r/EPA
United States
Environmental Protection
Agency
Office of Prevention, Pesticides
and Toxic Substances
(7501C)
Pesticide
Fact Sheet
Name of Chemical: Pinoxaden
Reason for Issuance: Conditional Registration
Date Issued: July 2005
DESCRIPTION OF CHEMICAL
Generic Name:
Common Name:
Trade Name:
EPA PC Code:
Chemical Abstracts
Service (CAS) Number:
Year of Initial
Registration:
Pesticide Type:
Chemical Class:
U.S. Producer:
8-(2,6-diethyl-4-methylphenyl)-l,2,4,5-tetrahydro-7-oxo-7
H-pyrazolori,2-d][l,4,5]oxadiazepin-9-yl
2,2-dimethylpropanoate
Pinoxaden
Axial
147500
243973-20-8, 99607-70-2
2005
Herbicide
Phenylpyrazolin
Syngenta Crop Protection, Inc.
2.
USE PATTERNS AND FORMULATIONS
Application Sites:
Types of Formulations:
Pinoxaden is registered for use on wheat and barley
98% technical product
9.71% emulsifiable concentrate end-use product
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Types and Methods
of Application: For post emergence control of grass weeds in wheat
(including durum) and barley. One application per crop
season by agricultural workers using either open-cab ground
boom equipment or via aerial application..
Application Rates: Application rates of 0.036-0.062 Ib active ingredient per acre.
3 SCIENCE FINDINGS
Summary Science Statements
Based upon a battery of acute toxicity studies, pinoxaden has a low order of acute toxicity by the
oral, dermal and inhalation routes (Toxicity Categories III or IV). Pinoxaden is irritating to the eye,
but is not irritating to the skin. Pinoxaden is not a skin sensitizer. There is a complete toxicity data
base for pinoxaden and exposure data are complete or are estimated based on data that reasonably
accounts for potential exposures. Acute dietary exposure from food and water to pinoxaden will
occupy 1.5 % of the aPAD for females 13 - 49 years. Drinking water was incorporated directly into
the acute dietary assessment using the annual peak concentration for surface water generated by the
PRZM -EXAMS model as a high-end estimate. Chronic dietary exposure to pinoxaden from food
and water will utilize 0.9 % of the cPAD for the U. S. general population, and 2.1% of the cPAD for
children 1-2 years old, the highest exposed population subgroup. Drinking water was incorporated
directly into the chronic dietary assessment using the annual mean concentration for surface water
generated by the PRZM-EXAMS model as a high-end estimate. Based on the hazard
characterization data, EPA determined that the special FQPA Safety Factor should be reduced to Ix
because there are no concerns and no residual uncertainties with regard to pre- and/or postnatal
toxicity. The pinoxaden risk assessment team evaluated the quality of the exposure data and based
on these data, recommended that the special FQPA SF be reduced to Ix. Pinoxaden is not likely to
pose a cancer risk.
Available data indicate that pinoxaden use on wheat (including durum) and barley should result in
minimal risk to listed and non-listed dicotyledonous terrestrial plants; however confirmatory data
are needed for the two main degradates. No adverse acute and chronic effects are expected for non-
listed birds and mammals exposed to parent pinoxaden; however, confirmatory data are needed for
the formulated product with adjuvant. Potential indirect effects exist for listed birds and mammals
that rely on monocots and non-flowering plants for food or habitat. No unacceptable risks are
expected to listed and non-listed aquatic organisms. Listed and non-listed monocots and non-
flowering terrestrial plants are at risk from channelized runoff and drift from wheat and barley fields
The fate and disposition of pinoxaden in the environment suggest a compound that is an herbicide
that is persistent and mobile, stable to hydrolysis, and has the potential to reach aquatic
environments and organisms via sheet and channel run-off, discharged groundwater into surface
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waters, and spray drift from either ground or aerial spray application.
Hydrolysis of pinoxaden is pH dependent and occurs faster under basic conditions. Aqueous
photolysis of pinoxaden is not a major dissipation route when exposed to sunlight. In soil,
photolysis is also not a significant pathway for degradation for pinoxaden without hydrolytic
degradation.
Pinoxaden degrades rapidly under aerobic soil metabolism conditions with half-lives ranging from
2 to 3 days, forming the major degradate M2, which degrades further to form the degradate M3.
Under aerobic aquatic conditions, pinoxaden degrades rapidly to M2 (half-life < 1 day) to the major
transformation product, M2. M2 was the major product detected in the treated water-sediment
systems under both anaerobic and aerobic conditions. The minor transformation product M3 was
identified with maximums of 0.3%, 0.1% and 0.4% in water, sediment and total system,
respectively. Under aerobic aquatic conditions, more than 86% of applied activity remains (in total
system) in form of the major degradate M2.
Volatility is not a significant route of dissipation. The major degradates of pinoxaden (M2 and M3)
are considered to be mobile based on Freundlich Kads values ranging from 0.06-128 ml/g, and 0856-
0.28 ml/g, respectively, in three test soils (loamy sand, loam, silty clay loam textures).
Chemical Characteristics
Property
Physical State
Color
Odor
Melting Point (range)
Density
Solubility (Water)
Vapor Pressure
Octanol/Water Partition
Coefficient
PH
Technical
Solid
White
Odorless
120.5-121. 6°C
1.16X103kg/m3@24°C
200 mg/L at 20°C
4.6xlO-7Pa@25°C
LogPow =3.2@25°C
4.9@25°C
End-use
Liquid
Yellow orange
Thymol like
8.6 Ibs/gal ® 20°C
4.71 @25°C
Toxicology Characteristics
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Acute Toxicity of Pinoxaden Technical
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 > 5000 mg/kg
LD50 > 2000 mg/kg
LC50>5.22mg/L
Formulation is irritating to the eye
No erythema or edema were noted at
any point during the study. Non-
irritating to the skin.
Not a dermal sensitizer
Toxicity
Category
IV
III
IV
I
IV
N/A
Acute Toxicity of Axial ™ Herbicide
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
3129mg/kg = LD50
LD50 > 2000 mg/kg
LC50 > 5 mg/L
Ocular irritation in all rabbits
observed, which subsided within 7
days. Moderate irritant.
