IRIS Toxicological Review of 1,4-Dioxane (Inhalation) (External Review Draft)

Notice

EPA has released the Toxicological Review of 1,4-Dioxane (Inhalation) (External Review Draft) for public review and comment. New studies regarding the toxicity of 1,4-dioxane through the inhalation route of exposure are available that were not included in the 1,4-dioxane assessment that was posted on the IRIS database in 2010.

[Update] EPA announced that an independent panel of experts will meet in Morrisville, NC on March 19, 2012 to discuss the draft report. [Federal Register Notice Feb 13, 2012]

Report Information

EPA is conducting a peer review and public comment of the scientific basis supporting the human health hazard and dose-response assessment of 1,4-Dioxane (inhalation) that when finalized will appear on the Integrated Risk Information System (IRIS) database. Please refer to IRISTrack - 1,4-Dioxane (inhalation) for the latest schedule updates.

Patricia Gillespie

by phone at: 919-541-1964
by fax at: 919-541-2985
by email at: gillespie.patricia@epa.gov

Background

1,4-Dioxane is commonly used as a solvent, cleaning agent, chemical stabilizer, surface coating, adhesive agent, and an ingredient in chemical manufacture. The IRIS Program completed the assessment for oral exposure to 1,4-dioxane on August 11, 2010 and noted that new inhalation studies would be evaluated separately. Additional information regarding 1,4-dioxane toxicity resulting from exposure via inhalation has now been incorporated into the 2010 assessment without changing the oral toxicity conclusions of the previous assessment.

History/Chronology

Aug 2010	EPA released the final assessment of 1,4-dioxane on the IRIS Web site.
May 2011	EPA initiated the interagency science consultation on the draft Toxicological Review of 1,4-Dioxane (Inhalation).
Aug 2011	EPA released the external review draft for public review and comment. EPA concurrently released the interagency science consultation draft toxicological review and charge, and interagency comments with EPA's response.
Sep 2011	EPA extended the close of the public comment period to November 15, 2011. [Federal Register Notice Sep16, 2011]
Feb 2012	EPA announced that an independent panel of experts will meet in Morrisville, NC on March 19, 2012 to discuss the draft report. [Federal Register Notice Feb 13, 2012]
May 2012	EPA released the comments from the public comment period and external review workshop.

Next Steps

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

Additional Information

Comments on the assessment may be submitted and reviewed using the e-Government Regulations.gov Web site. From the site, select “Environmental Protection Agency” and the keyword “EPA-HQ-ORD-2011-0390" (for the docket ID) to comment on this report.

Citation

U.S. EPA. IRIS Toxicological Review of 1,4-Dioxane (Inhalation) (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-11/003A, 2011.

Downloads

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.

IRIS Toxicological Review of 1,4-Dioxane (Inhalation) (External Review Draft) (PDF) (374 pp, 4 MB, about PDF)
Charge to External Peer Reviewers (PDF) (4 pp, 50 KB, about PDF)
Consolidated Comments from the External Peer Review (Final) (PDF) (58 pp, 2 MB, about PDF)