Toxicity assessment of polygalae radix aqueous extract orally administered to rats for 2 consecutive weeks

The objective of this study is to characterize a toxicity of Polygalae Radix (PR) in F344 rats and to find a dose levelsfor the 13 weeks toxicity study. PR is well known as medicinal herb in many Asian countries for treatment of expectorant, tonic,tranquillizer, antipsychotic agent and functional diet for improving memory. However, there is insufficient background informationon toxicological evaluation of PR extract to support its safe use. Therefore, we conducted toxicological evaluation ofthis drug in compliance with OECD and KFDA guideline in this study. The extract of PR was administered orally to F344 ratsat dose levels of 0, 500, 1000, 2000, 3500 and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and fivefemale rats. In the result, there were no treatment PR-related adverse changes in food consumption, hematology, clinical chemistry,urinalysis, gross finding at necropsy, organ weight examination. Four males at 5000 mg/kg/day were found dead during the treatment period. These animals showed salivation. The cause of death is still under investigation. The animals treated at500, 1000, 2000, 3500 and 5000 mg/kg/day showed salivation and all animals at 5000 mg/kg/day exhibited lower body weightand cumulative weight gain in compared to those of control animals. Therefore, we recommend that a dose group of 3500 mg/kg/day is a highest treatment group in 13-week exposure study.