r/EPA
United States
Environmental Protection
Agency
Office of Prevention, Pesticides
and Toxic Substances
(7501C)
Pesticide
Fact Sheet
Name of Chemical: Dinotefuran
Reason for Issuance: Conditional Registration
Year Issued: September 2004
Appendix I: Glossary of Terms and Acronyms
Appendix II: Bibliography
1. DESCRIPTION OF CHEMICAL
Generic Name:
Common Name:
Trade Name:
EPA PC Code:
Chemical Abstracts
Service (CAS) Number:
Year of Initial
Registration:
Pesticide Type:
Chemical Class:
Registrant:
Dinotefuran (N-methyl-N'-nitro-N"-[(tetrahydro-3-
furanyl)methyl)]guanidine)
Dinotefuran
Dinotefuran, MTI-446
044312
165252-70-0
2004
Insecticide
Neo-nicotinoid
Mitsui Chemicals, Inc.
2. USE PATTERNS AND FORMULATIONS
Pests/Application Sites:
Controls insect pests such as aphids, whiteflies, thrips,
leafhopper, leafminer, sawfly, mole cricket, white grubs,
lacebugs, billbugs, beetles, mealybugs, sawfly larvae, and
cockroaches in leafy vegetables, in residential and
commercial buildings, outdoor uses for professional turf
management, turf farms, professional ornamental
-------
Types of Formulations:
Types and Methods:
Application Rates:
Carrier:
production, golf courses, residential indoor, lawn and
garden use
Dinotefuran formulations include the technical product,
formulation intermediates, soluble concentrates, granulars,
soluble granules, baits, gels, and ready-to-use (RTU) sprays
Soil incorporation, foliar application, bait application, spot
treatment. Foliar application can be made aerially or with
tractor-mounted sprayers or spreaders, as well as, handheld
equipment such as low-pressure handwand sprayers,
backpack sprayers, turf guns, ready-to-use trigger sprayers,
and hose-end sprayers. Bait applications can be made in
bait stations or as spot treatment with the gel bait
formulations
Application rates vary with sites and pests
Maximum application rate 0.54 Ibs a.i./A/season
Water
3. SCIENCE FINDINGS
Dinotefuran is a broad-spectrum insecticide, which is proposed for food uses in/on leafy
vegetables (except Brassicd) (group 4), and for use in professional turf management,
professional ornamental production, and in the residential indoor, pet, lawn and garden markets.
Dinotefuran is a neonicotinoid in the nitroguanidine sub-class, same as another insecticide
clothianidin. Available product chemistry, toxicology, ecological effects and environmental fate
data supporting the proposed uses have been reviewed. The data and estimated risks to human
health and the environment from its proposed uses are summarized below.
PHYSICAL AND CHEMICAL CHARACTERISTICS
Technical dinotefuran is an odorless white crystalline solid. It has a solubility of 39.83
g/L in water, and is highly soluble in dichloromethane, acetone, methanol, and ethyl acetate.
Technical dinotefuran has a melting point of 107.5° C, and a log Pow of-0.549 at 25° C. It is non-
flammable, is not explosive to thermal, shock and frictional tests, and has a vapor pressure of
<1.7x 10-6Paat25°C.
HAZARD CHARACTERIZATION
Acute Toxicity
Technical dinotefuran has low acute toxicity by the oral (toxicity category IV), dermal
(toxicity category IV), and inhalation (toxicity category IV) routes. It is not a dermal sensitizer,
causes a low level of skin irritation (toxicity category IV) and moderate eye irritation (toxicity
category II) (Table I).
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Table 1. Acute Toxicity Profile of Dinotefuran
Guideline No.
81-1
81-1
81-2
81-3
81-4
81-5
81-6
Study Type
Acute Oral - Rat
Acute Oral - Mouse
Acute Dermal - Rat
Acute Inhalation - Rat
Primary Eye Irritation -
Rabbit
Primary Skin Irritation -
Rabbit
Dermal Sensitization
(Guinea Pig Maximization
test)
MRID#
45639823
45639824
45639901
45639902
45639903
45639904
45639905
Toxicity Category
III
III
IV
IV
II
IV
Not a sensitizer
Subchronic and Chronic Toxicity
The main target tissues are the nervous system and the immune system, with effects seen
in several species. Nervous system toxicity is manifested as clinical signs and decreased motor
activity seen after acute dosing (in both rats and rabbits) and increased motor activity seen after
repeated dosing; these findings are consistent with effects on the nicotinic cholinergic nervous
system. The results of subchronic, chronic, and other toxicity studies conducted on dinotefuran
are summarized in Table 2.
Developmental and Reproductive Toxicity
No adverse effects in fetuses were seen in the developmental toxicity studies in rats or
rabbits, at maternally toxic doses, and offspring (including decreased spleen and thymus
weights, and decreased grip strength) effects in the reproduction study occurred at the same
doses causing parental effects. There was a qualitative increase in sensitivity in rat pups in the
reproductive toxicity study.
Immune System Toxicity
Immune system toxicity is manifested as decreases in spleen and thymus weights seen in
multiple studies and species (including dogs, rats, and mice). There are also indications of
endocrine-related toxicity, manifested in the reproductive toxicity study (in rats) as decreases in
primordial follicles and altered cyclicity in females, abnormal sperm parameters in males;
changes in testes or ovary weight were also seen in several species (mouse, dog, and rat).
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Carcinogenicitv
Dinotefuran has been classified as "Not likely to be carcinogenic to humans." This
classification is based on the lack of evidence for carcinogenicity in mice and rats.
Mutagenicity
Submitted studies were found to be acceptable. There is no concern for mutagenicity
resulting from exposure to dinotefuran.
Table 2. -Subchronic, Chronic, and Other Toxicity of Dinotefuran
Guideline No.
870.3100
870.3100
870.3150
Study Type
90-Day oral toxicity
in rats
90-Day oral toxicity
in mice
90-Day oral toxicity
in dogs
MRID#
MRID:
45654205,
45654203
(range-
finding)
45654206,
45654204
(range-
finding)
45639906
Results
NOAEL: 38/384 [M/F] mg/kg/day
LOAEL: 384 [M] mg/kg/day based
on adrenal histopathology; 1871 [F]
mg/kg/day based on 1 body
weight/body weight gain, changes in
hematology/clinical chemistry,
changes in organ weights, and
adrenal histopathology
NOAEL: 4,442/5,414 [M/F]
mg/kg/day
LOAEL: 10,635/11,560 [M/F]
mg/kg/day, based on 1 body weight,
body weight gain
NOAEL: 307/not determined [M/F]
mg/kg/day
LOAEL: 862 [M] mg/kg/day, based
on 1 body weight gain, hemorrhagic
lymph nodes; <59 [F], based on 1
body weight, body weight gain
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Guideline No.
Study Type
MRID#
Results
870.3200
28-Day dermal
toxicity (rats)
45639908,
45639937
(range-
finding)
Systemic:
NOAEL: 1,000 mg/kg/day
LOAEL: not determined (no effects
seen)
Dermal:
NOAEL: 1,000 [M], <200 [F]
mg/kg/day
LOAEL: not determined/< 1000
[M/F] mg/kg/day based on lack of
effects in males, T in acanthosis/
hyperkeratosis in high dose females
(lower doses not evaluated
histopathologically)
870.3465
28-Day inhalation
toxicity (rat)
45639909,
46072401
NOAEL:<0.22 [M] mg/L, 0.22 [F]
mg/L
LOAEL: 1 body weight gain, food
consumption [M]; increased clinical
signs (protruding eyes) [F]
870.3700a
Prenatal
developmental
toxicity study (rats)
45654207,
45639910
(range-
finding)
Maternal
NOAEL: 300 mg/kg/day
LOAEL: 1,000 mg/kg/day based on
1 body weight gain and food
consumption
Developmental
NOAEL: 1,000 mg/kg/day
LOAEL: not determined (no effects
seen)
870.3700b
Prenatal
developmental
toxicity study
(rabbits)
45654208,
45639911,
45639912
(range-
finding)
Maternal
NOAEL: 52 mg/kg/day
LOAEL: 125 mg/kg/day based on 1
body weight gains, food
consumption, and necropsy findings
Developmental
NOAEL: 300 mg/kg/day
LOAEL: >300 mg/kg/day (no
effects seen)
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Guideline No.
870.3800
870.4100a
870.4100b
870.4200a
Study Type
Reproduction and
fertility effects (rats)
Chronic toxicity (rats)
Chronic toxicity
(dogs)
Carcinogenicity (rats)
MRID#
45639913,
45639914
(range-
finding)
45640001
45654209
45640001
Results
Parental/systemic
NOAEL: 241/268[M/F] mg/kg/day
LOAEL: 822/907[M/F] mg/kg/day,
based on 1 food consumption,
weight gain in males, soft feces in
females, and 1 spleen weights in
both sexes
Reproductive (tentative)
NOAEL: 241/268 [M/F] mg/kg/day
LOAEL: 822/907 [M/F] mg/kg/day,
based on 1 uterine weights and
microscopic alterations in the uterus
and vagina of F0 females, 1 numbers
of primordial follicles in Fx females,
altered estrous cyclicity in F0 and Fx
females, T in abnormal sperm
morphology in F0 and Ft males, 1
testicular sperm count in F0 males,
and 1 in sperm motility in Fx males
Developmental
NOAEL: 241/268 [M/F] mg/kg/day
LOAEL: 822-935/907-1,005 [M/F]
mg/kg/day based on 1 body weights,
body weight gains, and spleen
weights in Fx and F2 males and
females, 1 thymus weights in F2
males and females, and 1 forelimb
grip strength (Fj males) or hindlimb
grip strength (Fx females)
See 870.4300 Combined chronic
toxicity/carcinogenicity (rats)
NOAEL: <20/22 [M/F] mg/kg/day
LOAEL: 20/108 [M/F] mg/kg/day
based on 1 thymus weight, 1 food
efficiency, body weight, and body
weight gain in females, 1 thymus
weight in males
See 870.4300 Combined chronic
toxicity/carcinogenicity (rats)
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Guideline No.
870.4200b
870.4300
870.5100
870.5100
870.5300
870.5375
870.5395
870.6200a
Study Type
Carcinogenicity
(mice)
Combined chronic
toxicity/
carcinogenicity (rats)
Bacterial reverse
mutation test
Bacterial reverse
mutation test
In vitro mammalian
cell gene mutation test
In vitro mammalian
chromosome
aberration test
In vivo mammalian
cytogenics -
micronucleus assay
Acute neurotoxicity
screening battery
MRID#
45639917
45640001
45640003
45654210
45640002
45654211
45654212
45640005
Results
NOAEL: <3 [M], <4 [F] mg/kg/day
LOAEL: 3/4 [M/F] mg/kg/day
based on 1 spleen weights at week
79 terminal sacrifice in males and
increased ovarian weights at week
53 in females
NOAEL: 99.7/127.3 [M/F]
mg/kg/day
LOAEL: 991/1,332 [M/F]
mg/kg/day based on 1 body weight
gain, food efficiency in females, T
incidences of kidney pelvic
mineralization and ulceration in
males
Negative. ± S9 up to 16,000
//g/plate
Negative. ± S9 up to limit dose of
5000 //g/plate
Negative, ± S9 up to 2,002 //g/mL
(Mouse lymphoma L5178Y cells)
Negative for clastogenic/aneugenic
activity up to 2,000 //g/mL
(CHL/IU cells)
Negative at oral doses up to 1,080
mg/kg/day for 2 days
NOAEL: 750 [M], 325 [F]
mg/kg/day
LOAEL: 1,500 [M], 750 [F]
mg/kg/day based on 1 motor activity
on day 1
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Guideline No.
870.6200b
Study Type
Sub chronic
neurotoxicity
screening battery
MRID#
45640004
Results
NOAEL: 33/40 [M/F] mg/kg/day
LOAEL: 327/400 [M/F] mg/kg/day
based on T motor activity during
week 2
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Guideline No.
870.7485
Study Type
Metabolism and
pharmacokinetics
(rats)
MRID#
45640006
Results
Absorption was > 90% regardless of
dose. The radiolabel was widely
distributed through the body and
was completely excreted within 168
hours of treatment. Urine was the
primary elimination route,
accounting for 88-99.8%. Excretion
into the urine was rapid, being 84-
99% complete within 24 hours of
treatment. Absorption of the
radioactivity was linear within the
dose range of 50 and 1,000 mg/kg.
Elimination of radioactivity was fast
for all groups with a T1/2 ranging
from 3.64 to 15.2 hours for the low
and high doses, respectively.
Radioactivity was rapidly
transferred from maternal blood to
milk and widely distributed in the
fetal tissues. The Cmax for milk and
fetal tissues was detected 0.5 hours
after maternal treatment. The
concentrations of radioactivity in
fetal tissue and maternal milk
declined quickly and were below
detection limits 24 hours post-
treatment. After IV or oral
treatment, 75- 93% of the
administered radiolabeled test
material, or nearly 93-97% of total
urinary radiolabel, was excreted
unchanged in the urine. The parent
compound was also the primary
component in the plasma, milk, bile,
feces, and most tissues collected 4-8
hours after treatment and at both
dose levels. Less than 10% of the
parent compound was metabolized
into numerous minor metabolites
that were not well resolved by
HPLC or 2D-TLC. For all
parameters measured in this study,
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Guideline No.
Study Type
MRID#
Results
no sex-related or dose-related
differences or label position effects
were found.
Special study
Neonatal rat
metabolism study (12-
day old rat pups)
45640007
After a single oral 50 mg/kg dose of
[G-14C] MTI-446 to 12-day-old rats,
absorption was high (absorption
could not be adequately determined
but may have approached 80%) and
the radiolabel was widely
distributed within the body.
Approximately 32-36% of the
administered dose was excreted
within 4 hours of treatment. Urine
was the primary elimination route as
indirectly evidenced by finding high
radioactive areas in the kidneys and
bladder by whole body
autoradiography. No areas of tissue
sequestration were found and no
gender-related differences were
identified. The test material was
essentially not metabolized, the
parent compound accounting for
>97% of the radiolabel in the
excreta, plasma, kidneys, and
stomach, and nearly 61-83% in
intestines (and contents), and liver.
DOSE RESPONSE ASSESSMENT AND FOOD QUALITY PROTECTION ACT (FOPA)
CONSIDERATION
Dose Response Assessment
Based on submitted data, the Agency determination for the acute and chronic Reference
Doses (RfDs), toxicological endpoint selections, and appropriate margins of exposure (MOEs) for
use as appropriate in occupational/residential exposure risk assessments, is summarized below:
Acute Dietary Reference Dose (aRfD): For the general population, including infants and
children, the dose and endpoint for establishing an aRfD is a NOAEL of 125 mg/kg/day
from the developmental toxicity study in rabbits (MRID 45654208). No effects were seen
on developing fetuses in the developmental toxicity studies (rat or rabbit), so a separate
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endpoint for females 13-49 is not required. An uncertainty factor of 100 was selected (lOx
inter-species extrapolation and lOx intra-species variability), and therefore the aRfD is 1.25
mg/kg/day.
Chronic Dietary Reference Dose (cRfD): For all populations, the dose and endpoint for
establishing an cRfD is a LOAEL of 20 mg/kg/day from the one year toxicity study in dogs
(MRID 45654209). The NOAEL is 22 mg/kg/day in females; no NOAEL was determined
for males (less than 20 mg/kg/day). The Agency determined that the available data does
not support the reduction of the default 10X UF for the use of a LOAEL (i.e. lack of a
NOAEL in the selected study). Therefore, an uncertainty factor of 1,000 was selected (lOx
inter-species extrapolation,!Ox intra-species variability, and 1 Ox for extrapolation from
LOAEL to NOAEL), and the cRfD is 0.02 mg/kg/day.
Incidental Oral Short-Term (1-30 Days) Exposure: The dose and endpoint chosen is the
NOAEL of 33 mg/kg/day, from the 90-day neurotoxicity study in rats (MRID 45640005).
An MOE of 100 should be required (lOx inter-species extrapolation and lOx intra-species
variability).
Incidental Oral Intermediate-Term (1-6 Months) Exposure: The dose and endpoint
chosen is the NOAEL of 22 mg/kg/day, from the one year toxicity study in dogs (MRID
45654209). An MOE of 100 should be required (lOx inter-species extrapolation and lOx
intra-species variability).
Dermal Absorption Factor: A dermal absorption factor of 30% was chosen by the
Agency, after a comparison to structurally related chemicals (27% for thiamethoxam, and
30% for acetamiprid, based on dermal absorption studies for those chemicals). This is
considered a conservative estimate, based on the inclusion of residues remaining in the
skin, which may not be absorbed. A confirmatory dermal absorption study is required.
Dermal Short-Term (1-30 Days) Exposure: Quantification of short-term dermal risk is
not required, because no effects were seen in an acceptable dermal toxicity study in rats
(MRID 45639908) at doses up to the limit dose.
Dermal Intermediate-Term (1-6 Months) Exposure: The dose and endpoint chosen is
the NOAEL of 22 mg/kg/day, from the one year toxicity study in dogs (MRID 45654209).
An MOE of 100 should be required (lOx inter-species extrapolation and lOx intra-species
variability).
Dermal Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the
LOAEL of 20 mg/kg/day, from the one year toxicity study in dogs (MRID 45654209).
Inhalation Short- (1-30 Days) & Intermediate-Term (1-6 Months) Exposure: The dose
and endpoint chosen is the LOAEL of 60 mg/kg/day (0.22 mg/L), from the 28-day
inhalation toxicity study in rats (MRID 45639909). Although neurotoxicity was not
evaluated in this study, use of this endpoint, along with an extra lOx uncertainty factor for
extrapolation from LOAEL to NOAEL, will be protective of neurotoxic effects seen in rats
and rabbits (NOAELs >33 mg/kg/day), for both short-term and intermediate-term
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durations. An MOE of 100 should be required (lOx inter-species extrapolation and lOx
intra-species variability).
Inhalation Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the
LOAEL of 20 mg/kg/day, from the one year toxicity study in dogs (MRID 45654209.
Absorption via inhalation is presumed to be equivalent to oral absorption.
Margins of Exposure: Table 3 Presents a summary of target Margins of Exposure (MOEs)
for risk assessment.
Table 3. Summary of Margins of Exposure for Risk Assessment.
