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EURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches (2018)
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EURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches (2018)

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The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commission's Joint Research Centre (JRC). This annual EURL ECVAM status report provides updates on the progress being made in the development, validation and regulatory acceptance of alternative-to-animal methods and approaches and their dissemination. In the areas of toxicology and safety assessment, significant progress has been made in demonstrating how in vitro and computational methods can be combined to 'read-across' toxicological properties between similar chemicals to avoid unnecessary animal testing. Alternative methods are also being increasingly employed for the identification of endocrine disruptors and the assessment of chemical mixtures. However the use of alternative methods alone to fully characterise complex toxicological properties of chemicals, such as chronic systemic health effects, remains a formidable challenge. Recommendations have been published on how to improve multi-centre validation studies of alternative methods for the quality control of vaccines and how the data generated can be used for product specific validation by vaccine manufacturers. Recent advances in the ecotoxicology field include the development of a Threshold of Toxicological Concern approach (eco-TTC) for environmental safety assessment and the use of integrated non-animal methods to predict the bioaccumulation potential of chemicals in fish. Addressing the biomedical research domain, EURL ECVAM launched a major study to review the use of alternative methods and models for understanding biology and disease and for developing novel approaches to diagnosis and therapy. The validation of alternative methods intended for regulatory use has progressed on a number of fronts including novel methods for predicting the skin sensitisation potential of chemicals, assessing the leaching (bioelution) of chemicals from metal alloys, and for determining acute toxicity in fish. Two EURL ECVAM validation studies deal with methods for the identification of endocrine disruptors and involve the EU Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL). Several multi-stakeholder discussions on validation took place in various fora which indicate that although well-established validation principles are still relevant today, the process of validation needs to be continually adapted to keep pace with scientific and technological progress. Reflecting the potential application and impact of emerging organ-on-chip devices, EURL ECVAM conducted an international survey of developers and stakeholders to identify the issues determining end-user confidence and to solicit opinions on how best to approach validation to facilitate uptake and acceptance. The EURL ECVAM Scientific Advisory Committee (ESAC) was renewed during 2018 and one of its first mandated tasks is to deliver an opinion on the scientific validity of antibodies and non-antibody affinity reagents generated using animal-free technologies used in research and diagnostics.
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ISSN 1831-9424
ISBN 978-92-79-97417-5
DOI 10.2760/818599
Catalogusnummer KJ-NA-29455-EN-N
ISSN 1831-9424
ISBN 978-92-76-07879-1
DOI 10.2760/858311
Catalogusnummer KJ-NA-29455-EN-E
ISSN 1018-5593
ISBN 978-92-79-97418-2
DOI 10.2760/792308
Catalogusnummer KJ-NA-29455-EN-C
PDF
ISSN 1831-9424 ISBN 978-92-79-97417-5 DOI 10.2760/818599 Catalogusnummer KJ-NA-29455-EN-N
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Grootte: 10 177KB
ISSN 1831-9424 ISBN 978-92-76-07879-1 DOI 10.2760/858311 Catalogusnummer KJ-NA-29455-EN-E
Papier
ISSN 1018-5593 ISBN 978-92-79-97418-2 DOI 10.2760/792308 Catalogusnummer KJ-NA-29455-EN-C
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