United States Office of Prevention, Pesticides
Environmental Protection and Toxic Substances
Agency (7501C)
vvEPA Pesticide
Fact Sheet
Name of Chemical: Fluoxastrobin
Reason for Issuance: New Chemical
Date Issued: NOVEMBER 2005
L DESCRIPTION OF CHEMICAL
Generic Name: Fluoxastrobin ((2E)-(2-[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyljoxy phenyl)-(5,6-dihydro-l,4,2-dioxazin-3-
yl)methanone O-methyloxime)
Common Name: Fluoxastrobin
Trade Name: HEC 480 SC
Chemical Class: strobilurins, methoxyacrylates
EPA Chemical Code: 028869
Chemical Abstracts
Service (CAS) Number: 361377-29-9
Year of Initial Registration: 2005
Pesticide Type: Fungicide
U.S. Producer: Bayer CropScience
-------
Chemical Structure:
ci
CH
2. USE PATTERN AND FORMULATIONS
Pests/Application Sites:
Types of Formulations:
Types and Methods:
Application Rates:
Fluoxastrobin is a new strobilurin-type fungicidal active
ingredient (a.i.) for the control of fungal diseases such as
early blight, late blight, leaf spots, leaf rust, and
Rhizoctonia solani. Fluoxastrobin has been registered for
foliar use on peanuts, tuberous and corm vegetables, leaf
petiole vegetables, fruiting vegetables, and turf, as well as
seed treatment for potato, peanut and turf. Turf
applications are labeled for professional pest control
operators only, not for homeowners.
Fluoxastrobin will be marketed in its technical form (94.8%
a.i., a white crystalline solid) for use in formulations, and
as the formulation HEC 480 SC Fungicide (40.3% a.i., an
off- white suspension concentrate).
FIEC 480 SC Fungicide can be applied by chemigation or
by ground or aerial spray, post-emergence. For seed
treatment it is applied by slurry or mist type equipment.
For foliar treatment of agricultural crops, HEC 480 SC
fungicide can be applied up to 4 - 6 times per season at
rates of 0.12 to 0.18 Ib a.i./A, 7- to 14-day application
intervals, and a maximum seasonal application rate of 0.72
Ib a.i./A (including seed treatment use); PHIs range from 3
to 14 days. For turf, FIEC 480 SC fungicide is applied up
to 4 times per season at application rates of 0.27 to 0.55 Ib
a.i./A, a minimum 21-day application interval, and a
maximum seasonal application rate of 2.2 Ib a.i./A. For
seed treatment on peanuts and potato seed pieces, HEC 480
SC is applied using slurry or mist-type equipment at a rate
ofuptoO.OlOlba.i./CWT.
Carrier:
Water
-------
;L SCIENCE FINDINGS
Fluoxastrobin is a broad-spectrum strobilurin fungicide that has been proposed for use on
peanuts, tuberous (potato) and corm vegetables, leaf petiole vegetables, fruiting vegetables, turf,
and for seed treatment of potato, peanut and turf. The HEC 480 SC Fungicide label-suggests
rotating, alternating, or tank-mixing with products having different modes of action and/or
limiting the total number of applications per season in an effort to delay the development of
resistance in plant pathogen populations.
PHYSICAL AND CHEMICAL PROPERTIES
Technical fluoxastrobin is a white, crystalline solid. It is essentially insoluble in water
(solubility of 0.0023 g/L in water at pH 7), but is highly soluble in dichloromethane,
polyethylene glycol 400, acetone, ethyl acetate, acetonitrile, and dimethylsulfoxide. Technical
fluoxastrobin has a melting point of 103-105° C, and a log Pow of 2.85 at 20° C. It does not
dissociate in water at pH 4 to 9 and has a vapor pressure of 5.63xlO"10 Pa at 20° C.
HAZARD CHARACTERIZATION
Acute Toxicity
Fluoxastrobin technical has a low order of acute toxicity based on its classification in
Toxicity Category III (LD50 > 2000 mg/kg) via the oral and dermal routes, and Toxicity Category
IV by the inhalation route of exposure. Fluoxastrobin is a moderate eye irritant (Toxicity
Category III), but is neither a dermal irritant nor a sensitizer.
The end use product HEC 480 SC Fungicide is an emulsifiable concentrate. This product
has a very low order of acute toxicity based on its classification in Acute Toxicity Category IV
for all exposure routes. This product is presently classified as a dermal sensitizer but not due to
the active ingredient.
Subchronic and Chronic Toxicity
Fluoxastrobin has a mild or low toxicity following repeated administration in the rat and
mouse but higher toxicity in the dog. In both the 90-day and one-year oral feeding dog studies,
there was liver toxicity in the form of cholestasis as evidenced by hepatocytomegaly and
cytoplasmic granular changes associated with increased liver weight and increased serum liver
alkaline phospatase (ALP). The no observed adverse effect level (NOAEL) of 1.5 mg/kg/day in
the one year dog study was used for setting the chronic reference Dose (RfD).
In the 90-day oral toxicity study in rats, the urinary system in males was a target organ as
evidenced by increased kidney weight and histopathology findings in kidneys, urinary bladder,
and urethra including the presence of calculi in the urethra and kidneys. The adrenal glands seem
-------
to be another target organ in males of the 90-day rat study where vacuolation was seen in the
zona fasciculate of the adrenal cortex. The adrenal changes are not likely to be endocrine related
effects.
In the 90-day oral toxicity in mice, increases in liver and kidney weights were observed.
Developmental and Reproductive Toxicity
In the rat and rabbit developmental toxicity studies and the two-generation reproduction
rat study, there was no increased susceptibility to prenatal or postnatal exposure to fluoxastrobin
and no effects on reproduction.
Neurotoxicity
Fluoxastrobin is not acutely neurotoxic in rats up to a single high dose of 2000
mg/kg/day or by repeated dietary feeding in the rat subchronic neurotoxicity screening study
where the top dose was nearly half the limit dose of 1000 mg/kg/day. There were no treatment-
related neurotoxicity findings in dogs.
Immune System Toxicity
Fluoxastrobin is not immunotoxic based on repeated dosing studies in rats and mice.
Carcinogenicity
The carcinogenic potential of fluoxastrobin was adequately tested in rats and mice of
both sexes. There was no evidence of carcinogenicity in rats or mice.
Mutagenicity
Fluoxastrobin and its major metabolites gave negative results in a battery of genotoxicity
tests.
DOSE RESPONSE ASSESSMENT AND FOOD QUALITY PROTECTION ACT (FOPA)
CONSIDERATION
Dose Response Assessment
Based on submitted data, the Agency determination of the acute and chronic Reference
Doses (RfDs), toxicological endpoint selections, and appropriate margins of exposure (MOEs)
for use as appropriate in occupational/residential exposure risk assessments, is summarized
below:
-------
Acute Dietary Reference Dose (aRfD): No acute toxicity endpoint was identified for
either females age 13-49 years or the general population. There was no endpoint noted in
the database from a single dose exposure that could be used for risk assessment. This
included the acute neurotoxicity (tested to the limit dose) and developmental studies as
well as the other short- and long-term studies.
Chronic Dietary Reference Dose (cRfD): Fluoxastrobin has a mild or low toxicity
following repeated administration in all tested species other than the dog. The dog
appears to be the most sensitive species. For all populations, the dose and endpoint for
establishing a cRfD is a LOAEL of 7.7 mg/kg/day (NOAEL for females) from the one
year toxicity study in dogs. The NOAEL is 1.5 mg/kg/day (NOAEL for females) based
on body weight reductions and liver toxicity (cholestasis) in both sexes. An uncertainty
factor (UF) of 100 was selected (lOx inter-species extrapolation, lOx intra-species
variability) and the cRfD is 0.015mg/kg/day.
Incidental Oral Short-Term (1-30 Days) Exposure: The dose and endpoint chosen is
the NOAEL of 3.0 mg/kg/day from the 90-day oral toxicity study in the dog. The UF is
100.
Incidental Oral Intermediate-Term (1-6 Months) Exposure: The dose and endpoint
chosen is the NOAEL of 3.0 mg/kg/day based on 90 day-oral toxicity studies in the dog.
TheUFis 100.
Dermal Absorption Factor: A dermal absorption factor of 2.3% was chosen by the
Agency based on a study which was conducted using five male rhesus monkeys.
Dermal Short-Term (1-30 Days) Exposure: There was no systemic or localized hazard
noted in a 28-day dermal toxicity study in the rat and there are no developmental or
reproductive toxicity concerns, therefore this risk assessment is not necessary.
Dermal Intermediate-Term (1-6 Months) Exposure: The dose and endpoint chosen is
the NOAEL of 3.0 mg/kg/day based on 90-day oral toxicity tests in the dog..
Dermal Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the
NOAEL of 1.5 mg/kg/day based on a chronic oral toxicity study in the dog.
Inhalation Short- (1-30 Days) & Intermediate-Term (1-6 Months) Exposure: The
dose and endpoint chosen is the NOAEL of 3.0 mg/kg/day based on 90-day oral toxicity
studies in the dog.
Inhalation Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the
NOAEL of 1.5 mg/kg/day based on a chronic oral toxicity study in the dog.
-------
Margins of Exposure: Table 1 presents a summary of target Margins of Exposure
(MOEs) for risk assessment. MOE's less than 100 are considered to be of concern.
Table 1 Summary of the Margins of Exposure That Are Used in Risk Assessment
Route ^s^"^
^^^ Duration
Short-Term
(1-30 Days)
Intermediate-Term
(1 - 6 Months)
Long-Term
(> 6 Months)
Occupational (Worker) Exposure
Dermal
Inhalation
N/A
100
100
100
100
100
Residential (Non-Dietary) Exposure
Oral
Dermal
Inhalation
100
N/A
100
100
100
100
N/A
100
100
The MOEs for occupational and residential exposures are based on the conventional uncertainty
factor of 100X (10X for intraspecies variation and 10X for interspecies extrapolation.)
FQPA Decisions
Special FQPA Safety Factor
The toxicology database for fluoxastrobin is adequate to support the reduction of the
special FQPA SF to IX because there are no/low concerns and no residual uncertainties with
regard to pre- and/or postnatal toxicity.
Endocrine disruption
In the available toxicity studies on fluoxastrobin, there was no estrogen, androgen, and/or
thyroid mediated toxicity. The findings of increased incidences of uterine adenocarcinoma and
thyroid follicular cell adenoma in the rat chronic toxicity/carcinogenicity study were determined
to be unrelated to treatment. These observations, which were found within random occurrence in
this strain of rats, are not treatment-related and, henceforth, are not indicative of possible
endocrine disruption. When additional appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, fluoxastrobin may be subjected to
further screening and/or testing to better characterize effects related to endocrine disruption.
4.
HUMAN HEALTH EXPOSURE AND RISK ASSESSMENT
-------
Residue Profile
Following multiple foliar applications, detectable combined residues of fluoxastrobin
and its Z-isomer are likely to be present in/on tomato, pepper, and trimmed celery at up to 0.6
ppm. Residues on peanut hay are likely to be much higher (up to 17 ppm), but non-detectable
(<0.01 ppm) in peanut nutmeats and tuberous and corm vegetables. The residue of concern in/on
primary and rotated plant commodities for tolerance setting and risk assessment purposes are
fluoxastrobin and its Z-isomer. The residues of concern for livestock for tolerance setting and
risk assessment purposes are fluoxastrobin, its Z-isomer, and the phenoxy-hydroxypyrimidine
metabolite. Based upon the results of the poultry metabolism study, EPA concludes that the
proposed uses do not require tolerances for poultry commodities because there is no reasonable
expectation of finite residues in poultry commodities.
Dietary Exposure and Risk
The dietary exposure and risk estimates for fluoxastrobin are summarized in Table 2.
Table 2 Chronic Dietary Exposure and Risk Estimates for Fluoxastrobin.
Population Subgroup
U.S. Population
All infants (< 1 yr)
Children 1-2 yrs
Children 3 -5 yrs
Children 6-12 yrs
Youth 13-19 yrs
Adults 20-49 yrs
Adults 50+ yrs
Females 13 -49 yrs
cPAD,
mg/kg/day
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
DEEM-FCID
Exposure,
mg/kg/day
0.0015
0.00091
0.0037
0.0031
0.0021
0.0014
0.0013
0.0013
0.0012
%
cPAD
10%
6.0%
25%
20%
14%
9.2%
8.7%
8.7%
8.3%
Lifeline
Exposure,
mg/kg/day
0.0014
0.00085
0.0033
0.0027
0.0018
0.0013
0.0013
0.0013
0.0014
% cPAD
9.5%
5.6%
22%
18%
12%
8.4%
8.6%
8.5%
9.6%
* cPAD = chronic PAD, is reported to 2 significant figures, and % cPAD = (Exposure + cPAD) x 100%.
**The values for the population with the highest risk for each type of risk assessment are bolded.
A drinking water assessment for fluoxastrobin was conducted for fluoxastrobin used
according to proposed labeling for HEC 480 SC Fungicide. The results from the use of these
models are summarized in Table 3.
-------
Table 3 Summary of Estimated Surface Water and Groundwater Concentrations of
Fluoxastrobin
Exposure Duration
Acute (peak)
Chronic (average of yearly means)
Fluoxastrobin and its Zrisomer
Surface Water Cone., ppb a
28
14
Ground Water Cone., ppb b
<1
a From the Tier 2 PRZM-EXAMS - Index Reservoir model. Input parameters are based on the turf use (4 ground
applications of 0.55 Ibs ai/A per application with a 21-day interval), which generates the highest EDWCs
b From the Tier 1 SCIGROW model, also based on turf use (4 ground applications of 0.55 Ibs ai/A per application
with a 21-day interval)
Residential Exposure Estimates
Proposed use of fluoxastrobin on turf may result in individuals of varying ages
potentially being exposed from activities in areas that have been treated. Potential routes of
exposure include dermal (adults and children) and incidental oral ingestion (toddlers only).
