Toxicology of Diethylene Glycol Butyl Ether 1. Exposure and Risk Assessment

Abstract

Diethylene glycol mono-n-butyl ether (DGBE) is a glycol ether solvent used in many consumer products including hard-surface cleaners and paints; its acetate ester (DGBA) is also used in paints. The highest consumer exposure to DGBE was estimated to be about 0.06 mg/kg/day from use in cleaners, and to DGBA was 0.19 mg/kg/day by inhalation from use in paints. DGBA was shown to be rapidly metabolized to DGBE, and its systemic toxicity was considered to be similar to DGBE. Prior toxicology studies and those required by a 1988 TSCA Final Test Rule, detailed in the following four papers, confirm that DGBE (and by implication DGBA): (1) can be absorbed dermally, (2) is not genotoxic in a battery of assays, (3) is not a systemic nor a reproductive toxicant by the dermal route in rats, and (4) is not neurotoxic by the dermal route in rats. There is an adequate margin of safety between the no observed adverse effect level in the animal studies and the estimated human exposure levels, confirming that there is no risk of systemic toxicity from the use of DGBE or DGBA in consumer products.

Fertility and developmental toxicity studies of diethylene glycol monobutyl ether (DGBE) in rats

“…The mechanism of DGBE interaction with cells is not clear, possibly involving generation of oxidative stress during hepatic detoxification [12]. Under conditions of repeated exposure, DGBE is nephrotoxic, causing intravascular hemolysis [8,13]. Rats treated with DGBE in drinking water for 13 weeks showed slight hepatocyte hypertrophy and minor pathological changes in the kidneys.…”

Health hazard evaluation report: HETA-97-0214-2689, Dorma Door Controls, Inc., Reamstown, Pennsylvania.

“…10 Hematotoxicity, associated with EGBE in rats, was reported in only one study at very high doses of DGBE; and like other glycol ethers, DGBE was not genotoxic. 10 Except for one case of hypersensitivity associated with DGBE in an office worker, there are no reports of adverse effects in humans from the use of DGBE-containing products. 10,12 No occupational standards have been established for exposure to DGBE.…”

“…10 Except for one case of hypersensitivity associated with DGBE in an office worker, there are no reports of adverse effects in humans from the use of DGBE-containing products. 10,12 No occupational standards have been established for exposure to DGBE.…”

“…10 The dermal route is the most likely route for human exposure because of the extensive use of DGBE in cleaning products and coatings: DGBE has been extensively tested by this route, and has caused no target organ, fertility, developmental, or nervous system toxicity in animal studies. 10 Hematotoxicity, associated with EGBE in rats, was reported in only one study at very high doses of DGBE; and like other glycol ethers, DGBE was not genotoxic. 10 Except for one case of hypersensitivity associated with DGBE in an office worker, there are no reports of adverse effects in humans from the use of DGBE-containing products.…”