title: Mutagenicity and preclinical safety assessment of the aqueous extract of Clinacanthus nutans leaves.
abstract: BACKGROUND
  Clinacanthus nutans (CN) is used traditionally for treating various illnesses. Robust safety data to support its use is lacking.
  
  
  OBJECTIVE
  To evaluate the adverse effects of aqueous extract of CN leaves (AECNL).
  
  
  METHODS
  The oral toxicity of the AECNL was tested following Organisation for Economic Co-operation and Development (OECD) guidelines. Mutagenicity (Ames test) of AECNL was evaluated using TA98 and TA100 Salmonella typhimurium strains.
  
  
  RESULTS
  No mortality or morbidity was found in the animals upon single and repeated dose administration. However, significant body weight loss was observed at 2000 mg/kg during sub-chronic (90 d) exposure. In addition, increased eosinophil at 500 mg/kg and decreased serum alkaline phosphatase levels at 2000 mg/kg were observed in male rats. Variations in glucose and lipid profiles in treated groups were also observed compared to control. Ames test revealed no evidence of mutagenic or carcinogenic effects at 500 μg/well of AECNL.
  
  
  CONCLUSIONS
  The median lethal dose (LD50) of the AECNL is >5000 mg/kg and the no-observed-adverse-effect level is identified to be greater than 2000 mg/kg/day in 90-d study.
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Elham
authors.initials: E
authors.lastname: Farsi
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Kameh
authors.initials: K
authors.lastname: Esmailli
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Armaghan
authors.initials: A
authors.lastname: Shafaei
authors.affiliation: c School of Physics , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Pegah
authors.initials: P
authors.lastname: Moradi Khaniabadi
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Bassel
authors.initials: B
authors.lastname: Al Hindi
authors.affiliation: d Eman Biodiscovery , Penang , Malaysia , and.
authors.forename: Mohamed B
authors.initials: MB
authors.lastname: Khadeer Ahamed
authors.affiliation: b Advanced Medical and Dental Institute , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Doblin
authors.initials: D
authors.lastname: Sandai
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Munavvar
authors.initials: M
authors.lastname: Abdul Sattar
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Zhari
authors.initials: Z
authors.lastname: Ismail
authors.affiliation: a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
authors.forename: Amin Malik Shah
authors.initials: AM
authors.lastname: Abdul Majid
authors.affiliation: e Department of Pharmacology , Quest International University , Perak , Malaysia.
authors.forename: Aman Shah
authors.initials: AS
authors.lastname: Abdul Majid
mesh_terms: D027901:Acanthaceae / Q000737:chemistry*; D000818:Animals; D004353:Drug Evaluation, Preclinical; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000633:toxicity*; D018515:Plant Leaves / Q000737:chemistry*; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects* / Q000235:genetics; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic
chemical_list: D010936:Plant Extracts
keywords: In vitro and in vivo toxicology; LD50; NOAEL; OECD; acute; sub-acute; sub-chronic