Metabolic Test Substance Concentration Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 >5000 Negative ≥333 ≥333 Test 2 >5000 Negative ≥333 Present Test 1 >5000 Negative ≥667 ≥333 Test 2 >5000 Negative ≥333 Remarks - Results The test substance did not lead to an increase in the number of revertant colonies, either with or without S9 mix. Positive controls confirmed the sensitivity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. Microbiological Associates (1995) Genotoxicity chromosome aberration test in vitro – Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. EC Directive 92/69/EEC B.10 Mutagenicity - In Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Peripheral lymphocytes Metabolic Activation System Aroclor-1254 induced rat liver S9-mix Vehicle Dimethylsulphoxide Remarks - Method No significant protocol deviations. Metabolic Exposure Harvest Test Substance Concentration (μg/mL) Activation Period (hours) Time Absent Test 1A 33, 100, 133*, 180*, 240*, 333 24 24 Test 1B 133*, 180*, 240*, 333 48 48 Test 2 33, 100*, 133, 180*, 240*, 333 24 24 Present Test 1A 33*, 100*, 333* 3 24 Test 1B 333* 3 48 Test 2 33*, 100*, 333* 3 24 *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1A 333p 333 Negative ≥240 Test 1B 333 333 Positive Test 2 333 Negative ≥240 Present Test 1A 333p >333 333 Negative Test 1B >333 333 Negative Test 2 >333 333 Negative
Metabolic Activation Test Substance Concentration Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 ≥333 ≥333 >5000 Negative Test 2 ≥333 >5000 Negative Present Test 1 ≥667 ≥333 >5000 Negative Test 2 ≥333 >5000 Negative Remarks - Results The test substance did not lead to an increase in the number of revertant colonies, either with or without S9 mix. Positive controls confirmed the sensitivity of the test system. The notified chemical was not mutagenic to bacteria under the conditions of the test. Microbiological Associates (1995) Genotoxicity – in vitro chromosome aberration test Notified chemical OECD TG 473 In vitro Mammalian Chromosome Aberration Test. EC Directive 92/69/EEC B.10 Mutagenicity - In Mammalian Chromosome Aberration Test. Species/Strain Human Cell Type/Cell Line Peripheral lymphocytes Metabolic Activation System Aroclor-1254 induced rat liver S9-mix Vehicle Dimethylsulphoxide Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period (hours) Harvest Time Absent Test 1A 33, 100, 133*, 180*, 240*, 333 24 24 Test 1B 133*, 180*, 240*, 333 48 48 Test 2 33, 100*, 133, 180*, 240*, 333 24 24 Present Test 1A 33*, 100*, 333* 3 24 Test 1B 333* 3 48 Test 2 33*, 100*, 333* 3 24 *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1A 333p ≥240 333 Negative Test 1B 333 333 Positive Test 2 ≥240 333 Negative Present Test 1A 333p >333 333 Negative Test 1B >333 333 Negative Test 2 >333 333 Negative
STD1260-FR.docx