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ADDENDUM for PROPYLENE GLYCOL Supplement to the 1997 Toxicological Profile for Propylene Glycol BACKGROUND STATEMENT

Administrator of ATSDR prepares toxicological profiles on the 100 most common substances detected at National Priorities List Sites, or on the Priority List and the toxicological profiles be revised " no less often than once every three years ". CERCLA further mandates that the Administrator will establish and maintain an inventory of literature, research and studies on the health effects of toxic substances [ §116)]. The purpose of this addendum is to provide to the public, other federal, state, and local agencies a non-peer reviewed supplement of the scientific data that were published in the open peer-reviewed literature since the initial release of the toxicological profile in 1997. Chapter numbers in this addendum coincide with the toxicological profile for propylene glycol (1997). This document is to be used in conjunction with the toxicological profile, and does not replace it. SUMMARY Propylene glycol is a colorless, odorless liquid which is generally recognized as safe (GRAS) by the Food and Drug Administration (FDA) under 21 CFR §184.1666, for use as a direct food additive under the conditions prescribed. It is also approved by the U.S. FDA for use as certain indirect food additives. Propylene glycol is used as a constituent in a large variety of cosmetics, and is approved and used as a vehicle for topical pharmaceutical preparations. It has a wide range of other practical applications, e.g., used as deicers, coolants, antifreeze, heat transfer and hydraulic fluids, plasticizers and other products. Propylene glycol has low toxicity, is not acutely toxic, and does not irritate the skin. However, contact dermatitis has been reported from a wide variety of topical preparations. Inhalation of the vapors of propylene glycol may present no significant hazard in ordinary applications, but limited human experiences indicate that its mists may be irritating to some individuals [Dow Chemical, 2006]. One study using propylene glycol evaluated the reproductive effects of male and female rats over two generations. Groups of male and female Sprague-Dawley rats were exposed via inhalation to 0, 300, 1,000, or 3,000 parts per million (ppm) of propylene glycol for 6 hours/day for 5 weeks prior to mating, and 6 hours/day 7 days/week during mating and gestation. These investigators observed decreased fertility, and decreased ovary weights in maternal rats. In the dams' offspring, they noticed decreased body weights, reduced survival and litter size, slight delays in 2 3 PROPYLENE GLYCOL puberty onset, and histologic changes in liver and …