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Two-Week Repeated Dose Toxicity of Atractylodis Rhizoma Alba in F344 Rats

  • Han, Hyoung-Yun (Korea Institute of Toxicology) ;
  • Yang, Young-Su (Korea Institute of Toxicology) ;
  • Kim, Soo Nam (Korea Institute of Toxicology) ;
  • Han, Su-Cheol (Korea Institute of Toxicology) ;
  • Lee, Jong-Hwa (Korea Institute of Toxicology) ;
  • Jeong, Ja Young (Toxicological Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation) ;
  • Roh, Hang-sik (Toxicological Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation) ;
  • Seok, Ji Hyeon (Toxicological Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation) ;
  • Lee, Joo Sang (College of Pharmacy, Drug Research and Development Center, Catholic University of Daegu) ;
  • Kim, Jeong-Ah (College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University) ;
  • Min, Byung-Sun (College of Pharmacy, Drug Research and Development Center, Catholic University of Daegu)
  • Received : 2016.01.06
  • Accepted : 2016.02.29
  • Published : 2016.09.30

Abstract

This research is to estimate the toxicity of Atractylodis Rhizoma Alba (ARA) in F344 rats and to find a dose level for the 13 weeks toxicity study. A hot water extract of ARA (ARWE) was administered orally to F344 rats at dose levels of 0 (vehicle control), 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed to five male and five female F344 rats. According to the result, there were no ARWE-related adverse changes in mortality, body weights, food consumption, urinalysis, hematology, clinical chemistry, gross finding at necropsy, and organ weight examination. Salivation was observed in 3500 and 5000 mg/kg/day in male and female rats but it could not have found any relationship with ARWE administration. Based on our findings, ARWE may not cause toxicity in rats under the experimental conditions. Therefore, dose level of 5000 mg/kg/day as a highest treatment group in 13-week exposure study is recommended for further toxicity assessment.

Keywords

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