UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Pesticide Fact Sheet
Name of Chemical: Pyrasulfotole
Reason for Issuance: Conditional Registration
Date Issued: August, 2007
I. Description of Chemical
Chemical Name:
Common Name:
Chemical Formula:
EPA PC Code:
Chemical Abstracts
Service (CAS) Number:
Year of Initial
Registration:
Pesticide Type:
Chemical Class:
U.S. Producer:
(5-hydroxyl-l,3-dimethyl-lH-pyrazol-4-yl)[2-
(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone
Pyrasulfatole
CH
HO
CH,
000692
365400-11-9
2007
Herbicide
Pyrazole
Bayer CropScience
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II. Use Patterns and Formulations
Application Sites:
Pyrasulfotole is registered for use on cereal grains including wheat,
barley, oats, rye, and triticale.
Types of Formulations: Technical grade manufacturing use product (98.6% pyrasulfatole)
Liquid end-use product (4.4% pyrasulfatole)
Liquid end-use product (3.3% pyrasulfatole; 26.3% bromoxynil)
Application Methods
And Rates:
Pyrasulfatole may be applied as a single application to wheat,
barley, oats, and triticale at 0.045 pounds of active ingredient per
acre. It may be applied as a single application to rye at 0.0037
pounds of active ingredient per acre. It may be applied preplant,
preemergence, or postemergence between from the 1 leaf stage up
to flag leaf stage. Ground or aerial equipment may be used.
Ground sprinkler irrigation is also permitted.
III. Physical and Chemical Properties:
Table 1 — Physical and Chemical Properties of Pyrasulfotole
Melting point
PH
Density
Water solubility at 20°C
Solvent solubility at 20°C
Vapor pressure
Dissociation constant, pKa
n-Octanol/water partition
coefficient, Log(Kow) at 23 °C
UV/visible absorption spectrum
Pure: 20 FC
No boiling point, decomposition starts at 245°C
3.03 at 22.9°C (1% aqueous dispersion)
1.53
pH 4 buffer: 4.2 g/L
pH 7 buffer: 69.1 g/L
pH 9 buffer: 49 g/L
ethanol: 2 1.6 g/L
n-hexane: 0.038 g/L
tolune: 6.86 g/L
acetone: 89.2 g/L
dichloromethane: 120-150 g/L
ethyl acetate: 37.2 g/L
dimethyl sulfoxide: > 600
2.7 x 10'7Pa(20°C)
4.2
pH4: 0.276
pH7: -1.362
pH9: -1.580
Xmax=264,241 nm in water, 0. 1M HC1, 0. 1M NaOH
respectively
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IV. HUMAN HEALTH RISK ASSESSMENT
A. Toxicity
1. Acute Toxicity: Pyrasulfotole has a low to moderate order of acute toxicity via
the oral, dermal, and inhalation routes (Category III or IV). Pyrasulfotole is not a
dermal sensitizer or irritant (Category IV) and has been shown to be a moderate
eye irritant (Category III). The acute toxicity findings for pyrasulfatole are
summarized below in Table 2:
Table 2 — Acute Toxicity
Acute Toxicity of Pyrasulfotole
Guideline
No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation - rat
Primary Eye Irritation -
rabbit
Primary Skin Irritation -
rabbit
Dermal sensitization -
guinea pig
Results
LD50 > 2000 mg/kg
LD50 > 2000 mg/kg
LC50>5.03mg/L
Formulation is moderately irritating
to the eye
Not an irritant to the skin
Not a dermal sensitizer
Toxicity
Category
III
III
IV
III
IV
N/A
2. Subchronic Toxicity: Ocular toxicity was observed in male and female rats
exposed to pyrasulfotole for 90 days (subchronic oral exposure) either in the diet or
by gavage. Mortality and multi-organ histopathology in the kidney, urinary
bladder, thyroid, and ureters were also observed in the dietary study. In mice,
toxicity of the urinary bladder was observed in males, while toxicity of the adrenal
glands was observed in females treated in the diet for 28 days. Neither effect was
reproduced in the 90-day toxicity study in mice; however, urinary bladder toxicity
was observed in the 29-day toxicity study in the dog, the 90-day toxicity study in
the rat, and the mouse carcinogenicity study. Rats treated with pyrasulfotole for 28
days by the dermal route demonstrated toxicity of the thyroid and pancreas.
3. Chronic Toxicity: Chronic oral exposure of rats to pyrasulfotole resulted in
extensive eye toxicity at almost all doses tested. These included corneal opacity,
neovascularization of the cornea, inflammation of the cornea, regenerative corneal
hyperplasia, corneal atrophy, and/or retinal atrophy. Ocular toxicity is believed to be
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an indirect result of tyrosinemia caused by inhibition of the liver enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD). In mice, ocular toxicity was not
observed at any dose, thereby reflecting accepted differences in effects among rodent
species for HPPD inhibitors. Long-term exposure of mice to pyrasulfotole did cause
toxicity of the urinary system, including the kidney, urinary bladder, and ureters at
the highest dose tested, as well as gallstone formation at all doses tested. Dogs
treated with pyrasulfotole for one year exhibited toxicity of the urinary system
(kidneys and bladder) at mid and high doses, as well as cataracts at a very low
incidence at the highest dose tested.
4. Carcinogenicity: Pyrasulfotole is classified as "Suggestive Evidence of
Carcinogenic Potential", based on increased incidences of corneal tumors in male rats
at the highest dose tested (2500 ppm) in the chronic toxicity/carcinogenicity study in
rat and urinary bladder transitional cell tumors in male and female mice at the highest
dose tested (4000 ppm) in the mouse carcinogenicity study. These tumors were
observed at doses that were considered excessive due to increased mortality caused
by urinary bladder stones. In addition, the progression of non-neoplastic related
lesions in both the rats and mice was biologically plausible by non-genotoxic modes
of action for both the corneal tumors and the bladder tumors. The chronic RfD of
0.01 mg/kg/day, based on the rat chronic toxicity/carcinogenicity study
(NOAAEL=25 ppm [1 mg/kg/day] and LOAEL of 250 ppm [10 mg/kg/day]) would
be protective of both non-cancer and potential cancer precursor effects. Therefore,
quantifications of separate cancer risk was not required.
5. Prenatal and Postnatal Sensitivity: Increased quantitative susceptibility of
offspring was observed in the rabbit developmental toxicity study, since offspring
toxicity (skeletal anomalies/variations) was observed at a lower dose than maternal
toxicity (decreased body weight gain, food consumption). No evidence of
quantitative susceptibility following in utero and/or postnatal exposure was observed
in the prenatal developmental toxicity study in rats, the developmental neurotoxicity
(DNT) study in rats, or in the 2-generation rat reproductive toxicity study. Offspring
toxicity [skeletal variations; decreased body weight (males)] was observed at the
same dose as maternal toxicity (clinical signs, decreased body weight, enlarged
placenta) in the prenatal developmental toxicity study in rats. Offspring toxicity
(e.g., ocular toxicity, effects on learning/memory, effects on brain morphometry) was
also observed at the same dose as maternal toxicity (ocular opacity) in the DNT
study. Finally, offspring toxicity (ocular toxicity) was observed at the same as or
higher doses than parental toxicity (thyroid effects) in the 2-generation rat
reproductive toxicity study
6. Metabolism: Following oral administration of 10 mg/kg phenyl or pyrazole ring-
labeled pyrasulfotole, -60% of radiolabeled compound was excreted in the urine after
6 hours, while -73% of the administered dose was recovered in the urine by the time
of sacrifice (52 hours). Therefore, approximately 60% of the compound was
absorbed within 6 hours of exposure. Less than 2% of the administered dose
remained in the residual carcass and tissues at sacrifice, and the highest residues were
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7. Mutagenicity: Pyrasulfotole was negative for mutations and chromosomal
aberrations across four in vitro/in vivo genotoxicity studies and was considered not to
pose a mutagenic concern.
8. Toxicology Profile: The toxicological profile for pyrasulfatole is discussed in Table
3 below:
Table 3 — Toxicology Profile
Subchronic, Chronic and Other Toxicity Profile for Pyrasulfotole
Guideline
No.
Study Type
MRID No./Doses
Results
N/A
2 8-day oral
toxicity (mouse;
dietary)
46801843
0,200, 1000, or 5000
ppm (equal to 0/0,
35.8/45.0, 192/233, or
961/1082mg/kg
bw/day [M/F])
LOAEL = 961/1082 mg/kg/day [M/F],
based on gritty content in the urinary
bladder and histopathology (urothelial
hyperplasia, diffuse submucosal
granulation tissue, diffuse suburothelial
mixed-cell infiltrate) in the urinary
bladder (males) and subcapsular
hyperplasia of the adrenal gland
(females)
NOAEL = 192/233 mg/kg/day [M/F].
870.3100
90-day oral
toxicity (mouse;
dietary)
46801844
0, 100, 1500, or 3000
ppm (equal to 0/0,
16.5/19.7, 124/152,
259/326, or 500/617
mg/kg bw/day [M/F])
LOAEL not observed
NOAEL = 500/617 mg/kg/day (M/F).
870.3200
28-day dermal
toxicity (rat)
46801904
0, 10, 100, or 1000
mg/kg bw/day
LOAEL =100 mg/kg/day based on
focal degeneration of the pancreas
(both sexes) and alteration of thyroid
colloid (males)
NOAEL= 10 mg/kg/day.
870.6200
Subchronic
neurotoxicity
(rat; dietary)
46801916
0, 500, 2500, or 5000
ppm (equivalent to
0/0, 32/42, 166/206,
or 345/416 mg/kg
bw/day [M/F])
LOAEL = 42 mg/kg bw/day in females
based on increased incidences of
corneal opacity and corneal
neovascularization; not observed in
males The NOAEL was not observed
in females; 345 mg/kg bw/day in
males.
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870.6300
870.6200
870.4300
N/A
870.3150
Developmental
neurotoxicity
(rat; dietary)
Acute
neurotoxicity
(rat; gavage)
Combined
chronic
toxicity/carcinoge
nicity (rat;
dietary)
2 8 -day oral
toxicity (dog;
dietary)
29/90-day oral
toxicity (dog;
dietary)
46801917
0,3.8, 37, or 354
mg/kg bw/day
(gestation and
lactation)
46801915
0, 200, 500, or 2000
mg/kg bw
46801910
0, 25, 250, 1000, or
2500 ppm (equivalent
to 0/0, 1.0/1.4, 10/14,
41/57, or 104/140
mg/kg bw/day [M/F])
46801845
0, 5000, 13000 or
26000 ppm
(equivalent to 0/0,
174/171, 469/440 or
860/782 mg/kg
bw/day [M/F])
46801901
0, 1500, 9000 or
18000 ppm; study
terminated on day 29
Maternal LOAEL = 37 mg/kg/day,
based on ocular opacities during
lactation
Maternal NOAEL = 3.8 mg/kg/day.
Offspring LOAEL = 37 mg/kg/day
based on ocular opacity (post-
weaning), decreased body weight,
delayed preputial separation (males),
increase in number of trials to criterion
and decreases in trial latencies (passive
avoidance; PND 22 males), retinal
degeneration at ophthalmoscopy
(females), decreased brain weight
(PND 21 females), decreased cerebrum
length (PND 21 females), and
decreased cerebellum height (PND 21
males)
Offspring NOAEL = 3.8 mg/kg/day.
