste containing Bromine. Final report on behalf of the Nordisk Ministerråd, Statens Forurensningstilsyn, Norsk Renholdsverks-forening, Elektronikkretur AS, Hvitevareretur AS, Stena Miljø AS, RENAS AS.

Tanaka, H., Hagiwara, A., Kurata, Y., Ogiso, T., Futakuchi, M., Ito, N. (1994): Thirteen-week oral toxicity study of magnesium chloride in B6C3F1 mice. Toxicol. Let. 73, 25-32

Tange, L. & Drohmann, D. (2004). Environmental issues related to end-of-life options of plastics containing brominated flame retardants. Fire Mater. 2004; 28:5, 403-410.

TOXNET (2010): Toxicology Data Network; http://toxnet.nlm.nih.gov, Online Search 2010

http://www.socopse.se/

http://cordis.europa.eu/home_en.html



U.S. Environmental Protection Agency (EPA): Anonymous (2009). Polybrominated Diphenyl Ethers (PBDEs) Action Plan

US EPA (1997). Exposure Factors Handbook Vol. I-III. (Update to Exposure Factors Handbook EPA/600/8-89/043 – May 1989). US Environmental Protection Agency (EPA), Office of Research and Development, EPA/600/P-95/002Fa, Washington, DC, (Available from the US EPA website at http://www.epa.gov/nceawww1/software.htm)

US EPA (2005): EPA Comments on Chemical RTK HPV Challenge Submission: 2,2'-(1,2-Ethanediyl)bis(4,5,6,7-tetrabromo-1H-Isoindole-1,3(2H)-dione). Summary of EPA Comments; April 29, 2005

US EPA (2005): EPA comments on the robust summaries and test plan for 2,2'-(1,2-ethanediyl)bis(4,5,6,7-tetrabromo-1H-isoindole-1,3(2H)-dione. Summary of EPA Comments; April 29, 2005

US EPA (2009). Methodology for risk-based prioritization under ChAMP. US EPA Office of Pollution Prevention & Toxics

US EPA (2009): Initial Risk-Based Prioritization of High Production Volume (HPV) Chemicals Benzene, 1,1’-[1,2-ethanediylbis(oxy)]bis[2,4,6-tribromo- (CASRN 37853-59-1) (CA Index Name: Benzene, 1,1’-[1,2-ethanediylbis(oxy)]bis[2,4,6-tribromo-); April 2009

US EPA (2010): Screening-Level Hazard Characterization - Trixylenyl Phosphate (CASRN 25155-23-1); June, 2010

US NTP (1981): Testing Status of Agents at NTP: Diethyl ethylphosphonate. http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=78-38-6, Online Search, 2010

US NTP (1982): Testing Status of Agents at NTP: Firemaster 680. http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=salmonella.overallresults&cas_no=37853-59-1&endpointlist=SA, Online Search 2010

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US NTP (2006): Testing Status of Agents at NTP: Tetrabromobisphenol A-bis(2,3-dibromopropyl ether). http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=21850-44-2, Online search 2010

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Verbruggen et al. (2005). Environmental Risk Limits for several phosphate esters, with possible application as flame retardant. RIVM

Vlarip (2010). Saskia Walraedt, VLARIP en Eco²Chem Project leader. Diamant Building, Auguste Reyerslaan, 80, B - 1030 Brussel. Mobile +32 496 59 36 19. E-mail [email protected]. www.vlarip.be

Voluntary Industry Commitment by the US and European Producers of Selected Brominated Flame Retardants covered under OECD’s Risk Reduction Programme (1995)

Voluntary Plan in Japan concerning the Risk Management of Selected Brominated Flame Retardants (1995)

mailto:[email protected]


Washington State Department of Ecology and Washington State Department of Health. Flamme et al. (2008). Alternatives to Deca-BDE in Televisions and Computers and Residential Upholstered Furniture

Watson, A., Brigden, K., Shinn, M. & Cobbing, M. (2010). Toxic Transformers – a review of the hazards of brominated & chlorinated substances in eletrical and electronic equipment. Greenpeace Research Laboratories Technical Note 01/2010.

WHO (1994). IPCS, Environmental Health Criteria 162. Brominated Diphenyl Ethers. World Health Organization, Geneva, 1994.

WHO (1997). IPCS, Environmental Health Criteria 192. Flame retardants: a general introduction. World Health Organization, Geneva, 1997.

WHO (World Health Organization) (1994): IPCS, Environmental Health Criteria 162. Brominated diphenylethers; World Health Organization, Geneva, 1994

WHO (World Health Organization) (1995): IPCS, Environmental Health Criteria 172. Tetrabromobisphenol A and Derivates; World Health Organization, Geneva, 1995

WHO (World Health Organization) (1997): IPCS, Environmental Health Criteria 194. Aluminium; World Health Organization, Geneva, 1997

WWF (On-line information). Killer whales with toxics. Information available on website


12 Annexes


Annex 1: Overview of NGO’s and their relevance for this study

NGO Contact details Relevance

Ecobaby http://www.ecobaby.nl/

Identification, evaluation and prevention of effects of hazardous environmental factors during pregnancy and in the neonatal and postneonatal period

European Environmental Bureau http://www.eeb.org

Federation of Environmental Citizens Organisations: to ensure the EU secures a healthy environment and rich biodiversity for all

Friends of the Earth http://www.foei.org http://www.foe.co.uk

Not relevant for flame retardants (climate&energy, forests&biodiversity, food sovereignty, economic justice, water)

Greenpeace http://www.greenpeace.org/~toxics Greener electronics

Health and Environment Alliance http://www.env-health.org Raise awareness of how environmental

protection improves health

Health Care Without Harm http://www.noharm.org Very interesting since focussing on consumer products

International Chemical Secretariat (Chemsec) http://www.chemsec.org Precaution, Substitution, Polluter Pays and

Right to Know

Northern Alliance for Sustainability http://www.anped.org

Redirected to other NGO’s (Health and Environment Alliance, Health care without harm, WECF and Ecobaby)

Women in Europe for a Common Future (WECF)

http://wecf.eu/english/chemicals-health/

WECF raises awareness amongst consumers and encourages them to ask questions about the products they allow into their homes

WWF http://www.wwf.org Focussed on environmental concentrations/biomonitoring: no link with consumer products

European Consumers' Organisation (BEUC) [email protected] Test reports on flame retardants in

consumer products

http://www.eeb.org/

http://www.foei.org/

http://www.foei.org/

http://www.greenpeace.org/%7Etoxics

http://www.env-health.org/

http://www.noharm.org/


http://www.anped.org/

http://www.wwf.org/


Annex 2: List of consulted stakeholders

Organisation Contact details Website / Email Feedback

MANUFACTURERS & ASSOCIATIONS

European Flame Retardant Association (EFRA) ad hoc

Phosphorus, Inorganic and Nitrogen Flame Retardants Association (PINFA) ad hoc European Brominated Flame Retardant Industry Panel (EBFRIP)

EBFRIP consists of Albemarle, Chemtura and ICL-IP, who were already contacted at the start of the project

Consultant to BSEF (Bromine Science and Environmental Forum )/EBFRIP no information Albemarle ad hoc Chemtura ad hoc ICL-IP ad hoc Nabaltec AG Alustr. 50-52 D-92421 Schwandorf no information Chemische Fabrik Budenheim KG Rheinstr. 27 55257 Budenheim no information

DOWNSTREAM USERS

Plastics Europe/European Extruded Polystyrene Insulation Board Association ad hoc

Plastics Europe

European Composites Industry Association (EuCIA): c/o European Plastics Converters, Avenue de Cortenbergh 66, 1000 Bruxelles, Belgium http://www.eucia.org answer from one member received

Plastics Europe

POLYNT GmbH (member of EuCIA): Kieselstrasse 2 56357 Miehlen - Germany Amtsgericht Koblenz, HRB 20782 www.polynt.it answer received

Plastics Europe [email protected] ad hoc

European Plastics Converters association (EuPC): ABS and Polystyrene polymers [email protected] no answer

European Apparel and Textile Confederation no information

The flame retardant textiles network ltd. [email protected] answer received

http://www.polynt.it/






Verband TEGEWA e.V. Mainzer Landstr. 55 D - 60329 Frankfurt no information

Textil-bekleidung (German Association of Textile and Upholstered furniture) no information

Essenscia forwarded the request to Centexbel

Centexbel answer received

European bedding industries' association (EBIA)

Europur & Euro-Moulders (automotive) Diamant building Boulevard Reyers, 80, B-1030 Brussels Belgium

Caligen (member of EuroPUR) no answer

European bedding industries' association (EBIA) no answer

CEFIC no answer European Resin Manufacturers Association (ERMA) answer received

European Furniture Manufacturers Federation (UEA) [email protected] no data: redirected to Europur (foam producers) Chairman of the British Furniture Confederation (BFC)

[email protected] [email protected] no data

European Man made fibres Association (CIRFS) www.cirfs.org no answer

Rhodia UK Ltd. Textiles Flame Retardants Business no answer Council of European Producers of Materials for Construction (CEPMC): fire working group no data

European Association of Adhesives and Sealants Manufacturers (FEICA) no data

European Council of producers and importers of paints, printing inks and artists' colours [email protected] no answer

Confederation of European Paper Industries (CEPI) answer received

European Rubber Chemicals Association (ERCA) no data

European Tyre and Rubber Manufacturers' Association (ETRMA)

Avenue des Arts 2 box 12, B1210 Brussels (Belgium) tel: + 32-2-218.49.40 fax: + 32-2-218.61.62 [email protected] answer received





Chemical Industries Association Fire Retardant Sector Group (FRSG): represents chemical and pharmaceutical businesses throughout the UK [email protected] no answer Furniture Industry Research Association (FIRA)

Furniture Industry Research Association (FIRA) no data


Annex 3: Substances banned, polymeric, reactive mode of integration

*Not banned if <= 0.1 % by weight (RoHS+European Court of justice C‑14/06)

More detailed information on the applications of these substances is given in the Excel file ‘Annex 3’, which can be found on the CD-rom.

