File No: LTD/1382
November 2008
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
Glycine, N-coco acyl derivs., potassium salts (Potassium Cocoyl Glycinate)
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, Water, Heritage and the Arts.
For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by
appointment only at 334-336 Illawarra Road, Marrickville NSW 2204.
This Full Public Report is also 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 8800
FAX + 61 2 8577 8888
Website: www.nicnas.gov.au
Director
NICNAS
TABLE OF CONTENTS
FULL PUBLIC REPORT 3
1. APPLICANT AND NOTIFICATION DETAILS 3
2. IDENTITY OF CHEMICAL 3
3. COMPOSITION 4
4. PHYSICAL AND CHEMICAL PROPERTIES 4
5. INTRODUCTION AND USE INFORMATION 5
6. HUMAN HEALTH IMPLICATIONS 6
6 .1 Exposure assessment 6
6 .1 .1 Occupational exposure 6
6.1.2. Public exposure 6
6 .2 . Human health effects assessment 6
6 .3 . Human health risk characterisation 8
6.3.1. Occupational health and safety 8
6.3.2. Public health 8
7. ENVIRONMENTAL IMPLICATIONS 8
7 .1 . Environmental Exposure & Fate Assessment 8
7 .1 .1 Environmental Exposure 8
7 .1 .2 Environmental fate 9
7 .1 .3 Predicted Environmental Concentration (PEC) 9
7 .2 . Environmental effects assessment 9
7 .2 .1 Predicted No-Effect Concentration 9
7 .3 . Environmental risk assessment 9
8. CONCLUSIONS AND REGULATORY OBLIGATIONS 9
Hazard classification 9
Human health risk assessment 10
Environmental risk assessment 10
Recommendations 10
Regulatory Obligations 11
Appendix A: Physical and Chemical Properties 13
Appendix B: Toxicological Investigations 14
B .1 . Acute toxicity ?oral 14
B .2 . Irritation ?skin 14
B .3 . Irritation ?eye 15
B .4 . Skin sensitisation 16
B .5 . Genotoxicity ?bacteria 16
Appendix C: Environmental Fate and Ecotoxicological Investigations 18
C.1. Environmental Fate 18
C.1.1. Ready biodegradability 18
BIBLIOGRAPHY 19
Created on 10/11/2008 9:17 AM Last Saved 10/11/2008 9:50 AM
November 2008 NICNAS
FULL PUBLIC REPORT
Glycine, N-coco acyl derivs., potassium salts (Potassium cocoyl glycinate)
1. APPLICANT AND NOTIFICATION DETAILS
APPLICANT(S)
Estee Lauder Pty Ltd (ABN 008 444 719)
21 Rosebery Avenue Rosebery NSW 2018
NOTIFICATION CATEGORY
Limited-small volume: Chemical other than polymer (1 tonne or less per year).
EXEMPT INFORMATION (SECTION 75 OF THE ACT)
No details are claimed exempt from publication.
VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT)
Variation to the schedule of data requirements is claimed as follows: Melting Point, Boiling Point, Density,
Water Solubility, Hydrolysis as a Function of pH, Partition Coefficient, Adsorption/Desorption, Dissociation
Constant, Particle Size, Flash Point, Flammability, Autoignition Temperature, Explosive Properties.
PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S)
None
NOTIFICATION IN OTHER COUNTRIES
Unknown
2. IDENTITY OF CHEMICAL
MARKETING NAME(S)
Potassium Cocoyl Glycinate
CAS NUMBER
301341-58-2
CHEMICAL NAME
Glycine, N-coco acyl derivs., potassium salts
OTHER NAME(S)
Amilite GCK-11F, Amilite GCK-12
MOLECULAR FORMULA
C14H26O3N K (as lauroyl derivative)
The notified chemical is a mixture of glycine N-acyl derivatives of fatty acids from coconut oil. The main
component (47%) represents the derivative of lauric acid.
