UnM«ri Sata	OMa •( PwUta «<4 T«ik S«>cy	w«tii«|nii. OC 204C0
540/FS-89-025
v>EPA Pesticide
Fact Sheet
Name of Chemical: Tefiuthrin
Reason for Issuance: Conditional Registration - New Chemical
Date Issued:	February 3, 1989
Fact Sheet Number: 190.0
1.	Description of Chemical
Generic Name: 2,3,5,6-tetraf luoro-4-methylphenyl)methyl-( la,3a)-(Z)-
( + )-3-( 2-chloro-3,3,3-trif luoro-l-propenyl)-2,2-dimethyl-
cyclopropane carboxylate
Cormon Name: Tefluthria
Trade Name: Force*
Othei- Proposed Names: N/A
Code Number: lClA 0993
EPA Shaughnessy Code: 128912
Chemical Abstracts Service (CAS) Number: 79-538-32-2
Year of Initial Registration: 1989
Pesticide Type: Insecticide
Chemical Family: Pyrethroid
U.S. and Foreign Producers: ICI Americas, Inc.
2.	Use Patterns and Formulations
Application Sites: Cornseeds
Types and Methods o$ Application: Ground Application: In-band
treatment - incorporated into the top 1 inch of soil during corn planting
operations.

-------
-2-
^pplication Rates: Applied to corn seeds at a rate of qp to 0.163 pounds
active ingredient per acre overall and 0.7 lbs ai/A in the band. The
product is applied onoe per season.
Types of Fomulations: 1.5% granular and 89% technical.
Limitations:
o Registration is being approved with an expiration date of
July 31, 1993. Tolerances expire July 31, 1994.
o RESTRICTED USE PESTICIDE. Toxic to fish and aquatic
organisms. For retail sale to and use only by
Certified Applicators, or persons under their direct
supervision, and only for those uses covered by the
Certified Applicator's certification,
o CROP ROTATION RESTRICTION: Do not rotate to crops
other than corn,
o ENDANGERED SPECIES RESTRICTION: For ground application,
do not apply this product within 20 yards of water
(ponds, streams, or lakes).
3. Science Findings
Surrary Science Statement: Tefluthrin is a new synthetic pyrethroid.
Technical Tefluthrin exhibits high mammalian toxicity by the oral,
dermal, and inhalation route of exposure. It is not considered to be
mutagenic, carcinogenic, nor teratogenic in test anjjiels. It is readily
absorbed by iterate Is, and the majority of the residue is largely excreted
in the feces and urine by 48 hours. The results of the acute toxicty on

-------
-3-
the end-use formulation (Ftorce) indicates the product is of moderate to
i
lew toxicity. The end use product is irritating to the eyes and can cause
eye injury- Goggles or face shield are required vfoen handling the product.
Sufficient data are available to characterize tefluthrin from an
environmental and ecological effects standpoint. The results of acute
oral and sub-acute dietary studies indicates that tef luthrin is practically
non-toxic or slic^itly toxic to birds. Avian reproduction data indicates
tefluthrin has no adverse effects on reproduction in birds. The results
of acute toxicity studies-indicate that tefluthrin is extremely toxic
to fish and other aquatic organisms. Based upon the high toxicity to
aquatic organisms from Laboratory tests chronic fish, aquatic invertebrate
and exposure data (aquatic residue monitoring study) are being required
to assess potential hazards to aquatic organisms in the environment.
Tefluthrin is very voter soluble (lew mobility, low runoff, and
low leaching), highly lipophilic (strongly binds or adsorbs to soil
organic matter) and is a very stable and persistent oonpound. Estimated
B.viromental Concentration in water is expected to be extremely lew
from this use but the chemical will accuiulate and persist in sediment.
Based upon its low mobility it is not expected to leach into grrxindwater.
Tefluthrin may pose a risk to endangered aquatic species. Pending
a formal consultation with the Fish and Wildlife Service to determine use
limitations with respect to these species, the product label consists of
language *A\ich will minimize the risk to endangered species.

-------
-4-
Chemical Characteristics:
Physical State: Crystalline solid
Color: Off vAiite
Odor: Nooe
Boiling Point: Deoonposes at 295 *C
Melting ftaint: 44.6 *C (Pure), 39.4 to 43.2 *C (Technical)
Vapor Pressure: 8 x 10-6 KPa at 20 *C
Density: 1.48 g/cm^ at 25 #C
Storage Stability: 9 months at ambient tenperature
Octanol/Water Partition Coefficient: log 1^,/w = 6.5 at 20 *C
Flannability: Flashpoint 124 *C
Solubility: Vfeter - 0.02 ppro; Methanol - 263 g/L; Acetone, Toluene,
Ethyl Acetate, Hexane, and Dicloranethane >500 g/L
Toxicology Characteristics;
Technical Fonrnilati.cn:
Acute Oral "toxicity-Rat? LD50 = 21.8 mg/kg(males); 34.6 nq/kg (females)
"toxicity category I.
Acute Dermal "toxicity-Rat: LD50 = 316.0 mg/kg(males); 177 mg/kg (females)
"toxicity category I.
Acute Inhalation Toxicity-Rat: LCcjq = 49.1 itq/ro3(males); 37.1 mg/m3 (females)
"toxicity category I.
Primary Dermal Irritation-Rabbit: Slightly irritating,
"toxicity category IV.
Primary Eye Irritation-Rabbit: (not available).

