Project objectives:
The goal of the project OSIRIS is to develop integrated testing strategies (ITS) fit for 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 this end, operational procedures are 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.
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Project
Summary:
The envisaged decision theory framework includes 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
takes into account cost-benefit analyses, and it aims to close the gap between risk and societal risk perception. It is based on the new REACH paradigm to move
away from extensive standard testing to a more intelligent, substance-tailored approach.
The work is organised in the five interlinked research Pillars
- Chemical Domain,
- Biological Domain,
- Exposure,
- Integration Strategies and Tools,
- Case Studies,
with a particular focus on more complex, long-term and high-cost endpoints. Case studies will demonstrate the feasibility and effectiveness of the new
ITS methodologies, and provide guidance in concrete form.
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Professor Paul Bardos