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Repeated oral dose toxicity and genotoxicity of a standardized Quisqualis indica extract

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Abstract

Quisqualis indica L. of Combretaceae family is a traditional medicine that is widely used for various gastrointestinal discomfort including stomach pain, constipation, and digestive problem. In this study, the potential repeated dose toxicity and genotoxicity of a standardized Quisqualis indica L. extract (HU033) were determined under good laboratory practice conditions. For the repeated dose toxicity test, HU033 was orally administered to Sprague–Dawley (SD) rats at doses of 500, 1000, and 2000 mg/kg/day for 13 consecutive weeks. The genotoxicity of HU033 was determined with a standard battery of genotoxicity test, including an in vitro bacterial reverse mutation test, an in vitro chromosomal aberration test, and an in vivo micronucleus test. After 13 weeks of repeated dose of HU033 by oral administration, there was no treatment related adverse clinical sign including food consumption, organ weights, and histopathological findings or significant decrement in bodyweight. The no-observed-adverse-effect level of HU033 was higher than 2000 mg/kg in both male and female SD rats. No target organs were identified. In addition, no evidence of HU033 genotoxicity was detected based on results from the bacterial reverse mutation test, chromosomal aberration test, and micronucleus test. Based on results of this study, HU033 could be safely used in food and medical products within the tested dose range.

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Funding

This work was supported by the Korea Institute of Planning and Evaluation for Technology in Food, Agriculture and Forestry (IPET) through the Agri-Bio Industry Technology Development Program funded by the Ministry of Agriculture, Food, and Rural Affairs (MAFRA) (2016190262).

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Authors and Affiliations

  1. College of Veterinary Medicine (BK21 FOUR Program), Chungnam National University, 99 Daehak-ro, Daejeon, 34131, Republic of Korea

    Jeong-Won Kim, Je-Won Ko & Tae-Won Kim

  2. R&D Center, Huons. Co. Ltd., College of Pharmacy, Hanyang University, Sangnok-gu, Ansan-si, Kyeonggi-do, 15588, Republic of Korea

    Hyunjun Kim, Hyunjin Park, Ji-Soo Yoon & Myeong-Il Kim

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  1. Jeong-Won Kim
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Correspondence to Je-Won Ko or Tae-Won Kim.

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Kim, JW., Kim, H., Park, H. et al. Repeated oral dose toxicity and genotoxicity of a standardized Quisqualis indica extract. Toxicol Res. 38, 577–589 (2022). https://doi.org/10.1007/s43188-022-00140-6

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  • DOI: https://doi.org/10.1007/s43188-022-00140-6

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