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

상륙 추출물의 F344 랫드에서 2주 반복 경구투여 독성평가

  • 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)
  • Received : 2018.03.22
  • Accepted : 2018.05.10
  • Published : 2018.06.30

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

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