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我们是否需要在我们的成员档案中为物质的纳米形式建立一种横向阅读方法,以依赖于领导者提交的非纳米形式的研究作为终点?
问题(中文)
我们是否需要在我们的成员档案中为物质的纳米形式建立一种横向阅读方法,以依赖于领导者提交的非纳米形式的研究作为终点?
Question (EN)
Do we need to set up a read-across approach in our member dossier for the nanoform of the substance for the endpoints where we rely on the studies on the non-nanoform submitted by the lead?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
是的。由于非纳米形态和纳米形态之间存在差异,您需要针对每个终点和每个纳米形态,证明为什么物质非纳米形态生成的信息足以评估纳米形态,即从非纳米形态到每个纳米形态的预测可靠且准确,并且不会低估危害。要在您的档案中报告横向参照,请遵循《如何准备注册和 PPORD 档案》手册第 9.6.3 章“如何在 IUCLID 中报告横向参照”中的建议。
Answer (EN)
Yes. Due to the differences between non-nanoforms and nanoforms you need to demonstrate for each endpoint and each nanoform why the information generated on the non-nanoform of the substance is adequate for assessing the nanoform, i.e. that the prediction from the non-nanoform to each nanoform is reliable and accurate, and does not underestimate the hazard.
To report the read-across in your dossier, follow the advice given in the manual “How to prepare registration and PPORD dossiers”, chapter 9.6.3 ‘How to report read-across in IUCLID'.