EPA Pesticide Fact Sheet: (CAS) N-(cyanomethyl) -4-(trifluoromethyl) -3-(pyridinecarboximide) or (upac) N-cyanomethyl-4-trifluoromethyl Nicotinamide (flonicamid).


EPA 732-F-04-001
NEW CHEMICAL FACT SHEET
1. DESCRIPT ION OF THE CHEMICAL
Generic Names: (CAS) N-(cyanomethyl)-4-(trifluoromethyI)-3-(pyridinecarboximide) or
(UPAC) N-cyanomethyl-4-trifluoromethyl nicotinamide
MolecuUr Formula: C9H6N3OF3
Molecule r Weight: 229.2
Structure:
Common Name: Flonicamid
Trade Nsme: Flonicamid, IKI-220
End Use Product Name: F1785 GH 50 WG
EPA Shaughnessy Code (OPP Chemical Code): 128016
Chemica Abstracts Service (CAS) Number: 158062-67-0
Year of Initial Registration: 2003
Pesticide Type: Insecticide
Producers: Technical Flonicamid - ISK Biosciences; End Use Product - FMC
2. USE PATTERNS AND FORMULATIONS
Application S tes:
Type and Methods of
Application:
Use on ornamental plants grown in commercial greenhouses and
interiorscapes
foliar spray
Types of Formulations: 98.4% a.i. Technical; 50% wettable granular end-use product
Target Pests:
3. SCIENCE FINDINGS
Aphids, thrips, whiteflies, leafhoppers, mealybugs, plant bugs,
scale, stinkbugs
SUMMARY STATEMENT
The toxicology data base is complete for this use pattern with one exception: a 90 day
inhalation study is required as a condition of registration to address concerns for repeated
exposure via the inhalation route as a result of greenhouse use.
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In a battery of acute toxicity studies Flonicamid technical is classified as Toxicity
Category 111 fot oral exposure and Category IV for all other routes of exposure. It is not a dermal
sensitizer.
In a batiery of acute toxicity studies, F1785 GH 50 WG Insecticide is classified as
Toxicity Category II for eye irritation, Category III for oral and dermal exposure, and Category
IV for inhalation and dermal irritation. It is not a dermal sensitizer.
For env ronmental fate and effects the submitted data are sufficient to support use in
greenhouses ani interior landscapes. Based on the available data, the compound is readily
susceptible to microbial degradation and is very mobile in the environment. Under certain
conditions, flonicamid could move into surface and ground water through runoff and leaching.
Wildlife, plants, drinking water, and ground water are not expected to be exposed to the
pesticide for thti following reason: greenhouse applications differ from general agricultural uses
in that runoff water from irrigation is not normally released directly back into the open
environment.
The Agency has determined that this use of flonicamid met the criteria for OP
replacement. For this reason, the Agency has determined that registration of these products is in
the public interest arid the products are eligible for registration under FIFRA Sec.3(c)(7)(C).
CHEMICAL CHARACTERISTICS
Tcchnica Grade
Physical: Powder
Color: Light Beige
Odor: Odorless
HUMAN HEALTH ASSESSMENT
Acute Toxicity :>f Technical flonicamid
Acute Oral - Rat: LD50(M) = 884 mg/kg; LD50(F) = 1768 mg/kg.
Toxicity Category III
Acute Dermal - Rat: I.DJ0(M) > 5000 mg/kg.
Toxicity Category IV
Acute Ii halation - Rat: LC50 > 4.9 mg/L
Melting Point:
Vapor Pressure:
Henry's Law Constant:
Qctanol-water partition coefficient (Kow):
Water Solubility:
Dissociation Constant in water:
157.5°C
9.43 x 10'7 Pa at 20°C
4.2 x 10-' PamVmole (20°C)
1.9 (30°)
5.3 g/L (20°C)
Pka= 11.6 ±0.03
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Toxicity Category IV
Primary Eye Irritation - Rabbit: Not an eye irritant
Toxicity Category IV
Primary Skin Irritation - Rabbit; Not a skin irritant.
Toxicity Category IV
Dermal Sensitization - Guinea Pig: Not a sensitizer..
