Dietary safety of a dual-enzyme preparation for animal feed: Acute and subchronic oral toxicity and genotoxicity studies.

Autor: Dillon GP; Alltech Ireland, Sarney, Summerhill Road, Dunboyne, Co Meath, Ireland. Electronic address: gdillon@alltech.com., Gaffney MA; Alltech Ireland, Sarney, Summerhill Road, Dunboyne, Co Meath, Ireland., Curran CM; Alltech Ireland, Sarney, Summerhill Road, Dunboyne, Co Meath, Ireland., Moran CA; Alltech France SARL, Rue Charles Amand, 14500 Vire, France.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2017 Aug; Vol. 88, pp. 106-117. Date of Electronic Publication: 2017 Jun 03.
DOI: 10.1016/j.yrtph.2017.06.001
Abstrakt: Animal feed is routinely supplemented with exogenous enzymes to improve nutrient utilization, such as proteases to enhance protein hydrolysis in vivo and xylanases to alleviate feed related anti-nutritional factors. The present studies were conducted to evaluate the potential oral toxicity and genotoxicity of a dual-enzyme preparation, Vegpro ® concentrate (VPr-C). Acute oral toxicity studies were conducted in adult male and female Sprague-Dawley Crl CD rats and CHS Swiss ICO:OFI (IOPS Caw) mice. Thirteen week preliminary and final subchronic oral toxicity studies were conducted in male and female rats. Genotoxicity was evaluated through a bacterial reverse mutation test (Ames test), an in-vitro mammalian chromosomal aberration test, and a mammalian micronucleus test. The LD 50 was >2000 mg/kg of BW in mice and rats. In the 13-week oral toxicity study, the No Observed Adverse Effects Level (NOAEL) was 1000 mg/kg BW per day for females and 300 mg/kg BW per day for males. VPr-C showed no mutagenic activity in Salmonella typhimurium, did not induce significant chromosomal aberrations in cultured human lymphocytes, and did not increase the frequency or proportion of micronucleated immature erythrocytes in mice. There was no evidence of acute or subchronic toxicity or genotoxicity associated with the test article at these test dosages.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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