FULL PUBLIC REPORT - Home - NICNAS Web viewThe notified chemical is used at a maximum of 20% in...

File No STD/1028

18 May 2004

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)

FULL PUBLIC REPORT

Notified Chemical in AG 6206

This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage.

For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:

LibraryNational Occupational Health and Safety Commission25 Constitution AvenueCANBERRA ACT 2600AUSTRALIA

To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.

This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:

Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.TEL: + 61 2 8577 8800FAX + 61 2 8577 8888.Website: www.nicnas.gov.au

DirectorChemicals Notification and Assessment

TABLE OF CONTENTS

FULL PUBLIC REPORT........................................................................................................................................51. APPLICANT AND NOTIFICATION DETAILS.......................................................................................52. IDENTITY OF CHEMICAL.......................................................................................................................53. COMPOSITION...........................................................................................................................................54. INTRODUCTION AND USE INFORMATION........................................................................................65. PROCESS AND RELEASE INFORMATION...........................................................................................66. PHYSICAL AND CHEMICAL PROPERTIES........................................................................................117. TOXICOLOGICAL INVESTIGATIONS.................................................................................................158. ENVIRONMENT.......................................................................................................................................219. RISK ASSESSMENT................................................................................................................................2610. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS...........................................................................................................................................................2811. MATERIAL SAFETY DATA SHEET.................................................................................................2912. RECOMMENDATIONS......................................................................................................................2913. BIBLIOGRAPHY.................................................................................................................................30

File No: STD/1028

5 May 2023

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)

FULL PUBLIC REPORT


This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment and Heritage.

For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at:

LibraryNational Occupational Health and Safety Commission25 Constitution AvenueCANBERRA ACT 2600AUSTRALIA

To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.

This Full Public Report is available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:

Street Address: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA.Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.TEL: + 61 2 8577 8800FAX + 61 2 8577 8888Website: www.nicnas.gov.au

DirectorChemicals Notification and Assessment

5 May 2023 NICNAS

FULL PUBLIC REPORT


1. APPLICANT AND NOTIFICATION DETAILS

APPLICANT(S)Akzo Nobel Chemicals Pty Ltd (ACN 000 017 354) Level 2, 369 Royal Parade, Parkville, Victoria 3052

NOTIFICATION CATEGORYStandard: Chemical other than polymer (more than 1 tonne per year).

EXEMPT INFORMATION (SECTION 75 OF THE ACT)Data items and details claimed exempt from publication: chemical name, CAS No., molecular and structural formulae, spectral data, customer details, import volume and certain marketing names.

VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)Variation to the schedule of data requirements is claimed as follows: Particle size, Flammability Limits, Acute Inhalation Toxicity. In addition data for a close analogue was substituted for all physico-chemical properties except partition coefficient and all mammalian toxicity data except those for skin sensitisation and genotoxicity.

PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)None.

NOTIFICATION IN OTHER COUNTRIESThe notifier states “None”.

2. IDENTITY OF CHEMICAL

MARKETING NAME(S)AG 6206, the formulation to be imported contains 75% notified chemical in an aqueous solution.

METHODS OF DETECTION AND DETERMINATION

ANALYTICALMETHOD

Gas chromatography/ Mass spectroscopy.

3. COMPOSITION

DEGREE OF PURITY99%

HAZARDOUS IMPURITIES/RESIDUAL MONOMERS

Chemical Name hexanolCAS No. 111-27-3 Weight % 0.6 – 0.9Hazardous Properties Harmful if swallowed and inhaled. Irritating to respiratory system and skin.

NON HAZARDOUS IMPURITIES/RESIDUAL MONOMERS (>1% by weight)None.

ADDITIVES/ADJUVANTS Water is present in AG 6206.

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5 May 2023 NICNAS

Chemical Name WaterCAS No. 7732-18-5 Weight % 25

4. INTRODUCTION AND USE INFORMATION

MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARSThe notified chemical will be imported in an aqueous solution at a concentration of 75% or less (AG 6206). It will also be imported as part of a proprietary blend of ethoxylated non ionic surfactants and water at concentrations less than 75%.

MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS

Year 1 2 3 4 5Tonnes 30–100 100–300 100–300 100–300 100–300

USEThe notified chemical functions as a surfactant in a wide range of applications. It is particularly useful in aqueous alkaline applications where low foaming and effective wetting properties are desirable. Typical applications include a variety of cleaning products such as vehicle cleaning and machine dishwashing, personal care, industrial and commercial cleaning products, and as an adjuvant in agricultural chemicals.

The maximum concentration used in concentrates is 20%. These concentrates are further diluted 5 – 100 times depending on the particular application.

5. PROCESS AND RELEASE INFORMATION

5.1. Distribution, Transport and Storage

PORT OF ENTRYThe notified chemical will initially be imported through Sydney, or Melbourne.

IDENTITY OF MANUFACTURER/RECIPIENTSAG 6206, the product containing the notified chemical, will arrive at wharf and be delivered to the customers site by road transport for storage and reformulation. It may be initially stored and distributed in a third party warehouse in either Melbourne or Sydney.

TRANSPORTATION AND PACKAGINGAG 6206 will be imported in 200 L steel drums or 1000 L isotainers. These drums or isotainers will be transported by road from the wharf to warehouse or delivered to the customers site for reformulation.

The following table describes the transportation and packaging arrangements for formulated products:

Product Type Container Size/Description Distribution ModeConsumer cleaning product (eg dishwashing detergent)

0.5-5 litres Plastic bottles are filled at the site of formulation and packed in cardboard cartons. The boxes are transported to retail stores by road transport.

Institutional cleaning product (eg heavy duty detergent for cleaning of vehicles/kitchens)

5-50 litres Plastic/steel containers are filled at site of formulation. The containers are transported by road to wholesale stores.

Industrial (brewery cleaning) 200 litres Plastic/steel drum filled at site of formulation and transported by road to customer site.


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Agricultural formulation 1-200 litres Plastic/steel container filled at site of formulation and transported to a wholesale store.

5.2. Operation DescriptionThe notified chemical will be imported as an aqueous solution. Reformulation will be carried out in Australia.

Formulation of Domestic/Institutional/Industrial Cleaning Products

The typical composition of a liquid cleaning agent includes 5–40 wt% surfactant(s) together with other constituents such as a hydrotropic material, additives (eg hand lotion, colourant, perfume), and water added to give the formulation its desired characteristics. Alkyl glucosides are useful when process temperatures are not too high and the medium is not too acidic, and favourable ecotoxicological properties are desired (Balzer 1997). The notified chemical is used at a maximum of 20% in cleaning formulations and is particularly suitable for alkaline cleaning applications.

Customers for the notified chemical have not been identified as yet. Most potential customers operate manufacturing facilities in metropolitan Sydney, Melbourne, Brisbane or Adelaide. Of the maximum of 300 tonnes to be imported per year it is estimated that 80% will be used in cleaning products. Cleaning products are typically formulated by stirring the ingredients for 1-4 hours in a mixing tank, usually stainless steel and ranging in size from approximately 150-250,000 L. Mixing usually takes place at room temperature. The notified chemical can be added directly to the mixing vessel from a 205 L drum or it can be added to the mixer via a manifold and metering system from a drum or storage vessel. Smaller quantities are often pre-weighed into smaller drums or buckets before addition to the mixer. Product is packed off into containers ranging in size from < 1 L (generally plastic containers) to 205 L (drums). The containers are filled either by gravity feed from the mixing vessel or by pneumatic filling. The larger packs are distributed to repackagers and to the larger cleaning companies.

