Subchronic toxicological evaluation of Bojungikki-tang water extract: 13-Week oral repeated-dose toxicity study in Crl:CD (SD) rats

Abstract

Bojungikki-tang is a traditional herbal medicine used to boost immunity and reduce fatigue. However, there is not enough scientific evidence about its toxicological safety profile to support its continued clinical application. The objective of this study was to investigate the subchronic toxicity profile of Bojungikki-tang water extract (BITW) in Sprague Dawley rats who were exposed to it in multiple doses and various concentrations. BITW was administered to rats orally, once daily at doses of 0, 500, 1000, or 2000mg/kg/day for 13 weeks. We checked toxicological parameters including general observations, organ/body weights, food consumption, ophthalmological signs, hematological and serum biochemical values, urinalysis values and histopathological findings. The 13 week repeated oral administration of BITW to rats at doses at doses levels of less than or equal to 2000mg/kg/day caused no significant toxicological changes and only minor nonsignificant changes. Our findings indicate that administration of BITW for up to 13 weeks may be safe and nontoxic, with a no-observed-adverse-effect-level of >2000mg/kg/day for both male and female rats.