IRIS Toxicological Review of Methanol (External Review Draft; December 2009)
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Abstract
NOTE: The IRIS Toxicological Review of Methanol (external review draft; December 2009) was released for public comment and external peer review in January 2010 (Federal Register Notice Jan 12, 2010). The draft assessment was placed on hold in June 2010 (Press Release Announcement Jun 15, 2010) pending a review of certain underlying cancer studies. The non-cancer portion of the draft assessment was not impacted by the review of the cancer studies and was subsequently re-released for public comment and external peer review (Press Release Announcement Apr 11, 2011). The non-cancer methanol assessment peer review panel met in July 2011 and that panel’s report is available. The original draft assessment (December 2009) has been archived but is available on this web page for the sake of transparency.
In March 2012 EPA announced that it would no longer rely on certain data (Ramazzini update) that were utilized in the December 2009 draft assessment to characterize the carcinogenic potential of methanol.
Methanol is a high production volume chemical with many commercial uses. It is a basic building block for numerous chemicals. Many of its derivatives are used in the construction, housing or automotive industries. Consumer products that contain methanol include varnishes, shellacs, paints, windshield washer fluid, antifreeze, adhesives, deicers, and Sterno heaters. This draft IRIS health assessment addresses both non-cancer and cancer human health effects that may result from chronic exposure to this chemical. This draft assessment provides an inhalation reference concentration (RfC) for chronic non-cancer health effects, a cancer assessment, and a reassessment of the oral reference dose (RfD). This is the first RfC and cancer assessment for methanol.
Impact/Purpose
EPA is conducting a peer review of the scientific basis supporting the human health hazard and dose-response assessment of methanol that will appear in the Integrated Risk Information System (IRIS) database.Status
Following the External Peer Review, the final assessment will be published on the IRIS database.Citation
U.S. EPA. IRIS Toxicological Review of Methanol (External Review Draft; December 2009). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-09/013, 2010.History/Chronology
| Date | Description |
|---|---|
| 01- Sep 1988 | EPA posted the assessment of an oral reference dose for methanol on the IRIS Database. |
| 02- Jul 1993 | EPA revised the oral reference dose for methanol. |
| 03- May 2002 | EPA started draft development of an IRIS reassessment of methanol. |
| 04- Jun 2009 | An external peer review of unpublished New Energy Development Organization (NEDO) studies (for a 24-month rat study and an 18-month mouse study) was completed. |
| 05- Dec 2009 | EPA hosted an interagency science consultation on the draft IRIS Toxicological Review of Methanol. |
| 06- Jan 2010 | EPA released the External Review Draft for public review and comment, and announced the public listening session would be held on February 23, 2010. [Federal Register Jan 12, 2010] |
| 07- Mar 2012 | EPA announced that data from the Ramazzini Institute (Ramazzini update) on lymphomas and leukemias would not be used in IRIS assessments. This decision impacted the cancer assessment contained in the December 2009 draft methanol assessment, which was released in January 2010 for external peer review. The December 2009 draft assessment has been archived. |
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-2009-0398" (for the docket ID) to comment on this report.Download(s)
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 Methanol (External Review Draft) with Notice (PDF) (491 pp, 5.1 MB, about PDF)
- Charge to External Peer Reviewers (PDF) (5 pp, 28.3 KB, about PDF)
Related Link(s)
- PBPK code and supporting files for implementation in acslX (AEgis Technologies) Description: When the .zip file has been downloaded and the contents properly extracted to your computer, you should see an acslX workspace file "Methanol - Jan 2010.aws" within the top level folder ("Methanol - Jan 2010"). From within acslX, choose "Open existing workspace" and select this file. The workspace contains two projects/folders, "Methanol_EPA" and "monkey_EPA". "Methanol_EPA" contains the .csl code and supporting files for the methanol PBPK model for mice, rats, and humans, as described in Chapter 3 (with application in Chapter 5) and Appendix B. The folder/project "monkey_EPA" contains the .csl code and supporting files for the analysis described in section 3.4.7. (1.19Mb, ZIP file) (ZIP) (1.2 MB, about ZIP)
- NEDO: Toxicological Research of Methanol as a Fuel for Power Station (Oct 1987) Scanned PDF (PDF) (289 pp, 11.6 MB, about PDF)
- Comments from Peer Reviewers on the NEDO Methanol Review (Jun 2009) (PDF) (109 pp, 425.8 KB, about PDF)
- IRIS Toxicological Review of Methanol (Non-Cancer) (External Review Draft; April 2011)