A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment

Authors : Scholz S, et al
Publisher : Regulatory Toxicology and Pharmacology

Scholz S, Sela E, Blaha L, Braunbeck T, Galay-Burgos M, García-Franco M, Guinea J. Klüver N, Schirmer K, Tanneberger K, Tobor-Kaplon M, Witters H, Belanger S, Benfenati E, Creton S, Cronin MTD, Eggen RIL, Embry M, Ekman D, Gourmelon A, Halder M, Hardy B, Hartung T, Hubesch B, Jungmann D, Lampi MA, Lee L, Léonard M, Küster E, Lillicrap A, Luckenbach T, Murk AJ, Navas JM, Peijnenburg W, Repetto G, Salinas E, Schüürmann G, Spielmann H, Tollefsen KE, Walter-Rohde S, Whale G, Wheeler JR, Winter MJ. 2013.

A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment. Regulatory Toxicology and Pharmacology, Available online 23 October 2013, ISSN 0273-2300, http://dx.doi.org/10.1016/j.yrtph.2013.10.003.



? Alternatives are yet only available for acute fish toxicity testing.? Limited access to animal test data hinders the development of alternatives.? Successful validation of alternative approaches is required to replace animal tests.? Mechanistic approaches should be developed and implemented in regulatory testing.? Integrated testing strategies combine experimental and non-testing alternatives.

Tests with vertebrates are an integral part of environmental hazard identification and risk assessment of chemicals, plant protection products, pharmaceuticals, biocides, feed additives and effluents. These tests raise ethical and economic concerns and are considered as inappropriate for assessing all of the substances and effluents that require regulatory testing. Hence, there is a strong demand for replacement, reduction and refinement strategies and methods. However, until now alternative approaches have only rarely been used in regulatory settings. This review provides an overview on current regulations of chemicals and the requirements for animal tests in environmental hazard and risk assessment. It aims to highlight the potential areas for alternative approaches in environmental hazard identification and risk assessment. Perspectives and limitations of alternative approaches to animal tests using vertebrates in environmental toxicology, i.e. mainly fish and amphibians, are discussed. Free access to existing (proprietary) animal test data, availability of validated alternative methods and a practical implementation of conceptual approaches such as the Adverse Outcome Pathways and Integrated Testing Strategies were identified as major requirements towards the successful development and implementation of alternative approaches. Although this article focusses on European regulations, its considerations and conclusions are of global relevance.


Cell lines;
Exposure-based waiving;
Fish embryo test;
Acute toxicity;
Chronic toxicity;
Endocrine disruption;

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