Zusammenfassung
Für die Bewertung des gesundheitlichen Risikos von Pflanzenschutzmitteln (PSM) und Biozidprodukten (BP) ist die korrekte Abschätzung der Aufnahme der darin enthaltenen Wirkstoffe über die Haut erforderlich. In dieser Veröffentlichung wird dargestellt, wie das Bundesinstitut für Risikobewertung (BfR), in Abhängigkeit von den verfügbaren Daten, die dermale Absorption von Wirkstoffen in PSM und BP ableitet. Dabei finden zwei neue Bewertungsleitfäden der EFSA und der OECD Verwendung. Grundlegende Prinzipien der Studienauswertung werden ebenso beschrieben wie Möglichkeiten zur Abschätzung der Hautabsorption, wenn keine produktspezifischen experimentellen Daten vorliegen. Die Publikation dieser Vorgehensweise stellt einen ersten Schritt für die Harmonisierung der Bewertung in den Zulassungsverfahren von PSM und BP dar.
Abstract
A correct estimate of dermal absorption of the contained active ingredients is needed for the health risk assessment of plant protection and biocidal products. In this paper, the approach is reported that is currently taken by the Federal Institute for Risk Assessment to derive the dermal absorption rate of active substances in plant protection or biocidal products, depending on the available data. It is explained what use is made of two new guidance documents that were recently released by EFSA and OECD. Basic principles of the assessment of dermal absorption studies are described but also opportunities for estimations in the absence of product-specific experimental data. This publication is considered a first step towards harmonisation of assessment in the authorisation processes for plant protection and biocidal products.
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Niemann, L., Martin, S., Golle, M. et al. Die Vorgehensweise des Bundesinstitutes für Risikobewertung bei der Abschätzung der dermalen Absorption von Wirkstoffen in Pflanzenschutzmitteln und Biozidprodukten. J. Verbr. Lebensm. 8, 381–388 (2013). https://doi.org/10.1007/s00003-013-0842-z
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DOI: https://doi.org/10.1007/s00003-013-0842-z