The evaluation of inhalation studies for exposure quality: A case study with formaldehyde
Autor: | Andrew D. Kraft, George M. Woodall, John E. Whalan, Susan L. Makris, Barbara S. Glenn, Paul Reinhart, Audrey Galizia, John Stanek, Annie M. Jarabek |
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Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
media_common.quotation_subject Human error Hazard analysis Toxicology 03 medical and health sciences 0302 clinical medicine Test article Formaldehyde Environmental health Humans Medicine Quality (business) media_common Inhalation exposure Air Pollutants Inhalation Exposure Inhalation business.industry Research General Medicine Inhalation chamber 030104 developmental biology business Risk assessment 030217 neurology & neurosurgery Environmental Monitoring |
Zdroj: | Toxicology Letters. 312:167-172 |
ISSN: | 0378-4274 |
Popis: | The inherent complexity of generating and monitoring a test article in an inhalation chamber can make inhalation toxicity testing challenging. Poor study design, human error, and electrical and mechanical problems can adversely affect an inhalation exposure and undermine a study's results. We have developed a process for evaluating seven key elements of exposure quality in inhalation chamber studies: 1) test article characterization, 2) generation method, 3) chamber sampling and analytical method, 4) chamber concentrations, 5) particle size characteristics, 6) chamber type, and 7) controls. For each study evaluated, exposure deficiencies are documented, and a study is given an overall rating (Robust, Adequate, or Poor) for the quality of its exposure characterization and documentation. In combination with the systematic consideration of experimental features other than exposure, these ratings can inform the utility of a study for use in hazard identification and/or exposure-response analysis. Exposure quality evaluations of 204 formaldehyde inhalation studies are presented as a case study. Of these, 34% were rated Robust because they had comprehensive exposure documentation and no serious deficiencies in the key elements of exposure quality. Another 19% of studies with minor uncertainties or limitations were rated Adequate. Conversely, 47% of the studies were rated Poor due to multiple serious exposure deficiencies. This formaldehyde case study illustrates the need to carefully consider the exposure quality of inhalation toxicity studies when their results are used to support hazard and risk assessments. |
Databáze: | OpenAIRE |
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