EBS (1996e) 7.11. Genotoxicity – in Analogous chemical. OECD TG 473 In vitro Mammalian Chromosome Aberration Test. Cell Type/Cell Line CHO cells (WBL) Metabolic Activation System Aroclor 1254 rat liver induced S9 fraction. Vehicle tetrahydrofuran Remarks - Method Maximum concentrations were determined based on solubility. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 2, 4, 8, 16*, 32* ,64* μg/mL 16 hours 36 hours Test 2 2, 4, 8, 16*, 32*, 64* μg/mL 16 hours 40 hours Present Test 1 2, 4, 8, 16*, 32*, 64* μg/mL 16 hours 36 hours Test 2 2, 4, 8, 16*, 32*, 64* μg/mL 16 40 hours *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None. None. >32 μg/mL None. Test 2 None. None. >16 μg/mL None. Present Test 1 None. None. >32 μg/mL None. Test 2 None. None. 64 μg/mL None. Remarks - Results DMBA and MNNG were used as positive controls and induced distinct increases in the proportion of cells with structural chromosomal aberrations. The analogous chemical was not clastogenic to CHO cells treated in vitro under the conditions of the test. EBS (1996f) 7.12. Genotoxicity – in vivo Analogous chemical. OECD TG 475 Mammalian Bone Marrow Chromosome Aberration Test. Species/Strain Mouse/CD-1 Route of Administration Oral – gavage Vehicle Peanut oil Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours
Since the test substance did not reach 60% degradation it cannot be classified as readily biodegradable. EBS 8.1.2. Bioaccumulation Not determined. The notified chemical has the potential to bioaccumulate but this is unlikely due to its low environmental exposure. 8.2. Ecotoxicological investigations 8.2.1. toxicity to fish Analogous chemical. OECD TG 203 Fish, Acute Toxicity Test – semi-static. EC Directive 92/69/EEC C.1 Acute Toxicity for Fish - semi-static. Species Rainbow trout (Oncorhynchus mykiss) Exposure Period 96 hours Auxiliary Solvent None. Water Hardness 150 mg CaCO3/L Analytical Monitoring Total Organic Carbon (TOC) Remarks – Method The test material was prepared as a Accommodated Fraction (WAF) due to its expected low water solubility. The mixtures were stirred at room temperature for 24 h and allowed to settle for 1 h. Following the settling period the water phase containing the WAF was removed from the bottom outlet of the vessel. Each concentration was tested in duplicate, with the renewed daily, using freshly prepared WAF. The test vessels were exposed to 16 hours of light and 8 hours of dark. The dissolved oxygen, pH and temperature were measured before and after media renewal. These environmental parameters all varied within acceptable limits. Concentration mg/L (WAF) Number of Fish Mortality Nominal Actual 0 h 24 h 48 h 72 h 96 h 0 10 0 0 0 0 0 100 10 0 0 0 0 0 1000 10 0 0 0 0 0 LL50 >1000 mg/L (WAF) at 96 hours. NOEL 1000 mg/L (WAF) at 96 hours. Remarks – Results The TOC analysis indicated that the total organic carbon content of the WAFs was below the quantification limit of 1 ppm. Under the study conditions the test substance is not toxic to fish, up to the limit of its water solubility. EBS (1996j) 8.2.2. Acute toxicity to aquatic invertebrates Analogous chemical. OECD TG 202 Daphnia sp. Acute Immobilisation Test – static test.
The notified chemical is not expected to be harmful based on animal studies using a close analogue. Studies in human volunteers indicated that the notified chemical is unlikely to be a skin irritant or sensitiser. In addition to the low hazard presented by the notified chemical, exposure will be controlled through the use of enclosed blending facilities and PPE such as protective clothing, eyewear and gloves. Thus, there is a low OHS risk due to likely low hazard and low exposure. 9.2.5. Public health – risk characterisation It is not expected that the public will be exposed to the notified chemical. In the unlikely case of a spill, the low hazard presented by the notified chemical translates to low risk to public health. 10. CONCLUSIONS – ASSESSMENT LEVEL OF CONCERN FOR THE ENVIRONMENT AND HUMANS 10.1. Hazard classification on the available data the notified chemical is not classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous Substances. And as a comparison only, the classification of notified chemical using the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations 2003) is presented below. This system is not mandated in Australia and carries no legal status but is presented for information purposes. On environmental grounds the notified chemical would be classified as Chronic IV. 10.2. Environmental risk assessment The notified chemical is not considered to pose a risk to the environment based on its reported use pattern. 10.3. health risk assessment 10.3.1. Occupational health and safety There is Low Concern to occupational health and safety under the conditions of the occupational settings described. 10.3.2. Public health There is Negligible Concern to public health when used in lubricant additives that are not available to the public. 11. MATERIAL SAFETY DATA SHEET 11.1. Material Safety Data Sheet The MSDS of the notified chemical provided by the notifier was in accordance with the NOHSC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 2003). It is published here as a matter of public record. The accuracy of the information on the MSDS remains the responsibility of the applicant. 11.2. The label for the notified chemical provided by the notifier was in accordance with the NOHSC National Code of Practice for the Labelling of Workplace Substances (NOHSC 1994). The accuracy of the information on the label remains the responsibility of the applicant. 12. RECOMMENDATIONS Occupational Health and Safety