Banned substances Substances with reactive mode of integration Polymeric substances

Substance CAS number



BROMINE BROMINE BROMINE Decabromdiphenyl ether* 1163-19-5 2,4,6-tribromophenol 118-79-6 Copolymer based on dibromostyrene 148993-99-1 Hexabromobiphenyl 59536-65-1 Tribromoneopentyl alcohol 1522-92-5 Brominated polystyrene 88497-56-7

Diester/ether diol of tetrabromophthalic anhydride 20566-35-2 Polymerised dibromostyrene 88497-56-7

Tetrabromobisphenol A bis (allyl ether) 25327-89-3 Phenoxy terminated carbonate oligomer of TBBPA

94334-64-2 and 71342-77-3

2,4,6-tribromophenyl allyl ether 3278-89-5 End capped brominated epoxy 135229-48-0 Dibromoneopentyl glycol 3296-90-0 Poly(pentabromobenzyl acrylate) 59447-57-3

1,4-bis(pentabromophenoxy)tetrabromobenzene 58965-66-5 Brominated epoxy oligomer and

polymer 68928-70-1

Pentabromobenzyl acrylate 59447-55-1 PHOSPHORUS Tetrabromophthalic anhydride 632-79-1 Oligomeric ethyl ethylene phosphate 184538-58-7 Tetrabromophthalate diol 77098-07-8 Polymeric phosphonate no data Tetrabromobisphenol A 79-94-7 Ammonium polyphosphate 68333-79-9 PHOSPHORUS Red phosphorus 7723-14-0

56386-64-2, 218768-84-4 Dimethyl propyl phosphonate 18755-43-6 Melamine polyphosphate

Phosphonic acid, (3-{[hydroxymethyl]amino}-3-oxypropyl)-dimethyl ester

20120-33-6

N,N-(bis)-hydroxyethyl-aminomethane phosphonic acid diethyl ester 2781-11-5

Dihydrooxaphosphaphenanthrene no data


Banned substances Substances with reactive mode of integration Polymeric substances




Phosphonic acid no data Phosphorus polyol proprietary


Annex 4: Substances/applications not relevant for a domestic environment or no longer used

An overview of the substances and their applications that are not relevant for a domestic environment or are no longer used is given in the Excel file ‘Annex 4’, which can be found on the CD-rom.


Annex 5: Substances assessed under existing legislation

More detailed information on the applications of these substances is given in the Excel file ‘Annex 5’, which can be found on the CD-rom.

Substance CAS No. Existing legislation Decabromodiphenyl ether 1163-19-5 EU RAR Hexabromocyclodecane 25637-99-4 EU RAR Chloroparaffins (SCCP) 85535-84-8 EU RAR Chloroparaffins (MCCP) 85535-85-9 EU RAR Tris (2-chloroethyl)phosphate 115-96-8 EU RAR Tris (2-chloro-1-methylethyl)phosphate 13674-84-5 EU RAR Tris (2-chloro-1-(chloromethyl)ethyl)phosphate 13674-87-8 EU RAR Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) 38051-10-4 EU RAR

Tetrabromobisphenol A 79-94-7 EU RAR (human health)

Triphenylphosphate 115-86-6 UK RAR (environment)

2-Ethylhexyldiphenyl phosphate 1241-94-7 UK RAR (environment)

Tricresylphosphate 1330-78-5 UK RAR (environment)

Trixylyl phosphate 25155-23-1 UK RAR (environment)

Cresyl diphenyl phosphate 26444-49-5 UK RAR (environment)

Tris-(isopropylphenyl)phosphate

26967-76-0 and 68937-41-7


Isopropylphenyl diphenyl phosphate (IPP) 28108-99-8 UK RAR (environment)

Isodecyl diphenyl phosphate 29761-21-5 UK RAR (environment)

Tert-Butylphenyl diphenyl phosphate (BDP) 56803-37-3 UK RAR (environment)

Resorcinol bis-diphenylphosphate (RDP) 57583-54-7 UK RAR (environment)


Annex 6: EU RAR and UK RAR summary

The summaries of the relevant sections of the EU RAR and UK RAR (environment only) are given in the Excel file ‘Annex 6’, which can be found on the CD-rom.


Annex 7: Consumer exposure assessment

The consumer exposure assessment is given in the Excel file ‘Annex 7’, which can be found on the CD-rom.


Annex 8: Environmental core set of applications

The environmental core set applications for service life and for disposal are given in the Excel file ‘Annex 8’, which can be found on the CD-rom.


Annex 9: Overview physic-chemical data

The overview of physico-chemical data is given in the Excel file ‘Annex 9’, which can be found on the CD-rom.


Annex 10: DNEL derivation

The report on DNEL derivation is given in the Excel file ‘Annex 10’, which can be found on the CD-rom.


Annex 11: Overview of available data on effects for each flame retardant in the environmental core set of applications

Legend: good: long-term ecotox data available medium: acute ecotox data available for different trophic levels poor: acute ecotox data available NA: not available

Flame retardant CAS number Environmental effect data

Aquatic Sediment

Magnesium hydroxide 1309-42-8, 13760-51-5 NA NA

Boehmite (aluminium hydroxideoxide) 1318-23-6 NA NA

Dimethyl propane phosphonate 18755-43-6 Poor NA

Tris(tribromoneopentyl)phosphate 19186-97-1 NA NA

Aluminium hydroxide 21645-51-2 Medium NA

Tris(2,4,6 tribromophenoxy)triazine 25713-60-4 NA NA

Bis-(2-ethylhexyl)tetrabromophthalate 26040-51-7 Good NA

Bis-(isopropylphenyl) phenylphosphate 28109-00-4 NA NA

Tris-(tert-butylphenyl)phosphate 28777-70-0 NA NA

Ethylene bis(tetrabromophtalimide) 32588-76-4 Poor NA

1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 Medium NA

Melamine phosphate 415836-09-9, 20208-95-1 Poor NA

Guanidine phosphate 5423-23-4 NA NA

Isodecylphosphate 56572-86-2 NA NA

Bisphenol A-bis(diphenylphosphate) 5945-33-5 and 181028-79-5 Good NA

Bis-(tert-butylphenyl)phenylphosphate 65652-41-7 NA NA

Hypophosphite, aluminium salt 7784-22-7 NA NA

Hypophosphite, calcium salt 7789-79-9 NA NA

Diethyl ethylphosphonate 78-38-6 Medium NA

Triethyl phosphate 78-40-0 Good Poor


Annex 12: Default parameters for estimating exposure in different product/article categories acc. to ECETOC-TRA

Descriptor (AC/PC) Subcategory Dermal oral Dermal/or

al Inhalation

Body part considered

Contact area (cm²)

Volume product swallowed

Area product mouthed(cm²)

Thickness layer (cm)

Amount of product used (g/event)

Exposure time (hr)

Glues DIY-use (carpet glue, tile glue, wood parquet glue)

One hand 428.8 - - 0.01 15,000 6 PC1 Adhesives and sealants

sealants fingertips 35.7 - - 0.01 390 4

Waterborne latex wall paint

Inside hands/one hand

428.8 - - 0.01 3750 2.2

Solvent rich, high solid, waterborne paint


428.8 - - 0.01 1300 2.2

PC9a Coatings, paints, thinners, removers

Aerosol spray can - - - - 0.01 300 0.33 PC9b Fillers, putties, plasters

Fillers and putty fingertips 35.7 - - 0.01 1000 4

Clothing (all kind of material), towel

Whole body except feet, hands and head

14315 0.1 10 0.01 500 8

Bedding, mattress

Whole body except feet, hands and head

14315 0.01 10 0.001 25000 8

AC5 Fabrics, textiles and apparel

Car seats, chair, flooring

Upper part of the body 8750 - - 0.001 16000 8

AC6 Leather articles2

Furniture (sofa) Upper part of the body 8750 - - 0.001 10000 4

AC11 wood articles

Walls and flooring (also applicable to non-wood materials)


428.8 - - 0.001 3000 8

Plastic, larger articles (plastic chair, PVC-flooring)

Upper part of the body 8750 - - 0.001 8000 8

Toys (doll, car, animals, teething rings)

Hands and forearms (child)

556.8 0.01 10 0.001 - - AC13 Plastic articles

Plastic small articles (ball pen, mobile phone)

fingertips 35.7 0.1 - 0.001 75 8


Annex 13: Overview of available data for each flame retardant in the consumer core set of applications

Legend: default route of exposure: n = no, y = yes, (y) = yes, however, due to VP considerations only for applications where abrasive tasks can be assumed during service life no data = no data is available poor = minor database is available medium = medium database is available good = good database is available


Application Default route of exposure for consumers

Human health effect data


Data availability

triphenyl phosphate

115-86-6

AC2; wire & cable (PVC) AC6; furniture sofa (PVC)

n y

n n

y y

medium

2-ethylhexyl diphenyl phosphate

1241-94-7


n y

n n

y y

medium

magnesium hydroxide

1309-42-8, 13760-51-5

AC2; wire & cable, interior part, housing AC5; flooring, furniture sofa

n y

n n

(y) y

Low, read across

boehmite (aluminium hydroxideoxide)

1318-23-6

AC2; wire & cable, interior part AC13; toys

n y

n y

(y) n

Low, read across

aluminium hydroxide

1318-23-7 21645-51-2

AC2; wire & cable AC13; flooring (PVC flex)

n y

n n

(y) y

Low, read across

tricresyl phosphate 1330-78-5


n y

n n

y y

good

bisphenol A-bis(diphenylphosphate)

181028-79-5 5945-33-5

AC2; wire & cable AC2;housing large and small articles AC5; clothes (assumed) AC13; flooring (PVC) AC6; furniture sofa (PVC & TAC)

n y y y y

n n y n n

y y y y y

medium

dimethyl propane phosphonate

18755-43-6

PC9a; paints PC9b; construction foam AC0; construction material (enclosed)

y y n

n n n

y y n

no data

tris (tribromo neopentyl) phosphate

19186-97-1

AC2; E & E AC5; textiles, furniture, carpets

n y

n n

y y

Low, not adequate for DNEL derivation

melamine phosphate

20208-95-1, 41583-09-9

PC9a; paints AC6; furniture sofa (textile back-coating)

y y

n n

y y

No data, read across

tetrabromobisphenol A bis(2,3-dibromopropylether)

21850-44-2

AC2, exterior parts E&E AC5, flooring AC0, construction material

n y n

n n n

y y y

Poor- Medium + read-across

diethylphosphinate, aluminium salt

225789-38-8

AC2; wire & cable AC5 : interior part

n n

n n

(y) (y)

Low - medium






Data availability

trixylyl phosphate 25155-23-1


n y

n n

y y

Good

tris(2,4,6 tribromophenoxy)triazine

25713-60-4

AC2; housing, large articles AC2; housing, small articles

n y

n n

y y


cresyl diphenyl phosphate

26444-49-5


n y

n n

y y

Good

tris-(isopropylphenyl)phosphate, Isopropylphenyl diphenyl phosphate

26967-76-0, 68937-41-7, 28108-99-8


n y

n n

y y

Good

bis-(isopropylphenyl) phenylphosphate

28109-00-4


n y

n n

y y

no data

tris-(tert-butylphenyl)phosphate

28777-70-0, 78-33-1


n y

n n

y y

read-across to tris-(tert-butylphenyl) phosphate

isodecyl diphenyl phosphate

29761-21-5

AC5; flooring (PVC) y n y medium

ethylene bis(tetrabromophtalimide)

32588-76-4

PC9b; construction foam AC2; exterior parts and housing, AC2: wire & cable, interior E&E parts AC0; construction material (small exterior parts)

y y n n

n n n n

y y y y

Medium - good

1,2-bis(2,4,6-tribromophenoxy)ethane

37853-59-1

AC2, housing large articles AC0, construction material (adhesives, sealants)

n n

n n

y y

good

guanidine phosphate

5423-23-4

AC5; textile (no data, clothes assumed)

y y y no data, read across

isodecylphosphate 56572-86-2


n y

n n

y y

no data

tert-butylphenyl)phenylphosphate

56803-37-3


n y

n n

y y

Medium - good

resorcinol bis-diphenylphosphate

57583-54-7

AC2, E & E n n y Medium - good

bis-(tert-butylphenyl)phenylphosphate

65652-41-7


n y

n n

y y

No data, read-across to (tert-butylphenyl)phenylphosphate

hypophosphite, aluminium salt

7784-22-7

AC2; wire & cable AC2; housing E&E

n y

n n

(y) (y)

no data

hypophosphite, calcium salt

7789-79-9

AC2; E & E exterior part y n (y) no data






Data availability

diethyl ethylphosphonate

78-38-6 PC9b; construction foam AC0; construction material (enclosed after installation)

y n

n n

y n


triethyl phosphate 78-40-0 PC9b; construction foam AC0; construction material (enclosed after installation)

y n

n n

y n

good

decabromodiphenylethane

84852-53-9

AC2: housing large articles n n y medium


Annex 14: Operational landfill and incineration techniques compliant with EU requirements

EU Requirements

LANDFILL

Annex I of the Landfill Directive defines the minimum conditions for a compliant landfill.

