Key Opportunities to Replace, Reduce, and Refine Regulatory Fish Acute Toxicity Tests

Abstract

Fish acute toxicity tests are conducted as part of regulatory hazard identification and risk-assessment packages for industrial chemicals and plant protection products. The aim of these tests is to determine the concentration which would be lethal to 50% of the animals treated. These tests are therefore associated with suffering in the test animals, and Organisation for Economic Cooperation and Development test guideline 203 (fish, acute toxicity) studies are the most widely conducted regulatory vertebrate ecotoxicology tests for prospective chemical safety assessment. There is great scope to apply the 3Rs principles-the reduction, refinement, and replacement of animals-in this area of testing. An expert ecotoxicology working group, led by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research, including members from government, academia, and industry, reviewed global fish acute test data requirements for the major chemical sectors. The present study highlights ongoing initiatives and provides an overview of the key challenges and opportunities associated with replacing, reducing, and/or refining fish acute toxicity studies-without compromising environmental protection.

Development of an Enhanced Mechanistically Driven Mode of Action Classification Scheme for Adverse Effects on Environmental Species

“…From a practical point of view, the scheme will assist in two distinct approaches that are, or will be, applied to fill regulatory data gaps for algae, invertebrates, and fish, for chemical legislations such as the European Union’s Regulation, Evaluation, Authorisation, and restriction of CHemicals (REACH), Water Framework Directive, etc., namely, the identification of analogues for read-across and assignment of chemicals to individual QSARs. The scheme will provide a clear means to assign chemicals to toxicologically relevant and species-specific categories, allowing for read-acrossthe application of these techniques is clearly recognized as one way of reducing in vivo testing . The concepts of “Next-Generation Read-Across” (NGRA), whereby there is a greater emphasis on the collection of evidence to support the justification of similarity, will benefit from the transparency of the new scheme, the data underpinning it, as well as the linkage to AOPs, which could support the collection of NAM data.…”

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

“…The development of novel in vitro approaches is firstly linked to the campaigns carried out in this decade by few associations, which strongly ask for a significant reduction in animal testing [ 18 ], leading to finding alternative methods and solutions to animal testing in the cosmetic, pharmaceutical, and nutraceutical fields. In particular, the principle of the 3Rs (Refine, Reduce, Replace) has been considered a stimulating opportunity to improve in vitro methods, even if nowadays it is not possible to completely abolish animal experimentation [ 19 ]. The scientific world gave the introduction of experimental in vitro models a strong impulse, implementing European Union (EU)-validated alternative methods in compliance with Good Laboratory Practice (GLP).…”

Development of In Vitro Corneal Models: Opportunity for Pharmacological Testing

“…In particular, the principle of the 3Rs (Refine, Reduce, Replace) has been considered a stimulating opportunity to improve in vitro methods, even if nowadays it is not possible to completely abolish the animal experimentation. 24 Scientific world gave the introduction of experimental in vitro models a strong impulse, implementing EU validated alternative methods in compliance with Good Laboratory Practice (GLP). In addition, the new Medical Devices Regulation (MDR 745/2017) is a further opportunity for companies operating in the preclinical sector, 25 stimulating the exponential evolution of in vitro technologies.…”