At the end of the blending process, a sample of product is normally taken for quality control using a pipette.

The blending vessel and filling lines will be cleaned after the formulation of each batch by flushing the system with water. Cleaning residues are either reused again in the blending process or process wastewater will be sent to a waste water pit on the manufacturing site. After emptying, the drums containing AG 6206 will be sent to a drum recycler, and the isotainers sent back to the manufacturer of the notified chemical.

Domestic/Institutional/Industrial Cleaning Products End Use

Cleaning products are generally applied by one of the following methods:• washing with liquid cleaner, for example, with a cloth or sponge, and wiping the surface;• spraying the surface and then wiping;• applying liquid cleaner by mop or brush;• applying the cleaner as a liquid stream, for example, using a wash or squeeze bottle; or high pressure;• applying the cleaning solution by machine, for example, in hot and cold water pressure cleaners, including steam and foam cleaning; or• soaking in liquid cleaner.

In most cases, the cleaning product as marketed needs to be diluted with water prior to application. The dilution factor, which is often on the label, depends on the type of surface to be cleaned, the soil loading, and the type and method of application. For example, in degreasing and oven cleaning a dilution factor up to 1:5 is often used; as a spray for floor and wall cleaning dilution ranges from 1:10 to 1:30, and as a wash for delicate surfaces dilution ranges from 1:20 to 1:100.


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Formulation of Brewery Cleaner

The notified chemical may be used as a dispersant in the formulation of brewery cleaner. Formulation is normally high alkaline aqueous solution containing 25-48% caustic soda and dispersant (up to 20%).

Ingredients are blended in a mixing vessel followed by batch adjustment and laboratory quality control testing. After filling of 1000 L isotainers or road tanker and road transport to the brewery, conductivity controlled dosing to vats or tanks occurs. Stainless steel vats or tanks are prerinsed with water then washed with the formulation. Waste water containing the formulation is recirculated, reclaimed and disposed of via trade waste sewer. Release to sewer occurs following pH control. Containers/road tankers are rinsed at suppliers site and containers are reused or recycled.

Good work practices minimise the probability of spillage occurring. The chemical or the formulation are non volatile therefore do not represent an emission hazard to atmosphere. Discharges to sewer are controlled by Local or State government environmental legislation.

Formulation of Agricultural Chemical

The manufacture of agricultural chemical formulations (using approximately 20% of the imported volume) is a simple mixing process and is the same as that described for the cleaning products. The notified chemical will be blended with agrochemical active ingredients (eg simazine or glyphosate) together with other surfactants, additives and solvents/water. No elevated temperatures or pressures are involved. The agricultural product is filled into containers and then warehoused for distribution to resellers.

5.3. Occupational exposure

Category of Worker

State No. Task Duration

Task Frequency

Exposure Controls Personal Protection

Consumer/Institutional/Industrial Cleaning

Transport and storage

Aqueous solution

(max 75%)

50 4 h/day 52 days/year Spill kits are carried on vehicles. Storage

warehouses are fully bunded and have effluent

traps

If required to clean up spill,

chemical resistant gloves

and safety goggles.

Warehouse Aqueous solution

(max 75%)

10 2 h/day 100 days/year

Storage warehouses are fully bunded and have

effluent traps

If required to clean up spill,

chemical resistant gloves

and safety goggles.

Process operator

Aqueous solution

(max 75%)

100 2.5 h/day 52 days/year Dedicated filling lines. Exhaust ventilation, eye

wash stations.

Long sleeve overalls, chemical

resistant gloves, safety goggles

and safety boots.


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Quality control

Aqueous solution

(max 20%)

5 1 h/day 52 days/year Analysis occurs in fume cupboards. Eyewash

stations.



and safety boots.

Packaging Formulated liquid (max

20%)

20 3 h/day 52 days/year Dedicated filling lines. Exhaust ventilation, eye

wash stations.



and safety boots.

End use Formulated liquid (max

20% in concentrate)

5000 0.5 h/day

365 days/year Containers fit for purpose. Appropriate labelling and

dilution instructions. Household products,

relatively small volume containers may contain

child-proof closures. May be corrosive solutions and

scheduled poisons/hazardous

substances

Dependent on formulation.

Eye protection must be

recommended if the

concentration of the notified

chemical is 5% or greater due to

its irritant nature.

Agricultural chemical production workersa) drum

handlingb) transfer

of chemical to mixer-insert & remove drum pump

c) filling of formulation into containers

Aqueous solution (max 75%)

50 (total)

4 20 Dedicated filling lines. Exhaust ventilation, eye

wash stations.



and safety boots.

Exposure during formulation of cleaning products or agricultural chemicals is likely to be limited to drips or spills while adding the concentrated solution to the mixing vessel, sampling and testing small amounts for quality control, drumming off and cleaning and maintenance of lines, mixing and dispensing machinery. Potential dermal and ocular exposure is likely to be prevented by the use of personal protective equipment. Local exhaust ventilation is employed to prevent inhalation exposure to fumes and aerosols.

There is a high likelihood of splashes and spills of the notified chemical when it is diluted for use and when it is used for cleaning. The probability of ocular exposure is dependent on work practices employed to minimise splashes and spills.

5.4. Release

RELEASE OF CHEMICAL AT SITE


5 May 2023 NICNAS

The notified chemical may be released during reformulation (both cleaning and agricultural applications) via spills (0.1%), drum residues (0.1%) and equipment washings (0.1%). Spilt material and washings will end up in the on-site wastewater pit or treatment plant, while the drums will either be collected by licensed waste contractors or reused by the company. In either case it is likely that the drums will be rinsed before leaving the site, with the rinsate going into the process or the on-site wastewater pit or treatment plant. The effluent from the wastewater pit or treatment plant will be released to sewer, generally after some form of treatment. Thus, a maximum of 0.3% (900 kg) of the notified chemical will be released to sewer presuming none is removed during treatment.

Direct release to soil is expected to be negligible during formulation. Some spills of the notified chemical may be absorbed with an absorbent and disposed of to landfill.

The process described above is a simple blending process conducted within a closed system. Consequently, release to the atmosphere is expected to be negligible.

RELEASE OF CHEMICAL FROM USEGiven the use pattern of the notified chemical, initial release is entirely expected to occur to the aquatic compartment. Assuming the maximum importation volume of up to 300 tonnes and all cleaning operations using the notified chemical occurring year round, the average daily releases will be as shown in the table below. This release is expected to be relatively diffuse, however, a large proportion of the release will occur in major coastal metropolitan centres.

Product Type Cleaners Agrochemicals All SpillsVolume Used (tonne/year)

240 (80%) 59.85 (19.95%) 0.15 (0.05%)

Release Rate 100% 20% 100%Release to Sewer

(tonne/year)240 14.37 0.15

Emission to sewer1 61.5 3.7 0.039PEC effluent2 30.8 1.85 0.020PEC water3 3.1 0.185 0.002

TOTAL PEC Water mg/L

3.3 mg/L per year (0.009 mg/L/d)

1. Emission to sewer is calculated as the emission rate (mg/year)/volume of wastewater. The volume of wastewater used is 3900 ML which assumes 200 L per person per day released to sewers Australia wide for a population of 19.5 million.

