United States Environmental Protection Agency
Office of Prevention, Pesticide and Toxic Substance (7501C)
   r/EPA
Pesticide
Fact  Sheet
Name of Chemical:    Fluopicolide
Reason for Issuance:   New Chemical
Date Issued:          December 19, 2007
Description of Chemical

Generic Name:


Common Name:

EPA Chemical Code:

Chemical Class:


Chemical Abstracts
Service (CAS) Number:

Registration Status:

Pesticide Type:

U.S. Producer:
   2,6-dichloro-jV-[[3-chloro-5-(trifluoromethyl)-2-
   pyridinyljmethyl] benzamide

   Fluopicolide

   027412

   benzamide
   Pyridine

   239110-15-7
   New Chemical Registration

   Fungicide

   ValentU.S. Corporation

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Use Pattern and Formulations

Fluopicolide is a new fungicide approved for foliar use on grape; grape, raisin; vegetable,
cucurbit, group 9; vegetable fruiting, group 8; vegetable, leafy, except Brassica, group 4;
and vegetable, tuberous and corm (except potato), subgroup ID. Non-food uses for turf
and ornamentals are also approved.

Fluocopicolide belongs to the benzamide class and the pyridine class.  The mode of
action of fluopicolide has not been determined; however, it is a mode of action unlike the
known modes of action of other registered fungicides. Fluopicolide is a mesosystemic
fungicide; it translocates toward the stem tips via the xylem but it does not translocate
toward the roots. Fluopicolide is effective at low application rates against a wide range
of Oomycete  (Phycomycete) diseases including downy mildews (Plasmopara,
Pseudoperonospara, Peronospora, Bremia), late blight (Phytophthora), and some Pythium
species.

Fluopicolide is formulated as a suspension concentrate.  There are four end use products
and one technical proposed for registration in the U.S. Fluocopicolide Technical is for
formulating use only.  Two of these products: V-10161 VPP for turfgrass and ornamental
use, and V-10161  4 SC for cucurbit vegetables, fruiting vegetables, grapes, leafy
vegetables, and  sweet potatoes are both formulated as 39.5% fluocopicolide. While the
other two products: V-10162 Premix for cucurbit vegetables, fruiting vegetables, Lettuce
(head and leaf),  and V-10162 VPP for turf, and ornamental are both formulated as  5.54%
Fluocopicolide and 55.40% Propamocarb Hydrochloride.

There is a previously existing tolerance for residues of fluopicolide on imported grapes.
Three foliar applications are to be made to grapes in Europe at the maximum seasonal
application rate  of 0.36 Ib ai/A. Minimum retreatment intervals of 10 days and a
preharvest interval of 21 days are to be observed.

2,6-Dichlorobenzamide (BAM) is a metabolite and/or environmental degradate of both
fluopicolide and dichlobenil. For use on imported grapes BAM was not included in the
risk assessment  however, both parent fluopicolide and BAM were included in risk
assessments for uses of fluopicolide on domestic crops since more exposure to BAM is
expected with domestic uses.

No Codex, Canadian, or Mexican MRLs have been established for fluopicolide.

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SCIENCE FINDINGS
Structure and Nomenclature
Table 1 Fluopicolide Nomenclature.
Chemical structure
Empirical Formula
Common name
Company experimental name
IUPAC name
CAS name
CAS Registry Number
End-use products (EPs)
Chemical Class
Known Impurities of Concern
F3C\^'^/-C1 C
1 I H
V^Nx
'Y*\
/^^
3 Cl
Ci4H8Cl3F3N20
Fluopicolide
AE C638206
2,6-dichloro-A^-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide
2,6-dichloro-Ar-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide
239110-15-7
1. V-10161 VPP
2. V-10161 4 SC
3. V-10162Premix
4. V-10162VPP
5. Fluopicolide Technical
Fungicide
None
Physical and Chemical Properties

The physical/chemical properties of fluopicolide as they affect inhalation or dermal
exposure are not relevant for an imported crop.
Table 2. Physicochemical Properties of Fluopicolide.
Parameter
Molecular Weight
Melting point/range
pH
Density
Water solubility (20 C)
Solvent solubility (g/L at 20 C)




Vapor pressure at 25 C
Value
383.59
149 C
6.5 at 22.0 C
1.65 g/cc
2.86 mg/L at pH 4
2.80 mg/L at pH 7
2.80 mg/L at pH 9
n-Hexane:
Ethanol:
Toluene:
Ethyl acetate:
Acetone:
Die hloro methane :
Dimethyl sulfoxide:
0.20
19.2
20.5
37.7
74.7
126
183
S.OSxlO'7 Pa
Reference

MRID 46474015
MRID 46474013
MRID 46474016
MRID 46474021
MRID 46474022




MRID 46474023

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Table 2. Physicochemical Properties of Fluopicolide.
Parameter
Dissociation constant (pKa)
Octanol/water partition coefficient
Log(Kow)
UV/visible absorption spectrum
Value
No evidence of ionization in the pH range of 1.9 to
9.8
Log Pow = 3.26 at pH 7.8 and 22  1 C
Log POW = 2.9 at pH 4.0, 7.3 and 9. 1 and 40 C
Absorption maxima wavelengths (nm):
In methanol: 203 and 27 1
In methanol/HCl: 202 and 270
In methanol/NaOH : 2 1 9 and 27 1
Reference
MRID 46474017
MRID 46474018
MRID 46474019
MRID 46474014
Hazard Characterizations

The toxicology database for fluopicolide (AC 638206) is complete and deemed adequate
       for hazard assessment and for FQPA evaluation.

Fluopicolide is a fungicide that is effective in controlling plant disease caused by
Oomycetes.  The biological activity is mesosystemic in that it controls pathogens on
contact through translocation toward the stem tips and not the roots. The exact mode of
action of disease control has  not been fully determined. The test substance is mostly used
on grapes and raisins.

The toxicity database is complete for fluopicolide and is adequate for risk assessment
evaluations and determination of FQPA. All studies evaluated were deemed acceptable
and met guideline criteria except for one reverse gene mutation study. This study was
unacceptable because purity  of the test material was not provided; however, there were
enough adequate studies for gene mutation that this does not constitute a data gap.

The studies that are available and were considered (animal, human, general literature) for
Fluopicolide (AC638206) are as follows:

       Acute- oral, dermal, inhalation, eye irritation,  skin irritation, dermal sensitization
       Sub chronic- oral 90-day rat, oral 90-day mouse (2 studies), oral 90-day dog
       Chronic-  oral rat (combined chronic/carcinogenicity) and oral dog
       Reproductive/developmental- oral developmental rat and rabbit, rat
       reproduction/fertility
       Other- acute and subchronic rat neurotoxicity, oral mouse carcinogenicity,
       mutagenicity studies  (in vitro and in vivo), metabolism/pharmacokinetics studies
       and phenobarbital 28-day hepatotoxicity mouse studies (2 studies)

Toxicology

Acute Toxicity:  Fluopicolide has moderate toxicity with no deaths noted in male or
female rats at doses of > 2000 mg/kg when given orally, and > 4000 mg/kg dermally.
Following inhalation exposure, an LCso of >1.789 to < 5.16 mg/L was calculated.
Toxicity was observed primarily in the inhalation  studies and included a decrease in body
weight, decrease in mean body temperature and signs of irritation (piloerection, hunched

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posture, reddened nostrils). Moderate eye irritation occurred in the form of chemosis and
corneal opacities, but all effects were gone by 72 hours. Slight dermal irritation occurred,
but the test substance was not a skin sensitizer.

Subchronic Toxicity: The most common effect observed in the 90 day studies was a
decrease in body weight gain. Weight gain was markedly decreased in male and female
rats in a subchronic study at doses that exceeded the limit dose (1668-1673 mg/kg/day),
and male and female rats in a subchronic neurotoxicity study had reduced body weight
gain at doses of 780.6 and 125.2 mg/kg/day, respectively. There was no effect on weight
gain in dogs or mice in subchronic studies. Besides effects on body weight and body
weight gain, no definitive cross-species target organ was identified in subchronic studies
with fluopicolide. No organ  lesions were found in dogs administered up to 1000
mg/kg/day for 90 days. Male rats had hypertrophy of the zona glomerulosa in the adrenal
gland, trabecular hyperostosis of the bone joint, and decreased bone marrow cellularity
after exposure to 1668 mg/kg/day for 90 days.  Similar lesions in the adrenal gland and
bone marrow were found in female rats administered 119 mg/kg/day for 90 days. In mice,
females administered 965 mg/kg/day showed an increased incidence of hepatic oval cell
proliferation.

Chronic Toxicity: As in the  subchronic studies, the main effect in the chronic studies was
a decrease in body weight gain with no definitive  cross-species target organ identified.
Male dogs had reduced weight  gain after exposure to 1000 mg/kg/day for one year; body
weight of females was not affected.  Mice had  severely decreased body weight and body
weight gain with administration of 551.0 and 772.3 mg/kg/day to males and females,
respectively, for 18 months. Male and female rats had decreased weight gain after
exposure to 109.4 and 142.2  mg/kg/day for 2 years, respectively. No organ lesions were
found in dogs administered up to 1000 mg/kg/day for 52 weeks.  Thyroid cystic follicular
hyperplasia was seen in male rats after 109.4 mg/kg/day for two years. In mice, altered
liver cell foci were seen in males and females given 551.0 or 772.3 mg/kg/day,
respectively, for 18 months.

Carcinogenicity: No evidence for carcinogenicity was seen in rats administered
fluopicolide in food for 24 months.  Treatment of rats did not result in an increase in
overall tumor incidence or an increase in the incidence of any specific type of tumor.  In
contrast, mice had an increased incidence of hepatocellular adenoma following
administration of 3200  ppm in the diet for 18 months (551.0 and 772.3 mg/kg/day for
males and females, respectively).

Neurotoxicity: No evidence  of neurotoxicity was seen in acute or subchronic oral rat
neurotoxicity studies with fluopicolide. A transient decrease in body temperature was the
only finding in male and female rats given a single dose of 2000 mg/kg. Brain weight,
brain morphometry, and neuropathology were not affected by treatment.

Developmental Toxicity: In  developmental toxicity studies, maternal toxicity was clearly
evident only in rabbits as increased mortality, abortion, and decreased body weight gain
at 60 mg/kg/day, the highest  dose tested.  Minimal maternal toxicity was observed in rats
dosed with 700 mg/kg/day; slightly reduced body weight gain did not result in lower

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absolute body weight. At the same dose affecting the dam, 700 mg/kg in rats and 60
mg/kg in rabbits, fetal growth was affected in both species and observed as decreases in
body weight and crown-rump length. Also, at 700 mg/kg, delays in fetal ossification and
increased incidence of skeletal malformations were observed in rat fetuses, with neither
of these effects seen in rabbit fetuses. No external or visceral abnormalities were
observed in either species. In rats the adverse effect was judged to be greater in the fetus
than in the dam, suggesting a greater susceptibility in the fetus compared to that of the
dam.

Reproductive Toxicity: Reproductive performance was not affected in a two-generation
reproduction toxicity study in which fluopicolide was administered to male and female
rats at nominal dietary concentrations of 0, 100, 500, or 2000 ppm (0, 7.4-8.8, 36.4-43.7,
144.6-179.9 mg/kg/day, respectively, for males and 0, 8.1-9.4, 41.0-46.9, 159.7-193.9
mg/kg/day, respectively, for  females).  Evidence of parental toxicity in the high-dose
groups included decreased body weight gain in FO females and kidney toxicity in FO and
FI males and females. Kidney lesions consisted of cortical tubular basophilia or dilation,
medullary granular casts, cortical scarring, interstitial inflammation, and/or
corticomedullary mineralization. Body weight of the high-dose FI and F2 pups was
significantly less than that of the controls beginning on lactation day 14. The high-dose
pups had decreased weight gain throughout the 28-day lactation interval. Overall weight
gain during lactation was decreased by 8-9% of the control level in the high-dose FI male
and female pups and by 11-14% in  the high-dose 72 male and female pups. No other
effects on offspring growth or survival were noted in either generation.

Dermal toxicity: Acute dermal toxicity studies showed that fluopicolide was only a slight
dermal irritant (Tox. Category IV).  A dermal subchronic toxicity study showed no
systemic or local effects at the limit dose.

Toxicologicol Endpoints
Table 3. Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Dietary and
Non-Occupational Human Health Risk Assessments
Exposure/
Scenario
Acute Dietary
(All Populations)
Chronic Dietary
(All Populations)
Point of
Departure
None
Maternal
NOAEL=20
mg/kg/day
Uncertainty/FQPA
Safety Factors
None
UFA=10x
UFH=10x
FQPA SF = IX
RfD, PAD,
Level of
Concern for
Risk
Assessment
None
Chronic RfD =
0.2 mg/kg/day
cPAD = 0.2
mg/kg/day
Study and
Toxicological
Effects
An endpoint
attributable to a
single dose was not
identified from the
available data.
Developmental
Toxicity Study in
Rabbits
LOAEL = 60
mg/kg/day based on
death, abortions/
premature deliveries,
decreased food

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Incidental Oral
Intermediate-Term
(1-6 months)







Dermal Short-
Intermediate- and
Long-Term (1-30
days and 1-6
months)






Inhalation Short-
Intermediate- and
Long-term (1-30
days and 1-6
months)





Cancer (oral,
dermal, inhalation)



maternal
NOAEL = 20
mg/kg/day







maternal
NOAEL = 20
mg/kg/day








maternal
NOAEL = 20
mg/kg/day










UFA=10x
UFH=10x
FQPA SF = IX







UFA=10x
UFH=10x
FQPA SF = IX








UFA=10x
UFH=10x
FQPA SF = IX










MOE = 100
(occupational)

MOE = 100
(residential)





MOE = 100
(occupational)
MOE = 100
(residential)






MOE = 100
(occupational)

MOE = 100
(residential)





consumption,
decreased body
weight gain.
Developmental
Toxicity Study in
Rabbits
LOAEL = 60
mg/kg/day based on
death, abortions/
premature deliveries,
decreased food
consumption,
decreased body
weight gain.
Developmental
Toxicity Study in
Rabbits
LOAEL = 60
mg/kg/day based on
death, abortions/
premature deliveries,
decreased food
consumption,
decreased body
weight gain.
Developmental
Toxicity Study in
Rabbits
LOAEL = 60
mg/kg/day based on
death, abortions/
premature deliveries,
decreased food
consumption,
decreased body
weight gain.
Classification: "Not Likely to be Carcinogenic to Humans".

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response
data and  used to mark the beginning of extrapolation to determine risk associated with lower
environmentally relevant human exposures. NOAEL = no observed adverse effect level.  LOAEL = lowest
observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-
term risk assessment. UFDB = to account for the absence of key data (i.e., lack of a critical study). FQPA
SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference
dose.  MOE = margin of exposure. LOG = level of concern. N/A = not applicable.

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Food Quality Protection Act Considerations

FQPA Safety Factor

       The Agency has determined that reliable data show that it would be safe for
infants and children to reduce the FQPA safety factor to IX for fluopicolide.  That
decision is based on the following findings:  (1) The toxicity database for fluopicolide is
complete. (2) There is no indication that fluopicolide is a neurotoxic chemical and there
is no need for a developmental neurotoxicity study or additional UFs to account for
neurotoxicity. (3). Although there is qualitative evidence of increased susceptibility in the
prenatal developmental studies in rats, the risk assessment team  did not identify any
residual uncertainties after establishing toxicity endpoints and traditional UFs to be used
in the risk assessment of fluopicolide. The degree of concern for pre-and/or postnatal
toxicity is low. (4) There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based on 100% crop
treated and tolerance-level residues.  Conservative ground and surface water modeling
estimates were used. Similarly conservative Residential SOPs were used to assess post-
application exposure to children as well as incidental oral exposure of toddlers.  These
assessments will not underestimate the exposure and risks posed by fluopicolide.

       EPA is retaining the 10X FQPA SF for BAM for those exposure scenarios that do
not rely on dichlobenil toxicity data. These scenarios are acute dietary for the general
population including infants and children, females 13-49 years of age, chronic dietary,
and incidental oral non-dietary.  This is due to the incompleteness of the  data base with
regard to the systemic neurotoxic potential of BAM, including olfactory toxicity via the
oral route of exposure.

       For the dermal and inhalation routes  of exposure, for which the Agency is relying
on dichlobenil toxicity data, the Agency has reduced the FQPA SF for BAM toxicity to
IX. The reasons for this are that, based on a comparison of toxicity via the intraperitoneal
route of exposure, higher doses of BAM are needed to induce levels of olfactory toxicity
that are similar to those caused by dichlobenil, and olfactory toxicity was the  endpoint
chosen for these exposure scenarios.

Dietary Exposure and Risk

       Dietary exposure assessments were conducted using the Dietary Exposure
Evaluation Model DEEM-FCID, Version  2.03,  which uses food consumption data
from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994-1996 and 1998.  A dietary exposure assessment was
conducted for residues of fluopicolide in food and drinking water. A second assessment
was conducted for combined residues of BAM in food and drinking water from uses of
both fluopicolide and dichlobenil.

