Implementation challenges for designing Integrated ITS
Bart De Wever(1,2), Horst W. Fuchs(3), Marianna D. Gaca(4), Cyrille Krul(5), Stan Mikulowski (6); Albrecht Poth(7), Erwin L Roggen(8), Maya R. Vilà (9).
(1): Henkel AG & Co. KGaA, Germany; (2): ALTEXA Development, Monaco (3): Cell Systems, Germany; (4) British American Tobacco, United Kingdom; (5): Netherlands Organisation for Applied Scientific Research (TNO), The Netherlands; (6): Biovator, Sweden; (7): Harlan Cytotest Cell Research, Germany; (8): Novozymes AS, Denmark; (9): Leitat Technological Center, BioInVitro Research Area, Spain.
Erwin L Roggen
Department of Toxicology
Tel. +45 44464220
e-mail: [email protected]
This paper has been published in the journal ‘Toxicology in Vitro’ by Elsevier: the Official Journal of the European Society for Toxicology in Vitro and The American Society for Computation and Cellular Toxicology. Volume 26, issue 3, April 2012, ISSN 0887-2333, www.elsevier.com/locate.toxinvit
At the In Vitro Testing Industrial Platform (IVTIP) Autumn 2009 meeting entitled‘Toxicology in the 21st century (‘TOX21’) – working our way towards a visionary reality’ all delegates endorsed the emerging concept of the „21C‟ vision as the way forward to enable a thorough, reliable and systematic approach to future toxicity testing without the use of animals. One of the emerging concepts focused on integrating a defined number of tests modelling in vivo-relevant and well-characterized toxicity pathways representing mechanistic endpoints. At this meeting the importance of Integrated Testing Strategies (ITS) as tools towards reduction and eventually replacement of the animals currently used for hazard identification and risk assessment was recognized.
At the following IVTIP Spring 2010 meeting entitled „Integrated In Vitro Testing Strategies (ITS) – Implementation Challenges’, various aspects of ITS were discussed. Examples on how to develop and implement an ITS were presented: eye irritation of anti-microbial cleaning products and reproductive toxicity in the context of REACH. A list of practical aspects to be considered when establishing an ITS emerged from the discussions. In addition, the recommendations of a recent ECVAM-EPAA workshop on the validation of ITS were discussed.
In conclusion, the outcome of this workshop improved our understanding of some important factors that may impact the design of an ITS in relation to its purpose, (e.g., screening, or early decision making versus regulatory), the context in which they need to be applied (ICH guidelines, REACH) and the status and quality of the available tools. A set of recommendations of best practices were established and the importance of the applicability of the individual tests as well as the testing strategy itself was highlighted.