Journal of Ginseng Research

The Korean Society of Ginseng (고려인삼학회)
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Acute and repeated dose 26-week oral toxicity study of 20(S)-ginsenoside Rg3 in Kunming mice and Sprague-Dawley rats

  • Li, Chunmei (School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University) ;
  • Wang, Zhezhe (School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University) ;
  • Li, Guisheng (School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University) ;
  • Wang, Zhenhua (School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University) ;
  • Yang, Jianrong (School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University) ;
  • Li, Yanshen (School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University) ;
  • Wang, Hongtao (School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University) ;
  • Jin, Haizhu (Department of Food and Biological Engineering, Wenjing College of Yantai University) ;
  • Qiao, Junhua (Yantai University Hospital, Yantai University) ;
  • Wang, Hongbo (School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University) ;
  • Tian, Jingwei (School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University) ;
  • Lee, Albert W. (NutraSource, Inc.) ;
  • Gao, Yonglin (School of Life Science, Center for Mitochondria and Healthy Aging, Yantai University)
  • Received : 2018.04.29
  • Accepted : 2018.10.11
  • Published : 2020.03.15
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Abstract

Background: 20(S)-ginsenoside-Rg3 (C42H72O13), a natural triterpenoid saponin, is extracted from red ginseng. The increasing use of 20(S)-ginsenoside Rg3 has raised product safety concerns. Methods: In acute toxicity, 20(S)-ginsenoside Rg3 was singly and orally administrated to Kunming mice and Sprague-Dawley (SD) rats at the maximum doses of 1600 mg/kg and 800 mg/kg, respectively. In the 26-week toxicity study, we used repeated oral administration of 20(S)-ginsenoside Rg3 in SD rats over 26 weeks at doses of 0, 20, 60, or 180 mg/kg. Moreover, a 4-week recovery period was scheduled to observe the persistence, delayed occurrence, and reversibility of toxic effects. Results: The result of acute toxicity shows that oral administration of 20(S)-ginsenoside Rg3 to mice and rats did not induce mortality or toxicity up to 1600 and 800 mg/kg, respectively. During a 26-week administration period and a 4-week withdrawal period (recovery period), there were no significant differences in clinical signs, body weight, food consumption, urinalysis parameters, biochemical and hematological values, or histopathological findings. Conclusion: The mean oral lethal dose (LD50) of 20(S)-ginsenoside Rg3, in acute toxicity, is above 1600 mg/kg and 800 mg/kg in mice and rats, respectively. In a repeated-dose 26-week oral toxicity study, the no-observed-adverse-effect level for female and male SD rats was 180 mg/kg.

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References

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