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Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 08.06.2020 Revision: 08.06.2020 Version number 4 * 1 Identification of the substance/mixture and of the company/undertaking · Product identifier · Trade name: WALLOXEN RO 50 · Article number: 511278 · CAS Number: 61791-12-6 · NLP Number: 500-151-7 · Registration number 01-2119958762-26 · Relevant identified uses of the substance or mixture and uses advised against . · Application of the substance / the mixture Emulsifier · Uses advised against No further relevant information available. · Details of the supplier of the safety data sheet · Manufacturer/Supplier: Wall Chemie GmbH Am Selder 25 D-47906 KEMPEN DEUTSCHLAND Tel.: +49 2152 8999 0 E-Mail: [email protected] · Further information obtainable from: Safety and health group · Emergency telephone number: This number is serviced during office hours: +49 2152 8999 0 Giftinformationszentrum Nord 24h-information: +49 551 19240 2 Hazards identification · Classification of the substance or mixture This Product is classified as not dangerous for the purpose of the relevant directives and therefore does not require labelling. Nevertheless we recommend to be careful with the material as you used to be with other chemicals. · Classification according to Regulation (EC) No 1272/2008 The substance is not classified, according to the CLP regulation. · Label elements · Labelling according to Regulation (EC) No 1272/2008 Void · Hazard pictograms Void · Signal word Void · (Hazard-determining) components of labelling: 61791-12-6 castor oil ethoxylated · Hazard statements Void · Other hazards · Results of PBT and vPvB assessment · PBT: Not applicable. · vPvB: Not applicable. 3 Composition/information on ingredients · Chemical characterisation: Substances · CAS No. Description 61791-12-6 castor oil ethoxylated · Identification number(s) · NLP Number: 500-151-7 EU (Contd. on page 2)

Transcript of Page 1/7 Safety data sheet - Wall Chemie · Page 1/7 Safety data sheet according to 1907/2006/EC,...

Page 1: Page 1/7 Safety data sheet - Wall Chemie · Page 1/7 Safety data sheet according to 1907/2006/EC, Article 31 Printing date 28.05.2018 Version number 3 Revision: 28.05.2018 47.0.1

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* 1 Identification of the substance/mixture and of the company/undertaking

· Product identifier

· Trade name: WALLOXEN RO 50

· Article number: 511278· CAS Number:61791-12-6

· NLP Number:500-151-7

· Registration number 01-2119958762-26· Relevant identified uses of the substance or mixtur e and uses advised against . · Application of the substance / the mixture Emulsifier· Uses advised against No further relevant information available.

· Details of the supplier of the safety data sheet· Manufacturer/Supplier:Wall Chemie GmbHAm Selder 25D-47906 KEMPENDEUTSCHLANDTel.: +49 2152 8999 0E-Mail: [email protected]

· Further information obtainable from: Safety and health group· Emergency telephone number:This number is serviced during office hours: +49 2152 8999 0Giftinformationszentrum Nord 24h-information: +49 551 19240

2 Hazards identification

· Classification of the substance or mixtureThis Product is classified as not dangerous for the purpose of the relevant directives and thereforedoes not require labelling. Nevertheless we recommend to be careful with the material as you usedto be with other chemicals.

· Classification according to Regulation (EC) No 1272 /2008The substance is not classified, according to the CLP regulation.

· Label elements· Labelling according to Regulation (EC) No 1272/2008 Void· Hazard pictograms Void· Signal word Void

· (Hazard-determining) components of labelling: 61791-12-6 castor oil ethoxylated· Hazard statements Void· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients

· Chemical characterisation: Substances· CAS No. Description61791-12-6 castor oil ethoxylated

· Identification number(s)· NLP Number: 500-151-7

EU

(Contd. on page 2)

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4 First aid measures

· Description of first aid measures· General information: No special measures required.· After inhalation: Supply fresh air; consult doctor in case of complaints.· After skin contact: Immediately wash with water and soap and rinse thoroughly.· After eye contact: Rinse opened eye for several minutes under running water.· After swallowing:Seek medical treatment.Rinse mouth.Do not induce vomiting.

· Information for doctor:· Most important symptoms and effects, both acute and delayedNo further relevant information available.

· Indication of any immediate medical attention and s pecial treatment neededRisk of aspiration.

