Planta Med 2015; 81 - PM_70
DOI: 10.1055/s-0035-1565447

A subchronic oral toxicity study on medical herb extract, KIOM CRC#BP10A, in male and female mice

ES Cho 1, YJ Lee 1, JS Park 1, J Kim 1, NS Kim 1, OS Bang 1
  • 1KM Convergence Research Group, Korea Institute of Oriental Medicine, Daejeon, Korea, Republic of (South)

Our recent study demonstrated that KIOM CRC#BP10A (BP10A), a 1:1 mixture of two medicinal herb extracts, Peucedanum praeruptorum DUNN and Descurainia sophia (L.) Webb ex Prantl, exerts a potent anti-tumor effects in diverse animal xenograft cancer models. But there is limit information concerning its toxicities in vivo. The present study is aimed at conducting histopathological and biochemical studies in a 28-day subchronic toxicity studies using 4 weeks old male and female ICR mice.

Ethanolic extracts of Peucedanum praeruptorum DUNN and Descurainia sophia (L.) Webb ex Prantl were prepared separately and mixed at 1:1 ratio and named as BP10A. BP10A was administered at dosages of 0 (vehicle control), 500, 1000 and 2000 mg/kg by gastric lavage. Histopathological studies of major organs and blood chemistry analyses were performed after euthanization.

There were no statistically significant differences in body weights between the treatment groups and the control group in each week. But there were some sporadic, statistically significant changes in some hematology and serum biochemical parameters. Differences between two groups in all absolute organ weights and relative organ weights (organ-to-body weight ratios) seem not to be related with drug treatment for male and females. Also, no macroscopic pathological findings were observed in liver and kidney of all animals.

In conclusion, BP10A is considered to be non-toxic when orally administered to ICR mice during 4 weeks. Our present study demonstrates that the NOAEL (no observed adverse effect level) for BP10A was 2000 mg/kg bw/day, the highest dose tested, in male and female mice.