United States
Environmental Protection
Agency
Office of Prevention,
Pesticide and Toxic
Substance (7501C)
r/EPA
Common Name
Chemical Name:
Trade Names:
EPA Chemical Code:
Chemical Abstracts
Service (CAS) Number:
Chemical Class:
Registration Status:
Pesticide Type:
Mode of Action:
Route of Exposure:
Producer:
Fenazaquin
Import Tolerance
August 2007
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Description of Chemical
Fenazaquin
4-tert-butylphenethyl quinazolin-4-yl ether (IUPAC)
3-[2-[4-(l,l-dimethylethyl) phenyl] ethoxy]
quinazoline (CAS)
Pride®, Magister®
044501
120928-09-8
Quinazoline
No Registered Products
Miticide and Insecticide
Disrupt biochemistry of insect mitochondria
Ingestion and Dermal
Pentagon Fine Chemicals (England)
-------
Use Pattern and Formulations
Fenazaquin belongs to the quinazoline class of chemicals and is a pesticide intended to
control mites and insects (especially whiteflies). Its route of exposure is ingestion and
dermal, and its mode of action is the disruption of the biochemistry of insect
mitochondria.
In 2005 countries throughout Europe, North Africa, the Middle-East, Asia, and in Latin
America had approved its use on pome and citrus fruits. The majority of usage (>80%) is
in Europe. Table 1 provides a general summary of the use directions for apples, pears
and citrus fruits. The Agency also received a label for a 200 g/L F1C formulation from
the U.K., with use directions for apples. This U.K. label specifies a maximum use rate of
150 g ai/ha on apples with a 30-day PHI.
Table 1. Summary of Directions for Use of Fenazaquin.
Applic. Timing,
Type, and Equip.
Formulation
[gai/L]
Applic. Rate
(g ai/ha)
[Ib ai/A]
Max. No.
Applic. per
Season
Max. Seasonal
Applic. Rate
(g ai/ha)
[Ib ai/A]
PHI1
(days)
Use
Directions
and
Limitations
Apples/Pears 2
Early to late season
foliar application 3;
ground equipment
200 g/L F1C
100-250
[0.09-0.22]
1
250
[0.22]
28
Only a single
application is
allowed per
calendar year
Citrus Fruits (Oranges, Mandarins, Lemons) 4
Early to late season
foliar application;
ground equipment
100 g/L EC
200 g/L F1C
100-450
[0.09-0.40]
1
450
[0.40]
21
Only a single
application is
allowed per
calendar year
2 Fenazaquin is reportedly approved for use on apples and/or pears in the following countries: Algeria,
Argentina, Azerbajian, Bulgaria, Chile, China, Croatia, Cyprus, Czech Rep., France, Germany, Greece,
Hungary, Israel, Italy, Jordan, Korea, Lebanon, Macedonia, Morocco, Peru, Poland, Portugal,
Romania, Russia, Slovakia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan,
Turkey, United Kingdom, Uzbekistan, and Yugoslavia.
3 Apply after petal fall.
4 Fenazaquin is reportedly approved for use on citrus in the following countries: Chile, China, Greece,
Italy, Korea, Morocco, South Africa, Spain, Taiwan, and Turkey.
Science Findings
Product chemistry data supporting the use of fenazaquin are summarized below.
-------
1. Physical/Chemical Structure and Nomenclature:
Table 2 presents the structure and nomenclature of fenazaquin below.
Table 2. Fenazaquin Nomenclature.
Compound
Common name
Molecular weight
Company experimental names
IUPAC name
CAS name
CAS registry number
End-use products (EP)
\^ JL Q
H3C CH3
Fenazaquin
306.4
XDE-436, EL-436, XRD-562;,DE-436
4-ter/-butylphenethyl quinazolin-4-yl ether
4-[2-[4-(l,l-dimethylethyl)phenyl]ethoxy]quinazoline
120928-09-8
100 g/L EC (MAGISTER® 100 EC)
200 g/L F1C (MAGISTER® 200 SC and MATADOR® 200 SC)
2. Physical and Chemical Properties
Table 3 presents the physicochemical properties of fenazaquin below.
Table 3. Physicochemical Properties of Fenazaquin.
Parameter
Melting point/range
pH
Relative Density
Water solubility (20°C)
Solvent solubility
(g/L at 23°C)
Vapor pressure (25°C)
Dissociation constant, pKa
Octanol/water partition
coefficient, Log(K0w)
UV/visible absorption
spectrum
Value
77.5-80°C
Not determined due to low solubility
1.16at21°C
0.102mg/LatpH5&7
0.135mg/LatpH9
acetonitrile 33-50
n-chlorobutane >500
dichloromethane >600
dimethylformamide 300-400
hexane 33-50
methanol 50-100
N-methyl-2-pyrrolidone >500
acetone 400-500
chloroform >500
ethyl acetate 400-500
ethylene glycol <5
isopropanol 50-100
toluene >500
1.9xlO-5Pa
2.44
5.71at25°C; 5.51at20°C
Not available
Reference
Evaluation on
Fenazaquin,
Issue No. 150,
Pesticides Safety
Directorate,
Depart, for
Environment,
Food, and Rural
Affairs, U.K.,
March 1996
3. Toxicology Summary
-------
Table 4a and 4b lists toxicity studies that the applicant has submitted. These include an
acute oral study and subacute, chronic, carcinogenicity, developmental and mutagenicity
studies.
Table 4a. Acute Toxicity Data - Fenazaquin Technical
Study/ Species
870. 11 00 Acute Oral (Rat)
870. 1200 Acute Dermal, Rabbits
870. 1300 Acute Inhalation, Rats
870.2400 Primary Eye Irritation, Rabbits
870.2500 Primary Skin Irritation, Rabbits
870.2600 Dermal Sensitization, Guinea pig
MRID
46684003
N/A
N/A
N/A
N/A
N/A
Results
LD50= 134/138mg/kg
(male/female)
Toxicity
Category
II
-------
Table 4b. Subchronic, Chronic and Other Toxicity Profile - Fenazaquin Technical
Guideline
No.
870.3100
870.3100
870.3100
870.3150
870.3700a
870.3700b
Study Type
90-Day oral
toxicity (rat)
(Fischer 344 from
Charles River
Laboratories Inc.,
Wilmington, MA)
90-Day oral
(gavage) toxicity
(rat) (Fischer 344
from Charles River
Laboratories Inc.,
Wilmington, MA)
90-Day oral
toxicity (hamster)
90-Day oral
toxicity (dog)
Prenatal
developmental (rat)
(Crl:CD® (SD) BR
from Charles River
Laboratories Inc.,
Portage, Michigan)
Prenatal
developmental
(rabbit)
MRID No. (year)/
Classification /Doses
45029904 (1992)
Acceptable/guideline
0, 15,45, 150, or450ppm
M:.0, 1.0, 3.0, 9.6, and 28.7
mg/kg/d
F:0.0, 1.2,3.5, 11.5, and
33.0 mg/kg/d
45029905 (1992)
Acceptable/guideline
0, 1, 3, 10, or 30 mg/kg/day
45029903 (1992)
Acceptable/guideline
Males: 0, 5, 25, 75, or 150
mg/kg/day
Females: 0, 5, 25, 50, or 100
mg/kg/day
45029901 (1992)
Acceptable/guideline
0, 1, 5, or 15 mg/kg/day
45029911(1989)
Acceptable/guideline
0, 3, 10, 40 mg/kg/d
45029912 (1990)
Unacceptable/guideline
0, 3, 13, 60 mg/kg/d
Results
NOAEL = 9.6 mg/kg/day
LOAEL = 28.7 mg/kg/day based on
decreased body weight, body weight
gain, and food consumption.
NOAEL = 10 mg/kg/day
LOAEL = 30 mg/kg/day based on
decreased body weight, body weight
gain, and food
consumption/efficiency .
NOAEL = 25 mg/kg/day
LOAEL = 75/50 mg/kg/day (M/F)
based on decreased body weight and
testicular atrophy.
NOAEL = 5 mg/kg/day
LOAEL =15 mg/kg/day based on
decreased body weight, body weight
gain, and food
consumption/efficiency .
Maternal NOAEL = 10 mg/kg/day
LOAEL = 40 mg/kg/day based on
findings (as early as GD 6-9) of
decreased body weight gain, food
intake, and food efficiency.
Developmental NOAEL = 40
mg/kg/day
LOAEL = > 40 mg/kg/day.
Maternal NOAEL = 60 mg/kg/day
LOAEL = > 60mg/kg/day based on
lack of findings.
Developmental NOAEL = 60
mg/kg/day
LOAEL = > 60 mg/kg/day based on
lack of findings.
-------
870.3800
870.4300
870.4100
870.4200
870.5100
870.5300
870.5375
Reproduction and
fertility effects (rat)
(Crl:CD® (SD) BR
from Charles River
Breeding
Laboratories,
Raleigh, NC)
Chronic toxicity/
Carcinogenicity
Rat (Fischer 344
from Taconic
Laboratory
Animals and
Services,
Germantown, N.Y)
Chronic toxicity
(dog)
Carcinogenicity
(hamster)
Gene Mutation
Bacterial reverse
mutation assay
Gene Mutation
Mammalian cell
culture (mouse
lymphoma cells)
Cytogenetics
Chromosomal
aberrations (CHO
cells)
46684001 (1991)
Acceptable/guideline
0, 1,5, or25mg/kg/d
45029907 (1992)
Acceptable/guideline
0, 10, 100, 200, or 400/450
(males/females) ppm
M: .0.0, 0.46, 4.5, 9.2, and
18.3 mg/kg/d
F: 0.0, 0.57, 5.7, 11.5, and
25.9 mg/kg/d
45029906 (1993)
Acceptable/guideline
0, 1, 5, or 12 mg/kg/d
45029913 (1992)
Acceptable/guideline
0,2, 15, or 30/35 (males/
females) mg/kg/d
44742909 (1989)
Acceptable/guideline
44742908 (1989)
Acceptable/guideline
44742907 (1989)
Acceptable/guideline
Parental/Systemic NOAEL = 5
mg/kg/day
LOAEL = 25 mg/kg/day based on
excessive salivation and decreased
body weight/weight gain and food
intake.
Reproductive NOAEL = 25
mg/kg/day
LOAEL = >25 mg/kg/day.
Offspring NOAEL = 5 mg/kg/day
LOAEL = 25 mg/kg/day based on
decreased weight gain during
lactation.
NOAEL = 9.2 mg/kg/day
LOAEL =18.3 mg/kg/day based on
decreased body weight, body weight
gain, and food
consumption/efficiency .
NOAEL = 5 mg/kg/day
LOAEL =12 mg/kg/day based on
decreased body weight, body weight
gain, and food
consumption/efficiency .
NOAEL = 2/15 mg/kg/day (M/F)
LOAEL =15/35 mg/kg/day (M/F)
based on decreased body weight (F)
and body weight gain (M/F)-food
consumption was not recorded.
No evidence of Carcinogenicity
Negative ± S9 up to 3000 ug/mL in
the absence of cytotoxicity with
precipitation above this
concentration.
Negative -S9 severely cytotoxic at
concentrations up to 10 ug/mL
Positive + S9 at concentrations (up to
12 ug/mL) that were severely
cytotoxic (10-20% survival)
Negative ± S9 for
clastogenic/aneugenic activity up to
concentrations that reduced cell
survival by -50% (1 ug/mL-S9; 60
ug/mL+S9). Compound
precipitation was evident at levels >
24 ug/mL +/-S9.
-------
870.5395
870.5915
870.5550
No
Guideline
Micronucleus
Assay (mouse)
In vivo SCE Assay
(mouse)
In vitro UDS Assay
In viro UDS Assay
44742904 (1989)
Acceptable/guideline
44742905 (1989)
Unacceptable/guideline
(each data point had 3 males
which is lower than the
guideline recommended
5/sex/dose)
44742906 (1989)
Acceptable/guideline
45029908 (1989)
Acceptable/non-guideline
Negative for clastogenic/aneugenic
activity in mouse bone marrow up to
the highest dose tested in
males/females (1600/1200 mg/kg,
repeated on two days). In a
preliminary study, the median lethal
doses (MLD) were 3 1917 2430 mg/kg
(M/F).
Negative in this cytogenetic assay
(no increase in SCE) of bone marrow
from male CD-I mice treated with
doses up to levels that produced
death (2000 mg/kg).
Negative up to cytotoxic
concentrations (>0.5 to 1.0 ug/mL).
Negative for DNA damage and repair
in this in vivo/in vitro test system up
to the maximum tolerated dose (600
mg/kg).
-------
870.7485
Metabolism and
pharmacokinetics
(species)
V-M-^*'** *"-v
44742901 (1992)
Unacceptable/guideline
Irrespective of dose, most of an orally
administered radiolabeled fenazaquin
was in rat excreta (89.5-107.7%) at
168 hours with approximately 20%
of the radiolabel in urine. After
initial uniform distribution, about
0.5-1.6% of the dose was in the
carcass and below 0.04% of the dose
in each tissue. There was no
radiolabel in the expired air and no
evidence for bioaccumulation. Based
on excretion and tissue residue data,
bioavailability is conservatively
estimated at about 20% of an
administered dose.
Non-metabolized fenazaquin was
higher in feces (1.0-15.0% of
administered dose) than in urine
(below 0.5% of dose) and some of
the major metabolites were identified
including AN-1 (urine) in addition to
the fecal metabolites F-l, F-2 and F3.
The metabolic pathway of fenazaquin
involved cleavage of the ether bond,
resulting in the formation of the
respective alcohol (4-OH quinazoline
metabolite) and carboxyl acid (AN-1)
derivatives. Other biotransformation
reactions included oxidation of one of
the methyl groups on the alkyl side
chain to produce either an alcohol (F-
1) or carboxylic acid (F-2)
metabolites. Finally, hydroxylation at
the O-ether alkyl moiety of F-l or the
2-position of the quinazoline ring of
F-2 resulted in F-l A and F-3
metabolites, respectively.
-------
Non-
guideline
Special studies:
Potential to induce
hepatic
hypertrophy and
peroxisome acyl-
CoA oxidase
activity in mice
44742903 (1993)
Acceptable/non-guideline
Fenazaquin and several of its analogs
(with varying susceptibilities to
metabolism of the ether bond or the
alkylbenzene substituents) were
assessed for their ability to increase
liver peroxisomal fatty acyl-CoA
oxidase (FAO, a marker of
peroxisomal proliferation) and
relative liver weight in groups of five
CD-I female mice. The FAO
peroxisomal activity data indicate
that oxidation of the t-butyl
substituent on the alkylbenzene
moiety (to the corresponding
carboxylic acid) of fenazaquin and
related compounds appears to be the
critical step for heptatocellular
peroxisome proliferation.
4. Hazard Characterizations
a. Acute Exposure
Fenazaquin is acutely toxic when administered orally in rats (LD50 = 134/138 mg/kg in
males/females). No data were made available on acute toxicity by other routes of
exposure.
b. Repeated Exposure
The major findings following repeated oral administration in rats, hamsters and dogs
were decreases in body weight, body weight gain, food intake, and food efficiency.
With one exception, these findings occurred at the highest tested dose (< 35 mg/kg/day)
in each of the subchronic or chronic toxicity studies.
In the 90-day hamster study which used doses up to 150 (males) and 100 (females)
mg/kg/day, the magnitude of the decrease was dose-dependent for body weight (8-23%
and 19-28% in males and females, respectively) and body weight gain (16-74% and 39-
61% in males and females, respectively); however, due to food spillage problems, food
consumption and efficiency data were not presented. In the same study, testicular
atrophy (dose-dependent decreased weight and hypospermatogenesis) and decreased
prostate weight/relative weight were also evident at 75 and 150 mg/kg/day.
At the doses used (< 35 mg/kg/day) in all remaining subchronic and chronic toxicity
studies, there were no organ specific toxicity findings.
Similar effects on body weight/weight gain and food intake/efficiency were also
identified in parental animals of the rat developmental and reproduction studies and
in the offspring of the reproduction rat study. There were no developmental findings
in the rat study (up to 40 mg/kg) and no parental or developmental findings of any kind
-------
up to 60 mg/kg/day in the rabbit developmental study.
There are no specific neurotoxicity studies, including acute-, subchronic-, or
developmental. There is no clear evidence of consistent neurotoxicity findings in the
available toxicity studies. Findings of excessive salivation in the rat reproduction toxicity
study are unlikely to be a sign of neurotoxicity since the chemical is not known to have a
neurotoxic mode of action and no similar clinical findings were reported in the 90-day or
chronic/carcinogenicity studies.
Fenazaquin appears to increase peroxisomal proliferation in rats and mice but hamsters
were resistant since peroxisomal beta oxidation was not increased in the 90-day hamster
study.
A supplementary report (MRID 44742910) was provided as justification for using the
hamster as an appropriate animal model for fenazaquin. Based on the report, the NOAEL
in a three-month feeding study in mice was 150 mg/kg/day in males and > 600 mg/kg/day
in females and the only effect observed was a decrease in body weight gain. (The actual
90-day mouse study was not made available to EPA.) In the similar rat and hamster
toxicity studies, the NOAEL was 10 and 25 mg/kg/day, respectively, based on decreased
body weight gain (in addition to hamster testicular atrophy) thus showing that the rat and
hamster were more sensitive to the effects of fenazaquin than mice. Additionally, a
comparative pharmacokinetic analysis showed that peak plasma levels were not
proportional to dose in both male and female mice, but area under the curve (AUC) was
well correlated to dose. Peak plasma levels were observed between 0.5-4 hours post
dosing. Plasma elimination rate of fenazaquin was dose dependent and became slower at
doses >300 mg/kg. Conversely, rat peak plasma level was reached in 8 hours and AUC
was proportional to dose while elimination was independent of dose. Results from the
pharmacokinetics study indicated similar pharmacokinetics of radiolabeled fenazaquin in
the hamster at doses between 5 and 125 mg/kg with peak plasma levels being reached in
2 hours.
The hamster was chosen over the mouse for a second carcinogenicity study based on
findings in the hamster of slower elimination kinetics and greater systemic toxicity.
Because of the high tolerance of the mouse in regard to effect on body weight gain, the
laboratory chose to use Syrian golden hamsters as a secondary rodent model, along with
rats.
5. Food Quality Protection Act Considerations
Based on the hazard and exposure data, the fenazaquin risk assessment team has
recommended that the FQPA Safety Factor be reduced to IX because:
a. there is an adequate toxicity database for the food import tolerance on fenazaquin;
b. the exposure data are complete or are estimated based on data that reasonably
account for potential exposures;
c. there is no evidence of susceptibility following in utero and/or postnatal exposure
in the developmental toxicity studies in rats or rabbits, and in the two-generation
10
-------
rat reproduction study;
d. there are no residual uncertainties concerning pre- and postnatal toxicity;
e. the dietary food exposure assessment utilizes proposed tolerance level or higher
residues and 100% CT information for all commodities and, therefore, will not be
underestimated;
f. there is no potential for dietary drinking water exposure; and
g. there are no residential uses.
6. Classification of Carcinogenic Potential
EPA reviewed the carcinogenicity study in hamsters, as well as the carcinogenicity study
conducted in rats, the mutagenicity studies, and discussed the possible carcinogenic mode
of action of fenazaquin. Based on the weight of evidence of these studies, and in
accordance with the 2005 Guidelines for Carcinogen Risk Assessment, the members
concluded that the negative hamster findings along with the negative tumor findings in
the 24-month rat study and negative mutagenicity findings support a cancer classification
of "Not likely to Be Carcinogenic to Humans" for fenazaquin. EPA concluded that
the carcinogenicity study in hamsters is "Acceptable/Guideline" and satisfies the
guideline requirement for a carcinogenicity study [OPPTS 870.4200; OECD 451] in
hamsters. Despite the enteritis and administration of antibiotics, the study is considered
acceptable based on the adequacy of dosing based on evidence of systemic toxicity,
acceptable survival rate at 17 months, and lack of evidence for tumorigenicity in two
species, hamsters and rats.
7. Toxicological Doses and Endpoints
Table 5 summaries the toxicological doses and endpoints for use in the fenazaquin
dietary assessment.
11
-------
Table 5. Summary of Toxicological Doses and Endpoints for Fenazaquin for Use in
Dietary and Non-Occupational Human Health Risk Assessments
Exposure/
Scenario
Acute Dietary (All
Populations,
including Females
13-49 and
Infants/Children)
Chronic Dietary
(All Populations)
Short- and
Intermediate-Term
Incidential Oral (1-
30 days; 1-6
months)
Short- ,
Intermediate-, and
Long-Term Dermal
(1-30 days; 1-6
months)
Short-,
Intermediate-, and
Long-Term
Inhalation (1-30
days; 1-6 months)
Cancer (oral,
dermal, inhalation)
Point of
Departure
NOAEL= 10
mg/kg/day
NOAEL= 5
mg/kg/day
Uncertainty /FQPA
Safety Factors
UFA= 10 x
UFH= 10 x
FQPA SF= 1 x
UFA= 10 x
UFH= 10 x
FQPA SF= 1 x
RfD, PAD,
Level of
Concern for
Risk
Assessment
Acute RfD =
0.1 mg/kg/day
aPAD = 0.1
mg/kg/day
Chronic RfD =
0.05 mg/kg/day
cPAD = 0.05
mg/kg/day
Study and Toxicological Effects
Rat developmental toxicity
LOAEL = 40 mg/kg/day based on
findings (as early as GD 6-9) of
decreased body weight gain, food
intake, and food efficiency.
Rat two-generation toxicity study
LOAEL = 25 mg/kg/day based on
excessive salivation and decreased
body weight/weight gain and food
intake.
These exposure scenarios do not apply to this risk assessment because there are no proposed
registered residential uses of fenazaquin.
These exposure scenarios do not apply to this risk assessment because there are no proposed
registered residential or occupational uses of fenazaquin.
These exposure scenarios do not apply to this risk assessment because there are no proposed
registered residential or occupational uses of fenazaquin.
Classification: "Not likely to be Carcinogenic to Humans" based on the absence of
significant tumor increases in two adequate rodent carcinogenicity studies.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response
data and used to mark the beginning of extrapolation to determine risk associated with lower
environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest
observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose. N/A = not applicable.
8. Dietary Exposure and Risk
Acute and chronic dietary risk analyses were made with the DEEM-FCID™ model to
form a conservative evaluation of exposure for fenazaquin. The acute dietary analysis
made at the 95th percentile indicate risk estimates are reasonably below the 100% of the
aPAD threshold level of concern for each population subgroup. For the most highly
exposed population subgroup, children 1-2 years of age, acute dietary risk was estimated
to be 48% of the aPAD with an exposure of 0.047574 mg/kg/day. In conjunction,
chronic analysis yielded risk estimates well below the 100% of the cPAD threshold level
12
-------
of concern for each population subgroup. Likewise, for children 1-2 years of age,
chronic dietary risk proved to be 25% of the cPAD with an exposure of 0.012690
mg/kg/day. Table 6 summarizes the results of the acute and chronic dietary assessments.
Table 6. Summary of Dietary Exposure and Risk for Fenazaquin
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old3
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
(95.0 Percentile)
Dietary
Exposure
(mg/kg/day)
0.014857
0.011808
0.047574
0.034100
0.020877
0.015223
0.010338
0.008336
0.011299
% aPAD1
15
12
48
34
21
15
10
8.3
11
Chronic Dietary
Dietary
Exposure
(mg/kg/day)
0.003092
0.004650
0.01269
0.009100
0.004865
0.002967
0.001967
0.002020
0.002177
% cPAD1
6.2
9.3
25
18
9.7
5.9
3.9
4.0
4.4
Cancer
Dietary
Exposure
(mg/kg/day)
NA2
NA
Risk
NA
NA
1 Report %PADs to 2 significant figures.
2 Not Applicable (NA).
3 The values for the highest exposed population for each type of risk assessment should be bolded.
9. Anticipated Residue and Percent Crop Treated (%CT) Information
EPA assumes that fenazaquin residues are in/on all registered food commodities at
tolerance levels and that 100% of all PsACs are treated.
10. Aggregate Risk Assessments and Risk Characterization
There are no proposed or existing residential uses for fenazaquin. The proposed use is
limited to apples, pears and citrus fruits exported to the U.S. only. The exposure/risk
assessment is limited to dietary food only (no aggregate).
11. Occupational Exposure and Risk
As this assessment is for an import tolerance, the anticipated exposure route for the US
population is via the diet (food only). Thus, occupational exposure risk assessments for
incidental oral, dermal, and inhalation routes of exposure are not required.
13
-------
12. Proposed and Established Tolerances
Table 7 lists the proposed and established tolerance for Fenazaquin. EPA established no
tolerances for livestock commodities as EPA does not expect any residues in those
commodities.
Table 7. Tolerance Summary for Fenazaquin.
Commodity
Apple
Pear
Citrus fruits
Citrus oil
Apple, pomace, wet
Citrus, pulp, dried
Proposed Tolerance
(ppm)
0.2
0.2
0.5
None
None
None
Recommended
Tolerance (ppm)
0.2
0.2
0.5
10
None
None
Comments;
Correct Commodity Definition
Adequate data are available
Adequate data are available
Adequate data are available.
Fruit, citrus, group 10, except
grapefruit
Based on HAFT residues of 0.40
ppm and an average processing
factor of 25x for citrus oil, a
separate tolerance is required for
Citrus, oil
Although residues were shown to
concentrate in wet apple pomace
(1.7x) and dried citrus pulp
(3.2x), tolerance are not required
for these feedstuff as they are
unlikely to be imported.
13. Data Gaps
A. Current Import Tolerances
1. Additional storage stability data are required on apples to support the sample
storage intervals from the tests conducted on pears and apples in Argentina
during 1993/94 and on apples in Chile during 1995. Gowan must submit data
demonstrating the stability of fenazaquin in frozen apples for intervals up to
25 months.
2. Gowan must submit a reference standard for fenazaquin to the National
Pesticide Standards Repository.
B. Future Tolerances
1. Radio validation data demonstrating the extraction efficiency of the proposed
single analyte enforcement methods were not submitted. However, the
available data indicate fenazaquin tolerances may be enforced using the
existing FDA Multiresidue Methods in PAM, Vol I. Testing of fenazaquin
through the multiresidue methods indicated that fenazaquin was adequately
recovered from whole oranges and from orange oil. Radiovalidation data for
the single analyte methods should be submitted with future petitions.
14
-------
2. For future petitions, the following information is needed for each of the ILV
studies: (i) a description of the number of trials required to obtain the reported
recovery values; (ii) a description of any problems encountered and a written
description of any changes or modifications that were made to the method
during the ILV; (iii) discussion of any steps considered critical; (iv) time
required for analysis of one set of samples; and (v) details of communications
between the independent laboratory and the method developers or others
familiar with the method.
3. Gowan must develop and validate (ILV and radiovalidation) an analytical
enforcement method capable of quantitating parent fenazaquin and its dimer
prior to conducting crop field trial studies to support any new uses.
14. Labeling Deficiencies
Although a general summary of the use directions on apples, pears and citrus
fruits was provided, additional information is required detailing the maximum
allowed use rates and minimum PHIs allowed for apples, pears and citrus fruits in
each country in which these uses are allowed. Representative labels (and
translations) should be submitted for each crop from the major growing regions
(Europe, South America, and Asia).
Contact Person at USEPA:
Dan Peacock
Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7504P)
Insecticide-Rodenticide Branch
1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001
Office Location and telephone number:
7262, Potomac Yard South
2777 South Crystal Dr.
Arlington V.A. 22202
703-305-5407
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.
15
-------
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
LCso
LD
'50
LOAEL
LOAEC
LOC
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
16
-------
LOD
LOQ
mg/kg/day
mg/L
MOE
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
ug
ug/L
uL/g
USDA
WPS
Limit of Detection
Limit of quantitation
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
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 to be Part of the Data Base Supporting the Registration of
17
-------
Fenazaquin
MRID
Citation Reference
43798700 DowElanco (1995) Submission of Toxicology Data in Support of the Registration of
Fenazaquin. Transmittal of 2 Studies.
43798701 Francis, P.; Boss, S.; Cries, C. (1992) A Carcinogenicity Study in Syrian Golden
Hamsters Administered EL-436 (Compound 193136) Orally for 18 Months: Lab
Project Number: T6K TCHMST AM: HC0307: H00390. Unpublished study prepared
by Lilly Research Labs. 2781 p.
43798702 Francis, P. (1995) Supplement to the "Carcinogenicity Study in Syrian Golden
Hamsters Administered EL-436 (Compound 193136) Orally for 18 Months": A Review
of the Historical Incidence of Adrenocortical Adenomas in Hamsters: Lab Project
Number: HC0307: H00390: H00790. Unpublished study prepared by Lilly Research
Labs. 12 p.
44742900 Dow Agrosciences LLC (1999) Submission of Toxicity and Residue Chemistry Data in
Support of the Petition for Tolerance for Fenazaquin in/on Apples, Pears,and Citrus
Fruits. Transmittal of 21 Studies.
44742901 Althaus, W.; Magnussen, J. (1992) Disposition and Metabolism of Orally Administered
(carbon-14)-EL-436 in Fischer 344 Rats: Lab Project Number: R18289: R31489:
R37189. Unpublished study prepared by DowElanco. 193 p.
44742902 Dow AgroSciences Europe (1990) Body Weight Data for Rats, Hamsters, Mice from
Studies R04790, R12188, R27388, R02789, R05289, R05389, H00489, H00190,
M21989, M06288: Lab Project Number: T6K-006. Unpublished study prepared by
Jellinek, Schwartz, and Connolly, Inc. 92 p.
44742903 Stott, W.; Vedula, U.; Bond, D. et al. (1993) Potential of XDE-436 Analogues to
Induce Hepatic Hypertrophy and Peroxisome ACYL-CoA Oxidase Activity in Mice:
Lab Project Number: T2.02. 201.000.001. Unpublished study prepared by The Dow
Chemical Company. 38 p.
44742904 Francis, P.; Parton, J.; Garriott, M. (1989) The Effect of EL-436 (Compound 193136)
on the in Vivo Induction of Micronuclei in Bone Marrow of ICR Mice: Lab Project
Number: 890718ATX2884: 890725MNT2884. Unpublished study prepared by The
Lilly Research Laboratories. 31 p.
44742905 Francis, P.; Brunny, J.; Garriott, M. (1989) The Effect of EL-436 (Compound 193136)
on the in Vivo Induction of Sister Chromatid Exchange in Bone Marrow of Male CD-I
Mice: Lab Project Number: 890911ATX2884: 89092926SCE2884. Unpublished study
prepared by The Lilly Research Laboratories. 35 p.
44742906 Francis, P.; Yount, D.; Garriott, M. (1989) The Effect of EL-436 (Compound 193136)
on the Induction of Unscheduled DNA Synthesis in Primary Cultures of Adult Rat
Hepatocytes: Lab Project Number: 890516UDS2884: 890718UDS2884. Unpublished
study prepared by The Lilly Research Laboratories. 29 p.
44742907 Francis, P.; Kindig, D.; Garriott, M. (1989) The Effect of EL-436 (Compound 193136)
on the in Vitro Induction of Chromosome Aberrations in Chinese Hamster Ovary Cells:
Lab Project Number: 890725CTX2884: 890802CAB2884: 890816CAB2884.
Unpublished study prepared by The Lilly Research Laboratories. 41 p.
44742908 Francis, P.; Michealis, K.; Ricardson, K. (1989) The Effect of EL-436 (Compound
193136) on the Induction of Forward Mutation at the Thymidine Kinase Locus of
18
-------
L5178Y Mouse Lymphoma Cells: Lab Project Number: 890719MLT2884:
890726MLA2884: 890816MLA2884. Unpublished study prepared by The Lilly
Research Laboratories. 51 p.
44742909 Francis, P.; Scheming, I; Ricardson, K. (1989) The Effect of EL-436 (Compound
193136) on the Induction of Reverse Mutations in Salmonella Typhimurium and
Escherichia coli Using the Ames Test: Lab Project Number: 890327AMT2884:
890814AMS2884. Unpublished study prepared by The Lilly Research Laboratories. 45
P-
44742910 Francis, P. (1990) EL-436 (Compound 193136): Experimental Miticide: Justification
for Use of the Hamster in an Oncogenic Study. Unpublished study prepared by The
Lilly Research Laboratories. 44 p. {OPPTS 870.4100}
44742911 Dennis, S. (1998) Supplemental Report for: (carbon-14)-XDE-436 Nature of Residues
in Apples: Lab Project Number: ABC-0455SUPPL: ABC-0455. Unpublished study
prepared by Jellinek Schwartz and Connolly, Inc. 459 p.
44742912 Dennis, S. (1998) Supplemental Report for: The Disposition of (carbon-14)-Fenazaquin
in the Lactating Goat: Lab Project Number: GHE-P-6987SUPPL. Unpublished study
prepared by Jellinek Schwartz and Connolly, Inc. 1078 p.
44742913 Dennis, S. (1998) Supplemental Report for: Nature of (carbon-14)-XDE-436 Residues
in Oranges: Lab Project Number: ABC-0454SUPPL. Unpublished study prepared by
Jellinek, Schwartz and Connolly, Inc. 426 p.
44742914 Dennis, S.; Perkins, J. (1998) Determination of Fenazaquin in/on Various Raw
Agricultural and Processed Commodities: Lab Project Number: JSC-98-100:
DOWM101198-DE92C: ERC91.17. Unpublished study prepared by Jellinek, Schwartz
and Connolly, Inc. 297 p. {OPPTS 860.1340}
44742915 Gambie, A. (1993) Independent Method Validation of DowElanco Method ERC 91.9
Determination of Fenazaquin in Residues in Apples: Lab Project Number: R92-36L:
GHE-P-3051: IRI 360180. Unpublished study prepared by Inveresk Research
International Limited. 56 p. {OPPTS 860.1340}
44742916 Rawle, N. (1998) Independent Method Validation for the Determination of Fenazaquin
in Apple Juice: Lab Project Number: CEMS-913: REV 98-012. Unpublished study
prepared by CEM Analytical Services Ltd. 20 p. {OPPTS 860.1340}
44742917 Rawle, N. (1998) Independent Method Validation for the Determination of Fenazaquin
in Orange and Lemon Juice: Lab Project Number: REV 98-013: CEMS-914.
Unpublished study prepared by CEM Analytical Services Ltd. 36 p. {OPPTS
860.1340}
44742918 Long, T.; Gill, J. (1996) Independent Method Validation of DowElanco Analytical
Method ERC 94.15 for the Determination of Fenazaquin in Orange and Mandarin
Whole Fruit: Lab Project Number: GHE-P-5115: REV96-009. Unpublished study
prepared by Restec Laboratories Ltd. 46 p. {OPPTS 860.1340}
44742919 Conrath, B.; West, S. (1998) Multi-Residue Methods Testing for Fenazaquin: Lab
Project Number: 44216: RES97095. Unpublished study prepared by ABC Laboratories
Inc. 67 p. {OPPTS 860.1360}
44742920 Dennis, S. (1998) Supplemental Report for: The Stability of Fenazaquin in Fortified
Apples Stored Under Frozen Conditions: Lab Project Number: GHE-P-3048SUPPL.
Unpublished study prepared by Jellinek, Schwartz and Connolly, Inc. 690 p. {OPPTS
860.1380}
44742921 Dennis, S. (1998) Supplemental Report for: The Stability of Fenazaquin in Fortified
Orange Peel and Flesh Under Frozen Conditions: Lab Project Number: GHE-P-
19
-------
3154SUPPL. Unpublished study prepared by Jellinek, Schwartz and Connolly, Inc. 840
p. {OPPTS 860.1380}
44743000 Dow Agrosciences LLC (1998) Submission of Residue Chemistry Data in Support of
the Petition for Tolerance of Fenazaquin in/on Apples, Pears, and Citrus Fruits.
Transmittal of 18 Studies.
44743001 Dennis, S. (1998) Supplemental Report for: Livestock Feeding Study with (carbon-14)-
Fenazaquin in Dairy Cattle: Lab Project Number: GHE-P-3159SUPPL: R92-7: DWC
632. Unpublished study prepared by Dow AgroSciences Europe. 300 p. {OPPTS
860.1480}
44743002 Hastings, M. (1998) Residues of Fenazaquin in Apples at Harvest Following a Single
Application of Magister 200SC (EF-1127), South Africa-1997: Lab Project Number:
GHE-P-7372: R97-122. Unpublished study prepared by Dow AgroSciences Europe. 32
P-
44743003 Hastings, M. (1998) Residues of Fenazaquin in Pears at Harvest Following a Single
Application of Magister 200SC (EF-1127), South Africa-1997: Lab Project Number:
R97-123: GHE-P-7373. Unpublished study prepared by Dow AgroSciences Europe. 30
p. {OPPTS 860.1500}
44743004 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Mandarins at
Intervals Following a Single Application of Magister 100 EC (EF-1131), Spain~1996:
Lab Project Number: GHE-P-6256 SUPPL: R96-169. Unpublished study prepared by
Dow AgroSciences Europe. 373 p. {OPPTS 860.1500}
44743005 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Harvest Following a Single Application of Magister 10 (EF-1131), Spain~1994: Lab
Project Number: GHE-P-4064SUPPL: R94-135. Unpublished study prepared by Dow
AgroSciences Europe. 99 p. {OPPTS 860-1500}
44743006 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Pears at Harvest
Following Application of an Magister SC Formulation (EF-1127)~Italy 1992: Lab
Project Number: GHE-P-3002SUPPL: R92-42. Unpublished study prepared by Dow
AgroSciences Europe. 159 p. {OPPTS 860.1500}
44743007 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Harvest Following a Single Application of Magister 100 EC (EF-1131), Spain-1996:
Lab Project Number: GHE-P-6227SUPPL: R96-066. Unpublished study prepared by
Dow AgroSciences Europe. 168 p. {OPPTS 860.1500}
44743008 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Lemons at Harvest
and in Lemon Process Fractions Following Application of an EC Formulation (EF-
1131)-Spain 1991: Lab Project Number: GHE-P-2676SUPPL: R91-41: XDE-436.M.
Unpublished study prepared by Dow AgroSciences Europe. 1320 p. {OPPTS 860.1500,
860.1520}
44743009 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Pears at Harvest
Following Application of Magister 200 SC (EF-1127)~France 1993: Lab Project
Number: GHE-P-3474SUPPL: R93-81. Unpublished study prepared by Dow
AgroSciences Europe. 151 p. {OPPTS 860.1500}
44743010 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Intervals Following a Single Application of Magister 100 EC (EF-1131), Spain-1996:
Lab Project Number: GHE-P-6228SUPPL: R96-067. Unpublished study prepared by
Dow AgroSciences Europe. 292 p. {OPPTS 860.1500}
44743011 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Intervals Following a Single Application of Magister 100 EC (EF-1131) Spain~1996:
20
-------
Lab Project Number: GHE-P-6255SUPPL: R96-164. Unpublished study prepared by
Dow AgroSciences Europe. 171 p. {OPPTS 860.1500}
44743012 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Mandarins at
Harvest Following a Single Application of Magister 100 EC (EF-1131) Spain~1995:
Lab Project Number: GHE-P-5145SUPPL: R95-153. Unpublished study prepared by
Dow AgroSciences Europe. 136 p. {OPPTS 860.1500}
44743013 Dennis, S. (1998) Supplemental Report for Residues of Fenazaquin in Lemons at
Harvest Following Application of an EC Formulation (EF-113 l)~Italy 1995: Lab
Project Number: GHE-P-3081SUPPL: R92-43: XDE-436.M. Unpublished study
prepared by Dow AgroSciences Europe. 379 p. {OPPTS 860.1500}
44743014 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Mandarins at
Intervals Following a Single Application of Magister 10 (EF-1131), Spain~1994: Lab
Project Number: GHE-P-4065S SUPPL: R94-136. Unpublished study prepared by Dow
AgroSciences Europe. 157 p. {OPPTS 860.1500}
44743015 Dennis, S. (1998) Supplemental Report for: The Effect of Application Timing on
Fenazaquin Residues in Apples at Harvest Using an SC Formulation (EF-1127)~France
1990: Lab Project Number: GHE-P-2534SUPPL: R90-23. Unpublished study prepared
by Dow AgroSciences Europe. 248 p.
44743016 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Intervals
Following Application of an SC Formulation (EF-1127)~France 1990: Lab Project
Number: GHE-P-2536SUPPL: R90-55. Unpublished study prepared by Dow
AgroSciences Europe. 652 p. {OPPTS 860.1500}
44743017 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Harvest
Following Application of an SC Formulation (EF-1127)~Italy 1992: Lab Project
Number: GHE-P-2877RSUPPL: R92-41: XDE-436.M. Unpublished study prepared by
Dow AgroSciences Europe. 260 p. {OPPTS 860.1500}
44743018 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Apples at
Harvest Following One or Two Applications of Magister 200 SC (EF 1127)~Italy
1993: Lab Project Number: GHE-P-3328SUPPL: R93-121: 360898. Unpublished study
prepared by Dow AgroSciences Europe. 60 p. {OPPTS 860.1500}
44743100 Dow Agrosciences LLC (1999) Submission of Residue Chemistry and Product
Chemistry Data in Support of the Petition for Tolerance of Fenazaquin in/on Apples,
Pears, and Citrus Fruits. Transmittal of 30 Studies.
44743101 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Apples at
Harvest Following Application of Magister 200 SC (EF 1127)~Italy 1993: Lab Project
Number: GHE-P-3327SUPPL: R93-84B: 360882. Unpublished study prepared by Dow
Agrosciences Europe. 152 p. {OPPTS 860.1500}
44743102 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Apples at
Harvest Following Application of an SC Formulation (EF 1127)~Spain 1992: Lab
Project Number: GHE-P-2888SUPPL. Unpublished study prepared by Dow
Agrosciences Europe. 136 p. {OPPTS 860.1500}
44743103 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Intervals
Following Application of an SC Formulation (EF 1127)~UK 1990: Lab Project
Number: GHE-P-2535SUPPL: R90-53: ERC91.9. Unpublished study prepared by Dow
Agrosciences Europe. 459 p. {OPPTS 860.1500}
44743104 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Intervals
and in Apple Process Fractions Following a Single Application of an SC Formulation
(EF 1127)~UK 1991: Lab Project Number: GHE-P-2637SUPPL: 91/21: ERC 91.9.
21
-------
Unpublished study prepared by Dow Agrosciences Europe. 1701 p. {OPPTS 860.1520}
44743105 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Citrus (Oranges
and Mandarins) Flesh and Peel at Intervals Following Application of an EC
Formulation (EF 1131)»Spain 1990: Lab Project Number: GHE-P-2537SUPPL: R90-
6A. Unpublished study prepared by Dow Agrosciences Europe. 1513 p. {OPPTS
860.1500}
44743106 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Oranges at Harvest
Following an Application of an EC Formulation (EF 113 l)~Italy 1992: Lab Project
Number: GHE-P-3122SUPPL: R9244B1.S: R 92-441. Unpublished study prepared by
Dow Agrosciences Europe. 231 p. {OPPTS 860.1500}
44743107 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Orange Process
Fractions Following Application of an EC Formulation (EF 113 l)~Spain 1992: Lab
Project Number: GHE-P-3225SUPPL: AG/REP/13958: AMH/AG267. Unpublished
study prepared by Dow Agrosciences Europe. 246 p. {OPPTS 860.1520}
44743108 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Harvest Following Application of Pride 200 SC (EF 1127)-Morocco 1993: Lab Project
Number: GHE-P-3533SUPPL: CEMS-315: R93-142. Unpublished study prepared by
Dow Agrosciences Europe. 112 p. {OPPTS 860.1500}
44743109 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Mandarin Peel
and Pulp Following Application of an SC Formulation (EF 1127), Spain-1991: Lab
Project Number: GHE-P-2678SUPPL: R91.40: ERC 91.17. Unpublished study
prepared by Dow Agrosciences Europe. 707 p. {OPPTS 860.1500}
44743110 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Oranges at Harvest
and in Orange Process Fractions Following a Single Application of an SC Formulation
(EF 1127)»Spain 1991: Lab Project Number: GHE-P-2677SUPPL. Unpublished study
prepared by Dow Agrosciences Europe. 761 p. {OPPTS 860.1500}
44743 111 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Apples at
Harvest Following a Single Application of Magister 200 SC Formulation (EF 1127),
Germany-1995: Lab Project Number: GHE-P-4683SUPPL: RL95-073A: RL95-073B.
Unpublished study prepared by Dow Agrosciences Europe. 70 p. {OPPTS 860.1500}
44743112 Pinheiro, A. (1997) Amended Report for Residues of Fenazaquin in Apples After
Treatment with Magister 200 SC-Chile: Lab Project Number: LARP95178R: GHB-P
369-R3. Unpublished study prepared by Dow AgroSciences. 76 p. {OPPTS 860.1500}
44743113 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Mandarins at
Harvest Following a Single Application of Magister 10 Formulation (EF 1131), Spain--
1994: Lab Project Number: GHE-P-4066SUPPL: R94-137. Unpublished study
prepared by Dow Agrosciences Europe. 95 p.
44743114 Gagnotto, S.; De Vito, R.; Silva, C. (1998) Amended Report for Residues of
Fenazaquin in Pears Following Application of Magister 200 SC~Argentina, 1993-95:
Lab Project Number: LARP C017: GHB-P 309R1. Unpublished study prepared by
Dow AgroSciences. 60 p. {OPPTS 860.1500}
44743115 Amaral, L.; Silva, C. (1998) Amended Report for Residues of Fenazaquin in Pears
After Treatment with Magister 200 SC~Chile: Lab Project Number: LARP95179R:
GHB-P 365R. Unpublished study prepared by Dow AgroSciences. 72 p. {OPPTS
860.1500}
44743116 Gagnotto, S.; Silva, C.; De Vito, R. (1998) Amended Report for Residues of
Fenazaquin in Apples Following Application of Magister 200 SC~Argentina, 1993-95:
Lab Project Number: LARP C016: GHB-P 308-R1. Unpublished study prepared by
22
-------
Dow AgroSciences. 63 p. {OPPTS 860.1500}
44743117 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Oranges at Harvest
and in Orange Process Fractions (Juice and Marmalade) Following Application of an
EC Formulation (EF 1131)»Spain 1992: Lab Project Number: GHE-P-3082RSUPPL:
R92-47B 93/96: R92-47B 93/97. Unpublished study prepared by Dow Agrosciences
Europe. 598 p. {OPPTS 860.1520}
44743118 Utting, A.; Perm, M. (1998) Residues of Fenazaquin in Apples and Pears After
Application of Magister 20SC Acaricide in New Zealand, 1997: Lab Project Number:
GHF-P 1697: 96-329-E: 97-330-E. Unpublished study prepared by Dow AgroSciences.
29 p. {OPPTS 860.1500}
44743119 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Apples and
Pears After Application of Magister 20SC Acaricide in New Zealand, 1997: Lab
Project Number: GHE-P-1697SUPPL: 96-330E. Unpublished study prepared by Dow
Agrosciences Europe. 728 p. {OPPTS 860.1500}
44743120 Moreland, I; Ghosh, D.; losson, I. (1992) Characterisation of DE 436 Technical, RMM
1836: Lab Project Number: 91033/DB. Unpublished study prepared by Dowelanco Ltd.
46 p. {OPPTS 830.1670}
44743121 Richardson, N. (1996) Fenazaquin (Technical) Initial Characterisation: Lab Project
Number: 91003/CE: GHE-P-5315: 9479A. Unpublished study prepared by Huntingdon
Life Sciences. 110 p.
44743122 Dennis, S. (1998) Fenazaquin-Description of Manufacturing Process and Solubility
Data: Lab Project Number: JSC-98-103. Unpublished study prepared by Dow
Agrosciences Europe Inc. 19 p.
44743123 Richardson, N. (1996) Fenazaquin Technical-Five Batch Analysis: Lab Project
Number: GHE-P-5317: 91033/CF. Unpublished study prepared by Huntingdon Life
Sciences, Inc. 119 p.
44743124 Knowles, S.; Drossopoulos, M. (1998) Re-assay Fenazaquin, AGR289213: Lab Project
Number: GHE-P-7285: P98-039. Unpublished study prepared by Huntingdon Life
Sciences, Inc. 21 p.
44743125 Richardson, N.; Comb, A. (1996) Fenazaquin Technical-Impurity Standard
Characterisation: Lab Project Number: GHE-P-5319: 91033/CF. Unpublished study
prepared by Huntingdon Life Sciences, Inc. 85 p.
44743126 Knowles, S. (1992) XDE 436 (Technical): Determination of Physico-Chemical
Properties: Final Report: Lab Project Number: DES/061: 92/DES061/0338: 91033/CA.
Unpublished study prepared by Life Science Research, Ltd. and ICIFCMO. 137 p.
44743127 Saunders, D.; Powers, F. (1991) Vapor Pressure of EL-436: Lab Project Number:
AAC8849. Unpublished study prepared by Dowelanco. 46 p.
44743128 Knowles, S. (1992) XDE 436 (Technical): Determination of Physico-Chemical
Properties: (Vapour Pressure Determination) Final Report: Lab Project Number:
DES/061: 93/DES061/0305: 91003/CA. Unpublished study prepared by Pharmaco, Ltd.
and University of Leeds. 39 p.
44743129 Boothroyd, S. (1998) Determination of the Dissociation Constant of XDE 436
(Technical) Batch Number RMM 1836: Lab Project Number: 91033/CD: GHE-P-3168.
Unpublished study prepared by Pharmaco, Ltd. 44 p.
44743130 Saunders, D.; Powers, F. (1989) Octanol/Water Partition Coefficient of El 436: Lab
Project Number: AAC8841. Unpublished study prepared by DowElanco. 32 p.
23
-------
45029900 Great Lakes Chemical Corporation (1998) Submission of Toxicity, and Residue
Chemistry Data in Support of the Petition for Tolerance of Fenazaquin in/on Apples,
Pears, and Citrus Fruits. Transmittal of 56 Studies.
45029901 Cosse, P.; Stebbins, K.; Stewart, H. et al. (1992) XDE-436: 13-Week Dietary Toxicity
Study in Beagle Dogs: Lab Project Number: DR-0316-5240-002: DR-0316-5240-002A.
Unpublished study prepared by The Dow Chemical Company. 217 p.
45029902 Scott, W.; Cosse, P.; Stebbins, K. et al. (1991) XDE-436: Palatability Probe and Two-
Week Repeated Dosing Toxicity Study in Beagle Dogs: Lab Project Number: DR-
0316-5240-001: DR-0316-5240-001P: DR-0316-5240-001 A. Unpublished study
prepared by The Dow Chemical Company. 72 p.
45029903 Francis, P.; Boss, S.; Cries, C. (1992) A Subchronic Study in Syrian Golden Hamsters
Treated Orally with EL-436 (Compound 193136) for 3 Months: Lab Project Number:
H00190. Unpublished study prepared by Lilly Research Laboratories. 488 p.
45029904 Cocke, P.; Francis, P.; Gries, C. (1992) A Subchronic Toxicity Study in Fischer 344
Rats Given EL-436 (Compound 193136) in the Diet for 3 Months: Lab Project
Number: R27388. Unpublished study prepared by Lilly Research Laboratories. 373 p.
45029905 Francis, P.; Ward, V.; Gries, C. (1992) A Subchronic Toxicity Study in Fischer 344
Rats Treated Orally with EL-436 (Compound 193136) for 3 Months Followed by a 1-
Month Reversibility Period: Lab Project Number: R12188. Unpublished study prepared
by Lilly Research Laboratories. 545 p.
45029906 Cosse, P.; Sebbins, K.; McGuirk, R. et al. (1993) XDE-436: 1-Year Dietary Toxicity
Study in Beagle Dogs: Lab Project Number: DR-0316-5240-003: PRE XDE-436-1YR.
Unpublished study prepared by The Dow Chemical Company. 259 p.
45029907 Cocke, P.; Francis, P.; Boss, S. et al. (1992) A Chronic/Oncogenic Toxicity Study in
Fischer 344 Rats Administered EL-436 (Compound 193136) in the Diet for 2 Years:
Lab Project Number: R05289: R05389. Unpublished study prepared by Lilly Research
Laboratories. 3209 p.
45029908 Proudlocke, R. (1993) Fenazaquin: In Vivo Rat Liver DNA Repair Test: Lab Project
Number: DWC 662/931816. Unpublished study prepared by Huntingdon Research
Centre Ltd. 47 p. {OPPTS 870.5550}
45029909 Christian, M.; Martin, T.; Hoberman, A. (1992) Reproductive Effects of EL-436
(Compound 193136) Administered Orally Via Gavage to Crl: CD(SD)BR Rats for Two
Generations, with One Litter per Generation: Lab Project Number: 112-003.
Unpublished study prepared by Argus Research Laboratories, Inc. 782 p.
45029910 Christian, M.; Martin, T.; Hoberman, A. (1992) Reproductive Effects of EL-436
(Compound 193136) Administered Orally Via Gavage to Crl: CD(SD)BR Rats for Two
Generations, with One Litter per Generation: Lab Project Number: 112-003.
Unpublished study prepared by Argus Research Laboratories, Inc. 782 p.
45029911 Francis, P.; Higdon, G. (1989) A Teratology Study of EL-436 (Compound 193136)
Administered By Gavage to CD Rats: Lab Project Number: R08989. Unpublished
study prepared by Lilly Research Laboratories. 365 p.
45029912 Francis, P.; Higdon, G. (1990) A Teratology Study of EL-436 (Compound 193136)
Administered By Gavage to New Zealand White Rabbits: Lab Project Number:
B02289. Unpublished study prepared by Lilly Research Laboratories. 285 p.
45029913 Francis, P.; Boss, S.; Gries, C. (1992) A Carcinogenicity Study in Syrian Golden
Hamsters Administered EL-436 (Compound 193136) Orally for 18 Months: Lab
Project Number: H00390: H00790: HC0307. Unpublished study prepared by Lilly
Research Laboratories. 2781 p.
24
-------
45029914 MacDonald, A. (1998) Characterisation of Unknown Fenazaquin Metabolites from
Apples: Lab Project Number: GHE-P-7205: E98-001. Unpublished study prepared by
Dow AgroSciences. 122 p.
45029915 Magnussen, I; Wooten, H. (1992) (Carbon-14) XDE-436 Nature of Residues in
Apples: Lab Project Number: ABC-0455. Unpublished study prepared by DowElanco.
68 p.
45029916 Portwood, D. (1998) The Disposition of (carbon-14)-Fenazaquin in the Lactating Goat:
Lab Project Number: GHE-P-6987: 3L. Unpublished study prepared by Inveresk
Research International Limited. 157 p. {OPPTS 860.1300}
45029917 Caley, C. (1997) The Metabolism of Fenazaquin in Apples-Live Phase and Initial
Chromatography: Lab Project Number: GHE-P-7103: 14761. Unpublished study
prepared by Inveresk Research International Limited. 144 p. {OPPTS 860.1300}
45029918 Gambie, A.; Long, T.; Draper, R. (1993) The Stability of Fenazaquin in Fortified
Apples Stored Under Frozen Conditions: Lab Project Number: ST91-5: GHE-P-3048.
Unpublished study prepared by DowElanco Europe. 12 p.
45029919 Gambie, A.; Draper, R. (1993) The Stability of Fenazaquin in Fortified Orange Peel
and Flesh Under Frozen Conditions: Lab Project Number: ST91-6: GHE-P-3154.
Unpublished study prepared by DowElanco Europe. 18 p.
45029920 Gambie, A.; Briant, R. (1993) Livestock Feeding Study with (carbon-14)-Fenazaquin in
Dairy Cattle: Lab Project Number: R992-7: GHE-P-3159: HRC/DWC 632/930597.
Unpublished study prepared by DowElanco Europe, and Huntingdon Research Centre
Ltd. 68 p. {OPPTS 860.1480}
45029921 Hastings, M.; Thorpe, T. (1997) Residues of Fenazaquin in Mandarins at Intervals
Following A Single Application of Magister 100 EC (EF-1131), Spain-1996: Lab
Project Number: GHE-P-6256: R96-169: R96-169 A. Unpublished study prepared by
DowElanco Europe. 42 p. {OPPTS 860.1500}
45029922 Butcher, S. (1995) Residues of Fenazaquin in Oranges at Harvests Following a Single
Application of Magister 100 EC (EF-1131), Spain-1994: Lab Project Number: R94-
135: GHE-P-4064: R94-135 A. Unpublished study prepared by DowElanco Europe. 29
p. {OPPTS 860.1500}
45029923 Gambie, A. ; Laurie, D. (1993) Fenazaquin Residues in Pears at Harvest Following
Application of an SC Formulation (EF-1127)-Italy 1992: Lab Project Number: R92-42:
GHE-P-3002: R92-42-A. Unpublished study prepared by DowElanco Europe. 20 p.
{OPPTS 860.1500}
45029924 Hastings, M.; McLaughlin, E. (1997) Residues of Fenazaquin in Oranges at Harvest
Following a Single Application of Magister 100 EC (EF-1131), Spain-1996: Lab
Project Number: R96-066: GHE-P-6277: R96-066A. Unpublished study prepared by
DowElanco Europe. 39 p.
45029925 Gambie, A.; Long, T. (1993) Fenazaquin Residues in Lemons at Harvest and in Lemon
Fractions Following Application of an EC Formulation (EF-1131)-Spain 1991: Lab
Project Number: R91-41: GHE-P-2679: R91-41A. Unpublished study prepared by
DowElanco Europe. 42 p. {OPPTS 860.1500, 860.1530}
45029926 Butcher, S.; Berryman, T. (1994) Residues of Fenazaquin in Pears at Harvest Following
Application of Magister 200 EC (EF-1127)-France 1993: Lab Project Number: R93-81:
GHE-P-3474: R93-81A. Unpublished study prepared by DowElanco Europe. 20 p.
{OPPTS 860.1500}
45029927 Hastings, M.; McLaughlin, E. (1997) Residues of Fenazaquin in Oranges at Intervals
Following a Single Application of Magister 100 EC (EF-113 l),-Spain 1996: Lab
25
-------
Project Number: GHE-P-6228: R96-067: R96-067B. Unpublished study prepared by
DowElanco Europe. 41 p. {OPPTS 860.1500}
45029928 Gamble, A.; Perkins, I; Draper, R. (1993) Fenazaquin Residues in Apples Sampled at
Intervals Following a Single Application of an SC Formulation (EF-1127)-Germany
1991: Lab Project Number: GHE-P-2920: R91-39: R91-39B. Unpublished study
prepared by DowElanco Europe. 25 p. {OPPTS 860.1500}
45029929 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples Sampled at
Intervals Following a Single Application of an SC Formulation (EF-1127)-Germany
1991: Lab Project Number: GHE-2920SUPPL. Unpublished study prepared by
DowElanco Europe. 832 p. {OPPTS 860.1500}
45029930 Hastings, M; Thorpe, T. (1997) Residues of Fenazaquin in Oranges at Intervals
Following a Single Application of Magister 100 EC (EF-113 l)-Spain 1996: Lab Project
Number: GHE-P-6255: R96-164: R96-164A. Unpublished study prepared by
DowElanco Europe. 32 p.
45029931 Long, T.; Gil, I; Leeson, H. (1996) Residues of Fenazaquin in Mandarins at Harvest
Following a Single Application of Magister 100 EC (EF-1131)-Spain 1995: Lab Project
Number: GHE-P-5145: R95-153: R95-153A. Unpublished study prepared by
DowElanco Europe. 76 p. {OPPTS 860.1500}
45029932 Gambie, A.; Laurie, D. (1993) Fenazaquin Residues in Lemons at Harvest Following
Application of an EC Formulation (EF-113 l)-Italy 1992: Lab Project Number: R92-43:
GHE-P-3081: R92-43A. Unpublished study prepared by DowElanco Europe. 25 p.
{OPPTS 860.1500}
45029933 Butcher, S.; Rickard, G. (1995) Residues of Fenazaquin in Mandarins at Harvest
Following a Single Application of Magister 10 (EF-113 l)-Spain 1994: Lab Project
Number: R94-136: GHE-P-4065: R94-136A. Unpublished study prepared by
DowElanco Europe. 30 p. {OPPTS 860.1500}
45029934 Butcher, S.; Rickard, G. (1995) Residues of Fenazaquin in Oranges at Intervals
Following a Single Application of Magister 10 (EF-1131), Spain-1994: Lab Project
Number: GHE-P-4063: R94-134: R94-134A. Unpublished study prepared by
DowElanco Europe. 30 p. {OPPTS 860.1500}
45029935 Dennis, S. (1998) Supplemental Report for: Residues of Fenazaquin in Oranges at
Intervals Following a Single Application of Magister 10 (EF-1131), Spain-1994: Lab
Project Number: GHE-P-4063 SUPPL. Unpublished study prepared by DowElanco
Europe. 186 p.