5 Firefighting measures

· Extinguishing media· Suitable extinguishing agents:CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

· Special hazards arising from the substance or mixtu reIn case of fire, the following can be released:Organic decomposition productsCarbon oxides (COx)

· Advice for firefighters· Protective equipment: Use suitable breathing apparatus if necessary.

* 6 Accidental release measures

· Personal precautions, protective equipment and emer gency proceduresWear protective equipment. Keep unprotected persons away.Particular danger of slipping on leaked/spilled product.Avoid contact with the eyes and skin.

· Environmental precautions: Do not allow to enter sewers/ surface or ground water.· Methods and material for containment and cleaning u p:Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).

· Reference to other sectionsNo dangerous substances are released.See Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage

· Handling:· Precautions for safe handlingNo special measures required.Open and handle receptacle with care.Wear protective clothing.Do not eat, drink or smoke in working area.

· Information about fire - and explosion protection: No special measures required.(Contd. on page 3)

EU

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· Conditions for safe storage, including any incompat ibilities· Storage:· Requirements to be met by storerooms and receptacle s: Store only in the original receptacle.· Information about storage in one common storage fac ility: Not required.· Further information about storage conditions: None.· Storage class: Combustible liquid.· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection

· Additional information about design of technical fa cilities: No further data; see item 7.

· Control parameters· Ingredients with limit values that require monitori ng at the workplace:· DNELsOral DNEL (Long-term, systemic effects) 0.14205 mg/kg/d (consumer)Dermal DNEL (Long-term, systemic effects) 0.56819 mg/kg/d (worker)

0.2841 mg/kg/d (consumer)Inhalative DNEL (Long-term, systemic effects) 1.00181 mg/m³ (worker)

0.24704 mg/m³ (consumer)

· PNECsPNEC 1.18 mg/l (fresh water)

0.118 mg/l (seawater)1.18 mg/l (water (intermittent release))

· Additional information: The lists valid during the making were used as basis.

· Exposure controls· Personal protective equipment:· General protective and hygienic measures:Keep away from foodstuffs, beverages and feed.Do not eat, drink, smoke or sniff while working.Wash hands before breaks and at the end of work.The recommended specification of the protective clothing articles is to be chosen according to theduration of the exposition, the concentration and the amount of the dangerous substances at theworking environment. Seek advice of the suppliers.

· Respiratory protection: Not required.· Protection of hands:

Protective gloves

· Material of glovese.g. Nitrile rubber, NBRRecommended thickness of the material: ≥ 0.5 mm

· Penetration time of glove materialMinimum breakthrough time : > 120 min (Permeation according to EN 374 Part 3: level 4)

· Eye protection:

Tightly sealed goggles (EN 166).

(Contd. on page 4) EU

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· Body protection: Protective work clothing

9 Physical and chemical properties

· Information on basic physical and chemical properti es· General Information· Appearance:

Form: FluidColour: Yellowish

· Odour: Characteristic· Odour threshold: Not determined.

· pH-value (10 g/l) at 20 °C: ca. 6.0 - 7.5

· Change in conditionMelting point/freezing point: < 0 °CInitial boiling point and boiling range: Undetermined.

· Flash point: > 100 °C

· Flammability (solid, gas): Not applicable.

· Decomposition temperature: Not determined.

· Auto-ignition temperature: Not determined.

· Explosive properties: Product does not present an explosion hazard.

· Explosion limits:Lower: Not determined.Upper: Not determined.

· Vapour pressure: Not determined.

· Density: ca. 0.95 g/cm³(70°C)· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.

· Solubility in / Miscibility withwater: Partly miscible.

Gel formation possible.

· Partition coefficient: n-octanol/water: Product is an emulsifier.

· Viscosity:Dynamic: Not determined.Kinematic: Not determined.

· Other information No further relevant information available.

10 Stability and reactivity

· Reactivity Product is stable under normal ambient conditions.· Chemical stability· Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.

(Contd. on page 5) EU

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· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information

· Information on toxicological effects· Acute toxicity Based on available data, the classification criteria are not met.· LD/LC50 values relevant for classification:Oral LD50 6,500 mg/kg (mouse) (REACH Dossier)Dermal LD50 >2,000 mg/kg (rabbit) (REACH Dossier)

· Primary irritant effect:· Skin corrosion/irritation Based on available data, the classification criteria are not met.· Serious eye damage/irritation Based on available data, the classification criteria are not met.· Respiratory or skin sensitisation No sensitising effects known.· CMR effects (carcinogenity, mutagenicity and toxici ty for reproduction)· Germ cell mutagenicity Based on available data, the classification criteria are not met.· Carcinogenicity Based on available data, the classification criteria are not met.· Reproductive toxicity Based on available data, the classification criteria are not met.· STOT-single exposure Based on available data, the classification criteria are not met.· STOT-repeated exposure Based on available data, the classification criteria are not met.· Aspiration hazard Based on available data, the classification criteria are not met.