-------
-5-
Acute Delayed Neurotoxicity - Hen: No signs of delayed neurotoxicity.
i
90-Day Feeding Study - Rat: NOEL = 50 ppm; LEL = 150 ppm;
Alterations in liver wei<£it, hemoglobin and cholesterol.
90-Day Oral Dosing Study - Dog: NOEL = 0.5 mgAg; LEL = 1.5 mgAg;
Increased triglycerides and AST (=SG0T).
2-Year Chronic/Onoogenicity Study - Mouse: NOEL = 3.4 mgAg;
LEL = 13.5 mgAg; Hemangiarratous uteri and liver necrosis.
Not oncogenic at 54.4 mg/kg (f*TD).
1-Year Oral Dosing Study - Dog: NOEL = 0.5 mg/kg; -- 2 mgAg;
Ataxia in both sexes.
Teratogenicity - Rat: Maternal NOEL = 1 mgAg; LEL = 3 irgAg;
Decreased body weight at 3 mgAg and pyrethroid toxicity at 5 mg/kg.
Developmental NOEL = 3 mg/kg; LEL = 5 mg/kg; Decreased ossifications.
Teratogenicity - Rabbit: Maternal NOEL <3 mgAg (LOT).
Pyrethroid signs. Developmental NOEL >12 mg/kg (HDT).
Multigeneration Reproduction Study - Rat: Parental NOEL = 50 ppn;
LEL = 250 ppm; Body weight effects. Reproductive NOEL = 50 ppm;
f-F.r. = 250 ppm; Pup weight effects.
Mutagenicity:
Reverse nutation (Salmonella [in vitro]): Not rrutagenic at
5000 ug/plate (precip) in S^ typhimiriun strains with/without S-9.
TK Locus in L5178Y Mouse Lynphama Cells (in vitro): Not nutagenic
up to 4000 ug/mL (cytotox).

-------
¦ 61
Bone Harrow Cytogenics (Rat [in vivo]): No chromosome damage
i
up to 12 mg/kg (cytobox).
Micronucleus (Moose [in vivo]): No micronuclei at 50 nig/kg
(single IP dose at KTD).
Dominant Lethal (Mouse [in vivo]): No dominant lethals at 10
mg/kg (MTD).
Unscheduled DNA Synthesis (Rat Hepatocytes): Absence of unscheduled
DNA synthesis up to 10~2 M (cytotox).
End Use Formulation
Hie stated results for the following acute studies are for the
1.67% formulation: oral (rat), dermal (rat), inhalation (rat), primary
dermal irritation (rabbit) and primary eye irritation (rabbit).
Acute Oral Toxicity - Rat: LD50 >2940 mg/kg (males);
Approx, « 1550 mg/kg (females), "toxicity Category III.
Acute Dermal "toxicity - Rat: LD50 >2000 mg/kg (males and females).
"toxicity Category IV.
Acute Inhalation "toxicity - Rat: 4-hour	= 2304 mg/nr* {females),
>3929 mg/nt3 (males); "toxicity Category III.
Primary Dermal Irritation - Rabbit: Slightly irritating;
"toxicity Category IV.
Primary Eye Irritation - Rabbit: Unwashed eyes showed corneal opacity,
chenosis, and conjunctival discharge clearing in 4 days;
"toxicity Category II.
Dermal Sensitization - Guinea Pig: Not a sensitizer.

-------
-7-
Physiological and Biochemical Characteristics;
Foliar Absorptions N/A
Translocation: Not translocated.
Mechanist) of Pesticidal Action: Neurotoxicity characteristic of
pyrethroid insecticides - contact action.
Environmental Characteristics;
The environmental fate data indicate that tefluthrin and its soil-aged
residues have very low vertical mobility. Tefluthrin has extremely
high Kd adsorption coefficient values aid 3Chday aged residues in
loany sand and sandy loam soils did not move significantly
beyond the top 5 inches in 35-inch soil columns. When leached with
the equivalent of 66 cm of rainfall and only 0.3 percent of the
applied material vras found in the leachate. Based on the nobility
data, tefluthrin and its degradates" are not likely to leach and
contaminate ground water. However, Tefluthrin is stable in water
at pH 5 and 1 and stable with respect to degradation under sunlight
in water and on soil with isomerization to its trans iscmar being
the major transformation. Also, field dissipation data indicate
that tefluthrin is quite persistent with a half-life of 92 to 124
days and is even more stable under anaerobic soil conditions-
Therefore, it cannot be excluded that under year by year usage
and over a long period of time leaching micfrit be observed. Field
dissipation studies conducted for periods of 1 year did not indicate
movement belcw the 10 cm depth under actual use conditions. In stumary,
although graurekater contamination is not likely to occur, it cannot be

