title: Sub-chronic safety evaluation of the ethanol extract of Aralia elata leaves in Beagle dogs.
abstract: Aralia elata Seem. (A. elata) is a traditional Chinese medicine to treat some diseases. This investigation aims to evaluate the pharmaceutical safety of the ethanol extract of A. elata leaves, namely ethanol leaves extract (ELE), in Beagle dogs. In sub-chronic oral toxicity study, dogs were treated with the ELE at doses of 50, 100 and 200 mg/kg for 12 weeks and followed by 4 weeks recovery period. During experimental period, clinical signs, mortality, body temperature, food consumption and body weight were recorded. Analysis of electrocardiogram, urinalysis, ophthalmoscopy, hematology, serum biochemistry, organ weights and histopathology were performed. The results showed that both food consumption and body weight significantly decreased in high-dose group. Treatment-related side effects and mortality were observed in high-dose female dogs. Some parameters showed significant alterations in electrocardiogram, urinalysis, serum biochemistry and relative organ weights. These alterations were not related to dose or consistent across gender, which were ascribed to incidental and biological variability. The findings in this study indicated that the no-observed adverse effect level (NOAEL) of the ELE was 100 mg/kg in dogs and provided a vital reference for selecting a safe application dosage for human consumption.
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China; Research Center for Pharmacology and Toxicology, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China.
authors.forename: Fengjin
authors.initials: F
authors.lastname: Li
authors.affiliation: Research Center for Pharmacology and Toxicology, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China.
authors.forename: Xiaoli
authors.initials: X
authors.lastname: He
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China.
authors.forename: Wenying
authors.initials: W
authors.lastname: Niu
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China.
authors.forename: Yuenan
authors.initials: Y
authors.lastname: Feng
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China.
authors.forename: Jingqi
authors.initials: J
authors.lastname: Bian
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China. Electronic address: hxkuang@hotmail.com.
authors.forename: Haixue
authors.initials: H
authors.lastname: Kuang
authors.affiliation: Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, China. Electronic address: hrbxiaohongbin@126.com.
authors.forename: Hongbin
authors.initials: H
authors.lastname: Xiao
mesh_terms: D000818:Animals; D027983:Aralia / Q000737:chemistry / Q000633:toxicity*; D015415:Biomarkers / Q000097:blood / Q000652:urine; D001777:Blood Coagulation / Q000187:drug effects; D001833:Body Temperature Regulation / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D004562:Electrocardiography; D000431:Ethanol / Q000737:chemistry*; D005260:Female; D006801:Humans; D008297:Male; D023421:Models, Animal; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D008517:Phytotherapy; D010936:Plant Extracts / Q000302:isolation & purification / Q000633:toxicity*; D018515:Plant Leaves / Q000737:chemistry / Q000633:toxicity*; D010946:Plants, Medicinal; D018570:Risk Assessment; D012737:Sex Factors; D012997:Solvents / Q000737:chemistry*; D013997:Time Factors; D059550:Toxicity Tests, Subchronic / Q000379:methods*
chemical_list: D015415:Biomarkers; D010936:Plant Extracts; D012997:Solvents; D000431:Ethanol
keywords: Aralia elata Seem.; Beagle dogs; Sub-chronic toxicity