UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Pesticide Fact Sheet
Name of Chemical: Metconazole
Reason for Issuance: Registration
Date Issued: September, 2007
1. Description of Chemical
Chemical Name: 5-[(4-Chlorophenyl)methyl]-2,2-dimethyl-l-(l//-l,2,4-triazol-l-
ylmethyl)cyclopentanol
Common Name:
Metconazole
Chemical Formula:
cis-Metconazole
trans-Metconazole
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EPA PC Code:
125619
Chemical Abstracts
Service (CAS) Number:
Year of Initial
Registration:
Pesticide Type:
Chemical Class:
U.S. Producer:
125116-23-6
2007
Fungicide
Sterol biosynthesis inhibitor - DMI-Fungicide
Kureha Corporation and Valent USA
II. Use Patterns and Formulations
Application Sites: Turf and ornamentals
Types of Formulations: Metconazole Technical (72078-1)
V-10116 VPP Fungicide (59639-144)
Application Methods
And Rates: Metconazole may be applied at an application rate of 0.25 to 0.6 Ib
a.i./A per year. It may be applied by ground spray only.
III. Physical and Chemical Properties:
Table 1 - Physical and Chemical Properties of Metconazole
Table 1. Physicochemical Properties of the Technical Grade Metconazole
Parameter
Molecular Weight
Melting point/range
PH
Relative density (20°C)
Water solubility (20°C)
Value
319.837
100.0-108.4°C (using Electrothermal Digital Melting
Point Apparatus) (AC900,768 technical grade)
No data were submitted.
1.14 (relative density to water at 4 deg C, using capillary-
stoppered, density-specific gravity bottle) (Lot No. AC
8879-140B)
Using shake flask method:
18.7±1.0 mg/L (cw-isomer, WL148271, KNF-S-474m)
13.6±1.7 mg/L (trans-isomer, WL148271, KNF-S-474m)
Reference
44721503
44721505
44721505
44721505
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Table 1. Physicochemical Properties of the Technical Grade Metconazole
Parameter
Solvent solubility (g/L) at 20°C
Vapor pressure (20°C)
Dissociation constant (pKa)
Octanol/water partition coefficient Log (Kow)
UV/visible absorption spectrum
Value
hexane: 1.40
toluene: 103
2-propanol: 132
ethyl acetate: 260
dichloromethane:481
methanol: 403
acetone: 363
Using gas-saturation method at 20°C:
< 1.23xlO'5 Pa or 9.23 x 10'8 mm Hg (AC 900,768)
< 1.04xlO'5 Pa or 7.80 x 10'8 mm Hg (cw-isomer, CL
354,801)
< 1.96X10'6 Pa or 1.47 x 10'8 mm Hg (trans-isomer, CL
354,802)
11.38±0.03 and 1.06±0.03 (in water using
spectrophotometric method) (Lot No. AC 8879-140B)
Kow (log Kow) = 7090±989 (3.85) (using flask shaking
method) (Lot No. AC 8879-140B) (TGAI)
KOW (log KOW) = 7150±803 (3.85) (using flask shaking
method) (cw-isomer, CL 354,801)
KOW (log KOW) = 6800±1700 (3.8) (using flask shaking
method) (/raws-isomer, CL 354,802)
Not required for TGAI; required for pure active ingredient
Reference
44721505
44721505
44721505
44721505
IV. HUMAN HEALTH RISK ASSESSMENT
A. Toxicity
1. Acute Toxicity: Metconazole has low or minimal acute toxicity via the oral
(Category III-IV), dermal (Category III), and inhalation routes of exposure (Category
IV). It is moderately irritating to the eye (Category III), and minimally irritating to
the skin (Category IV); it is not a skin sensitizer.
Table 2 - Acute Toxicity
Table A.2 Acute Toxicity Profile - Metconazole Technical
Guideline No.
870.1100
870.1100
870.1100
Study Type
Acute oral [mouse]
Acute oral [rat]
Acute oral [rat]
MRID(s)
44721512
44721512
44721513
Results
LD50 = >566
mg/kg
LD50 = >566
mg/kg
LD50 = >1459
mg/kg
Toxicity
Category
III
III
III
-------
870.1100
870.1200
870.1200
870.1200
870.2400
870.2500
870.2600
Acute oral [rat]
Acute dermal [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
Acute eye irritation [rat]
Acute dermal irritation
[rabbit]
Skin sensitization
[guinea pig]
44721514
44721512
44721512
44721512
44721513
44721513
44721513
LD50 = >5000
mg/kg
Dermal LDso >
2000
Dermal LDso >
2000
LD50 = >5.6
mg/L
moderate irritant
mild irritant
neg.
IV
III
III
IV
III
IV
-------
2. Subchronic Toxicity: A 28-day oral toxicity study in rats showed decreased body
weight gain and food consumption at 1000 and 3000 ppm, as well as effects on blood
cells, increased liver enzyme levels, decreased glucose and decreased cholesterol
levels at 3000 ppm. Increased liver, spleen, and kidney weights were observed at
1000 and 3000 ppm. Increased fatty vacuolation and hepatocellular hypertrophy at
1000 and 3000 ppm were also observed, indicating that the liver is the primary target
organ for metconazole toxicity. 90-day oral toxicity studies in rat and mouse showed
similar effects, with hisotpathological changes again demonstrating that the liver is
the primary target organ for metconazole. A 90-day oral toxicity study in dogs
showed a decrease in food consumption at 600 ppm in females, and at 6000 ppm in
males, with a corresponding decrease in body weight gain. All dogs at the high (6000
ppm) dose had cataracts by the end of the study. Effects on blood cells were
observed in males at 600 ppm, and in both sexes at 6000 ppm. High dose animals also
showed histopathological changes in the liver, kidney, and spleen. Subchronic dermal
exposure in rats (21 days) did not result in effects on body weight gain, food
consumption, eyes, hematology, or blood chemistry. Liver weights were increased in
females at 500 ppm, and in both sexes at 1000 ppm, as well as decreased thymus
weights in males at 500 and 1000 ppm, but these were not considered adverse since
the histopathology of these organs was normal.
3. Chronic Toxicity: A chronic toxicity study in rats showed increased liver weights
in males at 12 months and in females at 24 months, as well as an increase in females'
spleen weights at 24 months at doses of 13.1 mg/kg/day in males and 53.8 mg/kg/day
in females. Increased hepatocellular lipid vacuolation and centrilobular hypertrophy
in both males and females at these doses. A chronic toxicity study in dogs showed a
decrease in body weight gain during the first 13 weeks in males, increased incidence
of Kupffer cell pigmentation in females, and increased alkaling phosphatase activity
in both sexes at 38.5 and 36.8 mg/kg/day in males and females, respectively.
4. Carcinogenicity: There were no treatment-related increases in tumors in rat and
mouse carcinogenicity studies after exposure to metconazole.
5. Developmental Toxicity/Developmental Neurotoxicity: A pre-natal development
study in rats showed reduced maternal food consumption at 30 and 75 mg/kg/day,
correlating with poor weight gain, but no increase in pre-implantation loss. Post-
implantation loss was significantly increased at 75 mg/kg/day, and an increase in fetal
visceral abnormalities was also seen at this level. An increase in skeletal
abnormalities, including extra lumbar ribs, cervical ribs and extra pre-sacral
vertebrae, was observed at 30 and 75 mg/kg/day. A pre-natal development study in
rabbits showed a reduction in maternal body weight gain at 40 mg/kg/day, again
corresponding to a decrease in food consumption. An increase in maternal liver
weight was also seen at that dose, along with decreased red blood cell parameters and
increased alkaline phosphatase levels. The 40 mg/kg/day dose also showed increased
fetal resorptions and a slight decrease in fetal body weight.
There was no evidence of neurotoxicity observed in the toxicology database.
-------
6. Reproductive Toxicity: An acceptable new two-generation reproduction study in
rats (MRID 46808447) using cis/trans metconazole was submitted and reviewed by
HED. This study replaces the two-generation reproduction study with cis-only
metconazole (MRID 44721608) that was used in the human health risk assessment for
proposed tolerance on imported bananas (Memo Date: 7/06/06). In the new study,
parental systemic toxicity was evident at 750 ppm, and included decreased body
weight and decreased weight gain in male and female parental animals, increased
incidence of fatty hepatocyte change in male parental animals, and increased
incidence of spleen congestion in FI parental females. Offspring toxicity was also
evident at 750 ppm as decreased viability index on lactation day 0 and reduced body
weight in F2 offspring. Reproductive toxicity was evident at 750 ppm as prolonged
duration of gestation and decreased gestation index driven by dystocia (maternal
deaths during delivery).
Available evidence (two developmental toxicity studies and one two-generation
reproductive toxicity study) suggest there is no concern for pre- and/or post-natal
toxicity resulting from exposure to metconazole, because the pre and postnatal effects
observed in rats and rabbits occurred only at maternally toxic dose levels.
7. Metabolism: Metabolism studies in rats indicated that metconazole is excreted
primarily in the feces with greater than 90% of the administered dose excreted by
three days post-dosing. Biliary excretion is the major route of elimination. Plasma
kinetic studies show a low potential for bioaccumulation following single or multiple
dosing regimens and the plasma half-life of low- and high-dose rats was slightly
shorter in males than females. In an experiment in which the triazole ring was labeled,
a single high (200 mg/kg) dose of metconazole showed approximately 5% of the
parent compound was excreted as free triazole.
8. Mutagenicity: There is no mutagenicity concern for metconazole. When the
genotoxic potential of metconazole was tested in several in vitro and in vivo
mutagenicity assays, all tests were negative with the exception of the chromosomal
aberration assay (in the presence of S-9 mix (metabolic activation)). Overall,
metconazole is considered to be non-genotoxic.
9. Toxicology Profile: The toxicological profile for metconazole is discussed in Table
3 below:
Table 3 - Toxicology Profile
Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
870.3100
Study Type
MRID No. (year)/
Classification /Doses
44721515(1990)
Results
NOAEL(M/F) = 9.1/10.1
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
870.3100
870.3100
870.3150
870.3150
Study Type
28-Day oral
toxicity rodents
(rat)
90-Day oral
toxicity rodents
(rat)
90-Day oral
toxicity rodents
(mouse)
28-Day oral
toxicity
non-rodents (dog)
90-Day oral
toxicity non-rodents
MRID No. (year)/
Classification /Doses
M/F: 0, 30, 100, 1000,
3000 ppm
M:0, 2.7, 9.1,90.5,
261.1 mg/kg/day
F: 0,3.1, 10.1,97,287.4
mg/kg/day
Acceptable/guideline
44721517(1991)
M/F: 0, 30, 100, 300,
1000, 3000 ppm
M:0, 1.94,6.4, 19.2,
64.3, 192.7 mg/kg/day
F:0, 2.1,7.2, 22.1,71.4,
208.0 mg/kg/day
Acceptable/guideline
44721519(1991)
M/F: 0, 30, 300, 3000
(wkl)/2000(wk2-13)
ppm
M:0, 9.58, 50.5, 341.1
mg/kg/day
F: 0, 6.94, 60.7, 438.5
mg/kg/day
Acceptable/guideline
44721520(1991)
M/F: 0, 100, 1000, and
7000-10000 ppm in diet
Unacceptable/non-
guideline (some
preliminary test data
provided)
44721521 (1991)
M/F: 0, 60, 600, 6000
Results
mg/kg/day
LOAEL (M/F) = 90.5/97
mg/kg/day based on depression
of body weight in M, liver and
kidney weight increases with
associated histopathological
effects (hypertrophy and fatty
vacuolation) in liver only.
NOAEL (M/F) = 6.4/7.2
mg/kg/day
LOAEL (M/F) = 19.2/22.1
mg/kg/day based on increased
spleen weight in females and
hepatic vacuolation in males.
NOAEL (M/F) = 9.58/6.94
mg/kg/day
LOAEL (M/F) = 50.5/60.7
mg/kg/day based on increase in
absolute and relative liver
weights, hepatocellular
hypertrophy and vacuolation, and
increase in relative spleen weight
(F), elevated AST and ALT
activity.
NOAEL (M/F) = 100 ppm in diet
LOAEL (M/F) = 1000 ppm in
diet (increase in relative and
absolute thyroid wt. in one/two
females)
Deficiencies: low n (2M/2F per
dose); decrease in food
consumption means low
exposure to test compound;
actual dose received per dose
group not provided.