While it is assumed that most residential use will result in short-term (1 to 30 days)
postapplication exposures, it is also believed that intermediate-term exposures (> 30 days to 180
days) are possible, albeit unlikely. Recreational exposures to turf are expected to be similar to,
or in many cases less than those evaluated for Home Uses, so they were not evaluated separately.
The resulting risks for children, which are lower than those for adults, are presented in Table 4.
Table 4 Children's Residential Combined Risk from Turf Treated with
Fluoxastrobin
Scenario
High Contact Activities (HCA)
Hand-to-Mouth (HTM)
Object-to-Mouth (OTM)
Soil Ingestion (SI)
Duration
Intermediate-Term
Short-Term
Short-/Intermediate-Term
Short-/Intermediate-Term
Route
Dermal
Oral
Oral
Oral
Daily Dose
(mg/kg/day)
0.00246
0.00821
0.00205
0.000028
MOE
1200
365
1500
110000
Total
MOE1
235
1 Total MOE = 1 / (1/MOEHCA+ 1/MOEHTM + 1/MOEOTM + 1/MOESI)
The total MOE for children's combined risk from activities on treated turf is larger than
100, and therefore does not exceed EPA's level of concern.
Other (Spray Drift, etc.)
Fluoxastrobin can be directly applied to residential turf by non-resident professional
applicators, and does not result in exposures of concern. Based on this assessment, EPA believes
that it is unlikely there is a higher potential for risk of exposure to spray drift from residential
uses versus agricultural uses of this chemical.
-------
Aggregate Risk
As per FQPA, 1996, when there are potential residential exposures to the pesticide,
aggregate risk assessment must consider exposures from three major sources: oral, dermal and
inhalation exposures. The toxicity endpoints selected for these routes of exposure may be
aggregated as follows:
For short-term aggregate exposure assessment, incidental oral and inhalation cannot be
combined due to differences in the endpoint, i.e. neurotoxicity for incidental oral and
decreases in body weight for inhalation. No quantification of dermal risk is required.
For intermediate-term aggregate exposure, oral and dermal and inhalation endpoints can
be aggregated because of the use of a common endpoint (decreased body weight gain).
For long-term aggregate exposure, incidental oral and dermal and inhalation endpoints
can be aggregated because of the use of oral equivalents and a common endpoint
(decreased thymus weight).
Short and Intermediate-Term Aggregate Risk
There is potential short- and intermediate-term exposure to fluoxastrobin via the dietary
(which is considered background exposure) and residential (which is considered primary)
pathways. For adults, these pathways lead to exposure via the oral (background) and dermal
(primary) routes. For children these pathways lead to exposure via the oral (background), and
incidental oral and dermal (primary) routes.
Chronic Aggregate Risk Assessment (Food and Drinking Water)
There is potential chronic exposure to fluoxastrobin via food and drinking water, i.e., the
dietary route. DWLOCs were calculated to determine if aggregate chronic risks are of concern.
The chronic DWLOCs are much greater than the EDWCs; thus, chronic aggregate risks do not
trigger the Agency's concern.
Cumulative Risk Characterization/Assessment
EPA has not made a common mechanism of toxicity finding as to fluoxastrobin and any
other substances, and fluoxastrobin does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that
fluoxastrobin has a common mechanism of toxicity with other substances.
Occupational Exposure/Risk Pathway
There is potential for occupational handler exposure from the application of fluoxastrobin
on both food and non-food use sites resulting from handling fluoxastrobin products (i.e.,
-------
mixer/loaders and applicators); and there is potential for occupational postapplication exposure
resulting from entering areas previously treated with fluoxastrobin.
Occupational handlers may be exposed by the dermal route and by the inhalation route
during mixing, loading and application of fluoxastrobin for both short- and intermediate-term
durations.
Only one occupational handler scenario related to seed treatment triggered the agency's
concern. Although the combined MOE (accounting for both dermal and inhalation exposures)
was below 100, the risk estimate is probably not a real risk concern, for the following reasons:
First, the inhalation component of the risk estimate is driving the low MOE, but this component
was calculated using surrogate data from a dust formulation, and fluoxastrobin is a liquid
formulation, which is less prone to be available in the air (if the fluoxastrobin liquid formulation
is aerosolized, then inhalation exposure could be a concern). Additionally, at the chemical level,
fluoxastrobin is not volatile. Also, the dermal component of the combined MOE is also a
conservative screening level estimate, because it is an intermediate-term estimate, while actual
exposures are short- and intermediate term in duration (a short term dermal endpoint was not
identified).
Short-/Intermediate-Term Postapplication Risk
Fluoxastrobin has been proposed for both food (i.e., agricultural) and non-food (i.e.,
residential and commercial) use sites. Agricultural postapplication exposures may occur from a
variety of activities following treatment of peanut, leafy vegetable, fruiting vegetable and potato
and tuber vegetable crops. Use sites with potential residential exposures include golf course turf,
turf farms, recreational turf, and residential lawns.
The MOEs for all occupational/agricultural postapplication activities exceed 100 on the
day of treatment (i.e., day 0) for all reentry tasks for all proposed use sites, and therefore, do not
exceed the Agency's level of concern.
The reentry interval (REI) of 12 hours appearing on the proposed fluoxastrobin end use
label is acceptable.
Non-occupational Off-Target Exposure
Based on this assessment and required label restrictions, the Agency believes it is
unlikely that there is higher potential for risk of exposure to spray drift from residential uses of
this chemical than have been assessed for direct agricultural applications.
5. ENVIRONMENTAL EXPOSURE AND RISK
10
-------
The slow biodegradation, compounded with low mobility in soils, low water solubility,
and a relatively low octanol/water partition coefficient suggest that fluoxastrobin may have
limited potential for runoff and low bioaccumulation. The low vapor pressure and low Henry's
Law Constant suggest that this compound is not expected to volatilize from water or soils in
natural environments. Fluoxastrobin's soil degradates, HEC 5725-E-des-chlorophenyl (HEC
7155) and HEC5725-carboxylic acid (HEC 7180) have higher mobilities than does
fluoxastrobin.
Environmental Fate Characteristics
Biodegradation under aerobic conditions could take several months to several years,
depending on the soil texture (half life of 29.4 days in sandy loam to 393 days in loamy sand;
average half-life of 141 days).
Fluoxastrobin is expected to have low to medium mobility, as it absorbs strongly to all
tested soils. Fluoxastrobin could persist for several months in non-sand soils to several years in
sandy type soils. Under field conditions of intended use areas in the US, fluoxastrobin was
shown to persist for over a year but did not seem to leach underground.
Fluoxastrobin (E + Z isomers, 98:2 isomer ratio) is stable toward abiotic hydrolysis in
sterile buffered solutions at pH 4, 7, and 9 at 50° C. In contrast, direct aqueous photodegradation
under laboratory conditions is rapid, with an average half life of 4.1 days (24 hour irradiation) and
formation of HEC5725-oxazepine. This laboratory half-life corresponds to a predicted
environmental half life of 20.1 summer sunlight in Phoenix, Arizona (33° N) and 28.3 days in
Edmondton, Alberta, Canada (53°N). However, aqueous photolysis with the formation of
HEC5725-oxazepine was not observed under field conditions since photodegradation in turbid
and/or deeper waters may be limited by the attenuation of sunlight due to unfavorable conditions.
Photodegradation on soils is much slower at a predicted environmental rate of 146 days.
Ecological Effects and Risk
Terrestrial Animals
Toxicity
Based on submitted acute and reproduction data using bobwhite quail, rats, honeybees,
and earthworms, fluoxastrobin is classified as practically non-toxic to terrestrial animals.
Exposure
The calculated mean residue EECs ranged up to 170 ppm for short turf grass.
Birds and mammals in the field may be exposed to seed treated with pesticides by
ingesting material directly with the diet. They also may be exposed by other routes, such as
11
-------
incidental ingestion of contaminated soil, dermal contact with treated seed surfaces and soil
during activities in the treated areas, preening activities, and ingestion of drinking water
contaminated with pesticide.
Risk
Birds
Fluoxastrobin is classified as practically non-toxic to birds on an acute exposure basis.
All calculated avian acute and chronic RQs using bobwhite quail were less than LOCs, with acute
values ranging from <0.002 to <0.06 and chronic values ranging from 0.02 to 0.68 respectively.
Mammals
All calculated mammalian acute RQs were less than LOCs with the exception of small
mammal (15-g) consumption of predicted maximum residue levels of fluoxastrobin on short grass
following the maximum application rate for turf (i.e., 4 times per year). The RQ value for a 15-g
mammal, based on consumption of short grass at the maximum residue level (314 mg/kg diet)
following the maximum application rate for turf, is <0.15. A definitive LD50 was not established
for laboratory rats because the available acute toxicity data show no mortality at the highest doses
tested. The RQ value of <0.15 is based on an acute mammalian LD50 value of >2000 mg/kg.
Although the acute endangered LOG is exceeded for the 15-g mammal (based on
maximum short grass residue and maximum application rates for turf), there is uncertainty
associated with the RQ value because it based on the highest dose tested where no mortality was
observed. In addition, RQ values for the 15-g mammal do not exceed the acute endangered
species LOG of 0.1, based on consumption of mean residue levels of short grass (RQ <0.08) or
reduction in the application rate of turf from 4 to 2 times per year (RQ < 0.10). Furthermore, use
of the >5000 mg/kg LD50 value for the TEP (40.5% fluoxastrobin) results in RQ values well
below acute LOCs. Therefore, acute mammalian risks associated with exposure to fluoxastrobin
on short grass are unlikely.
All calculated mammalian chronic RQs were less than LOCs, with chronic values ranging
from 0.01 to 0.31. Mammalian RQ values based on exposure to treated seeds were also well
below levels of concern.
Non-Target Insects
An appropriate label statement is required to protect foraging honeybees if the LD50 is <
11 jig/bee. Based on the acute contact toxicity study to honeybees, the LD50 for fluoxastrobin is
>200 jig/bee. Therefore, the label statement is not required. Fluoxastrobin is classified as
practically non-toxic to honeybees.
Earthworms
12
-------
Earthworm exposures to fluoxastrobin and its degradates in soil are not expected to be an
exposure route of concern because acute and subchronic LC50 toxicity values for both the parent
and fluoxastrobin degradates are relatively high at >1000 mg/kg, and no significant mortality
and/or sublethal effects were observed in any of the treatment groups.
Terrestrial Plants
Toxicity
Fluoxastrobin is not likely to cause adverse effects to non-target terrestrial plants, based
on data from emergence and vegetative vigor tests on 10 different species of plants, after
application of the formulated product at a single concentration of 0.54 Ibs ai/A. This
concentration is equal to the maximum application rate for fluoxastrobin. In both the seedling
emergence and vegetative vigor tests, no monocot or dicot species were significantly affected by
the treatment, and no reductions exceeded 25%. The respective NOAEC and EC25 values were
0.54 and >0.54 Ibs ai/A for all test species.
Exposure
At the maximum label application rate for fluoxastrobin, no non-target monocot or dicot
species were significantly affected by the treatment, and no growth reductions exceeded 25%. If
use directions for approved uses are followed, non-target exposures are expected to be minimal.
Risk
All acute non-endangered and endangered RQs for non-target terrestrial and semi-aquatic
plants are less than LOCs, with acute non-endangered values ranging from <0.04 to <0.45 and
acute endangered species values ranging from 0.04 to 0.45, respectively.
Aquatic Animals
Toxicity
On an acute basis, Fluoxastrobin is moderately toxic to estuarine/marine fish; highly toxic
to freshwater fish and invertebrates; and very highly toxic to estuarine/marine invertebrates.
Chronic LOCs are also exceeded for estuarine/marine invertebrates and mollusks. Chronic
effects for estuarine/marine invertebrates include reduced survival and reductions in wet weight
of surviving adults following a 28-day exposure duration. No data were available to assess the
chronic toxicity of fluoxastrobin to estuarine/marine mollusks. Therefore, the NOAEC value was
estimated based on the acute-to-chronic ratio for mysid shrimp.
13
-------
Exposure
Surface water concentrations ranging from 4.3 to 32.9 ppb resulting from fluoxastrobin
application to selected crops were predicted with the Tier II models PRZM-EXAMS. Peak EECs
were then compared to acute toxicity endpoints to derive acute RQs. The 60-day EECs were
compared to chronic toxicity endpoints (NOAEC values) to derive chronic RQs for freshwater
and estuarine/marine fish, and 21-day EECs were compared to chronic toxicity endpoints for
freshwater and estuarine/marine invertebrates.
Risk
The ecological risks to fish and invertebrates are considered conservative estimates
because they are based on worst case exposure and use scenarios. Nonetheless, because of the
potential for exposure and possible adverse effects of fluoxastrobin to endangered and non-
endangered fish and invertebrates, the registrant is required to provide information on the
proximity of Federally listed freshwater fish and invertebrates to the fluoxastrobin use sites. This
requirement may be satisfied in one of three ways: 1) having membership in the FIFRA
Endangered Species Task Force (Pesticide Registration [PR] Notice 2000-2); 2) citing FIFRA
Endangered Species Task Force data; or 3) independently producing these data, provided the
information is of sufficient quality to meet FIFRA requirements. The information will be used by
the OPP Endangered Species Protection Program to develop recommendations to avoid and
mitigate adverse effects to listed species.
Risk quotients (RQs) were calculated from the ratio of estimated environmental
concentrations (EECs) to ecotoxicity values. Peak EECs were compared to acute ecotoxicity
endpoints to derive acute RQs for aquatic animals. Chronic RQs were derived by comparing 60-
day EECs to NOAEC values (chronic toxicity endpoints) for freshwater organisms and 21-day
EECs to NOAEC values for estuarine/marine organisms. The RQs are then compared to the
Agency's levels of concern (LOCs) to indicate when a pesticide's use as directed on the label has
the potential to cause adverse effects on non-target organisms. These LOCs are part of the
Agency's interpretive policy and are used to analyze potential risk to non-target organisms and
the need to consider regulatory action.