2. PEC effluent is the emission to sewer multiplied by the percentage removal from sewer. It is assumed that 0.5 is removed in the STP due to degradation.

3. PEC water is the PEC effluent divided by a dilution factor for receiving waters. As the majority of cleaning products are formulated and used in coastal areas (particularly major metropolitan centres) a dilution rate of 10 (ocean outfall) is used.

There may be localised release to soil in the event cleaning solutions are discarded directly to this compartment (eg, onto lawns or gardens), but this is not expected to be significant.

During application of agrochemicals direct release to soil of 80% of the import volume is expected (ie up to 59.9 tonnes).The nature of surfactants indicates they could associate with sludge due to hydrophobic moieties or remain in solution due to hydrophilic moieties. Consequently, once in the sewage treatment plant, the chemical may end up in receiving waters or associated with sludge where it could be incinerated, or in some cases, applied to agricultural land. In the above assessment it has been conservatively assumed that all the notified substance will end up in receiving waters.

5.5. DisposalDuring formulation, empty drums are sent to a drum recycler, while empty isotainers are returned to the manufacturer of the notified chemical.

From end use of the cleaning products, the majority of the notified chemical will be released to sewer


5 May 2023 NICNAS

and subsequently the aquatic environment. The notified chemical used in agrochemicals will subsequently be released to the environment, generally the soil.

In both cases the empty containers are likely to be flushed with water, which will go to sewer, and then disposed of in the general rubbish which will be disposed of to landfill.

5.6. Public exposureThe notified chemical may be sold to the public in formulations of up to 20% as part of domestic cleaning products.

Public exposure to the notified chemical (in products) as a result of transportation within Australia is unlikely unless there is an accident. The material safety data sheets (MSDS) supplied for the notified chemical have adequate instructions for clean-up and disposal of any accidental spills and therefore public exposure as a result of a transport accident is likely to be negligible.

AG 6206 will be reformulated in Australia to produce formulated products. Direct public exposure as a result of reformulation is considered to be negligible since adequate engineering controls and standard operating procedures largely prevent any significant release of the notified chemical into the immediate vicinity of the site of reformulation.

Since the notified chemical will be in products sold to the general public, widespread public exposure is expected. Members of the public are likely to make accidental dermal and possibly ocular contact with the notified chemical as a result of spills and splashes during dilution and use. During dilution of cleaning products, members of the public are likely to be exposed to the notified chemical at concentrations of less than 20%. During floor cleaning, members of the public are only likely to be exposed to the notified chemical at a concentration of 0.1-2%. As a worst case, it is estimated that floor cleaning will be conducted once per day every day of the year. Although public exposure is expected to occur frequently, the amounts to which people will be exposed is likely to be very small and the concentration of the notified chemical is low. At concentrations greater than 5%, products containing the notified chemical are classified as eye irritants. It is expected that cleaning products containing the notified chemical would carry appropriate directions to avoid contact with eyes as well as first aid directions.

Since cleaning products are stored and used in a domestic environment, there is the possibility of accidental ingestion by a child. The notified product is an acetal of a sugar structure, as such it is likely to break down in acidic environments (pH < 4) to fatty acid and glucose therefore it has a low acute oral toxicity. No adverse effects are expected as a result of ingestion of the notified chemical in the product.

The notified chemical may be released into the environment as a result of disposal of waste from reformulation, accidental spills during transport or disposal of diluted products and containers after use. The environmental releases are expected to be relatively small and most of the notified chemical released into the environment is expected to enter sewers where large dilutions are expected. Therefore, environmental concentrations are expected to be very low and indirect public exposure as a result of releases into the environment is expected to be negligible

6. PHYSICAL AND CHEMICAL PROPERTIES

The following test results describe the chemical and physical properties for a related alkyl glucoside. A partition coefficient test for the notified chemical has been conducted and the results are similar to those obtained for a related alkyl glucoside.

Appearance at 20oC and 101.3 kPa

Clear pale yellow liquid.

Melting Point/Freezing Point -5oC

METHOD Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.Remarks Conducted on a related alkyl glucoside (84% solid, 16% water).


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TEST FACILITY Huntingdon Research Centre (1993a)

Boiling Point 100oC at 101.3 kPa

Remarks Reported on MSDS

Density 1182.9 kg/m3 at 20oC (liquid)

METHOD Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.Remarks Conducted on a related alkyl glucoside (84% solid, 16% water). A test report is

not available for AG 6206 however in internal testing reported on the MSDS the density was 1170 kg/m3.


Vapour Pressure 510-8 kPa at 25oC.

METHOD Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.Remarks The vapour pressure of the notified chemical was determined using the vapour

pressure isoteniscope method on a sample of a related alkyl glucoside (84% solid, 16% water). The vapour pressure of a known mass of the sample was determined at various temperatures ranging from ambient to 250ºC. Extrapolation of the resulting vapour pressure/temperature curve was used to determine the vapour pressure of the substance at 25ºC. The value calculated suggests that the notified chemical is very slightly volatile.


Water Solubility 79% (w/w) at 20oC

METHOD Directive 84/449/EEC (OJ No. L251, 19.9.84), Part A, Methods A1-A17.Remarks Mixtures of the test substance (a related alkyl glucoside, 84% solid, 16% water) in

distilled water were prepared at concentrations between 5 and 95% (w/w). The resulting solutions were incubated at 30ºC for 30 min, mixed using a whirlimixer, ultrasonicated for 15 min and then allowed to equilibrate at 20ºC for 24 h. After 24 h, solutions containing the test substance at concentrations of below 79.273% (w/w) appeared clear and free flowing while those above this concentration were cloudy and immobile. Therefore, the solubility of the notified chemical as determined by visual assessment is equal to 79% (w/w).


Hydrolysis as a Function of pH Not determined

Remarks Saccharides such as the notified chemical are susceptible to hydrolysis under extremes of pH. However in the environmental pH range of 4-9, significant hydrolysis is unlikely to occur.

Partition Coefficient (n-octanol/water)

log Kow at 20oC = 1.1

METHOD EC Directive 92/69/EEC A.8 Partition Coefficient. (Shake Flask Method)Remarks The partition coefficient of the related alkyl glucoside was determined using the

shake flask method. A stock solution of the test substance (~0.3 g) in water saturated octanol (200 mL) was prepared. To aliquots (10, 20 and 40 mL) of this solution was added octanol saturated water (40 mL) and the resulting bi-phasic solutions were shaken mechanically for 15 min. The phases were separated by centrifugation at 3000 rpm for 15 min followed by analysis by HPLC to determine the concentration of the test substance in each phase. The ratio of these equilibrium concentrations was then used to calculate the partition coefficient. The value obtained is indicative of partitioning into the aqueous phase.



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Partition Coefficient (n-octanol/water)Notified Chemical

log Kow at 20oC = 1.72-1.77

METHOD EC Directive 92/69/EEC A.8 Partition Coefficient. (HPLC Method)Remarks The partition coefficient of the notified chemical was determined using the HPLC

method. An aliquot of the test substance (~0.1 g) was diluted to 20 mL with 50% aqueous methanol. In addition to this solution, standard solutions of 2-butanone, aniline, benzyl alcohol, benzonitrile, benzene and toluene were also prepared in methanol. A comparison of the retention time for the notified chemical against those obtained for the standards was used to calculate the partition coefficient. The value obtained is indicative of partitioning into the aqueous phase.