       Acute: An acute dietary assessment was not conducted because an endpoint
       attributable to a single dose was not identified from the available  data for
       fluopicolide.

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       Chronic: The chronic dietary (food and drinking water) exposure to fluopicolide
       is below the Agency's level of concern for the general U.S. population and all
       population subgroups. The chronic dietary exposure estimates are 6% cPAD for
       the general U.S. population and 9% cPAD for children 1-2 years old, the most
       highly exposed subgroup. A conservative chronic dietary exposure assessment
       for the metabolite of fluopicolide, BAM was conducted using maximum residues
       from field trials and 100% crop treated. The chronic dietary exposure estimates
       for BAM are 29% of the chronic cPAD for the general U.S. population and 93%
       cPAD for all infants (< year old), the most highly exposed group which is not of
       concern to the Agency.

       Cancer: Fluopicolide has been classified as "not likely to be carcinogenic to
       humans", and is thus not expected to pose a cancer risk.

Residential Handler, Postapplication and Occupational Exposures

       Total MOEs for residential handlers are well above the LOG of 100, and are not
of concern. Residential postapplication exposure via the dermal route is likely for adults
and children entering treated lawns. The short-/intermediate-term MOEs for each
scenario are above the LOG of 100, and are not of concern. The results of the handler
and postapplication occupational exposure indicate that risks are not of concern. The
total MOEs range from 100 to 19,000.

Aggregate Risk

       The Agency does not expect that fluopicolide will pose an aggregate acute risk
because an endpoint attributable to a single dose  was not identified from the available
data for fluopicolide. The acute dietary exposure estimates for BAM at the 99.9th
percentile of the exposure distribution are 11% of the acute aPAD for the general U.S.
population and 28% aPAD for all infants <1 year old, the most highly exposed group.

       The chronic dietary exposure estimates for fluopicolide are 6% cPAD for the
general U.S. population and 9% cPAD for children 1-2 years old, the most highly
exposed subgroup.  The chronic dietary exposure estimates for BAM are 29% of the
chronic cPAD for the general U.S. population and 93% cPAD for all infants (< year old),
the most highly exposed group which is not of concern to the Agency. Based on the use
pattern, chronic residential exposure to residues of fluopicolide is not expected.

       Fluopicolide is proposed for registration of uses that could result in short-term
residential exposure.  The Agency has concluded that food, water and residential
exposures result in  aggregate MOEs greater than the LOG of 100 for all population
groups, and the aggregate short-term estimates for fluopicolide are below the Agency's
level of concern. Also, short-term exposures for fluopicolide's metabolite BAM, may
occur as a result of activities on treated turf. Incidental  oral exposures related to turf
activities have been combined with chronic dietary exposure  estimates to assess short-
term aggregate exposure for BAM. Since aggregate MOEs for BAM are greater than the

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LOG, they represent risk estimates that are below the Agency's level of concern.

       The intermediate-term aggregate risk for fluopicolide and BAM is the same as
calculated for the short-term aggregate risk.  In examining long-term aggregate risk, the
Agency has assumed that the only pathway of exposure relevant to that time frame is
dietary exposure. Therefore, the long-term aggregate risk is composed of exposures to
fluopicolide residues in food and drinking water and is equivalent to the chronic dietary
risk. The chronic risk estimates are below the Agency's level of concern for all
population subgroups.

Cumulative Risk

       Fluopicolide and the herbicide dichlobenil can form the common metabolite,
BAM. To support existing tolerances and to establish new tolerances for fluopicolide,
EPA conducted a human health risk assessment for exposure to BAM resulting from the
use of all current and pending uses of fluopicolide and dichlobenil. This risk assessment
is conservative in terms of potential dietary and non-dietary exposures. The assessment
includes evaluations of risks for various subgroups, including those composed of infants
and children. For this assessment the Agency retained the additional tenfold (10X) FQPA
safety factor (SF) for the protection of infants and children.
ENVIRONMENTAL RISK ASSESSMENT

Fate Characterization

       Fluopicolide will not volatilize from soil or aqueous solution. Neither photolysis
nor hydrolysis is expected to be a significant degradation pathway for the dissipation of
fluopicolide. Photolysis does, however, enhance the degradation of fluopicolide soil
degradates. The primary pathway for dissipation of fluopicolide is by microbial or
mineral-catalyzed degradation in soil. Fluopicolide is unlikely to leach in soil but its
moderate water solubility suggests the potential for runoff in storm or irrigation water.
The range of BCFs for edible tissue, nonedible tissue, and whole fish indicate a low
potential for bioconcentration in fish and living organisms.  The 2,6-Dichlorobenzamide
(BAM) is the major potential toxic degradation product from aerobic soil metabolism,
aquatic photolysis and soil photolysis studies. Guideline fate studies for BAM were not
available, therefore, literature data were used to assess its fate properties.

Risk Assessment

       A screening-level  (Level I) risk assessment, based on proposed uses was
completed. The calculated RQs for most groups are well below 1.0. The highest RQs
(eg., 3.95) were determined from the small mammal ornamentals/short grass
consumption scenarios. For the food and turf uses, there are no acute or chronic LOCs
exceeded for any of the aquatic organisms. Acute LOCs are not exceeded for aquatic
organisms exposed to the degradate, BAM (2,6-dichlorobenzamide) based on the
scenario with the highest EEC, Florida nursery. There were no chronic LOCs exceeded
                                        10

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for the turf or food uses. There are no avian acute LOCs exceeded for the food uses.
There were no acute or chronic dietary-based mammalian LOCs exceeded for BAM for
any of the proposed uses.
DATA NEEDS AND LABEL REQUIREMENTS

Label Requirements

      Sufficient rotational crop data is not available to support the proposed rotational
       crop restrictions.  The label must be modified to state that rotation is limited only
       to those crops on the current label.

Data Requirements

      Additional storage stability data are needed for celery and spinach reflecting a
       storage interval of 38 months. One study should be conducted on any
       representative leafy vegetable.

Government Performance Results Act

Registration of fluopicolide will meet objectives of 6 PRA title 3.1.1 by assuring new
pesticides enter the market are safe for humans and the environment.
Contact Person at USEPA:

Janet Whitehurst
Environmental Protection Agency
Office of Pesticide Programs
Registration Division
Fungicide Branch
1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001

Office Location and telephone number:

7873, Potomac Yard South
2777 South Crystal Dr.
Arlington V.A. 22202
703-305-6129
                                       11

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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
ADNT
a.i.
aPAD
ARI
BCF
CAS
ChE
ChEI
cPAD
%CT
DAT
DEEM-FCID

DNA
DNT
DIT
DWLOC
EC
EEC
EPA
FQPA
GLC
GLN
LCso
Acute delayed neurotoxicity
Active Ingredient
Acute Population Adjusted Dose
Aggregate Risk Index
Bioconcentration Factor
Chemical Abstracts Service
Cholinesterase
Cholinesterase inhibition
Chronic Population Adjusted Dose
Percent crop treated
Days after treatment
Dietary Exposure Evaluation Model - Food Consumption
Intake Database
Deoxyribonucleic acid
Developmental neurotoxicity
Developmental immunotoxicity
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a terrestrial
ecosystem.
U.S. Environmental Protection Agency
Food Quality Protection Act
Gas Liquid Chromatography
Guideline Number
Median Lethal Concentration. A statistically derived
concentration of  a substance that can be expected to cause
death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed,
e.g., mg/1, mg/kg  or ppm.
                                     12

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LD50
LOAEL
LOAEC
LOC
LOD
LOQ
mg/kg/day
mg/L
MOE
MRID

MTD
NA
NOEC
NOEL
NOAEL
NOAEC
NPDES
OP
OPP
OPPTS
PAD
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRZM/
EXAMS
RAC
RBC
RED
REI
RfD
SCI-GROW
SF
TGAI
UF
ug
ug/L
uL/g
Median Lethal Dose. A statistically derived single dose that
can be expected to cause death in 50% of the test animals when
administered by the route indicated (oral, dermal, inhalation).
It is expressed as a weight of substance per unit weight of
animal, e.g., mg/kg.
Lowest Observed Adverse Effect Level
Lowest Observed Adverse Effect Concentration
Level of Concern
Limit of Detection
Limit of quantitation
Milligram Per Kilogram Per Day
Milligrams  Per Liter
Margin of Exposure
Master Record Identification (number), EPA's system of
recording and tracking studies submitted
Maximum tolerated dose
Not Applicable
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
No Observed Adverse Effect Concentration
National Pollutant Discharge Elimination System
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million

Tier II Surface Water Computer Model
Raw Agriculture Commodity
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Tier I Ground Water Computer Model
Safety Factor
Technical Grade Active Ingredient
Uncertainty Factor
micrograms
Micrograms Per Liter
Microliter per gram
                                     13

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USDA
WPS
United States Department of Agriculture
Worker Protection Standard
APPENDIX II:
Citations Considered to be Part of the Data Base Supporting the Registration of
Fluopicolide
                  Study Information For Ingredient
                 027472 / 239110-15-71 Fluopicolide
MRID
46474000
j Citation
I
j Bayer CropScience LP (2005) Submission of Product Chemistry and
j Residue Data in Support of the Petition for Tolerance of Fluopicolide.
j Transmittal of 45 Studies.
Receipt
Date
07-Feb-
2005

         Smith, C. (2004) Fluopicolide (AE C638206) Technical: Product Chemistry
46474001  Data Summary to Support a Tolerance in/on Imported Commodities.
         Unpublished study prepared by Bayer Ag, Institute of Product Info. 7 p.
                                                 07-Feb-
                                                  2005
t
46474002
46474003
I
46474004
\ Smith, C. (2004) Fluopicolide (AE C638206) Technical: Product Identity
j and Composition, Description of Materials Used to Produce the Product,
| Description of the Production Process, Discussion of Formation of
j Impurities, and Certified Limits. Unpublished study prepared by Bayer Ag,
Institute of Product Info. 108 p.
j Bowen, T. (2004) Material Accoutability of AE C638206 Technical:
| Analytical Profile of Five Representative Batches and the Batch Used in
\ the Long Term Toxicological Testing. Project Number: PA/04/001 ,
| C040168. Unpublished study prepared by Bayer Cropscience Gmbh. 37 p.
j Smith, C. (2004) Analytical Method: Determination of AEC638206 in AE
| CC638206 Technical Materials by HPLC; Validation of the Analytical
| Method AM000103FP1 for the Determination of AEC638206 in AE
CC638206 Technical Materials; Analytical Method: Determination of
j Group 1 Impurities in AE CC638206 Technical Materials by HPLC;
j Validation of the Analytical Method AM000203FP1 for the Determination
| of Group 1 Impurities in AE CC638206 Technical Materials; Analytical
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
                                    14

-------
           Method: Determination of Group 2 Impurities in AE CC638206 Technical
           Materials by HPLC; Validation of the Analytical Method AM000303FP1 for
           the Determination of Group 2 Impurities in AE CC638206 Technical
           Materials. Project Number: C033933, C033934, C033936. Unpublished
           study prepared by Bayer Ag, Institute of Product Info. 14 p.
           Bowen, T. (2003) Analytical Method: Determination of AE C638206 in AE
 46474005 i C638206 Technical Materials by HPLC. Project Number: AM000103FP1,
          i C033933. Unpublished study prepared by Bayer Cropscience Gmbh. 10 p.
                                                                  07-Feb-
                                                                   2005
          j Bowen, T. (2003) Validation of the Analytical Method AM000103FP1 for
          ^tne Determiation of AE C638206 in AE C638206 Technical Materials.
          | project Number: AF03/005, C033934, AM000103FP1. Unpublished study
          j prepared by Bayer Cropscience Gmbh. 39 p.
 46474007
 Bowen, T. (2003) Analytical Method: Determination of Group 1 Impurities
 in AE C638206 Technical Materials by HPLC. Project Number:
 AM000203FP1, C033936. Unpublished study prepared by Bayer
 Cropscience Gmbh. 16 p.
r~
 46474008
| Bowen, T. (2003) Validation of the Analytical Method AM000203FP1 for
| the Determiation of Group 1 Impurities in AE C638206 Technical
I Materials. Project Number: AF03/007, C033937, AM000203FP1.
j Unpublished study prepared by Bayer Cropscience Gmbh. 39 p.
                                                                  07-Feb-
                                                                   2005
                                                                           07-Feb-
                                                                            2005
                                                                           07-Feb-
                                                                            2005
46474009
 46474010
 46474011
          j Bowen, T. (2003) Analytical Method: Determination of Group 2 Impurities
           in AE C638206 Technical Materials by HPLC. Project Number: C033938,
          j AM000303FP1. Unpublished study prepared by Bayer Cropscience
          j Gmbh. 16 p.
 Bowen, T. (2003) Validation of the Analytical Method AM000303FP1 for
 the Determiation of Group 2 Impurities in AE C638206 Technical
 Materials. Project Number: AF03/008, C033940. Unpublished study
 prepared by Bayer Cropscience Gmbh. 35 p.

 Muehleberger, B.; Eyrich, U. (2003) AE C638206 Technical: Physical
 Characteristics, Color, Appearance and Odor. Project Number: C031788,
 PA/02/091. Unpublished study prepared by Bayer Cropscience Gmbh. 11
          { Franke, J. (2004) AE C638206 Technical: Thermal Stability in the
          ^ Presence of Iron and Iron Ions at Ambient and Elevated Temperatures.
          I Project Number: C040784, 20040010/01. Unpublished study prepared by
          | Siemens Axiva GmbH & Co. KG. 21 p.
                                                                  07-Feb-
                                                                   2005
                                                                           07-Feb-
                                                                            2005
                                                                           07-Feb-
                                                                            2005
                                                                  07-Feb-
                                                                   2005
           Muehlberger, B.; Eyrich, U. (2003) Determination of the pH-Value of AE
 46474013 | C638206. Project Number: PA02/092, C031789. Unpublished study
          j prepared by Bayer Cropscience Gmbh. 11 p.
                                                                  07-Feb-
                                                                   2005
 46474014
 46474015
 Muehlberger, B. (2003) AE C638206 Spectral Data (UV/VIS, IR,
 (Hydrogen-l)-NMR, (Carbon-13)-NMR, MS) and Molar Extinction
 Coefficient. Project Number: PA02/088, C034149. Unpublished study
 prepared by Bayer Cropscience Gmbh. 42 p.
 Smeykal, H. (2003) AE C638206 Technical: Melting Point/ Melting Range.
 Project Number: 20030348/01, C033115. Unpublished study prepared by
 Siemens Axiva GmbH & Co. KG. 12 p.
                                                                           07-Feb-
                                                                            2005
                                                                           07-Feb-
                                                                            2005
                                         15

-------
1 	
46474016
_,_
46474017
__
46474018
46474019
46474020
_..
46474021
r~~
46474022
! Smeykal, H. (2003) AE C638206 (Pure): Relative Density. Project
I Number: C034154, 20030755/03. Unpublished study prepared by
Siemens Axiva GmbH & Co. KG. 10 p.
I r
I Bright, A. (2000) AE C638206 (99.6% w/w): Dissociation Constant. Project
I Number: C008405, CHR/00/026, 00040604. Unpublished study prepared
! by Aventis Cropscience UK Ltd. 17 p.
i Bright, A. (2000) AE C638206 (99.6% w/w): Partition Coefficient. Project
| Number: CHR/00/025, 00040603, C008404. Unpublished study prepared
j by Aventis Cropscience UK Ltd. 22 p.
1
| Muehlberger, B. (2003) AE C638206: Partition Coefficient 1-
| Octanol/Water (HPLC-Method). Project Number: PA03/005, C032556.
j Unpublished study prepared by Bayer Cropscience Gmbh. 29 p.
\ Comb, A. (1999) AE C638206 (99.6% w/w): Water Solubility. Project
! Number: C006351 , AGV/278/994204, AGV/278. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 23 p.
I Muehlberger, B. (2003) Water Solubility of AE C638206 at pH 4, pH 7 and
pH 9 (Column-Elution Method). Project Number: C034161, PA02/089.
Unpublished study prepared by Bayer Cropscience Gmbh. 25 p.
j Muehlberger, B. (2003) AE C638206: Solubility in Organic Solvents.
| Project Number: PA02/090, C031136. Unpublished study prepared by
| Bayer Cropscience Gmbh. 28 p.
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
         ! Bright, A. (2000) AE C638206 (99.6% w/w): Vapour Pressure. Project
46474023 j Number: CHR/00/027, 00040605, C008406. Unpublished study prepared
         i by Aventis Cropscience UK Ltd. 30 p.
                                                                           07-Feb-
                                                                             2005
         j Smith, C. (2005) Fluopicolide (AE C638206): Residue Chemistry Data
         j Summary to Support the Petition for Tolerances in/on Imported Grapes
46474024 j and Raisins, Including Directions for Use, Proposed Tolerances, and
         { Submittal of Samples. Project Number: B004860, 00782, C024784.
         { Unpublished study prepared by Bayer Ag, Institute  of Product Info. 43 p.
                                                                           07-Feb-
                                                                             2005
46474025
          Smith, C. (2004) Metabolism of [U-(Carbon-14)-Phenyl]- and [2,6-(Carbon-
          14)-Pyridinyl]-AE C638206 in Vines (Amended Report Replacing Report
          CU99E503, Document B004329). Project Number: B004860, CU99E503,
          CU99E503A. Unpublished study prepared by Bayer Ag, Institute of
          Product Info. 17 p.
                                                                           07-Feb-
                                                                             2005
46474026
          Rupprecht, J. (2004) Metabolism of [U-(Carbon-14)-Phenyl]- and [2,6-
          (Carbon-14)-Pyridinyl]-AE C638206 in Vines (Amended Report Replacing
          Report CU99E503, Document B004329). Project Number: CU99E503,
          CU99E503A, B004860. Unpublished study prepared by Agrevo USA Co.
          108 p.
                                                                           07-Feb-
                                                                             2005
46474027
         { Smith, C. (2005) Determination of the Residues of AE C638206 and
         ! Metabolites in Wheat (Straw and Grain), Grapes and Cabbage Using
         | LC/MS/MS: Method Validation; Modification M001 of the Residue
         J Analytical Method 00782 for the Determination of the Residues of AE
         I C638206 and Metabolites AE C657188 and AE C653711 in/on Grape and
         j Potato by HPLC-MS/MS; Validation of the Modification M002 to the
         j Analytical Method 00782 for the Determination of the Residues of AE
         I C638206 and Metabolites AE C657188, AE C653711  and AE 1344122
                                                                           07-Feb-
                                                                             2005
                                        16

