Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies.

Agmatine, 1-Amino-4-guanidinobutane, is a ubiquitous naturally occurring molecule present in low amounts in a wide variety of foodstuff. Clinical trials have demonstrated the safety of oral agmatine sulfate and have led to its development as an effective dietary ingredient for promoting resilient nerve functions. Although clearly required, the mutagenic and genotoxic effects of agmatine have not been previously reported. The present study, therefore, undertook to assess the safety profile of agmatine using currently accepted in vitro and in vivo mutagenicity and genotoxicity tests. The test item was G-Agmatine®, a proprietary brand of agmatine sulfate. Using the bacterial reverse mutation assay (Ames test), the study found that G-Agmatine® has no mutagenic effects. It had no clastogenic effects as observed by the in vitro chromosomal aberration test using Chinese Hamster lung cells. And it lacked genotoxic effects as evidenced by the lack of increased frequency of micronucleated polychromatic immature erythrocytes following oral administration in the mouse micronucleus test. Taken together with previously published data, results of the present study further support the safety of agmatine sulfate as a dietary ingredient.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. GAD M. GILAD, PhD reports was provided by Gilad&Gilad LLC. GAD M. GILAD, PhD reports a relationship with Gilad&Gilad LLC that includes: employment and equity or stocks. GAD M. GILAD, PhD has patent licensed to Gad M. Gilad. Gad M. Gilad reports a relationship with Gilad&Gilad LLC that includes: employment, equity or stocks, and funding grants. VARDA H. Gilad reports a relationship with Gilad&Gilad LLC that includes: employment, equity or stocks, and funding grants. GAD M. GILAD has patents issued to Gad M. Gilad. Varda H. Gilad has patents issued to Varda H. Gilad. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2024 The Authors. Published by Elsevier B.V.)