Location

In order to avoid a serious environmental risk, following characteristics of the site have to be taken into account, or corrective measures have to be taken:

• the distances from the boundary of the site to residential and recreation areas, waterways, water bodies and other agricultural or urban sites

• the existence of groundwater, coastal water or nature protection zones in the area

• the geological and hydrogeological conditions in the area; the risk of flooding, subsidence, landslides or avalanches on the site

• the protection of the nature or cultural patrimony in the area.

Leachate treatment

Water control and leachate management, with respect to the characteristics of the landfill and the meteorological conditions, is to be foreseen in order to:

• control water from precipitations entering into the landfill body,

• prevent surface water and/or groundwater from entering into the landfilled waste

• collect contaminated water and leachate, unless proved that it does not pose any potential hazard to the environment

• treat contaminated water and leachate collected from the landfill to the appropriate standard required for their discharge.

Protection of soil, groundwater and surface water is to be achieved by

• the combination of a geological barrier and a bottom liner during the operational phase

• the combination of a geological barrier and a top liner during the passive phase or post closure phase

•

Geological barrier

The geological barrier is determined by geological and hydrogeological conditions below and in the vicinity of the landfill site providing sufficient attenuation capacity to prevent a potential risk to soil and groundwater. The landfill base and sides consist of a mineral layer which satisfies permeability and thickness requirements with a combined effect in terms of protection of soil, groundwater and surface water at least equivalent to following requirements:


• landfill for hazardous waste: K ≤ 1,0 × 10-9 m/s; thickness ≥ 5m,

• landfill for non-hazardous waste: K ≤ 1,0 × 10-9 m/s; thickness ≥ 1m,

• landfill for inert waste: K ≤ 1,0 × 10-7 m/s; thickness ≥ 1m.

Where the geological barrier does not naturally meet the above conditions it can be completed artificially and reinforced by other means giving equivalent protection. An artificially established geological barrier should be no less than 0,5 metres thick.

Leachate collection

In addition to the geological barrier a leachate collection and sealing system is added to ensure that leachate accumulation at the base of the landfill is kept to a minimum. Both an artificial sealing liner and a drainage layer ≥ 0,5 m are requested, except for inert waste landfills where Member States are free to impose specific provisions.

Surface sealing

A surface sealing consists of a gas drainage layer, an artificial sealing liner, an impermeable mineral layer, a drainage layer > 0,5 m and a top soil cover > 1 m

Gas control

Appropriate measures are taken in order to control the accumulation and migration of landfill gas. It has to be collected from all landfills receiving biodegradable waste and it must be treated and used or flared.

Nuisances and hazards

Measures are taken to minimise nuisances and hazards arising from the landfill through emissions of odours and dust, wind-blown materials, noise and traffic, birds, vermin and insects, formation and aerosols, fires. The landfill is equipped so that dirt originating from the site is not dispersed onto public roads and the surrounding land.

Stability

The emplacement of waste on the site has to take place in such a way as to ensure stability of the mass of waste and associated structures, particularly in respect of avoidance of slippages. Where an artificial barrier is established it must be ascertained that the geological substratum, considering the morphology of the landfill, is sufficiently stable to prevent settlement that may cause damage to the barrier.

Barriers

The landfill is secured to prevent free access to the site. The gates are locked outside operating hours. The system of control and access to each facility contains a programme of measures to detect and discourage illegal dumping in the facility.

INCINERATOR

The objective of waste incineration is to treat wastes so as to reduce their volume and hazard, whilst capturing (and thus concentrating) or destroying potentially harmful substances that are, or may be, released during incineration. Incineration processes can also provide a means to enable recovery of the energy, mineral and/or chemical content from waste.

The main stages of an incineration process are:


• drying and degassing: volatile content is evolved (e.g. hydrocarbons and water) at temperatures generally between 100 and 300 °C

• pyrolysis and gasification: pyrolysis is the further decomposition of organic substances in the absence of an oxidising agent at approx. 250 – 700 °C. Gasification of the carbonaceous residues is the reaction of the residues with water vapour and CO2 at temperatures, typically between 500 and 1000 °C, but can occur at temperatures up to 1600 °C. Thus, solid organic matter is transferred to the gaseous phase. In addition to the temperature, water, steam and oxygen support this reaction

• oxidation: the combustible gases created in the previous stages are oxidised, depending on the selected incineration method, at flue-gas temperatures generally between 800 and 1450 °C

In fully oxidative incineration the main constituents of the flue-gas are: water vapour, nitrogen, carbon dioxide and oxygen. Depending on the composition of the material incinerated and on the operating conditions, smaller amounts of CO, HCl, HF, HBr, HI, NOX SO2, VOCs, PCDD/F, PCBs and heavy metal compounds (among others) are formed or remain. Depending on the combustion temperatures during the main stages of incineration, volatile heavy metals and inorganic compounds (e.g. salts) are totally or partly evaporated. These substances are transferred from the input waste to both the flue-gas and the fly ash it contains. A mineral residue fly ash (dust) and heavier solid ash (bottom ash) are created. In municipal waste incinerators, bottom ash is approximately 10 % by volume and approximately 20 to 30 % by weight of the solid waste input. Fly ash quantities are much lower, generally only a few per cent of input. The proportions of solid residue vary greatly according to the waste type and detailed process design.

The Waste Incineration Directive sets the following requirements:

• Achieve a level of incineration such that the slag and bottom ashes Total Organic Carbon (TOC) content is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material

• The temperature reached in the incineration process, both for incineration and co-incineration plants, has to reach 850 °C for at least two seconds, for hazardous waste incineration with more than 1% of halogenated organic substances this has to be 1100 °C

• Prevent emissions into the air giving rise to significant ground-level air pollution; in particular, exhaust gases are discharged in a controlled fashion and in conformity with relevant Community air quality standards by means of a stack the height of which is calculated in such a way as to safeguard human health and the environment

• Air emission limit values are to be respected for incineration plants and co-incineration plants. Member States may set emission limit values for polycyclic aromatic hydrocarbons or other pollutants. For co-incineration a mixing rule is applied to take into account emissions from the waste incineration and emissions from the other fuels applied

• Limit values are set in the Waste Incineration Regulation for dust, HCl, HF, NOx, different heavy metals, dioxins and furans, SO2, TOC (gaseous and vaporous organic substances expressed as total organic carbon). However recital 13 of the Waste Incineration Regulation clarifies: ‘Compliance with the emission limit values


laid down by this Directive should be regarded as a necessary but not sufficient condition for compliance with the requirements of Directive 96/61/EC. Such compliance may involve more stringent emission limit values for the pollutants envisaged by this Directive, emission limit values for other substances and other media, and other appropriate conditions.’

• Water discharge limits from the cleaning of exhaust gases are to be respected

• Limit values are set for total suspended solids, different heavy metals, dioxins and furans. See remark above

• Residues (waste) resulting from the operation of the incineration or co-incineration plant are minimised in their amount and harmfulness. Residues are to be recycled, where appropriate, directly in the plant or outside in accordance with relevant Community legislation. Transport and intermediate storage of dry residues in the form of dust, such as boiler dust and dry residues from the treatment of combustion gases, takes place in such a way as to prevent dispersion in the environment e.g. in closed containers. Prior to determining the routes for the disposal or recycling of the residues from incineration and co-incineration plants, appropriate tests are carried out to establish the physical and chemical characteristics and the polluting potential of the different incineration residues. The analysis concerns the total soluble fraction and heavy metals soluble fraction

The Integrated Pollution Prevention and Control Reference Document on the Best Available Techniques for Waste Incineration (BREF waste incineration) of August 2006 sets the standards for BAT to be used when issuing permits to waste incinerators.

Waste treatment options for identified waste categories

Hereafter, the major waste treatment options are given for the identified waste categories. This will allow an identification of the potential environmental exposure pathways for each flame retardant of the disposal core set.

Plastic waste

Plastics are one of the major matrices for flame retardants. Plastic waste is generated either directly for the disposal of plastic products or as a secondary waste after treatment, sorting out, dismantling or recycling of other waste streams like cable, furniture, building and construction waste … Plastic containing waste from electrical and electronic equipment (WEEE) is subject to specific regulation and as such discussed separately (see 0).

Plastic waste streams seldomly reach the degree of purity to be recycled as a single polymer. The EUROSTAT statistics from the Waste Statistics Regulation are not able to present a distribution of the treatment of generated plastic waste over the general treatment options recycling, incineration or landfill. As such, other literature srouces were consulted to identify the disposal options for the plastic waste under consideration.

An overview of the specific disposal options by polymer is given in Annex 15. Technically for most plastics recycling methods are existing, either well established or in an experimental phase. Mechanical recycling or repolymerisation often leads to downcycling allowing for only one or a limited number of loops, leading to final disposal at the end.


Because the waste in a post-consumer phase is often mixed up with other wastes or components, separation is not always feasible and homogeneous waste fractions can not always be achieved. Plastics are high calorific and therefore energy recovery through incineration is often applied. Plastics which can be recycled through simple techniques of extrusion are often shipped to non-OECD countries. Landfilling remains for most plastics a waste treatment option that is frequently applied. All flame retardants under consideration can be found in the input streams for recycling operations (sometimes substandard techniques applied in non-OECD countries), for incineration and for landfilling.

Waste from electrical and electronic equipment (WEEE)

Waste from electrical or electronic equipment is a very complex waste stream containing a large and differentiated set of possible contaminants. The WEEE directive discerns ten classes of WEEE: large household appliances, small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools (with the exception of large-scale stationary industrial tools), toys, leisure and sports equipment, medical devices (with the exception of all implanted and infected products), monitoring and control instruments and automatic dispensers.

According to the WEEE Directive, treatment of WEEE shall, as a minimum, include the removal of all fluids. Besides, all contaminants have to be removed and recycled from any separately collected WEEE fraction. The Directive provides in its article 6.1 and Annex II a list of 15 parts that have to be separated, among which plastic containing brominated flame retardants, but also other parts that may contain flame retardants like printed circuit boards or electric cables of E&E. These separate waste streams are then either recycled, landfilled or incinerated.

After removal of hazardous components, treatment of WEEE generally includes (manual) disassembly and separation of materials. Different separated fractions, such as plastics, polyurethane foam, metals, oil and other are nearly all recycled according to the proper treatment method.

