Core C: Product Analysis Core

核心C：产品分析核心

• 批准号: 10248512
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 30.45万
• 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: 2018-09-14 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10248512
• 关键词: Aerosols; Allergens; Characteristics; Chemicals; Cigar; Data; Data Analyses; Data Sources; Databases; Dose; Electronic Nicotine Delivery Systems; Ensure; Flavoring; Goals; Health Surveys; Heating; Inhalation; Irritants; Laboratories; Manufacturer Name; Mass Fragmentography; Measures; Methods; Monitor; Outcome; Parents; Pattern; Physical condensation; Population Assessment of Tobacco and Health; Process; Production; Reaction; Reproduction; Research; Risk Assessment; Sales; Science; Smoke; Smoking; System; Testing; Time; Tobacco use; Toxic effect; Toxicology; Variant; carcinogenicity; evaporation; exposed human population; hookah; human subject; improved; preference; programs; respiratory; tobacco exposure; tobacco flavor; tobacco products; trend; vapor

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.

摘要：WNY调味烟草产品研究中心（Croft）的重点是 烟草产品中使用的调味剂的毒性，特别关注电子尼古丁输送系统 （末端）。调味化学品是末端产品中使用的补充溶液的重要组成部分，水培烟草 和调味雪茄。为此，Croft中的大多数项目都需要有关内容和/或排放的数据 产品中的调味料。产品分析核心（PAC）将提供有关化学成分的及时数据 在Croft中进行测试的产品，并将告知项目相对受欢迎程度和产品 特定产品和口味的变化。 PAC核心的基本目标是集中生产 与产品功能相关的数据，然后可以养活Croft项目，有助于改善研究 效率。我们计划以下三个高度集成的特定目标： AIM 1：确定所用的调味剂及其在末端的浓度补充解决方案，水培烟草产品 和调味雪茄。我们提出了一种识别和定量调味化学品的方法 使用GC-MS和GC-Q-TOF-MS方法的烟草产品。烟草产品的测试也将涉及 确定致癌，诱变，呼吸过敏原，敏化剂和敏化剂的调味成分 刺激物。我们还将确定调味剂的产品间和产物内变异性，并确定 品牌间调味剂的变异性。 AIM 2：确定来自沃特皮管产生的气溶胶和烟雾的调味产量和吸入剂量 烟草产品和调味雪茄。在AIM 1中鉴定出烟草产品中的调味料后，我们将 测量使用吸烟机在实验室环境中产生的气溶胶，烟雾或蒸气中的调味产率。 我们还将测试生成的气溶胶，以实现调味剂的潜在反应和热分解产物。在 为了确保符合GLP标准，所有测试都将在完全合规的质量系统中进行。 AIM 3：使用二级数据分析监测调味的烟草产品市场份额的趋势。此外 为了监视产品本身的特征，我们将利用市场扫描仪数据和路径数据库 识别末端和其他烟草产品中最常见的口味和最畅销的末端 品牌。监管科学的结果：除了为1-4提供项目的相关数据外，我们还将 开发一种毒理学风险评估口味的方法，考虑到类型和 烟草产品和气溶胶/烟雾/蒸气中调味化学品的浓度，鉴定任何 潜在的热分解和反应产物以及呼吸道风险评估。这种方法会 有助于确定任何特定于吸入的问题的证据，这些问题可能使得化合物不适合 用于烟草产品。 PAC产生的结果可以帮助制定适当的产品标准 并在烟草产品中为调味剂实施强大的质量管理系统。