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答案（中文）
附件九中，8.7.3第1栏指出，“如果现有的重复剂量毒性研究（例如28天或90天研究、OECD 421或422筛选研究）表明对生殖器官或组织有不良影响，或揭示与生殖毒性相关的其他问题”，则必须进行扩展一代生殖毒性研究（EOGRTS）。因此，EOGRTS并非附件九的自动要求，而是依赖于其他试验对不良影响的指示。如果您正在等待此类试验的结果以确定是否需要进行EOGRTS，您可以在IUCLID第7.8.1节中标记为数据豁免的终点研究记录中注明这一点。要将终点研究记录指示为等待另一项研究结果的 EOGRTS 数据豁免，请将“数据豁免”字段设置为“非科学必要研究”，并在“终点”字段中选择一个引用 EOGRTS 的选项列表值。在数据豁免记录中，在“数据豁免理由”下选择“其他：”值，并说明您正在等待另一项研究的结果。请明确说明您引用的是哪项/哪几项研究，最好在“交叉引用”字段中指明相关章节。如果您有任何 ECHA/主管部门对该测试的决定，也请在数据豁免理由中包含决定编号。通过采用这种方法，您无需在知道是否需要进行此项研究之前提交附件 IX 中的 EOGRTS 测试提案。一旦重复剂量毒性研究完成，您应立即提交注册更新，除了报告最终测试的结果外，还应在第 7.8.1 节中 (i) 修改数据放弃记录，以解释在测试中未观察到符合 8.7.3 第 1 栏的不良影响；或 (ii) 将数据放弃记录替换为 EOGRTS 的测试提案。
Answer (EN)
At Annex IX, it is indicated in Column 1 of 8.7.3 that the extended one-generation reproductive toxicity study (EOGRTS) must be performed “if the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity”. Therefore, the EOGRTS is not an automatic requirement at Annex IX, but relies on the indication of adverse effects from other tests.If you are awaiting the results of such test(s) to determine if you need to conduct the EOGRTS, you can indicate this in an endpoint study record flagged as data waiving in IUCLID section 7.8.1. To indicate an endpoint study record as a data waiving for EOGRTS pending the outcome of another study, set the field ‘Data waiving’ to ‘study not scientifically necessary’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the data waiving record, select under ‘Justification for data waiving’ the value ‘other:’ and explain that you are awaiting the outcome of another study. Be explicit on which study/studies you refer to, preferably by indicating the relevant section(s) in the field ‘Cross-reference’. If you have any ECHA/authority decision on the test, also include the decision number in the data waiving justification.By following this approach, you do not need to submit a testing proposal for the EOGRTS at Annex IX, before you know if this study is needed. Once the repeated dose toxicity study is finalised, you should without delay submit an update of the registration, and in addition to reporting the results of the finalised test, in section 7.8.1 either (i) amend the data waiving record to explain that no adverse effects in line with Column 1 of 8.7.3 were observed in the test; or (ii) replace the data waiving record with a testing proposal for the EOGRTS.