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STRUCTURAL FORMULA
Component derivatives in the Amilite GCK-11F mixture:
47% lauroyl derivatives C12
18% myristoyl derivatives C14
9% palmitoyl derivatives C16
6% capryloyl derivatives C10
6% oleoyl derivatives C18:1
2% linoleoyl derivatives C18:2
3% stearoyl derivatives C15
MOLECULAR WEIGHT
2 6 7 ?3 7 9 Da
295 Da (as lauroyl derivative)
ANALYTICAL DATA
Reference IR spectra were provided. Major peaks observed at 3310, 2920, 2850, 1550 and 1410 cm-1
3. COMPOSITION
DEGREE OF PURITY 85%
None
HAZARDOUS IMPURITIES/RESIDUAL MONOMERS
NON HAZARDOUS IMPURITIES/RESIDUAL MONOMERS (>1% by weight)
Chemical Name Potassium sulfate
CAS No. 7778-80-5 Weight % 1 .2
Chemical Name Potassium cocoate
CAS No. 61789-30-8 Weight % 1 3 .2
Chemical Name Potassium Chloride
CAS No. 7447-40-7 Weight % 0 .6
None
ADDITIVES/ADJUVANTS
4. PHYSICAL AND CHEMICAL PROPERTIES
APPEARANCE AT 20篊 AND 101.3 kPa: White to light yellow solid
Property Value Data Source/Justification
Melting Point/Freezing Point Not determined Imported as a mixture in water.
Boiling Point Not determined Imported as a mixture in water.
Density Not determined Imported as a mixture in water.
< 10-5 kPa
Vapour Pressure Estimated.
Water Solubility < 19.2 g/L (approximate) at 25癈 Measured (visual observation).
Hydrolysis as a Function of pH Not determined Expected to be very slow in the
environmental pH range (4?).
Hydrolytic stability in cosmetic
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formulations is a functional
requirement.
Partition Coefficient Not determined The notified chemical is an ionic
(n-octanol/water) surfactant. Log P is expected to be low.
Adsorption/Desorption Not determined Mobility in soils is not expected to be
high. The water solubility suggests
some potential for mobility in soil, but
the notified chemical can be expected
to adsorb to organic carbon, soil and
sediment because it is a surfactant.
Dissociation Constant Not determined As a potassium salt of a carboxylic
acid, the notified chemical is expected
to be ionised over the environmental
pH range (4?).
Particle Size Not determined Imported as a mixture in water.
Flash Point Not determined Imported as a mixture in water.
Flammability Not determined Notified chemical is a solid.
Autoignition Temperature Not determined Not expected to autoignite.
Explosive Properties Not determined Not expected to be explosive based on
absence of structural alerts for
explosivity.
DISCUSSION OF PROPERTIES
For full details of tests on physical and chemical properties, please refer to Appendix A.
R e a c tiv ity
Expected to be stable under normal environmental and usage conditions. The CIR compendium and report (CIR
2001, 2004) raised concerns about the possible formation of potentially carcinogenic nitrosated derivatives of
the analogue chemicals (acyl sarcosines) for which the precursor amine sarcosine is a secondary amine.
Secondary amines are of more concern for nitrosamine formation than primary or tertiary amines. The nitrogen
in the notified chemical itself is secondary, however its functional group is an amide rather than amine.
Therefore the possibility of nitrosamine formation in the notified chemical is considered to be low.
5. INTRODUCTION AND USE INFORMATION
MODE OF INTRODUCTION OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
The notified chemical is imported as an ingredient (23%) in a finished cosmetic product.
MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS
Year 1 2 3 4 5
Tonnes 0 .2 1 0 .2 3 0 .2 6 0 .2 9 0 .3 5
PORT OF ENTRY
Sydney
IDENTITY OF MANUFACTURER/RECIPIENTS
The cleanser containing the notified chemical is made by Estee Lauder, United States, Inc and imported by
Estee Lauder Australia Limited.
TRANSPORTATION AND PACKAGING
The cleanser containing the notified chemical will be imported by ship inside 125ml bottles, which are packed
inside cardboard cartons. The cartons will be transported from the wharf to Estee Lauder's central warehouse
at Rosebery, NSW. The cartons will be transported to a principal retailer's central distribution centres and
retails chains by road.
USE
The notified chemical functions as a surfactant in a cosmetic product (facial cleanser) and is used at a level of
23%.
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OPERATION DESCRIPTION
Warehouse workers will be involved in transporting the Cleanser from the wharf to Estee Lauder's distribution
centre and placing the pallets of product into the warehouse.
A further two warehouse workers in the notifier's warehouse will be involved in transferring pallets from the
Estee Lauder's central warehouse to the retailer's central distribution depots. Packers will pick products from
the shippers and repack them for further transport directly to stores.