-------
          in/on Wheat by HPLC-MS/MS; Modification MOOS of the Analytical Method
          00782 for the Determination of the Residues of AE C657378 (3-OH-BAM)
          in/on Cereals (Wheat) by HPLC-MS/MS; Progress Report: ILV of
          Analytical Method 00782 Modification M002 and MOOS for the
          Determination of the Residues of AE C638206 and Metabolites
          AEC657188, AEC653711, AE1344122 and C065. Project Number:
          C024784, 00782, C031433. Unpublished study prepared by Bayer Ag,
          Institute of Product Info. 15 p.
         j Zietz, E. (2002) Determination of the Residues of AE C638206 and
         | Metabolites in Wheat (Straw and Grain), Grapes and Cabbage Using
46474028 | LC/MS/MS: Method Validation. Project Number: 00782, IF/101/05424/00,
         j 01/009. Unpublished study prepared by Institut Fresenius Chemische und
         j Biologische. 74 p.
46474029
j Schoening, R.; Billian, P. (2003) Modification M001 of the Residue
j Analytical Method 00782 for the Determination of Residues of AE
 C638206 and its Metabolites AE C657188 and AE C653711 in/on Grape
j and Potato by HPLC-MS/MS. Project Number: C031433, 00782/M001,
j MR/336/02. Unpublished study prepared by Bayer Ag, Institute of Product
j Info. 56 p.
46474030
 Schoening, R.; Billian, P. (2003) Validation of the Modification M002 to the
 Analytical Method 00782 for the Determination of Residues of AE
 C638206 and its Metabolites AE C657188, AE C653711 and AE 134412
 in/on Wheat by HPLC-MS/MS. Project Number: C038955, 00782/M002,
 MR/071/03. Unpublished study prepared by Bayer Ag, Institute of Product
 Info. 69 p.
                                                                  07-Feb-
                                                                   2005
07-Feb-
 2005
07-Feb-
 2005
46474031
 Schoening, R.; Billian, P. (2003) Modification MOOS of the Analytical
 Method 00782 for the Determination of Residues of AE C657378 (3-OH-
 BAM) in/on Cereals (Wheat) by HPLC-MS/MS. Project Number: C038960,
 00782/M003, MR/148/03. Unpublished study prepared by Bayer Ag,
 Institute of Product Info. 39 p.
46474032
 Grant, J. (2004) Progress Report: Independent Laboratory Validation of
 "Validation of the Modification M002 to the Analytical Method 00782 for
 the Determination of Residues of AE C638206 and it Metabolites AE
 C657188, AE C653711 and AE 1344122 in/on Wheat by HPLC-MS/MS"
 for Tomatoes and "Modification MOOS to the Analytical Method 00782 for
 the Determination of Residues of AE C657378 (3-OH-BAM) in/on Cereals
 (Wheat) by HPLC-MS/MS" for Wheat Forage According to PR Notice 96-
 1, OPPTS 860.1340 Guidelines, and SANCO/825/00 Rev. 7. Project
 Number: RAACX098, 49181. Unpublished study prepared by ABC
 Laboratories. 61 p.
07-Feb-
 2005
07-Feb-
 2005
46474033
 Reiner, H. (2004) Extraction Efficiency (Radiovalidation) of the Residue
 Method for the Determination of AE C638206 Residues in Plant Samples
 Using Aged Radioactive Residues. Project Number: C046034,
 M/9991415/8, MEF/04/506. Unpublished study prepared by Bayer Ag,
 Institute of Product Info. 60 p.
46474034
 Smith, C. (2005) Progress Report: PAM I Multiresidue Protocol Testing for
 AE C638206 (Fluopicolide) and its Metabolites AE C653711 (BAM), AE
 C657378 (BAM-OH), AE C657188 (PCA), and AE 1344122 (P1X). Project
 Number: 1551, RAACX039, A. Unpublished study prepared by Bayer Ag,
 Institute of Product Info. 8  p.
07-Feb-
 2005
07-Feb-
 2005
                                        17

-------

! Ford, C. (2004) Progress Report: RAM 1 Multif residue Protocol Testing for
j AE C638206 (Fluopicolide) and its Metabolites AE C65371 1 (BAM), AE
16474035 | C657378 (BAM-OH), AE C657188 (PCA), and AE 1344122 (P1X). Project
j Number: 1551 , RAACX039, A. Unpublished study prepared by Pyxant
j Labs Inc. 230 p.
j Smith, C. (2004) Determination of the Storage Stabulity of AE C638206
j and the Metabolites AE C65371 1 (BAM) and AE C657188 (PCA) in
16474036 j Grape, Potato, Cabbage and Wheat Grain. Project Number: C045739,
j IF/02/0004949, 02/19. Unpublished study prepared by Bayer Ag, Institute
j of Product Info. 14 p.
Zeitz, E. (2004) Determination of the Storage Stability of AE C638206 and
the Metabolites AE C65371 1 (BAM) and AE C657188 (PCA) in Grape,
16474037 Potato, Cabbage and Wheat Grain. Project Number: C045739,
IF/02/00004949, 02/19. Unpublished study prepared by Institut Fresenius
Chemische und Biologische. 87 p.
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
46474038
          Smith, C. (2004) Fluopicolide: Crop Field Trials. Project Number:
          C0282420, C032071, C028236. Unpublished study prepared by Bayer Ag,
          Institute of Product Info. 27 p.
                                                                 07-Feb-
                                                                  2005
         j Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71
         j Formulation: Residue Behaviour in Grapevine: European Union (Northern
46474039 | Zone) 2001. Project Number: 01R284, C028242. Unpublished study
         { prepared by Bayer Cropscience Gmbh, Bayer Ag, Institute of Product Info.
         { and Aventis Cropscience, Centre de Recherche de La Dargoire. 138 p.
                                                                           07-Feb-
                                                                             2005
46474040
Sender, K. (2003) 4.44%AE C638206 + 66.7% Fosetyl-Aluminum WG71
Formulation: Residue Behaviour in Grapevine: European Union (Northern
Zone) 2002. Project Number: 02R288, C032071. Unpublished study
prepared by Bayer Cropscience Gmbh, Bayer Ag, Institute of Product Info.
and Aventis Cropscience, Centre de Recherche de La Dargoire. 113 p.
         j Sender, K. (2003) AEC638206 SE10 Formulation: Residues at Harvest in
         j Grapevine: European Union (Northern Zone) 2001. Project Number:
46474041 j 01R280, C028236. Unpublished study prepared by Bayer Cropscience
         J Gmbh, Bayer Ag, Institute of Product Info, and Aventis Cropscience,
          Centre de Recherche de La Dargoire. 65 p.
                                                                           07-Feb-
                                                                             2005
                                                                           07-Feb-
                                                                             2005
46474042
          Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71
          Formulation: Residue Behaviour in Table Grapes and Wine Grapes:
          European Union (Southern Zone) 2001 (Including Amendments No.1).
          Project Number: C028243, C033415, 01R285. Unpublished study
          prepared by Bayer Cropscience Gmbh. 147 p.
46474043
          Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71
          Formulation: Residue Behaviour in Grapevine: European Union (Southern
          Zone) 2002. Project Number: C032072, 02/R/289. Unpublished study
          prepared by Bayer Cropscience Gmbh. 116 p.
                                                                 07-Feb-
                                                                  2005
                                                                 07-Feb-
                                                                  2005
         ! Sender, K. (2003) AEC638206 SE10 Formulation: Residues at Harvest in
         ! Table Grapes and Wine Grapes: European Union (Southern Zone) 2001.
46474044 j Project Number: 01R281, C028237, 01R281/1. Unpublished study
         { prepared by Bayer Cropscience Gmbh and Bayer Ag, Institute of Product
         { Info. 66 p.
46474045 ! Zietz, E. (2003) AE C638206 SE10 Formulation: Determination of the
                                                                           07-Feb-
                                                                             2005
                                                                           07-Feb-
                                        18

-------
           Residues in Red Grapes Following Three Treatments under Field
           Conditions in Southern Europe 2000: Final Report. Project Number:
           C031908, IF/100/10689/00, DR/OO/EUS/003. Unpublished study prepared
           by Institut Fresenius Chemische und Biologische, Agrologia S.L., and
           Promo-Vert S.A. 148 p.
           Bayer CropScience LP (2005) Submission of Residue and Toxicity Data in
 46474100 i Support of the Petition for Tolerance of Fluopocolide on Grapes and
           Raisins. Transmittal of 48 Studies.
                                                                     2005
                                                                    07-Feb-
                                                                     2005
 46474101
 Kaethner, M. (2004) Evaluation of Residue Decline Data from European
 Field Residue Trials of Grapes Treated with AE C638206 and Harvested
 0-28 Days After the Last Treatment. Project Number: C043671.
 Unpublished study prepared by Bayer Ag, Institute of Product Info. 8 p.
 46474102
 Smith, C. (2004) C638206 SE10 Formulation: Determination of the
 Residues in Processed Fractions Derived from Red Grapes Following
 Three Treatments Under Field Conditions in Southern Europe 2000.
 Project Number: OOS041R, OORF021/2, OOF/VI/FR/P04. Unpublished
 study prepared by Bayer Ag, Institute of Product Info. 17 p.
r~
 46474103
! Zietz, E. (2003) AE C638206 SE10 Formulation: Determination of the
| Residues in Processed Fractions Derived from Red Grapes Following
 Three Treatments Under Field Conditions in Southern Europe 2000: (Final
I Report). Project Number: DR/OO/EUS/056, IF/100/19787/00, C035551.
j Unpublished study prepared by Institut Fresenius Chemische und
j Biologische. 111 p.
          I Smith, C. (2004) C638206 SE10 Formulation: Determination of the
          j Residues in Processed Fractions Derived from White Grapes Following
          j Four Treatments Under Field Conditions in Northern Europe 2000
 46474104 j (Including AE C638206: Determination of the Residues in White Grapes
          j Following Four Treatments Under Field conditions in Northern Europe
          | 2000). Project Number: C037343, C034684, IF/100/18377/00.
          j Unpublished study prepared by Bayer Ag, Institute of Product Info.. 18 p.
07-Feb-
 2005
07-Feb-
 2005
07-Feb-
 2005
                                                                    07-Feb-
                                                                     2005
 46474105
 Zietz, E.; Schram, M. (2003) AE C638206 SE10 Formulation:
 Determination of the Residues in Processed Fractions Derived from White
 Grapes Following Four Treatments Under Field Conditions in Northern
 Europe 2000 (Including Field Report): (Final Report). Project Number:
 DR/OO/EUN/057, IF/100/18377/00, DR/OO/EUN/002. Unpublished study
 prepared by Institut Fresenius Chemische und Biologische. 253 p.
          j Smith, C. (2004) AE C638206 SE10 Formulation: Determination of the
          | Residues in Red Grapes Following Three Treatments under Field
 46474106 I Conditions in Southern Europe 2000. Project Number: C031908,
          i IF/100/10689/00, OOR021/1. Unpublished study prepared by Bayer Ag,
          ! Institute of Product Info. 15 p.
07-Feb-
 2005
                                                                    07-Feb-
                                                                     2005
 46474107
 Lemke, V. (2004) Evaluation of Acute and Chronic Dietary Exposure to
 Fluopicolide and Assessment of Potential Risk - Proposed Import
 Tolerances for Grapes. Project Number: RAACX105, B004787.
 Unpublished study prepared by Bayer Corp. 35 p.
07-Feb-
 2005
 46474108
 Payraudeau, V.; Smith, C. (2004) Fluopicolide (AE638206): Toxicology
 Data Summary for the EPA Import Tolerance: Acute, Subchronic, Chronic,
 Teratology, Reproduction and Neurotoxicity Studies. Project Number:
 C008135, C009846, C008274. Unpublished study prepared by Bayer Ag,
07-Feb-
 2005
                                          19

-------
           Institute of Product Info. 15 p.

          j Smith, C. (2004) AE C638206: Rat Acute Oral Toxicity. Project Number:
 46474109 j C008135, TOX/283/15, TOX/99324. Unpublished study prepared by Bayer
          ! Ag, Institute of Product Info. 6 p.
r~
          i McRae, L. (2000) AE C638206: Rat Acute Oral Toxicity. Project Number:
 46474110 | 015/003096/AC, TOX/99324, TOX/00/283/15. Unpublished study
          j prepared by Huntingdon Life Sciences, Ltd. 19 p.
                                                                   07-Feb-
                                                                    2005
                                                                   07-Feb-
                                                                    2005
 46474111
 Smith, C. (2004) AE638206: Rat 90-Day Dietary Toxicity Study with 4
 Week Off-Dose Period. Project Number: C008603, TOX/00/283/4,
 TOX/99198. Unpublished study prepared by Bayer Ag, Institute of Product
 Info. 25 p.
r~
 46474112
j Mallyon, B. (2000) AE C638206: Rat 90-Day Dietary Toxicity Study with 4
j Week Off-Dose Period. Project Number: TOX/00/283/4, TOX/99198,
j C008603. Unpublished study prepared by Aventis Cropscience UK Ltd.
I 442 p.
07-Feb-
 2005
07-Feb-
 2005
 46474113
 Smith, C. (2004) AE C638206: Mouse 90-Day Dietary Toxicity Study.
 Project Number: C008604, TOX/00/283/5, TOX/99216. Unpublished study
 prepared by Bayer Ag, Institute of Product Info. 15 p.
r~
 46474114
 46474115
 Mallyon, B. (2000) AE C638206: Mouse 90-Day Dietary Toxicity Study.
 Project Number: TOX/00/283/5, TOX/99216, C008604. Unpublished study
 prepared by Aventis Cropscience UK Ltd. 272 p.
 Smith, C. (2004) AE C638206: 90-Day Toxicity Study in the Mouse by
 Dietary Administration. Project Number: C01838, 605303, SA/00363.
 Unpublished study prepared by Bayer Ag, Institute of Product Info. 14 p.
07-Feb-
 2005
07-Feb-
 2005
07-Feb-
 2005
 46474116
 46474117
 Wason, S. (2001) AE C638206: 90-Day Toxicity Study in the Mouse by
 Dietary Administration. Project Number: SA/00363, 605303, C018138.
 Unpublished study prepared by Aventis Cropscience. 343 p.
 Smith, C. (2004) AE C638206: Dog 90-Day Oral Toxicity Study. Project
 Number: C010655, TOX/00/283/25, TOX/99292. Unpublished study
 prepared by Bayer Ag, Institute of Product Info. 11 p.
          j Mallyon, B. (2000) AE C638206: Dog 90-Day Oral Toxicity Study. Project
 46474118 | Number: TOX/00/283/25, TOX/99292, C010655. Unpublished study
          j prepared by Aventis Cropscience UK Ltd. 303 p.
07-Feb-
 2005
07-Feb-
 2005
                                                                   07-Feb-
                                                                    2005
 46474119
r~
 46474120
 Smith, C. (2004) AE C638206: Rat Oral Developmental Toxicity
 (Teratogenicity) Study (Including Addendum). Project Number: C016312,
 C044366, TOX99195. Unpublished study prepared by Bayer Ag, Institute
 of Product Info. 16 p.
 Hofmann, T. (2004) AE C638206: Rat Oral Developmental Toxicity
 (Teratogenicity) Study (Including Addendum). Project Number: 2000/0858,
 99/0566, TOX99195. Unpublished study prepared by Aventis Pharma
 Deutschland Gmbh. 239 p.
07-Feb-
 2005
07-Feb-
 2005
 46474121
 Smith, C. (2004) AE C368206: Rabbit Oral Developmental Toxicity
 (Teratogenicity) Study (Including Addendum). Project Number: C016495,
 99/0567. Unpublished study prepared by Bayer Ag, Institute of Product
 Info. 14 p.
07-Feb-
 2005
                                         20

