TERATOGENICITY STUDY ON BROMPERIDOL IN RATS

A teratogenicity study on bromperidol, a neuroleptic, was carried out in Wistar-Imamichi rats. Bromperidol was administered orally at the dose levels of 0.2, 1.5 and 10.0 mg/kg/day for 11 days from day 7 to day 17 of gestation. About two-thirds of pregnant females in each group were sacrificed on day 21 of gestation, and their fetuses were examined. The remaining dams were allowed to litter naturally, and the post-natal development of the offspring was observed. Treatment of bromperidol caused sedation of pregnant females in 1.5 and 10.0 mg/kg groups with concomitant decrease in body weight and in food and water intake in dose-dependent manner. Effect of bromperidol treatment on F1 generation was observed mainly in animals of 10.0 mg/kg group, suggesting overall growth retardation such as decrease in live fetal weight, retarded ossification of metacarpals and metatarsals, a slight decrease in day 1 viability index, a marginal delay in eyelid opening, reduction in growth rate and decrease in organ weight. No treatment-related external and internal abnormalities were observed in fetuses (F1), and no apparent effect on behavior, learning ability and reproductive function of offspring (F1) was found.