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参考书和数据库是否被视为物质数据的可靠来源?

问题(中文)
参考书和数据库是否被视为物质数据的可靠来源?
Question (EN)
Are reference books and databases regarded as reliable sources of substance data?
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)
一般来说,只要待注册物质与参考文献中描述的物质在均质性、杂质、粒度等方面具有可比性,就可以使用来自可靠且科学认可的参考文献或数据库的数据。相似性证明文件需要在注册档案中提交。参考文献或数据库通常使用二手数据来源。使用此类数据时,应引用原始来源并由专家核实。更多信息,请参阅《信息要求和化学品安全评估指南》第 R.7 a、b、c 章中每个终点下包含同行评审数据的参考书和数据汇编。对于某些终点,这些来自参考文献或数据库的数据可以单独用于满足信息要求。但是,通常情况下,这些数据必须与其他证据相结合,并作为证据权重法或横向阅读法的一部分提交,以支持拟议的调整要求的理由。
Answer (EN)
In general, there is the possibility to use data from reliable, scientifically accepted reference literature or databases, provided that the substance to be registered and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc.The documentation of similarity needs to be submitted in the registration dossier. References to literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert.For more information, see the reference books and data compilations containing peer reviewed data under each endpoint in the Guidance on Information Requirements and Chemical Safety Assessment, chapters R.7 a, b, c. For some endpoints, these data from reference literature or databases may be used on their own to fulfil the information requirement. However, in general they will have to be combined to other pieces of evidence and submitted as part of a weight-of-evidence approach or read-across approach to support the justification proposed to adapt the requirement.