TEST FACILITY Safepharm (1998a)

Adsorption/Desorption Not determined.Remarks The notified chemical is surface active and contains both hydrophobic and

hydrophilic moieties. In contact with soil such molecules strongly adsorb to the soil particles and as such are not mobile in either terrestrial or aquatic compartments. The notified chemical is expected to behave in a similar manner.

Dissociation Constant Not determined.Remarks The notified chemical does not contain any acidic or basic groups.

Particle Size Not determined.

Remarks Test not conducted as the notified chemical is a liquid.

Flash Point > 110 oC

METHOD EC Directive 92/69/EEC A.9 Flash Point.Remarks Conducted on a related alkyl glucoside (84% solid, 16% water).TEST FACILITY Huntingdon Research Centre (1993a)

Flammability Limits Not flammable

Remarks The flammability limits were not determined, as the test substance could not be ignited with a flame under the conditions of the test. The notified chemical was not flammable under the conditions of the test.

TEST FACILITY Conducted on a related alkyl glucoside (84% solid, 16% water).Huntingdon Research Centre (1993a)

Autoignition Temperature Does not self-ignite up to a temperature of 450oC

METHOD 92/69/EEC A.15 Auto-Ignition Temperature (Liquids and Gases).Remarks No self ignition of the test substance was observed under the conditions of the test.TEST FACILITY Conducted on a related alkyl glucoside (84% solid, 16% water).

Huntingdon Research Centre (1993a)

Explosive Properties Not determined.

Remarks Test not conducted.

Reactivity

Remarks The notified chemical is expected to be stable under normal environmental conditions. No test of oxidising properties was performed, as the test method is not applicable to liquids. The notified chemical does not have any structural indications of oxidising properties of other unusual activity.

Viscosity 775 mPa.s


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Remarks Reported on the MSDS for AG 6206

Surface Tension 30.2 mN/m for a 1% (w/v) aqueous solution at 23oC

METHOD OECD harmonised ring method.Remarks The surface tension of the notified chemical was determined on a 1% (w/v)

aqueous solution of a related alkyl glucoside with a direct reading surface tension/torsion balance using the OECD harmonised ring method. The value indicates that the notified chemical is surface active.



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7. TOXICOLOGICAL INVESTIGATIONS

Most investigations were conducted with a close analogue (the same related alkyl glucoside used to test some physico-chemical properties) as indicated in the summary table below. Certain other investigations were conducted with AG6206 containing 75% of the notified chemical.

Endpoint and Result Assessment ConclusionRat, acute oral LD50 > 2000 mg/kg bw low toxicity (result for analogue)Rat, acute dermal LD50 > 2380 mg/kg bw low toxicity (result for analogue)Rabbit, skin irritation non-irritating (result for analogue)Rabbit, eye irritation severely irritating (results for analogue)Guinea pig, skin sensitisation - non-adjuvant test (Buehler).

no evidence of sensitisation (result for AG6206)

Rat, repeat dose toxicity – 28 day oral repeat dose NOAEL – 750 mg/kg/dayNOEL – 150 mg/kg/day.

(result for analogue)Genotoxicity - bacterial reverse mutation non mutagenic (result for AG6206)Genotoxicity – in vitro metaphase chromosome analysis of human lymphocytes

non genotoxic (result for AG6206)

7.1. Acute toxicity – oral

TEST SUBSTANCE Analogue.METHOD EC Directive 92/69/EEC B.1 Acute Toxicity (Oral).

Species/Strain Rat/CDVehicle Distilled waterRemarks – Method Oral gavage administration. Examinations included external appearance

and behaviour, bodyweight (day 1 prior to dosing, day 8 and day 15) mortality and macroscopic examination on Day 15.

RESULTS

Group Number and Sexof Animals

Dosemg/kg bw

Mortality

Control 10 (5 male, 5 female) 0 0Exposed 1 10 (5 male, 5 female) 2000 0Exposed 2 10 (5 male, 5 female) 5000 4 (2 male, female, all mortality

observed 5 hours after dosing).

LD50 > 2000 mg/kg bwSigns of Toxicity Pilo-erection, hunched posture, waddling, lethargy, decreased respiratory

rate, ptosis (only in 5 g/kg group), pallor of extremities, ataxia (5 g/kg group only), prostate (only in 5 g/kg group). A bodyweight loss was recorded for one female dosed at 2.0 g/kg on Day 8; slightly low bodyweight gains were recorded on Day 8 for two males dosed at 2 g/kg and one male treated at 5 g/kg; these rats achieved anticipated gains on Day 15.

Effects in Organs No abnormalities were recorded at the macroscopic examination on day 15. No histopathology evaluation was conducted.

CONCLUSION The notified chemical is of low toxicity via the oral route.

TEST FACILITY Huntingdon Research Centre (1992a).

7.2. Acute toxicity – dermal


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TEST SUBSTANCE Analogue.METHOD EC Directive 84/449/EEC B.3 Acute Toxicity (Dermal) – Limit Test.

Species/Strain Rat/CDVehicle None.Type of dressing Occlusive.Remarks – Method One day prior to treatment hair was removed from the dorso-lumbar

region of each rat with electric clippers (approximately 10% of total body surface), 24-hour exposure period. No control animals were included in this study. Observations included irritation, bodyweights, clinical signs and macroscopic examination.

RESULTS


Dosemg/kg bw

Mortality

1 10 (5 males, 5 females) 2380 0

LD50 > 2380 mg/kg bwSigns of Toxicity - Local No signs of irritation, no clinical signs of toxicity, slight changes in

bodyweight gains (low) were recorded for 4 males and 5 females on Day 8 and for 3 of these females on Day 15.

Signs of Toxicity - Systemic NoneEffects in Organs NoneRemarks – Results None

CONCLUSION A structurally similar chemical to the notified chemical is of low toxicity via the dermal route and the notified chemical is likely to have a low order of toxicity via the dermal route.

TEST FACILITY Huntingdon Research Centre (1993b).

7.3. Acute toxicity – inhalationData not provided.

7.4. Irritation – skin

TEST SUBSTANCE Analogue

METHOD EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).Species/Strain Rabbit/New Zealand White.Number of Animals 3Vehicle None.Observation Period 72 hours.Type of Dressing Semi-occlusive.Remarks – Method 0.5 ml of test substance applied for four-hour period. Animals assessed

for clinical signs, and dermal responses.

RESULTS

Lesion Mean Score*Animal No.

Maximum Value Maximum Duration of Any

Effect

Maximum Value at End of

Observation Period

1 2 3Erythema/Eschar 0 0 0 0 0 0Oedema 0 0 0 0 0 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.


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Remarks – Results No irritation observed, no clinical signs observed.

CONCLUSION A structurally similar chemical is non-irritating to skin and thus the notified chemical is likely to be non-irritating to skin.


7.5. Irritation – eye


METHOD EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).Species/Strain Rabbit/New Zealand WhiteNumber of Animals 1Observation PeriodRemarks – Method 0.1 ml was placed into the lower everted lid of one eye then eyelids held

together for one second before releasing. Clinical signs and ocular responses were evaluated.

