Question (EN)
What should I report in IUCLID (>1000tpa) for the pre-natal developmental toxicity studies (PNDT) if I need to submit an update of the registration, when the study in the first species is still on-going and I wish to wait for its results before starting the one in the second species?
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 节中分别提供一项终点研究记录，并注明为关键研究、证据权重、数据豁免或测试提案。在您所指的情况下，您已收到在两个物种中进行 PNDT 测试的决定，并且已开始对第一个物种进行测试。但是，您希望等待第一个物种的 PNDT 测试结果出来后再启动第二个物种的研究。在这种情况下，您应该在 IUCLID 第 7.8.2 节中包含以下终点研究记录：第一个物种记录：您应该将正在进行的第一个物种 PNDT 测试的终点研究记录注明为数据豁免。将“数据豁免”字段设置为“其他理由”。在“数据豁免理由”下，选择值“其他：”，并在相邻的文本字段中输入以下句子：“此信息将根据 ECHA 决议编号 TPE-F-xxxxxxxxxx-xx-xx 稍后提交”，其中“x”字符替换为 ECHA 向您签发的决议编号。第二个物种记录：您应将第二个物种 PNDT 测试的终点研究记录指定为数据豁免。将“数据豁免”字段设置为“其他理由”。在“数据豁免理由”下，选择值“其他：”并在相邻的文本字段中输入以下句子：“在第一个物种的测试结果可用后，可以顺序进行第二个物种的 PNDT 测试。此信息将根据 ECHA 决策编号 TPE-F-xxxxxxxxxx-xx-xx 稍后提交”，其中将“x”字符替换为 ECHA 向您颁发的决策编号。研究完成后，您必须立即提交注册更新，并在 IUCLID 第 7.8.2 节中报告最终测试的结果。请注意，基于第一个物种研究的结果，可以永久免除第二个物种测试的唯一原因列于 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 月发布的新闻通讯。
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.In the situation you refer to, you have received the decision to carry out the PNDT test in two species, and you have started the testing in the first species. However, you would like to wait for the results of the PNDT test in the first species before initiating the second species study. In this situation, you should include in IUCLID section 7.8.2 the following endpoint study records:First species record: You should indicate the endpoint study record for the ongoing first species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.Second species record: You should indicate the endpoint study record for the second species PNDT test as a data waiving. Set the field ‘Data waiving’ to ‘other justification’. Under ‘Justification for data waiving’ select the value ‘other:’ and type the following sentence in the adjacent text field: “The second species PNDT test may be performed sequentially once the first species test results are available. This information will be submitted later based on ECHA decision number TPE-F-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the decision number issued to you by ECHA.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.