Lack of skin sensitization hazard potential for alpha-glycosyl isoquercitrin (AGIQ) utilizing the Local Lymph Node Assay.
Lack of skin sensitization hazard potential for alpha-glycosyl isoquercitrin (AGIQ) utilizing the Local Lymph Node Assay.
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DOI：
10.1016/j.toxrep.2022.05.021
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发表时间：
2022
影响因子：
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通讯作者：
Maronpot, Robert R
中科院分区：
文献类型：
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作者：
Vij, Puneet;Donahue, Douglas A;Burke, Keith P;Hayashi, Shim-Mo;Maronpot, Robert R
皮肤致敏是安全评价的一个重要方面，是化学品毒理学评价的重要组成部分。α -糖基异槲皮苷（AGIQ），作为食品添加剂在日本上市，并于2005年被香料和提取物制造商协会（FEMA）专家小组（2005年）和美国食品和药物管理局（2007年）公认为安全（GRAS）。局部淋巴结测定（LLNA）用于评估AGIQ引起皮肤致敏的可能性。结果表明，当AGIQ浓度分别为5%、10%和25%时，N， N-二甲基甲酰胺[DMF]进行测试时，刺激筛选后未见过度刺激（耳肿胀< 25%，红斑评分< 3）。在缺乏刺激的基础上，在主试验中分别以DMF的10%、25%和50%对AGIQ进行进一步评估，刺激指数分别小于阳性阈值1.6，即1.2、1.4和1.2。因此，AGIQ在LLNA中不是皮肤增敏剂。局部应用AGIQ治疗DMF， SI值小于1.6。所有动物在研究的生命阶段都存活了下来，并被观察到正常。AGIQ在LLNA中不是皮肤致敏剂。AGIQ没有产生大于1.6的SI值，因此无法计算EC1.6。AGIQ制剂的浓度和均匀性均在验收标准内。
Skin sensitization is an important aspect of safety assessment and is a key component in the toxicological evaluation of chemicals. alpha-Glycosyl isoquercitrin (AGIQ), is marketed in Japan as a food additive and is generally recognized as safe (GRAS) by the expert panel of the Flavor and Extract Manufacturers Association (FEMA) in 2005 and the U.S. Food and Drug Administration (FDA) in 2007. The Local Lymph Node Assay (LLNA) was used to assess AGIQ’s potential to cause skin sensitization. Results indicate that no excessive irritation was observed after the irritation screen (ear swelling < 25 % and erythema score < 3) when AGIQ was tested at 5 %, 10 %, and 25 % in N, N-dimethyl formamide [DMF]. Based on lack of irritation, AGIQ was further evaluated at 10 %, 25 %, and 50 % in DMF in the main test resulting in stimulation indices of less than the positive threshold of 1.6 i.e., 1.2, 1.4, and 1.2 respectively. Therefore, AGIQ was not a dermal sensitizer in the LLNA. Topical application of AGIQ in DMF resulted in SI value less than 1.6. All animals survived in-life phase of the study and were observed to be normal. AGIQ is not a dermal sensitizer in the LLNA. AGIQ did not produce a SI value greater than 1.6 and an EC1.6 therefore could not be calculated. Concentration and homogeneity of AGIQ formulations were within acceptance criteria.