REPRODUCTIVE TOXICITY OF TAUROHYODEOXYCHOLIC ACID

The reproductive toxicity of taurohyodeoxycholic acid ydroxy-5-,beta-c holanoyl-yl-2-amino-ethyl-sulfonic acid, THDCA, Io(R), Praxis(R), CAS 2958-04-5), a new synthetized biliary acid patented in Europe, Japan a nd the United States for prevention and therapy of gallstones and rela ted symptoms, was assayed by performing segment I (fertility and gener al reproductive performance) and segment II (teratology) studies. In t he first study THDCA was administered (100, 220 or 500 mg/kg by oral r oute) to male and female rats prior to and in the early stage of pregn ancy. No adverse effects or dose-related abnormalities were observed i n the reproductive performance of either sex; no death or evidence of teratogenicity in fetuses were also observed. In the second study THDC A was administered (100, 220 or 500 mg/kg by oral route) to rats and r abbits during the fetal organogenesis period. No maternal toxicity, te ratogenicity or adverse effects on growth of embryos and fetuses and n o reduction of the viability index were observed. From these studies t he no-effect dose can be estimated at 500 mg/kg.