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Propylene Glycol Monomethyl Ether (PGME): Inhalation Toxicity and Carcinogenicity in Fischer 344 Rats and B6C3F1 Mice

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674, pjspencer@ dow.com

James W. Crissman

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674

William T. Stott

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674

Richard A. Corley

Pacific Northwest National Laboratory, Richland, Washington 99352

Frank S. Cieszlak

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674

Alan M. Schumann

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674

Jerry F. Hardisty

Experimental Pathology Laboratories, Inc., Research Triangle Park, North Carolina 27709

A series of inhalation studies with propylene glycol monomethyl ether (PGME) vapor were undertaken to characterize its subchronic toxicity in mice and chronic toxicity/oncogenicity in rats and mice. Groups of male and female Fischer 344 rats and B6C3F1 mice were exposed to 0,300, 1,000, or 3,000 ppm vapor from 1 week to 2 years. Primary treatment-related effects included: initial sedation of animals exposed to 3,000 ppm and its subsequent resolution correlating with induction of hepatic mixed function oxidase activity and S-phase DNA synthesis; elevated mortality in high-exposure male rats and mice (chronic study); elevated deposition of alpha_2U-globulin (_2U-G) and associated nephropathy and S-phase DNA synthesis in male rat kidneys; accelerated atrophy of the adrenal gland X-zone infemale mice (subchronic study only); and increased occurrence and/or severity of eosinophilic foci of altered hepatocytes in male rats. No toxicologically relevant statistically significant increases in neoplasia occurred in either species. A numerical increase in the incidence of kidney adenomas occurred in intermediate-exposure male rats; however, the association with _2U-G nephropathy, a male rat specific effect, indicated a lack of relevance for human risk assessment.

Key Words: Propylene glycol monomethyl ether • PGME • glycol ether • carcinogenicity • inhalation • toxicity • rats • mice • alpha2U-globulin nephropathy • altered heptocellular foci • cell proliferation.

Toxicologic Pathology, Vol. 30, No. 5, 570-579 (2002)
DOI: 10.1080/01926230290105848


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