title: Safety assessment of widely used fermented virgin coconut oil (Cocos nucifera) in Malaysia: Chronic toxicity studies and SAR analysis of the active components.
abstract: Fermented Virgin Coconut Oil (FVCO) is widely used in the Southeast Asia as food and traditional medicine. The objective of the present study is the evaluation of chronic safety of the commercialized FVCO of Malaysia and other Southeast Asian countries. A single dose of 5000 mg/kg of FVCO was administered orally in rats (each group, n = 5) for the acute toxicity study and 175, 550 and 2000 mg/kg for sub-chronic and chronic studies (each group, n = 10), respectively. The behavior, mortality, and body weight of the rats were assessed to determine the toxic effects of FVCO. The haematology, biochemistry and histopathology of the treated rats were evaluated. The treated rats were safe with the dose of 5000 mg/kg in acute, sub-chronic and chronic indication. Abnormal clinical signs and morphology (gross necroscopy), changes of organ weight, anomalous haematology and biochemistry indexes were not found in comparison with the control (p > 0.05). In general, food and water intake were higher in the treated rats related to control. It was concluded that the presence of the antioxidant active compounds of FVCO might be the reason of safety. The structure activity relationship (SAR) provides a comprehensive mechanism to determine the safety that is the presence of the electron donating phenolic groups, carbonyl groups, and carboxylic acid in the ortho and meta position of the aromatic rings. The SAR showed the antioxidant properties of myristic acid and lauric acid determined by GC-MS analysis. This result suggests the safety of FVCO for chronic use, nutritional activity that FVCO formulation complies the requirements of regulatory agencies.
authors.affiliation: EMAN Testing & Research Laboratory, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia; Department of Biology, Faculty of Sciences, University of Zakho, Iraq.
authors.forename: Ahmad H
authors.initials: AH
authors.lastname: Ibrahim
authors.affiliation: EMAN Testing & Research Laboratory, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia.
authors.forename: Md Shamsuddin Sultan
authors.initials: MS
authors.lastname: Khan
authors.affiliation: Department of Biology, Faculty of Sciences, University of Zakho, Iraq.
authors.forename: Sawsan S
authors.initials: SS
authors.lastname: Al-Rawi
authors.affiliation: EMAN Biodiscoveries Sdn. Bhd., Suite 126, Level 1, EUREKA Complex, Universiti Sains Malaysia (USM), Minden, 11800, Penang, Malaysia.
authors.forename: Mohamed B Khadeer
authors.initials: MB
authors.lastname: Ahamed
authors.affiliation: Department of Pharmacology, QUEST International University, Malaysia.
authors.forename: Aman Shah Bin Abdul
authors.initials: AS
authors.lastname: Majid
authors.affiliation: EMAN Testing & Research Laboratory, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia.
authors.forename: Fouad Saleih R
authors.initials: FS
authors.lastname: Al-Suede
authors.affiliation: The First People's Hospital of Changde City, Hunan Province, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Ji
authors.affiliation: EMAN Testing & Research Laboratory, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia. Electronic address: aminmalikshah@gmail.com.
authors.forename: Amin Malik Shah Abdul
authors.initials: AM
authors.lastname: Majid
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D000074263:Coconut Oil; D004305:Dose-Response Relationship, Drug; D005260:Female; D005285:Fermentation; D059022:Food Safety; D008296:Malaysia; D008297:Male; D010938:Plant Oils / Q000008:administration & dosage / Q000737:chemistry* / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D010938:Plant Oils; D000074263:Coconut Oil
keywords: Fermented virgin coconut oil; SAR; Safety; Southeast Asia; Toxicity