-------
 46474122
          Hofmann, T. (2004) AE C638206: Rabbit Oral Developmental Toxicity
          (Teratogenicity) Study (Including Addendum). Project Number: C016495,
          C044368, 2000/0859. Unpublished study prepared by Aventis Pharma
          Deutschland Gmbh. 217 p.
r~
 46474123
          Smith, C. (2004) AE C638206: Study of Reproductive Performance in CD
          Rats Treated Continuously Through Two Successive Generations by
          Dietary Administration; AE C638206: Additional Microscopic Examination
          to a Study of Reproductive Performance in CD Rats Treated Continuously
          Through Two Successive Generations by Dietary Administration. Project
          Number: C033054, C04/3545, AES/056. Unpublished study prepared by
          Bayer Ag,  Institute of Product Info.. 43 p.
07-Feb-
 2005
07-Feb-
 2005
           Blee, M. (2003) AE C638206: Study of Reproductive Performance in CD
           Rats Treated Continuously Through Two Successive Generations by
 46474124  Dietary Administration. Project Number: C033054, AES/056/023443,
           AES/056. Unpublished study prepared by Huntingdon Life Sciences, Ltd.
           960 p.
 46474125
          Blee, M. (2004) AE C638206: Additional Microscopic Examination to a
          Study of Reproductive Performance in CD Rats Treated Continuously
          Through Two Successive Generations by Dietary Administration. Project
          Number: BAG/391043545, BAG/391 A. Unpublished study prepared by
          Huntingdon Life Sciences, Ltd. 450 p.
                                                                             07-Feb-
                                                                              2005
07-Feb-
 2005
 46474126
          Blee, M. (2002) AE C638206: Preliminary Study of Effects on
          Reproductive Performance in CD Rats by Dietary Administration. Project
          Number: C023472, 049/013609, AES/049. Unpublished study prepared  by
          Huntingdon Life Sciences, Ltd. 217 p.
         j Smith, C. (2004) AE C638206: 52-Week Toxicity Study by Oral Route
46474127 j (Gavage) in Beagle Dogs. Project Number: C029194, 20961/TCC.
         ! Unpublished study prepared by Bayer Ag, Institute of Product Info. 13 p.
 46474128
          Chevalier, G. (2002) AE C638206: 52-Week Toxicity Study by Oral Route
          (Gavage) in Beagle Dogs. Project Number: C029194, 20961/TCC.
          Unpublished study prepared by Centre International de Toxicologie. 785 p.
07-Feb-
 2005
                                                                              07-Feb-
                                                                               2005
07-Feb-
 2005
 46474129
         j Smith, C. (2004) AE C638206: Carcinogenicity Study by Oral Route
         j (Dietary Admixture) in C57BL/6 Mice. Project Number: C038732,
         j 21557/TCS. Unpublished study prepared by Bayer Ag, Institute of Product
         | Info. 21  p.
 46474130
          Chevalier, G. (2003) AEC638206: Carcinogenicity Study by Oral Route
          (Dietary Admixture) in C57BL/6 Mice. Project Number: C038732,
          21557/TCS. Unpublished study prepared by Centre International de
          Toxicologie. 2242 p.
07-Feb-
 2005
07-Feb-
 2005
 46474131
          Smith, C. (2004) AE C638206: 28-Day Explanatory Toxicity Study in the
          C57BL/6 Female Mouse. Project Number: C040806, 99/0567.
          Unpublished study prepared by Bayer Ag, Institute of Product Info. 18 p.
\ Langrand-Lerche, C. (2004) AE C638206: 20-Day Explanatory Toxicity
46474132 j Study in the C57BL/6 Female Mouse . Project Number: C040806,
| SA/03313. Unpublished study prepared by Aventis Cropscience. 217 p.
1R.741,, | Langrand-Lerche, C. (2002) Phenobarbitol: 28-Day Hepato-Toxicity Study
j jn the C57BL/6 MouSe. Project Number: C026075, SA/02013, 605655.
07-Feb-
2005
07-Feb-
2005
                                          21

-------
 46474134
Unpublished study prepared by Aventis Cropscience. 204 p.

Langrand-Lerche, C. (2004) Phenobarbital and Clofibric Acid: Reference
28-Day Study for the Hepatotoxicity in the C57BL/6 Mouse. Project
Number: C042531, SA/03310. Unpublished study prepared by Aventis
Cropscience. 466 p.
r~
          j Frith, C.; Highman, B.; Burger, G.; et. al. (1983) Spontaneous Lesions in
 46474135  Virgin and Retired Breeder Balb/C and C57BL/6 Mice. Laboratory Animal
          j Science 33(3): 273-286.
07-Feb-
 2005
                                                                  07-Feb-
                                                                   2005
 46474136
Cunningham, M. (1996) Role of Increased DMA Replication in the
Carcinogenic Risk of Nonmutagenic Chemical Carcinogens
(Phenobarbital, Oxazepam, Methapyrilene, Saccharin). Mutation
Research 365: 59-69.
r~
 46474137
Ito, N.; Hasegawa, R.; Imaida, K.; et. al. (1992) Pathological Markers for
Non-Genotoxic Agent-Associated Carcinogens (Clofibrate, DEHP, DEHA,
TCA, PB, Alachlor). Toxicology Letters 64/65: 613-620.
07-Feb-
 2005
07-Feb-
 2005
 46474138
r~
 46474139
Smith, C. (2004) AE C638206: Combined Carcinogenicity and Toxicity
Study by Dietary Administration to CD Rats for 104 Weeks. Project
Number: C038733, AES/024/032124, AES/024. Unpublished study
prepared by Bayer Ag, Institute of Product Info. 35 p.
Cooper, S. (2003) AE C638206: Combined Carcinogenicity and Toxicity
Study by Dietary Administration to CD Rats for 104 Weeks. Project
Number: C038733, AES/024/032124, AES/024. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 3517 p.
07-Feb-
 2005
07-Feb-
 2005
 46474140
Payraudeau, V.; Smith, C. (2004) Fluopicolide (AE C638206):
Genotoxicity Data Summary. Project Number: C008172, C012560,
C012562. Unpublished study prepared by Bayer Ag, Institute of Product
Info. 9 p.
07-Feb-
 2005
 46474141
Smith, C. (2004) AE C638206: Bacterial Reverse Mutation Test. Project
Number: C008172, TOX/99189, TOX/00/283/7. Unpublished study
prepared by Bayer Ag, Institute of Product Info. 10 p.
r~
 46474142
Stammberger, I. (2004) AE C639206: Bacterial Reverse Mutation Test
(Including Amendment 2). Project Number: C008172, C045895,
TOX/99189. Unpublished study prepared by Aventis Pharma Deutschland
Gmbh. 54 p.
07-Feb-
 2005
07-Feb-
 2005
          I Smith, C. (2004) AE C638206 00 1C96 0002 (OP 2050045): Reverse
          j Mutation Assay in Four Histidine-Requiring Strains of Salmonella
 46474143 I typhimurium and One Trytophan-Requiring Strain of Escherichia coli.
          j Project Number: C012560, 1849/6. Unpublished study prepared by Bayer
          ! Ag, Institute of Product Info. 12 p.
           Ballantyne, M. (2001) AE C638206 00 1C96 0002 (OP 2050045): Reverse
          i Mutation in Four Histidine-Requiring Strains of Salmonella typhimurium
 46474144  and One Trytophan-Requiring Strain of Escherichia coli. Project Number:
          j C012560,  1849/6, 1849/6/D6171. Unpublished study prepared by
          j Covance Laboratories, Ltd. 64 p.
                                                                  07-Feb-
                                                                   2005
                                                                  07-Feb-
                                                                   2005
 46474145
Smith, C. (2004) AE C638206 00 1C99 0005: Reverse Mutation Assay in
Four Histidine-Requiring Strains of Salmonella typhimurium and One
07-Feb-
 2005
                                          22

-------
           Trytophan-Requiring Strain of Escherichia coli. Project Number: C012562,
           1849/5. Unpublished study prepared by Bayer Ag, Institute of Product Info.
           12 p.
          i Ballantyne, M. (2001) AE C638206 00 1C99 0005: Reverse Mutation in
          ! Four Histidine-Requiring Strains of Salmonella typhimurium and One
 46474146 J Trytophan-Requiring Strain of Escherichia coli. Project Number: C012562,
          j 1849/5/D6171, 1849/5. Unpublished study prepared by Covance
          i Laboratories, Ltd. 57 p.
                                                                  07-Feb-
                                                                   2005
          f Smith, C. (2004) AE C638206 00 1B96 0002 (R001737): Reverse
           Mutation Assay in Four Histidine-Requiring Strains of Salmonella
 46474147 | typhimurium and One Trytophan-Requiring Strain of Escherichia coli.
          j Project Number: C012564, 605201. Unpublished study prepared by Bayer
          | Ag, Institute of Product Info. 12 p.
 46474148
Ballantyne, M. (2001) AE C638206 00 1B99 0002 (ROO1737): Reverse
Mutation in Four Histidine-Requiring Strains of Salmonella typhimurium
and One Trytophan-Requring Strain of Escherichia coli. Project Number:
C012564, 1849/8/D6171, 1849/8. Unpublished study prepared by
Covance Laboratories, Ltd. 60 p.
                                                                  07-Feb-
                                                                   2005
07-Feb-
 2005
          j Bayer CropScience LP (2005) Submission of Toxicity, Pesticide Fate and
 46474200 j Product Chemistry Data in Support of the Petition for Tolerance of
          j Fluopicolide in/on Imported Grapes and Raisins. Transmittal of 47 Studies.
                                                                  07-Feb-
                                                                   2005
          j Smith, C. (2004) AE C638206 00 1C96 0001 (OP2050046): Reverse
          j Mutation Assay in Four Histidine-Requiring Strains of Salmonella
 46474201 | tymphimurium and One Tryptophan-Requiring Strain of Escherichia coli.
          | Project Number: C012566, 1849/7, 605202. Unpublished study prepared
          { by Bayer Ag, Institute of Product Info. 12 p.
|          j Ballantyne, M. (2001) AE C638206 00 1C96 0001 (OP2050046): Reverse
{          i Mutation in Four Histidine-Requiring Strains of Salmonella tymphimurium
I 46474202 j and One Tryptophan-Requiring Strain of Escherichia coli. Project Number:
|          j 1849/7/D6171, 1849/7, TOX/20135. Unpublished study prepared by
{          j Covance Laboratories, Ltd. 64 p.
                                                                  07-Feb-
                                                                   2005
                                                                  07-Feb-
                                                                   2005
 46474203
 46474204
Smith, C. (2004) AE C638206: In Vitro Chinese Hamster Lung V79 Cell
HPTR Mutation Test. Project Number: C026130, TOX99190. Unpublished
study prepared by Bayer Ag, Institute of Product Info. 13 p.
Stammberger, I.; Graeser, D. (2005) AE C638206: In Vitro Chinese
Hamster Lung V79 Cell HPTR Mutation Test (Including Amendment 2).
Project Number: 2000/0333, TOX99190, C026130. Unpublished study
prepared by Aventis Pharma Deutschland Gmbh and Aventis Pharma
Deutschland Gmbh. 56 p.
07-Feb-
 2005
07-Feb-
 2005
 46474205
Smith, C. (2004) AE C638206: In Vitro Chinese Hamster Lung V79 Cells
Chromosome Aberration Assay. Project Number: C008174, TOX99191.
Unpublished study prepared by Bayer Ag, Institute of Product Info. 12 p.
          j Stammberger, I.; Graeser, H. (2004) AE C638206: In Vitro Chinese
          j Hamster Lung V79 Cells Chromosome Aberration Assay (Including
 46474206 j Amendment No. 1). Project Number: 2000/0315, 2000/1301, C008174.
          ! Unpublished study prepared by Aventis Pharma Deutschland Gmbh and
          I Aventis Pharma Deutschland Gmbh. 53 p.
07-Feb-
 2005
                                                                  07-Feb-
                                                                   2005
                                         23

-------
 46474207
 Smith, C. (2004) AE C638206: In Vitro Mammalian Chromosome
 Aberration Test in Human Lymphocytes. Project Number: C011815,
 605137. Unpublished study prepared by Bayer Ag, Institute of Product
 Info. 10 p.
r~
 46474208
j Allais, L. (2001) AE C638206: In Vitro Mammalian Chromosome
| Aberration Test in Human Lymphocytes. Project Number:
j AES/031/004381, AES/031, 605137. Unpublished study prepared by
j Huntingdon Life Sciences, Ltd. 30 p.
07-Feb-
 2005
07-Feb-
 2005
          j Smith, C. (2004) AE C638206: Mouse Erythrocyte Micronucleus Test.
 46474209 j Project Number: C008175, TOX/99192. Unpublished study prepared by
          | Bayer Ag, Institute of Product Info. 8 p.
                                                                  07-Feb-
                                                                    2005
          j Roth, T. (2005) AE C638206: Mouse Erythrocyte Micronucleus Test.
 46474210 j Project Number: 2000/0263, TOX/99192, TOX/00/283/10. Unpublished
          j study prepared by Aventis Pharma Deutschland Gmbh. 33 p.
                                                                  07-Feb-
                                                                    2005

           Smith, C. (2004) AE C638206: Induction of Micronucles in the Bone
 46474211  Marrow of Treated Mice. Project Number: C035885, 2014/70. Unpublished
           study prepared by Bayer Ag, Institute of Product Info. 10 p.
                                                                  07-Feb-
                                                                    2005
 46474212
r~
 46474213
 Whitwell, J. (2003) AE C638206: Induction of Micronuclei in the Bone
 Marrow of Treated Mice. Project Number: 2014/70/D6172, 2014/70,
 C035885. Unpublished study prepared by Covance Laboratories, Ltd. 58
 P-
07-Feb-
 2005
 Smith, C. (2004) AE C638206: Micronucleus Test on the Male Mouse.
 Project Number: C037549, T/3072923. Unpublished study prepared by
 Bayer Ag, Institute of Product Info. 11  p.
07-Feb-
 2005
          j Herbold, B. (2003) AE C638206: Micronucleus-Test on the Male Mouse.
 46474214 j Project Number: AT00749, T/3072923, C037549. Unpublished study
           prepared by Bayer Ag Inst. of Toxicology. 47 p.
                                                                  07-Feb-
                                                                    2005
           Smith, C. (2004) AE C638206: In Vivo Rat Liver Unscheduled DNA
           Synthesis (DNA Repair) Test (Including Addendum). Project Number:
           C008141, C010494, TOX/00/283/21. Unpublished study prepared by
           Bayer Ag, Institute of Product Info. 10 p.
                                                                  07-Feb-
                                                                    2005
46474216
46474217
46474218
1
46474219
j Mason, C.; Bright, J. (2000) AE C638206: In Vivo Rat Liver Unscheduled
j DNA Synthesis (DNA Repair) Test (Including First Addendum). Project
j Number: AES/002/003189, TOX/99330, TOX/00/283/21. Unpublished
j study prepared by Huntingdon Life Sciences, Ltd. and Aventis
j Cropscience UK Ltd. 44 p.
j Smith, C. (2004) AE C638206: Neurotoxicity Study by a Single Gavage
j Administration to CD Rats Followed by a 14-Day Observation Period.
! Project Number: C019695, AES/046/013157. Unpublished study prepared
j by Bayer Ag, Institute of Product Info. 25 p.
j Cooper, S. (2002) AE C638206: Neurotoxicity Study by a Single Oral
j Gavage Administration to CD Rats Followed by a 14-Day Observation
| Period. Project Number: AES/046/013157, AES/046, 013157.
j Unpublished study prepared by Huntingdon Life Sciences, Ltd. 360 p.
I Cooper, S. (2002) AE C638206: Dose Range and Time to Peak Effect in
j Rats by Acute Oral Administration. Project Number: AES045/12582,
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
07-Feb-
2005
                                         24

-------
          AES/045, 012582. Unpublished study prepared by Huntingdon Life
          Sciences, Ltd. 244 p.
          Smith, C. (2004) AE C638206: Neurotoxicity Study by Dietary
46474220 ! Administration to CD Rats for 13 Weeks. Project Number: C019700,
         | AES/051. Unpublished study prepared by Bayer Ag, Institute of Product
         ! Info. 22 p.
                                                                   07-Feb-
                                                                     2005
46474221
 Cooper, S. (2002) AE C638206: Neurotoxicity Study by Dietary
 Administration to CD Rats for 13 Weeks. Project Number:
 AES/0517014550, AES/051, 014550. Unpublished study prepared by
 Huntingdon Life Sciences, Ltd. and Huntingdon Life Sciences Ltd. 396 p.
07-Feb-
 2005
         j  Bolton, N. (2002) Further Validation of Neurotoxicity Procedures Following
         |  Oral Gavage Administration of D-Amphetamine or Diisopropyl
46474222 |  Fluorophosphate to CD Rats to Meet EPA FIFRA Requirements. Project
         |  Number: HLS027/982493, C045769, HLS/027. Unpublished study
         j  prepared by Huntingdon Life Sciences Ltd. 199 p.
                                                                   07-Feb-
                                                                     2005
           Blacker, A. (2004) Justification for Waiving a Developmental Neurotoxicity
46474223   Study of Fluopicolide (AE C638206). Project Number: AMB/11/04,
           B004879.  Unpublished study prepared by Bayer CropScience LP. 7 p.

