United States
Environmental Protection
Agency
r/EPA
Office of Prevention, Pesticides
and Toxic Substances
(7505P)
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Flufenoxuron
New Chemical
Tolerances Established
September 2006
Description of Chemical
Generic Name:
Common Name:
Trade Name in
Foreign Countries:
Chemical Type:
EPA Chemical Code:
Chemical Abstracts
Service (CAS) Number:
Registration Status:
Pesticide Type:
U.S. Producer:
N-[[[4-[2-clair-4-(trifluoromethyl)phenoxy]-2-
fluorophenyl]amino]carbonyl]-2,6-difluorobenzamide
Flufenoxuron
Cascade
Benzoylurea
108203
101463-69-8
Not Registered, Import Tolerances Established
Insecticide/Acaricide
BASF Corporation
26 Davis Drive, PO Box 13528
Research Triangle Park 27709-3528
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Tolerances Established
Import tolerances were established in the 40 CFR §180.XXX in or on apple (0.50 ppm);
grape (0.70 ppm); grape, raisin (2.0 ppm); cattle, meat (0.10 ppm); cattle, fat (4.5 ppm);
cattle, meat byproducts (0.50 ppm); goat, meat (0.10 ppm); goat, fat (4.5 ppm); goat,
meat byproducts (0.50 ppm); horse, meat (0.10 ppm); horse, fat (4.5 ppm); horse, meat
byproducts (0.50 ppm); sheep, meat (0.10 ppm); sheep, fat (4.5 ppm); sheep, meat
byproducts (0.50 ppm); milk (0.20 ppm); milk, fat (4.0 ppm); orange (0.30 ppm); orange,
oil (60 ppm); and pear (0.50 ppm).
Use Pattern and Formulations
Flufenoxuron is a benzoylurea type insecticide/acaricide which inhibits chitin
biosynthesis (MOA Group 15) in nymphal mites and Lepidopteran larvae. There are
currently no food/feed uses or tolerances for flufenoxuron in the U.S. BASF Corporation
is supporting the use of flufenoxuron on apples, grapes and oranges grown for export to
the U.S. in selected European and South American countries. Flufenoxuron is formulated
as 50 and 100 g/L EC, DC or F1C under the trade name Cascade®. Depending on the crop
and the country of use, these formulations are proposed for one to four foliar applications
per season to the above crops at rates equivalent to 40-250 g ai/ha/application (0.036-0.22
Ib ai/A/application).
Science Findings
Available product chemistry data supporting the use of flufenoxuron are summarized
below in Tables 1 and 2.
Table 1 Nomenclature and Physiochemical Properties of Flufenoxuron
Physical Chemical Structure
Common Name
Company Experimental Names
Molecular Weight
IUPAC Name
CAS Name
CAS#
Empirical Formula
PC Code Number
Water Solubility
Log (Kow)
F
Flufenoxuron
CL 81 1,678 WL 1151 10
488.77
l-[4-(2-chloro-a,a,a-trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-
difluorobenzoyl)urea
N-[[[4-[2-clair-4-(trifluoromethyl)phenoxy]-2-
fluorophenyl]amino]carbonyl]-2,6-difluorobenzamide
101463-69-8
C21HnClF6N203
108203
.36xlO'6g/L
4.01
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Table 2 Physiochemical Properties of Technical Grade Flufenoxuron
Parameter
Melting Point
pH
Relative Density at 20° C
Water Solubility at 25° C
Solvent Solubility (g/L) at 20° C
Vapor pressure at 20°C
Dissociation constant (pK )
Octanol/water partition coefficient
Log(KOW) at 25° C
Density
Value
1 69-1 72° C
6.1
1.57g/mL
1.36xlQ-6g/L
Solvent
Hexane
Octan-1-ol
Methanol
Dicloromethane
Cyclohexane
Dimethyl sulfoxide
Dimethyl formamide
Acetone
g/100mL(20°C)
0.012
1.12
3.55
18.7
96.4
287
287
73.6
6.52 x l(T12Pa
10.1
4.01
1.57g/mL
TOXICOLOGY SUMMARY
The Registrant submitted the studies listed in Tables 3 and 4, which include a number of
toxicity studies and summaries published in the public literature. These include the usual
acute studies for flufenoxuron technical. The Registrant has also submitted oral, dermal
and inhalation studies as well as chronic, carcinogenicity and developmental studies as
shown in Table 4.
Table .1 Acute Toxicitv of Flufenoxuron ,
Guideline No.
870.1100(81-1)
870.1200(81-2)
870.1300(81-3)
870.2400(81-4)
870.2500(81-5 )
87.2600(81-6)
Study Type
Acute Oral (rat)
Acute Dermal
Acute Inhalation (rat)
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization (guinea pig)
Results (LD50/LC50)
SOLD > 5000 mg/kg (M) LD50
> 5000 mg/kg (F)
NA
NA
NA
NA
NA
Toxicity Category
IV
NA
NA
NA
NA
NA
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Table 4 Subchronic, Chronic, and Other Toxicity Profile
Guideline No./ Study Type
870.3 lOOa
90-Day oral toxicity rodents
(rat)
870.3 lOOb
90-Day oral toxicity rodents
(mouse)
870.3150
90-Day oral toxicity in
nonrodents (dog)
870.3200
21/28-Day dermal toxicity
(rat)
870.3250
90-Day dermal toxicity
870.3465
90-Day inhalation toxicity
870.3700a
Pre-natal developmental in
rodents (rat)
870.3700b
Pre-natal developmental in
nonrodents (rabbit)
870.3800
Reproduction and fertility
effects (rats)
MRID No. (year)/
Classification/Doses
MRID 44448406 (1987)
Acceptable/guideline
Doses: 0, 50, 500, 5,000,
50,000 ppm
M & F: 0, 2.5, 25, 250, 500,
2500 mg/kg/day
MRID 44448408 (1991)
Acceptable/Guideline
Doses: 0, 50, 500, 5,000,
50,000 ppm (Limit dose)
M& F: 0, 7.5, 75, 750, 1500,
7500 mg/kg/day
MRID 44448409 (1987)
Acceptable/Guideline in
conjunction with the chronic
dog study (MRID 44448411)
Doses: 0, 0.05% (500 ppm),
0.5% (5000 ppm), 5% (50,000
ppm) in the diet 0, 38, 375,
3750 (3.5x Limit dose)
mg/kg/day
NA1
NA
NA
MRID 44448415 (1991)
Unacceptable/Guideline,
upgradeable upon review of
stability and certain fetal
external examination data.
