Ethyl acetate (CASRN 141-78-6)
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0157
Ethyl acetate;
CASRN 141-78-6
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 Ethyl acetate
File First On-Line 03/01/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 03/01/1988 |
Inhalation RfC Assessment (I.B.) | no data | |
Carcinogenicity Assessment (II.) | no data |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Ethyl acetate
CASRN — 141-78-6
Last Revised — 03/01/1988
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
|
---|---|---|---|---|
Mortality and body Rat Oral Subchronic U.S. EPA, 1986 |
NOEL: 900 mg/kg/day LOAEL: 3600 mg/kg/day |
1000
|
1
|
9E-1 mg/kg/day |
*Conversion Factors -- none
__I.A.2. Principal and Supporting Studies (Oral RfD)
U.S. EPA. 1986. Rat oral subchronic study with ethyl acetate. Office of Solid Waste, Washington, DC.
Ethyl acetate is fairly nontoxic [LD50 orally in rats: 11.3 g/kg, (Smyth et al., 1962)] and because of its characteristic fruity odor and pleasant taste when diluted, it is primarily used as fruit essences. Pertinent information regarding the mutagenicity, teratogenicity and carcinogenicity of ethyl acetate could not be located in the available literature. Therefore, the U.S. EPA, Office of Solid Waste, under the RCRA Land Disposal Ban, sponsored the 90-day subchronic study of ethyl acetate with rats. Four groups of rats (30/sex/group) were gavaged daily with 0, 300, 900 and 3600 mg/kg/day of ethyl acetate. Six weeks after the initial dosing, 10 rats/sex were subjected to interim sacrifice while the remaining rats continued on the dosing regimen until the final sacrifice (90 days). This study generated data on weekly body weights and food consumption, clinical signs of toxicity, ophthalmological evaluations, moribundity, mortality, blood and urine chemistry and gross and histopathologic evaluations of target organs. Evaluation of the data indicated that male rats exposed to the high dose (3600 mg/kg/day) of ethyl acetate showed significant toxic effects, which resulted in depressed body and organ weights, and depressed food consumption. Female rats exposed to the high dose showed slight but nonsignificant depression of above parameters compared with controls. The next lower dose (900 mg/kg/day) did not produce any adverse effects in either male or female rats and is, therefore, considered a NOEL. By applying an uncertainty factor of 1000 to this NOEL of 900 mg/kg/day, an RfD of 0.9 mg/kg/day or 63 mg/day for a 70-kg person can be recommended.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 1000 is applied: 10 for intra- and 10 for interspecies extrapolation, and 10 to extrapolate subchronic to chronic exposure.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
None.
__I.A.5. Confidence in the Oral RfD
Study — High
Database — Low
RfD — Low
The principal study is a well-designed oral study that includes several toxicologic endpoints; high confidence in the study is recommended. The data base did not provide information on additional subchronic/chronic or reproductive toxicity studies; therefore, low confidence is recommended. 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, 1987
Other EPA Documentation — U.S. EPA, 1986
Agency Work Group Review — 06/11/1986
Verification Date — 06/11/1986
Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the RfD for Ethyl acetate conducted in November 2001 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.
__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 — Ethyl acetate
CASRN — 141-78-6
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Ethyl acetate
CASRN — 141-78-6
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 — Ethyl acetate
CASRN — 141-78-6
Last Revised — 08/01/1989
_VI.A. Oral RfD References
Smyth, H.F., C.P. Carpenter, C.S. Weil, U.C. Pozzani and J.A. Striegel. 1962. Range-finding toxicity data: List VI. Am. Ind. Hyg. Assoc. 23: 95-107.
U.S. EPA. 1986. Rat oral subchronic study with ethyl acetate. Office of Solid Waste, Washington, DC.
U.S. EPA. 1987. Health and Environmental Effects Profile for Ethyl Acetate. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Solid Waste and Emergency Response, Washington, DC.
_VI.B. Inhalation RfD References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Ethyl acetate
CASRN — 141-78-6
Date |
Section |
Description |
---|---|---|
08/01/1989 | VI. | Bibliography on-line |
01/01/1992 | I.A.7. | Primary contact changed |
01/01/1992 | IV. | Regulatory actions updated |
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. |
_VIII. Synonyms
Substance Name — Ethyl acetate
CASRN — 141-78-6
Last Revised — 03/31/1987
- 141-78-6
- ACETIC ACID, ETHYL ESTER
- ACETIC ETHER
- ACETIDIN
- ACETOXYETHANE
- AETHYLACETAT
- ESSIGESTER
- ETHYLACETAAT
- Ethyl Acetate
- ETHYL ACETIC ESTER
- ETHYLE (ACETATE D')
- ETHYL ETHANOATE
- ETILE (ACETATO DI)
- OCTAN ETYLU
- RCRA WASTE NUMBER U112
- UN 1173
- VINEGAR NAPHTHA