Acute and chronic RQs for freshwater organisms are summarized in Table 15. Estimates
of benthic sediment exposure to pesticides can be provided by PRZM/EXAMS but this
assessment was not performed for fluoxastrobin because toxicity data related to sediment
exposure are not available. Therefore, acute (10-day) and chronic (28-day) sediment toxicity
testing, as described in the OPPTS 850.1735 and 850.1740 protocols, are required in order to
reduce uncertainties and evaluate risks to freshwater and estuarine/marine sediment-dwelling
organisms.
14
-------
Table 5 Acute and Chronic Risk Quotients for Freshwater Fish and Invertebrates
Exposed to Fluoxastrobin.
Crop
Application
Rate (State -
application
type) [# of
apps.]
Potatoes (ID -
aerial)
0.12 [6]
Potatoes (ID -
ground)
0.12 [6]
Potatoes (ME -
aerial)
0.12 [6]
Potatoes (ME -
ground)
0.12 [6]
Tomatoes (CA)
0.18 [4]
Tomatoes (FL)
0.18 [4]
Peppers
0.18 [4]
Peppers
0.18 [4] no drift
Cabbage
0.18 [4]
Peanuts
0.18 [4]
EECs
Peak/
21-day
Average/
60-day Average
(Hg/L)
8.8
8.6
8.4
4.3
4.1
3.9
32.9
31.9
30.8
28.7
27.8
26.7
8.4
8.0
7.6
21.0
20.0
18.3
25.2
23.6
18.5
24.6
22.9
17.9
12.8
12.3
11.1
19.7
19.2
18.5
Acute Risk Quotients
Freshwater
Fish3
LC50 = 435
Hg/L
0.02
0.01
0.08f
0.07f
0.02
0.05f
0.06f
0.06f
0.03
0.05f
Freshwater
Invertebrateb
LC50 = 120
Hg/L
0.07f
0.04
0.27e
0.24e
0.07f
0.18e
0.21e
0.21e
0.1P
0.16e
Chronic Risk Quotients
Freshwater
Fish3
NOAEC = 55.7
Hg/L
0.15
0.07
0.55
0.48
0.14
0.33
0.33
0.32
0.20
0.33
Freshwater
Invertebrate0
NOAEC = 180
Hg/L
0.05
0.02
0.18
0.02
0.04
0.11
0.13
0.13
0.07
0.11
15
-------
Crop
Application
Rate (State -
application
type) [# of
apps.]
Turf(FL)
0.55 [4]
Turf(FL)
0.55 [2]
Turf (PA)
0.55 [4]
Turf (PA)
0.55 [2]
EECs
Peak/
21-day
Average/
60-day Average
(Hg/L)
20.9
19.6
18.5
9.4
8.9
8.4
21.5
20.7
19.8
10.4
10.0
9.6
Acute Risk Quotients
Freshwater
Fish3
LC50 = 435
jig/L
0.05f
0.02
0.05f
0.02
Freshwater
Invertebrateb
LC50 = 120
Hg/L
0.17e
0.08f
0.18e
0.09f
Chronic Risk Quotients
Freshwater
Fish3
NOAEC = 55.7
Hg/L
0.33
0.15
0.36
0.17
Freshwater
Invertebrate0
NOAEC = 180
Hg/L
0.11
0.05
0.12
0.06
a Rainbow trout (Oncorhynchus mykiss)
b Amphipod (Gammarus pulex)
0 Water flea (Daphnia magna)
d exceeds acute high risk (RQ > 0.5), restricted use (RQ > 0.1)1 and endangered species level of concern (RQ >0.05)
e exceeds acute restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05)
f exceeds acute endangered species level of concern (RQ >0.05)
g exceeds chronic level of concern (RQ > 1.0)
For the current application rates modeled on major crops where fluoxastrobin is applied,
acute endangered species LOCs are exceeded for freshwater fish (in Maine potatoes, Florida
tomatoes, peppers, peanuts, and turf at the maximum application rate of 4x/year) and freshwater
invertebrates (in all crops with the exception of ground application of potatoes in Idaho). Acute
RQ values range from 0.01 to 0.08 for freshwater fish, and from 0.04 to 0.27 for freshwater
invertebrates. Chronic RQs for freshwater fish (0.07 to 0.55) and invertebrates (0.02 to 0.18) are
less than chronic LOCs.
The acute and chronic RQs for estuarine and marine animals are summarized in Table 16.
16
-------
Table 6 Acute and Chronic Risk Quotients for Estuarine/Marine Fish and
Invertebrates Exposed to Fluoxastrobin.
Crop
Application
Rate (State -
application
type) [# of
apps]
Potatoes (ID -
aerial)
0.12 [6]
Potatoes (ID -
ground)
0.12 [6]
Potatoes (ME -
aerial)
0.12 [6]
Potatoes (ME -
ground)
0.12 [6]
Tomatoes (CA)
0.18 [4]
Tomatoes (FL)
0.18 [4]
Peppers
0.18 [4]
Peppers
0.18 [4] no drift
Cabbage
0.18 [4]
Peanuts
0.18 [4]
EECs
Peak/
21-day
Average/
60-day Average
(ng/L)
8.8
8.6
8.4
4.3
4.1
3.9
32.9
31.9
30.8
28.7
27.8
26.7
8.4
8.0
7.6
21.0
20.0
18.3
25.2
23.6
18.5
24.6
22.9
17.9
12.8
12.3
11.1
19.7
19.2
18.5
Acute Risk Quotients
Estuarine/
Marine Fish a
LC50 = >1374
Hg/L
0.01
O.003
O.02
<0.02
<0.01
0.02
0.02
0.02
0.01
O.01
Estuarine/
Marine
Invertebrate"
LC50 = 51.6
Hg/L
0.17e
0.08f
0.64d
0.56d
0.16e
0.41e
0.49e
0.48e
0.25e
0.38e
Chronic Risk Quotients
Estuarine/
Marine Fish c
NOAEC = 176
Hg/L
0.05
0.02
0.18
0.15
0.04
0.10
0.11
0.10
0.06
0.11
Estuarine/
Marine
Invertebrateb
NOAEC = 0.61
jig/L
14g
6.7g
52g
46g
13g
33g
39g
38g
20g
31g
17
-------
Crop
Application
Rate (State -
application
type) [# of
apps]
Turf(FL)
0.55 [4]
Turf(FL)
0.55 [2]
Turf (PA)
0.55 [4]
Turf (PA)
0.55 [2]
EECs
Peak/
21-day
Average/
60-day Average
(H.S/L)
20.9
19.6
18.5
9.4
8.9
8.4
21.5
20.7
19.8
10.4
10.0
9.6
Acute Risk Quotients
Estuarine/
Marine Fish a
LC50 = >1374
O.02
-
~
O.01
-
~
0.02
-
~
0.01
-
~
Estuarine/
Marine
Invertebrate"
LC50 = 51.6
jig/L
0.41e
-
~
0.18e
-
~
0.42e
-
~
0.20e
-
~
Chronic Risk Quotients
Estuarine/
Marine Fish c
NOAEC = 176
~
0.11
..
~
0.05
..
~
0.11
..
~
0.05
Estuarine/
Marine
Invertebrate"
NOAEC = 0.61
Hg/L
32g
-
..
15g
~
..
34g
~
..
16g
~
a Sheepshead minnow (Cyprinodon variegatus)
b Mysid shrimp (Mysidopsis bahia)
0 Estimated on the assumption that acute to chronic ratio for estuarine/marine fish is the same as freshwater fish
d exceeds acute high risk (RQ > 0.5), restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05)
e exceeds acute restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05)
f exceeds acute endangered species level of concern (RQ >0.05)
g exceeds chronic level of concern (RQ > 1.0)
Acute LOCs for estuarine/marine fish are not exceeded; peak EECs for all major crops are
well below the NOAEC value (RQ range: <0.003 to <0.02). No estuarine/marine chronic fish
data were submitted, so a NOAEC value was estimated based on the assumption that the acute-to-
chronic NOAEC ratio for estuarine/marine fish is the same as for freshwater fish. Based on the
estimated NOAEC value, chronic RQ values for estuarine/marine fish, ranging from 0.02 to 0.18,
are less than the chronic LOCs. Acute and chronic LOCs for estuarine/marine invertebrates are
exceeded for all major crops modeled (acute RQ range: 0.08 to 0.64; chronic RQ range: 6.7 to
52). Estuarine/marine invertebrates appear to be much more sensitive to fluoxastrobin, with acute
and chronic RQs approximately two and 290 times higher than their freshwater counterparts.
Aquatic Plants
Toxicity
Based on data using duckweed, and freshwater green algae, fluoxastrobin and its
degradates are classified as practically non-toxic to non-target aquatic plants.
18
-------
All acute non-endangered and endangered species RQs are less than LOCs for both
vascular and non-vascular plants. The range of RQ values for both vascular and non-vascular
aquatic plants is 0.004 to 0.43.
Exposure
The exposure data that were used for aquatic animals were also used for aquatic plants.
Risk
Aquatic plant risk to non-vascular plants was evaluated based on marine diatom (S.
capricornatum) toxicity studies using fluoxastrobin and its degradates HEC 7155 and HEC 7180.
Vascular plant risk was based on duckweed (L. gibba) toxicity studies performed using
fluoxastrobin technical only. For aquatic vascular and non-vascular plants, peak EECs were
compared to acute EC50 and NOAEC toxicity endpoints to derive acute non-endangered and
endangered species RQs, respectively.
The acute non-endangered and endangered species RQs that were calculated for aquatic
vascular and non-vascular plants are summarized in Table 18.
Table 7 Acute Non-Endangered and Endangered Species Risk Quotients for
Aquatic Vascular and Non- Vascular Plants Exposed to Fluoxastrobin
Crop
Application
Rate (# of
apps)
Potatoes (ID -
aerial)
0.12(6)
Potatoes (ID -
ground)
0.12(6)
Potatoes (ME -
aerial)
0.12(6)
Potatoes (ME -
ground)
0.12(6)
Tomatoes (CA)
0.18(4)
EECs
Peak
(Hg/L)
8.8
4.3
32.9
28.7
8.4
Acute Non-Endangered
Risk Quotients
Vascular
plant a
EC50 = 1200
Hg/L
0.01
0.004
0.03
0.02
0.01
Non-vascular
Plant"
EC50 = 260
Hg/L
0.03
0.13
0.03
0.11
0.03
Acute Endangered Species
Risk Quotients
Vascular
plant a
NOAEC = 160
Hg/L
0.06
0.03
0.21
0.18
0.05
Non-vascular
Plant"
NOAEC = 76
Ug/L
0.12
0.06
0.43
0.38
0.11
19
-------
Crop
Application
Rate (# of
apps)
Tomatoes (FL)
0.18(4)
Peppers
0.18(4)
Peppers
0.18 (4) no drift
Cabbage
0.18(4)
Peanuts
0.18(4)
Turf(FL)
0.55 (4)
Turf(FL)
0.55 (2)
Turf (PA)
0.55 (4)
Turf (PA)
0.55 (2)
EECs
Peak
(Hg/L)
21
25.2
24.6
12.8
19.7
20.9
9.4
21.5
10.4
Acute Non-Endangered
Risk Quotients
Vascular
plant a
EC50 = 1200
jig/L
0.02
0.02
0.02
0.01
0.02
0.02
0.01
0.02
0.01
Non-vascular
Plant11
EC50 = 260
Hg/L
0.08
0.1
0.09
0.05
0.08
0.08
0.04
0.08
0.04
Acute Endangered Species
Risk Quotients
Vascular
plant a
NOAEC = 160
jig/L
0.13
0.16
0.15
0.08
0.12
0.13
0.06
0.13
0.07
Non-vascular
Plantb
NOAEC = 76
Hg/L
0.28
0.33
0.32
0.17
0.26
0.28
0.12
0.28
0.14
a Duckweed (Lemna gibba)
b Green algae (Selenastrum capricornutum)
0 exceeds acute high risk (RQ > 1.0) and endangered species level of concern (RQ > 1.0)
All of the fluoxastrobin acute non-endangered or endangered species RQs are less than the
LOCs for vascular and non-vascular aquatic plants, so no level of concern is reached. The range
of RQ values for both vascular and non-vascular aquatic plants is 0.004 to 0.43. Aquatic EECs
for all major crops were well below available toxicity endpoint values for the fluoxastrobin
degradates HEC 7155 and HEC 7180, as well. Therefore, fluoxastrobin degradates are not a
concern for aquatic organisms and plants.
Risk to Endangered Species
The preliminary risk assessment for endangered species indicates that fluoxastrobin
exceeds the endangered species LOCs for the following combinations of analyzed uses and
species:
20
-------
• Use of fluoxastrobin on the following crop scenarios indicate an exceedance of the
endangered species LOG for freshwater fish: Maine potatoes (ground and aerial
application), Florida tomatoes, peanuts, and turf (at the maximum application rate of 4
times per year).
• Use of fluoxastrobin on Idaho potatoes (aerial application only), Maine potatoes (ground
and aerial application), tomatoes, peppers, cabbage, peanuts, and turf (at maximum
[4x/year] and reduced [2x/year] application rates) indicate endangered LOG exceedances
for endangered freshwater invertebrates.
Use of fluoxastrobin on Idaho and Maine potatoes (aerial and ground application),
tomatoes, peppers, cabbage, peanuts, and turf (at maximum [4x/year] and reduced
[2x/year] application rates) indicate endangered acute and chronic LOG exceedances for
estuarine/marine invertebrates.
• Use of fluoxastrobin on Maine potatoes (ground and aerial application), Florida tomatoes,
peppers, cabbage, peanuts, and turf in Florida (at maximum [4x/year] application rates
only) and Pennsylvania (for applications of both 4 and 2x/year) indicate chronic LOG
exceedances for estuarine/marine mollusks.
