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供应商是否可以使用公开文献(例如互联网、在线数据库)中提供的数据来进行 CLP 下的物理危害分类?
问题(中文)
供应商是否可以使用公开文献(例如互联网、在线数据库)中提供的数据来进行 CLP 下的物理危害分类?
Question (EN)
May a supplier use data which is available in open literature, e.g. from the internet, online databases, for the purpose of physical hazard classification under CLP?
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,只要数据可靠且足以进行危险分类,就可以。此外,应充分记录现有的研究,以评估其质量和充分性。物质和混合物的物理危险性应通过基于 CLP 附件 I 第 2 部分中提到的方法或标准进行的测试来确定。这些方法可以在通常用于对运输物质和混合物进行分类的《联合国测试和标准手册》中找到:http://www.unece.org/trans/danger/publi/manual/manual_e.html。但是,如果已经从参考文献或数据库中获得了足够可靠的信息,并且待分类物质和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,则测试不是强制性的。公开文献或数据库通常使用二手数据源。使用此类数据时,应引用原始来源并由专家核实。这应包括检查是否有足够的文件来评估所用测试的适用性,以及测试是否采用可接受的质量保证水平进行。包含物理化学数据的有用数据汇编列于欧洲化学品管理局 (ECHA) 网站上《信息要求和化学品安全评估指南》第 R.7.1.1.2 节“物理化学性质的可用信息”中。
Answer (EN)
Yes, he may, provided the data is reliable and adequate for the purpose of hazard classification. Further to this, available studies should be sufficiently documented to assess their quality and adequacy.
The physical hazards of substances and mixtures should be determined through testing based on the methods or standards referred to in part 2 of Annex I to CLP. These methods can be found for example in the UN Manual of Tests and Criteria, which is normally used to classify substances and mixtures for transport:http://www.unece.org/trans/danger/publi/manual/manual_e.html.
However, testing is not mandatory in cases where adequate and reliable information from reference literature or databases is already available and where the substance to be classified and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc.
Open literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert. This should involve the check that there is sufficient documentation to assess the suitability of the test used, and that the test was carried out using an acceptable level of quality assurance. Useful data compilations containing physicochemical data are listed in section R.7.1.1.2- 'Available information on physicochemical properties' of the Guidance on information requirements and chemical safety assessment on ECHA's website.