File No: STD/1348

May 2010

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)

FULL PUBLIC REPORT

Chemical in Niax additive RA-1

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 Report3

1.APPLICANT AND NOTIFICATION DETAILS3

2.IDENTITY OF CHEMICAL3

3.COMPOSITION3

4.PHYSICAL AND CHEMICAL PROPERTIES4

5.INTRODUCTION AND USE INFORMATION4

6.HUMAN HEALTH IMPLICATIONS5

6.1Exposure assessment5

6.2.Human health effects assessment6

6.3.Human health risk characterisation7

7.ENVIRONMENTAL IMPLICATIONS8

7.1.Environmental Exposure & Fate Assessment8

7.2.Environmental effects assessment8

7.3.Environmental risk assessment9

8.CONCLUSIONS AND REGULATORY OBLIGATIONS9

Hazard classification9

Human health risk assessment9

Environmental risk assessment9

Recommendations9

Regulatory Obligations10

Appendix A: Physical and Chemical Properties11

Appendix B: Toxicological Investigations13

B.1.Acute toxicity oral13

B.2.Acute toxicity dermal13

B.3.Acute toxicity inhalation13

B.4.Irritation skin14

B.5.Irritation eye15

B.6.Skin sensitisation15

B.7.Repeat dose toxicity16

B.8.Genotoxicity bacteria17

B.9.Genotoxicity in vivo18

Appendix C: Environmental Fate and Ecotoxicological Investigations20

C.1.Environmental Fate20

C.2.Ecotoxicological Investigations21

Bibliography24

Full Public Report

Chemical in Niax additive RA-1

1. APPLICANT AND NOTIFICATION DETAILS

Applicant(s)

Momentive Performance Materials Australia Pty Ltd (ABN 47 105 651 063)

Level 2, 600 Victoria Street

Richmond VIC 3121

Isochem Australia Pty Ltd

25 Valley Park Crescent

North Turramurra NSW 2074

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:

Chemical Name, Other Names, CAS Number, Molecular Formula, Structural Formula, Molecular Weight, Spectral Data, Methods of Detection and Determination, Purity, Hazardous Impurities, Additives/Adjuvants, Import Volume, Use Details, Identity of Manufacturer/Recipients.

Variation of Data Requirements (Section 24 of the Act)

Variation to the schedule of data requirements is claimed as follows:

Boiling point, Particle size, Flammability, Hydrolysis, Bioaccumulation, Explosive properties, and Oxidising properties.

Previous Notification in Australia by Applicant(s)

None

Notification in Other Countries

USA, Canada, China

2. IDENTITY OF CHEMICAL

Marketing Name(s)

Niax Additive RA-1 (product containing the notified chemical at 1% by weight)

None

May 2010NICNAS

FULL PUBLIC REPORT: STD/1348Page 24 of 24

4. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20C and 101.3 kPa: Clear, dark brown liquid, like honey (notified chemical)

Property

Value

Data Source/Justification

Melting Point/Freezing Point

--

No definitive melting point temperature was able to be determined.

Boiling Point

--

Not determined.

Density

1143kg/m3 at 20oC

Measured.

Vapour Pressure

0.29 kPa at 25oC

The high vapour pressure measured is attributed to impurities contained in the test substance. The notified chemical is not expected to be volatile based on the apparently high molecular weight and hydrophilic structure.

Water Solubility

>500 g/L at 20oC

Measured.

Hydrolysis as a Function of pH

Not tested

The notified chemical, as a salt, will dissociate into its respective ions in water. The notified chemical is not expected to hydrolyse over the environmental pH range (49).

Partition Coefficient

(n-octanol/water)

log Pow 5

>5

Positive**

Test 2 (confirmatory assay)

Not performed

>5

>5

Negative

*At 1 and 5 L/plate in TA 98, at 1 L/plate in the TA 100 and at 5 L/plate concentrations in the WP2 strain.

**At 1 L/plate in TA 98 and at 5 L/plate concentrations in the WP2 strain.

Remarks - Results

In the initial or main assay performed using plate incorporation method of exposure, a statistically significant increase in the frequency of revertants was observed in both tests, with and without metabolic activation. However, it is noted that increase in the frequency of revertants was not consistent with respect to the dose and strain of the bacteria, with and without metabolic activation.

The confirmatory assay performed using the pre-incubation method of exposure revealed no statistically significant increases in any of the strains exposed to the same concentrations of the test substance, with and without metabolic activation.

All positive controls showed a statistically significant increase in the number of mutants as compared to the corresponding negative control.

Conclusion

The notified chemical was weakly mutagenic to bacteria under the conditions of the test.

Test Facility

Toxikon Corporation (2005b)

B.9. Genotoxicity in vivo

Test Substance

Notified chemical (at