The list of endangered/threatened freshwater fish species where potatoes, tomatoes,
peppers, and peanuts are grown is comprised of 84 different species representing 36 States. The
three States with the largest number of endangered/threatened freshwater fish species include
California, Washington, and Oregon. Within these States, the majority of endangered/threatened
fish species are salmon and steel head (Orcorhynchus sp.). The predominant endangered fish
species in Florida and North Carolina, where tomatoes, peppers, and peanuts are grown, is the
sturgeon (Acipenser sp.).
The list is of freshwater invertebrates is primarily comprised of bivalves (70% of all listed
invertebrates; present in 20 States), crustaceans (i.e., amphipods, crayfish, and shrimp) (-19 of all
listed invertebrates; present in 6 States), and snails (~11% of all listed invertebrates; present in 2
States). While the majority of listed freshwater invertebrates are bivalves, the amphipod
(Gammarus acherondytes) was listed as endangered in Illinois. The identification of an
endangered amphipod is a factor because this species was identified as the most sensitive
freshwater invertebrate from the available effects data. It appears, however, that the endangered
amphipods in Illinois are present only in caves, where pesticides are not likely to be present in
water at concentrations that would cause adverse effects.
The Agency's levels of concern for endangered and threatened freshwater fish and
invertebrates and estuarine/marine invertebrates and mollusks are exceeded for the use of
fluoxastrobin. However, the Agency recognizes that there are no Federally listed
estuarine/marine invertebrates/mollusks.
The registrant must provide information on the proximity of Federally listed freshwater
fish and invertebrates to the fluoxastrobin use sites. This requirement may be satisfied in one of
21
-------
three ways: 1) having membership in the FIFRA Endangered Species Task Force (Pesticide
Registration [PR] Notice 2000-2); 2) citing FIFRA Endangered Species Task Force data; or 3)
independently producing these data, provided the information is of sufficient quality to meet
FIFRA requirements. The information will be used by the OPP Endangered Species Protection
Program to develop recommendations to avoid adverse effects to listed species. The registrant has
satisfied this requirement using option #1 above.
7. SUMMARY OF REGULATORY POSITION AND RATIONALE
Available data provide adequate information to support the conditional registration of
fluoxastrobin technical and the proposed end-use product. Fluoxastrobin technical has a
relatively low toxicity fungicide, and there is reasonable certainty that no harm will result to the
general population or to infants and children from aggregate exposure to the proposed uses on
peanuts, tuberous and corm vegetables, leaf petiole vegetables, fruiting vegetables, turf and seed
treatment (potato, peanut and turf). The results of the risk assessment suggest the potential for
direct effects to endangered freshwater fish, and both endangered and non-endangered freshwater
invertebrates, estuarine/marine invertebrates, and mollusks. In addition, in order to reduce the
uncertainties associated with the risk assessments, additional studies and data will be required as
a condition of registration.
Although fluoxastrobin is a member of the strobilurin group that includes already
marketed active ingredients, the Agency believes that growers would benefit from a new active
ingredient that can be an effective disease management tool for both curative and preventative
purposes. In many cases, the efficacy of fluoxastrobin will be comparable to others currently on
the market. However, diverse qualities of strobilurin fungicides suggest that there can be a
valuable place for this strobilurin active ingredient for some important diseases. In addition, new
chemicals, especially with similar attributes, increase competition and should lower price. Thus,
growers will receive benefits through lower production costs which, presumably, would be passed
on to the consumer. Therefore, the registration of fluoxastrobin is considered to be in the public
interest.
8. SUMMARY OF CONFIRMATORY DATA REQUIREMENTS
Available data provide adequate information to support the conditional registration of
fluoxastrobin and establishment of the associated tolerances for residues. However, in order to
reduce the uncertainties associated with the risk assessments, the following studies or data will be
required as a condition of registration:
• Submit additional information concerning the mouse immunotoxicity subacute feeding
study.
Sediment-bound fluoxastrobin is persistent (half-life = 141 days), and concentrations in
suspended or bottom sediments are likely to be higher than those of the sediment
interstitial pore water and/or water column. Given the potential risks to freshwater and
estuarine/marine invertebrates based on fluoxastrobin concentrations in the water column,
22
-------
acute (10-day) and chronic (28-day) sediment toxicity testing, as described in the OPPTS
850.1735 and 850.1740 protocols, will be required in order to reduce uncertainties and
evaluate risks to freshwater and estuarine/marine sediment dwelling organisms.
860.1300 Nature of the Residue - Livestock - provide comparison of chromatograms for goat
metabolism study
860.1340 Residue Analytical Method - Plant and Livestock Commodities - Provide revisions to
include instructions for analysis of all crops and specification of the additional ions to be
monitored.
860.1380 Storage Stability - Provide raw data and other background parameters.
860.1500 Crop Field Trials - Provide summaries of weather conditions during each trial.
860.1520 Processed Food and Feed - A new peanut study must be submitted.
860.1650 Submittal of Analytical Reference Standards - As is required for all new chemicals.
860.1900 Field Accumulation in Rotational Crops- Provide weather conditions and soil
characteristics.
Labeling Restrictions
The Restricted Entry Interval (REI) is 12 hours.
Directions for Use
"Not for use by residential users."
"Do not use in greenhouses."
"Maximum seasonal application rate for turf includes turf seed treatment."
9. CONTACT PERSON AT EPA
Mail Address:
Tony Kish, Acting Product Manager (22)
Fungicide Branch
Registration Division (7505C)
Office of Pesticide Programs
Environmental Protection Agency
Washington, DC 20460
Office Location and Telephone Number:
23
-------
Room 249
1801 South Bell Street
Arlington, VA 22202
Phone: 703-308-9443
email: kish.tony@epa.gov
DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational
purposes only and may not be used to fulfill data requirements for pesticide registration and
reregi strati on.
Appendix I
GLOSSARY OF TERMS AND ABBREVIATIONS
ai
ARTF
CAS
CFR
cPAD
CSFII
DEEM-FCID
DFR
DWLOC
EC50
EDSP
EDSTAC
EDWC
EEC
EPA
FFDCA
FIFRA
FQPA
HED
hr
Kow
Ib
LC50
LD
50
Active Ingredient
Agricultural Reentry Task Force
Chemical Abstracts Service
Code of Federal Regulations
Chronic Population Adjusted Dose
Continuing Surveys of Food Intakes by Individuals
Dietary Exposure Evaluation Model - Food Consumption Intake Database
Dislodgeable Foliar Residue
Drinking Water Level of Concern
Effective Concentration - concentration of chemical in water at which an
effect is seen in 50% of the exposed population
Endocrine Disrupter Screening Program
Endocrine Disrupter and Testing Advisory Committee
Estimated Drinking Water Concentration
Estimated Environmental Concentrations
United States Environmental Protection Agency
Federal Food, Drug and Cosmetic Act
Federal Insecticide, Fungicide and Rodenticide Act
Food Quality Protection Act
Health Effects Division, Office of Pesticide Programs
Hour
Octanol/Water Partition Coefficient
pound
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/L, 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
24
-------
LOAEL
LOAEC
LOG
m3
mg/kg/day
mg/L
MOE
MTD
NA
NOEC
NOEL
NOAEL
NOAEC
OPP
OPPTS
PAD
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
REI
RfD
RQ
SCI-GROW
SF
SOP
TC
TGAI
TTR
UF
Hg
Hg/L
USDA
WPS
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
cubic meter
milligrams per kilogram (body weight) per day
Milligrams per Liter
Margin of Exposure
Maximum Tolerated Dose
Not Applicable
No Observed Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
No Observed Adverse Effect Concentration
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Safety Factor
Standard Operating Procedure
Transfer Coefficient
Technical Grade Active Ingredient
Turf Transferable Residue
Uncertainty Factor
Micrograms
Micrograms per Liter
United Stated Department of Agriculture
Worker Protection Standard
25
-------
FLUOXASTROBIN BIBLIOGRAPHY
MRID
45865300
45865301
45865302
45865303
45865304
45865305
45865306
Citation Receipt Date
Bayer CropScience (2003) Submission of Product Chemistry, Environmental Fate 04-Feb-2003
and Residue Data in Support of the Applications for Registration of
Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for
Tolerance of Fluoxastrobin for Use on Peanut, Tuber and Corm Vegetables, Leaf
Petioles, Fruiting Vegetables and Seed Treatments. Transmittal of 35 of 165
Studies.
Fontaine, L. (2003) Product Chemistry of HEC 480 SC Fungicide: Lab Project 04-Feb-2003
Number: 200452: 200028: G200413. Unpublished study prepared by Bayer
CropScience. 161 p. {OPPTS 830.1550, 830.1600, 830.1670, 830.1800,
830.6302, 830.6303, 830.6317, 830.6320, 830.7000, 830.7100, 830.7300}
Fontaine, L. (2003) Product Chemistry of Fluoxastrobin Technical: Lab Project 04-Feb-2003
Number: VB1-2005-0011201-00: 2001-05-23: PF-F/PB-A. Unpublished study
prepared by Bayer CropScience. 266 p. {OPPTS 830.1550, 830.1620, 830.1670,
830.1700, 830.1750, 830.1800}
Fontaine, L. (2003) Product Chemistry of Fluoxastrobin Technical: Lab Project 04-Feb-2003
Number: BR 2254: PF-E/FT-EA: 14 0120 0966. Unpublished study prepared by
Bayer CropScience. 141 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6313,
830.6314, 830.6315, 830.6316, 830.6317, 830.6320, 830.7000, 830.7050,
830.7200, 830.7220, 830.7300, 830.7370, 830.7520, 830.7560, 830.7840,
830.7950}
Hellpointner, E. (1999) Hydrolysis of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) 04-Feb-2003
HEC 5725 in Sterile Aqueous Buffer Solutions: Lab Project Number: M
1110904-6: MR-058-99: PF-E/MR. Unpublished study prepared by Bayer AG.
44 p.
rumhard, B. (2001) Aqueous Hydrolysis of HEC5725 Under Conditions of 04-Feb-2003
Processing Studies: Lab Project Number: M1771 136-6: MR-426-01: PF-E/MR.
Unpublished study prepared by Bayer AG. 34 p.
Stupp, H. (2001) Photolysis of HEC 5725 in Aqueous Solution: Lab Project 04-Feb-2003
Number: MR 072-00: M 1120905-8. Unpublished study prepared by Bayer AG.
81 p.
26
-------
45865307
45865308
45865309
45865310
45865311
45865312
45865313
45865314
45865315
Hellpointner, E. (2001) Determination of the Quantum Yield and Assessment of the 04-Feb-2003
Environmental Half-Life of the Direct Photogradation in Water of HEC 5725:
Lab Project Number: M1430940-1: MR 540/00. Unpublished study prepared by
Bayer AG. 3 9 p.
Hellpointner, E. (2001) Photolysis of HEC 5725 on Soil Surface: Lab Project 04-Feb-2003
Number: Ml 130939-6: MR 347/00. Unpublished study prepared by Bayer AG.
92 p.
Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation of (Methoxyiminotolyl- 04-Feb-2003
Ring-UL-(Carbon 14)) HEC 5725 in Soil Laacher Hof AXXa: Lab Project
Number: M 125 0886-O: MR 230/01: THS 4727. Unpublished study prepared by
Bayer AG. 58 p.
Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation and Metabolism of 04-Feb-2003
(Methoxyiminotolyl-Ring-UL-(Carbon 14)-and (Pyrimidine-2-(Carbon 14) HEC
5725 inThre Soils: Lab Project Number: M 125 0894-9: MR-231/01: MR-23 l-O
1. Unpublished study prepared by Bayer Ag. 124 p.
Stupp, H. (2002) HEC 2725 Carboxylic Acid: Degradation of HEC 5725 C 04-Feb-2003
Carboxylic Acid (HEC71 SO) in Three Soils Under Aerobic Conditions: Lab
Project Number: M125 1146-O: MR522/01. Unpublished study prepared by
Bayer Ag. 54 p.
Hellpointner, E. (2002) Anaerobic Aquatic Degradation and Metabolism of HEC 04-Feb-2003
5725: Lab Project Number: M152006-3: MR-406/01: HPO-225. Unpublished
study prepared by Bayer Ag. 76 p.
Brumhard, B.; Oi, M. (2002) Aerobic Degradation and Metabolism of 04-Feb-2003
(Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 5725 in the Water/Sediment
System: Lab Project Number: M15 1 0903-9: MR-396/01: M151 0903-9.
Unpublished study prepared by Bayer Ag. 75 p.
Hein, W. (2000) Adsorption/Desorption of (Phenyl-UL-(Carbon 14)) HEC 7155 04-Feb-2003
(Deschlorophenyl HEC 5725) on Four Different Soils: Lab Project Number:
BAY33: FM776. Unpublished study prepared by Staatliche Lehr-und
Forschungsanstalt fuer Landwirtschaft. 44 p.
Pent, G. (1998) Adsorption/Desorption of (Methoxyiminotolyl-Ring-UL- 04-Feb-2003
(Carbon 14)) HEC 5725 on Four Different Soils: Lab Project Number: BAY27:
FM767. Unpublished study prepared by Staatliche Lehr-und Forschungsanstalt
fuer Landwirtschaft. 46 p.
27
-------
45865316
45865317
45865318
45865319
45865320
45865321
45865322
45865323
45865324
Stupp, H. (2001) Adsorption and Desorption of HEC 5725-Carboxylic Acid in 04-Feb-2003
Soil: Lab Project Number: MR411-01: M1311123-2: MR41 1/01. Unpublished
study prepared by Bayer Ag. 63 p.
Schramel, O. (2001) Dissipation of HEC 5725 (100 EC) in Soil under Field 04-Feb-2003
Conditions: France, Germany, Great Britain, Italy: Lab Project Number:
R812390: R812404: R812412. Unpublished study prepared by Bayer Ag. 184 p.