LOAEL = 200 mg/kg bw (F) and 2000
mg/kg bw (M) based on decreased
locomotor activity on day 0
NOAEL not observed in females; 500
mg/kg bw in males.
LOAEL = 10/14 mg/kg (M/F) based on
corneal opacity, neovascularization of
the cornea, inflammation of the cornea,
regenerative corneal hyperplasia,
corneal atrophy, and/or retinal atrophy
(both sexes), hepatocellular
hypertrophy along with increased
serum cholesterol (males) and an
increased incidence of chronic
progressive nephropathy (males)
NOAEL = 1.0/1.4 mg/kg (M/F).
LOAEL = 171/174 mg/kg bw/day
(F/M) based on increases in serum
triglycerides and elevated liver weights
(M&F), and increased midzonal
multifocal vacuolation of liver (M)
NOAEL not observed.
N/A
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870.3150
90-day oral
toxicity (dog;
dietary)
46801902
0, 100, 500, or 1000
ppm (equivalent to
0/0, 3/3, 17/17, or
40/33 mg/kgbw/day
[M/F])
LOAEL not established
NOAEL = 40/33 mg/kg bw/day (M/F).
870.3100
90-day oral
toxicity (rat;
dietary)
46801842
0, 2, 30, 1000, 7000,
or 12000 ppm
(equivalent to 0/0,
0.13/0.15, 1.96/2.32,
66/77, 454/537, or
830/956 mg/kg
bw/day [M/F])
LOAEL = 77 mg/kg bw/day (F) and
454 mg/kg bw/day (M), based on
increased incidences of corneal opacity
(M&F), mortality, and histopathology
in the kidney, urinary bladder, thyroid,
and ureters (M)
NOAEL = 2.32 mg/kg bw/day (F) and
66 mg/kg bw/day (M).
870.3700
Prenatal
developmental
toxicity (rat;
gavage)
46801905
0, 10, 100, or 300
mg/kg bw/day
Maternal LOAEL = 100 mg/kg/day
based on increased incidence of
salivation, decreased corrected body
weight gain, decreased body weight
during GD 6-8 and enlarged placenta.
Maternal NOAEL = 10 mg/kg/day.
Developmental LOAEL = 100
mg/kg/day based on increased fetal
and/or litter skeletal variations; and
decreased body weight (males);
Developmental NOAEL = 10
mg/kg/day.
870.3700
Prenatal
developmental
toxicity (rabbit;
gavage)
46801906
0, 10, 75, or 250
mg/kg bw/day
Maternal LOAEL = 250 mg/kg bw/day
based on decreased body weight gain
during GD 8-10 and decreased food
consumption Maternal NOAEL = 75
mg/kg bw/day.
Developmental LOAEL = 75 mg/kg
bw/day based on increased incidences
of fetal/litter skeletal variations
Developmental NOAEL = 10
mg/kg/day.
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870.3800
Reproduction and
fertility effects
(rat; dietary)
46801907
0,30, 300 or 3000
ppm (equivalent to
premating doses of
0/0,2.5/3.1,26.3/32.6,
or 272.4/345.7 mg/kg
bw/day [Fo M/F]; and
0/0, 3.68/4.2,
34.1/38.9 or
353.6/393.4 mg/kg
bw/day [Fi M/F])
Parental LOAEL = 2.5/3.1 mg/kg
bw/day (M/F), based on colloid
alteration and/or pigment deposition in
the thyroid
Parental NOAEL not observed.
Offspring LOAEL = 26.3/32.6 mg/kg
bw/day [M/F] based on corneal opacity
and/or corneal neovascularization (Fl
and F2 generations)
Offspring NOAEL = 2.5/3.1 mg/kg
bw/day [M/F].
Reproductive LOAEL = 26.3/32.6
mg/kg bw/day (M/F), based on delayed
balano-preputial separation in FI pups.
Reproductive NOAEL = 2.5/3.1 mg/kg
bw/day (M/F).
870.4100
Chronic toxicity
(dog; dietary)
46801908
0,250, 1000, or 3000
ppm (equivalent to
0/0, 7/9, 34/33, or
101/93 mg/kg bw/day
[M/F])
LOAEL = 34 (M) & 93 (F) mg/kg/day,
based on increased incidence and
severity of kidney tubular dilatation
(M) and cataracts (F).
NOAEL = 7 (M) & 33 (F) mg/kg/day.
870.4200
Carcinogenicity
(mouse; dietary)
46801909
0/0, 13.6/16.7,
137/168 and 560/713
mg/kg bw/day (M/F)
LOAEL = 13.6/16.7 mg/kg bw/day
(M/F) based on increased incidences of
gallstones
NOAEL not observed.
870.5100
Gene mutation
(bacterial; in
vitro)
46801911
0, 16, 50, 158, 500,
1581 or 5000 ng/plate
(+/- S9)
Negative
870.5300
Gene mutation
(mammalian; in
vitro)
46801912
0, 30, 60, 120, 240,
480, or 960 ug/mL
(+/- S9)
Negative
870.5375
Chromosome
aberration
(mammalian; in
vitro)
46801913
0, 200, 400, 500, 600,
800, 1000, 1500,
2000, or 2500 ug/mL
(+/- S9)
Negative (chromosome isodeletions
observed at cytotoxic concentration
only).
870.5395
Erythrocyte
micronucleus
(mouse; in vivo)
46801914
0/0, 125/250, 250/500
or 5 00/1000 mg/kg
bw (M/F)
Negative
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870.7485
Metabolism and
Pharmacokinetics
46801918
0 or 10 mg/kgbw
(single low dose;
dietary and iv); high
dose and repeated
dosing not tested
Following oral administration, -60%
of radioactivity absorbed and excreted
in urine in 6 hrs; -70% of radioactivity
excreted in urine and 30% in feces by
52 hrs; hydroxymethyl AE 0317309
(2%), desmethyl AE 0317309 (<9%),
and AE B197555 (benzoic acid; <2%)
observed as metabolites in urine &
feces; further metabolism unknown;
<2% of administered dose remained in
residual carcass and tissues after 52
hrs, highest residues in liver and
kidney.
9. FQPA Hazard Considerations: EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor to IX. That
decision is based on the following findings:
• The toxicology database is complete.
• There are no residual uncertainties concerning pre- and postnatal toxicity. Clear
NOAELs were established for all exposure scenarios and these are considered
protective of the offspring susceptibility observed in the rabbit developmental
toxicity study. The concern for increased susceptibility seen in rabbit
developmental toxicity study is low because a) there is well established
developmental NOAEL in the rabbit developmental toxicity study in rabbits
protecting fetuses from skeletal anomalies/variations, b) the increased
succeptibility was not seen in rat developmental toxicity study, developmental
neurotoxicity study in rats and two generation reproduction study in rats, c) the
NOAEL of the study chosen for the chronic RfD is lOx lower than the rabbit
developmental toxicity study NOAEL (10 mg/kg/day).
• There are no registered or proposed uses of pyrasulfotole which would result in
residential exposure.
• There are no residual uncertainties identified in the exposure databases. The
dietary food exposure assessments were performed based on 100% crop treated
and tolerance-level residues for all proposed commodities. By using this
screening-level assessment, the acute and chronic exposures/risks will not be
underestimated. The dietary drinking water assessment (unrefined estimates)
utilizes values generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates of water
concentrations.
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10. Toxicological Endpoints: A summary of the toxicological endpoints and doses
chosen for the relevant exposure scenarios for dietary and occupational human health
risk assessments is provided in the table below. The conventional interspecies
extrapolation (10X) and intraspecies variation (10X) uncertainty factors were applied
for all exposure scenarios. As stated above, the FQPA SF for increased
susceptibility was reduced to IX for all exposures scenarios. A summary of the
toxicological endpoints are shown below in Table 4:
Table 4 ~ Summary of Toxicological Doses and Endpoints for Pyrasulfotole
for Use in Human Health Risk Assessments
Exposure/Scenario
Acute Dietary (All
populations)
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)
Dose Used
in Risk
Assessment
NOAEL =
3.8
mg/kg/day
NOAEL=
1.0
mg/kg/day
NOAEL=
2.5
mg/kg/day
NOAEL =
10
mg/kg/day
Uncertainty/FQPA
Safety Factors
UFA = 10X
UFH = 10X
UFp-QpA = IX
UFA = 10X
UFH = 10X
UFp-QpA = IX
UFA = 10X
UFH = 10X
UFFQPA=1X
UFA = 10X
UFH = 10X
Study and Toxicological Effects
Developmental neurotoxicity (rat;
dietary) Offspring LOAEL = 37
mg/kg/day based on delayed
preputial separation (males),
decreased cerebrum length (PND
21 females), and decreased
cerebellum height (PND 21
males)
Combined chronic
toxicity/carcinogenicity (rat;
dietary) LOAEL = 10/14
mg/kg/day (M/F) based on
corneal opacity,
neovascularization of the cornea,
inflammation of the cornea,
regenerative corneal hyperplasia,
corneal atrophy, and /or retinal
atrophy (both sexes), and
hepatocellar hypertrophy along
with increased serum cholesterol
(males)
Reproduction and fertility effects
(rat; dietary) Offspring LOAEL =
26.3/32.6 mg/kg bw/day [M/F]
based on corneal opacity and/or
corneal neovascularization (Fl
and F2 generations)
28-day dermal toxicity (rat)
LOAEL = 100 mg/kg bw/day
(M/F) based on focal
degeneration of pancreas (both
sexes) and alteration of thyroid
colloid (males)
10
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Exposure/Scenario
Dermal Long-Term
(>6 months)
Inhalation (All
durations)
Dose Used
in Risk
Assessment
NOAEL=
1.0
mg/kg/day
Estimated
dermal
absorption
factor =
2.5%
NOAEL =
1.0
mg/kg/day
100%
inhalation
asumed
Uncertainty/FQPA
Safety Factors
UFA = 10X
UFH = 10X
UFA = 10X
UFH = 10X
Study and Toxicological Effects
Combined chronic
toxicity/carcinogenicity (rat;
dietary) LOAEL = 10/14
mg/kg/day (M/F) based on
corneal opacity,
neovascularization of the cornea,
inflammation of the cornea,
regenerative corneal hyperplasia,
corneal atrophy, and/or retinal
atrophy (both sexes), and
hepatocellular hypertrophy along
with increased serum cholesterol
(males)
Combined chronic toxicity/
carcinogenicity (rat; dietary)
LOAEL = 10/14 mg/kg/day (M/F)
based on corneal opacity,
neovascularization of the cornea,
inflammation of the cornea,
regenerative corneal hyperplasia,
corneal atrophy, and/ or retinal
atrophy (both sexes), and
hepatocellular hypertrophy along
with increased serum cholesterol
(males)
Cancer (oral, Classification: "Suggestive Evidence of Carcinogenic Potential" based on increased incidences of
dermal, cornea! tumors in male rats (oral carcinogenicity study) and urinary bladder tumors in male and
inhalation) female mice (oral carcinogenicity study).
UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH =
potential variation in sensitivity among members of the human population (intraspecies), UFFQPA
= FQPA Safety Factor
B. Dietary Exposure and Risk
1. Dietary Exposure from Food: As to residues in food, EPA relied upon tolerance
level residues and assumed 100% crop treated for all commodities for both acute and
chronic exposures.
