Question (EN)
I am preparing a registration dossier for a substance with a tonnage above 1000 t/y. I am planning to address the information requirement for the pre-natal developmental toxicity (PNDT) study with a testing proposal. However, I would like to wait for the results of the test in the first species before starting the test in the second species. How should I report this in IUCLID?
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）
REACH 附件 X 要求注册人提供两项针对不同物种的产前发育毒性研究。对于这两个物种，您需要在 IUCLID 第 7.8.2 节中分别提供终点研究记录，并将其标记为关键研究、证据权重、数据豁免或测试方案。在进行脊椎动物测试以满足 REACH 附件 IX 和 X 的信息要求之前，您需要先向 ECHA 提交测试方案并获得进行测试的决定。在您提到的情况下，您即将提交附件 X 中 PNDT 研究的测试方案。因此，您应该在 IUCLID 第 7.8.2 节中包含以下终点研究记录：第一和第二物种记录：您应该为第一和第二物种创建单独的终点研究记录，并通过将“信息类型”字段设置为“计划中的实验研究”来将其分别标记为测试方案。请提供计划测试的“指南”、“测试材料信息”和“物种”信息。此外，请确保在两条记录的“信息类型论证”字段中，包含REACH法规提供的适应性可能性为何无法满足信息要求以及为何必须进行动物试验的说明。最后，在“附加论证”字段中的至少一条记录中，阐明您计划按顺序（取决于第一个物种的PNDT研究结果）对两个物种进行测试。研究完成后，您必须立即提交注册更新，并在IUCLID第7.8.2节中报告最终测试结果。请注意，基于第一个物种研究结果，第二个物种的测试可以永久免除的唯一理由列于REACH附件X第8.7.2节第2栏。有关PNDT研究信息要求的更多信息，请阅读2014年10月发布的简报。
Answer (EN)
REACH Annex X requires registrants to provide two pre-natal developmental toxicity studies in different species. For each of the two species, you need to provide an endpoint study record in IUCLID section 7.8.2 indicated as key study, weight of evidence, data waiving, or testing proposal. Before carrying out a test in vertebrate animals to fulfil information requirements for REACH Annexes IX and X, you need to first submit a testing proposal to ECHA and receive the decision to carry out the test. In the situation you refer to, you are about to submit a testing proposal for the PNDT study at Annex X. You should therefore include in IUCLID section 7.8.2 the following endpoint study records:First and second species records: You should create separate endpoint study records for the first and second species and indicate each of them as a testing proposal by setting the field ’Type of information’ to ‘experimental study planned’. Provide information on the ‘Guideline’, ‘Test material information’ and ‘Species’ of the planned test. In addition, ensure to include in the field ‘Justification for type of information’ of both records the considerations for why the adaptation possibilities offered by the REACH Regulation cannot be used to address the information requirement and animal testing is necessary.Finally, include in at least one of the records in the field ‘Attached justification’ the clarification of that you propose to carry out the testing of the two species in a sequential manner (depending on the results of the PNDT study in the first species).Once a study is finalised, you must without delay submit an update of the registration, and report the results of the finalised test in IUCLID section 7.8.2. Note that the only reasons for why the testing in the second species could be permanently waived based on the results of the first species study are listed in REACH Annex X, section 8.7.2, column 2.For further information on the information requirements for the PNDT studies, please read the Newsletter, issued on October 2014.