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The annual EURL ECVAM status report describes research, development and validation activities, as well as initiatives that promote the regulatory use and international adoption of non-animal methods and approaches and their dissemination in the regulatory and research arenas. EU policies and legislation call for innovative and more efficient ways of safety testing and chemical risk assessment that do not depend on animal testing. Advanced technologies such as computational models, in vitro methods and organ-on-chip devices are being developed, evaluated and integrated to translate mechanistic understanding of toxicity into safety testing strategies. The ultimate goal is to achieve better protection of human health and the environment while supporting EU innovation and industrial competitiveness, without the use of animals. The development and use of non-animal models and methods are also essential for advancing basic, applied and translational research. Education also plays an essential role in enabling a shift to non-animal methods through the introduction of the Three Rs (Replacement, Reduction and Refinement of animal use in science) into secondary school curricula and programmes of higher education., JRC.F.3-Chemicals Safety and Alternative Methods

The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commision's Joint Research Centre. The EURL ECVAM status report informs about research and development activities, test method submissions, validation and peer reviews, activities that promote the regulatory acceptance and international adoption of alternative methods and approaches and their dissemination. Replacement, reduction and refinement of animal testing (Three Rs) in basic, applied and translational research, as well as for regulatory purposes is anchored in EU legislation. Innovative technologies (e.g., computational models, in vitro methods, organ-on-chip devices) are developed, evaluated and integrated in assessment strategies for chemicals and products safety testing in order to preserve a high level of protection for human health and the environment. Important activities to promote the development and use of alternative methods and approaches are also pursued in the areas of basic and applied research as well as for education purposes., JRC.F.3-Chemicals Safety and Alternative Methods

The JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) conducted a validation study of the AR-CALUX in vitro method. The method is applied to the detection of compounds with endocrine disrupting potential and more specifically (anti)androgen activity. The objectives of the study included assessing the reproducibility (within and between laboratories) and the relevance of the in vitro method. The participating laboratories included three test facilities from the European Union Network of Validation Laboratories for alternative methods (EU-NETVAL), being RISE, Covance, and Charles River, and, the test method submitter Biodetection Systems. The validation study report presents the results of the method performed on 46 test chemicals, evaluated for reproducibility within and between laboratories, variability within the measurements, and classification. A comparison of the classifications was made with publicly available ARTA classifications. It was concluded that this test method is reliable, has high reproducibility, low variability and merits proposal to OECD for the development of a test guideline. The statistical report and the final SOP are part of this report and can be found as separate files., JRC.F.3-Chemicals Safety and Alternative Methods

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). The EURL ECVAM status report provides updates on the progress made in the development, validation and regulatory acceptance and use of alternative methods and approaches and their dissemination. The status report describes research, development and validation activities, as well as on initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination., JRC.F.3-Chemicals Safety and Alternative Methods

Every year, EURL ECVAM prepares a Status Report with the primary purpose of which is to inform its stakeholders and all interested parties (the public, press etc.) on updates on the status of alternative methods and approaches. The EURL ECVAM status report provides updates on activities since the last report published in October 2016. It reports on research and development, validation activities as well as on activities which promote the regulatory and international adoption and use of alternative approaches and their dissemination. It describes primarily, but not exclusively, all the activities that EURL ECVAM has undertaken or has been involved in since the publication of the last report., JRC.F.3-Chemicals Safety and Alternative Methods

Replacement, Reduction and Refinement of animal testing is anchored in EU legislation. Alternative non-animal approaches facilitate a shift away from animal testing. Cell-based methods and computational technologies are integrated to translate molecular mechanistic understanding of toxicity into safety testing strategies., JRC.F.3-Chemicals Safety and Alternative Methods

The EURL ECVAM status report provides an update on the progress made in the development, validation and regulatory acceptance of alternative methods and approaches and their dissemination since the last report published in June 2014. It is informing on ongoing research and development activities, validation studies, peer reviews, recommendations, strategies and regulatory/international acceptance of alternative methods and approaches and dissemination activities. R&D activities within large European or International consortia continued in toxicity areas where 3Rs solutions are more difficult to find due to the underlying complexity of the area. On the other hand, toxicity areas where promising non-animal approaches have been developed, their validation and regulatory acceptance/international adoption could be progressed. Particular emphasis was given to the best and most intelligent combination and integration of these different non-animal approaches to ultimately obtain the required information without resorting to animal testing., JRC.I.5-Systems Toxicology

The EURL ECVAM status report provides an update on the progress made in the development, validation and regulatory acceptance of alternative methods and approaches since the last report published in April 2013. It is informing on ongoing research and development activities, validation studies, peer reviews, recommendations, strategies and international acceptance of alternative methods and approaches. R&D activities are ongoing for the complex endpoints where the toxicological processes and the mechanistic understanding have not been sufficiently elucidated yet and for which 3Rs solutions are more difficult to find. On the other hand, good progress In the validation and regulatory acceptance is made in areas where non-animal alternative methods have been developed and validated and where the focus lies in an intelligent combination/ integration of the various non-animal approaches., JRC.I.5-Systems Toxicology

The genome of Arabidopsis has been searched for sequences of genes involved in acyl lipid metabolism. Over 600 encoded proteins have been identified, cataloged, and classified according to predicted function, subcellular location, and alternative splicing. At least one-third of these proteins were previously annotated as “unknown function” or with functions unrelated to acyl lipid metabolism; therefore, this study has improved the annotation of over 200 genes. In particular, annotation of the lipolytic enzyme group (at least 110 members total) has been improved by the critical examination of the biochemical literature and the sequences of the numerous proteins annotated as “lipases.” In addition, expressed sequence tag (EST) data have been surveyed, and more than 3,700 ESTs associated with the genes were cataloged. Statistical analysis of the number of ESTs associated with specific cDNA libraries has allowed calculation of probabilities of differential expression between different organs. More than 130 genes have been identified with a statistical probability > 0.95 of preferential expression in seed, leaf, root, or flower. All the data are available as a Web-based database, the Arabidopsis Lipid Gene database (http://www.plantbiology.msu.edu/lipids/genesurvey/index.htm). The combination of the data of the Lipid Gene Catalog and the EST analysis can be used to gain insights into differential expression of gene family members and sets of pathway-specific genes, which in turn will guide studies to understand specific functions of individual genes.