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OSIRIS, a quest for proof of principle for integrated testing strategies of chemicals for four human health endpoints

: Vermeire, Theo; Aldenberg, Tom; Buist, Harrie; Escher, Sylvia; Mangelsdorf, Inge; Pauné, Eduard; Rorije, Emiel; Kroese, Dinant


Regulatory toxicology and pharmacology 67 (2013), Nr.2, S.136-145
ISSN: 0273-2300
Fraunhofer ITEM ()
integrated testing strategy; ITS; weight of evidence; OSIRIS; 3R principle; exposure-based waiving; REACH; data quality

Chemical substances policies in Europe are aiming towards chemical safety and at the same time a reduction in animal testing. These goals are alleged to be reachable by mining as many relevant data as possible, evaluate these data with regard to validity, reliability and relevance, and use of these data in so-called Integrated Testing Strategies (ITS). This paper offers an overview of four human health endpoints that were part of the EU-funded OSIRIS project, aiming to develop ITS fit for the EU chemicals legislation REACH. The endpoints considered cover their categorical as well as continuous characteristics: skin sensitisation, repeated dose toxicity, mutagenicity and carcinogenicity. Detailed papers are published elsewhere in this volume. The stepwise ITS approach developed takes advantage of existing information, groups information about similar substances and integrates exposure considerations. The different and possibly contradictory information is weighted and th e respective uncertainties taken into account in a weight of evidence (WoE) approach. In case of data gaps, the ITS proposes the most appropriate method to acquire the missing information. Each building block for the ITS, i.e. each in vivo test, in vitro test, (Q)SAR model or human evidence, is evaluated with regard to quality.