Route ^^
.s^ Duration
Short-Term
(1-30 Days)
Intermediate-Term
(1 - 6 Months)
Long-Term
(> 6 Months)
Occupational (Worker) Exposure
Dermal
Inhalation
Not required
1,000
100
1,000
1,000
1,000
Residential (Non-Dietary) Exposure
Oral
Dermal
Inhalation
100
Not required
1,000
100
100
1,000
N/A
1,000
1,000
The MOEs for occupational and residential exposures are based on the conventional
uncertainty factor of 100X (lOx inter-species extrapolation and lOx intra-species variability). An
additional uncertainty factor of 10X (to extrapolate from a LOAEL to a NOAEL) is required for
long term dermal and for inhalation exposure of all durations.
The doses and toxicological endpoints selected for the various exposure scenarios are
summarized in Table 4.
Table 4. Summary of Toxicological Dose and Endpoints for Dinotefuran
Exposure
Scenario
Acute Dietary
(General
population
including infants
and children)
Dose Used in Risk
Assessment, UF
NOAEL = 125
mg/kg/day
UF = 100
Acute RfD = 1.25
mg/kg/day
Special FQPA SF*
and Level of Concern
for Risk Assessment
FQPA SF = 1
aPAD = acute RfD
FQPA SF
= 1.25 mg/kg/day
Study and Toxicological Effects
Developmental Toxicity Study in
Rabbits
LOAEL = 300 mg/kg/day based on
clinical signs in does (prone position,
panting, tremor, erythema) seen
following a single dose.
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Exposure
Scenario
Chronic Dietary
(All populations)
Short-Term
Incidental Oral (1
to 30 days)
Intermediate-Term
Incidental Oral (1
to 6 months)
Short-Term
Dermal (1 to 30
days)
Intermediate-Term
Dermal (1 to 6
months)
Long-Term Dermal
(>6 months)
Short-Term
Inhalation (1 to 30
days)
Intermediate-Term
Inhalation (1 to 6
months)
Long-Term
Inhalation (>6
months)
Dose Used in Risk
Assessment, UF
LOAEL= 20
mg/kg/day
UF = 1,000
Chronic RfD =
0.02 mg/kg/day
NOAEL= 33
mg/kg/day
NOAEL= 22
mg/kg/day
No quantitation
required.
Oral study NOAEL
22 mg/kg/day
(dermal absorption
rate = 30%)
Oral study LOAEL=
20 mg/kg/day
(dermal absorption
rate = 30%)
Inhalation study
LOAEL= 60
mg/kg/day
Inhalation study
LOAEL= 60
mg/kg/day
Oral study LOAEL=
20 mg/kg/day
(inhalation
absorption rate =
100%)
Special FQPA SF*
and Level of Concern
for Risk Assessment
FQPA SF = 1
cPAD =
chronic RfD
FQPA SF
= 0.02 mg/kg/day
Residential LOC for
MOE = 100
Occupational = NA
Residential LOC for
MOE =100
Occupational = NA
Residential LOC for
MOE = NA
Occupational LOC for
MOE = NA
Residential LOC for
MOE =100
Occupational LOC for
MOE =100
Residential LOC for
MOE = 1,000
Occupational LOC for
MOE = 1,000
Residential LOC for
MOE = 1,000
Occupational LOC for
MOE = 1,000
Residential LOC for
MOE =1,000
Occupational LOC for
MOE = 1,000
Residential LOC for
MOE = 1,000
Occupational LOC for
MOE = 1,000
Study and Toxicological Effects
Chronic Toxicity Study in Dogs
LOAEL = 20 mg/kg/day based on
decreased thymus weight in males
Subchronic Neurotoxicity study in
rats
LOAEL = 327 mg/kg/day based on
increased motor activity during week
2
Chronic Toxicity Study in Dogs
LOAEL = 108 mg/kg/day based on
decreased body weight and body
weight gain in females
No quantitation required. No systemic
toxicity was seen at the limit dose in a
28-day dermal toxicity study in which
neurotoxicity was evaluated. No
developmental toxicity concerns.
Chronic Toxicity Study in Dogs
LOAEL = 108 mg/kg/day based on
decreased body weight and body
weight gain in females
Chronic Toxicity Study in Dogs
LOAEL = 20 mg/kg/day based on
decreased thymus weight in males
28-day Inhalation Toxicity Study in
Rats
LOAEL = 60 mg/kg/day based on
decreased body weight gain in males
28-day Inhalation Toxicity Study in
Rats
LOAEL = 60 mg/kg/day based on
decreased body weight gain in males
Chronic Toxicity Study in Dogs
LOAEL = 20 mg/kg/day based on
decreased thymus weight in males
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Exposure
Scenario
Cancer (oral,
dermal, inhalation)
Dose Used in Risk
Assessment, UF
Special FQPA SF*
and Level of Concern
for Risk Assessment
Study and Toxicological Effects
Not required; no evidence of
carcinogenicity.
UF = uncertainty factor, FQPA SF = Special FQPA safety 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, LOG = level of concern, NA = Not Applicable
FQPA Decisions
The toxicology database for dinotefuran is adequate for FQPA assessment. Available
studies include developmental toxicity studies in rats and rabbits, a reproductive toxicity study in
rats, and acute and subchronic neurotoxicity studies in rats. Although there is generally low
concern and no residual uncertainties for pre- and/or postnatal toxicity resulting from exposure to
dinotefuran, some uncertainty is raised by a deficiency in the data (a lack of a NOAEL in the
chronic dog study) and the need for a developmental immunotoxicity study (DIT).
The absence of a NOAEL for the chronic dog study and the need for a DIT study generate
some uncertainty regarding the protectiveness of chronic regulatory endpoint and long-term level
of concern. Accordingly, EPA does not have reliable data supporting adoption of a safety factor
other than the default additional 10X factor as specified in FFDCA section 408(b)(2)(C). The
chronic endpoint and long-term level of concern have therefore been generated using a overall
safety/uncertainty factor of 1000 (representing 100X for inter-and intra-species variation and an
additional 10X pursuant to FFDCA section 408(b)(2)(C).
The Agency does not have similar concerns regarding acute, short-term, and intermediate
term risk assessments. First, the absence of a NOAEL only occurred in a chronic study. Second,
reliable data show that the DIT is unlikely to result in a NOAEL for acute, short-term, or
intermediate term effects that is lower than the NOAELs currently being used to assess the risk
from such effects. EPA has required a Developmental Immunotoxicity Study (DIT) with
dinotefuran based on the changes in the thymus weight in offspring in the reproduction study and
in adult rats and dogs. There is, however, little evidence to support a direct effect of dinotefuran on
immune function. This is because lymphoid organ weight changes can be secondary to
generalized toxicity (e.g., reductions in body weight, body weight gain, and/or food efficiency). In
the reproduction study, decreased thymus weights were seen in offspring in the presence of
decreased body weight only at the Limit Dose (10,000 ppm). In the 1-year dog study, decrease in
thymus weight was seen in the absence of other toxicity, however, no decrease in thymus weight
was seen in the subchronic study in dogs which was conducted at higher doses (i.e., the results of
the 1-year study was not supported by the results of the 90-day study).
Further, the only evidence on dinotefuran's potential immunological effect is found in
studies with prolonged exposure. In the reproduction study, the effect of concern [i.e, decrease in
thymus weight in only one generation (F2)] was seen only following approximately 13 weeks of
exposure to the parental animals at close to the Limit Dose (1000 mg/kg). Similarly, thymus
effects in the chronic dog study were only observable after long-term exposures, but were not seen
in the 90-day dog study.
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Finally, it is clear that DIT study, which is performed in the rat, will have to be conducted
at high doses (close to the Limit Dose) to elicit a potential single dose effect and this will result in
a potential NOAEL higher than that currently used for various risk assessments. As noted, in the
rat reproduction study, effects only occurred at doses close to the Limit Dose (1000 mg/kg/day).
The Limit Dose is the maximum dose recommended for testing in the Series 870 Health Effects
Harmonized Test Guidelines; toxic effects occurring only at or near the Limit Dose are of less
concern for human health since they may be specifically related to the high dose exposure and may
not occur at the much lower doses to which humans are exposed. Additionally, in the acute
neurotoxicity study in the rat, the LOAEL was 750 mg/kg/day in females and 1500 mg/kg/day in
males based on reductions in motor activity indicating that high doses are required to elicit
Dinotefuran-induced toxicity in rats.
The NOAELs in the critical studies selected for acute dietary (125 mg/kg/day), short term
incidental oral (33 mg/kg/day), and intermediate term incidental oral and dermal (22 mg/kg/day)
exposure scenarios are lower than the offspring NOAEL (241 mg/kg/day) in the reproduction
study. Therefore, EPA is confident that the doses selected for these risk assessments will address
the concerns for the thymus weight changes seen in the offspring in the reproduction study and
will not underestimate the potential risk from exposure to dinotefuran.
The Agency believes there are reliable data showing that the regulatory endpoints are
protective of children despite the need for a developmental neuorotoxicity study. Developmental
neurotoxicity data received and reviewed for other compounds in this chemical class
(neonicotinoids) including thiacloprid, clothianidin, and imidacloprid, indicate that the results of
the required DNT study will not likely impact the regulatory doses selected for dinotefuran.
In addition, the acute and chronic dietary food exposure assessment utilized proposed
tolerance level residues and 100% crop treated information for all commodities. By using these
screening-level assessments, acute and chronic exposure/risks will not be underestimated.
Furthermore, the dietary drinking water assessment (Tier 1 estimates) uses values generated by
models and associated modeling parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. Finally, the residential assessment for
children's postapplication exposures is based upon maximum application rates in conjunction with
chemical-specific study data and are not expected to underestimate risk.
4. HUMAN HEALTH EXPOSURE AND RISK ASSESSMENT
Dinotefuran can be applied by the foliar route to leafy vegetables, and therefore, residues
may be present in or on crops at harvest. Dinotefuran may also potentially be present in drinking
water, given its high water solubility, high mobility in soils, and potential persistence in the
environment. Therefore, exposures and risks from food and drinking water need to be assessed, as
well as from residential uses. Risk assessments were conducted for acute and chronic dietary,
intermediate-term oral and dermal, and short- and intermediate-term inhalation exposures.
Page 15 of 63
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Residue Profile
The submitted lettuce metabolism data are sufficient to support the proposed use on leafy
vegetables. The total toxic residues requiring regulation include dinotefuran and its metabolites
DN and UF in the tolerance expression and dinotefuran, DN (l-methyl-3-(tetrahydro-3-
furylmethyl)guanidine), UF (l-methyl-3-(tetrahydro-3-furylmethyl)urea), and PHP (6-hydroxy-5-
(2-hydroxyethyl)-methyl-l,3-diazinane-2-ylidene-N-nitroamine) for risk assessment purposes.
However, the plant metabolism data indicated that PHP was found to be a major metabolite (>10%
total radioactive residues) only in apples, but not in the other plants studied (lettuce, potato, rape,
and rice), and hence the use of the recommended tolerance in/on leafy vegetables will not
underestimate the exposure in the risk assessment; and therefore, the PHP metabolite was not
included in the dietary risk assessment for leafy vegetables.
The residues of concern for ruminants and poultry tolerances are dinotefuran. The residues
of concern for risk assessment are dinotefuran, UF and FNG (2-nitro-l-(tetrahydro-3-
furylmethyl)guanidine) in ruminants, and dinotefuran and FNG in poultry. However, no methods
and no tolerances for livestock commodities are needed for the use on leafy vegetables, since no
significant livestock feedstuffs are associated with leafy vegetables.
Dietary Exposure and Risk
Acute and chronic dietary exposure analyses were conducted using the Dietary Exposure
Evaluation Model-Food Consumption Intake Database (DEEM-FCID™, versionl.3) program and
the Lifeline™ model (version 2.0), which both incorporate consumption data from the United
States Department of Agriculture's (USDA's) Continuing Surveys of Food Intakes by Individuals
(CSFII), 1994-96/1998. The dietary risk analyses incorporated tolerance level residues and
assumed 100% of the leafy vegetables had been treated with dinotefuran. Nevertheless, the acute
and chronic risk estimates are below the Agency's level of concern for the general U.S. population
(<1% aPAD; <10% cPAD) and all population subgroups. A cancer dietary risk assessment for
dinotefuran is not required. The dietary exposure and risk estimates for dinotefuran are
summarized in Table 5 below.
Table 5. Summary of Dietary Exposure and Risk for Dinotefuran Using Both DEEM-FCID (Upper
Row) and LifeLine (Lower Row) Software
Population Subgroup*
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Acute Dietary
(95 Percentile)
Dietary Exposure
(mg/kg/day)
0.0085
0.0089
0.0026
0.0025
0.0076
%aPAD**
0.68
0.7
0.21
0.2
0.61
Chronic Dietary
Dietary
Exposure
(mg/kg/day)
0.0017
0.0018
0.00089
0.00087
0.0015
%cPAD**
8.6
8.8
4.4
4.3
7.7
Page 16 of 63
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Population Subgroup*
Children 3-5 years old
Children 6-12 years old
Youth 13- 19 years old
Adults 20-49 years old
Adults 50+ years old
Females 13-49 years old
Acute Dietary
(95 Percentile)
Dietary Exposure
(mg/kg/day)
0.0077
0.0095
0.0092
0.0086
0.0081
0.0075
0.0072
0.0088
0.0090
0.0081
0.0093
0.0095
0.010
%aPAD**
0.60
0.76
0.70
0.69
0.60
0.60
0.60
0.71
0.70
0.65
0.70
0.76
0.80
Chronic Dietary
Dietary
Exposure
(mg/kg/day)
0.0014
0.0017
0.0016
0.0016
0.0014
0.0014
0.0014
0.0018
0.0018
0.0018
0.0019
0.0019
0.0019
%cPAD**
7.0
8.6
8.1
8.0
7.1
7.1
6.9
9.1
9.1
8.8
9.4
9.4
9.7
* The values for the highest exposed population for each type of risk assessment are bolded.
** %PADs are reported to 2 significant figures.
A drinking water assessment for dinotefuran was conducted based on FIRST (FQPA Index
Reservoir Screening Tool) was used to calculate the surface water EDWCs and the Screening
Concentration in Ground Water (SCI-GROW) model was used to calculate the groundwater
EDWC. All EDWCs values are less than the lowest drinking water level of comparison
(DWLOC) values of 12,000 |ig/L (all infants and children subgroups) and 180 |ig/L (children 3-5
years old and children 6-12 years old) determined for the acute and chronic scenarios, respectively.
Therefore, the EDWCs do not exceed Agency's level of concern.
Residential Exposure Estimates
There is a potential for exposure to homeowners in residential settings during the
application of products containing dinotefuran. There is also a potential for exposure from
entering areas previously treated with dinotefuran such as lawns where children might play, or golf
courses, and home gardens that could lead to exposures for adults. As a result, risk assessments
have been completed for both residential handler and postapplication scenarios.
The Agency combines risks resulting from exposures to individual chemicals when it is
likely they can occur simultaneously based on the use pattern and the behavior associated with the
exposed population. For this assessment, the Agency has added together risk values for adults
applying dinotefuran to residential lawns and then being exposed to the treated lawn. For children,
Page 17 of 63
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dermal and incidental oral exposures from hugging treated pets were combined, and dermal and
incidental oral exposures from activities on treated lawn were combined. These are considered to
represent worst case scenarios for co-occurring residential exposures.
Combined Adults Residential Exposure
Residential handlers may be exposed dermally and by inhalation during mixing, loading
and application of dinotefuran for short-term durations. However, a short-term dermal
endpoint was not identified. For this reason, and because the short-and intermediate-term
inhalation endpoints are the same, intermediate-term risks are assessed for residential
handlers as a screen for their potential short-term exposures. Because common toxicity
endpoints were identified for both dermal and inhalation routes, a combined risk from both
routes of exposure is assessed. Combined risk was estimated by calculating an aggregate
risk index (ARI) of combining risks was employed as follows:
dermal for postapp.
inhal for M/L/A
\
All residential handler estimated exposures meet or exceed the Agency's target ARI of 1,
and are therefore not of concern.
Residential postapplication exposures are assumed to be mostly of short-term duration (1 to
30 days); although intermediate-term (1 to 6 months) exposures are possible. Because
there are numerous dinotefuran use products and scenarios, those scenarios assessed were
chosen to cover the major residential use sites (i.e. turf, home garden, etc.) and highest use
rates and exposures. The margins of exposure (MOEs) for postapplication exposure to
dinotefuran are above the target MOE of 100, and therefore do not exceed Agency's level
of concern for the following scenarios: 1) exposure to adults and children from turf
products; 2) exposure to adults in vegetable gardens.
The risks from the combined exposures of adults applying dinotefuran to residential lawns
and then being dermally exposed from post-application activities on the treated lawn are
summarized in Table 6 below. Since the total ARI for adult's combined exposure is larger
than the target ARI of 1, it does not exceed Agency's level of concern.
Table 6. Adult Residential Combined Risk
Scenario
M/L/A Liquids to Lawn: hose-
end sprayer
Postapplication on Treated
Lawn
Rate
0.54 Ib ai/A
[Dinotefuran 10SL (10%); Dinotefuran 20% Turf
& Ornamental]
0.54 Ib ai/A
[Dinotefuran 10SL (10%); Dinotefuran 20% Turf
& Ornamental]
Route
Dermal
Inhalation
Dermal
ARI
17
970
12
Total ARI
7
Page 18 of 63
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Combined Children's Residential Exposures/Risks
Children's combined risks from hugging treated pets and activities on treated lawns are
summarized in Table 7 below. Because the toxicity endpoint (i.e., NOAEL = 22
mg/kg/day, based on body weight gain) is the same for both dermal and incidental oral
exposures, the total combined risk (i.e., total MOE) for children is calculated by adding the
daily doses from all relevant exposure routes and activities and comparing this total to the
common toxicity endpoint NOAEL. Since the total MOE for children's combined
exposure from treated lawns exceeds the target MOE of 100, it does not exceed Agncy's
level of concern
Table 7. Children's Residential Combined Risk From treated Turf
Scenario
Activities on Turf
Activities on Turf
Activities on Turf
Activities on Turf
Route
Dermal
HTM (Hand-to-Mouth)
OTM (Object-to-Mouth)
SI (Soil Ingestion)
Daily Dose (mg/kg/day)
0.002
0.000027
0.0251
0.0178
MOE
700
5800
11,000
800,000
Total MOE
590
The Agency believes that the calculated risks represent conservative estimates of exposure
because maximum application rates are used to define residue levels upon which the
calculations are based. Estimates are thought to be conservative even when measures of
central tendency (e.g., most transfer coefficients are thought to be central tendency) are
used because values that would be considered to be in the lower percentile aspect of any
input parameter have not been used in the calculations. Further, because a short-term
dermal toxicity endpoint was not identified, the intermediate-term endpoint was used for all
dermal risk estimates, even though residential exposure duration for both handlers and
postapplication are believed to be short-term based on the use pattern and pesticide half-
life. This is an additional high-end input to the risk estimates.
Aggregate Risk
As per FQPA, 1996, when there are potential residential exposures to the pesticide,
aggregate risk assessment must consider exposures from three major sources: oral, dermal and
inhalation exposures. The toxicity endpoints selected for these routes of exposure may be
aggregated as follows:
For short-term aggregate exposure assessment, incidental oral and inhalation cannot be
combined due to differences in the endpoint, i.e. neurotoxicity for incidental oral and
decreases in body weight for inhalation. No quantification of dermal risk is required.
For intermediate-term aggregate exposure, incidental oral and dermal and inhalation
endpoints can be aggregated because of the use of a common endpoint (decreased body
weight gain).
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For long-term aggregate exposure, incidental oral and dermal and inhalation endpoints can
be aggregated because of the use of oral equivalents and a common endpoint (decreased
thymus weight).
For the proposed uses, human health aggregate risk assessments have been conducted for
acute aggregate exposure (food + drinking water), chronic aggregate exposure (food + drinking
water), and residential intermediate-term exposure to children (from dermal and incidental oral
exposures) and adults (from dermal and inhalation exposures). The intermediate-term aggregate
risk assessment was performed as a screening level assessment, since a short-term aggregate risk
assessment could not be performed. A cancer aggregate risk assessment was not performed
because dinotefuran is not carcinogenic. All potential exposure pathways were assessed in the
aggregate risk assessment. None of the aggregate exposure and risk estimates exceed Agency's
level of concern.
Acute Aggregate Risk Assessment (Food and Drinking Water)
The acute aggregate risk assessment takes into account exposure estimates from dietary
consumption of dinotefuran (food and drinking water). The results of the food only
unrefined acute dietary exposure assessment (using tolerance level residues, not refined by
percent crop treated, and processing factors for food) are all below Agency's level of
concern. The DWLOCs were calculated from the difference between the food exposure
and the aPAD. The EDWCs for surface and ground water EDWCs are several orders of
magnitude less than the calculated DWLOCs for acute exposure to the combined residues
of dinotefuran and its metabolites. Therefore, the acute aggregate risk associated with the
proposed uses of dinotefuran do not exceed Agency's level of concern for the general U.S.
population or any population subgroups. The acute dietary risks to four most sensitive
population subgroups are summarized in Table 8 below.
Table 8.-Aggregate Risk Assessment for Acute Exposure to [dinotefuran]
Population
Subgroup
U.S.
Population
All infants (< 1
year old)
Children (3-5
years old)
Females (13-49
years old)
aPAD
(mg/kg/day
'
1.25
1.25
1.25
1.25
% aPAD
(Food)
0.68
0.21
0.76
0.76
Surface
Water
EDWC
(ppb)
75.78
75.78
75.78
75.78
Ground
Water
EDWC
(ppb)
5.06
5.06
5.06
5.06
Acute DWLOC
(ppb)
43,000
12,000
12,000
37,000
Chronic Aggregate Risk Assessment (Food and Drinking Water)
The chronic aggregate risk assessment takes into account exposure estimates from dietary
consumption of dinotefuran (food and drinking water). The results of the food only
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unrefined chronic dietary exposure assessment (using tolerance level residues, not refined
by percent crop treated, and processing factors for food) are all below Agency's level of
concern. The DWLOCs were calculated from the difference between the food exposure
and the aPAD. The EDWCs for surface and ground water EDWCs are less than the
calculated DWLOCs for chronic exposure to the combined residues of dinotefuran and its
metabolites. Therefore, the chronic aggregate risk associated with the proposed uses of
dinotefuran do not exceed Agency's level of concern for the general U.S. population or any
population subgroups. The acute dietary risks to four most sensitive population subgroups
are summarized in Table 9 below.
Table 9.-Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to dinotefuran
Population
Subgroup
U.S.
Population
All infants (<
1 year old)
Children (3-5
years old)
Females (13-
49 years old)
cPAD
(mg/kg/day)
0.02
0.02
0.02
0.02
% cPAD
(FOOD)
8.6
4.4
8.6
9.4
Surface
Water
EDWC
(ppb)
20.97
20.97
20.97
20.97
Ground
Water
EDWC
(ppb)
5.06
5.06
5.06
5.06
Chronic DWLOC
(ppb)
640
190
180
550
Short-term risk
For dinotefuran, short- and intermediate-term aggregate risk assessments based on
exposure from oral, inhalation, and dermal routes were considered. However, for short-
term aggregate exposure assessment, oral and inhalation risk estimates cannot be combined
due to the different bases of their endpoints; i.e., neurotoxicity for oral and decrease in
body weight for inhalation. Also, because no systemic toxicity was seen at the limit dose
in a 28-day dermal toxicity study, no quantification of short-term dermal risk is required.
Therefore, a short-term aggregate risk assessment cannot be performed for dinotefuran.
However, an intermediate-term aggregate risk assessment was performed as a screening
level assessment, which will apply to short-term aggregate risk.
Intermediate-term risk
Intermediate-term aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure level). An
intermediate-term aggregate risk assessment was performed as a screening level assessment
for adults and children.
The child subgroup with the highest estimated chronic dietary exposure (children 3-5 years
old) was used to calculate the intermediate-term aggregate risk, including chronic dietary
(food and drinking water) and residential dermal and oral exposures. All acceptable MOEs
must be identical for all MOEs to be included in the intermediate-term risk assessment.
Based on the toxicity endpoint information, all acceptable MOEs are 100, and an oral
Page 21 of 63
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endpoint for hand-to-mouth residential exposure was identified. In this case, the chronic
dietary endpoint (NOAEL) was used to incorporate dietary (food and water), and
residential exposures in the aggregate risk assessment. An intermediate-term residential
exposure scenario was identified and includes dermal and oral exposure routes. To
complete the aggregate intermediate-term exposure and risk assessment, chronic dietary
(food and drinking water) and residential dermal and oral exposures must be included.
For children's combined exposure on turf, the total MOE was estimated to be 590. The
average (chronic) dietary exposure for the highest exposed child subgroup (children 3-5
years old) was estimated to be 0.0017 mg/kg/day. The aggregate risk assessment for
intermediate-term exposure to children is summarized in Table 10 below:
Table 10. Aggregate Risk Assessment for Intermediate-Term Exposure of Children to
Dinotefuran.
Populati
on
Children
3-5 yrs
old
NOAE
L
mg/kg/
day
22
Target
MOE1
100
Max
Expos
ure2
mg/kg
/day
0.22
Average
Food
Exposure
mg/kg/day
0.0017
Residential
Exposure3
mg/kg/day
0.037227
Aggreg
ate
MOE
(food
&
residen
tial)4
565
Max Water
Exposure5
mg/kg/day
0.181
Ground
Water
EDWC6
Hg/L
20.97
Surface
Water
EDWC6
Hg/L
5.06
Interm
ediat
e-
Term
DWL
OC7
Hg/L
1810
1 The target MOE of 100 is based on the standard inter- and intra-species safety factors, lOx for intra -species variability and lOx
for inter-species extrapolation.
2 Maximum exposure (mg/kg/day) = NOAEL/Target MOE
3 Residential exposure to children playing on treated lawns (combined dermal + oral hand-to-mouth + oral object-to-mouth + oral
soil ingestion)
4 Aggregate MOE = [NOAEL/(Avg. Food Exposure + Residential Exposure)]
5 Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure)
6 The use site producing the highest level was used; i.e. turf.
7 DWLOC (ng/L) = [Maximum water exposure (mg/kg/day) x body weight (10 kg)]/[Water exposure (1L) x 10"3 mg/ng]
Compared with the EDWCs, the aggregate intermediate-term DWLOC does not exceed
Agency's level of concern for the subgroup population of children 3-5 years old.
For adults, the worst case intermediate-term aggregate risk assessment includes the
following scenarios: 1) dermal and inhalation exposures to residential handlers (i.e. M/L/A
of liquids to lawns by hose-end sprayers); 2) dermal postapplication exposures on treated
lawns; and 3) oral dietary exposures (i.e. food + drinking water). Based on the toxicity
endpoint information, the acceptable MOEs are not all identical. The intermediate-term
inhalation endpoint has a UF/MOE of 1,000, because a NOAEL was not reached and a
LOAEL was used instead, while the assessments for incorporating food, water and dermal
exposures have UFs/MOEs of 100. In this case, the aggregate risk index (ART) method
was used to calculate DWLOC values for the adult aggregate intermediate-term risk
assessment.
The highest estimated average (chronic) dietary exposure occurred with females 13-49
years old (i.e. 0.0019 mg/kg/day). The adult residential combined risks from dermal (ARI
= 17) and inhalation (ARI = 970) exposures to residential handlers; and dermal
Page 22 of 63
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postapplication exposures (ARI = 12) on treated lawns were assessed and combined. The
aggregate risk assessment for intermediate-term exposure to adults is summarized in Table
11 below.
Table 11. Aggregate Risk Assessment for Intermediate-Term Exposure of Adults to
Dinotefuran.
Polulation
Females
14-49 yrs
old
Target
ARI1
1
ARI
Food2
116
Residential ARIs3
Applicators
Dermal
Exposur
e
17
Inhalatio
n
Exposure
970
Postapplic
ation
Dermal
Exposure
12
Max
Water
Exposure
ARI4
1.18
Ground
Water
EDWC5
Hg/L
20.97
Surface
Water
EDWC5
Hg/L
5.06
Intermedi
ate-Term
DWLOC6
Hg/L
5600
1 ARI (Aggregate Risk Index) = MOECalcl]laled / MOEAceeptable
2ARIFood= [22/0.0019] / 100 = 116
3 ARI^ = MOEcalOTlaled/100 and, ARI^ = MOE1Iltal/l,000
ARlwater ~ 1/[1/1- ( 1 1 ARIResidential aplicalor denial) + ( 1 / ^ARIResidenliai applicator inhalation) ~*~ ( I'ARlpostapplication dermal)]
5 The use site producing the highest level was used; i.e. turf.
6 DWLOC (|ig/L) = [Maximum water exposure (mg/kg/day) x body weight (60 kg)]/[Water exposure (2 L) x 10"3 mg/|ig]; where
Maximum water exposure = NOAEL (22) / [ARIWaler (1.18) x 100] = 0.1866 mg/kg/day
Compared with the EDWCs, the aggregate intermediate-term DWLOC does not exceed
Agency's level of concern for the subgroup population of females 13-49 years old.
Occupational Exposure
The proposed uses of dinotefuran include numerous occupational use patterns, involving
many different types of formulations and product packagings. There is potential for exposure from
the mixing, loading, and applying of dinotefuran on both food and non-food use sites, and from
entering areas previously treated with dinotefuran.
Occupational handlers may be exposed dermally and by inhalation during mixing, loading
and application of dinotefuran for both short- and intermediate-term durations. A short-term
dermal endpoint was not identified by the HIARC. For this reason, and because the short-and
intermediate-term inhalation endpoints are the same, only intermediate-term baseline risks are
assessed for handlers. Intermediate term risk estimates should cover short-term risks, as well.
Further, because common toxicity endpoints were identified for both dermal and inhalation routes,
a combined risk from both routes of exposure is assessed. Combined risk was estimated by
calculating an aggregate risk index (ARI) because, while dermal and inhalation endpoint effects
are the same, they occur at different dose levels and have different associated levels of concern for
the MOE. The following formula is used to calculate the ARI:
ARItotal = l/[(l/ARIdermal) + (l/ARIinhal)]
where, ARIdeimal = MOEcaMated/100 and,
= MOEinhal/l,000
Occupational handler exposure scenarios were organized and assessed according to the
proposed dinotefuran product uses. The following handler scenarios were identified:
Page 23 of 63
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(1) mixing/loading/applying of liquids by high-pressure handwand;
(2) mixing/loading/applying of liquids by low-pressure handwand;
(3) mixing/loading/applying of liquids by backpack sprayer;
(4) open mixing/loading of liquids for groundboom, aerial and chemigation
applications;
(5) applying liquids by groundboom in open cabs;
(6) applying liquids aerially in enclosed cockpits;
(7) flagging for aerially applied liquids;
(8) open mixing/loading of granulars for groundboom, aerial and chemigation
applications;
(9) applying granulars by aerial;
(10) flagging for aerially applied granulars;
(11) open mixing/loading/applying granulars for application by belly grinder spreaders;
(12) open mixing/loading/applying granulars for application by push-type spreaders;
(13) applying granulars by tractor drawn spreaders;
(14) open pour hand application of granulars;
(15) mixing/loading/applying of liquids for application by handgun (lawn) sprayer;
(16) mixing/loading/applying of water-dispersible granules for application by handgun
(lawn) sprayer;
(17) open mixing/loading/applying of granulars for application by sprinkler can;
(18) hand application of granular baits by spoon;
(19) hand placement of bait stations;
(20) hand application of gel baits by syringe; and
(21) hand application of ready-to-use (RTU) trigger-pump sprays
Handler exposure data from individual worker exposure studies, Pesticide Handlers
Exposure Database (PHED), as well as Outdoor Residential Exposure Task Force (ORETF) with
the use of gloves, the calculated ARIs for the following handler scenarios were greater than 1, and
therefore, do not exceed Agency's level of concern
Occupational postapplication exposures and risks were assessed for the proposed food use
on leafy vegetables and for the proposed non-food use scenarios of golf course maintenance, turf
farm re-entry, and nursery and greenhouse ornamental production. Data from chemical-specific
residue dissipation studies, as well as Outdoor Residential Exposure Task Force (ORETF) were
used in calculating the risk estimates.
These proposed uses involve foliar applications to turf and ornamentals, and foliar and soil
application to leafy vegetables. Therefore, there is a potential for short- and intermediate-term
exposure to workers entering dinotefuran-treated areas to perform a variety of agricultural tasks,
and a risk assessment is required. Long-term postapplication exposure is not expected for
greenhouse workers engaged in the production of nursery ornamentals because of the infrequent
application intervals, the relatively short half-life of dinotefuran and the concern for pest resistance
from over-application.
Generally, inhalation exposure is expected to be negligible for most postapplication
scenarios except for greenhouses, where, due to their enclosed nature, the airborne concentration
of volatile or semi-volatile pesticides may result in concerns for greenhouse workers following
application of such pesticides. However, because the vapor pressure of dinotefuran is very low
(1.0 x 10"9 mm Hg @ 30 deg C), dinotefuran postapplication greenhouse inhalation risk is
Page 24 of 63
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considered to be negligible. In addition, because an estimate of inhalation exposure to applicators
using greenhouse application methods (e.g., high-pressure handwand sprayers) and products did
not exceed HED's level of concern, the potential postapplication exposure to any residual airborne
concentration of dinotefuran also is not considered to be of concern.
Data from chemical-specific residue dissipation studies were submitted for use in
completing the postapplication risk assessments for ornamental, turf and agricultural (leafy
vegetable) applications. These studies were designed to determine the dissipation rate of
dislodgeable foliar residues (DFR) following the application of dinotefuran. Aside from minor
study limitations, each of these studies was found to be acceptable and the data deemed to be
usable for risk assessment purposes. The highest estimated day zero residue values were used as a
screen for estimated day zero residue exposure.
Using the intermediate-term dermal toxicity endpoint (a short-term endpoint was not
identified by the HIARC) and data from the residue dissipation studies, the MOEs for all major
postapplication activities reach the target MOE of 100 on the day of treatment (i.e., day 0) for all
proposed uses (turf, ornamentals and leafy vegetables), and therefore, do not exceed Agency's
level of concern.
Non-occupational Off-Target Exposure
Relative to post-application exposure, spray drift is often a potential source of exposure to
residents nearby to agricultural spraying operations. This is particularly the case with aerial
application, but, to a lesser extent, could also be a potential source of exposure from ground
application methods. As indicated in this assessment, dinotefuran can be directly applied to
residential turf. The rates of application to residential turf are equal to the agricultural rates of
application. Application rates to turf are the highest rates for any use scenario. The resulting
margins of exposure are not of concern to the Agency. Therefore, based on this assessment, the
Agency believes that it is unlikely that there is higher potential for risk of exposure to spray drift
from agricultural uses of this chemical than have been assessed for direct residential applications.
5. ENVIRONMENTAL EXPOSURE AND RISK
Dinotefuran has a moderate molecular weight, a very high water solubility, and a low
octanol/water partition coefficient that suggest the potential for runoff and low bioaccumulation.
The low vapor pressure and a very low Henry's Law Constant suggest that this compound is not
expected to volatilize substantially from water or soils in natural environments. Dinotefuran's
degradates, MNG and DN-phosphate, also have high solubility in water at 11,480 ppm and
619,400 ppm, respectively. A summary of selected physical and chemical properties for
dinotefuran is presented in Table 11 below.
Table 11. Selected Physical/Chemical Properties for Dinotefuran
: # ; ' ; ; ; ; ; ; ; ; ; ; .'1^;^;;;;;;;;;;;;;; :
Molecular Weight
;-;^^^^
202.2 g/mol
Page 25 of 63
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•• : • -. .Parameter •••:;--------••
Water Solubility (20°C)
Vapor Pressure (30°C)
Henry's Law Constant
Octanol/Water Partition Coefficient, Kow
LogKow
.. ..-. -. Value -. •
39,830 ppm
<1.275xlO-8mmHg
8.63 x ID'14 Arm .mVmol
0.283
-0.549
Environmental Fate Characteristics
The major route of dissipation for dinotefuran appears to be aqueous photolysis (half-life
1.8 days). However, dinotefuran is stable to hydrolysis in a range of pH's of 4-9 and appears to be
relatively persistent to metabolism both in aerobic and anaerobic conditions (approximate half-
lives 50-100 days). It is considered to be very highly mobile (Knr = 6 - 45) in various soil types.
This compound and its degradates (MNG, DN) are highly water soluble (11,480 - 619,400 ppm)
and it has a low octanol/water partition coefficient (Kow = 0.283) which suggests a low potential
for fish bioaccumulation.
The high water solubility of dinotefuran, coupled with its very high mobility, and
resistance to biodegradation shows that this compound has a strong potential to leach to the
subsurface. Furthermore, there is the potential for exposure to adjacent bodies of water through
spray drift and runoff events. Once in the rivers, ponds, or other bodies of water, the fate of
dinotefuran is somewhat uncertain. Although aqueous photolysis appears to occur under
laboratory tests conditions, this may not be an important degradation pathway in relatively deeper
natural bodies of water (> 2m). The degradates of dinotefuran that are most likely to be observed
in adjacent bodies of water are MNG, and DN. The photolysates UF, and DN-2-OH +DN-3-OH
were not observed in metabolism studies.
Table 12. Environmental Fate Parameters for Dinotefuran and MNG
Parameter
Water Solubility (25°C)
Hydrolysis Half-Life (pH 7)
Aerobic Soil Metabolism Half-Life (upper
confidence bound value, 90th percentile,
from 2 values)
Aerobic Soil Metabolism Half-Life (mean)
Aerobic Aquatic Metabolism Half-life
(upper confidence bound value, 90th
percentile, from 2 values)
Aqueous Photolysis Half-Life
Dinotefuran
39,830 ppm
stable
138.4 days
81.5 days
80.8 days
1.8 days
MNG
11, 480 ppm
stable
459.3
(3x one value)
153.1
Calculated
2x459.3
= 918.6
2.4 days
MRID#
45640112
45639706
45640102
45640112
45640111
45640117
45640105
45640107
Page 26 of 63
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Table 12. Environmental Fate Parameters for Dinotefuran and MNG
Parameter
Adsorption/Desorption Coefficient (Lowest
non-sand Kd)
Organic Carbon Adsorption/Desorption
Coefficient (lowest non-sand Koc)
Dinotefuran
0.22
22 mL/g
MNG
0.16
16 mL/g
MRID#
45640114
45640116
Table 13. Environmental Fate Parameters for DN and DN-2-OH
Parameter
Water Solubility (25°C)
Hydrolysis Half-Life (pH 7)
Aerobic Soil Metabolism Half-Life (3 times
single value calculated by Biowin Program)
Aerobic Soil Metabolism Half-Life
Aerobic Aquatic Metabolism Half-life
(one value only)
Aqueous Photolysis Half-Life
Adsorption/Desorption Coefficient (Lowest
non-sand Kd)
Organic Carbon Adsorption/Desorption
Coefficient (lowest non-sand Koc)
DN-2-OH
1, 000,000 ppm
(1)
stable
180
60 days
342 days (N/A -
(assumed same
asDN)
533.2 days (N/A
- assumed same
asDN)
N/A
10 mL/g
DN
619,400 ppm
stable
N/A
114 days (2)
114 days x 3 =
342 days
533.2 days
2.08
87 mL/g
MRID#
45639707
45640102
45640117.
45640117
45640108
45640113
Table 14. Environmental Fate Parameters for UF
Parameter
Water Solubility (25°C)
Hydrolysis Half-Life (pH 7)
Aerobic Soil Metabolism Half-Life (upper
confidence bound value, 90th percentile,
from 2 values)
Aerobic Soil Metabolism Half-Life (mean)
Aerobic Aquatic Metabolism Half-life
Dinotefuran
39,830 ppm
stable
138.4 days
8 1.5 days (2)
80.8 days
UF
4,171 ppm
stable
180 days
60 days
360(2x180
days)
MRID#
45640112
45640102
45640112
45640111
45640117
Page 27 of 63
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Table 14. Environmental Fate Parameters for UF
Parameter
Aqueous Photolysis Half-Life
Adsorption/Desorption Coefficient (Lowest
non-sand Kd)
Organic Carbon Adsorption/Desorption
Coefficient (lowest non-sand Koc)
Dinotefuran
1.8 days
0.22
22 mL/g
UF
Assumed Stable
-500 days
Not available
10.48 mL/g
MRID#
45640105
45640114
45640113
Ecological Effects and Risk
Terrestrial Hazard
Dinotefuran was tested on various species of birds (bobwhite, Japanese quail, and mallard
duck). The parent compound is practically nontoxic to Japanese quail on an acute basis
(LD50 > 2,000 ppm) and slightly toxic to mallard duck (LC50 = 5,000 ppm) and Japanese
quail (LC50 > 1,301 ppm) on a subacute dietary basis. Although there appeared to be no
significant treatment-related effects on bobwhite quail reproductive parameters, chronic
testing on mallard duck (NOAEC = 2,150 ppm) showed effects on several endpoints that
included number of hatchlings/eggs laid, eggs set, and 14-day old survivors.
Dinotefuran is slightly to practically nontoxic on an acute basis to surrogate wild mammal
species (laboratory rat) (LD50 = 1,000 - 3,000 mg/kg). Developmental test on the rat
produced a NOAEC > 1,000 mg/kg bw/day and reproductive NOAEC at 3000 ppm. There
were some affects in reproductive mammalian tests (such as slight decreases in testicular
sperm counts in F0 males and sperm mortality in Fx males), however these affects did not
change reproductive success of dose groups compared to the controls. These biological
anomalies observed in rats are common in these laboratory studies and are not considered
affects from endocrine disruption. The degradates MNG and DN were not tested on birds
or surrogate mammals.
Dinotefuran is highly toxic to bees on an acute oral basis (LD50 = 0.023 ug ai/bee) and on
an acute contact basis (LD50 = 0.047 ug ai /bee.
The Tier I seedling emergence and vegetative vigor studies showed that parent dinotefuran
caused effects on plants below the statistical 25% level. Therefore, no EC25 endpoints were
produced in those tests, so toxic affects on plants would be observed at levels higher than
the maximum labeled application rate (0.536 Ibs ai/Acre).
Aquatic Hazard
Submitted data indicate that dinotefuran is practically nontoxic on an acute basis to
freshwater and estuarine/marine fish (LC50 > 99.3 ppm), as well as freshwater
invertebrates (EC50 > 968.3 ppm). Chronic toxicity testing on freshwater invertebrates
showed no treatment related effects and a NOAEC was calculated at > 95.3 ppm.
However, dinotefuran appears to be highly toxic to the estuarine/marine invertebrates
Page 28 of 63
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(mysid shrimp EC50 = 0.79 ppm). Since an estuarine/marine chronic study was not
submitted for this compound there is an uncertainty regarding chronic risk to estuarine
invertebrates.
The degradates MNG and DN (in its stable form, DN-phosphate) were tested on aquatic
plants; and MNG was tested on invertebrates (daphnids). Both degradates do not appear to
be toxic to any of these organisms. None of the studies reviewed by EFED indicate any
potential endocrine disruption effects on fish or invertebrates. Refer to Appendix V for
hazard information on parent and degradate compounds.
Table 15. Ecological Toxicity Data Summary for Dinotefuran
A. Acute Toxicity to Japanese Quail
Species
Japanese quail
(Coturnixjaponica)
%ai
97.26
LD50
(mg/kg)
>2,000
Toxicity Category
Practically nontoxic
MRIDNo.
45639720
B. Subacute Toxicity to Mallard Duck
Species
Mallard duck
(Anas platyrhynchos)
%ai
99.2
5-Day
LC50
(ppm)
>5,000
Toxicity Category
Practically non-toxic
MRIDNo.
45639722
C. Subacute Toxicity to Japanese Quail
Species
Japanese quail
(Coturnixjaponica)
%ai
97.26
5-Day
LC50
(ppm)
>1301
Toxicity Category
Slight- practically
non toxic
MRIDNo.
45639721
D. Chronic Toxicity to Mallard Duck
Species
Mallard duck
(Anas
platyrhynchos)
%ai
99.3
NOAEC
(ppm)
2,150
LOAEC
(ppm)
5,270
Endpoints affected
Number of
hatchlings/ eggs laid,
number of hatchlings/
eggs set, and 14-day
old survivors/esss set
MRIDNo.
45639723
Page 29 of 63
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E. Chronic Toxicity to Bobwhite Quail
Species
Northern
bobwhite quail
(Colinus
virginianus)
%ai
99.3
NOAEC
(ppm)
5,270
LOAEC
(ppm)
>5,270
Endpoints
Affected
None
MRID No.
45639724
F. Mammalian Acute and Chronic Toxicity
Test Species
laboratory rat
(Rattus
norvegicus)
laboratory rat
(Rattus
norvegicus)
laboratory rat
(Rattus
norvegicus)
Rabbit
% ai
99.1
98.9
92.9
92.9
Toxicity
Value
LD50 = 2,804 mg/kg males,
and 2,000 mg/kg for
females
Reproductive NOAEL =
3,000 ppm and LOAEL =
10, 000 ppm
Developmental NOAEL >
1,000 mg/kg bw/day
LOAEL was not
established
Developmental NOAEL >
300 mg/kg bw/day
LOAEL was not
established
Affected
Endpoints
Morbidity
Decreased uterine weights,
miscroscopic alterations in
uterus and vagina of F0
females; decreased
numbers of primordial
follicles in F{ females,
altered estrous cyclicity in
F0females; slight increases
in abnormal sperm
morphology in F0 and Fl
males, and slight deceases
in testicular sperm count in
F0 males and sperm
mortality inF, males.
No statistically significant
effects on developmental
endpoints
No statistically significant
effects on developmental
endpoints
MRID No.
Author/ Year
45639823
Glaza, Steven
M./1997
45639913
45639914
Becker, H./ 2002
45654207
45639910
45654208
45639911
45639912
Page 30 of 63
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G. Nontarget Insect Toxicity
Species
Honeybee (Apis
mellifera)
Honeybee (Apis
mellifera)
Honeybee (Apis
mellifera)
Honeybee (Apis
mellifera)
Predacious mite
(Typhlodromus pyri
Scheuten)
Parasitoid wasp
(Aphidius
rhopalosiphi)
Predacious bug
(Onus laevigatus)
%ai
99.5
21.4
21.4
MTI-
446
20%
SG
21.09
21.09
21.09
Endpoint/ Test type
LD50 = 0.023 ug a.i./bee/
acute oral
LD50 = 0.047 ug a.i./bee/
contact
LD50 = 0.032 ug a.i./bee/
acute oral
LD50= 0.061 uga.i./bee/
contact
LD50 = 0.024 ug a.i./bee/
contact
LD50 = 0.0076 ug
a.i./bee/ acute oral
48-hour RT25 = 90(75-
110) hour
LC50 = 30.1ga.i./ha
NOAEC= <15ga.i./ha
LC50 = 77.2 mg a.i./ha
NOAEC = 7 mg a.i./ha
LC50= 13.3 mg a.i./ha
NOAEC = <1. 36 mg
a.i./ha
LOAEC= 8. 8 mg a.i./ha
Toxicity
Category
Highly
toxic
Highly
toxic
Highly
toxic
N/A
N/A
N/A
N/A
MRID No.
45639725
45639726
45639727
45639728
45640120
45640121
45640122
Page 31 of 63
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H. Freshwater Fish Acute Toxicity
Species/
Flow-through or
Static
Rainbow trout
(Oncorhynchus
mykiss)
Flow-through
Bluegill sunfish
(Leopmis
macrochims)
Flow-through
Carp
(Cyprinus carpio)
Test Material
Purity
MTI-446
97.26 %
MTI-446
97.26 %
MTI-446
97.26 %
96 -hour
LC50
(mg/L)
>99.5
>99.3
>99.1
Toxicity Category
Practically
nontoxic
Practically
nontoxic
Practically
nontoxic
MRID#
45639714
45639715
45639716
I. Freshwater fish Chronic Toxicity
Species/Static or Flow-
through
Rainbow Trout
(Oncorhynchus mykiss)
Flow-through
%ai
98.9
LOAEC
(ppm)
N/A
NOAEC
(ppm)
N/A
Effects
N/A
MRID No.
456397-19
INVALID STUDY
J. Freshwater Invertebrate Acute Toxicity
Species/Static or
Flow-through
Waterflea
(Daphnia magna)
Flow-Through
Waterflea
(Daphnia magna)
Flow-Through
Test
Material
Purity
MTI-446
97.26 %
DN
Phosphate
48-hour LC50
orEC50
measured in
mg/L
>968.3
>110.6
Toxicity
Category
Practically
nontoxic
Practically
nontoxic
MRID No.
45639709
45639710
K. Freshwater Invertebrate Chronic Toxicity
Species/Static or Flow-
through
Waterflea
(Daphnia magna)
Test Material
Purity
MTI-446
97.26%
Study Type
21 -day chronic
toxicity test
Chronic Endpoints
Affected
None
NOAEC = 95.3
ppm; LOAEC
>95.3 ppm
MRID No.
45639718
Page 32 of 63
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L. Estuarine/Marine Fish Acute Toxicity
Species/Static
or Flow-through
Sheepshead Minnow
(Cyprinodon
variegatus)
%ai
99.2
96-hour
LC50
(ppm)
>109
Toxicity Category
Practically nontoxic
MRID No.
45639717
M. Estuarine/Marine Invertebrate Acute Toxicity
Species/Static or
Flow-through
Eastern oyster
(Crassostrea virginica)
Mysid Shrimp
(Mysidopsis bahia)
% ai.
99.6
99.2
96-hour LC50
or EC50 (ppm)
>141
0.79
Toxicity
Category
Practically
nontoxic
Highly toxic
MRID No.
45639711
45639713
N. Nontarget Aquatic Plant Toxicity (Tier I)
Species
Test
Material
Purity
Endpoints
EC50/IC50
(mg a.i. /L)
NOAEC
(mg a.i. /L)
MRID No.
Vascular Plants
Duckweed
(Lemna Gibba)
99.2% a.i.
Growth
>110
110
45639731
Nonvascnlar Plants
Green Algae
(Pseudokirchneri
ella subcapitatd)
Green Algae
(Selenastrum
capricornutum)
Green Algae
(Selenastrum
capricornutum)
97.26% a.i.
MNG
DN
Phoshpate
Cell density
Growth rate
Growth rate
97.6
>98.7
>100.4
25
98.7
100.4
45639732
45639733
45639734
Exposure and Risk to Terrestrial and Aquatic Organisms
In order to evaluate the potential risk to terrestrial and aquatic organisms from the use of
dinotefuran, risk quotients (RQs) were calculated from the ratio of estimated environmental
concentrations (EECs) to ecotoxicity values. The RQ values were calculated using the Tier I
models, ELL-FATE and GENEEC,EECs, based on the maximum application rate of dinotefuran
for the proposed uses. These RQs were then compared to the levels of concern (LOG) criteria used
by EFED for determining potential risk to non-target organisms and the subsequent need for
possible regulatory action. All risk quotients were less than the target LOG of 1. Therefore, the
Page 33 of 63
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proposed uses of dinotefuran do not trigger acute or chronic risks to non-endangered or
endangered aquatic and terrestrial organisms (e.g., mammals, birds, fish, invertebrates, and plants).
Although dinotefuran is potentially highly toxic to bees, the proposed uses of this compound are
not associated with areas high in pollinating insects. Based upon ecotoxicological data on two of
its degradates, DN was found to be nontoxic to freshwater invertebrates (daphnids) and aquatic
plants (green algae) and MNG was found to be nontoxic to green algae.
Exposure of surface waters to dinotefuran is possible through surface water runoff, soil
erosion, and off-target spray drift. Due to the low adsorption potential of dinotefuran (Koc's< 45),
the exposure to surface and ground water is expected to be high.
Tier I Estimated Drinking Water Concentrations (EDWCs) for dinotefuran, and for its
major transformation products - l-methyl-2-nitroguanidine (MNG), l-methyl-3-(tetrahydro-3-
furylmethyl)guanidine (DN), l-methyl-3-(tetrahydro-3-furylmethyl)urea (UF), and DN-2-
OH+DN-3-OH were calculated for use in the human health risk assessment.
The degradates UF and DN-2-OH are photolysates and are not likely to be formed in the
leafy vegetable scenario that includes soil incorporation of the parent. The formation of these
degradates would be a result of direct exposure of parent to surface waters through spray drift,
followed by photolysis. The above estimated values for DN, UF, and DN-2-OH+DN-3-OH
(Photolysates) are considered to be the upper bound estimates since these degradates are likely to
form only in puddles or small water pockets in the field through photolysis. The combined peak
concentration for the parent and the degradates is estimated at 52.06 ppb and the combined annual
average surface water concentration is estimated at 9.64 ppb.
Based upon the aerobic soil metabolism and field dissipation studies, MNG is the only
major degradate expected to be formed in soils. MNG contains the nitro guanidine structure and
therefore is considered to posses similar toxicity as the parent. DN is also structurally similar to
the parent and therefore considered to share similar toxicity as the parent. DN has been found to
form under anaerobic conditions only. None of the degradates of dinotefuran are expected to have
any higher toxicity than the parent.
Risk to nontarget insects
Dinotefuran parent is highly toxic to bees and since this chemical is an insecticide,
protection of pollinators is a concern. The turf and leafy vegetable uses in this assessment are not
expected to include areas highly associated with pollinating insects. Therefore potential kill events
via direct spray or nontarget spray drift on pollinating insects in these areas appears to be minimal.
Risk to terrestrial plants
In the Tier I seedling emergence and vegetative vigor tests, no plant species showed at least
a 25% detrimental effect on any parameter, when compared to the controls. Risk quotients could
not be calculated since there was no EC25 data available for terrestrial plants. No Tier II terrestrial
plant tests are required at this time.
Risk to endangered species
Page 34 of 63
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Risks to endangered species were evaluated for aquatic and terrestrial organisms. There
were no LOCs which exceeded EFED's Tier I screen and no other concerns for endangered
species have been identified for this risk assessment.
6. SUMMARY OF REGULATORY POSITION AND RATIONALE
Available data provide adequate information to support the conditional registration of
dinotefuran technical and end-use products for use on leafy vegetables.
Labeling Restrictions
Manufacturing Use Products
Precautionary Statements/Environmental Hazards:
This pesticide is toxic to shrimp. Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or other waters unless it is in accordance with the
requirements of a National Pollutant Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do not discharge
effluent containing this product to sewer systems without previously notifying the local
sewage treatment plant authority. For guidance, contact your State Water Board or
Regional Office of the EPA.
This product is highly toxic to bees exposed to direct treatment or residues on blooming
crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds
if bees are visiting the area
End-Use Products
1. Precautionary Statements/Environmental Hazards:
This pesticide is toxic to shrimp. Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high water mark. Do not apply when
weather conditions favor drift from treated areas. Drift and runoff from treated areas may
be hazardous to aquatic organisms in water adjacent to treated areas. Do not dispose
equipment washwaters or rinsate into a natural drain or water body.
