title: Integrated testing strategy (ITS) for bioaccumulation assessment under REACH.
abstract: REACH (registration, evaluation, authorisation and restriction of chemicals) regulation requires that all the chemicals produced or imported in Europe above 1 tonne/year are registered. To register a chemical, physicochemical, toxicological and ecotoxicological information needs to be reported in a dossier. REACH promotes the use of alternative methods to replace, refine and reduce the use of animal (eco)toxicity testing. Within the EU OSIRIS project, integrated testing strategies (ITSs) have been developed for the rational use of non-animal testing approaches in chemical hazard assessment. Here we present an ITS for evaluating the bioaccumulation potential of organic chemicals. The scheme includes the use of all available data (also the non-optimal ones), waiving schemes, analysis of physicochemical properties related to the end point and alternative methods (both in silico and in vitro). In vivo methods are used only as last resort. Using the ITS, in vivo testing could be waived for about 67% of the examined compounds, but bioaccumulation potential could be estimated on the basis of non-animal methods. The presented ITS is freely available through a web tool.
authors.affiliation: Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Lombardo
authors.affiliation: Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Roncaglioni
authors.affiliation: Laboratory of Evironmental Chemistry and Toxicology, Department of Environmental Health Science, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Via G. La Masa 19, Milan 20156, Italy. Electronic address: benfenati@marionegri.it.
authors.forename: Emilio
authors.initials: E
authors.lastname: Benfentati
authors.affiliation: Analytisches Laboratorium, Bahnhofstr. 1, Luhnstedt 24816, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Nendza
authors.affiliation: Centre for Fish and Wildlife Health, University of Bern, PO Box 8466, Bern CH-3001, Switzerland.
authors.forename: Helmut
authors.initials: H
authors.lastname: Segner
authors.affiliation: Departament d'Enginyeria Quimica, Universitat Rovira i Virgili, Av. Països Catalans 26, Catalunya, Tarragona 43007, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fernández
authors.affiliation: Department of Ecological Chemistry, Helmholtz Centre for Environmental Research-UFZ, Permoserstraße 15, Leipzig 04318, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Kühne
authors.affiliation: Department of Environmental Engineering, Technical University of Denmark, Miljøvej, Kgs. Lyngby DK-2800, Denmark; Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire MK44 1LQ, UK.
authors.forename: Antonio
authors.initials: A
authors.lastname: Franco
authors.affiliation: SIMPPLE S.L., Cr Joan Maragall 1 1r, Catalunya, Tarragona 43003, Spain.
authors.forename: Eduard
authors.initials: E
authors.lastname: Pauné
authors.affiliation: Department of Ecological Chemistry, Helmholtz Centre for Environmental Research-UFZ, Permoserstraße 15, Leipzig 04318, Germany; Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Leipziger Strasse 29, Freiberg 09596, Germany.
authors.forename: Gerrit
authors.initials: G
authors.lastname: Schüürmann
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D000818:Animals; D005062:European Union; D033161:Government Regulation; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000032:analysis / Q000493:pharmacokinetics* / Q000633:toxicity; D006801:Humans; D019221:Mandatory Reporting; D009930:Organic Chemicals / Q000032:analysis / Q000493:pharmacokinetics* / Q000633:toxicity; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards
chemical_list: D015386:Hazardous Substances; D009930:Organic Chemicals
keywords: Alternative methods; Bioaccumulation; In silico methods; Integrated testing strategy; REACH; Reduce animal testing