Reproductive toxicity of taurohyodeoxycholic acid

The reproductive toxicity of taurohyodeoxychofic acid (3α, 6α-dihydroxy-5-β-chofanoyl-2-amino-ethyl-sulfonic acid, THDCA, Io®, Praxis®, CAS 2958-04-5), a new synthetized biliary acid patented in Europe, Japan and the United States for prevention and therapy of gallstones and related symptoms, was assayed by performing segment I (fertility and general reproductive performance) and segment II (teratology) studies. In the first study THDCA was administered (100, 220 or 500 mg/kg by oral route) to male and female rats prior to and in the early stage of pregnancy. No adverse effects or dose-related abnormalities were observed in the reproductive performance of either sex; no death or evidence of teratogenicity in fetuses were also observed