David A. Basketter
DABMEB Consultancy, Sharnbrook, UK
Harvey Clewell
The Hamner Institutes for Health Sciences, Research Triangle Park, NC, USA
Ian Kimber
Faculty of Life Sciences, University of Manchester, UK
Annamaria Rossi
CAAT-Europe, University of Konstanz, Germany
Bas Blaauboer
Doerenkamp-Zbinden Chair on Alternatives to Animal Testing in Toxicological Risk Assessment, Institute for Risk Assessment Sciences, Division of Toxicology, Utrecht University, The Netherlands
Robert Burrier
Stemina Biomarker Discovery, Madison, WI, USA
Mardas Daneshian
CAAT-Europe, University of Konstanz, Germany
Chantra Eskes
SeCAM, Agno, Switzerland
Alan Goldberg
CAAT, Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Baltimore, MD, USA
Nina Hasiwa
CAAT-Europe, University of Konstanz, Germany
Sebastian Hoffmann
seh consulting + services, Cologne, Germany
Joanna Jaworska
Procter & Gamble, Brussels, Belgium
Thomas B. Knudsen
US EPA, Research Triangle Park, NC, USA
Robert Landsiedel
BASF, Ludwigshafen, Germany
Marcel Leist
CAAT-Europe, University of Konstanz, Germany
Paul Locke
CAAT, Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Baltimore, MD, USA
Gavin Maxwell
Unilever, SEAC, Bedford, UK
James McKim
CeeTox, Kalamazoo, MI, USA
Emily A. McVey
NOTOX B.V., ‘s-Hertogenbosch, The Netherlands
Gladys Ouédraogo
L’Oréal, Paris, France
Grace Patlewicz
DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, USA
Olavi Pelkonen
Department of Pharmacology and Toxicology, University of Oulu, Finland
Erwin Roggen
Novozymes A/S, Denmark
Costanza Rovida
CAAT-Europe, University of Konstanz, Germany
Irmela Ruhdel
Animal Welfare Academy / German Animal Welfare Federation, Munich, Germany
Michael Schwarz
Toxicology, University of Tuebingen, Germany
Andreas Schepky
Beiersdorf, Hamburg, Germany
Greet Schoeters
VITO, Mol, Belgium
Nigel Skinner
Agilent Technologies, Inc., Berkshire, UK
Kerstin Trentz
Bioservices, Planegg, Germany
Marian Turner
Freelance science writer
Philippe Vanparys
ALTOXICON BVBA, Vosselaar, Belgium
James Yager
Johns Hopkins Bloomberg School of Public Health, Environmental Health Sciences, USA
Joanne Zurlo
CAAT, Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Baltimore, MD, USA
Thomas Hartung
CAAT, Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Baltimore, MD, USA; CAAT-Europe, University of Konstanz, Germany
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Abstract
Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science.
