Preclinical study of safety of Dendropanax morbifera Leveille leaf extract

General and genetic toxicology

Jun Won Yun, Seung Hyun Kim, Yun Soon Kim, Eun Jin Choi, Ji Ran You, Eun Young Cho, Jung Hee Yoon, Euna Kwon, Hyoung Chin Kim, Ja June Jang, Jin Sung Park, Jeong Hwan Che, Byeong Cheol Kang

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Ethnopharmacology relevance: Dendropanax morbifera Leveille (DM) has been used in traditional medicines for infectious and skin diseases, and dysmenorrhea. It exhibits a diverse therapeutic potential including anti-cancer, anti-thrombotic, anti-diabetic, anti-oxidant, and anti-inflammatory activities. Aim of the study: Despite promising health benefits of DM, knowledge of its potential adverse effects is very limited. The current study focused on the investigation of subchronic toxicity and genotoxicity of extract obtained from DM according to the test guidelines published by the Organization for Economic Cooperation and Development. Materials and methods: We conducted a toxicological evaluation of DM extracts using 14-day repeated-dose toxicity study and 13-week repeated-dose toxicity study in Sprague-Dawley rats administered orally at doses of 500, 1000, or 2000 mg/kg/day. The clastogenicity of DM extract was also evaluated by in vitro chromosome aberration assay and in vivo micronucleus assay. Results: Assessment of subchronic toxicity of DM extract by oral administration in rats revealed unremarkable treatment-related findings with respect to food/water consumption, body weight, mortality, urinalysis, hematology, serum biochemistry, necropsy, organ weight and histopathology at doses of 500, 1000, and 2000 mg/kg. Accordingly, the level of no-observed-adverse-effect for DM extract in 13-week subchronic toxicity study was considered to be 2000 mg/kg/day in rats. The data observed from in vitro chromosome aberration assay and in vivo micronucleus assay exclude any clastogenicity of DM extract. Conclusion: The results suggest that the oral consumption of DM extract has no adverse effects in humans and represents a safe traditional medicine.

Original languageEnglish
Article number111874
JournalJournal of Ethnopharmacology
Volume238
DOIs
StatePublished - 28 Jun 2019

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Micronucleus Tests
Traditional Medicine
Chromosome Aberrations
Toxicology
Infectious Skin Diseases
Ethnopharmacology
Safety
No-Observed-Adverse-Effect Level
Dysmenorrhea
Urinalysis
Organ Size
Insurance Benefits
Hematology
Oxidants
Biochemistry
Drinking
Oral Administration
Sprague Dawley Rats
Anti-Inflammatory Agents
Body Weight

Keywords

  • Clastogenicity
  • Dendropanax morbifera extract
  • Genotoxicity
  • Subchronic toxicity
  • Traditional medicine

Cite this

Yun, Jun Won ; Kim, Seung Hyun ; Kim, Yun Soon ; Choi, Eun Jin ; You, Ji Ran ; Cho, Eun Young ; Yoon, Jung Hee ; Kwon, Euna ; Kim, Hyoung Chin ; Jang, Ja June ; Park, Jin Sung ; Che, Jeong Hwan ; Kang, Byeong Cheol. / Preclinical study of safety of Dendropanax morbifera Leveille leaf extract : General and genetic toxicology. In: Journal of Ethnopharmacology. 2019 ; Vol. 238.
@article{2b03a300633043479508bc22763cc1c4,
title = "Preclinical study of safety of Dendropanax morbifera Leveille leaf extract: General and genetic toxicology",
abstract = "Ethnopharmacology relevance: Dendropanax morbifera Leveille (DM) has been used in traditional medicines for infectious and skin diseases, and dysmenorrhea. It exhibits a diverse therapeutic potential including anti-cancer, anti-thrombotic, anti-diabetic, anti-oxidant, and anti-inflammatory activities. Aim of the study: Despite promising health benefits of DM, knowledge of its potential adverse effects is very limited. The current study focused on the investigation of subchronic toxicity and genotoxicity of extract obtained from DM according to the test guidelines published by the Organization for Economic Cooperation and Development. Materials and methods: We conducted a toxicological evaluation of DM extracts using 14-day repeated-dose toxicity study and 13-week repeated-dose toxicity study in Sprague-Dawley rats administered orally at doses of 500, 1000, or 2000 mg/kg/day. The clastogenicity of DM extract was also evaluated by in vitro chromosome aberration assay and in vivo micronucleus assay. Results: Assessment of subchronic toxicity of DM extract by oral administration in rats revealed unremarkable treatment-related findings with respect to food/water consumption, body weight, mortality, urinalysis, hematology, serum biochemistry, necropsy, organ weight and histopathology at doses of 500, 1000, and 2000 mg/kg. Accordingly, the level of no-observed-adverse-effect for DM extract in 13-week subchronic toxicity study was considered to be 2000 mg/kg/day in rats. The data observed from in vitro chromosome aberration assay and in vivo micronucleus assay exclude any clastogenicity of DM extract. Conclusion: The results suggest that the oral consumption of DM extract has no adverse effects in humans and represents a safe traditional medicine.",
keywords = "Clastogenicity, Dendropanax morbifera extract, Genotoxicity, Subchronic toxicity, Traditional medicine",
author = "Yun, {Jun Won} and Kim, {Seung Hyun} and Kim, {Yun Soon} and Choi, {Eun Jin} and You, {Ji Ran} and Cho, {Eun Young} and Yoon, {Jung Hee} and Euna Kwon and Kim, {Hyoung Chin} and Jang, {Ja June} and Park, {Jin Sung} and Che, {Jeong Hwan} and Kang, {Byeong Cheol}",
year = "2019",
month = "6",
day = "28",
doi = "10.1016/j.jep.2019.111874",
language = "English",
volume = "238",
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Yun, JW, Kim, SH, Kim, YS, Choi, EJ, You, JR, Cho, EY, Yoon, JH, Kwon, E, Kim, HC, Jang, JJ, Park, JS, Che, JH & Kang, BC 2019, 'Preclinical study of safety of Dendropanax morbifera Leveille leaf extract: General and genetic toxicology', Journal of Ethnopharmacology, vol. 238, 111874. https://doi.org/10.1016/j.jep.2019.111874

