IRIS Toxicological Review of Acetone (External Review Draft)
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Acetone is produced endogenously in the human body, although usually under conditions of stress such as starvation or high levels of exertion. Acetone is also produced synthetically for a range of commercial processes, mostly as a solvent and intermediate in the synthesis of high- value chemicals. Among the most common chemicals that use acetone in the synthetic process are methyl methacrylate, cellulose acetate, methacrylatic acid and higher methacrylates, bisphenol A, methyl isobutyl ketone, and a number of pharmaceutical applications. Acetone is used as a solvent for high-production-volume coatings
and adhesives, and is the primary ingredient in most commercial nail polish removers. It is also listed as a contaminant on more than 560 National Priority List Superfund sites.
Acetone's levels of production and variety of uses, coupled with it's volatility and water solubility, result in a high potential for exposure to acetone.
The draft Toxicological Review for Acetone (ToxR) identifies blood and kidney effects as critical effects, with a reference dose (RfD) of 0.3 mg/kg/d. The draft ToxR provides a new RfD based on a drinking water study to replace
a lower RfD derived from a gavage study. The draft ToxR does not propose a reference concentration (RfC) and proposes a cancer weight-of-evidence determination of class D not
classifiable as to human carcinogenicity under the Guidelines for Carcinogen Risk Assessment (1986). Both determinations are consistent with the existing IRIS assessment. The cancer weight of evidence under the Proposed Guidelines for Carcinogen Risk Assessment (1996) is "cannot be determined."
Acetone is produced endogenously in the body. Commercially, acetone is used as a solvent and as a synthetic intermediate. It is used as a solvent for high production volume coatings and adhesives, and is the primary ingredient in most commercial nail polish removers. EPA's assessment of the carcinogenic potential and noncancer effects of acetone was entered on IRIS in the late 1980's. The IRIS Program prepared an update of the assessment for acetone, which incorporated health effects information published since the last assessment was prepared, as well as new risk assessment methods. The IRIS assessment for acetone consists of a Toxicological Review and IRIS Summary. The Toxicological Review was a critical review of the physicochemical and toxicokinetic properties of the chemical; and its toxicity in humans and experimental systems. The assessment presents reference values for the noncancer effects of acetone (RfD and RfC), where supported by available data, and a cancer assessment. The Toxicological Review and IRIS Summary was subject to internal peer consultation, Agency review, and external peer review. The final product reflects the Agency's consensus opinion on the toxicity of acetone.
The U.S. Environmental Protection Agency (EPA) is hereby providing for public information a draft Toxicological Review and draft IRIS Summary to external peer reviewers for EPA's health assessment of acetone (CAS No. 67-64-1). These documents are provided for public viewing during an external scientific peer review period. While EPA is not soliciting public comments by this action, any scientific views received on the content of the Toxicological Review or IRIS Summary prior to September 14, 2001, will be considered in subsequent drafts.
This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.