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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.

journal_name

J Ethnopharmacol

journal_title

Journal of ethnopharmacology

authors

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

doi

10.1016/j.jep.2019.111874

subject

Has Abstract

pub_date

2019-06-28 00:00:00

pages

111874

eissn

0378-8741

issn

1872-7573

pii

S0378-8741(18)33287-2

journal_volume

238

pub_type

杂志文章

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Preclinical study of safety of Dendropanax morbifera Leveille leaf extract: General and genetic toxicology.