Abstract: Objective To further evaluate acute toxicity and mutagenicity of Huolianxiang-I on the basis of previous pharmacodynamics results in order to provide theory basis for its further application. Methods The acute toxicity and mutagenecity of Huolianxiang-I were examined by acute oral toxicity test, mouse bone marrow polychromatic erythrocyte micronucleus test,mouse bone marrow chromosome aberration test and Ames test. Results For acute oral toxicity, maximum tolerance doses of male and female mice are higher than 10g·kg^-1 which are actually innocuity.For mutagenicity,negative results were seen in mouse bone marrow polychromatic erythrocyte micronucleus test,mouse bone marrow chromose aberration test and Ames test showing that Huolianxiang-I has no mutagenecity in this study. Conclusion No evident acute toxicity and mutagenicity are found in this study demonstrating that Chinese medicine compound Huolianxiang-I is safe.