Abstract |
Groups of eight inseminated female Wistar rats were treated daily from day 6 to day 19 p.c., by gavage, with doses of 0, 30, 100, and 500 mg/kg body weight (dose volume 10 ml/kg bw) of ALM 1195 in 0.5% aqueous carboxymethylcellulose. The fetuses were delivered by cesarean section on day 20 p.c. Investigations were performed for the general tolerance of the test compound by the females as well as on its effect on intrauterine development. 2/3 of the fetuses underwent skeletal evaluation while 1/3 of fetuses were evaluated viscerally. Mortality of the females was not affected by treatment. Increased water consumption and urination was observed in a single female in the 500 mg/kg dose group for one day only, so that toxicological relevance of these findings remains equivocal. Maternal feed intake was not affected to a toxicologically relevant degree at a dose level up to and including 500 mg/kg, while corrected body weight change was marginally decreased at the 500 mg/kg dose level. Necropsy revealed no treatment- related gross pathological findings at a dose level up to and including 500 mg/kg bw/day. |