United States
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
(7505P)
P/EPA
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Saflufenacil
New Chemical
Tolerances Established
August 2009
I. DESCRIPTION OF CHEMICAL
Description of Chemical
Generic Name:
Common Names:
Trade Names Used:
Chemical Class:
Chemical Structure:
(N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-
3,6-dihydro-l(2H)-pyrimidinyl)benzyl]-N-isopropyl-N-
methylsulfamide)
Saflufenacil; Benzamide
Kixor® Herbicide
LDPH, PPO inhibitor
o
-------
EPA Chemical Code:
118203
Chemical Abstracts
Service (CAS) Number:
Registration Status:
Pesticide Type:
U.S. Producer:
372137-35-4
Conditionally registered
Herbicide
BASF Corporation
Agricultural Product Division
26 Davis Drive, P.O. Box 13528
Research Triangle Park, NC 27709
Tolerances Established
Tolerances were established in the 40 CFR §180.649 for the following commodities:
Table 1. Tolerance Summary for Saflufenacil.
Commodity
Vegetable, legume,
group 06
Vegetable, foliage of
legume, group 07
Fruit, citrus, group 10
Fruit, pome, group 1 1
Fruit, stone, group 12
Nut, tree, group 14
Pistachio
Almond, hulls
Grain, cereal, group 1 5
Grain, cereal, forage,
fodder and straw group
16
Sorghum stover
Cotton, undelinted seed
Cotton, gin byproducts
Sunflower, seed
Grape
Animal - Kidney
Proposed
Tolerance
(ppm)
0.03
0.1
0.03
0.03
0.03
0.03
-
0.2
0.03
0.1
0.1
0.03
0.03
0.7
0.03
0.02
Recommended
Tolerance (ppm)
0.03
0.10
0.03
0.03
0.03
0.03
0.03
0.10
0.03
0.10
-
0.03
0.10
1.0
0.03
-
Correct Commodity
Definition/Comments
Vegetable, legume, group 6
Vegetable, foliage of legume,
group 7
Translated from tree nuts
Included in crop group 16
Individual tolerances required
-2-
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Table 1. Tolerance Summary for Saflufenacil.
Commodity
Animal - Liver
Milk
Cattle, meat
Cattle, fat
Cattle, liver
Cattle, meat byproducts,
except liver
Goat, meat
Goat, fat
Goat, liver
Goat, meat byproducts,
except liver
Hog, meat
Hog, fat
Hog, liver
Hog, meat byproducts,
except liver
Sheep, meat
Sheep, fat
Sheep, liver
Sheep, meat byproducts,
except liver
Horse, meat
Horse, fat
Horse, liver
Horse, meat byproducts,
except liver
Proposed
Tolerance
(ppm)
0.8
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Recommended
Tolerance (ppm)
-
0.01
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
Correct Commodity
Definition/Comments
for each species
II. USE PATTERNS AND FORMULATIONS
Application Sites: Saflufenacil is registered as a selective herbicide, developed for the
control of broadleaf weeds by pre-plant and pre-emergence applications to cereal small
grains, corn, chickpeas, cotton, edible beans, edible peas, lentils, lupine, sorghum,
soybeans and sunflowers; post-emergence applications to fruit tree orchards, nut tree
orchards, and vineyards; and fallow croplands and non-agricultural areas, including
pine plantations, rights-of-way, and bare ground. Additionally, Saflufenacil is used as a
dessicant and/or defoliant on sunflowers.
