Pronamide (CASRN 23950-58-5)
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0095
Pronamide; CASRN 23950-58-5
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 Pronamide
File First On-Line 01/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 01/01/1994 |
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 — Pronamide
CASRN — 23950-58-5
Last Revised — 01/01/1994
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 pronamide 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 |
---|---|---|---|---|
No effects 2-Year Dog Feeding Rohm & Haas, Co., 1970a |
NOEL: 300 ppm LEL: None |
100 |
1 |
7.5E-2 mg/kg/day |
*Conversion Factors: l ppm = 0.025 mg/kg/day (assumed dog food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
Rohm and Haas, Company. 1970a. MRID No. 00085508, 00107949, 00133113. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Groups of 4 purebred beagle dogs of each sex were fed diets containing 0, 30, l00, or 300 ppm pronamide for two years. Body weights were determined weekly and food consumption daily. Weights of heart, lung, liver, and testes were determined and major tissues/organs examined histologically. There were no effects of compound administration on clinical studies, estrus findings, organ weights, or histopathologic findings.
__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 — Even though the database is not complete, the use of an MF was not considered necessary since the studies at hand do not indicate that the most sensitive toxicologic endpoint will be substantially <7.5 mg/kg/day.
__I.A.4. Additional Studies/Comments (Oral RfD)
The use of a 100-fold uncertainty factor applied to the NOEL (5.0 mg/kg/day) for maternal toxicity in the rabbit teratology study yields a value that is not significantly different than the RfD. Alteration of the RfD value can be made when the 2-year rat feeding study is reviewed.
Data Considered for Establishing the RfD
1) 2-Year Feeding - dog: Principal study - see discussion above; core grade minimum
2) 90-Day Feeding - dog: NOEL=33.7 mg/kg/day; LEL=101.25 mg/kg/day (increased liver weight); core grade supplementary (Rohm and Haas, 1967a)
3) 90-Day Feeding - rat: NOEL=2.5 mg/kg/day; LEL=7.5 mg/kg/day (increased liver/body weight ratio in males; increased liver weight in females); core grade supplementary (Rohm and Haas, 1967b)
4) 3-Generation Reproduction - rat: NOEL=15 mg/kg/day (HDT); core grade supplementary (Rohm and Haas, 1970b)
5) Teratology - rabbit: Maternal NOEL=5 mg/kg/day; Maternal LEL=20 mg/kg/day (punctate vacuolation of hepatocyctes and anorexia); core grade minimum (Rohm and Haas, 1985)
6) 2-Year Feeding (oncogenic) - rat: NOEL=15 mg/kg/day (HDT); core grade supplementary) (Rohm and Haas, 1970c)
Data Gap(s): Chronic Rat Feeding Study; Rat Teratology Study; Rat Reproduction Study
__I.A.5. Confidence in the Oral RfD
Study — High
Database — Medium
RfD — Medium
The principal study appears to be of good quality and is given a high confidence rating. Additional studies are of fair quality, but since there are data gaps, the database is given a medium confidence rating. Medium confidence in the RfD follows.
__I.A.6. EPA Documentation and Review of the Oral RfD
Pesticide Data Evaluation Record and Registration Standard, May 1985
Pesticide Registration Files
Agency Work Group Review — 05/30/1986, 12/14/1993
Verification Date — 05/30/1986
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 Pronamide conducted in September 2002 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 — Pronamide
CASRN — 23950-58-5
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Pronamide
CASRN — 23950-58-5
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 — Pronamide
CASRN — 23950-58-5
Last Revised — 03/01/1991
_VI.A. Oral RfD References
Rohm and Haas, Company. 1967a. MRID No. 00085507. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rohm and Haas, Company. 1967b. MRID No. 00085506. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rohm and Haas, Company. 1970a. MRID No. 00085508, 00107949, 00133113. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rohm and Haas, Company. 1970b. MRID No. 00085510, 00107950, 00133114. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rohm and Haas, Company. 1970c. MRID No. 00083666, 00083667, 00133111. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rohm and Haas, Company. 1985. MRID No. 00148065. 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 — Pronamide
CASRN — 23950-58-5
Date |
Section |
Description |
---|---|---|
03/01/1988 | I.A.4. | Text clarified |
03/01/1991 | I.A.4. | 1st sentence deleted; citations added |
03/01/1991 | I.A.4. | 3) study - deleted |
03/01/1991 | I.A.4. | 4) study - text revised |
03/01/1991 | III.A. | Health Advisory on-line |
03/01/1991 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory actions updated |
01/01/1994 | I.A. | Oral RfD noted as pending change |
01/01/1994 | I.A.6. | Work group review date added |
08/01/1995 | I.A., I.A.6. | 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. |
12/03/2002 | I.A.6. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Pronamide
CASRN — 23950-58-5
Last Revised — 01/31/1987
- 23950-58-5
- BENZAMIDE, 3,5-DICHLORO-N-(1,1-DIMETHYL-2-PROPYNYL)-
- 3,5-DICHLORO-N-(1,1-DIMETHYL-2-PROPYNYL)BENZAMIDE
- KERB
- KERB 50W
- N-(1,1-DIMETHYLPROPYNYL)-3,5-DICHLOROBENZAMIDE
- PROMAMIDE
- Pronamide
- PROPYZAMIDE
- RCRA WASTE NUMBER U192
- RH 315