Preclinical study of safety of Dendropanax morbifera Leveille leaf extract : General and genetic toxicology. / Yun, Jun Won; Kim, Seung Hyun; Kim, Yun Soon; Choi, Eun Jin; You, Ji Ran; Cho, Eun Young; Yoon, Jung Hee; Kwon, Euna; Kim, Hyoung Chin; Jang, Ja June; Park, Jin Sung; Che, Jeong Hwan; Kang, Byeong Cheol.

In: Journal of Ethnopharmacology, Vol. 238, 111874, 28.06.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Preclinical study of safety of Dendropanax morbifera Leveille leaf extract

T2 - General and genetic toxicology

AU - Yun, Jun Won

AU - Kim, Seung Hyun

AU - Kim, Yun Soon

AU - Choi, Eun Jin

AU - You, Ji Ran

AU - Cho, Eun Young

AU - Yoon, Jung Hee

AU - Kwon, Euna

AU - Kim, Hyoung Chin

AU - Jang, Ja June

AU - Park, Jin Sung

AU - Che, Jeong Hwan

AU - Kang, Byeong Cheol

PY - 2019/6/28

Y1 - 2019/6/28

N2 - Ethnopharmacology relevance: Dendropanax morbifera Leveille (DM) has been used in traditional medicines for infectious and skin diseases, and dysmenorrhea. It exhibits a diverse therapeutic potential including anti-cancer, anti-thrombotic, anti-diabetic, anti-oxidant, and anti-inflammatory activities. Aim of the study: Despite promising health benefits of DM, knowledge of its potential adverse effects is very limited. The current study focused on the investigation of subchronic toxicity and genotoxicity of extract obtained from DM according to the test guidelines published by the Organization for Economic Cooperation and Development. Materials and methods: We conducted a toxicological evaluation of DM extracts using 14-day repeated-dose toxicity study and 13-week repeated-dose toxicity study in Sprague-Dawley rats administered orally at doses of 500, 1000, or 2000 mg/kg/day. The clastogenicity of DM extract was also evaluated by in vitro chromosome aberration assay and in vivo micronucleus assay. Results: Assessment of subchronic toxicity of DM extract by oral administration in rats revealed unremarkable treatment-related findings with respect to food/water consumption, body weight, mortality, urinalysis, hematology, serum biochemistry, necropsy, organ weight and histopathology at doses of 500, 1000, and 2000 mg/kg. Accordingly, the level of no-observed-adverse-effect for DM extract in 13-week subchronic toxicity study was considered to be 2000 mg/kg/day in rats. The data observed from in vitro chromosome aberration assay and in vivo micronucleus assay exclude any clastogenicity of DM extract. Conclusion: The results suggest that the oral consumption of DM extract has no adverse effects in humans and represents a safe traditional medicine.

AB - Ethnopharmacology relevance: Dendropanax morbifera Leveille (DM) has been used in traditional medicines for infectious and skin diseases, and dysmenorrhea. It exhibits a diverse therapeutic potential including anti-cancer, anti-thrombotic, anti-diabetic, anti-oxidant, and anti-inflammatory activities. Aim of the study: Despite promising health benefits of DM, knowledge of its potential adverse effects is very limited. The current study focused on the investigation of subchronic toxicity and genotoxicity of extract obtained from DM according to the test guidelines published by the Organization for Economic Cooperation and Development. Materials and methods: We conducted a toxicological evaluation of DM extracts using 14-day repeated-dose toxicity study and 13-week repeated-dose toxicity study in Sprague-Dawley rats administered orally at doses of 500, 1000, or 2000 mg/kg/day. The clastogenicity of DM extract was also evaluated by in vitro chromosome aberration assay and in vivo micronucleus assay. Results: Assessment of subchronic toxicity of DM extract by oral administration in rats revealed unremarkable treatment-related findings with respect to food/water consumption, body weight, mortality, urinalysis, hematology, serum biochemistry, necropsy, organ weight and histopathology at doses of 500, 1000, and 2000 mg/kg. Accordingly, the level of no-observed-adverse-effect for DM extract in 13-week subchronic toxicity study was considered to be 2000 mg/kg/day in rats. The data observed from in vitro chromosome aberration assay and in vivo micronucleus assay exclude any clastogenicity of DM extract. Conclusion: The results suggest that the oral consumption of DM extract has no adverse effects in humans and represents a safe traditional medicine.

KW - Clastogenicity

KW - Dendropanax morbifera extract

KW - Genotoxicity

KW - Subchronic toxicity

KW - Traditional medicine

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DO - 10.1016/j.jep.2019.111874

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JO - Journal of Ethnopharmacology

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