NOAEL (M/F) = 2.5/2.6
mg/kg/day
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
Study Type
MRID No. (year)/
Classification /Doses
Results
(dog)
ppm in diet
M: 0, 2.5, 24.4, 225.2
mg/kg/day
F: 0, 2.6, 24.3, 206.6
mg/kg/day
Acceptable/guideline
LOAEL (M/F) = 24.4/24.3
mg/kg/day based on decreased
food consumption and body
weight gain in females and
elevated platelets and
reticulocytes in males.
870.3200
21-day Dermal
Toxicity
46808439 (2006)
0, 250, 500, 1000
mg/kg/day
Acceptable/guideline
NOAEL: lOOOmg/kg
LOAEL: > 1000 mg/kg
No evidence of dermal toxicity
870.6200
Subchronic (13-
week) Oral
Neurotoxicity- rat
46808440(2002)
0,50, 170, 500 ppm
M: 0,4.84, 15.69,47.08
mg/kg/day
F: 0,5.10, 17.62,49.82
mg/kg/day
Acceptable/Non-
guideline
Systemic NOAEL (M/F) =
4.84/5.10 mg/kg/
Systemic LOAEL (M/F) =
15.69717.62 mg/kg/ based on
decreases in body weight and
food consumption.
Neurotoxicity NOAEL (M/F) >
47.08/49.82 mg/kg/day
870.3700
Prenatal
development in
rodents (rat)
44721522(1991)
0, 12, 30, 75 mg/kg/day
Gavage
Acceptable/Guideline
Maternal NOAEL =12
mg/kg/day
LOAEL = 30 mg/kg/day based
on decrease in body weight gain.
Developmental NOAEL = 12
mg/kg/day
LOAEL = 30 mg/kg/day based
on increased incidence of
skeletal variations
(predominantly lumbar ribs).
870.3700
Prenatal
development in
rodents (rat)
46808443(2002)
0, 1,4, 16, 64 mg/kg/day
Gavage
Acceptable/Guideline
Maternal NOAEL= 16
mg/kg/day
LOAEL= 64 mg/kg/day based on
decreased body weight and food
consumption, increased placental
weight and increased incidence
of swollen placentae
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
Study Type
MRID No. (year)/
Classification /Doses
Results
Developmental NOAEL= 16
mg/kg/day
LOAEL= 64 mg/kg/day based on
based on an increase in early and
late resorptions, decreased fetal
body weight and increased
incidence of incomplete
ossification of sternebrae.
870.3700
Prenatal
developmental in
non-rodents (rabbit)
Definitive Study
44721602 (1997)
0, 5, 10, 20, 40
mg/kg/day gavage
Acceptable/Guideline
Maternal NOAEL = 20
mg/kg/day
LOAEL = 40 mg/kg/day based
on reductions in body weight
gain, food consumption, and
changes in various hematology
parameters (reductions in
hematocrit, hemoglobin, mean
corpuscular volume and
increases in platelet counts and
alkaline phosphatase activity).
Developmental NOAEL = 20
mg/kg/day
LOAEL = 40 mg/kg/day based
on increases in post-implantation
losses.
870.3700
Prenatal
developmental in
non-rodents (rabbit)
44721603 (1991)
0, 4, 10, 25, 62.5
mg/kg/day (Exp. #1)
0,2,4, 10 mg/kg/day
(Exp. #2)
Acceptable/Guideline
Maternal NOAEL = 25
mg/kg/day
LOAEL = 62.5 mg/kg/day based
on body weight changes and
slight clinical signs
(anorexia/reduced or altered
fecal output, cold ears).
Developmental NOAEL = 4
mg/kg/day
LOAEL = 10 mg/kg/day based
on examining data from the two
experiments. Effects at 62.5
mg/kg/day show total litter loss,
decreased live fetuses, increased
early and late resorptions.
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
Study Type
MRID No. (year)/
Classification /Doses
Results
Effects at 25 mg/kg/day show
some malformations:
hydrocephaly (4 fetuses from 4
different litters, but NOT seen at
62.5 mg/kg/day) and limb effects
(2 fetuses from 2 different litters,
with one fetus with same effect
at 62.5 mg/kg/d). Hydrocephaly
and limb effects were observed
at 10 mg/kg/day in Experiment
#2, but not at that same dose in
Experiment #1.
870.3800
Reproduction and
fertility effects
2-generation- rat
46808447(2002)
0,30, 150 and 750 ppm
M/F: 0/0, 2/2, 10.8/10.6,
53.2/53.0 mg/kg/day
Acceptable/Guideline
Parental/Systemic NOAEL
(M/F) = 9.8/10.8 mg/kg/day
LOAEL (M/F) = 49.4/53.2
mg/kg/day based on: decreased
body weight and decreased
weight gain in male and female
parental animals, increased
incidence of fatty hepatocyte
change in male parental animals,
and increased incidence of spleen
congestion in Fl parental
females.
Reproductive NOAEL (M/F) =
>49.4/ 10.8 mg/kg/day
LOAEL (M/F) = 53.2 mg/kg/day
based on increased gestation
length and decreased gestation
index driven by dystocia
(difficult labor).
Offspring NOAEL (M/F) =
9.8/10.8 mg/kg/day
LOAEL (M/F) = 49.4/53.2
mg/kg/day based decreased
viability on lactation day 0 and
decreased body weight in F2
offspring.
870.4100a
Chronic toxicity
rodents (rat)
44721609(1992)
0, 10, 100, 300, 1000
NOAEL = (M/F) = 4.3/16.0
mg/kg/day
10
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
Study Type
MRID No. (year)/
Classification /Doses
Results
ppm
M: 0, 0.44, 4.3, 13.1,
43.9mg/kg/day
F: 0,0.52,5.3, 16.0,53.
mg/kg/day
Acceptable/Guideline
LOAEL = (M/F) = 13.1/ 53.8
mg/kg/day based on an increase
in mean adjusted liver weights at
12 months (M) and 24 months
(F), increase in spleen weights at
24 months (F), and increased
hepatocellular lipid vacuolation
(M/F) and centrilobular
hypertrophy (M/F).
870.4100b
Chronic toxicity-
dog
44721610
0, 30, 300, 1000, 3000
ppm in diet
M:0, 1.1, 12.0,38.5,
110.0 mg/kg/day
F:0, 1.1, 10.3,36.8,
113.7 mg/kg/day
Acceptable/Guideline
NOAEL (M/F) = 12.0/10.3
mg/kg/day
LOAEL (M/F) = 38.5/36.8
mg/kg/day based on decreased
body weight gain weeks 1-13
(males), increased alkaline
phosphatase activity (both sexes)
and increased incidence of
Kupffer cell pigmentation
(females).
870.4200
Carcinogenicity
rat
44721611 (1992)
0, 100,300, 1000 ppm
M: 0,4.6, 13.8,46.5
mg/kg/day
F: 0, 5.5, 16.6, 56.2
mg/kg/day
Acceptable/Guideline
Non-neoplastic findings at (M/F)
13.8/56.2 mg/kg/day: increased
incidence of hepatocellular lipid
vacuolation (M/F), centrilobular
hypertrophy (M/F), liver pigment
deposition (M), histiocytic foci
in the spleen (M/F),and increase
in severity of chronic renal
nephropathy (M). Evidence of
mononuclear cell leukemia (F).
870.4300
Carcinogenicity-
mouse
44721612(1992)
0,30,300, 1000 ppm
M:0, 4.5, 39.5, 166.9
mg/kg/day
F:0, 5.9, 58.1, 195.5
mg/kg/day
Acceptable/Guideline
Non-neoplastic findings at (M/F)
166.9/58.1 mg/kg/day: increase
in vacuolation, hypertrophy,
splenic atrophy and adrenal
corticomedullary pigmentation,
sinusoidal hypercellularity/single
cell necrosis. Neoplastic
findings: increase in liver cell
11
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
870.5500
870.5300
870.5375
870.5395
870.5550
Study Type
Salmonella
typhimurium and
Escherichia coll
Reverse Mutation
Assay
In vitro Mouse
Lymphoma
Mutagenesis Assay
WL136184*
*cis only isomer
In vitro
Cytogenetics Test
In vivo Mammalian
Erythrocyte
Micronucleus Test:
Mouse
In vivo/in vitro
Mammalian UDS
test
MRID No. (year)/
Classification /Doses
44721613 (1990)
Up to limit dose of 5000
ug/ plate (S.
typhimurium) and (E.
coli) in the presence and
absence of metabolic
activation
(+S9)
Acceptable/Guideline
44721615(1991)
Six doses up to 125
ug/ml (toxicity was
observed above that
dose) in the presence
and absence of metabolic
activation
(±S9)
Acceptable/Guideline
44721616(1991)
From 6.25 to 400 ug/ml,
with and without
metabolic activation (+
S9)
Acceptable/Guideline
44721618(1995)
Up to the limit dose of
2000 mg/kg
Acceptable/Guideline
44721620 (1995)
Up to the limit dose of
2000 mg/kg
Results
tumors at high dose (M/F):
Increased incidence of
hepatocellular adenomas in
males and hepatocellular
carcinomas in females.
Test material was not cytotoxic
with or without S9 activation in
five S. typhimurium strains and
one strain of E. coli, and did not
induce a genotoxic response in
any strain.
There was no evidence of
biologically significant induction
of mutant colonies.
Weakly positive (induced
chromosome aberrations in
Chinese hamster ovary cells) in
the presence of S9 activation,
negative without S9 activation.
There was no statistically
significant increase in the
frequency of mi cr enucleated
polychromatic erythrocytes in
mouse bone marrow at any dose
or collection time.
Negative for unscheduled DNA
synthesis.
12
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
870.7485
870.7485
870.7485
870.7485
870.7485
870.7485
Study Type
Rat
Metabolism and
pharmacokinetics:
rat
Metabolism and
pharmacokinetics:
rat
Metabolism and
pharmacokinetics:
rat
Metabolism and
pharmacokinetics:
rat
WL136184*
*cis only isomer
Metabolism and
pharmacokinetics:
rat
WL136184*
*cis only isomer
Metabolism and
pharmacokinetics:
rat
MRID No. (year)/
Classification /Doses
Acceptable/Guideline
44721622 (1992)
single high dose: 164
mg/kg
Radiolabel:
(cyclopentyl-14C)
Acceptable/Guideline
44721622 (1992)
single high dose: 164
mg/kg
Radiolabel:
(cyclopentyl-14C )
Acceptable/Guideline
44721623 (1991)
single low dose: 2 mg/kg
Radiolabel:
(cyclopentyl-14C)
Acceptable/Guideline
44721624(1991)
single high dose: 200
mg/kg (males only)
Radiolabel:
(Triazole - 14C)
Acceptable/Guideline
44721625 (1991)
single low dose: 2 mg/kg
Radiolabel:
(Cyclopentyl - 14C)
Acceptable/Guideline
46808449 (2002)
male/female rat
single low dose: 2 mg/kg
single high dose: 200
mg/kg
repeated dose: 2 mg/kg
Results
Approximately 94% of
radioactivity in excreta after five
days: feces (males - 81.3%,
females - 65.5%) and urine
(males - 13.6%, females - 28.4%)
Approximately 94% of
radioactivity in excreta after five
days: feces (males - 81.3%,
females - 65.5%) and urine
(males - 13.6%, females - 28.4%)
Approximately 94% of
radioactivity in excreta after 72
hrs: feces (males - 80%, females
- 67%) and urine (males - 14.8%,
females - 26%). Metabolite
information presented.
Approximately 96% of
radioactivity in excreta after
seven days: feces (76%) and
urine (20%). Metabolite
information presented.
Excretion/retention in bile-duct
cannulated rats. Approximately
80% of radioactivity was
excreted in the bile after 48 hrs:
males (78.7%) and females
(83.3%).
Low potential for
bioaccumulation following single
or multiple dosing regimen. The
time to maximum plasma
concentration for male and
female rats treated with either 2
mg/kg or 200 mg/kg was the
13
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Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1
Guideline
No.
870 748S
O / \J . 1 T"O~J
870.7600
Study Type
Effects on rat/mice
liver enzymes
WL136184*
*cis only isomer
14-day Mechanistic
Study
In Vivo Dermal
Penetration Study
MRID No. (year)/
Classification /Doses
Acceptable/Non-
guideline
44721626(1991)
0, 300 ppm in diet
(mice) and 0, 1000 ppm
in diet (rats) for seven
or 28 days
Acceptable/Non-
guideline
46665402 (2005)
0, 30, 300, 1000 ppm in
diet (mice) for 14 days.
F: 4.5, 48, 151
mg/kg/day
Acceptable/TVow-
guideline
46808450 (1990)
Acceptable/Non-
guideline
Results
earliest sampling interval, 0.25
hours and 4 hours, respectively
The plasma half-life of low- and
high-dose rats was slightly
shorter in males than females,
-20-25 hours and -34 hours,
respectively.
Increased liver weight,
cytochrome P450,
ethoxycoumarin O-deethylase,
ethylmorphine N-demethylase,
and lauric acid 1 1-hydroxylase in
both rats and mice. No effect on
ethoxyresorufm O-deethylase,
palmitoyl-CoA oxidation, or
peroxisome proliferation (in
terms of peroxisome number or
morphology).
Increased liver weight (300 and
1000 ppm); increased hepatic
drug metabolizing enzymes (300
and 1000 ppm) after 7 days;
enlarged livers (1000 ppm) at
days 3, 7 and 14; hepatic
hypertrophy and vacuolation
(300 and 1000 ppm) at day 14;
increased ALT and AST
activities at 1000 ppm (day 14);
increased lipid peroxide (300 and
1000) at day 14; increased
PCNA labeling at 1000 ppm at
day 3 and 7.
Dermal absorption= 16% (72
hrs)
1 cis/trans ratio is 85:15. All studies used cis/trans mixture unless otherwise noted.
14
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10. FQPA Hazard Considerations: The toxicology risk assessment team addressed the
potential enhanced sensitivity to infants and children as required by FQPA, in accordance with
the 2002 OPP lOx Guidance document, and recommended reducing the 10X FQPA Safety
Factor to IX for the dietary and residential risk assessments. The recommendation is based on
the following:
• There is no evidence of susceptibility following in utero exposure in the rat and rabbit
developmental toxicity studies and following both in utero and post-natal exposure in the
two-generation rat reproduction study.
• There is no evidence of increased susceptibility in the offspring based on the result of the
two-generation reproduction study.
• The residue levels used in the dietary assessment were the established tolerance levels for
banana, soybean commodities, and livestock commodities, and assumed 100% crop
treated (actions completed previously). Therefore, the acute and chronic dietary, food
only, exposure is considered an upper bound conservative estimate. The contribution
from drinking water is minimal. The Agency concludes that the acute and chronic
exposure estimates in this analysis are unlikely to underestimate actual exposure.
• The drinking water component of the dietary assessment utilizes water concentration
values generated by model and associated modeling parameters which are designed to
provide conservative, health protective, high-end estimates of water concentrations which
will not likely be exceeded.
• While there is potential for postapplication residential exposure, the best data and
approaches currently available were used in the metconazole residential assessment. The
Agency used the current conservative approaches for residential assessment. The Agency
believes that the calculated risks represent conservative estimates of exposure because
maximum application rates are used to define residue levels upon which the calculations
are based. Exposures are unlikely to be under estimated because the assessment was a
screening level assessment.
11. Toxicological Endpoints: A summary of the toxicological endpoints and doses chosen for
the relevant exposure scenarios for dietary and occupational human health risk assessments is
provided in the table below. The conventional interspecies extrapolation (10X) and
intraspecies variation (10X) uncertainty factors were applied for all exposure scenarios. As
stated above, the FQPA SF for increased susceptibility was reduced to IX for all exposures
scenarios. A summary of the toxicological endpoints are shown below in Table 4:
15
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Tables 4a and 4b ~ Summary of Toxicological Doses and Endpoints for Metconazole for
Use in Human Health Risk Assessments
Table 4a. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and
Non-Occupational Human Health Risk Assessments
Exposure/
Scenario
Acute Dietary
(General
Population,
including
Infants and
Children)
Acute Dietary
(Females 13-49
years of age)
Chronic
Dietary (All
Populations)
Incidental Oral
Short-Term (1-
30 days)
Incidental Oral
Intermediate-
Term (1-6
months)
Dermal Short-
Term (1-30
days)
Dermal
Point of
Departure
Uncertainty/FQ
PA Safety
Factors
RfD, PAD,
Level of
Concern for
Risk
Assessment
Study and Toxicological Effects
An appropriate dose/endpoint attributable to a single dose was not observed in the
available oral toxicity studies reviewed.
NOAEL=
12
mg/kg/day
NOAEL=
4.3
mg/kg/day
NOAEL=
9.1
mg/kg/day
NOAEL=
6.4
mg/kg/day
UFA= 10x
UFH= 10x
FQPA SF= Ix
UFA=10x
UFH= 10x
FQPA SF= Ix
UFA= 10x
UFH=10x
FQPA SF= Ix
UFA= 10x
UFH=10x
FQPA SF= Ix
Acute RfD =
0.12
mg/kg/day
aPAD=0.12
mg/kg/day
Chronic RfD =
0.04
mg/kg/day
cPAD = 0.04
mg/kg/day
Residential
LOC for MOE
= 100
Residential
LOC for MOE
= 100
Developmental toxicity in rats:
LOAEL= 30 mg/kg/day based on
increases in skeletal variations.
Chronic oral toxicity study in
rats: LOAEL =13.1 mg/kg/day
based on increased liver (M)
weights and associated
hepatocellular lipid vacuolation
(M) and centrilobular
hypertrophy (M). Same effects
seen in F at 54 mg/kg/day, plus
increased spleen wt.
28-Day oral toxicity study in
rats: LOAEL = 90.5 mg/kg/day
based on decreased body weight
(M), increased liver and kidney
weight and hepatocellular
hypertrophy and vacuolation
(M/F).
90-Day oral toxicity study in
rats: LOAEL = 19.2 based on
increased spleen wt (F) and
hepatic vacuolation (M).
Quantification of dermal risk is not required due to lack of systemic or dermal toxicity
at the Limit Dose in a 21 -day dermal toxicity study in the rat and the lack of target
organ toxicity, neurotoxicity, developmental or reproductive toxicity.
16
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Table 4a. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and
Non-Occupational Human Health Risk Assessments
Exposure/
Scenario
Intermediate-
Term (1-6
months)
Inhalation
Short- Term
(1-30 days)
Inhalation
Intermediate-
Term (1-6
months)
Cancer (oral,
dermal,
inhalation)
Point of
Departure
Uncertainty/FQ
PA Safety
Factors
RfD, PAD,
Level of
Concern for
Risk
Assessment
Study and Toxicological Effects
NOAEL=
9.1
mg/kg/day
NOAEL=
6.4
mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= Ix
UFA= 10x
UFH=10x
FQPA SF= Ix
Residential
LOC for MOE
= 100
Residential
LOC for MOE
= 100
28-Day oral toxicity study in
rats: LOAEL = 90.5 mg/kg/day
based on decreased body weight
(M), increased liver and kidney
weight and hepatocellular
hypertrophy and vacuolation
(M/F).
90-Day oral toxicity study in
rats: LOAEL =19.2 mg/kg/day
based on increased spleen wt (F)
and hepatic vacuolation (M).
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 date (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. LOC = level of concern. N/A = not applicable.
Table 4b. Summary of Toxicological Doses and Endpoints for Metconazole for Use in
Occupational Human Health Risk Assessments
Exposure/
Scenario
Dermal Short-
Term (1-30
days)
Dermal
Intermediate -
Term (1-6
months)
Inhalation Short-
Term (1-30
days)
Point of
Departure
Uncertainty
Factors
Level of Concern
for Risk
Assessment
Study and Toxicological Effects
Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the
Limit Dose in a 21-day dermal toxicity study in the rat and the lack of target organ toxicity,
neurotoxicity, developmental or reproductive toxicity.
NOAEL=9.1
mg/kg/day
UFA=10x
UFH=10x
Occupational LOC
for MOE =100
28-Day oral toxicity study in rats:
LOAEL = 90.5 mg/kg/day based on
decreased body weight (M),
increased liver and kidney weight and
hepatocellular hypertrophy and
17
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Table 4b. Summary of Toxicological Doses and Endpoints for Metconazole for Use in
Occupational Human Health Risk Assessments
Exposure/
Scenario
Inhalation
Intermediate-
term (1-6
months)
Cancer (oral,
dermal,
inhalation)
Point of
Departure
NOAEL=6.4
mg/kg/day
Uncertainty
Factors
UFA=10x
UFH=10x
Level of Concern
for Risk
Assessment
Occupational LOC
forMOE=100
Study and Toxicological Effects
vacuolation (M/F).
90-Day oral toxicity study in rats:
LOAEL =19.2 mg/kg/day based on
increased spleen wt (F) and hepatic
vacuolation (M).
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 (intraspecies). UFH = potential variation in sensitivity among members of the human
population (interspecies). 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 date (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
B. Dietary Exposure and Risk
1. Dietary Exposure from Food and Drinking Water: Acute and chronic dietary
(food and drinking water) exposure assessments were conducted for the proposed
uses on turf and ornamentals, and all registered food uses (imported bananas, and
Section 18 on soybeans), and drinking water. The residue levels used in the
assessment were the established tolerance levels for banana, soybean commodities,
and livestock commodities, and assumed 100% crop treated. Therefore, the dietary,
food only, exposure is considered an upper bound conservative estimate.
Estimated concentrations of metconazole in drinking water from the proposed uses on
turf and ornamentals were provided by EFED and incorporated directly into the acute
and chronic assessments.
A Tier II drinking water assessment for the proposed uses on turf and ornamentals
was performed using PRZM/EXAMS modeling with index reservoir (IR) scenarios
and percent cropped area (PCA) adjustment factors. For the acute assessment the 1 in
10 year annual peak concentration of metconazole in drinking water was used, and is
not expected to exceed 45.48 ug /L. For the chronic assessment, the 1 in 10 year
annual average concentration of metconazole in drinking water was used, and is not
expected to exceed 31.25 ug /L.
2. Aggregate Risk Exposures: Based on the proposed uses on turfgrass, and that fact
that common toxicity endpoints exist for the incidental oral, and acute and chronic
dietary routes of exposure, then acute, chronic, and short-term aggregate exposure and
risk assessments are required.
3. Acute Aggregate Risk: Acute aggregate exposures include food plus drinking water
exposures. The acute dietary exposure estimate at the 95th percentile is 2% aPAD for
18
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females 13-49 years old, the only population subgroup of concern, which is below the
Agency's level of concern.
4. Chronic Aggregate Risk: Chronic aggregate exposures include food plus drinking
water exposures. The chronic dietary (food and drinking water) exposure to
metconazole is below the Agency's level of concern for the general U.S. population
and all population subgroups. The chronic dietary exposure estimates are 4% cPAD
for the general U.S. population and 10% cPAD for all infants (<1 year old), the most
highly exposed population subgroup.
5. Short- and Intermediate Term Aggregate Risk: Dietary, incidental oral and
inhalation routes of exposure have the same toxicity endpoints, and therefore, can be
aggregated. The short- and intermediate-term aggregate risk assessments take into
account average (chronic) exposure estimates from dietary consumption of
metconazole (food and drinking water) and non-occupational/residential use on turf
(dermal for adults, and dermal plus incidental oral for children). Postapplication
exposures from the use on turf are considered predominantly short-term (1-30 days).
Although exposures are expected via the dermal route, quantification of dermal risk is
not required, since a dermal endpoint was not identified for short-, or intermediate-
term exposures. Therefore, short- and intermediate-term postapplication aggregate
risk assessments were conducted only for average dietary and incidental oral
exposures to toddlers.
The short-and intermediate-term aggregate MOEs from dietary exposure (food +
drinking water) and non-occupational/residential handler exposure (inhalation) for
adults are 3,000 and 2,900, respectively; which are not of concern, since they are
greater than the level of concern MOE of 100. The short-and intermediate-term
aggregate MOEs from dietary exposure (food + drinking water) and non-
occupational/residential exposure (incidental oral) for children 1-2 years old are 470
and 520, respectively; which are not of concern, since it is greater than the level of
concern MOE of 100.
These aggregate exposure assessments are considered conservative estimates, that
should not underestimate risks, because of the following inputs: 1) dietary inputs used
crop specific (turf) screening level drinking water modeling data (i.e., Tier II surface
water model); 2) maximum application rates and minimum application intervals were
used; and 3) conservative SOPs and upper level estimates of exposure were employed.
6. Cancer Aggregate Risk: There were no treatment-related tumors observed in
carcinogenicity studies in rats and mice. As a result, a cancer assessment was not
conducted.
7. Cumulative Risk: Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider
"available information concerning the cumulative effects" of a particular pesticide's
residues and "other substances that have a common mechanism of toxicity." Unlike
19
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other pesticides for which EPA has followed a cumulative risk approach based on a
common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to metconazole and any other substances. For the purposes of this action,
therefore, EPA has not assumed that metconazole has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
B. Handler and Worker Risk Assessments
1. Occupational: Short- (1 - 30 days) and intermediate-term (1-6 months) exposures
are possible for occupational metconazole handlers. Only inhalation toxicity endpoints
were identified for these anticipated exposure durations. A Margin of Exposure (MOE)
> 100 is adequate to protect occupational pesticide handlers. All metconazole
occupational handler MOEs are estimated to be > 100 for the proposed uses, and
therefore, do not cause concern for FED.
There is the possibility for agricultural workers to have postapplication exposure to
metconazole following its use on commercially grown ornamentals in nurseries and
greenhouses, as well as golf course turf. However, because dermal toxicity endpoints for
the appropriate durations of exposure were not identified, and because inhalation
exposure is considered to be insignificant for postapplication exposures, no occupational
postapplication exposure assessment was conducted.
2. Residential: There is potential adult short-term dermal and inhalation exposure to
metconazole from its proposed use on turf and ornamentals. However, because dermal
toxicity endpoints for the appropriate duration of exposure were not identified, only
residential handler inhalation exposures/risks have been assessed.
An MOE > 100 is adequate to protect residential pesticide handlers. All metconazole
residential handler MOEs are estimated to be > 100 for the proposed uses, and therefore,
do not cause concern.
Adults, adolescents and toddlers may be exposed to metconazole from its proposed
residential uses. Adults and adolescents may experience short- and intermediate-term
dermal exposure from golfing and other activities on treated turf, as well as from tending
treated ornamentals. Toddlers may experience short- and intermediate-term dermal and
incidental oral exposure from activities on treated turf. Because dermal toxicity
endpoints for the appropriate durations of exposure were not identified, and because
inhalation exposure is considered to be insignificant for postapplication exposures, only
toddler incidental oral postapplication exposures have been assessed. Chemical-specific
turf transferable residue studies were submitted for use in estimating postapplication
20
-------
exposures.
Postapplication risks to toddlers following the application of metconazole to home lawns
were calculated for short- and intermediate-term exposures. All MOEs for the toddler
lawn exposure scenarios were >100, and therefore, are not of concern. In addition the
total MOE for combined toddler exposures (i.e., hand-to-mouth, object-to-mouth, and
incidental ingestion of soil) is >100, and therefore, is not of concern.
III. ENVIRONMENTAL RISK ASSESSMENT
A. Environmental Fate Characterization: Metconazole is stable to hydrolysis under
environmental conditions. It is moderately to slightly degradable by direct photolysis in
water. However, photodegradation in water is not expected to be a major route of
dissipation in aquatic systems as metconazole has been shown to partition rapidly to the
sediment (DT50 in water ranged from 1-15 days) and slowly degrade while in sediment
(DT50 for total system ranged from 116-814 days). Aerobic soil metabolism is the only
significant route of degradation of metconazole. Based on three aerobic soil metabolism
studies, the half-life values are in the range of 192.5 days to 660 days. In a soil photolysis
study, metconazole degraded with an estimated half-life of 72 days. Field dissipation
studies indicate that metconazole dissipated with a DT50 ranging from 33 to 138 days.
Adsorption/desorption studies of metconazole in four soils (pH 5.8-7.6, 0.74-2.29 % OC)
produced Koc values ranging between 1026 and 2723 ml/g. This Koc range suggests the
chemical is slightly mobile (FAO Classes). The ranges of BCFs for edible tissue,
nonedible tissue, and whole fish indicate a low potential for bioconcentration in fish.
Also, given the relative short depuration time, it is considered that the risk for
bioaccumulation of metconazole in fish is low.
B. Exposure Characterization: Metconazole has potential to reach surface water via run-
off and spray drift and to reach ground water via leaching. However, the submitted
terrestrial field dissipation studies show no significant leaching of metconazole, and
ground water modeling estimate a concentration of less than 1 ppb.
Estimated environmental concentrations (EECs) in surface water were calculated for
metconazole using the Tier II PRZM/EXAMS models and employing maximum
application rates for metconazole usage on turf, small grains, soybeans, sugar beets,
peanuts, stone fruits, and tree nuts. The peak (l-in-10 year) surface water EECs were
between 2.89 and 88.19 |ig/L (dependent on scenario and application method). For the
terrestrial assessment, EECs for metconazole were calculated using the terrestrial Tier I
model T-REX using the maximum application rate for the evaluated uses. Upper bound
dietary EECs ranged from approximately 1.53 ppm for metconazole residues on fruits,
pods, seeds, and large insects for soybean application to 446 ppm on short grass for turf
application.
C. Effects Characterization: Results of acute toxicity studies in freshwater and
estuarine/marine fish indicate that metconazole is moderately toxic on an acute basis.
21
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The LC50 = 1.71 mg ai/L for freshwater fish (28-day study, OECD204) and the LC50 =
6.3 mg ai/L for estuarine/marine fish. The NOAEC for freshwater fish was 0.00291 mg
ai/L based on dry and wet weights and length. For the eastern oyster, the ECso = 2.0 mg
ai/L based on shell growth. Acceptable or supplemental toxicity data for estuarine/marine
fish (chronic) and for invertebrates (freshwater and estuarine/marine, acute and chronic)
were not provided to the Agency. In lieu of these data, toxicity data from other conazole
pesticides were use to characterize the risks, assuming that metconazole toxicity was
similar to the other conazoles.
Metconazole is classified as slightly toxic to birds based on gavage (LDso = 777 mg
ai/kg-bwt) and dietary (LC50 1078 mg ai/kg-diet) studies in bobwhite quail. Adverse
effects were observed in a reproduction study using bobwhite quail (reduction in live 3-
week embryos, hatching success, chick survival, chick body weights, and adult female
body weight gain), resulting in a NOAEC of 58 mg ai/kg-diet. the acute toxicity tests for
mammals produced definitive LD50s (combined for males and females) of 566, 660, and
1459 mg ai/kg-bwt as well as one non-definitive LDso of >5000 mg ai/kg-bwt (no
mortalities). The parental, offspring, and reproductive NOAEC for the 2-generation rat
study was 150 mg ai/kg-diet. Significant effects were categorized as parental,
reproductive, and offspring. Parental effects include decreased body weight and
decreased weight gain in male and female parental animals, increased incidence of fatty
hepatocyte change in male parental animals, and increased incidence of spleen congestion
in Fl parental females. Reproductive effects included increased gestation length and
decreased gestation index driven by dystocia. Offspring effects included decreased
viability on lactation day 0 and decreased body weight in F2 offspring. Results of
available toxicity studies indicate that metconazole is practically non-toxic to honey bees
on an acute contact basis.
Seedling emergence studies and vegetative vigor studies were conducted for ten species
using two different end-use products (Caramba and Metconazole 50 WDG). The studies
with Caramba did not provide any definitive EC25S (all were > 0.097 Ibs ai/acre, the
highest concentration tested). For the seedling emergence study conducted with
Metconazole 50 WDG, the most sensitive monocot was ryegrass (EC25 = 0.78 Ibs ai/acre
and NOAEC = 0.30 Ibs ai/acre), and the most sensitive dicot was the radish (EC25 = 0.15
Ibs ai/acre and NOAEC = 0.075 Ibs ai/acre). For the vegetative vigor study conducted
with Metconazole 50 WDG, there were no reductions in growth parameters based on the
EC25 (> 0.60 Ibs ai/acre) and NOAEC (0.60 Ibs ai/acre) in the four tested monocots, and
the most sensitive dicot was radish (EC25 = 0.44 Ibs ai/acre, NOAEC < 0.038 Ibs ai/acre,
and EC05 = 0.0036 Ibs ai/acre).
Contact toxicity studies on the effects of metconazole to honey bees indicate that there
are no effects at concentrations less than 95.3 jig ai/bee.
The most sensitive ECso values for aquatic vascular plants and non-vascular plants are
0.022 and 0.081 mg ai/L, respectively. The respective NOAECs are 0.00051 and 0.031
mg ai/L.
22
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D. Potential Risks to Non-Target Organisms:
1. Aquatic: Based on this analysis, direct toxic exposure is expected for
estuarine/marine fish (chronic), and freshwater and estuarine/marine invertebrates
(acute and chronic). Available toxicity data for aquatic plants coupled with the results
of this screening-level assessment show that use of metconazole is likely to result in
direct toxic exposure to vascular aquatic plants (proposed application to turf and
ornamentals only) and to non-vascular aquatic plants (proposed application to
ornamentals only). Labeling restrictions limiting number of applications and requiring
a buffer zone will reduce these risks. The specific labeling language addressing these
concerns is provided below.
2. Terrestrial: Results of this screening-level assessment using available toxicity data
suggest that use of metconazole is likely to result in toxic exposure to birds and
mammals on an acute basis and to mammals on a chronic basis. ). Labeling
restrictions limiting number of applications will reduce these risks. The specific
labeling language addressing these concerns is provided below. The Tier I terrestrial
plant model, TERRPLANT, was used to assess risks to terrestrial and semi-aquatic
plants. Results of this screening-level assessment suggest that use of metconazole is
likely to result in toxic exposure to semi-aquatic dicots. ). Labeling restrictions
limiting number of applications and requiring a buffer zone will help reduce these
risks. The specific labeling language addressing these concerns is provided below.
The results of this risk assessment suggest that the patterns of metconazole use are
such that they coincide in time and space to areas frequented by avian and
mammalian wildlife. These areas have been of demonstrated use by wildlife as
sources of food and cover. The potentially problematic wildlife food items suggested
by this risk assessment are likely to be present in and around the treated areas. In
addition, there is potential for indirect effects to all taxonomic groups due to changes
in habitat caused by vegetation changes.
A considerable uncertainty in this assessment comes from the fact that metconazole
(94% purity used in formulation) comprises two geometric isomers; cis andirons,
with a typical ratio of 85:15 cis:trans. The technical grade material is 94 % pure with
a minimum of 80 % cis isomer. The submitted data do not provide information on
the differences in degradation rates between the two geometric isomers or the relative
contribution of each isomer to the total amount of residues identified in each of the
environmental fate studies. Therefore, the environmental concentrations presented in
this risk assessment assume fate properties and degradation rates are the same for
both isomers.
Estimated levels of metconazole in the environment, when compared with minimum
toxicity values, are likely to result in direct risks to Federally Listed Threatened and
Endangered ("listed") and non-listed species from several different taxa. Indirect
risks are also identified for listed and non-listed species. Labeling restrictions
limiting number of applications and requiring will reduce these risks. The specific
labeling language addressing these concerns is provided below.
23
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IV. PROPOSED REGULATORY DECISION
A. Unconditional Registration: We recommended registration of metconazole for control
of diseases in turfgrass and ornamentals.
1. Conditional Data:
850.1075/72-la,c: Freshwater fish LCso, both cold and warm water fish
850.1010/72-2a: Freshwater invertebrate LC50
850.1055/72-3c: Estuarine/marine invertebrate LCso
850.1300/72-4a: Fish early life stage (estuarine/marine)
850.1400/72-4b: Aquatic invertebrate Life cycle Freshwater and Estuarine/marine
850.1735: Whole Sediment Acute Toxicity invertebrates, freshwater
B. Tolerances: No tolerances are required for the proposed non-food uses of metconazole
on turf and ornamentals.
C. Required Label Statements: End use products containing metconazole as an active
ingredient will be required to add the following protective language on the product
labeling:
1. Environmental Hazards: "Do not apply directly to water, or to areas where surface
water is present, or to intertidal areas below the mean high water mark. Do not
contaminate water when disposing of equipment washwater or rinsate. Drift and
runoff may be hazardous to aquatic organisms in water adjacent to treated areas. "
2. Directions for Use:
- "Do not make more than three applications per year (2 Ibs active ingredient/year)."
24
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Contact Person at EPA
Mary Waller
Product Manager
Fungicide Branch
Registration Division (7505P)
Office of Pesticide Programs
Environmental Protection Agency
Aerial Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460
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.
25
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Bibliography
Study Information For
Product Registration - Section 3
59639-RUU
MRID
Citation
Valent U.S.A. Corp. (2006) Submission of Product Chemistry,
46805800 Environmental Fate and Toxicity Data in Support of the Application for
Registration of V-10116 VVP Fungicide. Transmittal of 9 Studies.
Taylor, E. (2006) Metconazole 50 WDG: Product Identity and
Composition, Description of Materials Used to Produce the Product,
Description of Production Process, Description of Fomulation Process,
46805801 Discussion of Fomation of Impurities, Preliminary Analysis, Certified
Limits, Enforcement Analytical Method, Submittal of Samples. Project
Number: 200600078, 2006/10116/001, VAM/27B/001. Unpublished
study prepared by Valent Dublin Laboratory. 142 p.