RESULTS Dulling of the cornea and neo-vascularisation was observed one hour after instillation and was still present on day 21. Iridial inflammation was observed one, two and three days after instillation. Conjunctival irritation was still present on day 21 and some injection of blood vessels to diffuse redness with or without slight to obvious swelling was observed.

Lesion Mean Score*Animal No.

Maximum Value

Maximum Duration of Any

Effect

Maximum Value at End of Observation

Period1 2 3

Conjunctiva: redness 2 2 21 days 1Conjunctiva: chemosis 2 2 7 days 0Conjunctiva: dischargeCorneal opacity 2 3 21 days 3Iridial inflammation 1 1 3 days 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

CONCLUSION A structurally similar chemical is severely irritating to the eye thus the notified chemical is expected to be severely irritating to the the eye.

TEST FACILITY Huntingdon Research Centre (1992c).

7.6. Skin sensitisation

TEST SUBSTANCE Notified chemical (AG6206).

METHOD OECD TG 406 Skin Sensitisation - Buehler Delayed Contact.Species/Strain Guinea pig/Dunkin HartleyPRELIMINARY STUDY Maximum Non-irritating Concentration: undiluted

Topical induction: undilutedTopical challenge: undiluted

MAIN STUDYNumber of Animals Test Group: 20 Control Group: 10Induction phase Induction Concentration: undilutedSigns of Irritation None

CHALLENGE PHASE1st challenge Topical application: undiluted2nd challenge Topical application: not conducted

Remarks – Method Topical induction, elicitation, no positive control.


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RESULTS No skin reactions were noted at challenge sites at any observation period (day 1-30).

Animal Challenge Concentration Number of Animals ShowingSkin Reactions after:

1st challenge 2nd challenge24 h 48 h 24 h 48 h

Test Group 0 0 0 0

Control Group 0 0 0 0

CONCLUSION There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test.

TEST FACILITY Safepharm (1998b).

7.7. Repeat dose toxicity

TEST SUBSTANCE Analogue.

METHOD The method followed was that outlined in Annex V, Part B, Method B7 in the EEC Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals No. 407, “Repeated Dose Oral Toxicity – Rodent: 28-day or 14 – day study”.

Species/Strain Rat / Sprague-DawleyRoute of Administration Oral – gavage.

Exposure Information Total exposure days: 28 days;Dose regimen: 7 days per week;Post-exposure observation period: - All animals were killed andexamined macroscopically on day 29.

Vehicle Distilled water.Remarks – Method No significant protocol deviations.

RESULTS


Dosemg/kg bw/day

Mortality

I (control) 5 male, 5 female 0 (distilled water) 0II (low dose) 5 male, 5 female 15 mg/kg/day 0III (mid dose) 5 male, 5 female 150 mg/kg/day 0IV (high dose) 5 male, 5 female 750 mg/kg/day 0

V (control recovery)VI (high dose recovery)

Mortality and Time to DeathNo mortality was observed during treatment period.

Clinical ObservationsThree female rats receiving 750 mg/kg/day had a thin looking appearance throughout week 3. Overall bodyweight gain was lower than control for females receiving 750 mg/kg/day. Slightly lower than control food consumption was recorded for females receiving 750 mg/kg/day.

Laboratory Findings – Clinical Chemistry, Haematology, UrinalysisDifferences from control seen in haematology, biochemistry, macroscopic and microscopic pathology were not considered to be treatment related.

Effects in Organs


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Higher than control liver weight (bodyweight adjusted) was recorded for males treated at 750 mg/kg/day, but this finding was not associated with histopathological or biochemical change.

Remarks – ResultsIn this sub-acute rat toxicity study with the analogue, lower food consumption and hence bodyweight gains for female rats from the high dosage group was thought to be treatment related. Some of these female rats were reported as being clinically thin during week 3. However the final bodyweight of the rats was comparable to that of controls and the rats were otherwise healthy.

Higher than control liver weights were recorded for the high dosage male group. Although this finding may possibly be adaptive in nature it was not considered to be of toxicological importance in view of the absence of histopathological or biochemical changes.

Considering the above findings 750 mg/kg/day was rejected as a no effect level (NOEL) for the notified chemical in the rat, but was considered to represent the no adverse effect level (NOAEL).

No effects considered to be related to treatment were seen in rats treated at 150 or 15 mg/kg/day.

CONCLUSIONThe No Observed (Adverse) Effect Level (NO(A)EL) was established as 750 mg/kg bw/day in this study, based on there being no treatment related toxic effects observed in rats treated with the highest dose.

TEST FACILITY Huntingdon (1994).

7.8. Genotoxicity – bacteria

TEST SUBSTANCE Notified chemical (AG6206).

METHOD OECD TG 471 Bacterial Reverse Mutation Test.Species/Strain S. typhimurium:

TA1535, TA1537, TA98, TA100.E. coli: WP2 uvrA,

Metabolic Activation System S9Concentration Range inMain Test

a) With metabolic activation: 0 - 5000 g/plate.b) Without metabolic activation: 0 - 5000 g/plate.

Vehicle NonePhysical Form Amber viscous liquid.Remarks – Method Positive and negative controls were utilised appropriately. No

cytotoxicity was observed at 5000 g/plate in preliminary test.

RESULTS

Metabolic Activation

Test Substance Concentration (µg/plate) Resulting in:Cytotoxicity in

PreliminaryTestCytotoxicity in

Main TestPrecipitation Genotoxic Effect

PresentTest 1 None None None NegativeTest 2 None None NegativeAbsentTest 1 None None None NegativeTest 2 None None Negative

Remarks – Results No toxicity was exhibited to any of the strains of bacteria used. No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation.

CONCLUSION The notified chemical was not mutagenic to bacteria under the conditions of the test.


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TEST FACILITY Huntingdon Research Centre (1998c).

7.9. Genotoxicity – in vitro


METHOD OECD TG 473 In vitro Mammalian Chromosomal Aberration Test.Cell Type/Cell Line Human lymphocytes.Metabolic Activation System

S9

Vehicle NonePhysical Form Liquid


Test Substance Concentration (μg/mL) Exposure Period

HarvestTime

PresentTest 1 625, 2500, 5000 18 hours 18 hoursTest 2 312.5, 1250, 2500 32 hours 32 hoursAbsentTest 1 156.3, 625, 1250 18 hours 18 hoursTest 2 131.3, 525, 1050 32 hours 32 hours*Cultures selected for metaphase analysis.

RESULTS


Test Substance Concentration (µg/mL) Resulting in:Cytotoxicity in

PreliminaryTestCytotoxicity in

Main TestPrecipitation Genotoxic Effect

PresentTest 1 5000 - NegativeTest 2 - - NegativeAbsentTest 1 1250 - NegativeTest 2 525 - Negative

Remarks – Results No evidence of clastogenic activity in human lymphocytes cultured in vitro.

CONCLUSION The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test.



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8. ENVIRONMENT

8.1. Environmental fate

8.1.1. Ready biodegradability

8.1.1.1. Test 1

TEST SUBSTANCE AG 6206

METHOD OECD TG 301 D Ready Biodegradability: Closed Bottle Test.Inoculum Secondary activated sludgeExposure Period 28 dayAuxiliary Solvent Deionising waterAnalytical Monitoring Electrochemistry, pH.Remarks – Method Sodium acetate was used as a reference substance.

