Emerging Chemicals of Concern in Evolving Electronic Nicotine Delivery Systems

项目总结/摘要 电子尼古丁输送系统（ENDS）作为“更安全”的产品销售，并越来越多地用于 美国和世界各地。考虑到ENDS是包含塑料、玻璃和金属的高度工程化产品， 部件以及电子液体，有毒化合物，这些化合物对可燃烟草使用者来说不是典型的危险 产品可能存在于终端。最近的研究表明，ENDS气溶胶含有阻燃剂， ENDS使用者的尿中三（2-氯乙基）磷酸盐（TCEP）代谢物显著升高， 与非使用者相比，使用阻燃剂的人会将注意力集中在这些潜在的新风险上。这项研究的前提是， ENDS装置的部件和再填充溶液中的成分使用可 含有ECC，包括邻苯二甲酸酯增塑剂、酚类化合物和阻燃剂。这些化学物质 已广泛用作增塑剂、阻燃剂、润滑剂、消泡剂稳定剂和表面活性剂 在塑料、电子、医疗设备和其他消费品中。因为这些化学物质不是 它们与存在它们的材料结合，随着时间的推移，它们可以渗入周围的介质。研究 已经证明，暴露于由消耗品引起的ECC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，仍然缺乏关于ENDS中幼儿保育类儿童的类型和水平的信息， 关于ENDS的安全性可能低估了ECC的健康风险。特别是，ENDS中的ECC 可能是一个突出的问题，因为在ENDS气溶胶中观察到的已知有毒物质水平普遍较低 与香烟烟雾相比。同时缺乏科学数据和具体的监管规则 因此，有必要对ENDS中ECC的类型和水平进行调查。我们的具体目标是：（1）表征 通过识别电子烟油中的ECC类型和水平来识别电子烟油与ECC的污染;（2）识别 并测量ENDS某些部分中的ECC类型和水平，包括可再填充的弹药筒/坦克，以及 作为环境污染物的潜在暴露源;（3）描述环境污染物的类型和水平 在ENDS气溶胶中，从而为未来评估归因于ECCs的风险提供重要信息 （4）研究和表征电子商务中ECC类型和水平的异同点， 液体、提取样品和ENDS气溶胶。填补这一知识空白对于提供数据至关重要， 直接告知并促进ENDS产品的循证安全性评价，并促进 ENDS中ECC的监管产品标准。此外，这项探索性研究的结果可以 作为未来研究ENDS中ECC趋势的参考点，因为市场继续 不断发展，新的产品设计被引入，FDA对市场的监管也在增加。

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.