STD/1033 - Home - NICNAS Web viewThis Assessment has been compiled in accordance with the provisions of the

File No: STD/1033

22 June 2006

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)

FULL PUBLIC REPORT

Poly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C16-18 and C18-unsatd. acyl) derivs., Me sulfates (salts)

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:

LibraryAustralian Safety and Compensation Council25 Constitution AvenueCANBERRA ACT 2600AUSTRALIA

To arrange an appointment contact the Librarian on TEL + 61 2 6279 1162 or email [email protected]

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

DirectorNICNAS

TABLE OF CONTENTS

FULL PUBLIC REPORT........................................................................................................................................51. APPLICANT AND NOTIFICATION DETAILS.....................................................................................52. IDENTITY OF CHEMICAL.....................................................................................................................53. COMPOSITION........................................................................................................................................64. INTRODUCTION AND USE INFORMATION......................................................................................75. PROCESS AND RELEASE INFORMATION.........................................................................................7

5.1. Distribution, transport and storage...................................................................................................75.2. Operation description.......................................................................................................................75.3. Occupational exposure.....................................................................................................................75.4. Release.............................................................................................................................................85.5. Disposal............................................................................................................................................85.6. Public exposure................................................................................................................................8

6. PHYSICAL AND CHEMICAL PROPERTIES........................................................................................97. TOXICOLOGICAL INVESTIGATIONS...............................................................................................12

7.1. Acute toxicity – oral.......................................................................................................................127.2. Acute toxicity – dermal..................................................................................................................137.3. Acute toxicity – inhalation.............................................................................................................137.4.1 Irritation – skin...............................................................................................................................137.4.2 Irritation – skin...............................................................................................................................137.4.3 Irritation – skin - human volunteers...............................................................................................147.5.1 Irritation – eye................................................................................................................................147.5.2 Irritation – eye................................................................................................................................157.6.1 Skin sensitisation............................................................................................................................167.6.2 Skin sensitisation............................................................................................................................177.7. Repeat dose toxicity.......................................................................................................................177.8 Genotoxicity – bacteria..................................................................................................................187.9 Genotoxicity – in vivo....................................................................................................................19

8. ENVIRONMENT....................................................................................................................................208.1. Environmental fate.........................................................................................................................20

8.1.1. Ready biodegradability..............................................................................................................208.2. Ecotoxicological investigations......................................................................................................20

8.2.1. Acute toxicity to fish.................................................................................................................208.2.2. Acute toxicity to aquatic invertebrates......................................................................................218.2.3. Algal growth inhibition test.......................................................................................................22

9. RISK ASSESSMENT..............................................................................................................................239.1. Environment...................................................................................................................................23

9.1.1. Environment – exposure assessment.........................................................................................239.1.2. Environment – effects assessment.............................................................................................249.1.3. Environment – risk characterisation..........................................................................................24

9.2. Human health.................................................................................................................................249.2.1. Occupational health and safety – exposure assessment............................................................249.2.2. Public health – exposure assessment.........................................................................................259.2.3. Human health – effects assessment...........................................................................................259.2.4. Occupational health and safety – risk characterisation.............................................................269.2.5. Public health – risk characterisation..........................................................................................26

10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS..........................................................................................................................................................27

10.1. Hazard classification......................................................................................................................2710.2. Environmental risk assessment......................................................................................................2710.3. Human health risk assessment........................................................................................................27

10.3.1. Occupational health and safety.............................................................................................2710.3.2. Public health.........................................................................................................................27

11. MATERIAL SAFETY DATA SHEET..............................................................................................2711.1. Material Safety Data Sheet.............................................................................................................2711.2. Label...............................................................................................................................................27

12. RECOMMENDATIONS....................................................................................................................2812.1. Secondary notification....................................................................................................................29

13. BIBLIOGRAPHY...............................................................................................................................29

Created on 20/02/2002 2:11 PM Last Saved 23/07/2015 12:30:00AM

FULL PUBLIC REPORT

2006 NICNAS

FULL PUBLIC REPORT

Poly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C16-18 and C18-unsatd. acyl) derivs., Me sulfates (salts)

1. APPLICANT AND NOTIFICATION DETAILS

APPLICANTConcept Chemical Corporation Pty Ltd (ABN 38 001 907 464)14/33 Ryde Road, Pymble NSW 2073

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:

Percent weight of hazardous and non-hazardous impuritiesIdentity of sites

VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)Variation to the schedule of data requirements is claimed as follows:

Melting Point/Boiling PointDensityVapour pressureWater SolubilityHydrolysis as a function of pHPartition coefficientAdsorption/DesorptionDissociation constantFlash pointFlammabilityAutoignitionExplosivityReactivityAcute oral toxicityAcute dermal toxicitySkin irritationEye irritationSkin sensitisationMutagenicityIn vitro clastogenicityBiodegradation

PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANTNone

NOTIFICATION IN OTHER COUNTRIESNone

2. IDENTITY OF CHEMICAL

CHEMICAL NAMEPoly(oxy-1,2-ethanediyl), α-[2-[bis(2-aminoethyl)methylammonio]ethyl]-ω-hydroxy-, N,N'-bis(C16-18 and C18-unsatd. acyl) derivs., Me sulfates (salts)

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MARKETING NAMEAccosoft 780 (Ingredient of this product)

CAS NUMBER468743-76-2

MOLECULAR FORMULAUnspecified

STRUCTURAL FORMULA

MOLECULAR WEIGHTThe notified chemical is a UVCB substance (based on ranging chain lengths). The average molecular weight of the notified chemical is 866.08.

SPECTRAL DATA

METHOD Infra Red spectroscopyRemarks IR peaks: 3327, 3007, 2926, 2856, 1741, 1652, 1544, 1463, 1378, 1247, 1216, 1127, 1058,

1007, 953, 818 and 763 cm-1

TEST FACILITY Stepan Company (1999)

METHODS OF DETECTION AND DETERMINATION

METHOD Potentiometric titrationRemarks According to the ASTM D5070 “Standard Test Method for Synthetic Quaternary

Ammonium Salts in Fabric Softeners by Potentiometric Titrations”.TEST FACILITY Not reported

3. COMPOSITION

DEGREE OF PURITY73% of the product Accosoft 780

The notified chemical is a UVCB substance that has not been isolated; it is only manufactured in liquid products such as Accosoft 780.

4. INTRODUCTION AND USE INFORMATION

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MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARSImported as an ingredient (73%) of the imported product Accosoft 780.

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

Year 1 2 3 4 5Tonnes 50 70 80 100 100

USEAnti-static agent to be used in consumer fabric softener products.

5. PROCESS AND RELEASE INFORMATION

5.1. Distribution, transport and storage

PORT OF ENTRYMelbourne

IDENTITY OF MANUFACTURER/RECIPIENTSAccosoft 780 containing 73% of the notified chemical will be imported by the notifier and distributed to customers who will reformulate it into fabric softener products.

TRANSPORTATION AND PACKAGINGAccosoft 780 will be imported in steel 200 L drums, and transported by road in commercial carrier trucks either to the notifier’s warehouse before distribution to reformulation customers, or directly to the customer’s reformulation facilities.

5.2. Operation descriptionReformulationAccosoft 780 containing 73% of the notified chemical will be transferred from product drums to a mixing vessel through a single unloading pump. The mixing vessel will typically be 20,000 L maintained under agitation/circulation.

In the mixing vessel, Accosoft 780 will be blended with water and other ingredients (including colour, thickener, fragrance, preservative, non-ionic surfactants). The blending process can be completed without heating. If heat is used during the blending process, it should not exceed 50°C. The mixing process takes approximately 30-60 minutes.

