使用下一代风险评估做出防晒活性成分的安全决定:索-4案例研究研究
Maria T Baltazar1, Sophie Cable1, Richard Cubberley1
1Safety, Environmental and Regulatory Science (SERS), Unilever Colworth Science Park, Sharnbrook, UK.
ALTEX
|May 21, 2025
概括
使用非动物方法的下一代风险评估 (NGRA) 显示,基-4 (BP-4) 是安全的. 这种方法提供了可靠的紫外线过器安全数据,而无需对动物进行试验.
科学领域:
- 毒理学 毒理学 毒理学
- 风险评估 风险评估
- 皮肤病学 皮肤病学
背景情况:
- 索-4 (BP-4) 是一种UV过器,用于身体乳液.
- 传统的安全评估通常依赖于动物数据.
- 使用非动物方法评估BP-4的安全性对于监管合规性和道德考虑至关重要.
研究的目的:
- 为BP-4进行下一代风险评估 (NGRA).
- 将非动物方法与传统的安全评估方法进行比较.
- 为了评估BP-4在5%度的身体乳液中的安全性.
主要方法:
- 基于生理学的动力学 (PBK) 建模来预测BP-4的吸收,新陈代谢和分泌.
- 在和体外新方法方法 (NAMs) 以表征生物活性.
- 使用体外起点 (PoDNAM) 和预测的血Cmax计算生物活性:暴露比率 (BERs).
主要成果:
- PBK建模预测了BP-4的低系统暴露 (血Cmax为1.27μM).
- 大多数计算的BER都高于11,这表明了足够的安全边际.
- 最低的BER (3.3和4.3) 与适应性基因转录变化有关,而不是不良影响.
结论:
- NGRA为评估紫外线过器安全性提供了强大的非动物方法.
- 在5%的身体乳液中,BP-4表现出良好的安全性.
- 这项研究支持在化学安全评估中对NAM的监管接受.
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