Cyhalothrin/Karate (CASRN 68085-85-8)
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0279
Cyhalothrin/Karate;
CASRN 68085-85-8
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 Cyhalothrin/Karate
File First On-Line 06/30/1988
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 06/30/1988 |
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 — Cyhalothrin/Karate
CASRN — 68085-85-8
Last Revised — 06/30/1988
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 |
---|---|---|---|---|
Reduced body weight 3-Generation Coopers Animal Health |
NOEL: 10 ppm (0.5 mg/kg/day) LEL: 30 ppm (1.5 mg/kg/day) |
100
|
1
|
5E-3
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)
Coopers Animal Health, Inc. and Imperial Chemical Industries, Ltd. 1984. MRID No. 00154802. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Cyhalothrin was administered in the diet at dose levels of 0, 10, 30, and 100 ppm throughout the duration of the study. The principal effect noted was a reduction in body weight gain for both males and females during the premating periods and for pups during the weaning period. There also appeared to be a decrease in the number of viable pups in the F2A and F3B generations at the highest dose level.
__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. An additional UF was not considered necessary since the chronic rat study and other studies generally showed higher NOELs; thus, the toxicological endpoint in the 3-generation reproduction study is the most sensitive indicator of Cyhalothrin's toxicity.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD:
1) 3-Generation Reproduction - rat: Principal study - see previous description; core grade guideline (Imperial Chemicals Industries, 1984)
2) 2-Year Feeding - rat: NOEL=2.5 mg/kg/day; LEL=12.5 mg/kg/day (reduced body weight gain, food consumption, plasma triglycerides); core grade guideline (Coopers Animal Health, 1984)
3) 26-Week Oral (capsule) - dog: NOEL=1 mg/kg/day; LEL=2.5 mg/kg/day (passage of liquid feces); core grade guideline (Imperial Chemicals Industries, 1981a)
4) Teratology - rat: Maternal toxicity NOEL=10 mg/kg/day; Maternal toxicity LEL=15 mg/kg/day (reduced body weight, food consumption); Teratogenic and Fetotoxic NOEL=15 mg/kg/day (HDT); core grade minimum (Imperial Chemicals Industries, 1981b)
5) Teratology - rabbit: Maternal toxicity NOEL=10 mg/kg/day; Maternal toxicity LEL=30 mg/kg/day (decrease in body weight gain); Teratogenic and Fetotoxic NOEL=30 mg/kg/day (HDT); core grade minimum (Imperial Chemicals Industries, 1981c)
Data Gap(s): none
__I.A.5. Confidence in the Oral RfD
Study — High
Database — High
RfD — High
The critical study on which the RfD is based is of high quality and sufficient duration; therefore, the critical study is given a high confidence rating. The other toxicology studies on Cyhalothrin are also of high quality; thus, 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 Cyhalothrin/Karate 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 — Cyhalothrin/Karate
CASRN — 68085-85-8
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Cyhalothrin/Karate
CASRN — 68085-85-8
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 — Cyhalothrin/Karate
CASRN — 68085-85-8
Last Revised — 01/01/1990
_VI.A. Oral RfD References
Coopers Animal Health, Inc. 1984. MRID No. 00154803. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Imperial Chemical Industries, Ltd. 1984. MRID No. 00154802. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Imperial Chemical Industries, Ltd. 1981a. MRID No. 00154795. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Imperial Chemical Industries, Ltd. 1981b. MRID No. 00154800. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Imperial Chemical Industries, Ltd. 1981c. MRID No. 00154801. 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 — Cyhalothrin/Karate
CASRN — 68085-85-8
Date |
Section |
Description |
---|---|---|
01/01/1990 | VI. | Bibliography 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. |
10/28/2003 | I.A.6. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Cyhalothrin/Karate
CASRN — 68085-85-8
Last Revised — 06/30/1988
- 68085-85-8
- 91465-08-6
- CYCLOPROPANECARBOXYLIC ACID,3-(2-CHLORO-3,3,3-TRIFLUORO-1-PROPENYL)-2,2-DIMETHYL-,CYANO(3-PHENOXYPHENYL)METHYL ESTER
- CYHALOTHRIN
- CYHALOTHRINE
- Cyhalothrin/Karate
- GRENADE
- ICI 146814
- ICI-PP 563
- KARATE
- PP 321
- PP 563