File No: STD/1590
August 2017
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
Glycine, N-(1-oxododecyl)-, sodium salt (1:1) (INCI Name: Sodium Lauroyl Glycinate)
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (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 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 Energy.
This 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: / Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, 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
SUMMARY 3
CONCLUSIONS AND REGULATORY OBLIGATIONS 3
ASSESSMENT DETAILS 6
1. APPLICANT AND NOTIFICATION DETAILS 6
2. IDENTITY OF CHEMICAL 6
3. COMPOSITION 7
4. ANALOGUE IDENTITY 7
5. PHYSICAL AND CHEMICAL PROPERTIES 7
6. INTRODUCTION AND USE INFORMATION 8
7. HUMAN HEALTH IMPLICATIONS 9
7.1. Exposure Assessment 9
7.1.1. Occupational Exposure 9
7.1.2. Public Exposure 10
7.2. Human Health Effects Assessment 10
7.3. Human Health Risk Characterisation 11
7.3.1. Occupational Health and Safety 11
7.3.2. Public Health 12
8. ENVIRONMENTAL IMPLICATIONS 12
8.1. Environmental Exposure & Fate Assessment 12
8.1.1. Environmental Exposure 12
8.1.2. Environmental Fate 12
8.1.3. Predicted Environmental Concentration (PEC) 13
8.2. Environmental Effects Assessment 13
8.2.1. Predicted No-Effect Concentration 13
8.3. Environmental Risk Assessment 14
Appendix A: Physical and Chemical Properties 15
Appendix B: Toxicological Investigations 16
B.1. Acute toxicity – oral 16
B.2. Acute toxicity – dermal 16
B.3. Irritation – skin (in vitro) 17
B.4. Irritation – skin 17
B.5. Irritation – eye (in vitro) 18
B.6. Irritation – eye 18
B.7. Skin sensitisation 19
B.8. Repeat dose toxicity 20
B.9. Genotoxicity – bacteria 22
B.10. Genotoxicity – in vitro 23
B.11. Genotoxicity – in vitro 24
Appendix C: Environmental Fate and Ecotoxicological Investigations 25
C.1. Environmental Fate 25
C.1.1. Ready biodegradability 25
C.2. Ecotoxicological Investigations 25
C.2.1. Acute toxicity to fish 25
C.2.2. Acute toxicity to aquatic invertebrates 26
C.2.3. Algal growth inhibition test 27
BIBLIOGRAPHY 29
August 2017 NICNAS
SUMMARY
The following details will be published in the NICNAS Chemical Gazette:
ASSESSMENT REFERENCE / APPLICANT(S) / CHEMICAL OR TRADE NAME / HAZARDOUS chemical / INTRODUCTION VOLUME / USESTD/1590 / Clariant(Australia) Pty Ltd
Unilever Asia Private Limited / Glycine, N-(1-oxododecyl)-, sodium salt (1:1) (INCI Name: Sodium Lauroyl Glycinate) / Yes / ≤ 150 tonnes per annum / Ingredient in rinse off cosmetic products
CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available information, the notified chemical is recommended for hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia. The recommended hazard classification is presented in the following table.
Hazard classification / Hazard statementSkin irritation (Category 2) / H315 – Causes skin irritation
Eye damage (Category 1) / H318 – Causes serious eye damage
The environmental hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is presented below. Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes.
Hazard classification / Hazard statementAcute Category 3 / H402 – Harmful to aquatic life
Human health risk assessment
Provided that the recommended controls are being adhered to, under the conditions of the occupational settings described, the notified chemical is not considered to pose an unreasonable risk to the health of workers.
When used in the proposed manner, the notified chemical is not considered to pose an unreasonable risk to public health.
Environmental risk assessment
On the basis of the PEC/PNEC ratio and the reported use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.
Recommendations
Regulatory Controls
Hazard Classification and Labelling
· The notified chemical should be classified as follows:
- Skin irritation (Category 2): H315 – Causes skin irritation
- Eye damage (Category 1): H318 – Causes serious eye damage
The above should be used for products/mixtures containing the notified chemical, if applicable, based on the concentration of the notified chemical present and the intended use/exposure scenario.
Control Measures
Occupational Health and Safety
· A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical:
- Avoid contact with skin and eyes
· A person conducting a business or undertaking at a workplace should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical:
- Coveralls
- Impervious gloves
- Safety goggles
Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.
· A copy of the (M)SDS should be easily accessible to employees.
· If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation should be in operation.
Disposal
· Where reuse or recycling are not appropriate, dispose of the notified chemical in an environmentally sound manner in accordance with relevant Commonwealth, state, territory and local government legislation.
Emergency procedures
· Spills or accidental release of the notified chemical should be handled by containment, physical 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 concentration of the notified chemical exceeds 5% in rinse off cosmetic products;
- the notified chemical is used in leave on cosmetic products.
or
(2) Under Section 64(2) of the Act; if
- the function or use of the chemical has changed from ingredient in rinse off cosmetic products, or is likely to change significantly;
- the amount of chemical being introduced has increased, or is likely to increase, significantly;
- 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.
(Material) Safety Data Sheet
The (M)SDS of the notified chemical in solution provided by the notifier was reviewed by NICNAS. The accuracy of the information on the (M)SDS remains the responsibility of the applicant.
ASSESSMENT DETAILS
1. APPLICANT AND NOTIFICATION DETAILS
Applicants
Clariant (Australia) Pty Ltd (ABN: 30 069 435 552)
296-324 Ferntree Gully Road, Level 3, 3 Acacia Place
NOTTING HILL VIC 3168
Unilever Asia Private Limited (ABN: 29 142 738 538)
219 North Rocks Road
NORTH ROCKS NSW 2151
Notification Category
Standard: 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: analytical data, degree of purity, impurities and import volume.