The product containing 5% Accosoft 780 (3.7% of the notified chemical) will be transferred by stainless steel dedicated pipeline directly to a filling machine for automated filling into 1.25 L high density polyethylene (HDPE) bottles. The bottles will be packed into cardboard boxes and palletised for transport.

End UseThe packaged fabric softeners will be distributed to retail outlets for sale to the public.

5.3. Occupational exposureNumber and Category of Workers

Category of Worker Number Exposure Duration Exposure FrequencyCompounder 1-2 2 hours 48 times/yearMixing tank operator 1-2 2 hours 48 times /yearQuality control chemist 1 0.5 hours 48 times /yearFilling line operator 1-2 3 hours 48 times /year

Exposure DetailsTransport & StorageWaterside workers, transport workers and warehouse workers are only likely to be exposed to the notified chemical in the event of accidental spill involving breach of sealed import drums of Accosoft

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780.

FormulationThere is a possibility or dermal and/or ocular exposure to 73% of the notified chemical for workers involved in transfer of Accosoft 780 into the mixing vessel, and to 3.7% of the notified chemical for workers involved in transfer of formulated products into end use containers. Exposure during these operations is expected to be minimal, as the blending/dispensing process will employ a closed, sealed-delivery system. Exposure will be further limited by the use of recommended PPE including goggles, face shield, gloves and protective clothing.

End UseWorkers in retail outlets may be exposed to the formulated fabric softener products containing 3.7% of the notified chemical in the case of accidental spillage only.

5.4. Release

RELEASE OF CHEMICAL AT SITEEnvironmental release could arise from accidental spills associated with transport accidents and or mishandling of containers. In this scenario, it is expected that any spilt notified chemical would be physically contained and collected and would be subsequently destroyed by either thermal decomposition in high temperature incinerators or disposed of to secure landfill.

During the reformulation process, environmental release could arise from equipment malfunction. However, this is expected to be contained by standard physical engineering structures. The main source of environmental release arising during the reformulation process is as a result of equipment maintenance and cleaning operations. It is expected that up to 400 L of rinse water containing less than 0.1% notified chemical would be released to sewer per cleaning/maintenance operation.

Prior to the import containers being sent to drum recycling facilities, the drums are typically rinsed with hot water, and as such, are expected to contain much less than 1% residual notified chemical. The rinse water is recycled back into the mixing tank.

RELEASE OF CHEMICAL FROM USEDuring use, up to 80% of the notified chemical in the consumer products applied to fabrics remains with the fabric, the remainder being released to sewer. However, nearly 95% of the adhered notified chemical is subsequently released to sewer during the next fabric washing process. Therefore approximately 96% of applied notified chemical is released to sewer after one washing after initial application.

The consumer product containers are expected to contain less than 1% residual notified chemical and will most likely be disposed of as domestic waste to landfill.

5.5. DisposalIt is expected that only 1% of notified chemical will be disposed of to landfill as residual in consumer product containers. Nearly all of the imported quantity of notified chemical is expected to be eventually released to sewer, based on the suggested use patterns of products containing the notified chemical.

5.6. Public exposureThe public may be exposed to the notified chemical via two major routes: direct contact with fabric softener products formulated with Accosoft 780 and contact with textile articles treated with products containing the notified chemical.

Domestic End UseThere is likely to be wide, dispersive exposure to the notified chemical through end use of domestic fabric softener products. The most likely route of consumer exposure is through inadvertent dermal or ocular contact with fabric softeners, as they are usually used in machine washing. A higher level of exposure could occur if the fabric softeners were used hand wash clothes, without wearing gloves. Provided use is in accordance with instructions and warnings provided on product labels, biologically significant exposure is expected to be negligible.

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However as the fabric softener containing 3.7% of the notified chemical is used in a household situation, it may be also possible for small children to accidentally ingest it.

Treated TextilesThere is likely to be wide, dispersive exposure to textiles treated with products containing the notified chemical, via dermal contact. Exposure will be limited by the low concentration of notified chemical in final textile articles, which is estimated to be 0.005% of fabric weight. The notifier advised that approximately 5 to 8g of the notified chemical would be deposited on 2.7 kg of clothing through application of fabric softener in an automatic wash cycle. Approximately 94% of this quantity would be removed during the next wash cycle. Therefore, in general, consumer contact with the notified chemical in dry clothes is expected to be very low.

A possible scenario leading to higher exposure is if infants or children may mouth or suck on treated fabric such as clothes or bed linen.

6. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20oC and 101.3 kPa

The product Accosoft 780 (73% notified chemical) is a clear, yellow liquid.

The notified chemical is believed to be a low melting point solid, but is manufactured only in liquid form, in Accosoft 780.

Chemical Analogue DataData reported below are for the following chemical, that has been accepted as an analogue for the purpose of assessing physical and chemical properties of the notified chemical: The commercial form of the analogue chemical, of 75-85% purity, was used for the physical and chemical property testing below:

Chemical Name Fatty acids C10-C20 and C16-C18 unsaturated, reaction products with triethanolamine, dimethyl sulphate-quaternised

CAS Number 91995-81-2

Melting Point > 85oC

Remarks This analogue chemical decomposed slowly at the melting point

Boiling Point > 100oC at 101.3 kPa

Remarks This analogue chemical decomposed slowly at the boiling point

Density Approximately 1000 kg/m3

Remarks Based on the density of the commercial form of the analogue chemical

Vapour Pressure Expected to be negligible

METHOD EstimationRemarks Based on the fact that the notified chemical is an organic salt with a relatively high

molecular weight.

Water Solubility Between 10 and 500 mg/L

METHOD A preliminary test was carried out by step wise addition of water to 0.1 g of test substance. This was not found to dissolve in 10 mL of water (1%) at room temperature. No peak could be found in HPLC testing of the solution. The above result is based on visual appearance of stock solutions for ecotoxicity tests for Daphnia (10 mg/L – clear solution) and fish (500 mg/L – cloudy solution).

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Remarks This result is for the notified chemical

Hydrolysis as a Function of pH Not determined

Remarks The notified chemical has amide groups which may hydrolyse under extreme pH, but are unlikely to hydrolyse within the standard environmental pH range (4 – 9).

Partition Coefficient (n-octanol/water)

Not determined

Remarks The notified chemical is amphiphilic (having a polar water soluble group attached to a water insoluble hydrocarbon chain) in nature and belongs to the class of cationic surfactants and therefore, attempts to measure its n-octanol/water partition coefficient would be invalid.

Adsorption/Desorption 100% adsorbed to both soil types tested within 24 h.

METHOD OECD TG 106 Adsorption – Tier 1Remarks Suspensions of Accosoft 780 in 0.01M CaCl2 were prepared by sonification at a

concentration of 401 ppm (the lowest concentration that could be measured), and were subsequently added to soil samples of known dry weight using 3 soil solution ratios (1:10, 1:25, 1:100). The mixtures were agitated for an appropriate time. The soil suspensions were then separated by centrifugation and the aqueous phase was analysed using the preparation procedure in AOAC Official Method 954.06, followed by absorbance reading at 532 nm. The AOAC method is specific for the determination of quaternary ammonium compounds in aqueous solutions using eosin yellow.

The amount of test substance remaining on the soil was calculated as the difference between the initial concentration of suspension used and the amount remaining in the aqueous phase at the end of the experiment. Preliminary experiments to recover the test substance from soil by chloroform extraction indicated that it could not easily be recovered from the soil. For this reason the mass balance method was not expected to be successful.

Analysis was done using the parallel method where multiple sample tubes with the same soil/solution ratio are prepared, and an entire tube used for each measurement.

Two soil types were used in this experiment, as detailed in the following table.