12 Ecological information

· Toxicity· Aquatic toxicity:EC50 >93 mg/l (alga) (72 h; Desmodesmus subspicatus)

>100 mg/l (daphne) (48 h; Daphnia Magna)LC50 448 mg/l (fish) (48 h)NOEC 0.07 mg/l (alga) (96 h)

0.03 mg/l (daphne) (21 d)· Persistence and degradabilityThese surfactants comply with the biodegradability criteria as laid down in Regulation (EC) No.648/2004 on detergents. Data to support this assertion are held at the disposal of the competentauthorities of the Member States and will be made available to them, at their direct request or at therequest of a detergent manufacturer.readily biodegradableDegradation rate ≥70% Time (d) 28 days Method OECD 301D

· Behaviour in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:Water hazard class 1 (German Regulation) (Assessment by list): slightly hazardous for waterDo not allow undiluted product or large quantities of it to reach ground water, water course orsewage system.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

EU

(Contd. on page 6)

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13 Disposal considerations

· Waste treatment methods· RecommendationCan be burned with household garbage after consulting with the waste disposal facility operator andthe pertinent authorities and adhering to the necessary technical regulations.

· Waste disposal key:Determine wastes code in compliance with local waste management company according theEuropean Waste Catalogue (EWC).

· Uncleaned packaging:· Recommendation: Disposal must be made according to official regulations.· Recommended cleansing agents: Water, if necessary together with cleansing agents.

14 Transport information

· UN-Number· ADR, ADN, IMDG, IATA Void

· UN proper shipping name· ADR, ADN, IMDG, IATA Void

· Transport hazard class(es)

· ADR, ADN, IMDG, IATA· Class Void

· Packing group· ADR, IMDG, IATA Void

· Environmental hazards:· Marine pollutant: No

· Special precautions for user Not applicable.

· Transport in bulk according to Annex II ofMarpol and the IBC Code Not applicable.

· UN "Model Regulation": Void

15 Regulatory information

· Safety, health and environmental regulations/legisl ation specific for the substance ormixtureThis Product is classified as not dangerous for the purpose of the relevant directives and thereforedoes not require labelling. Nevertheless we recommend to be careful with the material as you usedto be with other chemicals.

· Chemical safety assessment: A Chemical Safety Assessment has been carried out.

16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guaranteefor any specific product features and shall not establish a legally valid contractual relationship.

· Department issuing SDS: Safety and Health group· Contact: Dr. Astrid Kawka, Dr. Dieter Kawka· Abbreviations and acronyms:

ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning theInternational Carriage of Dangerous Goods by Road)

(Contd. on page 7) EU

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IMDG: International Maritime Code for Dangerous GoodsIATA: International Air Transport AssociationGHS: Globally Harmonised System of Classification and Labelling of ChemicalsEINECS: European Inventory of Existing Commercial Chemical SubstancesCAS: Chemical Abstracts Service (division of the American Chemical Society)DNEL: Derived No-Effect Level (REACH)PNEC: Predicted No-Effect Concentration (REACH)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulative

· * Data compared to the previous version altered. EU

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Inhalt Life Cycle description .................................................................................................................................................... 2

Manufacture ............................................................................................................................................................. 2

Formulation .............................................................................................................................................................. 2

Uses at industrial sites .............................................................................................................................................. 3

Uses by professional workers ................................................................................................................................... 5

Consumer Uses ......................................................................................................................................................... 6

Article service life ..................................................................................................................................................... 6

Uses advised against ..................................................................................................................................................... 7

Exposure controls / personal protection ...................................................................................................................... 7

Risk characterisation related to combined exposure ................................................................................................... 8

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Life Cycle description

Manufacture ERC 1: Manufacture of substances PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 15: Use as laboratory reagent PC 24: Lubricants, greases, release products PC 25: Metal working fluids PC 32: Polymer preparations and compounds PC 35: Washing and cleaning products (including solvent based products) PC 36 : Water softener PC 37 : Water treatment chemicals PC 39 : Cosmetics, personal care products