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows: all physico-chemical endpoints except melting point, boiling point, density, water solubility and partition coefficient and all toxicological endpoints except in vitro genotoxicity.
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
Canada (2010), Europe (2014), Japan (2006) and Philippines (2006)
2. IDENTITY OF CHEMICAL
Marketing Name
Hostapon SLG (solution containing < 25% notified chemical)
CAS Number
18777-32-7
Chemical Name
Glycine, N-(1-oxododecyl)-, sodium salt (1:1)
Other Names
Sodium Lauroyl Glycinate (INCI name)
Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide
Glycine, N-(1-oxododecyl)-, monosodium salt (9CI)
Glycine, N-lauroyl-, monosodium salt (7CI,8CI)
Glycine, N-lauroyl-, sodium salt (6CI)
N-Lauroylglycine sodium salt
Sodium N-lauroylglycinate
Sodium N-lauroylglycine
Sodium dodecanoylglycinate
Sodium β-lauroylaminoacetate
Molecular Formula
C14 H27 N O3 . Na
Structural Formula
Molecular Weight
279.35 Da
Analytical Data
Reference NMR, IR, HPLC and UV spectra were provided.
3. COMPOSITION
Degree of Purity
40-60%
4. ANALOGUE IDENTITY
Chemical Name
Glycine, N-coco acyl derivs., sodium salt (INCI Name: Sodium cocoyl glycinate)
Other Name
SCG 3028
CAS Number
90387-74-9
Molecular Formula
Unspecified
Structural Formula
Molecular Weight
Unspecified
The notified chemical is similar to the analogue except for the proportion of fatty acids with different length of side chains. The notified chemical is a dodecanoic acid (C12) derivative with C8 and C10 impurities, whereas the analogue is a mixture of fatty acids (C8-C16) reacted with glycine. The analogue contains approximately 60% of the C12 component, which is the notified chemical.
5. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: pale yellow liquid (25% solution)Property / Value / Data Source/Justification /
Melting Point/Freezing Point / 143-174 °C / Measured
Boiling Point / Not determined / Measured. The notified chemical decomposes before reaching boiling point
Density / 1,340 kg/m3 at 28.1 °C / Measured
Vapour Pressure / 2.3 kPa at 20 °C / (M)SDS
Water Solubility / 2.0 ± 0.3 g/L at 20 °C
1.4 ± 0.2 g/L at 20 °C (active content) / Measured (critical micelle concentrations)
n-octanol Solubility / 380 mg/L n-octanol at 20 °C / Measured
Hydrolysis as a Function of pH / Not determined / Contains hydrolysable functionality, however, hydrolysis is expected to be slow in the environmental pH range (4–9) at ambient temperature.
Partition Coefficient
(n-octanol/water) / log Pow = -0.57 at pH 6.8 / Based on water and octanol solubilities
Surface Tension / 30.3 ± 0.5 mN/m at 20 °C / Measured
Adsorption/Desorption / Not determined / Expected to adsorb to soil and sediment based on surface activity
Dissociation Constant / Not determined / The notified chemical is expected to be ionised over the environmental pH range (4–9).
Flash Point / > 100 °C / (M)SDS
Flammability / Not determined / -
Autoignition Temperature / Not determined / -
Explosive Properties / Not determined / Contains no functional groups that would imply explosive properties
Oxidising Properties / Not determined / Contains no functional groups that would imply oxidising properties
Discussion of Properties
All the physical and chemical property studies were carried out on dry powder form of the notified chemical. For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified chemical is expected to be stable under normal conditions of use.
Physical hazard classification
Based on the submitted physico-chemical data depicted in the above table, the notified chemical is not recommended for hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia.
6. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 Years
The notified chemical will not be manufactured in Australia. It will be imported in solution at ≤ 25% concentration for reformulation in Australia into end-use cosmetic products, or in finished cosmetic products.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5Tonnes / < 150 / < 150 / < 150 / < 150 / < 150
Port of Entry
Melbourne, Sydney
Identity of Recipients
Clariant (Australia) Pty Ltd
Unilever Asia Private Limited
Transportation and Packaging
The notified chemical will be imported by air or sea in 200 L drums or 1000 L intermediate bulk containers (IBCs). The notified chemical will be transported by road from the port of entry to the warehouse for storage and to the site of reformulation. Where imported in finished cosmetic products, these will be transported to warehouses and then to retail outlets for sale.
Use
The notified chemical will be used in rinse-off cosmetic skin and hair cleansing products. The final concentration of the notified chemical in end-use cosmetic products will be ≤ 5%.
Operation description
The notified chemical will be imported as a component of finished cosmetic products, or at up to 25% for reformulation into cosmetic products for skin and hair cleansing. At the site of reformulation, the product containing the notified chemical will be manually transferred from either 200 L drums or 960 kg IBCs into the reformulation vessels for formulation of the final cosmetic products. Mixing and dispensing will be carried out in closed systems or under conditions designed not to generate aerosols or airborne dust. After reformulation, the final cosmetic products will be pumped into sealed holding tanks and then transferred into automated filing line via a circuit of pipes and pumps. The end-use cosmetic products will then be filled into consumer size packages of various sizes (200 – 1000 ml) for distribution to retailers. Samples will be collected at various stages during the reformulation and packaging for quality control testing.