title: Acute and sub-chronic toxicity study of the ethanol extract from leaves of Aralia elata in rats.
abstract: BACKGROUND
  Aralia elata Seem. (A. elata) is a well-known medicinal plant which has been used as a tonic, anti-arthritic and anti-diabetic agent in traditional Chinese medicine. This investigation aimed to evaluate the potential toxicological properties of the ethanol extract from leaves of A. elata, namely ethanol leaves extract (ELE), in rats by acute and sub-chronic toxicity studies.
  
  
  METHODS
  In the acute toxicity study, rats were orally administrated with ELE at doses of 1.00, 2.15, 4.64, and 10.00 g/kg to determine the oral medial lethal dose (LD50). Abnormal behavior, toxic symptom, and death were observed for 14 consecutive days. In the sub-chronic toxicity study, rats were orally administrated with ELE at doses of 0, 60, 180, and 540 mg/kg for 12 weeks and followed-up a 4-week recovery period. At the end of the treatment and recovery periods, the rats were sacrificed for hematological, biochemical, and histopathology analyses.
  
  
  RESULTS
  The acute toxicity study showed that oral administration of ELE induced the incidence of adverse effects. The death rate also increased in a dose-dependent manner. The LD50 value was 3.16 g/kg for female rats, and 5.84 g/kg for male rats, respectively. The sub-chronic toxicity study showed that daily oral administration of ELE induced no significant difference in food consumption. However, the body weight of male rats in high dose group increased slowly compared with the control group during the recovery period. The hematological and biochemical analysis showed that compared with the control group, HGB and MCV levels were significantly increased in ELE treatment groups at the end of the treatment period, while TP and GLB levels were significantly decreased at the end of the recovery period. The absolute and relative weight of thymus, brain and adrenal gland showed a significant difference in low or high dose group at the end of the treatment period, although no histological changes were observed in various organs.
  
  
  CONCLUSIONS
  The results of this study provided evidence that oral administration of ELE at dose of 540 mg/kg is safe in rats and may not exert severe toxic effects.
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; Department of Basic Medicine, College of Pharmacy, Heilongjiang University of Chinese Medicine, Harbin 150040, 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: hrbxiaohongbin@126.com.
authors.forename: Hongbin
authors.initials: H
authors.lastname: Xiao
mesh_terms: D000818:Animals; D027983:Aralia; D000431:Ethanol / Q000737:chemistry; D005260:Female; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000633:toxicity*; D018515:Plant Leaves / Q000737:chemistry; D017207:Rats, Sprague-Dawley; D012997:Solvents / Q000737:chemistry; D023382:Toxicity Tests, Acute; D059550:Toxicity Tests, Subchronic
chemical_list: D010936:Plant Extracts; D012997:Solvents; D000431:Ethanol
keywords: Acute toxicity; Aralia elata Seem.; Rats; Sub-chronic toxicity