Assessment of the safety of food azo dyes in the Ames test

Introduction. Synthetic food dyes (FD) have a number of advantages over natural ones and are increasingly used in the production of preparations and food products, which in turn increases attention to the issue of their safety. The safety assessment of FD includes testing for mutagenicity in “in vitro” and “in vivo” tests.

The aim of the work. To determine the mutagenic activity of the four most common synthetic FDs from the azo dyes (PaD) group in food products on the domestic market.

Materials and methods. The mutagenic activity of Sunset Yellow FCF, Tartrazine, Ponceau 4R, and Azorubine was assessed in the preincubation version of the Ames test on test strains of S. typhimurium TA1535, TA100, TA98, TA97, TA102 in the dose range of 8–5000 µg/plate with the addition of riboflavin to the microsomal activating mixture.

Results. No dependence of the frequency of revertant colonies on the concentration of the studied dyes was found, and the excess of the average number of colonies per dish in the experimental variants over the control was less than twofold, which indicates the absence of a mutagenic effect of the studied FaD samples.

Limitations. The study is limited to examining the mutagenicity of food azo dye samples in a single test that takes into account gene mutations in bacteria.

Conclusion. Sunset Yellow FCF, Tartrazine, Ponceau 4R, and Azorubine did not induce gene mutations in the Ames test.

Compliance with ethical standards. The study does not require the submission of a conclusion of the biomedical ethics committee or other documents.

Contribution:
Akhaltseva L.V. – search, analysis of literature data, setting up experiments, writing the article;
Yurchenko V.V. – analysis of literature data, editing the article;
Nikitina T.A. – search for literature sources, setting up experiments;
Mamonov R.A. – research concept, editing the article;
Vodyanova M.A. – editing the article.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Conflict of interest. The authors declare no conflict of interest.

Funding. The work was carried out within the framework of the state task «Complex system for assessing the genotoxicity of food additives» Centre for Strategic Planning of the Federal medical and biological agency.

Received: May 29, 2025 / Revised: July 1, 2025 / Accepted: October 15, 2025 / Published: December 19, 2025

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