Abstract |
The data presented in this submission is from a dose range-finding reproductive toxicity study in rats. This study was conducted for the purpose of selecting appropriate dose levels for a definitive two-generation reproductive toxicity study. However, since the substance is not being manufactured for commercial purposes, a definitive study is not planned at this time. Because the study was limited to a dose range-finding study, the study results should be considered as preliminary and interpreted with caution. The results of this study are summarized in the attachment, with complete details in the enclosed report. In brief, there were no effects on mating, fertility or fecundity. Thus, the results of the study provide no indication that the test substance is a reproductive taxicant. However, the results of the study also indicate small but statistically significant reductions in offspring survival at a high dose level (0.8%, approximately 600 mg/kg/day), but not at the highest dose level tested (1.2%, approximately 900 mg/kg/day). |