-------
-8-
totaLly excluded with continuous year by year usage. Fish accumulation
data indicate that tefluthrin and its degradates/metabolites are not
likely to accumulate significantly in fish. The confined rotation
crop studies shewed accumulation of 14C-tefluthrin residues occurred in
all rotated crops up to 410 days post-treatment with up to 0.75 lb ai/acre
(not confirmed).
Reentry and spray drift data are not required since tefluthrin is applied
at planting tines as a band treatment and then covered with soil.
Ecological Characteristics:
Avian Oral Toxicity: Mallard EXick ID50 = 4190 mg/kg
Avian Dietary "toxicity: Bobuftiite Quail DC 50 = 15,000 ppm
(8 days)
Mallard Duck LC50 = 2317 ppm
Avian Reproduction: Dietary administration at 5 ppm and 25 ppm for 20 weeks
had no adverse effects on reproduction in birds.
(NOEL - 25 ppm).
Freshwater Fish Acute "toxicity: Bluegill IC50 = 130 parts per trillion (ppt)
(96-hr DC50 - tech. grade)
Rainbow Trout = 60 opt
Freshwater Fish Acute "toxicity: Bluegill DC50 = 120 ppt
(96-hr LC50 ~ end-use product)
Rainbow Trout = 127 ppt
Freshwater Invertebrate Acute ^toxicity: Daphnia = 70 ppt
(48-hr LC50 - tech. grade)
Freshwater Invertebrate Acute Toxicity: Daphnia = 185 ppt
(48-hr LC50 - end-use product)
Marine Fish 6 Invertebrate "toxicity: Sheepshead Minnow = 130 ppt
(96-hr DC50 tech. grade)
Mysid Siriitp = 53 ppt
Pacific Oyster = >1 ppm

-------
-9-
Ttoleranoe Assessment:
Tolerances have been established for residues of trefluthrin in/or on
the following agricultural oamo&ities (40 CFR 180.440). These tolerances
are due to expire July 31, 1994.
Ccnmodities	Part Per Million
Corn, grain, field and pop	0.06
Corn, forage and fodder, field and pop	0.06
The provisional acceptable daily intake (PADI), based on a NOEL of
0.75 rng/kg/day from a nultigeneration reproduction study and a safety
factor of 1000, is 0.00075 mg/kg body weight/day. The theoretical maxinum
residue contribution fran the proposed tolerances is 0.00001 mg/kg body
weight/day. This is equivalent to about 1.4 percent of the PADI.
Reported Pesticide Incidents: None
4. Sumnary of Regulatory Position and Rationale
*	The Agency has determined that it should allow the conditional
registration of tefluthrin for agricultural use to control insects in/on
corn. Adequate data are available to assess the acute and chronic
toxicological effects of tefluthrin to hunans.
*	Since certain long-term fish, aquatic invertebrate, aquatic exposure,
and rotational crop data are missing and required, the registration is
being conditionally approved with a expiration date of July 31, 1993,
which coincides with the date for submission of the data required to
satisfy the retraining data gaps listed below. Similarly, the tolerances
have been established wi>th an expiration date of July 31, 1994.

-------
-10-
*	In view of the hi#i toxicity of tefluthrin to aquatic organisms
(invert Urates and fish) and the potential hazard associated with
exposure to this product, the Agency is concerned about exposure which
ray result frcro iuprqper 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 Data Gaps
Guidelines
Name of Study
Reference No.
Date Due
21-Day Denial
82-2
April 1989
21-Day Feeding
82-2
April 1989
Aquatic Invertebrate
Life-Cycle Test
72-4
August 1989
Aquatic Residue
Level Monitoring
70-1
March 1991
Fish Life Cycle
72-5
August 1990
Rotational Crop -Field
165-2
March 1993

-------
-11-
Oontact Person at EPA
George T. LaRooca
Product Manager (15)
Insecticide-Rodenticide Branch
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M Street SW.
Washington, DC 20460
Office location and telephone nuntoer:
toocti 211, Crystal Mall #2
1921 Jefferson Davis Highway
Arlington, VA 22202
Phone: (703) 557-2400
DISCLAIMER: The information presented in this Pesticide Fact Sheet is
for informational purposes only and may not be used to fulfill data
requirements for pesticide registration and reregistration.

-------