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Table 1: general reproduction data
A developmental toxicity study with the substance was performed according to OECD TG 414. Twenty-five inseminated female Wistar rats per dose group were administered (gavage) daily from day 6 to 20 p.c. the test substance at doses of 0, 100, 300, and 1000 mg/kg bw in Lutrol®(PEG 400). The fetuses were delivered by cesarean section on day 21 of gestation. Investigation was performed on general tolerance of the test substance by the females as well as on its effect on intrauterine development.
Appearance, behavior, mortality, absolute and corrected body weight gains, food intake, water intake, and fecal and urinary excretions were unaffected at dose levels up to and including 1000 mg/kg bw.
No treatment related gross pathological findings occurred at dose levels up to and including 1000 mg/kg bw.
The gestation rate, appearance and weights of placentas, postimplantation loss and correspondingly the number of fetuses, fetal sex distribution, and fetal weights were unaffected by the treatment at dose levels up to and including 1000 mg/kg bw.
A treatment related effect on malformations, external, visceral, and skeletal (including cartilage) deviations was not evident at dose levels up to and including 1000 mg/kg bw.
Summarizing and evaluating all data investigated revealed a NOAEL of 1000 mg/kg bw/day for each maternal toxicity and developmental toxicity.
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