Abstract: BACKGROUND AND AIM: To test the safety of Panax japonicus C.A.Mey complex formulation. MATERIALS AND METHODS: Acute toxicity test，bone marrow cell micronucleus test，mice sperm abnormality test，Ames test and 30 d feeding test were used to study the toxicity. Negative control and positive control groups were set up with administration of water and cyclophosphamide in bone marrow cell micronucleus test and mice sperm abnormality test,respectively. Negative control group animals received water in 30 d feeding test. RESULTS: In acute toxicity test, male and female KM mice were fed with 20 g/kg dose of Panax japonicus C.A.Mey complex, no toxic symptoms were observed. The results of bone marrow cell micronucleus test，mice sperm abnormality test and Ames test were negative. In the 30 d feeding test, no obvious toxic effects in clinical, blood examination and biochemical index examinations, organism weight and pathological studies were detected in rats with the dose of 6 g/kg，which is 200 times the clinical prescribed dose. CONCLUSION: Panax japonicus C.A.Mey complex formulation could pass the toxicological assessment using the tests mentioned above.

Key words: panax japonicus C.A.Mey complex formulation, acute toxicity, micronucleus, sperm abnormality, Ames test, 30 d feeding test