2. Dietary Exposure from Water: In both acute and chronic dietary drinking water
was incorporated directly into the dietary assessment using the chronic
concentration for surface water generated by the FIRST model. Modeled estimates of
drinking water concentrations were directly entered into the dietary exposure model.
For acute dietary risk assessment, the water concentration value of 4.0 ppb was used
11
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to access the contribution to drinking water. For chronic dietary risk assessment, the
water concentration of value 2.8 ppb was used to access the contribution to drinking
water.
The pyrasulfotole risk assessment team determined that the residue of concern in
drinking water for risk assessment purposes is parent only. Pyrasulfotole-benzoic
acid was identified as the only environmental degradate in the soil metabolism and
terrestrial field dissipation studies. Based on available toxicology studies on
pyrasulfotole-benzoic acid, EPA determined that it is not of toxicological concern;
and, thus should not be included in the drinking water assessment for pyrasulfotole.
3. Aggregate Exposure Risk Assessments: For pyrasulfotole, aggregate exposure risk
assessments were performed for the following scenarios: acute aggregate exposure
(food and drinking water), and chronic aggregate exposure (food and drinking water).
Short- and intermediate-term assessments, which are used to evaluate aggregate
dietary and residential exposures, were not performed because there are no registered
or proposed residential non-food uses. Although pyrasulfotole is classified as
"Suggestive Evidence of Carcinogenicity", it was determined that separate
quantifications of cancer risks is not required, and that the chronic RfD will be
protective of cancer and non-cancer effects (please refer to the section above for
Carcinogenicity).
4. Acute Aggregate Risk: From food and water, pyrasulfotole and its metabolites
pyrasulfotole-desmethyl, will occupy 2% of the aPAD for the general U.S. population
and at 4% of the aPAD for children 1-2 years old, the most highly exposed
population subgroup. Therefore, the acute aggregate risk associated with the
proposed uses of pyrasulfatole are not of concern to the general U.S. population or
any subgroup.
5. Chronic Aggregate Risk: The exposure to pyrasulfotole and pyrasulfotole-
desmethyl from food and water will utilize 2% of the cPAD for the general U.S.
population and at 7% of the cPAD for children 1-2 years old, the most highly
exposed population subgroup. Therefore, the chronic aggregate risk associated with
the proposed uses of pyrasulfatole are not of concern to the general U.S. population
or any subgroup.
6. Cancer Aggregate Risk: Pyrasulfotole is classified as "Suggestive Evidence of
Carcinogenicity". However, for the reasons stated above in the Section for
Carcinogenicity, it was determined that separate quantifications of cancer risks is not
required, and that the chronic RfD will be protective of cancer and non-cancer
effects.
A summary of the acute and chronic dietary exposure analyses are shown in
Table 5 below:
12
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Table 5 — Summary of the Dietary Exposure and Risk to Pyrasulfatole
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Youth 13- 19 years old
Adults 20 - 49 years old
Females 13-49 years old
Adults 50 + years old
Acute Dietary Risk
Dietary
Exposure
(mg/kg/day)
0.000633
0.001259
0.001393
0.000431
0.000378
0.000431
0.000331
% aPAD
2
3
4
1
1
1
1
Chronic Dietary Risk
Dietary
Exposure
(mg/kg/day)
0.000224
0.000410
0.000698
0.000190
0.000168
0.000190
0.000160
% cPAD
2
4
7
2
2
2
2
7. Cumulative Risk: Pyrasulfotole belongs to a class of herbicides (including
mesotrione, isoxaflutole, and topramezone) that inhibit the liver enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the catabolism
(metabolic breakdown) of tyrosine (an amino acid derived from proteins in the diet).
Inhibition of HPPD can result in elevated tyrosine levels in the blood, a condition
called tyrosinemia. HPPD-inhibiting herbicides have been found to cause a number
of toxicities in laboratory animal studies including ocular, developmental, liver and
kidney effects. Of these toxi cities, it is the ocular effect (corneal opacity) that is
highly correlated with the elevated blood tyrosine levels. In fact, rats dosed with
tyrosine alone show ocular opacities similar to those seen with HPPD inhibitors.
Although the other toxicities may be associated with chemically-induced tyrosinemia,
other mechanisms may also be involved.
There are marked differences among species in the ocular toxicity associated with
inhibition of HPPD. Ocular effects following treatment with HPPD inhibitor
herbicides are seen in the rat but not in the mouse. Monkeys also seem to be
recalcitrant to the ocular toxicity induced by HPPD inhibition. The explanation of
this species-specific response in ocular opacity is related to the species differences in
the clearance of tyrosine. A metabolic pathway exists to remove tyrosine from the
blood that involves a liver enzyme called tyrosine aminotransferase (TAT). In
contrast to rats where ocular toxicity is observed following exposure to HPPD-
inhibiting herbicides, mice and human are unlikely to achieve the levels of plasma
tyrosine necessary to produce ocular opacities because the activity of TAT in these
13
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species is much greater compared to rats. Thus, humans and mice have a highly
effective metabolic process for handling excess tyrosine.
HPPD inhibitors (e.g., Nitisinone) are used as an effective therapeutic agent to treat
patients suffering from rare genetic diseases of tyrosine catabolism. Treatment starts
in childhood but is often sustained throughout patient's lifetime. The human
experience indicates that a therapeutic dose (1 mg/kg/day dose) of Nitisinone has an
excellent safety record in infants, children and adults and that serious adverse health
outcomes have not been observed in a population followed for approximately a
decade. Rarely, ocular effects are seen in patients with high plasma tyrosine levels;
however these effects are transient and can be readily reversed upon adherence to a
restricted protein diet. This indicates that an HPPD inhibitor in it of itself cannot
easily overwhelm the tyrosine-clearance mechanism in humans.
Therefore, exposure to environmental residues of HPPD-inhibiting herbicides are
unlikely to result in the high blood levels of tyrosine and ocular toxicity in humans
due to an efficient metabolic process to handle excess tyrosine. In the future,
assessment of HPPD-inhibiting herbicides will consider more appropriate models and
cross species extrapolation methods.
C. Handler and Worker Risk Assessments
1. Worker Exposure: Based on the proposed use patterns, short-term (1-30 days),
dermal and inhalation exposures are expected for applicators, especially
mixer/loaders using open-pour loading of liquids for aerial applications, and
applicators using groundboom equipment. In addition, there is a possibility for
agricultural workers to experience post-application exposures to dislodgeable
pesticide residues.
2. Applicator and Mixer Loader Risk Assessment: Exposure/risks for short-term
dermal and inhalation handler mixer/loader exposures were presented at baseline
(workers wearing a single layer of work clothing consisting of a long-sleeved shirt,
long pants, shoes plus socks and no protective gloves). Risks to pilots are assessed
using the engineering control (enclosed cockpits) and baseline attire (long-sleeve
shirt, long pants, shoes, and socks). A Margin of Exposure (MOE) of 100 is adequate
to protect occupational pesticide handlers. All MOEs are greater than 100 provided
mixer/loaders wear protective gloves as specified on the labels, and therefore are
below EPA's level of concern. Exposure/risks for short and intermediate-term
dermal and inhalation exposures at baseline are presented in Table 6 below:
14
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Table 6 ~ Summary of Short-Term Occupational Exposure and Risk Estimates for
Pyrasulfatole
Table 9.1. Short-Term Occupational Exposure and Risk Estimates for use of Pyrasulfotole on Small Cereal Grains.
Exposure
Scenario
Mitigation2
Daily
Dermal
Dose
(mg/kg/day)3
Daily
Inhalation
Dose
(mg/kg/day)3
Dermal
MOE4
Inhalation
MOE4
Combined
MOE5
Mixer/Loader
Aerial
Applications
Baseline
0.056
0.00093
180
1,100
150
Applicator
Aerial
Equipment
Engineering
control
0.000096
0.000052
100,000
19,000
16,000
1. Short-term handler assessment was conducted assuming 1) the maximum proposed application rate for cereal grains (0.045 Ib ai/A); and 2)
1200 and 200 acres treated per day for mixer/loaders and applicators, respectively (based on Exposure SAC SOP #9 "Standard Values for Daily
Acres Treated in Agriculture," industry sources, and HED estimates).
2. Baseline Dermal: Long-sleeve shirt, long pants, and no gloves. Baseline Inhalation: no respirator. Engineering control: enclosed cockpit and
baseline attire (long-sleeve shirt, long pants, shoes, and socks).
3. Dose (mg/kg/day) = Unit exposure(mg/lb ai) x App Rate (Ib ai/acre) x Area Treated (acres/day) x %Absorption (2.5% dermal and
100% inhalation) / Body weight (70 kg).
4. MOE = NOAEL/Dose; where the short-term dermal NOAEL = 10 mg/kg/day and the short-term inhalation NOAEL =1.0 mg/kg/day
5. Combined MOE = NOAEL / (dermal + inhalation daily dose)
3. Postapplication Handler Risk Assessment: Post-application inhalation exposure is
expected to be negligible due to the low vapor pressure of pyrasulfotole, and
therefore not of concern. Post-application dermal exposure to workers was estimated
using the EPA's Science Advisory Council for Exposure Policy (ExpoSAC; Policy
003.1, Rev. 7 Aug. 2000, Regarding Agricultural Transfer Coefficients (TCs);
Amended ExpoSAC Meeting notes - 13 Sept 01), which lists scouting and irrigating
as the activities with the highest (i.e., most conservative) TCs related to the proposed
uses. A MOE of 100 is adequate to protect postapplication handlers. All MOEs are
greater than 100 and therefore below EPA's level of concern. A summary of
occupational short-term post-application risks associated with the proposed uses of
pyrasulfotole are presented in Table 7 below:
Table 7 ~ Summary of Short-Term Occupational Post-Application Risks for Pyrasulfatole
Table 9.2. Summary of Short-Term Occupational Post-Application Risks for Pyrasulfotole on Small Cereal Grains.
Activities
Scouting, irrigation
TC (cn^/hr)1
100
1500
Maximum Application Rate
(Ib ai/acre)
0.045
MOE at Day 0
350,000
23,000
REI (days)
(Target MOE= 100)
12 hours
12 hours
1. TC = transfer coefficient.
4. Residential Exposure: Currently there are no proposed residential uses for
pyrasulfotole.
15
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V. ENVIRONMENTAL CHARACTERIZATION
A. Environmental Fate Characterization
Pyrasulfotole is highly soluble in water (69 g/L), has a low vapor pressure (6.8 x 10"7 Pa)
and low octanol-water partitioning coefficient (0.04). Therefore, volatilization from
water and soil surfaces is not expected to be an important route of environmental
dissipation and bioaccumulation is unlikely. Pyrasulfotole is expected to be persistent
under certain conditions and moderately mobile to mobile in the environment. It is stable
to hydrolysis and photolysis and moderately susceptible to microbial degradation under
aerobic conditions in soils. Depending on soil, site and meteorological conditions
Pyrasulfotole may be transported off-site via runoff, leaching and spry drift. In terrestrial
field dissipation studies, pyrasulfatole showed half-lives that ranged from 6 to 18 days,
and dissipated from the soil profile between 44 and 531 days. The amount of total
residues carried over to the following growing season ranged from 4.7 to 37%. To
address concerns with the potential leaching of pyrasulfatole that may result from the
persistence and mobility described above, label language will be required in the form of a
surface water advisories that stresses the potential of runoff after treatment, describes
conditions that may promote leaching to groundwater, and suggests practices that may
reduce contamination of water. This label language is described in more detail in the
following section for Required Labeling.
B. Potential Risks to Non-Target Plants
As would be expected with any herbicide, Agency levels of concern were exceeded for
non-target terrestrial and aquatic vascular plants. The results of this screening-level
assessment indicate that the proposed uses of pyrasulfotole have the potential for direct
adverse effects for terrestrial and semi-aquatic dicotyledonous plants, and listed
freshwater vascular plants. The non-listed species LOG for aquatic vascular plants was
not exceeded in any of the use scenarios modeled, however, the listed species LOG was
exceeded at application rates greater than 0.040 Ib ai/A, indicating the potential for risk to
listed aquatic vascular plants exposed to pyrasulfotole. Regarding listed species, EFED's
screening level analysis shows the possibility of direct effects to listed aquatic vascular
plants, terrestrial and semi-aquatic dicotyledonous plants. For indirect effects, all other
taxa will be considered since there is a potential for indirect effects to taxa that might rely
on plants for some stage of their life-cycle. Therefore, at this time, no Federally listed
can be excluded from the potential for direct and/or indirect effects from the proposed
uses of pyrasulfotole.
The Agency strategy to mitigate these risks involve label language that is intended to
keep the pesticide on the intended treatment area, and therefore reducing the potential for
exposure to non-target plants. For example, spray drift management language will be
required on the labeling, which advises users of applicator responsibilities and offers
specific techniques to reduce the possibility of spray drift. In addition, the use of buffer
strips will be discussed in the surface water advisory language, which may further reduce
16
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possible exposure to non-target plants.
C. Potential Risks to Non-Target Animals
Pyrasulfotole is classified as practically nontoxic to fish and freshwater invertebrates, and
'highly toxic' to estuarine/marine invertebrates, on an acute basis (the risk mitigation
measures described above regarding labeling intended to keep the pesticide on the
intended treatment area are also expected to mitigate risks to estuarine/marine
invertebrates). No acute LOCs for aquatic animals were exceeded for the proposed use.
Laboratory studies demonstrate chronic growth effects in fish at 0.58 mg a.i./L, and
effects on freshwater invertebrate survival at 12.8 mg a.i./L. None of the freshwater
aquatic animal RQs for chronic exposure exceeded the Agency's LOG, however, chronic
toxicity data are not available for estuarine/marine invertebrates, the most acutely
sensitive aquatic animal taxon. These data are not required for the currently proposed
use. However, this requirement is reserved, and may be required for future proposed uses
of pyrasulfotole.
Pyrasulfotole is classified as 'practically nontoxic' to birds and mammals on an acute
exposure basis. No acute risks are expected to these taxa from the proposed use. Avian
reproduction studies indicated only slight effects on growth at levels greater than 167 mg
a.i./kg. No chronic avian RQs exceed the Agency LOG. At application rates > 0.023 Ib
a.i./A, some mammalian chronic risks are indicated for the proposed use of
pyrasusulfatole (RQ's range from 1.05 to 1.87). Chronic risk to mammals is not expected
at the lower labeled application rates.
VI. Regulatory Decision
A. Conditional Registration: A conditional registration is recommended for pyrasulfotole
for use as a selective herbicide for control of broadleaf weeds in wheat, barley, oats, rye
and triticale.
1. Conditional data needed to confirm
• In vivo dermal penetration study
• Revisions to the analytical methods
• Submission of an analytical reference standard for pyrasulfotole, pyrasulfotole-
desmethyl and labeled internal standards to the EPA National Pesticide Standards
Repository
• Toxicity of residues in sediment to benthic organisms (freshwater and marine)
2. Public Interest Finding: A conditional registration under FIFRA Section 3(c)(7)(C)
may be granted if EPA determines that use of the pesticide during such period will
not cause any unreasonable adverse effect on the environment, and that use of the
17
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pesticide is in the public interest.
B. TOLERANCES
1. Tolerance Levels: The tolerance is established for residues of pyrasulfotole and
pyrasulfotole-desmethyl, in or on aspirated grain fractions, at 0.40 ppm, barley, grain
at 0.02 ppm, barley, hay at 0.30 ppm, barley, straw at 0.20 ppm, cattle, meat
byproducts, except liver at 0.06 ppm, eggs at 0.02 ppm, goat, fat at 0.02 ppm, goat
meat at 0.02 ppm, goat, meat byproducts, except liver at 0.06 ppm, hog, fat at 0.02
ppm, hog, meat at 0.02 ppm, hog, meat byproducts at 0.02 ppm, horse, fat at 0.02
ppm, horse, liver at 0.35 ppm, horse, meat at 0.02 ppm, horse, meat byproducts,
except liver at 0.06 ppm, milk at 0.01 ppm, oat, forage at 0.10 ppm, oat, grain at 0.08
ppm, oat, hay at 0.50 ppm, oat, straw at 0.20 ppm, poultry, fat at 0.02 ppm, poultry,
meat at 0.02 ppm, poultry, meat byproducts at 0.02 ppm, rye, forage at 0.20 ppm, rye,
grain at 0.02 ppm, rye, straw at 0.20 ppm, sheep, fat at 0.02 ppm, sheep, liver at 0.35
ppm, sheep, meat at 0.02 ppm, sheep, meat byproducts, except liver at 0.06 ppm,
wheat, forage at 0.20 ppm, wheat, grain at 0.02 ppm, wheat, hay at 0.80 ppm, and
wheat, straw at 0.20 ppm.
2. International MRLs: All EPA recommended tolerances are harmonized with those
being established in Canada and Australia.
C. REQUIRED ENVIRONMENTAL LABEL STATEMENTS: End use products
containing pyrasulfatole as an active ingredient will be required to add the following
protective language on the product labeling:
1. Environmental Hazards: "Do not apply directly to water, or to areas where surface
water is present, or to intertidal areas below the mean high water mark. Do not
contaminate water when disposing of equipment washwater or rinsate."
2. Ground Water Advisory: "Pyrasulfatole is known to leach through soil into ground
water under certain conditions as a result of label use. Use of this chemical in areas
where soils are permeable, particularly where the water table is shallow, may result in
ground water contamination."
3. Surface Water Advisory: "This product may contaminate water through drift of
spray in wind. This product has a high potential for runoff for several months or
more after application. Poorly draining soils and soils with shallow water tables are
more prone to produce runoff that contains this product. A level, well maintained
vegetative buffer strip between areas to which this product is applied and surface
water features such as ponds, streams, and springs will reduce the potential for
contamination of water from rainfall runoff. Runoff of this product will be reduced
by avoiding applications when rainfall is forecasted to occur within 48 hours."
18
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4. Spray Drift Management
Spray drift is always a potential source of exposure to residents nearby to spraying
operations. This is particularly the case with aerial application, but, to a lesser extent,
could also be a potential source of exposure from the ground application method
employed for pyrasulfotole. The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and
other parties to develop the best spray drift management practices. On a chemical by
chemical basis, the Agency is now requiring interim mitigation measures for aerial
applications that must be placed on product labels/labeling. The Agency has
completed its evaluation of the new database submitted by the Spray Drift Task
Force, a membership of U.S. pesticide registrants, and is developing a policy on how
to appropriately apply the data and computer model to its risk assessments for
pesticides applied by air, orchard airblast and ground hydraulic methods. After the
policy is in place, the Agency may impose further refinements in spray drift
management practices to reduce off-target drift with specific products with significant
risks associated with drift.
Contact Person at EPA
Joanne I. Miller
Product Manager 23
Herbicide Branch
Registration Division (7505P)
Office of Pesticide Programs
Environmental Protection Agency
Aerial Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460
DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational
purposes only and may not be used to fulfill data requirements for pesticide registration and
reregi strati on.
19
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26
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Acute Toxicity to Freshwater Fish
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46801723 Hoberg, J. (2004) AE 0317309 - Acute Toxicity to Mysids (Americamysis
Bahia) Under Static Conditions. Project Number: 13798/6158, EBAIX011.
Unpublished study prepared by Springborn Smithers Laboratories. 49 p.
46801726 Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of AE 0317309
Technical to the Sheepshead Minnow (Cyprinodon Variegatus) Under Static
Conditions. Project Number: EBAIX012, 200820. Unpublished study prepared
by Bayer Corp. 30 p.
Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study
27
-------
MRID
Citation Reference
46801727 Kern, M.; Lam, C. (2004) Chronic Toxicity of AE 0317309 Technical to the
Daphnia Magna Under Static Renewal Conditions. Project Number: EBAIX014.
Unpublished study prepared by Bayer Corp. 55 p.
46801728 Kern, M.; Lam, C. (2004) Early Life Stage Toxicity of AE 0317309 Technical
to the Fathead Minnow (Pimephales Promelas) Under Flow-Through
Conditions. Project Number: EBAIX015, A9841201. Unpublished study
prepared by Bayer Corp. 77 p.
Seed germination/seedling emergence and vegitative vigor
MRID
Citation Reference
46801926 Pallett, K.; Gosch, H. (2006) Non-Target Terrestrial Plants: Seedling Emergence
and Growth Test (Tier 2) Suspo-Emulsion: 50 + 12.5 g/L (Code: AE 0317309
02 SE06 A102). Project Number: SE04/006, EBAIX020. Unpublished study
prepared by Bayer Cropscience Gmbh. 79 p.
46801927 Pallett, K.; Gosch, H. (2006) Non-Target Terrestrial Plants: Vegetative Vigour
Test (Tier 2) AE 0317309 + Mefenpyr di-ethyl (AE F107892); Suspo-Emulsion:
50 + 12.5 g/L. Project Number: VV04/005, EBAIX021. Unpublished study
prepared by Bayer Cropscience Gmbh. 67 p.
46801936 Pallett, K.; Gosch, H. (2006) Non-Target Terrestrial Plants: Seedling Emergence
and Seedling Growth Test (Tier 2): AE 0317309 + Mefenpyr di-ethyl +
Bromoxynil. Project Number: SE/05/001, EBAIX028. Unpublished study
prepared by Bayer Cropscience Gmbh. 86 p.
46801937 Pallett, K.; Gosch, H. (2006) Non-Target Terrestrial Plants: Vegetative Vigour
Test (Tier 2): AE 0317309 + Mefenpyr di-ethyl + Bromoxynil. Project Number:
VV/05/002, EBAIX029. Unpublished study prepared by Bayer Cropscience
Gmbh. 78 p.
Aquatic plant growth
MRID
Citation Reference
46801737 Kern, M.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the Green Alga
Pseudokirchneriella subcpitata (AKA Selenastrum capricornutum). Project
Number: EBAIX005, A9883501, 200714. Unpublished study prepared by Bayer
Corp. 41 p.
28
-------
46801738 Kern, M.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the Freshwater
Diatom Navicula pelliculosa. Project Number: 200761, EBAIX006, A9883401.
Unpublished study prepared by Bayer Corp. 41 p.
46801739 Kern, M.; Roberts, 1; Lam, C. (2004) Toxicity of AE 0317309 Technical to the
Blue-Green Algae Anabaena flos-aquae. Project Number: 200752, EBAIX008,
A9883801. Unpublished study prepared by Bayer Corp. 40 p.
