Metabolic Test concentration (g/mL) Controls Activation Number -S9 IA treatment time = 3 hours (20 hours harvest) Positive: 0, 5.73, 8.19*, 11.7*, 16.7* and 23.9* g/mL MMC Negative: II treatment time = 17.8 hours (20.3 hours harvest) 0, 1.25, 2.5*, 5*, 10*, 15*, 20 and 25 g/mL vehicle +S9 IA treatment time = 3 hours (20 hours harvest) Positive: 0, 8.19, 11.7*, 16.7*, 23.9* and 34.2* g/mL CP Negative: II treatment time = 3 (20 hours harvest) vehicle 0, 5, 10*, 15, 20*, 25*, 30* and 35 g/mL MMC - mitomycin C CP - cyclophosphamide DMSO dimethylsulphoxide – * - cultures selected for metaphase analysis OECD TG 473 Test method: No significant increase in with chromosomal Comment: aberrations, polyploidy, or endore-duplication was observed in the cultures analyzed in both the initial and confirmatory assays. The results of positive controls were not reported. The notified chemical was non clastogenic under the Result: conditions of the test. 9.3.3 Micronucleus in the Bone Marrow Cells of the Mouse No report of micronucleus assay was provided. in vivo 9.4 Overall Assessment of Toxicological Data The notified chemical was of very low acute oral toxicity (LD50>2 000 mg/kg) and low acute dermal toxicity (LD50>2 000 mg/kg) in rats. It was not an eye or skin irritant in rabbits, nor a skin sensitiser in guinea pigs. The notifier provided a report of using an Irritection Assay System to assess the potential ocular irritancy for the notified chemical. The results in vitro suggested that the notified chemical may have the potential to produce, at most, minimal eye irritation (Emmons, 2000), which was in consistent with the test results. in vivo In a repeat dose oral toxicity study in rats, a NOEL was established as 1 000 mg/kg/day, the highest dose tested. In genotoxicity studies, the notified chemical was not mutagenic in
Metabolic Activation Number Test concentration (g/mL) Controls -S9 IA treatment time = 3 hours (20 hours harvest) 0, 5.73, 8.19*, 11.7*, 16.7* and 23.9* g/mL Positive: MMC Negative: vehicle II treatment time = 17.8 hours (20.3 hours harvest) 0, 1.25, 2.5*, 5*, 10*, 15*, 20 and 25 g/mL +S9 IA treatment time = 3 hours (20 hours harvest) 0, 8.19, 11.7*, 16.7*, 23.9* and 34.2* g/mL Positive: CP Negative: vehicle II treatment time = 3 (20 hours harvest) 0, 5, 10*, 15, 20*, 25*, 30* and 35 g/mL MMC - mitomycin C CP - cyclophosphamide DMSO – dimethylsulphoxide * - cultures selected for metaphase analysis Test method: OECD TG 473 Comment: No significant increase in with chromosomal aberrations, polyploidy, or endore-duplication was observed in the cultures analyzed in both the initial and confirmatory assays. The results of positive controls were not reported. Result: The notified chemical was non clastogenic under the conditions of the test. 9.3.3 Micronucleus in the Bone Marrow Cells of the Mouse No report of in vivo micronucleus assay was provided. 9.4 Overall Assessment of Toxicological Data The notified chemical was of very low acute oral toxicity (LD50>2 000 mg/kg) and low acute dermal toxicity (LD50>2 000 mg/kg) in rats. It was not an eye or skin irritant in rabbits, nor a skin sensitiser in guinea pigs. The notifier provided a report of using an Irritection Assay System to assess the potential ocular irritancy in vitro for the notified chemical. The results suggested that the notified chemical may have the potential to produce, at most, minimal eye irritation (Emmons, 2000), which was in consistent with the in vivo test results. In a repeat dose oral toxicity study in rats, a NOEL was established as 1 000 mg/kg/day, the highest dose tested. In genotoxicity studies, the notified chemical was not mutagenic in
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