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    Exposure informed testing under REACH

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    Authors
    Vermeire TG
    Bakker J
    Bessems JGM
    van de Bovenkamp M
    Dang Z
    van Engelen JGM
    Gunnarsdottir S
    Hagens WI
    Links I
    Marquart H
    Mikkers J
    van Zijverden M
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    Series/Report no.
    RIVM rapport 601017001
    Type
    Report
    Language
    en
    
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    Title
    Exposure informed testing under REACH
    Translated Title
    De rol van blootstelling in REACH-teststrategieen
    Publiekssamenvatting
    De mate waarin mensen blootstaan aan chemicalien kan het aantal testen met proefdieren beinvloeden dat nodig is om de veiligheid van een stof te beoordelen. Dit betekent dat bepaalde onderzoeken niet nodig zijn als mensen of organismen in het milieu niet of nauwelijks aan een stof staan blootgesteld (Exposure Based Waiving, EBW). Hierdoor zijn minder proefdieren nodig. Bij relatief hoge blootstellingen kunnen juist extra testen met proefdieren nodig zijn (Exposure Based Triggering, EBT).
    Goede kennis van deze blootstelling via modellering of meting is hiervoor onontbeerlijk, zowel voor EBW als EBT. Dit geldt voor alle relevante stadia in de levenscyclus van een stof, van productie tot de afvalfase. Alleen dan kan gezegd worden of een blootstelling niet of juist wel relevant is. Het gaat om blootstelling van de mens, direct via consumentenproducten of op de werkplek of indirect via het milieu, en om blootstelling van organismen in het milieu.
    Het RIVM en TNO hebben onderzocht hoe dit onderdeel van teststrategieen kan worden aangewend om proefdiergebruik te verminderen. Het rapport is een deelproduct van het Europese Zesde Kaderproject OSIRIS (Optimized Strategies for Risk Assessment of Industrial Chemicals through Integration of Non-Test and Test Information). Doel van dit project is om teststrategieen te ontwikkelen voor toepassing onder REACH die het proefdiergebruik kunnen verminderen.
    De nieuwe Europese Verordening voor registratie, beoordeling, autorisatie en beperkingen voor chemische stoffen (REACH) verplicht de industrie om een registratiedossier voor haar stoffen in te dienen. De verplichte testen zijn in REACH vastgelegd en afhankelijk van de hoeveelheid stof die op de markt komt. Onder bepaalde voorwaarden, zoals de mate van blootstelling, kan hiervan worden afgeweken.

    The level of exposure of humans and organisms in the environment to chemical substances can directly influence the number of tests with experimental animals that are necessary to ensure the adequate safety assessment of those substances. The consequence of this approach is that some tests may be waived if it can be shown that humans or organisms in the environment are either not or only minimally exposed to these substances (Exposure-Based Waiving, EBW). In such cases, fewer experimental animals are needed. In contrast, extra testing can be necessary - and therefore extra experimental animals - when the exposure to such substances is high (Exposure-Based Triggering, EBT).
    Extensive knowledge of the level and type of exposure through modelling or monitoring is essential for both EBW and EBT. Such modelling/monitoring applies to all relevant life-cycle stages of a substance, from the production to the waste stage. Only if such knowledge is available can the exposure be assessed to be relevant or not. In this context, the term exposure encompasses the direct exposure of humans to substances at the workplace or via consumer products, the indirect exposure of humans to substances via the environment as well as the exposure of organisms in the environment.
    RIVM and the Netherlands Organisation for Applied Scientific Research (TNO) have investigated how EBW and EBT can be used as a determinant in applying testing strategies and how EBW can be used to reduce the number of experimental animals required for the tests. This report is a product of the European Union's Sixth Framework Project OSIRIS (Optimized Strategies for Risk Assessment of Industrial Chemicals through Integration of Non-Test and Test Information). The aim of OSIRIS is to develop testing strategies for application under REACH that will lead to a reduction in the number of animal tests.
    The new European Regulation for the Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) requires industry to submit a registration dossier. REACH has established tonnage-dependent testing requirements for industry. Under specific conditions, such as where exposure can be shown to be absent or minimal, REACH allows waiving of the tests.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    TNO
    Sponsors
    EU Commission within the Sixth Framework Programme (2002-2006)
    General of RIVM within the framework of Project S/601001 (Integrated Testing Strategies)
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