Manufacture Environmental release category:

Process category: Product category formulated:

Substance supplied to that use in form of:

Technical function oft he substance during formulation

Industrial Manufacture

ERC 1 PROC 1, PROC 2, PROC 3, PROC 4, PROC 8a, PROC 8b, PROC 15

PC 24, PC 25, PC 32, PC 35, PC 36, PC 37, PC 39

As such emulsifier

Formulation ERC 2: Formulation of preparations PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PC 35: Washing and cleaning products (including solvent based products) PC 37: Water treatment chemicals

Formulation Environmental release category:

Process category:

Product category formulated:

Substance supplied to that use in form of:

Technical function of the substance during formulation:

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Water treatment chemicals

ERC 2 PROC 5, PROC 4, PROC 3, PROC 2, PROC 1

PC 37, PC 35 As such Corrosion inhibitors and anti-scaling agents

Uses at industrial sites ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6b: Industrial use of reactive processing aids ERC 6c: Industrial use of monomers for manufacture of thermoplastics ERC 7: Industrial use of substances in closed systems PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 7: Industrial spraying PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 10: Roller application or brushing PROC 11: Non industrial spraying PROC 13: Treatment of articles by dipping and pouring PROC 15: Use as laboratory reagent PROC 17: Lubrication at high energy conditions and in partly open process PROC 18: Greasing at high energy conditions PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 20: Heat and pressure transfer fluids in dispersive, professional use but closed systems PROC 21: Low energy manipulation of substances bound in materials and/or articles PROC 22: Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting PROC 23: Open processing and transfer operations with minerals/metals at elevated temperature PROC 25: Other hot work operations with metals PC 14: Metal surface treatment products, including galvanic and electroplating products PC 15: Non-metal-surface treatment products PC 16: Heat transfer fluids PC 17: Hydraulic fluids PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents PC 25: Metal working fluids PC 32: Polymer preparations and compounds PC 37: Water treatment chemicals SU 2a: Mining (without offshore industries) SU 8: Manufacture of bulk, large scale chemicals (including petroleum products) SU 9: Manufacture of fine chemicals

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SU 10: Formulation [mixing] of preparations and/or re-packaging (excluding alloys) SU 12: Manufacture of plastics products, including compounding and conversion

Uses at industrial sites Environmental release category:

Process category:

Product category formulated:

Substance supplied to that use in form of:

Subse-quent service life relevant for that use:

Sector of end use:

Technical function of the substance during formulation:

Process regulators, other than polymerisation or vulcanisation processes

ERC 4 PROC 1, PROC 2, PROC 3, PROC 4, PROC 5, PROC 7, PROC 8a, PROC 8b, PROC 9

PC 37, PC 20

As such yes SU 8 Process regulators, other than polymerisation or vulcanisation processes

Metal surface treating agents ERC 5 PROC 10, PROC 11, PROC 13, PROC 15, PROC 17, PROC 18, PROC 19, PROC 20, PROC 25: PROC 23, PROC 21

PC 14, PC 25

As such yes SU 2a Plating agents and metal surface treating agents

Processing aids ERC 6b PROC 13, PROC 19, PROC 8a, PROC 8b, PROC 9, PROC 11, PROC 22

PC 20, PC 17, PC 16

As such yes SU 10 Processing aid, not otherwise listed

Lubricants and lubricant additives

ERC 7 PROC 1, PROC 2, PROC 3, PROC 4, PROC 5, PROC 7, PROC 15

PC 15 As such yes SU 9 Lubricants and lubricant additives

Polymerisation ERC 6c PROC 5, PROC 3, PROC 8a, PROC 8b, PROC 9,

PC 32 As such yes SU 12 Process regulators, other than polymerisation or

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PROC 11, PROC 13, PROC 10

vulcanisation processes

Uses by professional workers

ERC 8a: Wide dispersive indoor use of processing aids in open systems

ERC 8d: Wide dispersive outdoor use of processing aids in open systems

ERC 9a: Wide dispersive indoor use of substances in closed systems

ERC 9b: Wide dispersive outdoor use of substances in closed systems

PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated

facilities

PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated

facilities

PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing)

PROC 10: Roller application or brushing

PROC 11: Non industrial spraying

PROC 12: Use of blowing agents in manufacture of foam PROC 13: Treatment of articles by dipping and pouring

PROC 16: Using material as fuel sources, limited exposure to unburned product to be expected

PROC 17: Lubrication at high energy conditions and in partly open process

PROC 18: Greasing at high energy conditions PROC 19: Hand-mixing with intimate contact and only PPE available.

