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    Evaluation of the applicability of the Benchmark approach to existing toxicological data. Framework: Chemical compounds in the working place

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    Authors
    Appel MJ
    Bouman HGM
    Pieters MN
    Slob W
    Type
    Report
    Language
    en
    
    Metadata
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    Title
    Evaluation of the applicability of the Benchmark approach to existing toxicological data. Framework: Chemical compounds in the working place
    Translated Title
    Evaluatie van de bruikbaarheid van de Benchmark benadering voor bestaande toxicologische data
    Publiekssamenvatting
    Vijf stoffen in de werkomgeving waarvoor risico-evaluaties beschikbaar waren, werden geselecteerd voor analyse met de benchmark-benadering. De kritische studies werden voor elk van deze stoffen geanalyseerd. De onderzochte toxicologische parameters betroffen zowel continue als ordinale gegevens. Het bleek dat dosis-respons modellering redelijk kon worden toegepast op de beschikbare gegevens. Kritische-effect-doseringen ('Critical Effect Doses', CEDs) werden afgeleid voor bijna alle toxicologische parameters. De resulterende 'overall' benchmark dosering benaderde voor twee stoffen de NOAEL en was voor twee stoffen hoger dan de LOAEL. Voor 1 stof kon, na analyse met de benchmark benadering, geen conclusie worden getrokken ten aanzien van de dosis-respons relatie, in welk geval bij het gebruik van de studie als meest kritische studie vraagtekens kunnen worden gezet. Geconcludeerd wordt dat the benchmark-benadering toepasbaar lijkt op toxiciteitsstudies uitgevoerd volgens OECD protocollen, op voorwaarde dat effecten ten minste bij twee doseringen optreden. In die situaties waarbij een effect slechts bij 1 dosering optreedt, vertoont de benchmark-benadering geen verbetering ten opzichte van de NOAEL-benadering. Echter in deze gevallen is elke benadering, en dus ook de NOAEL-benadering onbetrouwbaar. Effecten optredend in slechts 1 dosisgroep kunnen het gevolg zijn van een experimentele factor anders dan de toegediende dosering. Het optreden van effecten bij twee doseringen is dan ook een voorwaarde. De analyse van de vijf stoffen met de benchmark-benadering illustreert dat met de benchmark-benadering een completer beeld van de toxiciteit van stoffen kan worden verkregen.<br>
    Five chemicals used in workplace, for which a risk assessment had already been carried out, were selected and the relevant critical studies re-analyzed by the Benchmark approach. The endpoints involved included continuous, and ordinal data. Dose-response modeling could be reasonablyapplied to the dose-response data encountered, and Critical Effect Doses (CEDs) could be derived for almost all of the endpoints considered. The resulting benchmark dose for the study as a whole was close to the NOAEL in two cases, and higher than the LOAEL in two other cases where no NOAEL could be derived. In the fifth case the dose-response data were considered inconclusive after analysis by the Benchmark approach, making the choice of the study involved as the critical study doubtful.It is concluded that the Benchmark approach appears applicable to OECD toxicity studies, if at least two dose groups with (different) effects are observed. In situations where only one dose group shows effects the benchmark approach does not offer much of an improvement over the NOAEL approach. However, the situation that bserved effects are not replicated in other dose groups may give unreliable results whatever approach used, including the NOAEL approach. A single significantly different dose group could be the result of some unknown experimental factor otherthan the applied dose, and therefore replication of effects in different dose groups is a prerequisite, whatever method of analysis is used. The re-analysis of the five compounds selected illustrates that the Benchmark approach helps in getting a more complete view of the toxicity of the compound, if effects at different levels are observed in different dose groups.<br>
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    Adviescentrum voor chemische arbeidsomstandigheden (ACCA) TNO
    Sponsors
    VROM
    URI
    http://hdl.handle.net/10029/260579
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