Evaluation of the genotoxicity of the food dye tartrazine in a micronucleus test in vivo

Author:

Akhaltseva Lyudmila V.1ORCID,Yurchenko Valentina V.1ORCID,Yurtseva Nadezda A.1ORCID,Konyashkina Mariya A.1ORCID

Affiliation:

1. Centre for Strategic Planning of FMBA of Russia

Abstract

Introduction. Food azo dye Tartrazine (E102) is widely used in the production of food, pharmacological and cosmetic products. Despite the approval for use, interest in a comprehensive assessment of the impact of food colours, especially synthetic ones, on health continues unabated. The analysis of literature evaluating the genotoxicity of Tartrazine in vivo studies revealed some inconsistencies in the results, that showed the possibility to test a retail food colouring in one of recommended tests. Materials and methods. The Tartrazine genotoxicity (produced in India, purity 88.37%) was studied in the micronucleus test on male mouse bone marrow cells (hybrids F1 CBA x C57Bl6/j). The test substance was double enteral administrated in the dose range 250-2000 mg/kg. The frequency of polychromatophilic erythrocytes (PCEs) with micronuclei (MNs) was estimated by the analysis of 4000 PCEs. The proportion of PCE among all erythrocytes was determined by analyzing 1000 cells per animal. Results. There was no increase in the frequency of micronucleated polychromatophilic erythrocytes over a concurrent negative control with double enteral administration of Tartrazine in all doses studied. The proportion of PCEs among all erythrocytes did not change. Limitations of the study are due to the methodology of the test: only cytogenetic disorders in a single tissue were analyzed under conditions of double enteral administration of the studied sample. Conclusion. The sample of the food dye Tartrazine (E 102) in the dose range of 250-2000 mg/kg did not show cytogenetic activity in the in vivo micronucleus test on mouse bone marrow cells after a double enteral administration.

Publisher

Federal Scientific Center for Hygiene F.F.Erisman

Subject

Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health,Pollution,General Medicine

Reference26 articles.

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2. GIORD. The world market of food dyes: intensive growth of the natural segment. Available at: https://www.giord.ru/news/novosti_otrasli/mirovoy_rynok_pishchevykh_krasiteley_intensivnyy_rost_naturalnogo_segmenta/ (in Russian)

3. European Food Safety Authority. Scientific opinion on the re-evaluation of tartrazine (E 102) as a food additive. EFSA J. 2009; 7(11): 1331–82. https://doi.org/10.2903/j.efsa.2009.1331

4. WHO. Food Additives Series, No. 73. Safety evaluation of certain food additives: prepared by the Eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Geneva; 2017.

5. EMA/CHMP/ICH/126642/2008. ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. European Medicines Agency; 2013. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-s2-r1-genotoxicity-testing-data-interpretation-pharmaceuticals-intended-human-use-step_en.pdf

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