The No Observed (Adverse) Effect (NO(A)EL) was established as 150 mg/kg bw/day in this study, based on the mortality and morphological alterations in the stomach, liver and spleen at the higher dose. NOTOX B.V. (2005t) 7.8. Genotoxicity bacteria – Notified chemicals (>98.2% purity) OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity Reverse Mutation Test – Bacteria. Guideline stipulated by the Japanese Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry and Ministry of the Environment (revised April 30, 2004). Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, WP2 E. coli: uvrA Metabolic Activation System S9 fraction from phenobarbital /-naphthoflavone induced rat livers Concentration Range in a) With metabolic activation: 0-5000 µg/plate. Main Test b) Without metabolic activation: 0-5000µg/plate. Vehicle Milli-Q water Remarks Method No significant protocol deviation. – Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Present Test 1 >5000 >5000 >5000 Negative Test 2 Absent Test 1 >5000 >5000 >5000 Negative Test 2 Remarks Results All bacterial strains showed a negative response over the entire dose – range. The negative and strain specific positive control values were within the laboratory’s background historical control data ranges indicating that the test conditions were adequate and the metabolic activation system functioned properly. The notified chemical was not mutagenic to bacteria under the conditions of the test. NOTOX B.V. (2005u) 7.9. Genotoxicity in vitro – Notified chemical (>98.2% purity) OECD TG 473 Mammalian Chromosomal Aberration Test. In
The No Observed (Adverse) Effect (NO(A)EL) was established as 150 mg/kg bw/day in this study, based on the mortality and morphological alterations in the stomach, liver and spleen at the higher dose. NOTOX B.V. (2005t) 7.8. Genotoxicity – bacteria Notified chemicals (>98.2% purity) OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test Bacteria. Guideline stipulated by the Japanese Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry and Ministry of the Environment (revised April 30, 2004). Plate incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, TA100, E. coli: WP2 uvrA Metabolic Activation System S9 fraction from phenobarbital /-naphthoflavone induced rat livers Concentration Range in Main Test a) With metabolic activation: 0-5000 µg/plate. b) Without metabolic activation: 0-5000µg/plate. Vehicle Milli-Q water Remarks – Method No significant protocol deviation. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Present Test 1 >5000 >5000 >5000 Negative Test 2 Absent Test 1 >5000 >5000 >5000 Negative Test 2 Remarks – Results All bacterial strains showed a negative response over the entire dose range. The negative and strain specific positive control values were within the laboratory’s background historical control data ranges indicating that the test conditions were adequate and the metabolic activation system functioned properly. The notified chemical was not mutagenic to bacteria under the conditions of the test. NOTOX B.V. (2005u) 7.9. Genotoxicity – in vitro Notified chemical (>98.2% purity) OECD TG 473 In Mammalian Chromosomal Aberration Test.