Parameter OECD Soil Type 1 OECD Soil Type 5Soil Texture Clay Loamy sandOrganics % 1.4 1.6

Clay % 30 3Silt % 60 18

Sand % 10 79pH (0.01M CaCl2) 5.7 6.5

The results showed that the test substance adsorbed onto soil after 2 hours in OECD soil #1 for all soil/solution ratios tested and in OECD soil #5 for 1:10 and 1:25 soil/solution ratios. For the 1:100 soil/solution ratio (OECD soil #5), the test substance was completely adsorbed after 24 hours, with 6% remaining in suspension after 2 and 6 hours. The test results have been summarised in the table below.

Ratio OECD Soil Type 1 OECD Soil Type 51:10 100% in 2 h 100% in 2 h1:25 100% in 2 h 100% in 2 h1:100 100% in 2 h 100% in 24 h

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The mass balance was done on the 1:100 soil/solution ratio for each soil type. The Test substance could not be recovered off the OECD soil #1. The mass balance for OECD soil #5 was 42%. This is consistent with preliminary experiments and indicates that either the test substance is intractably adsorbed to the soil or, less likely, is degraded on the soil. With OECD soil #5, it is not possible to conclude with confidence that 40% has not simply precipitated from the suspension.

It should be noted that the rate of adsorption appears to be much more strongly correlated to the clay content, rather than the organic content, and this should be taken into consideration when using the results of this test to determine partitioning in sewage treatment plants.

TEST FACILITY Investigative Science Incorporated (2006)

Dissociation Constant Not expected to possess any dissociation constants that lie within the environmentally relevant range of pH 4 to 9.

METHOD pKa calculations using ACD/pKa v6.0 modelRemarks The quaternary ammonium group is expected to retain its cationic charge

throughout.

Particle Size Not determined

Remarks The notified chemical is believed to be a low melting point solid, but is manufactured only in liquid form (such as the product Accosoft 780), for which particle size is not applicable

Flash Point Not determined

Remarks The flash point of the product Accosoft 780 is 31.5°, due to the presence of flammable solvent.

Flammability Limits Not determined

Remarks The flammable limits of the product Accosoft 780 are 2-13% in air, on the basis of its flammable solvent content.

Autoignition Temperature Not determined

Remarks The autoignition temperature of the product Accosoft 780 is 399°C, based on its flammable solvent content.

Explosive Properties Not expected to show any explosive tendencies.

METHOD Criteria for assessing explosivity in Bretherick (1990)Remarks The notified chemical contains none of the functional groups expected to cause or

enhance explosivity.

Reactivity Not designed or expected to be reactive in use.

Remarks The main thermal decomposition products of the notified chemical are expected to be carbon monoxide, carbon dioxide and water, together with smaller amounts of oxides of nitrogen and sulfur.

7. TOXICOLOGICAL INVESTIGATIONS

Chemical Analogue Data

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Data reported below are for the following chemical, that has been accepted as an analogue for the purpose of assessing toxicological properties of the notified chemical. The commercial form of the analogue chemical of 75-85% purity, was used for the toxicological testing below:

Chemical Name Fatty acids C10-C20 and C16-C18 unsaturated, reaction products with triethanolamine, dimethyl sulphate-quaternised

CAS Number 91995-81-2

Endpoint and Result Assessment ConclusionRat, acute oral LD50 > 5000 mg/kg bw low toxicityRat, acute dermal LD50 > 2000mg/kg bw low toxicityRat, acute inhalation not availableRabbit, skin irritation (100%) irritatingRabbit, skin irritation (20%) slightly irritatingHuman volunteers, skin irritation non-irritatingRabbit, eye irritation (100%) irritatingRabbit, eye irritation (20%) slightly irritatingGuinea pig, skin sensitisation – adjuvant test. inadequate evidence of sensitisationGuinea pig, skin sensitisation –non-adjuvant test. inadequate evidence of sensitisationRat, repeat dose – oral gavage - toxicity – 90 days. NOEL 300 mg/kgGenotoxicity – bacterial reverse mutation non mutagenicGenotoxicity – in vivo Mouse micronucleus non genotoxic

7.1. Acute toxicity – oral

TEST SUBSTANCE Analogue chemical (commercial form)

METHOD EC Directive 92/69/EEC B.1 Acute Toxicity (Oral).Species/Strain Rat/Sprague-DawleyRemarks - Method No significant protocol deviations.

RESULTS

Group Number and Sexof Animals

Dosemg/kg bw

Mortality

1 5/sex 2000 02 5/sex 5000 0

LD50 > 5000 mg/kg bwRemarks - Results No abnormality in behaviour was noted in the animals treated at the dose

level of 2000 mg/kg.A slight decrease in the spontaneous activity of the animals treated at the dose level of 5000 mg/kg was observed for a few hours after treatment and was accompanied with a slight reduction in the body weight gain of the males. From day 2 to day 15, the general behaviour of the females was not influenced by the treatment.No deaths occurred at the dose levels of 2000 and 5000 mg/kg.The macroscopic examination revealed no abnormalities in all animals.

CONCLUSION The analogue chemical (commercial form) is of low toxicity via the oral route.

TEST FACILITY Centre International de Toxicologie (1991)

7.2. Acute toxicity – dermal

TEST SUBSTANCE Analogue chemical (commercial form containing 85% partially hydrogenated tallow EQ and 15% 2-propanol)

METHOD OECD TG 402

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Species/Strain RatLD50 > 2000 mg/kg bw

Remarks Only a brief summary of the study was providedCONCLUSION The analogue chemical (commercial form) is of low toxicity via the

dermal route.

TEST FACILITY Centre International de Toxicologie (1991a).

7.3. Acute toxicity – inhalation

There was no acute inhalation toxicity test submitted.7.4.1 Irritation – skin


METHOD EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 maleObservation Period 15 dType of Dressing Semi-occlusive.Remarks - Method No significant protocol deviations. Residual test substance was removed

by a dry compress after 4 h.

RESULTS

Lesion Mean Score*Animal No.

Maximum Value

Maximum Duration of Any Effect

Maximum Value at End of Observation Period

1 2 3Erythema/Eschar 2.7 2.0 0.3 3 10 days 0Oedema 2.0 2.0 0.3 4 2 days 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

Remarks - Results Cutaneous reactions which were slight in one animal and marked in 2 animals were observed after the application of the test substance.The cutaneous lesions consisted of erythema (scores of 1 to 3) and oedema (scores of 1 to 4) and were no longer observed on day 3 for one animal or between day 8 and day 11 for the other 2 animals. A desquamation of the skin at the treatment site remained between day 8 and day 15.The pH of the test substance was 3 at 5% in water.

CONCLUSION The analogue chemical (commercial form) is irritating to the skin.

TEST FACILITY Centre International de Toxicologie (1991b)

7.4.2 Irritation – skin

TEST SUBSTANCE Analogue chemical (commercial form) (20% in water)

METHOD EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation).Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 maleVehicle WaterObservation Period 72 hType of Dressing Semi-occlusive.Remarks - Method No significant protocol deviations. The test substance was not washed

from the skin after the 4 h treatment period.

RESULTS

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Maximum Value



1 2 3Erythema/Eschar 0.7 0 0 1 48 h 0Oedema 0 0 0 0 - 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

Remarks - Results One hour after the removal of the dressing, no cutaneous reactions were observed in the animals.After 24 and 48 hours, only a slight erythema was noted in one animal.No cutaneous reactions persisted after 72 hours.The pH of the test substance was approximately 3.

CONCLUSION The analogue chemical (commercial form) (20% in water) is slightly-irritating to the skin.

TEST FACILITY Centre International de Toxicologie (1990)

7.4.3 Irritation – skin - human volunteers


METHOD Open epicutaneous test (Burckhardt-Test)Study Group 20 human volunteersObservation Period 40 minutesRemarks - Method The analogue chemical (commercial form) was applied in a concentration

of 5% AS, 10% AS, 20% AS and 50% AS.The test solution was continuously applied (1 to 2 drops) with a glass stick to an area of about 3 cm in diameter on the skin of inner surface of the forearm for 30 minutes. The application is repeated each 30 seconds.

