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In Vivo Evaluation of the Safety of Hydrolyzed GMP Powder containing Highly Concentrated Sialic Acid (23%) produced by Enzyme Separation and Solvent Enrichment Method using Micronucleus Test in Mice

Kim, Hee-Kyong (MEDINUTROL Co.)
Cho, Hyang-Hyun (MEDINUTROL Co.)
Noh, Hye-Ji (MEDINUTROL Co.)

Publication Information

Journal of Dairy Science and Biotechnology / v.34, no.2, 2016 , pp. 83-89 More about this Journal

Abstract

This study was designed to determine the mutagenic potential of hydrolyzed glycomacropeptide (GMP) powder (hereafter referred to as 23%-GNANA; product name: HELICOBACTROL-23) in a micronucleus test using bone marrow in ICR mice. Three experimental groups were used: a 3-step concentration group, with a maximum concentration of 2,000 mg/kg, and other sequentially two-fold lower concentrations, a negative control group, and a positive control group. The test material was administered for 2 d to observe the frequency of micronucleus formation up to 48 h after the test material was absorbed by the body. When the polychromatic erythrocyte (PCE) content of erythrocytes was compared, no significant differences were noted between the negative control group and the test group (p<0.05). Similarly, when the average numbers of micronucleated PCE (MNPCE) in 2,000 PCE per animal were compared, no significant difference was observed between the negative control group and the test group (p<0.05). No dose-response relationship with regard to the concentration of the test material administered was noted. These results allow us to conclude that hydrolyzed whey protein powder does not cause formation of micronuclei in mouse bone marrow cells under the applied conditions. In this study, the average frequency of micronucleus formation in PCE was significantly higher in the positive control group compared with the negative control group; thus, the test conditions were appropriate for detecting the frequency of micronucleus formation induced by the test material. In conclusion, the safety of 23%-GNANA test substance was verified in an in vivo micronucleus test in mice, conducted before the registration of HELICOBACTROL-23 as a food additive.

Keywords

hydrolyzed GMP (glycomacropeptide) powder; sialic acid; in vivo micronucleus test; frequency of micronucleus formation;

Citations & Related Records

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