6. HUMAN HEALTH IMPLICATIONS
6 .1 Exposure assessment
6 .1 .1 Occupational exposure
NUMBER AND CATEGORY OF WORKERS
Exposure Duration Exposure Frequency
Category of Worker Number
(hours/day) (days/year)
Transport and Storage 12 4 12
Packers 5 4 12
3 x 105
End Users <1 365
EXPOSURE DETAILS
The imported finished product is fully packaged inside cartons and workers are not expected to come into
contact with the notified chemical except in the case of an accidental breach of packaging.
6.1.2. Public exposure
Since the finished product will be sold to the general public there will be widespread dermal exposure to the
product containing 23% of the notified chemical. Due to its use as a wash-off facial cleanser, accidental ocular
exposure is also expected.
The following exposure estimate was derived using published consumer exposure data in the Food and
Chemical Toxicology journal (Loretz et al 2008) and exposure calculations from the SCCP's Notes of
Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (2006).
The maximum dermal exposure is estimated using a retention factor of 0.01 with the concentration of the
notified chemical calculated as being 23% of the final product. Assuming a worst-case scenario, a 60 kg person
may apply the facial cleanser 1- 2 times daily using an average of 4.06 g per day. The dermal absorption level
is assumed to be 100% (in the absence of measured data and given the low molecular weight). This results in a
dermal exposure estimate of 0.16 mg/kg bw/day.
6 .2 . Human health effects assessment
The results from toxicological investigations conducted on the notified chemical are summarised in the table
below. Details of these studies can be found in Appendix B. Published information from the Cosmetic
Ingredient Review (CIR) on similar modified fatty acids known as acyl sarcosines and sarcosinates is included
in the health effects assessment. An example is Sodium Lauroyl Sarcosinate (structural formula shown).
E n d p o in t Result and Assessment Conclusion
Rat, acute oral toxicity oral LD50 > 2000 mg/kg bw
low toxicity
Rabbit, skin irritation Irritating at 5% concentration
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Rabbit, eye irritation Irritating at 5% concentration
Guinea pig, skin sensitisation ?adjuvant test no evidence of sensitisation up to 2.5% concentration
Mutagenicity ?bacterial reverse mutation non-mutagenic
Toxicokinetics, metabolism and distribution
No information was provided. N-acyl derivatives of sarcosine (acyl sarcosines) and their salts (sarcosinates) are
structurally similar to the notified chemical and are also used as surfactant-cleansing agents in cosmetic products.
A skin permeability test on rats revealed that acyl sarcosines and sarcosinates enhanced the skin absorption of
other ingredients when applied together in the same formulation (CIR 2001). Due to this finding, cosmetic
products containing the notified chemical should be carefully formulated to avoid combining with other
ingredients (including colourants and dyes) if transdermal absorption is a health concern. The analogue, Sodium
Lauroyl Sarcosinate is reported as not being hydrolysable by either gastric or intestinal enzymes in vitro. In a
metabolism study in rats, 82%-89% of a 50 mg/kg oral dose of Sodium Lauroyl Sarcosinate was excreted in the
urine and faeces within 24 hours, and 1%-2% was excreted over the next 24 hours (CIR 2001), suggesting that it
is not readily absorbed through the gastrointestinal wall. In an oral dosing study in rats, radiolabelled Sodium
Lauroyl Sarcosinate was administered and tissue samples (including urine and faeces) were analysed. At 24 hours
after administration, 42% was present in the urine and less than 2% were found in organs such as the liver,
kidneys, teeth and oral mucosa. Around 1% of the compound remained adhered to the teeth, oral mucosa and
tongue and the radioactivity could not be washed out by physiological saline, indicating that Sodium Lauroyl
Sarcosinate was absorbed into the blood. But the uptake is not permanent according to a different study, which
found that frequent application did not cause an accumulation of radiolabelled sarcosinate in bone or muscle
(CIR 2001). The notified chemical is likely to have similar absorption, metabolism and elimination kinetics as
sarcosinates and is not likely to lead to bioaccumulation.
Acute toxicity
The oral LD50 of the notified chemical was determined to be over 2000 mg/kg bw in a test conducted in rats
(Bozo Research Center Inc 1997). Based on this data, the notified chemical is considered to be of low toxicity
via the oral route.
