United States
Environmental Protection
Agency
Office of Prevention, Pesticides
and Toxic Substances
(7501P)
?/EPA
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Prothioconazole
New Chemical
Tolerances Established
March 14,2007
Description of Chemical
Generic Name:
Common Name:
Trade Name:
Chemical Class:
EPA Chemical Code:
CAS Number:
Registration Status:
Pesticide Type:
U.S. Producer:
Tolerances Established
Prothioconazole (2-(2-(l-chlorocyclopropyl)-3-(2-
chlorophenyl)-2-hydroxypropyl)-1,2-dihydro-3#-
l,2,4-triazole-3-thione)
Prothioconazole
PROLINE ® 480 SC Fungicide
Triazolinthione
113961
178928-70-6
New Chemical Registration
Fungicide
Bayer CropScience
2 T. W. Alexander Drive
Research Triangle Park, NC 27709
Tolerances were established for prothioconazole in the 40 CFR §180.626 section as summarized
below:
Tolerances for combined residues of prothioconazole and its desthio metabolite:
Barley, grain 0.35 ppm
Barley, hay 7.0 ppm
Barley, straw 4.0 ppm
Grain, aspirated grain fractions 11
Pea and bean, dried shelled, except soybean, subgroup 6C 0.90 ppm
Peanut, nutmeat 0.02 ppm
-------
Peanut, hay 6.0 ppm
Rapeseed, seed 0.15 ppm
Wheat, grain 0.07 ppm
Wheat, forage 6.0 ppm
Wheat, hay 4.5 ppm
Wheat, straw 5.0 ppm
Tolerances for prothioconazole, the desthio metabolite, and conjugates
convertible to these compounds by acid hydolysis, calculated as parent:
Cattle, fat 0.1 ppm
Cattle, meat 0.02 ppm
Cattle, meat byproducts 0.20 ppm
Goat, fat 0.1 ppm
Goat, meat 0.02 ppm
Goat, meat byproducts 0.20 ppm
Hog, meat byproducts 0.05 ppm
Horse, fat 0.1 ppm
Horse, meat 0.02 ppm
Horse, meat byproducts 0.20 ppm
Milk 0.02 ppm
Poultry, liver 0.02 ppm
Sheep, fat 0.1 ppm
Sheep, meat 0.02 ppm
Sheep, meat byproducts 0.20 ppm
Use Patterns and Formulations
Prothioconazole is a broad-spectrum systemic fungicide produced by Bayer CropScience for the
control of diseases caused by ascomycetes, basidiomycetes, and deuteromycetes.
Prothioconazole may be applied alone or as a tank mix with other fungicides, insecticides, or
herbicides. Application through any type of irrigation system is prohibited.
EPA and the Pest Management Regulatory Agency (PMRA) of Canada jointly reviewed
prothioconazole. The crops proposed for joint review include barley, canola, chickpeas, the
oilseed crop group, the dried shell and bean subgroup, lentils and wheat. Uses on peanuts were
proposed for the U.S. only.
Prothioconazole is formulated as a 4 Ib/gal suspension concentrate (equivalent to a flowable
concentrate; F1C) formulation (Proline® 480 SC Fungicide, 41% active ingredient). The product
is applied as broadcast post emergence foliar or soil sprays (application to soil for peanuts only)
using ground or aerial equipment at 0.088-0.178 Ib ai/A/application (0.100-0.200 kg
ai/ha/application). The proposed maximum seasonal rates range 0.285-0.713 Ib ai/A (0.320-
0.800 kg ai/ha), and the proposed retreatment intervals are 5-21 days. The PHIs range from 7
days for dried shelled peas and beans to 36 days for oilseed crops. The directions for use of
prothioconazole are summarized in Table 1.
PROTHIOCONAZOLE FACT SHEET - Page 2 of 5 5
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Table 1. Summary of Directions for Use of Prothioconazole
Applic.
Timing,
Type, and
Equip.
Applic. Rate
(Ib ai/A)
[fl oz/A]
Max. No.
Applic. per
Season
Retreatment
Interval
(days)
Max. Seasonal
Applic. Rate
(Ib ai/A)
[fl oz/A]
PHI
(days)
Use Directions and Limitations
Barley (for Fusarium Head Blight)
Broadcast
foliar
spray;
Ground or
aerial
0.134-0.178
[4.3 - 5.7]
2
7 to 14
0.293
[9.37]
32
Apply as a preventative foliar spray
within the time period when 70 to 100%
of the barley heads on the main stem are
fully emerged when weather conditions
are favorable for disease development
and up to 3 to 5 days after full head
emergence.
Barley (for Leaf and Stem Diseases)
Broadcast
foliar
spray;
Ground or
aerial
0.0875-0.134
[2.8-4.3]
2
7 to 14
0.269
[8.6]
32
Apply as a preventative foliar spray
when the earliest disease symptoms
appear on the leaves or stems.
Chickpea
Broadcast
foliar
spray;
Ground or
aerial
0.134-0.178
[4.3 - 5.7]
3
10 to 14
0.534
[17.1]
7
Apply at first sign of disease. Use
higher use rate when conditions are
favorable for severe disease pressure
and/or when growing less disease
resistant varieties.
Dried Shelled Peas and Beans Subgroup, except Soybean
(Grain, Sweet, White and White Sweet lupins; Field, Kidney, Dry lima, Pinto and Tepary beans; Adzuki bean,
Blackeyed pea, Catjang, Cowpea, Crowder pea, Moth bean, Mung bean, Rice bean, Southern pea and Urd bean; Dry
broad bean; Guar; Lablab bean; Pea [including Field pea] and Pigeon pea)
Broadcast
foliar
spray;
Ground or
aerial
Broadcast
foliar
spray;
Ground or
aerial
Broadcast
foliar
spray;
Ground or
aerial
0.134-0.178
[4.3-5.7]
0.134-0.178
[4.3-5.7]
0.134-0.178
[4.3-5.7]
3
3
Rapes
2
5 to 14
10 to 14
eed (Canola),
5 to 7
0.534
[17.1]
Lentils
0.534
[17.1]
ndian rapeseed,
0.356
[11.4]
7
7
and Cran
36
Apply at the first sign of disease. Use
higher use rate when conditions are
favorable for severe disease pressure
and/or when growing less disease
resistant varieties.
Apply at early flower or at the first sign
of disease. Use higher use rate when
conditions are favorable for severe
disease pressure and/or when growing
less disease resistant varieties.
ibe
Apply when the crop is 20 to 50%
bloom stage (not after the 50% bloom
stage).
Utilize higher rate for fields with history
of heavy disease pressure or for dense
crop stands.
Peanut
PROTHIOCONAZOLE FACT SHEET - Page 3 of 5 5
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Table 1. Summary of Directions for Use of Prothioconazole
Applic.
Timing,
Type, and
Equip.
Broadcast
foliar
spray;
Ground or
aerial
Applic. Rate
(Ib ai/A)
[fl oz/A]
0.156-0.178
[5.0-5.7]
Max. No.
Applic. per
Season
4
Retreatment
Interval
(days)
14 to 21
Max. Seasonal
Applic. Rate
(Ib ai/A)
[fl oz/A]
0.713
[22.8]
PHI
(days)
14
Use Directions and Limitations
Use higher rate when conditions are
favorable for severe disease pressure
and/or when growing less disease
resistant varieties.
Wheat (spring, durum and winter; for Fusarium Head Blight)
Broadcast
foliar
spray;
Ground or
aerial
0.134-0.178
[4.3-5.7]
2
7 to 14
0.293
[9.37]
30
Apply within the time period from when
at least 75% of the wheat heads on the
main stem are fully emerged to when
50% of the heads on the main stem are
in flower. Optimal timing of
application may be at or around 15%
flower.
Wheat (spring, durum and winter; for Leaf and Stem Diseases)
Broadcast
foliar
spray;
Ground or
aerial
0.134-0.156
[4.3 - 5.0]
2
7 to 14
0.293
[9.37]
30
Apply as a preventative foliar spray or
when the earliest disease symptoms
appear on the leaves or stems.
Science Findings
The Agency has completed a human health risk assessment for the uses of the new active
ingredient prothioconazole. For the approved crops, the risk estimates from acute and chronic
dietary (food + water) exposures do not exceed the Agency's LOG.
The toxicology database is extremely large, especially the number of complex toxicology
studies. The toxicity database for prothioconazole (and its metabolites) is considered complete
and deemed adequate for endpoint selection for exposure and risk assessment, for FQPA
evaluation, and to support the approved uses and tolerances.
With respect to cancer, EPA has concluded prothioconazole and its metabolites are not
carcinogenic, and are classified "Not likely to be Carcinogenic to Humans."
Available product chemistry and toxicology data supporting the proposed tolerance are
summarized below.
PROTHIOCONAZOLE FACT SHEET - Page 4 of 5 5
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Physical/Chemical Structure:
Prothioconazole -
Prothioconazole-Desthio -
OH Cl
Table 2. Prothioconazole Nomenclature.
Empirical Formula
Common name
Company experimental name
IUPAC name
CAS name
CAS registry number
End-use product/EP
Chemical Class
Known Impurities of Concern
C14H15C12N3OS
Prothioconazole
JAU 6476
2-[(2RS)-2-(l-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2ff-l,2,4-triazole-
3(4//)-thione
2-[2-( 1 -Chlorocyclopropyl)-3 -(2-chlorophenyl)-2-hydroxypropyl]- 1 ,2-dihydro-
3H- l,2,4-triazole-3 -thione
178928-70-6
PROLINE ® 480 SC Fungicide
Triazolinthione
None
The physical and chemical properties of prothioconazole are summarized in Table 3.
Table 3. Physicochemical Properties of the Technical-Grade Prothioconazole.
Parameter
Molecular Weight
Melting point
Density (g/ml at 20°C)
Value
344.26 g/mol
139.1- 144.5 °C
1.36 (pure active ingredient)
1.17 at 20 °C (end use product)
Reference
MRID 46246003
MRID 46246003
MRID 46246003
PROTHIOCONAZOLE FACT SHEET- Page 5 of 55
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Table 3. Physicochemical Properties of the Technical-Grade Prothioconazole.
Parameter
Water solubility (g/L)
Solvent solubility at 20 °C (g/L)
Vapor pressure (Pa at 20 or 25 °C)
Dissociation constant, pKa
Octanol/water partition coefficient, Log(K0w)
UV/visible absorption spectrum
Value
5.0 pH 4 buffer at 20 °C
0.3 pH 8 buffer at 20 °C
2.0 pH 9 Buffer at 20 °C
g/L at room temp
acetone >250
acetonitrile 10-100
dichloromethane 100-250
dimethylsulfoxide 100-250
ethyl acetate <250
n-heptane <0.1
1-octanol 10-100
polyethylene glycol >250
2-propanol 10-100
xylene 1-10
<4 x 10'7
6.9
at 20 °C
unbuffered: Kow = 11300; log Kow = 4.05
pH4:Kow=14600;log = 4.16
pH7:Kow = 6600;log=3.82
pH9:Kow=100;log = 2.00
Peak maxima at 275 nm. No absorption
at >300 nm.
Reference
MRID 46246003
MRID 46246003
MRID 46246003
MRID 46246003
MRID 46246003
MRID 46246003
Toxicological Characteristics
In addition to prothionconazole^er se, the major metabolite prothioconazole-desthio is of
toxicological interest. Residues of prothioconazole-desthio, the major metabolite/degradate in
plants, together with residues of its 4-hydroxy metabolites, may also be found in edible ruminant
tissues and milk. Because of the toxicological significance of the parent prothioconazole and
prothioconazole-desthio, this Fact Sheet provides summaries of the available toxicity
information for both compounds.
Table 4. Acute Toxicity of Prothioconazole Technical
Guideline No.
870.1100
870.1200
870.1300
870.2400
Study Type
Acute oral toxicity (rat)
Acute dermal toxicity
(rat)
Acute inhalation toxicity
(rat)
Primary eye irritation
(rabbit)
MRID No.
46246230
46246244
46246246
46246249
T. ix Toxicity
Results „ x J
Category
LD50 >= 6200
mg/kg (M, F)
LD50 >= 2000
mg/kg (M,F)
LC50 >= 4.99 mg/L
(M,F)
Not an irritant IV
PROTHIOCONAZOLE FACT SHEET- Page 6 of 55
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Table 4. Acute Toxicity of Prothioconazole Technical
Guideline No.
870.2500
870.2600
Study Type
Primary skin irritation
(rabbit)
Dermal sensitization
(Guinea pig)
MRID No.
46246302
46246305
T. ix Toxicity
Results „ x J
Category
Not an irritant IV
Not a sensitizer Negative
Table 5. Acute Toxicity of Prothioconazole-desthio
Guideline No.
870.1100
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral toxicity (rat)
Acute oral toxicity
(mouse)
Acute dermal toxicity
(rat)
Acute inhalation toxicity
(rat)
Primary eye irritation
(rabbit)
Primary skin irritation
(rabbit)
Dermal sensitization
(Guinea pig)
MRID No.
46246231
46246242
46246243
46246247
46246250
46246250
46246304
Results
LD50 = 2806
mg/kg (M, F)
(approximate)
LD50 = 2235
mg/kg (M)
LD50 = 3459
mg/kg (F)
LD50 >= 5000
mg/kg (M,F)
LC50 >= 5.077
mg/L
(M,F)
Slight irritant
(iritis, discharge)
Not an irritant
Not a sensitizer
Toxicity
Category
III
III
IV
IV
III
IV
Negative
Table 6. Toxicity Profile for Prothioconazole Technical
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.3700a
Prenatal develop-
mental in rats - oral
46246316(1996)
0, 80, 500, 1000
mg/kg/day
Acceptable/Guideline
Maternal Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 500 mg/kg/day based on increased urination and
water consumption, and decreased body weight gain.
Developmental Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 500 mg/kg/day based on increased incidence of
delayed ossification, increased incidence of dysplastic pubic
bone, and increased incidence of left punctiform 14th rib.
PROTHIOCONAZOLE FA CT SHEET - Page 7 of 55
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Table 6. Toxicity Profile for Prothioconazole Technical
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.3700a
Prenatal develop-
mental in rats - oral
46246317(2002)
0, 40, 200, 1000
mg/kg/day
Acceptable/Nonguideline
Range finding study for above, no endpoints were
determined.
870.3700a
Prenatal develop-
mental in rodents
(rat) - dermal
46246323 (2001)
0, Technical 1000
mg/kg/day, 62.5
mg/kg/day diluted EC 250
formulation, 250
mg/kg/day EC 250
formulation
Acceptable/Nonguideline
Maternal Toxicity
NOAEL > 1000 mg/kg/day
LOAEL > 1000 mg/kg/day
Developmental Toxicity
NOAEL = 1000 mg/kg/day
LOAEL > 1000 mg/kg/day
870.3700a
Prenatal develop-
mental in rats - oral
46923601 (2004)
0, 20, 80, 750 mg/kg/day
Acceptable/Nonguideline
Maternal Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 750 mg/kg/day based on increased water
consumption, decreased food consumption and decreased
body weight gain.
Developmental Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 750 mg/kg/day based on increased incidence of
rudimentary ribs (comma-shaped).
870.3700b
Prenatal develop-
mental in nonrodents
(rabbit)
46246330 (1997)
0, 80, 100, 300, 480
mg/kg/day
pilot study
Acceptable/Nonguideline
Maternal Toxicity
NOAEL < 80 mg/kg/day
LOAEL = 80 mg/kg/day based on reduced food consumption
and body wts.
Developmental NOAEL = 300 mg/kg/day
LOAEL = 480 mg/kg/day based on decreased body wt, and
small fetuses.
870.3700b
Prenatal develop-
mental in nonrodents
(rabbit)
46246328 (1998)
0, 10, 30, 80, 350*
mg/kg/day
* Additional group added
after start of study
Acceptable/Guideline
Maternal Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 350 mg/kg/day based on decreased body wt and
decreased food consumption.
Developmental Toxicity
NOAEL = 80 mg/kg/day
LOAEL = 350 mg/kg/day based on abortions, total
resorptions, and lower fetal body weight
870.4100a
Chronic toxicity
rodents (rat)
46246335 (2000)
0, 5, 50, 750 mg/kg/day
Rat, 53 weeks
Acceptable/Guideline
NOAEL = 50 mg/kg/day
LOAEL = 750 mg/kg/day based on decreased body weight
and body weight gain, alterations in hematology and clinical
chemistry parameters indicative of liver and kidney damage,
increased liver and kidney weights, and accompanying
histopathological alterations in the liver, kidney and urinary
bladder. FOB conducted at 27 and 52 weeks.
PROTHIOCONAZOLE FACT SHEET - Page 8 of 5 5
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Table 6. Toxicity Profile for Prothioconazole Technical
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.4 lOOb
Chronic toxicity
non-rodent (dog)
46246336 (2001)
0, 5, 40, 125 mg/kg/day
one year
Acceptable/Guideline
NOAEL = 5 mg/kg/day
LOAEL = 40 mg/kg/day based on decreased T3 and T4
thyroid hormones, increased urine volume, and increased
incidence of chronic inflammation and pigmentation in the
kidneys of the male animals, and decreased T4 thyroid
hormone, increased spleen weight, increased incidence of
spleen pigmentation, and increased incidence of crystals
present in the kidneys of the female animals.
870.4200
Carcinogenicity rats
46246338 (2001)
M: 0, 5, 50, 750/500
mg/kg/day
F: 0,5,50,750/625
mg/kg/day
106 weeks
Unacceptable/Guideline
for Carcinogenicity
because dose levels too
high.
NOAEL = 50 mg/kg/day
LOAEL = 500/625 (M/F) mg/kg/day based on increased
mortality and decreased body weight/body weight gain,
changes in clinical chemistry (APh, creatinine, urea) and
hematological parameters, increased liver and kidney
weights, and liver (hypertrophy and eosinophilic/clear cell
focus) and kidney/urinary bladder pathology.
870.4300
Carcinogenicity mice
46246339 (2001)
0, 10, 70, 500 mg/kg/day
80 weeks
Acceptable/Guideline
NOAEL = 10 mg/kg/day
LOAEL = 70 mg/kg/day based on kidney (tubular
degeneration/regeneration in males) effects.
no evidence of Carcinogenicity
Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665)
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.3700a
Prenatal develop-
mental in rodents
(rat) - dermal
46246326 (1991)
0, 30 mg/kg/day
Pilot study, used with
46246325
Acceptable/Nonguideline
Discussed in appendix 1 of MRID 46246325
Maternal Toxicity
NOAEL = 30 mg/kg/day
LOAEL > 30 mg/kg/day
Developmental Toxicity
NOAEL = 30 mg/kg/day
LOAEL > 30 mg/kg/day
870.3700a
Prenatal develop-
mental in rodents
(rat) - dermal
46246325 (1991)
0, 100, 300, 1000
mg/kg/day
Acceptable/Guideline
When combined with
46246326
Maternal Toxicity
NOAEL = 1000 mg/kg/day
LOAEL > 1000 mg/kg/day
Developmental Toxicity
NOAEL = 30 mg/kg/day
LOAEL =100 mg/kg/day based on structural alterations (14th
rib)
870.3700a
Prenatal develop-
mental in rodents
(rat) - oral
46246322 (1991)
0, 1, 3 mg/kg/day
Acceptable/Nonguideline
results combined
with 46246321
Maternal Toxicity
NOAEL = 3 mg/kg/day
LOAEL > 3 mg/kg/day
Developmental Toxicity
NOAEL = 3 mg/kg/day
LOAEL > 3 mg/kg/day
Combined with 46246321
PROTHIOCONAZOLE FACT SHEET - Page 9 of 5 5
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Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665)
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.3700a
Prenatal develop-
mental in rodents
(rat) - oral
46246321 (1991)
0, 10, 30, 100 mg/kg/day
Acceptable/Guideline
results combined with
46246322
Maternal Toxicity
NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on decreased body weight
gains, increased liver weight with histopathology
Developmental Toxicity
NOAEL < 10 mg/kg/day
LOAEL < 10 mg/kg/day based on structural alterations
(supernumery ribs) and incomplete/delayed ossification at all
levels.
