File No: EX/210 (STD/1555) August 2017 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) PUBLIC REPORT Z-149 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
This assessment report is for an extension of original assessment certificate for Z-149. Based on the submission of new information by the extension notifier, some sections of the original assessment report have been modified. These modifications have been made under the heading ‘Extension Application’ in the respective sections. SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE EX/210 (STD/1555) BP Australia Pty Ltd Z-149 Yes ≤ 46 tonnes per annum Additive in engine oil CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification Based on the available information, the notified chemical is recommended for hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia. The recommended hazard classification is presented in the table below. Hazard classification Hazard statement Skin sensitisation (Category 1) H317 – May cause an allergic skin reaction Based on the available information, the notified chemical is recommended for hazard classification according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) with the following risk phrase: R38: Irritating to skin R43: May cause sensitisation by skin contact The environmental hazard classification according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is presented below. Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes. Hazard classification Hazard statement Acute (Category 2) H401 - Toxic to aquatic life 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 in the proposed manner, 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 reported use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment. Recommendations Hazard Classification and Labelling The notified chemical should be classified as follows:
TA1535, TA1537, WP2uvrA), Benzo(a)pyrene (TA98). The dose range for Test 2 was determined by the results of Test 1. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test* Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 - ≥ 150 > 5000 Negative Test 2 ≥ 150 > 500 Negative Present Test 1 - ≥ 500 > 5000 Negative Test 2 ≥ 500 > 1500 Negative * Not conducted Remarks - Results Positive and negative controls performed as expected confirming the validity of the test system. No significant increases in the frequency of the revertant colonies were recorded following treatment with the notified chemical at any dose level, with or without metabolic activation. The notified chemical was not mutagenic to bacteria under the conditions of the test. Harlan (2014j) Genotoxicity – in vivo Notified chemical OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/ Hsd: ICR (CD-1®) Route of Administration Oral – gavage Vehicle Arachis oil Remarks - Method Range finding test found no marked difference in toxic response between the sexes. It was therefore considered acceptable to use males only for the main test. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours I (vehicle control) 7 M 0 24 II (low dose) 7 M 250 24 III (mid dose) 7 M 500 24 IV (high dose) 7 M 1000 24 V (high dose) 7 M 1000 48 VI (positive control, CP) 5 M 50 24 CP=cyclophosphamide. Doses Producing Toxicity No statistically significant decreases in ratio of polychromatic erythrocytes to normochromatic erythrocytes were observed in any group exposed to the notified chemical. Genotoxic Effects No statistically significant increases in the frequency of micronucleated polychromatic erythrocytes were observed in the high dose group exposed for 48 hr or the low-dose group exposed for 24 hr.