Ha, S. (2006) Physical and Chemical Properties of Metconazole 50 WDG.
46805802 Project Number: 200600068, V/06/30023A, VA/030/01. Unpublished
study prepared by Valent Dublin Laboratory. 50 p.
Receipt
Date
05-Apr-
2006
05-Apr-
2006
46805803
46805804
Hewitt, A. (2005) Metconazole (KNF-S-474m): Atomization Droplet Size
Spectra for the 50 WDG Formulation. Project Number: 200600023,
UQ/792B. Unpublished study prepared by University of Queensland
Centre for Pesticide Application. 168 p.
Rodabaugh, D. (2006) An Acute Oral Toxicity Study in Rats with V-
10116 50 WP (Up/Down Study Design). Project Number: 200600055,
VP/29421, ODV00039. Unpublished study prepared by Charles River
Laboratories, Inc. 71 p.
Rodabaugh, D. (2006) An Acute Dermal Toxicity Study in Rats with V-
46805805 10116 50 WP. Project Number: 200600059, VP/29468, ODV00040.
Unpublished study prepared by Charles River Laboratories, Inc. 56 p.
46805806
46805807
Rodabaugh, D. (2006) An Acute Nose-Only Inhalation Toxicity Study in
Rats With V-10116 50 WP. Project Number: 200600073, VP/29474,
ODV00041. Unpublished study prepared by Charles River Laboratories,
Inc. 75 p.
Rodabaugh, D. (2006) A Primary Eye Irritation Study in Rabbits With V-
10116 50 WP. Project Number: 200600060, ODV00042, VP/29479.
05-Apr-
2006
05-Apr-
2006
05-Apr-
2006
05-Apr-
2006
05-Apr-
2006
05-Apr-
2006
26
-------
Unpublished study prepared by Charles River Laboratories, Inc. 45 p.
Rodabaugh, D. (2006) A Primary Skin Irritation Study in Rabbits With V-
46805808 10116 50 WP. Project Number: 200600061, VP/29495, ODV00043.
Unpublished study prepared by Charles River Laboratories, Inc. 45 p.
46805809
Total Rows: 10
Study Information For
Product Registration - Section 3
72078-R
05-Apr-
2006
Rodabaugh, D. (2006) A Dermal Sensitization Study in Guinea Pigs with
V-10116 50 WP: Modified Buehler Method. Project Number: 200600062, 05-Apr-
ODV00044, 999/233. Unpublished study prepared by Charles River 2006
Laboratories, Inc. 67 p.
MRID
Citation
ValentU.S.A. Corp. (2006) Submission of Environmental Fate, Toxicity,
46805100 Exposure and Risk Data in Support of the Application for Registration of
Metconazole Fungicide Technical. Transmittal of 12 Studies.
Fichera, L. (2006) Independent Laboratory Validation of ValentU.S.A.
Corporation Analytical Method "Determination of Metconazole and its
46805101 Metabolites Mil, M21 & M30 in Soil" . Project Number: VP/29516,
200600074, 050197. Unpublished study prepared by Golden Pacific
Laboratories, LLC (GPL). 142 p.
46805102
Dix, M. (2005) Metconazole (KNF-S-474m): Independent Laboratory
Validation (ILV) - Determination of Metconaole Residues in Water.
Project Number: 200600026, 12709/6227, RM/41/W1. Unpublished study
prepared by Springborn Smithers Laboratories. 61 p.
Porch, J.; Krueger, H.; Martin, K. (2006) Metconazole: A Tier II Toxicity
Test to Determine the Effects of the Test Substance on Seedling
46805103 Emergence of Ten Species of Plants. Project Number: 200600070,
VP/28601, 263/152. Unpublished study prepared by Wildlife
International, Ltd. 149 p.
46805104
Porch, J.; Krueger, H.; Martin, K. (2006) Metconazole: A Toxicity Test to
Determine the Effects of the Test Substance on Vegetative Vigor of Ten
Receipt
Date
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
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2006
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2006
27
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46805105
Species of Plants. Project Number: 263/153, 200600046, VP/28609.
Unpublished study prepared by Wildlife International, Ltd. 169 p.
Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole on
Turfgrass in Georgia. Project Number: 200600066, V/27271, V/04/27271. 03-Apr-
Unpublished study prepared by Valent Dublin Laboratory and Agriscope, 2006
LLC. 381 p.
46805106
Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole on
Turfgrass in New Jersey. Project Number: 200600065, V/27254,
RM/41V. Unpublished study prepared by Valent Dublin Laboratory and
Crop Management Strategies, Inc. 397 p.
Stearns, J. (2005) Transferable Turf Reside of Metconazole on Turfgrass.
46805107 Project Number: V/25718, 200600025, V/03/25718. Unpublished study
prepared by Valent Dublin Laboratory and Agriscope, LLC. 113 p.
Stearns, J. (2005) Transferable Turf Residue of Metconazole on Turfgrass.
46805108 Project Number: 200600024, V/27246, V/04/27246. Unpublished study
prepared by Valent Dublin Laboratory and Agsearch. 109 p.
46805109
Rose, A.; Leggett, M.; Assaf, N. (2006) Environmental Fate and
Ecological Risk Assessment For Metconazole Use on Turf and
Ornamentals. Project Number: 200600092, VP/30526. Unpublished study
prepared by Valent U.S.A. Corporation. 62 p.
46805110
46805111
46805112
46808400
Kureha Corporation (2006) Submission of Product Chemistry,
Environmental Fate, and Toxicity Data in Support of the Application for
Registration of Metconazole Fungicide Technical. Transmittal of 52
Studies.
Wustner, D. (2006) Physical and Chemical Properties of Metconazole
46808401 Fungicide Technical. Project Number: 200600080, V/06/281/MET.
Unpublished study prepared by Valent U.S.A. Corporation. 41 p.
03-Apr-
2006
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2006
03-Apr-
2006
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2006
Creek, M. (2006) Metconazole (KNF-S-474m): Toxicology Data
Summary and Toxicity Endpoint Selection Justification. Project Number: 03-Apr-
200600089, MRC/2006/02. Unpublished study prepared by Valent U. S. A. 2006
Corporation. 26 p.
Assaf, N. (2006) Aggregate Human Health Risk Assessment Associated
with Metconazole Professional Prduct Use on Turf Grass and Ornamental 03-Apr-
Plants. Project Number: 200600084, VP/30513. Unpublished study 2006
prepared by Valent U.S.A. Corporation. 23 p.
Driver, J.; Ross, J. (2006) Worker Risk Estimates for Metconazole When
Used as an Ornamental and Turf Fungicide. Project Number: 200600086, 03-Apr-
VALENT/001/06. Unpublished study prepared by Infoscientific.com. 18 2006
P-
03-Apr-
2006
03-Apr-
2006
28
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46808402
Yacoub, R. (2006) BAS 555 F: (TGAI): Stability to Normal and Elevated
Temperature, Metal and Metal Ions and pH: Final Report. Project
Number: 200600087, 2006/7006764, 238696. Unpublished study prepared
by BASF Agro Research. 12 p.
Ha, S. (2006) UV/vis Absorption of Metconazole. Project Number:
46808403 200600091, V/30023C. Unpublished study prepared by Valent U.S.A
Corporation. 49 p.
Fisk, P. (1991) WL148271 (KNF-S-474m): Hydrolysis as a Function of
46808404 pH. Project Number: 200300392, SBGR/90/308. Unpublished study
prepared by Sittingbourne Research Center. 39 p.
van der Gaauw, A. (2002) [T-14-Carbon]-KNF-474m: Aqueous
46808405 Photolysis. Project Number: 842052, 200300086. Unpublished study
prepared by RCC Umweltchemie Ag. 63 p.
Lentz, N. (2005) Metconazole (KNF-S_474m): Photodegradation on Soil.
46808406 Project Number: 200600041, 017961/1. Unpublished study prepared by
Ricerca Biosciences, LLC. 124 p.
Rose, A. (2006) Data Waiver: Photodegradation in Air. Project Number:
46808407 200600090, VP/30577. Unpublished study prepared by Valent U.S.A.
Corporation. 4 p.
Assaf, N. (2006) Metconazole (KNF-S-474m): Degradation Under
46808408 Aerobic Conditions in Soil. Project Number: 200600095, VP/28329.
Unpublished study prepared by Valent U.S.A. Corporation. 200 p.
46808409
Gedik, L.; Keirs, D.; Fang, C. (2001) Metconazole (BAS 555F):
Degradation in Soil Under Anaerobic Conditions. Project Number:
200400117, 399019. Unpublished study prepared by Inveresk Research
International. 93 p.
Gohre, K. (2006) Metconazole (KNF-S-474m): Metabolism Under
46808410 Anaerobic Aquatic Conditions. Project Number: 200600083, VP/28311.
Unpublished study prepared by Valent U.S.A. Corporation. 209 p.
Gohre, K. (2006) Metconazole (KNF-S-474m): Soil
46808411 Absorption/Desorption. Project Number: 200600082, VP/28612.
Unpublished study prepared by Valent U.S.A. Corporation. 137 p.
46808412
Maurer, J. (2006) Estimation of Adsorption Coefficient (Koc) of
Metconazole Degradate M30 by High Performance Liquid
Chromatography. Project Number: 200600085, VP/29431. Unpublished
study prepared by Valent U.S.A. Corporation. 42 p.
Johnson, A.; Gillham, A.; Ahmed, S. (1998) Metconazole 85:15 cis:trans,
46808413 Metconazole 95% cis, A Comparative Acute Oral Toxicity (LD50) Study
with Northern Bobwhite. Project Number: 200600028, CYD/621/984073.
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
29
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Unpublished study prepared by Valent U.S.A. Corporation. 62 p.
46808414
46808415
46808416
46808417
46808418
Hakin, B.; Rodgers, M.; Andersons, A.; et. al. (1991) Dietary Toxicity
(LC50) of WL148271 to the Bobwhite Quail. Project Number:
200300447, SLL/184/901426. Unpublished study prepared by Huntingdon
Life Sciences, Ltd. 31 p.
Hakin, B.; Rodgers, M.; Anderson, A.; et. al. (1991) Dietary Toxicity
(LC50) of WL148271 to the Mallard Duck. Project Number: 200300449,
SLL/185/901427. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 30 p.
Johnson, A.; Ahmed, S. (1999) Metconazole 85:15 cis:trans, Assessment
to Determine the Effects on Reproduction in the Northern Bobwhite.
Project Number: 200600029, CYD/622/984096. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 335 p.
Temple, D.; Martin, K.; Beavers, J.; et. al. (2005) Metconazole (KNF-S-
474m): A Reproduction Study with the Mallard. Project Number:
200600045, 556/102. Unpublished study prepared by Wildlife
International, Ltd. 153 p.
Toy, R. (1990) WL 148271 (KNF-S-474m): Acute Toxicity to Salmo
gairdneri, Daphnia Magna and Selenastrum capricormutum. Project
Number: 200300453, SBGR/89/188. Unpublished study prepared by
Sittingbourne Research Center. 46 p.
Toy, R. (1991) WL 148271 (KNF-S-474m): 96 hr Acute Toxicity to
46808419 Pimephales promelas. Project Number: 200300452, SBGR/90/240.
Unpublished study prepared by Sittingbourne Research Center. 24 p.
46808420
46808421
46808422
Cafarella, M. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to
Eastern Oyster (Crassostrea virginica). Project Number: 200600042,
12709/6235. Unpublished study prepared by Springborn Smithers
Laboratories. 54 p.
Sayers, L. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to Mysids
(Americamysis bahia) Under Static Conditions. Project Number:
200600043, 12709/6233. Unpublished study prepared by Springborn
Smithers Laboratories. 41 p.
Sayers, L. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to
Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions.
Project Number: 200600044, 12709/6234. Unpublished study prepared by
Springborn Smithers Laboratories. 50 p.
Cafarella, M. (2006) Metconazole (KNF-S-474m) - Life Cycle Toxicity
46808423 Test with Mysids (Americamysis bahia). Project Number: 12709/6236,
200600069. Unpublished study prepared by Springborn Smithers
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
30
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Laboratories. 79 p.
Mitchell, G.; Boeri, R.; Kowalski, P.; et. al. (1996) Toxicity of AC 900,
768 (Metconazole) Technical to Rainbow Trout (Onchorynchus mykiss)
46808424 in a Flow-Through Prolonged Toxicity Test. Project Number: 200600027,
954/96/129. Unpublished study prepared by T.R. Wilbury Laboratories,
Inc. 152 p.
46808425
46808426
46808427
Koa, L. (1996) CL 900, 768 (Metconazole): Bioconcentration and
Elimination of [Triazole-3,5-(14Carbon)]CL 900, 768- Derived Residues
by Bluegill Sunfish. Project Number: 200300455, MET/96/012.
Unpublished study prepared by American Cyanamid Co. 216 p.
Harrison, E.; Hillaby, J. (1991) WL148271: KNF-S-474m: Acute Topical
and Oral Toxicity to the Honey Bee, Apis mellifera L.. Project Number:
200300450, SBGR/90/230. Unpublished study prepared by Sittingbourne
Research Center. 26 p.
Hillaby, J.; Harrison, E. (1991) WL 136184 (KNF-S-474c): Toxicity to
the Earthworm, Eisenia foetida, in a 14-Day Artificial Soil Test. Project
Number: 200300451, SBGR/91/208. Unpublished study prepared by
Sittingbourne Research Center. 23 p.
Hoberg, J. (2006) Metconazole (KNF-S-474m) - Toxicity to the
46808428 Duckweed, Lemna gibba. Project Number: 12709/6232, 200600076.
Unpublished study prepared by Springborn Smithers Laboratories. 81 p.
46808429
46808430
46808431
46808432
46808433
Hoberg, J. (2006) Metconazole (KNF-S-474m) - Acute Toxicity to the
Freshwater Green Alga, Pseudokirchneriella subcapitata. Project Number:
200600096, 12709/6228. Unpublished study prepared by Springborn
Smithers Laboratories. 56 p.
Hoberg, J. (2006) Metconazole (KNF-S-474m) - Acute Toxicity to the
Freshwater Blue-Green Alga, Anabaena flos-aquae. Project Number:
200600093, 12709/6230. Unpublished study prepared by Springborn
Smithers Laboratories. 62 p.
Hoberg, J. (2006) Metconazole (KNF-S-474m) - Toxicity to the
Freshwater Diatom, Navicula pelliculosa. Project Number: 200600097,
12709/6229. Unpublished study prepared by Springborn Smithers
Laboratories. 57 p.
Hoberg, J. (2006) Metconazole (KNF-S-47m) - Acute Toxicity to the
Marine Diatom, Skeletonema costatum. Project Number: 200600098,
12709/6231. Unpublished study prepared by Springborn Smithers
Laboratories. 57 p.
Collins, C. (1990) WL 148271 (KNF-S-474m): Acute Inhalation Toxicity
Study - LC50 Rats (4 Hour Exposure). Project Number: 200300398,
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
-------
579/45. Unpublished study prepared by Springborn Smithers
Laboratories. 53 p.
Gardner, J. (1990) WL 148271: Skin and Eye Irritancy and Skin
46808434 Sensitization Potential. Project Number: 200300399, SBGR/89/218.
Unpublished study prepared by Sittingbourne Research Center. 29 p.
Glaza, S. (1995) Dermal Sensitization Study of CL 900, 768 in Guinea
46808435 Pigs - Maximation Test. Project Number: HWI/40804288, 200300400.
Unpublished study prepared by Hazleton Wisconsin, Inc. 57 p.
46808436
Creek, M. (2006) Justification for Waiving an Acute Neurotoxicity and a
Developmental Neurotoxicity Study with Metconazole Fungicide
Technical. Project Number: 200600088, MRC/2006/01. Unpublished
study prepared by Valent U.S.A. Corporation. 5 p.
Pickersgill, N. (1991) WL 148271: Oral (Capsule) Maximum Tolerated
46808437 Single Dose Study in the Beagle. Project Number: 579/21, 200400248.
Unpublished study prepared by Hazleton Uk. 46 p.
46808438
46808439
46808440
46808441
46808442
46808443
Bonnette, K. (2006) A 14-Day Range-Finding Dermal Toxicity Study in
Fischer 344 Rats with Metconazole Technical. Project Number:
ODV00035, 200600040. Unpublished study prepared by Charles River
Laboratories, Inc. 352 p.
Bonnette, K. (2006) Metconazole (KNF-S-474m): A 21-Day Dermal
Toxicity Study in Fischer 344 Rats. Project Number: 200600094,
VP/28361. Unpublished study prepared by Charles River Laboratories,
Inc. 297 p.
Cooper, S. (2002) KNF-474m: Neurotoxicity Study by Dietary
Administration to CD Rats for 4 Weeks. Project Number: 200300088,
KRA/068/022386. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 272 p.
Cooper, S. (2002) KNF-474m: Preliminary Neurotoxicity Study by
Dietary Administration to CD Rats for 2 Weeks. Project Number:
200300087, KRA/065/020005. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 160 p.
Fulcher, S. (2002) KNF-474m: Preliminary Teratology Study by Oral
Gavage Administration to CD Rats. Project Number: 200300082,
KRA/064/020002. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 63 p.
Fulcher, S. (2002) KNF-474m: Teratology Study by Oral Gavage
Administration to CD Rats. Project Number: 200300084,
KRA/069/022919. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 156 p.
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
32
-------
Tesh, J. (1990) An Appraisal of the Effects of WL 148271/KNF-S-474m
46808444 (Technical) Upon Pregnancy in the Rabbit. Proj ect Number: 200400247,
QRT/0049. Unpublished study prepared by Life Science Research. 9 p.
46808445
Hoberman, A. (1996) An Oral Development (Embryo-Fetal
Toxicity/Teratogenicity) Pilot Study with AC 900, 768 in Rabbits. Project
Number: 200300463, ARGUS/101/027P. Unpublished study prepared by
Argus Research Laboratories, Inc. 153 p.
Willoughby, C. (1991) WL 148271: Preliminary Study to Assess Effects
46808446 on Reproductive Performance in Rats. Proj ect Number: 2003 00426,
91/0109. Unpublished study prepared by Life Science Research. 151 p.
Teramoto, S. (2002) KNF-474m: Reproductive Toxicity Study in Rats.
46808447 Project Number: 200400253, IET/00/0146. Unpublished study prepared
by Institute of Environmental Toxicology. 425 p.
Teramoto, S. (2002) A Measurement Study of Serum Steroid Hormone
Concentrations and Hepatic Drug-Metabolizing Enzyme Contents During
46808448 Late Gestation in Rats Fed Diets Containing KNF-474m. Project Number:
IET/02/0058, 200400255. Unpublished study prepared by Institute of
Environmental Toxicology. 111 p.
Yamamoto, E. (2002) Metabolism of KNF-474m in Rats. Proj ect Number:
46808449 200400254, IET/01/8002. Unpublished study prepared by Institute of
Environmental Toxicology. 113 p.
46808450
46808451
46808452
46901700
46901702
Cornelissen, K. (1990) KNF-S1474m (WL 148271): A Study of
Absorption and Excretion Following Percutaneous Administration to the
Rat. Proj ect Number: 200600072, 579/47. Unpublished study prepared by
HazletonUk. 142 p.
Mann, P. (2002) KNF-474m Validation of an Analytical Method and
Dietary Formulation Preparation, Homogeneity and Stability. Project
Number: 200300083, KRA/067/014561. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 27 p.
Mann, P. (2002) KNF-474m: Validation of an Analytical Method and
Liquid Formation Preparation, Homogeneity, and Stability. Project
Number: 200300085, KRA/066/014562. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 25 p.
ValentU.S.A. Corporation (2006) Submission of Environmental Fate,
Residue, Exposure and Risk Data in Support of the Application for
Registration of Metconazole Fungicide Technical. Transmittal of 16
Studies.
Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole in
Ontario, Canada. Proj ect Number: V/26251, 200600147, V/26251/03/A.
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
03-Apr-
2006
26-Jul-
2006
26-Jul-
2006
33
-------
46901703
Unpublished study prepared by Valent Dublin Laboratory, Vaughn
Agricultural Research Serv., Ltd. and Agvise Inc. 274 p.
Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole in
Madera, California. Project Number: 200600146, V/26219,
V/26219/03/A. Unpublished study prepared by Excel Research Services,
Inc. and Valent Dublin Laboratory. 264 p.
Fujie, G. (2006) RM-41C-1-1: Determination of cis-Metconazole and
46901704 trans-Metconazole in Crops. Project Number: RM/41C/1/1, RM/41C/4.
Unpublished study prepared by Valent Dublin Laboratory. 43 p.
Gohre, K. (2006) Radiovalidation of Residue Methodology for
46901705 Metconazole in Animal Tissue. Project Number: VP/30188, 200600145.
Unpublished study prepared by Valent Dublin Laboratory. 35 p.
46901706
Noon, P. (2006) Independent Laboratory Validation of the Analytical
Method RM-41C-1, Determination of cis-Metconazole and trans-
Metconazole in Crops. Project Number: 200600132, 120/010, VP/29874.
Unpublished study prepared by North Coast Laboratories, Inc. 105 p.
Green, C. (2006) Magnitude of the Residues of Metconazole on Cherries.
46901707 Project Number: 25654, 200600148, V/03/25654. Unpublished study
prepared by CMS Inc., Columbia Ag Research, Inc. and Agsearch. 214 p.
Green, C. (2006) Magnitude of the Residues of Metconazole on Peaches.
46901708 Project Number: 25662, 200600150, V/25662/05/M. Unpublished study
prepared by CMS Inc., Agriscope, LLC and Agsearch. 224 p.
46901709
Green, C. (2006) Magnitude of the Residues of Metconazole on Plums
and Dried Plums. Project Number: 25671, 200600149, V/03/25671.
Unpublished study prepared by Agsearch, Agsolutions, Inc. and Excel
Research Services, Inc. 195 p.
46901710
46901711
Green, C. (2006) Magnitude of the Residues of Metconazole on Pecans.
Project Number: 27211, 200600111, V/04/27211. Unpublished study
prepared by Agricultural Research Associates, Biological Research
Service, Inc. and South Texas Ag Research, Inc. 141 p.
Green, C. (2006) Magnitude of the Residues of Metconazole on Peanut
Nutmeats and Peanut Processing Fraction. Project Number: 200600181,
46901712 25689, V/04/25689. Unpublished study prepared by Ashgrow Crop
Management Systems, Inc., Coastal Ag Research, Inc. and Carolina Ag-
Research Service, Inc. 367 p.
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
Green, C. (2006) Magnitude of the Residues of Metconazole on Almonds.
Project Number: 25700, 200600153. Unpublished study prepared by 26-Jul-
Valent U.S.A. Corporation, Research 2000, Inc. and Excel Research 2006
Services, Inc. 214 p.
26-Jul-
2006
26-Jul-
2006
34
-------
46901713
46901714
46901715
Green, C. (2006) Dissipation of Dislodgeable Foliar Residues of
Metconazole on Peach Leaves. Project Number: 200600075, 29209, 26-Jul-
V/05/29209. Unpublished study prepared by Excel Research Services, 2006
Inc. and Valent Dublin Laboratory. 108 p.
Rose, A.; Leggett, M. (2006) Environmental Fate and Ecological Risk
Assessment for Metconazole Use on Orchards (Tree Nuts and Stone Fruit) 26-Jul-
and Peanuts. Project Number: 200600312, VP/30966. Unpublished study 2006
prepared by Valent U.S.A. Corporation. 97 p.
Gagne, J. (2006) Metconazole: An Analysis of the Potential Risk to
Endangered Species of Mammals Associated with Tree Nuts, Peanuts, and 26-Jul-
Stone Fruits. Project Number: 200600311, V/ES/1. Unpublished study 2006
prepared by Valent U.S.A. Corporation. 95 p.
Assaf, N. (2006) Metconazole Aggregate Human Health Exposure Risk
46901716 Assessment. Project Number: 200600313, VP/30959. Unpublished study
prepared by Valent U.S.A. Corporation. 23 p.
Wustner, D. (2006) Summary of Metconazole Residue Chemistry Data.
46901717 Project Number: 200600310, V/RES/2. Unpublished study prepared by
Valent U.S.A. Corporation. 63 p.
Kureha Corporation (2006) Submission of Product Chemistry and Residue
46901900 Data in Support of the Application for Registration of Metconazole
Fungicide Technical. Transmittal of 15 Studies.
Wustner, D. (2006) Metconazole Fungicide Technical Particle Size,
46901901 Distribution and Shape. Project Number: V/PC/2, 200600194.
Unpublished study prepared by Valent U.S.A. Corporation. 13 p.
