危害和风险之间的区别:在毒理学研究中普遍存在的剂量范围与现实生活中的香味暴露
Kaushal Joshi1, Arianna Bartlett1, Wolfgang Dekant2
1Research Institute for Fragrance Materials, Mahwah, New Jersey, United States of America.
Regulatory toxicology and pharmacology : RTP
|February 21, 2026
概括
香水安全是最重要的. 风险评估表明,在动物研究中,有毒剂量远远超过人类因食品和香料使用而受到的典型暴露,从而确保了消费者的安全.
科学领域:
- 毒理学 毒理学 毒理学
- 风险评估 风险评估
- 暴露科学 暴露科学
背景情况:
- 香水安全是消费者和行业的关键问题.
- 香料材料研究所 (RIFM) 采用了一个透明的风险评估框架.
- 从历史上看,系统性毒性评估依赖于动物研究,但RIFM十多年来没有进行新的研究.
研究的目的:
- 将动物毒性数据置于香料成分对人类现实的暴露水平的背景下.
- 为了说明动物试验中使用的剂量与人类日常暴露之间的显著差异.
- 证明暴露科学在可靠的风险评估中的应用.
主要方法:
- 确定甲和p-cymene的没有观察到的不良影响水平 (NOAEL) 和人类等效剂量 (HED).
- 利用来自食品和香水的摄入数据作为比较器.
- 采用Creme RIFM总体暴露模型进行香味暴露评估.
主要成果:
- 副作用的程度需要每天摄入极高量的杏仁或树.
- 通过使用香料来达到有毒水平需要不切实际的每日应用次数 (数十万次喷雾).
- 计算的NOAEL和HED值突显出动物研究剂量和人类暴露之间存在相当大的安全差距.
结论:
- 动物研究数据必须在考虑现实的人类暴露场景时进行解释.
- 暴露科学的进步对于准确和有意义的香味风险评估至关重要.
- 目前的风险评估实践确保了香水成分对消费者的安全.
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