化妆品原料的过敏性体外方法——氨基酸衍生化反应法(ADRA)方法转化与验证  

In chemico skin sensitisation:Amino acid Derivative Reactivity Assay(ADRA) transformation and validation

作　　者：沈立 王雪梅 张慧文 所雅琼 吴景[1] 邢书霞[1] Li Shen;Xuemei Wang;Huiwen Zhang;Yaqiong Suo;Jing Wu;Shuxia Xing(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《日用化学工业（中英文）》2023年第2期157-164,共8页China Surfactant Detergent & Cosmetics

摘　　要：在皮肤致敏不良结果通路(AOP)的第一个关键事件中化学反应为亲电物质与皮肤蛋白中的亲核中心共价结合,即皮肤与物质接触后,可能与皮肤上的蛋白结合形成抗原,导致不良反应。采用半胱氨酸和赖氨酸衍生物替代皮肤组织,模拟皮肤蛋白与化合物结合,通过计算半胱氨酸和赖氨酸衍生物反应后耗竭值(百分比)将物质分类,以此区分皮肤敏化剂和非敏化剂,此种方法称之为氨基酸衍生化反应法(ADRA)。本实验选择10种致敏性已知的物质,探究ADRA方法用于化合物致敏性评价的准确度,并在10种物质中随机选取几种物质采用国内已转化验证过的方法直接反应多肽法(DPRA)对结果进行验证。结果表明,10种物质致敏性判定结果符合样品自身致敏性,认定ADRA致敏性判定准确度较好,可作为皮肤致敏AOP的第一个关键事件替代实验方法。A skin sensitizer refers to a substance that will lead to an allergic response following repeated skin contact as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.The current knowledge of the chemical and biological mechanisms associated with skin sensitisation has been summarised as an Adverse Outcome Pathway(AOP) starting with a molecular initiating event through intermediate events to the adverse effect,namely allergic contact dermatitis.Using cysteine and lysine derivatives instead of skin tissue,simulating the reaction of skin proteins with compounds,classifying the substances by calculating the percentage of depletion value after the reaction of cysteine and lysine derivatives to distinguish skin sensitizers and desensitizers,this method is called Amino acid Derivative Reactivity Assay(ADRA).In this study,ten known allergens were selected to explore the accuracy of the sensitivity evaluation of ADRA method,and verified accuracy by DPRA that several substances were randomly selected among the ten substances.The results show that the sensitivity determination results of 10 substances are consistent with the sensitivity of samples,and the accuracy of determination of ADRA sensitivity is good.

关 键 词：皮肤致敏性 替代实验 氨基酸衍生化反应(ADRA) 

分 类 号：TQ658[化学工程—精细化工]