Doses: 0, 10, 100, 1000
mg/kg/day (Limit dose)
GD 6-16, inclusive
MRID 4444841 6 (1991)
Acceptable/Guideline
Doses: 0, 10, 100, 1000
mg/kg/day (Limit dose)
GD 6- 18, inclusive
MRID 4444841 7 (1991)
Acceptable/Guideline
Doses: 0,50, 190,710, 10,000
ppm
M: 0,3.75, 14.33,53.64,771.6
mg/kg/day
F: 0,4.26, 16.0,60.98,907.4
mg/kg/day
Results
NOAEL = 25 mg/kg/day (M/F)
LOAEL = 250 mg/kg/day (M/F), based on decreased hemoglobin levels
and hematocrit levels, and red cell counts in females and decreased
erythroid:myeloid ratios in males.
NOAEL = 7500 mg/kg/day (M/F)
LOAEL was not established.
NOAEL = 7.5 mg/kg/day (M/F; based on chronic toxicity study in dog).
LOAEL = 38 mg/kg/day (M/F), based on decreased hemoglobin,
hematocrit levels, and erythrocyte counts in males and increased absolute
liver weights, bone marrow hyperplasia and methemoglobinemia in males
and females.
NA
NA
NA
Maternal NOAEL = 1000 mg/kg/day
LOAEL was not observed.
Developmental NOAEL = 1000 mg/kg/day
LOAEL was not observed.
Maternal NOAEL 1000 mg/kg/day
LOAEL was not established.
Developmental NOAEL = 100 mg/kg/day LOAEL = 1000 mg/kg/day,
based on delayed fetal growth.
Parental Toxicity
NOAEL = 771.6/907.4 mg/kg/day (M/F)
LOAEL was not established.
Rep. Toxicity
NOAEL = 771 .6/907.4 mg/kg/day (M/F)
LOAEL was not established.
Offspring Toxicity
NOAEL = 3.75/4.26 mg/kg/day (M/F)
LOAEL = 14.33/16.0 mg/kg/day, based on lower pup body weight.
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Table 4 (continued) Subchronic, Chronic, and Other Toxicity Profile
Guideline No./ Study Type
MRID No. (year)/
Classification/ Doses
Results
870.4 lOOb
Chronic toxicity dogs
MRID 44448411 (1989)
Acceptable/Guideline
Doses: 0, 10, 100, 500, 50,000
ppm
M & F: 0, 0.75, 7.5, 37.5, 3750
mg/kg/day
NOAEL = 7.5 mg/kg/day (M/F)
LOAEL = 37.5 mg/kg/day (M/F), based on decreased erythrocyte counts,
and mean hemoglobin concentration and increased mean cell volume,
platelet counts in males, methemoglobinemia and sulfhemoglobinemia in
males and females.
870.4200
Combined chronic
toxicity/carcinogenicity
rodents (rat)
MRIDs 44448410 & 44448412
(1990)
Acceptable/Guideline
Doses:
Chronic phase: 0, 1, 5, 50, 500,
5000, 50000 (> Limit dose)
ppmM: 0, 0.044, 0.226, 2.21,
22.03, 232.5, 2470.6
mg/kg/day F: 0, 0.05, 0.279,
2.82,28.33,301.0,3205.6
mg/kg/day
Carcinogenicitv phase: 0, 500,
5000, 50000 (> Limit dose)
ppmM:0, 21.57, 217.5,
2289.8 mg/kg/day F: 0, 25.92,
276.4, 2900.9 mg/kg/day
NOAEL = 22.03/28.33 mg/kg/day (M/F)
LOAEL = 232.5/301 mg/kg/day (M/F), based on decreased body weight
and weight gain.
No evidence of carcinogenicity.
870.4300
Carcinogenicity mice
MRID 44448414 (1992)
Acceptable/Guideline
Doses: 0, 500, 5,000, 50,000 (>
Limit dose) ppm
M: 0, 56, 559, 7356 mg/kg/day
F: 0, 73, 739, 7780 mg/kg/day
63 IB CF strain
NOAEL = 559/73 mg/kg/day (M/F)
LOAEL = 7356/739 (M/F), based on decreased body weight and body
weight gain and liver lesions in males and females and spleen lesions in
males. Dosing was adequate (> 7.5x the limit dose). Total incidence of
vascular tumors (combined hemangiosarcomas of the liver and spleen)
among high-dose females (16%) was significantly increased over controls
(0%) and was slightly outside the published data for historical controls
(mean: 3.7%; range: 0%-14%). The overall increase in splenic
hemangiosarcomas in high-dose females (14%, p<0.01) and the increase
in total vascular tumors in the liver of high-dose males (20% vs 12% in
controls) occurred at doses that exceeded the limit dose.
870.4300
Carcinogenicity mice
MRID 44448413 (1996)
Acceptable/Guideline
Doses: 0, 100, 1,000, 10,000 (>
limit dose) ppm
M:0, 15.3, 152, 1592
mg/kg/day F: 0, 17.4, 187,
1890 mg/kg/day
63 IB CF strain
NOAEL = 1592/187 mg/kg/day (M/F)
LOAEL = 1890 mg/kg/day (F), based on decreased body weight and body
weight gains. LOAEL for males not established.
No evidence of carcinogenicity
Gene Mutation
870.5100
reverse gene mutation assay
in bacteria
44448419(1991)
Unacceptable/guideline
Salmonella typhimurium
strains TA98, TA100,
TA1535, andTA1538;
Escherichia coli strain WP2
were exposed to flufenoxuron
at doses 0,31.25, 62.5, 125,
250,500, 1000, 2000, and
4000 ug/plate. Inappropriate
positive controls for strains
TA1535 and WP2 with +S9
and TA100, TA1537, TA1538,
and TA98 -S9.
No evidence of induced mutant colonies over background.
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Table 4 (continued) Subchronic, Chronic, and Other Toxicity Profile
Guideline No./ Study Type
MRID No. (year)/
Classification/ Doses
Results
Gene Mutation
870.5300
forward gene mutation assay
in mammalian cells
46607201 (1986)
Acceptable/guideline
CH V79 cells exposed to
flufenoxuron at concentrations
up to 1350ug/mL(±S9)
There was no evidence that flufenoxuron induced mutant colonies over
background in the ± S9 activation.
Cytogenetics
870.5375
in vitro mammalian
cytogenetic assay
46607202(1987)
Acceptable/guideline
CHO cells exposed to
flufenoxuron at doses up to
150ug/mL(±S9).
No evidence of increased chromosomal aberrations in the presence of S9.
Cytogenetics
870.5375
in vitro mammalian
cytogenetic assay
46607204(1988)
Unacceptable/guideline
Rat liver epithelioid cells
exposed to flufenoxuron at
doses up to 450 ug/mL (-S9)
and/or 160 |ig/mL (+S9).
Not clastogenic with or without S9 activation, at any dose tested; however,
the negative results were not followed-up experiment with a much longer
harvest time and in the absence of S9.
870.5375
in vitro mammalian
cytogenetic assay
46607205 (1992)
Acceptable/guideline
Human lymphocytes cultures
exposed to flufenoxuron at
doses up to 160 ug/rnL (±S9)
No evidence of increased chromosomal aberrations in the ±S9 activation.
Cytogenetics
870.5385
in vivo mammalian
cytogenetic assay
46607206 (1986)
Acceptable/guideline
CD rats oral dosed with
flufenoxuron at doses up to
4000 mg/kg (>limit dose)
No increase in aberrant cells was seen in the bone marrow chromosomal
aberration assay.
Other Effects
870.5395
in vivo mammalian
cytogenetic assay
46607208(1993)
Acceptable/guideline
Doses: 0, 500, 1000, and 2000
mg/kg (limit dose)
Did not induce micronucleated polychromatic erythrocytes (PMCEs) in
bone marrow at any dose
Other Genotoxic Effects
870.5550
UDS synthesis in mammalian
cell culture
46607207(1988)
Unacceptable/guideline
Doses: 0, 188, 375, 750, and
1500 mg/kg oral gavage.
No justification for upper dose
tested.
Did not induce UDS at any dose
Other Genotoxic Effects
870.5575
Mitotic gene conversion in
Saccharomyces cerevisiae
44448419(1991)
Acceptable/guideline
Doses: 0, 0.01,0.1,0.25, 0.5,
and 1.0mg/mL±S9.
No increase in the mitotic gene conversion at either histidine or tryptophan
loci ± S9.
Non-guideline
Replicative DNA synthesis in
rat hepatocytes
46607209(1992)
Unacceptable/non-guideline
Doses: 0, 2000 and 4000
mg/kg oral gavage. No positive
control data.
No increased in the incidence replicative DNA synthesis over untreated
controls.
870.6200a
Acute neurotoxicity
screening battery
NA
NA
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Table 4 (continued) Subchronic, Chronic, and Other Toxicity Profile
Guideline No./ Study Type
MRID No. (year)/
Classification/ Doses
Results
870.6200b
4-Week Subchronic
neurotoxicity screening
battery
46482203 (2003)
Acceptable/non-guideline
because
of duration
Doses: 0, 1000, 5000, 20000
ppm
M:0, 88.3,435.4, 1774.6
mg/kg/day
F: 0,94.9, 474.5, 1934.4
mg/kg/day
NOAEL= 88.3/94.9 mg/kg/day (M/F)
LOAEL = 435.4/474.5 mg/kg/day (M/F), based on decreased body weight
and body weight gains in males.
870.6300
Developmental neurotoxicity
NA
NA
870.7485
Metabolism and
pharmacokinetics (rat)
44448422(1992)
Acceptable/guideline
Doses:
M&F:3.5or350mg/kg
single oral dose (labeled the
aniline and difluorobenzene
ring), -single gavage dose of 5
mg/kg for 14 days followed by
labeled 5 mg/kg,-in bile duct
cannulated, single dose of 5
mg/kg
Metabolic fate of flufenoxuron was determined using two label positions
(aniline and difluorobenzene ring). At the high dose, saturated absorption
was observed. Approximately 86% of the low dose and 1% of the high
dose was absorbed in 168 hours; the majority of which occurred within 48
hours. For the low dose ring, urine (9-27%) was major route of excretion
(much less was in the urine at the high dose). Conversely, 93-102% of the
high dose and 4-19% of the low dose was eliminated in feces. Elimination
via expired air was insignificant. Biliary excretion using the aniline ring
label showed that all the radioactivity in the feces of females and 40% of
that in males are the biliary excretion products. Accumulation of
radioactivity in muscle and adipose tissue 4 hours post dosing with 3.5
mg/kg benzyl label was 30% and 42%, respectively. At 168 hours post
dose, these values were 6% and 19%, respectively, suggesting an
accumulation in the adipose tissue. High doses of both labels resulted in
negligible tissue burden (<0.3%), indicating saturation absorption.
Urinary samples showed 10 urinary metabolites and parent accounted for -
5% of the dose in the urine and was considered non-significant. Fecal
analysis indicated that parent compound accounting for the greatest
portion of radioactivity. Most fecal metabolites represented < 1% of the
administered dose. The results of the metabolism characterization studies
with both label positions suggest that metabolism of flufenoxuron
proceeds via hydrolysis to a benzoic acid metabolite, a phenyl urea
metabolite (4-[2-chloro, a, a, a-trifluoro-p-tolyoxy]-2-fluorophenyl urea),
an aniline metabolite (4-[2-chloro, a, a, a-trifluoro-p tolyoxy]-2-
fluoroaniline), and subsequently several minor components.
870.7600
Dermal penetration
1 NA = not applicable.
NA
NA
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Toxicological Endpoints
Table 5. Summary of Toxicological Dose and Endpoints for Flufenoxuron for Use in Human Risk Assessment!
Exposure
Scenario
Acute Dietary
(females 13-50 years
of age)
Acute Dietary
(general population
including infants and
children)
Chronic Dietary
(all populations)
Oral - All Durations2
(Residential)
Dermal - All
Durations2
(Occupational/
Residential)
Inhalation - All
Durations2
(Occupational/
Residential)
Cancer (oral, dermal,
inhalation)
Dose Used in
Risk
Assessment,
UF
An endpoint of c
Quantification of ac
FQPA SF and Level
of Concern for Risk
Assessment
oncern attributed to single
ute risk to general populat
Study and Toxicological Effects
dose effect was not identified in the database.
on including infants and children is not required.
An endpoint of concern attributed to single dose effect was not identified in the database.
Quantification of acute risk to general population including infants and children is not required.
NOAEL= 3.75
mg/kg/day
UF= 100
Chronic RfD =
0.0375 mg/kg/day
NOAEL = 3. 75
mg/kg/day
oral NOAEL=
3.75 mg/kg/day
(dermal absorption
rate= 100%)
oral
NOAEL= 3.75
mg/kg/day
(inhalation
absorption rate =
100%)
FQPASF=1X
cPAD = (chronic RfD/
FQPA SF) = 0.0375
mg/kg/day
Residential LOG for
MOE =100
Occupational LOC for
MOE =100
Residential LOC for
MOE =100
Occupational LOC
for MOE = 100
Residential LOC for
MOE =100
2-Generation Reproduction Toxicity - Rat
LOAEL =14.33/16.0 (M/F) mg/kg/day, based
on decreased body weights during lactation
days 4-21.
2-Generation Reproduction Toxicity - Rat
LOAEL = 14.33/16.0 (M/F) mg/kg/day, based
on decreased body weights during lactation
days 4-21.
