Iprodione (CASRN 36734-19-7)
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0291
Iprodione;
CASRN 36734-19-7
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 Iprodione
File First On-Line 06/30/1988
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 04/01/1991 |
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 — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
Last Revised — 04/01/1991
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 |
---|---|---|---|---|
Increased RBC Heinz 1-Year Dog Feeding Rhone-Poulenc, 1984 |
NOEL: 100 ppm (4.2 LEL: 600 ppm (15 |
100
|
1
|
4E-2
mg/kg/day |
*Conversion Factors -- Dose conversions based on actual food consumption data
__I.A.2. Principal and Supporting Studies (Oral RfD)
Rhone-Poulenc, Inc. 1984. MRID No. 00144391, 41327001. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Beagle dogs (6/sex/dose) (Balbeggie Kennels, Fife, Scotland) were administered 0, 4.2, 15, and 90 mg/kg/day Iprodione Technical (96.5% pure) for 52 weeks, starting at 15 to 17 weeks of age (bw 2.7 to 6.8 kg). At 15 and 90 mg/kg/day effects noted in males were decreased prostate weight, increased RBC Heinz bodies. At 90 mg/kg/day increased absolute and relative adrenal weight and increased absolute and relative liver weight were observed in males. The effects noted in females at 90 mg/kg/day were increased absolute and relative adrenal weight, slight decrease in uterus weight, and increased liver weight. Increased RBC Heinz bodies at 15 and 90 mg/kg/day. The dose of 4.2 mg/kg/day was considered a NOEL in both sexes.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 100 was used to account for inter- and intraspecies differences.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD:
1) 1-Year Feeding - dog: Principal study - see previous description; core grade minimum
2) 3-Generation Reproduction - rat: NOEL=500 ppm (25 mg/kg/day); LEL=2000 ppm (100 mg/kg/day) (lower kidney weights in F3 females; core grade minimum (Rhone-Poulenc, 1976a)
3) 24-Month Feeding (oncogenic) - rat: NOEL=1000 ppm (HDT; 50 mg/kg/day); core grade minimum (Rhone-Poulenc, 1978a)
4) 18-Month Feeding (oncogenic) - mouse: NOEL=12,500 ppm (HDT; approximately 1870 mg/kg/day); core grade minimum (Rhone-Poulenc, 1978b)
5) Developmental toxicity - rabbit: Maternal toxicity NOEL=20 mg/kg/day; LEL=60 mg/kg/day (increased abortions, body weight loss, lowered food consumption); Developmental toxicity NOEL=60 mg/kg/day; LEL=200 mg/kg/day (skeletal variations [13th full rib, sternebrae malaligned], delayed ossification); core grade minimum (Rhone-Poulenc, 1985)
Other Data Reviewed:
1) 90-Day Feeding - dog: NOEL=2400 ppm; LEL=7200 ppm (liver hypertrophy, increased SAP [serum alkaline phosphatase]; core grade minimum (Rhone-Poulenc, 1976b)
2) 5-Month Feeding - rat: NOEL=1000 ppm (HDT); core grade minimum (Rhone- Poulenc, 1973)
Data Gap(s): Developmental toxicity - Rat; Study under review
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — High
RfD — High
The critical study is of adequate quality and is given a medium confidence rating. The database on chronic toxicity is of adequate quality; therefore, the database is given a high confidence rating. High 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 — 07/15/1987
Verification Date — 07/15/1987
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 Iprodione conducted in November 2001 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 — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
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 — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
Last Revised — 09/01/1990
_VI.A. Oral RfD References
Rhone-Poulenc, Inc. 1973. MRID No. 00157376. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1976a. MRID No. 00071927. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1976b. MRID No. 00157377, 00157378. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1978a. MRID No. 00071997. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1978b. MRID No. 00070963, 00112530. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1984. MRID No. 00144391, 41327001. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc, Inc. 1985. MRID No. 00155469. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
_VI.B. Inhalation RfD References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
Date |
Section |
Description |
---|---|---|
02/01/1989 | I.A.7. | Contacts' phone numbers corrected |
09/01/1990 | I.A.4. | Citations added |
09/01/1990 | VI. | Bibliography on-line |
04/01/1991 | I.A. | Text edited |
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 — Iprodione
CASRN — 36734-19-7
Primary Synonym — Rovral
Last Revised — 06/30/1988
- 36734-19-7
- CHIPCO 26019
- 3-(3,5-DICHLOROPHENYL)-N-(1-METHYLETHYL)-2,4-DIOXO-1-IMIDAZOLIDINECARBOXAMIDE
- FA 2071
- GLYCOPHEN
- GLYCOPHENE
- 1-IMIDAZOLIDINECARBOXAMIDE, 3-(3,5-DICHLOROPHENYL)-N-(1-METHYL- ETHYL)-2,4-DIOXO-
- Iprodione
- 1-ISOPROPYL CARBAMOYL-3-(3,5-DICHLOROPHENYL)-HYDANTOIN
- LFA 2043
- MRC 910
- NRC 910
- PROMIDIONE
- ROP 500 F
- Rovral
- RP 26019