2,4-Dinitrophenol (CASRN 51-28-5) |
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0152
2,4-Dinitrophenol;
CASRN 51-28-5
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 2,4-Dinitrophenol
File First On-Line 03/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 07/01/1991* |
Inhalation RfC Assessment (I.B.) | message | 10/01/1991* |
Carcinogenicity Assessment (II.) | no data |
*A comprehensive review of toxicological studies was completed (05/27/05) - please see sections I.A.6. and I.B. for more information.
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — 2,4-Dinitrophenol
CASRN — 51-28-5
Last Revised — 07/01/1991
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.
NOTE: The Oral RfD for 2,4-dinitrophenol may change in the near future pending the outcome of a further review now being conducted by the RfD/RfC Work Group.
__I.A.1. Oral RfD Summary
Critical Effect |
Experimental Doses* |
UF
|
MF
|
RfD
|
---|---|---|---|---|
Cataract formation Human Chronic and Horner, 1942 |
NOEL: none LOAEL: 2 mg/kg/day |
1000
|
1
|
2E-3
mg/kg/day |
*Conversion Factors -- none
__I.A.2. Principal and Supporting Studies (Oral RfD)
Horner, W.D. 1942. Dinitrophenol and its relation to formation of cataracts. Arch. Ophthal. 27: 1097.
Over 100 anecdotal cases of cataracts resulting from therapeutic use of 2,4- dinitrophenol were reviewed. The length of time and amount of drug taken varied among the population. It was estimated that over 1% of the population administered 2,4-dinitrophenol developed cataracts. Data did not allow for calculation of a NOEL; cataracts were observed in patients receiving as little as 2 mg/kg/day, the lower range of the recommended therapeutic dose.
In the Ambient Water Quality Criteria Document for Nitrophenols (U.S. EPA, 1980), an ADI was also calculated based on a 6-month feeding study in rats administered five dietary levels of 2,4-dinitrophenol (Spencer et al., 1948). A NOEL between 5.4 mg/kg and 20 mg/kg was demonstrated. If one uses the lower figure of 5.4 mg/kg and an uncertainty factor of 1000, the resulting RfD of 0.005 is comparable to that determined from the human data.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — The UF of 1000 includes uncertainties in the following areas: extrapolation of an approximately subchronic exposure to chronic exposure, the range of human sensitivity, and extrapolation from a LOAEL to a hypothetical no-effect level.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Embryotoxicity, but not teratogenicity, was observed in mice treated with doses of 2,4-dinitrophenol producing overt signs of toxicity (Gibson, 1973).
__I.A.5. Confidence in the Oral RfD
Study — Low
Database — Low
RfD — Low
Since the chosen study only describes anecdotal data and the supporting data base is meager, the confidences in the chosen study, database and RfD are rated low.
__I.A.6. EPA Documentation and Review of the Oral RfD
Source Document — This assessment is not presented in any existing U.S. EPA document.
Other EPA Documentation — U.S. EPA, 1980
Agency Work Group Review — 11/06/1985, 02/05/1986
Verification Date — 02/05/1986
A comprehensive review of toxicological studies published through May 2005 was conducted. No new health effects data were identified that would be directly useful in the revision of the existing RfD for 2,4-Dinitrophenol and a change in the RfD is not warranted at this time. For more information, IRIS users may contact 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 — 2,4-Dinitrophenol
CASRN — 51-28-5
The health effects data for 2,4-dinitrophenol were reviewed by the U.S. EPA RfD/RfC Work Group and determined to be inadequate for the derivation of an inhalation RfC. The verification status for this chemical is currently not verifiable. For additional information on the health effects of this chemical, interested parties are referred to the documentation listed below.
U.S. EPA. 1980. Ambient Water Quality Criteria Document for Nitrophenols. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Water Regulations and Standards, Criteria and Standards Division, Washington, DC. EPA 440/5-80-063.
U.S. EPA. 1984. Health and Environmental Effects Profile for Dinitrophenols (Selected). 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.
Agency Work Group Review — 06/13/1991
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).
A comprehensive review of toxicological studies published through May 2005 indicated that there is insufficient health effects data to derive an RfC for 2,4-Dinitrophenol at this time. For more information, IRIS users may contact the IRIS Hotline at hotline.iris@epa.gov or 202-566-1676.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — 2,4-Dinitrophenol
CASRN — 51-28-5
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 — 2,4-Dinitrophenol
CASRN — 51-28-5
Last Revised — 10/01/1991
_VI.A. Oral RfD References
Gibson, J.E. 1973. Teratology studies in mice with 2-secbutyl-4, 6- dinitrophenol (dinoseb). Food Cosmet. Toxicol. 11: 31.
Horner, W.D. 1942. Dinitrophenol and its relation to formation of cataracts. Arch. Ophthal. 27: 1097.
Spencer, H.C., V.K. Rowe, E.M. Adams and D.D. Irish. 1948. Toxicological studies on laboratory animals of certain alkyl dinitrophenols used in agriculture. J. Ind. Hyg. Toxicol. 30: 10-25.
U.S. EPA. 1980. Ambient Water Quality Criteria Document for Nitrophenols. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office for the Office of Water Regulations and Standards, Criteria and Standards Division, Washington, DC.
_VI.B. Inhalation RfD References
U.S. EPA. 1980. Ambient Water Quality Criteria Document for Nitrophenols. Prepared by the Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Cincinnati, OH for the Office of Water Regulations and Standards, Criteria and Standards Division, Washington, DC. EPA 440/5-80-063.
U.S. EPA. 1984. Health and Environmental Effects Profile for Dinitrophenols (Selected). 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.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — 2,4-Dinitrophenol
CASRN — 51-28-5
Date |
Section |
Description |
---|---|---|
03/01/1988 | I.A.3. | Text corrected |
03/01/1990 | I.A.2. | U.S. EPA, 1980 citation added |
03/01/1990 | VI. | Bibliography on-line |
07/01/1991 | I.A. | Oral RfD summary noted as pending change |
07/01/1991 | I.B. | Inhalation RfC now under review |
10/01/1991 | I.B. | Inhalation RfC message on-line |
10/01/1991 | VI.B. | Inhalation RfC references added |
01/01/1992 | I.A.7. | Secondary contact changed |
01/01/1992 | IV. | Regulatory actions updated |
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.A.6., I.B. | Screening-Level Literature Review Findings message has been added. |
06/22/2005 | I.A.6., I.B. | Screening-Level Literature Review Findings message has been removed and replaced by comprehensive literature review conclusions. |
_VIII. Synonyms
Substance Name — 2,4-Dinitrophenol
CASRN — 51-28-5
Last Revised — 03/31/1987
- 51-28-5
- ALDIFEN
- CHEMOX PE
- 2,4-DINITROFENOL
- DINITROFENOLO
- 2,4-Dinitrophenol
- Dinitrophenol, 2,4-
- alpha-DINITROPHENOL
- 2,4-DNP
- FENOXYL CARBON N
- 1-HYDROXY-2,4-DINITROBENZENE
- MAROXOL-50
- NITRO KLEENUP
- NSC 1532
- PHENOL, 2,4-DINITRO-
- PHENOL, alpha-DINITRO-
- RCRA WASTE NUMBER P048
- SOLFO BLACK 2B SUPRA
- SOLFO BLACK B
- SOLFO BLACK BB
- SOLFO BLACK G
- SOLFO BLACK SB
- TERTROSULPHUR BLACK PB
- TERTROSULPHUR PBR