ACROLEIN: HAZARD CHARACTERIZATION AND EXPOSURE–RESPONSE ANALYSIS

Abstract

Acrolein has been assessed as a Priority Substance under the Canadian Environmental Protection Act. Adverse health effects associated with exposure to acrolein are primarily confined to the tissue of first contact and are concentration related. A tolerable concentration of 0.4 μg/m³ has been derived, based upon the benchmark dose associated with a 5% increase in degenerative changes in the nasal respiratory epithelium of rats in a short-term inhalation study. For ingestion, a provisional tolerable concentration of 1.5 μg/L (7.5 μg/kg body weight per day) has been derived, based upon the benchmark dose associated with a 5% adverse response for non-neoplastic lesions in the gastrointestinal tract of rats in a subchronic oral study.

ACKNOWLEDGMENTS

To ensure transparency and defensibility of the health assessments, a cut-off date for consideration of new data is specified so as not to compromise the integrity of several stages of internal and external review. Data obtained after October 1998 were not considered for inclusion in this assessment.

Sections of the Assessment Report and supporting documentation on genotoxicity were reviewed by D. Blakey of the Environmental and Occupational Toxicology Division of Health Canada. M. Walker of Health Canada provided statistical support. Sections of the supporting documentation pertaining to human health were reviewed externally by R. Parent (Consultox Ltd.), W.F. Mayr and S. Jacobi (both from Degussa AG), primarily to address adequacy of coverage. Accuracy of reporting, adequacy of coverage and defensibility of conclusions with respect to hazard characterization and dose-response analyses were considered in written review by staff of the Information Department of BIBRA International and at a panel meeting of the following members, convened by Toxicology Excellence for Risk Assessment (TERA) on November 16, 1998, in Cincinnati, Ohio: M. Aardema, Procter & Gamble; J. Christopher, California Environmental Protection Agency; M. Dourson, TERA; M. Friedman, private consultant; M. Gargas, ChemRisk Division of McLaren/Hart; H. Heck, Chemical Industry Institute of Toxicology (written comments); G. Leikauf, University of Cincinnati; M. Moore, Environmental Protection Agency; R. Tardiff, The Sapphire Group, Inc.; V. Vu, Environmental Protection Agency; and V. Walker, New York State Department of Health.