Reverse Mutation Assay (Wagner, 1998) Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 Strains: Salmonella typhimurium and WP2 and WP2 Escherichia coli uvrA 0, 100, 333, 1 000, 3 333 and 5 000 with and g/plate Concentration range: without S9 mix; each dose was tested in triplicate in two independent assays (initial and confirmatory); Test substance was delivered in acetone was also used as a negative control; appropriate strain specific positive control reference substances were used. Liver fraction (S9 mix) from rat pretreated with Aroclor Metabolic activation: 1254 OECD TG 471 pre incubation method Test method: – TSCA 799.9510 Neither precipitate nor toxicity was observed in either Comment: experiment. No positive responses were observed in all strains tested with and without S9 activation. The notified substance tested in acetone showed no evidence Result: of mutagenic activity in strains of Salmonella typhimurium and E.coli. Chromosome Damage The notifier stated that on the basis of negative findings in bacterial mutagen assays investigations of clastogenic potential were not considered necessary. Overall Assessment of Toxicological Data The notified chemical has very low acute oral toxicity (LD50 > 2 000 mg/kg) in rats and very low dermal toxicity (LD50 > 2 000 mg/kg) in rabbits. In an acute inhalation study the LC50 was established at greater than 3.87 mg/L/4h which was the maximum attainable concentration. Skin irritancy was manifested in the acute dermal irritation study, following a 24 hour exposure to the notified chemical. However, these findings were not observed in the skin irritation study. The notified chemical was a moderate eye irritant. The notified substance was not sensitising to guinea pig skin. Repeat dose oral testing has not been conducted on the notified chemical. The notified chemical did not exhibit mutagenic activity in the bacterial system tested. No genotoxicity data was provided. Based on the data provided the notified chemical would not be classified as hazardous under the NOHSC (NOHSC, 1999). Approved Criteria for Classifying Hazardous Substances
Salmonella typhimurium Reverse Mutation Assay (Wagner, 1998) Strains: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2 uvrA and WP2 Concentration range: 0, 100, 333, 1 000, 3 333 and 5 000 g/plate with and without S9 mix; each dose was tested in triplicate in two independent assays (initial and confirmatory); Test substance was delivered in acetone was also used as a negative control; appropriate strain specific positive control reference substances were used. Metabolic activation: Liver fraction (S9 mix) from rat pretreated with Aroclor 1254 Test method: OECD TG 471 – pre incubation method TSCA 799.9510 Comment: Neither precipitate nor toxicity was observed in either experiment. No positive responses were observed in all strains tested with and without S9 activation. Result: The notified substance tested in acetone showed no evidence of mutagenic activity in strains of Salmonella typhimurium and E.coli. Chromosome Damage The notifier stated that on the basis of negative findings in bacterial mutagen assays investigations of clastogenic potential were not considered necessary. Overall Assessment of Toxicological Data The notified chemical has very low acute oral toxicity (LD50 > 2 000 mg/kg) in rats and very low dermal toxicity (LD50 > 2 000 mg/kg) in rabbits. In an acute inhalation study the LC50 was established at greater than 3.87 mg/L/4h which was the maximum attainable concentration. Skin irritancy was manifested in the acute dermal irritation study, following a 24 hour exposure to the notified chemical. However, these findings were not observed in the skin irritation study. The notified chemical was a moderate eye irritant. The notified substance was not sensitising to guinea pig skin. Repeat dose oral testing has not been conducted on the notified chemical. The notified chemical did not exhibit mutagenic activity in the bacterial system tested. No genotoxicity data was provided. Based on the data provided the notified chemical would not be classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999).
NA694FR.docx