RESULTS

Remarks - Results The method chosen was stated to be suitable for testing substances with a high level of irritation to the skin.20 volunteers applied analogue chemical (commercial form) (5% AS) to the left arm. 1 of 20 volunteers showed a slight erythema after 16 minutes of exposure and which disappeared 10 minutes after the end of application.The same volunteers applied analogue chemical (commercial form) (10% AS, 20% AS and 50% AS) to the right arm. All volunteers showed no reactions.

CONCLUSION The analogue chemical (commercial form) is non-irritating to the skin.

TEST FACILITY Henkel KGaA (1991)

7.5.1 Irritation – eye


METHOD EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 maleObservation Period 8 dRemarks - Method No significant protocol deviations. Fluorescein was used during

examinations.

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RESULTS


Maximum Value



1 2 3Conjunctiva: redness 1.7 1.0 2.0 2.0 7 d 0Conjunctiva: chemosis 2.0 1.3 3.0 3.0 6 d 0Conjunctiva: discharge 3** 3** 3** 3** 2 d 0Corneal opacity 0.7 0.3 1.7 2.0 7 d 0Iridial inflammation 0.0 0.0 1.0 1.0 3 d 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.**White purulent discharge

Remarks - Results After the instillation of the test substance, marked conjunctival reactions (chemosis: mean scores at 2.0 or 3.0 in 2 animals and redness: score of 2.0 in one animal, during 72 hours) or moderate (redness in 2 animals and chemosis in one animal) were observed. White purulent discharge occurred in 3 animals at 24 h and 1 animal at 48 h.After 24, 48 and 72 hours, an irritation of the iris (score 1) was noted in one animal.Corneal opacity which was slight (score of 1) in 2 animals or moderate (score maximal of 2) for 72 hours in one animal was observed on an area less than a half or less than one quarter of the cornea.All the ocular lesions had resolved between day 4 and day 8.The pH of the test substance was 3.at 5% in water.

CONCLUSION The analogue chemical (commercial form) is irritating to the eye.

TEST FACILITY Centre International de Toxicologie (1991c)

7.5.2 Irritation – eye

TEST SUBSTANCE Analogue chemical (commercial form) (20% in water)

METHOD EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation).Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3 maleObservation Period 3 dRemarks - Method No significant protocol deviations. Fluorescein was used at the 24 h

examination.

RESULTS


Maximum Value



1 2 3Conjunctiva: redness 0 0.3 0 1 1 d 0Conjunctiva: chemosis 0 0 0 0 - 0Conjunctiva: discharge 0 0 0 0 - 0Corneal opacity 0 0 0 0 - 0Iridial inflammation 0 0 0 0 - 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

Remarks - Results One hour after the instillation of the test substance, slight (chemosis, enanthema) conjunctival reactions were observed in all the animals.After 24 hours, only a slight redness of the conjunctiva persisted in one animals.No ocular reactions were noted after 48 and 72 hours.

CONCLUSION The analogue chemical (commercial form) (20% in water) is slightly-

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irritating to the eye.

TEST FACILITY Centre International de Toxicologie (1990d)

7.6.1 Skin sensitisation


METHOD OECD TG 406 Skin Sensitisation - maximisation method.Species/Strain Guinea pig/Pirbright whitePRELIMINARY STUDY Maximum Non-irritating Concentration: intradermal: All

concentrations used found to be irritating (0.5% - 3%)topical: 5%

MAIN STUDYNumber of Animals Test Group: 20 Control Group: 10

INDUCTION PHASE Induction Concentration:intradermal: 0.5% (v/v) with Paraffine perliquidtopical: 5% (v/v) with Paraffine perliquid

Signs of Irritation Intradermal injection: An examination of the injections was performed one and 24 hours after treatment. On both dates weak dermal reactions were observed at the test group animals and all but three control group animals showed no effects.Topical induction: In the test group animals, one hour after the exposure ended, weak to moderate skin reactions were observed and after 24 hours weak skin reactions were seen. The control group animals also showed weak skin reaction on both times.

CHALLENGE PHASEtopical: 2% (v/v) with Paraffine perliquid

Remarks - Method No significant protocol deviations. The study report was a translation.

RESULTS

Animal Challenge Concentration Number of Animals Showing Skin Reactions after challenge

24 h 48 hTest Group

2% 1/20 1/20Control Group

0 0/10 0/10

Remarks - Results 24 and 48 hours after termination of the challenge moderate skin reactions were observed in 19 test group animals and in the 10 control group animals.Neither test group animals nor control group animals died during the study and no significant difference was observed in their body weights.The observed effects occurring in both control and test animals may be due to irritation. Such irritation effects would mask any sensitisation effects if they were present.

CONCLUSION No conclusion can be drawn from this study as to the sensitising potential of the analogue chemical (commercial form).

TEST FACILITY Henkel KGaA (1991a)

7.6.2 Skin sensitisation


METHOD OECD TG 406 Skin Sensitisation – Buehler Test.

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Species/Strain Guinea pig/Pirbright white/Charles RiverPRELIMINARY STUDY Maximum Non-irritating Concentration:

topical: 15%,(w/w) in saline (minimally irritating)MAIN STUDY

Number of Animals Test Group: 10 Control Group: 10INDUCTION PHASE Induction Concentration:

Topical: 15%Signs of Irritation One hour after terminating the third induction, 6 test group animals

showed slight and one moderate effects on the exposed skin area. 24 hours later 9 test group animals showed up to strong effects. The control group animals showed no dermal alterations on the treated skin areas at any time.

CHALLENGE PHASEchallenge topical: 5%

Remarks - Method No positive controls were included in the study. A rechallenge was not performed.

RESULTS

Animal Challenge Concentration Number of Animals ShowingSkin Reactions after challenge.

Left Flank Right flank24 h 48 h 24 h 48 h

Test Group 5% 4 6 7 4

Control Group 5% 3 2 2 2

Remarks - Results Slight erythema only was seen in both test and control animals after challenge, and the higher incidence in test animals is noted in the table above. Skin reactions that occurred only at 48 h or were sustained at the same level between 24 h and 48 h occurred in both test and control animals, however at a higher incidence in the test animals. No test group animals or control group animals died during the study and no significant difference was observed in their body weights.

CONCLUSION Based on the data above it is considered the erythema is likely to be due to irritation rather than sensitisation. However the possibility remains that a sensitisation response may have occurred, based on the higher incidence of slight erythema in the test animals.

TEST FACILITY Henkel KGaA (1991b)

7.7. Repeat dose toxicity


METHOD OECD TG 408 Repeated Dose 90-Day Oral Toxicity Study in Rodents.Species/Strain Sprague-Dawley CD (Charles River)Route of Administration Oral – gavage.

Dose – 0, 100, 300, 1000 mg/kg bw/dayExposure Information Total exposure days: 90 days;

Dose regimen: 5/7 days per week;Post-exposure observation period: Not stated

VehicleRemarks - Method Based on summary only of study, there were no significant protocol

deviations. Recovery groups for the control and high dose groups were included.

RESULTS

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Mortality and Time to DeathIn the course of the study there were no mortality and clinical symptoms of intoxication.

Clinical Observations and Laboratory Findings – Clinical Chemistry, Haematology, UrinalysisIn comparison of the control group there was no differences in food intake, body weight gain, haematological parameters, status of the eyes and organ weights which could be considered as attributable to the administration of the test substance.

Effects in OrgansAt gross necropsy, effects were observed in the high dose (1000 mg/kg bw/day) group in the following organs: fore stomach (irritations and even ulcerations) and urinary bladder (epithelium desquamation). These pathological lesions were considered to be treatment related.

