Evaluation of the genotoxicity of the food dye Sunset Yellow FCF in a micronucleus test in vivo

Introduction. Sunset Yellow food azo dye (E110) is actively used to impart yellow-orange hues to food, pharmacological and cosmetic products. The control of consumption and the quality of the synthetic food dyes themselves, worries researchers from various countries, including the countries producing this segment of food additives, which are also used in the domestic food industry. Therefore, the safety assessment of azo dyes, including genotoxicity, is relevant.

Materials and methods. Genotoxicity of the Sunset Yellow (produced in India, purity being 90,46%) was studied in the micronucleus test on bone marrow cells (hybrids F1 CBA × C57Bl6/j) in male mice. The test sample was injected twice into mice stomach in the dose range of 250–2000 mg/kg. The frequency of polychromatophilic erythrocytes (PCEs) with micronuclei was estimated by analysis of 4000 PCEs. The proportion of PCEs among all erythrocytes was determined by analyzing of 500 cells per animal.

Results. No change in the proportion of PCEs was observed with the introduction of Sunset Yellow over the entire range of doses studied. We revealed a significant increase in the frequency of PCE with micronuclei over the parallel negative control at the maximum dose, going beyond the upper 95% CI of the accumulated negative control, a linear dependence of the effect on the dose.

Limitations. The data obtained do not allow us to determine the mechanism of the genotoxic action of the test substance.

Conclusion. The studied sample of Sunset Yellow food colouring under conditions of double injection showed poor cytogenetic activity in vivo micronucleus test on bone marrow cells in mice.

Compliance with ethical standards. The study was approved by the local ethical committee of the Research Institute of EDiTO of the N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation, carried out under the European Convention for the Protection of Vertebrate Animals Used for Experiments or Other Scientific Purposes (ETS N 123), Directive of the European Parlimicronuclei ament and Council of the European Union 2010/63/EU of 22.09.2010 on the protection of animals used for scientific purposes.

Contribution:
Akhaltseva L.V. — cytome analysis, search for literature sources, analysis of literature, writing a text;
Yurchenko V.V. — concept and design of the study, work with animals, preparation of preparations for cytome analysis, statistical analysis, analysis of literature, writing a text;
Yurtseva N.A. — work with animals, preparation of preparations for cytome analysis, cytome analysis, search for literature sources;
Konyashkina M.A. — work with animals, preparation of preparations for cytome analysis; search for literature sources, analysis of literature.
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. 

Acknowledgment. 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 FMBA of Russia.

Received: July 26, 2022 / Accepted: August 04, 2022 / Published: September 30, 2022