caa a22 4500 445853891 CHVBK 20180317145422.0 cr unu---uuuuu 170323e20110501xx s 000 0 eng 10.1007/s00204-011-0693-2 doi (NATIONALLICENCE)springer-10.1007/s00204-011-0693-2 Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010 [Elektronische Daten] [Sarah Adler, David Basketter, Stuart Creton, Olavi Pelkonen, Jan van Benthem, Valérie Zuang, Klaus Andersen, Alexandre Angers-Loustau, Aynur Aptula, Anna Bal-Price, Emilio Benfenati, Ulrike Bernauer, Jos Bessems, Frederic Bois, Alan Boobis, Esther Brandon, Susanne Bremer, Thomas Broschard, Silvia Casati, Sandra Coecke, Raffaella Corvi, Mark Cronin, George Daston, Wolfgang Dekant, Susan Felter, Elise Grignard, Ursula Gundert-Remy, Tuula Heinonen, Ian Kimber, Jos Kleinjans, Hannu Komulainen, Reinhard Kreiling, Joachim Kreysa, Sofia Leite, George Loizou, Gavin Maxwell, Paolo Mazzatorta, Sharon Munn, Stefan Pfuhler, Pascal Phrakonkham, Aldert Piersma, Albrecht Poth, Pilar Prieto, Guillermo Repetto, Vera Rogiers, Greet Schoeters, Michael Schwarz, Rositsa Serafimova, Hanna Tähti, Emanuela Testai, Joost van Delft, Henk van Loveren, Mathieu Vinken, Andrew Worth, José-Manuel Zaldivar] The 7th amendment to the EU Cosmetics Directive prohibits to put animal-tested cosmetics on the market in Europe after 2013. In that context, the European Commission invited stakeholder bodies (industry, non-governmental organisations, EU Member States, and the Commission's Scientific Committee on Consumer Safety) to identify scientific experts in five toxicological areas, i.e. toxicokinetics, repeated dose toxicity, carcinogenicity, skin sensitisation, and reproductive toxicity for which the Directive foresees that the 2013 deadline could be further extended in case alternative and validated methods would not be available in time. The selected experts were asked to analyse the status and prospects of alternative methods and to provide a scientifically sound estimate of the time necessary to achieve full replacement of animal testing. In summary, the experts confirmed that it will take at least another 7-9years for the replacement of the current in vivo animal tests used for the safety assessment of cosmetic ingredients for skin sensitisation. However, the experts were also of the opinion that alternative methods may be able to give hazard information, i.e. to differentiate between sensitisers and non-sensitisers, ahead of 2017. This would, however, not provide the complete picture of what is a safe exposure because the relative potency of a sensitiser would not be known. For toxicokinetics, the timeframe was 5-7years to develop the models still lacking to predict lung absorption and renal/biliary excretion, and even longer to integrate the methods to fully replace the animal toxicokinetic models. For the systemic toxicological endpoints of repeated dose toxicity, carcinogenicity and reproductive toxicity, the time horizon for full replacement could not be estimated. Springer-Verlag, 2011 Alternative methods nationallicence Toxicokinetics nationallicence Skin sensitisation nationallicence Repeated dose toxicity nationallicence Carcinogenicity nationallicence Reproductive toxicity nationallicence Adler Sarah Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET), Federal Institute for Risk Assessment (BfR), Berlin, Germany aut Basketter David DABMEB Consultancy Ltd, Sharnbrook, UK aut Creton Stuart NC3Rs, London, UK aut Pelkonen Olavi Department of Pharmacology and Toxicology, University of Oulu, Oulu, Finland aut van Benthem Jan Laboratory for Health Protection Research, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands aut Zuang Valérie ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Andersen Klaus Department of Dermatology and Allergy Centre, Odense University Hospital, University of Southern Denmark, Odense, Denmark aut Angers-Loustau Alexandre ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Aptula Aynur SEAC, Unilever, Colworth Science Park, Sharnbrook, UK aut Bal-Price Anna ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Benfenati Emilio Laboratory of Environmental Chemistry and Toxicology, Instituto di Ricerche Farmacologiche "Mario Negri”, Milan, Italy aut Bernauer Ulrike Federal Institute for Risk Assessment (BfR), Berlin, Germany