Emerging Chemicals of Concern in Evolving Electronic Nicotine Delivery Systems

项目摘要/摘要 电子尼古丁递送系统(Ends)被宣传为“更安全”的产品，并越来越多地在 美国和世界各地。考虑到末端是含有塑料、玻璃和金属的高度工程化的产品 部件和电子液体，有毒化合物，对可燃烟草使用者来说不是典型的危险 产品可能最终存在。最近的研究表明，END气雾剂含有阻燃剂， 终端用户尿液中三(2-氯乙基)磷酸(TCEP)的代谢物显著升高 与非使用者相比，阻滞剂将注意力集中在这些潜在的新风险上。这项研究的前提是 终端设备的组件和再灌装溶液中的成分使用可以 含有ECC，包括邻苯二甲酸酯增塑剂、酚类化合物和阻燃剂。这些化学品 广泛用作增塑剂、阻燃剂、润滑剂、消泡稳定剂和表面活性剂。 在塑料、电子产品、医疗器械和其他消费产品中。因为这些化学物质不是 随着时间的推移，它们与所呈现的材料结合在一起，可以渗透到周围的媒体中。研究 已记录由消耗品引起的接触ECCs与不良健康相关 结果，包括致癌活动、内分泌干扰、生殖和发育异常。 然而，关于EDS中ECCs的类型和水平的信息仍然缺乏，目前的知识 关于END的安全性，可能低估了ECCs的健康风险。特别是，END中的ECC 可能是一个突出的问题，因为观察到终端气溶胶中已知的毒物水平普遍较低。 与香烟烟雾相比。同时缺乏科学数据和具体的监管规则 有必要对END中ECC的类型和水平进行调查。我们的具体目标是：(1)塑造 通过确定电子液体中ECCs的类型和水平来确定电子液体受到ECCs的污染；(2)确定 并测量端部某些部分的ECC的类型和水平，包括可再充装的药筒/罐 作为喉舌，是ECCs的潜在暴露源；(3)表征ECCs的类型和水平 最终，为评估可归因于ECC的风险的未来努力提供重要信息 以达到最终使用目的；(4)考察和表征电子政务中ECC的类型和水平的异同 液体、提取的样品和末端气雾剂。填补这一知识缺口是提供以下数据的基础 直接为最终产品的基于证据的安全评估提供信息并做出贡献，并帮助开发 ECCs的监管产品标准。此外，这种探索性研究的结果可以是 作为未来工作的参考点，随着市场的继续发展，最终审查ECC的趋势 进化，新的产品设计被引入，FDA对市场的监管增加。

PROJECT SUMMARY/ABSTRACT Electronic nicotine delivery systems (ENDS) are marketed as “safer” products and increasingly used in the U.S. and worldwide. Considering that ENDS are highly engineered products containing plastic, glass and metal parts as well as e-liquids, toxic compounds that are not typical hazards for users of combustible tobacco products may exist in ENDS. Recent studies suggesting that ENDS aerosol contains flame retardants, and that ENDS users had significantly higher urinary metabolites of tris(2-chloroethyl) phosphate (TCEP), a flame retardant, than nonusers, focus attention on these potentially novel risks. The premise of this research is that components of ENDS devices and ingredients in refill solutions are manufactured using materials that may contain ECCs, including phthalate plasticizers, phenolic compounds, and flame retardants. These chemicals have been widely applied as plasticizers, flame retardants, lubricants, anti-foaming stabilizers, and surfactants in plastics, electronics, medical devices, and other consumer products. Because these chemicals are not bonded to the materials in which they present, they can leach into the surrounding media with time. Studies have documented that exposure to ECCs resulting from consumables are associated with adverse health outcomes, including carcinogenic activity, endocrine disruption, reproductive and developmental abnormalities. However, information regarding the types and levels of ECCs in ENDS is still lacking, and current knowledge regarding the safety of ENDS may underestimate the health risks from ECCs. In particular, ECCs in ENDS may be a prominent concern, given the observed general lower levels of known toxics in ENDS aerosols compared to cigarette smoke. Concurrent dearth of the scientific data and specific regulatory rules necessitates an investigation of the types and levels of ECCs in ENDS. Our specific aims are: (1) characterize the contamination of e-liquids with ECCs by identifying the types and levels of ECCs in e-liquids; (2) identify and measure the types and levels of ECCs in certain parts of ENDS, including refillable cartridge/tanks, as well as mouthpieces, which are potential exposure sources of ECCs; (3) characterize the types and levels of ECCs in ENDS aerosols, thus to provide vital information in future efforts to assess the risks from ECCs attributable to ENDS use; (4) examine and characterize the similarities and differences in types and levels of ECCs in e- liquids, extracted samples, and ENDS aerosols. Filling this knowledge gap is fundamental to provide data that directly informs and contributes to evidence-based safety evaluation of ENDS products, and to development of regulatory product standards for ECCs in ENDS. Additionally, the results from this exploratory research can be used as a point of reference for future work examining trends in ECCs in ENDS as the market continues to evolve, new product designs are introduced, and FDA regulation of the market increases.