46901902
Edwards, V. (1991) [cyclopentyl-(Carbon 14)]WL148271 (KNF-S-
474m): Metabolism in Wheat. Project Number: 200300436,
SBGR/91/017. Unpublished study prepared by Sittingbourne Research
Center, Biotech. 56 p.
Edwards, V. (1991) [triazole-14(Carbon)] WL136184 (KNF-S-474c):
46901903 Metabolism in Wheat. Project Number: 200400092, SBGR/91/016.
Unpublished study prepared by Sittingbourne Research Center. 108 p.
Kao, L. (1997) CL 900768 (Metconazole): Metabolism of [Triazole-3,5-
(Carbon 14)] CL 900768 in Canola Under Field Conditions. Project
46901904 Number: 200600109, MET/97/015, M96P768MPB1. Unpublished study
prepared by Excel Research Services, Inc., American Cyanamid Co. and
Enviro-Quest. 314 p.
Kao, M. (1997) CL 900768 (Metconazole): Metabolism of [p-
46901905 Chlorophenyl-U-(Carbon 14)] CL 900768 in Canola Under Field
Conditions. Project Number: 200600107, MET/97/016, M96P768MB2.
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
35
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46901906
Unpublished study prepared by Excel Research Services, Inc., Ag-Quest
Inc. and American Cyanamid Co. 350 p.
Class, T.; Schluter, H. (2002) Metconazole (BAS 55 F; AC 900768):
Metabolism of Carbon-14 Labeled AC 900768 in Peas. Project Number:
200600104, MET/02/006. Unpublished study prepared by Cyanamid
Forshung Gmbh (CFS) and PTRL Europe Gmbh. 178 p.
Satoh, K. (2002) Metabolic Fate of KNF-474m in Mandarins. Project
46901907 Number: 200400252, IET/01/8005. Unpublished study prepared by
Institute of Environmental Toxicology. 280 p.
46901908
46901909
46901910
46901911
46901912
46901913
46901914
46901915
Johnston, A.; Cameron, S.; Young, C. (1992) The Disposition of (Carbon
14)-WL148271 (KNF-S-474M) in the Lactating Goat. Project Number:
ffil/143140, 200300446. Unpublished study prepared by Inveresk
Research International. 170 p.
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
Jalal, M. (2006) Metconazole (KNF-S-474m): Metabolism by Lactating
Goats. Project Number: 200600151, VP/28 111, V/04/28 111. Unpublished 26-Jul-
study prepared by Valent Dublin Laboratory and Genesis Midwest 2006
Laboratories. 294 p.
Johnston, A.; Cameron, S.; Young, C. (1991) The Disposition of (Carbon
14)-WL136184 (KNF-S-474C) in the Laying Hen. Project Number: 26-Jul-
200400250, IRI/150949. Unpublished study prepared by Inveresk 2006
Research International. 121 p.
Johnston, A.; Young, C.; Cameron, S. (1992) The Disposition of (Carbon
14)-WL136184 (KNF-S-474C) in the Laying Hen. Project Number: 26-Jul-
200400251, IRI/151324. Unpublished study prepared by Inveresk 2006
Research International. 76 p.
Jalal, M. (2006) Metconazole (KNF-S-474m): Metabolism by Laying
Hens. Project Number: 200600176, VP/28337, V/04/28337. Unpublished 26-Jul-
study prepared by Genesis Midwest Laboratories, Acorn NMR Inc and 2006
Valent Dublin Laboratory. 453 p.
Hill, A.; Standen, M. (1993) Metconazole: Confined Rotational Crop
Study Using [Cyclopentyl-(Carbon 14)]- and [Triazole-(Carbon 14)]- 26-Jul-
WL148271. Proj ect Number: 200300437, SBGR/92/104. Unpublished 2006
study prepared by Sittingbourne Research Center. 201 p.
Green, C. (2006) Magnitude of the Residues of Metconazole in Dairy
Cattle Milk and Meat. Proj ect Number: 200600291,29111, V/05/29 111. 26-Jul-
Unpublished study prepared by Genesis Midwest Laboratories and Valent 2006
Dublin Laboratory. 401 p.
Wustner, D. (2006) Justification for Waiving a Feeding/Residue Study in 26-Jul-
Laying Hens with Metconazole Fungicide Technical. Project Number: 2006
36
-------
200600292, V/RES/1. Unpublished study prepared by Valent U.S.A.
Corporation. 19 p.
BASF Corporation (2006) Submission of Toxicity, Fate, Residue,
Environmental Fate Data in Support of the Applications for Registration
46902200 of Caramba Fungicide, BAS 556 OIF Fungicide, Metconazole Fungicide
Technical and the Petition for Tolerance of Metconazole on Crop and
Livestock Commodities. Transmittal of 32 Studies.
Hassink, J. (2005) Hydrolysis of Metconazole (TGAI Batch 43705).
46902201 Project Number: 209413, 2005/1016371. Unpublished study prepared by
BASF Aktiengesellschaft. 17 p.
46902202
Williams, M.; Heim, L. (1996) Determination of the Aqueous Photolysis
Rate with AC 900, 768 (WL 148, 271). Project Number: ENV/95/014/01,
42254, MK/324/001. Unpublished study prepared by ABC Laboratories,
Inc. 93 p.
Bissinger, T. (1996) Photochemical Degradation of Metconazole (CL
46902203 900768) in Soil. Project Number: CFS/1996/076, DELS, MK/620/013.
Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 52 p.
Rice P. (2002) Calculation of DT50 and DT90 Values of Metconazole
46902204 (BAS 555 F) in Five Soils. Project Number: EXA/01/028, MK/620/021.
Unpublished study prepared by BASF Agro Research. 18 p.
46902205
46902206
46902207
46902208
Steinfuhrer, T. (1996) (14-Carbon)-Metconazole (CL 900768):
Degradation in Water Sediment Systems. Project Number: DES37,
CFS/1995/029, MK/630/002. Unpublished study prepared by Cyanamid
Forshung Gmbh (CFS). 122 p.
Jackson, S.; White, M.; Nejad, H. (2006) Oklahoma 2004 Metconazole
Terrestrial Field Dissipation Study. Project Number: 2006/7007134,
141527. Unpublished study prepared by Crop Guard Research, Inc. and
BASF Agro Research and Agvise Laboratories. 212 p.
Jackson, S.; White, M.; Nejad, H. (2006) Mississippi 2003 Metconazole
Terrestrial Field Dissipation Study. Project Number: 2006/7007133,
141530. Unpublished study prepared by BASF Agro Research, Agvise
Laboratories and Valent Dublin Laboratory. 222 p.
Jackson, S.; White, M.; Nejad, H. (2006) North Dakota 2003 Metconazole
Terrestrial Field Dissipation Study: Final Report. Project Number:
138071, 2006/7007132. Unpublished study prepared by BASF Agro
Research, Agvise Laboratories and Valent Dublin Laboratory. 218 p.
Nejad, H. (2006) Validation of BASF Method Number D0506 for
46902209 Determination of Metconazole (BAS 555 F) and its Metabolites Ml 1,
M21, M30 and Triazol in Soil Using LC/MS/MS. Project Number:
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
37
-------
138074, 2006/7006766. Unpublished study prepared by BASF Agro
Research. 81 p.
Ibrahim, A.; Hauser, R. (2006) Independent Method Validation of BASF
Analytical Method D0506: Method for Determination of Metconazole
46902210 (BAS 555 F) and its Metabolites Ml 1, M21, M30 and Triazol in Soil
Using LC/MS/MS. Project Number: 238588, 2K6/238588, 2006/7007031.
Unpublished study prepared by Adpen Labs. 136 p.
46902211
46902212
46902213
Smith, K., Nejad, H. (2006) Freezer Storage Stability of Metconazole and
Metabolites in Three Soils for Up to 18 Months. Project Number:
2006/7007139, 257989. Unpublished study prepared by BASF Agro
Research and Valent Dublin Laboratory. 84 p.
Jatzek, D. (2002) BAS 555 F - Determination of the Chronic Effect on the
Reproduction of the Water Flea Daphnia magna Straus. Project Number:
01/0051/51/1, 2002/1004678. Unpublished study prepared by BASF
Aktiengesellschaft. 43 p.
Zok, S. (2001) BAS 555 F - Early Life-Stage Toxicity Test on the
Rainbow Trout (Oncorhynchus mykiss). Project Number:
52F0051/015001, 2001/1015080. Unpublished study prepared by BASF
Aktiengesellschaft. 167 p.
Porch, I; Krueger, H.; Krip, W.; et. al. (2006) Caramba (BAS 555 01 F):
A Toxicity Test to Determine the Effects of the Test Substance on
46902214 Seedling Emergence of Ten Species of Plants. Project Number: 147/223,
238702, 2006/7007216. Unpublished study prepared by Wildlife
International, Ltd. 105 p.
Porch, I; Krueger, H.; Kendall, T.; et. al. (2006) Caramba (BAS 555 01
F): A Toxicity Test to Determine the Effects of the Test Substance on
46902215 Vegetative Vigor of Ten Species of Plants. Project Number: 147/224,
238705, 2006/7007217. Unpublished study prepared by Wildlife
International, Ltd. 137 p.
46902216
Saha, M.; Gooding, R. (2006) The Determination of Residues of
Metconazole (BAS 555 F) and its Metabolites in Plant Matrices Using
LC/MS/MS: Final Report. Project Number: 2005/5000141, 238522.
Unpublished study prepared by BASF Agro Research. 221 p.
Perez, R.; Ibrahim, A.; Hauser, R.; et. al. (2006) Independent Method
Validation of BASF Analytical Method D0508: The Determination of
46902217 Residuesof Metconazole (BAS 555 F) and Its Metabolites in Plant
Matrices Using LC/MS/MS. Project Number: 238582, 2006/7007032,
2K6/238582. Unpublished study prepared by Adpen Labs. 296 p.
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
46902218
Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability
of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
38
-------
at < -ISDegrees Celsius in Cereal Grain (Germany, 1995). Project
Number: DER31, CFS/1997/001, MK/326/004. Unpublished study
prepared by Cyanamid Forshung Gmbh (CFS). 38 p.
Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability
of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer
46902219 at < -18 Degrees Celsius in Cereal Green Plant and Straw (Germany,
1996). Project Number: DER43, CFS/1997/022, MK/326/005.
Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 49 p.
Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability
of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer
46902220 at < -18 Degrees Celsius in Carrots and Lettuce (Germany, 1996). Project
Number: DER48, CFS/1997/060, MK/326/006. Unpublished study
prepared by Cyanamid Forshung Gmbh (CFS). 55 p.
46902221
Kretschmer, S. (2000) Metconazole (CL 900768): Storage Stability of
Residues of the Metabolite Triazolylalanine (CL 147267) in Wheat Grain.
Project Number: P/342/G, B/342, MK/326/016. Unpublished study
prepared by PTRL Europe Gmbh. 37 p.
Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability
of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer
46902222 at < -18 Degrees Celsius in Rape Seed and Rape Oil (Germany, 1996).
Project Number: DER49, CFS/1977/061, MK/326/007. Unpublished
study prepared by Cyanamid Forshung Gmbh (CFS). 55 p.
46902223
Gooding, R.; Saha, M. (2006) Freezer Storage Stability of BAS 555 F
(Metconazole) and its Metabolites in Plant Samples: Amended Final
Report. Project Number: 2006/7007240, 138032. Unpublished study
prepared by BASF Agro Research. 177 p.
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Wheat: Final Report. Project Number:
46902224 137711, 2006/7006723. Unpublished study prepared by BASF Agro
Research, Southeast Ag Research, Inc. and Shoffner Farm Research. 203
P-
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Barley: Final Report. Project Number:
46902225 137714, 2006/7006917. Unpublished study prepared by BASF Agro
Research, ACDS Research, Inc. and Alvey Lab & Agr Research Services.
175 p.
46902226
Jordan, J.; Saha, M. (2006) The Magnitude of Metconazole (BAS 555 F)
and its Metabolites and Pyraclostrobin (BAS 500 F) Residues in Oats:
Final Report. Project Number: 137717, 2006/7006724. Unpublished study
prepared by BASF Agro Research, ACDS Research, Inc. and Southeast
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
39
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Ag Research, Inc. 255 p.
46902227
Jordan, J.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Rye: Final Report. Project Number: 26-Jul-
137720, 2006/7006725. Unpublished study prepared by BASF Agro 2006
Research, Southeast Ag Research, Inc. and Midwest Research, Inc. 146 p.