Bauer, M; Andre, I; Zielinski, C. (2002) Terrestrial Field Dissipation of 04-Feb-2003
HEC 5725 in California Soil, 1999: Final Report: Lab Project Number:
AG990009: F99568-001: 99.109. Unpublished study prepared by Battelle
Memorial Institute and Plant Services, Inc. 236 p.
Bauer, M.; Andre, I; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in Georgia Soil, 1999: Final Report: Lab Project Number: AG990010:
F99541-001: HC022102. Unpublished study prepared by Battelle Memorial
Institute and Bayer Research Farm. 197 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in New York Soil, 1999: Final Report: Lab Project Number: AG990011:
F99565-001: AR99352. Unpublished study prepared by Battelle Memorial
Institute and A.C.D.S. Research, Inc. 241 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in New York Soil, 1999: Final Report: Lab Project Number: HC022104:
200217: AG990012. Unpublished study prepared by Battelle Memorial Institute
and A.C.D.S. Research, Inc. 174 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in Washington Soil, 1999: Final Report: Lab Project Number: AG990013:
F99538-001: 99-40. Unpublished study prepared by Battelle Memorial Institute
and Quails Agricultural Laboratories, Inc. 191 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in California Turf, 1999: Final Report: Lab Project Number: AG990014:
HC022701: 200219. Unpublished study prepared by Battelle Memorial Institute
and Plant Sciences, Inc. 253 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in New York Turf, 1999: Final Report: Lab Project Number: AG990015:
F99565-001: HC022702. Unpublished study prepared by Battelle Memorial
Institute and A.C.D.S. Research, Inc. 261 p. 04-Feb-2003
28
-------
45865325
45865326
45865327
45865328
45865329
45865330
45865331
45865332
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in Manitoba Soil, 1999: Final Report: Lab Project Number: AG990024:
F99559-001: HC022107. Unpublished study prepared by Battelle Memorial
Institute and Enviro-Quest. 188 p.
Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003
5725 in Prince Edward Island Soil, 1999: Final Report: Lab Project Number:
AG990025: F99564-001: HC022106. Unpublished study prepared by Battelle
Memorial Institute and Atlantic AgriTech. 173 p.
Stupp, H. (20) Photolysis of HEC5725 in Water/Sediment Systems: Lab Project 04-Feb-2003
Number: MR 322/01: M 112 1135-4: PF-E/MR. Unpublished study prepared by
Bayer AG. 54 p.
Schramel, O. (2001) Residue Analytical Method 00611 (MR-645/99) for the 04-Feb-2003
Determination of HEC 5725-E-Isomer, HEC 5725-Z-Isomer,
HEC-5725-E-Des-Chlorophenyl and HEC 5725-E/Z-Carboxylic Acid in Soil by
HPLC-MS/MS: Lab Project Number: P 60190031: MR-645/99: 00611.
Unpublished study prepared by Bayer AG. 74 p. {OPPTS 850.7100}
Bauer, M. (2002) Independent Laboratory Validation of Bayer Method 00611 04-Feb-2003
"Residue Analytical Method for the Determination of HEC 5725-E-Isomer, HEC
5725-Z-Isomer, HEC-5725-E-Des-Chlorophenyl and HEC 5725-E/Z-Carboxylic
Acid in Soil by HPLC-MS/MS": Lab Project Number: AG000082: HC112101:
200317. Unpublished study prepared by Battelle. 85 p. {OPPTS 850.7100}
Sommer, H. (1999) Method for Determination of HEC 5725 and HEC 7155 in 04-Feb-2003
Test Water from Aquatic Toxicity Test by HPLC: Lab Project Number: P 604
97052: 109230: 00579. Unpublished study prepared by Bayer Ag. 15 p.
Sommer, H. (2001) Enforcement Methods for Determination of HEC 5725 in 04-Feb-2003
Drinking and Surface Water by HPLC-MS/MS: Lab Project Number: P 684
017047: MR-201/01: 00692. Unpublished study prepared by Bayer Ag. 27 p.
{OPPTS 840.1400}
Schramel, O. (2001) Determination of the Storage Stability of HEC 5725- 04-Feb-2003
E-isomer HEC 5725-Z-Isomer, HEC5725-E-Des-Chlororphenyl and HEC
5725-E/Z-Carboxylic Acid in Soil After a Storage Period of 14 Months: Lab
Project Number: P64190032: MR-646199: MR-646-99. Unpublished study
prepared by Bayer Ag. 85 p.
29
-------
45865333
45865334
45865335
45865400
Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 5725- 04-Feb-2003
amide on Soil Using High Performance Liquid Chromatography (HPLC): Lab
Project Number: M 138 1128-4: MR314-01: 314/01. Unpublished study prepared
by Bayer Ag. 35 p.
Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 5725- 04-Feb-2003
hydroxyphenyl on Soil Using High Performance Liquid Chromatography
(HPLC): Lab Project Number: M 138 1127-3: MR313-01: 313/01. Unpublished
study prepared by Bayer Ag. 35 p.
Schafer, H. (2001) Calculation of DT50 Values of HEC 5725 Metabolite HEC 04-Feb-2003
7155 in Soil: Lab Project Number: P668 01 6557: MR-552-01. Unpublished
study prepared by Bayer Ag. 21 p.
Bayer CropScience (2003) Submission of Environmental Fate, Fate, and Toxicity 04-Feb-2003
Data in Support of the Applications for Registration of Fluoxastrobin Technical
and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin on
Peanuts, Tuberous and Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and
Seed Treatments. Transmittal of 32 of 165 Studies.
45865401
45865402
45865403
45865404
45865405
Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 04-Feb-2003
5725-Carboxylic Acid on Soil Using High Performance Liquid Chromatography
(HPLC): Lab Project Number: M 138 1130-7: 247/01: MR247-01. Unpublished
study prepared by Bayer Ag. 34 p.
Schafer, H. (2001) Calculation of Temperature Referenced First Order DT50 04-Feb-2003
Values HEC 5725 Based on Field Dissipation Studies Conducted in Europe: Lab
Project Number: MR-562-01: P 668 01 6561. Unpublished study prepared by
Bayer Ag. 33 p.
Schafer, H. (2001) Calculation of a DT-50 Value of HEC 5725 Metabolite 04-Feb-2003
Oxazepine Generated by Photolysis in Aqueous Solution: Lab Project Number:
MR-262/0 1: MR262-01: P 668 01 6521. Unpublished study prepared by Bayer
Ag. 16 p.
Schafer, H. (2001) Predicted Environmental Concentration of HEC 5725 and its 04-Feb-2003
Metabolite HEC 7155 in Ground Water Recharge Based on PELMO: Use in
Winter Cereals in Northern and Southern Europe: Lab Project Number: P 668 01
6558: MR-545/01. Unpublished study prepared by Bayer Ag. 20 p.
Malekani, K. (2003) Fate of HEC 5725 in the Environment (Summary): Lab 04-Feb-2003
Project Number: 200415. Unpublished study prepared by Bayer CropScience. 99
P-
30
-------
45865406
45865407
45865408
45865409
45865410
45865411
45865412
45865413
45865414
Heimbach, F. (1999) Acute Toxicity of HEC 5725 (tech.) to Water Fleas 04-Feb-2003
(Daphnia magna): Lab Project Number: HBF/DM 211: E 320 1674-3.
Unpublished study prepared by Bayer Ag. 47 p. {OPPTS 850.1010}
Dorgerloh, M; Sommer, H. (2002) Acute Toxicity of HEC 5725 (E:Z; 65:35) to 04-Feb-2003
Water Fleas (Daphnia magna): Lab Project Number: E 320 2187-3: DOMA
21071. Unpublished study prepared by Bayer Ag. 51 p. {OPPTS 850.1010}
Hendel, B.; Sommer, H. (2001) Acute Toxicity of HEC 5725-Carboxylic Acid 04-Feb-2003
(Tech) to Water Fleas (Daphnia magna): Lab Project Number: E 320 1976-8:
HDB/DM 249. Unpublished study prepared by Bayer Ag. 26 p. {OPPTS
850.1010}
Hendel, B. (2000) Acute Toxicity of HEC 5725-Deschlorophenyl to Water Fleas 04-Feb-2003
(Daphnia magna): Lab Project Number: E 320 1800-4: HDB/DM 227.
Unpublished study prepared by Bayer Ag. 24 p. {OPPTS 850.1010}
Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 5725: A 96-Hour Shell Deposition 04-Feb-2003
Test with the Eastern Oyster (Crassostrea virginica): Lab Project Number:
99-B-133: HC831501: 2357-BR. Unpublished study prepared by T.R. Wilbury
Laboratories, Inc. 30 p.
Boeri, R.; Wyskiel, D.; Ward, T. (2002) HEC 5725: A 96-Hour Flow-Through 04-Feb-2003
Acute Toxicity Test with the Saltwater Mysid, (Americamysisbahia): Lab Project
Number: 99-B-131: HC833101: 2358-BR. Unpublished study prepared by T.R.
Wilbury Laboratories, Inc. 31 p.
Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Bluegill (Lepomis 04-Feb-2003
macrochirus) in a Static Test: Lab Project Number: E 252 1696-1: DOMA 99089:
00579. Unpublished study prepared by Bayer Ag. 48 p. {OPPTS 850.1075}
Dorgerloh, M. (2000) HEC 5725 Acute Toxicity (96 Hours) to Common Carp 04-Feb-2003
(Cyprinus carpio) in a Static Test: Lab Project Number: DOMA 20011: E
28601782-4. Unpublished study prepared by Bayer Ag. 37 p. {OPPTS 850.1075}
Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Rainbow Trout 04-Feb-2003
(Oncorhynchus mykiss) in a Static Test: Lab Project Number: E 250 1605-9:
DOMA 99065: 00579. Unpublished study prepared by Bayer Ag. 48 p. {OPPTS
45865415
Dorgerloh, M.; Sommer, H. (2001) HEC 5725-Carboxylic Acid-Acute Toxicity
(96 Hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test (Limit
Test): Lab Project Number: E 280 2104-7: DOMA 21020: 00683. Unpublished
study prepared by Bayer Ag. 41 p. {OPPTS 850.1075}
04-Feb-2003
-------
45865416
45865417
45865418
45865419
45865420
45865421
45865422
45865424
45865425
Dorgerloh, M. (2000) HEC 5725-Deschlorophenyl-Acute Toxicity (96 Hours) to 04-Feb-2003
Rainbow Trout (Oncorhynchus mykiss) in a Static Test: Lab Project Number: E
280 1761-5: DOMA 20012: 00579. Unpublished study prepared by Bayer Ag. 46
p. {OPPTS 850.1075}
Kern, M.; Woodard, D.; Mattern, G. (2002) Acute Toxicity of HEC 5725 04-Feb-2003
(Technical) to the Sheepshead Minnow (Cyprinodon variegatus) Under Static
Conditions: Lab Project Number: HC830901: 110322. Unpublished study
prepared by Bayer CropScience. 30 p.
Hendel, B. (2000) Influence of HEC 5725 (tech.) on the Reproduction Rate of 04-Feb-2003
Water Fleas (Daphnia magna): Lab Project Number: E 321 1798-1: HDB/RDM
64. Unpublished study prepared by Bayer Ag. 80 p. {OPPTS 850.1300}
Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 5725: A Flow-Through Life Cycle 04-Feb-2003
Toxicity Test with the Saltwater Mysid (Americamysis bahia): Lab Project
Number: 99-B-132: HC843101: 2359-BR. Unpublished study prepared by T.R.
Wilbury Laboratories, Inc. 48 p.
Scheerbaum, D. (2001) HEC 5725-Fish (Rainbow Trout), Early-Life Stage 04-Feb-2003
Toxicity Test, Under Flow-Through Conditions: (Final Report): Lab Project
Number: 991028BD: FSR69122. Unpublished study prepared by Dr. U.
Noack-Laboratorium. 84 p. {OPPTS 850.1400}
Dorgerloh, M.; Weber, E. (2001) (Carbon 14)-HEC 5725-Bioconcentration and 04-Feb-2003
Biotransformation in Bluegill (Lepomis macrochirus) under Flow-Through
Conditions: Lab Project Number: DOM 20032: E 244 1857-1: DOMA 20032.
Unpublished study prepared by Bayer Ag. 160 p. {OPPTS 850.1730}
Barfknecht, R. (2000) HEC 5725 Techn. Ai: Acute Oral Toxicity for Bobwhite 04-Feb-2003
Quail: Lab Project Number: E 292 1560-5: BAR/LD032. Unpublished study
prepared by Bayer Ag. 38 p. {OPPTS 850.2100}
04-Feb-200345865423Barfknecht, R. (2001) HEC 5725 Techn.: 5-Day Dietary
LC50 for Bobwhite Quail (Colinus virginianus): Lab Project Number: E 295
1558-5: BAR/LC007. Unpublished study prepared by Bayer Ag. 34 p. {OPPTS
850.2200}
Barfknecht, R. (2001) HEC 5725 Techn.: 5-Day Dietary LC50 for Mallard Duck 04-Feb-2003
(Anas platyrhynchos): Lab Project Number: E 297 1559-8: BAR/LC 009.
Unpublished study prepared by Bayer Ag. 35 p. {OPPTS 850.2200}
Frieling, W. (2001) Reproduction Study in Bobwhite Quail with HEC 5725 04-Feb-2003
Techn: (By Dietary Admixture): Lab Project Number: 259774. Unpublished
study prepared by NotoxB.V. 211 p. {OPPTS 850.2300}
32
-------
45865426
45865427
Bowers, L.; Stoughton, t> (2003) Effect of Technical HEC 5725 on Mallard 04-Feb-2003
Reproduction: Lab Project Number: HC740801: 200084. Unpublished study
prepared by Bayer CropScience. 129 p.