Skin irritation
The notified chemical caused moderate to severe erythema in the skin of rabbits when tested at 5%, and although
the symptoms had resolved after one week, all animals showed obvious scaling by the end of the study period
(Ajinomoto Co Inc 1998a). Based on the persistence of skin scaling in all animals tested, the notified chemical is
classified as irritating to the skin.
Eye irritation
In an eye irritation test in rabbits, 5% notified chemical caused iridial inflammation, corneal opacity and signs of
conjunctival irritation in all animals tested. Four out of 6 animals continued to show conjunctival redness at the
end of the observation period (Ajinomoto Co Inc 1998b). Based on the persistence of conjunctival redness, the
notified chemical is classified as a severe eye irritant.
Sensitisation
The notified chemical did not produce a reaction in a guinea pig maximisation test (Ajinomoto Co Inc 2004)
when tested up to the maximum non-irritating concentration of 2.5%, and is therefore not considered to be a skin
sensitiser.
Subchronic and chronic toxicity
No information on repeat dose toxicity was available for the notified chemical. The Cosmetic Ingredient Review
reports that weanling rats given a diet containing 2% Sodium Lauroyl Sarcosinate for 6 months had no effect on
weight gain, feeding, general health or behaviour. There were no abnormalities of the internal organs. Rats fed
0.5% Sodium Lauroyl Sarcosinate for 100 days also showed no signs of toxicity. In a chronic toxicity study, 200
albino Wistar rats were fed Sodium Lauroyl Sarcosinate ranging from 0.05% to 2.0% for a period of 2 years.
There were no significant differences in lesions, fertility, mortality, haematology or body weight gain between the
control and treated groups. The only significant change after 24 months was minor hyperplasia of the stratified
squamous epithelium and excess keratin formation in the stomach mucosa of rats treated at the highest doses (1%
and 2%) (CIR 2001).
Mutagenicity
The notified chemical was not mutagenic to bacteria in the presence or absence of metabolic activation in an
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Ames test (BML Inc 1994).
Reproductive and developmental toxicity
There is insufficient information to classify the notified chemical regarding reproductive toxicity but published
information on sodium lauroyl sarcosinate describes that rats fed up to 1000 mg/kg/day did not experience
adverse effects on fertility in a 2-year oral toxicity study (CIR 2001).
Carcinogenicity
No carcinogenicity data was available for the notified chemical. The CIR compendium and report (CIR 2001 and
CIR 2004) on acyl sarcosines addresses health concerns arising from the reaction of a secondary amine group in
the starting material sarcosine that can lead to the formation of nitrosated derivates (N-nitrososarcosine) that are
known to be carcinogenic. Because of this reaction, the report recommends that sarcosine should not be used in
cosmetic products in which nitrosamine compounds may be formed. However the possibility of nitrosamine
formation in the notified chemical is less likely as the functional group is an amide rather than an amine, and
therefore the potential for carcinogenicity due to nitrosamine formation is low.
Health hazard classification
Based on the eye irritation and skin irritation tests, the notified chemical is classified as hazardous under the
Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).
Xi; R41 Risk of serious damage to eyes
R38 Irritating to skin
6 .3 . Human health risk characterisation
6.3.1. Occupational health and safety
Workers are not likely to be exposed to the product containing the notified chemical, unless there was a
packaging breakage in which minor dermal contact is possible. The notified chemical causes skin irritation and
there is a risk of workers experiencing symptoms of skin irritation after a single exposure. However the
likelihood of exposure is very low and the risk to workers is not considered to be unacceptable.
6.3.2. Public health
The public will have widespread dermal exposure to the notified chemical, which is proposed to be used at a
level of 23% in facial cleansers. Eye exposure is also a possibility due to accidental contact. The notified
chemical caused persistent eye irritation at 5% in animal tests, and eye contact with the cleanser containing
23% could lead to serious eye damage. If the product were diluted with water when eye contact occurs,
significant eye irritation may still occur and in a worst-case scenario may lead to eye damage. Skin scaling was
evident in animals when tested at 5% and there is potential for significant skin irritation when used as a facial
cleanser at the proposed concentration, particularly in individuals with sensitive or damaged skin. However the
animal test was conducted using a 24-hour patch application simulating a `leave-on' application, whereas
cleansers are typically used as a `wash-off' product where the exposure time is relatively brief. In this case,
skin irritation may not necessarily occur with normal use.