-3-
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Type of Formulations: Technical grade manufacturing use product (97.4%
saflufenacil) and five end-use products:
Product
name
Optill™
Treevix™
Sharpen™
Integrity™
BAS 800
02/03 H
%
saflufenacil
17.8
70.0
29.74
6.24
12.27
Co-active
ingredients
Imazethapyr
(50.2%)
n/a
n/a
Dimethenamid
(55.04%)
n/a
form
Water-
dispersible
granule
Water-
dispersible
granule
Suspension
concentrate
Emulsifiable
concentrate
Emulsifiable
concentrate
use
Clearfield® corn
Legumes
Fruit trees
Nut trees
Grape vines
Field and row
crops
Field corn
Popcorn
Sweet corn
Grain sorghum
Noncropland
Application Methods and Rates:
III. PHYSICAL AND CHEMICAL PROPERTIES
Description Value
Melting point
pH @ 25 °C
Density @ 20 °C
Water solubility (g/100 mL)
@20°C
189.9°C, with a peak
maximum of 193. 4°C. BAS
800 H (PAI) is also stable
under nitrogen up to 220°C
4.426
1.595g/cc(PAI)
PAI:
0.0014 at pH 4
0.0025 at pH 5
0.21 atpH7
Could not be determined at
pH 9 due to degradation
-4-
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Description Value
Solvent solubility (g/100 mL
at 20 °C)
Acetonitrile
Di chl orom ethane
N,N-DMF
Acetone
Ethyl acetate
THF
Butyrolactone
Methanol
Isopropyl alcohol
Toluene
Olive oil
1-octanol
n-heptane
Vapor pressure (Pa, 20 °C)
Dissociation constant (pKa)
Octanol/water partition
coefficient
UV/visible absorption
spectrum (nm)
Henry's Law Constant
TGAI/MUP 95.4%
19.4
24.4
55.4
27.5
6.55
36.2
35.0
2.98
0.25
0.23
0.01
<0.01
<0.005
PAI
4.5 x 10'15
4.41 + 0.025
Kow 368.3
log Kow 2.6
271. 8 at pH 1.12
271. 4 at pH 6.94
309.4 at pHl 1.69
4.01 x 10'20 atm/m3/mol
IV. HUMAN HEALTH RISK ASSESSMENT
A. Toxicity
1. Acute Toxicity: Saflufenacil has low acute toxicity via the oral, dermal and
inhalation routes of exposure (Toxicity category III or IV). It is slightly irritating to
the eye (Toxicity category III). It is neither a dermal irritant nor sensitizer. The acute
toxicity findings are summarized below:
Table : Acute Toxicity Profile - Saflufenacil.
Guideline No.
870.1100
Study Type
Acute oral [rat]
MRID(s)
47128101
Results
LD50 was >2000
mg/kg bw
Toxicity
Category
III
Purity
93.8%
-5-
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870.1200
870.1300
870.2400
870.2400
870.2500
870.2600
Acute dermal [rat]
Acute inhalation [rat]
Acute eye irritation [White New
Zealand rabbit]
Acute eye irritation [White New
Zealand rabbit]
Acute dermal irritation [rabbit]
Skin sensitization [Guinea Pig]
47128102
47128103
47128105
47128104
47128106
47128107
LD50 >2000
mg/kg
LC50 >5.3 mg/L
minimal irritation
minimal irritation
slightly irritating
not a sensitizer
III
IV
III
III
IV
N/A
93.8%
93.8%
93.8%
93.8%
93.8%
93.8%
2. Subchronic/ChronicToxicity: The primary target organ is the hematopoietic
system. PPO inhibition in mammals may disrupt heme synthesis, which in turn
causes anemia. In the submitted studies, decreased hematological parameters
[decreased red blood cells (RBC), decreased hematocrit (Ht), decreased mean
corpuscular hemoglobin concentration (MCHC), and mean corpuscular volume
(MCV)] were observed at about the same dose level across species, with the
exception of the dog, where effects were observed at a slightly higher dose. These
effects occurred around the same dose level from short- through long-term exposures,
without increasing in severity. Effects were also seen in the liver (increased weight,
centrilobular fatty change, lymphoid infiltrate) in mice, the spleen (increased spleen
weight and extramedullary hematopoiesis) in rats, and in both these organs (increased
iron storage in the liver and extramedullary hematopoiesis in the spleen) in dogs.
These effects also occurred around the same dose level from short- through long-term
exposures, without increasing in severity. No dermal toxicity was seen at the limit
dose in a 28-day dermal toxicity study in rats.
3. Carcinogenicity: Saflufenacil is classified as "Not Likely Carcinogenic to
Humans", based on no evidence of increased incidence of tumors at the tested doses
in rats and mice. Saflufenacil is weakly clastogenic in the in vitro chromosomal
aberration assay in V79 cells in the presence of S9 activation; however, the response
was not evident in the absence of S9 activation.
4. Prenatal and Postnatal Sensitivity: There was evidence of increased susceptibility
in rabbit and rat developmental toxicity studies and in the 2-generation reproduction
study in the rat. Developmental effects such as decreased fetal body weights and
increased skeletal variations occurred at doses that were not maternally toxic in the
rat developmental study, indicating increased quantitative susceptibility. In rabbits,
developmental effects, such as increased liver porphyrins were observed at doses that
were not maternally toxic, indicating increased quantitative susceptibility. In the 2-
generation reproduction study in rats, offspring effects such as increased number of
stillborn pups, decreased viability and lactation indices, decreased pre-weaning body
weight and/or body weight gain, and changes in hematological parameters were
observed at a dose resulting in less severe maternal toxicity (decreased food intake,
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body weight/weight gain and changes in hematological parameters and organ weights
indicative of anemia), indicating increased qualitative susceptibility.
