Biokinetics working group: in vitro to in vivo extrapolation

This publication is the second volume of a series of six Annual Reports that summarises the activities of a Research Initiative in the field of repeated dose systemic toxicity, which started on 1 January 2011. The Research Initiative is co-funded by the European Commission Directorate-General for Research & Innovation within the HEALTH theme of the Seventh European Research Programme (FP7) and Cosmetics Europe. The framework for this Research Initiative was created in June 2009 through the FP7 call for proposals 'Alternative Testing Strategies: Towards the replacement of in vivo repeated dose systemic toxicity testing' with a total funding of EUR 50 million. The Research Initiative follows the long-term target in chemical safety testing 'Safety Evaluation Ultimately Replacing Animal Testing' (SEURAT), which was presented by the FP7 HEALTH theme in 2008. It is called 'SEURAT-1' indicating that this is the first step in the specific area of repeated dose systemic toxicity addressing the global long-term strategic target SEURAT. The aim of the SEURAT-1 Research Initiative is the development of a long-term research strategy for research and development work leading to pathway-based human safety assessments in the field of repeated dose systemic toxicity testing of chemicals. The overall goal is to establish animal-free Innovative Toxicity Testing (ITT) methods, enabling robust safety assessment that will be more predictive than existing testing procedures. In order to achieve this, a cluster of projects has been organised, consisting of five research projects, supported by a 'data handling and servicing project' and a 'coordination and support project'. The Scientific Expert Panel, which is composed of the SEURAT-1 project coordinators and external international experts in the field of repeated dose systemic toxicity, provides scientific advice regarding the research work and future orientation of the SEURAT-1 Research Initiative and, thus, plays a key role in its scientific coordination.