REACH是否提供足够的信息来规范对生殖有毒物质的使用?
Gaby A M Eliesen1, M Woutersen1, J van Engelen1
1National Institute for Public Health and the Environment (RIVM), Centre for Safety of Substances and Products (VSP), Bilthoven, the Netherlands.
Regulatory toxicology and pharmacology : RTP
|July 27, 2023
概括
目前的REACH法规缺乏足够的数据来对生殖毒性进行分类和风险评估,特别是对于低量物质. 需要改进以确保工人和消费者对危险化学品的安全.
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:
- 危害分类和风险评估对于保护个人免受有毒物质的影响至关重要.
- REACH法规 (化学品的注册,评估,授权和限制) 规定了欧盟的化学品安全.
- 评估生殖毒性是化学品安全评估的关键组成部分.
研究的目的:
- 评估目前REACH信息要求对分类生殖毒性物质的充分性.
- 确定在不同位生产的物质中评估生殖毒性的局限性.
- 为更好的危险分类和风险评估提出改善REACH信息要求的建议.
主要方法:
- 对现有的REACH关于生殖毒性信息要求的分析.
- 对每年生产低于10 (tpa) 的物质的数据充足性的评估.
- 基于对10-100tpa之间产生的物质的选研究对分类结果的评估.
- 检查100tpa以上产生的物质的数据要求,包括扩展的一代生殖毒性研究.
主要成果:
- 信息要求不足以对低量 (<10 tpa) 的物质进行分类.
- 仅进行查研究 (10-100 tpa) 的物质通常不会被归类为1B类,原因是错过了效果.
- 由于研究要求有限,准确的风险评估在低位水平上具有挑战性.
- 高量物质 (>100 tpa) 具有更高的生殖毒性检测和风险评估的可能性.
- 无论量如何,没有专门的哺乳研究是强制性的.
结论:
- 目前的REACH要求不足以解决低和中等量物质的生殖毒性.
- 需要改进,例如自动后续研究和增加低位研究.
- 强化数据要求对于可靠的风险评估和化学安全至关重要.
关键词:
在 CLP 中,我们可以使用 CLP数据要求 数据要求生育能力 生育能力 生育能力胎儿的发育 胎儿的发育哺乳期 哺乳期 是一个在REACH系统中,我们可以使用REACH.生殖性毒性 生殖性毒性更多相关视频
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