US EPA

On September 8, 2011, the Toxicological Review of n-Butanol (External Review Draft) was released for external peer review and public comment. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White House Offices before public release. In the new IRIS process, introduced by the EPA Administrator, all written comments on IRIS assessments submitted by other federal agencies and White House Offices will be made publicly available. Accordingly, interagency comments with EPA's response and the interagency science consultation draft of the IRIS Toxicological Review of n-Butanol and the charge to external peer reviewers are posted on this site.

The draft Toxicological Review of n-butanol provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic exposure to n-butanol. n-Butanol is widely used as an organic solvent and is an intermediate in the manufacture of other organic chemicals such as acetates, acrylates and glycol ethers. n-Butanol is also a natural component of many foods and formed during the fermentation of carbohydrates.

EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for n-butanol. IRIS is an EPA database containing Agency scientific positions on potential adverse human health effects that may result from chronic (or lifetime) exposure to chemicals in the environment. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of two steps of the risk assessment paradigm, i.e., hazard identification and dose-response evaluation. IRIS assessments are used in combination with specific situational exposure assessment information to evaluate potential public health risk associated with environmental contaminants.

Following external peer review the assessment will be revised taking into consideration external peer review and public comments. The revised assessment will undergo a final EPA internal review and review by other federal agencies and White House offices, then the final assessment will be posted to the IRIS database.

U.S. EPA. IRIS Toxicological Review of n-Butanol (Interagency Science Consultation Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-11/081C, 2011.