Abstract: Objective: Propolis complex capsule was a kind of constituent of herbal medicine by means of tradition propolis compounded preparation. It was necessary to make the toxicological assessment. Methods: The acute toxicity LD50 test in mice, micronuclei test of bone marrow cell and sperm shape abnormality test and chromosome malformation analysis of testicle reproductive cell were assyed with Ames test and 30d feeding test in mice. Result: According to the result of acute toxicity LD50 test in mice, the Propolis complex capsule showed no acute toxicity. All three genotoxicity tests were negative. The develop- mental toxicity and embryotoxicity had also not been found in teratogenicity test.Abnormal phenomena had not been found in 30d feeding test.Conclusion: Propolis complex capsule was safe in use.

Key words: propolis complex capsule, safety, toxicity tests