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Toxicity Assessment of Phytolaccae Radix Aqueous Extract Orally Administered to F344 Rats for Two Consecutive Weeks  

Han, Hyoung-Yun (College of Veterinary Medicine, Chungnam National University)
Kang, Myung-Gyun (Korea Institute of Toxicology)
Yoon, Seokjoo (Korea Institute of Toxicology)
Seok, Ji-Hyeon (Toxicological Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation)
Kim, Jeong Ah (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University)
Kim, Tae-Won (College of Veterinary Medicine, Chungnam National University)
Min, Byung Sun (College of Pharmacy, Drug Research and Development Center, Daegu Catholic University)
Publication Information
Korean Journal of Pharmacognosy / v.49, no.2, 2018 , pp. 124-131 More about this Journal
Abstract
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.
Keywords
Phytolaccae Radix; Rats; Toxicity; Dose;
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