The product containing the notified chemical may lead to significant eye damage and irritation, but the risk
may be minimised by the use of clear and appropriate directions for use and safety precautions to avoid eye
contact. First aid information should also be included to minimise adverse effects if eye contact occurs.
Although the notified chemical may cause serious damage to eyes and is classified as a skin irritant, under the
proposed usage in a wash-off product, the risk for public health is not considered to be unacceptable.
7. ENVIRONMENTAL IMPLICATIONS
7 .1 . Environmental Exposure & Fate Assessment
7.1.1 Environmental Exposure
RELEASE OF CHEMICAL AT SITE
No releases are expected as the notified chemical will be imported as part of a finished cosmetic facial cleanser
and no reformulation will occur in Australia.
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RELEASE OF CHEMICAL FROM USE
As the notified chemical will be used in water-based cosmetic facial cleansers, most release of the chemical
will be from bathrooms or similar `wet' areas, which normally drain to sewer. Consequently, the major
proportion of the introduced quantity of the notified chemical is expected to be released into the domestic
sewer system.
RELEASE OF CHEMICAL FROM DISPOSAL
Residues in empty containers are expected to be disposed of to landfill, together with the empty
containers. Waste and expired material is similarly expected to be disposed of to landfill.
7.1.2 Environmental fate
The notified chemical is readily biodegradable, and can therefore be expected to degrade during sewage
treatment and if discharged to aquatic environments. Degradation in landfill can also be expected, based on the
ready biodegradability and chemical structure of the notified chemical. For the details of the environmental fate
studies please refer to Appendix C.
7.1.3 Predicted Environmental Concentration (PEC)
The following PECs are estimated based on the worst-case assumption that there is no elimination during
sewage treatment. Environmental exposure is expected to remain below these estimates under actual
conditions of use, as the notified chemical is readily biodegradable.
Predicted Environmental Concentration (PEC) for the Aquatic Compartment
Total Annual Import/Manufactured Volume 350 kg/year
Proportion expected to be released to sewer 100%
Annual quantity of chemical released to sewer 350 kg/year
Days per year where release occurs 365 days/year
Daily chemical release: 1 kg/day
Water use 2 0 0 .0 L/person/day
Population of Australia (Millions) 2 1 .1 6 1 million
Removal within STP 0%
Daily effluent production: 4 ,2 3 2 ML
Dilution Factor - River 1 .0
Dilution Factor - Ocean 1 0 .0
PEC - River: 0 .2 道 L
g/
PEC - Ocean: 0 .0 2 奠 /L
g
7 .2 . Environmental effects assessment
No ecotoxicity data were submitted.
7.2.1 Predicted No-Effect Concentration
As ecotoxicity data for the notified chemical were not provided, it is not possible to calculate a Predicted No-
Effect Concentration (PNEC).
7.3. Environmental risk assessment
Without a PNEC, it is not possible to calculate a risk quotient. Based on the proposed use, low volume, diffuse
release pattern and ready biodegradability, the risk to the aquatic environment is expected to be acceptably low.
8. CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available data the notified chemical is classified as hazardous under the Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(2004)]. The classification and labelling details are:
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Xi; R41 Risk of serious damage to eyes
R38 Irritating to skin
and
As a comparison only, the classification of the 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 presented for information purposes.
Hazard category Hazard statement
Skin irritation 2 Causes skin irritation
Serious eye damage 1 Causes serious eye damage
Human health risk assessment
Under the conditions of the occupational settings described, the notified chemical is not considered to pose an
unacceptable risk to the health of workers.
When used in the proposed manner, the notified chemical is not considered to pose an unacceptable risk to
public health.
Environmental risk assessment
On the basis of the ready biodegradability and the reported use pattern, the notified chemical is not considered to
pose a risk to the environment.