WEEE is often exported to non-OECD countries, both legally and illegally, for manual disassembly and recovery of the more valuable parts, discarding the other. Work conditions and environmental conditions can be very variable.

Electrical and electronic equipment is also often exported as, often low grade, second hand good to third world countries before it enters the waste phase. The capacity to treat the hazardous waste generated after disposal of the good is often limited or lacking in several countries of destination.

Unfortunately no reliable statistics from the Waste statistics Regulation or from the trade statistics are available on the amount of generated and disposed WEEE, nor of E&E exported as second hand good. WEEE, containing flame retardants, ends up as:

• Dismantled and the separate fractions (metals, plastics, pollutants…) recycled or disposed of by incineration or landfill

• Exported (legally or illegally) for recycling in non-OECD countries

• Exported as second hand good to non-OECD countries

Landfilling of non-depolluted WEEE, even on landfills for hazardous waste, is prohibited based on Council Decision of 19 December 2002 establishing criteria and procedures for


the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive1999/31/EC.

Cable and wire scrap

Cable scrap is a frequently occurring waste stream. It originates as a sorted out fraction of construction and demolition waste, sorted out metal waste, or from the deconstruction of electric and electronic equipment, etc…

Cable consists of three major components: conductors, insulation and protective jacket. The insulation and jacket coating of the cables often is composed of PVC, cross linked polyethylene or elastomers. It contains a wide range of stabilizers, pigments and flame retardants.

The steps of a typical treatment chain are collection, sorting shredding separation of the recyclable parts from the residue and eventually recycling (metals and sometimes plastic covering).

Cable scrap does not end up on landfills, because of the intrinsic economic value of its metal content. Cable insulation and coating, and its flame retardant content, end up at:

• Incineration plants complying with EU legal provisions

• Sub standard burning or incineration activities, frequently outside Europe

• Depending on the quality and the purity of the plastic fraction, plastic recycling

Building and construction waste

Building and construction waste accounts for approximately 25% of all wastes generated, among which wastes from activities such as construction, total or partial demolition of buildings and other civil engineering activities, road planning and maintenance. Among them, numerous materials can be found including concrete, bricks, gypsum, wood, glass, metal, plastic, solvents, asbestos and excavated soil59.

The levels of recycling and re-use vary greatly from one Member State to another. Some dispose their construction and demolition waste in a large extent in landfills, without removing the amount of hazardous wastes, while others manage to achieve 90% recycling rates.

Flame retardants in construction and demolition waste end up both in the inert or mineral fraction (as residue of paints, coatings, fittings, PUR foam residues etc…) and in the non mineral fractions that can be sorted out from the waste stream (as insulation, PVC and other plastics, cable, roofing etc…)

• According to the data collected under the Waste Statistics Regulation 2150/2002/EC, mineral wastes are treated in 2006 in EU-27 as follows: 45% recycling, mainly to secondary raw materials used in construction again, and 55% landfilling, often in landfills for inert waste. For EU-15 the figures are 55% recycling and 45% landfilling.

59 Service Contract on Management of Construction and Demolition Waste, Framework contract ENV.G.4/FRA/2008/0112, European Commission, DG Environment – in preparation


• Mixed wastes, among which the mixed non inert fraction of building and construction waste, are not or ample recycled, 25% of it (in general) is incinerated with or without energy recovery and 75% of the mixed fractions is still landfilled in EU-27.

• Sorted out fractions, like plastics, glass, metals…. have each their own treatment distribution. They are often characterised with higher figures for recycling or incineration with energy recovery.

• Building and construction waste is treated within the EU, and is seldom exported.

Flooring waste

Carpet, as the major floor covering envisaged in this project, is made from two major components: the fibre which forms the surface and a backcoating which holds the fibres together. A wide range of natural and synthetic materials can be used in both components. The surface fibre can be wool, nylon, polypropylene, polyester, sisal or jute, amongst others. The principal backcoating components include polypropylene, jute, rubber latex, glass fibre, PVC or bitumen. Carpets and other textile based floor coverings contain flame retardants, either in the textile phase or in the backcoating.

Carpet waste continues to end up in landfill or in incineration plants because it is a complex and often polluted waste in the post-consume phase, which is difficult and expensive to recycle. In 2009 in the UK a total of 583,000 tonnes of flooring material is disposed of every year, of which probably less than 1% is thought to be recycled, a little goes to incineration but the vast majority, perhaps 90%, goes to landfill60.

60 Flooring, towards a Resource Efficiency Plan, A Scoping Study - Pete Thomas Environmental for the Construction Products Association, UK, 2009


Figure 12-1 : Landfilling of flooring waste in the UK

At a European level the balance between landfill and incineration may be better for some EU-15 Member States and worse for some EU-12 Member States. Recycling however remains rather modest.

Furniture waste

The UK furniture market61, as representative for the EU market, shows that upholstered furniture forms the largest fraction of furniture groups. Flame retardants can mainly be found in upholstered furniture and in bedding. They are applied in upholstering textiles, textile coating agents, fillings and adhesives.

Furniture is either disposed of directly, as bulky waste which is landfilled or incinerated, or it is dismantled in its different composing elements (wood, metals, textiles, glass etc…) for possible further recycling. Reuse and refurbishment of furniture is increasing but remains less important.

Paints, coatings, sealants and adhesives waste

Flame retardant containing paints, coatings, sealants and adhesives in a post-consumer phase are found as a pollutant on wood, metals or other articles which are often mixed up with building and construction waste or other waste streams:

For building and construction waste, see 0

For wood waste, 40.5 % of the reported quantity of generated wood waste in EU-27 is recycled. The rest is either landfilled or incinerated. Wood waste landfilling is discouraged by the targets on landfilling biodegradable waste as included in the Landfill Directive. Although at EU level no strict ban on landfilling wood waste exists, several Member States have introduced bans or limitations for this kind of biodegradable, recyclable and highly calorific waste.

Although waste from paints, coatings, sealants and adhesives is reported in separate fractions, the waste treatment statistics are not available on that level of detail. Within the Waste Statistics Directive, statistics on waste from paints, coatings, sealants and adhesives are included in the statistics for the large category of Chemical wastes (Chemical compound waste + Chemical preparation wastes + Other chemical wastes). The amount of recycling cannot directly be retrieved from the EUROSTAT waste statistics. Incineration with or without energy recovery and landfilling are both covering about 50% of the waste incineration and disposal operations. However, this is usually pre-consumer waste and therefore out-of-scope of this exercise.

Textile waste

According to the EUROSTAT statistics from the Waste Statistics Regulation, about 33% of all reported generated textile waste is recycled. It is strange to observe that 67% of the

61 The waste guide on www.wasteonline.org.uk

http://www.wasteonline.org.uk/


reported textile waste would therefore be landfilled or incinerated, since it is reported as textile waste and therefore presumably separated from other waste fractions.

Landfill of textiles is expected to decrease because textile waste is considered as a biodegradable waste for which the landfill diversion targets from the landfill Directive are applicable. Furthermore, a large fraction of textile waste will be reused, or exported as second hand before it enters the waste phase.


Annex 15: Disposal options per polymer

Acrylic resin can be recycled in few applications. It can be applied as filler material in a limited set of applications, or as a component in composite plastic scrap recycling. It will partially end up in landfills and incinerators62.

ABS can be regranulated by shredding, washing and drying and applied to produce high grade ABS. As virgin ABS is somewhat expensive, recycling ABS is economically very attractive. Recycled ABS can be blended with virgin material to produce products with lower cost while preserving the high quality. However, ABS can also end up in incineration and landfill

Butylic sealant if sorted out, often has the same waste treatment properties of other butyl products like tyres. Export for recycling in Asian countries often takes place. Butyl reclaim is used in tape, sealants and adhesives63. Butylic sealant can end up in incineration and landfill

EDPM is fit for physical recycling (reclaiming, grinding and surface activation), recovery of base chemicals (pyrolysis, gasification and hydrogenation) and incineration with energy recycling64

Epoxy resin (electronic compounds) recycling has been difficult because the epoxy resin cannot be remelted for curing in the moulding process. Most of the waste is therefore disposed of at landfills or incinerated65

Polystyrene: Expandable polystyrene (EPS), Extruded polystyrene foam (XPS) and High impact polystyrene (HIPS) and its alloys can be reprocessed to make hardwood replacement for garden furniture, slate replacement for roofing tiles and new plastics items such as coat hangers, CD and video cases. It is also appreciated as a high calorific waste stream for incineration. The process consists of compaction, collection, granulation, blending and extrusion.66 Because of this low tech approach the waste is frequently exported to non OECD countries for recycling.

Polyphenyl ether (PPE) is often combined or blended with polystyrene and has a similar waste treatment trajectory

Polycarbonate: if clean and homogeneous PC waste can be recycled into new PC applications by granulation, drying, extruding, pelletizing and moulding. Tests have shown that two flame retardants maintain their effectiveness, but that the strength of the material suffers upon recycling67. Other recycling techniques include chemical recycling. The process of PC recycling is a developed process, but has not finished evolving. Polycarbonate can be recycled but will partially end up in landfills and incinerators

Polyethylene: High density polyethylene and Polyethylene terephthalate (PET) are considered easy to recycle plastics. PET can be recycled into new PET applications,

62 http://www.wealthywaste.com/acrylic-scrap-recycle Dr. Yashpal Singh, 11 August, 2010 63 http://www.usrubberreclaiming.com 64 Development of a continuous process for EPDM devulcanization in an extruder (2006) Sutanto, Poppy – rijksuniversiteit Groningen 65 Recycling of epoxy resin compounds for moulding electronic components, MASATOSHI Iji in Journal of materials Science, vol. 33 66 http://www.epsrecycling.org 67 Flame Retardancy of Polycarbonate upon Repeated Recycling, David Statler JR, Evan Stajduhar, Rakesh K. Gupta, Department of Chemical Engineering, West Virginia University, Journal of Fire Sciences July 2008

http://www.wealthywaste.com/acrylic-scrap-recycle

http://www.usrubberreclaiming.com/


although PET recycling is a complex process because of chemical and mechanical degradation during reprocessing that affect mechanical properties of the recycled products. Other polyethylene and polyolefins are often downcycled. PE and PET are the plastics best received by recycling or collection centers and may therefore best be deviated from landfill or incineration

Polypropylene (PP) shares a lot of characteristics with hard polyethylene. New items that are made from PP include lower quality products like traffic cones, compost bins, worm farms, garden furniture, garden edging and other plastic products. PP is often exported for recycling or ends up in incineration plants or landfills

Phenolic resins: recycling of phenolic resins is difficult, since the waste cannot be remelted. Techniques for chemical recycling are emerging,68 but the main waste treatment option remains incineration or landfill

Polyamide: once it has been separated from its backcoating materials, PA 6 is relatively easy to depolymerise. This produces fresh caprolactam that can be used to manufacture PA 6 with no loss in quality, and so is suitable for further recycling. DuPont has developed a comparable technique for PA 6.6.69 Polyamid recycling has the potential to achieve genuine closed loop recycling, but this is not achieved until now. It is often disposed of with the other constituents of waste carpet