2-Generation Reproduction Toxicity - Rat
LOAEL = 14.33/16.0 (M/F) mg/kg/day, based
on decreased body weights during lactation
days 4-21.
2-Generation Reproduction Toxicity - Rat
LOAEL = 14.33/16.0 (M/F) mg/kg/day, based
on decreased body weights during lactation
days 4-21.
"not likely to be carcinogenic to humans"
1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose, MOE =
margin of exposure.
2 As there are no registered or proposed domestic uses of flufenoxuron, residential or occupational exposure assessments
were not conducted. However, if in the future domestic uses are proposed that would result in occupational and/or
residential exposure to flufenoxuron, these endpoints will be applicable.
Food Quality Protection Act Considerations
FQPA Safety Factor
The EPA selected endpoints for risk assessment and evaluated the potential for increased
susceptibility of infants and children from exposure to flufenoxuron according to the
February 2002 OPP 10X guidance document. The FQPA safety factor (SF) was reduced
to Ix by the EPA based on the following toxicological considerations:
• There is no evidence of increased susceptibility in the developmental study in
rats.
• In the rabbit developmental study, there is evidence of increased susceptibility;
however, the effects are well characterized and clear NOAELs and LOAELs are
established. Since the effects occurred at the limit dose, the delayed fetal growth
may be considered a high dose effect.
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• In the 2-generation reproduction study in rat, there is evidence for the increased
susceptibility; however, the effects were well characterized, clear NOAELs and
LOAELs were established for offspring toxicities, and the endpoints were used for
risk assessment. Therefore, there is no residual uncertainty for pre- and/or post-natal
susceptibility.
• The toxicological database is complete for FQPA assessment.
• The chronic dietary food exposure assessment utilizes proposed tolerance level
residues and assumes 100% CT information for all commodities. By using these
screening-level assessments, actual exposures/risks will not be underestimated.
Risk assessments were conducted for the chronic dietary exposure scenario only. The
chronic reference dose (cRfD) was calculated by dividing the no-observed-adverse-
effect-level (NOAEL) by 100 (1 OX for interspecies extrapolation, 10X for intraspecies
variation). Since the FQPA SF has been reduced to IX, the chronic population adjusted
dose (cPAD) is equal to the cRfD.
Exposure Assessment
Dietary-Exposure Assessment: An unrefined, chronic dietary exposure assessment was
performed for the general U.S. population and various population subgroups assuming
tolerance level residues and 100% crop treated (%CT) for all commodities. As there are
no proposed domestic uses of flufenoxuron, drinking water was not incorporated into the
dietary assessment. The chronic dietary exposure estimates are below HED's level of
concern (<100% cPAD) for the general U.S. population (14% cPAD) and all population
subgroups (Table 6). The most highly-exposed population subgroup is children 1-2 years
old at 63% cPAD.
Table 6. Summary of Dietary Exposure and Risk for Flufenoxuron.
Population Subgroup
General U.S. Population
All Infants (< 1 yr)
Children l-2yrs
Children 3-5 yrs
Children 6-1 2 yrs
Youth 13-19 yrs
Adults 20-49 yrs
Adults 50+ yrs
Females 13 -49 yrs
Chronic Dietary
cPAD (mg/kg/day)
0.0375
Exposure (mg/kg/day)
0.005262
0.008469
0.023448
0.016271
0.008996
0.004562
0.003334
0.002961
0.003227
% cPAD
14
23
63
43
24
12
8.9
7.9
8.6
Water Exposure/Risk Pathway
As there are currently no registered or proposed domestic uses for flufenoxuron, a
drinking water assessment was not conducted.
Residential (Non-Occupational*) Exposure/Risk Pathway
As there are currently no registered or proposed residential uses for flufenoxuron, a
residential exposure assessment was not conducted.
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Occupational Exposure/Risk Pathway
As there are currently no registered or proposed domestic uses for flufenoxuron, an
occupational_exposure assessment was not conducted.
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ADDITIONAL CONFIRMATORY DATA
A. Toxicology
1. Confirmatory data on external fetal observations from the developmental
toxicity study in rat should be submitted.
B. Analytical Methods1
1. The proposed tolerance enforcement method for plant commodities
(HPLC/UV Method SAMS 432-3) should be revised to include an alternate
confirmatory analysis using LC/MS/MS, which has been shown to adequately
detect and quantify flufenoxuron in BASF Method 544/0.
2. The proposed tolerance enforcement method for milk (HPLC/UV Method
SAMS 486-1) should be revised to include an alternate confirmatory analysis
that is distinct from the primary analytical method.
3. To support the use of Method SAMS 457-2 as an enforcement method, an
ILV trial should be conducted with this method using samples of liver and
muscle fortified at the method LOQ and the recommended tolerances for meat
byproducts (0.8 ppm) and meat (0.2 ppm). Any proposed HPLC/UV method
must also be revised to include a confirmatory analysis using an analytical
method that is distinct from the primary analytical method. In addition,
radiolabeled method validation data are requested for the proposed
enforcement method using tissue samples from the goat metabolism study.
4. Completion of adequate Primary Method of Validation by the Analytical
Chemistry Branch.
C. Repository Standard
1. The EPA National Pesticide Standards Repository has requested that
additional reference standard be submitted for flufenoxuron.
D. Revised Section F
1. Based on submitted data, current commodity definitions, and protective
tolerance expressions, HED-recommended tolerances for apple (0.50 ppm);
grape (0.70 ppm); grape, raisin (2.0 ppm); cattle, meat (0.10 ppm); cattle, fat
(4.5 ppm); cattle, meat byproducts (0.50 ppm); goat, meat (0.10 ppm); goat,
fat (4.5 ppm); goat, meat byproducts (0.50 ppm); horse, meat (0.10 ppm);
horse, fat (4.5 ppm); horse, meat byproducts (0.50 ppm); sheep, meat (0.10
ppm); sheep, fat (4.5 ppm); sheep, meat byproducts (0.50 ppm); milk (0.20
ppm); milk, fat (4.0 ppm); orange (0.30 ppm); orange, oil (60 ppm); and
pear (0.50 ppm).
E. Additional residue data needed to support registrant requested petitioned
tolerances2:
1. To support the available grape and apple processing studies, data are
requested demonstrating the stability of flufenoxuron in frozen samples of
1 An adequate HPLC/ultraviolet (UV) method (SAMS 432-3) and liquid chromatography (LC)/mass
spectrometry (MS)/MS method (BASF Method 544/0) are available for collecting data on flufenoxuron
residues in/on plant commodities. Adequate HPLC/UV methods are also available for collecting data on
flufenoxuron residues in milk (Method SAMS 486-1) and livestock tissues (Method SAMS 457-2).
2 BASF originally petitioned the Agency for tolerances in or on apple at 1 parts per million (ppm), pear at 1
ppm, orange at 0.3 ppm, orange oil at 60 ppm, grape at 0.2 ppm, raisin at 0.8 ppm, meat at 0.3 ppm, cattle,
meat by-products at 1.5 ppm, cattle, fat at 6 ppm, milk at 0.6 ppm, and milk, fat at 3 ppm.
-------
juice (apple, grape or orange), wet apple pomace, raisins, dried pulp and
orange oil for up to 9 months.
2. Three additional pear field trials should be conducted in Argentina (2 trials)
and Chile (1 trial) using the appropriate formulation at the maximum
seasonal rate being proposed for the given country. Duplicate samples of
whole fruit should be collected from each trial at the minimum PHI.
3. New orange field trials are requested. Based on the amount of orange
products (fresh fruit and juice) imported from each country, and the type of
formulation, maximum seasonal use rate and PHI being proposed for each
country, a total of 12 field trials should be conducted, with the trials being
distributed between Brazil (6 trials), Spain (4 trials) and Greece (2 trials).
These trials should be conducted at the maximum seasonal rate being
proposed for a given country and use the appropriate formulation (e.g. EC in
Brazil). Duplicate samples of whole fruit should be collected from each trial
at the minimum PHI.
4. Processing data on dried pulp and finished orange oil are requested.
F. Foreign labels:
1. The most recent versions of foreign BASF flufenoxuron labels should be
submitted along with English translations.
-------
Contact Person at USEPA
Mailing address:
Richard Gebken
Product Manager (10)
Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
Fungicide Branch
1200 Pennsylvania Avenue NW
Washington, D.C. 20460
Office location and telephone number:
Room S-7319, One Potomac Yard
2777 S. Crystal Drive
Arlington, VA 22202
703-308-9354
DISCLAIMER: The information in this Pesticide Fact Sheet is for information only
and is not to be used to satisfy data requirements for pesticide registration. The
information is believed to be accurate as of the date on the document.
-------
APPENDIX I
GLOSSARY OF TERMS AND ABBREVIATIONS
ADNT
a.i.
aPAD
ARI
BCF
CAS
ChE
ChEI
cPAD
%CT
DAT
DEEM-FCID
DNA
DNT
DIT
DWLOC
EC
EEC
EPA
FQPA
GLC
GLN
LD50
LOAEL
LOAEC
LOG
LOD
LOQ
mg/kg/day
mg/L
MOE
Acute delayed neurotoxicity
Active Ingredient
Acute Population Adjusted Dose
Aggregate Risk Index
Bioconcentration Factor
Chemical Abstracts Service
Cholinesterase
Cholinesterase inhibition
Chronic Population Adjusted Dose
Percent crop treated
Days after treatment
Dietary Exposure Evaluation Model - Food Consumption Intake
Database
Deoxyribonucleic acid
Developmental neurotoxicity
Developmental immunotoxicity
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.
U.S. Environmental Protection Agency
Food Quality Protection Act
Gas Liquid Chromatography
Guideline Number
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.
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.
Lowest Observed Adverse Effect Level
Lowest Observed Adverse Effect Concentration
Level of Concern
Limit of Detection
Limit of Quantitation
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
-------
MRID
MTD
NA
NOEC
NOEL
NOAEL
NOAEC
NPDES
OP
OPP
OPPTS
PAD
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
RAC
RBC
RED
REI
RfD
SCI-GROW
SF
TGAI
UF
"L/g
USDA
WPS
Master Record Identification (number), EPA's system of recording
and tracking studies submitted
Maximum tolerated dose
Not Applicable
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
No Observed Adverse Effect Concentration
National Pollutant Discharge Elimination System
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
Raw Agriculture Commodity
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Tier I Ground Water Computer Model
Safety Factor
Technical Grade Active Ingredient
Uncertainty Factor
micrograms
Micrograms Per Liter
Microliter per gram
United States Department of Agriculture
Worker Protection Standard
-------
APPENDIX II
Citations Considered Part of the Data Base Supporting the Establishment of
Flufenoxuron Import Tolerances.
MRID
Citation
Receipt Date
44448400
American Cyanamid Co. (1997) Submission of Product Chemistry, Toxicology
and Residue Data in Support of the Petition for Tolerance of Flufenoxuron on
Apples, Pears, Oranges, Grapes, Meat and Milk Products. Transmittal of 36
Studies.
09-Dec-1997
44448401
American Cyanamid Company (1997) Summary Volume: (Flufenoxuron
Insecticide): Lab Project Number: CY 174: ARGE 93.001: BEGR 87.006.
Unpublished study. 356 p.
09-Dec-1997
44448402
Gorter de Vries, R.; Wong, G. (1997) Flufenoxuron: Product Identity,
Description of Beginning Materials, Manufacturing Process, and Discussion
and Formation of Impurities: Lab Project Number: CFS 1996-151: CHDV
36#4.1: 334. Unpublished study prepared by Cyanamid Forschung GmbH and
American Cyanamid Co. 54 p. {OPPTS 830.1550, 830.1600, 830.1620,
830.1670}
09-Dec-1997
44448403
Ahuja, E.; Fang, L. (1997) Flufenoxuron (AC 811,678): Preliminary Analysis,
Certification of Limits, and Analytical Methods: Lab Project Number: APBR
720: APBR 639: APBR 675. Unpublished study prepared by American
Cyanamid Co. 315 p. {OPPTS 860.1700, 860.1750, 860.1800}
09-Dec-1997
44448404
Wong, G.; Camilleri, P.; Dearing, E. (1997) Technical Flufenoxuron: Physical
and Chemical Properties: Lab Project Number: P 177.1: SBGR.88.184: CY
164. Unpublished study prepared by American Cyanamid Co., Shell Research
Ltd. and RCC Notox. 189 p. {OPPTS 830.6302, 830.6303, 830.6304,
830.6313, 830.6314, 830.6315, 830.6316, 830.6317, 830.6319, 830.6320}
09-Dec-1997
44448405
Gardner, J. (1989) WL 115110 (CASCADE): Acute Oral Toxicity (in Rats):
Lab Project Number: SBGR.89.001. Unpublished study prepared by Shell
Research Ltd. 21 p. {OPPTS 870.1100}
09-Dec-1997
44448406
Esdaile, D. (1987) WL115110: A 90 Day Feeding Study in Rats: Lab Project
Number: SBGR.86.256: 3412. Unpublished study prepared by Shell Research
Ltd. 476 p. {OPPTS 870.3100}
09-Dec-1997
44448407
Esdaile, D. (1986) WL 115110: A 28 Day Feeding Study in Rats: Lab Project
Number: SBGR.86.085: 3321. Unpublished study prepared by Shell Research
Ltd. 316 p. {OPPTS 870.3100}
09-Dec-1997
44448408
Esdaile, D. (1991) WL 115110: A 90 Day Feeding Study in Mice and
Flufenoxuron (WL115110): A 28 Day Range-Finding Feeding Study in Mice:
Lab Project Number: SBGR.86.257: SBGR.91.179: 3413. Unpublished study
prepared by Shell Research Ltd. 484 p. {OPPTS 870.3100}
09-Dec-1997
44448409
Greenough, R.; Duffen, J.; Goburdhun, K. (1987) WL 115110: 13 Week Oral
Toxicity Study in Dogs: Lab Project Number: IRI 635469: 3394. Unpublished
study prepared by Inveresk Research International Ltd. 184 p. {OPPTS
870.3150}
09-Dec-1997
-------
MRID
Citation
Receipt Date
44448410
Esdaile, D. (1990) WL115110: A Two Year Chronic Toxicity Study in Rats:
Lab Project Number: SBGR.89.150: 3588: 3588 SI. Unpublished study
prepared by Shell Research Ltd. 2759 p. {OPPTS 870.4100}
09-Dec-1997
44448411
Greenough, R.; Goburdhun, R.; Parkinson, C. (1989) WL 115110: 52 Week
Oral Toxicity Study in Dogs: Lab Project Number: IRI 635474: 5248:
SRC3395. Unpublished study prepared by Inveresk Research International. 340
p. {OPPTS 870.4100}
09-Dec-1997
44448412
Esdaile, D.; Berry, P. (1992) WL115110: A Two Year Oncogenicity Feeding
Study in Rats: Lab Project Number: SBGR. 89.135: 3460: AIA 3460.
Unpublished study prepared by Shell Research Ltd. 1313 p. {OPPTS
870.4200}
09-Dec-1997
44448413
Broadmeadow, A. (1996) WL115110: Oncogenicity Study by Dietary
Administration of B6C3F1 Mice: Lab Project Number: 95/SHL011/0875:
SHL/011: 95/0875. Unpublished study prepared by Huntingdon Life Sciences
Ltd. 1242 p. {OPPTS 870.4200}
09-Dec-1997
44448414
Esdaile, D.; Berry, P. (1992) WL115110: A 2 Year Oncogenicity Feeding
Study in Mice: Lab Project Number: SBGR.89.151: 3459: SLL 170.
Unpublished study prepared by Shell Research Ltd. 1828 p. {OPPTS
870.4200}
09-Dec-1997
44448415
Hazelden, K.; Wilson, J.; Barton, S. (1991) WL115110: Teratogenicity Study
in Rats and WL115110 Dose Range Finding Study in Rats, Preliminary to
Teratogenicity Study: Lab Project Number: IRI 3756: IRI 3940: 3369.
Unpublished study prepared by Inveresk Research International. 162 p.
{OPPTS 870.3700}
09-Dec-1997
44448416
Hazelden, K.; Wilson, J.; Barton, S. (1991) WL115110: Teratogenicity Study
in Rabbits and WL115110 Dose Range Finding Study in Rabbits, Preliminary
to Teratogenicity Study: Lab Project Number: IRI 3757: IRI 3942: 3371.
Unpublished study prepared by Inveresk Research International. 141 p.
{OPPTS 870.3700}
09-Dec-1997
44448417
James, P.; Jones, K.; Parker, C. et al. (1991) The Effect of WL115110 on
Reproductive Function of Two Generations in the Rat: Lab Project Number:
SLL/138: SLL 138/891394: 3800. Unpublished study prepared by Huntingdon
Research Centre Ltd. 692 p. {OPPTS 870.3800}
09-Dec-1997
44448418
Masters, R.; James, P. (1996) WL 115110: Supplemental Data to the Two-
Generation Rat Reproduction Study: Lab Project Number: SLL274/932233:
SLL176/920004: CY150. Unpublished study prepared by Huntingdon Life
Science Ltd. 181 p. {OPPTS 870.3800}
09-Dec-1997
44448419
Brooks, T.; Wiggins, D. (1991) Microbial Mutagenicity Studies with WL
115110: Lab Project Number: SBGR.86.026: 3214. Unpublished study
prepared by Shell Research Ltd. 61 p. {OPPTS 870.5265}
09-Dec-1997
44448420
Clare, M.; McEnaney, S.; Meyer, A. (1992) Flufenoxuron: WL115110
Structural Chromosomal Aberration Studies: Lab Project Number:
SBGR.86.047: SBGR.86.216: SBGR.87.117. Unpublished study prepared by
Hazleton UK and Shell Research Ltd. 195 p. {OPPTS 870.5300}
09-Dec-1997
-------
MRID
Citation
Receipt Date
44448421
Allen, J.; Cifone, M.; Nishitomi, T. et al. (1997) Flufenoxuron: Other
Genotoxicity Studies with WL115110: Lab Project Number: SLL 86/8621:
3881: 2L283. Unpublished study prepared by Huntingdon Research Centre
Ltd., Hazleton Laboratories America, Inc. and Mitsubishi-Kasei Institute of
Toxicological & Environmental Sciences. 106 p. {OPPTS 870.5385, 870.5550,
870.5395}
09-Dec-1997
44448422
Huckle, K.; Hutson, D.; Mayo, B. et al. (1992) Flufenoxuron (WL115110):
General Metabolism in the Rat: Lab Project Number: SBGR.87.186:
SBGR.86.104: HRC/SLL 193/911344. Unpublished study prepared by
Huntingdon Research Centre Ltd. and Shell Research Ltd. 717 p. {OPPTS
860.1300}
09-Dec-1997
44448423
Edwards, V. (1991) The Metabolism of (carbon 14) WL115110 in Tomatoes:
Lab Project Number: SBGR.87.066: 3421. Unpublished study prepared by
Shell Research Ltd. 34 p. {OPPTS 860.1300}
09-Dec-1997
44448424
Caley, C.; Cameron, B.; MacDonald, A. (1991) The Distribution and
Metabolism of (carbon 14) WL115110 in the Apple: Lab Project Number: IRI
142828: 7498. Unpublished study prepared by Inveresk Research International.
