Abstract
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 Caenorhabditis elegans. Small organisms like C. elegans 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 C. elegans 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.
Highlights
Developmental and Reproductive Toxicity (DART) is a critical safety evaluation of chemicals under chemical legislations throughout the world
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 Caenorhabditis elegans
To get an overview of the contribution of new approach methodologies (NAMs) to the current literature, we performed a PubMed search for studies related to DART in six different species published after January 2018
Summary
Developmental and Reproductive Toxicity (DART) is a critical safety evaluation of chemicals under chemical legislations throughout the world. In the European context, chemicals are controlled under REACH (Registration, Evaluation and Authorization of Chemicals). The goal of REACH is to protect human health and the environment. In the EU, a chemical compound cannot be used or imported until sufficient information has been provided regarding the safety of the compound [1]. ECHA (the European Chemicals Agency) critically evaluate the results of safety tests and maintain the ECHA database [2]. In the USA, the National Toxicology Program (NTP) provides information on toxicity and human health risks of compounds. Information is stored in the United States Environmental Protection Agency (US-EPA) Toxicity Reference Database (ToxRefDB) [3]
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