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 ne...

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Main Authors: Varda H. Gilad, Erzsébet Béres, Adél Vértesi, Gábor Hirka, Gad M. Gilad
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Toxicology Reports
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Online Access:http://www.sciencedirect.com/science/article/pii/S2214750024001033
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author Varda H. Gilad
Erzsébet Béres
Adél Vértesi
Gábor Hirka
Gad M. Gilad
author_facet Varda H. Gilad
Erzsébet Béres
Adél Vértesi
Gábor Hirka
Gad M. Gilad
author_sort Varda H. Gilad
collection DOAJ
description 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.
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spelling doaj-art-6817895292b946c2beb842272e0969e52024-12-19T10:54:33ZengElsevierToxicology Reports2214-75002024-12-0113101720Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studiesVarda H. Gilad0Erzsébet Béres1Adél Vértesi2Gábor Hirka3Gad M. Gilad4Research, Gilad&Gilad LLC, 9149 Claretta Dr., Las Vegas, NV 89129, USAToxi-Coop ZRT., Arácsi út 97, Balatonfüred 8230, HungaryToxi-Coop ZRT., Arácsi út 97, Balatonfüred 8230, HungaryToxi-Coop ZRT., Arácsi út 97, Balatonfüred 8230, HungaryResearch, Gilad&Gilad LLC, 9149 Claretta Dr., Las Vegas, NV 89129, USA; Corresponding author.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.http://www.sciencedirect.com/science/article/pii/S2214750024001033agmatinedietary ingredientgenotoxicitymutagenicityneuroprotectionsafety
spellingShingle Varda H. Gilad
Erzsébet Béres
Adél Vértesi
Gábor Hirka
Gad M. Gilad
Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
Toxicology Reports
agmatine
dietary ingredient
genotoxicity
mutagenicity
neuroprotection
safety
title Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
title_full Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
title_fullStr Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
title_full_unstemmed Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
title_short Evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
title_sort evidence for safety of the dietary ingredient agmatine sulfate as assessed by mutagenicity and genotoxicity studies
topic agmatine
dietary ingredient
genotoxicity
mutagenicity
neuroprotection
safety
url http://www.sciencedirect.com/science/article/pii/S2214750024001033
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