This product is highly toxic to bees exposed to direct treatment or residues on blooming
crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds
if bees are visiting the treatment area.
2. Since the field trial data submitted did not reflect the use of surfactants in the
application sprays, the statements on the proposed label which state that control may be
improved by the addition of a nonionic surfactant to the spray mixture must be deleted,
until data depicting residues in the presence of a surfactant have been submitted and
reviewed.
3. Specify a 120-day plantback interval for all crops other than leafy vegetables.
Page 35 of 63
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7. SUMMARY OF CONFIRMATORY DATA REQUIREMENTS
Residue Chemistry
1. Additional storage stability data in/on lettuce may be required pending review of MRID
Numbers 45891614 and 45915401.
2. Confined Accumulation in Rotational Crops:
a. The dates of sample extraction and analysis must be submitted.. If samples from the
confined rotational crop study were stored >6 months from harvest to final analysis,
storage stability data may be required to support the sample storage intervals.
b. A new confined rotational crop study, reflecting a Ix application rate, will be required,
if any plantback interval less than 120 days is sought.
Toxicology
1. A confirmatory dermal absorption study in the rat is required.
2. A developmental neurotoxicity study in the rat is required.
3. A developmental immunotoxicity study in the rat with comparative measures between pups
and the parents is required. The protocol for this testing should be developed following
discussion with OPP/HED scientists.
Environmental Fate
1. Photodegradation in Soil. The aqueous photolysis study shows that
photolysis/photodegradation is a major degradation pathway for dinotefuran. However, the
Agency requires a valid soil photolysis study in order to better evaluate this route of
dissipation.
2. Aerobic Soil Metabolism
3. Anaerobic Aquatic/Soil Metabolism. This study needs to be repeated to assess any future
aquatic uses.
4. Aerobic Aquatic Metabolism. This study needs to be repeated to assess any future aquatic
uses.
Ecological Effects
1. Fish Early Life Stage Toxicity Test
2. Avian Acute Oral Test
Page 36 of 63
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3. Aquatic Invertebrate Life Cycle Test. This study will be needed to assess any future
aquatic uses.
9. CONTACT PERSON AT EPA
Rita Kumar, Senior Regulatory Specialist
Insecticide-Rodenticide Branch
Registration Division (7505C)
Office of Pesticide Programs
Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Office Location and Telephone Number
Room 215, Crystal Mall Building #2
1921 Jefferson Davis Highway
Arlington, VA 22202
(703)308-8291
E-mail: kumar.rita@epa.gov
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
reregi strati on.
Page 3 7 of 63
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Appendix I
GLOSSARY OF TERMS AND ABBREVIATIONS
ADNT Acute delayed neurotoxicity
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
ARI Aggregate Risk Index
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
ChE Cholinesterase
ChEI Cholinesterase inhibition
cPAD Chronic Population Adjusted Dose
%CT Percent crop treated
DAT Days after treatment
DEEM-FCID Dietary Exposure Evaluation Model - Food Consumption Intake Database
DNA Deoxyribonucleic acid
DNT Developmental neurotoxicity
DIT Developmental Immunotoxicity
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EPA U.S. Environmental Protection Agency
FQPA Food Quality Protection Act
GLC Gas Liquid Chromatography
GLN Guideline Number
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed
as the weight of substance per weight or volume of water, air or feed, e.g., mg/1,
mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit weight
of animal, e.g., mg/kg.
LOAEL Lowest Observed Adverse Effect Level
LOAEC Lowest Observed Adverse Effect Concentration
LOG Level of Concern
LOD Limit of Detection
LOQ Limit of quantitation
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number), EPA's system of recording and tracking
studies submitted
MTD Maximum tolerated dose
NA Not Applicable
NOEC No Observable Effect Concentration
Page 38 of 63
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GLOSSARY OF TERMS AND ABBREVIATIONS (Continued)
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NOAEC No Observed Adverse Effect Concentration
NPDES National Pollutant Discharge Elimination System
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/
EXAMS Tier II Surface Water Computer Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
TGAI Technical Grade Active Ingredient
UF Uncertainty Factor
jig micrograms
|ig/L Micrograms Per Liter
|iL/g Microliter per gram
USD A United States Department of Agriculture
WPS Worker Protection Standard
Page 39 of 63
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Appendix II
Citations Considered to be Part of the Data Base Supporting the Registration of
Dinotefuran
MRID Citation
45636500 Sumitomo Chemical Company (2002) Submission of Product Chemistry,
Toxicity and Efficacy Data in Shuriken Cockroach Gel Bait. Transmittal of
16 Studies.
45636501 Todd, R. (2002) Product Identity and Composition of Shuriken Cockroach
Gel Bait. Unpublished study prepared by Insect Control & Research, Inc. 8
p. (OPPTS 830.1550}
45636502 Todd, R. (2002) Description of Materials Used to Produce Shuriken
Cockroach Gel Bait. Unpublished study prepared by Insect Control &
Research, Inc. 30 p. {OPPTS 830.1600}
45636503 Kawada, H. (2002) Description of Manufacturing Process of Shuriken
Cockroach Gel Bait: Lab Project Number: SH1650. Unpublished study
prepared by Sumitomo Chemicals Company, Ltd. 9 p. {OPPTS 830.1650}
45636504 Todd, R. (2002) Discussion of the Formation of Impurities in the
Shuriken Cockroach Gel Bait. Unpublished study prepared by Insect Control
& Research, Inc. 7 p. {OPPTS 830.1670}
45636505 Todd, R. (2002) Certified Limits of Shuriken Cockroach Gel Bait.
Unpublished study prepared by Insect Control & Research, Inc. 7 p.
{OPPTS 830.1750}
45636506 Evans, A.; Mullee, D. (2002) S-1638 Gel Bait: Determination of General
Physico-Chemical Properties: Lab Project Number: SZF-0001: 483/038.
Unpublished study prepared by Safepharm Laboratories Limited. 15 p.
{OPPTS 830.6315, 830.7000, 830.7300}
45636507 Whittington, J. (2002) Shelf Life Storage Stability Characteristics of S-1638
Gel Bait: (One Month Interim Report): Lab Project Number: V-01-22483A:
VAM-24A-001: VL-006-05. Unpublished study prepared by Valent USA
Corporation. 55 p. {OPPTS 830.6317}
45636508 Whittington, J. (2002) Corrosion Characteristics of S-1638 Gel Bait:
(One Month Interim Report): Lab Project Number: V-01-22483B: SZF-0003:
V-24483B. Unpublished study prepared by Valent USA Corporation. 43 p.
{OPPTS 830.6320}
45636509 Kunimatsu, T. (2002) Acute Oral Toxicity Study of S-1638 Gel Bait in
Rats: Final Report: Lab Project Number: 3696. Unpublished study prepared
by Sumitomo Chemical Company. 26 p. {OPPTS 870.1100}
Page 40 of 63
-------
45636510 Kunimatsu, T. (2002) Acute Dermal Toxicity Study of S-1638 Gel Bait in
Rats: Final Report: Lab Project Number: 3699. Unpublished study prepared
by Sumitomo Chemical Company. 25 p. (OPPTS 870.1200}
45636511 Nakamura, Y. (2002) Primary Skin and Eye Irritation Test of S-1638 Gel
Bait in Rats: Lab Project Number: 3683. Unpublished study prepared by
Sumitomo Chemical Company. 18 p. {OPPTS 870.2500, 870.2400}
45636512 Nomura, N. (2002) A Skin Sensitization Study of S-1638 Gel Bait in
Guinea Pigs: Lab Project Number: 1-1778. Unpublished study prepared by
Bozo Research Center Inc. 39 p. {OPPTS 870.2600}
45636513 Gaynor, W. (2002) Efficacy of Two Cockroach Baits Against German
Cockroaches: (Shuriken Cockroach Bait): Lab Project Number:
G0171201001A098: 1201-017-0084. Unpublished study prepared by Insect
Control & Research, Inc. 103 p.
45636514 Gaynor, W. (2002) Efficacy of Two Cockroach Baits Against American
Cockroaches: (Shuriken Cockroach Gel Bait): Lab Project Number:
G0171201002A098: 1201-017-0085. Unpublished study prepared by Insect
Control & Research, Inc. 103 p.
45636515 Gaynor, W. (2002) Efficacy of Two Cockroach Baits Against German
Cockroaches: (Shuriken Cockroach Gel Bait): Lab Project Number:
G0171201001A086: 1201-017-0086. Unpublished study prepared by Insect
Control & Research, Inc. 59 p.
45636516 Gaynor, W. (2002) Efficacy of Two Cockroach Baits Against American
Cockroaches: (Shuriken Cockroach Gel Bait): Lab Project Number:
G0171201002A086: 1201-017-0087. Unpublished study prepared by Insect
Control & Research, Inc. 98 p.
45639100 Mitsui Chemicals, Inc. (2002) Submission of Product Chemistry and
Toxicity Data in Support of the Application for Registration of
Dinotefuran 20% SG and the Petition for Tolerance of Dinotefuran on Leafy
Vegetables and Cotton Seed Undelinated/Gin Byproducts. Transmittal of 14
Studies.
45639101 Ebihara, K.; Harnish, W. (2002) Dinotefuran 20% SG: Product Identity
and Disclosure of Ingredients, Including Manufacturing Process and
Discussion of Formation of Impurities. Unpublished study prepared by
Mitsui Chemicals, Inc. 60 p. {OPPTS 830.1550, 830.1600, 830.1620,
830.1650,830.1670}
45639102 Landis, W. (2002) Dinotefuran (MTI-446) 20% SG: Physical and Chemical
Properties. Unpublished study prepared by Mitsui Chemicals, Inc. 37 p.
45639103 Wolf, S. (2001) Validation of An Analytical Method for the
Determination of MTI-446 (Active Ingredient) in MTI-446 20% SG: Lab
Project Number: 806837. Unpublished study prepared by RCC Ltd. 45 p.
{OPPTS 830.1800}
Page 41 of 63
-------
45639104 Wolf, S. (2001) Determination of MTI-446 (Active Ingredient) in a Batch
of MTI-446 20% SG: Lab Project Number: 818278. Unpublished study
prepared by RCC Ltd. 36 p. (OPPTS 830.1800}
45639105 Tognucci, A. (2002) Determination of the Oxidation/Reduction of MTI-446
20% SG with Certain Agents: Lab Project Number: 796230. Unpublished
study prepared by RCC Ltd. 28 p. {OPPTS 830.6314}
45639106 Muller-Kafer, R. (2002) Determination of the Storage Stability and
Corrosion Stability of MTI-446 20% SG (Shelf Life at Room Temperature):
Lab Project Number: 796285. Unpublished study prepared by RCC Ltd. 43
p. {OPPTS 830.6317 and 830.6320}
45639107 Tognucci, A. (2002) pH-Determination of an Aqueous Dispersion of
MTI-446 20% SG: Lab Project Number: 796263. Unpublished study
prepared by RCC Ltd. 26 p. {OPPTS 830.7000}
45639108 Tognucci, A. (2002) Determination of the Bulk Density of MTI-446 20%
SG: Lab Project Number: 796274. Unpublished study prepared by RCC Ltd.
27 p. {OPPTS 830.7300}
45639109 Oda, S. (2001) Acute Oral Toxicity Study of MTI-446 20% SG in Rats:
Lab Project Number: B-4831. Unpublished study prepared by Bozo Research
Center, Inc. 37 p. {OPPTS 870.1100}
45639110 Oda, S. (2001) Acute Dermal Toxicity Study of MTI-446 20% SG in Rats:
Lab Project Number: B-4832. Unpublished study prepared by Bozo
Research Center, Inc. 37 p. {OPPTS 870.1200}
45639111 Decker, U. (2002) MTI-446 20% SG: 4-Hour Acute Inhalation Study in
Rats: Lab Project Number: 838743. Unpublished study prepared by RCC
Ltd. 86 p.
45639112 Ukon, Y. (2002) Eye Irritation Study of MTI-446 20% in Rabbits: Lab
Project Number: 1-1727. Unpublished study prepared by Bozo Research
Center, Inc. 30 p. (OPPTS 870.2400}
45639113 Ukon, Y. (2002) Skin Irritation Study of MTI-446 20% in Rabbits: Lab
Project Number: 1-1728. Unpublished study prepared by Bozo Research
Center, Inc. 24 p. {OPPTS 870.2500}
45639114 Ukon, Y. (2002) Skin Sensitization Study of MTI-446 20% in Guinea Pigs
(Buehler Test): Lab Project Number: 1-1729. Unpublished study prepared by
Bozo Research Center, Inc. 29 p. {OPPTS 870.2600}
45639200 Mitsui Chemicals, Inc. (2002) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran TK. Transmittal
of 2 Studies.
Page 42 of 63
-------
45639201 Ebihara, K.; Harnish, W. (2002) Dinotefuran TK: Product Identity and
Disclosure of Ingredients, Including Manufacturing Process and Discussion
of Formation of Impurities. Unpublished study prepared by Mitsui
Chemicals, Inc. 28 p. (OPPTS 830.1550, 830.1600, 830.1620, 830.1650,
830.1670}
45639202 Landis, W. (2002) Dinotefuran TK: Physical and Chemical Properties.
Unpublished study prepared by Mitsui Chemicals, Inc. 58 p.
45639600 Mitsui Chemicals, Inc. (2002) Submission of Product Chemistry,
Toxicity and Efficacy Data in Support of the Application for Registration
of Dinotefuran Ready To Use. Transmittal of 12 Studies.
45639601 Ebihara, K.; Renfroe, J. (2002) Dinotefuran Ready To Use Product
Identity and Disclosure of Ingredients, Including Manufacturing Process
and Discussion of Formation of Impurities. Unpublished study prepared by
Mitsui Chemicals, Inc. 51 p. {OPPTS 830.1550, 830.1600, 830.1620,
830.1650,830.1670}
45639602 Washburn, K. (2002) Dinotefuran Ready To Use Pump 0.5%: Product
Chemistry: End-Use Product: Final Report: Lab Project Number: 6685-01.
Unpublished study prepared by Stillmeadow, Inc. 14 p. {OPPTS 830.6302,
830.6303, 830.6304, 830.6314, 830.7000, 830.7100, 830.7300}
45639603 Anderson, W. (2002) Dinotefuran Ready To Use: Storage Stability with
Corrosion Characteristics: Lab Project Number: 6686-01. Unpublished study
prepared by Stillmeadow, Inc. 9 p. {OPPTS 830.6317 and 830.6320}
45639604 Kuhn, J. (2001) Dinotefuran Ready To Use Pump 0.5%: Acute Oral
Toxicity Study in Rats: Final Report: Lab Project Number: 6679-01.
Unpublished study prepared by Stillmeadow, Inc. 10 p. {OPPTS 870.1100}
45639605 Kuhn, J. (2001) Dinotefuran Ready To Use Pump 0.5%: Acute Dermal
Toxicity Study in Rabbits: Final Report: Lab Project Number: 6680-01.
Unpublished study prepared by Stillmeadow, Inc. 12 p. {OPPTS 870.1200}
45639606 Carter, L. (2002) Dinotefuran Ready To Use Pump 0.5%: Acute Inhalation
Toxicity Study in Rats: Final Report: Lab Project Number: 6681-01.
Unpublished study prepared by Stillmeadow, Inc. 20 p. {OPPTS 870.1300}
45639607 Kuhn, J. (2001) Dinotefuran Ready To Use Pump 0.5%: Acute Eye
Irritation Study in Rabbits: Final Report: Lab Project Number: 6682-01.
Unpublished study prepared by Stillmeadow, Inc. 17 p. {OPPTS 870.2400}
45639608 Kuhn, J. (2001) Dinotefuran Ready To Use Pump 0.5%: Acute Dermal
Irritation Study in Rabbits: Final Report: Lab Project Number: 6683-01.
Unpublished study prepared by Stillmeadow, Inc. 12 p. {OPPTS 870.2500}
Page 43 of 63
-------
45639609 Kuhn, J. (2002) Dinotefuran Ready To Use Pump 0.5%: Skin Sensitization
Study in Guinea Pigs: Final Report: Lab Project Number: 6684-01.
Unpublished study prepared by Stillmeadow, Inc. 17 p. (OPPTS 870.2600}
45639610 Kirkland, R. (2002) Efficacy of Dinotefuran Ready To Use as a Pump
Spray in the Control of Cockroaches: Lab Project Number: BIO 330-01.
Unpublished study prepared by Bio Research. 34 p. {OPPTS 810.3500}
45639611 Kirkland, R. (2002) Efficacy of Dinotefuran Ready To Use as a Pump
Spray in the Residual Control of Household Pests: Lab Project Number: BIO
332-01. Unpublished study prepared by Bio Research. 54 p. {OPPTS
810.3500}
45639612 Donahue, L. (2002) In vitro Efficacy Evaluations of Dinotefuran (MTI-446)
Ready To Use Formulation Against Selected Arthropod Pest Species: Final
Report: Lab Project Number: LNDOl-1. Unpublished study prepared by
Sierra Research Laboratories (SRL). 20 p. {OPPTS 810.3500}
45639700 Mitsui Chemicals, Inc. (2002) Submission of Product Chemistry,
Toxicity, Residue and Environmental Fate Data in Support of the
Application for Registration of Dinotefuran Technical and the Petition for
Tolerance of Dinotefuran on Leafy Vegetables and Cottonseed
Undelinted/Gin Byproducts. Transmittal of 35 Studies.
45639701 Ebihara, K.; Harnish, W. (2002) Dinotefuran Technical: Product Identity and
Disclosure of Ingredients, Including Manufacturing Process and Discussion
of Formation of Impurities. Unpublished study prepared by Mitsui
Chemicals, Inc. 82 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1650,
830.1670}
45639702 Malinski, M. (2000) MTI-446 Product Chemistry: Lab Project Number:
011098-1: MTI-446: 011098-0. Unpublished study prepared by Ricerca,
LLC. 193 p. {OPPTS 830}
45639703 Ramsay, N.; Craig, W. (2001) Dinotefuran 5-Batch Analysis of
Dinotefuran to Fulfill the Requirements of OPPTS Guidelines 830.1700 and
830.1800 and EC Council Directive 94/37/EEC Article 1.9 to 1.11: Lab
Project Number: 20426: 341084: 4108A. Unpublished study prepared by
Inveresk Research. 90 p. {OPPTS 830.1700, 830.1800}
45639704 Macdonald, E.; Graham, P. (2001) Physico-Chemical Testing with MNG:
Partition Coefficient: Lab Project Number: 19350: 281675: 8169.
Unpublished study prepared by Inveresk Research. 20 p. {OPPTS 830.7550}
45639705 Macdonald, E.; Graham, P. (2001) Physico-Chemical Testing with DN
Phosphate: Partition Coefficient: Lab Project Number: 19352: 281680: 8169.
Unpublished study prepared by Inveresk Research. 6 p. {OPPTS 830.7550}
Page 44 of 63
-------
45639706 Macdonald, E.; Graham, P. (2001) Physico-Chemical Testing with MNG:
Water Solubility: Lab Project Number: 19349: 281633: 8169. Unpublished
study prepared by Inveresk Research. 18 p. (OPPTS 830.7840}
45639707 Macdonald, E.; Graham, P. (2001) Physico-Chemical Testing with DN
Phosphate: Water Solubility: Lab Project Number: 19351: 281649: 8169.
Unpublished study prepared by Inveresk Research. 6 p. {OPPTS 830.7840}
45639708 Hewitt, A. (2002) Atomization Droplet Size Spectra for MTI-446
Insecticide: Lab Project Number: L02-001. Unpublished study prepared by
Stewart Agricultural Research Services, Inc. 20 p. {OPPTS 840.1100}
45639709 Peither, A. (2000) Acute Toxicity of MTI-446 to Daphnia Magna in a 48-
Hour Immobilization Test: Lab Project Number: 740968: MTI-446: 740970.
Unpublished study prepared by RCC Ltd. 32 p. {OPPTS 850.1010}
45639710 Kelly, C.; Murphy, C.; Allan, J. (2002) DN Phosphate Determination of
Acute Toxicity to Daphnia (48 h, Static): Lab Project Number: 20122:
800141. Unpublished study prepared by Inveresk Research. 24 p. {OPPTS
850.1010}
45639711 Drottar, K.; Kendall, T.; Krueger, H. (2001) MTI-446 Technical: A 96-Hour
Shell Deposition Test with the Eastern Oyster (Crassostrea virginica): Final
Report: Lab Project Number: 236A-106A. Unpublished study prepared by
Wildlife International, Ltd. 38 p. {OPPTS 850.1025}
45639712 Kendall, T.; Nixon, W. (2001) Analytical Method Verification for the
Determination of MTI-446 Technical in Saltwater: Lab Project Number:
236C-102. Unpublished study prepared by Wildlife International, Ltd. 28 p.
{OPPTS 850.1035}
45639713 Blankinship, A.; Drottar, K.; Kendall, T.; et al. (2001) MTI 446-Technical: A
96-Hour Flow-Through Acute Toxicity Test with the Saltwater Mysid
(Mysidopsis bahia): Final Report: Lab Project Number: 236A-104A.
Unpublished study prepared by Wildlife International, Ltd. 38 p. {OPPTS
850.1035}
45639714 Peither, A. (1999) Acute Toxicity of MTI 446 to Rainbow Trout
(Oncorhynchus mykiss) in a 96-Hour Static Test: Lab Project Number:
740924. Unpublished study prepared by RCC, Ltd. 33 p. {OPPTS 850.1075}
45639715 Peither, A. (2000) Acute Toxicity of MTI-446 to Bluegill Sunfish
(Lepomis macrochirus) in a 96-Hour Static Test: Lab Project Number:
740946: 740957. Unpublished study prepared by RCC, Ltd. 33 p. {OPPTS
850.1075}
45639716 Peither, A. (2000) Acute Toxicity of MTI-446 to Common Carp (Cyprinus
carpio) in a 96-Hour Static Test: Lab Project Number: 741003: 741014.
Unpublished study prepared by RCC, Ltd. 33 p. {OPPTS 850.1075}
Page 45 of 63
-------
45639717 Blankinship, A.; Drottar, K.; Kendall, T.; et al. (2001) MTI-446
Technical: A 96 Hour Flow-Through Acute Toxicity Test with the
Sheepshead Minnow (Cyprinodon variegatus): Final Report: Lab Project
Number: 236A-105. Unpublished study prepared by Wildlife International,
Ltd. 39 p. (OPPTS 850.1075}
45639718 Peither, A. (2000) Influence of MTI-446 on Survival and Reproduction
of Daphnia magna in a Semistatic Test over Three Weeks: Lab Project
Number: 752106: 752117. Unpublished study prepared by RCC, Ltd. 40 p.
{OPPTS 850.1300}
45639719 Peither, A. (2001) Toxic Effects of MTI-446 to Rainbow Trout
(Oncorhynchus mykiss) in an Early-Life Stage Toxicity Test: Lab Project
Number: 794338: 794340. Unpublished study prepared by RCC, Ltd. 54 p.
{OPPTS 850.1400}
45639720 Burri, R. (2000) MTI-446 Technical: Acute Oral Toxicity Test in the
Japanese Quail: Lab Project Number: 746425. Unpublished study prepared
by RCC, Ltd. 46 p.
45639721 Burri, R. (2000) MTI-446 Technical: Avian Dietary Toxicity Test in the
Japanese Quail: Lab Project Number: 746436. Unpublished study prepared
by RCC, Ltd. 47 p. {OPPTS 850.2200}
45639722 Burri, R. (2000) MTI-446 Technical: Avian Dietary Toxicity Test in the
Mallard Duck: Lab Project Number: 793754: 904994. Unpublished study
prepared by RCC, Ltd. 46 p. {OPPTS 850.2200}
45639723 Mitchell, L.; Martin, K.; Beavers, J.; et. al. (2002) MTI-446 Technical: A
Reproduction Study with the Mallard: Final Report: Lab Project Number:
236-115. Unpublished study prepared by Wildlife International, Ltd. 157 p.
45639724 Mitchell, L.; Martin, K.; Beavers, J.; et al. (2002) MTI-446 Technical: A
Reproduction Study with the Northern Bobwhite: Final Report: Lab Project
Number: 236-114. Unpublished study prepared by Wildlife International,
Ltd. 159 p.
45639725 Harnish, W. (2000) Acute Contact and Oral Toxicity of MTI-446, Active
to Honey Bees: Lab Project Number: 41421F001. Unpublished study
prepared by Landis International, Inc. 68 p. {OPPTS 850.3020}
45639726 Harnish, W. (2000) Acute Contact and Oral Toxicity of MTI-446, 20% WG
to Honey Bees: Lab Project Number: 41421F002. Unpublished study
prepared by Landis International, Inc. 62 p. {OPPTS 850.3020}
45639727 Thompson, H. (1998) A Formulation Containing MTI-446: Acute Contact
and Oral Toxicity to Honey Bees (Apis mellifera): Lab Project Number:
FP2400. Unpublished study prepared by Central Science Laboratory,
National Bee Unit. 47 p.
Page 46 of 63
-------
45639728 Hummel, R. (2001) Evaluation of Toxicity of Residues of MTI-446 on
Alfalfa to Honey Bees (Apis mellifera): Lab Project Number: 43421F001.
Unpublished study prepared by Landis International, Inc. 46 p. (OPPTS
850.3030}
45639729 Porch, 1; Martin, K.; Krueger, H. (2001) MTI-446 20% SG: A Toxicity
Test to Determine the Effects of the Test Substance on Seedling Emergence
of Ten Species of Plants: Final Report: Lab Project Number: 236-116.
Unpublished study prepared by Wildlife International, Ltd. 54 p. {OPPTS
850.4100}
45639730 Porch, J.; Brignole, A.; Krueger, H.; et al. (2001) MTI-446 20% SG: A
Toxicity Test to Determine the Effects of the Test Substance on Vegetative
Vigor of Ten Species of Plants: Final Report: Lab Project Number: 236-
117. Unpublished study prepared by Wildlife International, Ltd. 74 p.
{OPPTS 850.4150}
45639731 Batscher, R. (2002) Toxicity of MTI-446 to the Aquatic Higher Plant
Lemna Gibba in a 7-Day Semistatic Growth Inhibition Test: Lab Project
Number: 827752. Unpublished study prepared by RCC, Ltd. 55 p. {OPPTS
850.4400}
45639732 Seyfried, B. (2000) Toxicity of MTI-446 to Pseudokirchneriella
subcapitata (Formerly Selenastrum capricornutum) in a 96-Hour Algal
Growth Inhibition Test: Lab Project Number: 740981: 740992. Unpublished
study prepared by RCC, Ltd. 37 p. {OPPTS 850.5400}
45639733 Kelly, C.; Ferguson, K. (2002) MNG Alga, Growth Inhibition Test (96
h): Lab Project Number: 19918: 800199. Unpublished study prepared by
Inveresk Research. 29 p. {OPPTS 850.5400}
45639734 Kelly, C.; Ferguson, K. (2002) DN Phosphate Alga, Growth Inhibition
Test (96 h): Lab Project Number: 19849: 800183: 8169. Unpublished study
prepared by Inveresk Research. 28 p. {OPPTS 850.5400}
45639735 Volkel, W. (2002) (Carbon 14)-MTI-446: Plant Metabolism in Rape: Lab
Project Number: 767880. Unpublished study prepared by RCC, Ltd. 110 p.
{OPPTS 860.1300}
45639800 Mitsui Chemicals, Inc. (2002) Submission of Environmental Fate,
Residue and Toxicity Data in Support of the Application for Registration
of Dinotefuran Technical and the Petition for Tolerance of Dinotefuran on
Leafy Vegetables and Cottonseed Undelinted/Gin Byproducts. Transmittal of
24 of 149 Studies.
45639801 Mamouni, A. (2002) (Carbon-14)-MTI-446 Oil Seed Rape Incurred Residues
(Residue Method Efficiency): Lab Project Number: 842768. Unpublished
study prepared by RCC Ltd. 25 p. {OPPTS 860.1300}
45639802 Mamouni, A. (2002) (Carbon-14)-MTI-446 Plant Metabolism in Potato: Lab
Project Number: 734310. Unpublished study prepared by RCC Ltd. 116 p.
{OPPTS 860.1300}
Page 47 of 63
-------
45639803 McClanahan, R.; Lentz, N.; Waller, R. (1999) Metabolic Fate of MTI-446
in Rice: Lab Project Number: 7466-98-0021-EF-OO1-001: 7466-98-0021-EF-
000. Unpublished study prepared by Ricerca, Inc. 374 p. (OPPTS 860.1300}
45639804 Panthani, A.; Walsh, K.; Shah, J. (2002) Metabolism of (Carbon-14)-MTI-
446 in Apples: Lab Project Number: 012786-1: R160101: 012786-0-1.
Unpublished study prepared by Ricerca, LLC. 216 p. {OPPTS 860.1300}
45639805 Panthani, A.; Walsh, K.; Sandacz Herczog, K. (2002) Metabolism of
(Carbon-14)-MTI-446 in Lettuce (Postemergent Spray Treatment): Lab
Project Number: 012785-1: 012785-0-1: 012785-0. Unpublished study
prepared by Ricerca, LLC. 204 p. {OPPTS 860.1300}
45639806 Hatzenbeler, C.; Lentz, N. (2002) Metabolism of (Carbon-14)-MTI-446 in
Lactating Goats: Lab Project Number: 013346-1: 013346-0. Unpublished
study prepared by Ricerca, LLC. 181 p. {OPPTS 860.1300}
45639807 Hatzenbeler, C.; Lentz, N. (2002) Metabolism of (Carbon-14)-MTI-446 in
Laying Hens: Lab Project Number: 013347-1: 013347-0-1: 013347-0.
Unpublished study prepared by Ricerca, LLC. 178 p. {OPPTS 860.1300}
45639808 Wais, A. (2001) Validation of the Residue Analytical Method for MTI-446
in Lettuce: Lab Project Number: 784945. Unpublished study prepared by
RCCLtd. 52 p. {OPPTS 860.1340}
45639809 Wolf, S. (2001) Development and Validation of Residue Analytical
Method for the MTI-446 Metabolites DN and UF in Lettuce: Lab Project
Number: 836111. Unpublished study prepared by RCC Ltd. 69 p. {OPPTS
860.1340}
45639813 MacGregor, J.; Van Hoven, R.; Nixon, W. (2002) Independent Laboratory
Validation of Methods for the Analysis of MTI-446 and Its Metabolite MNG
in Soil: Lab Project Number: 236C-106: 836100: 739923. Unpublished study
prepared by Wildlife International Ltd. 134 p. {OPPTS 860.1340}
45639814 MacGregor, J.; Fischer, D.; Nixon, W. (2002) Independent Laboratory
Validation of Methods for the Analysis of MTI-446 and Its Metabolites DN
and UF in Lettuce: Lab Project Number: 236C-107: 836111: 784945.
Unpublished study prepared by Wildlife International Ltd. 162 p. {OPPTS
860.1340}
45639815 Van Hoven, R.; Nixon, W. (2002) Assessment of Multiresidue Methodology
as Presented in Pesticide Analytical Manual (PAM), Volume I, for the
Determination of Dinotefuran in Nonfatty and Fatty Plant Substrates: Lab
Project Number: 236C-103. Unpublished study prepared by Wildlife
International Ltd. 48 p. {OPPTS 860.1360}
45639817 Wais, A. (2002) MTI-446: Storage Stability in Lettuce, Cotton, Apple,
Tomato and Potato: Interim Report: Lab Project Number: 827537.
Unpublished study prepared by RCC Ltd. 36 p. {OPPTS 860.1380}
Page 48 of 63
-------
45639818 Mamouni, A. (2002) DN, MNG, UF: Storage Stability in Lettuce: Interim
Report: Lab Project Number: 834388. Unpublished study prepared by RCC
Ltd. 32 p. (OPPTS 860.1380}
45639819 Hummel, R. (2002) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 20% Applied to Head Lettuce and Leaf Lettuce: Lab
Project Number: 41409A005: 795306: 1714-01-414-01-09B-18.
Unpublished study prepared by Landis International, Inc. 209 p. {OPPTS
860.1500}
45639820 Hummel, R. (2002) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 20% Applied to Celery and Spinach: Lab Project
Number: 41409A006: 810055: 1714-01-414-01-09H-19. Unpublished study
prepared by Landis International, Inc. 200 p. {OPPTS 860.1550}
45639822 Hattermann, D. (2002) Confined Accumulation of (Carbon-14) MTI-446 in
Rotational Crops in California: Lab Project Number: 41429C008: 820901:
1651-01-414-01-29C-34. Unpublished study prepared by Landis
International, Inc. 98 p. {OPPTS 860.1850}
45639823 Glaza, S. (1997) Acute Oral Toxicity Study of MTI-446 in Rats: Final
Report: Lab Project Number: CHW 6648-118: TP6137. Unpublished study
prepared by Corning Hazleton, Inc. 66 p.
45639824 Glaza, S. (1997) Acute Oral Toxicity Study of MTI-446 in Mice: Final
Report: Lab Project Number: CHW 6648-119: TP6138. Unpublished study
prepared by Corning Hazleton, Inc. 44 p.
45639900 Mitsui Chemicals, Inc. (2002) Submission of Toxicity Data in Support of
the Application for Registration of Dinotefuran Technical and the
Petition for Tolerance of Dinotefuran on Leafy Vegetables and Cottonseed
Undelinted/Gin Byproducts. Transmittal of 17 of 148 Studies.
45639901 Glaza, S. (1997) Acute Dermal Toxicity Study of MTI-446 in Rats: Final
Report: Lab Project Number: CHW 6648-120: TP6273. Unpublished study
prepared by Corning Hazleton, Inc. 40 p.
45639902 Shepherd, N. (1999) MTI-446: Acute Inhalation (Nose-Only) Toxicity
Study in the Rat: Lab Project Number: 1300/3-D6154: 1300/3. Unpublished
study prepared by Covance. 64 p. {OPPTS 870.1300}
45639903 Glaza, S. (1998) Primary Eye Irritation Study of MTI-446 in Rabbits:
Final Report: Lab Project Number: COVANCE 6648-122: TP6275.
Unpublished study prepared by Covance Laboratories, Inc. 44 p.
45639904 Glaza, S. (1998) Primary Dermal Irritation Study of MTI-446 in Rabbits:
Final Report: Lab Project Number: COVANCE 6648-121. Unpublished
study prepared by Covance Laboratories, Inc. 34 p.
Page 49 of 63
-------
45639905 Glaza, S. (1997) Dermal Sensitization Study of MTI-446 in Guinea Pigs--
Maximization Test: Final Report: Lab Project Number: CO VANCE
6648-123: TP6276: 70300317. Unpublished study prepared by Covance
Laboratories, Inc. 88 p.
45639906 Weiler, M. (1999) 13-Week Dietary Toxicity Study with MTI-446 in Dogs:
Final Report: Lab Project Number: 6648-128. Unpublished study prepared
by Covance Laboratories, Inc. 436 p.
45639907 Kenwood, S. (2001) 14-Day Range-Finding Dermal Toxicity Study with
MTI-446 in Rats: Final Report: Lab Project Number: 6648-150. Unpublished
study prepared by Covance Laboratories, Inc. 120 p. (OPPTS 870.3200}
45639908 Kenwood, S. (2001) 28-Day Dermal Toxicity Study with MTI-446 in Rats:
Final Report: Lab Project Number: COVANCE 6648-149. Unpublished
study prepared by Covance Laboratories, Inc. 424 p. {OPPTS 870.3200}
45639909 Mita, I. (2002) MTI-446: 28 Day Inhalation (Nose-Only) Toxicity Study
in the Rat: Final Report: Lab Project Number: 719/16. Unpublished study
prepared by Covance Laboratories, Ltd. 252 p. {OPPTS 870.3465}
45639910 Sakurai, T. (1998) A Dose-Finding Teratogenicity Study of MTI-446
Given Orally to Rats: Lab Project Number: H-97162: Unpublished study
prepared by Nippon Experimental Medical Research Institute Co., Ltd. 52 p.
(OPPTS 870.3700}
45639911 Sakurai, T. (1998) A Dose-Finding Teratogenicity Study of MTI-446
Given Orally to Rabbits: Lab Project Number: H-97165: Unpublished study
prepared by Nippon Experimental Medical Research Institute Co., Ltd. 66 p.
{OPPTS 870.3700}
45639912 Sakurai, T. (1998) A Single 2-Week Repeated Dose Preliminary Study of
MTI-446 Given Orally to Rabbits: Lab Project Number: H-97164.
Unpublished study prepared by Nippon Experimental Medical Research
Institute Co., Ltd. 35 p. {OPPTS 870.3700}
45639913 Becker, H. (2002) MTI-446: Two-Generataion Reproduction Study in the
Han Wistar Rat by Oral (Dietary) Administration: Lab Project Number:
775192. Unpublished study prepared by RCC, Ltd. 1521 p. {OPPTS
870.3800}
45639914 Edwards, I; Knuppe, C.; Weber, K. (2001) MTI-446 Technical:
Preliminary Two Generation Study in the Han Wistar Rat: Lab Project
Number: 774990. Unpublished study prepared by RCC, Ltd. 358 p. {OPPTS
870.3800}
45639915 Teramoto, I. (1998) Repeated Dose Toxicity Test of MTI-446 Mixed in
the Diet for One Week Using Dogs: Lab Project Number: H-97327.
Unpublished study prepared by Jitsuiken Medical Research Institute, Inc. 43
p. {OPPTS 870.4100}
Page 50 of 63
-------
45639916 Teramoto, I. (1998) Repeated Dose Toxicity Test of MTI-446 by Forced
Oral Administration for One Week Using Dogs: Lab Project Number: H-
97326. Unpublished study prepared by Jitsuiken Medical Research Institute,
Inc. 40 p. (OPPTS 870.4100}
45639917 Weiler, M. (2000) 78-Week Dietary Carcinogenicity Study with MTI-446
in Mice: Final Report: Lab Project Number: COVANCE 6648-130.
Unpublished study prepared by Covance Laboratories, Inc. 2615 p.
45640000 Mitsui Chemicals, Inc. (2002) Submission of Toxicity and Environmental
Fate Data in Support of the Application for Registration of Dinotefuran
Technical and the Petition for Tolerance of Dinotefurn on Leafy Vegetables
and Cottonseed on Undelinted/Gin Byproducts. Transmittal of 10 of 148
Studies.
45640001 Weiler, M. (2000) 104-Week Dietary Combined Chronic Toxicity and
Carcinogenicity Study with MTI-446 in Rats: Final Report: Lab Project
Number: 6648-131. Unpublished study prepared by Covance Laboratories
Inc. 5209 p.
45640002 Lloyd, M. (2002) MTI-446 Technical Material: Mutation at the Thymidine
Kinase (tk) Locus of Mouse Lymphoma L5178Y Cells (MLA) using the
Microtitre(R) Fluctuation Technique: Final Report: Lab Project Number:
719/15: 719/15-D6173. Unpublished study prepared by Covance
Laboratories Inc. 61 p. {OPPTS 870.5300}
45640003 Oguma, Y. (1996) A DNA Repair Assay of Bacillus subtilis on MTI-446:
Lab Project Number: 4731. Unpublished study prepared by BML, Inc. 16 p.
(OPPTS 870.5500}
45640004 Weiler, M. (2001) 13-Week Dietary Neurotoxicity Study with MTI-446 in
Rats: Final Report: Lab Project Number: 6648-148. Unpublished study
prepared by Covance Laboratories Inc. 962 p. {OPPTS 870.6200}
45640005 Weiler, M. (2001) Acute Oral Gavage Neurotoxicity Study with MTI-446
in Rats: Final Report: Lab Project Number: 6648-147. Unpublished study
prepared by Covance Laboratories Inc. 721 p. {OPPTS 870.6200}
45640006 Cheng, T. (2000) Metabolism of (Carbon 14) MTI-446 in Rats: Lab
Project Number: 6648-136. Unpublished study prepared by Covance
Laboratories Inc. 519 p.
45640007 Cheng, T.; Howard, S. (2000) Absorption, Distribution, Metabolism and
Excretion of G-(Carbon 14) MTI-446 Following Administration of a Single
Dose to Neonatal Rats: Lab Project Number: 6648-141. Unpublished study
prepared by Covance Laboratories Inc. 76 p.
45640008 Hummel, R. (2002) Dissipation of Dislodgeable Foliar Residues on Leafy
Vegetables Following Application of MTI-446: Final Report: Lab Project
Number: 41409A004: 795295. Unpublished study prepared by RCC, Ltd and
Landis International, Inc. 137 p. {OPPTS 875.2100}
Page 51 of 63
-------
45640009 Hattermann, D. (2002) Dissipation of Dislodgeable Foliar Residues on
Ornamentals Following Application of MTI-446 20% SG: Final Report: Lab
Project Number: 43422A007: 832353. Unpublished study prepared by RCC
Ltd. 134 p. (OPPTS 875.2100}
45640010 Hattermann, D. (2002) Determination of Transferable Turf Residues on
Turf Treated with MTI-446 20% SG: Final Report: Lab Project Number:
42424A006. Unpublished study prepared by RCC Ltd. 190 p. {OPPTS
875.2100}
45640100 Mitsui Chemicals, Inc. (20020 Submission of Toxicity, Residue, Risk,
Exposure and Environmental Fate Data in Support of the Application for the
Registration of Dinotefuran Technical and the Petition for Tolerance of
Dinotefuran on Leafy Vegetables and Cottonseed Undelinted/Gin
Byproducts. Transmittal of 25 of 148 Studies.
45640101 Sydney, P. (1998) MTI-446: Determination of Hydrolysis as a Function
of pH: Final Report: Lab Project Number: MTO/098: 95/MTO098/1216.
Unpublished study prepared by Huntingdon Life Sciences. 47 p.
45640102 Ishii, M. (2000) Hydrolysis Study of MTI-446: Lab Project Number:
GH9901. Unpublished study prepared by Japan Analytical Chemistry
Consultants Co., Ltd. Ill p.
45640103 Mamouni, A. (2001) (Carbon-14)-MNG: Hydrolysis at Three Different pH
Values: Lab Project Number: 731215. Unpublished study prepared by RCC
Ltd. 45 p. {OPPTS 835.2110}
45640104 Mamouni, A. (2001) (Carbon-14)-DN Phosphate: Hydrolysis at Three
Different pH Values: Lab Project Number: 731237. Unpublished study
prepared by RCC Ltd. 31 p. {OPPTS 835.2110}
45640105 van der Gaauw, A. (2002) Aqueous Photolysis of (Carbon-14)-MTI-446
Under Laboratory Conditions and Determination of Quantum Yield: Lab
Project Number: 729011. Unpublished study prepared by RCC Ltd. 104 p.
{OPPTS 835.2210}
45640106 Ishii, M. (2000) Aqueous Photodegradation of MTI-446: Lab Project
Number: GP9901. Unpublished study prepared by Japan Analytical
Chemistry Consultants Co., Ltd. 197 p.
45640107 Burgener, A. (2001) Aqueous Photolysis of (Carbon-14)-MNG Under
Laboratory Conditions and Determination of Quantum Yield: Lab Project
Number: 731248. Unpublished study prepared by RCC Ltd. 69 p. {OPPTS
835.2210}
45640109 Shah, J.; Hatzenbeler, C. (2001) Photodegradation of (Carbon-14)-MTI-446
on Soil: Lab Project Number: 012788-1. Unpublished study prepared by
Ricerca, LLC. 99 p.
Page 52 of 63
-------
45640110 van der Gaauw, A. (2000) Estimation of the Degradation of MTI-446 by
Photo-Oxidation in Air: Lab Project Number: 731160. Unpublished study
prepared by RCC Ltd. 18 p.
45640111 Lentz, N. (2001) Aerobic Degradation of MTI-446 in Soil-Preliminary
Study: Lab Project Number: 012561-1. Unpublished study prepared by
Ricerca, Inc. 73 p.
45640112 Lentz, N. (2001) Aerobic Soil Metabolism of MTI-446: Lab Project
Number: 013184-1. Unpublished study prepared by Ricerca, LLC. 80 p.
45640113 Volkel, W. (2001) Adsorption/Desorption of (Carbon-14)-DN Phosphate on
Soils: Lab Project Number: 729066. Unpublished study prepared by RCC
Ltd. 76 p.
45640114 Volkel, W. (2001) Adsorption/Desorption of (Carbon-14)-MTI-446 on
Soils: Lab Project Number: 728998. Unpublished study prepared by RCC
Ltd. 102 p.
45640115 Ishii, M. (2000) Soil Adsorption of MTI-446: Lab Project Number:
GA9901. Unpublished study prepared by Japan Analytical Chemistry
Consultants Co., Ltd. 50 p.
45640116 Volkel, W. (2001) Adsorption/Desorption of (Carbon-14)-MNG on Soils:
Lab Project Number: 729055. Unpublished study prepared by RCC Ltd. 72
P-
45640117 Volkel, W. (2000) (Carbon-14)-MTI-446 Degradation and Metabolism in
Aquatic Systems: Lab Project Number: 709604. Unpublished study prepared
by RCC Ltd. 139 p.
45640118 Hummel, R. (2002) Terrestrial Field Dissipation of Residues Following
Application of MTI-446 to Bare Soil in California, Georgia, and New York:
Lab Project Number: 41421A007. Unpublished study prepared by RCC Ltd.
227 p.
45640119 Wais, A. (2001) Validation of the Residue Analytical Method for MTI-446
in Soil: Lab Project Number: 739923. Unpublished study prepared by
RCC Ltd. 77 p.
45640120 Aldershof, S. (2000) A Laboratory Dose-Response Study to Evaluate the
Effects of MTI-446 20% SG on Survival and Reproduction of the Predaceous
Mite Typhlodromus pyri Scheuten (Acari:Phytoseiidae): Lab Project
Number: RCC011TPL: 756268. Unpublished study prepared by MITOX
Stichting Bevordering Duurzame Plaagbestrijding. 27 p.
45640121 Aldershof, S. (2000) A Laboratory Dose-Response Study to Evaluate the
Effects of MTI-446 20% SG on Survival and Reproduction of the Parasitoid
Wasp Aphidius rhopalosiphi (DeStephani-Perez) (Hymenoptera:
Braconidae): Lab Project Number: RCC012ARL: 756270. Unpublished
study prepared by MITOX Stichting Bevordering Duurzame
Plaagbestrijding. 24 p.
Page 53 of 63
-------
45640122 Aldershof, S. (2000) A Laboratory Dose-Response Study to Evaluate the
Effects of MTI-446 20% SG on Survival and Reproduction of the Predacious
Bug Orius laevigatus (Fleber) (Hemiptera, Anthocoridae): Lab Project
Number: 756281: RCC013OLL. Unpublished study prepared by MITOX
Stichting Bevordering Duurzame Plaagbestrijding. 25 p.
45640123 Wolf, S. (2001) Development and Validation of a Residue Analytical
Method for the MTI-446 Metabolite MNG in Soil: Lab Project Number:
836100. Unpublished study prepared by RCC Ltd. 47 p.
45640124 Wais, A. (2002) MTI-446: Storage Stability in Soil: Interim Report: Lab
Project Number: 827572. Unpublished study prepared by RCC Ltd. 31 p.
(OPPTS 860.1380}
45640125 White, S.; Williams, M. (2002) Dinotefuran Technical: Food Quality
Protection Act (FQPA) Supplemental Information Document. Unpublished
study prepared by Mitsui Chemicals, Inc. 13 p.
45641800 Hartz Mountain Corporation (2002) Submission of Efficacy Data in
Support of the FIFRA 6(a)(2) Data Requirements for Dinotefuran.
Transmittal of 1 Study.
45641801 Sharp, M. (2002) In Vivo Activity of Flea Dermal Treatments against the Cat
Flea (Ctenocephalides felis) on Cats: Lab Project Number: 1589.
Unpublished study prepared by Sharp Veterinary Research. 33 p.
45644300 Sunimoto CHemical Company, Ltd. (2002) Submission of Product
Chemistry Data in Support of the Application for Registration of Shuriken
Coackroach Gel Bait. Transmittal of 1 Study.
45644301 Whittington, J. (2002) Quantitation of S-1638 in S-1638 Gel Bait by
High Performance Liquid Chromatography: Lab Project Number: V-01-
24483M1: VAM-24A-001: V-24483M1. Unpublished study prepared by
Valent USA Corporation. 32 p. {OPPTS 830.1800}
45653600 Mitsui Chemicals, Inc. (2002) Submission of Toxicity Data in Support of the
Application for Registration of Dinotefuran Cat Spot-On. Transmittal of 2
Studies.
45654200 Mitsui Chemicals, Inc. (2002) Submission of Product Chemistry, Residue
and Toxicity Data in Support of the Petition for Tolerance of Dinotefuran
on Leafy Vegetables and Cottonseed Undelinted/Gyn Byproducts and the
Application for Registration Dinotefuran Technical. Transmittal of 12
Studies.
45654201 Landis, W. (2002) Dinotefuran (MTI-446) Technical: Physical and
Chemical Properties. Unpublished study prepared by Mitsui Chemicals, Inc.
59 p.
45654203 Weiler, M. (1997) 4-Week Dietary Toxicity Study with MTI-446 in Rats:
Final Report: Lab Project Number: CHW 6648-125. Unpublished study
prepared by Corning Hazleton Inc. 254 p. {OPPTS 870.3050}
Page 54 of 63
-------
45654204 Weiler, M. (1997) 4-Week Dietary Toxicity Study with MTI-446 in Mice:
Final Report: Lab Project Number: CHW 6648-124. Unpublished study
prepared by Corning Hazleton Inc. 313 p. (OPPTS 870.3050}
45654205 Weiler, M. (1997) 13-Week Dietary Toxicity Study with MTI-446 in Rats:
Final Report: Lab Project Number: CHW 6648-127. Unpublished study
prepared by Corning Hazleton Inc. 488 p.
45654206 Weiler, M. (1997) 13-Week Dietary Toxicity Study with MTI-446 in Mice:
Final Report: Lab Project Number: CHW 6648-126. Unpublished study
prepared by Corning Hazleton Inc. 455 p.
45654207 Sakurai, T. (2002) Teratogenicity Study of MTI-446 Given Orally to
Rats: Lab Project Number: H-97163. Unpublished study prepared by Nippon
Experimental Medical Research Institute Co., Ltd. 112 p. {OPPTS
870.3700}
45654208 Sakurai, T. (1998) Teratogenicity Study of MTI-446 Given Orally to
Rabbits: Lab Project Number: H-97166. Unpublished study prepared by
Nippon Experimental Medical Research Institute Co., Ltd. 119 p. {OPPTS
870.3700}
45654209 Weiler, M. (1999) 52-Week Dietary Chronic Toxicity Study with MTI-446
in Dogs: Final Report: Lab Project Number: 6648-129. Unpublished study
prepared by Covance Laboratories Inc. 467 p.
45654210 Takeda, C. (1996) MTI-446: Microbial Reverse Mutation Assay: Lab
Project Number: CRC3113. Unpublished study prepared by Chromosome
Research Center (CRC). 15 p. {OPPTS 870.5100, 870.5265}
45654211 Takeda, C. (1996) MTI-446: In vitro Mammalian Cytogenetics Test: Lab
Project Number: CRC0076. Unpublished study prepared by Chromosome
Research Center (CRC). 15 p. {OPPTS 870.5375}
45654212 Nakajima, M. (1995) Micronucleus Test of EXP-316 with Mice: Lab
Project Number: 2498. Unpublished study prepared by An-Pyo Center. 33 p.
{OPPTS 870.5395}
45890400 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry,
Toxicity and Efficacy Data in Support of the Application for Registration
of Dinotefuran 10% Spot-On For Cats and the Petition for Tolerance of
Dinotefuran on Numerous RACs. Transmittal of 8 Studies.
45890500 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry and
Toxicity Data in Support of the Application for Registration of
Dinotefuran 10SL and the Petition for Tolerance of Dinotefuran for Use on
Numerous RACs. Transmittal of 8 Studies.
Page 55 of 63
-------
45890501 Fumoto, K.; Harnish, W. (2003) Dinotefuran 10% SL: Product Identity
and Disclosure of Ingredients, Including Manufacturing Process and
Discussion of Formation of Impurities. Unpublished study prepared by
Mitsui Chemicals, Inc. 36 p. (OPPTS 830.1550, 830.1660, 830.1650,
830.1670}
45890502 Washburn, K. (2003) Product Chemistry: End-Use Product: MTI-446 10%
SL: Final Report: Lab Project Number: 7333-02. Unpublished study
prepared by Stillmeadow, Inc. 16 p. {OPPTS 830.6302, 830.6303, 830.6304,
830.6314, 830.6315, 830.6316, 830.7000, 830.7100, 830.7300}
45890503 Oda, S. (2003) Acute Oral Toxicity Study of MTI-446 10% SL in Rats:
Lab Project Number: B-5041. Unpublished study prepared by Bozo Research
Center, Inc. 32 p. {OPPTS 870.1100}
45890504 Oda, S. (2003) Acute Dermal Toxicity Study of MTI-446 10% SL in Rats:
Lab Project Number: B-5042. Unpublished study prepared by Bozo Research
Center, Inc. 37 p. {OPPTS 870.1200}
45890505 Mulier, B. (2003) MTI-446 10%SL: A 4-Hour Acute Inhalation Toxicity
Study in the Rat: Lab Project Number: 846222. Unpublished study prepared
byRCCLtd. 82 p. {OPPTS 870.1300}
45890506 Nomura, N. (2003) An Eye Irritation Study of MTI-446 10% SL in
Rabbits: Lab Project Number: 1-1929. Unpublished study prepared by Bozo
Research Center, Inc. 31 p. {OPPTS 870.2400}
45890507 Nomura, N. (2003) A Skin Irritation Study of MTI-446 10% SL in
Rabbits: Lab Project Number: 1-1930. Unpublished study prepared by Bozo
Research Center, Inc. 24 p. {OPPTS 870.2500}
45890508 Nomura, N. (2003) A Skin Sensitization Study of MTI-446 10% SL in
Guinea Pigs (Buehler Test): Lab Project Number: 1-1931. Unpublished study
prepared by Bozo Research Center, Inc. 32 p. {OPPTS 870.2600}
45890700 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 0.5% Ornamental
and Vegetable RTU and the Petition for Tolerance of Dinotefuran on
Numerous RACs. Transmittal of 1 Study.
45890701 Fumoto, K.; Harnish, W. (2002) Dinotefuran 0.5% Ornamental and
Vegetable RTU: Product Identity and Disclosure of Ingredients, Including
Manufacturing Process and Discussion of Formation of Impurities.
Unpublished study prepared by Mitsui Chemicals, Inc. 51 p. {OPPTS
830.1550, 830.1600, 830.1650, 830.1670}
45890800 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 20SG.
Transmittal of 1 Study.