aut Bessems Jos Centre for Substances and Integrated Risk Assessment, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands aut Bois Frederic Chair of Mathematical Modelling for Systems Toxicology, Compiegne and INERIS, DRC/VIVA/METO, Compiegne University of Technology, Verneuil en Halatte, France aut Boobis Alan Imperial College London, London, UK aut Brandon Esther Centre for Substances and Integrated Risk Assessment, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands aut Bremer Susanne ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Broschard Thomas Merck KGaA, Darmstadt, Germany aut Casati Silvia ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Coecke Sandra ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Corvi Raffaella ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Cronin Mark School of Pharmacy and Chemistry Liverpool, John Moores University, Liverpool, UK aut Daston George Miami Valley Innovation Center, The Procter and Gamble Company, Cincinnati, OH, USA aut Dekant Wolfgang Department of Toxicology, Julius-Maximilians-Universität Würzburg, Würzburg, Germany aut Felter Susan Procter and Gamble Company, Central Product Safety, Cincinnati, OH, USA aut Grignard Elise ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Gundert-Remy Ursula Department Toxicology, Medical School (Charité), Berlin, Germany aut Heinonen Tuula FICAM, School of Medicine, University of Tampere, Tampere, Finland aut Kimber Ian University of Manchester, Manchester, UK aut Kleinjans Jos Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands aut Komulainen Hannu Department of Environmental Health, National Institute for Health and Welfare (THL), Kuopio, Finland aut Kreiling Reinhard Clariant Produkte (Deutschland) GmbH, Sulzbach, Germany aut Kreysa Joachim ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Leite Sofia ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Loizou George Health and Safety Laboratory, Mathematical Sciences Unit, Health Improvement Group, Harpur Hill, Buxton, UK aut Maxwell Gavin SEAC, Unilever, Colworth Science Park, Sharnbrook, UK aut Mazzatorta Paolo Nestlé Research Center, Vers-chez-les-Blanc, Lausanne, Switzerland aut Munn Sharon ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Pfuhler Stefan Procter and Gamble Company, Central Product Safety, Cincinnati, OH, USA aut Phrakonkham Pascal ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Piersma Aldert Laboratory for Health Protection Research, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands aut Poth Albrecht Harlan Cytotest Cell Research GmbH, Roßdorf, Germany aut Prieto Pilar ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Repetto Guillermo University Pablo de Olavide, Sevilla, Spain aut Rogiers Vera Department of Toxicology, Vrije Universiteit Brussel, Brussels, Belgium aut Schoeters Greet Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium aut Schwarz Michael Institute of Pharmacology und Toxicology, University of Tuebingen, Tuebingen, Germany aut Serafimova Rositsa ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Tähti Hanna FICAM, School of Medicine, University of Tampere, Tampere, Finland aut Testai Emanuela Istituto Superiore di Sanità, Rome, Italy aut van Delft Joost Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands aut van Loveren Henk Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands aut Vinken Mathieu Department of Toxicology, Vrije Universiteit Brussel, Brussels, Belgium aut Worth Andrew ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Zaldivar José-Manuel ECVAM, Institute for Health & Consumer Protection, European Commission Joint Research Centre, Ispra, VA, Italy aut Archives of Toxicology Springer-Verlag 85/5(2011-05-01), 367-485 0340-5761 85:5<367 2011 85 204 https://doi.org/10.1007/s00204-011-0693-2 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00204-011-0693-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Adler Sarah Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET), Federal Institute for Risk Assessment (BfR), Berlin, Germany aut NATIONALLICENCE 700 1- Basketter David DABMEB Consultancy Ltd, Sharnbrook, UK aut NATIONALLICENCE 700 1- Creton 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