Recommendations
REGULATORY CONTROLS
Hazard Classification and Labelling
? The Office of the ASCC, Department of Employment and Workplace Relations (DEWR), should
consider the following health hazard classification for the notified chemical:
- Xi; R38 Irritating to skin
- R41 Risk of serious damage to eyes
? If the notified chemical is imported in future at higher concentrations, it should be further tested to
determine the skin and eye irritation potential at these concentrations, or labelled in a precautionary
manner as:
- C; R34 Causes burns
? The following risk phrases are recommended in the workplace on products/mixtures containing the
notified chemical:
- Concentration 1-5%: R36 Irritating to eyes
- Concentration 5%: R38 Irritating to skin, R41 Risk of serious damage to eyes
? The National Drugs and Poisons Standing Committee (NDPSC) should consider the notified chemical
for listing on the SUSDP based on the results of skin and eye irritation tests.
Material Safety Data Sheet
? The MSDS provided by the notifier should be amended as follows:
- Include the risk phrase `R38 Irritating to skin' and relevant safety phrases in the product MSDS
under Hazard Identification (Section 2).
CONTROL MEASURES
Occupational 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:
- Avoid contact with skin and eyes
? 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 Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)]
workplace practices and control procedures consistent with provisions of State and Territory hazardous
substances legislation must be in operation.
Public Health
? Consumer products containing the notified chemical should be labelled with a warning against eye
contact, and directions on first aid measures if the product contacts the eye (e.g. avoid contact with eyes,
in case of contact with eyes, rinse immediately with plenty of water and seek medical advice).
Precautionary warning on possible skin irritation is also recommended.
Disposal
? The notified chemical should be disposed of by landfill.
Emergency procedures
? Spills or accidental release of the notified chemical should be handled by containment, collection and
subsequent safe disposal.
Regulatory Obligations
Secondary Notification
This risk assessment is based on the information available at the time of notification. The Director may call for
the reassessment of the chemical under secondary notification provisions based on changes in certain
circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the
notifier, as well as any other importer or manufacturer of the notified chemical, have post-assessment regulatory
obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the
notified chemical is listed on the Australian Inventory of Chemical Substances (AICS).
Therefore, the Director of NICNAS 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 importation volume exceeds one tonne per annum notified chemical;
- the concentration of the notified chemical used in products has increased from 23%;
- if the chemical has begun to be reformulated in Australia;
or
(2 ) Under Section 64(2) of the Act; if
- the function or use of the chemical has changed from a wash-off surfactant in cosmetic products, or
is likely to change significantly;
- the amount of chemical being introduced has increased from 0.4 tonnes, or is likely to increase,
significantly;
- if the chemical has begun to be manufactured in Australia;
- additional information has become available to the person as to an adverse effect of the chemical on
occupational health and safety, public health, or the environment.
The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required.
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Material Safety Data Sheet
The MSDS of the notified chemical (and product containing the notified chemical) provided by the notifier were
reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.
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APPENDIX A: PHYSICAL AND CHEMICAL PROPERTIES
< 19.2 g/L at 25oC
Water Solubility
Method Not stated. There is no test report, just a brief description of the method and graphical
presentation of results.
Remarks The water solubility was determined by visual observation of the clarity of solutions that
had been prepared at 80oC and set aside for a week at lower temperatures. The notifier
claims a solubility of 1.92 g/L, but appears to have misinterpreted the units for one of the
axes in the graphical presentation of results.
Test Facility Ajinomoto (2008).
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APPENDIX B: TOXICOLOGICAL INVESTIGATIONS
B .1 . Acute toxicity ?oral
TEST SUBSTANCE Notified chemical
METHOD In-house test similar to OECD TG 401 ?Limit Test.
Species/Strain Mice/ICR
Vehicle 30% test solution was diluted with water to 20% solution at time of use.
Remarks - Method 10 animals (5 female, 5 male) were given 2000 mg/kg of the notified
chemical as a 20% test substance solution by oral gavage after being
deprived of food for approximately 16 hours. 10 mice (5 female, 5 male)
were given water only and served as the control. The animals were
observed for 14 days after administration.
RESULTS
LD50 > 2000 mg/kg bw
Signs of Toxicity None were observed.
Effects in Organs No changes in organs at necropsy.
Remarks - Results No deaths occurred and there were no abnormal clinical signs. There was
no significant difference in body weights of the animals in the treatment
group compared with that of the control group.
CONCLUSION The notified chemical is of low toxicity via the oral route.
