the test article utilised in the study was concluded to be non mutagenic. The positive control (with activation) had a range of average number of mutants per dose from approximately 200-400, while the analogue chemical had an average number of mutants of 8-9. Overall, the mutagenic potential of analogue chemical in this study was inconclusive. Under the study conditions, the mutagenic potential of the analogue chemical, was equivocal. 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 Group Number and Sex Dose Sacrifice Time of Animals mg/kg bw I (vehicle control) 5/sex 0 24, 48, 72 hrs II (low dose) 1250 “ “ III (mid dose) 2500 “ “ IV (high dose) 5000 “ “ V (positive control, CP) 50 24 hrs “ CP=cyclophosphamide. Doses Producing Toxicity No clinical noted. Genotoxic Effects There 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 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Durasyn 125, Durasyn 128, Durasyn 223, Durasyn 153 and Durasyn 156 The following is a table summary of results provided. This table summarises biodegradation testing performed on Durasyn 125, 128, 153 and 156 (while the third is the notified chemical, the others have been notified as STD 1243, 1245 1246 and 1247 respectively).
the test article utilised in the study was concluded to be non mutagenic. The positive control (with activation) had a range of average number of mutants per dose from approximately 200-400, while the analogue chemical had an average number of mutants of 8-9. Overall, the mutagenic potential of analogue chemical in this study was inconclusive. Under the study conditions, the mutagenic potential of the analogue chemical, was equivocal. 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 Group Number and Sex of Animals Dose mg/kg bw Sacrifice Time I (vehicle control) 5/sex 0 24, 48, 72 hrs II (low dose) “ 1250 “ III (mid dose) “ 2500 “ IV (high dose) “ 5000 “ V (positive control, CP) “ 50 24 hrs CP=cyclophosphamide. Doses Producing Toxicity No clinical noted. Genotoxic Effects There 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 8. ENVIRONMENT 8.1. Environmental fate 8.1.1. biodegradability Durasyn 125, Durasyn 128, Durasyn 223, Durasyn 153 and Durasyn 156 The following is a table summary of results provided. This table summarises biodegradation testing performed on Durasyn 125, 128, 153 and 156 (while the third is the notified chemical, the others have been notified as STD 1243, 1245 1246 and 1247 respectively).
STD1246FR.docx