Bruhnke, C. (2000) HEC 5725 A.I.-Acute Effects on the Honeybee Apis 04-Feb-2003
melifera (Hymenoptera, Apidae); Limit Test: Lab Project Number: 990222BN:
IBA64041. Unpublished study prepared by Noack-Laboratorium. 30 p. {OPPTS
45865428
45865429
45865430
45865431
45865432
45865500
Bowers, L. (2003) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget 04-Feb-2003
Phytotoxicity Study Using HEC 5725 SC 480: Lab Project Number: 200313:
HC451601: HC451602. Unpublished study prepared by Bayer CropScience. 97 p.
Dorgerloh, M. (2001) HEC 5725-Toxicity (7 Days) to Lemna gibba G3: Lab 04-Feb-2003
Project Number: E 412 1602-6: DOM 20017: MR-238/00. Unpublished study
prepared by Bayer Ag. 31 p. {OPPTS 850.4400}
Kern, M.; Lam, C. (2002) Toxicity of HEC 5725 Technical to Duckweed (Lemna 04-Feb-2003
gibba G3): Lab Project Number: HC883701: 200340. Unpublished study
prepared by Bayer CropScience. 36 p. {OPPTS 850.4400}
Dorgerloh, M. (2000) HEC 5725-Influence on the Growth of the Green Alga, 04-Feb-2003
Selenastrum capricornutum: Lab Project Number: E 323 1609-4: DOM 99061.
Unpublished study prepared by Bayer Ag. 38 p. {OPPTS 850.5400}
Dorgerloh, M.; Sommer, H. (2001) HEC 5725-Carboxylic Acid-Influence on the 04-Feb-2003
Growth of the Green Alga, Selenastrum capricornutum: Lab Project Number: E
323 1878-2: DOM 20061: MR-110/01. Unpublished study prepared by Bayer Ag.
47 p. {OPPTS 850.5400}
Bayer CropScience (2003) Submission of Fate, Toxicity, and Residue Data in 04-Feb-2003
Support of the Applications for Registration of Fluoxastrobin Technical and HEC
480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin on Peanut,
Tuber and Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and Seed
Treatments. Transmittal of 34 of 165 Studies.
45865501
Dorgerloh, M. (2000) HEC 5725~Deschlorophenyl~Influence on the Growth of
the Green Alga, Selenastrum capricornutum: Lab Project Number: E 323 1756-7:
DOM 20015: MR-245/00. Unpublished study prepared by Bayer Ag. 30 p.
{OPPTS 850.5400}
04-Feb-2003
33
-------
45865502
45865503
45865504
45865505
45865506
45865507
45865508
45865509
45865510
Meisner, P. (2000) Acute Toxicity of HEC 5725 Techn. Ai: to Earthworms 04-Feb-2003
(Eisenia fetida): Lab Project Number: E 310 1771-0: MPE/RG 318/00.
Unpublished study prepared by Bayer Ag. 19 p.
Meisner, P. (2000) Acute Toxicity of HEC 5725-Deschlorophenyl to Earthworms 04-Feb-2003
(Eisenia fetida): Lab Project Number: E 310 1759-6: MPE/RG 335/00.
Unpublished study prepared by Bayer Ag. 19 p.
Luehrs, U. (2002) HEC 5725-Deschlorophenyl: Effects on Reproduction and 04-Feb-2003
Growth of Earthworms (Eisenia fetida) in Artificial Soil: Lab Project Number:
14661022. Unpublished study prepared by Ibacon GmbH. 36 p.
Hendel, B. (2000) Influence of HEC 5725 (tech.) on Developement and 04-Feb-2003
Emergence of larvae of Chironomus riparius in a Water Sediment System: Lab
Project Number: E 416 1774-0: HDB/CH 41: MR-277/00. Unpublished study
prepared by Bayer Ag. 45 p.
Dorgerloh, M.; Sommer, H. (2001) Influence of HEC 5725-Carboxylic Acid 04-Feb-2003
on Developement and Emergence of Larvae of Chironomus riparius in a Water
Sediment System: Lab Project Number: E 416 2091-3: DOM 21061: 00683.
Unpublished study prepared by Bayer Ag. 56 p.
Koester, I; Weber, H. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14))HEC 04-Feb-2003
5725: Absorption, Distribution, Excretion and Metabolism in the Lactating Goat:
Lab Project Number: M 21819094: MR-142/01: M 181 9094-2. Unpublished
study prepared by Bayer Ag. 415 p. {OPPTS 860.1300}
Koester, I; Weber, H. (2001) (Chlorophenyl-UL-(Carbon 14))HEC 5725: 04-Feb-2003
Absorption, Distribution, Excretion and Metabolism in the Lactating Goat: Lab
Project Number: MR-143/01: M 51819097: MO-02-002409. Unpublished study
prepared by Bayer Ag. 290 p. {OPPTS 860.1300}
Klempner, A.; Weber, H. (2001) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: 04-Feb-2003
Absorption, Distribution, Excretion and Metabolism in Laying Hens: Lab Project
Number: M 31819103: MR-405/01: HEC4. Unpublished study prepared by Bayer
Ag. 331 p. {OPPTS 860.1300}
Klempner, A.; Weber, H. (2002) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 04-Feb-2003
5725: Absorption, Distribution, Excretion and Metabolism in Laying Hens: Lab
Project Number: M 91819073: MO-02-014542: MR-404/01. Unpublished study
prepared by Bayer Ag. 412 p. {OPPTS 860.1300}
34
-------
45865511
45865512
45865513
45865514
45865515
45865516
45865517
45865518
45865519
Reiner, H. (2001) Metabolism of (Chlorophenyl-UL-(Carbon 14)) HEC 5725 in 04-Feb-2003
Tomatoes: Lab Project Number: M1731026-0: MR 128/01. Unpublished study
prepared by Bayer CropScience. 71 p. {OPPTS 860.1300}
Reiner, H. (2001) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) 04-Feb-2003
HEC 5725 in Tomatoes: Lab Project Number: M1731027-1: MR 129/01.
Unpublished study prepared by Bayer CropScience. 70 p. {OPPTS 860.1300}
Stork, A. (2001) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 04-Feb-2003
5725 in Spring Wheat: Lab Project Number: M173 0927-9: MR 005/00.
Unpublished study prepared by Bayer CropScience. 265 p. {OPPTS 860.1300}
Stork, A. (2001) Metabolism of (Chlorophenyl-UL-(Carbon 14)) HEC 5725 in 04-Feb-2003
Spring Wheat: Lab Project Number: 0173 0934-7: MR-125/01: BD0402G.
Unpublished study prepared by Bayer Ag. 183 p. {OPPTS 860.1300}
Stork, A. (2001) Metabolism of (Pyrimidine-2-(Carbon 14)) HEC 5725 in Spring 04-Feb-2003
Wheat: Lab Project Number: M1730911-2: MR-126/01. Unpublished study
prepared by Bayer Ag. 206 p. {OPPTS 860.1300}
Stork, A. (2001) Residues of HEC 5725 in Spring Wheat after Seed Dressing: Lab 04-Feb-2003
Project Number: M173 0901-1: MR-379/01. Unpublished study prepared by
Bayer Ag. Ill p. {OPPTS 860.1300}
Stork, A. (2002) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 04-Feb-2003
5725 in Peanuts: Lab Project Number: M173 0935-8: MR-531/01:
MO-02-017618. Unpublished study prepared by Bayer CropScience Ag. 196 p.
{OPPTS 860.1300}
Stork, A. (2002) Metabolism of (Pyrimidine-2-(Carbon 14))HEC 5725 in Peanuts: 04-Feb-2003
Lab Project Number: M173 0936-9: MO-03-000144: MR-532/01. Unpublished
study prepared by Bayer CropScience Ag. 183 p. {OPPTS 860.1300}
Heinemann, O. (2001) Analytical Determination of Residues of the Fungicide 04-Feb-2003
HEC 5725 in/on Cereals, Cereal Processed Products and Vegetables by
HPLC-MS/MS: Lab Project Number: P60293003: MR-507/99: 00604.
Unpublished study prepared by Bayer Ag. 136 p. {OPPTS 860.1300, 860.1340,
45865520
Preu, M. (2001) Analytical Method 00649 for the Determination of Residues of
HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS: Lab Project
Number: P 602001007: MR-508/00: 00649. Unpublished study prepared by
Bayer Ag. 208 p. {OPPTS 860.1300, 860.1340, 860.1360}
04-Feb-2003
35
-------
45865521
45865522
45865523
45865524
45865525
45865526
45865527
Reiner, H. (2001) Extraction Efficiency Testing of the Residue Method 00604 04-Feb-2003
for the Determination of HEC 5725 Residues in Spring Wheat and Tomatoes
Using Radioactive Residues: Lab Project Number: M 9991050-3: MR-127/01:
00604. Unpublished study prepared by Bayer Ag. 52 p. {OPPTS 860.1340}
Preu, M. (2001) Extraction Efficiency of Method 00604 for Incurred Residues 04-Feb-2003
of HEC 5725 in Samples of Wheat Ear-Comparison of ASE with MethanoI/Water
(4/1,/v/v) and ASE with Methanol/Water (1/1, v/v): Lab Project Number: P
602011001: MR-023/01: 00604. Unpublished study prepared by Bayer Ag. 36 p.
{OPPTS 860.1340}
Bauer, M. (2002) Independent Laboratory Validation of the ASE Extraction 04-Feb-2003
Method as Described in Bayer Method 00604: "Analytical Determination of
Residues of the Fungicide HEC 5725 in/on Cereals, Cereal Processed Products
and Vegetables by HPLC-MS/MS.": Lab Project Number: 200319: AG000083:
HC111602. Unpublished study prepared by Battelle Memorial Institute. 43 p.
{OPPTS 860.1340}
South, N. (2002) Independent Laboratory Validation of the Microwave Extraction 04-Feb-2003
Method as Described in "Analytical Method 00649 for the Determination of
Residues of HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS.": Lab
Project Number: AG020018: HC111603: 200256. Unpublished study prepared by
Battelle Memorial Institute. 51 p. {OPPTS 860.1340}
Schoening, R. (2001) Residue Analytical Method 00691 for the Determination of 04-Feb-2003
Residues of HEC 5725 (E+Z~Isomer) and HEC 7154 in Animal Tissues by
HPLC with Electrospray MS/MS~Detection: Lab Project Number: P 602014706:
MR-194/01: 00691. Unpublished study prepared by Bayer Ag. 152 p. {OPPTS
860.1340}
Koester, J. (2001) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Extraction 04-Feb-2003
Efficiency Testing of the Residue Method for the Determination of HEC 5725 in
Animal Tissues Using Aged Radioactive Residues: Lab Project Number: M
9991134-6: MR-542/01: HEC 5. Unpublished study prepared by Bayer Ag. 74 p.
{OPPTS 860.1340}
Schoening, R. (2001) Modification and Independent Laboratory Validation of 04-Feb-2003
Residue Analytical Method 00691 for the Determination of Residues of HEC
5725 (E+Z~Isomer) and HEC 7154 in Animal Tissues: Lab Project Number:
110897: HC110201: 00691. Unpublished study prepared by Bayer Corporation.
101 p. {OPPTS 860.1340}
36
-------
45865528
45865529
45865530
45865531
45865532
45865533
45865534
45865600
Anderson, C. (2002) Multiresidue Method Testing for HEC 5725 E-and Z- 04-Feb-2003
Isomers and HEC 7154 According to PAM I, Appendix II, as Updated January,
1994: Lab Project Number: HC161601: 47115: 200292. Unpublished study
prepared by ABC Laboratories, Inc. 116 p. {OPPTS 860.1340}
De Haan, R. (2001) HEC 5725-A 29-Day Dairy Cattle Feeding Study: Lab 04-Feb-2003
Project Number: HC060401: 110888: BJ060401. Unpublished study prepared by
Bayer Corporation and Southwest Biolabs, Inc. 168 p. {OPPTS 860.1480}
Krolski, M. (2002) HEC 5725 480 SC-Magnitude of the Residues on Celery: Lab 04-Feb-2003
Project Number: US19CE01: 200228: AG000013. Unpublished study prepared
by Bayer CropScience and Battelle-AgriFood. 135 p. {OPPTS 860.1500}
Beedle, E. (2002) HEC 5725 480 SC and 50 WP-Magnitude of the Residue in 04-Feb-2003
Tomatoes and Peppers (Crop Group 8~Fruiting Vegetables, Except Curcurbits:
Lab Project Number: US19TO01: US19PP01: 200164. Unpublished study
prepared by Bayer CropScience and Battelle-AgriFood. 238 p. {OPPTS
860.1500}
Duah, F. (2002) HEC 5725 480 SC-Magnitude of the Residue in/on Peanuts: Lab 04-Feb-2003
Project Number: HC19PE01: 200348: HC057-OOD. Unpublished study prepared
by Bayer CropScience and Battelle-AgriFood. 198 p. {OPPTS 860.1500}
Krolski, M. (2003) HEC 5725 480 SC and 50 WP-Magnitude of the Residue in 04-Feb-2003
Potatoes: Lab Project Number: US19PO01: 200227: US024-OOH. Unpublished
study prepared by Bayer CropScience and Battelle-AgriFood. 195 p. {OPPTS
860.1500}
Beedle, E. (2002) HEC 5725 480 SC-Magnitude of the Residue in Tomato 04-Feb-2003
Processed Commodities: Lab Project Number: US19TO02: 200237: US19TO01.
Unpublished study prepared by Bayer CropScience, The National Food
Laboratory, Inc. and Battelle-AgriFood. 168 p. {OPPTS 860.1520}
Bayer CropScience (2003) Submission of Residue and Toxicity Data in Support 04-Feb-2003
of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC
Fungicide and the Petition for Tolerance of Fluoxastrobin on Peanut, Tuber and
Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and Seed Treatments.
Transmittal of 34 of 165 Studies.
45865601
Keffer, C. (2002) HEC 5725 480 SC-Magnitude of the Residue in Potato 04-Feb-2003
Processed Commodities: Lab Project Number: US19PO02: 200276: US006-01P.
