[Teratological study of trandolapril (RU44570) in rats]

A teratogenicity study was performed in Sprague-Dawley rats treated orally with trandolapril (RU44570) at the dosage levels of 3, 30 and 300 mg/kg/day from day 7 to day 17 of pregnancy. In each group, 24 or 25 female rats were sacrificed on day 20 of pregnancy for the examination of their fetuses, and 14 or 15 female rats were allowed to litter naturally for the postnatal examination of their offspring. Clinical symptoms and mortality attributable to administration of RU44570 were not observed in the dams (P). Body weight gain and food consumption were slightly depressed in the 300 mg/kg dosage group comparing with those of control group. However, RU44570 showed no adverse effect on the fetal mortality, prenatal development or teratogenicity of the fetuses. Incidence of dilatation of renal pelvis was slightly increased in fetuses in the 300 mg/kg dosage group comparing with that of the control group. However, the offspring in each treated group showed similar incidence of this abnormality to that of the control group in more advanced age. Therefore, these changes were considered to be reversible. No adverse effects on the postnatal development of the offspring containing reproductive ability were detected. The results suggest that non-effective dose level of RU44570 is 30 mg/kg for dams, 30 mg/kg for fetuses and 300 mg/kg for development in offspring, respectively.