Abstract

l-threonine, l-tryptophan and l-valine play a fundamental role in animal and human nutrition as essential amino acids required for normal growth. In addition, each amino acid is codified as a generally recognized as safe (GRAS) amino acid for the use in animal feed additives and presents no exposure risk from animal to humans consuming tissues or products from the target animal. Taking into account the important role of mutagenicity and genotoxicity in the risk of the three amino acid additives (l-threonine, l-tryptophan, and l-valine) fermentation products and other unknown impurities and derivatives from Corynebacterium glutamicum (C. glutamicum), the safety evaluation of these amino acid additives is not performed. Therefore, the purpose of this study is to evaluate toxicological effects, including Ames test, an in vitro mammalian chromosomal aberration test and an acute oral animal toxicity of the three amino acid additives in accordance with the Organisation for Economic Co-operation and Development (OECD) guidelines and the principles of Good Laboratory Practice (GLP). As a result, these amino acid additives were classified as non-mutagenic and non-clastogenic, and did not induce any toxicity in acute oral toxicity test. Collectively, these results suggest that the three amino acid additives are safe with no adverse effects, and able to be applied as an ingredient or other biological uses.

Highlights

  • Dietary ingestion of amino acids in domestic animals has been widely investigated and the important role of amino acids in modulation of metabolism, growth, reproduction and milk production was unveiled [1]

  • C. glutamicum was listed on the Qualified Presumption of Safety (QPS) list of European Food Safety Authority (EFSA) and the concerns for the safety of C. glutamicum when used for biotechnological process are rarely considered [9]

  • L-tryptophan fermentation product showed no substantial increases in numbers of revertants per plate in TA100, TA102, TA1535, TA98 and TA1537 strains at concentration levels (50, 150, 500, 1500, and 5000 μg/plate) in either the presence or absence of metabolic activation of S9 mix (Table 4)

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Summary

Introduction

Dietary ingestion of amino acids in domestic animals has been widely investigated and the important role of amino acids in modulation of metabolism, growth, reproduction and milk production was unveiled [1]. C. glutamicum was listed on the Qualified Presumption of Safety (QPS) list of European Food Safety Authority (EFSA) and the concerns for the safety of C. glutamicum when used for biotechnological process are rarely considered [9]. This microorganism has shown remarkable potential of biological production of various nutrients including organic acids, vitamins, and amino acids [10,11,12]. The importance of C. glutamicum as a role of industrial workhorse in the fields of medicine, biotechnology, and agriculture has been more emphasized

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