Polybutylene terephthalate (PBT) can be depolymerised with ethylene glycol to generate basic raw material equal in quality to material obtained from petroleum. PBT is sometimes exported to Asia for recycling.70

Polyurethane and other polyether waste can be recycled in the petrochemical industry or reused as a filling material in several applications. However, landfilling is the most used waste treatment method so far71. Incineration or pyrolysis with energy generation is considered a valuable alternative to landfilling and is increasingly getting popularity

Silicone: silicone sealants can be recycled by chemical depolymerisation or by grinding vulcanized rubber. The resultant powder is used as a compounding ingredient or as a replacement of raw polymer. No extended collection systems for post-consumer silicone have been set up, which limits recycling largely to pre-consumer wastes. Post-consumer waste often ends up at landfills or in incineration plants

Polyvinylchloride (PVC): PVC- or Vinyl Recycling has historically been difficult to perfect on the industrial scale. Recycling or upcycling post-consumer PVC plastic is developed in the process Vinyloop by Solvay. PVC however ends up in incineration plants and landfills as well. Recycling is complicated due to the large and in a post-consumption phase often unknown amount of additives

68 A Study on Material Recycling for Phenolic Resin Products, Tanaka Hisashi, Fukimoto Yutaka, Suehiro Kazuaki, Saga Univ., Fac. of Sci. and Eng. Journal of Network Polymer, Japan 69 http://www.greener-industry.org.uk/pages/nylon/8nylonPM3.htm 70 http://www.heathland.nl/pbt-recycling.html 71 http://www.plastemart.com/upload/Literature/PUrecycling.asp


Annex 16: Literature disposal phase: summary

A summary of the available literature on disposal phase is given in the Excel file ‘Annex 16’, which can be found on the CD-rom.


Annex 17: Data gaps environmental relevance

For several substances and applications, there was not enough data to decide whether or not the application belongs to the environmental core set. An overview of these data gaps is given in the Excel file ‘Annex 17’, which can be found on the CD-rom.


Annex 18: Inherent properties of substances on ‘inconclusive’ list

Human health Legend: ● : identified potential hazard ○ : no identified potential hazard – : no data available ?: inconclusive ( ): tentative assessment from non standard test results

Flame retardant CAS number Acute toxicity/irritation Sensitisation skin/respiratory

C M R

Triphenyl phosphate 115-86-6 ○/○ ○/- - ○ ○

Tris (2-chloroethyl)phosphate 115-96-8 ● /○ ○/- ● Cat 3 ○ ● Cat 2

Decabromodiphenyl ether 1163-19-5 ○/○ ○/- ○ ○ ○

2-ethylhexyl diphenyl phosphate 1241-94-7 ○/○ ○/- (○) ○ ○

Magnesium hydroxide 1309-42-8, 13760-51-5

○/(●) potential skin and eye irritant

○/○ (○) read-across (○) read-across (○) read-across

Boehmite (aluminium hydroxideoxide) 1318-23-6 ○/○ ○/○ - - -

Aluminium hydroxide 1318-23-7/ 21645-51-2

○/○ ○/○ ○ ○ ○

Tricresyl phosphate 1330-78-5 ● /○ ● /- ○ ○ ● male fertility ○ developmental

Tris (2-chloroisopropyl)phosphate 13674-84-5 ● /○ ○/- (●) read-across ○ ●

Tris (1,3-dichloroisopropyl)phosphate 13674-87-8 ○/○ ○/- ● Cat 3 ○ ○male fertility ○ developmental - female fertility

Bisphenol A-bis(diphenylphosphate) 181028-79-5 5945-33-5

○/○ ○/- - ○ -

Dimethyl propane phosphonate 18755-43-6 -/- -/- - - -

Tris(tribromoneopentyl)phosphate 19186-97-1 ○/- -/- - ○ (in vitro)/ - (in vivo)

-



C M R

Tetrabromobisphenol A bis(2,3-dibromopropylether) 21850-44-2 ○/● mild eye irritant ○/- (○) NTP study ongoing

(○) weight of evidence

(○) fertility (NTP study ongoing) - developmental

Diethylphosphinate, aluminium salt 225789-38-8 ○/● slight eye irritant ○/- - ○ (in vitro)/ - (in vivo)

-

Trixylyl phosphate 25155-23-1 ○/○ -/- - ○ (in vitro)/ - (in vivo)

● Cat 2 fertility - developmental

Hexabromocyclodecane 25637-99-4 ○/○ ○/- (○) ○ ● Cat 3 fertility - developmental

Tris(2,4,6 tribromophenoxy)triazine 25713-60-4 ○/- -/- - ○ (in vitro)/ - (in vivo)

-

Cresyl diphenyl phosphate 26444-49-5 (○)/● mild eye irritant -/- - ○ ○

Tris-(isopropylphenyl)phosphate 26967-76-0, 68937-41-7

○/○ ? eye irritation

○/- - (○) -

Isopropylphenyl diphenyl phosphate 28108-99-8 ○/○ ? eye irritation

○/- - (○) -

Bis-(isopropylphenyl) phenylphosphate 28109-00-4 -/- -/- - - -

Isodecyl diphenyl phosphate 29761-21-5 ○/(○) ○/- - (○) in-vitro - in-vivo

- fertility (○) developmental

Ethylene bis(tetrabromophtalimide) 32588-76-4 ○/○skin irritation, ? eye irritation

-/- - ○ in-vitro (bacteria) /- clastogenicity - in vivo

○

1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 ○/○ ○/- - ○ in-vitro (bacteria) /- clastogenicity - in vivo

○

Bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

38051-10-4 ○/○ ○/(○) (respiratory sensitisation)

- ○ ○

Melamine phosphate 41583-09-9, 20208-95-1

○/○ ○/- (○) read-across (○) read-across (○) read-across

Guanidine phosphate 5423-23-4 ●/● ○/○ - - -



C M R

Isodecylphosphate 56572-86-2 -/- -/- - - -

Tert-butylphenyl)phenylphosphate 56803-37-3 ○/● mild eye and skin irritant

-/- - ○ (in vitro)/ - (in vivo)

○

Resorcinol bis-diphenylphosphate 57583-54-7, 125997-21-9

○/○ (? eye irritant) -/- - (○) weight of evidence

○

Bis-(tert-butylphenyl)phenylphosphate 65652-41-7 (○)/(●) mild eye and skin irritant Read-across

-/- - ○ (in vitro)/-(in vivo) Read-across

-

Hypophosphite, aluminium salt 7784-22-7 -/- -/- - - -

Hypophosphite, calcium salt 7789-79-9 -/- -/- - - -

Tris-(tert-butylphenyl)phosphate 78-33-1/ 28777-70-2

(○)/(●) mild eye and skin irritant Read-across

-/- - ○ (in vitro)/-(in vivo) Read-across

-

Diethyl ethylphosphonate 78-38-6 ○ (oral)/- -/- - ○ AMES/ - in-vivo

-

Triethyl phosphate 78-40-0 ● (oral)/ ○ ○/- - ○ ○

Tetrabromobisphenol-A (TBBP-A) 79-94-7 ○/○ ○/○ - ○ in-vitro/ - in-vivo

○

Decabromodiphenylethane (DBDPE) 84852-53-9 ○/○ (? skin irritant) ○/○ - ○ in-vitro/ - in-vivo

○

Short chain chloroparaffins (SCCP) 85535-84-8 ○/○ ○/(○) respiratory sensitisation

(○) ○ (○)

Medium chain chloroparaffins (MCCP) 85535-85-9 ○/○ ○/- (○) (○) ○


Environment

Legend:

● : identified potential hazard

○ : no identified potential hazard

– : no data available

?: inconclusive

NA: not applicable

Environment

Substance CAS Persistence Bioaccumulation Acute aquatic toxicity

Chronic aquatic toxicity

Bromine

Tris(tribromoneopentyl)phosphate 19186-97-1 ● ● ? -

Bis-(2-ethylhexyl)tetrabromophthalate 26040-51-7 - ● ● Very toxic -

Ethylene bis(tetrabromophtalimide) 32588-76-4 ● ● ● Very toxic -

1,2-bis(2,4,6-tribromophenoxy)ethane 37853-59-1 ● ● ● Harmful -

Inorganic

Magnesium hydroxide 1309-42-8, 13760-51-5

NA - - -

Boehmite (aluminium hydroxideoxide) 1318-23-6 NA - - -

Aluminium hydroxide 21645-51-2 NA - ○ -

Phosphorus

Bisphenol A-bis(diphenylphosphate) 181028-79-5 - ● ● Toxic or harmful

NOEC 21d fish > 1 mg/L

Dimethyl propane phosphonate 18755-43-6 ● ○ - -

Trixylyl phosphate 25155-23-1 ● ○ ● Toxic NOEC 21d invertebrates= 0.007 mg/L

Tris-(isopropylphenyl)phosphate 26967-76-0 ● ● ● Toxic ● Toxic

Isopropylphenyl diphenyl phosphate 28108-99-8 ○ ○ ○ ○

Bis-(isopropylphenyl) phenylphosphate

28109-00-4 - - -

Tris-(tert-butylphenyl)phosphate 28777-70-0 - - -

Guanidine phosphate 5423-23-4 - - - -

Isodecylphosphate 56572-86-2 - - -

Bis-(tert-butylphenyl)phenylphosphate 65652-41-7 - - -


Environment

Substance CAS Persistence Bioaccumulation Acute aquatic toxicity

Chronic aquatic toxicity

Hypophosphite, aluminium salt 7784-22-7 - - -

Resorcinol bis-diphenylphosphate 57583-54-7 ● ○ ○ ○

Tricresyl phosphate

Hypophosphite, calcium salt 7789-79-9 - - -

Nitrogen

Melamine phosphate 415836-09-9, 20208-95-1

- ● Toxic -


1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006Austria - 67 - 57 - - - 58 - 63 - - 61 55 55 225 55 40 445 50 45 - Belgium - - - - - - - - - - - - - - - - - - - - - - Bulgaria - - - - - - - - - - - - - - - - - - - - - - Cyprus - - - - - - - - - - - - - - - - - - - - - - Czech Republic - - - - - - - - - - - - - 100 110 105 105 115 150 130 145 150Denmark - 80 - 83 - - - 85 - 88 - - 85 79 80 85 75 75 90 85 85 70Estonia - - - - - - - - - - - - - - - - - - - - - - Finland - 130 - 113 - - - 110 - 125 - - 102 91 105 95 85 95 105 110 85 100France - 859 - 715 - - - 681 - 657 - - 594 580 575 555 550 - 645 585 660 620Germany - - - - - - - - - - - - - 650 630 590 600 - 545 560 605 510Greece - - - - - - - - - - - - - 145 120 190 190 145 150 145 140 100Hungary - - - - - - - - - - - - - 205 190 200 235 195 210 195 195 - Ireland - - - - - - - - - - - - - 61 85 60 70 60 40 40 50 35Italy - - - - - - - - - - - - - 435 420 410 355 - 270 - - 280Latvia - - - - - - - - - - - - - - - - - - - - - - Lithuania - - - - - - - - - - - - - - - - - - - - - - Luxembourg - - - - - - - - - - - - - - - - - - - - - - Malta - - - - - - - - - - - - - - - - - - - - - - Netherlands - 77 - 99 - - - 96 - 92 - - 100 - - - - - - - 70 85Poland - - - - - - - - - - - - - 505 560 515 510 455 525 485 590 605Portugal - - - - - - - - - - - - - - - - - - - - - - Romania - - - - - - - - - - - - - - - - - - - - - - Slovakia - - - - - - - - - - - - - - - - - - - - - - Slovenia - - - - - - - - - - - - - 22 15 15 20 20 25 20 20 - Spain - - - - - - - - - - - - - 250 275 260 260 230 280 275 280 - Sweden - 116 - 148 - - - 117 - 115 - - 145 180 115 110 145 145 140 70 110 90United Kingdom - 1219 - 1002 - - - 858 - 787 - - 729 690 580 645 635 590 625 535 515 515

