Fluometuron (CASRN 2164-17-2)
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0241
Fluometuron;
CASRN 2164-17-2
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 Fluometuron
File First On-Line 09/30/1987
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 — Fluometuron
CASRN — 2164-17-2
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 |
---|---|---|---|---|
No adverse effects 103-Week Rat Feeding NCI, 1980 |
NOAEL: 250 ppm diet LEL: None |
1000
|
1
|
1.3E-2
mg/kg/day |
*Conversion Factors: 1 ppm = 0.05 mg/kg/day (assumed rat food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
NCI (National Cancer Institute). 1980. Bioassay of Fluometuron for Possible Carcinogenicity, CAS No. 2164-17-2, NCI-CG-TR-195, NTP-80-11, NIH Publ. No. 80-1751. National Institute of Health, Bethesda, MD.
Groups of rats (50/sex/dose) were fed diets containing 0, 125, or 250 ppm of fluometuron for 103 weeks. All surviving animals were killed at 103 to 105 weeks. Mean body weights and survival of the dosed groups of male and female rats were essentially the same as those of the corresponding control group. No observed effects were seen at the highest dose tested, 250 ppm (12.5 mg/kg/day), which was the NOAEL for this study.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 1000 was used to account for the inter- and
intraspecies differences and for the fact that the database on toxicity is
incomplete (e.g., lacking a mammalian reproductive study). Furthermore, the
available supporting studies are of low quality.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD:
1) 103-Week Feeding - rat: Principal study - see previous description; no
core grade
2) 90-Day Feeding - rat: NOEL=7.5 mg/kg/day; LEL=75 mg/kg/day (decrease in
body weight and enlarged spleens); no core grade (Ciba Agrochemical, 1965a)
3) 90-Day Feeding - dog: NOEL=10 mg/kg/day; LEL=100 mg/kg/day (inflammatory
reaction in kidney and liver); no core grade (Ciba Agrochemical, 1965b)
4) Teratology - rabbit: Maternal and Fetotoxic NOEL not established; LEL=50
mg/kg/day; minimum for teratogenicity otherwise supplementary (Ciba-Geigy,
1984)
5) 103-Week Feeding - mouse: NOEL=500 ppm (75 mg/kg/day); LEL=1000 ppm (150
mg/kg/day) (marginal increase in liver tumors); no core grade (NCI, 1980)
Data Gap(s): Chronic Rat Feeding Study; Chronic Dog Feeding Study; Rat
Reproduction Study; Rat Teratology Study; Rabbit Teratology Study
__I.A.5. Confidence in the Oral RfD
Study — Low
Database — Low
RfD — Low
The principal study appears to be of low quality and is given a low confidence rating. Since the database on toxicity is incomplete and of apparently low quality, the database is given a low confidence rating. Low 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 Standard, 1985; Pesticide
Registration Files
Agency Work Group Review — 07/08/1986, 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 Fluometuron conducted in August 2003 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 — Fluometuron
CASRN — 2164-17-2
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Fluometuron
CASRN — 2164-17-2
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 — Fluometuron
CASRN — 2164-17-2
Last Revised — 09/01/1990
_VI.A. Oral RfD References
Ciba Agrochemical Company. 1965a. MRID No. 00019034. Available from EPA.
Write to FOI, EPA, Washington, DC 20460.
Ciba Agrochemical Company. 1965b. MRID No. 00019035. Available from EPA.
Write to FOI, EPA, Washington, DC 20460.
Ciba-Geigy Corporation. 1984. MRID No. 00147554. Available from EPA. Write
to FOI, EPA, Washington, DC 20460.
NCI (National Cancer Institute). 1980. Bioassay of Fluometuron for Possible
Carcinogenicity, CAS No. 2164-17-2, NCI-CG-TR-195, NTP-80-11, NIH Publ. No.
80-1751. National Institute of Health, Bethesda, MD.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Fluometuron
CASRN — 2164-17-2
Date |
Section |
Description |
---|---|---|
03/01/1988 | I.A.1. | Dose conversion clarified |
09/01/1990 | I.A.2. | Text edited |
09/01/1990 | I.A.4. | Citations added |
09/01/1990 | III.A. | Health Advisory on-line |
09/01/1990 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory action updated |
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. |
_VIII. Synonyms
Substance Name — Fluometuron
CASRN — 2164-17-2
Last Revised — 09/30/1987
- 2164-17-2
- C 2059
- CIBA 2059
- COTORAN MULTI 50WP
- COTTONEX
- 1,1-DIMETHYL-3-(3-TRIFLUOROMETHYLPHENYL)UREA
- 1,1-DIMETHYL-3-(alpha,alpha,alpha-TRIFLUORO-m-TOLYL) UREA
- Fluometuron
- HERBICIDE C-2059
- LANEX
- NCI-C08695
- N-(3-TRIFLUOROMETHYLPHENYL)-N'-N'-DIMETHYLUREA
- N-(m-TRIFLUOROMETHYLPHENYL)-N',N'-DIMETHYLUREA
- PAKHTARAN
- 3-(5-TRIFLUORMETHYLPHENYL)-1,1-DIMETHYLHARNSTOFF
- 3-(m-TRIFLUOROMETHYLPHENYL)-1,1-DIMETHYLUREA
- UREA, 1,1-DIMETHYL-3-(alpha,alpha,alpha-TRIFLUORO-m-TOLYL)-
- UREA, N,N-DIMETHYL-N'-(3-(TRIFLUOROMETHYL)PHENYL)-