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The evaluation of inhalation studies for exposure quality: A case study with formaldehyde.
Toxicol Lett 2019; 312:167-172TL

Abstract

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.

Authors+Show Affiliations

U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: whalan@cox.net.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: stanek.john@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: woodall.george@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: reinhart.paul@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: galizia.audrey@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: glenn.barbara@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: kraft.andrew@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: makris.susan@epa.gov.U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA). 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA. Electronic address: jarabek.annie@epa.gov.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31100492

Citation

Whalan, John E., et al. "The Evaluation of Inhalation Studies for Exposure Quality: a Case Study With Formaldehyde." Toxicology Letters, vol. 312, 2019, pp. 167-172.
Whalan JE, Stanek J, Woodall G, et al. The evaluation of inhalation studies for exposure quality: A case study with formaldehyde. Toxicol Lett. 2019;312:167-172.
Whalan, J. E., Stanek, J., Woodall, G., Reinhart, P., Galizia, A., Glenn, B., ... Jarabek, A. M. (2019). The evaluation of inhalation studies for exposure quality: A case study with formaldehyde. Toxicology Letters, 312, pp. 167-172. doi:10.1016/j.toxlet.2019.05.011.
Whalan JE, et al. The Evaluation of Inhalation Studies for Exposure Quality: a Case Study With Formaldehyde. Toxicol Lett. 2019 Sep 15;312:167-172. PubMed PMID: 31100492.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The evaluation of inhalation studies for exposure quality: A case study with formaldehyde. AU - Whalan,John E, AU - Stanek,John, AU - Woodall,George, AU - Reinhart,Paul, AU - Galizia,Audrey, AU - Glenn,Barbara, AU - Kraft,Andrew, AU - Makris,Susan L, AU - Jarabek,Annie M, Y1 - 2019/05/14/ PY - 2018/10/10/received PY - 2019/02/28/revised PY - 2019/05/09/accepted PY - 2019/5/18/pubmed PY - 2019/7/2/medline PY - 2019/5/18/entrez KW - Exposure KW - Exposure quality KW - Formaldehyde KW - Formalin KW - Inhalation KW - Study quality SP - 167 EP - 172 JF - Toxicology letters JO - Toxicol. Lett. VL - 312 N2 - 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. SN - 1879-3169 UR - https://www.unboundmedicine.com/medline/citation/31100492/The_Evaluation_of_Inhalation_Studies_for_Exposure_Quality:_A_Case_Study_with_Formaldehyde L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-4274(18)32004-6 DB - PRIME DP - Unbound Medicine ER -