File No: LTD/1670

October 2014

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

PUBLIC REPORT

1-Propanaminium, 3-amino-N,N,N-trimethyl-, N-palm-oil acyl derivs., Me sulfates

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.

For the purposes of subsection 78(1) of the Act, this Public Report may be inspected at our NICNAS office by appointment only at Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.

This 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: / 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 5

1. APPLICANT AND NOTIFICATION DETAILS 5

2. IDENTITY OF CHEMICAL 5

3. COMPOSITION 6

4. PHYSICAL AND CHEMICAL PROPERTIES 6

5. INTRODUCTION AND USE INFORMATION 7

6. HUMAN HEALTH IMPLICATIONS 7

6.1. Exposure Assessment 7

6.1.1. Occupational Exposure 7

6.1.2. Public Exposure 8

6.2. Human Health Effects Assessment 8

6.3. Human Health Risk Characterisation 12

6.3.1. Occupational Health and Safety 12

6.3.2. Public Health 12

7. ENVIRONMENTAL IMPLICATIONS 13

7.1. Environmental Exposure & Fate Assessment 13

7.1.1. Environmental Exposure 13

7.1.2. Environmental Fate 14

7.1.3. Predicted Environmental Concentration (PEC) 14

7.2. Environmental Effects Assessment 15

7.2.1. Predicted No-Effect Concentration 15

7.3. Environmental Risk Assessment 15

Appendix A: Physical and Chemical Properties 16

Appendix B: Toxicological Investigations 17

B.1. Irritation – skin (in vitro) 17

B.2. Irritation – eye (in vitro) 17

B.3. Irritation – eye (in vitro) 17

B.4. Skin sensitisation – human volunteers 18

B.5. Skin sensitisation – human volunteers 19

BIBLIOGRAPHY 20

October 2014 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 / USE
LTD/1670 / Estee Lauder Pty Ltd / 1-Propanaminium, 3-amino-N,N,N-trimethyl-, N-palm-oil acyl derivs., Me sulfates / ND* / ≤ 1 tonne per annum / Component of cosmetic products

*ND = not determined

CONCLUSIONS AND REGULATORY OBLIGATIONS

Hazard classification

Based on the available information, the notified chemical cannot be recommended for classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).

Human health risk assessment

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 at ≤ 3% in body lotions, ≤ 3.8% in hair styling products, ≤ 0.6% in other leave-on cosmetic products and ≤ 5% in rinse-off cosmetic products, 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 assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.

Recommendations

Control Measures

Occupational Health and Safety

·  No specific engineering controls, work practices or personal protective equipment are required for the safe use of the notified chemical itself. However, these should be selected on the basis of all ingredients in the formulation.

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 for the 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.

Public Health

·  When formulating cosmetic and personal care products containing the notified chemical, formulators should take into account its irritation potential.

Disposal

·  Where reuse or recycling are unavailable or impracticable, dispose of the 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 physical 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 chemical is intended to use in aerosol spray cosmetics;

-  the concentration of the notified chemical exceeds or is intended to exceed 3% in body lotions, 3.8% in hair styling products, 0.6% in other leave-on cosmetic products or 5% in rinse-off cosmetic products;

-  additional information becomes available on the repeated dose toxicity potential of the notified chemical;

or

(2) Under Section 64(2) of the Act; if

-  the function or use of the chemical has changed from a component of 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 MSDS of the notified chemical and products 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.

ASSESSMENT DETAILS

1.  APPLICANT AND NOTIFICATION DETAILS

Applicant(s)

Estee Lauder Pty Ltd (ABN: 63 008 444 719)

165-175 Mitchell Road

Erskineville NSW 2043

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: all physico-chemical endpoints

Previous Notification in Australia by Applicant(s)

None

Notification in Other Countries

None

2.  IDENTITY OF CHEMICAL

Marketing Name(s)

Incroquat Palm

CAS Number

857026-47-2

Chemical Name

1-Propanaminium, 3-amino-N,N,N-trimethyl-, N-palm-oil acyl derivs., Me sulfates

Molecular Formula

Unspecified

Structural Formula

Molecular Weight

Approximately 466-493 Da

Analytical Data

Reference IR spectra were provided.

3.  COMPOSITION

Degree of Purity

> 99%

Hazardous Impurities/Residual Monomers
Chemical Name / 1,3-Propanediamine, N,N-dimethyl-
CAS No. / 109-55-7 / Weight % / < 0.001%
Hazardous Properties / Xn; R22 C; R34 R43
Conc. ≥ 25%: C; R34; R22; R43;
≥ 10% Conc. < 25%: C; R34; R43;
≥ 5% Conc. < 10%: Xi; R36/38; R43;
≥ 1% Conc. 5%: Xi; R43.
Non Hazardous Impurities (> 1% by weight)

