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Dimethyl phthalate (CASRN 131-11-3)
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0353
Dimethyl phthalate; CASRN 131-11-3
Health assessment information on a chemical substance is included in IRIS only after a comprehensive review of chronic toxicity data by U.S. EPA health scientists from several Program Offices and the Office of Research and Development. The summaries presented in Sections I and II represent a consensus reached in the review process. Background information and explanations of the methods used to derive the values given in IRIS are provided in the Background Documents.
STATUS OF DATA FOR Dimethyl phthalate
File First On-Line 09/07/1988
Category (section) |
Status |
Last Revised |
|---|---|---|
| Oral RfD Assessment (I.A.) | no data | 03/01/1994 |
| Inhalation RfC Assessment (I.B.) | message | 10/01/1990 |
| Carcinogenicity Assessment (II.) | on-line | 02/01/1993 |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
Not available at this time.
_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
The health effects data for dimethylphthalate were reviewed by the U.S. EPA RfD/RfC Work Group and determined to be inadequate for derivation of an inhalation RfC. The verification status of this chemical is currently not verifiable. For additional information on health effects of this chemical, interested parties are referred to the EPA documentation listed below.
U.S. EPA. 1987. Drinking Water Criteria Document for Phthalic Acid Esters Prepared by the Office of Health and Environmental Assessement, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Drinking Water, Washington, DC. (External Review Draft)
Agency Work Group Review — 07/26/1990
EPA Contacts:
Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202)566-1676 (phone), (202)566-1749 (FAX) or hotline.iris@epa.gov (internet address).
Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the RfC for Dimethyl phthalate conducted in August 2003 did not identify any critical new studies. IRIS users who know of important new studies may provide that information to the IRIS Hotline at hotline.iris@epa.gov or 202-566-1676.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
Last Revised — 02/01/1993
Section II provides information on three aspects of the carcinogenic assessment for the substance in question; the weight-of-evidence judgment of the likelihood that the substance is a human carcinogen, and quantitative estimates of risk from oral exposure and from inhalation exposure. The quantitative risk estimates are presented in three ways. The slope factor is the result of application of a low-dose extrapolation procedure and is presented as the risk per (mg/kg)/day. The unit risk is the quantitative estimate in terms of either risk per ug/L drinking water or risk per ug/cu.m air breathed. The third form in which risk is presented is a drinking water or air concentration providing cancer risks of 1 in 10,000, 1 in 100,000 or 1 in 1,000,000. The rationale and methods used to develop the carcinogenicity information in IRIS are described in The Risk Assessment Guidelines of 1986 (EPA/600/8-87/045) and in the IRIS Background Document. IRIS summaries developed since the publication of EPA's more recent Proposed Guidelines for Carcinogen Risk Assessment also utilize those Guidelines where indicated (Federal Register 61(79):17960-18011, April 23, 1996). Users are referred to Section I of this IRIS file for information on long-term toxic effects other than carcinogenicity.
_II.A. Evidence for Human Carcinogenicity
__II.A.1. Weight-of-Evidence Characterization
Classification — D; not classifiable.
Basis — Pertinent data regarding carcinogenicity was not located in the available literature.
__II.A.2. Human Carcinogenicity Data
None.
__II.A.3. Animal Carcinogenicity Data
Inadequate. A 2-year dietary study in rats by Lehman (1955) was not designed to measure carcinogenic effects.
__II.A.4. Supporting Data for Carcinogenicity
DMP was found to be a weak direct-acting mutagen in forward and reverse mutation assays in Salmonella typhimurium (Seed, 1982; Rubin et al., 1979, Kozumbo et al., 1982). DMP was active in the mouse lymphoma forward mutation assay only in the presence of metabolic activation (CMA, 1986). Negative results were found in a mouse dominant lethal test (Yurchenko and Gleiberman, 1980).
In vitro assays showed that liver homogenate-associated esterases hydroloyzed DMP to methanol and to the monoester which has been shown to be a nonmutagenic compound in Salmonella assay and to methanol (Kozumbo et al., 1982). Other research also indicates that DMP is hydrolyzed to monoesters (Kaneshima et al., 1978; Rowland, 1977; Albro and Moore, 1974).
_II.B. Quantitative Estimate of Carcinogenic Risk from Oral Exposure
Not available.
_II.C. Quantitative Estimate of Carcinogenic Risk from Inhalation Exposure
Not available.
_II.D. EPA Documentation, Review, and Contacts (Carcinogenicity Assessment)
__II.D.1. EPA Documentation
Source Document — U.S. EPA, 1980, 1987
The 1987 Drinking Water Criteria Document for Phthalic Acid Esters has received OHEA review.
