title: Toxicological evaluation of an Allium-based commercial product in a 90-day feeding study in Sprague-Dawley rats.
abstract: Proallium AP(®) is a commercial Allium extract intended to be used in active food packaging as the antibacterial and antioxidant effects of some organosulfur compounds are well known. However, there is little information on its toxicity and the Scientific Committee on Food (UE) requires the safety assessment of substances used in food contact materials. Thus, the aim of this study was to conduct for the first time a subchronic oral toxicity study of Proallium AP(®) with groups of 10 males and 10 females Sprague-Dawley rats fed a diet containing 0, 25, 100, 400 mg/kg/d for 90 days. No treatment-related clinical signs or mortality were noted. Besides, no treatment-related effects with regard to any of the toxicological biomarkers considered were observed, including biochemical, haematological and histopathology parameters. In conclusion, the non-observed-adverse-effect-level (NOAEL) for Proallium AP(®) in rats was determined to be a dietary dose of 400 mg/kg/d under the present experimental conditions, a value 500-fold higher than the exposure derived from its potential use in active packaging.
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, Universidad de Sevilla, Profesor García González n°2, 41012, Seville, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Mellado-García
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, Universidad de Sevilla, 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, Universidad de Sevilla, Profesor García González n°2, 41012, Seville, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Pichardo
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, Universidad de Sevilla, Profesor García González n°2, 41012, Seville, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Llana-Ruiz-Cabello
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: Department of Anatomy and Comparative Pathology and Anatomy, University of Córdoba, Campus de Rabanales Carretera Madrid-Cádiz s/n, Córdoba, 14071, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Blanco
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, Universidad de Sevilla, Profesor García González n°2, 41012, Seville, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Jos
authors.affiliation: Area of Toxicology, Faculty of Pharmacy, Universidad de Sevilla, Profesor García González n°2, 41012, Seville, Spain. Electronic address: camean@us.es.
authors.forename: A M
authors.initials: AM
authors.lastname: Cameán
mesh_terms: D000490:Allium / Q000737:chemistry*; D000818:Animals; D004305:Dose-Response Relationship, Drug; D005260:Female; D018857:Food Packaging; D008297:Male; D010936:Plant Extracts / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D010936:Plant Extracts
keywords: 90-Day oral; Allium extract; Proallium AP(®); Rats; Subchronic toxicity