OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity Reverse Mutation Test – using Bacteria. incorporation procedure Species/Strain TA1535, TA1537, TA98, S. typhimurium: WP2uvrA E. coli: Metabolic Activation System 10% rat liver S9 Concentration Range in a) With metabolic activation: 15-5000 Main Test b) Without metabolic activation: 15-5000 µg/plate Vehicle tetrahydrofuran Remarks - Method No significant protocol deviations. Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test Main Test Absent Test 1 None None 500, 1500 µg/plate None Present Test 1 None None 500, 1500 None Remarks - Results Negative controls were similar to historical values. Positive controls confirmed the sensitivity of the test system. The notified polymer was not mutagenic to bacteria under the conditions of the test. SafePharm (2002a) 7.10. Genotoxicity in vivo – 51% notified polymer in mineral oil. OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Rat/Crl:CD-1(ICR)BR Route of Administration Intraperitoneal injection Vehicle Arachis oil Remarks - Method In a preliminary range-finding test, there was no marked difference in toxicity to males or females. Therefore, males only were used for the main study. Group Number and Sex Dose Sacrifice Time of Animals mg/kg bw hours I (vehicle control) 6/male 0 24 I (vehicle control) 6/male 0 48 II (low dose) 6/male 500 24 III (mid dose) 6/male 1000 24 IV (high dose) 6/male 2000 24 IV (high dose) 6/male 2000 48 V (positive control, CP) 6/male 50 24 CP=cyclophosphamide. Doses Producing Toxicity None. Genotoxic Effects No statistically significant increases in the frequency of micronucleated PCEs in any of the test groups when compared to the control groups.
OECD TG 471 Bacterial Reverse Mutation Test. EC Directive 2000/32/EC B.13/14 Mutagenicity – Reverse Mutation Test using Bacteria. incorporation procedure Species/Strain S. typhimurium: TA1535, TA1537, TA98, E. coli: WP2uvrA Metabolic Activation System 10% rat liver S9 Concentration Range in Main Test a) With metabolic activation: 15-5000 b) Without metabolic activation: 15-5000 µg/plate Vehicle tetrahydrofuran Remarks - Method No significant protocol deviations. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 None None 500, 1500 µg/plate None Present Test 1 None None 500, 1500 None Remarks - Results Negative controls were similar to historical values. Positive controls confirmed the sensitivity of the test system. The notified polymer was not mutagenic to bacteria under the conditions of the test. SafePharm (2002a) 7.10. Genotoxicity – in vivo 51% notified polymer in mineral oil. OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Rat/Crl:CD-1(ICR)BR Route of Administration Intraperitoneal injection Vehicle Arachis oil Remarks - Method In a preliminary range-finding test, there was no marked difference in toxicity to males or females. Therefore, males only were used for the main study. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours I (vehicle control) 6/male 0 24 I (vehicle control) 6/male 0 48 II (low dose) 6/male 500 24 III (mid dose) 6/male 1000 24 IV (high dose) 6/male 2000 24 IV (high dose) 6/male 2000 48 V (positive control, CP) 6/male 50 24 CP=cyclophosphamide. Doses Producing Toxicity None. Genotoxic Effects No statistically significant increases in the frequency of micronucleated PCEs in any of the test groups when compared to the control groups.
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