Reproductive and Developmental Toxicity Studies of Amrubicin Hydrochloride(SM-5887) (4)-Perinatal and Postnatal Study in Rats.

Accession number;99A0241095
Title;Reproductive and Developmental Toxicity Studies of Amrubicin Hydrochloride(SM-5887) (4)-Perinatal and Postnatal Study in Rats.
Author; FURUHASHI TADAKAZU (Nippon Bioresear. Center Inc., Hashima Res. Lab.) KATO MASASHI (Nippon Bioresear. Center Inc., Hashima Res. Lab.) KATO KEIKO (Nippon Bioresear. Center Inc., Hashima Res. Lab.) SHINODA AKIHIRO (Nippon Bioresear. Center Inc., Hashima Res. Lab.) HAYASHI HARUMI (Nippon Bioresear. Center Inc., Hashima Res. Lab.) KIMURA HITOSHI (Nippon Bioresear. Center Inc., Hashima Res. Lab.) MAKINO KOHEI (Nippon Bioresear. Center Inc., Hashima Res. Lab.)
Journal Title;Japanese Pharmacology & Therapeutics
Journal Code:Z0947A
ISSN:0386-3603
VOL.27;NO.Suppl.1;PAGE.S.473-S.490(1999)
Figure&Table&Reference;FIG.1, TBL.19, REF.11
Pub. Country;Japan
Language;Japanese
Abstract;Intravenous administration of amrubicin hydrochloride(SM-5887) at 0.05, 0.25, and 1.2mg/kg was given to rats daily during the perinatal and lactation periods to examine its effects on dams, postnatal growth of the next generation, and development of the second generation. 1) Effects on dams. In the groups treated at 0.25mg/kg or less, no effects of SM-5887 were observed in general signs, body weight, body weight gain, food consumption, accumulated food consumption, necropsy findings or organ weights on Day 21 post partum, gestation length, number of implantations, gestation index, or delivery or nursing conditions. In the 1.2mg/kg group, lower values of body weight gain and food consumption were obtained in the final stages of pregnancy, and death, changes in general signs, including salivation, soil of hair, and alopecia, lower values of body weight, body weight gain, food consumption, and accumulated food consumption, small-sized thymus, a lower value of the thymus weight, and unsatisfactory nursing behavior were noted after delivery. Five dams lost her all offspring. 2) Effects on offspring(F1). In the groups treated at 0.25mg/kg or less, no effects of SM-5887 were observed in the number of live offspring, sex ratio of live offspring, number of stillborn offspring, birth index, viability index on day 4 after birth, weaning index, incidence of external anomalies, general signs, body weight changes, morphological differentiation, reflex functions, coordination, emotionality, learn ability, organ weights, necropsy findings, or reproductive functions.... (author abst.)