Moderate local irritation. Erythema
and edema subsided by day 14, but
desquamation was still present.
Not a dermal sensitizer.
Toxicity
Category
III
III
IV
III
III
n/a
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Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.3100
90-Day rats
gavage
46203239 (2003)
Acceptable/Guideline
0,3, 10,30, 100, or 300
mg/kg/day
NOAEL = 300/100 mg/kg/day (M/F)
LOAEL was not observed in males; = 300
mg/kg/day in females, based on increased water
consumption and urinary volume
870.3100
90-Day
rats - diet
46203235, 46203237
(2003)
Acceptable/Guideline
0, 150, 1000, 5000, or
10000 ppm( 0/0, 15/16,
98/110, 466/527 or
900/965mg/kg/day in
males/females)
NOAEL = 466/537 mg/kg/day (M/F)
LOAEL = 900/965 mg/kg/day based on decreased
body weight and body weight gain and increased
incidence of renal lesions in both sexes; decreased
food consumption and increased water
consumption in males; and increased urine volume
in females
870.3100
13-Week
oral
mice -
gavage
46203241 (2002)
Acceptable/Guideline
0, 10, 100, 400, 700 or
1000 mg/kg/day (limit
dose)
NOAEL = 700 mg/kg/day
LOAEL = 1000 mg/kg/day based on increased
incidence of piloerection and decreased body
weight gain in both sexes, and increased incidence
of renal tubular basophilia in males
870.3100
90-Day oral
mice - diet
46203236, 46224805
(2003)
Acceptable/Guideline
0, 1000, 2500, 5000 or
7000 ppm (0/0,
140.9/165.9,
365.0/436.7, 708.2/900.6
or 992.3/1311.7
mg/kg/day in
males/females)
NOAEL was not observed in females, but was
365.0 mg/kg bw/day in males
LOAEL =165.9 mg/kg bw/day in females, based on
decreased body weight and body weight gain and
708.2 mg/kg bw/day in males, based on decreased
food efficiency
870.3150
90-Day
dogs -
capsule
46203242 (2003)
Acceptable/Guideline
0,25, 100, 250 or 500
mg/kg/day
NOAEL = 100 mg/kg/day
LOAEL = 250 mg/kg/day based on clinical signs of
toxicity fluid feces, vomit, pale and thin
appearance, decreased activity, dehydration, cold
to touch, and regurgitation in both sexes, and
mucus in feces in the males) and decreased body
weights, body weight gains, and food consumption
in both sexes
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Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.3200
28-Day
dermal
toxicity - rat
46203243(2001)
Acceptable/Guideline
0, 10, 100, or 1000
mg/kg/day
LOAEL was not observed
NOAEL = 1000 mg/kg bw/day (the limit dose)
870.3700
Prenatal
development
al toxicity -
rabbit
46203303 (2003)
Acceptable/Guideline
0, 3, 10, 30, or 100
mg/kg/day
Maternal NOAEL = 30 mg/kg/day
Maternal LOAEL =100 mg/kg/day, based on
increased mortality, abortion, and decreased body
weights, body weight gains and food consumption
Developmental NOAEL = 30 mg/kg/day
Developmental LOAEL = 100 mg/kg day, based on
increased incidence of complete early litter
resorption
870.3700
Prenatal
development
al toxicity -
rat
46203305 (2003)
Acceptable/Guideline
0, 3, 30, 30, 300 or 800
mg/kg/day
Maternal NOAEL = 30 mg/kg/day
Maternal LOAEL = 300 mg/kg bw/day, based on
decreased body weight gains and food consumption
Developmental NOAEL = 30 mg/kg/day
Developmental LOAEL = 300 mg/kg/day, based on
delays in skeletal ossification in the skull and hind
digits
870.3800
Reproductio
n and
fertility
effects - rat
46203308 (2003)
Acceptable/Guideline
0, 10, 50, 250 and 500
mg/kg/day
Parental NOAEL = 250 mg/kg/day
Parental LOAEL = 500 mg/kg/day, based on
increased water consumption, renal tubular
atrophy, and chronic nephropathy in both sexes,
and increased incidence of renal pelvic dilatation in
the males
Offspring NOAEL = 250 mg/kg/dy
Offspring LOAEL = 500 mg/kg bw/day, based on
decreased body weights and body weight gains in
the Fj pups, and decreased body weights in the F2
males
Reproductive NOAEL = 500 mg/kg/day
Reproductive LOAEL was not observed
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Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.4100
Chronic
toxicity
dogs -
capsule
46203309 (2003)
Acceptable/Guideline
0, 5, 25 or 125
mg/kg/day
NOAEL = 125 mg/kg/day
LOAEL was not observed
870.4200
Carcinogenic
ity
mice - diet
46448801 (2004)
Unacceptable/Guideline
0, 10, 150,500, 1500 or
4000 ppm (0/0,
16.3/20.2, 60.7/75.7,
181.2/216.5 and
573.7/706.4 mg/kg/day
in males/females)
[4000 ppm dose
discontinued at Week 40]
NOAEL = 216.5/181.2 mg/kg/day (M/F)
LOAEL was not determined
870.4200
Carcinogenic
ity
mice- gavage
46224808 (2003)
Unacceptable/Guideline
0, 5, 40, 300 or 750
mg/kg
Study could not be interpreted due to gavage errors
and lung involvement.
870.4300
Chronic
toxicity/carci
nogenicity
rats - gavage
46224809 (2003)
Acceptable/Guideline
0, 1, 10, 100 250 or 500
mg/kg/day
NOAEL = 100 mg/kg/day
LOAEL = 250 mg/kg/day, based on mortality,
clinical signs, and increased serum urea and
creatinine in males, and decreased body weights
and body weight gains, increased water
consumption and incidence of urinalysis findings,
kidney surface granulation, and microscopic renal
lesions in both sexes
870.5100
In Vitro
bacterial
gene
mutation S.
typhimurium
/E. coli
46203314(2001)
Acceptable/Guideline
33, 100, 333, 1000,
2500, or 5000 |ig/plate
w/wo activation
(cytotoxicity was
observed at >1000
jig/plate)
No marked increases in the number of revertants
were observed at any concentration in any strain in
either trial.