__II.D.2. EPA Review (Carcinogenicity Assessment)
Agency Work Group Review — 08/26/1987
Verification Date — 08/26/1987
Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the cancer assessment for Dimethyl phthalate conducted in August 2003 did not identify any critical new studies. IRIS users who know of important new studies may provide that information to the IRIS Hotline at hotline.iris@epa.gov or 202-566-1676.
__II.D.3. EPA Contacts (Carcinogenicity Assessment)
Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202)566-1676 (phone), (202)566-1749 (FAX) or hotline.iris@epa.gov (internet address).
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_VI. Bibliography
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
Last Revised — 10/01/1990
_VI.A. Oral RfD References
None
_VI.B. Inhalation RfC References
U.S. EPA. 1987. Drinking Water Criteria Document for Phthalic Acid Esters Prepared by the Office of Health and Environmental Assessement, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Drinking Water, Washington, DC. (External Review Draft)
_VI.C. Carcinogenicity Assessment References
Albro, P.W. and B. Moore. 1974. Identification of the metabolites of simple phthalate diesters in rat urine. J. Chromatogr. 94: 209-218.
CMA (Chemical Manufacturers Association). 1986. Mutagenicity of 1C (di-n- butyl phthalate) in a mouse lymphoma mutation assay. Final report. Submitted to Hazleton Biotechnologies Company. HB Project No. 20989. September, 1986.
Kaneshima, H., T. Yamaguchi, T. Okui and M. Naitoh. 1978. Studies on the effects of phthalate esters on the biological system (Part 2) -- In vitro metabolism and biliary exretion of phthalate esters in rats. Bull. Environ. Contam. Toxicol. 19: 502-509.
Kozumbo, W.J., R. Kroll and R.J. Rubin. 1982. Assessment of the mutagenicity of phthalate esters. Environ. Health Perspect. 45: 103-109.
Lehman, A.J. 1955. Insect repellants. Food Drug Office Q. Bull. 19: 87-99.
Rowland, I.R., R.C. Cottrell and J.C. Phillips. 1977. Hydrolysis of phthalate esters by the gastro-intestinal contents of the rat. Food Cosmet. Toxicol. 15: 17-21.
Rubin, R.J., W. Kozumbo and R. Kroll. 1979. Ames mutagenic assay of a series of phthalic acid esters: Positive response of the dimethyl and diethyl esters in TA100. Soc. Toxicol. Ann. Meet., New Orleans, March 11-15. p. 11. (Abstract)
Seed, J.L. 1982. Mutagenic activity of phthalate esters in bacterial liquid suspension assays. Environ. Health Perspect. 45: 111-114.
Yurchenko, V.V. and S. Gleiberman. 1980. Study of long-term effects of repellant use. Part III. Study of mutagenic properties of dimethyl phthalate and phenoxyacetic acid N,N-diethylamide by dominant lethal mutations. Med. Parazitol. Parizit. Boleani. 49: 58-61. (Abstract) (Rus.)
U.S. EPA. 1980. Ambient Water Quality Criteria for Phthalate Esters. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Water Regulations and Standards, Washington, DC. EPA 440/5-80-067. NTIS PB 81-11- 117780.
U.S. EPA. 1987. Drinking Water Criteria Document for Phthalic Acid Esters. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Drinking Water, Washington, DC. External Review Draft.
_VII. Revision History
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
|
Date |
Section |
Description |
|---|---|---|
| 09/07/1988 | II. | Carcinogen summary on-line |
| 04/01/1989 | V. | Supplementary data on-line |
| 03/01/1990 | VI. | Bibliography on-line |
| 09/01/1990 | I.B. | Not verified; data inadequate |
| 10/01/1990 | I.B. | Inhalation RfC text modified |
| 10/01/1990 | VI.B. | Bibliography on-line |
| 08/01/1991 | II.D.3. | Primary and secondary contacts changed |
| 01/01/1992 | IV. | Regulatory Action section on-line |
| 02/01/1993 | II.D.3. | Primary contact changed |
| 03/01/1994 | I.A. | Work group review date added |
| 08/01/1995 | I.A. | EPA's RfD/RfC and CRAVE workgroups were discontinued in May, 1995. Chemical substance reviews that were not completed by September 1995 were taken out of IRIS review. The IRIS Pilot Program replaced the workgroup functions beginning in September, 1995. |
| 04/01/1997 | III., IV., V. | Drinking Water Health Advisories, EPA Regulatory Actions, and Supplementary Data were removed from IRIS on or before April 1997. IRIS users were directed to the appropriate EPA Program Offices for this information. |
| 10/28/2003 | I.B.6., II.D.2. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Dimethyl phthalate
CASRN — 131-11-3
Last Revised — 09/07/1988
- 131-11-3
- 1,2-benzenedicarboxylic acid, dimethyl ester
- dimethyl 1,2-benzenedicarboxylate
- dimethyl benzene-o-dicarboxylate
- Dimethyl phthalate
- DMP
- methyl phthalate
- phthalic acid, dimethyl ester