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Preclinical safety assessment of Angelica acutiloba using a 13-week repeated dose oral toxicity study in rats

Laboratory Animal Research volume 33, pages 223–230 (2017)Cite this article

Abstract

Angelica acutiloba (AA), a Japanese species of Danggui, has been used worldwide as a traditional herbal medicine with several bioactivities including anti-diabetic, anti-allergic, anti-inflammatory, anti-tumor, and anti-obesity. However, there is lack of toxicological data available to evaluate potential long-term toxicity and the no-observed-adverse-effect level (NOAEL) of AA extract in accordance with the test guidelines published by the Organization for Economic Cooperation and Development. In the 14-day repeat-dose toxicity study, no adverse effects on mortality, body weight change, clinical signs, and organ weights was found following repeat oral administration to rats for 14 days (125, 250, 500, 1000, and 2000 mg/kg body weight), leading that 2000 mg/kg is the highest recommended dose of AA extract for the 13-week repeat-dose oral toxicity study. In the 13-week repeat-dose oral toxicity study, the AA extract was orally administered to groups of rats for 13 weeks (125, 250, 500, 1000, and 2000 mg/kg body weight) to compare between control and AA extract groups. The administration of AA extract did not produce mortality or remarkable clinical signs during this 13-week study. And, the data revealed that there were no significant differences in food/water consumption, body weight, hematological parameters, clinical chemistry parameters, gross macroscopic findings, organ weight and histopathology in comparison to the control group. On the basis of these results, the subchronic NOAEL of the AA extract was more than 2000 mg/kg/day when tested in rats. And, the AA extract is considered safe to use orally as a traditional herbal medicine.

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Authors and Affiliations

  1. Department of Biotechnology, The Catholic University of Korea, Bucheon, Gyeonggi-do, Korea

    Jun-Won Yun

  2. Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Korea

    Euna Kwon, Seung-Hyun Kim, Ji-Ran You, Yun-Soon Kim & Byeong-Cheol Kang

  3. Department of Pathology, Seoul National University College of Medicine, Seoul, Korea

    In Ae Park

  4. Department of Urology, Seoul National University College of Medicine, Seoul, Korea

    Hyeon Hoe Kim

  5. Biomedical Center for Animal Resource and Development, Seoul National University College of Medicine, 103 Daehakro, Jongno-gu, Seoul, 03080, Korea

    Jeong-Hwan Che & Byeong-Cheol Kang

  6. Graduate School of Translational Medicine, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 110-744, Korea

    Byeong-Cheol Kang

  7. Designed Animal and Transplantation Research Institute, Institute of GreenBio Science Technology, Seoul National University, Pyeongchang-gun, Gangwon-do, Korea

    Byeong-Cheol Kang

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  1. Jun-Won Yun
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  2. Euna Kwon
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  4. Ji-Ran You
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  5. Yun-Soon Kim
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Correspondence to Jeong-Hwan Che or Byeong-Cheol Kang.

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Yun, JW., Kwon, E., Kim, SH. et al. Preclinical safety assessment of Angelica acutiloba using a 13-week repeated dose oral toxicity study in rats. Lab Anim Res 33, 223–230 (2017). https://doi.org/10.5625/lar.2017.33.3.223

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  • DOI: https://doi.org/10.5625/lar.2017.33.3.223

Keywords

Laboratory Animal Research

ISSN: 2233-7660