                                                                   07-Feb-
                                                                     2005
46474224
46474225
 Fisher, P.; Smith, C. (2004) Fluopicolide (AE C638206): Metabolism and
 Pharmokinetics Data Summary. Unpublished study prepared by Bayer Ag,
 Institute of Product Info. 11 p.
 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206 and [Pyridyl-2,6-
 (Carbon 14)]-AE C638206: Rat Blood and Plasma Kinetics Study. Project
 Number: C036987, SA/02012. Unpublished study prepared by Bayer Ag,
 Institute of Product Info. 16 p.
07-Feb-
 2005
07-Feb-
 2005
46474226
 Fisher, P.; Vinck, K. (2003) [Phenyl-U-(Carbon 14)]-AE C638206 and
 [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Blood and Plasma Kinetics
 Study. Project Number: SA/02012, C036987. Unpublished study prepared
 by Bayer Cropscience. 69 p.
07-Feb-
 2005
46474227
j D'Souza, R. (2000) [Carbon 14]-AE C638206: Preliminary Toxicokinetic
 Studies in the Rat. Project Number: TOX/00/283/24, TOX/99217,
 HFL1063. Unpublished study prepared by Aventis Cropscience UK Ltd.
 and HFL. 175 p.
46474228
 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Tissue Kinetic
 Study. Project Number: C036983, SA/02094. Unpublished study prepared
 by Bayer Ag, Institute of Product Info. 26 p.
07-Feb-
 2005
07-Feb-
 2005
46474229
46474230
| Fisher, P. (2003) [Phenyl-U-(Carbon 14)]-AE C638206 Rat Tissue Kinetic
j Study. Project Number: SA/02094, C036983. Unpublished study prepared
| by Bayer Cropscience. 168 p.
Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Single High & Low
Dose Rat A.D.E. Study; [Phenyl-U-(Carbon 14)]-AE C638206: Rat
Metabolism Following Administration of a Single Oral Low Dose (Including
Amendment No. 1); [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism
Following Administration of a Single Oral High Dose (Including
Amendment No. 1). Project Number: C017703, C039583, C039582.
Unpublished study prepared by Bayer Ag, Institute of Product Info. 51 p.
07-Feb-
2005
07-Feb-
2005
                                         25

-------
          I Totis, M. (2001) [Phenyl-U-(Carbon 14)]-AE C638206: Single High & Low
 46474231 j Dose Rat A.D.E. Study. Project Number: SA/00398, 605306, C017703.
           Unpublished study prepared by Aventis Cropscience. 78 p.
r~
 46474232
j Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism
| Following Administration of a Single Oral Low Dose (Including
| Amendment No. 1). Project Number: SA/00581, C039583. Unpublished
j study prepared by Aventis Cropscience and Bayer Cropscience. 160 p.
                                                                   07-Feb-
                                                                    2005
07-Feb-
 2005
 46474233 i
 Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism
 Following Administration of a Single Oral High Dose (Including
j Amendment No. 1). Project Number: SA/01157, C039582. Unpublished
 study prepared by Bayer Cropscience. 142 p.
07-Feb-
 2005
 46474234
 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Repeat Oral Low
 Dose A.D.M.E. Study in the Rat (Including Amendment No. 1). Project
 Number: C039584, SA/01288. Unpublished study prepared by Bayer Ag,
! Institute of Product Info. 35 p.

| Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Repeat Oral Low
j Dose A.D.M.E. Study in the Rat (Including Amendment No. 1). Project
| Number: SA/01288, C039584. Unpublished study prepared by Bayer
j Cropscience. 210 p.
07-Feb-
 2005
                                                                             07-Feb-
                                                                               2005
 46474236
 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Bile Excretion
 Study. Project Number: C021984, SA/01383, 605513. Unpublished study
 prepared by Bayer Ag, Institute of Product Info. 14 p.
          j Totis, M. (2002) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Bile Excretion
 46474237 | Study. Project Number: SA/01383, 605513, C021984. Unpublished study
          j prepared by Aventis Cropscience. 64 p.
07-Feb-
 2005
                                                                   07-Feb-
                                                                    2005
          j Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Tissue
 46474238 j Kinetic Study. Project Number: C036980, SA/02370. Unpublished study
           prepared by Bayer Ag, Institute of Product Info. 17 p.
                                                                   07-Feb-
                                                                    2005
 46474239
 Fisher, P. (2003) [2,6-Pyridyl-(Carbon 14)]-AE C638206: Rat Tissue
 Kinetic Study. Project Number: SA/02370, C036980. Unpublished study
 prepared by Bayer Cropscience. 63 p.
r~
 46474240
 Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low
 Dose Rat A.D.E. Study (Including Amendment No. 1); [Pyridyl-2,6-(Carbon
 14)]-AE C638206: Rat Metabolism Following Administration of a Single
 Oral Dose (Including Amendment No. 1). Project Number: C012385,
 C012989, C039580. Unpublished study prepared by Bayer Ag,  Institute of
 Product Info. 42 p.
07-Feb-
 2005
07-Feb-
 2005
 46474241
 46474242
 Le Lain, R. (2001) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low
 Dose Rat A.D.E. Study (Amended). Project Number: SA/00477, 605088,
 C012385. Unpublished study prepared by Aventis Cropscience. 55 p.
 Fisher, P. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Metabolism
 Following Administration of a Single Oral Low Dose (Including
 Amendment No. 1). Project Number: SA/00550, C039580. Unpublished
 study prepared by Bayer Cropscience. 193 p.
07-Feb-
 2005
07-Feb-
 2005
 46474243
 Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low
 Dose Rat Bile Excretion Study. Project Number: C032181, SA02157.
07-Feb-
 2005
                                          26

-------
           Unpublished study prepared by Bayer Ag, Institute of Product Info. 13 p.
 46474244
r~
 46474245
 46474246
 Gutierrez, L. (2003) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral
 Low Dose Rat Bile Excretion Study. Project Number: SA/02157, 605761,
 C032181. Unpublished study prepared by Bayer Cropscience. 48 p.

 Cousin, J.; Smith, C. (2004) Summary of Test Substance Batches Used
 on the Mammalian Toxicology Studies Submitted to Support the U.S.
 Tolerance Petition for Residues in/on Imported Grapes and Raisins.
 Unpublished study prepared by Bayer Ag, Institute of Product Info. 5 p.

 Gomez, C.; Tassel, J-P. (2000) AE C638206: Determination by HPLC
 Analysis in Ground Rodent Diet. Project Number:
 R&D/CRSA/ANL/00/054, ANL/235/OOE, 604941. Unpublished study
 prepared by Aventis Cropscience. 18 p.
r~
           Gomez, C.; Brousse, I.; Oullier, J-P.; et. al. (2000) AE C638206:
 4R474P47 ! Determination by HPLC Analysis in Ground Rodent Diet. Project Number:
          j R&D/CRSA/ANL/00/075, ANL/235/OOE/E/, 605022. Unpublished study
          j prepared by Aventis Cropscience. 19 p.
07-Feb-
 2005
07-Feb-
 2005
07-Feb-
 2005
                                                                  07-Feb-
                                                                   2005
 46708400
r~
 46708401
 Valent U.S.A. Corp. (2005) Submission of Product Chemistry, Residue,
 Environmental Fate and Fate Data in Support of the Petition for Tolerance
 of Fluopicolide for Use on Grapes and the Application for Registration of
 Fluopicolide Technical, V-10161 4 SC, V-10161 VPP Fungicide, V-10162
 Premixand V-10162 VPP Fungicide. Transmittal of 49 Studies.
 Hewitt, A. (2005) Atomization Droplet Size Spectra for Fluopicolide AG.
 Project Number: UQ/792B, 200500281. Unpublished study prepared by
 University of Queensland Centre for Pesticide Application. 132 p.
08-Dec-
 2005
08-Dec-
 2005
          j Muhlberger, B.; Lemke, G. (2005) AE C0638206 Storage Stability. Project
 46708402 j Number: PA3/069, 200501004. Unpublished study prepared by Bayer
          | Cropscience Gmbh. 18 p.
 46708403
r~
 46708404
 46708405
 46708406
 Smeykal, H. (2005) AE C638206: Thermal Stability in the Presence of
 Aluminum and Aluminum Ions at Ambient and Elevated Temperatures.
 Project Number: 20050498/01, 200500260. Unpublished study prepared
 by Siemens Axiva GmbH & Co. KG. 21 p.
 Muhlberger, B.; Lemke, G. (2004) AE C638206 Oxidizing or Reducing
 Potential Code: AC C638206 00 1C99 0007. Project Number: PA3/070,
 200501005. Unpublished study prepared by Bayer Cropscience Gmbh. 12
 P-
                                                                  08-Dec-
                                                                   2005
08-Dec-
 2005
08-Dec-
 2005
 Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00   j
 1C96 0001: Oxidizing Properties. Project Number: 20030348/06,          j 08-Dec-
 200500835. Unpublished study prepared by Siemens Axiva GmbH & Co.   I  2005
 KG. 10 p.                                                         j
mammmmmm^^
 Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00
 1C96 0001: Autp-Flammability (Solids-Determination of Relative Self-      08-Dec-
 Ignition Temperature). Project Number: 20030348/05, 200500834.          2005
 Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 10 p.
           Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00
 46708407 | 1C96 0001: Flammability (Solids). Project Number: 20030348/03,
          j 200500832. Unpublished study prepared by Siemens Axiva GmbH & Co.
                                                                  08-Dec-
                                                                   2005
                                         27

-------
          I KG. 9 p.
 46708408
           Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00
           1C960001: Explosive Properties. Project Number: 20030348/04,
           200500833. Unpublished study prepared by Siemens Axiva GmbH & Co.
           KG. 11 p.
r~
 46708409
           Bowen, T. (2005) Corrosion Characteristics of Fluopicolide Technical
           Grade Active Ingredient (AE C638206). Project Number: AF04/097,
           200501006. Unpublished study prepared by Bayer Cropscience Gmbh. 11
           P-
08-Dec-
 2005
08-Dec-
 2005
 46708410
 46708411
           Franke, J. (2004) AE C638206; Substance, Techncial AE C638206 00
           1C99 0015 Particle Size Distribution. Project Number: 20040728/01,
           200500261. Unpublished study prepared by Siemens Axiva GmbH & Co.
           KG. 12 p.

           Queyrel, I.; Rosati, D. (2001) AE C638206 and its Metabolites: AE
           C657188 (PCA), AE C653711 (BAM), and RPA 427967 (hydroxyl):
           Analytical Method for the Determination of the Residues in Soil. Project
           Number: 200500871, 0115425, 01/03. Unpublished study prepared by
           Aventis Cropscience, Centre de Recherche de La Dargoire. 46 p.
08-Dec-
 2005
08-Dec-
 2005
 46708412
           Krebber, R. (2005) Analytical Method 00924 for the Determination of AE
           C638206 and its Metabolites AE C657188 (PCA) and AE C653711 (BAM)
           in Drinking and Surface Water by HPLC-MS/MS. Project Number:
           MR/005/05, 200500874, 00924. Unpublished study prepared by Bayer Ag,
           .44 p.
 46708413
           Queyrel, I.; Rosati, D. (2003) Analytical Method AR-307-03 for the
           Determination of AE C638206 and its Metabolites AE C653711 and AE
           C657177 in Water. Project Number: 200500873,  0315132, AR/307/03.
           Unpublished study prepared by Bayer Cropscience. 44 p.
08-Dec-
 2005
08-Dec-
 2005
 46708414
 46708415
           Rose, A. (2005) Environmental Fate and Ecological Risk Assessment for
           Fluopicolide Use on Turf, Vegetables, and Grapes. Project Number:
           VP/29735, 200500284. Unpublished study prepared by Valent U.S.A.
           Corporation. 142 p.
           Godfrey, T. (2000) Soil: Analytical Method for the Determination of
           Residues of AE C638206. Project Number: DGM/CO1/00/0, 200500870.
           Unpublished study prepared by Aventis Cropscience UK Ltd. 31 p.
          I Peronne, H.; Rosati, D. (2005) Storage Stability of Residues of AE
          j C638206 and its Metabolites: BAM (AE C653711), PCA (AE C657188)
 46708416 j and RPA 427967 (AE 0608000) in Soils During Deep Freeze Storage for
          { at Least 24 Months. Project Number: 0415034, 200500875. Unpublished
          | study prepared by Bayer Cropscience. 48 p.
08-Dec-
 2005
08-Dec-
 2005
                                                                            08-Dec-
                                                                              2005
{ 46708417
          j Mills, E.; Simmonds, M. (2003) (Carbon 14)-AE C657188: Adsorption to
          | and Desorption from Three Soils. Project Number: CX/03/032,
          j 200500845. Unpublished study prepared by Battelle Agrifood, Ltd. 88 p.
          i Billian, P.; Schoning, R. (2004) Storage Stability of AE C638206 and its
          j Metabolites AE C657378 (3-OH_BAM), AE C553711 (BAM) and AE
 46708418  1344122 (P1X) in/on Cereals (Rest of Plant, Grain, Straw) for 24 Months.
          j Project Number: MR/177/04, 200500286, BCS/RD/D/ROCS. Unpublished
          j study prepared by Bayer Ag. 47 p.
08-Dec-
 2005
                                                                            08-Dec-
                                                                              2005
                                         28

-------
46708419
_,_
46708420
__
46708421
46708422
! Jacob, O.; Fitzmaurice, M. (2003) (Carbon 14)-AE C653711: Hydrolysis at
j pH 4, 5, 7 and 9. Project Number: CX/03/03, 200500852. Unpublished
j study prepared by Battelle Agrifood, Ltd. 67 p.
! Shepler, K.; Runes, H. (2002) Hydrolysis of (Carbon 14)-AE C638206 at
I pH 4, 5, 6, 7 and 9. Project Number: 1 124W, 200500851 . Unpublished
! study prepared by PTRL West, Inc. 87 p.
i Sur, R. (2004) AE 0608000: Hydrolytic Degradation. Project Number:
| M1 11 1405/3, 200500853, MEF/04/369. Unpublished study prepared by
j Bayer Ag. 68 p.
I
| Shepler, K.; Runes, H. (2003) Photolysis and Quantum Yield of (Carbon
| 14)-AE C638206 in Buffered Aqueous Solution. Project Number: 1119W,
| 200500854. Unpublished study prepared by PTRL West, Inc. 1 13 p.
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005

          { Hellpointner, E. (2004) Phototransformation of [pyridyl-2,6-(Carbon 14)]AE
 46708423 \ C638206 in Sterile Water Buffered at pH 7. Project Number: M1121324/4,
           200500855, MEF/043/04. Unpublished study prepared by Bayer Ag. 54 p.
                                                                             08-Dec-
                                                                              2005
 46708424
          Mackie, J. (2005) [Benzene Ring-U-(Carbon 14)]-AE C638206: Soil
          Photolysis. Project Number: 200500856, 394309, 398240. Unpublished
          study prepared by Inveresk Research International. 115 p.
r~
 46708425
          Lowrie, C.; Keirs, D. (2001) [Pyridyl-2. 6-(Carbon 14)] Labelled AE
          C638206: Photodegradation on Sandy Loam Soil. Project Number:
          396814, 20050857. Unpublished study prepared by Inveresk Research
          International. 44 p.
08-Dec-
 2005
08-Dec-
 2005
          | Allan, J. (2003) Route and Rate Degradation of (2,6-(Carbon 14)-pyridinyl]
          I and [U-(Carbon 14)-benzoyl]-AE 638206 in European Sandy Loam Under
 46708427 j Laboratory Aerobic Conditions at 20 (Degrees) C and Determination of
          j Aged in situ Kd Values at 25 C. Project Number: CU99E506, 200500858.
           Unpublished study prepared by Bayer Cropscience LP. 87 p.
                                                                             08-Dec-
                                                                              2005
         j Allan, J. (2003) The Route and Rate of Degradation of [2,6-(Carbon 14)-
         j pyridinyl] and [U-(Carbon 14)-benzoyl]-AE C638206 in Two Soils Under
46708428 j Laboratory Aerobic Conditions at 25 (Degrees) C. Project Number:
         | CUOOE509, 200500860. Unpublished study prepared by Bayer
         { Cropscience LP. 105 p.