46801740 Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the
Saltwater Diatom Skeletonema Costatum. Project Number: 200697, EBAIX007,
A9883601. Unpublished study prepared by Bayer Corp. 37 p.
Hydrolysis
MRID Citation Reference
46801705 Ripperger, R. (2004) [Pyrazole-3-(Carbon 14)] AE0317309: Hydrolytic
Degradation. Project Number: 200578, A9072401. Unpublished study prepared
by Bayer Corp. 59 p.
Photodegradation-water
MRID Citation Reference
46801706 Ripperger, R.; Meyer, B. (2005) [(Carbon 14)-UL-Phenyl] and [(Carbon 14)-3-
Pyrazole] AE 0317309: Phototransformation in Water. Project Number: 200987,
A9082401. Unpublished study prepared by Bayer Corp. 64 p.
Photodegradation-soil
MRID Citation Reference
46801707 Arthur, E.; Shepherd, I; Dominic, A. (2004) [Pyrazole-3-(Carbon 14)] AE
0317309: Phototransformation on Soil. Project Number: 200638, A9082101.
Unpublished study prepared by Bayer Corp. 85 p.
Photodegradation-air
MRID Citation Reference
29
-------
46801708 Meyer, B. (2005) AE 0317309: Calculation of the Chemical Lifetime in the
Troposphere. Project Number: MEAIM006. Unpublished study prepared by
Bayer Corp. 15 p.
Aerobic soil metabolism
MRID Citation Reference
46801709 Fliege, R. (2004) [Phenyl-U-(Carbon 14)]- and [Pyrazole-3-(Carbon 14)]-AE
0317309: Aerobic Soil Metabolism in a Loamy Sand Soil of US Origin Under
Laboratory Conditions at 25 degrees C. Project Number: MEF/386/03,
CB/02/011. Unpublished study prepared by Bayer Cropscience Gmbh. 129 p.
46801710 Fliege, R. (2004) [Phenyl-U-(Carbon 14)]- and [Pyrazole-3-(Carbon 14)]-AE
0317309: Aerobic Soil Metabolism in a Soil Metabolism in a Silt Loam Soil of
US Origin Under Laboratory Conditions at 25 degrees C. Project Number:
MEF/387/03, CB/02/012. Unpublished study prepared by Bayer Cropscience
Gmbh. 116 p.
Anaerobic soil metabolism
MRID Citation Reference
46801712 Ripperger, R. (2005) [Phenyl-UL-(Carbon 14)] and [Pyrazole-3-(Carbon 14)]
AE 0317309: Anaerobic Soil Metabolism. Project Number: 04MEAIP001,
MEAIP001. Unpublished study prepared by Bayer Corp. 92 p.
Anaerobic aquatic metab.
MRID Citation Reference
46801714 Shepherd, I; Arthur, E. (2005) [Phenyl-UL-(Carbon 14)] AE 0317309:
Anaerobic Aquatic Metabolism. Project Number: 200593, A9042102.
Unpublished study prepared by Bayer Corp. 72 p.
46801715 Arthur, E.; Shepherd, J. (2005) [Pyrazole-3-(Carbon 14)] AE 0317309:
Anaerobic Aquatic Metabolism. Project Number: 200495, A9042101.
Unpublished study prepared by Bayer Corp. 71 p.
Aerobic aquatic metab.
30
-------
MRID Citation Reference
46801713 Allan, I; Cheung, C. (2006) [Pyrazol-3-(Carbon 14)] AE 0317309 and [Phenyl-
UL-(Carbon 14)] AE 0317309: Aerobic Aquatic Metabolism. Project Number:
MEAIM008, A9042104. Unpublished study prepared by Bayer Corp. 101 p.
Leach/adsorp/desorption
MRID Citation Reference
46801703 Maurer, T.; Eyrich, U.; Fliege, R. (2003) Adsorption/Desorption of AE 0317309
on Five Soils and One Sediment. Project Number: CP/02/014, MO/03/012996,
MEF/186/03. Unpublished study prepared by Bayer Cropscience Gmbh. 84 p.
Terrestrial field dissipation
MRID Citation Reference
46801716 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in Kansas Soil,
2004. Project Number: MEAIY008, AI/002/S05/02. Unpublished study
prepared by Bayer Corp., Agvise Inc. and Diamond Ag Research, Inc. 191 p.
46801717 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in North Dakota
Soil, 2004. Project Number: MEAIY007, AI/002/S05/02. Unpublished study
prepared by Bayer Corp. and Agvise Inc. 188 p.
46801718 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in Washington
Soil, 2004. Project Number: MEAIY009, AI/002/S05/02. Unpublished study
prepared by Bayer Corp., Agvise Inc. and Quails Agricultural Laboratories, I.
195 p.
Product Identity and composition
MRID Citation Reference
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
-------
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Description of materials used to produce the product
MRID Citation Reference
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Description of production process
MRID Citation Reference
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Description of formulation process
MRID Citation Reference
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Discussion of formation of impurities
32
-------
MRID Citation Reference
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Preliminary analysis
MRID Citation Reference
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
Certified limits
MRID Citation Reference
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Enforcement analytical method
MRID Citation Reference
33
-------
46801701 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2469, AF04/086, AM006904FP1. Unpublished study prepared by
Bayer Corp. 325 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Color
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Physical state
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Odor
34
-------
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
Stability to sunlight, normal and elevated temperatures, metals, and metal ions
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Oxidizing or reducing action
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Flammability
MRID Citation Reference
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
35
-------
Explodability
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Storage stability of product
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801925 Swan, J. (2006) Stability of AE 0317309 02 SE06 A105. Project Number:
201423/1. Unpublished study prepared by Bayer Corp. 6 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
46801935 Swan, J. (2006) Stability of AE 0317309 + Bromoxynil EC23. Project Number:
201394/1. Unpublished study prepared by Bayer Corp. 6 p.
Corrosion characteristics
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801925 Swan, J. (2006) Stability of AE 0317309 02 SE06 A105. Project Number:
201423/1. Unpublished study prepared by Bayer Corp. 6 p.
36
-------
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
46801935 Swan, J. (2006) Stability of AE 0317309 + Bromoxynil EC23. Project Number:
201394/1. Unpublished study prepared by Bayer Corp. 6 p.
pH of water solutions or suspensions
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
UV/Visible absorption
MRID
Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Viscosity
MRID
Citation Reference
46801924 Frank, J. (2006) Product Chemistry of AE 0317309 SE 06 Herbicide. Project
Number: BR/2463, 201207, ANR/03206. Unpublished study prepared by Bayer
Corp. 235 p.
46801934 Frank, J. (2006) Product Chemistry of AE 0317309 + Bromo Herbicide. Project
Number: BR/2464, ANR/03906, ANR/04006. Unpublished study prepared by
Bayer Corp. 381 p.
37
-------
Melting point/melting range
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Density/relative density
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Dissociation constant in water
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Partition coefficient (n-octanol/water), generator column method
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Water solubility: Column elution method, shake flask method
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
38
-------
Corp. 323 p.
Vapor pressure
MRID Citation Reference
46801702 Fontaine, L. (2006) Product Chemistry of Pyrasulfotole Technical. Project
Number: BR/2470, PA03/044, PA05/102. Unpublished study prepared by Bayer
Corp. 323 p.
Sediment and soil absorption/desorption for parent and degradates
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Hydrolysis of parent and degradates as a function of pH at 25 C
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Direct photolysis rate of parent and degradates in water
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Photodegradation of parent and degradates in soil
MRID Citation Reference
39
-------
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Aerobic soil metabolism
MRID Citation Reference
46801710 Fliege, R. (2004) [Phenyl-U-(Carbon 14)]- and [Pyrazole-3-(Carbon 14)]-AE
0317309: Aerobic Soil Metabolism in a Soil Metabolism in a Silt Loam Soil of
US Origin Under Laboratory Conditions at 25 degrees C. Project Number:
MEF/387/03, CB/02/012. Unpublished study prepared by Bayer Cropscience
Gmbh. 116 p.
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Anaerobic soil metabolism
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Aerobic aquatic metabolism
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Anaerobic aquatic metabolism
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
40
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309 p.
Terrestrial field dissipation
MRID Citation Reference
46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
Aquatic invertebrate acute toxicity, test, freshwater daphnids
MRID Citation Reference
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Oyster acute toxicity test (shell deposition)
MRID Citation Reference
46801722 Dionne, E. (2004) AE 0317309 - Acute Toxicity to Eastern Oysters (Crassostrea
Virginica) Under Flow-Through Conditions. Project Number: 13798/6159,
EBAIX013. Unpublished study prepared by Springborn Smithers Laboratories.
55 p.
Fish acute toxicity test, freshwater and marine
MRID Citation Reference
46801726 Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of AE 0317309
Technical to the Sheepshead Minnow (Cyprinodon Variegatus) Under Static
Conditions. Project Number: EBAIX012, 200820. Unpublished study prepared
by Bayer Corp. 30 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
41
-------
Daphnid chronic toxicity test
MRID Citation Reference
46801727 Kern, M.; Lam, C. (2004) Chronic Toxicity of AE 0317309 Technical to the
Daphnia Magna Under Static Renewal Conditions. Project Number: EBAIX014.
Unpublished study prepared by Bayer Corp. 55 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Fish early-life stage toxicity test
MRID Citation Reference
46801728 Kern, M.; Lam, C. (2004) Early Life Stage Toxicity of AE 0317309 Technical
to the Fathead Minnow (Pimephales Promelas) Under Flow-Through
Conditions. Project Number: EBAIX015, A9841201. Unpublished study
prepared by Bayer Corp. 77 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Avian acute oral toxicity test
MRID Citation Reference
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Avian dietary toxicity test
MRID Citation Reference
46801730 Stoughton, T. (2005) Technical AE0317309: A Subacute Dietary LC50 With
Northern Bobwhite. Project Number: EBAIM002, A9721701. Unpublished
study prepared by Bayer Corp. 47 p.
42
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46801731 Stoughton, T. (2005) Technical AE0317309: A Subacute Dietary LC550 With
Mallards. Project Number: A9720801, EBAIM003. Unpublished study prepared
by Bayer Corp. 48 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Avian reproduction test
MRID Citation Reference
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Honey bee acute contact toxicity
MRID Citation Reference
46801735 Waltersdorfer, A. (2002) Contact Toxicity (LD50) to Honey Bees (Apis
Mellifera L.) Substance Technical. Project Number: AE/0317309/00/1C98/0,
CW02/048. Unpublished study prepared by Bayer Cropscience Gmbh. 18 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Terrestrial plant toxicity, Tier 1 (seeding emergence)
MRID Citation Reference
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Terrestrial plant toxicity, Tier 1 (vegetative vigor)
MRID Citation Reference
43
-------
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Aquatic plant toxicity test using Lemna spp. Tiers I and II
MRID
Citation Reference
46801736 Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of AD 0317309 Technical to
Duckweed (lemma gibba G3) Under Static Conditions. Project Number:
EBAIX009, A9883701, 200641. Unpublished study prepared by Bayer Corp. 40
P-
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Algal toxicity, Tiers 1 and II
MRID
Citation Reference
46801737 Kern, M.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the Green Alga
Pseudokirchneriella subcpitata (AKA Selenastrum capricornutum). Project
Number: EBAIX005, A9883501, 200714. Unpublished study prepared by Bayer
Corp. 41 p.
46801738 Kern, M.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the Freshwater
Diatom Navicula pelliculosa. Project Number: 200761, EBAIX006, A9883401.
Unpublished study prepared by Bayer Corp. 41 p.
46801739 Kern, M.; Roberts, J.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the
Blue-Green Algae Anabaena flos-aquae. Project Number: 200752, EBAIX008,
A9883801. Unpublished study prepared by Bayer Corp. 40 p.
46801740 Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of AE 0317309 Technical to the
Saltwater Diatom Skeletonema Costatum. Project Number: 200697, EBAIX007,
A9883601. Unpublished study prepared by Bayer Corp. 37 p.
46801747 Dykes, J. (2006) Study Profiles for AE 0317309, Ecological Effects. Project
Number: 001JAD2006, 02DT35542/A, 200820. Unpublished study prepared by
Bayer CropScience LP. 326 p.
Nature of the residue - plants, livestock
44
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MRID
Citation Reference
46801748 Koehn, D.; Haas, M. (2004) Metabolism of [Phenyl-U-(Carbon 14)] AE
0317309 in Wheat (Triticum aestivum) Following Treatment at a Nominal
Application Rate of 100 g a.s./ha. Project Number: MEF/193/03, CM/02/006,
CM02/006. Unpublished study prepared by Bayer Cropscience Gmbh. 108 p.
46801749 Koehn, D.; Haas, M. (2004) Metabolism of [Pyrazole-3-(Carbon 14)] AE
0317309 in Wheat (Triticum Aestium) Following Treatment at a Nominal
Application Rate of 100 g a.s./ha. Project Number: MEF/194/03, CM/02/007,
CM02/007. Unpublished study prepared by Bayer Cropscience Gmbh. 115 p.
46801801 Koehn, D.; Haas, M. (2004) Metabolism of [Phenyl-U-(Carbon 14)]AE 0317309
in Wheat Following Treatment at an Application Rate of 100 g/ha with and
without Safener. Project Number: M1731265/5, MEF/322/03. Unpublished
study prepared by Bayer Ag, Institute of Product Info. & Residue Anal.. 126 p.
46801802 Rupprecht, J. (2006) Metabolism of [Phenyl-U-(Carbon 14)]-AE 0317309 in the
Laying Hen. Project Number: MEAIM012, 204/0734C, ELECTRONIC/COPY.
Unpublished study prepared by Bayer Corp. and Southwest Bio-Labs, Inc. 93 p.
46801803 Rupprecht, J. (2006) Metabolism of [Pyrazole-3-(Carbon 14)]-AE 0317309 in
the Laying Hen. Project Number: MEAIM011, 204/0733C, . Unpublished study
prepared by Bayer Corp. and Southwest Bio-Labs, Inc. 91 p.
46801804 Rupprecht, J. (2006) Metabolism of [Phenyl-U-)Carbon 14)]-AE 0317309 in the
Lactating Goat. Project Number: MEAIM009, 205/007/12, MEAIM009/GML.
Unpublished study prepared by Bayer Corp. 102 p.
46801805 Rupprecht, J. (2006) Metabolism of [Pyrazole-3-(Carbon 14)]-AE 0317309 in
the Lactating Goat. Project Number: MEAIM010, 205/008/12, A9041001.
Unpublished study prepared by Bayer Corp. 98 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Residue analytical method
MRID
Citation Reference
46801716 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in Kansas Soil,
2004. Project Number: MEAIY008, AI/002/S05/02. Unpublished study
prepared by Bayer Corp., Agvise Inc. and Diamond Ag Research, Inc. 191 p.
46801717 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in North Dakota
45
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Soil, 2004. Project Number: MEAIY007, AI/002/S05/02. Unpublished study
prepared by Bayer Corp. and Agvise Inc. 188 p.
46801718 Lenz, M. (2006) Terrestrial Field Dissipation of AE 0317309 in Washington
Soil, 2004. Project Number: MEAIY009, AI/002/S05/02. Unpublished study
prepared by Bayer Corp., Agvise Inc. and Quails Agricultural Laboratories, I.
195 p.
46801806 Gould, T.; Brungardt, 1; Timberlake, B. (2006) Validation of Bayer
CropScience Method AI-001-P04-01: An Analytical Method for the
Determination of Residues of AE 0317309, AE 1073910, and AEB197555 in
Wheat Corn, and Soybean Matrices Using LC/MS/MS. Project Number:
RAAIX005, AI0141221 A/13, AI041217A/17. Unpublished study prepared by
Bayer Corp. 210 p.
46801807 Billian, P. (2005) Independent Laboratory Validation of the Analytical Method
AI-001-P04-01 for the Determination of Residues of AE 0317309, AE 1073910
and AE B197555 in Plant Material. Project Number: P612050574, MR/097/05,
AI/001/P04/01. Unpublished study prepared by Bayer Ag, Institute of Product
Info. & Residue Anal. 72 p.
46801808 Gould, T.; Brungardt, J. (2006) Extraction Efficiency of AE B197555, AE
1073910, and AE 0317309 by Method AI-001-P04-01. Project Number:
RAAIX011, AI/0001/P04/01. Unpublished study prepared by Bayer Corp. 60 p.
46801809 Lam, C.; Qadri, S. (2006) Validation of Bayer CropScience Method AI-004-
A05-01: Analytical Method for the Determination of Residues of AE 0317309
in Animal Tissues and Milk Using LC-MS/MS. Project Number: RAAIX006,
AI/004/A05/01. Unpublished study prepared by Bayer Corp. 100 p.
46801810 Billian, P.; Wirkner, H. (2005) Independent Laboratory Validation of the
Analytical Method AI-004-A05-01 for the Determination of Residues of AE
0317309 in Animal Tissues and Milk Using LC-MS/MS. Project Number:
P613050577, MR/122/05, AI/004/A05/01. Unpublished study prepared by
Bayer Ag, Institute of Product Info. & Residue Anal. 56 p.
46801811 Lam, C.; Qadri, S. (2006) "Extraction Efficiency of Bayer CropScience Method
AI-004-A05-01" Analytical Method for the Determination of Residues of AE
0317309 in Animal Tissue and Milk Using LC-MS/MS. Project Number:
RAAAIX010, AI/004/A05/01, RAAIX006. Unpublished study prepared by
Bayer Corp. 47 p.
46801812 Lam, C.; Qadri, S. (2006) Validation of Bayer CropScience Method AI-005-
A05-01: Analytical Method for the Determination of Residues of AEB197555
in Poultry and Eggs Using LC-MS/MS. Project Number: RAAIP012,
AI/005/A05/01, MWAIM012. Unpublished study prepared by Bayer Corp.. 91
P-
46801813 Nelson, S. (2006) Independent Laboratory Validation of Method AI-005-A05-
01 - "An Analytical Method for the Determinaiton of AE B1975 5 5 in Poultry
46
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and Eggs Using LC/MS/MS". Project Number: 06ILV01BAY, 06BAY27/REP,
RAAIP011. Unpublished study prepared by Enviro-Test Laboratories (ETL). 78
P-
46801814 Netzband, D.; Smith, D. (2006) AE 0317309: Analytical Method for the
Determination of AE 0317309 and its Metabolite AE B197555 in Soil and
Sediment by LC/MS/MS. Project Number: AI/002/S05/02. Unpublished study
prepared by Bayer Corp. 52 p.
46801815 Netzband, D. (2006) In House Laboratory Validation of an Analytical Method
for the Determination of Residues of AE 0317309 and its Metabolites AE
B197555 in Soil and Sediment Using LC/MS/MS. Project Number:
04MEAIX017, AI002/S05/02. Unpublished study prepared by Bayer Corp. 94 p.
46801820 Netzband, D. (2006) AE0317309: Analytical Method for the Determination of
AE 0317309 and its Metabolite AE B197555 in Water by LC/MS/MS. Project
Number: AI/003/W05/02, MEAIX018, P614/047066. Unpublished study
prepared by Bayer Corp. 41 p.
46801821 Netzband, D. (2006) In House Laboratory Validation of an Analytical Method
for the Determination of Residues of AE 0317309 and its Metabolite AE
B197555 in Water Using LC/MS/MS. Project Number: MEAIX018,
AI/003/W05/02. Unpublished study prepared by Bayer Corp. 79 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Multiresidue method
MRID
Citation Reference
46801817 Robaugh, D. (2006) PAM I Multiresidue Protocol Testing of AE 0317309 and
its Metabolite: AE 1073910: Final Report. Project Number: 1624, RAAIX016.
Unpublished study prepared by Pyxant Labs Inc. 165 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Storage stability data
MRID
Citation Reference
47
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46801720 Wolford, V. (2006) Study Profiles for AE 0317309, Environmental Fate. Project
Number: 001VEW2006. Unpublished study prepared by Bayer CropScience LP.
309 p.
46801818 Netzband, D. (2006) Stability of AE 0317309 and AE B197555 in Soil During
Frozen Storage, USA, 2005 (Reported Through a Maximum of 320 Days
Storage). Project Number: RAAIX008, 03BCS01, MEAIY007. Unpublished
study prepared by Bayer Corp. 35 p.
46801819 Coopersmith, H. (2006) Storage Stability of AE 031709, AE 1073910, and AE
B197555 in Soybean and Wheat Matrices (DATA to 11 Months of Storage).
Project Number: RAAIX009, AI050125A/12. Unpublished study prepared by
Bayer Corp. 290 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Meat/milk/poultry/eggs
MRID Citation Reference
46801823 Mackie, S. (2006) AE B197555 - Magnitude of the Residue in Laying Hens.
Project Number: RAAIP004, 205/016/09, RAAIP004/GML. Unpublished study
prepared by Bayer Corp., Genesis Midwest Laboratories and Agsource
Cooperative Services. 242 p.
46801824 Mackie, S. (2006) AE 0317309 - Magnitude of the Residue in Lactating Cows.
Project Number: RAAIX017, 205/015/10. Unpublished study prepared by Bayer
Corp. and Genesis Midwest Laboratories and Dairyland Laboratories, Inc. 303
P-
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Crop field trials
MRID Citation Reference
46801825 Milo, J.; Harbin, A. (2006) AE 031709 02 SE06 Al and AE 0317309 03 EC23
A8: Magnitude of the Residue in/on Wheat. Project Number: RAAIM002,
AI001/04H, AI002/04H. Unpublished study prepared by Bayer Corp., Enviro-
48
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Test Laboratories (ETL) and Bayer Research Farm. 1562 p.
46801830 Milo, 1; Harbin, A. (2006) AE 0317309 02 SE06 Al and AE 0317309 03 EC23
A8: Magnitude of the Residue in/on Barley. Project Number: RAAIM004,
AI035/04H, AI038/04H. Unpublished study prepared by Bayer Corp., Enviro-
Test Laboratories and ICMS, Inc. 848 p.
46801831 Milo, J.; Harbin, A. (2006) AE 0317309 02 SE06 Al and AE 0317309 03 EC23
A8: Magnitude of Residue in/on Oats. Project Number: RAAIM006,
AI060/04H, AI061/04H. Unpublished study prepared by Enviro-Test
Laboratories (ETL), Crop Management Strategies, Inc. and Aventis
Cropscience. 1625 p.
46801832 Milo, J.; Harbin, A. (2006) AE 0317309 02 SE06 Al - Magnitude of Residue
in/on Wheat Aspirated Grain Fractions and Wheat Processed Commodities.
