Toxicity assessment of phytolaccae radix aqueous extract orally administered to F344 rats for two consecutive weeks

Phytolaccae Radix has long been used as a traditional indigenous medicine to cure edema and rheumatism. However, there is insufficient background information on toxicological evaluation of Phytolaccae Radix extract to support the safe use. Therefore, we conducted a series of standardized, OECD and KFDA guidelines compliant in vivo study, to find a dose levels for the 13 weeks toxicity study. The extract of Phytolaccae Radix was administered orally to F344 rats at dose levels of 0, 500, 1000 and 2000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no test article-related adverse changes in clinical signs, body weight, food consumption, ophthalmology, hematology, clinical chemistry, gross finding at necropsy and organ weight examination. Therefore, we recommend that 2000 mg/kg/day is a highest treatment group in 13-week exposure study.