Evaluation of a water extract of So-Cheong-Ryong-Tang for acute toxicity and genotoxicity using in vitro and in vivo tests

Background So-Cheong-Ryong-Tang, a traditional Korean medicine, has been used empirically for the treatment of asthma, allergic rhinitis, and colds for hundreds of years. However, its genotoxicity has been rarely examined. Methods We therefore investigated the genotoxicity of an aqueous extract of So-Cheong-Ryong-Tang (SCRT) in two in vitro and one in vivo assays: a bacterial reverse mutation assay (Ames test), a chromosomal aberration assay, and a micronucleus assay, respectively. Results In the bacterial reverse mutation assay, SCRT did not increase revertant colony numbers in Salmonella. typhimurium strains (TA98, TA100, TA1535, and TA1537) or an Escherichia coli strain (WP2 uvrA ) regardless of metabolic activation or the duration of treatment. However, statistically significant differences in the incidence of chromosomal aberrations following SCRT >4000 μg/mL were observed in Chinese hamster lung cells exposed with or without an S9 enzyme and cofactor mixture. Conclusions These results suggest further genotoxic testing of SCRT, such as a comet assay, to ascertain its generally recognized safety.