OBJECTIVE： To evaluate the toxicological security of Compound gedan capsule.  METHODS： According to maximal tolerance dose （MTD） test， mice were orally treated with Compound gedan capsule at the dose of 20 g/kg for 14 days in the acute toxicity test. Ames test， marrow polychromatic erythrocytes （PCE） micronucleus test and mice sperm abnormality test were set up to investigate the inherent toxicity of Compound gedan capsule. In Ames test， the number of revertant colonies was recorded after Bacillus breslaviensis histidine auxotrophy TA97， TA98， TA100 and TA102 were treated with Compound gedan capsule at 8，40，200，1 000，5 000 μg/plate combined with or without S-9 suspension. In marrow PCE micronucleus test， 50 mice were divided into negative control group （distilled water）， positive control group （cyclophosphamide 40 mg/kg） and Compound gedan capsule low-dose， medium-dose and high-dose groups （2.5， 5.0， 10.0 g/kg） with 10 mice in each group； they were given relevant medicine intragastrically； the rate of micronucleus cell， the ratio of PCE to normochromatic erythrocyte were calculated 6 h after last administration. In mice sperm abnormality test， 25 mice were grouped and treated with relevant medicine （same dose as above） intragastrically once a day， for consecutive 5 d； the rate of sperm abnormality was calculated 35 days later. In thirty-days feeding study， 80 rats were randomly divided into negative control group and Compound gedan capsule low- dose， medium-dose and high-dose groups （0.67， 1.33， 2.67 g/kg）； they were given relevant medicine intragastrically for consecutive 30 d. The changes of body weight， weight gain， food intake， food utilization and blood routine index were observed in rats. RESULTS： The oral MTD in both male and female mice were more than 20 g/kg. The results of three genetic toxicity tests were all negative. The thirty-days feeding study of rats demonstrated that no toxicity symptom was found， and the index of blood test， blood biochemical index test and histopathological examination were all within normal range； no abnormal change was found. CONCLUSIONS： Compound gedan capsule is atoxic and doesn’t show genetic toxicity. No obvious toxic reaction is found in thirty-days feeding study of rats.