在ENDS产品中对缺少数据的模拟漏性化合物的评估的分析方法:一个案例研究
Cameron Smith1, Matthew Lyndon1, Lena Jeong1
1Juul Labs Inc., Washington, DC, United States.
Frontiers in chemistry
|August 21, 2023
概括
在电子尼古丁输送系统 (ENDS) 中调查可泄露化合物至关重要. 一种新的分析方法估计,缺乏数据的化合物的转移效率在ENDS气溶中低于2%,有助于毒理风险评估.
科学领域:
- 分析化学 分析化学
- 毒理学 毒理学 毒理学
- 材料科学 材料科学 材料科学
背景情况:
- 透性调查评估从容器封闭系统转移到产品中的化学物质.
- 电子尼古丁输送系统 (ENDS) 缺乏特定的可漏性研究指南,需要从口服吸入药物产品指南中进行调整.
- 在模拟的ENDS研究中发现了两种缺少数据的漏性化合物.
研究的目的:
- 开发和应用一种新的分析方法来量化ENDS气溶中缺少数据的可漏化合物.
- 为了确定这些可浸出化合物的从电子液体到气溶的转移效率.
- 通过建立相关的暴露限值,支持对ENDS的毒理风险评估.
主要方法:
- 模拟的可漏性研究使用老年JUULpods与无味电子液体.
- 使用液体染色学-质谱学/质谱学 (LC-MS/MS) 的定性气溶分析.
- 开发一种替代方法,以确定缺乏数据的化合物的方法极限,包括使用增值样本确定量化的极限.
主要成果:
- 定性气溶分析没有检测到漏性目标化合物的痕迹.
- 另一种方法为缺少数据的可浸化合物确定了保守的半定量值.
- 通过实验确定了可浸化合物的从电子液体到气溶的转移效率不到2%.
结论:
- 成功开发了一种新的分析方法,以估计ENDS气溶中缺少数据的可漏化合物的转移效率.
- 低转移效率 (<2%) 为在毒理风险评估中定义暴露限值提供了基础.
- 该方法解决了ENDS安全评估中的一个关键缺口,特别是对于毒理学数据有限的化合物.
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