Ethylphthalyl ethylglycolate (EPEG) (CASRN 84-72-0)
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0052
Ethylphthalyl ethylglycolate (EPEG);
CASRN 84-72-0
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 EPEG
File First On-Line 01/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 02/01/1995* |
Inhalation RfC Assessment (I.B.) | no data | |
Carcinogenicity Assessment (II.) | no data |
*A comprehensive review of toxicological studies was completed (2004) - please see section I.A.6 for more information.
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
Last Revised — 02/01/1995
The oral Reference Dose (RfD) is based on the assumption that thresholds
exist for certain toxic effects such as cellular necrosis. It is expressed
in units of mg/kg-day. In general, the RfD is an estimate (with uncertainty
spanning perhaps an order of magnitude) of a daily exposure to the human
population (including sensitive subgroups) that is likely to be without
an appreciable risk of deleterious effects during a lifetime. Please refer
to the Background Document for an elaboration of these concepts. RfDs
can also be derived for the noncarcinogenic health effects of substances
that are also carcinogens. Therefore, it is essential to refer to other
sources of information concerning the carcinogenicity of this substance.
If the U.S. EPA has evaluated this substance for potential human carcinogenicity,
a summary of that evaluation will be contained in Section II of this file.
__I.A.1. Oral RfD Summary
Critical Effect |
Experimental Doses* |
UF |
MF |
RfD |
---|---|---|---|---|
Kidney damage and Rat, Chronic Oral Hodge et al., 1953 |
NOEL: 0.5% of diet or LOAEL: 5% of diet or |
100 |
1 |
3E+0 mg/kg/day |
*Conversion Factors -- It is assumed that a rat eats 5% of its body weight/day; thus, 5000 mg/kg diet (i.e., 0.5% of diet) x 0.05 kg diet/kg bw/day = 250 mg/kg bw/day
__I.A.2. Principal and Supporting Studies (Oral RfD)
Hodge, H.C., E.A. Maynard, H.J. Blanchett, R.E. Hyatt, V.K. Rowe and H.C. Spencer. 1953. Chronic oral toxicity of ethylphthalyl ethyl glycolate in rats and dogs. Arch. Ind. Hyg. Occup. Med. 8: 289-295.
Groups of 25 male and 25 female rats were administered either 0, 0.05, 0.5 or 5% ethylphthalyl ethyl glycolate (EPEG) in the diet for 2 years. Over the 2- year period, seven blood samples were taken for hematology, and urinalyses were performed at the same time; gross histopathology was examined at the end of the study. No effects were observed in the low-dose groups, but the 5% group experienced decreased growth and survival. Kidneys of this group were granular, sometimes swollen and of a pale yellow color. The renal pelvis was dilated, and there were deposits of crystalline calcium oxalate in renal tubules.
Paired groups of dogs received doses of 0.01, 0.05 or 0.25 g EPEG/kg/day for 1 year. No effects of the test compounds were seen.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — The 100-fold factor represents two 10-fold subunits; one each for the expected intrahuman and interspecies variability of the toxicity of this chemical in lieu of specific data.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
There are no published data regarding reproductive effects of EPEG.
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — Low
RfD — Low
Confidence in this study is rated medium since there were sufficient numbers of rats, several endpoints were measured,and there were comparative studies on two species. This was, however, the only study of a chronic or subchronic nature referred to in the 1980 Ambient Water Quality Criteria Document. Confidence in the database is, therefore, rated low. Confidence in the RfD can be considered low to medium.
__I.A.6. EPA Documentation and Review of the Oral RfD
Source Document — U.S. EPA, 1980
The ADI in the 1980 Ambient Water Quality Criteria document was extensively reviewed by the Agency and was reviewed by the public.
Other EPA Documentation — None
Agency Work Group Review — 11/06/1985
Verification Date — 11/06/1985
A comprehensive review of toxicological studies published prior to 2004 was conducted. No new health effects data were identified that would be directly useful in the revision of the existing RfD for Ethylphthalyl ethylglycolate and a change in the RfD is not warranted at this time.
__I.A.7. EPA Contacts (Oral RfD)
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).
_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
This substance/agent has not undergone a complete evaluation and determination under US EPA's IRIS program for evidence of human carcinogenic potential.
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_VI. Bibliography
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
Last Revised — 08/01/1989
_VI.A. Oral RfD References
Hodge, H.C., E.A. Maynard, H.J. Blanchett, R.E. Hyatt, V.K. Rowe and H.C. Spencer. 1953. Chronic oral toxicity of ethylphthalyl ethyl glycolate in rats and dogs. Arch. Ind. Hyg. Occup. Med. 8: 289-295.
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- 117780.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
Date |
Section |
Description |
---|---|---|
08/01/1989 | VI. | Bibliography on-line |
05/01/1991 | I.A.4. | Text edited |
02/01/1995 | I.A.7. | Secondary contact's name changed |
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. |
12/03/2002 | I.A.6. | Screening-Level Literature Review Findings message has been added. |
09/29/2004 | I.A.6. | Screening-Level Literature Review Findings message has been removed and replaced by comprehensive literature review conclusions. |
_VIII. Synonyms
Substance Name — Ethylphthalyl ethylglycolate (EPEG)
CASRN — 84-72-0
Last Revised — 01/31/1987
- 84-72-0
- 1,2-BENZENEDICARBOXYLIC ACID, 2-ETHOXY-2-OXOETHYL-,ETHYL ESTER
- CARBETHOXYMETHYL ETHYL PHTHALATE
- DIETHYL o-CARBOXYBENZOYLOXYACETATE
- EPEG
- ETHYL CARBETHOXYMETHYL PHTHALATE
- Ethylphthalyl Ethylglycolate
- SANTICIZER E-15