         j Rupprecht, J.; Harbin, A. (2005) Degradation of [2,6 (Carbon 14)-pyridinyl]
         j and [U-(Carbon 14)-benzoyl]-AE C638206 in  a Sediment/Water System
46708429 J Under Laboratory Anaerobic Conditions at 20 (Degress)C. Project
         j Number: CUOOE513, 200500868. Unpublished study  prepared by Bayer
         j Cropscience LP. 66 p.
                                                                              08-Dec-
                                                                               2005
                                                                              08-Dec-
                                                                               2005
          j Norris, F. (2005) AE C638206: Terrestrial Soil Dissipation Under
 46708430 j Agricultural Field Conditions. Project Number: 01CU27801, 200500869,
          j AR/265/01. Unpublished study prepared by Bayer Cropscience LP. 436 p.
                                                                             08-Dec-
                                                                              2005
 46708431
          Bright, A. (2000) Homogeneity and Stability in Solvents AE C638206
          99.6% w/w. Project Number: CHR/00/024, 200500918. Unpublished study
          prepared by Aventis Cropscience UK Ltd. 30  p.
08-Dec-
 2005
          { Wetton, P.; Mullee, D. (2001) 2,6-dichlorobenzamide (BAM): Acute
 46708432 | Toxicity to Daphnia magna. Project Number: 1133/008, 200500877.
          | Unpublished study prepared by Safepharm Laboratories, Ltd. 41 p.
                                                                             08-Dec-
                                                                              2005
                                          29

-------
 46708433
 Young, B.; Abedi, J. (2003) The 48 Hour Acute Toxicity to the Water Flea,
 Daphnia magna, in a Static System AE C638206 Technical 971% w/w.
 Project Number: 02CU28564, 200500876. Unpublished study prepared by
 Bayer Cropscience LP. 43 p.
r~
 46708434
 Young, B.; Abedi, J. (2003) The 48 Hour Acute Toxicity to the Water Flea,
 Daphnia magna, in a Static System AE C638206 Technical 97.1% w/w.
 Project Number: 02CU28564, 200500876. Unpublished study prepared by
 Bayer Cropscience LP. 43 p.
08-Dec-
 2005
08-Dec-
 2005
 46708435
 46708436
j Dionne, E. (2003) AE C638206 - Acute Toxicity to Eastern Oysters
j (Crassostrea virginica) Under Flow-Through Conditions. Project Number:
| 200500879, 13798/6122. Unpublished study prepared by Springborn
j Smithers Laboratories. 54 p.
 Caferella, M. (2003) AE C638206 - Acute Toxicity to Mysids
 (Americamysis bahia) Under Static Conditions. Project Number:
 200500880, 13798/6121. Unpublished study prepared by Springborn
 Smithers Laboratories. 53 p.
r~
 46708438
 Young, B.; Abedi, J. (2003) The 96 Hour Acute Toxicity to the Rainbow
 Trout, Oncorhyncus mykiss, in a Static System AC C638206 Technical
 97.1% w/w. Project Number: 02CU20827, 200500882. Unpublished study
 prepared by Bayer Cropscience LP. 53 p.
08-Dec-
 2005
08-Dec-
 2005
08-Dec-
 2005
           Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour Static
 4R7no4oq  Acute Toxicity Test with the Common Carp (Cyprinus carpio). Project
          | Number: 149A/162, 200500887. Unpublished study prepared by Wildlife
          ! International, Ltd. 42 p.
 46708440
 Blankinship, A.; Palmer, S.; Kendall, T.; et. al. (2003) AE C638206: A 96-
 Hour Static Acute Toxicity Test with the Ricefish (Oryzial latipes). Project
 Number: 149A/164, 200500885. Unpublished study prepared by Wildlife
 International, Ltd. 42 p.
                                                                    08-Dec-
                                                                     2005
08-Dec-
 2005
 46708441
 Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour Static
 Acute Toxicity Test with the Zebra Fish (Brachydanio rerio). Project
 Number: 200500884, 149A/163. Unpublished study prepared by Wildlife
 International, Ltd. 40 p.
 AK70KAAK
 Meyer, B.; Young, B. (2003) Bioaccumulation and Metabolism of [2,6-
 (Carbon i4).pyrjdiny|]-AE C638206 in Bluegill Sunfish, Lepomis
08-Dec-
 2005
46708442
46708444
46708445
{ Cafarella, M. (2003) AE C638206: Acute Toxicity to Sheepshead Minnow
! (Cyprinodon variegatus) Under Static Conditions. Project Number:
1 13798/6120, 200500889. Unpublished study prepared by Springborn
j Smithers Laboratories. 48 p.
I Young, B.; Abedi, J. (2003) Effects on the Life-Cycle of the Water Flea,
j Daphnia magna, in a Static Renewal System AC C638206 Technical
| 97.7% w/w. Project Number: 02CU34046, 200500891. Unpublished study
| prepared by Bayer Cropscience LP. 82 p.
| Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: An Early Life-
j Stage Toxicity Test with the Fathead Minnow (Pimephales promelas)
j Under Flow-Through Conditions. Project Number: 149A/141A,
j 200500892. Unpublished study prepared by Wildlife International, Ltd. 77
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
 2005
                                          30

-------
          i  macrochirus, In a Flow-Through System. Project Number: 604CU,
          |  200500893. Unpublished study prepared by Bayer Cropscience LP. 104 p.
           Gallagher, S.; Beavers, J. (2001) AE C638206 Technical: An Acute Oral
 46708447 i Toxicity Study with the Mallard. Project Number: 512/113, 200500895.
          i Unpublished study prepared by Wildlife International, Ltd. 31  p.
r~
 46708448
           Gallagher, S.; Beavers, J. (2001) AE C638206 Technical: An Acute Oral
           Toxicity Study with the Northern Bobwhite. Project Number: 512/112,
           200500896. Unpublished study prepared by Wildlife International, Ltd. 31
           P-
                                                                             08-Dec-
                                                                               2005
                                                                             08-Dec-
                                                                               2005
 46708449
           Gallagher, S.; Beavers, J.; Martin, K. (2002) AE C638206 Technical: A
           Dietary LC50 Study with the Mallard. Project Number: 512/115,
           200500889. Unpublished study prepared by Wildlife International, Ltd. 54
           P-
 46708500
          Valent U.S.A. Corporation (2005) Submission of Toxicity, Fate, Residue
          and Environmental Fate Data in Support of the Applications for
          Registration of Fluopicolide Technical, V-10161 4 SC, V-10161 VPP
          Fungicide, V-10162 Premixand V-10162 VPP Fungicide, and the Petition
          for Tolerance of Fluopicolide for Use on Grapes. Transmittal of 48 Studies.
                                                                             08-Dec-
                                                                               2005
                                                                             08-Dec-
                                                                               2005
 46708501
           Gallagher, S.; Grimes, J.; Beavers, J.; et. al. (2002) AE C38206 Technical:
           A Dietary LC50 Study with the Northern Bobwhite. Project Number:
           512/114, 200500898. Unpublished study prepared by Wildlife
           International, Ltd. 54 p.
         j Temple, D.; Martin, K.; Beavers, J.; et. al. (2003) AE C638206 Technical:
4R7nocno | A Reproduction Study with the Mallard. Project Number: 149/186,
         I 200500902. Unpublished study prepared by Wildlife International, Ltd. 165
46708503
 46708504
          Waltersdorfer, A. (2001) Contact Toxicity (LD50) to Honey Bees (Apis
         | mellifera L.) Substance Pure: AE C638206 00 1B99 0002. Project
         | Number: CWOO/065, 200500904. Unpublished study prepared by Aventis
         i Crop Science. 16 p.
 46708505
           Sabbert, T. (2004) Tier 1 Seedling Emergence and Vegetative Vigor
           Nontarget Phytotoxicity Study Using AE C638206 SC40. Project Number:
           200721, 200500906, A6451402. Unpublished study prepared by Bayer
           Corp. 86 p.
                                                                             08-Dec-
                                                                               2005
                                                                              08-Dec-
                                                                                2005
           Temple, D.; Martin, K.; Beavers, J.; et. al. (2003) AE C638206 Technical:
          j A Reproduction Study with the Northern Bobwhite. Project Number:
          ! 149/185, 200500901. Unpublished study prepared by Wildlife
          | International, Ltd. 167 p.
                                                                             08-Dec-
                                                                               2005
                                                                             08-Dec-
                                                                               2005
                                                                             08-Dec-
                                                                               2005
 46708507
           Hoberg, J. (2003) AE C638206 - 7-Day Toxicity Test with Duckweed
           (Lemna gibba). Project Number: 13798/6125, 2005500908, EBACX/085.
           Unpublished study prepared by Springborn Smithers Laboratories. 61 p.
 46708508
         j Young, B.; Abedi, J. (2003) Effect to Anabaena flos-aquae (Blue-green
         j Alga) in a Growth Inhibition Test AE C638206 Technical 97.1% w/w.
         j Project Number:  02CU28566, 200500911. Unpublished study prepared by
         j Bayer CropScience LP. 51 p.
                                                                             08-Dec-
                                                                               2005
                                                                             08-Dec-
                                                                               2005
 46708509 j  Desjardins, D.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour     08-Dec-

-------
          Toxicity Test with the Freshwater Alga (Selenastrum capricornutum).
          Project Number: 149A/166A, 200500915. Unpublished study prepared by
          Wildlife  International, Ltd. 56 p.
46708510
Hoberg, J. (2003) AE C638206 - Acute Toxicity to the Marine Diatom,
Skeletonema costatum Under Static Conditions. Project Number:
13798/6124, 200500917, EBACX/008. Unpublished study prepared by
Springborn Smithers Laboratories. 66 p.
                                                                    2005
08-Dec-
 2005
46708512
Aufderheide, J.; Hughes, C. (2002) Acute Toxicity of AE C638206
Technical to the Earthworm, Eisenia fetida. Project Number: 47063,
200500268. Unpublished study prepared by Analytical Bio-Chemistry
Labs., Inc. 20 p.
08-Dec-
 2005
46708513
Fichera, L. (2005) Independent Laboratory Validation of Bayer Crop
Science Analytical Method Entitled "Analytical Method AR 307-03 for the
Determination of AE C638206 and its Metabolites AE C653711 and AE
C657188 in Water". Project Number: VP/29639, 200500262, 050203.
Unpublished study prepared by Golden Pacific Laboratories, LLC (GPL).
130 p.
08-Dec-
 2005
46708514
Needham, D. (2003) (Carbon 14)-AE C638206: Absorption, Distribution,
Metabolism and Excretion Following Repeated Oral Administration to the
Lactating Cow. Project Number: 2014/040, 200500925. Unpublished study
prepared by Covance Laboratories, Ltd. 200 p.

08-Dec-
 2005
46708515
Needham, D. (2003) (Carbon 14)-AE C638206: Absorption, Distribution,
Metabolism and Excretion Following Repeated Oral Administration to the
Laying Hen. Project Number: 2014/004, 200500923. Unpublished study
prepared by Covance Laboratories, Ltd. 226 p.
         I Cavaille, C.; Rosati, D. (2003) AE C638206 and its Metabolites AE
         j C653711 (BAM) and AE C657188 (PCA): Analytical Method AR 303-02
46708516 j for the Determination of Residues in Foodstuffs of Animal Origin. Project
          Number: C035414, 200500924, 02/125. Unpublished study prepared by
         j Bayer Cropscience. 85 p.
08-Dec-
 2005
                                                                   08-Dec-
                                                                    2005
46708517
Wustner, D. (2005) Determination of the Analytes and the Definition of the
Regulated Residues (of Fluopicolide): In/On Raw Agricultural
Commodities and Rotational Crops, and in Processed Commodities and
Secondary Residues in Meat, Milk, Poultry and Eggs. Project Number:
V/DWRES/1, 200500285. Unpublished study prepared by Valent U.S.A.
Corporation. 31 p.
46708518
Gedik, L.; McCombe, W. (2003) The Distribution and Metabolism of
(Carbon 14)-AE C638206 in the Lactating Cow. Project Number: 201123,
200500922, 21582. Unpublished study prepared by Inveresk Research
International. 200 p.
08-Dec-
 2005
08-Dec-
 2005
I
46708519
i~~
46708520
Gedik, L.; McCombe, W. (2003) The Distribution and Metabolism of
(Carbon 14)-AE C638206 in the Laying Hen. Project Number: 201500,
200500921, 21552. Unpublished study prepared by Inveresk Research
International. 186 p.
i
j Rupprecht, J. (2004) Metabolism of [U-(Carbon 14)-phenyl] and [2,6-
j (Carbon 14) pyridinyl]-AE C638206 in Lettuce (Amended Report
j Replacing Report 505CU, Document B004330). Project Number: 505CUA,
I 200500920, F9951 4/001 . Unpublished study prepared by Agrevo USA Co.
08-Dec-
2005
08-Dec-
2005
                                         32

-------
          and A & L Great Lakes Laboratories. 93 p.

         j Rupprecht, J. (2004) Metabolism of [U-(Carbon 14)-phenyl] and [2,6-
         | (Carbon 14) pyridinyl]-AE C638206 in Potatoes (Amended Report
46708521 j Replacing Report 502CU, Document B004328). Project Number: 502CUA,
         j 200500919, F99514/001. Unpublished study prepared by Agrevo USA Co.
         | and A & L Great Lakes Laboratories. 136  p.
                                                                  08-Dec-
                                                                   2005
46708522
 Grant, J. (2005) Independent Laboratory Validation of "Validation of the
 Modification M002 to the Analytical Method 00782 for the Determination of
 Residues of AEC638206 and its Metabolites AEC657188, AEC653711
 and AE 344122 in/on Wheat by HPLC-MS/MS" for Tomatoes and
 "Modification MOOS to the Analytical Method 00782 for the Determination
 of Residues of AEC657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC-
 MS/MS" for Wheat  Forage According to PR Notice 96-1, OPPTS 860-
 1340 Guideline, and SANCO/825/00 Rev. 7. Project Number: 49181,
 200500277, RAACX098. Unpublished study prepared by Analytical Bio-
 Chemistry Labs., Inc.  129 p.
46708523
 Grant, J. (2004) Independent Laboratory Validation of "Validation of the
 Modification M002 to the Analytical Method 00782 for the Determination of
 Residues of AE C638206 and its Metabolites AE C657188, AE C653711
 and AE 1344122 in/on Wheat by HPLC-MS/MS" for Tomatoes and
 "Modification MOOS to the Analytical Method 00782 for the Determination
 of Residues of AEC657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC-
 MS/MS" for Wheat  Forage According to PR Notice 96-1, OPPTS 860-
 1340 Guidelines, and SANCO/825/00 Rev. 7. Project Number: 49181,
 200500277, RAACX098. Unpublished study prepared by Analytical Bio-
 Chemistry Labs., Inc. 61 p.
08-Dec-
 2005
08-Dec-
 2005
46708524
i Schreier, T. (2005) Tolerance Enforcement Method for the Analysis of
j Residues of Fluopicolide in/on Crops: Method RM-43C-1. Project Number:
| FLUOPICOLIDE/002, 200500282, RM/43C/1. Unpublished study prepared
{ by Valent U.S.A. Corporation. 18 p.
46708525
 Ford, C. (2005) PAM I Multiresidue Protocol Testing for AE C638206
 (Fluopicolide) and its Metabolites AE C653711 (BAM), AE C657378
 (BAM-OH), AE C657188 (PCA) and AE 1344122 (PIX). Project Number:
 1551, 200500927, RAACX039. Unpublished study prepared by Pyxant
 Labs Inc. 327 p.
08-Dec-
 2005
08-Dec-
 2005
46708526
 Green, C. (2005) Extrapolation of 30-Month Storage Stability Data for
 Fluopicolide and Degradates BAM and PCA in Crop Samples to 48
 Months. Project Number: 29815, 200500259. Unpublished study prepared
 by Valent U.S.A. Corporation. 30 p.
         j Gould, T.; Dallstream, K.; Beedle, E. (2005) Storage Stability of AE
         ! C638206 and Metabolites in Potato, Sugar Beet, Tomato and Wheat
         j Processed Commodities. Project Number: RAACY001, 200501003.
         ! Unpublished study prepared by Bayer Corp. 81  p.
08-Dec-
 2005
                                                                  08-Dec-
                                                                   2005
         j Cavaille, C.; Rosati, D. (2004) Residues of AE C638206 and Major
         j Metabolites in Milk and Edible Cattle Tissues Following 28 Day Dosing of
46708528 j Technical Product to Lactating Cows: 2002.  Project Number: 0315145,
         j 200500928, 02/105. Unpublished study prepared by Bayer Cropscience
         j and RCC Umweltchemie Ag. 256 p.
46708529  Schreier, T. (2005) Waiver Request: Magnitude of the Residue of
                                                                  08-Dec-
                                                                   2005
                                                                  08-Dec-
                                        33

-------
1 	 p__^^
i Fluopicolide in Poultry and Eggs. Project Number: FLUOPICOLIDE/001 ,
| 200500225. Unpublished study prepared by Valent U.S.A. Corporation. 6
| P.
! Mackie, S. (2004) AE C638206: Magnitude of Residues in/on Bell Pepper
! Resulting from Foliar Application of EXP 11067B (2002). Project Number:
| 02CU33132, 200500934, 1501. Unpublished study prepared by Pyxant
I Labs Inc., Southeast Ag Research, Inc. and Ag. Consultants Inc. 149 p.
| Mackie, S. (2004) AE C638206: Magnitude of Residues in Cantaloupe
| Resulting from Foliar Applications of EXP 1 1 067B Under Maximum
I ,lR7nRco1 j Proposed Label Specifications (2002). Project Number: 02CU27825,
| 4C./U8JDCS j 200500933, 27825-0201 . Unpublished study prepared by Pyxant Labs
I \ Inc., Chemtrol Scientific Testing and Alvey Lab & Agr Research Services.
| | 149 p.
Mackie, S. (2004) AE C638206: Magnitude of Residues in Cucumbers
Resulting from Foliar Application of EXP 1 1 067B Under Maximum
Proposed Label Specifications (2002). Project Number: 02CU27779,
200500931 , 27779-0201 . Unpublished study prepared by Pyxant Labs
I Inc., Agricultural Systems Associates and Ag Research Associates, LLC.
113p.
r~ r~
j Mackie, S. (2005) AE C638206: Magnitude of Residues in Head Lettuce
j Resulting from Foliar Applications of EXP 1 1 067B Under Maximum
I ,,R7nRcoo 1 Proposed Label Specifications (2002). Project Number: 02CU27778,
| 4b/U8:Dcscs j 200500936, 27778-0101. Unpublished study prepared by Pyxant Labs
{ Inc., Agricultural Chemistry Development Services, Inc. (ACDS) and
j Glades Crop Care, Inc. 152 p.
i- r
| Mackie, S. (2005) AE C638206: Magnitude of Residues in Leaf Lettuce
j Resulting from Foliar Applications of EXP 1 1 067B Under Maximum
j Proposed Label Specifications (2002). Project Number: 02CU30473,
j 200500937, 30473-0101. Unpublished study prepared by Pyxant Labs
j Inc., Agricultural Chemistry Development Services, Inc. (ACDS) and
| Glades Crop Care, Inc. 138 p.
j Mackie, S. (2004) AE C638206: Magnitude of Residues in/on Chili Pepper
I I RAC Resulting from Foliar Application of EXP 1 1 067B (2002). Project
| 46708535 | Number: 02CU33133, 200500935, 33133-09801. Unpublished study
j prepared by Pyxant Labs Inc., South Texas Ag. Research and Arid Ag
j Research, Inc. 110 p.
r_,_ _,
{ Norris, F. (2003) AE C638206: Magnitude of Residues in/on Tomato RAC
j Resulting from Foliar Application of EXP 11067B (2001). Project Number:
46708536 j 01CU27776, 200500930, 27776-01. Unpublished study prepared by
j Enviro-Test Laboratories (ETL), Lab Services and Carolina Ag-Research
I I Service, Inc. 320 p.
| |
f *|
j Mackie, S. (2004) AE C638206: Magnitude of Residues in Potato
Resulting from Foliar Applications of EXP 1 1 067B Under Maximum
I ,,R7nRco7 i Proposed Label Specifications (2001). Project Number: 01CU27775,
| 4C./U8JDCS/ | 200500929, 27775-0101. Unpublished study prepared by Pyxant Labs
j Inc., Crop Management Strategies, Inc. and Agricultural Chemistry
j Development Services, Inc. (ACDS). 247 p.
r~~ r
{ 45700530 Mackie, S. (2004) AE C638206: Magnitude of Residues in Squash
j Resulting from Foliar Application of EXP 1 1 067B Under Maximum
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
34

-------
         i Proposed Label Specifications (2002). Project Number: 02CU27824,
         | 200500932, 27824-0101. Unpublished study prepared by Pyxant Labs
         I Inc., Crop Management Strategies, Inc. and Agricultural Systems
         I Associates. 114 p.
         ! Kowalsky, J. (2005) Fluopicolide: Magnitude of the Residues in Celery
         ! Resulting from Foliar Applications of EXP 11067B Under Maximum
46708539 j Proposed Label Specifications. Project Number: 02CU33134, 200500250,
         j 33134-0301. Unpublished study prepared by Pyxant Labs Inc., Glades
         ! Crop Care, Inc. and Agsearch. 216 p.
                                                                  08-Dec-
                                                                   2005
46708540
Kowalsky, J. (2005) Fluopicolide: Magnitude of Residues in Spinach
Resulting from Foliar Applications of EXP 11067B Under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33135,
200500249, 33135-0101. Unpublished study prepared by Pyxant Labs
Inc., Crop Management Strategies, Inc. and Ashgrow Crop Management
Systems, Inc. 212 p.
08-Dec-
 2005
46708541
Belyk, M. (2005) Magnitude of Residues on Grapes Treated with Three
Applications of the Fungicide EXP 11067B (AE C638206) with a 21 Day
PHI. Project Number: 02AC03, 200500938, 02AC03/01. Unpublished
study prepared by Enviro-Test Laboratories (ETL), A.C.D.S. Research,
Inc. and Vaughn Agricultural Research Serv., Ltd. 239 p.
08-Dec-
 2005
46708542
46708543
Zietz, E. (2003) AE C638206 Code AE C638206 00 SE10 A3:
Determination of the Residues in Processed Fractions Derived From
White Grapes Following Four Treatments Under Field Conditions In
Northern Europe 2000. Project Number: IF/100/18377/00, 200500939,
BKA/683/00/RES/1. Unpublished study prepared by Institut Fresenius
Chemische und Biologische. 130 p.

Norris, F. (2003) AE C638206: Determination of the Magnitude of
Residues in/on Tomato Processed Fractions Resulting from Foliar
Application of EXP 11067B. Project Number: 01CU27782, 200500940,
01/009. Unpublished study prepared by Bayer CropScience LP, California
Agricultural Research Inc. and  Hulst Research Farm Services. 266 p.
08-Dec-
 2005
08-Dec-
 2005
          Mackie, S. (2004) AE C638206: Magnitude of Residues in Processed
          Wheat Fractions Resulting from an Exaggerated Rate Application of EXP
46708544  11067Bto Bare Ground (2001). Project Number: 01CU27784, 200500941,
          27784/0502. Unpublished study prepared by Pyxant Labs Inc. and Alvey
          Lab & Agr Research Services. 169 p.
46708545
Mackie, S. (2004) AE C638206: Magnitude of Residues in Processed
Potato Fractions Resulting from Exaggerated Rate Applications of EXP
11067B (2001). Project Number: 01CU27781, 200500942, 27781/1101.
Unpublished study prepared by Pyxant Labs Inc., Quails Agricultural
Laboratories, I and Agsearch. 133 p.
                                                                  08-Dec-
                                                                   2005
08-Dec-
 2005
46708546
Meyer, B. (2003) Uptake of (Carbon 14) AE C638206 Residues in Soil by
Rotational Crops under Confined Conditions (Amended Report Replacing
Document No. B003699). Project Number: CU99E501. Unpublished study
prepared by Aventis CropScience and Bayer Cropscience Gmbh. 311 p.
08-Dec-
 2005
         j Mackie, S. (2005) AE C638206: Magnitude of Residues in Wheat when
4R7noc47  Used as a Rotational Crop after Potatoes that have had Foliar
          Applications of EXP 11067B at the Maximum Proposed Label
          Specifications (2001). Project Number: 01CU31873, 200500944, 31783-
                                                                  08-Dec-
                                                                   2005
                                        35

-------
           0201. Unpublished study prepared by Pyxant Labs Inc., Crop
           Management Strategies, Inc. and Mid South Agric. Research. 488 p.
           Creek, M. (2005) Fluopicolide: Toxicology Data Summary and Endpoint
 46708548 i Selection Justification. Project Number: 29866, 200500283. Unpublished
          i study prepared by Valent U.S.A. Corporation. 40 p.
r~
 46708600
          Valent U.S.A. Corporation (2005) Submission of Product Chemistry,
          Toxicity, Pesticide Fate, Exposure and Risk Data in Support of the
          Application for Registrations of Fluopicolide Technical, V-10161  4 SC, V-
          10161  VPP Fungicide, V-10162 Premixand V-10162 VPP Fungicide and
          the Petition for Tolerance of Fluopicolide on Grapes. Transmittal of 51
          Studies.
                                                                             08-Dec-
                                                                              2005
08-Dec-
 2005
          j Schungel, M. (2003) AE C638206 - AE C657378 Acute Toxicity in the Rat
 46708601 ! After Oral Administration. Project Number: T/4072771. Unpublished study
           prepared by Bayer Ag Inst. of Toxicology. 25 p.
          ! Schungel, M. (2003) AE C653711 (Metabolite of AE C638206) Acute
 46708602  Toxicity in the Rat After Oral Administration. Project Number: T/4073121.
          j Unpublished study prepared by Bayer Ag Inst. of Toxicology. 36 p.
                                                                             08-Dec-
                                                                              2005
                                                                             08-Dec-
                                                                              2005
           Coleman, D. (2005) AE C657188 (Plant Metabolite of AE C638206) Rat
 46708603 [ Acute Oral Toxicity. Project Number: TOX/20044, AES/018/003625/AC.
          j Unpublished study prepared by Huntingdon Life Sciences, Ltd. 21 p.
                                                                             08-Dec-
                                                                              2005
46708604
           Schungel, M. (2003) Project AE C638206 Acute Toxicity in the Rat After
           Oral Administration. Project Number: T2072634, AE1344122. Unpublished
           study prepared by Bayer Ag Inst. of Toxicology. 25 p.
08-Dec-
 2005
 46708605
          McRae, L. (2000) Rat Acute Dermal Toxicity AE C638206 Code: AE
          C638206 00 1C99 0005. Project Number: TOX/99325, 200500953,
          AGV/306/002691/AC. Unpublished study prepared by Huntingdon Life
          Sciences, Ltd. 18 p.
08-Dec-
 2005
46708606
j__
46708607
f
46708608
!___
46708609
1
46708610
r~
46708611
j Wesson, C. (2000) Rat Acute Inhalation Toxicity AE C638206. Project
j Number: TOX/99329, 374/091 , 200500956. Unpublished study prepared
j by Safepharm Laboratories, Ltd. 46 p.
I McRae, L. (2000) Rabbit Eye Irritancy AE C638206. Project Number:
j TOX/99327, 200500959, AGV/308/002879/SE. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 19 p.
Coleman, D. (2000) Guinea-Pig Skin Sensitization Study (Magnusson &
Kligman Method) AE C638206. Project Number: TOX/99328, 200500965,
AGV/309/002587/SS. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 30 p.
._
Mallyon, B. (2000) Mouse 28-Day Dietary Toxicity Study AE C638206
j Code: AE C638206 00 1C99 0004. Project Number: TOX/00/283/2,
j 200500715. Unpublished study prepared by Aventis Cropscience UK Ltd.
| 186 p.
| Higgs, P. (2000) Rat 28-Day Dietary Toxicity Study AE C638206 Code:
i AE C638206 00 1C99 0003. Project Number: TOX/00/283/1, 200500718.
i Unpublished study prepared by Aventis Cropscience UK Ltd. 287 p.
| McElligott, A. (2003) AE 1344122 28-Day Toxicity Study in the Rat by
j Dietary Administration. Project Number: SA/03054, 200500993.
|
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
                                          36

-------
 46708612
Unpublished study prepared by Bayer Cropscience. 357 p.

Eiben, R.; Rinke, M. (2003) AE C657378 Subacute Toxicity in Rats
(Administration in the Diet for 4 Weeks). Project Number: T1072327,
200500992. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
384 p.
r~
          j Mallyon, B. (2000) AE C638206 Dog 28-Day Oral Toxicity Study. Project
 46708613 | Number: TOX/00/283/3, 200500231. Unpublished study prepared by
          j Aventis Cropscience UK Ltd. 118 p.
08-Dec-
 2005
                                                                  08-Dec-
                                                                   2005
          { Eigenberg, E.; Stuart, B. (2003) A Subacute Dermal Toxicity Study in Rats
 46708614 j with AE C638206. Project Number: 200705, 200500968. Unpublished
           study prepared by Bayer Corp. 309 p.
r~
 46708615
Hofmann, T. (2000) AE C638206 Code: AE C638206 00 1C99 0005 Rat
Oral Developmental Toxicity (Tetratogenicity) Range Finding Study.
Project Number: 99/0533. Unpublished study prepared by Hoechst Ag
Pharma Development Toxicology. 39 p.
                                                                  08-Dec-
                                                                   2005
08-Dec-
 2005
 46708616
Hofmann, T. (2000) Rabbit Oral Developmental Toxicity (Teratogenicity)
Range Finding Study AE C638206 Code: AE C638206 00 1C99 0005.
Project Number: 2000/0467, T/041/99. Unpublished study prepared by
Aventis Pharma Deutschland Gmbh. 89 p.
           Herbold, B. (2003) AE 1344122 Salmonella/Microsome Test Plate
           Incorporation and Preincubation Method. Project Number: T/5072079.
           Unpublished study prepared by Bayer Ag Inst. of Toxicology. 56 p.
 46708618
Herbold, B. (2004) AE C638206 SC 480 Salmonella/Microsome Test Plate
Incorporation and Preincubation Method. Project Number: T/7073223,
200500973. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
54 p.
08-Dec-
 2005
                                                                  08-Dec-
                                                                   2005
08-Dec-
 2005
           Herbold, B. (2003) AE C657378 Salmonella/Microsome Test Plate
           Incorporation and Preincubation Method. Project Number: T/2063319,
           200500971. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
           53 p.

           Kitching, J. (2005) Bacterial Mutation Assay AE C657188 (Plant
           Metabolite of AE C638206). Project Number: TOX/20045, 200500969.
           Unpublished study prepared by Huntingdon Life Sciences,  Ltd. 28 p.
                                                                  08-Dec-
                                                                   2005
                                                                  08-Dec-
                                                                   2005
f
46708621
!___
46708622
l_
46708623
P_
46708624
T
j Koom, J. (1992) Evaluation of the Possible Mutagenic Activity of 2,6-
| Dichlorobenzamide in the Ames Salmonella/Microsome Test. Project
| Number: 56645/69/92, 200500946. Unpublished study prepared by Solvay
JDupharB.V. 23 p.
Herbold, B. (2003) Salmonella/Microsome Test Plate Incorporation and
Preincubation Method. Project Number: T/4072951, 200500972.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 53 p.
[ Herbold, B. (2003) AE 1C657188 V79/HPRT - Test in Vitro for the
Detection of Induced Forward Mutations. Project Number: T/8072081 ,
200500974. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
38 p.
j Herbold, B. (2003) AE 1344122 Metabolite of AE C638206 V79/HPRT -
j Test in Vitro for the Detection of Induced Forward Mutations. Project
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
08-Dec-
2005
                                          37

-------
          i Number: T/7072080, 200500975. Unpublished study prepared by Bayer
           Ag Inst. of Toxicology. 38 p.
 46708625
           Herbold, B. (2003) AE C653711 Metabolite of AE C638206 V79/HPRT -
          j Test in Vitro for the Detection of Induced Forward Mutations. Project
          | Number: T/4072078, 200500976. Unpublished study prepared by Bayer
          ! Ag Inst. of Toxicology. 38 p.
08-Dec-
 2005
 46708626
           Herbold, B. (2003) AE C657378 V79/HPRT - Test in Vitro for the
           Detection of Induced Forward Mutations. Project Number: T/4063320,
           20050097. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
           38 p.
08-Dec-
 2005
 46708627
           Lloyd, M. (2003) AE 1344122 (Metabolite of AE C638206) Induction of
           Chromosome Aberrations in Cultured Human Peripheral Blood
           Lymphocytes. Project Number: 2014/67, 200500979. Unpublished study
           prepared by Covance Laboratories, Ltd. 69 p.

 46708628
          j Kumaravel, T. (2003) AE C657378: Induction of Chromosome Aberrations
          | in Cultured Human Peripheral Blood Lymphocytes: Final Report. Project
          j Number: 2014/69, 200500980. Unpublished study prepared by Covance
          j Laboratories, Ltd. 69 p.
08-Dec-
 2005
08-Dec-
 2005
|46708629



i 46708630
          | Lloyd, M. (2003) AE C657188 (Metabolite of AE C638206) Induction of
          j Chromosome Aberrations in Cultured Human Peripheral Blood
          j Lymphocytes. Project Number: 2014/68, 200500978. Unpublished study
          j prepared by Covance Laboratories, Ltd. 65 p.
           Herbold, B. (2003) AE C657378 Micronucleus - Test on the Male Mouse.
           Project Number: T/3072950, 200500981. Unpublished study prepared by
           Bayer Ag Inst. of Toxicology. 47 p.
08-Dec-
 2005
08-Dec-
 2005
 46708631
           Brendter-Schwaab, S. (2004) AE C657378 (Project AE 638206)
           Unscheduled DNA Synthesis Test with Rat Liver Cells in Vivo. Project
           Number: T/3073210, 200500983. Unpublished study prepared by Bayer
           Ag Inst. of Toxicology. 37 p.
 46708632
           Weller, O.; Ries, S. (2002) Mass Spectroscopic Identification of
           Metabolites in Urine Samples of the Rat Metabolism Study Following
           Administration of a Single Oral Low Dose (Substudy of the Mass
{          J Spectroscopic Part of Study SA00550). Project Number: SA0055/MS,
{          { 200500985. Unpublished study prepared by Aventis Crop Science. 165 p.