Annex 19: Overview WFSC statistics on fire deaths


1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006Austria 60 70 60 43 75 54 59 153 58 39 45 - 45 33Belgium 140 - - - - - - - - - - - - - Bulgaria 110 101 109 93 92 95 96 100 98 97 - - 102 96Cyprus - - - - - - - - - - - - - - Czech Republic 104 107 109 118 135 96 105 100 99 109 100 - - -Denmark 70 84 95 105 75 79 84 84 74 79 - - 87 69Estonia 135 168 208 170 116 170 125 147 169 131 142 - 134 164Finland 108 99 87 85 69 54 105 53 - - - - - 119France 725 610 585 645 530 580 575 - - 823 500 - - 341Germany 701 596 614 620 585 522 529 518 488 - 475 - 498 424Greece 28 76 56 54 60 70 59 62 - - 40 - - - Hungary 365 335 300 290 177 205 145 135 149 136 - - 153 131Ireland 51 42 38 52 51 45 51 43 - - 38 - 41 -Italy - - 455 425 475 435 420 410 - - - - 41 112Latvia - - - 207 188 204 264 240 236 268 261 - 236 235Lithuania 149 254 320 272 227 238 202 207 244 236 255 - 295 307Luxembourg - - - - - - - 4 - - - - - - Malta - - - - - - - - - - - - - - Netherlands 84 93 82 125 67 76 73 62 - - - - - 80Poland 493 535 544 525 600 550 560 515 - 484 515 - 515 - Portugal - - 43 58 - - - - - - - - - - Romania 251 250 303 270 243 194 224 152 - 222 - - 209 - Slovakia 49 38 59 - 67 - 49 - - - 54 - - 49Slovenia - 10 30 27 30 22 17 39 - - - - - -Spain - 310 210 240 260 250 275 260 - - - - - -Sweden 107 120 105 108 117 179 71 106 - 137 135 - 105 83United Kingdom 700 641 736 709 723 656 623 595 606 578 593 - 485 504

Annex 20: Overview CTIF statistics on fire deaths


Annex 21: Overview WHO statistics on domestic fire deaths

Country Category 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008Exposure to uncontrolled fire in building or structure 18 25 34 29 16 16 23Exposure to controlled fire in building or structure 2 1 2 2 1 1Exposure to ignition or melting of nightwear 1Exposure to ignition or melting of other clothing and apparel 1 2 2 2 1 1Total - - - - - - - - 21 28 38 34 18 16 25Exposure to uncontrolled fire in building or structure 52 46 58Exposure to controlled fire in building or structure 2 2 2Exposure to ignition or melting of nightwear 2Exposure to ignition or melting of other clothing and apparel 2 3Total - - - - 58 51 - - - - 60 - - - -Exposure to uncontrolled fire in building or structure 30 14Exposure to controlled fire in building or structure 4 30Exposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparel 1 1Total - - - - - - - - - - - 35 45 - -Exposure to uncontrolled fire in building or structure Exposure to controlled fire in building or structureExposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparelTotal - - - - - - - - - - - - - - -Exposure to uncontrolled fire in building or structure 2 4 1 2 3 1 6 5 5 6 7 5 5Exposure to controlled fire in building or structure 2 1 1 3 1 3 1 1Exposure to ignition or melting of nightwear 2 1 1 1 1Exposure to ignition or melting of other clothing and apparel 3 1 1 3 1 4 1 1 2 2 1Total 5 2 6 1 2 7 4 10 10 7 8 13 8 8 -Exposure to uncontrolled fire in building or structure 26 25 16 12 12 10 14 6Exposure to controlled fire in building or structure 1 3 5 2 2 4 5 5 3 3 1 4Exposure to ignition or melting of nightwear 5 1 1 4 1 4 4 4 1 2 3Exposure to ignition or melting of other clothing and apparel 8 15 5 6 5 6 8 6 6 6 5 1Total 14 45 36 28 19 23 27 29 19 9 7 6 4 - -Exposure to uncontrolled fire in building or structure 138 166 132 138 121 116 123 120 120Exposure to controlled fire in building or structure 1 1 1 1 1Exposure to ignition or melting of nightwear 1 1Exposure to ignition or melting of other clothing and apparel 11 9 7 6 4 8 3 6 7Total - - - 149 177 140 145 126 124 127 127 127 - - -Exposure to uncontrolled fire in building or structure Exposure to controlled fire in building or structure 1 2 1 1 2 1Exposure to ignition or melting of nightwear 1 1 1 1 1Exposure to ignition or melting of other clothing and apparel 7 8 6 6 1 6 2 6 5 4 5Total - - 9 10 7 7 1 7 - 4 7 6 4 7 -Exposure to uncontrolled fire in building or structure 168 171 100 114 82 109 136 120Exposure to controlled fire in building or structure 14 9 6 11 4 10 3 4Exposure to ignition or melting of nightwear 3Exposure to ignition or melting of other clothing and apparel 8 4 1 3 2 2Total - - - - - - 190 184 107 125 89 122 141 126 -

Denmark

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Estonia

Finland

France

17.020200/09/549040-Evaluation of data on flame retardants in consumer products – Final report - 384|402 Country Category 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Exposure to uncontrolled fire in building or structure 206 216 224 249 267 236 227 258 201Exposure to controlled fire in building or structure 13 8 6 11 10 10 18 6 12Exposure to ignition or melting of nightwear 6 3 4 2 6 2 3 2 1Exposure to ignition or melting of other clothing and apparel 10 12 12 7 8 17 8 8 7Total - - - - 235 239 246 269 291 265 256 274 221 - -Exposure to uncontrolled fire in building or structure Exposure to controlled fire in building or structureExposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparelTotal - - - - - - - - - - - - - - -Exposure to uncontrolled fire in building or structure 16 23 18 24 26 24 21 28 34 63 21Exposure to controlled fire in building or structure 39 47 34 20 26 42 21 27 22 7 1Exposure to ignition or melting of nightwear 22 16 16 13 10 17 15 8 10 5Exposure to ignition or melting of other clothing and apparel 37 34 20 29 19 35 31 29 28 25 2Total - - 114 120 88 86 81 118 88 92 94 100 - 24 -Exposure to uncontrolled fire in building or structure Exposure to controlled fire in building or structureExposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparelTotal - - - - - - - - - - - - - - -Exposure to uncontrolled fire in building or structure 37 10Exposure to controlled fire in building or structure 23 19Exposure to ignition or melting of nightwear 6 4Exposure to ignition or melting of other clothing and apparel 8 5Total - - - - - - - - - 74 - - 38 - -Exposure to uncontrolled fire in building or structure 124 101 138 176 169 157 201 179 149 167 181 155Exposure to controlled fire in building or structure 34 5 22 31 4 1 4 1 1 1Exposure to ignition or melting of nightwear 2 1 17Exposure to ignition or melting of other clothing and apparel 4 5 2 5 6 5 6 5 6Total - - 162 113 162 207 178 164 219 183 155 173 187 162 -Exposure to uncontrolled fire in building or structure 112 76 95 106 94 75 74 109 98 59Exposure to controlled fire in building or structure 8 3 8 7 3 10 3 5 5 2Exposure to ignition or melting of nightwear 5 2 3 1 4 4 5 1Exposure to ignition or melting of other clothing and apparel 5 7 9 3 6 1 13 4 13 3Total - - - - 130 88 112 119 103 87 94 122 121 65 -Exposure to uncontrolled fire in building or structure 6 3 1 1 2 1Exposure to controlled fire in building or structureExposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparelTotal - - - - - - 6 3 - 1 1 2 1 - -Exposure to uncontrolled fire in building or structure 1 1Exposure to controlled fire in building or structure 1 2 2Exposure to ignition or melting of nightwear 1Exposure to ignition or melting of other clothing and apparel 1Total - - 2 1 - - - - - 2 - 1 - 3 -Exposure to uncontrolled fire in building or structure 6 18 31 29 32 36 22 26 22 31 40 22Exposure to controlled fire in building or structure 19 4 4 8 1 3 2Exposure to ignition or melting of nightwear 2 1 3 2 1 3Exposure to ignition or melting of other clothing and apparel 4 1 6 3 4 4 6 2 1 7 1Total - - 31 24 44 42 38 40 31 28 23 41 43 22 -

Malta

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Netherlands


Country Category 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008Exposure to uncontrolled fire in building or structure 180 147 171 179 201 168 244 271 348Exposure to controlled fire in building or structure 8 20 11 15 14 13 14 13 16Exposure to ignition or melting of nightwear 6 6 5 1 3 2 2 1 2Exposure to ignition or melting of other clothing and apparel 9 10 18 13 16 10 29 25 19Total - - - - - 203 183 205 208 234 193 289 310 385 -Exposure to uncontrolled fire in building or structure 3Exposure to controlled fire in building or structure 12 20Exposure to ignition or melting of nightwear Exposure to ignition or melting of other clothing and apparel 1Total - - - - - - - - 16 20 - - - - -Exposure to uncontrolled fire in building or structure 12 2 10 22 17 4 17 18 7 4Exposure to controlled fire in building or structure 59 40 46 39 32 24 19 29 33 25Exposure to ignition or melting of nightwear 2 2 1 2 1 2Exposure to ignition or melting of other clothing and apparel 1 1 2 1Total - - - - - 73 45 57 64 51 28 37 47 42 30Exposure to uncontrolled fire in building or structure 6 9 15 7 15 12 20 9 24 6 14 19Exposure to controlled fire in building or structure 1 3 4 1 3 1 1 1 1Exposure to ignition or melting of nightwear 1 1 2 1 1Exposure to ignition or melting of other clothing and apparel 6 1 2 2 4 2 2 2 2 2 1Total 14 13 22 10 24 16 24 9 26 9 16 21 - - -Exposure to uncontrolled fire in building or structure 4 3 4 1 10 5 6 4 2 2 5Exposure to controlled fire in building or structure 1 2 1Exposure to ignition or melting of nightwear 1Exposure to ignition or melting of other clothing and apparel 1 1Total - - - 5 3 4 4 10 5 6 4 3 2 7 -Exposure to uncontrolled fire in building or structure 9 20 27 27 44 60 56Exposure to controlled fire in building or structure 17 8 10 14 9 11 5Exposure to ignition or melting of nightwear 1 5 4 2 1 2 3Exposure to ignition or melting of other clothing and apparel 2 3 4 6Total - - - - - 29 36 45 43 54 79 64 - - -Exposure to uncontrolled fire in building or structure 78 123Exposure to controlled fire in building or structure 3 2 1 1 1 1Exposure to ignition or melting of nightwear 1 1 1 1 1 1 1Exposure to ignition or melting of other clothing and apparel 8 4 6 2 3 6 5 3 5 7Total - - - 87 128 9 5 4 7 7 4 6 9 - -Exposure to uncontrolled fire in building or structure 291 315 297 292 239 255 198Exposure to controlled fire in building or structure 8 11 10 6 6 10 4Exposure to ignition or melting of nightwear 8 7 4 5 1 3 6Exposure to ignition or melting of other clothing and apparel 19 21 18 17 12 10 17Total - - - - - - - 326 354 329 320 258 278 225 -

