对于要求根据REACH要求注册的聚合物标准信息要求,采用三级方法
Jens C Otte1, Heli Miriam Hollnagel2, Christiane Nagel1
1BASF SE, Carl-Bosch-Strasse 38, 67056, Ludwigshafen am Rhein, Germany.
Regulatory toxicology and pharmacology : RTP
|September 20, 2023
概括
建议在REACH下对聚合物注册 (PRR) 采用一个新的分层方法. 这种方法根据性能和危害对聚合物进行分组,优先考虑生物可用性评估,以减少动物试验并确保安全.
科学领域:
- 聚合物化学和毒理学
- 监管科学是一种监管科学.
- 环境健康风险评估环境健康风险评估
背景情况:
- 人工聚合物在消费品中无处不在.
- 目前对小分子的风险评估对于聚合物是不够的.
- 欧盟REACH法规要求对需要注册的聚合物 (PRR) 进行修订的数据标准.
研究的目的:
- 为聚合物数据生成提出一种新的三层监管方法.
- 在REACH下为聚合物制定标准信息要求 (SIR).
- 提高聚合物安全性评估,同时尽量减少动物试验.
主要方法:
- 聚合物根据化学结构,性能和危险概况进行分组.
- 将生物利用性评估整合到初始层 (一级) 中.
- 使用基于性质,效果,生物可用性和暴露的分层决策过程.
主要成果:
- 对于许多聚合物,一级数据 (危害,使用,暴露) 可能足够.
- 可以针对2级和3级进行进一步的测试,限制脊椎动物研究.
- 该方法优先考虑科学证据和动物福利.
结论:
- 拟议的分层策略为REACH下的聚合物风险评估提供了一个强大的框架.
- 聚合物的分组和生物利用度重点简化了对聚合物的数据要求.
- 这种方法可以确保达到适当的保护目标,同时减少对动物试验的依赖.
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