对于三个较低的烯酸盐,没有显著的风险水平的推导:专家小组的结论和建议
C R Kirman1, P J Boogaard2, J S Bus3
1SciPinion LLC, Bozeman, MT, 59715, USA.
Regulatory toxicology and pharmacology : RTP
|January 28, 2024
概括
毒理学专家为甲基烯酸 (MA),乙基烯酸 (EA) 和2-乙基烯酸 (2EHA) 确定了无显著风险水平 (NSRL). 这些癌症风险评估值有助于评估这些常见工业化学品的暴露风险.
科学领域:
- 毒理学和风险评估
- 化学安全和暴露评估
- 致癌和非新生病变的发生.
背景情况:
- 像甲基烯酸盐 (MA),乙基烯酸盐 (EA) 和2-乙基烯酸盐 (2EHA) 这样的低烯酸盐是广泛使用的工业化学品.
- 确定安全的暴露水平对于保护人类健康和环境至关重要.
- 以前的风险评估可能没有完全纳入最新的毒理学数据和方法.
研究的目的:
- 为三个较低的烯酸盐 (MA,EA和2EHA) 获得科学可靠的无显著风险水平 (NSRL).
- 利用系统的专家共识流程来确保数据质量,减少风险评估中的偏见.
- 在剂量反应评估中应用新的方法,包括考虑非新生病变和非线性推断.
主要方法:
- 一个经过修改的Delphi格式,涉及毒理学,MOA和癌症风险评估专家的五轮专家投入.
- 对现有科学数据的系统审查和对剂量反应评估的最佳实践的应用.
- 利用接触点的非瘤病变和低剂量风险评估的不确定性因子的非线性推断.
主要成果:
- 来自NSRL值:MA的每天530微克,EA的每天640微克,2EHA的每天1700微克.
- 对于经过测试的暴露途径 (MA/EA 吸入,2EHA 皮肤) 对衍生NSRLs的信心是中等到高的.
- 当将这些NSRL应用于替代暴露途径时,观察到较低的信任度.
结论:
- 该研究成功地使用专家共识方法为MA,EA和2EHA建立了数据驱动的NSRL.
- 使用的新方法提高了对这些烯酸盐的癌症风险评估的可靠性.
- 这些NSRL为有关烯酸盐暴露的监管和公共卫生决策提供了有价值的基准.
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