[Reproductive and developmental toxicity study of suplatast tosilate (IPD-1151T) (1)--Fertility study in rats by oral administration].
The effect of suplatast tosilate (IPD-1151T) on reproductive ability and fetal development of the rat was studied. IPD-1151T was administered orally at dose levels of 0 (control), 200, 600, and 1800 mg/kg/day for the premating, mating and early pregnant period. For parent animals, IPD-1151T caused no abnormalities in clinical signs, reproductive ability, or autopsy findings; the females at 1800 mg/kg/day showed a reduction in body weight gain from one week after the start of administration and a decrease in food consumption from the day of the start of administration to day 6 of pregnancy. For fetuses, IPD-1151T produced no abnormalities in external, visceral or skeletal examinations; embryofetal mortality was increased at 1800 mg/kg/day. The results suggest that the non-effective dose level of IPD-1151T is 1800 mg/kg/day for males and 600 mg/kg/day for females in general toxicity, 1800 mg/kg/day for both sexes in reproductive ability, and 600 mg/kg/day for fetuses under the conditions of this study.
Aso
S
S
Hita Research Laboratories, Chemical Biotesting Center, Chemicals Inspection and Testing Institute, Oita, Japan.
Sueta
S
S
Kajiwara
Y
Y
Morita
S
S
Horiwaki
S
S
Yamakita
O
O
D000014:Abnormalities, Drug-Induced; D000284:Administration, Oral; D000818:Animals; D001190:Arylsulfonates / Q000008:administration & dosage / Q000633:toxicity*; D004353:Drug Evaluation, Preclinical; D005260:Female; D005298:Fertility / Q000187:drug effects*; D006633:Histamine Antagonists / Q000008:administration & dosage / Q000633:toxicity*; D008297:Male; D011247:Pregnancy; D051381:Rats; D011919:Rats, Inbred Strains; D013452:Sulfonium Compounds / Q000008:administration & dosage / Q000633:toxicity*
D001190:Arylsulfonates; D006633:Histamine Antagonists; D013452:Sulfonium Compounds; C073028:suplatast tosilate