Combined with 46346322
870.3700a
Prenatal develop-
mental in rodents
(rat) - oral
46246320 (1990)
0, 100 mg/kg/day
Acceptable/Nonguideline
Maternal Toxicity
NOAEL = 100 mg/kg/day
LOAEL > 100 mg/kg/day
Developmental Toxicity
NOAEL <100 mg/kg/day
LOAEL = 100 mg/kg/day based on developmental delays
870.3700a
Prenatal develop-
mental in rodents
(rat) - oral
46246319(1992)
0, 30 mg/kg/day oral
Acceptable/Nonguideline
Maternal Toxicity
No NOAEL or LOAEL were determined
Developmental Toxicity
No NOAEL or LOAEL were determined, observations
included structural abnormalities, developmental delays,
death, shows 14th rib not completely reversible afterbirth.
Follow up of MRID 46246320, 46246321.
870.3700b
Prenatal
developmental in
nonrodents
(rabbit) - oral
46246327, (1991)
0, 2, 10, 50 mg/kg/day
Acceptable/Guideline
Maternal Toxicity
NOAEL = 10 mg/kg/day
LOAEL = 50 mg/kg/day based on decreased body wt gain,
decrease food consumption, increased resorptions, decreased
number of fetuses, liver histopathology.
Developmental Toxicity
NOAEL = 2 mg/kg/day
LOAEL =10 mg/kg/day based on structural alterations
including malformed vertebral body and ribs, arthrogryposis,
and other multiple malformations.
870.3700b
Prenatal
developmental in
nonrodents
(rabbit) - dermal
46246329 (1991)
0, 100, 300, 1000
mg/kg/day dermal
pilot study
Acceptable/Nonguideline
Maternal Toxicity
NOAEL = 300 mg/kg/day
LOAEL = 1000 mg/kg/day based on local dermal toxicity
Developmental Toxicity
NOAEL = 1000 mg/kg/day
LOAEL > 1000 mg/kg/day
870.4 lOOb
Chronic toxicity
dogs
46246337 (2001)
0, 40, 300, 2000 ppm
0, 1.35/1.55, 10.1/11.1,
69.9/77.1 (M/F)
mg/kg/day
30 weeks
Unacceptable/Guideline
Not tested at high enough
doses
GLP deficiencies
NOAEL = 69.9/77.1 (M/F) mg/kg/day
LOAEL > 69.9/77.1 (M/F) mg/kg/day
PROTHIOCONAZOLE FACT SHEET - Page 10 of 55
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Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665)
Guideline No./
Study Type
MRID No. (year)/
Classification /Doses
Results
870.4200
Carcinogenicity rats
46246342 (1999)
0, 20, 140, 980 ppm
0, 1.1/1.6,8.0/11.2,
51.6111A (M/F)
mg/kg/day
Acceptable/Guideline
NOAEL = 1.1/1.6 (M/F) mg/kg/day
LOAEL = 8.0/11.2 (M/F) mg/kg/day based on clinical
chemistry, histopathology (liver).
no evidence of carcinogenicity
870.4300
Carcinogenicity mice
46246340 (2000)
46246341 (2001)
0, 12.5, 50, 200 ppm
0,3.1/5.1, 12.8/20.3,
51.7/80.0 (M/F)
mg/kg/day
105 weeks
Acceptable/Guideline
NOAEL =12.8/20.3 (M/F) mg/kg/day
LOAEL = 51.7/80.0 (M/F) mg/kg/day based on decreased
body weight gain in males, decreased triglyceride levels in
both sexes, decreased cholesterol levels in males, changes in
glucose levels in males, increased liver weights in both sexes,
increased incidence of histopathological findings in the liver
hepatocytes in both sexes, decreased blood urea levels in
females, increased kidney weights in females, and increased
incidence of eosinophilic droplets in the cortical tubules of
the kidneys of females.
no evidence of carcinogenicity
870.6300
Developmental
neurotoxicity rats
46246418 (2004)
0, 40, 160, 500 ppm
0,3.6, 15.1,43.3
mg/kg/day during
gestation
0,8.1,35.7, 104.6 during
lactation
Acceptable/Nonguideline
Maternal Toxicity
NOAEL =15.1 mg/kg/day
LOAEL = 43.3 mg/kg/day based on dystocia
Developmental Toxicity
NOAEL = 3.6 mg/kg/day
LOAEL =15.1 mg/kg/day based on deviated snout and
malocclusion
Offspring Neurotoxicity potential could not be determined -
Brain morphometric changes and increased incidence of
peripheral nerve lesions were observed at high dose level, but
not measured at mid- and low-dose levels.
Toxicological Endpoints
Table 8. Summary of Toxicological Doses and Endpoints for Prothioconazole desthio
for Use in Human Health Risk Assessments
Exposure/
Scenario
Point of
Departure
Uncertainty/FQPA
Safety Factors
RfD, PAD, Level
of Concern for
Risk Assessment
Study and Toxicological Effects
Dietary and Non-Occupational Human Health Risk Assessments
Acute Dietary
(Females 13-49)
Acute Dietary
(General Population,
including infants and
children)
NOAEL =
2.0
mg/kg/day
None
UFA=10x
UFH=10x
FQPASF=10x
(UFDB)
None
Acute RfD =
0.002 mg/kg/day
aPAD = 0.002
mg/kg/day
None
Developmental Toxicity study in rabbits
LOAEL =10 mg/kg/day, based on
structural alterations including malformed
vertebral body and ribs, arthrogryposis,
and multiple malformations.
An appropriate study was not identified
PROTHIOCONAZOLE FACT SHEET - Page 11 of 5 5
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Table 8. Summary of Toxicological Doses and Endpoints for Prothioconazole desthio
for Use in Human Health Risk Assessments
Chronic Dietary (All
Populations)
Incidental Oral
Short- and
Intermediate-Term
(1-30 days and 1-6
months)
Dermal Short- and
Intermediate-Term
(1-30 days and 1-6
months)
Inhalation Short-
and Intermediate-
term (1-30 days and
1-6 months)
Cancer (oral,
dermal, inhalation)
NOAEL=1.1
mg/kg/day
N/A
N/A
N/A
UFA=10x
UFH=10x
FQPASF=10x
(UFDB)
N/A
N/A
N/A
Chronic RfD =
0.001 mg/kg/day
cP AD = 0.001
mg/kg/day
N/A
N/A
N/A
Chronic/Oncogenicity study in rats
LOAEL = 8.0 mg/kg/day based on liver
histopathology (hepatocellular vacuolation
and fatty change (single cell, centrilobular,
andperiportal)).
Incidental oral exposure endpoint not
identified because residential exposure is
not anticipated.
Dermal endpoints are not applicable
because residential exposure is not
anticipated.
Inhalation endpoints are not applicable
because residential exposure is not
anticipated
Classification: "Not likely to be Carcinogenic to Humans" based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies.
Occupational Human Health Risk Assessments
Dermal Short- and
Intermediate-Term
(1-30 days and 1-6
months)
Inhalation Short-
and Intermediate-
term (1-30 days and
1-6 months)
Cancer (oral,
dermal, inhalation)
NOAEL=30
mg/kg/day
NOAEL=2.0
mg/kg/day
Inhalation
absorption
are assumed
to be 100%
UFA=10x
UFH=10x
UFDB = 10x
UFA=10x
UFH=10x
UFDB = 10x
Occupational
LOCforMOE =
1000
Occupational
LOCforMOE =
1000
Dermal developmental study in rats
LOAEL =100 mg/kg/day based on an
increased incidence of supernumerary rib
(14th rib).
Developmental Toxicity study in rabbits
LOAEL =10 mg/kg/day, based on
structural alterations including malformed
vertebral body and ribs, arthrogryposis,
and multiple malformations.
Classification: "Not likely to be Carcinogenic to Humans" based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies.
For acute and chronic dietary (food and water) risk assessments, the lOx FQPA SF
(lOx) for the lack of NOAEL and a LOAEL from the developmental neurotoxicity
(peripheral nerve lesions and brain morphometrics).
has been retained in the form of an UFdb
study, regarding some neurotoxic endpoint
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 data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOG = level of
concern. N/A = not applicable.
The LOG for occupational exposure to prothioconazole desthio is based on the conventional uncertainty factor of lOOx (UFA =
lOx and UFH = lOx) and an additional UFDB (lOx) for the lack of NOAEL and a LOAEL from the developmental neurotoxicity
study, regarding some neurotoxic endpoint (peripheral nerve lesions and brain morphometrics).
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Food Quality Protection Act Considerations:
There are adequate data in the prothioconazole (including metabolites) database to characterize
the potential for pre-natal or post-natal risks to infants and children: two-generation reproduction
studies in rats; developmental studies in rats and rabbits; and a developmental neurotoxicity
study in rats. The effects seen in these studies suggest that pups are more susceptible: pup
effects were seen at levels below the LOAELs for maternal toxicity and, in general, were of
comparable or greater severity compared to the effects observed in adults. In addition, since the
developmental effects seen in the developmental neurotoxicity study were investigated at the
high dose level only, there is uncertainty concerning the LOAEL/NOAEL for developmental
effects in this study. Thus, the FQPA factor is retained at 10X. EPA is currently regulating at
doses lower than the lowest dose in the DNT. It is unlikely that the lowest dose tested in the
DNT will be a LOAEL.
Exposure Assessment:
Acute Dietary Exposure and Risk: A moderately refined acute dietary exposure assessment was
conducted for prothioconazole using empirical processing factors (PFs), livestock maximum
residues, and 100 percent crop treated (%CT). An acute endpoint was identified only for
females, 13-49 years of age. Dietary risk estimates were determined considering exposures from
food plus upper bound surface water EDWC point estimates based on the bean application
scenario.
The dietary exposure analyses result in acute dietary risk estimates that are below the Agency's
level of concern for food and drinking water. The most conservative exposure estimate, using
upper bound water residues from the bean application scenario resulted in exposure estimates at
the 95th percentile of 0.001192 mg/kg/day, which utilized 60% of the aPAD for females 13-49
years of age.
Chronic Dietary Exposure and Risk: A moderately refined chronic dietary exposure assessment
assumed empirical processing factors, average residues, livestock maximum residues, and
100%CT. Dietary risk estimates were determined considering exposures from food plus upper
bound surface water EDWC point estimates based on the bean application scenario. The dietary
exposure analysis results in chronic dietary risk estimates that are below the Agency's level of
concern for food plus drinking water. The highest exposure and risk estimates were for all
infants and children 1-2 years old. The highest exposure and risk estimates for food plus upper
bound water were for the all infants population subgroup, with an estimated exposure of
0.000948 mg/kg/day, which utilized 86% of the cPAD.
Cancer Exposure and Risk: The available toxicology studies in the mouse and rat showed no
increase in tumor incidence, and therefore the Agency concluded that prothioconazole or its
metabolites are not carcinogenic, and classified "Not Likely to be Carcinogenic to Humans"
according to the 2005 Cancer Guidelines. Therefore, a dietary cancer assessment was not
performed.
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Residential Exposure and Risk: Residential exposures are not expected, since there are no
proposed residential uses.
Aggregate Exposure and Risk: In accordance with the FQPA, the Agency must consider
aggregate pesticide exposures and risks from three major sources: food, drinking water, and
residential exposures. Consequently, an aggregate assessment adds together exposures from
relevant sources and compares the resulting estimate of total exposure to numerical estimates of
hazard (e.g., a NOAEL or PAD); alternatively, the risks themselves can be aggregated. When
aggregating exposures and risks from various sources, the Agency considers both the route and
duration of exposure.
Based on the Section 3 food crop uses, dietary aggregate exposures (i.e. food plus drinking
water) are expected. The Agency does not expect residential exposures at this time because no
residential uses have been proposed. Therefore, dietary (food plus drinking water) exposures
sufficiently define aggregate exposures for assessment of risks from the use of prothioconazole.
Estimates of pesticide residues in drinking water were incorporated directly into the dietary
exposure analysis to assess aggregate acute and chronic risk.
Cumulative Exposure and Risk: Prothioconazole is a member of the triazole-containing class of
pesticides, often referred to as the conazoles. EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the conazoles. At this time, there is not
sufficient evidence to determine whether conazoles share common mechanisms of toxicity.
Without such understanding, there is no basis to make a common mechanism of toxicity finding
for the diverse range of effects found. For information regarding EPA's procedures for
cumulating effects from substances found to have a common mechanism of toxicity, see EPA's
website at http://www.epa.gov/pesticides/cumulative.
To support existing tolerances and to establish new tolerances for conazole pesticides, including
prothioconazole, EPA conducted human health risk assessments for exposure to 1,2 4-triazole,
triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of
triazole-containing pesticides (as of 9/1/05), including prothioconazole. The risk assessment is a
highly conservative, screening-level evaluation in terms of hazards associated with the common
metabolites (e.g., use of maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures).
Acute and chronic aggregate risk estimates associated with these compounds are below the
Agency's level of concern for all durations of exposure and for all population subgroups,
including those of infants and children. The Agency's risk assessment for these common
metabolites is available in the propiconazole reregi strati on docket at http://www.regulations.gov,
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497.
Occupational Exposure and Risk: Occupational exposure to prothioconazole is limited to use of
the formulation PROLINE® 480 SC Fungicide, which is for application on barley, oilseed crops,
dried bean and pea crops, peanuts, and wheat. Short- and intermediate-term dermal and
inhalation exposures are expected from handler activities, and short- and intermediate-term
dermal exposures are expected from postapplication activities. The short- and intermediate-term
dermal exposure scenarios are assessed using the NOAEL of 30 mg/kg/day from the dermal
PROTHIOCONAZOLE FACT SHEET - Page 14 of 5 5
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developmental toxicity study in the rat. The short- and intermediate-term inhalation exposure
scenarios are assessed using the NOAEL of 2 mg/kg/day from the rabbit developmental toxicity
study.
EPA did not use a submitted prothioconazole-specific handler exposure study because the unit
exposure information was inappropriate for estimating exposure, the small scale of the study, the
choice of activity, and the use of Bayer employees as study subjects. An ethics review of this
study was completed (K.Sherman, 9/27/06) concluded that the study does not violate current
ethical standards. Although it was considered scientifically valid for qualitative purposes, the
study not meet HED's scientific standards for quantitative use in risk assessment
Short-/Intermediate-Term Handler Risk: Handlers are assumed to have potential short- (1-30
consecutive days) and intermediate-term (31-180 consecutive days) dermal and inhalation
exposure to prothioconazole and its degradates when mixing, loading and applying PROLINE®
480 SC Fungicide. Short- and intermediate-term risk is not of concern if the MOE attains or
exceeds the LOC of 1000.
PROLINE® 480 SC is applied aerially and by ground equipment. MOEs for mixers and loaders
reached or exceeded the LOC of 1000 for all scenarios except for wheat for aerial application,
even when engineering controls/PPE were applied (closed system and gloves). The LOC of
1000 was reached for mixers/loaders for groundboom application with single-layer PPE plus
gloves. Representative handler exposure scenarios include mixing and loading (M/L) for aerial
and groundboom equipment, application with aerial and groundboom equipment, and flagging
for aerial applications. Total MOEs range from 870 (closed M/L for aerial application to wheat)
to 5,000. The MOE of 870 is not considered a significant departure from the target LOC of
1000. Aerial and groundboom application exposure scenarios reach MOEs of 1000 with baseline
clothing and no gloves. With appropriate PPE and engineering controls (for aerial M/L
activities), the target MOE of 1000 is attained or exceeded for all handler activities.
Short-/Intermediate-Term Postapplication Risk: Postapplication workers are assumed to have
potential short- and intermediate-term dermal exposure (but not inhalation exposure) from the
uses of PROLINE® 480 SC Fungicide in low- to medium-height crops from activities such as
scouting, irrigation, hand weeding and hand harvesting. The quantitative hazard estimate of 30
mg/kg/day (LOAEL from the dermal developmental study in the rat) as used in the handler
assessment (see previous section) is used in the postapplication assessment. Postapplication
Risk: Currently available exposure and toxicity data support an interim 48 hour REI for all crops;
therefore, the postapplication worker risk assessment indicates no risk concerns for scouting and
irrigation. The interim 48 hour REI could change based on the requested brain morphometric
data from lower doses of the DNT.
Environmental Fate Characteristics/Ecological Effects
Environmental Fate Summary: Environmental risk assessments utilized environmental fate and
toxicity data for prothioconazole and two primary degradates; the prothioconazole-desthio and
prothioconazole-S-methyl. Risks were estimated using a total toxics residue approach for
exposure levels for aquatic organisms and to derive estimated concentrations in drinking water.
PROTHIOCONAZOLE FACT SHEET - Page 15 of 5 5
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In addition, for characterization purposes, unbound residues alone were used to estimate
exposures. The lowest available toxicity endpoint among prothioconazole and the two primary
degradates was used to evaluate risk.
Prothioconazole possesses a potential for direct adverse acute effects to non-target fresh- and
saltwater non-vascular plants, freshwater vascular plants, and saltwater invertebrates other than
mollusks at some of the proposed application rates. The results also indicate a potential for
adverse effects associated with chronic exposures to mammals for all proposed uses of
prothioconazole and a potential for adverse effects to semi-aquatic plant species.
Overall, potential risks appear to be greatest for estuarine/marine invertebrates, nonvascular
plants, and terrestrial mammals. Estimated risks may translate to reduced survival, reproduction,
or growth in affected species with subsequent effects at higher levels of biological organization.
Aquatic exposure estimated assuming ground application is 8 - 27 percent lower than when the
pesticide is applied aerially, which does not alter the overall risk conclusions.
For listed species, acute risk levels of concern were exceeded for estuarine/marine invertebrates,
semi-aquatic plants, aquatic plants, and freshwater fish. Listed species chronic risk levels of
concern were exceeded for mammals. Because aquatic plant risk quotients are above the
endangered species level of concern, the Agency considers this indicative of a potential for
adverse effects to those listed species that rely on a specific plant species (plant species obligate).
However, given the uncertainties in the screening level assessment, the levels of exceedance are
not deemed significant.
a. Hydrolysis
Prothioconazole is stable to hydrolysis at environmentally relevant pH's and temperatures. In a
study conducted in darkness for 7 days at 50°C, radio-labeled prothioconazole did not hydrolyze
in sterile aquatic buffer solutions (pH 7 and 9); radio-labeled prothioconazole was hydrolyzed
with a half-life of 120 days in sterile pH 4 aqueous buffer solution. Extrapolating from these
results, the half-life of prothioconazole at 25°C at pH 4 was estimated as between 679 days and
>10 years. No major transformation products were detected in any pH solution.
The metabolite prothioconazole-desthio is stable to hydrolysis at environmentally relevant pH's
and temperatures. In a study conducted in darkness for 30 days at 25°C, radio-labeled
prothioconazole-desthio did not hydrolyze in sterile pH 5, 7 and 9 aqueous buffer solutions.
b. Photolysis
Aqueous - Prothioconazole is rapidly photodegraded to prothioconazole-desthio in water under
favorable light conditions; however, prothioconazole-desthio is persistent under further
irradiation. Radio-labelled prothioconazole photodegrades with a half-life of approximately 9.7
days in sterile pH 7 aqueous buffered solution maintained at 25°C and irradiated with the
equivalent of 93 days of summer sunlight. Together, prothioconazole and prothioconazole-
desthio photodegrade with a half-life of 101.9 days. Prothioconazole-desthio, together with two
other major degradates, prothioconazole-thiazocine and 1,2,4-triazole, have maximum
PROTHIOCONAZOLE FACT SHEET- Page 16 of 55
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concentrations of 55.7%, 14.1%, and 11.9% of the applied, observed on the 11th, 5th, and 18th day
of incubation, respectively. No significant information was obtained for six minor
transformation products or several unidentified compounds. Photodegradation is expected to be
a potential route of dissipation for prothioconazole and prothioconazole-desthio together in the
environment when the compounds are present in clear, shallow surface water.