Remarks – ResultsOnly summary report was providedA further finding in the high dose group consisting of a distinct increase of alanin-aminotransferase in male and female animals indicated possible liver injury.

At the other dose levels there was no treatment related lesions.

CONCLUSIONThe No Observed Effect Level (NOEL) was established as 300 mg/kg bw/day in this study, based on the lesions in the stomach and bladder at 1000 mg/kg bw/day.

TEST FACILITY Henkel KGaA (1991c).

7.8 Genotoxicity – bacteria


METHOD OECD TG 471 Bacterial Reverse Mutation Test.Off. J. Europ. Commun. No 42, March 2, 1983Plate incorporation procedure

Species/Strain S. typhimurium: TA1538, TA1535, TA1537, TA98, TA100Metabolic Activation System S9 fraction from Aroclor 1254 induced rat liverConcentration Range inMain Test

1st test with and without metabolic activation: 8, 40, 200, 1000, 5000 µg/plate2nd test With and without metabolic activation: 6.25, 25, 100, 400, 1600 µg/plate

Vehicle Tween 80/Aqua bidestRemarks - Method No significant protocol deviations.

RESULTS

Metabolic Activation

Test Substance Concentration (µg/plate) Resulting in:Cytotoxicity in Main Test Precipitation Genotoxic Effect

AbsentTest 1 > 200 µg/plate Not noted negativeTest 2 > 100 µg/plate Not noted negativePresentTest 1 > 1000 µg/plate Not noted negativeTest 2 > 400 µg/plate Not noted negative

Remarks - Results Toxic effects were noted starting at concentrations of 100 µg/plate or higher.No enhanced revertant rates compared to concurrent negative controls, induced by the test substance, were observed in all tested strains, neither in the presence nor in the absence of metabolic activation.

CONCLUSION The analogue chemical (commercial form) was not mutagenic to bacteria

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under the conditions of the test.


7.9 Genotoxicity – in vivo


METHOD OECD TG 474 Mammalian Erythrocyte Micronucleus Test.Species/Strain Mice/albino CFW 1 WinkelmanRoute of Administration Oral – gavage/.Vehicle WaterRemarks - Method No significant protocol deviations. A dose of 5000 mg/kg bw was chosen

for the main study. The positive control used was cyclophosphamide at 10 mg/kg. The volume of dose for all groups was 20 mL/kg.

Group Number and Sexof Animals

Dosemg/kg bw

Sacrifice Timehours

Negative Control 6M/6F 0 24Positive Control 6M/6F 10 mg/kg (CP) 24

Test Group 6M/6F 5000 mg/kg 24Test Group 6M/6F 5000 mg/kg 48Test group 6M/6F 5000 mg/kg 72

CP = cyclophosphamide.

RESULTSDoses Producing Toxicity In the preliminary range-finding study using 3000, 4000 and 5000 mg/kg,

no animals up to the highest dose died within the first three days or showed signs of severe morbidity. Slight piloerection was observed at all animals up to 24 hours after administration.Based on the preliminary results 5000 mg/kg body weight was selected as appropriate dose for the micronucleus test and no significant toxicity at this dosage was noted in the main study.

Genotoxic Effects No increase in the frequency of micronucleated cells was observed, and was reduced in all female test groups and in male test groups at 48 h and 72 h sacrifice. This reduction was not statistically significant.The incidence of micronuclei in the negative control groups was in the range of historical control data. The positive control substance, cyclophosphamide, induced a statistically significant increase in the number of micronuleated cells in both sexes.. A slight reduction in the ratio of polychromatic to normochromatic erythrocytes was determined in female mice 24 and 48 hours after administration, demonstrating that the test substance had reached the bone marrow and indicating possibly a weak toxic effect to the bone marrow.

Remarks - Results No mortality was registered during the main study. Signs at clinical examination were slight piloerection.

CONCLUSION The analogue chemical (commercial form) was not clastogenic under the conditions of this in vivo Bone Marrow Cells of the Mouse test.


8. ENVIRONMENT

8.1. Environmental fate

8.1.1. Ready biodegradability

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TEST SUBSTANCE Notified Chemical

METHOD OECD TG 301 D Ready Biodegradability: Closed Bottle Test.Inoculum Supernatant from settled domestic activated sludge.Exposure Period 28 daysAuxiliary Solvent NoneAnalytical Monitoring No details were provided.Remarks - Method The percent biodegradation of the test item was determined from the

chemical oxygen demand (COD), which was determined by closed reflux (Stantec SOP #393). The test was validated by referencing to several control tests. These include procedure controls using the reference substance, phthalic acid, and an inoculum control.

RESULTS

Test substance Phthalic AcidDay % Degradation Day % Degradation

0 0 0 07 1.3 7 72.414 7.5 14 81.221 8.8 21 88.728 11.3 28 84.9

Remarks - Results Accuracy of the dissolved oxygen meter was ± 2%. At each time period, the dissolved oxygen content was measured in two replicate BOD bottles in the test series and two replicated BOD bottles in the inoculated control series. Endpoints were calculated using the average of these replicate readings. As the reference test biodegraded by > 60% in 14 days, the test was validated.

CONCLUSION The notified chemical was found to be not readily biodegradable (i.e.<60% degradation in 28 days), under the test conditions.

TEST FACILITY Stantec Consulting Ltd (2004a)

8.2. Ecotoxicological investigations

8.2.1. Acute toxicity to fish


METHOD OECD TG 203 Fish, Acute Toxicity Test – 96 h static.Species Rainbow Trout (Oncorhynchus mykiss).Exposure Period 96 hoursAuxiliary Solvent NoneWater Hardness ~280 mg CaCO3/LAnalytical Monitoring pH, dissolved oxygen, conductivity, temperature, visual observations,

water hardnessRemarks – Method The test solution was prepared by weighing 500.0 mg of the test item and

adding it to 1000 mL of laboratory dilution water to yield a nominal concentration of 500 mg/L. Each test solution was prepared by adding the appropriate amount of stock solution to 15 L of dilution water. The dilution series was set up as a 0.56 logarithmic series to achieve five exposure concentrations and a control. The stock solution remained cloudy after stirring for 1 hour, however, all dilutions remained clear at all times.

No chemical analysis was conducted to confirm the nominal concentrations of the test item.

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RESULTS

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

10 10 3 10 10 10 105.6 10 0 10 10 10 103.2 10 0 2 8 8 81.8 10 0 0 0 0 01.0 10 0 0 0 0 0

Control 10 0 0 0 0 0

LC50 >10.0 mg/L at 3 hours.3.8 mg/L at 24 hours2.7 mg/L at 48 hours2.7 mg/L at 96 hours – 95% C.I. = 1.8 - 5.6

NOEC 1.8 mg/L at 96 hoursRemarks – Results As mortality and impairment did not exceed 10% in the control, constant

conditions were maintained throughout the test, and the dissolved oxygen concentration was at least 60% of the air saturation value throughout the test, the test was considered valid.

CONCLUSION The notified chemical was found to be moderately toxic to the test organism based on the LC50 of 2.7 mg/L at 96 hours under the test conditions.

TEST FACILITY Stantec Consulting Ltd (2004b)

8.2.2. Acute toxicity to aquatic invertebrates


METHOD OECD TG 202 Daphnia sp. Acute Immobilisation Test and Reproduction Test – 48 hour static.

Species Daphnia magnaExposure Period 48 hoursAuxiliary Solvent NoneWater Hardness 273 mg CaCO3/LAnalytical Monitoring NoneRemarks - Method The test solution was prepared by weighing 10.03 mg of the test item and

adding it to 1000 mL of laboratory dilution water to yield a nominal concentration of 10 mg/L. Each test solution was prepared by adding the appropriate amount of dilution water. Definitive testing was conducted by setting up a dilution series to bracket the EC50 calculated in a range-finding test. The dilution series was set up as a 0.5 geometric series to achieve six exposure concentrations and a control. All solutions were visually clear.