Spain

Sweden

United Kingdom

Poland

Portugal

Romania

Slovakia

Slovenia


Annex 22: Questionnaire about fire statistics (example of Austria)

Dear Madam/Sir, We kindly request your cooperation. The European Commission, DG Health and Consumers, has commissioned ARCADIS Belgium to carry out the study 'Identification and evaluation of data on flame retardants in consumer products'. In order to be able to assess the benefits associated with the use of flame retardants in consumer products we kindly ask you to document the number of deaths from domestic fires for you country. Guidance for completing and returning the questionnaire: 1. Go to the data sheet for your country. 2. Complete the number of deaths from domestic fires for as many years as possible (preferably from 1985 to 2009). Statistical data from international organisations on the number of deaths from (domestic) fires have already been added for your information. 3. Add the source of the data in the column 'Remarks', if necessary, add any other remarks to the data provided by you. This can be specific assumptions, e.g. certain deaths that are (not) included, data are referring to deaths and injured, data do not solely refer to domestic fires, etc. 4. Return the completed questionnaire by April, 9th, 2010 to:

Arcadis Belgium Kortrijkseseteenweg 302, B-9000 Gent Fax. +32 (0)9 242 44 45

In case you have any questions concerning the questionnaire please to not hesitate to contact Arcadis Belgium.


WFSC1 CTIF2 WHO3 Domestic fire deaths Remarks1985 - - - 1986 67 - - 1987 - - - 1988 57 - - 1989 - - - 1990 - - - 1991 - - - 1992 58 - - 1993 - 60 - 1994 63 70 - 1995 - 60 - 1996 - 43 - 1997 61 75 - 1998 55 54 - 1999 55 59 - 2000 225 153 - 2001 55 58 - 2002 40 39 212003 445 45 282004 50 - 382005 45 45 342006 - 33 182007 - - 162008 - - 252009 - - -

1 World Fire Statistics Centre; total number of fire deaths2 Centre of Fire Statistics; total number of fire deaths3 World Health Organisation; total number of domestic fire deaths (including deaths by the exposure to ignition or melting of clothing a


Annex 23: Overview contacts questionnaire about fire statistics + response rate

Yes / No Quality Questionnaire send Contact by telephone Reminders by mailAustria Austrian Federal Fire Brigade Federation Markus Ebner No - 10 March 2010 Yes 2Belgium Federal documentation service of civil safety Johan Laekeman and Druyts Sebastiaa No - 10 March 2010 Yes 2Bulgaria Civil Protection National ServiceCyprus Cyprus Fire Service A. Kortas Yes Insufficient information 7 April 2010 No 1Czech Republic Fire and Rescue Service of the Czech Republic Vladimír Vonásek Yes Information 19 March 2010 Yes 1Denmark Danisch Emergency Management Agency Berit Lumbye Siemer Yes Information 10 March 2010 Yes 1Estonia FEU - Estonian Rescue Service Margo Klaos Yes Information 7 April 2010 No 1Finland Emergency Services College Esa Kokki Yes Information 10 March 2010 Yes 0France Bureau de la réglementation incendie et des risques de la vie courante Jean-Pierre Petiteau No - 10 March 2010 Yes 2Germany Deutscher Feuerwehrverband e.V. Silvia Darmstädter Yes Information 10 March 2010 Yes 0Greece FEU Tassos Pappas No - 7 April 2010 No 1Hungary FEU - Fire brigade of the city of Keszthely Károly Laczikó Yes Information 7 April 2010 No 0Ireland National Directorate for Fire and Emergency Management Peter Greene Yes Information 18 March 2010 Yes 3

Dipartimento dei Vigili del Fuoco, del Soccorso Pubblico e della Difesa CivileFEU - Alte Professionalità Vigili del Fuoco Paola De Nictolis Yes No information 7 April 2010 No 0

Latvia Stat fire and rescue service Janis Ivanovsks No - 10 March 2010 Yes 2Lithuania Fire and rescue department

Fédération Nationale des Corps de Sapeurs-Pompiers George Scheitweiler Yes No informtion Yes 0FEU - Fire brigade of the city of Luxemburg Erny Kirsch No - 7 April 2010 No 1

Malta Civil protection departmentNetherlands Fire Service Academy Rene Hagen Yes Information 16 February 2010 Yes 0Poland National headquarters of the state fireservice Slawomir Zajac Yes Information 19 March 2010 No 0

National authority for civil protectionFEU Pedro Rios No - 7 April 2010 No 1

Romania General Inspectorate for Emergency Situations Constana Ene No - 7 April 2010 Yes 1Slovakia Fire and rescue corpsSlovenia Administration for Civil Protection and Disaster Relief Natasa Horvat Yes Information 10 March 2010 Yes 1

Servicio Geologico Energia proteione civileFEU Javier Elorza No - 7 April 2010 No 1FEU Francisco Echeverria No - 7 April 2010 No 1FEU Javier Larrea No - 7 April 2010 No 1FEU Albert Vilanova No - 7 April 2010 No 1

Sweden Swedish Civil Contingencies Agency McIntyre Colin Yes Information 10 March 2010 Yes 1United Kingdom Fire and Resilience Directorate of the Department for Communities and Local GovernmSylvia Williams Yes Information 10 March 2010 Yes 0

Actions

No contact after 5 telephone calls




Country Organisation Contact Answer

Spain


Luxembourg

Italy

Portugal



Personal information, not for publication


Annex 24: Overview of the domestic fire deaths documented by the Members States in response to questionnaire on fire statistics

Country 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009AustriaBelgiumBulgariaCyprus 0 0 2Czech Republic 64 83 72 60 52 57 44 66 80 58 45 53 57 46 66 50 49 49 59 57 66 74 74 79 58 67 62Denmark 64 44 63 69 69 60 61 74 70 67 59 84 81 85 68 63 83Estonia 134 107 115 99 108 132 104 69 42Finland 98 86 90 86 81 84 96 64 93 90 74 73 83 72 67 68 47 60 76 82 63 99 69 80FranceGermany 347 330 392 326 388 545 625 587 562 466 497 592 491 433 429 397 395 467 385 364 407 346 310GreeceHungary 365 335 300 290 177 205 145 135 149 136 153 131 133 134 102Ireland 56 54 45 64 58 60 51 47 49 43 37 46 48 48 41 35 50 44 45 41 38 54 45 30 33 38 39 39 31 36ItalyLatviaLithuaniaLuxembourgMaltaNetherlands 51 47 80 56 58 41 39 42 42 52 38 40 46 38 33 58 56 44 68 44 25 62 41Poland 393 415 412 368 356 329 357 323 354 324 415 449 489 429 425PortugalRomaniaSlovakiaSlovenia 11 12 12 11 7 6 9 7 9 9 10 16 10 14 10SpainSweden 69 94 105 111 94 50 77 66 77 86United Kingdom 822 780 728 710 692 699 744 707 731 634 625 613 578 530 488 559 564 562 513 463 455 483 430 446 374 376 363 331 344


Annex 25: Overview of the number of domestic fire deaths per million inhabitants per year, documented by the Members States in response to questionnaire on fire statistics and EUROSTAT population statistics

Country 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009AustriaBelgiumBulgariaCyprus 2,51Czech Republic 6,20 8,04 6,97 5,80 5,03 5,51 4,25 6,37 7,76 5,62 4,36 5,13 5,52 4,46 6,40 4,85 4,76 4,77 5,75 5,58 6,47 7,25 7,24 7,71 5,64 6,45 5,92Denmark 12,48 8,57 12,24 13,37 13,14 11,37 11,52 13,93 13,13 12,53 10,99 15,60 15,01 15,71 12,53 11,57 15,16Estonia 98,03 78,60 84,81 73,28 80,15 98,16 77,47 51,46 31,33Finland 20,03 17,51 18,27 17,41 16,35 16,89 19,21 12,73 18,40 17,72 14,51 14,27 16,17 13,99 12,99 13,15 9,07 11,55 14,60 15,71 12,03 18,84 13,08 15,09FranceGermany 4,47 4,25 5,04 4,18 4,95 6,89 7,84 7,31 6,94 5,73 6,10 7,24 5,99 5,28 5,23 4,83 4,80 5,66 4,66 4,41 4,93 4,20 3,77GreeceHungary 35,21 32,37 29,02 28,10 17,18 19,94 14,14 13,21 14,61 13,37 15,15 13,00 13,21 13,34 10,17Ireland 16,51 15,73 12,96 18,29 16,46 16,94 14,43 13,26 13,86 12,23 10,55 13,06 13,53 13,45 11,44 9,73 13,81 12,04 12,18 10,99 10,06 14,09 11,54 7,57 8,19 9,25 9,27 9,04 7,04 8,09ItalyLatviaLithuaniaLuxembourgMaltaNetherlands 3,53 3,19 5,40 3,76 3,86 2,71 2,56 2,74 2,72 3,36 2,44 2,56 2,92 2,40 2,06 3,60 3,46 2,71 4,17 2,69 1,53 3,78 2,49Poland 10,19 10,75 10,66 9,52 9,21 8,51 9,33 8,45 9,26 8,48 10,87 11,77 12,83 11,26 11,14PortugalRomaniaSlovakiaSlovenia 5,35 6,03 6,03 5,36 3,36 3,02 4,72 3,36 4,36 4,35 5,01 8,01 5,01 6,99 4,97SpainSweden 7,79 10,61 11,82 12,46 10,51 5,57 8,54 7,29 8,45 9,37United Kingdom 14,60 13,84 12,93 12,61 12,28 12,38 13,14 12,46 12,86 11,12 10,93 10,69 10,05 9,19 8,44 9,65 9,71 9,65 8,79 7,90 7,74 8,19 7,26 7,50 6,26 6,26 6,01 5,45 5,62


Annex 26: Overview contacts questionnaire about flammability requirements and the use of flame retardants

Yes / No Quality Yes / No Quality Questionnaire send Contact by telephone Reminders by mailAustria Rapex contact point Helmuth Perz No - No - 10 March 2010 Yes 2Belgium Federal Public Service Health, Food Chain Safety and Environment Mieke Van de Velde Yes No requirments in place Yes No additional limitations 8 April 2010 Yes 1Bulgaria Ministry of Environment and Water Nikolai Savov

mitris Papamichailorka Klimosova

nnie FUGLØank Jensen

No - No - 19 March 2010 Yes 1Cyprus Rapex contact point No - No - 10 March 2010 Yes 2Czech Republic Rapex contact point Yes Requirements Yes No additional limitations 10 March 2010 Yes 2

