Remarks Results Positive control substances readily induced mutations in the tester strains – and negative controls were within historical levels. No significant increases in the revertant numbers were observed at any dose level in any strain. The notified chemical was not mutagenic to bacteria under the conditions of the test. Safepharm Laboratories 7.8 Genotoxicity in vitro – Notified chemical. OECD TG 473 In vitro Mammalian Chromosomal Aberration Test. Cell Type/Cell Line Human peripheral lymphocytes Metabolic Activation Phenobarbitone/-naphthoflavone-induced rat liver S9 fraction. System Vehicle Minimal Essential Media (MEM). Remarks Method None. – Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Present Test 1 0, 625, 1250*, 2500* and 5000* 4h 24h Test 2 0, 625, 1250*, 2500* and 5000* 4h 24h Absent Test 1 0, 625, 1250*, 2500* and 5000* 4h 24h Test 2 0, 625, 1250*, 2500* and 5000* 24h 24h *Dose levels selected for metaphase analysis. Remarks Results The test material did not induce a statistically significant increase in the – frequency of cells with chromosome aberrations in either the presence or absence of liver enzyme metabolising system in either of two separate experiments. No toxicity was observed as indicated by depression of mitotic index at any dose. Positive controls gave the expected increases in chromosomal aberrations and negative controls were within historical limits. The notified chemical was not clastogenic to human lymphocytes treated under the conditions of the test. in vitro Safepharm Laboratories (2004h). 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. Ready biodegradability Notified chemical. OECD TG 301 F Ready Biodegradability: Manometric Respirometry Test.
Remarks – Results Positive control substances readily induced mutations in the tester strains and negative controls were within historical levels. No significant increases in the revertant numbers were observed at any dose level in any strain. The notified chemical was not mutagenic to bacteria under the conditions of the test. Safepharm Laboratories 7.8 Genotoxicity – in vitro Notified chemical. OECD TG 473 In vitro Mammalian Chromosomal Aberration Test. Cell Type/Cell Line Human peripheral lymphocytes Metabolic Activation System Phenobarbitone/-naphthoflavone-induced rat liver S9 fraction. Vehicle Minimal Essential Media (MEM). Remarks – Method None. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Present Test 1 0, 625, 1250*, 2500* and 5000* 4h 24h Test 2 0, 625, 1250*, 2500* and 5000* 4h 24h Absent Test 1 0, 625, 1250*, 2500* and 5000* 4h 24h Test 2 0, 625, 1250*, 2500* and 5000* 24h 24h *Dose levels selected for metaphase analysis. Remarks – Results The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations in either the presence or absence of liver enzyme metabolising system in either of two separate experiments. No toxicity was observed as indicated by depression of mitotic index at any dose. Positive controls gave the expected increases in chromosomal aberrations and negative controls were within historical limits. The notified chemical was not clastogenic to human lymphocytes treated in vitro under the conditions of the test. Safepharm Laboratories (2004h). 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. Ready biodegradability Notified chemical. OECD TG 301 F Ready Biodegradability: Manometric Respirometry Test.