[Effect of isepamicin (HAPA-B) on reproduction. II. Teratological study in rats (intramuscular administration)]

Teratological study of isepamicin (HAPA-B), a new aminoglycoside antibiotic, was performed in Jcl: Wistar rat. The drug was given intramuscularly to dams at doses of 25, 100 and 200 mg/kg from day 7 to 17 after mating. The influence on dams, their fetuses and offspring was studied. A decrease in food intake and a development of pale color of the kidney of dams at a dose level of 200 mg/kg were observed in the prenatal study. The HAPA-B did not show any influence on prenatal development of fetuses. In the postnatal study, no effect of HAPA-B on parturition and lactation of dams was seen except that a discoloration of the kidney was observed at autopsy. However, some differences were observed between the control and treatment groups in postnatal development, behavior and reproduction performance of offspring. Dose-response effects of HAPA-B on offspring were not observed in the postnatal study. No effect dose levels of HAPA-B established in this study on rat fetuses and offspring were 200 mg/kg and 100 mg/kg on pregnant rat, respectively.