Unpublished study prepared by Bayer CropScience, The National Food
Laboratory, Inc., and Battelle-AgriFood. 159 p. {OPPTS 860.1520}
37
-------
45865602
45865603
45865604
45865605
45865606
Keffer, C. (2003) HEC 5725 480 SC-Magnitude of the Residue in Peanut 04-Feb-2003
Processed Commodities: Lab Project Number: US19PE01: 200406: US005-01P.
Unpublished study prepared by Bayer CropScience, Texas A&M University, and
Battelle-AgriFood. 136 p. {OPPTS 860.1520}
Neumann, B. (2001) Confined Rotational Crop Study with (Pyrimidine-2- 04-Feb-2003
(Carbon 14)) HEC5725: Lab Project Number: M 130 0930-6: MR-124/01.
Unpublished study prepared by Bayer Ag. 214 p. {OPPTS 860.1850}
Neumann, B. (2001) Confined Rotational Crop Study with (Methoxyiminotolyl- 04-Feb-2003
Ring-UL-(Carbon 14)) HEC 5725: Lab Project Number: M1300900-3: MR
086/01: IS4530A. Unpublished study prepared by Bayer CropScience. 215 p.
{OPPTS 860.1850}
Neumann, B. (2001) Confined Rotational Crop Study with (Chlorophenyl-UL- 04-Feb-2003
(Carbon 14)) HEC5725: Lab Project Number: M1300933-9: MR 392/00:
BD0302G. Unpublished study prepared by Bayer CropScience. 207 p. {OPPTS
860.1850}
Krolski, M. (2003) HEC 5725 480 SC-Magnitude of the Residues in Rotational 04-Feb-2003
Crops: Lab Project Number: HC19RC01: HC19RC02: HC19RC03. Unpublished
study prepared by Bayer CropScience and Battelle-AgriFood. 374 p. {OPPTS
45865607
45865608
45865609
45865610
Beedle, E.; Ying, S. (2002) HEC 5725 480 SC~Magnitude of the Residue in 04-Feb-2003
Rotational Crop of Cotton: Lab Project Number: US19CT01: 200311:
US218-OOR. Unpublished study prepared by Bayer CropScience, Texas A&M
University, and Battelle-AgriFood. 194 p. {OPPTS 860.1900}
Beedle, E. (2002) HEC 5725 480 SC~Magnirude of the Residue in Legume 04-Feb-2003
Vegetables (Crop Group 6) and Foliage of Legume Vegetables (Crop Group 7)
WhenPlanted as Rotational Crops: Lab Project Number: US19BP01: US19BL01:
US19BY01. Unpublished study prepared by Bayer CropScience and
Battelle-AgriFood. 623 p. {OPPTS 860.1900}
Beedle, E.; Ying, S. (2002) HEC 5725 480 SC~Magnitude of the Residue in a 04-Feb-2003
Rotational Crop of Alfalfa: Lab Project Number: US19AL01: 200282:
US195-OOR. Unpublished study prepared by Bayer CropScience and
Battelle-AgriFood. 170 p. {OPPTS 860.1900}
Lenz, C. (2003) HEC 5725 480 SC~Magnitude of the Residue in Rotational Crop 04-Feb-2003
Grasses (Crop Group 7-17): Lab Project Number: US19GS01: 200368:
US 148-OORA. Unpublished study prepared by Bayer CropScience and
Battelle-AgriFood. 174 p. {OPPTS 860.1900}
38
-------
45865611
45865612
45865613
45865614
45865615
45865616
45865617
45865618
45865619
45865620
Krolski, M. (2003) HEC 5725 480 SC-Magnitude of the Residue in Rotational 04-Feb-2003
Crops of Corn, Rice, Sorghum, and Wheat (Crop Groups 15 and 1): Lab Project
Number: US19CO01: US19RI01: US19SO01. Unpublished study prepared by
Bayer CropScience and Battelle-AgriFood. 751 p. {OPPTS 860.1900}
Krotlinger, F. (1996) HEC 5725: Study for Acute Oral Toxicity in Rats: Lab 04-Feb-2003
Project Number: 25231: T8060660: 109158. Unpublished study peparedby
Bayer Ag. 29 p. {OPPTS 870.1100}
Andrews, P. (1998) HEC 5725 N: Study for Acute Oral Toxicity in Rats: Lab 04-Feb-2003
Project Number: 27685: T 2062383: 109159. Unpublished study prepared by
Bayer Ag. 25 p. {OPPTS 870.1100}
Krotlinger, F. (2000) HEC 5725-Phenoxy-Hydroxypyrimidine (Metabolite of 04-Feb-2003
HEC 5725): Study for Acute Oral Toxicity in Rats: Lab Project Number: 305919:
T1070086. Unpublished study prepared by Bayer Ag. 27 p. {OPPTS 870.1100}
Eigenberg, D. (2003) An Acute Oral LD50 Study in the Rat with HEC 5725 04-Feb-2003
480 SC: Lab Project Number: 02-A12-NE: 200396. Unpublished study prepared
by Bayer CropScience LP. 22 p. {OPPTS 870.1100}
Krotlinger, F. (1998) HEC 5725: Study for Acute Dermal Toxicity in Rats: Lab 04-Feb-2003
Project Number: 27025: T9069103: 109161. Unpublished study prepared by
Bayer Ag. 29 p. {OPPTS 870.1200}
Eigenberg, D. (2003) An Acute Dermal LD50 Study in the Rat with HEC 5725 04-Feb-2003
480 SC: Lab Project Number: 02-A22-NF: 200395. Unpublished study prepared
by Bayer CropScience LP. 20 p. {OPPTS 870.1200}
Pauluhn, J. (1999) HEC 5725: Study on Acute Inhalation Toxicity in Rats: Lab 04-Feb-2003
Project Number: PH-28952: T8067483: 109268. Unpublished study prepared by
Bayer Ag. 78 p. {OPPTS 870.1300}
Pauluhn, J. (2003) HEC 5725 SC 480: Study on Acute Inhalation Toxicity in Rats: 04-Feb-2003
Lab Project Number: AT00190: T3072202. Unpublished study prepared by Bayer
Ag. 72 p. {OPPTS 870.1300}
Leuschner, P. (1999) Acute Eye Irritation Study of HEC 5725 by Instillation into 04-Feb-2003
the Conjunctival Sac of Rabbits: Lab Project Number: R 6504 A: T5060144:
9301/44/95. Unpublished study prepared by LPT Laboratory of Pharmacology
and Toxicology. 22 p. {OPPTS 870.2400}
39
-------
45865621
45865622
45865623
45865624
45865625
45865626
45865627
45865628
45865629
45865630
Merkel, D. (2003) Primary Eye Irritation Study in Rabbits: HEC 5725 480 SC: 04-Feb-2003
Lab Project Number: 02C-I35-NG: 200445: P324 BAY. Unpublished study
prepared by Product Safety Labs. 17 p. {OPPTS 870.2400}
Leuschner, P. (1999) Acute Skin Irritation Test (Patch Test) of HEC 5725 in 04-Feb-2003
Rabbits: Lab Project Number: R 6503 A: T5060144: 9300/44/95. Unpublished
study prepared by LPT Laboratory of Pharmacology and Toxicology. 20 p.
{OPPTS 870.2500}
Merkel, D. (2003) Primary Skin Irritation Study Rabbits: HEC 5725 480 SC: Lab 04-Feb-2003
Project Number: 02C-I25-NH: 200449: 12875. Unpublished study prepared by
Product Safety Labs. 18 p. {OPPTS 870.2500}
Stropp, G. (1996) HEC 5725: Study for the Skin Sensitization Effect in Guinea 04-Feb-2003
Pigs (Guinea Pig Maximization Test According to Magnusson and Kligman): Lab
Project Number: 25304: T4060666: 109164. Unpublished study prepared by
Bayer Ag. 28 p. {OPPTS 870.2600}
Merkel, D. (2003) Dermal Sensitization Study in Guinea Pigs (Buehler Method): 04-Feb-2003
HEC 5725 480 SC: Lab Project Number: 02C-I24-NI: 200450: 12876.
Unpublished study prepared by Product Safety Labs. 26 p. {OPPTS 870.2600}
Bomhard, E.; Hartmann, E. (1998) HEC 5725: Study on Subchronic Toxicity in 04-Feb-2003
CD-I Mice (Dietary Administration Over 3 Months): Lab Project Number:
27916: T1061888: 109167. Unpublished study prepared by Bayer Ag. 210 p.
{OPPTS 870.3100}
Bomhard, E.; Hartmann, E. (1998) HEC 5725: Study on Subchronic Toxicity in 04-Feb-2003
Wistar Rats (Dietary Administration Over 3 Months with a Subsequent Recovery
Period of 1 Month): Lab Project Number: 27918: T1061662: 109168.
Unpublished study prepared by Bayer Ag. 465 p. {OPPTS 870.3100}
Jones, R.; Hastings, T. (2001) Technical Grade HEC 5725: A Low-Dose 04-Feb-2003
Subchronic Toxicity Feeding Study in the Beagle Dog: Lab Project Number:
99-S76-FS: 110819. Unpublished study prepared by Bayer Corporation. 568 p.
{OPPTS 870.3150}
Jones, R.; Elcock, L. (2001) Technical Grade HEC 5725: A Subchronic Toxicity 04-Feb-2003
Feeding Study in the Beagle Dog: Lab Project Number: 99-S76-AK: 111012.
Unpublished study prepared by Bayer Corporation. 690 p. {OPPTS 870.3150}
Krotlinger, F.; Popp, A. (2000) HEC 5725: Study for Subacute Dermal Toxicity in 04-Feb-2003
Rats (4-Week Treatment Period): Lab Project Number: PH-30471: T1069312:
30471. Unpublished study prepared by Bayer Ag. 207 p. {OPPTS 870.3200}
40
-------
45865631
45865632
45865633
45865634
45865700
Becker, H.; Biedermann, K.; Leutkemeier, H. (1997) Developmental Toxicity 04-Feb-2003
Study with HEC 5725 in the Rat: Lab Project Number: R6886: T2054292:
627884. Unpublished study prepared by Research and Consulting Company Ag.
338 p. {OPPTS 870.3700}
Holzum, B. (1999) HEC 5725: Developmental Toxicity Study in Rabbits After 04-Feb-2003
Oral Administration: Lab Project Number: PH-29148: T6062099: 109407.
Unpublished study prepared by Bayer Ag. 502 p. {OPPTS 870.3700}
Young, A. (2001) A Pilot Reproductive Study with HEC 5725 in the Wistar Rat: 04-Feb-2003
Lab Project Number: 98-972-VI: 109086. Unpublished study prepared by Bayer
Corporation. 316 p. {OPPTS 870.3800}
Young, A.; Christenson, W. (2001) A Two-Generation Reproductive Toxicity 04-Feb-2003
Study with HEC 5725 in the Wistar Rat: Lab Project Number: 99-R72-BW:
110249. Unpublished study prepared by Bayer Corporation and Pathology
Associates International. 1473 p. {OPPTS 870.3800}
Bayer CropScience (2003) Submission of Toxicity, Product Chemistry, Residue, 04-Feb-2003
Environmental Fate, Risk and Exposure Data in Support of the Applications for
Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the
Petition for Tolerance of Fluoxastrobin for Use on Peanuts, Tuber and Corm
Vegetables, Leaf Petioles, Fruiting Vegetables and Seed Treatments. Transmittal
of 30 of 165 Studies.
45865701
45865702
45865703
45865704
Jones, R.; Hastings, T. (2002) Technical Grade HEC 5725: A Chronic Toxicity 04-Feb-2003
Feeding Study in the Beagle Dog: Lab Project Number: 99-C76-BD: 110920-1.
Unpublished study prepared by Bayer Corp. 1047 p. {OPPTS 870.4100}
Eiben, R. (2001) HEC 5725 Oncoogenicity Study on CD-I Mice: (Dietary 04-Feb-2003
Administration Over 18 Months): Lab Project Number: 31353: T5067480: 20028
HJC. Unpublished study prepared by Bayer AG. 1206 p. {OPPTS 870.4200}
Schladt, L.; Ruhl-Fehlert, C. (2001) HEC 5725 Combined Study on Chronic 04-Feb-2003
Toxicity and Carcinogenicity in Wistar Rats: (Dietary Administration for 2
Years): Lab Project Number: PH 31357: 31357: T4062600. Unpublished study
prepared by Bayer AG. 3759 p. {OPPTS 870.4300}
Herbold, B. (1996) HEC 5725 Salmonella/Microsome Test Plate Incorporation 04-Feb-2003
and Preincubation Method: Lab Project Number: 25186: 109098: 2053707.
Unpublished study prepared by Bayer Ag. 58 p. {OPPTS 870.5100}
41
-------
45865705
45865706
45865707
45865708
45865709
45865710
45865711
45865712
45865713
Herbold, B. (1998) HEC 5725 N Salmonella/Microsome Test Plate Incorporation 04-Feb-2003
and Preincubation Method: Lab Project Number: 27260: T 0061472: 109099.
Unpublished study prepared by Bayer AG. 54 p. {OPPTS 870.5100}
Herbold, B. (2000) HEC 5725-Phenoxy-Hydroxypyrimidine Special Study Ames 04-Feb-2003
Test Screening: Lab Project Number: 30476: T 1069925. Unpublished study
prepared by Bayer AG. 46 p. {OPPTS 870.5100}
Herbold, B. (2001) HEC 5725-Phenoxy-Hydroxypyrimidine Salmonella/ 04-Feb-2003
Microsome Test Plate Incorporation and Preincubation Method: Lab Project
Number: 30960: T 8069922. Unpublished study prepared by Bayer AG. 50 p.