RESULTS

Concentration mg/L Number of D. magna Number ImmobilisedNominal Actual 24 h 48 h

1.00 4 x 5 = 20 20 200.50 4 x 5 = 20 1 200.25 4 x 5 = 20 1 40.13 4 x 5 = 20 0 0

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0.625 4 x 5 = 20 0 00.0313 4 x 5 = 20 0 0Control 4 x 5 = 20 0 0

EC50 0.68 mg/L at 24 hours0.31 mg/L at 48 hours – 95% C.I. = 0.25 – 0.50

NOEC (or LOEC) 0.13 mg/L at 48 hoursRemarks - Results

CONCLUSION The notified chemical was found to be highly toxic to Daphnia based on the EC50 of 0.31 mg/L at 48 hours under the test conditions.

TEST FACILITY Stantec Consulting Ltd (2004c)

8.2.3. Algal growth inhibition test


METHOD OECD TG 201 Alga, Growth Inhibition Test.Species Selenastrum capricornutumExposure Period 96 hoursConcentration Range Nominal: 0.031, 0.063, 0.125, 0.250, 0.500 and 1.000 mg/LAuxiliary Solvent NoneAnalytical Monitoring NoneRemarks - Method The first stock solution was prepared by weighing 10.01 mg of the test

item and adding it to 1000 mL of filter-sterilised algal nutrient solution to yield a nominal concentration of 10.0 mg/L. A second stock solution was prepared by mixing 50 mL Stock 1 into 500 mL of filter-sterilised algal nutrient solution to yield a nominal concentration of 1 mg/L. Stock 2 was used as the highest test concentration and was diluted with filter-sterilised algal nutrient solution to prepare the test concentrations.


RESULTS

Biomass GrowthEbC50 NOEbC ErC50 NOErC

mg/L at 72 h mg/L mg/L at 72 h mg/L0.191 (0.177 – 0.195) 0.125 0.318 (0.298 – 0.344) 0.125

Remarks – Results The culture prior to testing was not observed to have unusual appearance. There were no unusual conditions or deviations from the test protocol. As there was a greater than 16-fold increase in cell numbers in the control sample, the test was considered to be valid.

CONCLUSION The notified chemical was found to be highly toxic to algae based on the EbC50 value of 0.191 mg/L at 72 hours under the test conditions. The 72 hour end point is used rather than the slightly lower toxicity end point at 96 hours, as this is the standard time, and some reversal occurs after 72 hours.

TEST FACILITY Stantec Consulting Ltd (2004d)

9. RISK ASSESSMENT

9.1. Environment

9.1.1. Environment – exposure assessment

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The notified chemical is intended for use as a fabric softener. The major environmental exposure of the notified chemical is from wash water after fabric cleaning activities. It is expected that the notified chemical will be used throughout Australia.

It is estimated that approximately 96% of the total volume of notified chemical that is applied to fabric will be released to the sewer after the first fabric washing, with the remainder being released from subsequent washings. Residual notified chemical in containers is expected to account for less than 1% of the total import volume. The majority of this is expected to be disposed of to secure landfill, where it should slowly degrade by biotic and abiotic processes.

Estimates of the predicted environmental concentrations (PECs) resulting from the treatment of fabric in a worst case scenario of all imported notified chemical being released to sewer, are provided in the following table.

Predicted Environmental Concentration (PEC) for the Aquatic CompartmentAnnual quantity of chemical released to sewer 100,000 kg/yearDays per year where release occurs 365 days/yearDaily chemical release: 273.97 kg/dayWater use 200.0 L/person/dayPopulation of Australia (Millions) 20.496 millionDaily effluent production: 4,099 MLDilution Factor - River 1.0Dilution Factor - Ocean 10.0PEC - River: 66.84 μg/LPEC - Ocean: 6.68 μg/L

The SIMPLETREAT model cannot be used as three required factors are either unknown (log POW and vapour pressure) or unclear (water solubility). Therefore, a figure of 90% adsorption has been used, based on a reference in Nabholz et al (1997, p203) based on typical levels of solids removal in Sewage Treatment Plants.

The OECD TG 106 – Tier 1 Adsorption/Desorption Test reports that up to 100% may be adsorbed to suspended soil and organic material, however its direct applicability to sewage treatment plants is questionable given the following problems. Firstly, not all of the notified chemical tested was in solution; the majority was simply suspended. Secondly, there appears to be a stronger correlation to clay content rather than organic carbon. Thirdly, it is quite likely that in the sandy loam (OECD soil #5), a large proportion (up to 40%) may simply have precipitated from suspension.

STP effluent re-use for irrigation occurs throughout Australia. The agricultural irrigation application rate is assumed to be 1000 L/m2/year (10 ML/ha/year). The notified chemical in this volume is assumed to infiltrate and accumulate in the top 0.1 m of soil (density 1000 kg/m 3). Using these assumptions, irrigation with a concentration of 6.68 µg /L may potentially result in a soil concentration of approximately 6.68 X 10-2 mg/kg. Assuming accumulation of the notified chemical in soil for 5 and 10 years under repeated irrigation, the concentration of notified chemical in the applied soil in 5 and 10 years may be approximately 3.34 X 10 -1 mg/kg and 6.68 X 10-1 mg/kg, respectively.

9.1.2. Environment – effects assessmentThe results of the ecotoxicological data indicate that the notified chemical is highly toxic to both aquatic invertebrates (72 h LC50 = 0.31 mg/L) and plants (72 h EbC50 = 0.191 mg/L), and moderately toxic to fish (LC50 = 2.7 mg/L). Based on this data, a PNEC was calculated, using a safety factor of 100, to be 1.91 µg/L.

9.1.3. Environment – risk characterisationThe risk of the release of all the imported notified chemical can be estimated by determining the aquatic risk quotient (RQ = PEC/PNEC).

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Removal by STP PEC PNEC QRiver

0 % 66.84 µg/L 1.91 µg/L 34.9990 % 6.68 µg/L 1.91 µg/L 3.5097 % 2.01 µg/L 1.91 µg/L 1.05

Ocean0 % 6.68 µg/L 1.91 µg/L 3.5090 % 0.67 μg/L 1.91 μg/L 0.3597 % 0.20 µg/L 1.91 µg/L 0.11

A figure of 97% removal in STPs has been chosen as the mitigation factor based on the average of the 6 hour (which is approximately the retention time in sewers) results of the OECD TG 106 - Tier 1 Adsorption/Desorption Test. However as noted above this needs to be treated with caution. Calculations show that 97.2% removal in the sewer is needed for an acceptable Q <1.

Also, as only approximately 25% of Australia sewage is released to fresh water, the Q values for freshwater may be divided by 4, and thus even using the Q for only 90% mitigation within the sewage treatment plant, 3.5/4 = 0.87, which is acceptable. Further, Nabholz et al (1993, p48), suggests that further mitigation (up to 90%) typically occurs in rivers

The above risk quotients, after considerable mitigation, indicates that the risk to aquatic organisms is only just acceptable. However, it should be noted that the applicability of the results of the OECD TG 106 – Tier 1 Adsorption/Desorption Test to STPs is questionable as the results were more strongly correlated to clay content, rather than organic content and actual complete adsorption to the loamy sand was not demonstrated.

9.2. Human health

9.2.1. Occupational health and safety – exposure assessmentWorker exposure to the notified chemical during consumer fabric softener formulation will be greater than for workers handling the notified chemical in the final product. Formulation workers will be exposed to the notified chemical as imported at concentration of 73%. Those workers handling the finished product eg during filling into bottles, will be exposed to the notified chemical at 3.7 % in the finished consumer fabric softener product.

