1. Toxicological evaluations of colostrum ultrafiltrate.
- Author
-
Thiel A, Glávits R, Murbach TS, Endres JR, Reddeman R, Hirka G, Vértesi A, Béres E, and Szakonyiné IP
- Subjects
- Administration, Oral, Animals, Female, Male, Mice, No-Observed-Adverse-Effect Level, Pregnancy, Rats, Rats, Wistar, Ultrafiltration, Colostrum chemistry, Dairy Products analysis, Dairy Products toxicity
- Abstract
Colostrum has been consumed safely for many years as a food collected directly from cows. More recently, an ultrafiltrated bovine colostrum product has been developed; however, its safety in toxicology studies has not been extensively evaluated. To assess the safety of bovine colostrum ultrafiltrate, in accordance with internationally accepted standards, the genotoxic potential was investigated in a bacterial reverse mutation test, an in vitro chromosomal aberration test, and an in vivo mammalian micronucleus test. No mutagenicity or genotoxic activity was observed in these three tests. A 90-day repeated-dose oral toxicity study in Hsd.Han Wistar rats was conducted at doses of 0, 1050, 2100, and 4200 mg/kg bw/day by gavage. After 90 days of continuous exposure, no mortality or treatment-related adverse effects were observed, and no target organs were identified. The no-observed-adverse-effect level (NOAEL) was determined to be 4200 mg/kg bw/day, the highest dose tested., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF