United States Office of Pesticides arid Toxic Substances
Environmental Protection Office of Pesticide Programs (TS-766C)
Agency Washington. DC 20460
EPA Pesticide
Fact Sheet
Name of Chemical: KARATE (PP321)
Reason for Issuance: Conditional Registration
Date Issued: May 16, 1988
Fact Sheet Number: 171
1. DESCRIPTION OF CHEMICAL
*_
Generic Name: PP321; [ 1 alpha(S), 3 alpha(Z)]—(±)
—cyano—(3—phenoxyphenyl) methyl 3(2—chioro—
3,3 ,3—trifluoro—l—propenyl )—2 ,2—dimethyl—
cyc]opropanecarboxylate.
Common Name: PP321
Trade Namer KARATE
EPA Shaughnessy Code: 128867(a)
Chemical Abstracts Service (CAS) Numbers:
Year of Initial Registration: 1988
Pesticide Type: Insecticide
Chemical Family: Synthetic pyrethroid
U.S. Producers: ICI Americas, Inc.
Wilmington, DE 19897
2. USE PATTERNS AND FORMULATIONS
Application Sites: Agricultural use in/on Cotton
Method of Application Foliar ground and aerial
application
Formulation Types: 13% liquid (EC)
Application Rates: 0.01—0.03 lb.ai/Acre
Usual Carriers: Organic solvents: Surfactants
Limitations: RESTRICTED USE pesticide. Use limited to
certified applicators or persons under their direct supervision.
3. SCIENCE FINDINGS
Summary Science Statement :
*pp321 comprises one of two diastereomers (enantiomeric pairs)
of Cyhalothrin. Cyhalothrin consists of 4 cis isomers in
the 2 configuration (enantiomeric pair A & B) of which PP321
consists of 2 cis isomers (enantiomeric pair B).

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Technical PP321 is a synthetic pyrethroid with
moderate acute toxicity. The results of the acute
toxicity on the end—use formulation indicates that
product is of moderate to high acute toxicity. The
end—use product is extremely irritating to the skin
and is a mild sensitizer. Technical PP321 is not
considered to be mutagenic or teratogenic in test
animals. On the basis of structural considerations
and metabolism and subchronic data on both PP321 and
cyhalothrin, the Aqency has accepted the long term
data on cyhalothrin in partial fulfillment of the
chronic toxicity requirements for PP321.
Sufficient data are available to characterize PP321
from an environmental fate and ecological effects standpoint.
The results of acute toxicity studies indicate that PP321 is
extremely toxic to fish and other aquatic organisms, but
is practically non—toxic to waterfowl and upland game birds.
However, reproduction data on mallards exposed to cyhalothrin
domonstrated adverse effects on numbers of eggs laid at
doses of 50 ppm, with a no-effect—level (NOEL) of 5 ppm
cyhalothrin. Since technical PP321 is the more biologically
active component of cyhalothrin, it may be more toxic;
therefore, the Aqency has determined that the repro
reproduction study be repeated using technical PP321.
An acute contact LD5O study indicated that PP321 is
highly toxic to bees with an LD5O of 0.909 ug/bee.
Formulated PP321 is also highly toxic to honey bees
with a reported LD5O of 0.098 ug/bee and an oral LD5O
of 0.483 ug/bee. PP321 is readily degraded by soil
and is virtually insoluble in water. There is little
or no potential for leaching.
The Agency has determined that the registration
of PP321 may effect endangered aquatic and avian species.
Pending a formal consultation with the Fish and Wildlife
Service to determine use limitations with respect to
these species, the product label contsists of language
which will mitigate the risk to endangered species.
A Tolerance Assessment has been conducted by
the Residue Chemistry Branch to provide a dietary
exposure analysis for the use on cotton. The refer-
ence dose (Rfd) used to determine this dietary exposure
is calculated to be 0.005 ppm based on a NOEL of 0.5 mgI
kg/day from a 3—generation rat reproduction study and
a safety factor of 100. The Theoretical Maximum
Residue Contribution (TMRC) for the U. S. population is
imately 2.6 % of the Average Daily Intake (ADI).

