title: A subchronic 90-day oral toxicity study of Origanum vulgare essential oil in rats.
abstract: Oregano essential oil (Origanum vulgare L. virens) (OEO) is being used in the food industry due to its useful properties to develop new active packaging systems. In this concern, the safety assessment of this natural extract is of great interest before being commercialized. The European Food Safety Authority requests different in vivo assays to ensure the safety of food contact materials. One of these studies is a 90 days repeated-dose oral assay in rodents. In the present work, 40 male and 40 female Wistar rats were orally exposed to 50, 100 and 200 mg/kg body weight (b.w.) OEO during 90 days following the OECD guideline 408. Data revealed no mortality and no treatment-related adverse effects of the OEO in food/water consumption, body weight, haematology, biochemistry, necropsy, organ weight and histopathology. These findings suggest that the oral no-observed-adverse-effect level (NOAEL) of this OEO is 200 mg/kg b.w. in Wistar rats, the highest dose tested. In conclusion, the use of this OEO in food packaging appears to be safe based on the lack of toxicity during the subchronic study at doses 330-fold higher than those expected to be in contact consumers in the worst scenario of exposure.
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Llana-Ruiz-Cabello
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Maisanaba
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Puerto
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain. Electronic address: spichardo@us.es.
authors.forename: S
authors.initials: S
authors.lastname: Pichardo
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Jos
authors.affiliation: Department of Pharmacology, Toxicology and Legal and Forensic Medicine, University of Córdoba, Campus de Rabanales Carretera Madrid-Cádiz s/n, Córdoba, 14071, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Moyano
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
authors.forename: A M
authors.initials: AM
authors.lastname: Cameán
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D005260:Female; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009822:Oils, Volatile / Q000008:administration & dosage / Q000633:toxicity*; D031341:Origanum / Q000737:chemistry*; D051381:Rats; D017208:Rats, Wistar; D059550:Toxicity Tests, Subchronic / Q000379:methods*
chemical_list: D009822:Oils, Volatile
keywords: 90-Day oral; Oregano essential oil; Rats; Subchronic toxicity