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

Stefan Scholz, Erika Sela, Ludek Blaha, Thomas Braunbeck, Malyka Galay-Burgos, Mauricio García-Franco, Joaquin Guinea, Nils Klüver, Kristin Schirmer, Katrin Tanneberger, Marysia Tobor-Kapłon, Hilda Witters, Scott Belanger, Emilio Benfenati, Stuart Creton, Mark T D Cronin, Rik I L Eggen, Michelle Embry, Drew Ekman, Anne GourmelonMarlies Halder, Barry Hardy, Thomas Hartung, Bruno Hubesch, Dirk Jungmann, Mark A. Lampi, Lucy Lee, Marc Léonard, Eberhard Küster, Adam Lillicrap, Till Luckenbach, Albertinka J. Murk, José M. Navas, Willie Peijnenburg, Guillermo Repetto, Edward Salinas, Gerrit Schüürmann, Horst Spielmann, Knut Erik Tollefsen, Susanne Walter-Rohde, Graham Whale, James R. Wheeler, Matthew J. Winter

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)506-530
Number of pages25
JournalRegulatory Toxicology and Pharmacology
Issue number3
Publication statusPublished - Dec 2013


  • 3Rs
  • Acute toxicity
  • Bioconcentration
  • Cell lines
  • Chronic toxicity
  • Endocrine disruption
  • Exposure-based waiving
  • Fish embryo test
  • QSAR
  • Read-across

ASJC Scopus subject areas

  • Toxicology


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