Project Number: RAAIM003, AI034/04P. Unpublished study prepared by Texas
A & M Food Protein Research, Bayer Corp. and Bayer CropScience. 226 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Processed food/feed
MRID Citation Reference
46801832 Milo, J.; Harbin, A. (2006) AE 0317309 02 SE06 Al - Magnitude of Residue
in/on Wheat Aspirated Grain Fractions and Wheat Processed Commodities.
Project Number: RAAIM003, AI034/04P. Unpublished study prepared by Texas
A & M Food Protein Research, Bayer Corp. and Bayer CropScience. 226 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Confined accumulation in rotational crops
MRID Citation Reference
46801833 Beedle, E. (2006) The Accumulation of [Phenyl-UL-(Carbon 14)] and
[Pyrazole-3-(Carbon 14)] AE 0317309 in Confined Rotational Crops. Project
Number: 201152, A9051601/MEAIX002, A9051601/MEAIX001. Unpublished
study prepared by Bayer Corp. 115 p.
49
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46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Field accumulation in rotational crops
MRID
Citation Reference
46801834 Milo, J.; Harbin, A. (2006) AE 0317309: Magnitude of the Residue in Corn and
Soybeans Planted as Rotational Crops Following Treatment of Wheat with AE
0317309 02 SE06 Al (120-Day Plant-back Interval). Project Number:
RAAIM021, AI089/04RA, AI089/04RB. Unpublished study prepared by: Bayer
Corp. and Bayer CropScience and Aventis CropScience. 220 p.
46801835 Dykes, J. (2006) Study Profiles for AE 0317309: Residue Chemistry. Project
Number: 002JAD2006, CM/02/006, CM/02/007. Unpublished study prepared
by Bayer Cropscience LP, Bayer Ag, Institute of Product Info. & Residue Anal.
and Bayer Corp. 739 p.
Acute oral toxicity
MRID
Citation Reference
46801734 Watersdorfer, A. (2006) Oral Toxicity (LD50) to Honey Bees (Apis Mellifera
L.), Substance Technical, Amended Report. Project Number: CW02/051,
C/027636, CW02/051/A1. Unpublished study prepared by Bayer Cropscience
Gmbh. 22 p.
46801836 Schungel, M. (2004) AE 0317309: Acute Toxicity in the Rat After Oral
Administration. Project Number: AT01067, T/3073706, TXAIM001.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801928 Schungel, M. (2005) AE 0317309 02 SE06 Al: Acute Toxicity in the Rat After
Oral Administration. Project Number: T/5075319, TXAIX019, 9370.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p.
46801938 Schungel, M. (2005) AE 0317309 03 EC23 A8: Acute Toxicity in the Rat After
Oral Administration. Project Number: AT01957, TXAIX031, T/4075101.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p.
50
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Acute dermal toxicity
MRID
Citation Reference
46801837 Schungel, M. (2004) AE 0317309: Acute Toxicity in the Rat After Dermal
Application. Project Number: AT01069, T/4073707, TXAIM002. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 26 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801929 Schungel, M. (2005) AE 0317309 02 SE06 Al: Acute Toxicity in the Rat After
Dermal Application. Project Number: T/7075320, AT01987, 13945/05.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p.
46801939 Schungel, M. (2005) AE 0317309 03 EC23 A8: Acute Toxicity in the Rat after
Dermal Application. Project Number: AT01956, TXAIX032, T/5075102.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p.
Acute inhalation toxicity
MRID
Citation Reference
46801838 Pauluhn, J. (2004) AE 0317309: Study on Acute Inhalation Toxicity in Rats.
Project Number: AT00964, T6073736, 8894. Unpublished study prepared by
Bayer Ag Inst. of Toxicology. 70 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801930 Pauluhn, J. (2005) AE 0317309 02 SE06 Al: Acute Inhalation Toxicity in Rats.
Project Number: AT01972, TXAIX021, T0073370. Unpublished study prepared
by Bayer Ag Inst. of Toxicology. 73 p.
46801940 Pauluhn, J. (2005) AE 0317309 03 EC23 A8: Acute Inhalation Toxicity in Rats.
Project Number: AT01974, TXAIX033, T1073344. Unpublished study prepared
by Bayer Ag Inst. of Toxicology. 80 p.
Acute eye irritation
MRID
Citation Reference
51
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46801839 Moore, G. (2006) AE 0317309 Technical: Primary Eye Irritation Study in
Rabbits. Project Number: 18739, 051202/5D. Unpublished study prepared by
Product Safety Laboratories. 14 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801931 Schungel, M. (2005) AE 0317309 02 SE06 Al: Acute Eye Irritation on Rabbits.
Project Number: AT02030, TXAIX023, T/1074442. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 23 p.
46801941 Schungel, M. (2005) AE 0317309 03 EC23 A8: Acute Eye Irritation on Rabbits.
Project Number: AT01910, T/5074437. Unpublished study prepared by Bayer
Ag Inst. of Toxicology. 23 p.
Acute dermal irritation
MRID Citation Reference
46801840 Schungel, M. (2004) AE 0317309: Acute Skin Irritation/Corrosion on Rabbits.
Project Number: AT01209, T7073179, TXAIM004. Unpublished study
prepared by Bayer Ag Inst. of Toxicology. 24 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801932 Schungel, M (2005) AE 0317309 02 SE06 Al: Acute Skin Irritation/Corrosion
on Rabbits. Project Number: AT02029, TXAIX022, T/7074439. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 23 p.
46801942 Schungel, M. (2005) AE 0317309 03 EC23 A8: Acute Skin Irritation/Corrosion
on Rabbits. Project Number: AT01911, TXAIX034, T/2074434. Unpublished
study prepared by Bayer Ag Inst. of Toxicology. 23 p.
Skin sensitization
MRID Citation Reference
46801841 Vohr, H. (2004) AE 0317309: Study for the Skin Sensitization Effect in Guinea
Pigs. Project Number: AT01261, T/4073013. Unpublished study prepared by
52
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Bayer Ag Inst. of Toxicology. 29 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
46801933 Vohr, H. (2005) AE 0317309 02 SE06 Al: Study for the Skin Sensitization
Effect in Guinea Pigs (Buehler Patch Test). Project Number: AT02026,
TXAIX024, T/7074970. Unpublished study prepared by Bayer Ag Inst. of
Toxicology. 29 p.
46801943 Vohr, H. (2005) AE 0317309 03 EC23 A8: Study for the Skin Sensitization
Effect in Guinea Pigs (Buehler Patch Test). Project Number: TXAIX036,
T/3074967. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 27 p.
90-Day oral toxicity in rodents
MRID Citation Reference
46801842 Langrand-Lerche, C. (2003) AE 0317309: 90-Day Toxicity Study in the Rat by
Dietary Administration. Project Number: SA/02017. Unpublished study
prepared by Bayer CropScience LP. 476 p.
46801844 Steiblen, G. (2003) AE 0317309: 90-Day Toxicity Study in the Mouse by
Dietary Administration. Project Number: SA/03015. Unpublished study
prepared by Bayer Cropscience. 324 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
90-day oral toxicity in nonrodents
MRID Citation Reference
46801901 Eigenberg, D. (2006) Technical Grade AE 0317309: A 90-Day Subchronic
Toxicity Feeding Study in the Beagle Dog: Revised Report. Project Number:
03/S76/PB, 201019/1. Unpublished study prepared by Bayer Corp. 15 p.
46801902 Eigenberg, D. (2005) Technical Grade AE 0317309: A 90-Day Subchronic
Toxicity Feeding Study in the Beagle Dog. Project Number: 03/S76/UG,
201210. Unpublished study prepared by Bayer Corp. and Charles River
Laboratories, Inc. 382 p.
53
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46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
21/28-day dermal toxicity
MRID
Citation Reference
46801843 McElligott, A. (2002) AE 0317309: Preliminary 28-Day Toxicity Study in the
Mouse By Dietary Administration. Project Number: C/026381, SA/02080,
605657. Unpublished study prepared by Bayer Cropscience. 254 p.
46801904 Krotlinger, F.; Schladt, L. (2005) Subacute Toxicity Study in the Rat (4 Weeks
Dermal Administration): AE0317309. Project Number: AT02678, T7075087,
06800/ROS. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 261
P-
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Prenatal developmental toxicity study
MRID
Citation Reference
46801905 Wason, S. (2006) AE 0317309: Developmental Toxicity Study in the Rat by
Gavage. Project Number: SA/03174. Unpublished study prepared by Bayer
Cropscience. 218 p.
46801906 Wason, S. (2006) AE 0317309: Developmental Toxicity Study in the Rabbit by
Gavage. Project Number: SA/03131. Unpublished study prepared by Bayer
Cropscience. 270 p.
46801921 Kennel, P. (2006) Effect of Tyrosinaemia on Pregnancy and Embryo-Fetal
Development in the Rat. Project Number: SA/05192. Unpublished study
prepared by Bayer Cropscience. 207 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Reproduction and fertility effects
54
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MRID Citation Reference
46801907 Eiben, R. (2005) Two-Generation Reproduction Study in the Wistar Rat by
Administration in the Diet. Project Number: T2063193, TXAIX005, AT02705.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 1328 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Chronic toxicity
MRID Citation Reference
46801908 Eigenberg, D. (2006) A Chronic Toxicity Feeding Study in the Beagle Dog with
Technical Grade AE 0317309. Project Number: 04C76/VB, 201450, AZ/10346.
Unpublished study prepared by Bayer Corp. 966 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Carcinogenicity
MRID Citation Reference
46801909 Steiblen, G. (2006) Carcinogenicity Study of AE 0317309 in the C57BL/6J
Mouse by Dietary Administration. Project Number: SA/03172. Unpublished
study prepared by Bayer Cropscience. 2431 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Combined chronic toxicity/carcinogenicity
MRID Citation Reference
55
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46801910 Wason, S. (2006) 6-Month Toxicity, Chronic Toxicity and Carcinogen!city
Study of AE 0317309 in the Wistar Rat by Dietary Administration. Project
Number: SA/02453, K04/004, K03/046. Unpublished study prepared by Bayer
Cropscience. 3775 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Bacterial reverse mutation test
MRID Citation Reference
46801911 Herbold, B. (2004) Salmonella/Microsome Test: Plate Incorporation and
Preincubation Method: AE 0317309. Project Number: AT01030, T/8072955.
Unpublished study prepared by Bayer Ag Inst. of Toxicology. 53 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
In vitro mammalian cell gene mutation test
MRID Citation Reference
46801912 Herbold, B. (2004) V79/HPRT-Test In Vitro for the Detection of Induced
Forward Mutations: AE 0317309. Project Number: TXAIM008, T/0072957,
AT01401A. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 46 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
In vitro mammalian chromosome aberration test
MRID Citation Reference
46801913 Thum, M. (2004) In Vitro Chromosome Aberration Test with the Chinese
Hamster V79 Cells: AE 0317309. Project Number: AT01285, T/9072956,
56
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TXAIM009. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 46 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Mammalian erythrocyte micronucleus test
MRID Citation Reference
46801914 Herbold, B. (2003) Micronucleus-Test Using Mice: AE 0317309. Project
Number: AT00719, T/2063346. Unpublished study prepared by Bayer Ag Inst.
of Toxicology. 47 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Neurotoxicity screening battery
MRID Citation Reference
46801915 Gilmore, R.; Sheets, L. (2005) An Acute Oral Neurotoxicity Screening Study
with Technical Grade AE 0317309 in Wistar Rats. Project Number:
04/N12/WL, 201392. Unpublished study prepared by Bayer Corp. 463 p.