Rapex contact point Yes Requirements No - 10 March 2010 No 2Danish Environmental Protection Agency No - Yes No additional limitations 8 April 2010 Yes 1

Estonia Rapex contact point Yes No requirments in place Yes No additional limitations 10 March 2010 Yes 2Finland Finnish consumer safety agency Yes Requirements Yes No additional limitations 19 March 2010 Yes 1France Rapex contact point er 5 telephone calls 10 March 2010 No 1

Federal Office of Consumer Protection and Food Safety 10 March 2010 No 2Federal Institute for Occupational Safety and Health 10 March 2010 No 1

Greece General Secretariat for Consumer Affairs of the Technical Control Directorate No - Yes No additional limitations 19 March 2010 No 1Hungary Hungarian Authority for Consumer protection Yes No requirments in place No - 19 March 2010 Yes 1Ireland Standards and Product Safety Department of Enterprise, Trade and Employment Yes Requirements Yes No additional limitations 10 March 2010 Yes 1Italy Rapex contact point 10 March 2010 No 1Latvia Rapex contact point 10 March 2010 No 1Lithuania Products Control Department of the State Non Food Products Inspectorate Yes No requirments in place No - 10 March 2010 No 1

Rapex contact point 10 March 2010 Yes 1

Malta Rapex contact point 10 March 2010 No 1Netherlands Food and Consumer Product Safety Authority Yes Requirements Yes No additional limitations 10 March 2010 No 1Poland Rapex contact point Yes No requirments in place Yes No additional limitations 10 March 2010 Yes 2

Rapex contact point 10 March 2010 No 2

Romania Rapex contact point No - No - 10 March 2010 Yes 2Slovakia Department of Consumer Protection and Internal Trade Yes No requirments in place Yes No additional limitations 10 March 2010 Yes 1Slovenia Ministry of the Economy No - No - 18 March 2010 Yes 1Spain Rapex contact point er 5 telephone calls 10 March 2010 No 1Sweden Swedish Chemical Agency Yes No requirments in place Yes No additional limitations 19 March 2010 Yes 0United Kingdom Consumer Product Safety of the Department for Business, Innovation & Skills Yes Requirements No - 19 March 2010 Yes 1

nformation, no proposal to contact other authority / organisation

nformation, proposal to contact other autority / organisation

nformation, proposal to contact other autority / organisation

Luxembourg To be contacted: Inspection du travail et des mines

er 5 telephone callser 5 telephone calls

ActionsUse flame retardants

Denmark

AnswerFlammability requirementsCountry Organisation Contact

Germany

Portugal To be contacted: National Authority of Civil Protection and Directorate General for Ec

er 5 telephone calls

nformation, no proposal to contact other authority / organisation

DiZWiFrMilvi PaidraHannu MattilaNo answer and no contact aftAstrid DrossPeter WandersTriantafillia Alexiou Márta Pálné TóthHarry Lester

Danute Banyte Manou Gillen

Peter DekkerAleksandra KurzynaFilomena Barella

Mihail MeiuErika GašparíkováBreda Goršek No answer and no contact aftMats ForkmanTerry Edge

No i

No i

No i

No answer and no contact aftNo answer and no contact aft

onomic Activities

No answer and no contact aft

No i

Personal

information, not

for publication

Pers.info

.info

.info

.info

.info

Pers

Pers

Pers

Pers


Annex 27: Questionnaire about flammability requirements and the use of flame retardants

Dear Madam/Sir, We kindly request your cooperation. The European Commission, DG Health and Consumers, has commissioned ARCADIS Belgium to carry out the study 'Identification and evaluation of data on flame retardants in consumer products'. In order to be able to assess the benefits associated with the use of flame retardants in consumer products we kindly ask you to document the Fire safety requirements that apply to consumer products in your country as well as the regulations concerning the use of flame retardants in consumer products

Fire safety requirements

in your country. Should you not be the contact person for this kind of information, may I kindly ask you to inform Lieven De Smet and forward this mail to the competent person in your country? Guidance for completing and returning the questionnaire: 1. Go to the sheet "Fire safety requirements"; please read the introduction and complete the table. 2. Go to the sheet "Use of flame retardants"; please read the introduction and complete the table. 3. Add, if necessary, any remarks to the information provided by you. 4. Return the completed questionnaire by April 9th, 2010 to: Arcadis Belgium Kortrijkseseteenweg 302, B-9000 Gent Fax. +32 (0)9 242 44 45 In case you have any questions concerning the questionnaire please to not hesitate to contact Arcadis Belgium. Thank you very much for your cooperation.


In Europe the fire safety of consumer products is regulated by the General Product Safety Directive. The General Product Safety Directive, however, does not give specific instructions on how to control the fire properties of consumer products. Each Member State must determine if and how the fire safety of consumer products is managed.

Please document the fire safety standards that apply in your country to the various types of consumer products (textiles, (upholstered) furniture, mattresses, electric and electronic equipment, etc.) used at home by completing the table below.

Product (category) Regulation1 Date entry into force Requirement Test method2 Remarks

Domestic upholstered seating furniture , covers of furniture and filling material of seating furniture, bed-bases, matresses, pillows and matresses pads

Statutory Instrument 1988/No. 1324, 1989/No. 2358 and 1993/No. 207The Furniture and Furnishings (Fire) (Safety) Regulations 1988 (as amended in 1989 and 1993)

1988

No ignition by CigaretteNo ignition by Match flameNo ignition by wooden crib (Crib 5)

BS 5852: Part IBS 5852: Part IIBS 6807BS 7177

(Example for the United Kingdom)

1 Please provide the official name of the regulation2 Please provide the official name of test method Use of flame retardants


Rulemaking by the European institutions imposed restrictions on the use of certain flame retardants in consumer products. See sheet "Annex use of flame retardants" sheet for an insight in the restrictions Europe places on the use of flame retardants in consumer products.

Please document the restrictions on the use of flame retardants in consumer products that apply in your country by completing the table below.

Flame retardant Regulation1 Date entry into force Scope2 Limit value3 Remarks

12345678…

1 Please provide the official name of the regulation2 Document the type of consumer products to which the restrictions apply 3 Document any limit values (e.g. concentrations) if there is not a complete ban

Annex use of flame retardants


Flame retardant Regulation Date entry into force Scope

tris (2,3 dibromopropyl)-phosphate

Council Directive 79/663/EEC of 24 July 1979 supplementing the Annex to Council Directive 76/769/EEC on the approximation of the laws,

regulations and administrative provisions of the Member States relating to the restrictions on the

marketing and use of certain dangerous substances and preparations

July 1980 textile applications

tris-(aziridinyl)-phosphinoxide

Council Directive 83/264/EEC of 16 May 1983 amending for the fourth time Directive 76/769/EEC on

the approximation of the laws, regulations and administrative provisions of the Member States

relating to restrictions on the marketing and use of certain dangerous substances and prep


PBB

Council Directive 83/264/EEC of 16 May 1983 amending for the fourth time Directive 76/769/EEC on

the approximation of the laws, regulations and administrative provisions of the Member States

relating to restrictions on the marketing and use of certain dangerous substances and preparations


PentaBDE

Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003 amending for the 24th time Council Directive 76/769/EEC relating to

restrictions on the marketing and use of certain dangerous substances and preparations

15 August 2004

articles may not be placed on the EU market if they, or flame-retarded parts

thereof, contain this substance in concentrations higher than 0,1 % by mass

OctaBDE

Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003 amending for the 24th time Council Directive 76/769/EEC relating to

restrictions on the marketing and use of certain dangerous substances and preparations

15 August 2004

articles may not be placed on the EU market if they, or flame-retarded parts

thereof, contain this substance in concentrations higher than 0,1 % by mass

PBB1

2005/618/EC: Commission Decision of 18 August 2005 amending Directive 2002/95/EC of the European

Parliament and of the Council for the purpose of establishing the maximum concentration values for

certain hazardous substances in electrical and electronic equipment

1 July 2006

maximum concentration value of 0,1 % by weight in homogeneous materials in new electrical and electronic equipment put on

the EU market

PBDE2

2005/618/EC: Commission Decision of 18 August 2005 amending Directive 2002/95/EC of the European

Parliament and of the Council for the purpose of establishing the maximum concentration values for

certain hazardous substances in electrical and electronic equipment electronic equipment

1 July 2006


the EU market

DecaBDE3

(2008/C 116/04): Judgment of the Court (Grand Chamber) of 1 April 2008 - European Parliament (C-

14/06), Kingdom of Denmark (C-295/06) v Commission of the European Communities

1 July 2008


the EU market

1 The Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment first stipulated PBB could not be used in new electronic equipment put on the EU market from 1 July 2006 onwards. This has been revised whereas it is evident that a total avoidance of brominated flame retardants is in some instances impossible to achieve.2 The Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment first stipulated PBB could not be used in new electronic equipment put on the EU market from 1 July 2006 onwards. This has been revised whereas it is evident that a total avoidance of brominated flame retardants is in some instances impossible to achieve.3 Annulment by the European Court of Justice of the exemption for DecaBDE as stipulated by 2005/717/EC: Commission Decision of 13 October 2005 amending for the purposes of adapting to the technical progress the Annex to Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment.


Annex 28: Contact details of the national focal points of the WHO

Country Contact person e-mailAT Ms. Barbara LEITNER [email protected] Mrs Anne KONGS

Mrs Leila [email protected];[email protected]

BG Mrs Finka DENKOVA [email protected] Ms. Eleni KYRIACOU [email protected] Ms. Magdalena POPPOVA [email protected] Mr Torsten SCHELHASE [email protected] Mr. Jesper Munk MARCUSSEN [email protected] Mr Gleb DENISSOV [email protected] Mr. Luis DE ANDRÉS RAMOS [email protected] Ms. Irmeli PENTTILÄ [email protected] Mr Gerard PAVILLON [email protected] Ms. Lemonia ANDRITSOPOULOU [email protected] Mr Laszlo PELIKAN [email protected] Ms. Sandra TOBIN [email protected] Ms Silvia BRUZZONE (Changed

post recently)Mr. Stefano MARCHETTI

[email protected]

[email protected] Ms. Liuda KASPARAVICIENE [email protected] Dr Yolande WAGENER

Mr Guy WEBERMs Monique KOSMALA

[email protected]@[email protected]

LV Ms. Sniedze KARLSONE [email protected] Dr. Kathleen ENGLAND [email protected] Dr. Jan W.P.F. KARDAUN [email protected] Ms Lucyna NOWAK [email protected] Ms Judite CATARINO

Mr. Jaime BOTELHO Mrs Eduarda GOIS

[email protected]@[email protected]

RO Mrs Ioana PERTACHE [email protected] Ms. Charlotte BJÖRKENSTAM [email protected] Mr. Milos KRAVANJA [email protected] Ms. Zuzana PODMANICKÁ [email protected] Ms Lois COOK [email protected]

Personal information: not for publication

Imagine the result - IFV Human health risk assessment 123 5.13.4 Environmental effects 124 ......

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