[negative]
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Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.5300
In Vitro
mammalian
gene
mutation
(L5178YTK+
46203318(2003)
Acceptable/Guideline
6.3, 12.5, 254200
(-S9) and 3.1,6.3, 12.5,
25,50, 100 or 150
Hg/mL (+S9)
No reproducible substantial (>2x solvent controls)
and/or concentration-dependent increases in mutant
colonies per 106 cells were observed at any dose
level in the presence or absence of S9.
[negative]
870.5375
In vitro
mammalian
cytogenetics
inV79
Chinese
Hamster
Lung
Fibroblasts
46203321(2001)
Acceptable/Guideline
6.3, 10, 12.5, 20, 25, 40,
50, 60, 75, 80 or 100
|ig/mL 10, 20, 40, 60, 80,
or 100 ng/mL (-S9); 10,
12.5, 20, 25, 30, 40, 50,
60, 70, 75, 80, 100 or
120 iig/mL (+S9)
Although there was not a clear dose-response and
several of the increases in percent aberrant cells
were within the historical control range (0.0-4.0%),
there was sufficient reproducible evidence of a
positive mutagenic effect in the presence and
absence of S9.
[positive]
870.5375
In vitro
mammalian
cytogenetics
inV79
Chinese
Hamster
Lung
Fibroblasts
46203322 (2002)
Acceptable/Guideline
10, 15,20,30,40,45,60,
75, 80, 90 and 100
|ig/mL(-S9);3.8,7.5,
15, 30, 45, 60 and 90
Hg/mL (+S9)
There was an increase in the percent aberrant cells
that exceeded the historical control range
with/without S9 metabolic activation.
[positive]
870.5395
In Vivo
mammalian
cytogenetics
micronucleu
s mice
46203325 (2002)
Acceptable/Guideline
2000 mg/kg (bone
marrow toxicity was not
induced)
There were no marked increases observed in mean
net nuclear grains (NNG) or percent cells in repair
(NNG > 5) at 2 or 16 hours post-dosing compared
to controls.
[negative]
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Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.5550
UDSin
mammalian
cells
46203329 (2001)
Acceptable/Guideline
0, 1.17,2.34,4.69,9.38,
18.75,37.5,75, 150,300,
or 600 |ig/mL (cytotoxic
levels >300 |ig/mL)
There were no marked increases observed in the
mean grains per nucleus or mean NNG in either
trial. Negative for increased UDS up to limit dose.
[negative]
870.5550
UDSin
mammalian
cells
46203325 (2002)
Acceptable/Guideline
2000 mg/kg
There were no marked increases observed in mean
net nuclear grains (NNG) or percent cells in repair
(NNG > 5) at 2 or 16 hours post-dosing compared
to controls.
[negative]
870.6200
Acute
neurotoxicity
rats - gavage
46203331,46203330
(2003)
Acceptable/Guideline
0, 100, 500 or 2000
mg/kg
NOAEL = 2000 mg/kg (for neurotoxicity)
LOAEL was not determined.
870.6200
Subchronic
neurotoxicity
rats -gavage
46203332 (2003)
Acceptable/Guideline
0, 10, 100 or 500
mg/kg/day
NOAEL = 500 mg/kg/day (for neurotoxicity)
LOAEL was not determined
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10
Subchronic, Chronic, and Other Toxicity Profile Of Pinoxaden
Guideline
No./ Study
Type
MRID No. (year)/
Classification /Doses
Results
870.7485
Metabolism-
Rat
46203333-46203336
(2001)
Acceptable/Guideline
0.5 or 300 mg/kg
Approximately 90% of the orally gavaged dose
was absorbed from the gastrointestinal tract.
Approximately, 90% of the absorbed dose was
excreted in the urine and feces in 72 hours and
excretion was nearly complete in 7 days. Excretion
in the urine ranged from 59-78% and in feces 20-
25%. Tissue distribution data indicated no
significant accumulation in the body. Billiary
excretion study did not indicate enterohepatic
circulation. No parent compound was detected in
the urine, feces or bile. Major metabolite in the
urine and feces was the hydrolysis product M2.
Major metabolites in the urine were M2 (65%-
85%) and M4 (5-13%) and in the feces 50%-70%)
and M4 (25%-35%) depending up on the dose.
There were no sex related differences in the
absorption, distribution, excretion or qualitative
profile of the metabolites.
870.7600
In Vivo
Dermal
penetration-
Rat
46203342 (2003)
Acceptable/Guideline
0.05, 0.25 or 4.0 mg/rat
(EC 100 formulation)
Low dose= 4%, 14%, 18% at 4, 10, 24 hours
Mid dose= 1%, 2%, 4% at 4, 10, 24 hours
High dose= 17%, 30%, 36% at 4, 10, 24 hours
Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study
identified as appropriate for use in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation
from laboratory animal data to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences. EPA has concluded that the
toxicology database for pinoxaden is complete.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute
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11
or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided
by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due
to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by
such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOG.
For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X
for intraspecies differences) the LOG is 100. To estimate risk, a ratio of the NOAEL to exposures
(margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOG.
A summary of the toxicological endpoints for pinoxaden used for human risk assessment is
shown in the following table:
Toxicological Dose and Endpoints for Pinoxaden for Use in Human Risk Assessment
Exposure
Scenario
Acute Dietary
(females 13-49)
Acute Dietary
(general
population)
Chronic Dietary
(all populations)
Incidental Oral
Short-Term
(1 - 30 days)
Dose Used in
Risk
Assessment, UF
NOAEL = 30
mg/kg/day
UF = 100
Acute RfD = 0.30
mg/kg
N/A
NOAEL = 30
mg/kg/day
UF = 100
Chronic RfD = 0.30
mg/kg/day
NOAEL = 30
mg/kg/day
Special FQPA
SF* and Level of
Concern for Risk
Assessment
FQPA SF - IX
aPAD = 0.30 mg/kg
N/A
FQPA SF - IX
cPAD = 0.30
mg/kg/day
LOC = MOE - 100
(residential includes
the FQPA SF)
Study and Toxicological
Effects
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
increased incidence of complete early
litter resorption
An endpoint of concern attributable to
a single dose effect was not identified
in the database.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
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12
Toxicological Dose and Endpoints for Pinoxaden for Use in Human Risk Assessment
Exposure
Scenario
Incidental Oral
Intermediate-Term
(1-6 months)
Dermal
Short-Term
(1 - 30 days)
Dermal
Intermediate-Term
(1-6 months)
Dermal
Long-Term
(> 6 months)
Inhalation
Short-Term
(1 - 30 days)
Inhalation
Intermediate-Term
(1-6 months)
Dose Used in
Risk
Assessment, UF
NOAEL = 30
mg/kg/day
NOAEL = 30
mg/kg/day
NOAEL = 30
mg/kg/day
NOAEL = 30
mg/kg/day
NOAEL = 30
mg/kg/day
NOAEL = 30
mg/kg/day
Special FQPA
SF* and Level of
Concern for Risk
Assessment
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(residential includes
the FQPA SF)
LOC for occupational
=100
Dermal-absorption
rate=40%
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(Occupational)
Dermal-absorption
rate=40%
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(Occupational)
Dermal-absorption
rate=40%
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(Occupational)
Inhalation-absorption
rate=100%
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(Occupational)
Inhalation-absorption
rate=100%
Study and Toxicological
Effects
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
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13
Toxicological Dose and Endpoints for Pinoxaden for Use in Human Risk Assessment
Exposure
Scenario
Inhalation
Long-Term
(> 6 months)
Cancer (oral,
dermal, inhalation)
Dose Used in
Risk
Assessment, UF
NOAEL = 30
mg/kg/day
Special FQPA
SF* and Level of
Concern for Risk
Assessment
LOC = MOE=100
(residential includes
the FQPA SF)
LOC = MOE=100
(Occupational)
Inhalation-absorption
rate=100%
Study and Toxicological
Effects
Developmental toxicity - rabbit
LOAEL = 100 mg/kg/day based on
morbid condition in one rabbit
(mortality), clinical signs of toxicity in
a morbid rabbit, abortion, decreased
body weights, body weight gains and
food consumption.
Not likely to pose a cancer risk.
Human Exposures and Risks
Acute risk
EPA has concluded that the acute dietary exposure from food and water to pinoxaden will occupy
1.5 % of the aPAD for females 13-49 years. Drinking water was incorporated directly into the
dietary assessment using the annual peak concentration for surface water generated by the PRZM
-EXAMS model as a high-end estimate (0.76 ppb; 90th percentile annual daily maximum). An
endpoint of concern attributable to a single dose effect was not identified in the database for the
general population, therefore, an acute risk assessment was not performed for the general population,
or for the general population including infants and children.
Chronic risk
EPA has concluded that chronic dietary exposure to pinoxaden from food and water will utilize 0.9
% of the cPAD for the U.S. general population, and 2.1 % of the cPAD for children 1-2 years old,
the highest exposed population subgroup. Drinking water was incorporated directly into the dietary
assessment using the annual mean concentration for surface water generated by the PRZM-EXAMS
model as a high-end estimate (0.000473 ppm; 90th percentile annual mean). There are no residential
uses for pinoxaden that result in chronic residential exposure to pinoxaden.
Cancer Risk
Although an acceptable cancer study in rats was submitted, the dietary cancer study in the mouse
was found to be unacceptable due to the failure to test at high enough doses. Nonetheless, based on
the following weight-of-evidence, a repeat carcinogenicity study in mice is not required at this time:
• No evidence of carcinogenicity was observed in an acceptable/guideline carcinogenicity
study in rats
• The gavage carcinogenicity study in mice was conducted at doses as high as 750 mg/kg/day.
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14
No tumors were observed in other organs except adenomas/carcinomas in the lungs.
However, the interpretation of the adenomas/carcinomas in the lungs was confounded by the
gavage errors that may have introduced the dosing solution in to the trachea and lungs, and
perhaps leading to lung tumors and excessive mortality.
No tumors were seen in the mouse dietary carcinogenicity study, however, the dosing was
considered to be inadequate due to the lack of significant systemic toxicity at doses up to
181.2 mg/kg/day (the study, performed under OECD and EPA guidelines, was terminated
early for humanitarian reasons due to excessive decreases in body weight gain in the high
dose animals).
• In the 90-day feeding study in mice, pinoxaden was tested up to 7000 ppm (1311 mg/kg/day;
Limit Dose), and did not produce any tumors or severe toxicity.
Pinoxaden was considered to be non-mutagenic.
This evidence convinces EPA that repeating the dietary mouse cancer study is unlikely to provide
additional useful information for the risk assessment, and that pinoxaden is not likely to pose a
cancer risk.
FOPA Safety Factor
There is a complete toxicity data base for pinoxaden and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. Based on the hazard characterization
data, EPA determined that the special FQPA SF should be reduced to Ix because there are no
concerns and no residual uncertainties with regard to pre- and/or postnatal toxicity. The pinoxaden
risk assessment team evaluated the quality of the exposure data and based on these data,
recommended that the special FQPA SF be reduced to Ix. This recommendation is based on the
following:
• The dietary exposure assessment utilizes proposed tolerance level residues and 100%
crop treated information for all commodities. By using these screening-level
assessments, chronic exposures/risks will not be underestimated.
• The dietary drinking water assessment utilizes values generated by a model and
associated modeling parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations.
• There are no residential uses proposed for pinoxaden at this time.
There are no concerns and no residual uncertainties with regard to pre- and/or
postnatal toxicity
Occupational Risk
Pinoxaden is intended for use as a postemergence herbicide for control of grass weeds in wheat
(including durum) and barley. The proposed use of pinoxaden is one application per crop season
at a rate of 0.036-0.062 Ib active ingredient per acre. The pre-harvest interval is 60 days, with an
REI of 48 hours, and a 30 day pre-grazing interval. There is a zero day plant back interval (FBI) for
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15
wheat and barley, a 30 day FBI for leafy and root crops, and a 120 FBI for all other cereal grains and
crops.
Based upon the proposed use pattern, HED believes the most highly-exposed occupational pesticide
handlers (i.e., mixers, loaders, applicators) are:
1) Mixer/loader using open-pour loading of liquids in support of aerial operations
2) Applicator using open-cab ground-boom equipment
3) Aerial applicator (pilot).
Short- (1-30 days) and intermediate-term (1-6 months) exposures were assessed. Although the
proposed labeling directs users not to apply more than one application per year, commercial
applicators may experience intermediate-term exposures since they may treat a number of farms
sequentially.
No chemical-specific data were available with which to assess potential exposure to pesticide
handlers. The estimates of exposure to pesticide handlers are based upon surrogate study data
available in Pesticide Handlers Exposure Database (PHED; v. 1.1,1998). It is HED policy to assess
handler exposure and risk using "baseline" personal protective equipment (PPE) which is comprised
of long-sleeved shirt, long pants, and shoes plus socks. If necessary, HED assesses risk using
"baseline" plus the use of protective gloves or other PPE as might be necessary or appropriate. The
proposed label directs applicators and other handlers to wear a long-sleeved shirt and long pants,
shoes plus socks and chemical resistant gloves.
Short- and intermediate-term handler risks were estimated for handlers and postapplication workers.
A dermal-absorption factor of 40% was used to calculate occupational risks. HED assumed 100%
inhalation absorption.
Provided that mixer/loaders use protective gloves as specified on the proposed label, all margins of
exposure (MOEs) are > 100 and therefore do not exceed HED's level of concern (MOE of at least
100).
There is a potential for agricultural workers to have post-application exposure to pesticides during
the course of typical agricultural activities. Based upon the proposed use pattern (early post-
emergence), the most conservative transfer coefficient (TC) applicable to pinoxaden is for scouting
at 100 cmVhr. Short-term exposures are expected. Post-application worker exposure is estimated
using the highest proposed application rate and a TC of 100 cm2/hr. This TC was obtained from an
interim TC policy developed by HED's Science Advisory Council for Exposure (ExpoSAC) using
proprietary data from the Agricultural Re-Entry Task Force (ARTF) database (SOP #3.1).
Lacking compound-specific dislodgeable foliar residue (DFR) data, HED assumes 20% of the
application rate is available as DFR on day zero after application, adapted from the ExpoSAC SOP
No. 003 (7 May 1998 - Revised 7 August 2000). The estimated MOE for postapplication workers
is 65,000 and does not exceed HED's level of concern (MOE of at least 100).
Environmental Characteristics
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16
STUDY TYPE
Hydrolysis
Photolysis in Water
Photolysis on Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Mobility -Leaching
Terrestrial Field Dissipation
HALF LIFE/OTHER
Stable
Not a major dissipation route when exposed to
sunlight
Not a significant pathway for degradation without
hydrolytic degradation
2-3 days
< 1 days
Mobile
The parent was not detected above the LOQ in
below the 0-15 cm depth. A degradate was
initially detected in the 0-15 cm depth, but was
detected above the LOQ in soil below the 0-15
depth.
soil
not
cm
Potential to Contaminate Groundwater
The fate and disposition of pinoxaden in the environment suggest a compound that is a systemic
herbicide that is persistent and mobile, stable to hydrolysis, and has the potential to reach aquatic
environments and organisms via sheet and channel run-off, discharged groundwater into surface
waters, and spray drift from either ground or aerial spray application.
Ecological Characteristics
Terrestrial Organisms
Minimal risk is expected for mammals potentially exposed from a maximum application of 0.0624
Ib ai per acre to wheat or barley. One pinoxaden degredate (NOA-447204) was slightly toxic to rats.
Parent pinoxaden, the formulation, and other tested degredates were practically non-toxic. Chronic
testing indicated some toxicity in mammals but only at dose levels above those expected from the
proposed use rates.
Parent pinoxaden is practically nontoxic to birds on an acute-oral and dietary basis. Because the
acute oral and dietary values classify pinoxaden are practically nontoxic to birds and no mortality
was reported at the highest test concentration, minimal risk is presumed.
Tests with the honey bee exposed via oral and contact routes of exposure were conducted with
parent pinoxaden, the 10.1% ai formulation, the formulation with adjuvant, and the adjuvant alone.
Only the formulation displayed toxicity that might be of concern, (LD50 >6.3 jig ai/bee). While the
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17
LD50 was not shown to exceed 11 jig ai/bee, pinoxaden is not expected to pose an unacceptable risk
to honey bees.
Aquatic Organisms
No unacceptable acute or chronic risks were identified for aquatic organisms. A number of the
aquatic studies that were submitted were found to be supplemental. The magnitude of the
uncertainties caused by not having a number of the studies were not considered to have a significant
impact on risk conclusions. For example, although a toxicity value for a freshwater arthropod (e.g.,
Daphnia magnd) was not available, acute risks to freshwater invertebrates as represented by the
mollusk shell deposition value are considered representative. The shell deposition study was 60
times more sensitive than the estuarine/marine fish study and 30 times more sensitive than the
arthropod study with the mysid shrimp.
No unacceptable acute or chronic risks are expected to aquatic animals from spray drift of the
formulated product and adjuvant. The toxicity of the formulation and adjuvant expressed as the
parent 96-h LC50 is >140 ppb, which far exceeds the estimated environmental concentration of less
than 3 ppb.
The Level of Concern (LOG) is not exceeded for aquatic plants based on EECs expected for a
maximum application of pinoxaden of 0.0624 Ib ai per acre to wheat or barley.
Plants
The LOG is exceeded for non-listed and listed monocots and non-flowering plants inhabiting
lowland areas subject to channelized runoff from either an aerial or ground application. The LOG
also is exceeded for any listed monocots and non-flowering plants exposed to drift from an aerial
application. No LOG is exceeded for the dicots exposed to sheet or channelized runoff or drift alone
from either aerial or ground application.
Risk to terrestrial plants is presumed only for monocots and non-flowering plants.
Nontarget Species
The Agency's LOG is exceeded for nontarget, listed, and threatened terrestrial monocots and non-
flowering plants from the proposed uses on wheat and barley, based on a conservative assessment.
Tier II Estimated EECs for pinoxaden and its degradates were estimated using EFED's aquatic
models PRZM-EXAMS (EXposure Analysis Modeling System). PRZM is used to simulate
pesticide transport as a result of runoff and erosion from an 10-ha agricultural field, and EXAMS
considers environmental fate and transport of pesticides in surface water and predicts EECs in a
standard pond (10,000-m2 pond, 2-m deep), with the assumption that the small field is cropped at
100%. The TERRPLANT model was used to calculate EECs for terrestrial plants. Model inputs
include the maximum application rate of 0.0624 Ib ai per acre, a runoff value of 0.05 based on the
water solubility of pinoxaden (3800 mg/L), no incorporation, and ground and aerial application.
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18
Mechanism of Pesticidal Action
Pinoxaden is a representative of the new phenylpyrazolin class of chemicals. The mode of action
is the inhibition of the enzyme, acetyl-coenzyme A carboxylase (ACCase). ACCase activity in plants
can be attributed to two isoenzymes located in different compartments of the plant cell, the
chloroplast and the cytosol. The chloroplastic enzyme is responsible for the de novo biosynthesis
of all fatty acids in the cell. The malonyl-coenzyme A produced by the cytosolic ACCase is
required for fatty acid elongation to form very long-chain fatty acids, and for the biosynthesis of
flavonoids and malonylated metabolites. Pinoxaden has been found to inhibit both the chloroplastic
and the cytosolic ACCase enzyme in gramineae.
4 SUMMARY OF REGULATORY POSITION AND RATIONALE
Available data provide adequate information to support the conditional registration of pinoxaden
(Axial) for postemergence use on barley and wheat.
Use. Formulation. Manufacturing Process or Geographic Restrictions
Environmental Hazards
For terrestrial uses: Do not apply directly to water, 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 wash water or rinsate.
Required Labeling
Contains petroleum distillates.
Do not use or store near heat or open flame.
0-day Plant Back Interval (FBI) for wheat and barley
30-day FBI for leafy and root crops
120-day FBI for other cereal grains and all other crops
Make only one application per crop season.
Do not graze livestock or feed forage of hay from treated areas for a minimum of 30 days
following application.
Do not allow spray to drift to adjacent fields seeded to crops other than wheat or barley.
Do not treat wheat or barley underseeded to forages.
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19
Do not apply this product through any type of irrigation system.
Do not harvest for 60 days following application.
Do not exceed an application rate of 0.045 Ib active ingredient per acre (6.9 oz/acre) when
used alone, or 0.0624 Ib active ingredient per acre (9.6 oz/acre) when tank mixed with
broadleaf weed herbicides.
Do not apply this product in a manner that allows spray to drift from the
application target site and causes or is likely to cause harm to humans,
animals or other non-target sites.
To avoid adverse effects on nontarget monocot species, the following mitigation measures
will be required:
For ground applications, the applicator must:
1. Apply when there is sustained wind away from native plant communities, OR
2. Use low-pressure nozzles according to manufacturer's specifications that produce only
coarse or very coarse droplets, OR
3. Leave 25 foot untreated buffer between treatment area and native plant communities
For aerial applications, the applicator must:
1. Apply only when there is sustained wind away from native plant communities, OR
2. Leave 150 foot untreated buffer between treatment area and native plants."
5 SUMMARY OF DATA DEFICIENCIES
Toxicology:
• None
Residue Chemistry:
• Guideline 860.1340: Additional validation data for pinoxaden and M2 residues in
livestock commodities (ruminant and poultry) are required as a condition of
registration.
Guideline 860.1380:Additional storage stability data for wheat and barley processed
fractions are required as a condition of registration.
Environmental Fate Data (Refer to Appendix A for details):
• None
Ecological Toxicity Data (Refer to Appendix A for details):
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20
• Guideline 72-1 (a,c): fish acute toxicity tests are required for parent pinoxaden to
replace supplemental studies.
Guideline 72-2: a freshwater invertebrate acute toxi city test is required using parent
pinoxaden to replace an unacceptable study.
Guideline 72-3a: an estuarine/marine fish acute toxicity test is required using parent
pinoxaden to replace a supplemental study.
• Guideline 72-3c: an estuarine/marine shrimp acute toxicity test is required using
parent pinoxaden to replace a supplemental study.
• Guideline 72-4a: a freshwater fish early life-stage study is required using parent
pinoxaden
Guideline 72-4b: a freshwater invertebrate life-cycle study is required using parent
pinoxaden
Additional Ecological Toxicity Studies needed as a result of Agency Review:
• Guideline 71-2 (a,b): Avian dietary studies in mallard duck and bobwhite quail are
being requested for the formulated product with adjuvant.
• Guideline 72-l(a,c): Acute fish toxicity studies are being requested for the
degradateNOA-407854 on warm water species only, for the degradateNOA-447204
on warm water & cold water species, and for the formulated product with adjuvant
on warm water and cold water species
Guideline 72-2: Freshwater invertebrate life-cycle studies are being requested for the
degradate NOA-447204 and formulated product with adjuvant.
• Guideline 72-3b: Marine/estuarine shell deposition studies are being requested for
the degradates NOA-407854 and NOA-447204.
• Guideline 72-4a: Freshwater-fish early life-stage studies are being requested for the
degradate NOA-407854, and the degredate NOA-447204
Guideline 72-4b: Freshwater invertebrate life-cycle studies are being requested for
the degradate NOA-447204, and for the degradate NOA-407854 to replace a
supplemental study.
• Guideline 123-1 (a,b): Seedling emergence and vegetative vigor studies are being
requested for each of the two main degradates (NOA-407854 and NOA-447204)
• Guideline 123-2: Tier II Aquatic plant growth studies are being requested for the
parent pinoxaden, degradates NOA-407854 and NOA-447204, and for the
formulation with adjuvant.
6 CONTACT PERSON AT EPA
Jim Tompkins
Product Manager 25
Herbicide Branch
Registration Division (7505C)
Office of Pesticide Programs
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21
Environmental Protection Agency
Aerial Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460
Office Location and Telephone Number
Room 239, Crystal Mall Building #2
1801 S.BellSt
Arlington, VA 22202
(703)305-5697
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.
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22
APPENDIX A: STATUS OF SUBMITTED DATA REQUIREMENTS AND DATA GAPS
Ecotoxicity:
Guide.
no.
71-l(a)
71-2(a)
71-2(b)
71-3
83-3(a)
71-4(a)
71-4(b)
71-5
72-l(a)
Study
description
Acute Avian Oral,
Bobwhite
Avian Dietary Toxicity,
Bobwhite
Avian Dietary Toxicity,
Duck
Mammalian Acute Oral,
Rat
Mammalian Reproductive,
Rat
Avian Reproductive,
Bobwhite
Avian Reproductive,
Duck
Field Testing,
Terrestrial Animals
Fish Acute Toxicity,
Warmwater fish
Test
material
Parent pinoxaden
Parent pinoxaden
Formulation +
adjuvant
Parent pinoxaden
Formulation +
adjuvant
Parent pinoxaden
Formulation
NOA-447204
(degradate)
SYN-502836
(metabolite)
SYN-519312
(metabolite)
Data
required?
yes
yes
yes
yes
yes
yes
yes
no
no
no
Data
requirement
satisfied?
yes
yes
no
yes
no
yes
yes
n/a
n/a
n/a
MRID
no.
462031-03
462031-04
none submitted
462031-05
none submitted
462032-14
462032-17
462032-15
462032-16
462032-18
Status
acceptable
acceptable
study
required
acceptable
study
required
acceptable
acceptable
n/a - see note
n/a - see note
n/a - see note
note: studies with the degradate and two metabolites were not required and
have not been reviewed by HED
Parent pinoxaden
NOA-407854
(degradate)
NOA-407854
(degradate)
Parent pinoxaden
yes
yes
yes
reserved
yes
yes
yes
yes
n/a
no
462033-08
462031-07
462031-08
none submitted
462030-36
acceptable
acceptable
acceptable
n/a
supplemental -
new study
required
deficiency: test fish were too old
NOA-407854
(degradate)
NOA-447204
(degradate)
Formulation +
adjuvant
yes
yes
yes
no
no
no
none submitted
none submitted
none submitted
study
required
study
required
study
required
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23
Guide.
no.
72-l(c)
72-2
72-3(a)
Study
description
Fish Acute Toxicity,
Rainbow Trout
Freshwater Invertebrate
Acute Toxicity
Estuarine/Marine Fish
Acute Toxicity
Test
material
Parent pinoxaden
Data
required?
yes
Data
requirement
satisfied?
no
MRID
no.
462030-34 +
464215-08
Status
invalid - new
study
required
deficiency: test material was not stable
NOA-407854
(degradate )
NOA-447204
(degradate)
yes
yes
yes
no
462030-35
462030-37
acceptable
supplemental -
new study
required
deficiency: TOC was too high
Formulation +
adjuvant
yes
no
462030-39
supplemental -
new study
required
deficiency: precipitant present but not centrifuged prior to analytical
determination
NOA-447204
(degradate )
yes
no
462030-41
supplemental -
new study
required
deficiency: TOC was too high
Parent pinoxaden
yes
no
462030-29
unacceptable -
see note below
note: the study is repairable if the following required information is available,
otherwise a new study is required: (1) if information can be supplied by the
testing laboratory on timing of analytical sampling (0, 24 and 48 hours) with
stock solution renewal and this timing is appropriate for reflecting the stability
of the test material, the study could be upgraded; (2) additionally, measured
concentration results prior to correction for percent recovery and the amount of
dilution water and stock solution flows into mixing chambers are needed to
evaluate nominal and measured concentrations appropriately
NOA-407854
(degradate )
Formulation +
adjuvant
yes
yes
yes
no
462030-30
462030-31
acceptable
supplemental -
new study
required
deficiency : precipitant present but not centrifuged prior to analytical
determination
Parent pinoxaden
yes
no
462030-38
supplemental -
see note below
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24
Guide.
no.
72-3(b)
72-3(c)
72-4(a)
72-4(b)
Study
description
Estuarine/Marine Mollusc
Acute Toxicity - Shell
deposition
Estuarine/Marine Shrimp
Acute Toxicity
Early Life Stage,
Fish
Life Cycle,
Aquatic Invertebrate
Test
material
Data
required?
Data
requirement
satisfied?
MRID
no.
Status
note: the study is repairable if the following required information is available,
otherwise a new study is required: samples were centrifuged before analysis
for the test material as required for poor solubility test materials to obtain the
concentration of soluble test material (EPA, 1994). However, the samples
were also acidified before centrifuging which potentially re-dissolved
paniculate test material. Provide documentation that acidification under this
circumstance did not re-dissolve pinoxaden prior to centrifuging. Also need
information on TOC concentration in dilution water, age of fish, and details of
the primary stock solution preparation
Parent pinoxaden
NOA-407854
(degradate )
NOA-447204
(degradate)
Parent pinoxaden
yes
yes
yes
yes
yes
no
no
no
462030-32
none submitted
none submitted
462030-33
acceptable
study
required
study
required
supplemental -
see note below
note: the study is repairable if the following required information is available,
otherwise a new study is required: samples were centrifuged before analysis
for the test material as required for poor solubility test materials to obtain the
concentration of soluble test material (EPA, 1994). However, the samples
were also acidified before centrifuging which potentially re-dissolved
paniculate test material. Repairable if the TOC concentration in the dilution
water is provided and it is below guideline limits, and documentation is
provided that acidification of water samples prior to centrifugation does not
result in dissolution of pinoxaden precipitant back into solution.
NOA-407854
(degradate)
yes
no
462031-01
unacceptable -
new study
required
note: Repairable to supplemental if the timing of use of a new stock batch (12
batches) with sample collection times is provided and the information supports
the stability of the compound throughout exposure. The study is not
upgradeable to acceptable because a NOAEC was not established and therefore
a new study is required even if the stock batch and sample timing
information is supplied.
Parent pinoxaden
NOA-447204
(degradate)
NOA-407854
(degradate)
yes
yes
yes
no
no
no
none submitted
none submitted
462030-42
study
required
study
required
supplemental -
new study
required
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25
Guide.
no.
72-5
72-6
72-7
123-l(a)
123-Kb)
123-2
Study
description
Life Cycle, Fish
Aquatic Bioaccumulation
Simulated or Actual Field
Testing, Aquatic Animal
Terrestrial Plants,
Seedling Emergence
Terrestrial Plants,
Vegetative Vigor
Aquatic Plant Growth,
Tier II
Test
material
Data
required?
Data
requirement
satisfied?
MRID
no.
Status
Deficiency: Precipitant was present and no filtration or centrifugation was
conducted on analytical samples collected from test chambers at the end of the
each renewal cycle. Report states solubility of test material is >100 ppm but
undissolved particles were observed after 2 to 3 days of mixing and approach
described insufficient to support that insoluble material was not present or did
not form during the exposure duration.
Parent pinoxaden
NOA-447204
(degradate)
Formulation +
adjuvant
NOA-407854
(degradate)
NOA-447204
(degradate)
Formulation +
adjuvant
NOA-407854
(degradate)
NOA-447204
(degradate)
Parent pinoxaden
yes
yes
reserved
reserved
reserved
yes
yes
yes
yes
yes
yes
yes
no
no
n/a
n/a
n/a
yes
no
no
yes
no
no
no
none submitted
none submitted
none submitted
none submitted
none submitted
462031-14
none submitted
none submitted
462031-15
none submitted
none submitted
462031-16
(Lemna)
study
required
study
required
n/a
n/a
n/a
acceptable
study
required
study
required
acceptable
study
required
study
required
supplemental -
new study
required
deficiency: test solutions were not renewed at least once. Perform new study
at acidic to neutral pH
NOA-447204
(degradate )
yes
no
462031-17
(Lemna)
supplemental -
new study
required
deficiency: test solutions were not renewed at least once. Perform new study
at acidic to neutral pH.
NOA-447204
(degradate )
yes
no
462031-18
(Lemna)
supplemental -
new study
required
deficiency: test solutions were not renewed at least once. Perform new study
at acidic to neutral pH.
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26
Guide.
no.
124-1
124-2
141-1
n/a
Study
description
Field testing,
Terrestrial plants
Field Testing,
Aquatic plants
Honey Bee Acute Contact
Honey Bee Acute Oral
Earthworm toxicity
Test
material
Parent pinoxaden
Data
required?
yes
Data
requirement
satisfied?
Tier I yes
Tier II no
MRID
no.
462031-19
(Selenastrum)
Status
supplemental -
new study
required
deficiency: study was conducted for only 72 hrs not 96 to 120 hrs. Perform
new study at acidic to neutral pH
Parent pinoxaden
yes
no
462031-20
(Anabaena)
supplemental -
new study
required
deficiency: study inoculum was 3 times greater than upper limit coupled with
reduced growth rate in controls. Perform new study at acidic to neutral pH
Formulation +
adjuvant
Parent pinoxaden
Parent pinoxaden
NOA-407854
(degradate)
yes
yes
yes
yes
no
yes
yes
Tier I yes
Tier II no
462031-21
(Pseudokirch-
neriella)
462031-22
(Skeletonema)
462031-23
(Navicula)
462031-24
(Selenastrum)
supplemental -
new study
required
acceptable
acceptable
supplemental -
new study
required
deficiency: study was conducted for only 72 hrs not 96 to 120 hrs. Perform
new study at acidic to neutral pH
NOA-447204
(degradate)
Formulation +
adjuvant
yes
yes
yes
no
462031-25
(Selenastrum)
464215-09
(Lemna)
acceptable
supplemental -
new study
required
deficiency: precipitant formed but no filtering or centrifugation was conducted
to measure soluble concentration. Perform new study at acidic to neutral pH
reserved
reserved
yes
no
n/a
n/a
yes
n/a
none submitted
none submitted
462031-13
462031-10
462031-09
462031-11
462031-12
462031-26
462031-27
462031-28
n/a
n/a
acceptable
supplemental
supplemental
supplemental
supplemental
supplemental
supplemental
supplemental
n/a: not applicable
reserved: not required for current assessment but reserve right to require if future conditions warrant
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27
Environmental Fate Data Requirements:
Guideline
no.
161-1
161-2
161-3
161-4
162-1
162-3,4
162-4
163-2
163-1
164-1
164-2
Study
Description
Hydrolysis
Photodegradation in Water
Photodegradation on Soil
Photodegradation in Air
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Laboratory Volatility
Leaching -
Adsorption/Desorption
Terrestrial Field Dissipation
Aquatic Field Dissipation
Data
required?
Yes
Yes
Yes
Yes
Waived
Yes
Yes
Reserved
Data
requirements
satisfied?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
MRID no.
46203005
46203008
46203009
46224803
N/A
46203011
46203012
46203013
46203014
46203015
Status
acceptable
acceptable
acceptable
acceptable
N/A
acceptable
acceptable
acceptable
acceptable
supplemental
A new study is not required at this time; however, a new study
may help refine the risk assessment and reduce uncertainty.
Waived
No
Yes
Yes
Yes
Reserved
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
N/A
46203016
46203017
46203018
46203019
46203023
46203024
46203025
46203026
N/A
unacceptable
acceptable
acceptable
acceptable
supplemental
supplemental
supplemental
supplemental
For the current use and application rate; no additional field
dissipation studies are required. Any changes in the use pattern
and/or application rate may necessitate a need for new field
dissipation studies.
Reserved
N/A
00094799
unacceptable
For the current use and application rate; no additional field
dissipation studies are required. Any changes in the use pattern
and/or application rate may necessitate a need for new field
dissipation studies.
N/A: Not applicable
Reserved: not required for current assessment but reserve right to require if future conditions warrant
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