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答案（中文）
对于水生毒性测试（第9.1节附件VII和VIII），第2栏的调整包括两个与水溶性相关的互补概念。“高度不溶于水”的概念与水生毒性的可能性相关；因此，无法设定一个通用的阈值。使用此概念豁免水生毒性测试需要进行针对特定物质的评估。在豁免声明中，注册人应证明在水溶性极限下不太可能发生水生毒性。这可能需要特定的信息，例如从转化/溶解研究或通过识别水溶性组分获得的信息。更多信息，请参阅演示文稿“物理化学、环境和人类健康相关终点的提示和技巧——水生毒性”。如果注册人无法证明不太可能发生水生毒性，则应将该物质视为“水溶性差”，而不是“极难溶于水”，因此必须考虑进行长期测试。“水溶性差”的概念与需要考虑进行长期测试而非短期测试有关。当水溶性低于1毫克/升或低于被测物质分析方法的检测限时，应将该物质视为水溶性差，并进行长期测试而非短期测试。有关更多信息，请参阅《信息要求和化学品安全评估指南》第 R.7b 章：终点特定指南 R.7.b，第 R.7.8.5 节。有关水生毒性测试的更多信息，请参阅 OECD 的《难处理物质和混合物水生毒性测试指南文件》。
Answer (EN)
For aquatic toxicity testing (Section 9.1 Annexes VII and VIII), Column 2 adaptations include two complementary concepts related to solubility in water.The concept of "highly insoluble in water" is associated with the likelihood for aquatic toxicity; consequently, a general threshold cannot be established. The use of this concept for waiving aquatic toxicity testing requires substance-specific assessment.In the waiving statement, registrants should justify that aquatic toxicity is unlikely to occur at the limit of the water solubility. This may require specific information, such as that obtained from transformation/dissolution studies or from the identifying the components of the water accommodated fraction. For more information, see the presentation Hints and Tips on Physicochemical, environmental and human health related endpoints - Aquatic Toxicity.If registrants cannot demonstrate that aquatic toxicity is unlikely to occur, the substance should be considered as "poorly water soluble", not as "highly insoluble in water", and therefore long-term testing has to be considered.The concept of "poorly water soluble" is associated with the need to consider long-term tests instead of short-term tests. Water solubility below 1mg/L or below the detection limit of the analytical method of the tested substance should be used for considering the substance as poorly water soluble and performing the long-term tests instead of the short-term tests. For more information, see the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b: Endpoint specific guidance R.7.b, section R.7.8.5.For more information regarding testing on aquatic toxicity, see the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures.