title: Safety assessment of standardised methanol extract of Cinnamomum burmannii.
abstract: The present study aims to evaluate the safety of methanol extract of Cinnamomum burmannii (MECB) by acute 14-day (single dose) and sub-chronic 28-day (repeated doses) oral administration to Sprague-Dawley rats. Our results showed that no toxicity was found in either acute or sub-chronic toxicity studies. MECB (containing 0.07% and 0.20% (w/w) of coumarin and trans-cinnamaldehyde, respectively), which was given orally at doses of 500, 1000 and 2000 mg/kg caused neither visible signs of toxicity nor mortality. No significant differences were observed in general condition, growth, organ weight, hematological parameters, biochemical values, or the gross and microscopic appearance of the organs from the treatment groups as compared to the control group. In conclusion, MECB did not cause any mortality nor did it cause any abnormalities in the necropsy and histopathology findings of treated rats. The LD50 for the MECB was found to be more than 2000 mg/kg. No adverse effects were observed in the treated rats at all the doses tested. The no-observed-adverse-effect level (NOAEL) for the 28-day study was determined to be 2000 mg/kg body weight/day.
authors.affiliation: School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Pulau Pinang, Malaysia. mariam@usm.my
authors.forename: Mariam
authors.initials: M
authors.lastname: Ahmad
authors.forename: Chung Pin
authors.initials: CP
authors.lastname: Lim
authors.forename: Gabriel Akyirem
authors.initials: GA
authors.lastname: Akowuah
authors.forename: Nur Najihah
authors.initials: NN
authors.lastname: Ismail
authors.forename: Mohd Akmal
authors.initials: MA
authors.lastname: Hashim
authors.forename: Sook Yee
authors.initials: SY
authors.lastname: Hor
authors.forename: Lee Fung
authors.initials: LF
authors.lastname: Ang
authors.forename: Mun Fei
authors.initials: MF
authors.lastname: Yam
mesh_terms: D000284:Administration, Oral; D000818:Animals; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D027424:Cinnamomum / Q000737:chemistry*; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal; D005260:Female; D008297:Male; D000432:Methanol; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry / Q000302:isolation & purification; D051381:Rats; D017207:Rats, Sprague-Dawley; D012449:Safety; D023382:Toxicity Tests, Acute
chemical_list: D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; D000432:Methanol
keywords: Acute toxicity; Cinnamomum burmannii; Sub-chronic toxicity