File No: std/1085 12 January 2005



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File No: STD/1085




12 January 2005


NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)


FULL PUBLIC REPORT




Lutensol XL 80

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:
Library

National Occupational Health and Safety Commission

25 Constitution Avenue

CANBERRA ACT 2600

AUSTRALIA
To arrange an appointment contact the Librarian on TEL + 61 2 6279 1161 or + 61 2 6279 1163.
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 8800

FAX + 61 2 8577 8888

Website: www.nicnas.gov.au

Director

Chemicals Notification and Assessment

TABLE OF CONTENTS


FULL PUBLIC REPORT 3

1. APPLICANT AND NOTIFICATION DETAILS 3

2. IDENTITY OF CHEMICAL 3

3. COMPOSITION 3

4. INTRODUCTION AND USE INFORMATION 3

5. PROCESS AND RELEASE INFORMATION 4

5.1. Distribution, Transport and Storage 4

5.2. Operation description 4

5.3. Occupational exposure 4

5.4. Release 5

5.5. Disposal 5

5.6. Public exposure 5

6. PHYSICAL AND CHEMICAL PROPERTIES 6

7. TOXICOLOGICAL INVESTIGATIONS 7

7.1. Acute toxicity – oral 8

7.2. Acute toxicity – dermal 8

7.3. Acute toxicity – inhalation 9

7.4. Irritation – skin 9

7.5. Irritation – eye 9

7.6. Skin sensitisation 10

7.7. Repeat dose toxicity 10

7.8. Genotoxicity – bacteria 12

7.9. Genotoxicity – in vitro 12

7.10. Genotoxicity – in vivo 12

7.11. Developmental toxicity 13

8. ENVIRONMENT 14

8.1. Environmental fate 14

8.1.1. Ready biodegradability 14

8.1.1.1. Study 1 14

8.1.1.2. Study 2 15

8.1.2. Bioaccumulation 16

8.2. Ecotoxicological investigations 16

8.2.1. Chronic toxicity to fish 16

8.2.3. Algal growth inhibition test 17

8.2.4. Inhibition of microbial activity 18

9. RISK ASSESSMENT 18

9.1. Environment 18

9.1.1. Environment – exposure assessment 18

9.1.2. Environment – effects assessment 19

9.1.3. Environment – risk characterisation 19

9.2. Human health 19

9.2.1. Occupational health and safety – exposure assessment 19

9.2.2. Public health – exposure assessment 20

9.2.3. Human health - effects assessment 20

9.2.4. Occupational health and safety – risk characterisation 20

9.2.5. Public health – risk characterisation 20

10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 20

10.1. Hazard classification 20

10.2. Environmental risk assessment 21

10.3. Human health risk assessment 21

10.3.1. Occupational health and safety 21

10.3.2. Public health 21

11. MATERIAL SAFETY DATA SHEET 21

11.1. Material Safety Data Sheet 21

11.2. Label 21

12. RECOMMENDATIONS 21

12.1. Secondary notification 22

13. BIBLIOGRAPHY 22




FULL PUBLIC REPORT




Lutensol XL 80


1. APPLICANT AND NOTIFICATION DETAILS







Applicant(s)




BASF Australia Ltd (ABN 62 008 437 867) of 500 Princes Highway Noble Park VIC 3174.






Notification Category




Standard: Polymer with NAMW < 1000 (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 and Structural Formulae, Molecular Weight, Spectral Data, Polymer Constituents, Purity, Hazardous and Non-hazardous Impurities/Residual Monomers, Additives/Adjuvants.








Variation of Data Requirements (Section 24 of the Act)




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

Part B: Vapour Pressure, Water Solubility, Hydrolysis as Function of pH, Partition Coefficient, Dissociation Constant, Flammability Limits, Explosive Properties, Reactivity.

Part C: Acute Dermal and Inhalation Toxicity, Skin Sensitisation, In Vitro/In Vivo Genotoxicity.







Previous Notification in Australia by Applicant(s)




None.






Notification in Other Countries




China (May 2003), Korea (October 2003), Canada and USA (under assessment).




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