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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 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data, as outlined in the IRIS assessment development process. Sections I (Health Hazard Assessments for Noncarcinogenic Effects) and II (Carcinogenicity Assessment for Lifetime Exposure) present the conclusions that were reached during the assessment development process. Supporting information and explanations of the methods used to derive the values given in IRIS are provided in the guidance documents located on the IRIS website.

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
gain, and increased
liver and kidney
weights

2-Year Dog Feeding
Study

Thomas et. al., 1967

NOEL: 0.01% of diet
(2.5 mg/kg/day)

LEL: 0.1% of diet
(25 mg/kg/day)

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).

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_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)

Substance Name — Diphenylamine
CASRN — 122-39-4

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Diphenylamine
CASRN — 122-39-4

Not available at this time.

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_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.

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_VI.B. Inhalation RfC References

None

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_VI.C. Carcinogenicity Assessment References

None

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_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.

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_VIII.  Synonyms

Substance Name — Diphenylamine
CASRN — 122-39-4
Last Revised — 01/31/1987

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