Emerging Chemicals of Concern in Evolving Electronic Nicotine Delivery Systems

不断发展的电子尼古丁传输系统中值得关注的新兴化学品

• 批准号: 9788465
• 负责人: RICHARD J O'CONNOR
• 金额: $ 21.01万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788465
• 关键词: Aerosols; Area; Asthma; Attention; Chemicals; Cigarette; Data; Development; Devices; Electronic Nicotine Delivery Systems; Electronics; Endocrine disruption; Engineering; Evaluation; Exposure to; Flame Retardants; Future; Glass; Goals; Guidelines; Health; Investigation; Knowledge; Liquid substance; Lubricants; Measures; Medical Device; Metals; Organic solvent product; Outcome; Phenols; Plasticizers; Plastics; Poison; Regulation; Reproducibility; Research; Research Priority; Risk; Safety; Sampling; Source; Temperature; Time; Tobacco; Toxic effect; Work; analytical method; carcinogenicity; cigarette smoke; consumer product; design; evidence base; exposed human population; exposure pathway; falls; hazard; inorganic phosphate; novel; packaging material; phthalates; reproductive; response; surfactant; time use; tobacco products; toxicant; trend; tris(2-carboxyethyl)phosphine; urinary; vaping

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.

项目摘要/摘要 电子尼古丁输送系统（末端）被销售为“更安全”的产品，并越来越多地用于 美国和全球。考虑到末端是高度工程的产品，其中包含塑料，玻璃和金属 零件和电子液体，对于复杂烟草用户而言并不是典型危害的有毒化合物 产品可能存在于目的。最近的研究表明，末端气溶胶含有阻燃剂，并且 末端用户的尿尿代谢产物明显更高（2-氯乙基）磷酸盐（TCEP），火焰 与非用户相比，阻碍了人们的注意力，将注意力集中在这些潜在的新型风险上。这项研究的前提是 末端设备和补充溶液中的成分的组件是使用可能的材料制造的 包含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 已被广泛应用为增塑剂，阻燃剂，润滑剂，抗泡沫稳定剂和表面活性剂 在塑料，电子，医疗设备和其他消费产品中。因为这些化学物质不是 他们可以随着时间的推移进入周围的媒体，与他们展示的材料结合在一起。研究 已经记录到，消耗品引起的ECC的暴露与不利健康有关 结局，包括致癌活性，内分泌破坏，生殖和发展异常。 但是，关于目的的ECC的类型和水平的信息仍然缺乏，并且当前的知识 考虑到目的的安全可能会低估ECC的健康风险。特别是ECC的目的 鉴于观察到的一般较低水平的末端气溶胶中的一般较低水平的较低水平，可能是一个突出的问题 与香烟烟相比。科学数据和特定监管规则的同时死亡 需要对ECC的类型和水平进行末端的投资。我们的具体目的是：（1）表征 通过识别电子液体中的ECC的类型和水平，将电子液体污染与ECC污染； （2）识别 并测量末端某些部分的ECC的类型和水平，包括可再填充的墨盒/坦克 作为喉舌，是ECC的潜在暴露来源； （3）表征ECC的类型和水平 在目的的气溶胶中，为了在未来的努力中提供至关重要的信息，以评估ECCS的风险 结束使用； （4）检查并表征E-中ECC类型和水平的相似性和差异 液体，提取的样品并结束气溶胶。填补这一知识差距是提供数据的基础 直接告知并有助于基于证据的产品的安全评估，并为开发 ECC末端的监管产品标准。此外，这项探索性研究的结果可能是 用作未来工作的参考点 引入了进化，新产品设计，以及对市场的FDA调节。