Bangpungtongsung-san (BPS) is a traditional Korean herbal formula used as an anti-inflammatory, antipyretic, antiobesity, and choleretic agent, which consists of 18 herbs. As part of a safety evaluation of BPS, the present study evaluated the potential genotoxicity of an aqueous BPS extract using a standard battery of tests, including, the Ames test, chromosomal aberration test, and mouse micronucleus test. The BPS extract was not found to be genotoxic under the conditions of the Ames test. In micronucleus test, oral administration of BPS at doses up to 2,000 mg/kg did not increases the incidence of micronucleated polychromatic erythrocyte. The chromosomal aberration test showed that the BPS extract induced an increase in the number of structural and numerical chromosomal aberrations in the group treated with BPS at high dose levels (2,500 and 4,000 μg/mL) for 6 h, in the presence of the metabolic activation system (S-9 mix), compared with the vehicle control. In conclusion, these results indicate that BPS extract may act as a genotoxic agent.

Key words: Ames test, Bangpungtongsung-san, Chromosomal aberration test, Genotoxicity, Herbal formula, Micronucleus test