RESULTS

Test substance Sodium acetateDay % degradation Day % degradation

0 0 07 50 7 8014 63 14 8521 71 2128 71 28

Remarks – Results The reference substance met all requirements, thus indicating the study was valid. The test substance was 71% biodegraded at day 28 in the Closed Bottle test. However, according to Guideline 301D, the substance cannot be considered to be readily biodegradable as from the graph it appears to have failed to satisfy the 10 day window criterion whereby 60% degradation must be attained within 10 days of the degradation exceeding 10%. However, a literature report (Garcia, 1997) confirms the ready biodegradability of alkylglucosides in both the OECD closed bottle and modified screening tests.

CONCLUSION The notified chemical is not ready biodegradable but can be considered to be inherently biodegradable.

TEST FACILITY Akzo Nobel Central Research Arnhem (1997).

8.1.1.2. Test 2


METHOD OECD TG 301 D Ready Biodegradability: Closed Bottle Test.Inoculum Secondary activated sludgeExposure Period 28 dayAuxiliary Solvent Deionising waterAnalytical Monitoring Electrochemistry, pH.Remarks – Method The test method was modified to allow for increased measurements to

better test for the 10-day window criterion. Sodium acetate was used as a reference substance.

RESULTS


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Test substance Sodium acetateDay % degradation Day % degradation

0 0 0 03 4 3 -7 42 7 6110 42 10 -14 67 14 7017 71 17 -21 67 2124 71 2428 71 28

Remarks – Results The test conditions (pH and temperature) remained within appropriate ranges. The reference substance met all requirements, thus indicating the study was valid. The test substance was 71% biodegraded at day 28 in the Closed Bottle test and satisfied the 10-day window criterion whereby 60% degradation must be attained within 10 days of the degradation exceeding 10% (64% was achieved).

CONCLUSION The notified chemical is ready biodegradable.

TEST FACILITY Akzo Nobel Central Research Arnhem (2004).

8.1.1.3 Test 3


METHOD Biodegradability in Seawater test OECD 306Inoculum Nutirient fortified seawaterExposure Period 28 dayAuxiliary Solvent Sea waterAnalytical Monitoring O2 ElectrodeRemarks – Method A predetermined amount of the test compound is dissolved in test

medium (nutrient-fortified sea water) to give a test concentration of 2-10 mg/L. Solutions are incubated in filled closed bottles in the dark at 20 C. Biodegradation is followed by oxygen analyses over a 28 day period.Sodium benzoate was used as a reference substance.

RESULTS

Test substance Sodium BenzoateDay % degradation Day % degradation

0 0 0 05 63.5 5 62.915 70 15 7428 66.9 28 69.8

Remarks – Results With in 3-7 days the biodegradation of the reference substance (sodium benzoate) had exceeded 50%, so the study was valid.Biodegradation of the test substance reached 70% on day 15 and by day 28 it was 66.9%.

CONCLUSION The notified chemical is readily biodegradable in seawater after 28 days.

TEST FACILITY TERRA Environment Norway (1998).


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8.1.2. BioaccumulationNo study available. It is unlikely to bioaccumulate as it is unlikely to partition to fat given the log Pow of 1.7 and is inherently biodegradable.

8.2. Ecotoxicological investigations

The following ecotoxity data were provided by the notifier.

8.2.1. Acute toxicity to fish

TEST SUBSTANCE AG 6206 (75% notified chemical)

METHOD OECD TG 203 Fish, Acute Toxicity Test – Rainbow trout, semistatic conditions.

Species Rainbow trout Oncorhynchus mykissExposure Period 96 hourAuxiliary SolventWater Hardness 100 mg CaCO3/LAnalytical Monitoring NoneRemarks – Method Actual concentrations not measured, daily renewal of test water, fish were

not fed during exposure. Observations on abnormal behaviour and mortality were conducted at 3 and 6 hours and then at 24 hours intervals until the end of the study. Water temperature was 14oC, the DOC was 9.4 mg/L or greater and a 16 hours light and 8 hours dark luminescence cycle was maintained.

RESULTS

Concentration mg/L Number of Fish MortalityNominal(ai) Actual 3 h 24 h 48 h 72 h 96 h

180 - 10 0 0 0 0 0320 - 10 0 0 0 0 0560 - 10 0 0 10 10 101000 - 10 0 0 10 10 101800 - 10 0 10 10 10 10

LC50 420 mg/L at 96 hours (95% C.I. 320-560 mg/L) (notified chemical).NOEC 180 mg/L at 96 hours.Remarks – Results The LC50 was determined by the Thompson’s (1947) moving averages

method.

CONCLUSION The notified chemical is slightly toxic to fish

TEST FACILITY Safepharm (1998d)

8.2.2. Acute toxicity to aquatic invertebrates


METHOD OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction test, static test conditions.

Species Daphnia magnaExposure Period 48 hoursAuxiliary SolventWater Hardness 250 mg CaCO3/LAnalytical Monitoring NominalRemarks – Method 2 replicates of 10 daphnids were exposed to an aqueous dispersion of the


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test material at nominal concentrations of 18, 32, 56, 100, 180, 320, 560, 1000 and 1800 mg/l for 48 hours under static test conditions. The test was conducted under static conditions with a photoperiod of 16 hours light and 8 hours dark and at a temperature of 21oC. The daphnia were not fed during the study. The concentration of the test substance in each test solutions was not determined.

RESULTS

Concentration mg/L Number of D. magna % ImmobilisedNominal(ai) Actual 24 h 48 h

18 - 10 0 032 - 10 0 056 - 10 0 0100 - 10 0 0180 - 10 0 0320 - 10 0 15560 - 10 0 651000 - 10 0 951800 - 10 0 100

LC50 490 mg/L at 48 hours (95% C.I. 420-580 mg/L) (notified chemical).NOEC 180 mg/L at 48 hours

Remarks – Results The results are based on nominal concentrations. The LC50 was determined by the Thompson’s (1947) moving averages method.

CONCLUSION The notified chemical is very slightly toxic to Daphnia magna.

TEST FACILITY Safepharm (1998e).

8.2.3. Algal growth inhibition test

TEST SUBSTANCE AG 6206 (75% notified chemical).

METHOD OECD TG 201 Alga, Growth Inhibition Test

Species Scenedesmus subspicatusExposure Period 72 hoursConcentration RangeNominal

62.5, 125, 250, 500 and 1000 mg ai/L (three replicate flasks per concentration)

Remarks – Method The nominal cell density in the test vessels was 104 cells/mL. The vessels were covered, incubated at 24oC, continuously illuminated and shaken at 100 rpm for 72 hours.

Biomass Growth NOECEbC50

mg/L at 72 hErC50

mg/L at 72 hmg/L at 72 h

180 780 Not determined

CONCLUSION The notified chemical is very slightly toxic to algae.

TEST FACILITY Safepharm (1998f).


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8.2.4 Assessment of Inhibition of Nitrification of Activated Sewage Sludge


METHOD ISO Guidelines No 9509 Method for Assessing the Inhibition of Nitrification of Activated Sewage Sludge

Remarks – Method Allylthioureas was used as a reference substance.

