Acute and Repeated Dose (28 Days) Oral Safety Studies of ALIBIRD in Rats

作者:Anadon Arturo*; Martinez Maria A; Ares Irma; Castellano Victor; Martinez Larranaga Maria R; Corzo Nieves; Olano Agustin; Montilla Antonia; Recio Isidra; Martinez Maqueda Daniel; Miralles Beatriz; Fornari Tiziana; Garcia Risco Monica R; Gonzalez Monserrat; Reglero Guillermo
来源:Journal of Food Protection, 2013, 76(7): 1226-1239.
DOI:10.4315/0362-028X.JFP-13-032

摘要

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 close of 2,000 mg/kg of body weight and resulted in no adverse events or mortality; a daily close of 2,000 mg/kg of body weight for 28 clays 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.

  • 出版日期2013-7