Under the study conditions, the mutagenic potential of the analogue chemical, was equivocal. Sitek Research Laboratories (2001) 7.11. Genotoxicity in vivo – Analogue chemical 6 OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 84/449/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/CD-1 Route of Administration Oral gavage – Vehicle Arachis oil Remarks - Method No deviations from protocol noted. Group Number and Sex Dose Sacrifice Time of Animals for each mg/kg bw hours sacrifice time I (vehicle control) 5/sex 0 24, 48, 72 hrs II (low dose) 5/sex 1250 24, 48, 72 hrs III (mid dose) 5/sex 2500 24, 48, 72 hrs IV (high dose) 5/sex 5000 24, 48, 72 hrs V (positive control, CP) 5/sex 50 24 hrs CP=cyclophosphamide. Doses Producing Toxicity No clinical signs noted. Genotoxic Effects was no indication of toxicity at any dose level. Remarks - Results There was no statistically significant increase in micronucleated PCEs in any test group when compared to vehicle control. There were no differences in the PCE/NCE ratio in any dose group as compared to the control. Positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes, confirming the system. The analogue chemical was not clastogenic under the conditions of this in vivo mouse micronucleus test.. Safepharm Laboratories Limited (1995b) 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Notified chemical OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Activated sludge Exposure Period 28 Days Auxiliary Solvent None specified Analytical Monitoring IC and TOC
Under the study conditions, the mutagenic potential of the analogue chemical, was equivocal. Sitek Research Laboratories (2001) 7.11. Genotoxicity – in vivo Analogue chemical 6 OECD TG 474 Mammalian Erythrocyte Micronucleus Test. EC Directive 84/449/EC B.12 Mutagenicity - Mammalian Erythrocyte Micronucleus Test. Species/Strain Mouse/CD-1 Route of Administration Oral – gavage Vehicle Arachis oil Remarks - Method No deviations from protocol noted. Group Number and Sex of Animals for each sacrifice time Dose mg/kg bw Sacrifice Time hours I (vehicle control) 5/sex 0 24, 48, 72 hrs II (low dose) 5/sex 1250 24, 48, 72 hrs III (mid dose) 5/sex 2500 24, 48, 72 hrs IV (high dose) 5/sex 5000 24, 48, 72 hrs V (positive control, CP) 5/sex 50 24 hrs CP=cyclophosphamide. Doses Producing Toxicity No clinical signs noted. Genotoxic Effects was no indication of toxicity at any dose level. Remarks - Results There was no statistically significant increase in micronucleated PCEs in any test group when compared to vehicle control. There were no differences in the PCE/NCE ratio in any dose group as compared to the control. Positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes, confirming the system. The analogue chemical was not clastogenic under the conditions of this in vivo mouse micronucleus test.. Safepharm Laboratories Limited (1995b) 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Notified chemical OECD TG 301 B Ready Biodegradability: CO2 Evolution Test. Inoculum Activated sludge Exposure Period 28 Days Auxiliary Solvent None specified Analytical Monitoring IC and TOC
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