Issues in the inhalation toxicity testing and hazard assessment for low density particulate ma-terials such as synthetic amorphous silica (SAS)

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Wolfgang Dekant - , University of Würzburg (Author)
  • Evangelia E. Antoniou - , MetaAnalyses.com (Author)
  • Axel Bosch - , Wacker Chemie AG (Author)
  • Gustav Gerd Bruer - , Fraunhofer Institute for Toxicology and Experimental Medicine (Author)
  • Thomas Colnot - , CiS Toxicology, Osorno, Chile (Author)
  • Otto Creutzenberg - , Fraunhofer Institute for Toxicology and Experimental Medicine (Author)
  • Claus-Peter Drexel - , Evonik Operations GmbH (Author)
  • Rodger Duffin - , University of Edinburgh (Author)
  • Nils Krueger - , Evonik Industries AG Evonik Business Services (Author)
  • Jürgen Nolde - , Grace Europe Holding GmbH (Author)
  • Craig Poland - , Regulatory Compliance Limited (Author)
  • Dirk Schaudien - , Fraunhofer Institute for Toxicology and Experimental Medicine (Author)
  • Tobias B. Schuster - , Evonik Operations GmbH (Author)
  • Michael Stintz - , Mechanical Process Engineering Group (Author)
  • Klaus Weber - , AnaPath GmbH, Friedrich-Alexander University Erlangen-Nürnberg (Author)
  • Benno Wessely - , Mechanical Process Engineering Group (Author)
  • Maurice P. Zeegers - , Maastricht University (Author)

Abstract

Inhalation toxicity testing of particulate materials is mandated for classification. According to CLP, particulate materials should be tested as marketed and many particulate materials are marketed as non-respirable particles. However, OECD TG 413 requires exposure to particle sizes that are respirable and reach the alveoli. The requirement for exposure of rats to respirable particles is thus in contrast to CLP and requires the application of high shear forces. The exposure to artificially small particles causes a number of issues that hamper the interpretation of the results of the testing. These issues are aerosol altering in the exposure system, assessment of the adversity of the inflammatory lung responses, inclusion of recovery groups, and extrapolation of the results to humans exposed under occupational condition. In addition, effects of many particulate materials after testing according to OECD 413 are not intrinsic properties, but a general reaction of the lung to the deposited material, show very similar NOAECs for chemical diverse materials, and often are completely reversible.

Details

Original languageEnglish
Pages (from-to)2-11
Number of pages10
JournalToxicology Letters
Volume385
Issue numberSuppl. 1
Publication statusPublished - 2023
Peer-reviewedYes

External IDs

Scopus 85149826388

Keywords