TEST FACILITY Bozo Research Center Inc (1997)
B .2 . Irritation ?skin
TEST SUBSTANCE The notified chemical at 5% in aqueous solution
METHOD In-house modified Draize test
Species/Strain Rabbit/New Zealand White
Number of Animals 4 M a le s
Vehicle Distilled water
Observation Period 7 days
Type of Dressing Occlusive
Remarks - Method 0.3 ml of the test substance solution was placed on a patch with adhesive
plaster and applied to previously clipped area of skin. The area was
covered with a torso cover and left for 24 hours. Skin irritation was
assessed according to the Draize scale at 24, 48 and 72 hours and 1 week
after the application.
RESULTS
Lesion Mean Score* Maximum Maximum Duration Maximum Value at End
V a lu e o f A n y E ffe c t of Observation Period
Erythema/Eschar 1 .0 8 2 < 7 days 0
Oe d e ma 0 0 0 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
Remarks - Results At the end of the observation period, all animals showed scaling of the skin.
CONCLUSION The notified chemical is irritating to the skin based on the persistence of
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scaling at the end of the observation period.
TEST FACILITY Ajinomoto Co Inc (1998a)
B .3 . Irritation ?eye
TEST SUBSTANCE The notified chemical at 1% and 5%, in aqueous solution.
METHOD In-house modified Draize test
Species/Strain Rabbit/New Zealand White
Number of Animals 6 M a le s
Observation Period 7 days
Remarks - Method The observation period is 7 days, which is a shorter period than the 21 days
recommended in the OECD test method. The report using 5% test substance
did not provide individual scores for conjunctival symptoms at the 48 and
72 hour observation points, therefore the mean overall scores could not be
calculated for conjunctival redness, chemosis and discharge. SLS (5%) was
used as a positive control.
RESULTS
1% test substance
Lesion Mean Score* Maximum Maximum Duration Maximum Value at End
V a lu e o f A n y E ffe c t of Observation Period
Conjunctiva: redness 0 .3 3 1 < 72 hours 0
Conjunctiva: chemosis 0 0 0 0
Conjunctiva: discharge 0 0 0 0
Corneal opacity 0 0 0 0
Iridial inflammation 0 0 0 0
*Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals.
5% test substance
Lesion Mean Score at Maximum Maximum Duration Maximum Value at End
24 hours* V a lu e o f A n y E ffe c t of Observation Period
Conjunctiva: redness 2 .8 3 3 .0 Present after 7 days 1
Conjunctiva: chemosis 1 .8 3 3 .0 < 7 days 0
Conjunctiva: discharge 1 .6 7 3 .0 < 7 days 0
Mean Score^
Corneal opacity 0 .0 8 1 .0 < 48 hours 0
Iridial inflammation 0 .3 3 1 .0 < 48 hours 0
*Calculated on the basis of the scores at 24 hours for ALL animals.
^ Calculated on the basis of the scores at 24, 48 and 72 hours for ALL animals.
Remarks - Results 1% test substance: Only slight irritation effects observed at this
concentration, which cleared within 72 hours.
5% test substance: Corneal opacity and iridial inflammation were only
observed in one animal at the 24 hour observation. Conjunctival irritation
was maximal at 24 hours and slowly improved over time. However
redness of the conjunctiva was still present after 7 days.
CONCLUSION The notified chemical is severely irritating to the eye based on the
persistence of irritation effects at the end of the observation period.
TEST FACILITY Ajinomoto Co Inc (1998b)
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November 2008 NICNAS
B .4 . Skin sensitisation
TEST SUBSTANCE Notified chemical
METHOD OECD TG 406 Skin Sensitisation ?Guinea Pig Maximisation Test
EC Directive 96/54/EC B.6 Skin Sensitisation.
Species/Strain Guinea pig/Hartley
VEHICLE Physiological saline for intradermal and water for topical application.
Maximum Non-irritating Concentration:
PRELIMINARY STUDY
intradermal: 0.1%
to p ic a l: 2 . 5 %
Maximum concentration to cause mild-moderate irritation:
intradermal: 0.1% (no irritation, but necrosis observed at 0.25% and
0.5%)
to p ic a l: 5 %
MAIN STUDY
Number of Animals Test Group: 10 Control Group: 5
Induction Concentration:
INDUCTION PHASE
intradermal: 0.1%
to p ic a l: 5 %
CHALLENGE PHASE
1st challenge to p ic a l: 2 . 5 , 1 %
Remarks - Method No observations of irritation during the induction phase were included in
the study.
