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Evaluation of the acute, sub-chronic and chronic oral toxicity, genetic toxicity, and safety of a Lomens-P0

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Abstract

Extracts of Hordeum vulgare and Chrysanthemum zawadskii, two traditional herbal medicines, have long been used to treat women's diseases. Our previous studies have confirmed that these extracts could help relieve the symptoms of premenstrual syndrome by inhibiting prolactin release. A mixture of these natural products was named Lomens-P0. In this study, we conducted three genotoxicity tests (bacterial reverse mutation, mammalian chromosome aberration, and mammalian erythrocyte micronucleus studies) and four oral toxicity tests (single-dose, 2-week repeated-dose, and 13-week repeated-dose studies in rodents, and a single-dose dose-escalation toxicity study in a non-rodent model) to confirm the potential toxicity and safety of Lomens-P0. The results of this series of tests indicated Lomens-P0 did not induce genotoxicity, and the NOAEL for the rodent was 2000 mg/kg BW/day. Similarly, no toxic effects were evident in the single-dose-escalation study in the non-rodent model. In conclusion, we confirmed that Lomens-P0 might have potential utility as a raw material for nutraceuticals and natural medicines.

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Acknowledgements

This work was supported by the Korean Institute of Planning and Evaluation for Technology in Food, Agriculture, and Forestry (IPET) through the High Value-added Food Technology Development Program, funded by the Ministry of Agriculture, Food and Rural Affairs (MAFRA) (317041-5).

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Authors and Affiliations

  1. Research Institute, Genencell Co., Ltd., Yongin, Gyeonggi-do, 16950, Republic of Korea

    Yong Joon Jeong, Hyelin Jeon & Eun Jeong Kim

  2. Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University, Yongin, Gyeonggi-do, 17104, Republic of Korea

    Se Chan Kang

  3. BioMedical Research Institute, Kyung Hee University, Yongin, Gyeonggi-do, 17104, Republic of Korea

    Se Chan Kang

  4. Korea Conformity Laboratories, Incheon, 21999, Republic of Korea

    Hyeon Yeol Ryu & Kyung Seuk Song

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  1. Yong Joon Jeong
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  2. Hyelin Jeon
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Correspondence to Se Chan Kang.

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Jeong, Y.J., Jeon, H., Kim, E.J. et al. Evaluation of the acute, sub-chronic and chronic oral toxicity, genetic toxicity, and safety of a Lomens-P0. Toxicol Res. 38, 69–90 (2022). https://doi.org/10.1007/s43188-021-00090-5

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  • DOI: https://doi.org/10.1007/s43188-021-00090-5

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