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如果我正在等待另一项测试的结果以完成扩展一代生殖毒性研究 (EOGRTS) 的研究设计,我应该在 IUCLID (>1000tpa) 中报告什么?
问题(中文)
如果我正在等待另一项测试的结果以完成扩展一代生殖毒性研究 (EOGRTS) 的研究设计,我应该在 IUCLID (>1000tpa) 中报告什么?
Question (EN)
What should I report in IUCLID (>1000tpa) if I am waiting for the results of another test to finalise the study design of the extended one-generation reproductive toxicity study (EOGRTS)?
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)
在附件X中,EOGRTS是解决生殖毒性问题的标准信息要求。如果您希望在开始EOGRTS之前等待另一项测试的结果(例如,90天研究或产前发育毒性研究的结果),则应在IUCLID第7.8.1节中注明,并将终点研究记录标记为测试提案。要将终点研究记录指示为EOGRTS的测试提案,请将“信息类型”字段设置为“计划的实验研究”,并在“终点”字段中选择与EOGRTS相关的选项列表值之一。在测试提案记录中,您可以说明您打算遵循的顺序测试和测试指南。ECHA将评估此测试提案,并可能设定时间表以允许进行此顺序测试。
Answer (EN)
At Annex X, the EOGRTS is the standard information requirement to address reproductive toxicity. If you would like to wait for the results of another test (e.g. results from a 90-day study or from a prenatal developmental toxicity study) before starting the EOGRTS, you should indicate this in IUCLID section 7.8.1 with an endpoint study record flagged as testing proposal.
To indicate an endpoint study record as a testing proposal for EOGRTS, set the field ‘Type of information’ to ‘experimental study planned’ and choose in the field ‘Endpoint’ one of the picklist values referring to the EOGRTS. In the testing proposal record you can explain the sequential testing and the test guideline(s) that you intend to follow. ECHA will evaluate this testing proposal and may set a timeline to allow this sequential testing.