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.

中文翻译：

---

食用染料丽春红 4R 在小鼠微核试验中的致突变活性评价

介绍。食品单偶氮染料 E124 Ponceau 4R 用于食品、制药和化妆品行业。根据遗传毒性的主要标记事件对 E124 遗传安全性评估的现有数据进行分析，结果发现其不一致，可能与研究样品中杂质的定量和/或定性差异有关。本工作的目的是评估国内市场上几种 E124 商品样品在小鼠微核试验中的致突变活性。材料和方法。研究了来自不同制造商（印度）的三个 E124 样品。为了评估丽春红 4R 物质的身份，使用了 MIR 光谱法——通用 ART 技术。将染料水溶液以125至2000mg/kg的剂量向雄性CBA×C57Bl6/j)小鼠的胃施用两次，间隔24小时，并在最后一次注射后24小时制备制剂。为了评估具有微核 (MN) 的多染性红细胞 (PCE) 的频率，分析了 4000 个 PCE，PCE 在所有红细胞中的比例 – 每只动物 500 个细胞。结果。所有样品中均测定了丽春红 4 R。在以线性剂量依赖性方式研究的所有水平的暴露后，所有 E124 样品均导致 PCE 与 MN 的频率增加（p < 0.05–0.001，T 检验）。所有红细胞中 PCE 的比例没有变化。局限性。所获得的数据无法确定测试物质的遗传毒性作用机制。结论。以 125-2000 mg/kg 的剂量进行两次注射后，对小鼠骨髓中 MN PCE 频率的分析揭示了三种丽春红 4R 样品的遗传毒性。