Cultured Human 15.6-5000 mg/mL (+/- -ve 9 Lymphocytes S9) 9.4 Overall Assessment of Toxicological Data The studies demonstrated that the notified chemical (ammonium methanethiosulfonate) has low acute oral and dermal toxicity, is a severe eye irritant, is possibly a skin irritant and does not cause dermal sensitisation. A 28-day oral repeat dose study in rats revealed induction of mild anaemia at the highest dose of 1000 mg/kg/day. The compound showed no genotoxic activity in reverse mutation tests in bacteria (Ames test) nor direct clastogenic activity in human lymphocytes at non-toxic doses. On the basis of submitted data, the notified chemical would be classified as hazardous in accordance with Worksafe Australia’s Approved Criteria for Classifying with respect to eye irritation. Hazardous Substances 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS Results of ecotoxicity tests are summarised. While the chemical can be classified as non-toxic to fish and algae, it is slightly toxic to water fleas, with a 21 day EC50 of 31.8 mg/L. Also, the chemical does not appear to inhibit the activity of bacteria in aerobic sludge. This observation was made during the conduct of the ready biodegradation test. All ecotoxicity tests were performed to test methods following the EC Directive 92/69/EEC. Ecotoxicity test results Species Test Concentrations a Result (mg/L) (mg/L) Rainbow Trout 96 h acute 92.3 LC50 > 92.3 NOEC > 92.3 Water Flea 48 h acute 6.08, 12.2, 26, EC50 = 67.6 (Daphnia magna) 50.9, 105 Water Flea 21 d 5.9, 12.0, 24.7, EC50 = 36.8 (Daphnia 48.7, 101 EC50 magna) (reproduction) = 31.8 & 33.3 (Selenastrum 96 h growth 97.2 NOEC > 97.2 capricornutum ) Aerobic Sludge 5 d 10 NOEC > 10
Cultured Human Lymphocytes 15.6-5000 mg/mL (+/- S9) -ve 9 9.4 Overall Assessment of Toxicological Data The studies demonstrated that the notified chemical (ammonium methanethiosulfonate) has low acute oral and dermal toxicity, is a severe eye irritant, is possibly a skin irritant and does not cause dermal sensitisation. A 28-day oral repeat dose study in rats revealed induction of mild anaemia at the highest dose of 1000 mg/kg/day. The compound showed no genotoxic activity in reverse mutation tests in bacteria (Ames test) nor direct clastogenic activity in human lymphocytes at non-toxic doses. On the basis of submitted data, the notified chemical would be classified as hazardous in accordance with Worksafe Australia’s Approved Criteria for Classifying Hazardous Substances with respect to eye irritation. 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS Results of ecotoxicity tests are summarised. While the chemical can be classified as non-toxic to fish and algae, it is slightly toxic to water fleas, with a 21 day EC50 of 31.8 mg/L. Also, the chemical does not appear to inhibit the activity of bacteria in aerobic sludge. This observation was made during the conduct of the ready biodegradation test. All ecotoxicity tests were performed to test methods following the EC Directive 92/69/EEC. Ecotoxicity test results Species Test Concentrations a (mg/L) Result (mg/L) Rainbow Trout 96 h acute 92.3 LC50 > 92.3 NOEC > 92.3 Water Flea (Daphnia magna) 48 h acute 6.08, 12.2, 26, 50.9, 105 EC50 = 67.6 Water Flea (Daphnia magna) 21 d 5.9, 12.0, 24.7, 48.7, 101 EC50 = 36.8 EC50 (reproduction) = 31.8 & 33.3 (Selenastrum capricornutum ) 96 h growth 97.2 NOEC > 97.2 Aerobic Sludge 5 d 10 NOEC > 10
NA331FR.docx