Construction of a Limit Model for Isothiazolinones Migration from Children Sports Protection Articles to Sweat

doi:10.12141/j.issn.1000-565X.230271

Abstract

Abstract:

The physiological characteristics and behavioral patterns of infants are somewhat different from those of adults, resulting in a much higher frequency and amount of exposure to harmful chemicals than those of adults when using the same type of products. Therefore, national regulations and standards have set safety limits for harmful chemicals to protect the most vulnerable and sensitive infants. Isothiazolinone, as the common additive to improve antibacterial performance of children products, is a potential sensitizing compound that can induce allergic dermatitis. So far there is no chemical safety limit setting for it in China, while in the international existing regulations and standards, this chemical is only restricted with the total content limit. To this end, this study examined the chemical safety assessment method of infants, summarized the existing chemical safety limit model, and defined the key steps of constructing the limit model. First, dose-response data of the chemical was determined; then the dimension of the chemical limit was confirmed; after that, with the dimensional analysis method, the parameters based on product characteristics and human behavior patterns were introduced to establish the connection between the dose-response data and the chemical migration limit. On this basis, by introducing parameters of no expected sensitization inducing level, sensitization assessment factors, sweat rate and sports time, it proposed the limit model for isothiazolinones migration from children sports protection articles to sweat. Finally, the appropriate parameter values were selected based on the infant and product characteristics, and the model was applied to calculate the migration limits of the three isothiazolinones (MI, CMI and BIT) at 0.150, 0.014 and 0.150 mg/L, respectively. These migration limits are anticipated to be incorporated in the upcoming Chinese national standard Juvenile Products: General Requirements for Daily Sports Protection Articles scheduled for release by the end of 2023, which can be employed to protect of children’s skin from isothiazolinones.

Key words: children sports protection articles, isothiazolinone, chemical safety limit model, migration to sweat

CLC Number:

O657

MA Tongmei, ZHU Zhenhai, LI Qiong, HUANG Lina, HUO Weiqiang, FANG Han, LIU Zuoqi. Construction of a Limit Model for Isothiazolinones Migration from Children Sports Protection Articles to Sweat[J]. Journal of South China University of Technology(Natural Science Edition), 2024, 52(7): 72-80.

Figures/Tables 6

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暴露途径	具体描述	行为活动
吸入暴露	化学物质以气体和气溶胶的形式释放到密闭空间，吸入暴露通过婴童呼吸发生	婴童在密闭空间内发生的活动等
经口暴露	婴童特有的口部行为导致化学物质通过以下两种方式进行暴露：吞咽产品的脱落碎片；从被长时间口含住的产品内部迁移到唾液中，并进入到体内	用口部探索身边环境（吞食、咀嚼身边物品；吮吸物品表面、手指等）
经皮暴露	婴童皮肤与液、固体产品有一定时间接触，化学物质迁移到皮肤或汗液	匍匐爬行、使用洗护产品、穿戴衣物和护具等

修正因素	具体描述	选择理由	数值参考
个体差异（F_IV）	人种间的个体敏感性差异	NESIL基于人体斑贴实验数据计算，实验样本不全面，没有考虑人种间差异	10（覆盖所有人种间差异）
产品基质（F_ME）	不同产品基质中物质致敏性有差异	人体斑贴实验的基质为乙醇/DEP（最佳诱导过敏基质）	无接触产品：0.3 大多数产品：1 促过敏基质：3^1）
接触频率或持续时间（F_FD）	物质的致敏性可能会因为接触频率或持续时间增加而提高	人体斑贴实验为3周内进行9次24 h 的暴露，与产品使用情景不符	3^1）
身体使用部位（F_SA）	人体不同皮肤部位的过敏差异性	人体斑贴实验的测试区域通常是上背部脊柱两侧皮肤	弱过敏部位：1 正常部位：3^1）易过敏部位：10

应用场景	影响因素
运动时才佩戴护具	显性出汗率
护具仅覆盖身体局部	局部出汗率
婴童的运动强度适中	最大运动心率HRmax为40%~80%^1）
稳定的外部环境条件	湿度：40%~60%；风速：0~2 m/s；温度：20~30 ℃

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