Page 56 of 63
-------
45890801 Taylor, E. (2003) Dinotefuran 20% SG: Product Identity, Composition,
and Analysis: Lab Project Number: 2003-MTI446-001. Unpublished study
prepared by Valent U.S.A. Corporation. 153 p. (OPPTS 830.1550,
830.1600, 830.1650, 830.1670, 830.1750, 830.1800}
45890900 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 0.2% Lawn
Granule and the Petition for Tolerance of Dinotefuran on Numerous RACs.
Transmittal of 1 Study.
45890901 Fumoto, K.; Harnish, W. (2003) Dinotefuran 0.2% Lawn Granule: Product
Identity and Disclosure of Ingredients, Including Manufacturing Process
and Discussion of Formation of Impurities. Unpublished study prepared by
Mitsui Chemicals, Inc. 27 p. {OPPTS 830.1550, 830.1600, 830.1650,
830.1670}
45891000 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry and
Efficacy Data in Support of the Application for Registration of
Dinotefuran Fire Ant Bait 0.005% and the Petition for Tolerance of
Dinotefuran on Numerous RACs. Transmittal of 2 Studies.
45891100 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 0.5% Cockroach
Gel Bait Professional and the Petition for Tolerance of Dinotefuran on
Numerous RACs. Transmittal of 1 Study.
45891101 Fumoto, K.; Harnish, W. (2003) Dinotefuran 0.5% Cockroach Gel Bait
Professional: Product Identity and Disclosure of Ingredients, Including
Manufacturing Process and Discussion of Formation of Impurities.
Unpublished study prepared by Mitsui Chemicals, Inc. 40 p. {OPPTS
830.1550, 830.1600, 830.1650, 830.1670}
45891200 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 0.5% Roach Bait
Stations and the Petition for Tolerance of Dinotefuran on Numerous RACs.
Transmittal of 1 Study.
45891201 Fumoto, K.; Harnish, W. (2003) Dinotefuran 0.5% Roach Bait Stations:
Product Identity and Disclosure of Ingredients, Including Manufacturing
Process and Discussion of Formation of Impurities. Unpublished study
prepared by Mitsui Chemicals, Inc. 40 p. {OPPTS 830.1550, 830.1600,
830.1650,830.1670}
45891300 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran 0.4% Lawn
Granule and the Petition for Tolerance of Dinotefuran on Numerous RACs.
Transmittal of 2 Studies.
Page 5 7 of 63
-------
45891301 Fumoto, K.; Harnish, W. (2003) Dinotefuran 0.4% Lawn Granule: Product
Identity and Disclosure of Ingredients, Including Manufacturing Process
and Discussion of Formation of Impurities. Unpublished study prepared by
Mitsui Chemicals, Inc. 27 p. (OPPTS 830.1550, 830.1600, 830.1650,
830.1670}
45891302 Washburn, K. (2003) Dinotefuran 0.4% Granule: Product Chemistry:
End-Use Product: Final Report: Lab Project Number: 7376-03. Unpublished
study prepared by Stillmeadow, Inc. 13 p. {OPPTS 830.6302, 830.6303,
830.6304, 830.6314, 830.7000, 830.7300}
45891400 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry and
Efficacy Data in Support of the Application for Registration of
Dinotefuran 0.2% Roach Bait Stations and the Petition for Tolerance of
Dinotefuran on Numerous RACs. Transmittal of 3 Studies.
45891401 Fumoto, K.; Harnish, W. (2003) Dinotefuran 0.2% Roach Bait Stations:
Product Identity and Disclosure of Ingredients, Including Manufacturing
Process and Discussion of Formation of Impurities. Unpublished study
prepared by Mitsui Chemicals, Inc. 40 p. {OPPTS 830.1550, 830.1600,
830.1650,830.1670}
45891402 Gaynor, W.; Basit, A.; Kilbourn, R.; et. al. (2003) Efficacy of 0.2% w/w
Shuriken and Pre-Empt Cockroach Baits Against German and Oriental
Cockroaches (No Choice Box Method): Lab Project Number:
N3261102001A086: 326-0035. Unpublished study prepared by Insect
Control and Research, Inc. 157 p. {OPPTS 810.3500}
45891403 Gaynor, W.; Basit, A.; Kilbourn, R.; et. al. (2003) Efficacy of 0.2% w/w
Shuriken and Pre-Empt Cockroach Baits Against German and Oriental
Cockroaches (Choice Box Method): Lab Project Number:
N3261102001A098: 326-0036. Unpublished study prepared by Insect
Control and Research, Inc. 155 p. {OPPTS 810.3500}
45891500 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry and
Efficacy Data in Support of the Application for Registration of
Dinotefuran 0.5% Multi-Purpose RTU and the Petition for Tolerance of
Dinotefuran on Numerous RACs. Transmittal of 3 Studies.
45891501 Fumoto, K.; Renfroe, J. (2003) Dinotefuran 0.5% Multi-Purpose RTU:
Product Identity and Disclosure of Ingredients, Including Manufacturing
Process and Discussion of Formation of Impurities. Unpublished study
prepared by Mitsui Chemicals, Inc. 51 p. {OPPTS 830.1550, 830.1600,
830.1650,830.1670}
45891502 Foard, T.; Spero, N.; Zgidou, F.; et. al. (2003) Initial and Residual
Efficacy of a 0.5% Shuriken Spray Formulation Compared to RID (a 0.5%
Permethrin Aerosol) Against Body Lice on an Inanimate Surface: Lab
Project Number: 326-0038: N3260200001A992. Unpublished study prepared
by Insect Control and Research, Inc. 30 p. {OPPTS 810.3500}
Page 58 of 63
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45891503 Spero, N.; Basit, A.; Bertsch, M.; et. al. (2003) Evaluation of the Initial and
Residual Efficacy of a 0.5% w/w Shuriken Spray Against Cockroaches, Ants,
Mosquitoes and Fleas: Lab Project Number: 326-0037:
N3211002003 A260. Unpublished study prepared by Insect Control and
Research, Inc. 286 p. (OPPTS 810.3500}
45891600 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry, Residue
and Environmental Fate Data in Support of the Application for Registration
of Dinotefuran Technical. Transmittal of 19 Studies.
45891601 Hattermann, D. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 20% Applied to Tomato and Pepper: Lab Project
Number: 43415A010: 714-02-434-01-15B-34: 714-02-434-01-15B-35.
Unpublished study prepared by Landis International, Inc. 369 p. {OPPTS
860.1500}
45891602 Hummel, R. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 Applied to Cucurbit Vegetables: Final Report: Lab
Project Number: 43413 A014: 714-02-434-01-13 A-98: 714-02-434-01-13 A-
99. Unpublished study prepared by Landis International, Inc. 359 p. {OPPTS
860.1500}
45891603 Hummel, R. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 Applied To Head and Stem Brassica: Lab Project
Number: 43414A013: 714-02-434-01-14D-75: 714-02-434-01-14D-76.
Unpublished study prepared by Landis International, Inc. 308 p. {OPPTS
860.1500}
45891604 Hattermann, D. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 Applied to Grapes: Lab Project Number:
43403A018: 14-02-434-01-03B-140: 14-02-434-01-03B-141. Unpublished
study prepared by Landis International, Inc. 179 p. {OPPTS 860.1500}
45891605 Hummel, R. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 Applied to Potato: Final Report: Lab Project
Number: 14-02-434-01-08D-125: 14-02-434-01-08D-126: 14-02-434-01-
08D-127. Unpublished study prepared by Landis International, Inc. 182 p.
{OPPTS 860.1500}
45891606 Hummel, R. (2003) Comparison of MTI-446 Residues Detected on Leafy
Vegetable Raw Agricultural Commodity (RAC): Foliar Application Versus
Soil Application: Lab Project Number: 43409A015: 14-02-434-01-09B-121:
14-02-434-01-09B-122. Unpublished study prepared by Landis International,
Inc. 160 p. {OPPTS 860.1500}
45891607 Hattermann, D. (2003) Processed Commodity (PC) Residue Evaluation of
MTI-446 Applied to Grape: Lab Project Number: 43403 A019: 14-02-434-
01-03B-148: 14-02-434-01-03B-149. Unpublished study prepared by
Landis International, Inc. 227 p. {OPPTS 860.1520}
Page 59 of 63
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45891608 Hattermann, D. (2003) Processed Commodity (PC) Residue Evaluation of
MTI-446 Applied to Tomato: Lab Project Number: 43415A011: 714-02-434-
01-15B-62: 714-02-434-01-15B-63. Unpublished study prepared by
Landis International, Inc. 204 p. (OPPTS 860.1520}
45891609 Hattermann, D. (2003) Processed Commodity (PC) Residue Evaluation of
MTI-446 Applied to Potato: Lab Project Number: 43408A017: 14-02-434-
01-08D-138: 14-02-434-01-08D-139. Unpublished study prepared by
Landis International, Inc. 174 p. {OPPTS 860.1520}
45891610 Hummel, R. (2003) Terrestrial Field Dissipation of Residues Following
Application of MTI-446 to Bare Soil in California, Georgia, and New York:
Amended Final Report: Lab Project Number: 41421A007: 795284: 641-01-
414-01-21E-31. Unpublished study prepared by Landis International, Inc.
andRCCLTD. 19 p.
45891611 Hummel, R. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 20% Applied to Celery and Spinach: Amended Final
Report: Lab Project Number: 41490A006: 714-01-414-01-09C-26: 714-01-
414-01-09C-29. Unpublished study prepared by Landis International, Inc. 16
p. {OPPTS 860.1500}
45891612 Hummel, R. (2003) Raw Agricultural Commodity (RAC) Residue
Evaluation of MTI-446 20% Applied to Head Lettuce and Leaf Lettuce:
Amended Final Report: Lab Project Number: 41409A005: 714-01-414-01-
09B-07: 714-01-414-01-09B-08. Unpublished study prepared by Landis
International, Inc. 16 p. {OPPTS 860.1500}
45891613 Ross, V. (2003) Residues of MTI-446 and its Metabolites DN and UF in
Milk and Tissues of Dairy Cows: Lab Project Number: 02/46: 261/024360.
Unpublished study prepared by Huntingdon Life Sciences Ltd. 206 p.
{OPPTS 860.1480}
45891614 Wais, A. (2002) Storage Stability in Lettuce, Cotton, Apple, Tomato and
Potato: MTI-446: Lab Project Number: 827537. Unpublished study
prepared by RCC Ltd. 53 p. {OPPTS 860.1380}
45891615 Wais, A. (2002) Storage Stability in Soil: MTI-446: Lab Project Number:
827572. Unpublished study prepared by RCC Ltd. 31 p.
45891616 Volkl, S. (2003) Anaerobic Soil Degradation and Metabolism: (Carbon
14)-MTI-446: Lab Project Number: 841703. Unpublished study prepared by
RCC Ltd. 121 p.
45891617 Hug, R. (2002) Determination of the Storage Stability and Corrosion
Stability of MTI-446 20% SG (Shelf Life at Room Temperature): Interim
Report: Lab Project Number: 796285. Unpublished study prepared by RCC
Ltd. 49 p. {OPPTS 830.6317 and 830.6320}
45891618 Stearns, J. (2003) Magnitude of the Residues of V-10112 in Potatoes:
Lab Project Number: V-02-24871: 236C-124: V-24871. Unpublished study
prepared by ValentU.S.A. Corporation. 249 p. {OPPTS 860.1500}
Page 60 of 63
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45891619 Stearns, J. (2003) Magnitude of the Residues of V-10112 in Grapes: Lab
Project Number: V-02-24862: 236C-123: V-24862. Unpublished study
prepared by Valent U.S.A. Corporation. 241 p. (OPPTS 860.1500}
45900200 Mitsui Chemicals, Inc. (2003) Submission of Toxicity and Exposure and
Risk Data in Support of the Petition for Tolerance of Dinotefuran in/on
Leafy Vegetables, Gotten Seed Undelinted/gin Byproducts. Transmittal of 1
Study.
45900201 White, S.; Williams, M. (2003) Food Quality Protection Act (FQPA)
Supplemental Information Document: Dinotefuran Technical. 13 p.
45912200 Mitsui Chemicals, Inc. (2003) Submission of Reduced-Risk Rationale
Data in Support of the Application for Registration of Dinotefuran.
Transmittal of 1 Study.
45912201 Gale, E.; Harnish, W.; Kane, D.; et al. (2003) Reduced-Risk Pesticide
Rationale for Dinotefuran. Unpublished Study. 271 p.
45915400 Mitsui Chemicals, Inc. (2003) Submission of Residue Data in Support of
the Application for Registration of Dinotefuran Technical. Transmittal of
1 Study.
45915401 Mamouni, A. (2002) DN, MNG, UF: Storage Stability in Lettuce: Lab
Project Number: 834388. Unpublished study prepared by RCC Ltd. 64 p.
{OPPTS 860.1380}
46072400 Mitsui Chemicals, Inc. (2003) Submission of Toxicity Data in Support of the
Application for Registration of Dinotefuran Technical. Transmittal of 1
Study.
46072401 Gale, E. (2003) MTI-446 28-Day Inhalation (Nose Only) Toxicity Study
in the Rat: Response to USEPA. Project Number: 719/16. Unpublished study
prepared by Covance Laboratories, Ltd. 8 p.
46132900 Mitsui Chemicals, Inc. (2003) Submission of Residue Data in Support of
the Application for Registration of Dinotefuran Technical. Transmittal of
1 Study.
46132901 Airs, D. (2003) Validation of the Methods of Analysis for Determining
Concentrations of MTI-446 and Its Two Metabolites, DN and UF, in Bovine
Tissues and Milk and Eggs From Hens. Project Number: MTU/250,
MTU/250/024447, 2002054. Unpublished study prepared by Huntingdon
Life Sciences, Ltd. 154 p.
46133500 Mitsui Chemical, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran TK. Transmittal
of 1 Study.
46133501 Tognucci, A. (2003) Determination of the Storage Stability and
Corrosion Stability of MTI-446 Technical Concentrate (Shelf Life at Room
Temperature). Project Number: 832285. Unpublished study prepared by
RCC Ltd. 53 p.
Page 61 of 63
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46133600 Mitsui Chemicals, Inc. (2003) Submission of Product Chemistry Data in
Support of the Application for Registration of Dinotefuran Technical.
Transmittal of 1 Study.
46133601 Tognucci, A. (2003) Determination of the Storage Stability and
Corrosion Stability of MTI-446 Technical Material (Shelf Life at Room
Temperature). Project Number: 828865. Unpublished study prepared by
RCC Umweltchemie Ag. 53 p.
46254100 Mitsui Chemicals Inc. (2004) Submission of Efficacy Data in Support of
the Applications for Registration of Shuriken Cockroach Gel Bait,
Dinotefuran 0.2% Roach Bait Station and Dinotefuran 0.5% Roach Bait
Station. Transmittal of 5 Studies.
46254101 Miller, P.; Peters, B. (2003) Tray Study to Determine the Efficacy of
Sumitomo S-1638 Cockroach Gel and Bayer Premise Cockroach Gel Against
the German Cockroach. Project Number: C02/68/004, R03/1641.
Unpublished study prepared by University of Technology. 12 p.
46254102 Miller, P.; Peters, B. (2003) Field Study to Determine the Efficacy of
Sumitomo S-1638 Cockroach Gel and Bayer Premise Cockroach Gel Against
the German Cockroach. Project Number: C02/68/004, R03/1650.
Unpublished study prepared by University of Technology. 15 p.
46254103 Sembo, S. (2004) Field Test Results of a 0.25% Dinotefuran (Shuriken)
Gel Bait Against Cockroaches. Project Number: HPTR/20040006.
Unpublished study prepared by Sumitomo Chemical Co. 7 p.
46254104 Sembo, S. (2003) Field Test Results of a 0.5% Shuriken (Dinotefuran)
Gel Bait Against Cockroaches. Project Number: HPTR/20030034.
Unpublished study prepared by Sumitomo Chemical Co. 7 p.
46254105 Sembo, S. (2004) Laboratory Tests to Compare the Efficacy of Shuriken
(Dinotefuran) Gel Bait and Blattanex Bait Against Cockroaches. Project
Number: HPTR/20040007. Unpublished study prepared by Sumitomo
Chemical Co. 7 p.
46254200 Mitsui Chemicals, Inc. (2004) Submission of Efficacy Data in Support of the
Application for Registration of Dinotefuran Fly Bait. Transmittal of 1 Study.
46254201 Sembo, S. (2003) Oral Efficacy of Shuriken (Dinotefuran) and
Imidacloprid Against Houseflies. Project Number: HPTR/20030033.
Unpublished study prepared by Sumitomo Chemical Co. 6 p.
46254500 Mitsui Chemicals, Inc. (2004) Submission of Efficacy Data in Support of the
Application for Registration of Dinotefuran 20% PCO. Transmittal of 1
Study.
Page 62 of 63
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46254501 Sembo, S. (2004) Residual Activity of Solvent-Based Liquid Shuriken
(Dinotefuran) Formulations Against German Cockroaches. Project Number:
HPTR/20040010. Unpublished study prepared by Sumitomo Chemical Co. 6
P-
46254600 Mitsui Chemicals, Inc. (2004) Submission of Efficacy Data in Support of the
Application of Registration of Dinotefuran Total Release Fogger.
Transmittal of 1 Study.
46254601 Sembo, S. (2004) Insecticidal Efficacy of Shuriken (Dinotefuran) Total-
Release Aerosol Formulations Against Cockroaches. Project Number:
HPTR/20040008. Unpublished study prepared by Sumitomo Chemical Co. 8
P-
46270900 Mitsui Chemicals, Inc. (2004) Submission of Residue Data in Support of
the Application for Registration of Dinotefuran Technical. Transmittal of
1 Study.
46270901 MacGregor, 1; Van Hoven, R.; Nixon, W. (2002) Laboratory Validation
of Method(s) for the Analysis of MTI-446 and its Metabolites DN and UF in
Multiple Crop Substrates. Project Number: 236C/113. Unpublished study
prepared by Wildlife International, Ltd. 122 p.
46301600 Landis International (2004) Submission of Toxicity Data in Support of
the Application for Registration of Dinotefuran Technical. Transmittal of
1 Study.
46301601 Kuhn, J. (2004) Acute Eye Irritation Study in Rabbits: (Dinotefuran
Technical). Project Number: 8394/04. Unpublished study prepared by
Stillmeadow, Inc. 18 p.
Page 63 of 63
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