PROC 20: Heat and pressure transfer fluids in dispersive, professional use but closed systems

PC 24: Lubricants, greases, release products

PC 31: Polishes and wax blends

PC 38: Welding and soldering products (with flux coatings or flux cores.), flux products SU 2a: Mining (without offshore industries) SU 15: Manufacture of fabricated metal products, except machinery and equipment

Uses by professional workers

Environmental release category:

Process category:

Product category formulated:

Substance supplied to that use in form of:

Subse-quent service life relevant for that use:

Sector of end use:

Technical function of the substance during formulation:

Lubricants and lubricant additives

ERC 8a, ERC 8b PROC 10, PROC 11, PROC 13, PROC 17, PROC 18, PROC 19

PC 24, PC 31

As such Yes SU 2a Lubricants and lubricant additives

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Processing aids ERC 9a, ERC 9b PROC 20, PROC 12, PROC 13, PROC 16, PROC 17, PROC 9, PROC 8b, PROC 8a

PC 38 As such In a mixture

Yes SU 15 Processing aid, not otherwise listed

Consumer Uses

ERC 9a: Wide dispersive indoor use of substances in closed systems

PC 39: Cosmetics, personal care products

Consumer Uses Environmental release category:

Product category formulated:

Substance supplied to that use in form of:

Technical function of the substance during formulation:

Personal care ERC 9a PC 39 As such cosmetics

Article service life

AC 01: Other (non intended to be released): Lubricants and lubricant additives AC 02: Other (intended to be released): Other articles releasing grease or corrosion inhibitors AC 7: Metal articles ERC 10a: Wide dispersive outdoor use of long-life articles and materials with low release ERC 11a: Wide dispersive indoor use of long-life articles and materials with low release PROC 21: Low energy manipulation of substances bound in materials and/or articles PROC 23: Open processing and transfer operations with minerals/metals at elevated temperature PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles

Article service life Exposure related description of article:

Environmental release category:

Article category related to subsequent service life:

Process category:

Technical function of the substance during formulation:

Article used by workers:

Surface active agents Articles with foreseeable impact on indoor exposure due to elevated

ERC 10a AC 7, AC 01, AC 02

PROC 21, PROC 23, PROC 24

Surface active agents

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operating temperature, e.g. computers Articles with particular waste collection and treatment schemes, e.g. electronic equipment

Article used by consumers:

Surface active agents Articles with particular waste collection and treatment schemes, e.g. electronic equipment Articles with foreseeable impact on indoor exposure due to elevated operating temperature, e.g. computers

ERC 11a AC 02, AC 7, AC 01

PROC 21, PROC 23, PROC 24

Surface active agents

Uses advised against

No uses advised against are identified.

Exposure controls / personal protection General industrial hygiene practice.

PERSONAL PROTECTIVE EQUIPMENT Respiratory protection: Respiratory protection not required. For nuisance exposures use type OV/AG (US) or type ABEK

(EU EN 14387) respirator cartridges. Use respirators and components tested and approved under

appropriate government standards such as NIOSH (US) or CEN (EU).

Eye/face protection Use equipment for eye protection tested and approved under appropriate government standards

such as NIOSH (US) or EN 166(EU).

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Anhang zum Sicherheitsdatenblatt gemäß 1907/2006/EG, (VO (EU) Nr. 453/2010)

Druckdatum: 23.11.2016 überarbeitet am: 23.11.2016

Stoffsicherheitsbeurteilung WALLOXEN RO 30 / Walloxen RO 50 Seite 8/8

Skin and body protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal

technique(without touching glove's outer surface) to avoid skin contact with this product.

Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory

practices.Wash and dry hands.The selected protective gloves have to satisfy the specifications of

EU Directive 89/686/EEC and the standard EN 374 derived from it.

Impervious clothing, The type of protective equipment must be selected according to the

concentration and amount of the dangerous substance at the specific workplace.

Risk characterisation related to combined exposure The submission substance does not meet the criteria to be classified dangerous for physical, environmental and health

hazards nor is regarded as PBT or vPvB. Hence, according to Article 14(4) of the REACH regulation an exposure assessment

and risk characterization is not required.