Other toxicology data reviewed for this use are summarized in the following table:
STUDY TYPE - DOSE LEVELS
No Observed
Adverse
Effect Level
(NOAEL)
(mg/kg/day)
Lowest Observed Adverse Effect Level
(LOAEL)
(mg/kg/day)
DEVELOPMENTAL TOXICITY IN THE RAT
0, 20, 100, 500 nig/kg day
Maternal - 100
Developmental -
100
Maternal - 500, increased liver weights, liver and kidney
pathological changes,
Dev elopmenial - 500, increased incidence of cervical ribs
13-WEEK FEEDING RAT
0,3, 12,60, 119 mg/ki/day (Mi
0, 15, 72, 340 mg/kg/< ay (F)
12 (M), 72 (F)
60 (M), 340 (F) • kidney hyaline deposition (M&Flt Production
of blood cells in (issues other than bone marrow. This occurs in
severe anemia and other diseases affecting the blood), liver
ccmrilobular hypertrophy (F)
28-DAY RANGE-FINDING RAT
7 (Ml. 82 (F)
36 (M), 373 (F) - kidney hyaline deposition (M&F), liver
cenlrilobular hypertrophy, anemia, and incr cholesterol (F )
13-WEEK FEEDING DOG
(capsules]
8 (M), 20(F)
20 (M), 50 (F) - clinical and hematology changes (M&F),
increased adrenal weights & decreased thymus weights (M),
kidney tubular vacuolation (F)
13-WEEK FEEDING MOUSE
15 (M), 20 (F)
unacceptable
study due to lack
ofhistological
examinations
154 (M). 192 (F) • clinical and hematology changes, spleen
extramedullar hematopoiesis (Production of blood cells in
tissues other than bone marrow This occurs in severe anemia
and Qther diseases affecting the blood).
28-DAY DERMAL TOXICITY RAT
1000
>1000
METABOLISM - pilo pharmacokinetic and
elimination study
pilot study -
unacceptable/
guideline
-
MUTAGENICITY
negative
-
OCCUPATIONAL EXPOSURE
The following er d points were identified for use in the occupational risk assessment for the
greenhouse use:
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Summary of Toxicologieal Dose and Endpoints for Flonicamid (non-food use).
Exposure
Scenario
Dose Used in
Risk Assessment,
UF
Level of Concern for
Risk Assessment
Study and Toxicological Effects
Long-Term Dermal
(>6 months)
Oral NOAEL=
12 mg/kg/day
(dermal absorption
rate = 3.6 %)
Occupational LOC for
MOE = 100
90-Day oral rat
LOAEL = 60 mg/kg/day based on
kidney hyaline deposition.
Short- (1 to 30
days), Intermediate
(1 to 6 months)
and Long-Term
(>6 months)
Inhalation
Oral NOAEL- 12
mg/kg/day
(inhalation
absorption rate =
100%)
Occupational LOC for
MOE = 100
90-Day oral rat
LOAEL = 60 mg/kg/day based on
kidney hyaline deposition.
Cancer (oral,
dermal, inhalaticn)
Not determined.
NA
Studies not reviewed at this time.
UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level,
PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC =
level of concern, NA = Not Applicable
In addition, the Agency evaluated the preliminary findings of male and female lung tumors in a
flonicamid mouse oncogenicity study and determined an upper-bound Ql* of
0.0316 mg/kg/clay"1, which was used for a screening level cancer assessment for the proposed
uses. A full evaluation of the study findings will be conducted in the event food-use petitions are
submitted in th: future.
Pesticide handl ;rs may be exposed to flonicamid during mixing, loading and application.
Occupational pDstapplication exposure is expected for commercial greenhouse ornamental
production and maintenance of interiorscapes. Postapplication activities for which exposure is
anticipated include scouting, pinching, pruning, container relocation and re-planting
(interiorscapes).
Handler Exposure and Risk* Inhalation MOEs for non-cancer effects, at 5,200 to 520,000, are
above the targe: of 100 without the use of a respirator. Therefore they are not of concern to the
Agency. The h ighest estimated cancer risks for handlers (combined dermal and inhalation
exposure) was (>.2 x 10 6 for a mixer/loader applicator.
Characterization of Handler Exposure and Risk. The Agency believes that the use of
maximum application rates to assess short-/intermediale-term exposure for flonicamid handlers
leads to conservative exposure estimates. Handler risks were assessed separately from
postapplication worker risks. This may underestimate or overestimate the risk to greenhouse
workers who engage in both activities in a workday. However, the Agency believes that the
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uncertainties in attempting to assess a combined exposure, for which reliable data are lacking,
would lead to an unreliable final risk estimate.
Post Application Exposure and Risk. MOEs that exceed the target MOE of 100 are not of
concern. The Agency estimated long-term dermal MOEs for post application exposure scenarios
that exceeded 100. The most highly exposed worker is a hand pruner. where the long term dermal
MOE is 700. C nicer risks range from 3.8 x lO" to 7,6x 10"5. For the hand pruner, the estimated
cancer risk is 7.5 x 10 \
Characterization of Postapplication Exposure and Risk. For postapplication workers, a range
of application n tes were assessed, including the maximum, central and lowest rate.
Postapplication risks were estimated for long-term exposure, with the assumption that workers
would be exposed > 180 consecutive days per year. A 4-hour per day exposure duration is used
for estimating ciincer risk, and is considered to be a central-value assumption. However, the
assumption of 2 DO annual working days of exposure to "day of treatment" residue levels, adds a
conservative element to the results.
The range of transfer coefficients used in this assessment is believed to be sufficient to cover
most potential activities with greenhouse ornamentals and interiorscapes. The highest transfer
coefficient used (7000 ug/cm2) is most relevant to cut flower harvesting and bundling, which
only accounts fcr a subset of the activities subject to this application. Overall, the
postapplication exposure assessment for flonicamid use on greenhouse ornamentals and
interiorscapes is believed to result in high-end estimates of risk.
Residential Exposure and Risk. There are no existing or proposed uses of flonicamid at
residential sites. Currently, the Agency considers residential postapplication exposure to
ornamental plan s to be negligible. Post application exposure includes incidental oral exposure to
toddlers and exposure to ornamental plants in interiorscapes such as those found in public places
such as shopping malls.
ECOLOGICAL EFFECTS CHARACTERISTICS
The Agency eva uated the studies submitted by the registrant and the results are presented below.
In evaluating the submitted studies, the Agency considered the significance of EPA guideline
deviations in the context of this particular application in greenhouses and interiorscapes and
determined that deficient studies did not have to be repeated for greenhouse use.
Avian dietary (Uobwhite quail). Flonicamid technical is categorized as slightly toxic to
northern bobwhite quail on an acute dietary basis. The LCS0 is greater than 4613 mg/kg. The
NOAEC (no observed adverse effect concentration) is less than 4613 mg/kg. The endpoint(s)
affected were food consumption and body weight.
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Avian dietary (Mallard duck). Flonicamid technical is categorized as practically nontoxic to
mallard ducks on an acute dietary basis. The LCJ0 is greater than 5037 nig/kg. The NO A EC is
less than 5037 nig/kg. The endpoints affected were food consumption and body weight.
Fish toxicity, warmwater species (bluegill sunfish). In a 96 hour acute toxicity study,
flonicamid technical is categorized as slightly toxic to bluegill sunfish. The LC50 is greater than
98.8 mg a.i./L. "he NOAEC is greater than or equal to 98.8 mg a.i./L. No affected endpoints
were identified n this study.
Fish toxicity, coldwater species (rainbow trout). In a 96-hour acute toxicity study, flonicamid
is categorized slightly toxic to rainbow trout. The LC50 is greater than 97.9 mg a.i./L. The
NOAEC is grea.er than or equal to 97.9 mg a.i./L. No affected endpoints were identified in this
study.
Freshwater invertebrate toxicity (Daphnia magna). In a 48-hour acute toxicity study under
static conditions, flonicamid is categorized as slightly toxic to freshwater invertebrates. The EC50
(concentration at which 50% of the test organisms were immobilized) is greater than 98.6 mg
a.i./L. The NOAEC is greater than or equal to 98.6 mg a.i./L.
