VI (high dose recovery) 1000 “ “ Mortality and time to death One at the mid dose was probably not treatment related as no deaths occurred at the high dose. Clinical Observations No relevant signs. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis No treatment-related changes. A reduction on blood cell count in high dose and high dose recovery females was slight, and was within the range of historical controls, it was considered not to be treatment related. Effects in Organs No effect of the test substance was noted on organ weights and there were no macroscopic or microscopic findings. The No Observed Effect Level (NOEL) was established as 1000 mg/kg bw/day in this study. CIT (2002f). 7.8. Genotoxicity - bacteria Notified chemical. OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity Reverse Mutation Test – using Bacteria. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, TA102. WP2 uvrA. E. coli: Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction. Concentration in a) With metabolic activation: 0 - 5000 µg/plate. Main Test b) Without metabolic activation: 0 - 5000 µg/plate. Vehicle DMSO Metabolic Test Substance Concentration Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect PreliminaryTest Main Test Absent Test 1 None None 1250 None Test 2 “ “ Present Test 1 None 1250 “ “ Test 2 “ “ The notified chemical was not mutagenic to bacteria under the conditions of the test. CIT 7.9. Genotoxicity in vitro –
VI (high dose recovery) “ 1000 “ Mortality and time to death One at the mid dose was probably not treatment related as no deaths occurred at the high dose. Clinical Observations No relevant signs. Laboratory Findings – Clinical Chemistry, Haematology, Urinalysis No treatment-related changes. A reduction on blood cell count in high dose and high dose recovery females was slight, and was within the range of historical controls, it was considered not to be treatment related. Effects in Organs No effect of the test substance was noted on organ weights and there were no macroscopic or microscopic findings. The No Observed Effect Level (NOEL) was established as 1000 mg/kg bw/day in this study. CIT (2002f). 7.8. Genotoxicity - bacteria Notified chemical. OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria. Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, TA102. E. coli: WP2 uvrA. Metabolic Activation System Aroclor 1254 induced rat liver S9 fraction. Concentration in Main Test a) With metabolic activation: 0 - 5000 µg/plate. b) Without metabolic activation: 0 - 5000 µg/plate. Vehicle DMSO Metabolic Activation Test Substance Concentration Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None 1250 None Test 2 “ “ Present Test 1 None “ 1250 “ Test 2 “ “ The notified chemical was not mutagenic to bacteria under the conditions of the test. CIT 7.9. Genotoxicity – in vitro
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