Safety assessment of enzymatically converted chicken bile as a novel food material: Genotoxicity, teratogenicity, and acute and subchronic toxicity studies.

Enzymatically converted chicken bile (CB), prepared by converting taurine deoxycholic acid (TCDCA) to taurine ursodeoxycholic acid (TUDCA) in CB, possesses various functional activities. But their nutrient composition and safety assessment have not been fully investigated yet. CB was mainly composed of proteins and steroids. CB did not show genotoxic effects based on Ames test, mammalian erythrocyte micronucleus test, and in vitro mammalian chromosomal aberration test. There were no growth abnormalities or deaths in the acute toxicity test for mice, indicating that CB is nontoxic with an LD50 > 10 g/kg·body weight (BW). Subchronic toxicity test and genotoxicity test were performed based on intake of 0.5 g CB per person daily at expanded doses of 33.3, 100, and 300 times (278, 833, and 2500 mg/kg·BW). The result indicated that CB at 833 mg/kg·BW showed no toxicity on BW, body weight gain, food intake, hematological, serum biochemistry, absolute/relative organ weights, urinalysis, and pathological features of rats in the subchronic toxicity test, while CB at 833 mg/kg·BW induced maternal toxicity with no fetus teratogenicity or embryotoxicity in the teratogenicity test. In conclusion, CB did not show toxic effects and a long-term daily intake of CB at 0.5 g per person is considered safe, but pregnant women should avoid it. These findings could provide a reference for the safe use of CB in functional food.