GARD皮肤剂量反应测定及其在使用下一代风险评估 (NGRA) 框架进行香料的定量风险评估 (QRA) 中的应用
Shashikiran Donthamsetty1, Andy Forreryd2, Paul Sterchele1
1International Flavors & Fragrances, Hazlet, NJ, USA.
Regulatory toxicology and pharmacology : RTP
|March 9, 2024
概括
该GARDskin剂量反应测定准确预测人类对香料成分的敏感度水平. 这种新方法方法 (NAM) 通过可靠的定量风险评估 (QRA) 支持更安全的产品开发.
科学领域:
- 毒理学 毒理学 毒理学
- 皮肤敏感化 皮肤敏感化
- 在体外检测中进行检测.
背景情况:
- 新方法方法 (NAM) 对于皮肤敏感化的定量风险评估 (QRA) 是至关重要的.
- 香水行业优先考虑NAM来确定没有预期的敏感度诱导水平 (NESIL) 值.
- 经合组织已经采用了体外GARD皮肤测定 (TG 442E) 来识别皮肤敏感剂的危害.
研究的目的:
- 评估GARDskin剂量响应 (DR) 试验预测的精度和可重复性.
- 在下一代风险评估 (NGRA) 框架内评估GARDskin DR测定在香料QRA中的应用.
- 建立一种可靠的方法来推导香料成分的NESIL值.
主要方法:
- 使用了体外GARD皮肤试验,并修改了剂量反应测量协议.
- 应用线性回归模型来预测人类NESIL值.
- 使用NGRA框架对Isocyclocitral进行了QRA,以确定安全使用水平.
主要成果:
- 与已发表的数据相比,GARDskin DR测定在预测人类NESIL值方面表现出良好的一致性.
- 在三个独立的实验中,预测是可重现的.
- 使用NGRA框架的QRA成功确定了在各种消费产品中Isocyclocitral的安全使用水平.
结论:
- GARDskin DR测定是一种精确且可重复的方法,用于预测人类NESIL值.
- 这种测试支持在NGRA框架内确定香料材料的QRA的NESIL值.
- 这项研究推进了NAMs在化品和香水行业的强大皮肤敏感化风险评估中的使用.
关键词:
皮肤敏感化 皮肤敏感化香水材料是使用香水的材料.这是GARD测试.新方法方法论 (NAMs)下一代风险评估 (NGRA) 是指下一代风险评估.没有预期的敏感化诱导水平 (NESIL)经合组织 442E量化风险评估 (QRA) 是指进行量化风险评估.更多相关视频
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