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在Sprague-Dawley大鼠中对较高的烯酸的产前发育毒性评估

Quan Shi¹, Michael G Penman², Juan-Carlos Carrillo¹

¹Shell Product Stewardship, Shell Global Solutions International B.V., Carel van Bylandtlaan 16, The Hague 2596HR, the Netherlands.

Reproductive toxicology (Elmsford, N.Y.)

|November 30, 2024

概括

在大鼠中,较高的烯酸 (HO) 不会引起母体或发育毒性. 测试的最高剂量1000 mg/kg bw/day被确定为所有五个评估的HO的无观察不良影响水平 (NOAEL).

科学领域:

毒理学毒理学毒理学
发展生物学发展生物学
化学安全化学安全

背景情况:

高烯 (HO) 是各种工业应用的关键化学中间体.
监管评估,如REACH注册,需要全面的毒性评估.
了解HO的产前发育毒性对于确保安全处理和使用至关重要.

研究的目的:

为了评估五种特定的高奥莱芬的产前发育毒性.
确定对母体和胚胎胎毒性的没有观察到的不良影响水平 (NOAEL).
为了满足化学安全评估的监管要求.

主要方法:

产前发育性毒性研究是按照经合组织TG 414指南进行的.
在Sprague-Dawley大鼠中,给予了五种较高的烯 (Hex-1-ene,Nonene,分支,Octadec-1-ene和碳水化合物,C12-30,富含烯,乙烯聚合物). 根据产品) 通过 gavage.
剂量水平从怀孕第3天到第19天,从0到1000毫克/千克/天不等,并对母亲和胎儿的参数进行全面监测.

主要成果:

在任何接受较高的烯治疗组中都没有观察到对母亲的毒性或胚胎胎的毒性.
使用Hex-1-ene和Octadec-1-ene观察到的偶发骨和内脏形被认为是自发的,与治疗无关.
所有测试的高奥莱芬在最高剂量时都没有对胎儿发育产生不良影响.

结论:

对于所有五种较高的烯酸,没有观察到的不良影响水平 (NOAEL) 确定为每天1000毫克/千克体重,对母体和发育毒性.
这些发现表明,与测试的较高的烯酸盐相关的产前发育毒性风险较低.
这些结果支持在监管框架内安全使用这些较高的烯酸.

关键词:

在AOECD 41414中.阿尔基因是一种基.胚胎毒性胚胎毒性较高的油脂含量会导致较高的油脂含量没有观察到的不良影响水平 (NOAEL)产前发育毒性产前发展毒性产性产性产性

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