收稿日期: 2023-04-25
网络出版日期: 2023-06-20
基金资助
广东省自然科学基金资助项目(2022A1515010334);深圳技术大学自制仪器设备项目(JSZZ202201005)
Construction of a Limit Model for Isothiazolinones Migration from Children Sports Protection Articles to Sweat
Received date: 2023-04-25
Online published: 2023-06-20
Supported by
the Natural Science Foundation of Guangdong Province(2022A1515010334)
婴童的生理特征和行为模式与成人存在一定差异,导致其在使用相同类型产品时,对有害化学物质的暴露频率及暴露量远高于成人。因此,各国法规标准对婴童用品设置了有害化学物质的安全限值,用以保护最脆弱且敏感的婴童群体。异噻唑啉酮是一种能引起过敏性皮炎的强致敏性化合物,国内尚未设置其化学安全限值,国外也仅限于对其总含量的限制。为此,文中通过考察婴童的化学安全评估方法,总结现有化学安全限值模型,明确了构建限值模型的关键步骤。首先确定剂量反应数据;接着根据产品使用特征确定限值的量纲;然后基于量纲分析法,引入产品特征和人体行为模式参数,建立剂量反应数据与限值之间的联系。在此基础上,通过引入致敏阈值、总致敏评估因子、出汗率、运动时长构建了婴童运动护具中异噻唑啉酮汗液迁移限值模型。最后,结合婴童及产品特征选择合适的参数值,并应用该模型计算出3种异噻唑啉酮(MI、CMI和BIT)的迁移限值,分别为0.150、0.014和0.150 mg/L。该值拟在2023年底公布的国家标准《婴童用品 日常运动防护器具通用技术要求》中被应用,用以保障婴童皮肤免受异噻唑啉酮的危害。
马彤梅 , 朱镇海 , 李琼 , 黄理纳 , 霍炜强 , 方晗 , 刘作起 . 婴童运动护具中异噻唑啉酮汗液迁移限值模型的构建[J]. 华南理工大学学报(自然科学版), 2024 , 52(7) : 72 -80 . DOI: 10.12141/j.issn.1000-565X.230271
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.
| 1 | 张静,陈会明 .邻苯二甲酸酯类增塑剂的危害及监管现状[J].现代化工,2011,31(12):1-6. |
| ZHANG Jing, CHEN Hui-ming .Hazards and supervision status of phthalate plasticizer[J].Modern Chemical Industry,2011,31(12):1-6. | |
| 2 | 徐振东,顾娟红,黄丽娟,等 .加速溶剂萃取-快速液相色谱法测定纺织品中烷基苯酚和烷基苯酚聚氧乙烯醚[J].分析试验室,2012,31(8):112-115. |
| XU Zhen-dong, GU Juan-hong, HUANG Li-juan,et al .Determination of alkylphenols and alkylpheol polyethoxylates in textile by accelerated solvent extraction and rapid liquid chromatography[J].Chinese Journal of Analysis Laboratory,2012,31(8):112-115. | |
| 3 | 黄湘鹭,卢家灿,邢书霞,等 .欧盟RAPEX系统通报情况分析及对我国化妆品原料管理的启示[J].日用化学工业,2022,52(6):638-644. |
| HUANG Xianglu, LU Jiacan, XING Shuxia,et al .Information bulletin analysis of EU RAPEX system and enlightenment to cosmetic ingredient management in China[J].China Surfactant Detergent & Cosmetics,2022,52(6):638-644. | |
| 4 | 赵付文,孙卓军,高国庆,等 .食品接触塑料材料中有害重金属迁移量测定方法综述[J].化学分析计量,2015,24(1):101-105. |
| ZHAO Fuwen, SUN Zhuojun, GAO Guoqing,et al .Review of determination methods of harmful heavy metal migration amount in plastic materials contacting with food [J].Chemical Analysis and Meterage,2015,24(1):101-105. | |
| 5 | USEPA .Guidelines for human exposure assessment[R].Washington DC:Risk Assessment Forum,2019. |
| 6 | ECHA .Guidance on information requirements and chemical safety assessment,Chapter R.15:consumer exposure assessment[R].Helsinki:ECHA,2016. |
| 7 | 国家药品监督管理局 .全国婴童用品标准化工作组正式成立[EB/OL].(2020-06-03)[2023-01-20].. |
| 8 | HERMAN A, AERTS O, DE MONTJOYE L,et al .Isothiazolinone derivatives and allergic contact dermatitis:a review and update[J].Journal of the European Academy of Dermatology and Venereology,2019,33(2):267-276. |
| 9 | Commission European .Directive 2009/48/EC of the European parliament and of the council of 18 June 2009 on the safety of toys[Z].Brussels:European Commission,2009. |
| 10 | Safety of toys-Part 9:Organic chemical compounds-requirements:EN 71-9:2005+A1:2007 [S]. |
| 11 | NRC Committee on Pesticides in the Diets of Infants and Children .Pesticides in the diets of infants and children [R].Washington DC:National Academies Press (US),1993. |
| 12 | IPCS .Principles for the evaluating health in children associated with exposure to chemicals[R].Geneva:United Nations Environment Programme,International Labour Organization,World Health Organization,2006. |
| 13 | ARMSTRONG T W, HUSHKA LJ, Tell J G,et al .A tiered approach for assessing children’s exposure[J].Environmental Health Perspectives,2000,108(6):469-474. |
| 14 | USEPA .Child-specific exposure factors handbook (2008,Final Report)[R].Washington DC:USEPA,2008. |
| 15 | ESKENAZI B, BRADMAN A, CASTRIONA R .Exposure of children to organophosphate pesticides and their potential adverse health effects [J].Environmental Health Perspectives,1999,107(3):409-419. |
| 16 | LEWIS R G, FORTUNE C, WILLIS R D,et al .Distribution of pesticides and polycyclic aromatic hydrocarbons in house dust as a function of particle size[J].Environmental Health Perspectives,1999,107(9):721-726. |
| 17 | van E JGM, PRUD’HOMME de L LCH .Non-food products:How to assess children’s exposure?[R].Netherlands:RIVM,2007. |