Soil - Prothioconazole together with prothioconazole-desthio are considered stable to
photodegradation on loamy sand soil. Prothioconazole photodegradation on soil is insignificant
compared to metabolism. The major transformation product detected in both dark and irradiated
samples is prothioconazole-desthio. Prothioconazole and prothioconazole-desthio were added
together in the half-life calculations. Apparently, no significant transformation products are
specifically generated by phototransformation on soil surfaces. Photodegradation on soil is not
expected to be a potential route of dissipation for prothioconazole and prothioconazole-desthio in
the environment.
c. Metabolism
Aerobic soil metabolism -Prothioconazole rapidly dissipates from aerobic soil systems.
Relatively high amounts of prothioconazole-desthio and unextracted material were observed in
environmental fate studies, and are assumed to have similar toxicities. It is possible that toxic,
unextracted residues will become bioavailable in the environment. Calculated aerobic biotic
degradation of prothioconazole and prothioconazole-desthio was very slow in silt, loamy sand,
silty loam, and silty clay loam soils, with half-lives ranging from 533 to 1386 days. When
incubated in darkness for up to one year at 20 °C, maintained at 75% of 1/3 bar moisture,
prothioconazole degraded to prothioconazole-desthio, prothioconazole-S-methyl, 1,2,4-triazole,
prothioconazole-sulfonic acid, prothioconazole-triazolinone, prothioconazole-3, 4, 5, and 6-
hydroxy-desthio, 2-chlorobenzoic acid, and CC>2. However, the estimates of the aerobic soil
metabolism half-lives are uncertain given the assumptions associated with the unextracted
residues. Consequently, the Agency's estimates of prothioconazole's persistence in the soil may
be overestimated.
Aerobic aquatic metabolism - The aerobic aquatic metabolism of prothioconazole can not be
calculated adequately because prothioconazole quickly degrades to prothioconazole-desthio.
Furthermore, both chemicals are of similar toxicity and there is considerable unextracted
material in the studies. In addition to prothioconazole-desthio, prothioconazole degrades to
prothioconazole-S-methyl, 1,2,4-triazole, prothioconazole-triazolinone, prothioconazole-
triazolylketone, and CC>2. Prothioconazole-desthio appears to degrade more quickly in aerobic
water/sediment systems than in aerobic soil alone; half-lives in various water/sediment systems
range from 17.4 to 75.3 days. The Agency believes that the unextracted residues may consist of
parent and may be bioavailable in the environment. The Agency's calculations are conservative
because of the uncertainty associated with these unextracted residues. Thus, the Agency's
estimate of the persistence of prothioconazole and prothioconazole-desthio may be overstated.
Anaerobic aquatic metabolism - Prothioconazole and prothioconazole-desthio degraded slowly,
with half-lives ranging from 61.9 to 231 days in an anaerobic pond/sandy clay loam sediment
system. Prothioconazole degraded extensively in this system to prothioconazole-S-methyl.
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d. Adsorption/Desorption
Prothioconazole's rapid degradation made it impossible to calculate adsorption coefficients.
Nonetheless, prothioconazole-desthio is expected to be mobile in most soils, although it might
bind to some benthic sediments in aquatic environments. Soil binding is strongly correlated to
the soil organic carbon content. Prothioconazole-S-methyl, another significant degradate of
prothioconazole, is expected to have low to slight mobility, as indicated from high sorption
coefficients (Kd of 15.6-64.1 mg/L, K0c of 1973-2995 mL/goc). Mobility may be greater in
relatively coarse-grained, well-drained soils. Prothioconazole may be mobile in typical
agricultural soils.
e. Mobility
Prothioconazole's rapid degradation makes it impossible to determine its soil-water partition
coefficient. Qualitatively, however, prothioconazole may exhibit low potential of leaching,
likely to its rapid degradation. In contrast, prothioconazole-desthio has soil-water coefficients
ranging from 4.13 to 13.38 mg/L in four different soils, indicating moderate to high mobility.
Prothioconazole-desthio has a Kd less than 5 in some soils and is persistent (hydrolysis half-life
greater than 25 weeks). Furthermore, its photolysis half-life is greater than 1 week, aerobic soil
metabolism half-life is greater than 2-3 weeks, it is not volatile, and shows movement to 45 cm
during field dissipation studies. Together, these parameters indicate potential for groundwater
contamination.
f. Terrestrial Field Dissipation
In three terrestrial field dissipation studies, prothioconazole alone dissipated from the top layer of
soil with a DT50 of less than 2 or 3 days, but prothioconazole-desthio dissipated from the top
layer of soil with extremely variable DT50 of 28-422 days. Moderate amounts of
prothioconazole-S-methyl were detected above the level of quantitation (LOQ) in 0-15 cm soil,
and 1,2,4-triazole was detected at all soil depths, albeit not above the LOQ. Prothioconazole was
not detected below 15 cm in any of the three fields in California, Georgia or New York. In
contrast, prothioconazole-desthio was detected at levels above the LOQ down to 30 cm and at
levels above the minimum detection limit [MDL] but below the LOQ down to 45 cm in one
replicate in the California field study, and at levels below the LOQ at one to two sampling times
in the Georgia and New York field studies
g. Aquatic Field Dissipation
In three aquatic field dissipation studies, prothioconazole and prothioconazole-desthio dissipated
with long half-lives in sediment (203.9 days, 121.6 days, and 90.0 days in California, Arkansas,
and Arkansas cropped aquatic fields, respectively). Dissipation half-lives in paddy water were
extremely short (1.7 days, 0.9 days, and 0.6 days in California, Arkansas, and Arkansas cropped
aquatic fields, respectively), likely more due to adsorption than degradation. Prothioconazole
was detected in only three sampling intervals below LOQ but above the MDL in sediment below
3 inches. Prothioconazole-desthio was detected at 3-6 inch deep sediment through 28 DAT in the
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Arkansas flooded field and through 60 DAT in the Arkansas flooded and cropped field.
h. Bioaccumulation
Bioaccumulation factors (BCF) for prothioconazole and prothioconazole-desthio could not be
definitively calculated due to lack of clear accumulation plateaus. Nonetheless, there is minimal
uncertainty in the conclusion that neither chemical bioaccumulates. Despite prothioconazole's
very hydrophobic octanol-water partition coefficient (unbuffered log K0w of 4.05), significant
bioaccumulation in aquatic organisms is not anticipated due to its quick degradation. The
octanol-water partition coefficient for prothioconazole-desthio is unknown. The BCFs in fish for
prothioconazole and prothioconazole-desthio can not be definitively quantified; however, the
studies indicate that it is likely that prothioconazole-desthio does not bioaccumulate.
Exposure Characterization: Prothioconazole degrades rapidly to prothioconazole-desthio via
most degradation processes, and prothioconazole-desthio has a similar toxicological profile to
that of its parent. Therefore, this assessment is conducted considering prothioconazole and
prothioconazole-desthio jointly as the toxic moiety. Based on registrant-submitted
environmental fate data, prothioconazole is expected to degrade quickly to prothioconazole-
desthio, which is expected to be persistent with moderate mobility in the soil. Prothioconazole-
desthio is stable to hydrolysis, very slowly degraded by aerobic soil metabolism, anaerobic
aquatic metabolism, and aqueous photolysis, and moderately degraded by aerobic aquatic
metabolism. Transport to surface water of prothioconazole residues is predicted, and, in some
soils, transport to groundwater is also predicted, particularly in areas with porous soil of low
organic carbon content.
Effects Characterization: Prothioconazole and the prothioconazole-desthio are practically non-
toxic to birds, mammals, and honeybees under acute exposure conditions and only slightly toxic
to fish and freshwater aquatic invertebrates. Prothioconazole-desthio is very highly toxic to
aquatic plants and estuarine/marine invertebrates following acute exposure. Prothioconazole-
desthio is slightly more toxic to birds and mammals under chronic exposure conditions compared
to the parent compound based on the respective study-determined effect levels. In birds, chronic
exposure to prothioconazole-desthio did not cause any significant effects in adults or offspring.
In mammals, chronic effects of prothioconazole-desthio included decreased viability of offspring
and decreased offspring body weights.
Ecological Risk Summary: Overall, potential risks appear to be greatest for estuarine/marine
invertebrates and nonvascular plants, and terrestrial mammals. Functionally, estimated risks may
translate to reduced survival, reproduction, or growth in affected species with subsequent effects
at higher levels of biological organization. Aquatic exposure estimated assuming ground
application is 8 - 27 percent lower than when the pesticide is applied aerially. The exposure
estimates associated with ground application would not alter overall risk conclusions although
for some specific combination of crop and taxa, risk quotients may be below the LOG.
For listed species, acute risk levels of concern were exceeded for estuarine/marine invertebrates,
semi-aquatic plants, aquatic plants, and freshwater fish. Listed species chronic risk levels of
concern were exceeded for mammals. Because aquatic plant risk quotients are above the
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endangered species level of concern, the Agency considers this to be indicative of a potential for
adverse effects to those listed species that rely on a specific plant species (plant species obligate).
Because of the national extent of the proposed uses of prothioconazole, there is a potential to
affect some listed plant species and the species which depend upon listed or non-listed plant
species. Indirect effects in this case may not be limited to aquatic species as terrestrial animals
that rely on aquatic food items have potential to be affected indirectly.
Conclusions: Prothioconazole degrades rapidly to prothioconazole-desthio via most degradation
processes, and prothioconazole-desthio has a similar toxicological profile to that of its parent.
Prothioconazole-desthio is expected to be persistent with moderate mobility in the soil.
Prothioconazole-desthio is stable to hydrolysis, very slowly degraded by aerobic soil
metabolism, anaerobic aquatic metabolism, and aqueous photolysis, and moderately degraded by
aerobic aquatic metabolism. Transport to surface water of prothioconazole residues is predicted,
and, in some soils, transport to groundwater is predicted, particularly in areas with porous soil of
low organic carbon content.
Prothioconazole and the prothioconazole-desthio are practically non-toxic to birds, mammals,
and honeybees under acute exposure conditions and only slightly toxic to fish and freshwater
aquatic invertebrates. Prothioconazole-desthio is very highly toxic to aquatic plants and
estuarine/marine invertebrates following acute exposure. Prothioconazole-desthio is slightly
more toxic to birds and mammals under chronic exposure conditions compared to the parent
compound based on the respective study-determined effect levels. In birds, chronic exposure to
prothioconazole-desthio did not cause any significant effects in adults or offspring. In mammals,
chronic effects of prothioconazole-desthio included decreased viability of offspring and
decreased offspring body weights.
a. Risk to Aquatic Organisms
Regarding freshwater fish, aquatic-phase amphibians, and freshwater invertebrates potentially
exposed to prothioconazole for uses on wheat, bean, canola, and peanut, the RQs do not exceed
non-listed or listed species acute or chronic risk LOCs.
For estuarine/marine fish and invertebrates potentially exposed to prothioconazole for uses on
wheat, canola, bean, and peanuts, the RQs for estuarine/marine fish do not exceed any acute risk
LOCs with all RQs less than 0.01; chronic toxicity data were not available for a representative
fish species so RQs could not be calculated. The RQs for estuarine/marine mollusks similarly
did not exceed any acute risk LOCs with all RQs<0.01. Based on mysid shrimp toxicity data,
the listed species acute risk LOG of 0.05 is exceeded for estuarine/marine invertebrates for all
modeled scenarios while the acute non-listed species LOG of 0.5 is exceeded for use on beans
and peanuts (RQs = 0.55 & 0.57, respectively). Chronic RQ values were only calculated for
non-molluskan invertebrates since this was the only taxa with chronic toxicity data. The listed
and non-listed species chronic risk LOG (RQ>1.0) for estuarine marine invertebrates is exceeded
for all modeled uses with RQs ranging from 2.4 to 6.4. These risks are summarized in Table 9.
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Table 9. Risk Quotients for Estuarine/Marine Fish
and Invertebrates Exposed to Prothioconazole
Use
Wheat
Canola
Bean
Peanut
Application
Rate
Ibs ai/A
(#app/
interval
(d))
0.178
(2/7)
0.178
(2/5)
0.178
(3/5)
0.178
(4/14)
EECs
(PPb)
Peak
20.5
12.8
33.2
34.4
21-
day
20.2
12.5
32.7
33.3
60-
day
19.8
12.0
32.2
32.2
Fish RQs
LCso =
>10300
NOAEC
= N/A
Acute
<0.01
<0.01
<0.01
<0.01
Invertebrate
RQs
LC50 = 60
NOAEC = 5.2
Acute
0.34*
0.21*
0.55**
0.57**
Chronic
3.94
2.40
6.29
6.40
Mollusk
RQs
ECso=
3000
Acute
<0.01
<0.01
<0.01
<0.01
*Exceeds the listed species acute risk LOC (RQXX05)
**Exceeds the non-listed species acute risk LOC (RQ>0.50) and the listed species acute risk LOC
Bolded chronic RQs exceed the listed and non-listed species chronic risk LOC (RQ>1.0)
For both vascular and non-vascular aquatic plants, the listed species acute risk LOC of 1.0 is
exceeded for all scenarios, with RQs ranging from 1.20 to 5.9 (Table 10).
Table 11 lists the RQs for estuarine/marine non-vascular plants potentially exposed to
prothioconazole. These RQs exceed the listed species acute risk LOC for all uses (1.8 to 4.7)
and exceed or equal the non-listed species acute risk LOC at all proposed application rates
except canola (1.0 to 1.6).
Table 10. Risk Quotients for Freshwater Aquatic Plants
Exposed to Prothioconazole
Use
Wheat
Application
Rate
Ibs a.i./A
(#app/interval
(d))
0.178
(2/7)
EECs
(PPb)
Peak
20.5
Vascular Plant
RQs
EC50 = 35
NOAEC = 5.8
Acute
0.59
Acute
Listed
Species
3.5
Non-Vascular
Plant RQs
EC50 = 0.074
EC05 = 0.011
Acute
0.28
Acute
Listed
Species
1.9
PROTHIOCONAZOLE FACT SHEET - Page 21 of 5 5
-------
Table 10. Risk Quotients for Freshwater Aquatic Plants
Exposed to Prothioconazole
Use
Canola
Bean
Peanut
Application
Rate
Ibs a.i./A
(#app/interval
(d))
0.178
(2/5)
0.178
(3/5)
0.178
(4/14)
EECs
(PPb)
Peak
12.8
33.2
34.4
Vascular Plant
RQs
EC50 = 35
NOAEC = 5.8
Acute
0.37
0.95
0.98
Acute
Listed
Species
2.2
5.7
5.9
Non-Vascular
Plant RQs
EC50 = 0.074
EC05 = 0.011
Acute
0.17
0.45
0.46
Acute
Listed
Species
1.2
3.0
3.1
Aquatic plant acute risk LOG (RQ > 1.0); applies to non-listed and listed species
Table 11. Risk Quotients for Estuarine/Marine Non- Vascular Plants
Exposed to Prothioconazole
Use
Wheat
Canola
Bean
Peanut
Application
Rate
Ibs ai/A
(#app/interval
(d))
0.178
(2/7)
0.178
(2/5)
0.178
(3/5)
0.178
(4/14)
EECs
(PPb)
Peak
20.5
12.8
33.2
34.4
Non- Vascular Plant RQs
EC50 = 21
NOAEC = 7.3
Acute
1.0
0.62
1.6
1.6
Acute Listed
Species
2.9
1.8
4.5
4.7
Aquatic plant acute risk LOG (RQ > 1.0); applies to non-listed and listed species
b. Risk to Avian Species (Acute/Chronic)
No RQs exceed non-listed or listed species acute risk LOCs with RQs ranging from <0.01 to
0.05. No acute or chronic LOCs are exceeded for any proposed uses. Acute dietary-based RQs
range from <0.01 to 0.01 and dietary-based chronic RQs ranged from 0.01 to 0.18.
PROTHIOCONAZOLE FACT SHEET - Page 22 of 5 5
-------
c. Risk to Mammalians (Acute/Chronic)
For mammals, no acute risk LOCs are exceeded with RQs ranging from <0.01 to 0.01. Table 12
summarizes the chronic mammalian RQs for the proposed uses of prothioconazole. The non-
listed and listed species chronic risk LOG (RQ>1.0) is exceeded for all proposed uses of
prothioconazole. However, LOG exceedances are specific to food item with no exceedances
associated with mammals that consume seeds or fruits/pods/large insects with RQs ranging from
0.01 to 0.23. For all other food items, the chronic risk LOCs are exceeded, particularly for
smaller mammals. The highest RQs are for mammals that consume short grass with RQs
ranging from 1.0 to 3.8 followed by mammals that consume broadleaf plants/small insects (RQs
= 0.56 to 2.1) and tall grass (RQs = 0.45 to 1.7).
Table 12. Mammalian Dose-Based Chronic RQ Values for Uses of Prothioconazole;
Based on Rat NOAEL of 9.5 mg/kg bw and Upper-Bound Kenaga Residues
Use
Barley/
Wheat
(Fusariu
mhead
blight)
Application
Rate
Ibs ai/A
#app/interval
(d)
0.178
(2/7)
Body
Weight
(g)
15
35
1000
Avian Acute RQs for Specified Food Items
Short
Grass
2.9
2.4
1.3
Tall
Grass
1.3
1.1
0.60
Broadleaf
Plants/Small
Insects
1.6
1.4
0.74
Fruits/Pods
/
Lg Insects
0.18
0.15
0.08
Seeds
0.04
0.03
0.02
Barley
(leaf&
stem)
0.134
(2/7)
15
35
1000
2.2
1.8
0.99
0.99
0.85
0.45
1.2
1.0
0.56
0.13
0.12
0.06
0.03
0.03
0.01
Canola
&
Oilseed
crop
0.178
(2/5)
15
35
1000
3.1
2.6
1.4
1.4
1.2
0.65
1.7
1.5
0.80
0.19
0.16
0.09
0.04
0.04
0.02
Chickpe
a&
Lentils
0.178
(3/10)
15
35
1000
2.8
2.4
1.3
1.3
1.1
0.60
1.6
1.4
0.73
0.18
0.15
0.08
0.04
0.03
0.02
Peanut
0.178
(4/14)
15
35
1000
2.5
2.1
1.1
1.2
0.98
0.52
1.4
1.2
0.64
0.16
0.13
0.07
0.03
0.03
0.02
Dried
shell
peas &
beans
0.178
(3/5)
15
35
1000
3.8 1.7
3.2 1.5
1.7 0.79
2.1
1.8
0.97
0.23
0.20
0.11
0.05
0.04
0.02
Wheat
0.156
15
2.5 1.2
1.4
0.16
0.03
PROTHIOCONAZOLE FACT SHEET - Page 23 of 55
-------
Table 12. Mammalian Dose-Based Chronic RQ Values for Uses of Prothioconazole;
Based on Rat NOAEL of 9.5 mg/kg bw and Upper-Bound Kenaga Residues
Use
(leaf&
stem)
Application
Rate
Ibs ai/A
#app/interval
(d)
(2/7)
Body
Weight
(g)
35
1000
Avian Acute RQs for Specified Food Items
Short
Grass
Tall
Grass
2.2
1.2
0.98
0.53
Broadleaf
Plants/Small
Insects
1.2
0.65
Fruits/Pods
/
Lg Insects
0.13
0.07
Seeds
0.03
0.02
Bolded values exceed the chronic risk LOG (RQ>1.0) for non-listed and listed mammalian species
Chronic dietary-based mammalian RQs for proposed uses of prothioconazole are based on
effects levels associated with chemical concentrations in feed. The dietary-based RQs do not
exceed the chronic risk LOCs for any proposed uses of prothioconazole with RQs ranging from
0.02 to 0.51.
d. Risk to Terrestrial and Semi-aquatic Plants
Risk quotients for terrestrial and semi-aquatic plant (Table 13) for proposed uses of
prothioconazole exceed the acute plant risk LOG (RQ>1.0) for semi-aquatic listed plants; no
other LOCs are exceeded. Risk quotients for non-listed terrestrial and semi-aquatic plant species
are not calculated because an EC25 (>0.272 Ibs a.i./A, highest test level) could not be estimated
from the Tier II plant study.
