Genotoxic and cytotoxic potential of food azodyes: preclinical safety assessment using the in vivo micronucleus assay: Potencial genotóxico e citotóxico de azocorantes alimentícios: avaliação de segurança pré-clínica usando o ensaio do micronúcleo in vivo

This study evaluated the genotoxic effects of azodyes (ponceau 4R, red 40, sunset yellow and tartrazine) by the use of in vivo micronucleus assays. Swiss albinus young adult mice of both sexes, healthy and heterogeneous, were used in the micronucleus assay. Groups of animals were treated using a single dosing regimen and euthanized at 24 and 48 hours. The study design included treatment groups (0.5, 1.0 and 2 g/kg of azodyes) and negative (150 mM NaCl) and positive (50 mg/kg of NEU) control groups. Bone marrow polychromatic (PCE) and normochromatic (NCE) erythrocytes and micronucleated PCE (MNPCE) were statistically analyzed: frequency and PCE:NCE ratio. For animal groups treated with all azodyes, analyses of the frequency of MNPCEs and PCE/NCE ratio showed significant differences between the treatment groups (0.5-2 g/kg) and the control groups (NaCl and NEU). Each azodye exhibited genotoxic and systemic toxic effects correlated to treatment dose, time of euthanasia, and sex of the animal. The data suggest potential clastogenic and/or aneugenic effects that can potentiate systemic toxic risks associated with the azodyes whether the genotoxicity be dependent on dose (ponceau 4R, sunset yellow, and tartrazine), time (ponceau 4R, red 40, and sunset yellow), or sex (red 40 and tartrazine).