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Reproductive toxicity of taurohyodeoxycholic acid
F Feletti1, A S Tripodi, R Germogli
1Institute of Pharmacology II, University of Pavia, Italy.
Arzneimittel-Forschung
|August 1, 1993
Summary
Taurohyodeoxycholic acid (THDCA), a synthetic bile acid for gallstone treatment, showed no reproductive toxicity or teratogenicity in rats and rabbits. Studies confirmed its safety for fertility and fetal development at doses up to 500 mg/kg.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Pharmacology
Background:
- Taurohyodeoxycholic acid (THDCA) is a synthesized bile acid patented for gallstone prevention and therapy.
- Assessing the reproductive toxicity of novel therapeutic agents is crucial before widespread clinical use.
Purpose of the Study:
- To evaluate the reproductive toxicity and teratogenicity of THDCA.
- To determine the no-effect dose for reproductive parameters and fetal development.
Main Methods:
- Segment I studies assessed fertility and general reproductive performance in male and female rats administered THDCA orally (100, 220, 500 mg/kg).
- Segment II studies evaluated teratology in rats and rabbits during fetal organogenesis following oral THDCA administration (100, 220, 500 mg/kg).
Main Results:
- No adverse effects on reproductive performance, fertility, or general reproductive parameters were observed in rats at any dose.
- No maternal toxicity, teratogenicity, embryo-fetal growth retardation, or reduction in viability index were noted in rats or rabbits.
Conclusions:
- THDCA demonstrated a lack of reproductive toxicity and teratogenic potential in the conducted studies.
- The no-effect dose for THDCA was established at 500 mg/kg, indicating a favorable safety profile for reproductive health.