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）
不一定。作为关键安全评估 (CSA) 的一部分，您必须进行的风险表征范围取决于物质的危害特征。它必须涵盖所有危害，而不仅仅是那些需要分类的危害（REACH 附件 I 中的第 0.5 和 6 点）。首先，您必须考虑已识别的每一种物理、健康和环境危害，即使不需要分类。这包括收集预测或推导的无影响水平或最小影响水平（PNEC、DNEL 或 DMEL）（如适用）。您还应考虑相关的时间尺度、环境区域、人群、健康影响和暴露途径。只有在有剂量反应信息的情况下，才能推导刺激/腐蚀的 DNEL。因此，对于眼刺激等无法推导 DNEL 的终点事件，需要采用更定性的方法来评估和控制此类风险。这可能是由于pH值导致分类，或仅提供QSAR数据的情况。有关此方法的更多信息，请参阅《信息要求和化学品安全评估指南》第R.8章（E部分）和R.10章。如果没有其他危害，则只需描述在暴露场景（ES）中避免或管理眼睛风险的措施即可。如果已识别出其他危害，则您的评估也应解决这些危害。暴露评估和随后的风险表征应涵盖物质从制造到确定用途的生命周期的所有阶段。有关定性人体健康评估的更多信息，请参阅《如何进行定性人体健康评估实用指南》。提示：使用Chesar将帮助您确定暴露评估的范围和风险表征的类型。有关更多信息，请参阅Chesar 3用户手册第6章“生成CSR并将信息导出到IUCLID”。
Answer (EN)
Not necessarily. The scope of the risk characterisation, that you have to carry out as part of the CSA, depends on the hazard profile of the substance. It has to address every hazard, not just those that lead to a classification (points 0.5 and 6 in Annex I to REACH).Firstly, you have to consider each physical, health and environmental hazard identified, even if classification is not required. This includes collecting the predicted or derived no-effect levels or minimal effect levels (PNECs, DNELs or DMELs) if appropriate.You should also consider the relevant timescales, environmental compartments, human populations, health effects, and routes of exposure.DNELs for irritation/corrosion can only be derived if dose-response information is available. Therefore, for endpoints such as eye irritation where no DNEL can be derived, a more qualitative approach to assessing and controlling such risks is necessary. This may be the case where the pH led to the classification or where only QSAR data are available.For more information about this approach, see Guidance on Information Requirements and Chemical Safety Assessment, Chapters R.8 (Part E) and R.10.If there are no other hazards, then it is sufficient to describe the measures which ensure that the risks to eyes are avoided or managed in the exposure scenarios (ESs). If there are other hazards identified, then your assessment should address these also.The exposure assessment and the subsequent risk characterisation should cover all stages of the life cycle of the substance resulting from the substance's manufacture, and the identified uses.For more information on qualitative human health assessment, see the Practical Guide on How to undertake a qualitative human health assessment.Tip: Using Chesar will help you determine the scope of exposure assessment and the type of risk characterisation. For more information, see the Chesar 3 User Manual, chapter 6,Generating the CSR and exporting information to IUCLID.