Genotoxicity evaluation of Oryeong-san water extract using in vitro and in vivo tests

BACKGROUND: Oryeong-san, a mixture of five herbal plants, is a well-known therapy for renal-associated diseases such as those manifesting edema, dysuria, and oliguria. METHODS: In the present study, we investigatee the potential genotoxic effects of a water extract of Oryeong-san (ORSE) in three mutagenicity assays (an in vitro bacterial reverse mutation assay (Ames test) with Salmonella typhimurium and Escherichia coli strains, an in vitro mammalian chromosomal aberration test using Chinese hamster lung cells, and an in vivo micronucleus test using ICR mice bone marrow). RESULTS: ORSE showed no genotoxicity in the Ames test up to 5000 μg/plate; the in vitro chromosome aberration test showed no significant structural aberrations with and without the S9 mix up to 5000 μg/mL, or the in vivo micronucleus test up to 2000 mg/kg body weight. CONCLUSIONS: In conclusion, under the current test conditions, ORSE seems safe for use; however, other genotoxicity tests (e.g. sister-chromatid exchange or Comet) or chronic toxicity tests are warranted.