In the acute neurotoxicity study, a decrease in motor activity was observed on the
first day of dosing at the limit dose in males only. The finding was not accompanied
by any other neuropathological changes and was considered a reflection of a mild and
transient general systemic toxicity and not a substance-specific neurotoxic effect. In
the subchronic neurotoxicity study, systemic toxicity (anemia) was seen at 1000 (66.2
mg/kg/day) and 1350 (101 mg/kg/day) ppm in males and females, respectively.
There was no evidence of neurotoxicity or neuropathology in either study due to
treatment..
5. Metabolism: Rat metabolism data indicate that saflufenacil is well absorbed and
rapidly excreted. The maximum concentration of saflufenacil in blood and plasma
was reached within 1 hour (h) of dosing and declined rapidly after 24 h. Excretion of
orally dosed saflufenacil was essentially complete within 96 h, with the majority
eliminated within the first 24 to 48 h. There was a sex-dependent difference in the
excretion of orally administered saflufenacil. The main route of elimination in male
rats was via the feces, while urinary excretion was the major route of elimination in
females. The sex-dependent excretion was more pronounced at the low-dose level
than at the high-dose level. Also, males had significantly higher biliary excretion of
saflufenacil residues than females. Exhalation was not a relevant excretion pathway
of saflufenacil. At 168 h after dosing, saflufenacil residues remaining in tissues were
very low and occurred mainly in carcass, liver, skin, and gut contents.
The parent molecule and 3 major metabolites (M800H01, M800H03, and M800H07)
were identified and isolated from urine and feces. Minor metabolites that were
identified include M800H05, M800H16, M800H17, M800H18, M800M19, and
M800M20. There were no significant gender differences in metabolic profiles.
Saflufenacil was metabolized by three major transformation steps, which were
demethylation of the uracil ring system, degradation of the TV-methyl-TV-isopropyl
group to NH2, and cleavage of the uracil ring, forming a sulfonylamide group.
6. Mutagenicity: Saflufenacil was neither mutagenic in bacterial cells nor clastogenic
in rodents in vivo, and was considered not to pose a mutagenic concern.
9. Toxicology Profile: The toxicological profile is discussed in the table below:
Table 2. Subchronic, Chronic and Other Toxicity Profile for Saflufenacil.
Guideline No./ Study Type
870.3100
28-Day Oral Toxicity feeding-
mice
MRID No. (year)/ Classification
/Doses
47128110(2007)
Acceptable/non-guideline
0,50, 150,450, 1350, or 4050
ppm
Results
LOAEL = 36.6 mg/kg bw/day (males)
based on increased alanine
aminotransferase, aspartate
aminotransferase, urea and total bilirubin,
decreased hemoglobin and Ht and
-7-
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M\F: 0, 12.8/17.9, 36.6/63.4,
112/153.1,335/446,882/1630
mg/kg bw/day.
increased liver weight and centrilobular
fatty change.
NOAEL = 12.8 mg/kg bw/day.
LOAEL = 153.1 mg/kg bw/day (females)
based on moderate centrilobular fatty
change in the liver.
NOAEL = 63.4 mg/kg bw/day.
870.3100
28-Day Oral Toxicity feeding-rat
47128108 (2007)
Acceptable/non-guideline
0,50, 150,450, 1350, or 4050
ppm
M = 0,4.5, 13.4,39.2, 117,357;
F = 0, 5.0, 15.9, 43.6, 130.4, 376
mg/kg bw/day.
LOAEL = 39.2 mg/kg bw/day (males)
based on decreased Hb, MCV, and MCH.
NOAEL =13.4 mg/kg bw/day.
LOAEL = 130.4 mg/kg bw/day (females)
based on decreased Hb, Ht, MCV, and
MCH.
NOAEL = 43.6 mg/kg bw/day.
870.3100
90-Day Oral Toxicity feeding-
mice
47128111(2007)
Acceptable/guideline
0, 15 (males only), 50, 150, 450,
and 1350 (females only) ppm
M = 0,3.6, 12.4,36.7, 109.1;
F = 0, 17.6,51.8, 156.6,471.2
mg/kg bw/day
LOAEL = 36.7mg/kg bw/day (males)
based on multiple hematological changes,
liver weight increases with centrilobular
fatty change and lymphoid infiltrate in
males. NOAEL = 12.4mg/kg bw/day.
LOAEL = 156.6 mg/kg/day (females)
based on increased liver weight with
centrilobular fatty change and lymphoid
infiltrate. NOAEL = 51.8 mg/kg/day.
870.3100
90-Day Oral Toxicity feeding-rat
47128109 (2007)
Acceptable/guideline
0, 50, 150, 450 (males), 1350, or
4050 (females) ppm
M =0,3.5, 10.5,32.3,94.7
F = 0,4.3, 12.6, 110.5,344.7
mg/kg bw/day.
LOAEL = 32.3 mg/kg bw/day (M) and
110.5 mg/kg bw/day (F) based on
multiple hematological effects and
increased spleen weight and
extramedullary hematopoiesis. NOAEL
= 10.5 (M), 12.6 mg/kg bw/day (F).
870.3150
28-Day Oral Toxicity feeding-
dog
47128112(2005)
Acceptable/non-guideline
0, 30, 100, or 300 mg/kg bw/day.
LOAEL = 100 mg/kg bw/day based
decreased mean corpuscular volume,
MCH, and MCHC, bone marrow
hyperplasia, increased iron storage in the
liver and extramedullary hematopoiesis
in the spleen.
NOAEL = 30 mg/kg bw/day.
870.3150
90-Day Oral Toxicity feeding-
dog
47128113 (2006)
Acceptable/guideline
0, 10, 50, or 150 mg/kg bw/day
LOAEL = 50 mg/kg bw/day based on
lower MCV and MCH values in both
sexes.
NOAEL = 10 mg/kg bw/day.
870.3200
21/28-Day dermal toxicity (rat)
47128114(2006)
Acceptable/guideline
0, 100, 300, or 1000 mg/kg
LOAEL was not established. NOAEL =
1000 mg/kg bw/day.
870.3700a
Prenatal developmental in (rat)
47128115(2007)
Acceptable/guideline
0, 5, 20, or 60mg/kg/day
Maternal NOAEL = 20 mg/kg/day
LOAEL = 60 mg/kg/day based on
decrease hemoglobin and Ht, mean
corpuscular volume and MCH.
-8-
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Developmental NOAEL = 5 mg/kg/day
LOAEL = 20 mg/kg/day based on based
on decreased fetal body weights and
increase skeletal variations.
870.3700b
Prenatal developmental in (rabbit)
47128116(2006)
Acceptable/guideline
0, 50, 200, or 600 mg/kg/day
Maternal NOAEL = 200 mg/kg bw/day
LOAEL = 600 mg/kg bw/d based on
mortality and increased necropsy
findings.
Developmental NOAEL = 50 mg/kg/day
LOAEL = 200 mg/kg/day based on
increased liver porphyrins.
870.3800
Reproduction and fertility effects
(rat)
47128117(2007)
acceptable/guideline
0, 5, 15, or 50 mg/kg bw/day
Parental Systemic NOAEL = 15
mg/kg/day
Parental Systemic LOAEL = 50
mg/kg/day based on decreased food
intake, body weight, body weight gain
and changes in hematological parameters
and organ weights indicative of anemia.
Reproduction NOAEL = M/F 50
mg/kg/day
Reproduction
LOAEL was not established.
Offspring NOAEL = 15 mg/kg/day
Offspring LOAEL = 50 mg/kg/day
based on decreased number of live born
pups, increased number of stillborn pups,
decreased viability and lactation indices,
decreased pre-weaning body weight
and/or body weight gain and changes in
hematological parameters.
870.4300b
Chronic Toxicity
(dog)
47128118(2007)
Acceptable/guideline
0, 5, 20, or 80 mg/kg bw/day
LOAEL = 80 mg/kg bw/day based on
decreased albumin, MVH, and MCH.
NOAEL = 20 mg/kg bw/day.
870.4300
Chronic/Carcinogenicity
(rat)
47128120 (2007)
Acceptable/guideline
0, 20, 100, 250 (males), 500 or
1000 (females) ppm
M = 0, 0.9, 4.8, 12.0,24.2
F = 0, 1.3, 6.2, 31.4, 63.0 mg/kg
bw/day.
LOAEL = 31.4 mg/kg bw/day (females)
based on decreased hemoglobin, Ht,
MCVandMCH.
NOAEL = 6.2 mg/kg bw/day (females).
LOAEL was not established in males.
NOAEL = 24.2 mg/kg bw/day.
No evidence of carcinogenicity
870.4300
Chronic/Carcinogenicity
(mouse)
47128119(2007)
Acceptable/guideline
0, 1 (males), 5, 25, 75, or 150
(females) ppm
M = 0, 0.2, 0.9, 4.6, 13.8
F = 0, 1.2,6.4, 18.9, 38.1 mg/kg
bw/day.
satellite groups:
M = 0, 14.2
NOAEL = 4.6 mg/kg bw/day (males) and
18.9 mg/kg bw/day (females).
