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Alternatives to animal testing: EURL ECVAM publishes its Recommendation on the Direct Peptide Reactivity Assay for skin sensitisation testing

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Dec 12, 2013
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In its Recommendation, EURL ECVAM summarises key performance parameters of this in vitro method and its use within integrated approaches to assessing the skin sensitisation potential of chemicals

On 12 December 2013 the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM, part of the European Commission Joint Research Centre) published its Recommendation on the Direct Peptide Reactivity Assay (DPRA) for skin sensitisation testing.cover-dpra-rec

Information on the skin sensitisation potential of chemicals is a key requirement for chemical safety: under the EU Chemicals legislation (REACH), skin sensitisation is one of two health effects still requiring animal testing for chemicals produced or marketed at the lowest tonnage level requiring substance registration. Currently, assessment of the skin sensitisation potential of chemicals for regulatory purposes relies on animal testing, but scientific progress on understanding mechanisms of skin sensitisation has led to the development of alternative methods, amongst these the Direct Peptide Reactivity Assay (DPRA). 

Following validation of the DPRA by EURL ECVAM and independent scientific review by EURL ECVAM's Scientific Advisory Committee (ESAC), EURL ECVAM now summarises in its Recommendation the DPRA's performance characteristics, including its capacity to distinguish sensitisers from non-sensitisers, its reproducibility, its limitations and its possible contribution to an assessment of the potency of skin sensitising substances, important for a fuller safety assessment. Importantly, like other in vitro assays, the DPRA will likely be used in combination with other information sources and test methods, i.e. within so-called "Integrated Approaches to Testing and Assessment".

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