SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR TRADE NAME HAZARDOUS INTRODUCTION VOLUME USE STD/1524 Australia Pty Ltd Ethane, Yes ≤ 5 tonnes per annum Solvent in printing inks 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 Flammable Liquids Category 4 H227 – Combustible liquid. Reproductive Toxicity Category 2 Suspected Human Reproductive Toxicant H361 – Suspected of damaging fertility or the unborn child. Based on the available information, the notified chemical is recommended for hazard classification according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) as a substance toxic to reproduction Category 3 with the following risk phrase: R62/63: Possible risk of impaired fertility/Possible risk of harm to the unborn child Human health risk assessment Provided that the recommended controls are being adhered to, 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 assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment. Recommendations The notified chemical should be classified as follows: Flammable Liquids Category 4: H227 – Combustible liquid. Reproductive Toxicity Category 2 Suspected Human Reproductive Toxicant: H361 – Suspected of damaging fertility or the unborn child. The above should be used for products/mixtures containing the notified chemical, if applicable, based on the concentration of the notified chemical present and the intended use/exposure scenario. The (M)SDS provided by the notifier should be amended as follows: Revise the information for the notified chemical in Sections 2 and 3 to include the hazard classification for reproductive toxicity. Revise Section 8.2.2.2(c) respiratory protection to state: “Not required unless engineering controls are inadequate to control inhalation exposure (refer to Section 8.3 for ventilation recommendations).”
Mutagenicity Test: Chromosome Aberration Test Using Cultured Mammalian Cells, Japan (simplified chromosome aberration test) The test substance was examined at 1 sample per dose level. Species/Strain Chinese hamster Cell Type/Cell Line Lung fibroblasts (CHL/IU) Metabolic Activation System S9 mix (commercially prepared from rat liver, induction system not specified) Vehicle Water Remarks - Method The study was not conducted in compliance with GLP. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 6 24 hours Test 2 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 24 hours 24 hours Present Test 1 23.1, 46.3, 92.5, 185, 370*, 740*, 1480* 6 hours 24 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 - > 1,480 > 1,480 Negative Test 2 - > 1,480 > 1,480 Negative Present Test 1 - > 1,480 > 1,480 Negative Remarks - Results Positive controls produced high numbers of aberrations, indicative of sensitivity of the test system. The notified chemical was not clastogenic to Chinese hamster lung treated in vitro under the conditions of the test. CERI (2013) Genotoxicity – in vitro mammalian chromosome aberration test Notified chemical (99.98% in purity) OECD TG 473 In Mammalian Chromosome Aberration Test Species/Strain Chinese hamster Cell Type/Cell Line Lung cell line (CHL) Metabolic Activation System S9 mix (commercial Aroclor-1254 induced rat liver homogenate) Vehicle Distilled water Remarks - Method No significant deviations of the protocol were noted. Concentrations of the test substance for the main tests were determined using a range-finding test. Cytotoxicity was < 50% at all concentrations tested (up to 1,500 μg/mL). Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time