Integrated Testing Strategies (ITS) for safety assessment.

Costanza Rovida (1) , Nathalie Alépée (2) , Anne M Api (3) , David A Basketter (3) , Frédéric y Bois (4) , Francesca Caloni (5) , Emanuela Corsini (5) , Mardas Daneshian (1) , Chantra Eskes (6) , Janine Ezendam (7) , Horst Fuchs (8) , Patrick Hayden (9) , Christa Hegele-Hartung (10) , Sebastian Hoffmann (11) , Bruno Hubesch (12) , Miriam N Jacobs (13) , Joanna Jaworska (14) , André Kleensang (15) , Nicole Kleinstreuer (16) , Jon Lalko (3) , Robert Landsiedel (10) , Frédéric Lebreux (17) , Thomas Luechtefeld (15) , Monica Locatelli (18) , Annette Mehling (10) , Andreas Natsch (19) , Jonathan W Pitchford (20) , Donald Prater (21) , Pilar Prieto (22) , Andreas Schepky (23) , Gerrit Schüürmann (24) , Lena Smirnova (15) , Colleen Toole (25) , Erwin van Vliet (26) , Dirk Weisensee (27) , Thomas Hartung (15)

1 University of Konstanz
2 L'OREAL
3 DABMEB Consultancy Ltd
4 INERIS - Institut National de l'Environnement Industriel et des Risques
5 UNIMI - Università degli Studi di Milano = University of Milan
6 Societe européenne de toxicologie in vitro
7 Centre for Health Protection
8 Department of Computer Science [Chapel Hill]
9 EnFlo Laboratory
10 BASF
11 Seh consulting
12 Hubesch Consult BVBA
13 Institut für Technische Mechanik [Clausthal]
14 Procter & Gamble
15 CAAT EU - Centre for Alternatives to Animal Testing
16 Research Triangle Park
17 DCSO - Laboratoire de synthèse organique
18 UPMF IUG - Université Pierre Mendès France - Grenoble 2 - Institut d'urbanisme de Grenoble
19 Phytopathology Group
20 Mathematics
21 FDA - U.S. Food and Drug Administration
22 Institute for Health and Consumer Protection
23 Beiersdorf AG
24 Centre for Environmental Research
25 CCT - Center for Computation and Technology [Baton Rouge]
26 Catholic University Leuven
27 CellSystems GmbH

Integrated testing strategies (ITS), as opposed to single definitive tests 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: testing strategy; Tox21c; in vitro methods; skin sensitization; computational toxicology

Domains: Cellular Biology; Toxicology

Costanza Rovida, Nathalie Alépée, Anne M Api, David A Basketter, Frédéric y Bois, et al.. Integrated Testing Strategies (ITS) for safety assessment.. ALTEX - Alternatives to Animal Experimentations, 2015, 32 (1), pp.25-40. ⟨10.14573/altex.1411011⟩. ⟨hal-01127740⟩