Acute toxicity Green Alga- Tier 1. In a 72 hour acute toxicity study under static conditions, the
NOAEC was 43.8 mg/L based on growth rate and biomass. Reductions in cell density, growth
rate, and biomass did not exceed 50%, so the EC50 was greater than 96.7 mg/L.
Honey bee - acute contact & oral LC^ Flonicamid is categorized as practically nontoxic to
honeybees on both an acute contact and oral basis.
ENVIRONMENTAL FATE
The following table summarizes the environmental fate characteristics of flonicamid. See also
the chemical characteristics summarized on page 2 of this fact sheet.
PARAMETER
value
pH (20°C)
4.5
stable
stable
204 days
stable
77 days
Hydrolysis half life pH 5)
Hydrolysis half life pH 7)
Hydrolysis half life pH 9)
Aqueous photolysis half life
Soil photolysis half life
Soil-water distribution coefficient (Kd)
0.094 -0.454 mL/g
CONTACT PE RSON:
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Ann Sibold, Reviewer, PM-10
Insecticide Brarch , Registration Division (7505C)
Office of Pestic de Programs
U.S. EPA, Ariel Rios Building
1200 Pennsylvania Avenue NW
Washington, DC 20460
Office Location and Telephone Number:
Rm. 220, Crystd Mall # 2
1921 Jefferson Davis Highway
Arlington, VA 12202
(703) 305-6411
Electronic copies of the this fact sheet are available on the Internet. See
http://www.epa.gov/opprd001/factsheets/
Printed copies of this fact sheet can be obtained from EPA's National Center for
Environmental Publications and Information (EPA/NCEPI), PO Box 42419, Cincinnati, OH
45242-2419, telephone 1-800-490-9198; fax 513-489-8695.
For more information about EPA's pesticide registration program, please contact the
Registration Division (7505C), OPP, US EPA, Washington, DC 20460, telephone 703-305-5446.
For infoimation about the health effects of pesticides, or for assistance in recognizing and
managing pestic ide poisoning symptoms, please contact the National Pesticides
Telecommunications Network (NPTN). Call toll-free 1-800-858-7378, from 6:30 a.m. to 4:30
p.m. Pacific Time, or 9:30 a.m. to 7:30 p.m. Eastern Standard Time, seven days a week.
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4. TITLE AND SUBTITLE
ft r i F fuor omctl iy f ?-3-^py r id
N-cyanomethy -4-trif luoromelliy 1 nicorinamide
5. FUNDING NUMBERS
6. AUTHOR(S)
EPA, Office of Pesticide Programs, Registration Division
7. PERFORMING ORG/NIZATlON NAMEJS) AND ADDRESS(ES)
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505C)
401 M Street, S.V.
Washington, D.C. 20460
8. PERFORMING ORGANIZATION
REPORT NUMBER
9. SPONSORING/MONITORING AGENCY NAMEfS) AND ADDRESS(ES)
Same as #7
10. SPONSORING /MONITORING
AGENCY REPORT NUMBER
EPA 732-F-04-001
11, SUPPLEMENTARY YOTES
12a. DISTRIBUTION/AVAILABILITY STATEMENT
Publicly Available
12b. DISTRIBUTION CODE
13, ABSTRACT (Maximum 200 words)
This document contains up-to-date chemical information, including a summary
of the Agency's regulatory position and rationale, on a specific pesticide or
group of pesticides. A Fact Sheet is issued after one of the following actions
has occurred.
1.	Issiance or reissuance of a registration standard,
2.	Issi ance of each special review document,
3.	Registration of a significantly changed use pattern,
4.	Registration of a new chemical, or
5.	An immediate need for information to resolve controversial issues
relf.ting to a specific chemical or use pattern.
14. SUBJECT TERMS
Pesticides; Regulation; Chemical Information Fact Sheet;
Use Patterns , Science Findings
15. NUMBER OF PAGES
7
16. PRICE CODE
17. SECURITY CLASSIFICATION
OF REPORT
Unclassified
IB. SECURITY CLASSIFICATION
OF THIS PAGE ,
Unclassified
19. SECURITY CLASSIFICATION
Un?LTsMId
20. LIMITATION OF ABSTRACT
NbN 75*0-01 -2B0-5500	$*nn.d^'d -cm H93 (Rev 2-E9)

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