65 p. {OPPTS 860.1300}
09-Dec-1997
44448425
Edwards, V.; Standen, M. (1986) The Fate of the Candidate Insecticides
WL115110 and WL117559 in Plants Outdoors: Lab Project Number:
SBGR. 86.074: SRCAIU85: 3193. Unpublished study prepared by Shell
Research Ltd. 33 p. {OPPTS 860.1300}
09-Dec-1997
44448426
Cameron, B.; Chapleo, S.; Young, C. (1988) The Disposition of (carbon 14)-
WL115110 in the Lactating Goat and the Identification of Radioactive
Residues in Selected Tissues Following Multiple Oral Administration: Lab
Project Number: IRI 135737: IRI 136552: 4384. Unpublished study prepared
by Inveresk Research International. 83 p. {OPPTS 860.1300}
09-Dec-1997
44448427
Khunachak, A.; Furr, H.; Kennedy, E. (1997) Independent Laboratory
Validations of Crop Analytical Method SAMS 432-3 for All Crop
Commodities: Lab Project Number: RES 97-013: CS97PT01: 579/184-1012.
Unpublished study prepared by Centre Analytical Laboratories, Inc., Restec
Laboratories, Ltd. and Hazleton U.K. 207 p. {OPPTS 860.1340}
09-Dec-1997
44448428
Bixler, T. (1993) Analysis of Flufenoxuron by Multi-Residue Methods in FDA
Pesticide Analytical Manual Volume I: Lab Project Number: A025.026.
Unpublished study prepared by Huntingdon Analytical Services. 53 p. {OPPTS
860.1360}
09-Dec-1997
44448429
Skorczynski, S. (1997) Residue Analytical Methods for Animal Commodities
and Independent Laboratory Validation: Lab Project Number: RES 97-037:
SAMS 457-2: CY162. Unpublished study prepared by Centre Analytical Lab.,
Inc. and Shell Research Ltd. 88 p. {OPPTS 860.1340}
09-Dec-1997
44448430
Skorczynski, S. (1997) CL 811,678: Independent Laboratory Validation of
HPLC Method SAMS 486-1 for the Determination of CL 811,678 (CASCADE,
WL115110) Residues in Raw Whole Milk by Centre Analytical Laboratories,
Inc: Lab Project Number: RES 97-027: CS97PT03: 0361. Unpublished study
prepared by Centre Analytical Lab., Inc. 66 p. {OPPTS 860.1340}
09-Dec-1997
-------
MRID
Citation
Receipt Date
44448431
Lewis, C.; Gillard, D. (1993) Flufenoxuron: Residue Storage Stability: Lab
Project Number: 7178-579/68: A025.018: CY156. Unpublished study prepared
by Huntingdon Research Centre Ltd. and Hazleton UK. 157 p. {OPPTS
860.1380}
09-Dec-1997
44448432
Gill, J.; Pack, S. (1993) Flufenoxuron: Residues in Milk, Milk Products and
Tissues of Dairy Cows Arising From Consumption of Diet Containing Test
Compound: Lab Project Number: SBTR.92.038: SLL 171/911459: 4252.
Unpublished study prepared by Shell Research Ltd., Huntingdon Research
Centre Ltd. and Hazleton UK. 181 p. {OPPTS 860.1480}
09-Dec-1997
44448433
Schultz, E.; Charmasson, R.; Freeman, J. et al. (1997) Flufenoxuron:
Magnitude of the Residue in Apples: Lab Project Number: ARGE.93.001:
BEGR.87.006: 579/8. Unpublished study prepared by Agro Roca, S.A.,
Hazelton (sic) Europe and PRDL, Cyanamid Ag., Ltd. 474 p. {OPPTS
860.1500}
09-Dec-1997
44448434
Furr, H.; Young, H. (1997) Flufenoxuron (CL 811678): Magnitude of the
Residue in Oranges: Lab Project Number: 579/175: 4253: 4251. Unpublished
study prepared by Hazelton (sic) Europe and PRDL, Cyanamid Ag., Ltd. 293 p.
{OPPTS 860.1500}
09-Dec-1997
44448435
Bosio, P.; Carlon, R.; Furr, H. (1993) Flufenoxuron: Magnitude of the Residue
in Grapes: Lab Project Number: BEGR.89.001: BETR.91.015: BETR.92.010.
Unpublished study prepared by Shell Chimie and Hazelton (sic) Europe. 219 p.
{OPPTS 860.1500}
09-Dec-1997
44448436
Gillard, D. (1992) The HPLC Determination of Flufenoxuron (CASCADE)
Residues in Apples, Grapes, Cotton, Orange and Their Processed Fractions
from 1989 Field Trials: Lab Project Number: A025.012: 2010C589: CAR124-
89. Unpublished study prepared by EM Industries, Inc., Huntingdon Analytical
Services and California Agricultural Research, Inc. 368 p. {OPPTS 860.1520}
09-Dec-1997
46482200
BASF Corp. (2005) Submission of Product Chemistry and Residue Data in
Support of the Petition for Tolerance of Flufenoxuron on Apples, Pears,
Oranges and Grapes. Transmittal of 15 Studies.
28-Feb-2005
46482201
Fietz, G. (2002) Analytical Characterization of Five Batches: Flufenoxuron
Technical Grade: Final Report. Project Number: 2002/1011349, PCP06790.
Unpublished study prepared by BASF Aktiengesellschaft. 39 p.
28-Feb-2005
46482202
Peterson-Thiery, M. (2004) Flufenoxuron TC: Composition of the Technical
Grade Active Ingredient (TGAI): Final Report. Project Number: 2004/1004227.
Unpublished study prepared by BASF Aktiengesellschaft. 9 p.
28-Feb-2005
46482203
Kaspers, U.; Kaufmann, W.; van Ravenszwaay, B. (2003) BAS 307 I -
Subacute Neurotoxicity Study in Wistar Rats; Administration in the Diet for 4
Weeks: Final Report. Project Number: 30S0264/01073, 2003/1009768.
Unpublished study prepared by BASF Aktiengesellschaft. 268 p.
28-Feb-2005
46482204
Veit, P.; Bingemann, R. (2003) Metabolism of (Carbon)-14-BAS 307 I in
Grape-vine: Final Report. Project Number: 83283, 2003/1004676. Unpublished
study prepared by BASF Aktiengesellschaft. 105 p.
28-Feb-2005
-------
MRID
Citation
Receipt Date
46482205
Young, H. (1998) Flufenoxuron (AC 811678) 100 g a.i./I DC (DF800008): At
Harvest Residue Study on Flufenoxuron in Pears (France, South, 1997). Project
Number: FX/FR/97/753, FX/711/042, 97/753/609. Unpublished study prepared
by Cyanamid Agriculture, Ltd. 105 p.
28-Feb-2005
46482206
Young, H. (1998) Flufenoxuron (AC 811678) 100 g a.i./I DC (DF800008): At
Harvest Residue Study on Flufenoxuron in Pears (France, South, 1997). Project
Number: FX/FR/97/753, FX/711/042. Unpublished study prepared by
Cyanamid Agriculture, Ltd. 39 p.
