Evaluation of genotoxicity of Yukmijihwang-tang, a herbal formula.

Yukmijihwang-tang (Liu wei di huang tang, Rokumigan; YMJ) has been used for body enrichment; however, little toxicological evaluation of YMJ has been performed to assure its safety for clinical treatment. To increase the safety information for YMJ, its genotoxicity was evaluated. There was no increase in the number of revertant colonies in four strains of Salmonella typhimurium or one strain of Escherichia coli at any concentration of YMJ studied, regardless of the including when dosed with YMJ metabolized with and S-9 microsomal fraction. YMJ significantly increased structural aberrations in Chinese hamster lung (CHL) cells at the high concentrations (2500 and 5000 μg/ml) in the presence or absence of metabolic activation by the S-9 microsomal fraction. Oral administration of YMJ at doses up to 2000 mg/kg did not increase the incidence of micronucleated polychromatic erythrocytes in bone marrow. These results suggest that YMJ is not genotoxic at the proper dose.