File No: STD/1007
April 2002

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

FULL PUBLIC REPORT

CGL-074

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 National Occupational Health and Safety Commission which also conducts the occupational health and safety assessment. The assessment of environmental hazard is conducted by the Department of the Environment and Heritage and the assessment of public health is conducted by the Department of Health and Ageing.

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 9577 8888.

Website: www.nicnas.gov.au

Director

Chemicals Notification and Assessment

TABLE OF CONTENTS

FULL PUBLIC REPORT 3

FULL PUBLIC REPORT 4

1. APPLICANT AND NOTIFICATION DETAILS 4

2. IDENTITY OF CHEMICAL 4

3. COMPOSITION 5

4. INTRODUCTION AND USE INFORMATION 5

5. PROCESS AND RELEASE INFORMATION 5

5.1. Distribution, Transport and Storage 5

5.2. Operation Description 5

5.3. Release 6

5.4. Disposal 6

6. PHYSICAL AND CHEMICAL PROPERTIES 6

7. TOXICOLOGICAL INVESTIGATIONS 9

7.1. Acute toxicity – oral 9

7.2. Acute toxicity - dermal 10

7.3. Acute toxicity – inhalation not provided. 11

7.4. Irritation – skin 11

7.5. Irritation - eye 12

7.6. Skin sensitisation 13

7.7. 28-day Repeat dose oral toxicity 14

7.8. Genotoxicity - bacteria 17

7.9. Genotoxicity – in vitro 18

8. ENVIRONMENT 20

8.1. Environmental fate 20

8.1.1. Ready biodegradability 20

8.1.2. Bioaccumulation 20

8.2. Ecotoxicological investigations 21

8.2.1. Acute toxicity to fish 21

8.2.3. Algal growth inhibition test 22

8.2.4. Inhibition of microbial activity 22

9. RISK ASSESSMENT 24

9.1. Environment 24

9.1.1. Environment – exposure assessment 24

9.1.2. Environment – effects assessment 24

9.1.3. Environment – risk characterisation 24

9.2. Human health 24

9.2.1. Occupational health and safety – exposure assessment 24

9.2.2. Public health 25

9.2.3. Human health - effects assessment 25

9.2.4. Human health – risk characterisation 26

10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND 27

HUMANS 27

10.1. Environment 27

10.2. Health hazard 27

10.3. Human health 27

10.3.1. Human health – Occupational health and safety 27

10.3.2. Human health – public 27

11. RECOMMENDATIONS 28

11.1. Secondary notification 28

12. MATERIAL SAFETY DATA SHEET 28

13. BIBLIOGRAPHY 30

File No: STD/1007
April 2002

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

FULL PUBLIC REPORT

CGL 074

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 National Occupational Health and Safety Commission which also conducts the occupational health and safety assessment. The assessment of environmental hazard is conducted by the Department of the Environment and Heritage and the assessment of public health is conducted by the Department of Health and Ageing.

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 9577 8888.

Website: www.nicnas.gov.au

Director

Chemicals Notification and Assessment

FULL PUBLIC REPORT

CGL 074

1. APPLICANT AND NOTIFICATION DETAILS

Applicant(s)
CIBA SPECIALTY CHEMICALS
235 Settlement Road Thomastown VIC 3082
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
CAS number
Molecular formula
Structural formula
Molecular weight
Spectral data (UV/vis, IR, NMR) (except as shown in technical bulletin)
Estimated import
Number of sites at which the product will be formulated
Identity of sites at which the product will be formulated
Bibliographic material
References to composition of commercial form (other than ‘sterically hindered amine’ content: high (>99 %))
Variation of Data Requirements (Section 24 of the Act)
No variation to the schedule of data requirements is claimed.
Previous Notification in Australia by Applicant
none
Notification in Other Countries
Italy; Notification Number: 00-05-0376-00 1992

2. IDENTITY OF CHEMICAL

Other Name(s)
CGL-074
TKA 45024
CA37-0074 C18 monomer
Marketing Name(s)
CGL-074
Methods of Detection and Determination
AnalyticalMethod / 1H nmr spectroscopy
Infrared (IR) spectroscopy
Flow Injection LC/Apcl/Mass Spectroscopy
Test Facility / Ciba Specialty Chemicals Corporation
Tarrytown, NY 10591 USA

