Genotoxicity assessment of a herbal formula, Ojeok-san.

Ethnopharmacological Relevance: Ojeok-san (OJS, wuji powder, goshaku-san), a widely used herbal formula in traditional Korean medicine, is used to treat illnesses such as the common cold, fatigue and gastrointestinal disorders; however there is insufficient background information about its safety. To establish safety information for OJS, we evaluated its genotoxicity.

Materials And Methods: The ability of OJS to induce reverse mutations was evaluated in Salmonella typhimurium (TA100, TA1535, TA98 and TA1537) and Escherichia coli (WP2uvrA) in the presence or absence of the metabolic activation system (S-9 mix). Chromosomal aberrations were evaluated in response to OJS, and viability and metaphase were analyzed in Chinese hamster lung (CHL) cells in the presence or absence of S-9 mix. A micronucleus test was performed using bone marrow cells from male ICR mice. OJS was orally administered twice at a 24h interval at a dose of 500, 1000 and 2000 mg/kg in mice.

Results: There were no increases in the number of revertant colonies at any concentrations of OJS regardless of S-9 mix in all tester strains compared to the vehicle control. OJS did not significantly increase the number of structural aberration in CHL cells in the presence or absence of S-9 mix. The oral administration of OJS at doses up to 2000 mg/kg caused no significant increase in the number of micronucleated polychromatic erythrocytes (MNPCEs) and in the mean value for the ratio of PCE to total erythrocytes (PCE/(PCE+NCE)). NCE is normochromatic erythrocyte. OJS did not increase the incidence of MNPCEs in bone marrow.

Conclusions: These results suggest that OJS is toxicologically safe on genotoxicity studies.