Evaluation of mutagenic activity of the food dye Ponceau 4R in a micronuclear test in mice

Introduction. Food monoazo dye E124 Ponceau 4R is used in the food, pharmaceutical, and cosmetic industries. An analysis of the available data on the evaluation of the genetic safety of E124 based on the main marker events of genotoxicity revealed their inconsistency, possibly associated with quantitative and/or qualitative differences in the studied samples for impurities. The aim of the work is to evaluate the mutagenic activity in the micronucleus test in mice of several commercial samples of E124 present on the domestic market. Materials and methods. Three samples of E124 from different manufacturers (India) were studied. To assess the identity of Ponceau 4R substances, there was used method of MIR-spectroscopy – universal ART technique. Aqueous dye solutions were administered to the stomach of male CBA × C57Bl6/j) mice at doses of 125 to 2000 mg/kg twice with an interval of 24 hours and preparations were prepared 24 hours after the last injection. To assess the frequency of polychromatophilic erythrocytes (PCE) with micronuclei (MN), 4000 PCE were analyzed, the proportion of PCE among all erythrocytes – 500 cells per animal. Results. Ponceau 4 R was determined in all samples. All E124 samples caused an increase in the frequency of PCE with MN (p < 0.05–0.001, T test) after exposure at all levels studied in a linear dose-dependent manner. The proportion of PCE from all erythrocytes did not change. Limitations. The data obtained do not allow determining the mechanism of the genotoxic action of the test substance. Conclusion. An analysis of the frequency of MN PCEs in the bone marrow in mice after a double injection at doses of 125–2000 mg/kg revealed the genotoxicity of three samples Ponceau 4R.