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A. Chemical/Physical Characteristics of the Technical Material
Physical State: liquid
Color: light yellow
Odor: aromatic solvent odor at room temparature
Melting Point: not applicable
Vapor Pressure: 2.1 x 10—8 rnbars
Density: 0.830 + .005 g/mi
Solubility: 0.002 mg/mi at 20°C in water
pH: 5.6
Octanol/Water Partition Coefficient: 4.2 x iü
B. Toxicological Characteristics :
(Technical PP321)
Acute Oral (Mouse): males: 79 mg/kg Toxicity Category II
(LD5O) females: 56 mg/kg
Acute Dermal: males: 632 mg/kg
(LD5O) females: 696 mg/kg Toxicity Category II
Primary Dermal Irritation (rabbit): PIS= 0 Toxicity Category IV
(none observed)
Skin Sensitization (guinea pig): not a sensitizer
Acute Inhalation: LD5O (4 hour) males: 0.315 mg/i Toxicity
(end—use formulation) females: 0.175 mg/i Category II
Teratology: (rat) Maternal NOEL = 10 mg/kg/day
(Cyhaiothrin) Maternal LEL = 15 mg/kg/day
Fetotoxic NOEL = 15 mg/kg/day
Teratogenic NOEL = not teratogenic
(rabbit) Maternal NOEL = 10mg/kg/day
Maternal NOEL = 3Omg/ka/day
Fetotoxic NOEL = 15 mg/kg/day
Teratogenci NOEL = not teratogenic
2—Year Feedina/Oncogenicity: (rat) Oncogenic NOEL = 2.5 mg/kg/day
(Cyhalothrin) Systemic NOEL = 0.5 mg/kg/day
(mouse) Oncogenic NOEL = 15 mg/kg/day
Gene Mutation (Ames): negative
Structural Chromosome Aberration: negative
In Vitro Cytogenetics Assay: negative

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PP321 formulation— 13.1%
Acute Oral Toxicity in rats: Toxicity Category II
LD5O = 64 mg/kg
Acute Dermal Toxicity in rats: Toxicity Category III
LD5O = >2000 mi/mg
Acute Inhalation: Toxicity Category II
LC5O = 0.315 rng/l(M); 0.175 mg/l(F)
Primary Eye Irritation: Toxicity Category II
Primary Dermal Irritation: Toxicity Category I
PIS = 6.7
Dermal Sensitiztion: mild sensitizer
C. Physiological and Rio1 ’icai Characteristics
The mode of action in bioli,qicai systems is stomach and
contact exhibiting neuropathological characteristics typical
of pvrethroid insecticides. Slight repeilant effect.
Foliar absorption: N/A
Translocation: N/A
D. Environmental Characteristics
Adequate data are sufficient to define the fate of PP321
in the environment. PP321 is stable to photolysis
at environmental pH and temperature. It photodegrades
rapidly and is practically water insoluble. Tinder the
conditions of the soil TLC test using various soils,
(aged and unaged) PP321 residues are considered immobile
in soils with a half—life of <14 days in silt and
28—56 days in clay loam, respectively. Anaerobic conditions
did not alter either degradation rate or products. It
has a bioaccumuiation factor in fish of 858X. Residues
are depurated radidly in untreated water. Accumulated
residues are found in non—edible tissue. PP321 and its
degradates do not leach into the soil. There are no
concerns at this time in regard to ground water.

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E. Ecological Characteristics
Avian Acute Oral: Mallard duck — LD5O > 3950 mg/kg
Avian Subacute Dietary: Mallard duck — LC5O 3948 ppm
Bobwhite quail — LC5O > 5000 ppm
Freshwater Fish: Bluegill — LC5O = 0.21 ug/L
Rainbow Trout — LC5O = 0.24 ug/L
Freshwater Invertebrate: Daphnia magna LC5O = 0.36 ug/L
Marine/Estuarine Invertebrate: Mysid shrimp — LC5O = 4.9 ng/L
Eastern Oyster ECSO = 0.59 ng/L
Marine/Estuarine Fish: Sheepshead minnow — LC5O = 0.807 ng/L
4. Summary of Regulatory Position and Rationale
The Agency has determined that it should allow the
conditional registration of PP321 for agricultural use
to control insects in/on cotton. Adequate data are available
to assess the acute and chronic toxicological effects of PP321
to humans. However since certain long—term fish, aquatic
and avian data are missing and required, the registration
is being conditionally approved with an expiration date
of August 30, 1990 which coincides with the dates for
submission of the data recuired to satisfy the remaining
data gaps listed he1o .
In 7je’4 of the high toxicity of technical PP321 to
aquatic organisms (invertebrates and fish) and the
potential hazard associated with exposure to this
product, the Agency is concerned about exposure
which may result from improper application or use
and so is restricting use of this pesticide.
The Agency has determined that endangered species
labeling restrictions are necessary to protect endangered
species and is requiring specific limitations on use of
this product to prevent or mitigate exposure.
5. Summary of Major Data Gaps
1. Avian Reproduction — Mallard (71—4)
A final report is due in May, 1990.
2. Fish Life—Cycle (72—5)
A final report is due in August, 1990.
3. Aquatic Invertebrate Lifecycle (72—4)
A final report is due in August, 1989.

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6. Contact Person at EPA
George T. LaRocca
Product Manager (15)
Insecticide—Rodenticide Branch
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M Street, S. W.
Washington, D. C. 20460
Office location and telephone number:
Room 211, Crystal Mall #2
1921 Jefferson Davis Highway
Arlington, VA 22202
(703) 557—2400

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