Abstract：Objective To research the acute toxicity, genotoxicity and subchronic toxicity of silymarine extracts according to GB 15193.3-2003, GB 15193.4-2003,GB 15193.5-2003,GB 15193.7-2003 and GB 15193.13-2003. MethodsTest of maximum tolerated dose, Ames test,born marrow cell micronucleus test, mice sperm abnormality test and 90-day feeding study in rats were used to assess the safety of silymarine extracts. ResultsThe maximum tolerated dose（MTD）in mice of silymarine extracts were greater than 20.0g/kg·bw. Ames test, micronucleus test and sperm shape abnormality were negative. No significant differences were found in body weight gain, food intake,food lization rates and the ratio of organ weight between test groups and control group in 90d feeding study. Haemotological parameters and serum biochemical indices all fell into the ranges of normal values. No meaningful histological changes were observed in the rats' main tissues.The no-observed-adverse-effect-level（NOAEL）is more than 2.5g/kg·bw. ConclusionsNo significant toxic effects were found in Silymarine extracts in this study.
2016, Vol. 23 
