Core C: Product Analysis Core

摘要：WNY Flavour Tobacco Products研究中心（CRoFT）专注于 烟草制品中使用的香料的毒性，特别关注电子尼古丁输送系统 （完）香料化学品是用于ENDS产品、水烟和烟草的填充解决方案的重要组成部分 雪茄的味道。为此，森林和森林管理委员会内的大多数项目都需要关于下列物质的含量和/或排放量的数据： 产品中的调味料。产品分析核心（PAC）将及时提供化学成分数据 在CRoFT内测试的产品，并将告知项目有关的相对普及和产品 特殊产品和口味的变化。PAC核心的基本目标是集中生产 与产品功能相关的数据，然后可以为CRoFT项目提供信息，帮助改进研究 效率我们计划以下三个高度综合的具体目标： 目的1：确定使用的香料和他们的浓度在ENDS补充解决方案，水烟烟草产品 雪茄的味道。我们提出了一种方法来识别和定量的调味化学品， 烟草制品的气相色谱-质谱联用技术和气相色谱-质谱联用技术。烟草产品的检测还将涉及 识别致癌、致突变、呼吸道过敏原、致敏剂和 刺激物。我们还将确定调味品的产品间和产品内变异性， 调味品的品牌间差异。 目的2：测定ENDS气溶胶和自来水管产生的烟雾中的香料产率和吸入剂量 烟草制品和调味雪茄。在目标1中确定烟草制品中的香料后，我们将 测量在实验室环境中使用吸烟机产生的气溶胶、烟雾或蒸汽中的调味剂产量。 我们还将测试产生的气溶胶的潜在反应和调味品的热分解产物。在 为了确保符合GLP标准，所有测试都将在完全符合的质量体系中进行。 目的3：使用二手数据分析监测调味烟草产品市场份额的趋势。此外 为了监测产品本身的特性，我们将利用市场扫描数据和PATH数据库 确定ENDS和其他烟草产品中最常见的口味以及最畅销的风味ENDS 品牌监管科学的成果：除了为项目1-4提供相关数据外，我们还将 开发一种方法，用于香料的毒理学风险评估，考虑到类型和 烟草制品和气溶胶/烟雾/蒸汽中的香料化学品浓度， 潜在的热分解和反应产物，以及呼吸风险评估。这种方法将 有助于确定可能使化合物不适合吸入的特定问题的任何证据 在烟草产品中使用。PAC产生的结果有助于制定适当的产品标准 并对烟草制品中的调味料实施强有力的质量管理体系。

SUMMARY: The WNY Center for Research on Flavored Tobacco Products (CRoFT) is focused on the toxicity of flavorings used in tobacco products, with a particular focus on electronic nicotine delivery systems (ENDS). Flavoring chemicals are an essential part of refill solutions used in ENDS products, waterpipe tobacco and flavored cigars. To this end, most projects within CRoFT require data on the contents and/or emissions of flavorings in products. The Product Analysis Core (PAC) will provide timely data on the chemical constituents of products to be tested within the CRoFT and will inform projects about the relative popularity and product variation of particular products and flavors. The underlying goal of the PAC core is to centralize the production of data related to product features that can then feed the CRoFT projects, helping to improve research efficiency. We plan the following three highly integrated Specific Aims: AIM 1: Determine flavorings used and their concentrations in ENDS refill solutions, waterpipe tobacco products and flavored cigars. We propose an approach to the identification and quantitation of flavoring chemicals in tobacco products using GC-MS and GC-Q-TOF-MS methods. The testing of tobacco product will also involve identifying flavoring ingredients that are carcinogenic, mutagenic, respiratory allergens, sensitizers and irritants. We also will determine inter-product and intra-product variability in flavorings and determine intra- and inter-brand variability in flavorings. AIM 2: Determine flavoring yields and inhaled doses from ENDS aerosol and smoke generated from waterpipe tobacco products and flavored cigars. After identification of flavorings in tobacco products in Aim 1, we will measure flavoring yields in aerosol, smoke or vapor generated in laboratory settings using smoking machines. We will also test generated aerosols for potential reaction and thermal breakdown products of flavorings. In order to ensure compliance to the GLP standards, all tests will be done in a fully compliant quality system. AIM 3: Monitoring trends in flavored tobacco product market share using secondary data analysis. In addition to monitoring characteristics of products themselves, we will utilize market scanner data and PATH database to identify the most common flavors in ENDS and other tobacco products and top-selling flavored ENDS brands. Outcomes for Regulatory Science: In addition to providing relevant data for Projects 1-4, we will develop an approach for toxicological risk assessment of flavors that takes into account the type and concentration of flavoring chemicals in the tobacco products and aerosol/smoke/vapor, identification of any potential thermal breakdown and reaction products, and respiratory risk assessment. This approach will contribute to identifying any evidence of inhalation-specific issues that might make a compound unsuitable for use in tobacco products. Results generated by the PAC can help to develop appropriate product standards and implement robust quality management systems for flavorings in tobacco products.