{OPPTS 870.5100}
Herbold, B. (2001) HEC 5725-Dihydroxypyrimidine Special Study Ames Test 04-Feb-2003
Screening: Lab Project Number: 31123: T 8070506. Unpublished study prepared
by Bayer AG. 47 p. {OPPTS 870.5100}
Brendler-Schwaab, S. (1997) HEC 5725 Mutagenicity Study for the Detection of 04-Feb-2003
Induced Forward Mutations in the V79-HPRT Assay in Vitro: Lab Project
Number: 25785: T 2053716: 109155. Unpublished study prepared by Bayer AG.
36 p. {OPPTS 870.5300}
Herbold, B. (1996) HEC 5725 In Vitro Mammalian Chromosome Aberration Test 04-Feb-2003
with Chinese Hamster V79 Cells: Lab Project Number: 25187: T 0053705:
109156. Unpublished study prepared by Bayer AG. 35 p. {OPPTS 870.5375}
Herbold, B. (1999) HEC 5725 Micronucleus Test on the Mouse: Lab Project 04-Feb-2003
Number: 28393: T 9059870: 109157. Unpublished study prepared by Bayer AG.
41 p. {OPPTS 870.5395}
Sheets, L.; Gilmore, R.; Stuart, B. (2001) An Acute Oral Neurotoxicity Screening 04-Feb-2003
Study with Technical Grade HEC 5725 in Wistar Rats: Lab Project Number:
98-412-WG: 110509: 393-029. Unpublished study prepared by Bayer Corp. and
Experimental Pathology Laboratories Inc. 449 p. {OPPTS 870.6200}
Gilmore, R.; Hastings, T. (2002) A Subchronic Neurotoxicity Screening Study 04-Feb-2003
with Technical Grade HEC 5725 in Wistar Rats: Lab Project Number:
01-N72-CZ: 200366. Unpublished study prepared by Bayer Corp. 479 p. {OPPTS
45865714
Klempner, A. (2002) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Rat Metabolism
Part 1 of 2: Toxicokinetic Behaviour and Metabolism in the Rat: Lab Project
Number: M 71819099: MR-136/01: M 181 9099-7. Unpublished study prepared
by Bayer AG. 314 p. {OPPTS 870.7485}
04-Feb-2003
42
-------
45865715
45865716
45865717
45865718
45865719
45865721
45865722
45865723
Neumann, B.; Weber, E. (2002) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Rat 04-Feb-2003
Metabolism Part 2 of 2: Distribution of the Radioactivity in Male and Female
Rats Determined by Quantitative Whole Body Autoradiography: Lab Project
Number: M71819099: MR 332/01: M 181 9099-7. Unpublished study prepared
by Bayer CropScience. 113 p.
Klempner, A. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 5725: Rat 04-Feb-2003
Metabolism Part 1 of 2: Toxicokinetic Behaviour and Metabolism in the Rat: Lab
Project Number: M 21819076: MR-135/01: M 181 9076-2. Unpublished study
prepared by Bayer AG. 412 p. {OPPTS 870.7485}
Neumann, B.; Weber, E. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 04-Feb-2003
5725: Rat Metabolism Part 2 of 2: Distribution of the Radioactivity in Male and
Female Rats Determined by Quantitative Whole Body Autoradiography: Lab
Project Number: M21819076: MR 334/01: M 181 9076-2. Unpublished study
prepared by Bayer AG. 94 p. {OPPTS 870.7485}
Neumann, B. (2001) (Pyrimidine-2-(Carbon 14)) HEC 5725: Rat Metabolism: 1 04-Feb-2003
Part 1 of 2: Toxicokinetic Behaviour and Metabolism: Lab Project Number: M
61819098: MR 404/00: M 181 9098-6. Unpublished study prepared by Bayer
AG. 156 p. {OPPTS 870.7485}
Neumann, B.; Weber, E. (2001) (Pyrimidine-2-(Carbon 14)) HEC 5725: Rat 04-Feb-2003
Metabolism: Part 2 of 2: Distribution of the Radioactivity in Male and Female
Rats Determined by Quantitative Whole Body Autoradiography: Lab Project
Number: M61819098: MR 333/01: M 181 9098-6. Unpublished study prepared
by Bayer CropScience. 114 p. {OPPTS 870.7485}
Leser, K.; Hartmann, E. (2001) HEC 5725 Study on Subchronic Toxicity in 04-Feb-2003
Wistar Rats (Dietary Administration Over Two Months): Lab Project Number:
PH-31124: T3062320: 31124. Unpublished study prepared by Bayer AG. 494 p.
{OPPTS 870.3100}
Jones, R.; Jensen, T. (2000) The Homogenicity and Stability of HEC 5725 04-Feb-2003
Technical in Canine Ration: Lab Project Number: 98-876-VB: 109067.
Unpublished study prepared by Bayer Corp. 13 p.
Jones, R.; Jensen, T. (2001) The Homogenicity and Stability of HEC 5725 04-Feb-2003
Technical in Rodent Ration Using Purina Mills Certified Rodent 5002 Meal:
Revised Final Version: Lab Project Number: 98-872-WI: 109608. Unpublished
study prepared by Bayer Corp. 14 p.
43
-------
45865724
45865725
45865726
45865727
45865728
45865729
45865730
45873900
45873901
45911500
45911501
Krotlinger, F.; Romeike, A. (1997) HEC 5725 Study for Subacute Oral 04-Feb-2003
Toxicity oin Rats (Feeding Study Over 4 Weeks): Lab Project Number: 26541:
T9060661: 109166. Unpublished study prepared by Bayer AG. 246 p.
Krotlinger, F.; Hartmann, E. (2001) HEC 5725 N: Study for Subacute Oral 04-Feb-2003
Toxicity in Rats (Feeding Study Over 4 Weeks): Lab Project Number: PH-29147:
T2062329: 29147. Unpublished study prepared by Bayer AG. 250 p.
Andrews, P.; Vohr, H. (2001) HEC 5725 Study for Subacute Oral Toxicity in 04-Feb-2003
Mice (Feeding Study for 5 Weeks-Immunotoxicity Investigations): Lab Project
Number: PH 31405: 31405: T 7070398. Unpublished study prepared by Bayer
AG. 43 p.
Andrews, P. (2002) HEC 5725 and HEC 5725 A Comparative Study for Subacute 04-Feb-2003
Oral Toxicity in Rats (Feeding Study for 4 Weeks): Lab Project Number: 31817:
T 7070811: 06007 SAN. Unpublished study prepared by Bayer AG. 481 p.
Sabbagh, G. (2003) Drinking Water Exposure and Risk Assessment for HEC 04-Feb-2003
5725: Lab Project Number: 200361. Unpublished study prepared by Bayer
CropScience. 72 p.
Sabbagh, G. (2003) Aquatic Exposure Assessment for HEC 5725: Lab Project 04-Feb-2003
Number: 200362. Unpublished study prepared by Bayer CropScience. 67 p.
Lemke, V. (2002) Evaluation of Dietary Exposure to HEC 5725 and Assessment 04-Feb-2003
of Potential Risk: Lab Project Number: 200416. Unpublished study prepared by
Bayer CropScience. 35 p.
Bayer CropScience (2002) Submission of Risk and Exposure Data in Support of 10-Mar-2003
the Application for Registration of Fluoxastrobin Technical and HEC 480 SC
Fungicide. Transmittal of 1 Study.
Standart, V. (2003) Non-Dietary Exposure & Risk Assessment of HEC 5725 10-Mar-2003
480 SC During Use in Peanuts, Vegetables, Seed Treatment, and Turf: Lab
Project Number: 200470. Unpublished study prepared by Bayer CropScience. 34
P-
Bayer CropScience (2003) Submission of Toxicity Data in Support of the 17-Apr-2003
Applications for Registration of Fluoxastrobin Technical and HEC 80 SC
Fungicide. Transmittal of 2 Studies.
Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of 17-Apr-2003
Elimination of HEC 5725 when Administered Intravenously or Dermally to Male
Rhesus Monkeys: Final Report: Lab Project Number: VCBZ-102-03-16:
44
-------
VCBZ-102: 02C-P29-LT. Unpublished study prepared by Charles River
Laboratories. 118 p. {OPPTS 870.7600}
45911502
Sebesta, C. (2003) A Study to Determine the Dermal Absorption of (Carbon 14)
HEC 5725 in EC 100 Formulation when Administered Dermally to Male Rhesus
Monkeys: Final Report: Lab Project Number: 200478: VCBZ-0105:
02C-B29-NJ. Unpublished study prepared by Charles River Laboratories. 111 p.
{OPPTS 870.7600}
17-Apr-2003
46044200
Bayer CropScience (2003) Submission of Public Interest Finding Data in Support
of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC
Fungicide. Transmittal of 1 Study.
Ol-Aug-2003
46044201
46080400
Beedle, E.; Hall, T.; Malakani, K.; et. al. (2003) Public Interest Document for Ol-Aug-2003
Fluoxastrobin Fungicide. Project Number: 200642. Unpublished study. 75 p.
Bayer CropScience (2003) Submission of Toxicity Data in Support the FIFRA 25-Sep-2003
6(a)(2) Data Requirements for Fluoxystrobin. Transmittal of 2 Studies.
46080401
46080402
van Wijngaarden, R. (2003) Screening Studies on the Effects of Fluoxastrobin to 25-Sep-2003
Freshwater Invertebrates. Project Number: F03069. Unpublished study prepared
by Alterra, Green World Research. 12 p.
van Wijngaarden, R.; (2003) Acute Toxicity of Fluoxastrobin to Freshwater 25-Sep-2003
Invertebrates: Final Report. Project Number: ALT/RW/2003/1,
ALTERRA/RW/2003/1. Unpublished study prepared by Alterra, Green World
Research. 93 p.
46216600
Bayer CropScience (2004) Submission of Toxicity Data in Support of the
Application for Registration of Fluoxastrobin and HEC 480 SC Fungicide.
Transmittal of 4 Studies.
05-Mar-2004
46216601
Sturdivant, D. (2004) Summary of Toxicological End Points for HEC 5725.
Project Number: 200959. Unpublished study prepared by Bayer CropScience LP.
6 p.
05-Mar-2004
46216602
Sturdivant, D. (2004) Overview of Toxicology and Risk Assessment for HEC
5725 (Tier 3). Project Number: 200960. Unpublished study prepared by Bayer
CropScience LP. 12 p.
05-Mar-2004
46216603
Sturdivant, D. (2004) Summary of Individual Toxicology and Metabolism Studies
for HEC 5725 (Tier 2). Project Number: 200961. Unpublished study prepared by
Bayer CropScience LP. 108 p.
05-Mar-2004
45
-------
46216604
46397900
Sturdivant, D. (2004) Summary of Toxicology Studies on HEC 480 SC Fungicide 05-Mar-2004
Containing the Active Ingredient Fluoxastrobin. Project Number: 200962.
Unpublished study prepared by Bayer CropScience. 13 p.
Bayer CropScience (2004) Submission of Product Chemistry Data in Support of 04-Nov-2004
the FIFRA 6(a)(2) Data Requirements for Fluoxastrobin Technical. Transmittal of
1 Study.
46397901
46404900
46404901
46486100
46486101
46486102
Fontaine, L. (2004) Product Chemistry of Fluoxastrobin Technical. Project 04-Nov-2004
Number: BR/2361, 15/920/2213, ANR/20404. Unpublished study prepared by
Bayer Cropscience LP and Bayer Ag, Institute of Product Info. 455 p .
Bayer CropScience LP (2004) Submission of Toxicity Data in Support of the 16-Nov-2004
FIFRA 6(a)(2) Data Requirements for Fluoxastrobin. Transmittal of 1 Study.
Liebig, M. (2003) A Long-Term Indoor Microcosm Study on the Toxicity of 16-Nov-2004
Fluoxastrobin (EC 100) to the Amphipod Gammarus pulex L. in a Natural
Water-Sediment System. Pro-ject Number: P1MG. Unpublished study prepared
by ECT Oekotoxikologie Gmbh. 135 p.
Bayer CropScience LP (2005) Submission of Residue Data in Support of the 03-Mar-2005
Application for Registration of Fluoxastrobin. Transmittal of 4 Studies.
Beedle, E. (2005) Addendum 1: Incorporation of Internal Standard and a List of 03-Mar-2005
Additional Crop Matrices Analyzed by Method 00604 (US Submission);
Analytical Determination of Residues of the Fungicide HEC 5725 in/on Cereals,
Cereal Process Products and Vegetables by HPLC-MS/MS. Project Number:
MR/507/99/1, 00604/1, P60293003. Unpublished study prepared by Bayer Corp.
54p.
Beedle, E. (2005) Addendum 1: Additional Crop Matrices Analyzed by Method 03-Mar-2005
00649 (US Submission); Analytical Method 00649 for the Determination of
Residues of HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS. Project
Number: P602001007, MR/508/00/1, 00649/1. Unpublished study prepared by
Bayer Corp. 7 p.
46486103
De Haan, R. (2005) Addendum 1: Additional Information of Independent
Laboratory Validation; Modification and Independent Laboratory Validation of
Residue Analytical Method 00691 for the Determination of Residues of HEC
5725 (E + Z Isomer) and HEC 7154 in Animal Tissues. Project Number:
HC110201, 110897/1. Unpublished study prepared by Bayer Corp. lOp.
03-Mar-2005
46
-------
46486104 Schramel, O. (2001) Independent Laboratory Validation of Method 00691 for the 03-Mar-2005
Determination of Residues of HEC 5725 (E + Z-Isomer) and HEC7154 in
Matrices of Animal Origin by HPLC-MS/MS. Project Number: MR/475/01,
P613010040. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 30 p.
46569700 Bayer CropScience LP (2005) Submission of Product Chemistry Data in Support 13 -Jun-2005
of the Application for Registration of Fluoxastrobin Technical. Transmittal of 1
Study.
46569701 Andre, J. (2005) Freezer Storage Stability of HEC 5725 and Relevant Metabolites 13-Jun-2005
on Soil from California, Washington, Georgia, New York, Manitoba, and Prince
Edward Is- land. Project Number: 201275, AGO 10002. Unpublished study
prepared by Battelle. 102 p.
47
------- |