title: Toxicity assessment of Leonuri Herba aqueous extract orally administered to rats for 13 consecutive weeks.
abstract: BACKGROUND
  The Leonuri Herba has been traditionally used for women's disease in Asian countries.
  
  
  OBJECTIVE
  The objective of the present study was to evaluate the subchronic toxicity of Leonuri Herba aqueous extract in male and female F344 rats.
  
  
  METHODS
  Leonuri Herba aqueous extract was administered orally once daily at dose levels of 0, 125, 250, 500, 1000 and 2000 mg/kg/day for 13 weeks. Toxicological assessment was performed including mortality, clinical signs, body and organ weights, food consumption, ophthalmology, urinalysis, hematology, serum chemistry, gross findings and histopathologic examination.
  
  
  RESULTS
  There were no treatment related differences in clinical signs, urinalysis, hematology and serum chemistry, except for a histopathologic examination. The squamous cell hyperplasia in the forestomach was observed in both sexes of rats given 2000 mg/kg/day of Leonuri Herba aqueous extract.
  
  
  CONCLUSIONS
  In conclusion, the NOAEL (No Observed Adverse Effect Level) for Leonuri Herba aqueous extract was determined as 1000 mg/kg/day in both sexes of rats under the present experimental conditions. And the acceptable daily intake value for Leonuri Herba aqueous extract was calculated to be 10mg/kg body weight per day using a safety factor of 100 to the NOAEL.
authors.affiliation: College of Pharmacy, Chungnam National University, 99 Daehak-ro, Yuseong-gu, Daejeon, 305-764, Republic of Korea.
authors.forename: So-Ri
authors.initials: SR
authors.lastname: Han
authors.forename: Hyoung-Yun
authors.initials: HY
authors.lastname: Han
authors.forename: Byoung-Seok
authors.initials: BS
authors.lastname: Lee
authors.forename: Byung-Sun
authors.initials: BS
authors.lastname: Min
authors.forename: Moon-Koo
authors.initials: MK
authors.lastname: Chung
authors.forename: Ja
authors.initials: J
authors.lastname: Young Jeong
authors.forename: Hang-sik
authors.initials: HS
authors.lastname: Roh
authors.forename: Ji Hyeon
authors.initials: JH
authors.lastname: Seok
authors.forename: Sang Kyum
authors.initials: SK
authors.lastname: Kim
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004305:Dose-Response Relationship, Drug; D020834:Ethnopharmacology; D005260:Female; D006801:Humans; D031332:Leonurus / Q000737:chemistry*; D008297:Male; D008518:Medicine, East Asian Traditional; D009929:Organ Size; D009928:Organ Specificity; D010936:Plant Extracts / Q000302:isolation & purification / Q000494:pharmacology / Q000633:toxicity*; D051381:Rats; D011916:Rats, Inbred F344; D013270:Stomach / Q000187:drug effects / Q000473:pathology; D059550:Toxicity Tests, Subchronic; D014591:Uterine Diseases / Q000188:drug therapy
chemical_list: D010936:Plant Extracts
keywords: Herbal medicine; Leonuri Herba; Subchronic toxicity