Journal of Ginseng Research

The Korean Society of Ginseng (고려인삼학회)
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Assessing systemic, developmental, and reproductive toxicity and estrogenicity of Korean red ginseng extract G1899 in juvenile Sprague-Dawley Rats

  • Sangyun Kim (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Ji-Seong Jeong (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Woojin Kim (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Onju Ham (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Yixian Quah (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Soontag Jung (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Dong-Ju Park (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Min Jae Kim (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Byung-Cheol Han (R&D Headquarters, Korea Ginseng Corp.) ;
  • Eunji Kim (R&D Headquarters, Korea Ginseng Corp.) ;
  • Seung-Jin Lee (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology) ;
  • Wook-Joon Yu (Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology)
  • Received : 2023.10.29
  • Accepted : 2024.01.10
  • Published : 2024.05.01
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Abstract

Background: Korean red ginseng (KRG) is a product from ginseng roots, which is enriched with ginsenosides and has been utilized for a long time as an adaptogen to alleviate various physiological or disease conditions. While KRG is generally considered safe, conducting a thorough toxicological assessment of the spray-dried powder G1899 during the juvenile period is essential to establish its safety profile. This study aimed to assess the safety of G1899 during the juvenile period using Sprague-Dawley rats. Methods: Two studies were conducted separately: a juvenile toxicity study and a uterotrophic bioassay. To assess the potential toxicity at systemic, postnatal developmental, and reproductive levels, G1899 was orally gavaged once a day in post-weaning juvenile Sprague-Dawley (SD) rats at 0, 1250, 2500, or 5000 mg/kg/day. Estrogenicity was assessed by orally gavaging G1899 in immature female SD rats at 0, 2500, or 5000 mg/kg/day on postnatal days (PND) 19-21, followed by a uterotrophic bioassay. These studies were conducted in accordance with the Good Laboratory Practice (GLP) regulations and regulatory test guidelines. Results: Regarding juvenile toxicity, no abnormalities related to the G1899 treatment were observed in any group during the experiment. Moreover, no uterotrophic responses were observed in the dosed female group. Based on these results, the no observed adverse effect level (NOAEL) of G1899 was determined to be at least 5000 mg/kg/day for general systemic function, developmental/reproductive function, and estrogenic activity. Conclusion: Our results suggest that G1899 is not toxic to juveniles at doses of up to 5000 mg/kg/day.

Keywords

Acknowledgement

This work was supported by the R&D Headquarters of Korea Ginseng Corporation and Korea Institute of Toxicoloty (KK-2402). The authors would like to especially thank to the technical staff of the Korea Institute of Toxicology for their technical support.

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