Fluvalinate (CASRN 69409-94-5)
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0281
Fluvalinate;
CASRN 69409-94-5
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 Fluvalinate
File First On-Line 06/30/1988
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 — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
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 |
---|---|---|---|---|
Decreases in body 2-Year Feeding/ Zoecon, 1984 |
NOEL: 1 mg/kg/day LEL: 2.5 mg/kg/day |
100
|
1
|
1E-2
mg/kg/day |
*Conversion Factors and Assumptions — 1 ppm = 0.05 mg/kg/day (assumed rat food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
Zoecon Corporation. 1984. MRID No. 00128334, 00128335, 001150111. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Groups of weanling Charles River CD rats (85/sex/group) were administered 0, 0.25, 0.5, 1.0, and 2.5 mg/kg/day of fluvalinate by gavage in corn oil for a period of 2 years. Mean body weight gain was significantly depressed in males and females in the 2.5 mg/kg/day groups. There were no effects on opthalmology, clinical laboratory parameters, or organ weights. There was an increase in plantar ulcers in females in the 2.5 mg/kg/day group.
A 2-generation rat reproduction study (Zoecon, 1981) supports the principal study. One hundred fifty male and 150 female Charles River rats were assigned to one control and five treatment groups. The test material was administered in the diet at dosage levels of 0 (vehicle control, corn oil), 20, 100, 250, 500, and 1000 ppm (0, 1, 5, 12.5, 25, and 50 mg/kg/day) to the F0 generation. At 100 ppm (5 mg/kg/day) skin lesions were observed in both generations, and decreases in body weight gain were seen in both parent and offspring. A dosage of 20 ppm (1 mg/kg/day) in the diet was concluded to be a definitive NOEL for this study.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — Based on a chronic toxicity study, 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) 2-Year Feeding (oncogenic) - rat: Principal study - see previous description; core grade guideline
2) 2-Generation Reproduction - rat: Fetotoxic and Systemic NOEL=20 ppm (1 mg/kg/day); Fetotoxic and Systemic LEL=100 ppm (5 mg/kg/day) (decrease in pup weights, decreased female body weight gain, lower F1 maternal body weights during gestation and lactation, and skin lesions); core grade guideline (Zoecon Corp., 1981a)
3) 6-Month Feeding - dog: NOEL=5.0 mg/kg/day; LEL=15 mg/kg/day (emesis and diarrhea observed); core grade guideline (study accepted as chronic dog study) (Zoecon Corp., 1980a)
4) Teratology - rat: Development NOEL=10 mg/kg/day; LEL=50 mg/kg/day [decreased fetal weight and length, delayed ossification (not teratogenic at 50 mg/kg/day - HDT)]; core grade minimum (Zoecon Corp., 1980b)
5) Teratology - rabbit: Developmental NOEL=20 mg/kg/day; LEL=125 mg/kg/day (HDT; curved tibia and fibula); core grade guideline (Zoecon Corp., 1981b)
Data Gap(s): none
__I.A.5. Confidence in the Oral RfD
Study — High
Database — High
RfD — High
The critical study is of good quality and is given a high confidence rating. The supporting database is also of good 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 — 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 Fluvalinate 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 — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
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 — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
Last Revised — 03/01/1991
_VI.A. Oral RfD References
Zoecon Corporation. 1980a. MRID No. 00077025. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Zoecon Corporation. 1980b. MRID No. 00077027. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Zoecon Corporation. 1981a. MRID No. 00104253. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Zoecon Corporation. 1981b. MRID No. 00094112. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Zoecon Corporation. 1984. MRID No. 00128334, 00128335, 00150111. 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 — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
Date |
Section |
Description |
---|---|---|
03/01/1991 | I.A.4. | Citations added |
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 — Fluvalinate
CASRN — 69409-94-5
Primary Synonym — Mavrik
Last Revised — 06/30/1988
- 69409-94-5
- D-VALINE, N-(2-CHLORO-4-(TRIFLUOROMETHYL)PHENYL)-, CYANO(3-PHENOXYPHENYL)METHYL ESTER
- Fluvalinate
- Mavrik
- MAVRIK HR
- N-(2-CHLORO-4-(TRIFLUOROMETHYL)PHENYL)-D-VALINE CYANO(3-PHENOXYPHENYL)METHYL ESTER
- SPUR