Worker exposure during the formulation of the final product is expected to be minimal, as the blending/dispensing process will employ a closed, sealed-delivery system. Dermal and ocular exposure may occur during QC procedures prior to use, dispensing (decanting from the drum or connecting and disconnecting hoses for pumping) the solution of the notified chemical, charging the blending vessel, and QC sampling. Some exposure may occur during the maintenance of the manufacture equipment.

Worker exposure will be minimised by use of the appropriate personal protection equipment. When dispensing, charging of blending vessel, QC sampling and maintenance the workers will wear eye protection, gloves and overalls. Local exhaust ventilation will be used in areas where the raw materials are charged to blending vessels.

Worker exposure during the transport, storage, and distribution of the imported notified chemical and finished product is unlikely to occur unless there is an accidental spillage or packaging breach. Exposure for retail workers is not likely to occur, unless the packaging of the final product is breached.

9.2.2. Public health – exposure assessmentPublic exposure will usually be restricted to those people using the final consumer fabric softener products. The maximum concentration of notified chemical in the final consumer fabric softener product will be 3.7%. Contact may also occur to water containing fabric softener, in which the concentration would be substantially lower. Dermal and accidental ocular may occur when products are decanted for use. Accidental oral exposure to children could also

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occur. For a 10 kg child ingesting 20 g of fabric softener (containing 3.7% notified chemical) accidental exposure could occur to 740 mg, or 74 mg/kg.

After rinsing and drying, only low levels of residual chemical are expected to be on the treated clothing and other fabics, and it will be temporarily bound onto the fabric. Thus exposure of the public to the notified chemical is expected to be low. However there is also potential oral exposure to babies or children through the mouthing of treated fabrics. Under a worst case scenario which involves a child sucking 10 g of treated fabric every day, the possible daily exposure would be 3.0 mg/kg bw/day for a 10 kg child. (Based on maximum of 8 g of notified chemical deposited on 2.7 kg fabric, a maximum of 30mg of notified chemical is deposited on 10 g of treated fabric)

Direct public exposure during transport and storage is unlikely.

9.2.3. Human health – effects assessmentAcute toxicityThe commercial form of the analogue chemical is of low acute toxicity via the oral and dermal route.

IrritationBased on the studies provided in rabbits the commercial form of the analogue chemical is considered to be irritating to the skin while the analogue (20% of the commercial form) is slightly irritating. The commercial form of the analogue chemical was not irritating in the human volunteer skin test. Based on the studies provided for the rabbit eye test the commercial form of the analogue chemical is considered to be irritating to the eyes while the analogue (20% of the commercial form) is slightly irritating.

SensitisationTwo guinea pig sensitisation studies were provided. No conclusion could be drawn from the maximisation test, due to a high level of irritation evident in both control and test animals at challenge. The Buehler test gave equivocal results that can probably be attributed to irritation, however the possibility that they were indicative of a sensitisation response cannot be ruled out. The results only of other adjuvant and non-adjuvant guinea pig sensitisation studies on the commercial form of the analogue chemical were supplied via a HEDSET document (Henkel Iberica 1995). These results indicated that the analogue chemical (commercial form) chemical is non-sensitising.

Repeated Dose ToxicityIn a 90-day oral repeat dose study in rats, a No Observed Effect Level (NOEL) was established for the commercial form of the analogue chemical as 300 mg/kg bw/day, based on the lesions in the stomach and bladder at 1000 mg/kg bw/day.

GenotoxicityThe commercial form of the analogue chemical tested was not mutagenic to bacterial cells in a reverse mutation study with and without metabolic activation, or genotoxic to bone marrow cells of the mouse treated in vivo.

Based on the available data, the notified chemical is likely to be classified as a hazardous substance in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC 2004), with risk phrases R36/R38 – Irritating to eyes and skin.

9.2.4. Occupational health and safety – risk characterisationThe greatest potential for occupational exposure will occur at the formulation site. Inadvertent dermal and ocular exposure to 73% of the notified chemical can occur during handling of the imported solution. Similar exposure may also occur to 3.7% of the notified chemical in the final formulation and finished consumer fabric softener. Once the final consumer fabric softener product is packed, exposure should be low. Hence, exposure for warehousing and distribution workers and retail workers is unlikely unless the packaging is breached.

Based on animal testing of analogue chemical (commercial form), the notified chemical is a skin

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and eye irritant. Irritation effects on workers would be greater when handling more concentrated solutions, and would be reduced by the PPE and engineering controls in place at the formulation plant.

Available test reports on the sensitisation potential of the analogue chemical (commercial form) were not conclusive and did not distinguish well between irritation and sensitisation. However there were no strong indications of sensitisation potential. Provision of a local lymph node assay (LLNA) study on the notified chemical itself would clarify any uncertainty regarding this endpoint.

9.2.5. Public health – risk characterisation

The level of the notified chemical in the final consumer fabric softener product to which the public may have dermal or ocular exposure during use is low (3.7%).

Young children may accidentally ingest fabric softener product. The acute dermal toxicity of the chemical is low (LD50 > 5000 mg/kg) and the margin of safety would be 68 if a 10 kg child accidentally ingested 20 g of fabric softener.

Low levels of exposure may also occur from dermal contact with treated fabric or, in the case of young children, to oral contact with treated fabric. A worst case calculation of exposure to the notified chemical by a 10 kg child sucking treated fabric indicates possible daily exposure of 3.0 mg/kg bw/day. Based on the NOEL in the 90-day repeat dose study in rats, the margin of safety is 100.

Most consumer exposure would be dermal or ocular, where the irritation potential demonstrated in testing of the analogue chemical (commercial form) would be relevant. Testing of the commercial form of the analogue chemical at 20% indicated mild irritation. Irritation is likely to be reduced but not eliminated by the relatively low concentration of 3.7% of the notified chemical in the consumer product. Irritation potential would increase if higher levels were used in fabric softener products.

The analogue chemical (commercial form) did not give strong indications of skin sensitisation in animal testing however, the tests were not conclusive and further testing of the notified chemical would be needed to remove uncertainty about the sensitisation potential.

After rinsing and drying, low levels of residual chemical expected to be on the clothing/linen. Thus exposure and risk to the public through dermal contact with the treated fabric is expected to be low

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

10.1. Hazard classificationBased on the available data the notified chemical is likely to be classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous Substances. The classification and labelling details are:R36/38 Irritating to skin and eye

S24/25 Avoid contact with skin and eyesS26 In case of contact will eyes, rinse immediately with plenty of water and seek medical adviceS36/37/39 Wear suitable protective clothing, gloves and eye/face protection

and

As a comparison only, the classification of notified chemical using the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations 2003) is presented below. This system is not mandated in Australia and carries no legal status but is

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presented for information purposes.

Hazard category Hazard statementSkin corrosion/irritation 3 Causes mild skin irritationSerious eye damage/eye irritation

2A Causes serious eye irritation

Chronic hazards to the aquatic environment

1 Very toxic to aquatic life with long-lasting effects.

10.2. Environmental risk assessmentOn the basis of the Q (PECRiver/PNEC) ratio after very extensive mitigation, the notified chemical is not expected to pose a significant risk to the environment based on the notified use pattern. However, further testing work should be undertaken to confirm this finding, as this depends on a number of assumptions. This testing should be directed at determining the actual level of removal of notified chemical in STP’s and the mitigating effect that dissolved organic carbon, as opposed to clay, has on the ecotoxicity of the notified chemical.

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.

10.3.2. Public healthThere is No Significant Concern to public health when used in the proposed manner.

11. MATERIAL SAFETY DATA SHEET

11.1. Material Safety Data SheetThe MSDS of the 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 2003). 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 the 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 1994). The accuracy of the information on the label remains the responsibility of the applicant.