45029936 Perkins, J.; Gambie, A. (1991) The Effect of Application Timing on Fenazaquin
Residues in Apples at Harvest Using an SC Formulation (EF-1127)-France 1990: Lab
Project Number: R90-23: GHE-P-2534: R90-23A. Unpublished study prepared by
DowElanco Europe. 18 p. {OPPTS 860.1500}
45029937 Perkins, J.; Gambie, A.; Draper, R. (1992) Fenazaquin Residues in Apples at Intervals
Following Application of an SC Formulation (EF-1127)-France 1990: Lab Project
Number: R90-55: GHE-P-2536: R90-55A. Unpublished study prepared by DowElanco
Europe. 21 p. {OPPTS 860.1500}
45029938 Gambie, A.; Belts, G. (1992) Fenazaquin Residues in Apples at Harvest Following
Application of an SC Formulation (EF-1127)-France 1991: Lab Project Number: GHR-
P-2630: R91-45: R91-45A. Unpublished study prepared by DowElanco Europe. 18 p.
{OPPTS 860.1500}
45029939 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Harvest
Following Application of an SC Formulation (EF-1127)-France 1991: Lab Project
26
-------
Number: GHE-P-2630SUPPL. Unpublished study prepared by DowElanco Europe. 148
p. {OPPTS 860.1500}
45029940 Gamble, A.; Long, T. (1993) Fenazaquin Residues in Apples at Intervals Following a
Single Application of an SC Formulation (EF-1127)-Germany 1992: Lab Project
Number: R92-36: GHE-P-3151: 360196. Unpublished study prepared by Inveresk
Research International. 51 p. {OPPTS 860.1500}
45029941 Dennis, S. (1998) Supplemental Report for: Fenazaquin Residues in Apples at Intervals
Following a Single Application of an SC Formulation (EF-1127)-Germany 1992: Lab
Project Number: GHE-P-3151SUPPL. Unpublished study prepared by Dow
AgroSciences Europe. 495 p. {OPPTS 860.1500}
45029942 Gambie, A.; Long, T. (1993) Fenazaquin Residues in Apples at Harvest Following
Application of an SC Formulation (EF-1127)-Italy 1992: Lab Project Number: R92-41:
GHE-P-2877R: R92-41A. Unpublished study prepared by DowElanco Limited. 21 p.
{OPPTS 860.1500}
45029943 Butcher, S.; Shaw, I. (1994) Residues of Fenazaquin in Apples at Harvest Following
One or Two Applications of Magister 200 SC (EF-1127)-Italy 1993: Lab Project
Number: R93-121: GHE-P-3328: 360898. Unpublished study prepared by DowElanco
Europe. 47 p. {OPPTS 860.1500}
45029944 Butcher, S.; Shaw, I. (1994) Residues of Fenazaquin in Apples at Harvest Following
Application of Magister 200 SC (EF-1127)-Italy 1993: Lab Project Number: R93-84:
GHE-P-3327: 360882. Unpublished study prepared by DowElanco Europe. 52 p.
{OPPTS 860.1500}
45029945 Gambie, A. (1993) Fenazaquin Residues in Apples at Harvest Following Application of
an SC Formulation (EF-1127)-Spain 1992: Lab Project Number: R92-46: GHE-P-2888:
R92-46A. Unpublished study prepared by DowElanco Europe. 22 p. {OPPTS
860.1500}
45029946 Perkins, I; Gambie, A.; Teasdale, R. (1992) Fenazaquin Residues in Apples at
Intervals Following Application of an SC Formulation (EF-1127)-UK 1990: Lab
Project Number: R90-53: GHE-P-2535: R90-53A. Unpublished study prepared by
DowElanco Europe. 19 p. {OPPTS 860.1500}
45029947 Gambie, A.; Perkins, J.; Teasdale, R. et al. (1992) Fenazaquin Residues in Apples at
Intervals and in Apple Process Fractions Following a Single Application of an SC
Formulation (EF-1127)-UK 1991: Lab Project Number: R91-21: GHE-P-2637: R91-
21A. Unpublished study prepared by DowElanco Europe. 41 p. {OPPTS 860.1500,
860.1520}
45029948 Perkins, J.; Gambie, A.; Draper, R. et al. (1992) Fenazaquin Residues in Citrus
(Oranges and Mandarins) Flesh and Peel at Intervals Following Application of an EC
Formulation (EF-1131)-Spain 1990: Lab Project Number: R90-6: GHE-P-2537: R90-
6A. Unpublished study prepared by DowElanco Europe. 26 p. {OPPTS 860.1500}
45029949 Gambie, A.; Long, T. (1993) Fenazaquin Residues in Oranges at Harvest Application
of an EC Formulation (EF-113 l)-Italy 1992: Lab Project Number: R92-44: GHE-P-
3122: R92-44A. Unpublished study prepared by DowElanco Europe. 25 p. {OPPTS
860.1500}
45029950 Gambie, A.; Long, T.; Knight, C. (1994) Fenazaquin Residues in Oranges Process
Fractions Following Application of an EC Formulation (EF-113 l)-Spain 1992: Lab
Project Number: R92-47: GHE-P-3225: R92-47A. Unpublished study prepared by
DowElanco Europe. 28 p. {OPPTS 860.1520}
45029951 Gale, D.; Brett, T. (1994) Residue of Fenazaquin in Oranges at Harvest Following
27
-------
Application of Pride 200 SC (EF-1127)-Morocco 1993: Lab Project Number: R93-142:
GHE-P-3533: CEMR-315. Unpublished study prepared by DowElanco Europe. 33 p.
{OPPTS 860.1500}
45029952 Gambie, A.; Perkins, J.; Draper, R. et al. (1993) Fenazaquin Residues in Mandarin Peel
and Pulp Following Application of an SC Formulation (EF-1127)-Spain 1991: Lab
Project Number: R91-40: GHE-P-2678: R91-40A. Unpublished study prepared by
DowElanco Europe. 24 p. {OPPTS 860.1500}
45029953 Gambie, A.; Laurie, D.; Betts, G. et al. (1993) Fenazaquin Residues in Oranges at
Harvest and in Orange Process Fractions Following a Single Application of an SC
Formulation (EF-1127)-Spain 1991: Lab Project Number: R91-64: GHE-P-2677: R91-
64A. Unpublished study prepared by DowElanco Europe. 44 p. {OPPTS 860.1500,
860.1520}
45029954 Long, T. (1996) Residues of Fenazaquin in Apples at Harvest Following a Single
Application of Magister 200 SC (EF-1127), Germany-1995: Lab Project Number:
GHE-P-4863: RL95-073: 95089/G1-FFAP. Unpublished study prepared by DowElanco
Europe. 131 p. {OPPTS 860.1500}
45029955 Butcher, S.; Rickard, G. (1995) Residues of Fenazaquin in Mandarins at Harvest
Following a Single Application of Magister 10 (EF-1131), Spain-1994: Lab Project
Number: GHE-P-4066: R94-137. Unpublished study prepared by DowElanco Europe.
30 p. {OPPTS 860.1500}
45029956 Gambie, A.; Laurie, D.; Knight, C. (1993) Fenazaquin Residues in Oranges at Harvest
and in Orange Process Fractions (Juice and Marmalade) Following Application of an
EC Formulation (EF-1131), Spain-1992: Lab Project Number: GHE-3082R: R92-47:
R92-47A. Unpublished study prepared by DowElanco Europe. 82 p. {OPPTS
860.1500,860.1520}
45054400 Great Lakes Chemical Corporation (1998) Submission of Residue Chemistry Data in
Support of the Petition for Tolerance of Fenazaquin in/on Apples, Pears, and Citrus
Fruits. Transmittal of 1 Study.
45054401 Berard, D. (1992) Nature of (carbon-14)XDE-436 Residues in Oranges: Lab Project
Number: ABC-0454. Unpublished study prepared by DowElanco. 51 p.
46684000 Gowan Company (2005) Submission of Toxicity and Residue Data in Support of the
Petition for Tolerance of Fenazaquin for Use on Apples, Pears and Citrus. Transmittal
of 3 Studies.
46684001 Christian, M.; Hoar, R.; Hoberman, A. (1991) Reproductive Effects of EL-436
(Compound 193136) Administered Orally via Gavage to Crl:CD (SD) BR Rats for Two
Generations with One Litter Per Generation: Final Report. Project Number: 112/002,
112/002P, 193136. Unpublished study prepared by Argus Research Laboratories, Inc.,
Lancaster Laboratories Incorporated and Purity-Standard Laboratories. 1039 p.
46684002 Perkins, J.; MacDonald, A. (1998) Overview of the Metabolism of Fenazaquin in
Apples. Project Number: GHE/P/5586. Unpublished study prepared by Dowelanco Ltd.
19 p.
46684003 Wright, F.; Davis, R.; Francis, P. (1992) The Acute Toxicity of Technical EL-436
(Compound 193136) Administered Orally to Fischer 344 Rats. Project Number:
R16290, R40390. Unpublished study prepared by Lilly Research Laboratories. 45 p.
47097600 Gowan Co. (2007) Submission of Product Chemistry, Environmental Fate and Toxicity
Data in Support of the Applications for Registration of Fenazaquin Technical and
OWN 1708 Miticide/Insecticide. Transmittal of 35 Studies.
47097601 Cochran, R. (2003) Determination of Fenazaquin (XDE 436) in Fenazaquin Technical
28
-------
(Magister F Acaricidal Chemical) by High Pressure Liquid Chromatography. Project
Number: QA03004. Unpublished study prepared by Gowan Co. 8 p.
47097603 Hudson, J. (1990) Storage Stability of EL-426 for Regulatory Submission In EEC
Member Countries. Project Number: T6K908903. Unpublished study prepared by
Dowelanco. 7 p.
47097604 Perkins, J. (1998) Fenazaquin technical Lot ACD 13041 (AGR297296) - Extention of
Stability Data. Project Number: GHE/P/7288. Unpublished study prepared by
Dowelanco Ltd. 7 p.
47097606 Jackson, R. (1993) The Soil Leaching Characteristics of Fenzaquin. Project Number:
GHE/P/3008. Unpublished study prepared by Dowelanco Ltd. 42 p.
47097607 Saunders, D. (1992) Soil Adsorption and Desorption of EL-436: (GWN-1708
Miticide/Insecticide). Project Number: DGS9202. Unpublished study prepared by
Dowelanco. 84 p.
47097610 Diehl, M. (2003) Determination of the Quantum Yield of Direct Photodegradation of
[14-Carbon]-Fenazaquin in Aqueous Solution: (GWN-1708 Miticide/Insecticide).
Project Number: 849766. Unpublished study prepared by RCC Umweltchemie Ag. 104
P-
47097614 Berard, D. (1993) Dissipation of [14 Carbon] XDE-436 in Soil Exposed to Natural
Environmental Conditions: (GWN-1708 Miticide/Insecticide). Project Number:
ABC/0417. Unpublished study prepared by Dowelanco North American
Environmental. 33 p.