Table 13. RQ Values for Listed Terrestrial and
Semi-Aquatic Plants Exposed to Prothioconazole
Use(s)
Barley, Canola,
Chickpea, Dried
shell peas &
beans, Lentils,
Oilseed crops,
Peanut, Wheat
Barley (leaf &
stem)
Wheat (leaf &
stem)
Single
Application
Rate
Lbs a.i./A
0.178
0.134
0.156
RQs Based on Tier II Study on Cucumber
(EC25>0.272; NOAEC/EC05 = 0.03)
Adja
Ground
spray
0.36
0.27
0.31
icent
Aerial
spray
0.59
0.45
0.52
Semi-Aquatic
Ground
spray
3.0
2.3
2.6
Aerial
spray
3.3
2.5
2.9
Bolded values exceed listed plant acute risk LOG (RQ>1.0)
PROTHIOCONAZOLE FACT SHEET - Page 24 of 5 5
-------
Uncertainties and Data Gaps
The major uncertainty in characterizing effects of prothioconazole and/or prothioconazole-
desthio is associated with the toxicity of prothioconazole-desthio to estuarine/marine
invertebrates and the lack of an acceptable sediment toxicity test. For estuarine/marine
invertebrates, toxicity tests for prothioconazole-desthio indicated that both the LCso and the
chronic NOAEC are approximately 60 ppb based on mysid shrimp toxicity tests. This suggests
that chronic and acute thresholds are the same, a conclusion that is incongruent with typical
toxicological patterns. Risks to sediment dwelling invertebrates could not be estimated since the
submitted studies did not meet guideline requirements. It is recommended that guideline
sediment toxicity tests be submitted.
The environmental fate data submitted to the Agency are complete. However, because of the
considerable uncertainty surrounding soil extraction procedures, the unextracted material in the
aerobic soil, aerobic aquatic, and anaerobic aquatic metabolism studies was added to parent in
calculation of half-lives used in environmental fate modeling and fate characterization.
Therefore, the persistence and bioavailability of prothioconazole may be overestimated; resulting
in conservative estimated aquatic exposure. Importantly, Tier II modeling using the 90th
percentile unextracted-material-incorporated half-lives did not change risk estimates for aquatic
animals or aquatic plants relative to modeling using upper 90th percentile confidence bounds on
the mean half-lives calculated without incorporating unextracted material. In neither case do
aquatic concentrations approach levels-of-concern for aquatic animals; however, aquatic
concentrations are sufficiently high to result in risk quotients that exceed levels-of-concern for
aquatic plants. Finally, the adsorption coefficient (Kd or K0c) of prothioconazole could not be
calculated from submitted data because of the chemical's quick degradation in the systems.
Therefore, conclusions about the mobility of prothioconazole combined residues of concern are
drawn only from degradates. Similarly, bioaccumulation factors (BCF) of prothioconazole and
prothioconazole-desthio could not be definitively calculated due to lack of clear accumulation
plateaus. Therefore, there is also minimal uncertainty in the conclusion that neither chemical
bioaccumulates.
DATA GAPS
For the Developmental Neurotoxicity Study (MRID 46246418), brain morphometric
measurements from the mid and low dose animals must be submitted as well as addressing the
other deficiencies listed in the DER to allow the reconsideration of the FQPA database
uncertainty factor.
Data must be generated and submitted to confirm the degree of stability of the prothioconazole-
4-hydroxy in ruminant fat for a duration of 45 days.
The final report of the ongoing storage stability study with prothioconazole and desthio-
prothioconazole in plant commodities (interim results for which were reported in MRID
46477701) must be submitted.
PROTHIOCONAZOLE FACT SHEET - Page 25 of 5 5
-------
Based on the proposed tolerance expressions and the proposed enforcement methods, analytical
reference standards of the following compounds must be provided:
• prothioconazole-desthio
prothioconazole sulfonic acid potassium salt
[triazole-15N-13C]prothioconazole
• [triazole-15N-13C]prothioconazole-desthio
• [triazole-15N-13C]prothioconazole sulfonic acid
Environmental Fate and Effects
Repeating the sediment toxicity study following Agency guidelines in which the chemical is first
added to the sediment would reduce some uncertainty associated with assessing risks to sediment
dwelling invertebrates.
Contact person at USEPA
Tony Kish, Product Manager (22)
Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505P)
(703)-308-9443
Mailing Address:
By U.S. Mail:
Document Processing Desk
Office of Pesticide Programs (75 IOC)
US Environmental Protection Agency
401 M Street SW
Washington, DC 20460-0001
By Courier:
Document Processing Desk
Office of Pesticide Programs(7504P)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, Va.22202-4501
Office Location and Telephone Number - Registration Division
Seventh Floor, One Potomac Yard
2777 South Crystal Drive
Arlington, Va.22202-4501
PROTHIOCONAZOLE FACT SHEET- Page 26 of 55
-------
(703)305-0025
Disclaimer: The information in this Pesticide Fact Sheet is a summary only and is not to be used
to satisfy any data requirements for pesticide registration or reregi strati on.
ai
ARTF
°C
CAS
CFR
cPAD
CSFII
d
DEEM-FCID
DFR
DWLOC
EDSP
EDSTAC
EDWC
EEC
EFED
EPA
F
FFDCA
FIFRA
FQPA
g
HED
Ha
hr
Kd
kg
KQW
Ib
LCso
LD5
'50
GLOSSARY OF TERMS AND ABBREVIATIONS
Active Ingredient
Agricultural Reentry Task Force
Degrees Celsius
Chemical Abstracts Service
Code of Federal Regulations
Chronic Population Adjusted Dose
Continuing Surveys of Food Intakes by Individuals
Day(s)
Dietary Exposure Evaluation Model - Food Consumption Intake Database
Dislodgeable Foliar Residue
Drinking Water Level of Concern
Effective Concentration - concentration of chemical in water at which an
effect is seen in 50% of the exposed population
Endocrine Disrupter Screening Program
Endocrine Disrupter and Testing Advisory Committee
Estimated Drinking Water Concentration
Estimated Environmental Concentrations
Environmental Fate and Effects Division, Office of Pesticide Programs
United States Environmental Protection Agency
Female
Federal Food, Drug and Cosmetic Act
Federal Insecticide, Fungicide and Rodenticide Act
Food Quality Protection Act
Gram
Health Effects Division, Office of Pesticide Programs
Hectare
Hour
Partition coefficient
Kilogram
Octanol/Water Partition Coefficient
Pound
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of
water, air or feed, e.g., mg/L, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered by
the route indicated (oral, dermal, inhalation.). It is expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
PROTHIOCONAZOLE FACT SHEET- Page 27 of 55
-------
LOAEL
LOAEC
LOG
LOD
LOQ
M
m3
mg/kg/day
mg/L
ml
MOE
MRID
MTD
NA
NOAEL
NOAEC
NOEC
NOEL
OPP
OPPTS
PAD
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
REI
RfD
RQ
SCI-GROW
SF
SOP
TC
TGAI
TTR
UF
MS
ug/L
USDA
WPS
Lowest Observed Adverse Effect Level
Lowest Observed Adverse Effect Concentration
Level of Concern
Limit of Detection
Limit of Quantitation
Male
Cubic meter
Milligrams per kilogram (body weight) per day
Milligrams per Liter
Milliliter
Margin of Exposure
Master Record Identification Number
Maximum Tolerated Dose
Not Applicable
No Observed Adverse Effect Level
No Observed Adverse Effect Concentration
No Observed Effect Concentration
No Observed Effect Level
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Safety Factor
Standard Operating Procedure
Transfer Coefficient
Technical Grade Active Ingredient
Turf Transferable Residue
Uncertainty Factor
Micrograms
Micrograms per Liter
United Stated Department of Agriculture
Worker Protection Standard
PROTHIOCONAZOLE FACT SHEET - Page 28 of 55
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Study Information For Ingredient
113961 / 178928-70-6/Prothioconazole
MRID
46246000
46246001
46246002
46246003
46246004
46246005
46246006
46246007
46246008
46246009
46246010
46246011
Citation
Bayer CropScience (2004) Submission of Product Chemistry, Efficacy, Toxicity and Fate
Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide
and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole on Barley,
Oilseed Crop Group (Except Sunflower and Safflower), Dried Shell Pea and Bean (Except
Soybean) Crop Subgroup, Peanut, Rice, and Wheat. Transmittal of 50 of 298 Studies.
Schneider, J. (2001) Physical and Chemical Properties of JAU6476. Project Number:
14/0120/0950. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
298 p.
Fontaine, L. (2004) Product Chemistry of Prothioconazole Technical. Project Number:
BR/2281, ANR/02904, ANR/03004. Unpublished study prepared by Bayer Corp., Bayer Ag
Institut fuer Ruckstands-Analytik and Bayer Ag, Institute of Product Info. 409 p.
Fontaine, L. (2004) Product Chemistry of Prothioconazole Technical. Project Number:
BR/2282, 14/0210/0950, 2001/08/08. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik, Bayer Corp. and Bayer Ag, Institute of Product Info. 140 p.
Frank, J. (2004) Product Chemistry of Proline 480 SC. Project Number: BR/2283,
ANR/02804, 200420/1. Unpublished study prepared by Bayer Corp. 202 p.
Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse
Crops, Cereal Crops, Canola and Rapeseed: Volume 1 - Wheat. Project Number:
BYFCAN005, BYFCAN005/1. Unpublished study prepared by Bayer CropScience. 596 p.
Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse
Crops, Cereal Crops, Canola and Rapeseed: Volume 2 - Barley. Project Number:
BYFCAN005, BYFCAN005/2. Unpublished study prepared by Bayer CropScience. 404 p.
Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse
Crops, Cereal Crops, Canola and Rapeseed: Volume 3 - Canola. Project Number:
BYFCAN005, BYFCAN005/3. Unpublished study prepared by Bayer CropScience. 171 p.
Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse
Crops, Cereal Crops, Canola and Rapeseed: Volume 4 - Chickpea, Lentil & Dry Bean.
Project Number: BYFCAN005, BYFCAN005/4. Unpublished study prepared by Bayer
CropScience. 544 p.
Heimbach, F. (2001) Acute Toxicity of JAU6476 (tech.) to Water Fleas (Daphnia magna).
Project Number: E/3201675/4, HBF/DM212. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 50 p.
Kern, M; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC Formulation to the Waterflea
(Daphnia magna) Under Static -Renewal Conditions. Project Number: EBJAX072,
J6820701, 200514. Unpublished study prepared by Bayer Corp. 34 p.
Heimbach, F. (1990) Acute Toxicity of SXX 0665 (techn.) to Waterfleas (Daphnia magna).
Project Number: HBF/DM/95, E/3200404/1. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 28 p.
Receipt
Date
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 29 of 5 5
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46246012
46246013
46246014
46246015
46246016
46246017
46246018
46246019
46246020
46246021
46246022
46246023
46246024
46246025
Dorgerloh. M; Sommer, H. (2001) Acute Toxicity of JAU6476-S-Methyl to Waterfleas
(Daphnia magna). Project Number: E/3202119/8, DOM/21055, 00699/MR/250/01.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 40 p.
Sayers, L. (2004) JAU 6476-Desthio - Acute Toxicity to Crayfish (Promcambarus clarkii)
Under Static -Renewal Conditions: Amended Final Report. Project Number: 13798/6147,
EBJAY004, J6880601. Unpublished study prepared by Springborn Smithers Laboratories.
49 p.
Drottar, K.; Kendall, T.; Krueger, H. (2001) JAU 6476: A 96-Hour Shell Deposition Test
with the Eastern Oyster (Crassostreavirginica). Project Number: 149A/127, J6831501,
110956. Unpublished study prepared by Wildlife International, Ltd. 39 p.
Kendall, T.; Nixon, W. (2001) Analytical Method Verification for the Determination of
JAU-6476 in Saltwater. Project Number: 149C/115, J61 12401, 110957. Unpublished study
prepared by Wildlife International, Ltd. 30 p.
Drottar, K.; Blankinship, A.; Kendall, T.; et. al. (2002) JAU 6476: A 96-Hour Flow-Through
Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number:
149A/128A, J6833101, 110983. Unpublished study prepared by Wildlife International, Ltd.
38 p.
Drottar, K.; Palmer, S.; Kendall, T.; et. al. (2002) Desthio JAU 6476: A 96-Hour Flow-
Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number:
149A/129, J6833102, 110979. Unpublished study prepared by Wildlife International, Ltd. 39
P-
Dorgerloh, M. (1999) JAU6476 - Acute Toxicity (96 hours) to Rainbow Trout
(Oncorhynchus mykiss) in a Static Test. Project Number: E/250 1657/6, DOM/99076.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 5 1 p.
Kern, M.; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC to the Rainbow Trout
(Oncorhynchus mykiss) Under Static Conditions. Project Number: EBJAX073, J6812201,
200193. Unpublished study prepared by Bayer Corp. 33 p.
Grau, R. (1990) SXX 0665 techn.: Acute Toxicity to the Rainbow Trout in a Static Test.
Project Number: E/2800441/9, FF/298. Unpublished study prepared by Bayer Ag Institut
fuer Ruckstands-Analytik. 28 p.
Dorgerloh, M.; Sommer, H. (2001) JAU6476-S-Methyl - Acute Toxicity (96 hours) to
Rainbow Trout (Oncorhynchus mykiss) in a Semi-Static Test. Project Number:
E/2802052/9, DOM/21047, 00699. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 47 p.
Dorgerloh, M. (1999) JAU6476 - Acute Toxicity (96 Hours) to Bluegill (Lepomis
macrochirus) in a Static Test. Project Number: E/252 1695/0, DOM/99090, 00586.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 48 p.
Kern, M.; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC to the Bluegill (Lepomis
macrochirus) Under Static-Renewal Conditions. Project Number: 200599, EBJAX075,
J6810301. Unpublished study prepared by Bayer Corp. 34 p.
Grau, R. (1991) SXX 0665: Acute Toxicity to Golden Orfe in a Static Test. Project Number:
E/2820400/6, FO/1253. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-
Analytik. 29 p.
Dorgerloh, M. (2000) JAU6476 - Acute Toxicity (96 hours) to Common Carp (Cyprinus
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01 -Apr-
PROTHIOCONAZOLE FACT SHEET - Page 30 of 55
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carpio) in a Static Test. Project Number: E/2861781/3, DOM/20010. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 40 p.
2004
46246026
Kern, M; Lam, C. (2003) Acute Toxicity of JAU 6476-Desthio to the Fathead Minnow
(Pimephales promelas) Under Static-Renewal Conditions. Project Number: EBJAZ071,
J6811202, 200151. Unpublished study prepared by Bayer Corp. 35 p.
01-Apr-
2004
46246027
Kern, M.; Lam, C. (2004) Acute Toxicity of JAU 6476 Technical to the Sheepshead
Minnow (Cyprinodon variegatus) Under Static-Renewal Conditions. Project Number:
EBJA2140, J6830901, 200615. Unpublished study prepared by Bayer Corp. 35 p.
01-Apr-
2004
46246028
Hendel, B.; Sommer, H. (2001) Influence of JAU6476 (tech.) on the Reproduction Rate of
Water Fleas. Project Number: E/3211982/6, HDB/RDM67. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 79 p.
01-Apr-
2004
46246029
Dorgerloh, M.; Sommer, H. (2001) Influence of JAU6476-Desthio on the Reproduction Rate
of Water Fleas in a Static Renewal Laboratory Test System. Project Number: E/3211987/5,
DOM/21036. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
73 p.
01-Apr-
2004
46246030
Blankinship, A.; Kendall, T.; Krueger, H. (2003) Desthio JAU-6476: A Flow-Through Life
Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number:
149A/130A, J6843101, 200485. Unpublished study prepared by Wildlife International, Ltd.
107 p.
01-Apr-
2004
46246031
Dorgerloh, M.; Sommer, H. (2001) JAU6476 - Early Life Stage Toxicity to Rainbow Trout
(Oncorhynchus mykiss) Under Flow-through Conditions. Project Number: E/2841699/9,
DOM/20028, 00586. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-
Analytik. 102 p.
01-Apr-
2004
46246032
Gries, T.; Dorgerloh, M. (2002) JAU6476-Desthio: Early Life-Stage Toxicity Test with
Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions. Project Number:
1022/013/321. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 119 p.
01-Apr-
2004
46246033
Drottar, K.; Kendall, T.; Krueger, H. (2004) Desthio JAU 6476: A Flow-Through Life-Cycle
Toxicity Test with the Fathead Minnow (Pimephales promelas). Project Number:
149A/126A, J6851201, 200108. Unpublished study prepared by Wildlife International, Ltd.
130 p.
01-Apr-
2004
46246034
Dorgerloh, M.; Weber, E. (2001) (Carbon 14)-JAU6476-Bioconcentration and
Biotransformation in Bluegill (Lepomis macrochirus) Under Flow-Through Conditions.
Project Number: E/2442023/7, DOM/21003. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 168 p.
01-Apr-
2004
46246035
Dorgerloh, M.; Weber, E.; Spiegel, K. (2001) (Carbon 14)-JAU6476-Desthio -
Bioconcentration and Biotransformation in Bluegill (Lepomis macrochirus) Under Flow-
Through Conditions. Project Number: E/2441731/2, DOM/20006. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 131 p.
01-Apr-
2004
46246036
Barkfknecht, R. (1999) JAU6476 techn. ai.: Acute Oral Toxicity forBobwhite Quail
(Colinus virginianus). Project Number: 2921561/6, BAR/LD028. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 35 p.
01-Apr-
2004
46246037
Grau, R. (1990) SXX 0665 (Technical Grade): Acute Oral LD50 to Bobwhite Quail. Project
Number: E/2920414/2, VB/009. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 36 p.
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 31 of 55
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46246038
Barfknecht, R. (2001) JAU6476 techn.: 5-Day - Dietary LC50 for Bobwhite Quail (Colinus
virginianus). Project Number: E/2951563/1, BAR/LC005. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 32 p.
01-Apr-
2004
46246039
Barfknecht, R. (2001) JAU6476-Desthio.: 5-Day - Dietary LC50 for Bobwhite Quail
(Colinus virginianus). Project Number: E/2951564/2, BAR/LC011. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 34 p.
01-Apr-
2004
46246040
Barfknecht, R. (2001) JAU6476 techn.: 5-Day - Dietary LC50 to Mallard Duck (Anas
platyrhynchos). Project Number: E/2971562/2, BAR/LC010. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 31 p.
01-Apr-
2004
46246041
Martin, K.; Nixon, W. (2001) Analytical Method Verification for the Determination of
Desthio JAU 6476 in Avian Diet. Project Number: 149C/113, J6111901, 99/B/203.
Unpublished study prepared by Wildlife International, Ltd. 30 p.
01-Apr-
2004
46246042
Frieling, W. (2000) Reproduction Study in Bobwhite Quail with JAU 6476 (by Dietary
Admixture). Project Number: 259842, 88353, 259842/MO/OO/010540. Unpublished study
prepared by Notox B.V. 231 p.
01-Apr-
2004
46246043
Barfknecht, R. (2002) JAU6476-Desthio techn. ai.: Effects of a Subchronic Dietary
Exposure to the Northern Bobwhite Quail Including Effects on Reproduction and Behavior.
Project Number: E/2981830/1, BAR/REP006. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 106 p.
01-Apr-
2004
46246044
Frieling, W. (2000) Reproduction Study in Mallard Duck with JAU 6476 (by Dietary
Admixture). Project Number: 259919, 88353. Unpublished study prepared by Notox B.V.
207 p.
01-Apr-
2004
46246045
Frey, L.; Martin, K.; Beavers, J.; et. al.; (2001) Desthio JAU-6476: A Reproduction Study
with the Mallard (Anas platyrhynchos). Project Number: 149/181, 110617, J6740801.
Unpublished study prepared by Wildlife International, Ltd. 200 p.
01-Apr-
2004
46246046
Schmitzer, S. (2004) Effects of JAU 6476 SC 480 (Acute Contact and Oral) on Honey Bees
(Apis mellifera L.) in the Laboratory. Project Number: 18351035. Unpublished study
prepared by Institut fuer Biologische Analytik und Consulting IBACON GmbH. 31 p.
01-Apr-
2004
46246047
Moll, M.; Butzler, R. (2004) Effects of JAU SC 480 on the Parasitoid Aphidius rhopalosiphi,
Extended Laboratory Study. Project Number: 18352002. Unpublished study prepared by
Institut fuer Biologische Analytik und Consulting IBACON GmbH. 50 p.
01-Apr-
2004
46246048
Wilhelmy, H. (1999) JAU 6476 a.i.: Acute Effects on the Honeybee Apis mellifera. Project
Number: IBA64051, 990222BN. Unpublished study prepared by Dr. U. Noack-
Laboratorium fuer Angewandte Biologie. 32 p.
01-Apr-
2004
46246049
Sabbert, T. (2004) Tier 1 Seedling Emergence and Vegeatative Vigor Non-target
Phytotoxicity Study Using JAU 6476 480SC. Project Number: J6451601, J6451602,
200951. Unpublished study prepared by Bayer Corp. 84 p.
01-Apr-
2004
46246050
Sabbert, T. (2004) Tier 2 Seedling Emergence Non-target Phytotoxicity Study Using JAU
6476 480SC. Project Number: J6451603, 200952. Unpublished study prepared by Bayer
Corp. 57 p.
01-Apr-
2004
46246100
Bayer CropScience (2004) Submission of Environmental Fate and Residue Data in Support
of the Applications for Registration of Prothioconazole Technical and Proline 480 SC
Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group
(Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 32 of 55
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46246101
46246102
46246103
46246104
46246105
46246106
46246107
46246108
46246109
46246110
46246111
46246112
46246113
46246114
Subgroup, Peanut, Rice, and Wheat. Transmittal of 50 out of 297 Studies.
Kern, M; Banman, C.; Lam, C. (2004) Toxicity of JAU 6476 Technical to Duckweed
(Lemna gibba G3) Under Static -Renewal Conditions. Project Number: EBJAY002,
J6883701, 200488. Unpublished study prepared by Bayer Corp. 48 p.
Kern, M.; Banman, C.; Lam, C. (2003) Toxicity of JAU 6476 480 SC to Duckweed (Lemna
gibba G3) Under Static -Renewal Conditions. Project Number: EBJAX189, J6883703,
200672. Unpublished study prepared by Bayer Corp. 48 p.
Kern, M.; Roberts, I; De Haan, R. (2004) Toxicity of JAU 6476 Technical to the Blue-green
Alga Anabaena flos-aquae. Project Number: EBJAX078, J6883801, 200497. Unpublished
study prepared by Bayer Corp. 58 p.
Kern, M.; Banman, C.; Lam, C. (2003) Toxicity of JAU 6476-Desthio to Duckweed (Lemna
gibba G3) Under Static-Renewal Conditions. Project Number: EBJAX084, J6883702,
200469. Unpublished study prepared by Bayer Corp. 46 p.
Dorgerloh, M. (2000) JAU6476 Influence on the Growth of the Green Alga, Selenastrum
capricornutum. Project Number: E/3231610/6, DOM/99107. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 49 p.
Kern, M.; Lam, C. (2004) Toxicity of JAU 6476 480 SC Formulation to the Green Alga
Pseudokirchneriella subcapitata (a.k.a. Selenastrum capricornutum). Project Number:
EBJAX075, J6883501, 200602. Unpublished study prepared by Bayer Corp. 51 p.
Dorgerloh, M.; Sommer, H. (2001) JAU6476-S-Methyl Influence on the Growth of the
Green Alga, Selenastrum capricornutum. Project Number: E/3232061/7, DOM/21028.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 48 p.
Heimbach, F. (1990) Growth Inhibition of Green Algae (Scenedesmus subspicatus) by SXX
0665 Technical. Project Number: E/3230401/3, HBF/AL78. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 30 p.
Kern, M.; Lam, C. (2004) Toxicity of JAU 6476 Technical to the Freshwater Diatom
Navicula pelliculosa. Project Number: EBJAX085, J6883401, 200252. Unpublished study
prepared by Bayer Corp. 50 p.
Kern, M.; De Harm, R. (2004) Toxicity of JAU 6476 Technical to the Saltwater Diatom
Skeletonema costatum. Project Number: EBJAX076, J6883601, 200434. Unpublished study
prepared by Bayer Corp. 49 p.
Hoogendoorn, G. (2000) An Extended Laboratory Study to Evaluate the Effects of JAU6476
on the Predaceous Mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae). Project Number:
B060HAE. Unpublished study prepared by Mitox Stichting Duurzame. 30 p.
Anderson, J. (1999) Influence of JAU6476 Technical Ingredient on the Microbial
Mineralization of Nitrogen in Soils. Project Number: E/3371710/2, ALO/203199, 2445.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 23 p.
Anderson, J. (2000) Influence of the JAU6476 Technical Ingredient on Glucose Stimulated
Respiration in Soils. Project Number: E/3301708/2, AJO/203099. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 25 p.
Anderson, J. (2000) Influence of the Metabolite JAU6476-Desthio on the Microbial
Mineralization of Nitrogen in Soils. Project Number: E/337 1792/2, AJO/209400.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 21 p.
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 33 of 55
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46246115
Anderson, J. (2001) Influence of the Metabolite JAU6476-Desthio on the Microbial
Mineralization of Nitrogen in Soils. Project Number: E/3372075/7, AJO/219101.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 21 p.
01-Apr-
2004
46246116
Anderson, J. (1999) Influence of the Metabolite JAU6476-S-Methyl on the Microbial
Mineralization of Nitrogen Soils. Project Number: E/3371709/0, AJO/203399. Unpublished
study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 23 p.
01-Apr-
2004
46246117
Anderson, J. (1999) Influence of the Metabolite JAU6476-S-Methyl on Glucose Stimulated
Respiration in Soils. Project Number: E/3301707/1, AJO/203299. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 25 p.
01-Apr-
2004
46246118
Nienstedt, K. (2002) Reproduction Toxicity Test Exposing Folsomia Candida (Collembola)
to JAU6476 Technical. Project Number: 1022/028/641. Unpublished study prepared by
Springborn Laboratories (Europe) Ag. 34 p.
01-Apr-
2004
46246119
Moser, T.; Rombke, J. (2001) Acute and Reproduction Toxicity of JAU6476-Desthio to the
Collembolan Species Folsomia Candida According to the ISO Guideline 11267 "Soil
Quality-Inhibition of Reproduction of Collembola (Folsomia Candida) by Soil Pollutants"
(1999). Project Number: P1CR. Unpublished study prepared by ECT Oekotoxikologie
Gmbh. 28 p.
01-Apr-
2004
46246120
Nienstedt, K. (2001) Reproduction Toxicity Test Exposing Folsomia Candida (Collembola)
to JAU6476-Desthio. Project Number: 1022/020/641. Unpublished study prepared by
Springborn Laboratories (Europe) Ag. 36 p.
01-Apr-
2004
46246121
Moser, T.; Scheffczyk, A. (2001) Acute and Reproduction Toxicity of JAU6476-S-Methyl to
the Collembolan Species Folsomia Candida According to the ISO Guideline 11267 "Soil
Quality-Inhibition of Reproduction of Collembola (Folsomia Candida) by Soil Pollutants"
(1999). Project Number: P35CR. Unpublished study prepared by ECT Oekotoxikologie
Gmbh. 24 p.
01-Apr-
2004
46246122
Meisner, P. (2000) Acute Toxicity of JAU6476 (tech.) to Earthworms (Eisenia fetida).
Project Number: E/3101769/7, MPE/RG326/00. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 22 p.
01-Apr-
2004
46246123
Meisner, P. (2000) Acute Toxicity of JAU6476 EC 250 to Earthworms (Eisenia fetida).
Project Number: E/3101795/6, MPE/RG331/00. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 18 p.
01-Apr-
2004
46246124
Lechelt-Kunze, C. (2003) Prothioconazole (JAU 6476) SC 480: Acute Toxicity to
Earthworms (Eisenia fetida) Tested in Artifical Soil with 10% Peat. Project Number:
E/3102600/2, LKC/RG/A/16/03. Unpublished study prepared by Bayer Ag, Institute of
Product Info. 23 p.
01-Apr-
2004
46246125
Meisner, P. (2000) Acute Toxicity of JAU6476-Desthio to Earthworms (Eisenia fetida).
Project Number: E/3101844/1, MPE/RG338/00. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 20 p.
01-Apr-
2004
46246126
Heimbach, F. (2000) Acute Toxicity of JAU6476-S-Methyl to Earthworms (Eisenia fetida).
Project Number: E/3101743/9, HBF/RG321. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 19 p.
01-Apr-
2004
46246127
Meisner, P. (2000) Influence of JAU6476-EC 250 on the Reproduction of Earthworms
(Eisenia fetida). Project Number: E/3121753/2, MPE/RG325. Unpublished study prepared
by Bayer Ag Institut fuer Ruckstands-Analytik. 27 p.
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 34 of 5 5
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46246128
46246129
46246130
46246131
46246132
46246133
46246134
46246135
46246136
46246137
46246138
46246139
46246140
46246141
Meisner, P. (2000) Influence of JAU6476-Desthio on the Reproduction of Earthworms
(Eisenia fetida). Project Number: E/3 12 1799/2, MPE/RG3 22/00. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 24 p.
Heimbach, F. (2000) Influence of JAU6476-S-Methyl on the Reproduction of Earthworms
(Eisenia fetida). Project Number: E/3 121713/8, HBF/RG3 17. Unpublished study prepared
by Bayer Ag Institut fuer Ruckstands-Analytik. 24 p.
Kunze, L. (2002) JAU6476 EC 250: Effect on the Earthworm Fauna of a Grassland Area in
One Year. Project Number: E/3 1 12093/9, LKC/RGF58. Unpublished study prepared by
Bayer Ag, Institute of Product Info. 96 p.
Hendel, B. (2000) Influence of JAU6476 (tech.) on Developmental and Emergence of
Larvae of Chironomus riparius in a Water-Sediment System. Project Number: E/4161775/1,
HDB/CH42. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 53
P-
Hendel, B. (2000) Influence of SXX 0665 (tech.) on Development and Emergence of Larvae
of Chironomus riparius in a Water-Sediment System. Project Number: E/4161808/8,
HDB/CH43. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 53
P-
Hall, A.; Duah, F. (2002) JAU 6476 480 SC - Magnitude of Residue In/On Wheat Forage, A
Potential Wildlife Feed Item. Project Number: J619WH03, 111032, J6122/01W.
Unpublished study prepared by Bayer Corp. 148 p.
Hall, A.; Duah, F.; Daussin, S. (2004) JAU 6476 480 SC - Magnitude of Residue In/On Turf
Grass, A Potential Wildlife Feed Item. Project Number: J619GS01, 200832, J6043/01W.
Unpublished study prepared by Bayer Corp. 146 p.
Hall, A.; Duah, F.; Daussin, S. (2004) JAU 6476 480 SC - Magnitude of Residue In/On
Peanut Forage, A Potential Wildlife Feed Item. Project Number: J619PE03, 200833,
J6062/01W. Unpublished study prepared by Bayer Corp. 123 p.
Heimbach, F. (2002) Expert Statement Concerning the Evaluation of the Study Results of
Study LCK/RgF 58 "JAU6476 EC 250: Effect on the Earthworm Fauna of A Grassland Area
in One Year". Project Number: MO/02/014407. Unpublished study prepared by Bayer Ag,
Institute of Product Info. 8 p.
Rosenkranz, B. (2004) Effects of JAU 6476 SC 480 on the Predatory Mite Typhlodromus
pyri, Extended Laboratory Study - Dose Response Test-. Project Number: 18353062.
Unpublished study prepared by Institut fuer Biologische Analytik. 42 p.
Hall, A. (2004) Environmental Risk Assessment for Prothioconazole. Project Number:
201000. Unpublished study prepared by Bayer CropScience LP. 59 p.
Heinemann, O. (2003) 36 Months Storage Stability of Residues of JAU6476 and JAU6476-
Desthio During Frozen Storage In/On Wheat Matrices. Project Number: MR/354/01,
P64283007. Unpublished study prepared by Bayer Ag, Institute of Product Info. 47 p.
Tolliver, M. (2004) Tier II Summaries for Ecotoxicology Studies. Project Number: 201002.
Unpublished study prepared by Bayer CropScience LP. 1 12 p.
Haas, M.; Bornatsch, W. (2000) Metabolism of JAU 6476 in Spring Wheat (after foliar
application). Project Number: M/1730851/5, 110880, MR/198/99. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 149 p.
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 35 of 5 5
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46246142
Haas, M. (2001) Metabolism of JAU 6476 in Spring Wheat after Seed Dressing. Project
Number: M/1730885/2, 110881, MR/467/99. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 84 p.
01-Apr-
2004
46246143
Duah, F.; Lopez, R. (2004) The Metabolism of [Triazole-3, 5-(Carbon 14)] JAU6476 in
Wheat. Project Number: J6041601, 200733. Unpublished study prepared by Bayer Corp. 197
P-
01-Apr-
2004
46246144
Vogeler, K.; Sakamoto, H.; Brauner, A. (1993) Metabolism of SXX 0665 in Summer Wheat.
Project Number: M/1730365/5, MR/PF3906, PF/3906. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 114 p.
01-Apr-
2004
46246145
Haas, M. (2001) Metabolism of [Phenyl-UL-(Carbon 14)]JAU6476 in Peanuts. Project
Number: M/1730984/2, MR/193/01. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 130 p.
01-Apr-
2004
46246146
Haas, M. (2003) Metabolism of [trizole-UL-(Carbon 14)]JAU6476 in Peanuts. Project
Number: M1731145/2, MR/194/02. Unpublished study prepared by Bayer Ag, Institute of
Product Info. 145 p.
01-Apr-
2004
46246147
Beedle, E.; Ying, S. (2004) The Metabolism of [Triazole-UL-(Carbon 14)]JAU6476 in
Sugar Beets. Project Number: J6041603, 200467. Unpublished study prepared by Bayer
Corp. 91 p.
01-Apr-
2004
46246148
Beedle, E.; Ying, S. (2004) The Metabolism of [Phenyl-UL-(Carbon 14)]JAU6476 in Sugar
Beets. Project Number: J6041602, 200466. Unpublished study prepared by Bayer Corp. 86
P-
01-Apr-
2004
46246149
Weber, E.; Weber, H.; Spiegel, K. (2003) [Triazole-UL-(Carbon 14)]JAU6476: Absorption,
Distribution, Excretion, and Metabolism in the Lactating Goat. Project Number:
M51819114, MR/448/02. Unpublished study prepared by Bayer Ag, Institute of Product
Info. 308 p.
01-Apr-
2004
46246150
Weber, H.; Spiegel, K. (2001) [Phenyl-UL-(Carbon 14)]JAU6476: Absorption, Distribution,
Excretion, and Metabolism in the Lactating Goat. Project Number: M/91819082,
MR/092/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
205 p.
01-Apr-
2004
46246200
Bayer CropScience (2004) Submission of Residue and Toxicity Data in Support of the
Application for Registrations of Prothioconazole Technical Fungicide and Proline 480 SC
Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group
(Excpet Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop
Subgroup, Peanut, Rice and Wheat. Transmittal of 50 of 179 Studies.
01-Apr-
2004
46246201
Weber, H.; Weber, E.; Spiegel, K. (2002) ((Phenyl-UL-(Carbon 14))JAU6476-desthio:
Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat Including the
Validation of the Residue Analytical Method for the Determination of JAU6476-desthio,
JAU6476-3-hydroxy-desthio. Project Number: M91819091, SXX1, SXX2. Unpublished
study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 399 p.
01-Apr-
2004
46246202
Weber, H.; Spiegel, K. (2001) ((Phenyl-UL-(Carbon 14))JAU6476: Absorption,
Distribution, Excretion, and Metabolism in Laying Hens. Project Number: M/81819090,
MR/309/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
142 p.
01-Apr-
2004
46246203
Weber, H.; Justus, K. (2003) ((Triazole-UL-(Carbon 14))JAU6476: Absorption, 01-Apr-
Distribution, Excretion, and Metabolism in Laying Hens. Project Number: M/91819118, 2004
PROTHIOCONAZOLE FACT SHEET- Page 36 of 55
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46246204
46246205
46246206
46246207
46246208
46246209
46246210
46246213
46246214
46246215
46246216
46246217
46246218
MEF005/03. Unpublished study prepared by Bayer Ag, Institute of ProductInfo. 157 p.
Moore, S. ; Harbin, A. (2003) An Analytical Method for the Determination of JAU 6476,
JAU 6476-Desthio and JAU 6476-4-Hydroxy Residues in Various Bovine Matrices by LC-
MS/MS. Project Number: 200537. Unpublished study prepared by Bayer Corp. 131 p.
Justus, K.; Spiegel, K. (2004) (Triazole-UL-(Carbon 14))JAU6476: Extraction Efficiency of
the Residue Analytical Method for the Determination of JAU6476, JAU6476-4-hydroxy and
JAU 6476-desthio in Animal Tissues and Milk Using Aged Residues. Project Number:
M99912561/1, MEF/020/04. Unpublished study prepared by Bayer Ag, Institute of Product
Info. 58 p.
Gould, T.; Timberlanke, B.; Krolski, M.; et. al. (2004) Validation of Bayer CropScience
Method RPA JA/03/0 1 : JAU6476 : An Analytical Method for the Determination of Total
Residues of JAU6476 in Plant Matrices Using LC/MS-MS. Project Number: J61 1 1401,
200799, RPA/JA/03/01. Unpublished study prepared by Bayer Corp. 238 p.
Reed, D. (2004) Independent Laboratory Validation for the Determination of JAU6476,
JAU6476-Desthio, and JAU6476-4-Hydroxy in Bovine Milk and Liver: Final Report.
Project Number: RAYAY004, BAYER/15 17. Unpublished study prepared by Pyxant Labs
Inc. 298 p.
Gould, T.; Timberlake, B. (2004) Extraction Efficiency of JAU6476 and Metabolites by the
Method JA/03/01. Project Number RAYAY01 1. Unpublished study prepared by Bayer
Corp. 59 p.
Clark, J. (2004) Independent Laboratory Validation of "JAU6476: An Analytical Method for
the Determination of Residues of JAU6476 and desthio-JAU6476 in Plant Matrices by LC-
MS/MS". Project Number: RAJAY020, 48663. Unpublished study prepared by Analytical
Bio-Chemistry Labs., Inc. 77 p.
Rodgers, C. (2003) Testing of JAU 6476 Plus Five Metabolites Through the FDA
Multiresidue Methods as Described in the FDA Pesticide Analytical Manual (PAM) I,
Appendix II, Updated 1/94. Project Number: 200480, J6 162302, 47947. Unpublished study
prepared by Analytical Bio-Chemistry Labs., Inc. 133 p.
Duah, F. (2004) A 28-Day Feeding Study with JAU6476 in Dairy Cattle. Project Number:
200715, J6060401, 205/003/10. Unpublished study prepared by Bayer Corp. and Genesis
Midwest Laboratories. 498 p.
Heinemann, O.; Auer, S. (2001) JAU6476-desthio - Dairy Cattle Feeding Study. Project
Number: MR/535/00, P/673003007, 2001/03/30. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 262 p.
Lemke, V.; Helfrich, K. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Canola.
Project Number: J619CN01, RCJAY006, 200464. Unpublished study prepared by Bayer
Corp. and ICMS, Inc. 3 54 p.
Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Rice. Project Number:
J619RI01, RCJAY008, 200468. Unpublished study prepared by Bayer Corp. 501 p.
Fischer, D. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Peanuts. Project
Number: J619PE01, RCJAY007, 200508. Unpublished study prepared by Bayer Corp.,
Battelle and Bayer Research Farm. 490 p.
Kraai, M. (2004) KAU6476 480 SC - Magnitude of the Residue In/On Wheat Grain, Wheat
Aspirated Grain Fractions, and Wheat Processed Commodities. Project Number: J619WH02,
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET- Page 37 of 55
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46246219
46246220
46246221
46246222
46246223
46246224
46246225
46246226
46246227
46246228
46246229
46246230
46246231
RCJAY004, 200521. Unpublished study prepared by Bayer Corp., Texas A & M Research
Center and Battelle. 744 p.