| 18 | RENWICK A G, DORNE J L, WALTON K .An analysis of the need for an additional uncertainty factor for infants and children[J].Regulatory Toxicology and Pharmacology,2000,31(3):286-296. |
| 19 | USEPA .A review of the reference dose and reference concentration processes[R].Washington DC:Risk Assessment Forum,2002. |
| 20 | ATSDR .Toxicological profile[EB/OL].(2022-12-07)[2023-01-20].. |
| 21 | WHO . Guidelines for drinking-water quality:fourth edition incorporating the first and second addenda[R].Geneva:World Health Organization,2022. |
| 22 | IPCS .Principles for the assessment of risks to human health from exposure to chemicals[R].Geneva:World Health Organization,International Programme on Chemical Safety,1999. |
| 23 | SONICH-MULLIN C, FIELDER R, WILTSE J,et al .IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis[J].Regulatory Toxicology and Pharmacology,2001,34:146-152. |
| 24 | USEPA .Supplemental guidance for assessing susceptibility from early-life exposure to carcinogens[R].Washington DC:USEPA,2005. |
| 25 | 生态纺织品技术要求: [S]. |
| 26 | Safety of toys-Part 3:Migration of certain elements: [S]. |
| 27 | API A M, BASKETTER D A, CADBY P A,et al .Dermal sensitization quantitative risk assessment (QRA) for fragrance ingredients[J].Regulatory Toxicology and Pharmacology,2008,52:3-23. |
| 28 | SCCS .Opinion on skin sensitisation quantitative risk assessment for fragrance ingredients (QRA2) submission Ⅰ[R].Brussels:European Commission,2018. |
| 29 | EFSA .Food contact materials[R].Brussels:European Commission,2015. |
| 30 | Commission European .Regulation (EC) No1935/2004 of the European parliament and of the council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC[Z].Brussels:European Commission,2004. |
| 31 | EFSA .Note for guidance for food contact materials[R].Brussels:European Commission,2008. |
| 32 | van E JGM, VANDERZEEPARK M, PJCM J,et al .Chemicals in toys:a general methodology for assessment of chemical safety of toys with a focus on elements[R].Netherlands:RIVM,2008. |
| 33 | Safety of toys-Part 3:Migration of certain elements:EN71-3:2013 [S]. |
| 34 | KIMBER I, DEARMAN R J, BASKETTER D A,et al .Dose metrics in the acquisition of skin sensitization:thresholds and importance of dose per unit area[J].Regulatory Toxicology and Pharmacology,2008,52:39-45. |
| 35 | UPADHYE M R, MAIBACH H I .Influence of area of application of allergens on sensitization in contact dermatitis[J].Contact Dermatitis,1992,27(5):281-286. |
| 36 | SCCS .Opinion on methylisothiazolinone (MI) (P94) submission Ⅲ (sensitisation only)[R].Brussels:European Commission,2015. |
| 37 | CASSIMOS C, KANAKOUDI-TSAKALIDIS F, SPYROGLOU K,et al .Skin sensitisation to 2,4 dinitrochlorobenzene (DNCB) in the first months of life [J].Journal of Clinical and Laboratory Immunology,1980,3:111-113. |
| 38 | GERBERICK G F, ROBINSON M K, FELTER S P,et al .Understanding fragrance allergy using an exposure-based risk assessment approach[J].Contact Dermatitis,2001,45(6):333-340. |
| 39 | FELTER S P, ROBINSON M K, BASKETTER D A,et al .A review of the scientific basis for uncertainty factors for use in quantitative risk assessment for the induction of allergic contact dermatitis[J].Contact Dermatitis,2002,47(5):257-266. |
| 40 | 关宏岩,赵星,屈莎,等 .学龄前儿童(3~6岁)运动指南[J].中国儿童保健杂志,2020,28(6):714-720. |
| GUAN Hong-yan, ZHAO Xing, QU Sha,et al .Physical activity guideline for Chinese preschoolers aged 3-6 years[J].Chinese Journal of Child Health Care,2020,28(6):714-720. | |
| 41 | 张云婷,马生霞,陈畅,等 .中国儿童青少年身体活动指南[J].中国循证儿科杂志,2017,12(6):401-409. |
| ZHANG Yunting, MA Shengxia, CHEN Chang,et al .Physical activity guide for Chinese children and adolescents[J].Chinese Journal of Evidence-Based Pediatrics,2017,12(6):401-409. | |
| 42 | 张林凤 .关于运动强度分级的探讨[J].浙江体育科学,1998,20(5):23-26. |
| ZHANG Lin-feng .Discussion on grading the exercising intensity[J].Zhejiang Sport Science,1998,20(5):23-26. | |
| 43 | ARLEGUI L, SMALLCOMBE J W, FOURNET D,et al .Body mapping of sweating patterns of pre-pubertal children during intermittent exercise in a warm environment[J].European Journal of Applied Physiology,2021,121(12):3561-3576. |
/
| 〈 |
|
〉 |