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Integrated testing strategies (ITS) for safety assessment

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Costanza Rovida1, Nathalie Alépée2, Anne M. Api3, David A. Basketter4, Frédéric Y. Bois5, Francesca Caloni6, Emanuela Corsini7, Mardas Daneshian1, Chantra Eskes8, Janine Ezendam9, Horst Fuchs10, Patrick Hayden11, Christa Hegele-Hartung12, Sebastian Hoffmann13, Bruno Hubesch14, Miriam N. Jacobs15, Joanna Jaworska16, André Kleensang20, Nicole Kleinstreuer17, Jon Lalko3, Robert Landsiedel18, Frédéric Lebreux19, Thomas Luechtefeld20, Monica Locatelli21, Annette Mehling18, Andreas Natsch22, Jonathan W. Pitchford23, Donald Prater24, Pilar Prieto25, Andreas Schepky26, Gerrit Schüürmann27,28, Lena Smirnova20, Colleen Toole29, Erwin van Vliet30, Dirk Weisensee10 and Thomas Hartung1,20
1 CAAT Europe, University of Konstanz, Germany;
2 L’Oréal R&I, Aulnay, France;
3 Research Institute for Fragrance Materials, Inc., Woodcliff Lake, USA; 4DABMEB Consultancy Ltd, Sharnbrook, UK;
5 INERIS, DRC/VIVA/METO, Verneuil en Halatte, France;
6 Università degli Studi di Milano, Department of Health, Animal Science and Food Safety (VESPA), Milan, Italy;
7 Università degli Studi di Milano, Department of Pharmacological and Biomolecular Sciences (DISFEB), Milan, Italy;
8 European Society of Toxicology In Vitro, La croix Saint Ouen, France;
9 National Institute for Public Health and the Environment (RIVM), Centre for Health Protection, Bilthoven, The Netherlands;
10 CellSystems GmbH, Troisdorf, Germany;
11 MatTek Corp., Ashland, MA, USA;
12 Bayer AG, West Haven, USA;
13 seh consulting + services, Paderborn, Germany;
14 Cefic LRI and EPAA, Brussels, Belgium; Hubesch Consult BVBA, Sint-Pieters-Leeuw, Belgium;
15 Scientific Committee and Emerging Risks Unit, European Food Safety Authority, Parma, Italy; current address Centre for Radiation, Chemical and Environmental Hazards, Public Health England, UK;
16 Procter & Gamble, Modelling & Simulation Biological Systems, Brussels Innovation Center, Strombeek-Bever, Belgium;
17 ILS/NICEATM, Research Triangle Park, NC, USA;
18 BASF SE, Ludwigshafen, Germany;
19 Laboratoire de Synthèse Organique, CNRS UMR 7652, Ecole Polytechnique, Palaiseau, France;
20 Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;
21 REACH Mastery, Como, Italy;
22 Givaudan Schweiz AG, Dübendorf, Switzerland;
23 Departments of Biology and Mathematics, University of York, UK;
24 Food and Drug Administration, European Bureau, Brussels, Belgium;
25 EURL ECVAM, Systems Toxicology Unit, Institute for Health and Consumer Protection, European Commission, Joint Research Centre, Ispra, Italy;
26 Beiersdorf AG, Hamburg, Germany;
27 UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany;
28 Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Germany;
29 CeeTox Inc., Kalamazoo, MI, USA;
30 SeCAM Services & Consultation on Alternative Methods, Agno, Switzerland


Integrated testing strategies (ITS), as opposed to a single definitive test or fixed batteries of tests, are expected to efficiently combine different information sources in a quantifiable fashion to satisfy an information need, in this case for regulatory safety assessments. With increasing awareness of the limitations of each individual tool and the development of highly targeted tests and predictions, the need for combining pieces of evidence increases. The discussions that took place during this workshop, which brought together a group of experts coming from different related areas, illustrate the current state of the art of ITS, as well as promising developments and identifiable challenges. The case of skin sensitization was taken as an example to understand how possible ITS can be constructed, optimized and validated. This will require embracing and developing new concepts such as adverse outcome pathways (AOP), advanced statistical learning algorithms and machine learning, mechanistic validation and “Good ITS Practices”.


Keywords: in vitro methods, testing strategy, Tox21c, skin sensitization, computational toxicology



ALTEX (32)1: 25-40


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