Imazalil (CASRN 35554-44-0)
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0168
Imazalil;
CASRN 35554-44-0
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 Imazalil
File First On-Line 03/31/1987
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 |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Imazalil
CASRN — 35554-44-0
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 Penwalt Corp., 1977 |
NOEL: 1.25 mg/kg/day LEL: 5.0 mg/kg/day |
100
|
1
|
1.3E-2
mg/kg/day |
*Conversion Factors: none
__I.A.2. Principal and Supporting Studies (Oral RfD)
Penwalt Corporation. 1977. MRID No. 00069941, 00069949, 00069951, 00081172,
00084659, 00084660. Available from EPA. Write to FOI, EPA, Washington, DC
20460.
Twenty-four young beagle dogs, aged 189 to 212 days, were divided into four
groups of six animals each (3M and 3F) and fed 0, 1.25, 5.0, or 20 mg/kg
bw/day of Imazalil base (R23979) for 2 years. Signs of toxicity were limited
to decreased body weight gains at doses of 5 mg/kg bw/day and higher.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — 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)
None.
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=40 mg/kg (relative liver and kidney weight increase in females) (HDT);
core grade supplementary (Janssen R & D, Inc., 1967)
3) Teratology - rat: NOEL=10 mg/kg/day; LEL=40 mg/kg/day (increased maternal
mortality, decreased food consumption, decreased litter size, increased number
of dead fetuses); core grade minimum (Chevron Chemical, 1975)
4) 3-Generation Reproduction - rat: NOEL=40 mg/kg/day (HDT); LEL=none; core
grade minimum (Penwalt Corp., 1975)
Data Gap(s): Chronic Rat Feeding Study; Rabbit Teratology
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — Medium
RfD — Medium
The principal study appears to be of medium quality and is given a medium confidence rating. Several other studies are moderately supportive; therefore, confidence in the database can be considered medium to high. Confidence in the Rfd can also be considered medium to high.
__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 — 09/02/1986
Verification Date — 09/02/1986
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 Imazalil 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 — Imazalil
CASRN — 35554-44-0
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Imazalil
CASRN — 35554-44-0
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 — Imazalil
CASRN — 35554-44-0
Last Revised — 09/01/1990
_VI.A. Oral RfD References
Chevron Chemical Company. 1975. MRID No. 00081171. Available from EPA.
Write to FOI, EPA, Washington, DC 20460.
Janssen R & D, Inc. 1967. MRID No. 00031597. Available from EPA. Write to
FOI, EPA, Washington, DC 20460.
Penwalt Corporation. 1975. MRID No. 00069944, 00081162. Available from EPA.
Write to FOI, EPA, Washington, DC 20460.
Penwalt Corporation. 1977. MRID No. 00069941, 00069949, 00069951, 00081172,
00084659, 00084660. 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 — Imazalil
CASRN — 35554-44-0
Date |
Section |
Description |
---|---|---|
09/01/1990 | I.A. | Principal study clarified |
09/01/1990 | I.A.4. | Citations added |
09/01/1990 | 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 — Imazalil
CASRN — 35554-44-0
Last Revised — 03/31/1987
- 35554-44-0
- (+-)-1-(beta-(ALLYLOXY)-2,4-DICHLOROPHENETHYL)IMIDAZOLE
- 1-(2-(2,4-DICHLOROPHENYL)-2-(2-PROPENYLOXY)ETHYL)-1H-IMIDAZOLE
- 1-(2-(2,4-DICHLORPHENYL)-2-PROPENYLOXY)AETHYL)-1H-IMIDAZOL
- ENILOCONAZOL
- FUNGAFLOR
- Imazalil
- 1H-IMIDAZOLE, 1-(2-(2,4-DICHLOROPHENYL)-2-(2-PROPENYLOXY)ETHYL)-
- R 23979