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

Abstract

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.