van der Voet Monique, Teunis Marc, Louter-van de Haar Johanna, Stigter Nienke, Bhalla Diksha, Rooseboom Martijn, Wever Kimberley E, Krul Cyrille, Pieters Raymond, Wildwater Marjolein, van Noort Vera
Vivaltes, 1704 NA, Heerhugowaard the Netherlands.
Utrecht University of Applied Sciences, Innovative testing in Life Sciences & Chemistry, 3584 CH, Utrecht, the Netherlands.
Toxicol Res (Camb). 2021 Nov 28;10(6):1202-1210. doi: 10.1093/toxres/tfab109. eCollection 2021 Dec.
Implementation of reliable methodologies allowing Reduction, Refinement, and Replacement (3Rs) of animal testing is a process that takes several decades and is still not complete. Reliable methods are essential for regulatory hazard assessment of chemicals where differences in test protocol can influence the test outcomes and thus affect the confidence in the predictive value of the organisms used as an alternative for mammals. Although test guidelines are common for mammalian studies, they are scarce for non-vertebrate organisms that would allow for the 3Rs of animal testing. Here, we present a set of 30 reporting criteria as the basis for such a guideline for Developmental and Reproductive Toxicology (DART) testing in the nematode . Small organisms like are upcoming in new approach methodologies for hazard assessment; thus, reliable and robust test protocols are urgently needed. A literature assessment of the fulfilment of the reporting criteria demonstrates that although studies describe methodological details, essential information such as compound purity and lot/batch number or type of container is often not reported. The formulated set of reporting criteria for testing can be used by (i) researchers to describe essential experimental details (ii) data scientists that aggregate information to assess data quality and include data in aggregated databases (iii) regulators to assess study data for inclusion in regulatory hazard assessment of chemicals.
实施可靠的方法以实现动物实验的减少、优化和替代（3R原则）是一个需要数十年时间且仍未完成的过程。可靠的方法对于化学品的监管危害评估至关重要，因为测试方案的差异会影响测试结果，进而影响用作哺乳动物替代物的生物体预测价值的可信度。尽管哺乳动物研究有通用的测试指南，但对于可实现动物实验3R原则的非脊椎动物，此类指南却很稀缺。在此，我们提出一套30条报告标准，作为线虫发育和生殖毒理学（DART）测试指南的基础。像线虫这样的小型生物在新的危害评估方法中逐渐兴起；因此，迫切需要可靠且稳健的测试方案。对报告标准满足情况的文献评估表明，尽管研究描述了方法细节，但诸如化合物纯度、批次号或容器类型等关键信息往往未被报告。所制定的线虫测试报告标准集可被（i）研究人员用于描述基本实验细节；（ii）数据科学家用于汇总信息以评估数据质量并将数据纳入汇总数据库；（iii）监管机构用于评估研究数据，以纳入化学品的监管危害评估。
