Abstract: OBJECTIVE： To conduct a toxicological safety evaluation of Poria-Kudzu root tablets，a new health product. METHODS： A variety of recommended toxicity tests were conducted: acute oral toxicity，bacterial reverse mutation (Ames test)，mammalian erythrocyte micronucleus，mouse spermatogonial chromosome aberration，and 28-day oral toxicity tests. RESULTS： The median lethal dose (LD₅₀) of the acute oral toxicity test was >15.0 g/kg，which belongs to the non-toxic class. The results of the Ames，mammalian erythrocyte micronucleus，and mouse spermatogonial chromosome aberration tests showed no mutagenic effect. The results of the 28-day oral toxicity test indicated no significant effects on the body weight，food intake，food utilization rate，hematology，blood biochemistry，urine，organ-to-body weight ratio，and histopathology of rats. CONCLUSION： Under the experimental conditions of this study，Poria-Kudzu root tablets was non-toxic，with no relevant genotoxicity. The no-observed-adverse-effect level (NOAEL)，as determined in rats，was 10.0 g/kg.

Key words: Poria-Kudzu root compound tablets, toxicity, Ames test, micronucleus, aberration