[Reproduction study of propiverine hydrochloride (3)--teratological study in rabbits by oral administration]

A teratogenicity study was performed in New Zealand white rabbits by oral administration of propiverine hydrochloride (P-4) at dose levels of 0 (control), 2.4, 12 and 60 mg/kg/day to dams from day 6 to day 18 of pregnancy. Thirteen or fifteen pregnant rabbits in each group were sacrificed on day 29 of pregnancy for examination of their fetuses. In dams, the dose of 60 mg/kg caused mydriasis, body weight loss or decreased body weight gain and reduced food and water intakes. Autopsy and weighing of organ weight revealed no evidence due to drug administration in any group. There were no significant differences in embryo-fetal mortality, fetal body weight, or incidences of external, visceral or skeletal anomalies and skeletal variation between treated and control animals. The compound had no lethal effects on the embryos and no growth-inhibiting or teratogenic effects on the fetuses. The results suggest that the non-effective dose level of P-4 is 12 mg/kg/day in maternal animals and 60 mg/kg/day in fetuses.