46801916 Gilmore, R.; Hoss, H. (2005) A Subchronic Neurotoxicity Screening Study with
Technical Grade AE 0137309 in Wistar Rats. Project Number: 04/N72/VU,
201381, E/205. Unpublished study prepared by Bayer Corp. 574 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Developmental neurotoxicity study
MRID Citation Reference
46801917 Gilmore, R.; Sheets, L.; Hoss, H. (2006) A Developmental Neurotoxicity
Screening Study with Technical Grade AE 0317309 in Wistar Rats. Project
57
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Number: 04/D72/YE, 201439. Unpublished study prepared by Bayer Corp. 1083
P-
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Metabolism and pharmacokinetics
MRID
Citation Reference
46801918 Fischer, D.; Roensch, W. (2005) The Metabolism of [Phenyl-UL-(Carbon 14)]
and [Pyrazole-3-(Carbon 14)] AE 0317309 in Rats. Project Number:
MEAIX021. Unpublished study prepared by Bayer Corp. 218 p.
46801923 Wolford, V. (2006) Study Profiles for AE 0317309: Toxicology. Project
Number: AT01067, AT01069, AT00964. Unpublished study prepared by Bayer
Ag Inst. of Toxicology, Bayer Cropscience LP and Product Safety Laboratories.
420 p.
Data reporting for environmental chemistry methods
MRID
Citation Reference
46801815 Netzband, D. (2006) In House Laboratory Validation of an Analytical Method
for the Determination of Residues of AE 0317309 and its Metabolites AE
B197555 in Soil and Sediment Using LC/MS/MS. Project Number:
04MEAIX017, AI002/S05/02. Unpublished study prepared by Bayer Corp. 94 p.
46801816 Brumhard, B. (2005) Independent Laboratory Validation of Method AI002-S05-
01 for the Determination of AE 0317309 and its Metabolite AE B197555 in Soil
and Sediment by LC/MS/MS. Project Number: P611050012, MR/112/05,
AI002/S05/01. Unpublished study prepared by Bayer Ag, Institute of Product
Info. & Residue Anal. 30 p.
46801821 Netzband, D. (2006) In House Laboratory Validation of an Analytical Method
for the Determination of Residues of AE 0317309 and its Metabolite AE
B197555 in Water Using LC/MS/MS. Project Number: MEAIX018,
AI/003/W05/02. Unpublished study prepared by Bayer Corp. 79 p.
46801822 Krebber, R. (2005) Independent Laboratory Validation of Method AI-003-W05-
01 for the Determination of AE 0317309 and its Metabolites AE B1975 5 5 in
Water. Project Number: P/614/047066, MR/139/05, AI/003/W05/01.
Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue
58
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Anal. 29 p.
Non-Guideline Study
MRID
Citation Reference
46801700 Bayer CropScience LP (2006) Submission of Product Chemistry, Residue,
Toxicity and Environmental Fate Data in Support of the Application for
Registrations of Pyrasulfotole Technical, AE 0317309 + Bromo Herbicide and
AE 0317309 SE06 Herbicide and the Petition for Tolerance of Broxoxynil For
Use on Cereal Grains. Transmittal of 49 Studies.
46801711 Fliege, R. (2005) [Phenyl-UL-(Carbon 14)] and [Pyrazole-3-(Carbon 14)] AE
0317309: Aerobic Soil Metabolism in a European Soil. Project Number:
MEF/05/459, M1251487/8. Unpublished study prepared by Bayer Ag, Institute
of Product Info. & Residue Anal. 108 p.
46801719 Belyk, M. (2006) Terrestrial Field Dissipation of AE 0317309 in Canada, 2003-
2004. Project Number: 03BCS01, MEAIM004, AI/002/S05/01. Unpublished
study prepared by Bayer Corp., Vaughn Agricultural Research Serv., Ltd. and
Ag-Questlnc. 333 p.
46801741 Lechelt-Kunze, C. (2004) AE 0317309, Substance, Technical (Code: AE
0317309 00 1C96/001): Acute Toxicity to Earthworm (Eisenia fetida) Tested in
Artificial Soil. Project Number: E/310/2671/0, LKC/RG/A/27/04, 05/04.
Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue
Anal. 23 p.
46801744 Lechelt-Kunze, C. (2004) AE 0317309 Tech. (AE 0317309 00 1C96 0001):
Determination of Effects on Nitrogen Transformation in Soil. Project Number:
E/337/2699/9, LKC/N/26/03, 2979. Unpublished study prepared by Bayer Ag,
Institute of Product Info. & Residue Anal. 25 p.
46801746 Lechelt-Kunze, C. (2004) AE 0317309 Tech. (AE 0317309 00 1C96 0001):
Determination of Effects on Carbon Transformation in Soil. Project Number:
E/330/2698/1, 2978, LKC/C/23/04. Unpublished study prepared by Bayer Ag,
Institute of Product Info. & Residue Anal. 31 p.
46801800 Bayer CropScience LP (2006) Submission of Toxicity, Fate, Environmental Fate
and Residue Data in Support of the Application for Registration of Pyrasulfotole
Technical, AE 0317309 SE06 Herbicide and AE 0317309 EC23 Herbicide, and
the Petition for Tolerance of AE 0317309 in Cereal Crops. Transmittal of 45
Studies.
46801826 Radunz, L. (2006) Determination of Residues of Pyrasulfotole (AE 0317309) in
Cereals (Forage, Grain and Straw) Following an Application of AE 0317309
Herbicide at Either 25 or 50 g a.i./ha at Three Growth Stages. Project Number:
59
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BCS/0069, BA/H/0265, ATM/0018. Unpublished study prepared by Bayer
Australia, Ltd. and Serve-Ag Research Pty Ltd. 63 p.
46801827 Radunz, L. (2006) Determination of Residues of Pyrasulfotole (AE 0317309) in
Cereals (Forage, Grain and Straw) Following an Application of AE 0317309
Herbicide at Either 25 or 50 g a.i./ha at Three Growth Stages. Project Number:
BCS/0070, BA/H/0265, BAY03499. Unpublished study prepared by Bayer
Australia, Ltd. 63 p.
46801828 Radunz, L.; Ellis, A. (2006) Determination of Residues of Pyrasulfotole (AE
0317309) in Cereals (Forace, Grain and Straw) Following an Application of AE
0317309 Herbicide at Either 25 or 50 g a.i./ha at Three Growth Stages. Project
Number: BCS/0101, BA/H/0265, BCS/0101/01. Unpublished study prepared by
Bayer Australia, Ltd. 61 p.
46801829 Radunz, L. (2006) Determination of Residues of Pyrasulfotole (AE 0317309) in
Cereals (Forage, Grain and Straw) Following an Application of AE 0317309
Herbicide at Either 25 or 50 g a.i./ha at Three Growth Stages. Project Number:
BCS/0102, BA/H/0265, BCS/0102/01. Unpublished study prepared by Bayer
Australia, Ltd. 62 p.
46801845 Kennel, P. (2002) AE 0317309: Prleiminary 28-Day Toxicity Study in the Dog
by Dietary Administration. Project Number: C029072, SA/02053. Unpublished
study prepared by Bayer Cropscience. 224 p.
46801900 Bayer Cropscience LP (2006) Submission of Product Chemistry, Toxicity,
Environmental Fate, Exposure and Risk Data in Support of the Application for
Registrations of Pyrasulfotole Technical, AE 0317309 + Bromo Herbicide, AE
0317309 SE05 Herbicide and the Petition for Tolerance of Pyrasulfotole in/on
Cereal Grains. Transmittal of 48 of 143 Studies.
46801903 Eigenberg, D. (2006) A 14-Day Comparative Toxicity Feeding Study in Male
Beagle Dogs with Technical Grade AE 0317309. Project Number: 04/S16/UV,
201379. Unpublished study prepared by: Bayer Corp. 67 p.
46801919 Mann, P. (2005) Scientific Advisory Group Review of the Thyroid from SA
02453: A 6-Month Toxicity, Chronic Toxicity and Carcinogenicity Study of AE
0317309 in the Wistar Rat by Dietary Administration. Project Number: 393/043.
Unpublished study prepared by Experimental Pathology Laboratories, Inc. 84 p.
46801920 Totis, M. (2006) In Vitro Inhibition of HPPDase Using Liverbeads from
Different Species. Project Number: SA/04276. Unpublished study prepared by
Bayer Cropscience. 86 p.
46801922 Esdaile, D. (1995) Tyrosine: Exploratory 14-Day (Ocular Toxicity) Study in the
Rat and Mouse. Project Number: C021325, SA/94100. Unpublished study
prepared by Rhone-Poulenc - Secteur Agro. 118 p.
46801944 Lemke, V. (2006) Evaluation of Acute and Chronic Dietary Exposure to AE
0317309 and Assessment of Potential Risk. Project Number: RAAIX003.
60
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Unpublished study prepared by Bayer Corp. 133 p.
46801945 Tang, Z. (2006) Aquatic Ecological and Drinking Water Exposure Assessment
for AE 1317309 and its Major Metabolit AE B197555 (United States). Project
Number: MEAIY010. Unpublished study prepared by Bayer Corp. 54 p.
46801946 Tang, Z. (2006) Aquatic Ecological and Drinking Water Exposure Assessment
for AE 0317309 and its Metabolite AE B197555 (Canada). Project Number:
MEAIY014. Unpublished study prepared by Bayer Corp. 55 p.
46801947 Dobbs, M.; Lenz, M.; Meyer, B.; et. al. (2006) Ecological Risk Assessment for
the Cereal Herbicide AE 0317309. Project Number: EBAIP004. Unpublished
study prepared by Bayer Cropscience LP. 47 p.
46801948 Meyer, B.; Heintzelman, R.; Lemke, V.; et. al. (2006) AE0317309: Human
Health Risk Assessment for Use on Wheat, Barley and Oats. Project Number:
G201500. Unpublished study prepared by Bayer CropScience LP. 97 p.
46974300 Bayer CropScience (2006) Submission of Exposure and Risk Data in Support of
the Application for Registrations of Pyrasulfotole Technical, AE 0317309 SE06
Herbicide, and AE 0317309 +Bromo Herbicide. Transmittal of 1 Study.
46974301 Dobbs, M.; Giddings, 1; Priester, T.; et. al. (2006) Pyrasulfotole: An
Assessment of Risk to Endangered Species Associated with Small Grains.
Project Number: 06738, EBAIX036. Unpublished study prepared by
Compliance Services International. 166 p.
47111200 Bayer Crop Science (2007) Submission of Public Interest Data in Support of the
Registration of AE 0317309 (Pyrasulfotole) Technical, AE 0317309 SE06
Herbicide, and Huskie Herbicide. Transmittal of 1 Study
47111201 Nelson, I; Yen, P.; Heintzelman, R.; et. al.; (2007) Public Interest Document
Supporting the Registration of Pyrasulfotole (AE 0317309) to Control
Economically Important Broadleaf Weeds in Wheat, Barley, Oats and Triticale.
Project Number: PID/BAY07JNOQ. Unpublished study prepared by ABG, Inc.
82 p.
61
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