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Regul Toxicol Pharmacol. 2013 Dec;67(3):506-30. doi: 10.1016/j.yrtph.2013.10.003. Epub 2013 Oct 23.

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

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UFZ - Helmholtz Centre for Environmental Research, Department of Bioanalytical Ecotoxicology, 04318 Leipzig, Germany. Electronic address:


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.


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

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