None

Additives/Adjuvants

None

4.  PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20 ºC and 101.3 kPa: amber liquid
Property / Value / Data Source/Justification
Melting Point / 339.87 °C*
349.84 °C** / Calculated (weighted value)
Boiling Point / 772.46 °C*
799.24 °C** / Calculated (adapted Stein and Brown Method)
Density / Not determined / Imported in solution
Vapour Pressure / 1.43 × 10-23 kPa at 25 °C*
1.39 × 10-24 kPa at 25 °C** / Calculated (modified Grain method)
Water Solubility / Not determined / The notified chemical is expected to disperse in water based on its surface activity.
Hydrolysis as a Function of pH / Not determined / The notified chemical contains hydrolysable functionally that is expected to slowly hydrolyse under environmental conditions (pH 4-9).
Partition Coefficient
(n-octanol/water) / Not determined / The notified chemical is expected to partition to phase boundaries based on its surface activity.
Adsorption/Desorption / Not determined / Expected to sorb to soil, sediment and sludge due to its surface activity.
Dissociation Constant / Not determined / The notified chemical is a salt and is ionised in this form.
Surface Tension / 37.1 mN/m / Measured
Particle Size / Not determined / Liquid
Flash Point / Not determined / Imported in solution
Flammability / Not determined / Imported in solution
Autoignition Temperature / Not determined / Imported in solution
Explosive Properties / Not determined / Contains no functional groups that imply explosive properties
Oxidising Properties / Not determined / Contains no functional groups that imply oxidative properties

* For the notified chemical containing the fatty acid chain C16:0

**For the notified chemical containing the fatty acid chain C18:1

Discussion of Properties

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 for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia.

5.  INTRODUCTION AND USE INFORMATION

Mode of Introduction of Notified Chemical (100%) Over Next 5 Years

The notified chemical will be imported in finished cosmetic products at up to 5% concentration.

Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years

Year / 1 / 2 / 3 / 4 / 5
Tonnes / 1 / 1 / 1 / 1 / 1

Port of Entry

Sydney by wharf

Identity of Manufacturer/Recipients

Estee Lauder Pty Ltd

Transportation and Packaging

The products containing the notified chemical (at up to 5% concentration) will be imported in containers suitable for retail sale (e.g. 200 mL). These will be packaged in cardboard cartons. The cartons will be distributed within Australia by road.

Use

The notified chemical will be used as a component of cosmetic products at up to 5% concentration. The content in the final consumer products will vary, with the following proposed usage concentrations: body lotions (≤ 3%), hair styling products (≤ 3.8%), other leave-on cosmetic products (≤ 0.6%), and rinse-off cosmetic products (≤ 5%).

Operation description

The notified chemical will be imported as a component of finished cosmetic products. Reformulation will not take place in Australia.

The finished products containing the notified chemical will be used by consumers and professionals (such as workers in beauty salons). Application of products could be by hand or through the use of an applicator.

6.  HUMAN HEALTH IMPLICATIONS

6.1. Exposure Assessment

6.1.1. Occupational Exposure

Category of Workers

Category of Worker / Exposure Duration (hours/day) / Exposure Frequency (days/year)
Transport and storage / 4 / 12
Store persons / 4 / 12
Salon workers / 8 / 260

Exposure Details

Transportation and storage workers may only be exposed to the notified chemical as a component of end-use products (at up to 5% concentration) in the unlikely event of an accident.

Exposure to the notified chemical in end-use products may occur in professions where the services provided involve the application of cosmetic products to clients (e.g. workers in beauty salons). Such professionals may use some personal protective equipment (PPE) to minimise repeated exposure, and good hygiene practices are expected to be in place. If PPE is used, exposure of such workers is expected to be of a similar or lesser extent than that experienced by consumers using products containing the notified chemical.

6.1.2. Public Exposure

There will be widespread and repeated exposure of the public to the notified chemical (at ≤ 5% concentration) through the use of the cosmetic products. The principal route of exposure will be dermal.

Data on typical use patterns of cosmetic categories in which the notified chemical may be used are shown in the following tables (SCCS, 2012; Cadby et al., 2002). For the purposes of the exposure assessment via the dermal route, Australian use patterns for the various product categories are assumed to be similar to those in Europe. Based on the physico-chemical properties of the notified chemical and dermal absorption data for analogue chemicals (see Section 6.2, Toxicokinetics), dermal absorption of 10% was used for calculation purposes. An adult average bodyweight of 60 kg was used for the calculations.

Cosmetic products (dermal exposure):

Product type / Amount
(mg/day) / C
(%) / RF / Daily systemic exposure
(mg/kg bw/day)
Body lotion / 7820 / 3 / 1 / 0.391
Face cream / 1540 / 0.6 / 1 / 0.015
Hand cream / 2160 / 0.6 / 1 / 0.022
Hair styling products / 4000 / 3.8 / 0.1 / 0.025
Make-up remover / 5000 / 5 / 0.1 / 0.042
Shower gel / 18670 / 5 / 0.01 / 0.016
Hand wash soap / 20000 / 5 / 0.01 / 0.017
Shampoo / 10460 / 5 / 0.01 / 0.009
Hair conditioner / 3920 / 5 / 0.01 / 0.003
Facial cleanser / 800 / 5 / 0.01 / 0.001
Total / 0.54

C = concentration; RF = retention factor.

Daily systemic exposure = Amount × C (%) × RF × dermal absorption (%)/body weight (60 kg)

The worst case scenario estimation using these assumptions is for a person who is a simultaneous user of all products listed in the above table that contain the notified chemical. This would result in a combined internal dose of 0.54mg/kg bw/day.