Research Article
Volume 16 Issue 4 - 2021
Safety and Toxicological Evaluation of 2’-Fucosyllactose Produced by Fermentation via Genetically Engineered Corynebacterium glutamicum
Iris L Case1, Young-Ha Song2, Chang-Ku Jeong2, Jung-Min Kim2, Chun-Ja Nam3, Yunji Seol1 and Jong-Won Yoon2*
1Ace One RS, Inc., Clarksville, Maryland, USA
2Advance Protein Technologies Corp., Gyeonggi-do, Republic of Korea
3BiotoxTech Co., Ltd., Chungcheongbuk-do, Republic of Korea, Present Address, Chemon Inc., Republic of Korea
*Corresponding Author: Jong-Won Yoon, Advance Protein Technologies Corp., Gyeonggi-do, Republic of Korea.
Received: February 18, 2021; Published: March 29, 2021


The safety of 2’-fucosyllactose (2’-FL) produced by fermentation via genetically engineered Corynebacterium glutamicum was evaluated in acute and subchronic toxicity studies as well as a battery of mutagenicity and genotoxicity studies. An in vitro mutagenicity study using reverse bacterial mutation tests and an in vitro genotoxicity study with Chinese hamster lung cells demonstrated that 2’-FL was not mutagenic or clastogenic in the presence or absence of metabolic activation. An in vivo mouse micronucleus assay, 2’-FL did not induce micronuclei formation in the bone marrow cells of mice, indicating that it is non-clastogenic. An acute toxicity study found that the approximate lethal dose of 2’-FL was much greater than 7,500 mg/kg, the highest dose tested, in male and female juvenile rats (7 days old). In the 90-day oral toxicity study, the no observed adverse effect level (NOAEL) of 2’-FL was determined to be 7,500 mg/kg bw/day, the highest dose tested, for male and female rats. The results of these studies support the safety of 2’-FL as a food ingredient.

Keywords: 2’-Fucosyllactose; Safety; Acute Toxicity; Subchronic Toxicity; Mutagenicity; Clastogenicity; Genotoxicity


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Citation: Jong-Won Yoon., et al. “Safety and Toxicological Evaluation of 2’-Fucosyllactose Produced by Fermentation via Genetically Engineered Corynebacterium glutamicum”. EC Nutrition 16.4 (2021): 04-19.

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