Abstract According to some legislation grouping can streamline data gap filling for the hazard assessment of substances. The GRACIOUS Framework aims to facilitate the application of grouping of nanomaterials or nanoforms (NFs), in a regulatory context and to support innovation. This includes using grouping to enable read-across from (a) source(s), for which data and information exist, to a similar target NF where information is lacking. The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping. Initial collection of basic information allows selection of an appropriate pre-defined grouping hypothesis and a tailored Integrated Approach to Testing and Assessment (IATA), designed to generate new evidence to support acceptance or rejection of the hypothesis. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across. This approach gathers information to render risk assessment more efficient, affordable, as well as reducing the use of test animals.

中文翻译：

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用于对纳米材料进行分组和交叉阅读的框架——支持创新和风险评估

摘要 根据一些立法，分组可以简化物质危害评估的数据空白填充。GRACIOUS 框架旨在促进纳米材料或纳米形式 (NF) 在监管环境中的应用并支持创新。这包括使用分组来实现从存在数据和信息的 (a) 个源到缺少信息的类似目标 NF 的读取。该框架为 NF 的分组提供了一组初始假设，其中考虑了 NF 的身份和用途，以及分组的目的。基本信息的初步收集允许选择适当的预定义分组假设和量身定制的综合测试和评估方法 (IATA)，旨在产生新的证据来支持接受或拒绝假设。框架还支持需要开发自己的用户定义假设（和 IATA）的用户。此外，IATA 指导获取支持跨读所需的信息。这种方法收集信息，使风险评估更有效、更实惠，并减少测试动物的使用。