28-Feb-2005
46482207
Young, H. (1999) Flufenoxuron (AC 811678) 100 g a.s./L DC (CF 800008):
Decline Curve Residue Study on Flufenoxuron in Vines (Spain 1998): Final
Report. Project Number: FX/SP/98/350, FX/713/012, 4494. Unpublished study
prepared by Cyanamid Agriculture, Ltd. 39 p.
28-Feb-2005
46482208
Young, H. (1999) Flufenoxuron (AC 811678) 100 g a.s./L DC (CF800008):
Decline Curve Residue Study on Flufenoxuron in Vines (Hellas 1998): Final
Report. Project Number: FX/HE/98/351, FX/713/013, 4495. Unpublished study
prepared by Cyanamid Agriculture, Ltd. 44 p.
28-Feb-2005
46482209
Devine, H. (2002) BAS 307 I (Flufenoxuron) lOOg a.s./L DC Bas 307 02 I
(CF800008): Decline Curve Residue Study on Flufenoxuron in Vines (Hellas,
2000): Final Report. Project Number: FX/HE/00/511, CEMR/1356,
2002/1012032. Unpublished study prepared by CEM Analytical Services, Ltd.
38 p.
28-Feb-2005
46482210
Buraggi, S. (2002) Flufenoxuron DC: Decline Curve Residue Study on
Flufenoxuron 100 g a.s./L DC (RLM 11153) in Grapevine (Italy, 2000): Final
Report. Project Number: FX/IT/00/01, 2002/1015039, 0009. Unpublished study
prepared by BASF Agro Spa. 112 p.
28-Feb-2005
46482211
Bousquet, C. (2003) Flufenoxuron (AC 811678) 100 g a.s./I DC (CF 800008):
Decline Curve Residue Study on Flufenoxuron in Vines, Northern France,
2000: Final Report. Project Number: FL/FR/00/607, 2003/1005375.
Unpublished study prepared by European Agricultural Services (EAS). 53 p.
28-Feb-2005
46482212
Raunft, E.; Veit, P.; Weber, S. (2004) Study on the Residue Behaviour of
Flufenoxuron in Grapes After Application of BAS 307 10 I Under Field
Conditions in France (N) and Germany, 2003: Final Report. Project Number:
165616, 2004/1010558, AGR/15/03. Unpublished study prepared by BASF
Aktiensellschaft. 26 p.
28-Feb-2005
46482213
Devine, H. (2002) BAS 307 I (Flufenoxuron) lOOg a.s./L DC BAS 307 02 I
(CF800008): At Harvest Residue and Processing Study on Flufenoxuron in
Vines, (Spain, 2002): Final Report. Project Number: FX/SP/00/510,
2002/7010996, CEMR/1355. Unpublished study prepared by CEM Analytical
Services, Ltd. 70 p.
28-Feb-2005
46482214
Bousquet, C. (2003) Flufenoxuron (AC 811678) lOOg a.s./l DC (CF800008):
At Harvest Residue and Processing Study on Flufenoxuron in Vines, North
France, 2000: Final Report. Project Number: FL/FR/00/606, 2003/1005365.
Unpublished study prepared by European Agricultural Services (EAS). 77 p.
28-Feb-2005
-------
MRID
Citation
Receipt Date
46482215
Raunft, E.; Veit, P. (2004) Study on the Residue Behaviour of Flufenoxuron in
Grapes and Grape Process Fractions After Application of BAS 307 10 I Under
Field Conditions in Germany, 2003: Final Report. Project Number: 165613,
2004/1010557. Unpublished study prepared by BASF Aktiengesellschaft. 67 p.
28-Feb-2005
46607200
BASF Corporation (2005) Submission of Toxicity Data in Support of the
Petition for Tolerance of Flufenoxuron in/on Apples, Pears, Oranges, Grapes,
and Meat and Milk Products. Transmittal of 9 Studies.
09-Dec-1997
46607201
Thorpe, E. (1986) In Vitro Mutagenicity Studies with WL115110 (Insecticide)
Using Cultured Chinese Hamster V79 Cells. Project Number: SBGR/86/047,
500/70/729, CY155. Unpublished study prepared by Sittingbourne Research
Center. 42 p.
09-Dec-1997
46607202
Meyer A (1987) Genotoxicity Studies with WL115110: In Vitro Chromosome
Studies with WL115110. Project Number: CY155, SBGR/86/216, 506/70/729.
Unpublished study prepared by Sittingbourne Research Center, Biotech-. 28 p.
09-Dec-1997
46607203
Thorpe, E. (1988) Genotoxicity Studies with WL115110: In Vitro Chromosome
Studies with WL115110 and Glutathione Using Chinese Hamster Ovary (Cho)
Cells. Project Number: CY155, 506/70/729, SBGR/87/117. Unpublished study
prepared by Sittingbourne Research Center. 25 p.
09-Dec-1997
46607204
Meyer, A. (1988) Genotoxicity Studies with WL115110: In Vitro Chromosome
Studies with WL115110 Using a Rat Liver (RL4) Cell Line. Project Number:
506/70/729, SBGR/87/118, CY155. Unpublished study prepared by
Sittingbourne Research Center, Biotech. 56 p.
09-Dec-1997
46607205
McEnaney, S. (1992) Study to Evaluate the Chromosome Damaging Potential
of WL115110 By its Effects on Cultured Human Lymphocytes Using an In
Vitro Cytogenetics Assay. Project Number: 579/169, JHLRESRS/006,
SRS/6/HLC. Unpublished study prepared by Hazleton Uk. 44 p.
09-Dec-1997
46607206
Allen, J.; Proudlock, R.; Brooker, P. (1986) Genotoxicity Studies with WL
115110: In Vivo Chromosome Studies with Rat Bone Marrow Cells. Project
Number: 86/8621, AIA/3286, CY/161. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 27 p.
09-Dec-1997
46607207
Cifone, M. (1988) Mutagenicity Test on WL115110: In the In Vivo/In Vitro
Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay. Project Number:
ST87/129, 10342/0/494, CY/161. Unpublished study prepared by Sittingbourne
Research Center. 41 p.
09-Dec-1997
46607208
Koike, S. (1993) Micronucleus Test on WL115110 in Mice. Project Number:
2L283, CY/161. Unpublished study prepared by Mitsubishi-Kasei, Inst. of
Toxicological & Environmental Sciences. 18 p.
09-Dec-1997
46607209
Miyagawa, M. (1992) Replicative DNA Synthesis (RDS) Test Using Rat Livers
on WL115110. Project Number: 2B300, CY/161. Unpublished study prepared
by Mitsubishi-Kasei, Inst. of Toxicological & Environmental Sciences. 13 p.
09-Dec-1997
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