Diphenylamine (CASRN 122-39-4)
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0048
Diphenylamine;
CASRN 122-39-4
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 Diphenylamine
File First On-Line 01/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 09/01/1990 |
Inhalation RfC Assessment (I.B.) | no data | |
Carcinogenicity Assessment (II.) | no data | 07/01/1992 |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Diphenylamine
CASRN — 122-39-4
Last Revised — 09/01/1990
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
|
---|---|---|---|---|
Decreased body weight 2-Year Dog Feeding Thomas et. al., 1967 |
NOEL: 0.01% of diet LEL: 0.1% of diet |
100
|
1
|
2.5E-2
mg/kg/day |
*Conversion Factors -- 0.01% (1 ppm) = 0.025 mg/kg/day (assumed dog food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
Thomas, J.O., W.E. Ribelin, J.R. Woodward and F. Deeds. 1967. The chronic toxicity of diphenylamine for dogs. Toxicol. Appl. Pharmacol. 11: 184-194.
Eight male and 8 female purebred beagles were fed 0.01, 0.1, and 1% diphenylamine in the diet for 2 years. Decreased weight gain and anemia were noted at 0.1 and 1%. At 1%, increases in liver and kidney weights were observed.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 100 was used to account for inter- and intra- species differences.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD
1) 2-Year Feeding - Dog: Principal study - see discussion above
2) 2-Year Feeding (oncogenic) - rat: NOEL=3.1 mg/kg/day; LEL=31 mg/kg/day (kidney lesions) (Chemley Products, 1967)
3) 2-Generation Reproduction - rat: Fetotoxic NOEL=125 mg/kg/day; Fetotoxic LEL=250 mg/kg/day (reduced litter size and weight of young) (Food and Agriculture Organization of the United Nations, 1970)
Data Gap(s): Teratology - Rat; Teratology - Rabbit
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — Medium
RfD — Medium
The principal study appears to be of good quality and is given a medium confidence rating. Since the database on chronic toxicity is supportive but incomplete, it is given a medium confidence rating. Medium confidence in the RfD follows.
__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 — Pesticide Registration Files
Agency Work Group Review — 07/22/1986
Verification Date — 07/22/1986
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 Diphenylamine conducted in August 2003 identified one or more significant new studies. IRIS users may request the references for those studies from 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 — Diphenylamine
CASRN — 122-39-4
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Diphenylamine
CASRN — 122-39-4
Not available at this time.
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_VI. Bibliography
Substance Name — Diphenylamine
CASRN — 122-39-4
Last Revised — 04/01/1993
_VI.A. Oral RfD References
Chemley Products. 1967. MRID No. 00050962. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Food and Agriculture Organization of the United Nations. 1970. 1969 Evaluations of Some Pesticide Residues in Food. Rome, Italy. p. 91-99.
Thomas, J.O., W.E. Ribelin, J.R. Woodward and F. Deeds. 1967. The chronic toxicity of diphenylamine for dogs. Toxicol. Appl. Pharmacol. 11: 184-194.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Diphenylamine
CASRN — 122-39-4
Date |
Section |
Description |
---|---|---|
09/30/1987 | All | CASRN corrected |
09/01/1990 | I.A.4. | Citations added |
09/01/1990 | IV.F.1. | EPA contact changed |
09/01/1990 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory actions updated |
07/01/1992 | II. | Carcinogen assessment summary now under review |
03/01/1993 | III.A. | Health Advisory on-line |
03/01/1993 | VI.D. | Health Advisory references on-line |
04/01/1993 | VI.A. | Oral RfD reference corrected |
08/01/1995 | II. | 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. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Diphenylamine
CASRN — 122-39-4
Last Revised — 01/31/1987
- 122-39-4
- Aniline, N-phenyl-
- Anilinobenzene
- Benzenamine, N-phenyl-
- Benzene, anilino-
- Benzene, (phenylamino)-
- Big Dipper
- C.I. 10355
- DFA
- Diphenylamine
- DPA
- N,N-Diphenylamine
- No Scald
- N-Phenylaniline
- N-Phenylbenzenamine
- Scaldip