[          | Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711 (BAM): Single
| 46708633  Oral High Dose A.D.M.E. Study in the Rat. Project Number: SA/02327,
{           200500987. Unpublished study prepared by Bayer Cropscience. 97 p.

I          | Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711 (BAM): Single
| 46708634 j Oral Low Dose A.D.M.E. Study in the Rat. Project Number: SA02156,
{          | 200500986. Unpublished study prepared by Bayer Cropscience. 83 p.

|           Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711: Repeat Oral
I 46708635  Low Dose A.D.M.E. Study in the Rat. Project Number: SA/03018,
{           200500988. Unpublished study prepared by Bayer Cropscience. 94 p.
08-Dec-
 2005
08-Dec-
 2005
                                                                             08-Dec-
                                                                              2005
          j Gutierrez, L. (2002) (Pyridyl-2,6-(Carbon 14))-AE C657188 (PCA): Single
 46708636 | Oral Low Dose Rat A.D.M.E. Study. Project Number: SA/01093,
          | 200500989. Unpublished study prepared by Bayer Cropscience. 77 p.
                                                                             08-Dec-
                                                                              2005
                                         38

-------
 46708637
Cage, S. (2003) (Carbon 14))-EXP 11120A Comparative in Vitro Dermal
Penetration Study Using Human and Rat Skin. Project Number:
BAG/368/033121, 200500990. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 93 p.
r~
 46708638
Kemp, L. (2003) (Carbon 14) - EXP 11120A in Vivo Dermal Absorption in
the Male Rat. Project Number: BAG/367/033193, 200500991.
Unpublished study prepared by Huntingdon Life Sciences, Ltd. 120 p.
08-Dec-
 2005
08-Dec-
 2005
 46708639
Weller, O.; Ries, S. (2002) Mass Spectroscopic Identification of Three
Metabolites in an Urine Sample of the Rat Metabolism Study Following
Administration of a Single Oral Dose (Supplementary Substudy of the
Mass Spectroscopic Part of Study SA00550). Project Number:
SA005500/MS1, 200500984. Unpublished study prepared by Huntingdon
Life Sciences, Ltd. 21 p.
 46708640
Wustner, D. (2005) Worker Reentry Exposure and Risk Assessment of
Fluopicolide Fungicide Applied to Agricultrual Crops and Turf. Project
Number: V/RE/1, 200500266. Unpublished study prepared by Valent
U.S.A. Corporation. 13 p.
r~
          I Mackie, S. (2004) AE C638206: Dissipation of Dislodgeable AE C638206
          | Foliar Residues from Leaf Lettuce Resulting from Foliar Applications of
 46708641 j EXP 11067B Under Maximum Proposed Label Specifications. Project
          j Number: 200500994, 02CU27806. Unpublished study prepared by Central
          j California Research Laboratories. 180 p.
08-Dec-
 2005
08-Dec-
 2005
                                                                  08-Dec-
                                                                   2005
 46708642
Wustner, D. (2005) Handler Exposure and Risk Assessment of
Fluopicolide Fungicide Applied to Agricultural Crops, Ornamentals and
Turf. Project Number: V/MLA/1, 200500264. Unpublished study prepared
by Valent U.S.A. Corporation. 16 p.
           Wustner, D. (2005) Reentry Exposure and Risk Assessment of
 4R7r)oR4o j Fluopicolide Fungicide After Application to Residential Turf. Project
          I Number: V/RE/2, 200500265. Unpublished study prepared by Valent
          j U.S.A. Corporation. 12 p.
08-Dec-
 2005
                                                                  08-Dec-
                                                                   2005
          j Renaud, D. (2003) AE C638206 Henry's Law Constant Calculation Code:
 46708644 | AE C638206. Project Number: C/037664, 200501008. Unpublished study
          I prepared by Bayer Cropscience. 7 p.
46708645
1
46708646
Lechelt-Kunze, C. (2003) AE C638206 Technical: Effects on Survival,
Growth and Reproduction on the Earthworm Eisenia fetida Tested with 5%
Peat in the Test Substrate. Project Number: E/31 2/2368/5, 200500269.
Unpublished study prepared by Bayer Ag, Institute of Product Info. &
Residue Anal. 37 p.
Assaf, N. (2005) Chronic Dietary and Drinking Water Exposure Analyses
for Fluopicolide. Project Number: VP/29591, 200500229. Unpublished
study prepared by Valent U.S.A. Corporation. 31 p.
08-Dec-
2005
08-Dec-
2005
 46708647
 46708648
Repetto-Larsay, M. (2004) Evaluation of Potential Dermal Sensitization in
the Local Lymph Node Assay. Project Number: SA/04239, 200500945.
Unpublished study prepared by Bayer Cropscience. 41 p.

Assaf, N. (2005) Fluopicolide PRZM/EXAMS Modeling. Project Number:
VP/29680, 200500230. Unpublished study prepared by Valent U.S.A.
Corporation. 227 p.
08-Dec-
 2005
08-Dec-
 2005
                                          39

-------
 46708649
          Young, B.; Abedi, J. (2003) Effect of Pseudokirchneriella subcapitata
          (Green Alga) in a Growth Inhibition Test AE C638206 Technical 97.1%
          w/w. Project Number: 02CU28565, 200500910. Unpublished study
          prepared by Bayer Enivronmental Science. 52 p.
r~
          j Hungtingdon Life Sciences Ltd. (2000) Rabbit Skin Irritancy AE C638206.
 46708650 j Project Number: TOX/99326, 200500962. Unpublished study prepared by
          | Huntingdon Life Sciences, Ltd. 17 p.
08-Dec-
 2005
                                                                             08-Dec-
                                                                              2005
          | Herbold, B. (2004) AE C638206 SC 480 Micronucleus - Test on the Male
 46708651 j Mouse. Project Number: T/8073224, 200500992. Unpublished study
           prepared by Bayer Ag Inst. of Toxicology. 46 p.
                                                                             08-Dec-
                                                                              2005
 46709800
          Valent U.S.A. Corporation (2005) Submission of Product Chemistry and
          Toxicity Data in Support of the Application for Registration of V-10162
          Premix. Transmittal of 8 Studies.
08-Dec-
 2005

          I Taylor, E. (2005) Physical and Chemical Properties of V-10162 Premix.
 46709801 | Project Number: 200500274, 2005/10162PM/SC. Unpublished study
           prepared by Valent U.S.A. Corporation. 11 p.
                                                                             08-Dec-
                                                                              2005
 46709802
r~
 46709803
          Taylor, E. (2005) Product Identity and Composition, Description of
          Materials Used to Produce the Product, Description of Production
          Process, Description of the Formulation Process, Preliminary Analysis,
          Certified Limits, Enforcement Analytical Method, and Submittal of Samples
          for V-10162 Premix. Project Number: 200500248, 2005/10162PM/001.
          Unpublished study prepared by Valent U.S.A. Corporation. 75 p.
08-Dec-
 2005
           Krotlinger, F. (2003) AE B066752 04 SC61 A1-EXP11120B Study for
           Acute Oral Toxicity in Rats. Project Number: T8072207. Unpublished
           study prepared by Bayer Ag Inst. of Toxicology. 32 p.
08-Dec-
 2005
 46709804
 46709805
           Krotlinger, F. (2003) AE B066752 04 SC61 A1-EXP11120B Amended
           Study for Acute Dermal Toxicity in Rats. Project Number: 200500955,
           T/1072219. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
           33 p.
08-Dec-
 2005
           Pauluhn, J. (2003) AE C638206 & Propamocarb SC 62.5 + 625 Study on
           Acute Inhalation Toxicity in Rats According to OECD No. 403. Project
           Number: 200500957, T6072223. Unpublished study prepared by Bayer Ag
           Inst. of Toxicology. 68 p.
08-Dec-
 2005
         j Griffon, B. (2002) Acute Eye Irritation in Rabbits. Project Number:
46709806 ] 200500960, 24685. Unpublished study prepared by Centre International
         | de Toxicologie. 19 p.
                                                                              08-Dec-
                                                                               2005
          j Griffon, B. (2003) Acute Dermal Irritation in Rabbits. Project Number:
 46709807 j 200500963, 24684. Unpublished study prepared by Centre International
          | de Toxicologie. 18 p.
46709808
46709900
46709901
Griffon, B. (2003) Skin Sensitization Test in Guinea Pigs (Modified Buehler
Test: 9 Applications). Project Number: 200500966, 246686/TSG.
Unpublished study prepared by Centre International de Toxicologie. 36 p.
{ Valent U.S.A. Corporation (2005) Submission of Product Chemistry and
| Toxicity Data in Support of the Application for Registration of V-10161 4
| SC. Transmittal of 8 Studies.
f
! Taylor, E. (2005) Physical and Chemical Properties of V-10161 4 SC.
08-Dec-
2005
08-Dec-
2005
08-Dec-
                                          40

-------
           Project Number: 2005/01061/SC. Unpublished study prepared by Valent
           U.S.A. Corporation. 12 p.
46709902
j Taylor, E. (2005) Product Identity and Composition, Description of
j Materials Used to Produce the Product, Description of Production
j Process, Description of Formulation Process, Preliminary Analysis,
j Certified Limits, Enforcement Analytical Method, and Submittal of Samples
| for V-10161 4 SC. Project Number: 2005/161/001. Unpublished study
| prepared by Valent U.S.A. Corporation. 217 p.
                                                                      2005
                                                                    08-Dec-
                                                                      2005
          | Krotlinger, F. (2003) AE C638206 00 SC40 A2-EXP11067B Study for
46709903 | Acute Oral Toxicity in Rats. Project Number: T/6072205. Unpublished
          j study prepared by Bayer Ag Inst. of Toxicology. 25 p.
                                                                    08-Dec-
                                                                      2005
          j Krotlinger, F. (2005) AE C638206 00 SC40 A2-EXP11067B Study for
46709904 j Acute Dermal Toxicity in Rats. Project Number: T/9072217. Unpublished
          I study prepared by Bayer Ag Inst. of Toxicology. 25 p.

          j Pauluhn, J. (2003) AE C638206 SC 480 Study on Acute Inhalation
46709905 j Toxicity in Rats According to OECD No. 403. Project Number: T/1072200.
          j Unpublished study prepared by Bayer Ag Inst.  of Toxicology. 71 p.

                                                                    08-Dec-
                                                                      2005
46709906 < Griffon' B- (2003) Acute Irritation in Rabbits. Project Number: 24679.
j Unpublished study prepared by Centre International de Toxicologie. 20 p.
08-Dec-
2005
46709907
 Griffon, B. (2003) Acute Dermal Irritation in Rabbits. Project Number:
 24678/TAL. Unpublished study prepared by Centre International de
 Toxicologie. 18 p.
          j Griffon, B. (2003) Skin Sensitization Test in Guinea Pigs (Modified Buehler
46709908 j Test: 9 Applications). Project Number: 24680TSG. Unpublished study
           prepared by Centre International de Toxicologie. 32 p.
                                                                    08-Dec-
                                                                      2005
46745700
46745701
 Valent U.S.A. Corp. (2006) Submission of Toxicity Data in Support of the
 Petition for Tolerance of Fluopicolide for Use on Grapes and Raisins.
 Transmittal of 4 Studies.
                                                                     30-Jan-
                                                                      2006
 Payraudeau, V. (2005) Historical Control Data for Functional
 Observational Battery (FOB) and Motor Activity in CD Rats. Project
 Number: VP/02/12/05, 200600004. Unpublished study prepared by Bayer
 Cropscience and Huntingdon Life Sciences, Ltd. 15 p.
                                                                     30-Jan-
                                                                      2006
46745702
 Fowles, J. (2005) Historical Control Data for Long-Term Studies in C57bl/6
 Mice. Project Number: JRF/24/10/05, 200600003. Unpublished study
 prepared by Bayer Cropscience. 10 p.
                                                                     30-Jan-
                                                                      2006
46745703
j Fowles, J. (2005) Historical Control Data for Neoplasms in Long-Term
j Studies in CD Rats. Project Number: JRF/14/10/05, 200600001.
j Unpublished study prepared by Bayer Cropscience and Huntingdon Life
j Sciences, Ltd. 27 p.
46745704
 Fowles, J. (2005) Historical Control Data for Survival in Long-Term
 Studies in CD Rats. Project Number: JRF/25/10/05, 200600002.
 Unpublished study prepared by Bayer Cropscience and Huntingdon Life
 Sciences, Ltd. 9 p.
                                                                     30-Jan-
                                                                      2006
                                                                     30-Jan-
                                                                      2006
          j Valent U.S.A. Corporation (2006) Submission of Product Chemistry,
46821400 | Residue, Environmental Fate and Toxicity Data in Support of the
          j Registration of Fluopicolide Technical. Transmittal of 1 Study.
                                                                     24-Apr-
                                                                      2006
                                          41

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 46821401
Council Directive (2005) Report and Proposed Decision of the United
Kingdom Made to the European Commission Under Article 8(1) of
91/414/EEC. Project Number: 200600102. Unpublished study prepared by
Council Directive. 1321  p.
{          j Valent USA Corporation and Interregional Research Project No. 4 (2006)
{          | Submission of Residue Data in Support of the Application for Registration
| 47021700 j ofV-10161 4 SC and the Petitions for Tolerance of Fluopicolide for Use on
!          j Broccoli, Cabbage, Onion, Radish, Carrot, and Sugar Beet. Transmittal of
I          ! 7 Studies.
24-Apr-
 2006
                                                                  29-Dec-
                                                                   2006
 47021701
 47021702
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Broccoli
RAC Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33136.
Unpublished study prepared by Pyxant Labs Inc. 204 p.
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Cabbage
RAC Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33137.
Unpublished study prepared by Pyxant Labs Inc. 221 p.
r~
 47021703
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in Onion RAC
Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU27780.
Unpublished study prepared by Pyxant Labs Inc. 310 p.
29-Dec-
 2006
29-Dec-
 2006
29-Dec-
 2006
 47021704
 47021705
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Radish
RAC Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33129.
Unpublished study prepared by Pyxant Labs Inc. 306 p.
29-Dec-
 2006
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Carrot
RAC Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33130.
Unpublished study prepared by Pyxant Labs Inc. 211 p.

29-Dec-
 2006
 47021706
Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in Sugar Beet
RAC Resulting from Foliar Applications of EXP 11067B under Maximum
Proposed Label Specifications (2002). Project Number: 02CU33131.
Unpublished study prepared by Pyxant Labs Inc. 324 p.
          j Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Sugar Beet
          j Processing Fractions Resulting from Foliar Applications of EXP 11067B
 47021707  under 5X Maximum Proposed Label Specifications (2002). Project
          | Number: 02CU34312. Unpublished study prepared by Pyxant Labs Inc.
          I 312 p.
29-Dec-
 2006
                                                                  29-Dec-
                                                                   2006
                                                                           T
          j Valent USA Corporation. (2007) Submission of Environmental Fate Data
 47040400 j in Support of the Application for Registration of Fluopicolide Technical.
          j Transmittal of 1 Study.
 47040401
 47073700
Rupprecht, J. (2003) The Adsorption Desorption of AEC638206 in US and
European Soils. Project Number: CU99E512, 200500847. Unpublished
study prepared by Bayer Cropscience Lp. 77 p.

Valent U.S.A. Corporation (2007) Submission of Residue Data in Support
of the Application for Registration of Fluopicolide Technical. Transmittal of
1 Study.
                                                                  29-Jan-
                                                                   2007
29-Jan-
 2007
08-Mar-
 2007
                                          42

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 47073701
 Schreier, T. (2007) Tolerance Enforcement Method for the Analysis of
 Residues of Fluopicolide in/on Crops: Method RM-43C-2. Project Number:
 METHOD/RM/43C/2. Unpublished study prepared by Valent U.S.A.
 Corporation. 22 p.
r~
 47240600
j Valent USA Corporation (2007) Submission of Product Chemistry and
| Residue Data in Support of the Applications for Registration of
j Fluopicolide Technical, V 10161 4 SC, V 10161 VPP Fungicide, V 10162
j Premix, V 10162 VPP Fungicide and the Petition for Tolerance of
j Fluopicolide and Propamocarb hydrochloride for Use on Cereals.
j Transmittal of 1 Study.
08-Mar-
 2007
26-Sep-
 2007
 47240601
i Billian, P.; Schoning, R. (2007) Storage Stability of AE C638206 and its
j Metabolites AE C657378 (3/OH/BAM), AE C653711 (BAM) and AE
j 1344122 (P1x) in/on Cereals (Rest of Plant, Grain, Straw) for 25 Months,
j Plus 41 Month Addendum. Project Number: 200700330, MR/178/04,
| P642034707. Unpublished study prepared by Valent USA Corporation. 58
IP-
26-Sep-
 2007
 Total Rows: 328
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