Diphenamid (CASRN 957-51-7)
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0232
Diphenamid;
CASRN 957-51-7
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 Diphenamid
File First On-Line 09/30/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 03/01/1991 |
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 — Diphenamid
CASRN — 957-51-7
Last Revised — 03/01/1991
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.
__I.A.1. Oral RfD Summary
Critical Effect |
Experimental Doses* |
UF |
MF |
RfD |
---|---|---|---|---|
Liver toxicity 2-Year Dog Feeding Upjohn Co., 1966a |
NOEL: 3 mg/kg/day LEL: 10 mg/kg/day |
100
|
1
|
3E-2
mg/kg/day |
*Conversion Factors -- none
__I.A.2. Principal and Supporting Studies (Oral RfD)
Upjohn Company. 1966a. MRID No. 00076382. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Groups of purebred beagle dogs, 3 of each sex, were fed 0, 3, 10, or 30 mg/kg/day diphenamid for 2 years. Daily observations were made for the occurrence of untoward clinical signs, changes in food consumption, behavioral changes, stool consistency, urinary excretion, and indications of emesis. Histopathologic observations revealed no distinction between treated and control dogs, with the exception of an increase in portal macrophages and fibroblasts in the 10 and 30 mg/kg/day groups. A slight increase in liver weight occurred in the 10 and 30 mg/kg/day groups. At 30 mg/kg/day these effects were noted in a greater number of dogs.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — Based on a chronic exposure study, an uncertainty factor of 100 was used to account for the inter- and intraspecies 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 previous description; core grade minimum
2) 2-Year Feeding (oncogenic) - rat: Systemic NOEL=10 mg/kg/day; Systemic LEL=30 mg/kg/day (increase of liver (male and female) and thyroid (female) weight); core grade supplementary (Upjohn Co., 1966b)
3) 3-Generation Reproduction - rat: Fetotoxic NOEL=10 mg/kg/day; Fetotoxic LEL=30 mg/kg/day (liver congestion, hepatic cell glycogen depletion and irregular hepatic cell size); core grade minimum (Upjohn, 1966c)
Data Gap(s): Rat Teratology Study; Rabbit Teratolgy Study
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — Medium
RfD — Medium
The principal study appears to be of acceptable quality and is given a medium confidence rating. The database on chronic toxicity is incomplete, and is, therefore, given a medium confidence. Medium confidence in the RfD follows.
__I.A.6. EPA Documentation and Review of the Oral RfD
Pesticide Registration Files
Agency Work Group Review — 06/10/1986, 03/18/1987
Verification Date — 03/18/1987
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 Diphenamid conducted in September 2002 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 — Diphenamid
CASRN — 957-51-7
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Diphenamid
CASRN — 957-51-7
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 — Diphenamid
CASRN — 957-51-7
Last Revised — 03/01/1991
_VI.A. Oral RfD References
Upjohn Company. 1966a. MRID No. 00076382. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Upjohn Company. 1966b. MRID No. 00076381. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Upjohn Company. 1966c. MRID No. 00076383. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Diphenamid
CASRN — 957-51-7
Date |
Section |
Description |
---|---|---|
04/01/1989 | III. | Health Advisory on-line |
03/01/1991 | I.A. | Principal study year corrected |
03/01/1991 | I.A.4. | Citations added |
03/01/1991 | III.A.5. | Principal study year corrected |
03/01/1991 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory Action section on-line |
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 — Diphenamid
CASRN — 957-51-7
Last Revised — 09/30/1987
- 80W
- 957-51-7
- ACETAMIDE, N,N-DIMETHYL-2,2-DIPHENYL-
- BENZENEACETAMIDE, N,N-DIMETHYL-alpha-PHENYL-
- DIAMIDE
- DIF 4
- DIMID
- Diphenamid
- DIPHENAMIDE
- DIPHENYLAMIDE
- 2,2-DIPHENYL-N,N-DIMETHYLACETAMIDE
- DYMID
- ENIDE
- ENIDE 50
- FDN
- FENAM
- L-34314
- N,N-DIMETHYLDIPHENYLACETAMIDE
- N,N,DIMETHYL-2,2-DIPHENYLACETAMIDE
- N,N-DIMETHYL-alpha,alpha-DIPHENYLACETAMIDE
- N,N-DIMETHYL-alpha-PHENYLBENZENEACETAMIDE
- U 4513