TA1535, TA1537, WP2uvrA), Benzo(a)pyrene (TA98). The dose range for Test 2 was determined by the results of Test 1. Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect Preliminary Test* Main Test Absent Test 1 - 150 > 5000 Negative ≥ Test 2 150 > 500 Negative ≥ Present Test 1 - 500 > 5000 Negative ≥ Test 2 500 > 1500 Negative ≥ * Not conducted Remarks - Results Positive and negative controls performed as expected confirming the validity of the test system. No significant increases in the frequency of the revertant colonies were recorded following treatment with the notified chemical at any dose level, with or without metabolic activation. The notified chemical was not mutagenic to bacteria under the conditions of the test. Harlan (2014j) Genotoxicity in vivo – Notified chemical OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/ Hsd: ICR (CD-1®) Route of Administration Oral gavage – Vehicle Arachis oil Remarks - Method Range finding test found no marked difference in toxic response between the sexes. It was therefore considered acceptable to use males only for the main test. Group Number and Sex Dose Sacrifice Time of Animals mg/kg bw hours I (vehicle control) 7 M 0 24 II (low dose) 7 M 250 24 III (mid dose) 7 M 500 24 IV (high dose) 7 M 1000 24 V (high dose) 7 M 1000 48 VI (positive control, CP) 5 M 50 24 CP=cyclophosphamide. Doses Producing Toxicity No statistically significant decreases in ratio of polychromatic erythrocytes to normochromatic erythrocytes were observed in any group exposed to the notified chemical. Genotoxic Effects No statistically significant increases in the frequency of micronucleated polychromatic erythrocytes were observed in the high dose group exposed for 48 hr or the low-dose group exposed for 24 hr.
TA1535, TA1537, WP2uvrA), Benzo(a)pyrene (TA98). The dose range for Test 2 was determined by the results of Test 1. Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in Preliminary Test* Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 - ≥ 150 > 5000 Negative Test 2 ≥ 150 > 500 Negative Present Test 1 - ≥ 500 > 5000 Negative Test 2 ≥ 500 > 1500 Negative * Not conducted Remarks - Results Positive and negative controls performed as expected confirming the validity of the test system. No significant increases in the frequency of the revertant colonies were recorded following treatment with the notified chemical at any dose level, with or without metabolic activation. The notified chemical was not mutagenic to bacteria under the conditions of the test. Harlan (2014j) Genotoxicity – in vivo Notified chemical OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 2000/32/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/ Hsd: ICR (CD-1®) Route of Administration Oral – gavage Vehicle Arachis oil Remarks - Method Range finding test found no marked difference in toxic response between the sexes. It was therefore considered acceptable to use males only for the main test. Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time hours I (vehicle control) 7 M 0 24 II (low dose) 7 M 250 24 III (mid dose) 7 M 500 24 IV (high dose) 7 M 1000 24 V (high dose) 7 M 1000 48 VI (positive control, CP) 5 M 50 24 CP=cyclophosphamide. Doses Producing Toxicity No statistically significant decreases in ratio of polychromatic erythrocytes to normochromatic erythrocytes were observed in any group exposed to the notified chemical. Genotoxic Effects No statistically significant increases in the frequency of micronucleated polychromatic erythrocytes were observed in the high dose group exposed for 48 hr or the low-dose group exposed for 24 hr.
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