12. RECOMMENDATIONS

REGULATORY CONTROLSHazard Classification and Labelling

The notifier should apply the following health hazard classification for the notified chemical and products containing the notified chemical at 20%: R36/38 Irritating to skin and eye

The following safety phrases should be used: S24/25 Avoid contact with skin and eyes S26 In case of contact will eyes, rinse immediately with plenty of water and seek

medical advice S36/37/39 Wear suitable protective clothing, gloves and eye/face protection

CONTROL MEASURESOccupational Health and Safety

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Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical as introduced: Prevent spills and splashes

Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical as introduced Chemical resistant gloves, protective clothing, and safety goggles or safety glasses.

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.

Public health Product containing > 5% of the notified chemical should be packaged and labelled

according to the requirement of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), under the category “quaternary ammonium compounds”.

The following measures should be taken by the formulators of consumer products containing the notified chemical to minimise public exposure to the notified chemical:

Advice on the label of products containing the notified chemical should include information on the possibility of dermal and eye irritation to sensitive individuals and recommend washing of skin and eyes immediately following exposure to the fabric softener product.

Environment

The following control measures should be implemented by end users to minimise environmental exposure during use of the notified chemical:

o Do not allow concentrated material or contaminated packaging to enter drains, sewers or water courses.

Disposal

The notified chemical should be disposed of by thermal decomposition in incinerators or to landfill.

Emergency procedures

Spills/release of the notified chemical should be handled by physical containment and subsequent collection for safe disposal.

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:

(1) Under Section 64(1) of the Act; if: The import volume of the notified chemical exceeds 100 tonne per annum. If this

occurs, further testing may be required (for example, OECD TG 303A Simulation Test) relating to adsorption/desorption to the organic fraction (rather than clay) in the sewerage treatment plant and/or Local Lymph Node Assay (LLNA) for skin sensitisation

The concentration of the notifier chemical in fabric softeners is > 15%

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or

(2) 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.

13. BIBLIOGRAPHY

Boethling RS and Nabholz JV (1997) Environmental Assessment of Polymers under the U.S. Toxic Substances Control Act, Chapter 10. In: Ecological Assessment of Polymers: Strategies for Product Stewardship and Regulatory Programs. Hamilton JD and Sutcliffe R (Eds), Van Nostrand Reinhold NY.Dunnet, C W (1995) A Multiple Comparison Procedure for Comparing Several Treatments with a Control. J Am Stat Assoc 50, 1096-1121.

Bretherick (1990) Bretherick’s Handbook of Reactive Chemical Hazards, Fourth Edition. Butterworths, London, UK

Centre International de Toxicologie (1990) Analogue chemical (20% commercial form): Skin Irritation in Rabbits, Final Report July 1990, Study 6535 TAL for Stepan Europe Voreppe, France. Centre International de Toxicologie, Evreux, France (Unpublished report provided by notifier).

Centre International de Toxicologie (1990a) Analogue chemical (20% commercial form): Eye Irritation in Rabbits, Final Report July 1990, Study 6534 TAL for Stepan Europe Voreppe, France. Centre International de Toxicologie, Evreux, France (Unpublished report provided by notifier).

Centre International de Toxicologie (1991) Analogue chemical (commercial form): Acute Oral Toxicity in Rats, Final Report August 1991, Study 7640 TAR for Stepan Europe Voreppe, France. Centre International de Toxicologie, Evreux, France (Unpublished report provided by notifier).

Centre International de Toxicologie (19991a) Analogue chemical (commercial form): Acute Dermal Toxicity Test in rats. Study 7376 TAR 24/5/91. Summary only supplied as part of HEDSET on CAS91995-81-2 (Unpublished report provided by notifier).

Centre International de Toxicologie (1991b) Analogue chemical (commercial form): Skin Irritation in Rabbits, Final Report July 1991, Study 7641 TAL for Stepan Europe Voreppe, France. Centre International de Toxicologie, Evreux, France (Unpublished report provided by notifier).

Centre International de Toxicologie (1991c) Analogue chemical (commercial form): Eye Irritation in Rabbits, Final Report July 1991, Study 7642 TAL for Stepan Europe Voreppe, France. Centre International de Toxicologie, Evreux, France (Unpublished report provided by notifier).

Henkel KGaA (1989) Analogue chemical (commercial form): Salmonella/Mammalian-Microsome Mutagenicity Test (Ames Test), Final Report October 1989, Study 890793 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).

Henkel KGaA (1990) Analogue chemical (commercial form): Micronucleus Test in vivo in Bone Marrow Cells of the Mouse, Final Report February 1990, Study 890452 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).

Henkel KGaA (1991) Analogue chemical (commercial form): Skin Irritation in Human Volunteers, Final Report March 1991, Study HTX 910050. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany (Unpublished report provided by notifier).

Henkel KGaA (1991a) Analogue chemical (commercial form): Skin Sensitisation (Maximisation Method), Final Report March 1991, Study HTX900018 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany (Unpublished report provided by notifier).

Henkel KGaA (1991b) Analogue chemical (commercial form): Skin Sensitisation (Buehler Test), Final Report August 1991, Study HTX 910284 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).

Henkel KGaA (1991c) Analogue chemical (commercial form): 90 day subchronic oral toxicity in rat. Final Report 1991, Study TBD 910041 for Henkel KGaA, Dusseldorf, Germany. Department of Toxicology, Henkel KGaA, Dusseldorf, Germany. (Unpublished report provided by notifier).

June 2006STD/1033 28/29

FULL PUBLIC REPORT

2006 NICNAS

Henkel Iberica SA-Division PULCRA; KAP Corporation S.A.; Stepan Europe; CECA SA. (1995) HEDSET Data Sheet for CASRN 91995-81-2 / EINECS No. 295-343-8 / IUPAC Name: Fatty Acids, 110-20 and C16-18-unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized (unpublished document provided by notifier).

Investigative Science Incorporated (2006) Physical/Chemical test by OECD Method 106 – Tier 1 (Soil Adsorption/Desorption), Report 05-22-4 F, Investigative Science Incorporated, 1050 Cooke Blvd., Unit 2, Burlington, Ontario, Canada L7T4A8.

Nabholz, J.V., Miller, P. and Zeeman, M., “Environmental Risk Assessment of New Chemicals Under the Toxic Substances Control Act TSCA Section Five”, in Environmental Toxicology and Risk Assessment, W. G. Landis, J. S. Hughes and M. A. Lewis (Eds), 1993, pp 40-55

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

NOHSC (2003) National Code of Practice for the Preparation of Material Safety Data Sheets, 2nd edn [NOHSC:2011(2003)]. National Occupational Health and Safety Commission, Canberra, Australian Government Publishing Service.

NOHSC (2004) Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, Canberra, AusInfo.

Stantec Consulting Ltd (2004a), Notified chemical: Ready biodegradability evaluation. Stantec Consulting Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).

Stantec Consulting Ltd (2004b), Notified chemical: Acute Toxicity to Rainbow Trout. Stantec Consulting Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).

Stantec Consulting Ltd (2004c), Notified chemical: Acute Toxicity to Daphnia magna. Stantec Consulting Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).

Stantec Consulting Ltd (2004d), Notified chemical: Growth Inhibition Test with the Freshwater Green Alga, Selenastrum capricornutum. Stantec Consulting Limited, Guelph, Ontario, Canada (Unpublished report provided by notifier).

Stepan Company (1999) IR: Notified chemical, Stepan Company, Northfield, IL USA (Unpublished report provided by notifier).

United Nations (2003) Globally Harmonised System of Classification and Labelling of Chemicals (GHS). United Nations Economic Commission for Europe (UN/ECE), New York and Geneva.

June 2006STD/1033 29/29

Documents

STD/1033 - Home - NICNAS Web viewThis Assessment has been compiled in accordance with the provisions of the