3. COMPOSITION

Degree of Purity
> 92 %
Additives/Adjuvants
None

4. 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 introduced in a ready to use pelleted (granular) form.
Use
The notified chemical will be incorporated into masterbatch formulations of base polymer at 10-20 % and in end-use polymer products at 0.1 -1.0 %. Masterbatch formulations containing the notified polymer may be converted to articles or films for end use.
The principal function of the notified chemical in the polymer is to impart some resistance against solar ultra-violet radiation to polymers into which it is incorporated.

5. PROCESS AND RELEASE INFORMATION

5.1. Distribution, Transport and Storage

Port of Entry
Not specified.
Identity of Manufacturer
Ciba Specialty Chemicals Corporation
Tarrytown, NY 10591 USA
Transportation and Packaging
The notified chemical will be transported in 20 kg polythene bags housed within fireboard boxes (suitable for road/rail transport) or in 50 kg fibre drums designed for international transport. No repackaging operations will be carried out.

5.2. Operation Description

Masterbatch Production
The notified chemical is weighed and charged before being added to base polymer in a blending vessel for mixing with other components. The powdered masterbatch is then transferred to the feed hopper of an extruder from which molten strands are chopped into pellets and allowed to cool before being discharged via a closed transfer system for packaging. During this process, the notified chemical becomes encapsulated in the polymer matrix. Local exhaust ventilation ensures capture of fugitive dust/vapours released during processing. High temperature injection moulding processes are used for production of end-use articles or films containing the notified chemical.
Extrusion and Moulding Operations
At the factories of the final users, the small pellets of masterbatch containing the notified chemical (and possibly other additives) are mixed with polymer in an typical ratio of around 1:10 masterbatch: polymer in the hopper of an injection moulding machine, and again melted and extruded under pressure through dies or moulds of the appropriate shapes so as to produce the final plastic article. Since the notified chemical typically comprises 10-20% of the masterbatch, the final concentration in the finished polymer products is estimated as being typically around 1.0-2.0%, although the notifier indicated that the range could be 0.1-1%.
Initially up to 3 end users might use masterbatch material containing the notified chemical, although this may increase in the future. It was indicated that polymer containing the notified chemical would be used in the manufacture of a diverse range of plastic products where light stability is important. Use in agricultural and horticultural plastic products (presumably articles such as agricultural polyethylene pipe) was indicated as a major end use.

5.3. Release

Release of Chemical at Site of Masterbatch Preparation and Extrusion Moulding of Finished Articles
Masterbatch Preparation
Small quantities of the chemical could be lost during preliminary mixing with polymer and other components prior to extrusion of the masterbatch, and all of this is likely to be placed into landfill. Small spills of chemical would be swept up and either returned to the mix or disposed of with other factory waste to landfill. It is expected that the mixing and extrusion operations would be performed using vacuum extraction/filtration so that any particulate matter released to the air during operations would be captured and retained on the filters, and all solid material retained on the filters would also be placed into landfill.
On occasions the extrusion equipment would be cleaned out and some solid scrap material removed from the equipment and also placed into landfill, as would any of the granulated masterbatch lost during packaging. Emptied bags of the chemical would be shaken into the masterbatch mix to remove residual material and then be placed into landfill.
Extrusion and Moulding Operations
Apart from spills no release of the chemical during dry mixing of the masterbatch compound with polymer, filler and other materials is expected during injection moulding of the final articles although it is possible that some scrap plastic may be produced during finishing of the final products. All such waste would be placed into landfill.
Overall Manufacturing Release
While no details of likely release of the notified chemical were provided, large releases are not expected. If it is assumed that 2% is lost during masterbatch preparation and a further 3 % lost as scrap and waste from injection moulding, then total losses associated with manufacturing activities are 5 %. This equates to a maximum annual release of 500 kg, all of which will be placed into landfill.
Release of Chemical from Use
Once incorporated into plastic/polymer articles the notified chemical will be immobilised in the polymer matrix and little release is expected.

5.4. Disposal

Disposal via incineration in the presence of excess air, is the disposal route of choice. Waste arising from formulation processes is not expected to exceed 10-20 kg per year. Non-recyclable waste arising from article manufacturing sites is expected to be negligible and disposed of to landfill.

6. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20oC and 101.3 kPa / White to Yellowish Granules.
Melting Point / 59 – 64 oC
Method / OECD TG 102 Melting Point/Range
EC Directive 92/69/EEC A.1 Melting/Freezing Temperature.
Remarks / The melting range was determined using differential scanning calorimetry (Ciba Specialty Chemicals, 2000a). Small endotherms at 30 – 36 and 44 – 54 oC attributed to crystal phases.
Test Facility / Ciba Specialty Chemicals Corporation (2000)
Boiling Point / Not determined
Method / OECD TG 103 Boiling Point.
EC Directive 92/69/EEC A.2 Boiling Temperature.
Remarks / The substance thermally decomposed before boiling at atmospheric pressure (98.8 kPa) under nitrogen. Degradation was apparent from an exothermic transition above 260 oC (270 oC at the reduced pressure of 4 kPa). Accordingly, boiling point could not be determined.
Test Facility / Ciba Specialty Chemicals Corporation (2000)
Density / 1004 kg/m3 at 24 oC
Method / OECD TG 109 Density of Liquids and Solids.
EC Directive 92/69/EEC A.3 Relative Density.
Remarks / As the instrument used for analysis, a gas comparison pycnometer (Ciba Specialty Chemicals, 2000b), was not temperature controlled, therefore, the relative density was reported at 24 oC rather than 20 oC.
Test Facility / Ciba Specialty Chemicals Corporation (2000)
Vapour Pressure / Upper Limit (estimated): < 2x10-5 Pa at 20 oC.
Method / OECD TG 104 Vapour Pressure.
EC Directive 92/69/EEC A.4 Vapour Pressure
Handbook of Chemical Property Estimation Methods (Lyman et al, 1990).
Remarks / Attempts to measure the vapour pressure of the notified chemical using the “dynamic method” were unsuccessful due to thermal decomposition. The vapour pressure limit was estimated (Ciba Specialty Chemicals, 2000c) Ciba Specialty Chemicals, 2000c)(Ciba Specialty Chemicals, 2000c) at 20oC using the modified Watson correlation (Organisation for Economic Cooperation and Development 1993)and in the Handbook of Chemical Property Estimation Methods (Lyman et al, 1990).
Test Facility / Ciba Specialty Chemicals Corporation (2000)
Water Solubility / < 50 ppb (0.05 mg/L) at 20oC
Method / OECD TG 105 Water Solubility.
EC Directive 84/449 A.6 Water Solubility.
Remarks / Analytical Method: HPLC/evaporative light scattering detection. The water solubility was determined (Ciba Specialty Chemicals, 2000d) by stirring the compound in water at 30oC for three days and then allowed to equilibrate at 20oC for another day following which the filtered samples were analysed for contained test compound using HPLC after extraction with dichloromethane. The concentration of the test material in the water was found to be less than the detection limit of the method employed which was 50 µg/L.
Test Facility / Ciba Specialty Chemicals Corporation (2000)
Hydrolysis as a Function of pH
Remarks / No experimental data was provided due to the very low water solubility. However, the compound contains no functional groups which are susceptible to hydrolysis in the environmental pH region where 4<pH<9.
Partition Coefficient (n-octanol/water) / Log Kow at 20oC =10.15 (estimated)
Method / OECD TG 117 Partition Coefficient (n-octanol/water): HPLC Method.
Remarks / The value of Log Kow was estimated (Ciba Specialty Chemicals, 2000e) using methods based on the molecular structure of the compound described by Lyman et al, 1990. These authors state that values of Log Pow greater than 6 estimated by these methods are questionable, but nevertheless a high value for Log Pow is expected for the present compound due to the high content of aliphatic hydrocarbon.
Test Facility / Ciba Specialty Chemicals Corporation (2000)