Benfenati, E.

Bleeker, E.

Dimitrov, S.

Franco, Antonio

Giralt, F.

Kühne, R.

Lombardo, A.

Mclachlan, M.

Nendza, M.

Rallo, R.

Roncalioni, A.

Scheringer, M.

Segner, H.

Strempel, S.

Trapp, Stefan

Vermeire, T.

The efficient assessment of the bioaccumulation potential of chemicals under REACH with integrated test strategies (ITS) requires multiple tools. Existing data have to be searched and information from chemical structures and physico-chemical properties need to be evaluated prior to considering to conduct in-vivo experiments with vertebrates. The OSIRIS inventory of chemistry-driven and in-silico BCF modules for ITS compiles: · Sources of existing data · Computational methods - B/nonB classification models - QSARs - Physiological models - Exposure models - Read across · in-vitro tools · 3R (Refine, Reduce, Replace) modules The ITS components for bioaccumulation listed in the ECHA Guidance on information requirements and chemical safety assessment [1,2] have been extended with new knowledge generated in OSIRIS and complemented with feedback from stakeholders on the actual problems in using ITS for chemical registration. The alternative ITS modules share three major objectives to save time and money by reducing the number of experimental animals required to come to a conclusion about the bioaccumulation potential of chemicals under REACH: · Classification of non-B/B/vB-compounds · Omission of BCF studies, that are scientifically unnecessary or technically not feasible · Waiving of BCF studies, that provide no risk-relevant information The OSIRIS ITS for bioaccumulation will be publicly available (webtool) after further refinement based on stakeholder feedback. Its concepts and modules, as well as validation results, are presented in detail in a dedicated poster corner. [1] ECHA. 2008. Guidance on information requirements and chemical safety assessment Chapter R.11: PBT assessment. (http://echa.europa.eu/reach_en.asp). Accessed 6 March 2009. [2] ECHA. 2008. Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance. (http://echa.europa.eu/reach_en.asp). Accessed 6 March 2009. Acknowledgement - This work was supported by the EU 6th Framework Integrated Project OSIRIS (contract no. GOCE-ET-2007-037017), http://www.osiris-reach.eu

Online Research Database In Technology

Integrated testing strategies (ITS) for bioaccumulation: hierarchical scheme of chemistrydriven modules and definition of applicability domains

http://orbit.dtu.dk/ws/files/6332355/AbstractBook.pdf

Integrated testing strategies (ITS) for bioaccumulation: hierarchical scheme of chemistrydriven modules and definition of applicability domains

Abstract

Similar works

Full text

Available Versions

Online Research Database In Technology