47097615 Butcher, S. (1994) The Dissipation of Fenazaquin in Soil at Intervals Following
Application of EF 1127 - Germany 1993: (GWN-1708 Miticide/Insecticide). Project
Number: GHE/P/3610, R93/76. Unpublished study prepared by Dowelanco Ltd. 33 p.
47097616 Long, T. (1996) The Dissipation of Fenazaquin in Soil at Intervals Following a Single
Application of Magister 200 SC (EF-1127), Italy-1994: (GWN-1708
Miticide/Insecticide). Project Number: GHE/P/4517, R94/112. Unpublished study
prepared by Dowelanco Ltd. 62 p.
47097617 Francis, P. (1991) The Acute Toxicity of EL-436 (Compound 193136) to Daphia
magna in a Static Test System: (GWN-1708 Miticide/Insecticide). Project Number:
C00289. Unpublished study prepared by Lilly Research Laboratories. 37 p.
47097618 Francis, P.; Cocke, P.; Gunnoe, M. (1989) The Acute Toxicity of EL-436 (Compound
193136) to Rainbow Trout (Salmo gairdneri) in a Flow-through Test System: (GWN-
1708 Miticide/Insecticide). Project Number: F00989. Unpublished study prepared by
Lilly Research Laboratories. 37 p.
47097619 Francis, P.; Cocke, P.; Mohr, R. (1990) The Acute Toxicity of EL-436 (Compound
193136) to Bluegill (Lepomis macrochirus) in a Flow-through Test System: (GWN-
1708 Miticide/Insecticide). Project Number: F02389. Unpublished study prepared by
Lilly Research Laboratories. 37 p.
47097620 Grothe, D.; Smith, J. (1989) The Toxicity of EL-436 (Compound 193136) to Bobwhite
in a 19-Day Acute Oral Study: (GWN-1708 Miticide/Insecticide). Project Number:
A01688. Unpublished study prepared by Lilly Research Laboratories. 59 p.
47097621 Grothe, D.; Smith, J. (1989) The Toxicity of EL-436 (Compound 193136) to Mallards
in a 14-Day Acute Oral Study: (GWN-1708 Miticide/Insecticide). Project Number:
A00289. Unpublished study prepared by Lilly Research Laboratories. 46 p.
47097622 Grothe, D.; Seacat, J. (1989) The Toxicity of EL-436 (Compound 193136) to Juvenile
Bobwhite in a 5-Day Dietary Study: (OWN -1708 Miticide/Insecticide). Project
29
-------
Number: A01388. Unpublished study prepared by Lilly Research Laboratories. 41 p.
47097623 Grothe, D.; Smith, J. (1989) The Toxicity of EL-436 (Compound 193136) to Juvenile
Mallards in a 5-Day Dietary Study: (GWN-1708 Miticide/Insecticide). Project Number:
A01488. Unpublished study prepared by Lilly Research Laboratories. 40 p.
47097624 Waldrep, T. (1989) Influence of EL-436 on the Germination of Seeds of Ten Crop
Plants: (GWN-1708 Miticide/Insecticide). Project Number: 61989001. Unpublished
study prepared by Lilly Research Laboratories. 13 p.
47097625 Waldrep, T. (1989) Influence of EL-436 Postemergence Spray on the Vegetative Vigor
of Ten Crop Plants: (GWN-1708 Miticide/Insecticide). Project Number: 61989005.
Unpublished study prepared by Lilly Research Laboratories. 20 p.
47097626 Waldrep, T. (1989) Influence of EL-436 Preemergence Spray on the Seedling
Emergence and Vegetative Vigor of Ten Crop Plants: (GWN-1708
Miticide/Insecticide). Project Number: 61989007. Unpublished study prepared by Lilly
Research Laboratories. 27 p.
47097627 Francis, P.; Rock, G.; StClair, R. (1989) The Acute Dermal Toxicity and Primary
Dermal Irritation of Technical EL-436 (Compound 193136) in the New Zealand White
Rabbit: (GWN-1708 Miticide/Insecticide). Project Number: B03889. Unpublished
study prepared by Lilly Research Laboratories. 27 p.
47097628 Francis, P.; Herman, D.; Wolff, R. (1990) The Acute Inhalation Toxicity of EL-436
(Compound 193136) in the Fischer 344 Rat: (GWN-1708 Miticide/Insecticide). Project
Number: R/H/005/89. Unpublished study prepared by Lilly Research Laboratories. 40
P-
47097629 Francis, P.; Rock, G.; StClair, R. (1989) The Acute Ocular Irritation of EL-436
(Compound 193136) in the New Zealand White Rabbit: (GWN-1708
Miticide/Insecticide). Project Number: B05589. Unpublished study prepared by Lilly
Research Laboratories. 25 p.
47097630 Francis, P.; Rock, G.; StClair, R. (1989) A Guinea Pig Sensitization Study of EL-436
(Compound 193136): (Fenazaquin Technical). Project Number: G00489. Unpublished
study prepared by Lilly Research Laboratories. 33 p.
47097631 Castro, L. (2007) Production Information for Fenazaquin 200 SC. Project Number:
GWN/070302A. Unpublished study prepared by Gowan Co. 56 p.
47097632 DowElanco Europe (1992) Analytical Method: XDE 436 SC Acaricide. Project
Number: DOWM/101178/DE92A. Unpublished study prepared by Dowelanco Ltd. 16
P-
47097633 Smith, G. (19??) Physical and Chemical Stability of MAGISTER SC: EF 1127. Project
Number: 245/001, 90000072. Unpublished study prepared by Dowelanco Ltd. 7 p.
47097634 Hamilton, A. (1992) Generation of Formulation Physico/Chemical Data for Fenazaquin
200G/L SC, EF 1127. Project Number: 9000 I/DA. Unpublished study prepared by
DowElanco Ltd. 20 p.
47097635 Gorg, J. (2003) Statement on the Oxidizing Properties of MAGISTER 200 SC. Project
Number: 272/026. Unpublished study prepared by SCC Scientific Consulting
Company. 7 p.
47097636 Reed, D.; Olive, C. (1996) Packaging Storage Stability Trial for Fenazaquin 200 g/L
SC Acaricide, EF 1127. Project Number: KLP/91/063, GHE/P/3775. Unpublished
study prepared by DowElanco Europe. 16 p.
47097638 Long, T.; Press, A.; Greenwood, N. (1996) The Dissipation of Fenazaquin in Soil at
30
-------
Intervals Following a Single Application of Magister 200 SC Formulation (EF-1127):
Italy -1994. Project Number: R94/112, GHE/P/4517. Unpublished study prepared by
Dowelanco Ltd. 62 p.
47097639 Wright, F.; Davis, R.; Francis, P. (1992) The Acute Toxicity of a 200 g/L Aqueous
Suspension (AS) Formulation of EL-436 (Compound 193136) Administered Orally to
Fischer 344 Rats: (Fenazaquin Technical). Project Number: R39689, R32790, R40290.
Unpublished study prepared by Lilly Research Laboratories. 62 p.
47097640 Francis, P.; Rock, G.; StClair, R. (1990) The Acute Dermal Toxicity and Primary
Dermal Irritation of a 200 g/L Aqueous Suspension Formulation (FN 7195) of EL-436
(Compound 193136) in the New Zealand White Rabbit: (Fenazaquin Technical).
Project Number: B16289. Unpublished study prepared by Lilly Research Laboratories.
31 p.
47097641 Francis, P.; Herman, D.; Allen, D.; et. al. (1990) The Acute Inhalation Toxicity of a 200
g/L Aqueous Suspension Formulation (FN 7195) of EL-436 (Compound 193136) in the
Fischer 344 Rat: (Fenazaquin Technical). Project Number: R/H/009/89. Unpublished
study prepared by Lilly Research Laboratories. 45 p.
47097642 Francis, P.; Rock, G.; St. Clair, R. (1989) The Acute Ocular Irritation of a 200 g/L
Aqueous Suspension Formulation (FN 7195) of EL-436 (Compound 193136) in the
New Zealand White Rabbit: (Fenazaquin Technical). Project Number: B16389.
Unpublished study prepared by Lilly Research Laboratories. 29 p.
47097643 Wright, F.; Glenn, R.; Francis, P. (1992) A Guinea Pig Sensitization Study of an
Aqueous Suspension Formulation (FN 7195) Containing 200 g/L EL-436 (Compound
193136): (Fenazaquin Technical). Project Number: G00591. Unpublished study
prepared by Lilly Research Laboratories. 31 p.
47168700 Gowan Company (2007) Submission of Product Chemistry and Fate Data in Support of
the Application for Registration of Fenazaquin Technical. Transmittal of 6 Studies.
47168701 Ghosh, D. (1999) Determination of Physical State, Colour, and Odour and Estimation
of Photochemical Oxidative Degradation of Fenazaquin. Project Number: GHE/P/6786,
P97/027. Unpublished study prepared by Dow Agrosciences Europe. 20 p.
47168702 Lopez, A. (2007) Physical Properties of Fenazaquin. Project Number: 1588W,
1588W/1. Unpublished study prepared by PTRL West, Inc. 22 p.
47168703 Saunders, D. (1991) EL-436 Aged Soil Leaching Study. Project Number: AAC8857.
Unpublished study prepared by Dowelanco. 61 p.
47168704 Saunders, D. (1990) Hydrolysis of EL-436 in Aqueous Buffer. Project Number:
AAC8856. Unpublished study prepared by Dowelanco. 74 p.
47168705 Berard, D. (1992) Metabolism of [14C]XDE-436 in Soil Maintained Under Aerobic
Conditions. Project Number: ABC/0427. Unpublished study prepared by Dowelanco.
55 p.
47168706 Long, T.; Gambie, A. (1993) The Dissipation of Fenzaquin in Three Soil Types
Following Application of an SC Formulations (EF 1127) to Bare Soil-Germany 1992:
Final Report. Project Number: R92/35. Unpublished study prepared by Dowelanco Ltd.
46 p.
Dan Peacock, Flash Drive, 2gb, P:\Documents\Word, WP, Excel, etc\Fenazaquin\Fact Sheets\Fenazaquin Fact Sheets\Fenazaquin,
Fact Sheet, 8-1-2007, ver 3, final.doc
------- |