Suchergebnisse

This retrospective analysis of Acute Reference Doses (ARfD) values is based on pesticides that have been evaluatedand peer-reviewed in Europe between 2000 and 2008. The published database of the 198 ARfDs was analysed. For48% of all substances, no ARfD was considered necessary because of the low acute toxicity of these pesticides. The majority of ARfDs were based on studies that were required for pesticides and conducted for regulatory purposesand in which specific acute alerts were investigated. In less than 10% of cases, conservatively established ARfDswere based on repeated-dose toxicity or multigeneration studies. For 4 of these 198 pesticides, a refinement ofa conservative ARfD using an additional toxicity study would be justifiable because a more realistic calculationof the exposure component was not sufficient to eliminate any health concern. In the analysed database, specialstudies for ARfD refinement were submitted for 8 of the 198 pesticides. They were mostly performed in additionto the basic acute toxicity data requirements, in cases in which it was apparent that the acute intake estimationexceeded a conservatively established ARfD. However, several studies were not accepted by regulatory authoritiesbecause of quality deficiencies. The results of this analysis indicate that the development of a harmonised studydesign that produces consistent and robust toxicological data on the occurrence of acute effects and their doseresponse would be valuable for setting ARfDs. Such a protocol, plus additional research on the mode of actionfor acute effects observed in relevant targets for ARfD derivation, is considered as an important prerequisite foran improved acute risk assessment for pesticides.

There is growing concern that environmental substances with a potential to modulate the hormonal system may have harmful effects on human health. Consequently, a new EU regulation names endocrine disrupting properties as one of the cut-off criteria for the approval of plant protection products, although it currently fails to provide specific science-based measures for the assessment of substances with such properties. Since specific measures are to be presented by the European Commission in 2013 the development of assessment and decision criteria is a key challenge concerning the implementation of this new EU regulation. Proposals of such decision criteria for substances with potential endocrine disrupting properties in human health risk assessment were developed by the German Federal Institute for Risk Assessment (BfR) and discussed at an expert workshop in November 2009. Under consideration of the requirements laid down within the new plant protection product legislation and the scientific discussions during the workshop, a conceptual framework on evaluation of substances for endocrine disrupting properties in a regulatory context is presented in this paper. Central aspects of the framework include assessment of adversity of effects, establishment of a mode/mechanism of action in animals, considerations concerning the relevance of effects to humans and two options for a regulatory decision.