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OSIRIS – Optimized strategies for Risk Assessment of Industrial  Chemicals through Integration of Non –Test and Test Information

The goal of the project OSIRIS  (2007–2011) was to develop integrated testing strategies (ITS) fit for the registration, evaluation, authorisation and restriction of chemicals  (REACH) that enable to significantly increase the use of non-testing information for regulatory decision making, and thus to minimise the need for animal testing to the level needed from a risk. To this end, operational procedures were developed, tested and disseminated that guide a transparent and scientifically sound evaluation of chemical substances in a risk-driven, context-specific and substance-tailored manner.

For the first time, an ITS has been equipped with a decision theory framework including alternative methods such as chemical and biological read-across, in vitro results, in vivo information on analogues, qualitative and quantitative structure-activity relationships, thresholds of toxicological concern and exposure-based waiving. OSIRIS took into account cost-benefit analyses, and it aimed to close the gap between risk and societal risk perception. It was based on the new REACH paradigm to move away from extensive standard testing to a more intelligent, substance-tailored approach.
The work was organised in the five interlinked research Pillars:

– Chemical Domain – objective: to develop methods and guidance for transparent and scientifically sound use of chemistry-driven information in ITS,
– Biological Domain – objective: to provide efficient strategies and guidance for exploitation of all types of biological information on toxic effects of chemicals in ITS, focusing on reduced animal use and informed extrapolation across human and environmental toxicology, species, endpoints and time scales,
– Exposure – objective: to develop criteria for exposure informed testing as foreseen in the REACH regulation, and to refine relevant exposure assessment methods accordingly,
– Integration Strategies and Tools – objective: to develop weight-of-evidence approaches for ITS based on a computerized decision theory framework ready for web access, optimizing the use of existing data and non-test information, and minimizing the need for new testing in risk assessment procedures,
– Case Studies – objective: to evaluate the feasibility and effectiveness of the new ITS methodologies and to provide guidance for their use in concrete form, covering major human and environmental endpoints.

Project manager: prof. Marek Jakubowski, MD, PhD
Website: http://osiris.ufz.de

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