Risk assessment of oral exposure to diisononyl phthalate from children's products

Risk assessment of oral exposure to diisononyl phthalate from children's products
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DOI:
10.1016/j.yrtph.2004.06.005
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发表时间:
2004-10-01
影响因子:
3.4
通讯作者:
Zamula, WW
Zamula, WW
中科院分区:
医学3区
文献类型:
--
作者:
Babich, MA;Chen, SB;Zamula, WW

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邻苯二甲酸二烷基酯是用于聚氯乙烯 (PVC) 制成的家用产品的增塑剂。邻苯二甲酸二异壬酯 (DINP) 是软塑料玩具中的主要邻苯二甲酸酯。由于 DINP 与 PVC 结合不紧密,因此当儿童食用 PVC 产品时可能会释放出 DINP。欧洲、加拿大、日本和美国的监管机构一直在密切关注婴儿接触邻苯二甲酸盐的潜在慢性健康风险。本报告介绍了美国消费品安全委员会 (CPSC) 工作人员对儿童产品中 DINP 接触的风险评估。本报告包括 CPSC 慢性危害咨询小组 (CHAP) 的调查结果,其中:(1) 得出结论,DINP 不太可能对人类造成癌症危害;(2) 根据大鼠肝海绵状变性,建议可接受的每日摄入量 (ADI) 水平为 120 杯/公斤·天。该风险评估结合了对 24 种玩具中 DINP 迁移率的新测量,以及对儿童用嘴活动的新观察研究,并对用嘴的物体进行了详细描述。使用概率方法来估计暴露量。嘴巴行为以及因此暴露的程度取决于孩子的年龄。大约 42% 的测试软塑料玩具含有 DINP。软塑料玩具中 DINP 的估计暴露量在 12-23 个月大的儿童中最高。该年龄组的平均暴露量为 0.08(95% 置信区间 0.04-0.14)杯/公斤-天,第 99 个百分位数为 2.4(1.3-3.2)杯/公斤-天。作者得出的结论是,通过软塑料玩具口服接触 DINP 不太可能对儿童造成健康危害。作者表达的观点未经美国消费品安全委员会审查或批准,并不一定反映美国消费品安全委员会的观点。由于本材料是作者以官方身份编写的,因此属于公共领域,可以自由复制或重印。由爱思唯尔公司出版
Dialkyl phthalates are plasticizers used in household products made from polyvinyl chloride (PVC). Diisononyl phthalate (DINP) is the principal phthalate in soft plastic toys. Because DINP is not tightly bound to PVC, it may be released when children mouth PVC products. The potential chronic health risks of phthalate exposure to infants have been under scrutiny by regulatory agencies in Europe, Canada, Japan, and the U.S. This report describes a risk assessment of DINP exposure from children's products, by the U.S. Consumer Product Safety Commission (CPSC) staff. This report includes the findings of a CPSC Chronic Hazard Advisory Panel (CHAP) which: (1) concluded that DINP is unlikely to present a human cancer hazard and (2) recommended an acceptable daily intake (ADI) level of 120 mug/kg-d, based on spongiosis hepatis in rats. The risk assessment incorporates new measurements of DINP migration rates from 24 toys and a new observational study of children's mouthing activities, with a detailed characterization of the objects mouthed. Probabilistic methods were used to estimate exposure. Mouthing behavior and, thus, exposure depend on the child's age. Approximately 42% of tested soft plastic toys contained DINP. Estimated DINP exposures for soft plastic toys were greatest among children 12-23 months old. The mean exposure for this age group was 0.08 (95% confidence interval 0.04-0.14) mug/kg-d, with a 99th percentile of 2.4 (1.3-3.2) mug/kg-d. The authors conclude that oral exposure to DINP from mouthing soft plastic toys is not likely to present a health hazard to children. The opinions expressed by the authors have not been reviewed or approved by, and do not necessarily reflect the views of, the U.S. Consumer Product Safety Commission. Because this material was prepared by the authors in their official capacity, it is in the public domain and may be freely copied or reprinted. Published by Elsevier Inc.