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t4 Report: A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

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David A. Basketter1,§, Harvey Clewell2,§, Ian Kimber3,§, Annamaria Rossi4,§,
Bas Blaauboer5, Robert Burrier6, Mardas Daneshian7, Chantra Eskes8, Alan Goldberg9, Nina Hasiwa10, Sebastian Hoffmann11, Joanna Jaworska12, Thomas B. Knudsen13, Robert Landsiedel14, Marcel Leist15, Paul Locke9, Gavin Maxwell16, James McKim17, Emily A. McVey 18, Gladys Ouédraogo19, Grace Patlewicz20, Olavi Pelkonen21, Erwin Roggen22, Costanza Rovida23, Irmela Ruhdel24, Michael Schwarz25, Andreas Schepky26, Greet Schoeters27, Nigel Skinner28, Kerstin Trentz29, Marian Turner30, Philippe Vanparys31, James Yager32, Joanne Zurlo9, and Thomas Hartung33,§

1 DABMEB Consultancy, Sharnbrook, UK; author whitepaper sensitization
2 The Hamner Institutes for Health Sciences, Research Triangle Park, NC, USA; author whitepaper toxicokinetics
3 Faculty of Life Sciences, University of Manchester, UK; author whitepaper sensitization
4 CAAT-Europe, University of Konstanz, Germany; author whitepaper repeated dose toxicity
5 Doerenkamp-Zbinden Chair on Alternatives to Animal Testing in Toxicological Risk Assessment, Institute for Risk Assessment Sciences, Division of Toxicology, Utrecht University, The Netherlands; respondent toxicokinetics
6 Stemina Biomarker Discovery, Madison, WI, USA; respondent reproductive toxicity
7 CAAT-Europe, University of Konstanz, Germany; scientific writer toxicokinetics
8 SeCAM, Agno, Switzerland; respondent toxicokinetics
9 CAAT, Johns Hopkins University, Bloomberg School of Public Health, Department of Environmental Health Sciences, Baltimore, MD, USA
10 CAAT-Europe, University of Konstanz, Germany; scientific writer reproductive toxicity
11 seh consulting + services, Cologne, Germany; respondent repeated dose toxicity
12 Procter & Gamble, Brussels, Belgium; respondent sensitization
13 US EPA, Research Triangle Park, NC, USA; respondent reproductive toxicity
14 BASF, Ludwigshafen, Germany; respondent carcinogenicity
15 CAAT-Europe, University of Konstanz, Germany; respondent repeated dose toxicity
16 Unilever, SEAC, Bedford, UK; respondent sensitization
17 CeeTox, Kalamazoo, MI, USA; respondent repeated dose toxicity
18 NOTOX B.V., ‘s-Hertogenbosch, The Netherlands; scientific writer repeated dose toxicity
19 L’Oréal, Paris, France
20 DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, USA; respondent
21 Department of Pharmacology and Toxicology, University of Oulu, Finland; respondent toxicokinetics
22 Novozymes A/S, Denmark; respondent sensitization
23 CAAT-Europe, University of Konstanz, Germany; scientific writer sensitization
24 Animal Welfare Academy / German Animal Welfare Federation, Munich, Germany
25 Toxicology, University of Tuebingen, Germany; respondent reproductive toxicity
26 Beiersdorf, Hamburg, Germany; respondent sensitization
27 VITO, Mol, Belgium; respondent repeated dose toxicity
28 Agilent Technologies, Inc., Berkshire, UK
29 Bioservices, Planegg, Germany
30 Freelance science writer; scientific writer carcinogenicity
31 ALTOXICON BVBA, Vosselaar, Belgium; respondent carcinogenicity
32 Johns Hopkins Bloomberg School of Public Health, Environmental Health Sciences, USA; respondent
33 CAAT and CAAT-EU; author introduction, conclusion and whitepapers carcinogenicity and
reproductive toxicity


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.

ALTEX 29(1), 3-91
DOI: 10.14573/altex.2012.1.003

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