RESULTS
Remarks - Results No skin reactions (score 0) were observed at any site of application on
any animal when challenged with 2.5% or 1% test substance solution. No
skin reactions were observed at any site of application on any animal in
the control group. There were no deaths and no signs of systemic toxicity
in any group during the observation period. Six animals in the test group
and 4 animals in the control group at the challenge observation period
(day 24) showed body weight loss but all of these animals were recovered
at the end of the study on day 25. The reason for the temporary weight
loss was unclear.
CONCLUSION There was no evidence of reactions indicative of skin sensitisation to the
notified chemical under the conditions of the test.
TEST FACILITY Ajinomoto Co Inc (2004)
B .5 . Genotoxicity ?bacteria
TEST SUBSTANCE Notified chemical (30% aqueous solution)
METHOD Study in compliance with Japanese regulatory standards - Standards for
Mutagenicity Tests using Microorganism (Ministry of Labour, Japan) and
GLP standards.
Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100
E. coli: WP2uvrA
Metabolic Activation System S9 fraction from Phenobarbital and 5,6-benzoflavone activated rat liver
Concentration Range in a) With metabolic activation:
Main Test Salmonella typhimurium: 10-313 ?g/plate;
E. coli: 156-5000 ?g/plate
b) Without metabolic activation:
Salmonella typhimurium: 1.2-78 ?g/plate (TA100, TA1535, TA1537);
1.2-313 ?g/plate (TA98)
E. coli: 156-5000 ?g/plate
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November 2008 NICNAS
Vehicle W a te r
Remarks - Method Concentration of the tested material was 30% and the measured weights
of test substance were corrected accordingly. The positive controls used
were (2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 2-methoxy-
6-chloro-9-[3-(2-chloroethyl) aminopropylamino] acridine.2HCl, 2-
aminoanthracene, Benzo(a)pyrene. The preincubation method was used.
A second test (Test 2) was run for the strains TA100, TA1535 and TA
1537 due to the low number of doses without growth inhibition in the
preliminary toxicity test.
RESULTS
Metabolic Test Substance Concentration (?g/plate) Resulting in:
A c tiv a tio n Cytotoxicity in Preliminary Cytotoxicity in Main Test Precipitation G e n o to x ic E ffe c t
Test
Absent
Test 1 > 313 Negative
78 for S. typhimurium* 39 for S. typhimurium
> 5000 Negative
5000 for E.coli 2500 for E.coli
Test 2 - > 313 Negative
39 for S. typhimurium
Present
Test 1 > 313 Negative
313 for S. typhimurium 156 for S. typhimurium
> 5000 Negative
5000 for E.coli 2500 for E.coli
* Except for TA98, where cytotoxicity was observed at 313 ?g/plate.
Remarks - Results There was no significant increase in the number of revertant colonies with
or without metabolic activation compared to the negative control, and
there was no dose-related effect observed in any strain. The revertant
colonies of the positive control showed an increase of more than twice
that of the negative controls indicating that the study was performed
correctly.
CONCLUSION The notified chemical was not mutagenic to bacteria under the conditions
of the test.
TEST FACILITY General Laboratory, BML Inc 1994
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November 2008 NICNAS
APPENDIX C: ENVIRONMENTAL FATE AND ECOTOXICOLOGICAL INVESTIGATIONS
C. 1 . Environmental Fate
C.1.1. Ready biodegradability
TEST SUBSTANCE Liquid formulation containing 30 % notified chemical
METHOD OECD TG 301 C Ready Biodegradability: Modified MITI Test (I).
Inoculum Standard activated sludge (30 mg/L).
Exposure Period 28 days
Auxiliary Solvent None
Analytical Monitoring BOD and DOC
Remarks - Method The test substance (340 mg/L) contained 30% of the notified chemical.
RESULTS
Test substance A n ilin e
Da y % Degradation Da y % Degradation
7 6 5 .8 7 5 6 .7
14 7 3 .2 14 6 3 .6
21 7 5 .2 21 6 6 .2
28 7 9 .8 28 6 9 .5
Remarks - Results Biodegradability of the test substance based on DOC was > 90%.
Degradation also occurred in deionised water without activated sludge,
reaching 43% after 28 days based on BOD.
CONCLUSION The notified chemical is readily biodegradable.
TEST FACILITY Ajinomoto (1995).
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November 2008 NICNAS
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