拟议的REACH信息要求对内分泌干扰剂评估的资源和动物使用的影响
Natalie Burden1, Rebecca J Brown2, Rhiannon Smith2
1NC3Rs, Gibbs Building, 215 Euston Road, London, NW1 2BE, UK.
Regulatory toxicology and pharmacology : RTP
|July 5, 2024
概括
根据REACH规定,拟议的内分泌干扰剂 (ED) 评估可能需要数以百万计的动物试验,这引发了可行性问题. 进一步澄清对于化学品安全评估中的强有力的动物减少战略至关重要.
科学领域:
- 环境科学 环境科学
- 毒理学 毒理学 毒理学
- 监管科学 监管科学
背景情况:
- 已提出根据REACH对内分泌干扰剂 (ED) 评估的修订信息要求.
- 实施将显著增加对ED评估的数据需求.
研究的目的:
- 评估两种提议的ED政策选项的潜在动物使用和财务资源.
- 在实施新的ED评估要求之前,确定需要澄清的领域.
主要方法:
- 在REACH下分析ED政策选择的建议.
- 估计潜在的动物使用和财务影响.
主要成果:
- 拟议的要求可能会导致数以千万计的动物试验.
- 目前的方法似乎不适合广泛实施.
结论:
- 在实施拟议的ED评估政策方面存在重大挑战.
- 需要进一步澄清优先级,使用新方法方法 (NAM) 和证据权重方法.
- 欧洲委员会有机会制定一个透明的ED评估过程,优先考虑3R (替代,改进,减少动物试验).
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