46902228
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and Its Metabolites in Soybean: Final Report. Project
Number: 137726, 2006/7006995. Unpublished study prepared by BASF
Agro Research, Southeast Ag Research, Inc. and Agresources, Inc. 213 p.
46902229
46902230
Jordan, J.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Sugar Beet: Final Report. Project
Number: 137729, 2006/7006726. Unpublished study prepared by BASF
Agro Research, Agresources, Inc. and Agstat. 260 p.
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Wheat Processing Commodities: Final
46902231 Report. Project Number: 137723, 2006/7007147. Unpublished study
prepared by BASF Agro Research, Agresources, Inc. and Alvey Lab &
Agr Research Services. 236 p.
46902232
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Wheat Aspirated Grain Fractions.
Project Number: 257986, 2006/7007257. Unpublished study prepared by
BASF Agro Research. 131 p.
BASF Corporation (2006) Submission of Product Chemistry, Toxicity,
Residue, Risk and Exposure Data in Support of the Applications for
46902300 Registration of Caramba Fungicide and BAS 556 OIF Fungicide and the
Petition for Tolerance of Metconazole on Soybeans, Wheat, Triticale,
Rye, Oats, and Sugarbeet. Transmittal of 35 Studies.
White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole
(BAS 555 F) and its Metabolites in Soybean Processing Commodities:
46902301 Final Report. Project Number: 137732, 2006/7006996. Unpublished study
prepared by BASF Corporation, Agresources, Inc. and Midwest Research,
Inc. 208 p.
46902302
Jordan, J.; Saha, M. (2006) Magnitude of Residues of Metconazole (BAS
555 F) and its Metabolites in Sugar Beets and Sugar Beet Processed
Fractions Following Applications of BAS 555 OIF: Final Report. Project
Number: 137735, 2006/7006727. Unpublished study prepared by BASF
26-Jul-
2006
Leonard, R. (2005) The Magnitude of Metconazole Residues in Soybeans:
Final Report. Project Number: 204640, 2004/5000755. Unpublished study 26-Jul-
prepared by BASF Agro Research, Southeast Ag Research, Inc. and 2006
Shoffner Farm Research. 113 p.
26-Jul-
2006
26-Jul-
2006
26-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
40
-------
Corporation, Agresources, Inc. and Prairie Agricultural Research, Inc. 206
P-
White, M.; Saha, M. (2006) Field Accumulation of Residues of
Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from
46902303 Limited Field Trials in Mississippi: Final Report. Project Number:
V/04/27131, 2006/7007130. Unpublished study prepared by BASF
Corporation. 156 p.
White, M.; Saha, M. (2006) Field Accumulation of Residues of
Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from
46902304 Limited Field Trials in Ohio: Final Report. Project Number: V/04/27115,
2006/7007127. Unpublished study prepared by BASF Corporation and
Ag. Consultants Inc. 150 p.
White, M.; Saha, M. (2006) Field Accumulation of Residues of
Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from
46902305 Limited Field Trials in California: Final Report. Project Number:
V/04/27123, 2006/7007128. Unpublished study prepared by BASF
Corporation and Excel Research Services, Inc. 228 p.
BASF Corporation (2006) Human Health Risk Assessment for
46902306 Metconazole (BAS 555 F) Use in Various Crops. Project Number:
2006/7007250. Unpublished study prepared by BASF Corporation. 18 p.
46902307
Holmes, C.; Gagne, J.; Van Cott, A.; et. al. (2006) Metconazole:
Screening Level Ecological Risk Assessment for Wildlife, Aquatic
Organisms, Nontarget Plants, and Nontarget Insects. Project Number:
2006/7008102. Unpublished study prepared by BASF Corporation. 29 p.
Jackson, S. (2006) Tier II Drinking Water and Ecological Risk Exposure
46902308 Assessment for the Use of Metconazole. Project Number: 2006/7007247.
Unpublished study prepared by BASF Corporation. 26 p.
Jackson, S.; Holmes, C. (2006) Metconazole Buffer Distance
Requirements for Protection of Endangered Species Including Crops:
46902309 Soybeans, Sugar Beets, Wheat, Barley, Oats, Rye, Tree Nuts, Stone Fruit,
Peanuts, Turf and Ornamental Uses. Project Number: 2006/7008097,
ELECTRONIC. Unpublished study prepared by BASF Corporation. 24 p.
46902310
46902311
Gagne, J.; Van Cott, A. (2006) Metconazole: An Analysis of the Potential
Risk to Endangered Species of Mammals Associated with Soybeans,
Sugar Beets, Wheat, Barley, Oats, and Rye. Project Number:
20006/7008095. Unpublished study prepared by BASF Corporation. 97 p.
Canez, V. (2006) Metconazole: Agricultural Worker Reentry Exposure
Assessment Following Application to Soybeans and Other Low Profile
Field Crops. Project Number: 2006/7008091. Unpublished study prepared
by BASF Corporation. 29 p.
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
41
-------
46902312
Canez, V. (2006) Metconazole: Mixer/Loader and Applicator Exposure
Assessment Following Application to Soybeans and Other Low Profile
Field Crops. Project Number: 2006/7008100. Unpublished study prepared
by BASF Corporation. 28 p.
Finch, C. (2006) BAS 555 01 F (Caramba) Fungicide: Group A - Product
46902313 Identity, Composition, and Analysis. Project Number: FR0604,
2006/7008138. Unpublished study prepared by BASF Corporation. 46 p.
Weatherhead, P. (2000) Method Validation of RLA 12495.00 HPLC
Meth°cl for the Determination of Metconazole SL Formulations. Project
Number: RGL/4572, MK/220/007. Unpublished study prepared by BASF
Agro Research. 32 p.
Fries, J. (2004) Supplement to the Method Validation of RLA 12495.00
HPLC Method for the Determination of Metconazole SL Formulations
46902315 (Technical Report No. RLG 4572). Project Number: 180322/1,
2003/1021955. Unpublished study prepared by BASF Ag Research
Station. 16 p.
Baker, I. (2001) Metconazole 90 g/L SL- Chemical and Physical Stability
of Formula RLA 12307 (BAS 555 01 F) when Stored in HOPE Packs -
46902316 208 Week Final Report. Proj ect Number: RGL/4697, 97002/A,
9630/97002/83. Unpublished study prepared by BASF Agro Research. 81
P-
Yacoub, R. (2006) BAS 555 01 F: Determination of Oxidizing/Reducing
46902317 Action: Final Report. Project Number: 257980, 2006/7007115.
Unpublished study prepared by BASF Corporation. 13 p.
Bradley, D. (1997) Oral LD50 Study in Albino Rats with AC 900768 90
46902318 g/L SL (RLF 12307). Project Number: T/0977, A97/87, MK/460/016.
Unpublished study prepared by American Cyanamid Co. 22 p.
Bradley, D. (1997) Dermal LD50 Study in Albino Rats with AC 900766
46902319 90 g/L SL (RLF 12307). Project Number: T/0978, A97/88, MK/460/017.
Unpublished study prepared by American Cyanamid Co. 17 p.
Hoffman, G. (1996) Acute Inhalation Toxcity Study with CL 900,768 60
46902320 g/L SL (SF09381) in Rats. Project Number: 96/5283, MK/460/009.
Unpublished study prepared by Huntingdon Life Sciences. 100 p.
46902321
46902322
Anonymous (1999) Metconazole (AC 900768) Request to Waive the
Requirements for an Acute Inhalation Study with the AC 900768 90 g/L
SL Formulation. Proj ect Number: MK/460/028. Unpublished study
prepared by BASF Corporation. 8 p.
Boczon, L. (1997) Primary Eye Irritation Study (in Rabbits) with AC
900768 90 g/L SL Formulation (RLF 12307). Proj ect Number: T/0975,
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
42
-------
46902323
A97/86, MK/460/019. Unpublished study prepared by American
Cyanamid Co. 15 p.
Boczon, L. (1997) Primary Dermal Irritation Study (in Rabbits) with AC
900768 90 g/L SL Formulation (RLF 12307). Project Number: T/0976,
A97/85, MK/460/018. Unpublished study prepared by American
Cyanamid Co. 15 p.
46902324
Finch, C. (2006) BAS 556 01 F Fungicide: Group A - Product Identity,
46902325 Composition, and Analysis. Project Number: FR0605, 2006/7008139.
Unpublished study prepared by BASF Corporation. 62 p.
46902326
46902327
Yacoub, R. (2006) BAS 556 01 F: Determination of Physical State, pH,
Explodability, Relative Density, Flammability, and Viscosity: Final
Report. Project Number: 138251, 2006/7006656. Unpublished study
prepared by BASF Corporation. 12 p.
Yacoub, R. (2006) BAS 556 01 F: Determination of Oxidizing/Reducing
46902328 Action: Final Report. Project Number: 138254, 2006/7006762.
Unpublished study prepared by BASF Corporation. 13 p.
Yacoub, R. (2006) BAS 556 01 F: Accelerated Storage Stability. Project
46902329 Number: 2006/7006763. Unpublished study prepared by BASF
Corporation. 13 p.
Gamer, A.; Hellwig, J. (2006) BAS 556 UG F - Acute Oral Toxicity
46902330 Study in Rats. Project Number: 10A0515/051035, 2005/1019609.
Unpublished study prepared by BASF Aktiengesellschaft. 22 p.
Gamer, A.; Hellwig, J. (2006) BAS 556 UG F - Acute Dermal Toxicity
46902331 Study in Rats. Project Number: 11A0515/051060, 2005/1029610.
Unpublished study prepared by BASF Aktiengesellschaft. 23 p.
46902332
Hock, L.; Hellwig, J. (2005) BAS 556 UGF - Acute Inhalation Toxicity
Study in Wistar Rats 4-hour Liquid Aerosol Exposure. Project Number:
1310515/057008, 2005/1026595. Unpublished study prepared by BASF
Aktiengesellschaf. 37 p.
Remmele, M.; Hellwig, J. (2006) BAS 556 UG F - Acute Eye Irritation
Study in Rabbits. Project Number: 11H0515/052073, 2005/1029612.
24-Jul-
2006
Blanset, D. (1998) Dermal Sensitization Study with AC 900768 90 g/L SL
(RLF 12307) in Guinea Pigs - Buehler Method (Nine Inductions). Project 24-Jul-
Number: 97/1701, 971/97/153, MK/460/026. Unpublished study prepared 2006
by Huntingdon Life Sciences. 40 p.
24-Jul-
2006
Vanhook, C. (2005) Method AFR0039/01: BAS 556 F: Determination of
Metconazole and/or Pyraclostrobin Content in Technical Grade Material 24-Jul-
and Formulations by HPLC. Project Number: AFR0039/01, F200511, 2006
2005/5000101. Unpublished study prepared by BASF Corporation. 22 p.
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
24-Jul-
2006
43
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46902334
46902335
Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
Remmele, M.; Hellwig, J. (2006) BAS 556 UG F - Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18H0515/052136,
2005/1029611. Unpublished study prepared by BASF Aktiengesellschaft.
21 p.
Gamer, O.; Hellwig, J. (2006) BAS 556 UG F - Modified BUEHLER Test
(9 Inductions) In Guinea Pigs. Project Number: 33H0515/052137,
2005/1029613. Unpublished study prepared by BASF Aktiengesellschaft.
32 p.
Kureha Corporation (2006) Submission of Environemntal Fate Data in
46955600 Support of the Application for Registration of Metconazole Fungicide
Technical. Transmittal of 2 Studies.
46955601
46955602
Stearns, J. (2006) Transferable Turf Residue of Metconazole on Turf grass
Supplement - Detailed Weather Data. Project Number: V/25718,
46805107, 200600461. Unpublished study prepared by Valent U.S.A.
Corporation and Agriscope, LLC. 5 p.
Stearns, J. (2006) Transferable Turf Residue of Metconazole on Turf grass
Supplement - Detailed Weather Data. Project Number: V/27246,
46805108, 200600462. Unpublished study prepared by Valent U.S.A.
Corporation and Agsearch. 5 p.
Kureha Corporation (2007) Submission of Product Chemistry Data in
47095800 Support of the Application for Registration of Metconazole Fungicide
Technical. Transmittal of 1 Study.
Wustner, D. (2007) Metconazole Fungicide Technical (KNF-S0474m):
Product Chemistry Group A - Composition, Materials, Process and
47095801 Formation of Impurities - Alternate Manufacturing Site. Project Number:
V/PC/3, 200700037. Unpublished study prepared by Valent U.S.A.
Corporation and BASF Aktiengesellschaft. 51 p.
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