Invitation to the congress

Alternative Test Methods in Inhalation Toxicology

The new testing requirements under the upcoming new European Regulation of Chemical Substances (REACH) are triggering numerous toxicological studies on existent and new chemicals. Due to the importance of relevant toxicological data to ensure safe occupational work and consumer environments, an appreciable number of acute and repeated inhalation studies need to be performed. Endpoints, such as in vivo genotoxicity and developmental toxicity, which have been studied by non-inhalation methods, may have to be verified by inhalation studies. In addition, paradigms with regard to acute inhalation testing are currently under scrutiny and revision. OECD expert groups are involved in updating the OECD testing guideline 403 from 1981 into three modified guidelines 403, 433, and 436 in order to comply with the requirements set out by the Globally Harmonized System for Classification and Labelling (GHS). Likewise, acute inhalation tests need to consider aspects of animal welfare and reduction of animal numbers in such tests. The updated guidelines provide prove a better rationalization as to how these objectives can be successfully implemented in future testing strategies. Inhalation testing is always triggered by the likelihood of human exposure be it short-term high level or continuous low-level. Tiered approaches are introduced which more clearly appreciate the trigger and may waive the need to conduct inhalation studies. Moreover, derogation principles have been developed to put the outcome of such studies into a better perspective and more meaningful classification and labelling. The new requirements for testing have stimulated advocacy groups for animal welfare because of the increased need for animal testing. One major objective of this workshop is to present and discuss the future benefits of the updated or novel testing and regulatory approaches and how novel in vitro approaches could be utilized to account for the need for alternative test methodologies. This involves a critical discussion about the benefits and shortcomings of “inhalation-like in vitro assays” and how such approaches could find their way into the regulatory arena.