There were no test item related effects on clinical observations in pups or pup body weights. Pregnancy ratios were 11/12, 10/12, 10/11 and 11/12 for the 0, 100, 500, and 1000 mg/kg groups, respectively. A summary of other reproductive outcomes (means/litter) are provided in the table below: The No Observed (Adverse) Effect (NO(A)EL) was established as 1000 mg/kg bw/day in this study, based on the maternal and developmental toxicity results reported in this study. Cited in OPPT (2003). 7.12T. Toxicity to reproduction one generation study – Analogue (purity 100%) OECD TG 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. Species/Strain Rat/Crl:CD®BR Male and female/12 per sex per dose group Route of Administration Oral gavage – Exposure Information exposure days: 14 days premating through 4-day lactation period (approximately 50 days). Exposure levels: 0, 100. 500, 1000 mg/kg bw/day Vehicle Methyl cellulose (0.5%). Remarks Method Statement of GLP included. – No full study report provided. Group Number and Sex Dose Mortality of Animals mg/kg bw/day 1 12 males, 12 females 0 None reported 2 12 males, 12 females 100 None reported 3 12 males, 12 females 500 None reported 4 12 12 females 1000 None reported Mortality and Time to None reported. Effects on Parental (P) animals: There were no significant differences between the control and treated rats with respect to the reproductive performance of male or female rats which included mating index and fertility indices, gestation length, number of implantation sites, sex ratio, gestation ratio, percentage of pups born alive, and number of pups surviving to day 4 of lactation. Effects on 1st Filial Generation (F1) There were no test item related effects on clinical observations in pups or pup body weights. Remarks - Results A summary of reproductive outcomes are provided in the table below:
There were no test item related effects on clinical observations in pups or pup body weights. Pregnancy ratios were 11/12, 10/12, 10/11 and 11/12 for the 0, 100, 500, and 1000 mg/kg groups, respectively. A summary of other reproductive outcomes (means/litter) are provided in the table below: The No Observed (Adverse) Effect (NO(A)EL) was established as 1000 mg/kg bw/day in this study, based on the maternal and developmental toxicity results reported in this study. Cited in OPPT (2003). 7.12T. Toxicity to reproduction – one generation study Analogue (purity 100%) OECD TG 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. Species/Strain Rat/Crl:CD®BR Male and female/12 per sex per dose group Route of Administration Oral – gavage Exposure Information exposure days: 14 days premating through 4-day lactation period (approximately 50 days). Exposure levels: 0, 100. 500, 1000 mg/kg bw/day Vehicle Methyl cellulose (0.5%). Remarks – Method Statement of GLP included. No full study report provided. Group Number and Sex of Animals Dose mg/kg bw/day Mortality 1 12 males, 12 females 0 None reported 2 12 males, 12 females 100 None reported 3 12 males, 12 females 500 None reported 4 12 12 females 1000 None reported Mortality and Time to None reported. Effects on Parental (P) animals: There were no significant differences between the control and treated rats with respect to the reproductive performance of male or female rats which included mating index and fertility indices, gestation length, number of implantation sites, sex ratio, gestation ratio, percentage of pups born alive, and number of pups surviving to day 4 of lactation. Effects on 1st Filial Generation (F1) There were no test item related effects on clinical observations in pups or pup body weights. Remarks - Results A summary of reproductive outcomes are provided in the table below:
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