Environmental Assessment
IRIS Toxicological Review of Methanol (Non-Cancer) (2011 External Review Draft)
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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 methanol (non-cancer) that when finalized will appear on the Integrated Risk Information System (IRIS) database. Please refer to IRISTrack - methanol (non cancer) for the latest schedule updates.
Jeffrey S. Gift
- by phone at: 919-541-4828
- by fax at: 919-541-0245
- by email at: gift.jeff@epa.gov
Background
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, and deicers. This draft IRIS health assessment addresses non-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 and a reassessment of the oral reference dose (RfD).
History/Chronology
| Sep 1988 | EPA posted the assessment of an oral reference dose for methanol on the IRIS Database. |
| Jul 1993 | EPA revised the oral reference dose for methanol. |
| Dec 2009 | EPA hosted an interagency science consultation on the draft IRIS Toxicological Review of Methanol for cancer and non-cancer health effects. |
| Jan 2010 | EPA released the IRIS Toxicological Review of Methanol (External Review Draft) on cancer and non-cancer health effects for public review and comment, and announced the public listening session would be held on February 23, 2010. [Federal Register Jan 12, 2010] |
| Jun 2010 | Following a report from the National Toxicology Program, EPA placed on hold the draft Methanol Toxicological Review on cancer and non-cancer health effects (see June 15, 2010 press release). |
| Apr 2011 | EPA released the external review draft of the IRIS Toxicological Review of Methanol (Non-Cancer) for public review and comment. EPA also announced a public listening session to be held on May 26, 2011 in Arlington, VA. [Federal Register Apr 18, 2011] |
| Jun 2011 | EPA released a federal register notice announcing an addendum to the draft document, a 14-day public comment period for the addendum, and the details for an upcoming public workshop. [Federal Register Jun 22, 2011] |
| Oct 2011 | EPA releases the comments from the public comment period and external review workshop. |
| 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. |
Next Steps
Following the External Peer Review, the final assessment will be published on 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-2009-0398" (for the docket ID) to comment on this report.
Citation
U.S. EPA. IRIS Toxicological Review of Methanol (Non-Cancer) (2011 External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-11/001A, 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 Methanol (Non-Cancer) (External Review Draft) (PDF) (382 pp, 10 MB, about PDF)
- Charge to External Peer Reviewers (PDF) (4 pp, 26 KB, about PDF)
- Consolidated Comments from the External Peer Review (Final) (PDF) (134 pp, 635 KB, about PDF)
- Addendum to Methanol (Non-Cancer) Tox Review (Added 6/22/11) (PDF) (11 pp, 243 KB, about PDF)
Related Links
- PBPK Code and Supporting Files for Implementation in Acslx (Aegis Technologies) (ZIP) (1 MB, about ZIP)
- NEDO: Toxicological Research of Methanol as a Fuel for Power Station (Oct 1987) Scanned PDF (PDF) (289 pp, 12 MB, about PDF)
- Comments from Peer Reviewers on the NEDO Methanol Review (Jun 2009) (PDF) (109 pp, 436 KB, about PDF)
- 1. Table of Average Values(1) (PDF) (265 pp, 10 MB, about PDF)
- 2. Table of Average Values(2) (PDF) (375 pp, 12 MB, about PDF)
- 3. Individual Density & Individual Body Weight (PDF) (374 pp, 25 MB, about PDF)
- 4. Individual Body Weight Gain (PDF) (370 pp, 26 MB, about PDF)
- 5. Individual Food Consumption Rate, Individual Laboratory Test Results, Individual Organ Weight, Individual Body Weight to Organ Weight Ratio (PDF) (268 pp, 17 MB, about PDF)
- 6. Individual Major Pathological Findings & Pathological Findings (Male) (PDF) (352 pp, 17 MB, about PDF)
- 7. Individual Major Pathological Findings & Pathological Findings (Female) (PDF) (339 pp, 16 MB, about PDF)
- 8. Histopathological Sample Photographs (PDF) (33 pp, 3 MB, about PDF)
- 9. Supporting Documents (PDF) (53 pp, 708 KB, about PDF)
- 18-Month Carcinogenicity Inhalation Toxicity of Methanol in Mice: Main Discussion & Support Documents (PDF) (119 pp, 3 MB, about PDF)
- 1. Table of Average Values (PDF) (475 pp, 16 MB, about PDF)
- 2. Individual Density & Individual Body Weight (PDF) (358 pp, 20 MB, about PDF)
- 3. Individual Body Weight Gain (PDF) (342 pp, 18 MB, about PDF)
- 4. Individual Food Consumption Rate, Individual Urinalysis, Individual Hematological Tests, Individual Hemograms, Individual Plasma Biochemical Tests, Individual Organ Weight, Individual Organ Weight (PDF) (215 pp, 11 MB, about PDF)
- 5. Individual Major Pathological Findings & Pathological Findings (Male) (PDF) (445 pp, 19 MB, about PDF)
- 6. Individual Major Pathological Findings & Pathological Findings (Female) (PDF) (468 pp, 20 MB, about PDF)
- 7. Histopathological Sample Photographs (PDF) (28 pp, 2 MB, about PDF)
- 24-Month Carcinogenicity Inhalation Toxicity Test of Methanol in Rats: Main Discussion & Supporting Documents (PDF) (80 pp, 3 MB, about PDF)