An aliquot of either the test or reference substance was laced in a 500 mL conical flask. 1225 mL of deionised water was then added to the flask followed by 125 mL of washed activated sewage sludge. The mixtures were aerated at 0.5-1 L/min, and the flasks were maintained at a temperature of 21oC under normal laboratory lighting. After 4 hours contact the contents of each flask was filtered after which ammonium, nitrite and nitrate analysis was done.

RESULTS 4 hour EC50 > 1000 mg ai/LNOEC 1000 mg/L

CONCLUSION The notified chemical has not significant effect on the nitrifying activity of activated sewage sludge.

TEST FACILITY Safepharm (1998g).


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9. RISK ASSESSMENT

9.1. Environment

9.1.1. Environment – exposure assessmentReleaseThe notified chemical will eventually be released into the environment with approximately 80% being discharged into sewerage systems and approximately 20% being released through washing agricultural use. A small amount may go to landfill in disposed end-user containers.

FateCleaning applications:

Assuming that 80% of the importation volume is used and that all cleaning operations occur throughout the year and are conducted nationwide, the worst case predicted environmental concentration is:

Amount released to sewer 240 tonnesWater used per person 200 LAustralian population 19.5 millionNumber of days used 365 daysConcentration in the STPs effluent 2.4 × 1011/(200)(19.5 × 106)(365) = 0.17 mg/L

For that proportion of the chemical which reaches sewage treatment plants (ie is not volatilised or otherwise destroyed during passage to the plant), the proportions of the chemical which partition into the different environmental compartments may be estimated using the Simple Treat Model (EEC Technical Guidance Document, 1996). These estimates, based on the chemical having a calculated Henry’s constant of 2.2785 × 10-8 Pa/m3/mole based on measured vapour pressure and water solubility, a Log Pow of 1.7 and exceeding 60% biodegradation level within 28 days, indicate that the chemical would be expected to partition into the air, water and sewer sludge compartments and the amount degraded as follows:

Air 0%Water 33%Sewage Sludge 0%Degraded 67%

Accordingly, at equilibrium most of the notified chemical will degrade and the remainder will reside in the aqueous compartment where the modified PEC is 0.056 mg/L.

This release is expected to be relatively diffuse and widespread. There may also be localised release to soil in the event cleaning solutions are discarded directly to this compartment (eg, onto lawns or gardens) from wall cleaning or the disposal to landfill of rags used to clean ovens. While this is not expected to be significant, release of the notified chemical via these uses will serve to further reduce the value of the PEC calculated above.

The nature of surfactants indicates they could associate with sludge due to hydrophobic moieties or remain in solution due to hydrophilic moieties. Consequently, once in the sewage treatment plant, the chemical may end up in receiving waters or associated with sludge where it could be incinerated, or in some cases, applied to agricultural land. In the above assessment it has been conservatively assumed that all the notified substance will end up in receiving waters.

Any residual notified chemical disposed of into landfill in empty end-user containers may be mobile, due to its water solubility, but is expected to be slowly adsorbed to soil/sediment particles and be degrade due to biotic and abiotic processes.

Agricultural applications:

During application of agrochemicals direct release to soil of 20% (up to 60 tonnes) of the import volume is expected. Assuming a maximum level of 20% in a concentrate formulation, which is applied at a usage rate of 5 L per hectare, the application rate for the notified chemical is 1 L per hectare or 1170 gram per hectare of notified substance (specific gravity 1.17). In soil, assuming that the applied preparation is distributed in the top 10 cm over one


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hectare, the EEC would be 1170 g in 1,300,000 kg of soil would be 0.9 mg/kg of soil. In soil the notified chemical will degrade due to biotic and abiotic processes.Due to its low partition coefficient (1.1) the notified chemical is not expected to bioaccumulate.

9.1.2. Environment – effects assessmentThe results of the ecotoxicological data indicate the notified chemical is slightly toxic to fish and only very slightly toxic to Daphnia and algae, and not toxic to activated sewage sludge microorganisms. The most sensitive species is algae where the EbC50 is 180 mg/L.

A predicted no effect concentration (PNEC) can be determined when at least one acute EC50 for each of the three trophic levels is available (ie. fish, Daphnia, algae). The PNEC is calculated by dividing the LC50 or EC50 value of the most sensitive species in this case by an assessment safety factor of either 100 (OECD) or 1000 (EU). Using a worst case scenario safety factor of 100, since results for fish, daphnia and algae are available, the PNEC for the notifier polymer is 1.8 mg/L.

Under the OECD GHS characterisation scheme, the notified chemical should be not considered as ‘Harmful to Aquatic Life’.

9.1.3. Environment – risk characterisationDue to the proposed use pattern the notified chemical will be released into the environment, either the aquatic or the terrestrial. With its high water solubility, the notified chemical will be mobile in both aquatic and terrestrial compartment. However as a consequence of its surfactant characteristic, it is expected to eventually associate with soil and sediment. It is readily biodegradable, so will degrade through biological and abiotic processes to water and oxides of carbon.

The worst case PEC/PNEC ratio for the aquatic environment, assuming nationwide use, is 0.1. This value is significantly less than 1, indicating no immediate concern to the aquatic compartment.

Based on the indicated use patterns and its dispersed release, the likely risk to the environment is expected to be low.

9.2. Human health

9.2.1. Occupational health and safety – exposure assessmentTransport and storage workers are unlikely to be exposed unless containers are ruptured in an accident.

Process workers involved in producing cleaning products will use largely closed systems for introducing the imported concentrated solution into mixing vessels and filling the final products into containers. Some drips and spills can be expected and the notifier indicates that protective clothing, gloves and safety goggles will be worn. Exhaust ventilation is used to control exposure to aerosols and vapours. Quality control technicians perform tests on small amounts of product in fume cupboards and wear the same PPE as the process workers.

End users will typically be exposed to the notified chemical at a maximum concentration of 20% but the concentrate may be diluted further for use. If used neat there is potential for direct eye contact or transmission from the hands.

End users of agricultural chemicals containing the notified chemical at a maximum of 8% will dilute it further prior to spraying. The notifier indicates that protective clothing, gloves and safety goggles will be employed to control exposure.

9.2.2. Public health – exposure assessmentThe public will be using cleaning products containing up to 20% notified chemical. Duration of exposure to the concentrate should be approximately 10 minutes/day at most while it is diluted for use. Exposure of skin and secondary transmission from hand to eye is possible at this time.


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Once the notified chemical is diluted for use, it is at 0.1 – 2% and more extensive skin contact is likely. The likelihood of transmission from hand to eye is also increased.

Since the cleaning products are stored in a domestic environment, accidental ingestion (particularly by children) is possible.

The notified chemical may be released to the environment from disposal of waste, accidental transport spills or disposal of emptied containers and diluted product after use. However, indirect exposure to the public is expected to be very low either because of limited access to landfill or to accident sites or to large dilution in the environment.

9.2.3. Human health - effects assessmentGiven the results of toxicity studies on a close analogue as well as the chemical itself, the notified chemical is likely to be of low toxicity via the oral and dermal routes, is not a skin irritant or a skin sensitiser, is not likely to exhibit systemic effects on repeated or prolonged exposure and is not likely to be genotoxic. However, the notified chemical is a severe eye irritant.

The notified chemical would be classified as a hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999) and is assigned the risk phrase R41: risk of serious eye damage.

