Safety assessment of Gami-daebo-tang gagambang used for treating stroke sequelae

Objectives: This study aimed to investigate wheter Gami-daebo-tang gagambang, commonly used for treating stroke sequelae, induces acute toxicity or genetoxicity.Methods: Gami-daebo-tang gagambang contains that the root of <i>Angelica gigas Nakai</i> inducing acute headache and weakness, and the rhizome of <i>Cnidium officinale</i> MAKINO, an herb with potential teratogenicity. Teratogenicity is closely associated with genotoxicity. We analyzed whether Gami-daebo-tang gagambang induces acute toxicity and genotoxicity in accordance with Korean non-clinical test standards and OECD test guidelines TG471, TG473, TG474.Results: When male and female rats were given a single dose of Gami-daebo-tang gagambang, no toxic effects or organ damage were observed at dosages reaching 2,500 mg/kg. The bacterial reverse mutation assay showed no evidence of DNA mutations at concentrations up to 5,000 <i>μ</i>g/plate. In vitro studies indicated that Gami-daebo-tang gagambang did not cause structural or numerical chromosomal aberrations at concentrations as high as 2,000 <i>μ</i>g/mL. Moreover, animal studies demonstrated that the substance did not induce bone marrow toxicity or the formation of micronuclei in erythrocytes at doses up to 2,000 mg/kg.Conclusions: The studies conducted with different models showed that Gami-daebo-tang gagambang did not cause acute toxicity or genotoxicity. This study provides evidence for the safety of Gami-daebo-tang gagambang in terms of acute toxicity and genotoxicity, supporting its potential safe application in treating stroke sequelae.