Reproductive and developmental toxicty studies of biapenem in rats

Abstract

Biapenem (BIPM) was administered intravenously to rats at a daily dose of 30, 100 or 300mg/kg prior to and in the early stages of pregnancy (Seg. I), during the period of organogenesis (Seg. II) and during the perinatal and lactation periods (Seg. III) to evaluate the effects of this compound on reproduction and development.
No dead parent animal was observed in any of the studies. Soft feces by daily observation and large cecum at autopsy were noticed in all of the treated groups. A decrease in body weight with a decrease in food consumption was observed in the groups treated with BIPM at 100mg/kg and above. The reproductive function, maintenance of pregnancy, delivery and nursing behavior of the parents were not affected. In the F₁ fetuses, low body weight was found in the 300mg/kg group in Seg. II, but there were no effects on fetal lethality or teratogenecity in any of the studies.
There were no effects caused by BIPM on birth index, viability, physical and behavioral development of the F₁ pups. Low body weights of the F₁ pups were found at birth in the 300mg/kg group in Seg. II and during the developmental period in the 100mg/kg group and above in Seg. III. In the 100mg/kg group and above in Seg. III, female pups with delayed vaginal opening were observed frequently at 6 weeks of age, but the reproductive function was not affected later at 10 weeks of age. There were no effects caused by BIPM on the F₂ fetuses or pups.