9.2.4. Occupational health and safety – risk characterisationThe primary hazard of the notified chemical is severe eye irritation. The imported formulation and the 20% concentrate produced for industrial and agricultural use are also severe eye irritants. Therefore, there is a risk of serious eye damage from splashes or from secondary transfer to eyes from hands or gloves and eye protection is required to minimise this risk particularly when the concentrate is used undiluted.

9.2.5. Public health – risk characterisation

There is a risk of serious eye damage during dilution of cleaning products for use although this is expected to occur infrequently (10 minutes/day). Nevertheless, given the consequences of eye contact, eye protection should be employed.

The risk of adverse health effects is expected to be low from use of the diluted chemical in domestic situations or from accidental ingestion as the notified chemical is not expected to be an eye irritant in the diluted form and is not harmful if ingested. However, scenarios of accidental ingestion by children may involve spillage of product with the potential for ocular contact.

10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS

10.1. Hazard classificationBased on the available data the notified chemical is classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous Substances. The classification and labelling details are:

R41: Risk of serious eye damage.

10.2. Environmental risk assessmentOn the basis of the PEC/PNEC ratio the chemical is not considered to pose a risk to the environment based on its reported use patterns.

10.3. Human health risk assessment

10.3.1. Occupational health and safetyThere is Low Concern to occupational health and safety under the conditions of the occupational settings described provided eye protection is employed when working with


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concentrates.

10.3.2. Public healthThere is Low Concern to public health when used as described provided eye protection is worn while the concentrated solution is diluted or if it is used neat.

11. MATERIAL SAFETY DATA SHEET

11.1. Material Safety Data SheetThe MSDS of a product containing the notified chemical provided by the notifier was in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC, 1994a). It is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant.

11.2. LabelThe label for a product containing the notified chemical provided by the notifier was in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances (NOHSC, 1994b). The accuracy of the information on the label remains the responsibility of the applicant.

12. RECOMMENDATIONS

REGULATORY CONTROLSHazard Classification and Labelling

The NOHSC Chemicals Standards Sub-committee should consider the following health hazard classification for the notified chemical: R41: Risk of serious eye damage

Use the following risk phrases for products/mixtures containing the notified chemical: > 10% : R41: Risk of serious eye damage 5 – 10%: R36 Irritating to eyes

Products containing more than 10% notified chemical and available to the public must carry the following safety directions on the label: Risk phrases: R41, Risk of serious eye damage Safety phrases: S26, In case of contact with eyes, rinse immediately with plenty

of water and seek medical adviceS39, Wear eye/face protection

The National Drugs and Poisons Standing Committee (NDPSC) should consider the notified chemical for listing on the SUSDP.

– Warning Statements: 5: Irritant79: Will irritate eyes

– Safety Directions: 1: Avoid contact with eyes3: Wear eye protection when mixing or using6: Wash hands after use

– First Aid: If in eyes, hold eyes open, flood with water for at least 15 minutes and see a doctor.

CONTROL MEASURESOccupational Health and Safety

Employers should ensure that the following personal protective equipment is used by


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workers to minimise occupational exposure to the notified chemical as introduced, as diluted for use or in products:

– Protective clothing and footwear, impervious gloves and safety glasses or face shield.

Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.

A copy of the MSDS should be easily accessible to employees.

If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation.

Environment

The following control measures should be implemented by the manufacture to minimise environmental exposure during use of the notified chemical: Clear labelling indicating dilutions and potential hazards if not diluted.

Disposal

The pure notified chemical should be disposed of by landfill or by incineration. Preparations (products) containing the notified chemical, which are not going to be sold or used, should be disposed of to landfill or by incineration. At no time should they be applied directly to water or land.

Emergency procedures

Spills/release of the notified chemical should be handled by containment and the application of an absorbant (eg sand or straw).

12.1. Secondary notificationThe Director of Chemicals Notification and Assessment must be notified in writing within 28 days by the notifier, other importer or manufacturer:

The Director of Chemicals Notification and Assessment must be notified in writing within 28 days by the notifier, other importer or manufacturer:

(1) Under Section 64(2) of the Act: if any of the circumstances listed in the subsection arise.

The Director will then decide whether secondary notification is required.

No additional secondary notification conditions are stipulated.

13. BIBLIOGRAPHY

Akzo Nobel Central Research (1997) Biodegradability of AG6206 in the Closed Bottle Test. Project No. RGL F97098 T97006 C. Akzo Nobel Central Research, Arnhem, The Netherlands (unpublished report submitted by the notifier).

Akzo Nobel Central Research (2004) Biodegradability of AG6206 in the Closed Bottle Test. Project No. CER F04007 T03023 C. Akzo Nobel Central Research, Arnhem, The Netherlands (unpublished report submitted by the notifier).


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Balzer D (1997) “Alkyl polyglucosides” In Specialist Surfactants Chapter 7. Ed. Robb I D. Blackie Academic and Professional, Chapman and Hall, UK.

European Commission (1996) Technical Guidance Document in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances – Part III.

Garcia MT, Ribosa I, Campos E, Sanchez Leal J (1997) Ecological Properties of Alkylglucosides, Chemosphere, 35, 545.

Huntingdon Research Centre (1992a) Acute Oral Toxicity to the Rat. Project No. 911021D/KND 54/AC. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1992b) Skin Irritation to the Rabbit. Project No. 920058D/KND 55/SE. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1992c) Eye Irritation to the Rabbit. Project No. 920059D/KND 56/SE. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1993a) Physico-chemical properties. Project No. KND76/931443. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1993b) Acute Dermal Toxicity to the Rat. Project No. KND 73/930839/AC. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1993c) Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro. Project No. KND 72/931182. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

Huntingdon Research Centre (1994) Twenty Eight Day Oral Toxicity Study in the Rat. Project No. KND 69/931043. Huntingdon Research Centre Ltd, Cambridgeshire, England (unpublished report submitted by the notifier).

National Occupational Health and Safety Commission (1994a) National Code of Practice for the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Australian Government Publishing Service, Canberra.

National Occupational Health and Safety Commission (1994b) National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)]. Australian Government Publishing Service, Canberra.

NOHSC (1999) National Occupational Health and Safety Commission (1999): Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)]. Australian Government Publishing Service, Canberra.

Safepharm (1998a) AG 6206: Determination of Partition Coefficient. SPL Project Number 142/345. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Safepharm (1998b) AG 6206: Buehler Delayed Contact Hypersensitivity Study in the Guinea Pig. SPL Project Number 142/337. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Safepharm (1998c) AG 6206: Reverse Mutation Assay “Ames Test” Using Salmonella typhimurium and Escherichia coli. SPL Project Number 142/338. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Safepharm (1998d) AG 6206: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss). SPL Project Number 142/325. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Safepharm (1998e) AG 6206: Acute Toxicity to Daphnia magna. SPL Project Number 142/326. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).


5 May 2023 NICNAS

Safepharm (1998f) AG 6206: Algal Inhibition Test. SPL Project Number 142/327. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Safepharm (1998g) AG 6206: Assessment of Inhibition of Nitrification of Activated Sewage Sludge. SPL Project Number 142/328. Safepharm Laboratories Limited, Derby, UK (unpublished report submitted by the notifier).

Terra Environment (1998) Assessment of Aerobic Biodegradability in Seawater of AG6206. Test Ref No. 60431.Akn/1216/biodeg. Terra Environment, Bergen, Norway (unpublished report submitted by the notifier).


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