Lmke, V.; Murphy, J. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Wheat.
Project Number: J619WH01, RCJAY009, 200524. Unpublished study prepared by Bayer
Corp., Battelle and Vaughn Agricultural Research Serv., Ltd. 1270 p.
Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Barley. Project
Number: J619BA01, 200806, RCJAY005. Unpublished study prepared by Bayer Corp.,
Battelle and Agvise Inc. 797 p.
Fischer, D. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Dried Peas and Dried
Beans (Crop Subgroup 6C - Dried, Shelled Pea and Bean - Except Soybean). Project
Number: J619BY02, J619DP02, RCJAX007. Unpublished study prepared by Bayer Corp.,
Quails Agricultural Laboratories, I and Varco Ag. Research & Consulting. 564 p.
Harbin, A. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Rice Grain and Rice
Processed Commodities. Project Number: J619R102, RCJAY003, 200493. Unpublished
study prepared by Bayer Corp., Texas A & M Food Protein Research & and Battelle. 464 p.
Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Peanuts and Peanut
Processed Commodities. Project Number: J619PE02, RCJAY002, 200518. Unpublished
study prepared by Bayer Corp., Texas A & M Research Center and Battelle. 447 p.
Beedle, E. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Canola Seed and
Canola Processed Commodities. Project Number: J619CN02, RCJAY001, 200953.
Unpublished study prepared by Bayer Corp., Texas A & M Research Center and Battelle.
309 p.
Haas, M. (2001) Confined Rotation Crop Study with JAU 6476. Project Number: 1 10882,
M1300891/2. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
145 p.
Duah, F.; Kraai, M. (2004) The Accumulation of ((Triazole-3,5-(Carbon 14)) JAU6476 in
Confined Rotational Crops. Project Number: J6051601, 200623. Unpublished study
prepared by Bayer Corp. 324 p.
Lemke, V.; Lenz, C.; Murphy, J. (2004) JAU6476 480 SC - Magnitude of the Residue in
Field Rotational Crops - Wheat, Mustard Greens, and Turnips. Project Number: 200535,
J619RC01, J619RC02. Unpublished study prepared by Bayer Corp., Battelle and Bayer
Research Farm. 1202 p.
Lemke, V. (2004) Evaluation of Acute and Chronic Dietary Exposure to JAU6476 and
Assessment of Potential Risk. Project Number: 200996. Unpublished study prepared by
Bayer Corp. 78 p.
Bayer CropScience (2004) Tier II Summaries for Residue Chemistry Studies: (JAU 6476-
desthio). Project Number: 201004. Unpublished study prepared by Bayer CropScience Lp.
185 p.
Andrews, P. (1998) JAU 6476: Study for Acute Oral Toxicity in Rats. Project Number:
27500, T7062252. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p.
Krotilinger, F. (1991) SXX 0665: Study for Acute Oral Toxicity in Rats. Project Number:
20098, T9034877, 109274. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 72
P-
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 38 of 55
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46246232
46246233
46246234
46246235
46246236
46246237
46246238
46246239
46246240
46246241
46246242
46246243
46246244
46246245
46246246
46246247
Eigenberg, D. (2003) An Acute Oral LD50 Study in the Rat with JAU 6476 480 SC. Project
Number: 02/A12/NZ. Unpublished study prepared by Bayer Corp. 20 p.
Kroetlinger, F. (2002) JAU 6476-Asymmetric Isomer: Study for Acute Oral Toxicity in
Rats. Project Number: 32125, T/3071404. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 26 p.
Schungel, M. (2003) JAU 6476 DES-Chloro: Acute Toxicity in the Rat After Oral
Administration. Project Number: AT00329, T9072235. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 23 p.
Krotlinger, F. (2002) JAU 6476 - Methyl Study for Acute Oral Toxicity in Rats. Project
Number: 31997, T6071332. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
26 p.
Krotlinger, F. (2001) JAU 6476-Asymmetric Disulfide: Study for Acute Oral Toxicity in
Rats. Project Number: 3 1498, T6070919. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 26 p.
Krotlinger, F. (2000) JAU 6476 - Sulfonic Acid K. Salt: Study for Acute Oral Toxicity in
Rats. Project Number: 30237, T3069242. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 28 p.
Krotlinger, F. (2000) JAU 6476 Alpha-Hydroxy-Desthio: Study for Acute Oral Toxicity in
Rats. Project Number: 30109, T8069445. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 25 p.
Krotlinger, F. (2000) JAU 6476 Alpha-Acetoxy-Desthio Study for Acute Oral Toxicity in
Rats. Project Number: 301 10, T8069436. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 25 p.
Krotlinger, F. (2000) JAU 6476-Benzylpropyldiol Study for Acute Oral Toxicity in Rats.
Project Number: 29898, T9069086. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 28 p.
Krotlinger, F. (2000) JAU 6476 - Triazolinone: Study for Acute Oral Toxicity in Rats.
Project Number: 30108, T8069643. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 26 p.
Krotlinger, F. (1991) SXX 0665: Study for Acute Oral Toxicity in Mice. Project Number:
20097, T0034878, 109278. Unpublished study prepared by Berigische Univ. 65 p.
Krotlinger, F. (1991) SXX 0665: Study for Acute Dermal Toxicity in Rats. Project Number:
20094, T8034876. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 29 p.
Krotlinger, F. (1999) JAU 6476: Study for Acute Dermal Toxicity in Rats. Project Number:
28495, T3067398, 108994. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 27
P-
Eigenberg, D. (2003) An Acute Dermal LD50 Study in the Rat with JAU 6476 480 SC.
Project Number: 02/A22/OA, 200491. Unpublished study prepared by Bayer Corp. 20 p.
Pauluhn, J. (1999) JAU 6476: Study on Acute Inhalation Toxicity in Rats. Project Number:
PH/28954, T1067489, 109267. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 77 p.
Pauluhn, J. (1992) SXX 0665: Study for Acute Inhalation Toxicity in Rats. Project Number:
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01 -Apr-
PROTHIOCONAZOLE FACT SHEET - Page 39 of 5 5
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46246248
46246249
46246250
46246300
46246301
46246302
46246303
46246304
46246305
46246306
46246307
46246308
46246309
21087, T0034959, T/9034723. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 80 p.
Pauluhn, J. (2003) JAU 6476 480 SC: Study on Acute Inhalation Toxicity in Rats. Project
Number: AT00332, T5072295. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 69 p.
Leuschner, P. (1999) Acute Eye Irritation Study of JAU 6476 by Instillation into the
Conjunctiva! Sac of Rabbits. Project Number: R6506A, T7060146, 108997. Unpublished
study prepared by Laboratory of Pharmacology & Toxicology. 22 p.
Martins, T. (1991) SXX 0665: Study for Eye and Skin Irritation/ Corrosion in Rabbits.
Project Number: 19945, T4039651. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 25 p.
Bayer CropScience (2004) Submission of Toxicity Data in Support of the Applications for
Registration of Prothioconazole Technical Fungicide and Proline 480 SC Funicide and the
Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Except Sunflower
and Safflower), Dried Shell Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice,
and Wheat. Transmittal of 50 of 298 Studies.
Merkel, D. (2003) Primary Eye Irritation Study in Rabbits: JAU 6476 480 SC. Project
Number: 02C/I35/NX, 200607, 13229. Unpublished study prepared by Product Safety Labs.
16 p.
Leuschner, P. (1999) Acute Skin Irritation Test (Patch Test) of JAU 6476 in Rabbits. Project
Number: R/6505A, T7060146, 108998. Unpublished study prepared by Laboratorium fuer
Pharmakologie und Tox. 20 p.
Merkel, D. (2003) Primary Skin Irritation Study in Rabbits: JAU 6476 480 SC. Project
Number: 02C/I25/NY, 200606, 13230. Unpublished study prepared by Product Safety Labs,
Food Products Laboratory and Silliker Laboratories of New Jersey, Inc. 15 p.
Dreist, M.; Diesing, L. (1991) SXX 0665 Study for Skin-Sensitizing Effects in Guinea Pigs
(Buehler Patch Test). Project Number: 20719, T/0039594, 109277. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 35 p.
Stropp, G. (1996) JAU 6476: Study for Skin Sensitization Effect in Guinea Pigs (Guinea Pig
Maximization Test Method According to Magnusson and Kligman). Project Number:
25027B, 108999, T/5060667. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
28 p.
Vohr, H. (2003) JAU 6476 480 SC: Study for the Skin Sensitization Effect in Guinea Pigs
(Guinea Pig Maximization Test According to Magnusson and Kligman). Project Number:
AT00397, T/4072294. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p.
Vohr, H. (2002) JAU 6476 Des-Chloro Study for the Skin Sensitization Effect in Guinea
Pigs (Guinea Pig Maximization Test According to Magnusson and Kligman). Project
Number: AT0003 1, T/3071852. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 26 p.
Diesing, L. (1990) l-Chlor-2,4-dinitrobenzol Study for Suitability of Guinea Pig Strain
BOR: DHPW for Use in Studies on Skin Sensitizing Effect. Project Number: T/7033948,
193 16. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 43 p.
Schladt, L.; Hartmann, E. (1999) SXX 0665: Study on Subchronic Toxicity in Wistar Rats
(Dietary Administration Over 14 Weeks with a Subsequent Recovery Period Over 5 Weeks).
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 40 of 5 5
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46246310
46246311
46246312
46246313
46246314
46246315
46246316
46246317
46246318
46246319
46246320
46246321
46246322
46246323
Project Number: 29336, T2037354, 109446. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 545 p.
Wirnitzer, U. (1999) SXX 0665: Dose-Range-Finding Study inB6C3Fl Mice (Dietary
Administration for About 13 Weeks). Project Number: 29235, T2034753, 109445.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 327 p.
Wirnitzer, U.; Hartmann, E. (1999) JAU 6476: Study on Subchronic Toxicity in Wistar Rats
(Administration by Gavage Over 14 Weeks with a Subsequent Recovery Period of 4 Weeks).
Project Number: 28760, T9062416, 109095. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 559 p.
Andrews, P.; Hartman, E. (2001) JAU 6476-Sulfonic Acid K-Salt Study for Subchronic Oral
Toxicity in Rats (Feeding Study for 13 Weeks). Project Number: 31441, T/7069877.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 371 p.
Jones, R.; Stuart, B. (2001) Technical Grade JAU 6476: A Subchronic Oral Gavage Study in
the Beagle Dog. Project Number: 98/116/WH, 109442. Unpublished study prepared by
Bayer Corp. 13 14 p.
Hofmann, W.; Ruf, J.; Rinke, M. (2000) SXX 0665: Subchronic Toxicity Study in the
Beagle Dog (13 Week Feeding Study). Project Number: 29616, T/4039822. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 360 p.
Krotlinger, F.; Hartmann, E. (2000) JAU 6476 Study for Subacute Dermal Toxicity in Rats
(Four- Week Treatment Period). Project Number: 30115, T/2067397. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 227 p.
Stahl, B. (1996) JAU 6476: Developmental Toxicity Study in Rats After Oral
Administration. Project Number: 25827, T2060240, 109074. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 671 p.
Klaus, A. (2002) JAU 6476-des-chloro: Pilot Developmental Toxicity Study in Rats After
Oral Administration. Project Number: AT00172, T0063605. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 228 p.
Becker, H.; Marburger, A. (2001) JAU 6476 - Sulfonic Acid K Salt Dose Range-Finding
Study to a Prenatal Development Toxicity Study in the Rat. Project Number: R7936,
T8068554, 778274. Unpublished study prepared by RCC Umweltchemie Ag. 153 p.
Holzum, B. (1992) SXX 0665: Embryotoxicity Study on Postnatal Development of
Supernumerary Ribs in Rats Following Oral Administration. Project Number: 21792,
T/4039958, 109269. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 177 p.
Renhof, M. (1990) SXX 0665: Exploratory Study for Embryotoxic Effects in Rats Following
Oral Administration. Project Number: 18661, T/0030368. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 131 p.
Becker, H.; Leutkemeier, H.; Biedermann, K.; et. al. (1991) Embryotoxicity Study
(Including Teratogenicity) with SXX 0665 Technical in the Rat. Project Number: 236114,
R/5426, 108979. Unpublished study prepared by RCC Umweltchemie Ag. 324 p.
Becker, H.; Biedermann, K. (1991) Supplementary Study to the Embryotoxicity Study
(Including Teratogenicity) With SXX 0665 Technical in the Rat. Project Number: 281518,
R5437, T9034679. Unpublished study prepared by RCC Umweltchemie Ag. 193 p.
Young, A. (2001) A Dermal Developmental Toxicity Study with (JAU 6476, Technical
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01 -Apr-
PROTHIOCONAZOLE FACT SHEET - Page 41 of 5 5
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46246324
46246325
46246326
46246327
46246328
46246329
46246330
46246331
46246332
46246333
46246334
46246335
46246336
46246337
Material and Products) in the WistarRat. Project Number: 108993, 98/622/QZ. Unpublished
study prepared by Bayer Corp. 521 p.
Becker, H.; Marburger, A.; Biedermann, K. (2001) JAU 6476 - Sulfonic Acid K Salt
Prenatal Developmental Toxicity Study in the Rat. Project Number: 778285, R7997,
T9068555. Unpublished study prepared by RCC Umweltchemie Ag. 275 p.
Holzum, B. (1991) SXX 0665 Study for Embryotoxic Effects in Rats Following Dermal
Exposure. Project Number: 21058, T/6034739, 109280. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 232 p.
Bartmann, K. (1991) SXX 0665 Supplementary Study for Embryotoxic Effects in Rats
Following Dermal Exposure. Project Number: 20582, T/7037368, 109280. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 178 p.
Bartmann, K. (1991) SXX 0665: Study for Embryotoxic Effects in Rabbits Following Oral
Administration. Project Number: 21091, T/9037397, 109270. Unpublished study prepared
by Bayer Ag Inst. of Toxicology. 191 p.
Becker, H.; Biedermann, K. (1998) Developmental Toxicity Study with JAU 6476 in the
Rabbit. Project Number: 650981, R7235, T9054299. Unpublished study prepared by RCC
Umweltchemie Ag. 369 p.
Becker, H.; Biedermann, K. (1991) Dose Range-Finding Embryotoxicity Study (Including
Teratogenicity) with SXX 0665 Technical in the Rabbit (Dermal Application). Project
Number: 309554, R5425, T1040386. Unpublished study prepared by RCC Umweltchemie
Ag. 92 p.
Becker, H.; Biedermann, K. (1997) Dose Toleration Study to a Developmental Toxicity
Study with JAU 6476 in the Rabbit. Project Number: 650970, R7003, T/5055258.
Unpublished study prepared by RCC Umweltchemie Ag. 1 12 p.
Freshwater, K. (1999) A Pilot Reproductive Toxicity Study with JAU 6476 Technical in the
WistarRat. Project Number: 98/912/TF, 109079. Unpublished study prepared by Bayer
Corp. 306 p.
Eigenberg, D. (1992) Pilot Study to Establish Dose Levels for a Two-Generation
Reproduction Study in Rats Using Technical Grade SXX 0665 Administered via the Diet.
Project Number: 90/972/HV, 103274. Unpublished study prepared by Miles Inc. 232 p.
Eigenberg, D. (2001) A Two-Generation Dietary Reproduction Study in Rats Using SXX
0665. Project Number: 91/672/KO, 109835. Unpublished study prepared by Bayer Corp. 959
P-
Young, A. (2001) A Two-Generation Reproductive Toxicity Study with JAU 6476 in the
WistarRat. Project Number: 98/612/VH, 110500. Unpublished study prepared by Bayer
Corp. 1441 p.
Wirnitzer, U.; Popp, A. (2000) JAU 6476: Study on Chronic Toxicity in Wistar Rats
Administration via Gavage Over 1 Year. Project Number: 30536, T6067643. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 75 1 p.
Jones, R.; Stuart, B. (2001) Technical Grade JAU 6476: A Chronic Oral Gavage Study in the
Beagle Dog. Project Number: 99/C16/BF, 110921. Unpublished study prepared by Bayer
Corp. 980 p.
Henninger, K.; Wetzig, H.; Popp, A. (2001) SXX 0665 Chronic Toxicity Study in Beagle
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01 -Apr-
PROTHIOCONAZOLE FACT SHEET - Page 42 of 5 5
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46246338
46246339
46246340
46246341
46246342
46246343
46246344
46246345
46246346
46246347
46246348
46246349
46246350
46246400
Dogs (30 Week Feeding Study). Project Number: 31148, T/6044125. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 525 p.
Wirnitzer, U.; Hartmann, E. (2001) JAU 6476 Study on Carcinogenicity in Wistar Rats
(Administration by Gavage Over 2 Years). Project Number: 31512, T7067644. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 1780 p.
Schladt, L. (2001) JAU 6476 Oncogenicity Study in CD-I Mice (Administration via Gavage
for 18 Months). Project Number: 31510, T5068083. Unpublished study prepared by Bayer
Ag Inst. of Toxicology. 1396 p.
Wirnitzer, U.; Rinke, M. (2000) SXX 0665 Oncogenicity Study inB6C3Fl Mice (Dietary
Administration Over 2 Years). Project Number: 30045, T307337. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 1326 p.
Wirnitzer, U.; Rinke, M. (2002) SXX 0665: Oncogenicity Study in B6C3F1 Mice (Dietary
Administration Over 2 Years). Project Number: 30045A, T307337, 30045/1. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 13 p.
Schladt, L.; Hartmann, E.; Rinke, M. (1999) SXX 0665: Combined Study on Chronic
Toxicity and Carcinogrnicity in Wistar Rats (Dietary Administration Over 2 Years). Project
Number: PH/29419, T7037250, 109447. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 1854 p.
Herbold, B. (1996) JAU 6476: Salmonella/Microsome Test Plate Incorporation and
Preincubation Method. Project Number: 24859, T/9053957, 109055. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 57 p.
Herbold, B. (1990) SXX 0665: Salmonella/Microsome Test. Project Number: 108970,
T/7034730, 19539. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 48 p.
Herbold, B. (2003) JAU 6476 Des-chloro: Salmonella/Microsome Test Plate Incorporation
and Preincubation Method. Project Number: AT00304, T/1071508. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 5 1 p.
Herbold, B. (2002) JAU 6476-Methyl Salmonella/Microsome Test Plate Incorporation and
Preincubation Method. Project Number: 32267, T/90 17782. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 5 1 p.
Herbold, B. (2002) JAU 6476-Asymmetric Isomer: Salmonella/Microsome Test Plate
Incorporation and Preincubation Method. Project Number: 32103, T/9071191. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 5 1 p.
Herbold, B. (2001) JAU 6476-Asymmetric Disulfide Salmonella/Microsome Test Plate
Incorporation and Preincubation Method. Project Number: PH/3 1565, T/6070522, 3 1565.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 51 p.
Herbold, B. (2000) JAU 6476-Alpha-hydroxy-desthio Salmonella/Microsome Test Plate
Incorporation and Preincubation Method. Project Number: 30086, T/5069118. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 50 p.
Herbold, B. (2000) JAU 6476-Triazolinone Salmonella/Microsome Test Plate Incorporation
and Preincubation. Project Number: 30063, T/4069153. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 50 p.
Bayer CropScience LP (2004) Submission of Toxicity, Environmental Fate, Exposure and
Risk Data in Support of the Application for Registrations of Prothioconazole Technical
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
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46246401
46246402
46246403
46246404
46246405
46246406
46246407
46246408
46246409
46246410
46246411
46246412
46246413
46246414
Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole
for Use on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shelled
Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 50
of 297 Studies.
Herbold, B. (2000) JAU 6476-Alpha-acetoxy-desthio Salmonella/ Microsome Test Plate
Incorporation and Preincubation Method. Project Number: 30004, T/4069117. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 50 p.
Herbold, B. (2000) JAU 6476-Sulfonic Acid K.salt Salmonella/ Microsome Test Plate
Incorporation and Preincubation Method. Project Number: 29969, T/3068883. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 48 p.
Herbold, B. (2000) JAU 6476-Benzylpropyldiol Salmonella/ Microsome Test Plate
Incorporation and Preincubation Method. Project Number: 29700, T/9068870. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 55 p.
Brendler-Schwaab, S. (1996) JAU 6476 Mutagenicity Study for the Detection of Induced
Forward Mutations in the V79-HPRT Assay in Vitro. Project Number: 25605, T/9053713,
109056. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 38 p.
Brendler-Schwaab, S. (1999) SXX 0665 Mutagenicity Study for the Detection of Induced
Forward Mutations in the V79-HGPRT Assay in Vitro. Project Number: PH/28965,
T/0039189, 109284. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 39 p.
Herbold, B. (1996) JAU 6476 In Vitro Mammalian Chromosome Aberration Test with
Chinese Hamster V79 Cells. Project Number: PH/25718, T/9053704, T/5053782.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 42 p.
Gahlmann, R. (1995) SXX 0665 In Vitro Mammalian Chromosome Aberration Test with
Chinese Hamster Ovary (CHO) Cells. Project Number: 24457, T/3039191, 108971.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 35 p.
Herbold, B. (2003) JAU 6476 Des-Chloro In Vitro Chromosome Aberration Test with
Chinese Hamster V79 Cells. Project Number: AT00321, T/9071506. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 46 p.
Herbold, B. (1996) JAU 6476 Micronucleus Test on the Mouse. Project Number: 25572,
T/0060969. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 49 p.
Herbold, B. (1993) SXX 0665 Micronucleus Test on the Mouse. Project Number: 22089,
T/0044129, 108974. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 44 p.
Herbold, B. (2003) JAU 6476 Micronucleus-Test on the Male Mouse. Project Number:
T/5072907, AT00605. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 50 p.
Brendler-Schwaab, S. (1998) JAU 6476 Test on Unscheduled DNA Synthesis in Rat Liver
Primary Cell Cultures In Vitro. Project Number: 27417, T/3053852, 109059. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 32 p.
Brendler-Schwaab, S. (1999) JAU 6476 Test on Unscheduled DNA Synthesis with Rat Liver
Cells In Vivo. Project Number: 28905, T/4061476, T/8059770. Unpublished study prepared
by Bayer Ag Inst. of Toxicology. 34 p.
Brendler, S. (1992) SXX 0665 Mutagenicity Test on Unscheduled DNA Synthesis in Rat
Liver Primary Cell Cultures In Vitro. Project Number: 21187, T/5034729, 108975.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 3 1 p.
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
PROTHIOCONAZOLE FACT SHEET - Page 44 of 5 5
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46246415
Schmidt, U. (1999) JAU 6476 Investigation of the Inhibition of Cytochrome P450
Dependent Monooxygenases in Liver Microsomes (in vitro). Project Number: 28400,
109060. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p.
01-Apr-
2004
46246416
Sheets, L.; Lake, S. (2001) A Subchronic Oral Neurotoxicity Screening Study with
Technical Grade JAU 6476 in Wistar Rats. Project Number: 98/412/RY, 109968.
Unpublished study prepared by Bayer Corp. 482 p.
01-Apr-
2004
46246417
Sheets, L.; Lake, S. (2000) An Acute Oral Neurotoxicity Screening Study with Technical
Grade JAU 6476 in Wistar Rats. Project Number: 98/412/RG, 109250. Unpublished study
prepared by Bayer Corp. 439 p.
01-Apr-
2004
46246418
Sheets, L.; Lake, S. (2004) A Developmental Neurotoxicity Screening Study with Technical
Grade SXX 0665 in Wistar Rats. Project Number: 03/D72/NW, 200958. Unpublished study
prepared by Bayer Corp. 1111 p.
01-Apr-
2004
46246419
Justus, K. (2001) (Carbon 14)JAU6476: Rat Metabolism Part 2 of 2: Distribution of the
Total Radioactivity in Rats Determined by Quantitative Whole Body Autoradiography
(QWBA) with (Triazole-UL-(Carbon 14))JAU6476. Project Number: M/61819061,
MR/437/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik.
108 p.
01-Apr-
2004
46246420
Klein, O. (1999) (Carbon 14)SXX 0665: Investigation on the Distribution of the Total
Radioactivity in the Rat by Whole-Body Autoradiography (Part of the General Rat
Metabolism Study). Project Number: M/81819009, PF3554. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 22 p.
01-Apr-
2004
46246421
Justus, K. (2001) (Carbon 14)JAU6476: Rat Metabolism Part 1 of 2: Investigation of the
Biokinetic Behaviour and the Metabolism (ADME) in the Rat with [Triazole-UL-(Carbon
14)] and (Phenyl-UL-(Carbon 14))JAU6476. Project Number: M/61819061, MR/251/01.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 312 p.
01-Apr-
2004
46246422
Koester, J. (2001) [Phenyl-UL-(Carbon 14)]SXX0665: Biokinetic Behaviour and
Metabolism in the Rat (pilot study). Project Number: M/81819009, MR/056/01.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 82 p.
01-Apr-
2004
46246423
Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of Elimination of
JAU 6476 When Administered Intravenously or Dermally to Male Rhesus Monkeys: Final
Report. Project Number: QEAZ/172, 02C/P29/JW, QEAZ/172/02/370. Unpublished study
prepared by Charles River Laboratories. 104 p.
01-Apr-
2004
46246424
Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of Elimination of
SXX 0665 When Administered Intravenously or Dermally to Male Rhesus Monkeys: Final
Report. Project Number: QEAZ/173, 02C/P29/JV, QEAZ/173/02/412. Unpublished study
prepared by Charles River Laboratories. 105 p.
01-Apr-
2004
46246425
Sebesta, C. (2003) A Study to Determine the Dermal Absorption of (Carbon 14)SXX 0665
in SC 480 Formulation When Administered Dermally to Male Rhesus Monkeys: Final
Report. Project Number: VCBZ/100, 02C/B29/KU, VCBZ/100/02/471. Unpublished study
prepared by Charles River Laboratories. 103 p.
01-Apr-
2004
46246426
Weber, H. (1997) (Phenyl-UL-(Carbon 14))JAU 6476 250 EC: Dermal Absorption Pilot
Study in the Rat. Project Number: M/187/0840/8, MR/545/97. Unpublished study prepared
by Bayer Ag Institut fuer Ruckstands-Analytik. 62 p.
01-Apr-
2004
46246427
Wirnitzer, U.; Hartmann, E. (1999) JAU 6476 Dose Range-Finding Study in CD-I Mice 01-Apr-
Administration by Gavage Over 14 Weeks). Project Number: PH/28579, T1062643, 2004
PROTHIOCONAZOLE FACT SHEET - Page 45 of 5 5
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46246428
46246429
46246430
46246431
46246432
46246433
46246434
46246435
46246436
46246437
46246438
46246439
46246440
46246441
109063 . Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 1 p.
Andrews, P.; Romeike, A. (1997) JAU 6476: Study for Subacute Oral Toxicity in Rats
(Feeding Study for 4 Weeks). Project Number: 26398, T/80603 18, 109061. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 209 p.
Andrews, P.; Hartmann, E.; Schmidt, U. (1998) JAU 6476: Study for Subacute Oral Toxicity
in Rats (4 Week Study Comparing Different Modes of Administrations). Project Number:
PH/28332, T/4062402, 109062. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 198 p.
Krotlinger, F.; Hartmann, E. (1992) SXX 0665: Subacute Oral Toxicity Study in Rats.
Project Number: 21 173, T/1034716, 109271. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 180 p.
Detzer; Rinke (1999) SXX 0665: Subacute Toxicity Study in the Beagle Dog. Project
Number: 28890, T/2034799, 109272. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 205 p.
Pauluhn, J. (1991) SXX 0665: Orientative Study for Subacute Inhalation Toxicity in the Rat
(5x6 Hour Exposures). Project Number: 20368, T/5039580, 109273. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 154 p.
Pauluhn, J. (1992) SXX 0665: Aerosol Study for Subacute Inhalation Toxicity in the Rat .
Project Number: 21071, T/9040195, 109283. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 321 p.
Krotlinger, F. (1991) SXX 0665: Study for Acute Intraperitoneal Toxicity in Rats. Project
Number: 20095, T/7034875, 109279. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 62 p.
Schmidt, U. (2000) Determination of Enzyme Activities and Concentration of JAU 6476 in
the Liver and Kidneys of Dogs in the Subchronic Gavage Study. Project Number: 30260,
T/7/067/969, 98/1 16/WH. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 48
P-
Freyberger, A. (1996) JAU 6476: Interactions with Thyroid Peroxidase-Catalyzed Reactions
In Vitro. Project Number: 25 157. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 28 p.
Enzmann, H.; Watta-Gebert, B. (1991) SXX 0665: Liver Foci Test with Initiation and
Regeneration. Project Number: 20900. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 28 p.
Kroetlinger, F.; Vohr, H. (2002) JAU 6476: Plaque-Forming Cell Assay in Mice. Project
Number: 32090, T/7070695. Unpublished study prepared by Bayer Ag Inst. of Toxicology.
85 p.
Weber, H. (2001) (phenyl-UL-(Carbon 14))SXX 0665: Plasma Kinetics in Pregnant Rats
Following Oral or Dermal Administration. Project Number: M/61818106, MR/514/00.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 73 p.
Moore, K.; Budzowski, K. (1998) A Liquid Chromatographic Method for the Determination
of JAU 6476 in Dose Preparations. Project Number: 98/899/RI, 108384. Unpublished study
prepared by Bayer Corp. 16 p.
Rinke, M. (200 1) Assessment of Ovarian Findings in Rodents After Treatment with
01-Apr-
2004
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2004
01-Apr-
2004
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2004
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2004
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2004
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2004
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2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
PROTHIOCONAZOLE FACT SHEET- Page 46 of 55
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46246442
46246443
46246444
46246445
46246446
46246447
46246448
46246449
46246450
46246500
46246501
46246502
46246503
SXX0665. Project Number: MO/02/000457. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 15 p.
Stropp, G. (1996) Validation of the Magnusson-Kligman Maximization Test Method Used
by the Fachbereich Toxlkologie, Bayer AG Performed in Guinea Pigs of the Strain Hsd Poc:
DH. Project Number: T/1060339, 24605. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 31 p.
Vohr, H. (2002) Validation of the Magnusson-Kilgman Maximization Test Method Used by
the Fachbereich Toxikologie, Bayer AG Performed in Guinea Pigs of the Strain Crl:HA with
Alpha-Hexylzimtaldehyd. Project Number: T/8071893, AT00083. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 30 p.
Moore, K. (1991) A Liquid Chromatographic Method for the Determination of SXX 0665 in
Rodent Ration. Project Number: 101258. Unpublished study prepared by Mobay Chemical
Corp. 18 p.
Tolliver, M. (2004) Tier II Summaries for Toxicology Studies. Project Number: 201003.
Unpublished study prepared by Bayer CropScience LP. 474 p.
Standart, V. (2004) Occupational Exposure & Safety Assessment for Prothioconazole.
Project Number: 200955. Unpublished study prepared by Bayer CropScience LP. 20 p.
Maasfeld, W. (2002) Determination of Exposure to JAU 6476 and JAU 6476-desthio (SXX
0665) During Mixing/Loading and Application of JAU 6476 in Cereals. Project Number:
P/666/00/1501, MR/036/02. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 1 10 p.
Tolliver, M. (2004) Tier II Summaries for Occupational and Residential Exposure Studies.
Project Number: 201006, MR/036/02. Unpublished study prepared by Bayer CropScience
LP. 6 p.
Sommer, H. (200 1) Estimation of the Absorption Coefficient (Koc) of JAU6476 on Soil
Using High Performance Liquid Chromatography (HPLC). Project Number: M/138/1079/9,
MR/473/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 37
P-
Pent, G. (1998) Adsorption/Desorption of (phenyl-UL-(Carbon 14))SXX0665 on Four
Different Soils. Project Number: BAY28, FM768. Unpublished study prepared by Staatliche
Lehr- und Forschungsanstalt fuer. 46 p.
Bayer CropScience (2004) Submission of Environmental Fate Data in Support of the
Application for Registrations of Prothioconazole Technical Fungicide and Proline 480 SC
Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group
(Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop
Subgroup, Peanut, Rice, and Wheat. Transmittal of 48 of 297 Studies.
Hein, W. (1999) Adsorption/Desroption of S-methyl-JAU6476 on Four Different Soils.
Project Number: BAY30, FM/774. Unpublished study prepared by Staatliche Lehr- und
Forschungsanstalt fuer. 42 p.
Sommer, H. (200 1) Estimation of the Adsorption Coefficient (Koc) of JAU6476-thiazocine
on Soil Using High Performance Liquid Chromatography (HPLC). Project Number:
M/1381109/3, MR/265/01. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 34 p.
Riegner, K. (1999) Leaching Behavior of JAU6476 Formulated as 250 EC in Soil (Parent
2004
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2004
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2004
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2004
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2004
01-Apr-
2004
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2004
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2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01 -Apr-
PROTHIOCONAZOLE FACT SHEET- Page 47 of 55
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46246504
46246505
46246506
46246507
46246508
46246509
46246510
46246511
46246512
46246513
46246514
46246515
46246516
46246517
Leaching). Project Number: M/1320961/2, MR/098/99, 4430. Unpublished study prepared
by Bayer Ag Institut fuer Ruckstands-Analytik. 39 p.
Babczinski, P. (2001) Aged Soil Column Leaching of JAU6476. Project Number:
M/121 1074/6, MR/364/00. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 90 p.
Riegner, K. (1998) Hydrolysis of [Phenyl-UL-(Carbon-14)]JAU6476 in Sterile Aqueous
Buffer Solutions. Project Number: M/l 110902/4, MR/623/98, 4412. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 41 p.
Hellpointner, E. (1993) SXX 0655: Hydrolysis in Buffers. Project Number: M/l 110379/2,
PF/3882. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 39 p.
Gilges, M.; Bornatsch, W. (2001) Photolysis of JAU6476 in Sterile Aqueous Buffer. Project
Number: M/l 120917/1, MR/213/01. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 71 p.
Hellpointner, E. (2001) Determination of the Quantum Yield and Assessment of the
Environmental Half-life of the Direct Photodegradation in Water of JAU6476. Project
Number: M/1430957/9, MR/101/01, 214. Unpublished study prepared by Bayer Ag Institut
fuer Ruckstands-Analytik. 39 p.
Hellpointner, E. (1990) Determination of the Quantum Yield and Assessment of the
Environmental Half-life of the Direct Photodegradation of SXX 0665 in Water. Project
Number: M/1120358/0, PF3852, ME/24/93. Unpublished study prepared by Bayer Ag
Institut fuer Ruckstands-Analytik. 32 p.
Gilges, M. (2001) Photolysis of JAU6476 on Soil Surface. Project Number: M/1130918/3,
MR/242/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 47
P-
Hellpointner, E. (2001) Proazolthion (Proposed) [JAU6476]: Degradation and Metabolism
of JAU6476 in Aerobic Soils. Project Number: M/1250893/8, MR/104/01, 215. Unpublished
study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 101 p.
Gilges, M. (2000) Aerobic Degradation of JAU6476 in Two Soils. Project Number:
M/1250960/3, MR/549/99. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 59 p.
Gilges, M. (2001) Degradation of JAU6476-desthio (SXX0665) in Four Soils Under Aerobic
Conditions. Project Number: M/1251001/0, MR/327/00. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 58 p.
Gilges, M. (2001) Degradation of JAU6476-S-methyl (WAK7861) in Four Soils Under
Aerobic Condition. Project Number: M/125 1002/1, MR/340/00. Unpublished study prepared
by Bayer Ag Institut fuer Ruckstands-Analytik. 55 p.
Brumhard, B.; Oi, M. (2001) Aerobic Degradation and Metabolism of the Active Ingredent
JAU6476 in the Water/Sediment System. Project Number: M151/0899/3, MR/395/01,
BB J5 1 . Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 95 p.
Scholz, K. (2001) Anaerobic Aquatic Metabolism of JAU6476. Project Number:
M/1520919/7, MR/275/01. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 76 p.
Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in California Soil, 1999. Project
2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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46246520
46246521
46246522
46246523
46246524
46246525
46246526
46246527
46246529
46246531
46246534
46246535
Number: J6022102, 200051, F99534/001. Unpublished study prepared by Bayer Corp. and
A & L Great Lakes Laboratories. 124 p.
Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in Georgia Soil, 1999. Project
Number: J6022101, 110799, F99540/001. Unpublished study prepared by Bayer Corp.,
Bayer Research Farm and A & L Great Lakes Laboratories. 135 p.
Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in New York Soil, 1999. Project
Number: J6022103, 200053, F99557/001. Unpublished study prepared by Bayer Corp.,
A.C.D.S. Research, Inc. and A & L Great Lakes Laboratories. 134 p.
Lenz, M. (2004) Terrestrial Field Dissipation of JAU6476 in Saskatchewan Soil, 1999.
Project Number: J6022105, 200134, F99573/001. Unpublished study prepared by Bayer
Corp., A & L Great Lakes Laboratories and AgQuest. 137 p.
Lenz, M. (2004) Terrestrial Field Dissipation of JAU6476 in Manitoba Soil, 1999. Project
Number: J6022106, 200096, F99560/001. Unpublished study prepared by Bayer Corp., A &
L Great Lakes Laboratories and AgQuest. 137 p.
Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in a California Rice Field, 2000.
Project Number: J6022401, 200060, F005 19/001. Unpublished study prepared by Bayer
Corp., Agricultural Advisors, Inc. and A & L Great Lakes Laboratories. 181 p.
Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in an Arkansas Rice Field, 2000.
Project Number: J6022402, 200067, F00520/001. Unpublished study prepared by Bayer
Corp., Shoffner Farm Research and A & L Great Lakes Laboratories. 185 p.
Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in a Cropped Arkansas Rice Field,
2000. Project Number: J6022403, 200078, F00520/001. Unpublished study prepared by
Bayer Corp., Shoffner Farm Research, Battelle and A & L Great Lakes Laboratories. 148 p.
Schramel, O. (2001) Determination of the Storage Stability of JAU6476 and the Metabolites
JAU6476-desthio and JAU6476-S-methyl in Soil. Project Number: P64190027, MR/644/99.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 52 p.
Schramel, O. (2001) Dissipation of JAU 6476 (250 EC) in Soil Under Field Conditions
(France, Germany, Great Britain, Italy). Project Number: RA/2152/98, R812587, R812595.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 15 1 p.
Bauer, M. (2003) Independent Laboratory Validation of "Determination of JAU 6476,
Desthio (SXX 0665), S-methyl, and Thiazocine in Water by LC/MS/MS". Project Number:
AG030004, J6102401, 200484. Unpublished study prepared by Battelle. 62 p.
South, N. (2003) Independent Laboratory Validation of "Analysis of JAU 6476, Desthio, S-
methyl, and JAU 6476-thiazocine in Soil". Project Number: AG020026, J6102101, 200482.
Unpublished study prepared by Battelle. 62 p.
Lam, C. (2004) Analytical Method for the Determination of JAU 6476, Desthio, S-methyl
and JAU 6476-thiazocine in Soil and Sediment. Project Number: JA002/S04/01, 200515.
Unpublished study prepared by Bayer Corp. 30 p.
Sabbagh, G.; Arthur, E. (2004) Soil Adsorption Value (Koc) for JAU 6476. Project Number:
200817. Unpublished study prepared by Bayer Corp. 19 p.
Lam, C. (2004) Analytical Method for the Determination of JAU 6476, Desthio, S-methyl,
and JAU 6476-thiazocine in Water. Project Number: JA002/W04/01, 200517. Unpublished
study prepared by Bayer Corp. 32 p.
2004
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2004
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2004
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2004
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2004
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2004
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2004
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2004
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46246547
46246548
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46270401
Fisher, J. (2004) Calculation of Temperature Referenced Field Half-lives for JAU6476 and
JAU6476-desthio. Project Number: 200731. Unpublished study prepared by Bayer Corp. 27
P-
Pugsley, R.; Ritter, A.; Williams, W. (2004) Aquatic Environment and Drinking Water
Exposure Assessment of JAU6476 and Major Metabolites Resulting from JAU6476 Use on
Rice. Project Number: 746/36, 200840. Unpublished study prepared by Waterborne
Environmental, Inc. (WEI). 101 p.
Riegner, K. (1999) Leaching Behaviour of JAU 6476 Formulated as 250 EC in Soil (Parent
Leaching). Project Number: M/132/0961/2, 109139. Unpublished study prepared by Bayer
Ag Institut fuer Ruckstands-Analytik. 40 p.
Ramanarayanan, T. (2004) Degradation of JAU6476 and Its Major Metabolites in Two
Sediment- Water Systems Under Aerobic Conditions: Kinetics Modeling. Project Number:
200841. Unpublished study prepared by Bayer Corp. 33 p.
Ramanarayanan, T. (2004) Aquatic Ecological and Drinking Water Exposure Assessment for
JAU6476 and its Major Metabolites Resulting from JAU6476 Use on Barley, Canola,
Drybean, Peanut and Wheat. Project Number: 200842. Unpublished study prepared by Bayer
Corp. 122 p.
Hellpointner, E. (2000) Calculation of the Chemical Lifetime of JAU 6476 in the
Troposphere. Project Number: HPO/198, MR/323/00. Unpublished study prepared by Bayer
Ag Institut fuer Ruckstands-Analytik. lip.
Schramel, O. (2000) Residue Analytical Method 00610 (MR-642/99) for the Determination
of JAU 6476 and the Metabolites JAU 6476-S-methyl in Soil by HPLC-MS/MS. Project
Number: P60 190026, MR/643/99. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 61 p.
Sommer, H. (2002) Determination of the Storage Stability of JAU6476 and of the
Metabolites JAU6476-desthio and JAU6476-S-methyl in Soil. Project Number: P64190027,
MR/081/02. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 54
P-
Hellpointner, E. (1999) Calculation of the Chemical Lifetime of JAU 6476 in the
Troposphere. Project Number: HPO/172, MR/093/99. Unpublished study prepared by Bayer
Ag Institut fuer Ruckstands-Analytik. lip.
Schad, T. (200 1) Calculation of Degradation Rates of JAU 6476 Based on Aerobic Soil
Degradation Studies. Project Number: P668/01/6773, MR/383/01. Unpublished study
prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 20 p.
Tolliver, M. (2004) Tier II Summaries for Environmental Fate: (JAU 6476). Project
Number: 201005. Unpublished study prepared by Bayer CropScience LP. 195 p.
Tolliver, M. (2004) Prothioconazole (JAU6476) Tier 3 Summary. Project Number: 201008.
Unpublished study prepared by Bayer CropScience LP. 93 p.
Bayer CropScience (2004) Submission of Product Chemistry Data in Support of the
Applications for Registration of Prothioconazole Technical Fungicide and Proline 480 SC
Fungicide and the Petition for Tolerance of Prothioconazole for Use on Barley, Oilseed Crop
Group (Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean)
Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 1 Study.
Krohn, J. (1992) Octanol/Water Partition Coefficient of SXX 0665. Project Number:
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
01-Apr-
2004
17-May-
2004
17-May-
PROTHIOCONAZOLE FACT SHEET - Page 50 of 5 5
-------
46359100
46359101
46359102
46467300
46467301
46467302
46467303
46467304
46467305
46467306
46467307
46477400
Q/505/0507, 14/505/0507. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. lip.
Bayer CropScience (2004) Submission of Fate Data in Support of the Registration of
Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for
Tolerance of Prothioconazole Technical Fungicide for Use on Barley, Oilseed Crop Group,
Dried Shelled Pea and Bean Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 2
Studies.
Gilges, M. (2001) Photolysis of JAU6476 on Soil Surface. Project Number: M/l 130918/3,
MR/242/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 54
P-
Gilges, M. (2000) Aerobic Degradation of JAU6476 in Two Soils. Project Number:
M/1250960/3, MR/549/99. Unpublished study prepared by Bayer Ag Institut fuer
Ruckstands-Analytik. 68 p.
U.S. Triazole Task Force (2005) Submission of Toxicity and Residue Data in Support of the
Application for Registrations of Prothioconazole Technical Fungicide and Chipco Brand
Triton 70 WDG Fungicide, the Registrations of Lynx 45 WG Turf and Ornamental
Fungicide, Propiconazole Technical, Folicur 3.6 F Foliar Fungicide, Enable 2F, RH-7592
Technical and Propiconazole EC, and the Petitions for Tolerance of Tebuconazole,
Triadimefon, Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 7
Studies.
Wahle, B. (2004) A Subacute Toxicity Testing Study in the CD-I Mouse with 1,2,4-
Triazole. Project Number: 03/S71/QB, 200808, TZ524901. Unpublished study prepared by
Bayer Corp. and Huntingdon Life Sciences. 477 p.
Wahle, B. (2004) A Subchronic Toxicity Testing Study in the CD-I Mouse with 1,2,4-
Triazole. Project Number: 03/S71/QC, 201052, TZ524902. Unpublished study prepared by
Bayer Corp. and Bayer Ag Inst. of Toxicology and Dow Chemical Company. 765 p.
Wahle, B.; Sheets, L. (2004) A Combined Subchronic Toxicity / Neurotoxicity Screening
Study in the Wistar Rat with 1,2,4-Triazole. Project Number: 03/N72/QA, 201024,
T1072994. Unpublished study prepared by Bayer Corp. and Bayer Ag Inst. of Toxicology.
1257 p.
Young, A.; Sheets, S.; Elcock, L. (2005) A Two-Generation Reproductive Toxicity Study in
the Wistar Rat with 1,2,4-Triazole. Project Number: 03/R72/PZ, 201220, TZ521802.
Unpublished study prepared by Bayer Corp. 1570 p.
Reed, R. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole,
Triazolylalanine and Triazolylacetic Acid Residues in Milk: Final Report. Project Number:
MLI/03/04, ML03/1088/TTF, METH/160. Unpublished study prepared by Morse
Laboratories, Inc. 341 p.
Reed, R. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole,
Triazolylalanine and Triazolylacetic Acid Residues on Grapes: Final Report. Project
Number: MLI/03/05, ML03/1092/TTF, METH/160. Unpublished study prepared by Morse
Laboratories, Inc. 302 p.
Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole
Alanine and Triazole Acetic Acid Residues in Bananas. Project Number: 1487, METH/160.
Unpublished study prepared by Pyxant Labs Inc. 340 p.
Bayer CropScience (2005) Submission of Product Chemistry Data in Support of the
2004
09-Sep-
2004
09-Sep-
2004
09-Sep-
2004
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
09-Feb-
2005
22-Feb-
PROTHIOCONAZOLE FACT SHEET - Page 51 of 5 5
-------
46477401
46477700
46477701
46477702
46477703
46477704
46477705
46477706
46492900
46492901
46492902
46492903
46501400
Application for Registration of Prothioconazole Technical Fungicide. Transmittal of 1 Study.
Fontaine, L. (2005) Product Chemistry of Prothioconazole Technical. Project Number:
BR/2383, ANR/03 104, ANR/03005. Unpublished study prepared by Bayer Corp., Bayer Ag
Institut fuer Ruckstands-Analytik and U.S. Environmental Protection Agency. 182 p.
Bayer CropScience LP (2005) Submission of Residue and Efficacy Data in Support of the
Application for Registration of Proline 480 SC Foliar Fungicide. Transmittal of 6 Studies.
Duah, F. (2005) JAU6476 - Crop Residues Storage Stability Deficiency Study. Project
Number: J6131603, RAJAY037, 201262. Unpublished study prepared by Bayer Corp. 138
P-
Heinemann, O. (2000) Analytical Determination of Residues of JAU 6476 and Desthio-JAU
6476 in/on Cereals by HPLC-MS/MS. Project Number: P60293002, 00598, MR/401/99.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 87 p.
Heinemann, O. (2000) Analytical Determination of Residues of JAU6476 and JAU6476-
Desthio in/on Cereals and Canola by HPLC-MS/MS (Method Modification 00598/M001).
Project Number: P60293006, 00598/M001, MR/689/99. Unpublished study prepared by
Bayer Ag Institut fuer Ruckstands-Analytik. 92 p.
Heinemann, O. (2001) Analytical Determination of Residues of JAU6476-3 -Hydro xy
Hydroxydesthio, JAU6476-5-Hydroxy-Desthio, and JAU6476-Desthio in/on Matrices of
Animal Origin by HPLC-MS/MS. Project Number: P603003006, 00655, MR/537/00.
Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 190 p.
Bulman, P.; Henry, S. (2005) Proline 480 SC Fungicide (Prothioconazale) Fusarium Head
Blight Suppression in Wheat: Deficiency Response. Project Number: BYFCAN005/W,
544/01/03120, FD02NARDVOJB32. Unpublished study prepared by Bayer Cropscience LP.
92 p.
Henry, S.; Bulman, P. (2005) Proline 480 SC Fungicide (Prothioconazol) Fusarium Head
Blight Suppression in Barley: Deficiency Response. Project Number: BYFCAN005/B,
FD02NARDWJBG2, FD02NARDWJLB2. Unpublished study prepared by Bayer
CropScience. 80 p.
U.S. Triazole Task Force (2005) Submission of Residue and Toxicity Data in Support of
Triazole Products and the Petition for Tolerance of Tebuconazole, Triadimefon,
Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 3 Studies.
Maliani, N. (2004) Validation of the Residue Analytical Method: "Determination of 1,2,4-
Triazole, Triazole Alanine and Triazole Acetic Acid Residues in Plant and Animal
Matrices". Project Number: MLI/03/03, ML03/1081/TTF. Unpublished study prepared by
Morse Laboratories. 234 p.
Maliani, N. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole,
Triazolylalanine and Triazolylacetic Acid Residues in Tomatoes: Final Report. Project
Number: MLI/03/06, ML03/1093/TTF. Unpublished study prepared by Morse Laboratories,
Inc. 364 p.
Hoberman, A. (2005) Oral (Stomach Tube) Developmental Toxicity Study of 1,2,4-Triazole
in Rabbits. Project Number: VCB00002. Unpublished study prepared by Argus Research
Laboratories, Inc. 393 p.
U.S. Triazole Task Force (2005) Submission of Residue, Exposure and Risk Data in Support
of the Registrations of Lynx 2 and Lynx 45 WG Turf and Ornamental Fungicide, and the
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
22-Feb-
2005
10-Mar-
2005
10-Mar-
2005
10-Mar-
2005
10-Mar-
2005
18-Mar-
2005
PROTHIOCONAZOLE FACT SHEET - Page 52 of 5 5
-------
46501401
46501402
46501403
46501404
46553700
46553701
46568300
46568301
46580900
46616400
46616401
Applications for Registration of Chipco Brand Triton Fungicide and Chipco Brand Triton 70
WDG Fungicide, and the Petitions for Tolerance of Tebuconazole, Triademefon,
Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 4 Studies.
Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole
Alanine and Triazole Acetic Acid Residues in Eggs. Project Number:
U/S/TRIAZOLE/TASK/FORCE/1490, METH/160, U/S/TRIAZOLE/TASK/FORCE/1478.
Unpublished study prepared by Pyxant Labs Inc. and Morse Laboratories, Inc. 35 1 p.
Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole
Alanine and Triazole Acetic Acid Residues in Peanut Butter. Project Number:
U/S/TRIAZOLE/TASK/FORCE/1491, METH/160, U/S/TRIAZOLE/TASK/FORCE/1478.
Unpublished study prepared by Pyxant Labs Inc. and Morse Laboratories, Inc. 306 p.
Maliani, N. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole,
Triazolylalanine and Triazolylacetic Acid Residues in Soybeans. Project Number:
MLI/03/07, ML03/1094/TTF, METH/160. Unpublished study prepared by Morse
Laboratories, Inc. 332 p.
Heard, N. (2004) Triazole Alanine and Triazole Acetic Acid Aggregate Exposure
Assessments. Project Number: T022678/04. Unpublished study prepared by U.S. Triazole
Task Force. 152 p.
U.S. Triazole Task Force (2005) Submission of Toxicity, Residue, Risk and Exposure Data
in Support of the Application for Registrations of Propiconazole Technical, Folicur 3.6F
Foliar Fungicide, Lynx 45WG Turf and Ornamental Fungicide, Lynx 2, Enable 2F, RH-7592
Technical and Inline, the Registrations of Prothiconazole Technical Fungicide, Chipco (R)
Brand Triton (TM) Fungicide and Chipco Brand Triton 70 WD Fungicide, and the Petition
for Tolerance of Tebuconazole, Prothioconazole, Triticonazole, Triademefon, Triadimenol,
Fenbuconazole, Myclobutanil, Propiconazole, Tetraconazole and Epoxiconazole. Transmittal
of 1 Study.
Heard, N. (2005) 1,2,4-Triazole Aggregate Exposure Assessment. Project Number:
T022748/04. Unpublished study prepared by U.S. Triazole Task Force. 140 p.
U.S. Triazole Task Force (2005) Submission of Product Chemistry Data in Support of the
Applications for Registration of Prothioconazole Technical Fungicide, Chipco Brand Triton
Fungicide and Chipco Brand Triton 70 WDG Fungicide, the Registrations of Propiconazole
Technical, Lynx 2, Lynx 45 WG Turf and Ornamental Fungicide, Folicur 3.6F Foliar
Fungicide, Enable 2F, RH-7592 Technical and Propiconazole EC, and the Petitions for
Tolerance of Difenoconazole, Tebuconazole, Triadimefon, Myclobutanil, Tetraconazole and
Epoxiconazole. Transmittal of 1 Study.
Memmel, A. (2005) Storage Stability Studies for (3 Triazole Derived Metabolites) in
Apples, Wheat Flour, Milk, Peanut Butter and Eggs; Interim Report - Storage Stability
Through One Year. Project Number USTTF/15 11, ZOLE/TASK/FORCE/1511, 1511.
Unpublished study prepared by Pyxant Labs Inc. 170 p.
U.S. Triazole Task Force (2005) Submission of Residue Data in Support of the Petitions for
Tolerance of Triazole. Transmittal of 1 Study.
U.S. Triazole Task Force (2005) Submission of Toxicity and Product Chemistry Data in
Support of the Petitions for Tolerance of 1,2,4-Triazole and the Registrations of Lynx 45
WG Turf and Ornamental Fungicide, Lynx 2, Chipco Brand Triton Fungicide, Chipco Brand
Triton 70 WDG Fungicide. Transmittal of 2 Studies.
DairOsto, M.; Hess, F.; Juberg, D.; et. al. (2005) Scientific Assessment to Support Waiver
18-Mar-
2005
18-Mar-
2005
18-Mar-
2005
18-Mar-
2005
25-May-
2005
25-May-
2005
08-Jun-
2005
08-Jun-
2005
28-Jun-
2005
08-Aug-
2005
08-Aug-
PROTHIOCONAZOLE FACT SHEET - Page 53 of 5 5
-------
46616402
46714600
46714601
46714602
46714603
46714604
46714605
46714606
46714607
46727700
46727701
46765300
46765301
46841000
Exemptions for an Acute Neurotoxicity Study in the Rat, the Partial Chronic
Toxicity/Oncogenicity Studies in the Male Rat and Female Mouse with 1,2,4-Triazole.
Project Number: T004225/05. Unpublished study prepared by Isagro S.P.A., BASF
Corporation and Bayer CropScience LP. 83 p.
Jensen, T. (2004) The Homogeneity and Stability of 1, 2, 4-Triazole Technical in Rodent
Ration Using Purina Mills Certified Rodent Diet 5002 Meal. Project Number: 03/H72/RR,
201 185. Unpublished study prepared by Bayer Corp. 15 p.
Bayer CropScience LP (2005) Submission of Product Chemistry and Toxicity Data in
Support of the Application for Registration of Provost 433 SC Fungicide. Transmittal of 7
Studies.
Frank, J. (2005) Product Chemistry of Provost 433 SC Fungicide. Project Number: BR/244,
ANR/22005, ANR/21905. Unpublished study prepared by Bayer Corp. 53 p.
Moore, G. (2005) Acute Oral Toxicity Up and Down Procedure in Rats: AE 1344248 01
SC39 Al. Project Number: 181 15, P320/UDP. Unpublished study prepared by Product
Safety Laboratories. 15 p.
Moore, G. (2005) Acute Dermal Toxicity Study in Rats - Limit Test: AE 1344248 01 SC39
Al. Project Number: 181 16, P322. Unpublished study prepared by Product Safety
Laboratories. 15 p.
Moore, G. (2005) Acute Inhalation Toxicity Study in Rats - Limit Test: AE 1344248 01
SC39 Al. Project Number: 181 17, P330. Unpublished study prepared by Product Safety
Laboratories. 22 p.
Moore, G. (2005) Primary Eye Irritation Study in Rabbits: AE 1344248 01 SC39 Al. Project
Number: 18118, P324. Unpublished study prepared by Product Safety Laboratories. 16 p.
Moore, G. (2005) Primary Skin Irritation Study in Rabbits: AE 1344248 01 SC39 Al.
Project Number: 181 19, P326. Unpublished study prepared by Product Safety Laboratories.
16 p.
Moore, G. (2005) Dermal Sensitization Study in Guinea Pigs (Buehler Method): AE
1344248 01 SC39 Al. Project Number: 18120, P328. Unpublished study prepared by
Product Safety Laboratories. 23 p.
Bayer Cropscience LP (2005) Submission of Product Chemistry Data in Support of the
Application for Registration of Prosaro 421 SC Fungicide. Transmittal of 1 Study.
Frank, J. (2005) Product Chemistry of Prosaro 421 SC Fungicide. Project Number:
ANR/21305, ANR/21405, 12980. Unpublished study prepared by Bayer Corp. 268 p.
Bayer CropScience LP (2006) Submission of Public Interest Data in Support of the
Registrations of Prothioconazole Technical, Proline 480 SC Fungicide, Provost 433 SC
Fungicide, Prosaro 421 SC Fungicide. Transmittal of 4 Studies.
Nelson, J.; Heintzelman, R.; Kaiser, R.; et. al. (2006) Public Interest Document for
Prothioconazole Technical, Proline 480 SC Fungicide, Provost 433 SC Fungicide and
Prosaro 421 SC Fungicide. Project Number: PID/BAY05JN15. Unpublished study prepared
by ABG, Inc. 74 p.
Bayer CropScience (2006) Submission of Residue Data in Support of the Applications for
Registration of Prothioconazole Technical Fungicide, Proline 480 SC Fungicide and Provost
433 SC Fungicide and the Petition for Tolerance of Prothioconazole on Soybean. Transmittal
2005
08-Aug-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
19-Dec-
2005
09-Jan-
2006
09-Jan-
2006
22-Feb-
2006
22-Feb-
2006
22-May-
2006
PROTHIOCONAZOLE FACT SHEET - Page 54 of 5 5
-------
46841001
46841002
46923600
46923601
of 2 Studies.
Duah, F.; Harbin, A. (2006) JAU6476 480 SC - Magnitude of the Residue in/on Soybeans.
Project Number: RAJAY026, M/270206/01/1. Unpublished study prepared by Bayer
CropScience LP and Pyxant Labs Inc. 489 p.
Duah, F.; Harbin, A. (2006) JAU6476 480 SC - Magnitude of the Residue in/on Soybean
Aspirated Grain Fractions and Soybean Processed Commodities. Project Number:
RAJAY027, 1641. Unpublished study prepared by Texas A & M Food Protein Research,
GLP Technologies and Pyxant Labs Inc. 524 p.
Bayer CropScience LP (2006) Submission of Toxicity Data in Support of the Application for
Registrations of Prothioconazole Technical and Proline 480 SC Fungicide. Transmittal of 1
Study.
Young, A. (2006) Technical Grade JAU 6476: A Supplementary PreNatal Developmental
Toxicity Study in the Wistar Hanover (Crl: WI(HAN) Rat to Investigate Ocular
Abnormalities and Supernumerary Ribs. Project Number: 03/T12/UB, 201037,
MO/04/004745. Unpublished study prepared by Bayer CropScience LP. 1488 p.
22-May-
2006
22-May-
2006
30-Aug-
2006
30-Aug-
2006
PROTHIOCONAZOLE FACT SHEET - Page 55 of 5 5
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