title: Acute and repeated dose (28 days) oral safety studies of ALIBIRD in rats.
abstract: ALIBIRD, a test substance composed of oligosaccharides derived from lactulose, a hydrolysate of a whey protein concentrate, and a supercritical extract of rosemary (1:0.5:0.05), was prepared in the laboratory and evaluated for its safety as a multifunctional food additive. In oral toxicity studies (acute and 28 days repeated dose) using Wistar rats, ALIBIRD was administered in a single oral gavage dose of 2,000 mg/kg of body weight and resulted in no adverse events or mortality; a daily dose of 2,000 mg/kg of body weight for 28 days by gavage also resulted in no adverse effects or mortality. No abnormal clinical signs, behavioral changes, body weight changes, or changes in food and water consumption occurred in either study. There were no changes in hematological and serum chemistry values, organ weights, or gross or histological characteristics. Based on test results, it is concluded that ALIBIRD is well tolerated in rats at an acute and subchronic (28 days) dose of 2,000 mg/kg of body weight.
authors.affiliation: Departamento de Toxicología y Farmacología, Facultad de Veterinaria, Universidad Complutense de Madrid, 28040 Madrid, Spain. aanadon@ucm.es
authors.forename: Arturo
authors.initials: A
authors.lastname: Anadón
authors.forename: María A
authors.initials: MA
authors.lastname: Martínez
authors.forename: Irma
authors.initials: I
authors.lastname: Ares
authors.forename: Victor
authors.initials: V
authors.lastname: Castellano
authors.forename: Maria R
authors.initials: MR
authors.lastname: Martínez-Larrañaga
authors.forename: Nieves
authors.initials: N
authors.lastname: Corzo
authors.forename: Agustin
authors.initials: A
authors.lastname: Olano
authors.forename: Antonia
authors.initials: A
authors.lastname: Montilla
authors.forename: Isidra
authors.initials: I
authors.lastname: Recio
authors.forename: Daniel
authors.initials: D
authors.lastname: Martínez-Maqueda
authors.forename: Beatriz
authors.initials: B
authors.lastname: Miralles
authors.forename: Tiziana
authors.initials: T
authors.lastname: Fornari
authors.forename: Mónica R
authors.initials: MR
authors.lastname: García-Risco
authors.forename: Monserrat
authors.initials: M
authors.lastname: Gonzalez
authors.forename: Guillermo
authors.initials: G
authors.lastname: Reglero
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D023421:Models, Animal; D010936:Plant Extracts / Q000008:administration & dosage / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D027542:Rosmarinus / Q000737:chemistry*
chemical_list: D010936:Plant Extracts