LOAELs = 13.8 mg/kg bw/day (males)
and 38.1 mg/kg bw/day (females) based
on decreased red blood cells,
hemoglobin, and Ht and porphyria
observed in the satellite group.
No evidence of carcinogenicity
-9-
-------
F = 0, 39.0mg/kgbw/d
Gene Mutation
870.5100
In vitro Bacterial Gene Mutation
47128121 (2005)
Acceptable/guideline
0, 20, 100, 500, 2500, or 5000
ug/plate (saflufenacil hydrate)
There was no evidence of induced mutant
colonies over background.
Gene Mutation
870.5100
In vitro Bacterial Gene Mutation
47128122 (2005)
Acceptable/guideline
0, 20, 100, 500, 2500, or 5000
Ug/plate (saflufenacil anhydrate)
There was no evidence of induced mutant
colonies over background.
Gene Mutation
870.5300
In vitro Mammalian Cells Gene
Mutation (Chinese Hamster
Ovary Cells)
47128123 (2005)
Acceptable/guideline
0,312.5,625, 1250, 2500, or
5000 ug/mL
There was no evidence of induced mutant
colonies over background.
Cytogenetics
870.5375
In vitro Mammalian Cytogenetics
chromosomal aberration assay-
V79 cells
47128124 (2005)
Acceptable/guideline
0, 5, 10, and 20 ug/ml without S9
activation
0, 10, 20, and 40 ug/ml with S9
activation
Saflufenacil was considered clastogenic
in vitro in V79 cells in the presence of S9
metabolic activation. Saflufenacil was
not clastogenic in the absence of
metabolic activation.
Cytogenetics-other
870.5395 In Vivo Mammalian
Cytogenetics - Erythrocyte
Micronucleus assay in mice
47128125 (2005)
Acceptable/guideline
0, 500, 1000, or 2000 mg/kgbw.
There was no increase in the frequency
of micronucleated immature erythrocytes
in mouse bone marrow.
870.5550 Other Genotoxicity-/w
vivo unscheduled DNA synthesis
(rat)
47128126 (2005)
Acceptable/guideline
single oral dose of 1000, or 2000
mg/kg bw
Negative
870.6200a
Acute neurotoxicity battery (rat)
47128127 (2007)
Acceptable/Guideline
0, 125, 500, or 2000 mg/kgbw
Systemic LOAEL was 2000 mg/kg bw
(males) based on the decreased motor
activity representing mild and transient
systemic toxicity.
Systemic LOAEL was not established for
females.
Systemic NOAEL = 500 (M) and 2000
(F) mg/kg bw.
There was no evidence of neurotoxicity.
870.6200b
Subchronic neurotoxicity (rat)
47128128 (2007)
Acceptable/Guideline
0, 50, 250, 1000 (males), or 1350
(females) ppm
M = 0,3.3, 16.6,66.2
F = 0,3.9, 19.4, 101.0 mg/kg
bw/d.
Systemic NOAEL = 16.6 (males), 19.4
(females) mg/kg bw/day. Systemic
LOAEL = 66.2 (males) and 101
(females) mg/kg bw/day based on
decreased hemoglobin, Ht, mean
corpuscular volume and MCH.
There was no evidence of neurotoxicity.
870.7485
Metabolism and
pharmacokinetics
(rat)
47128130, 47128129 (2007)
4, 20, or 100 mg/kgbw (single
oral dose)
5 or 100 mg/kgbw (single dose)
100 mg/kg for 14 days
- 10-
Saflufenacil was rapidly absorbed,
distributed, and excreted. Regardless of
the dose administered, maximum
concentration of saflufenacil in blood and
plasma was reached within 1 h of dosing
and declined rapidly after 24 h.
-------
Excretion of orally dosed saflufenacil
was essentially complete within 96 h; the
majority was eliminated within the first
24 to 48 h. Demonstrating that the
majority of the saflufenacil residues
occurred in the plasma and was not
bound to cellular elements of the blood.
There was a sex-dependent difference in
the excretion of orally administered
saflufenacil. Following single low- and
high-dose administration or a repeat
high-dose administration, the main route
of elimination in male rats was via the
feces, while urinary excretion was the
major route of elimination in females.
There was significantly higher biliary
excretion of saflufenacil residues in
males than in females. Exhalation was
not a relevant excretion pathway of
saflufenacil. At 168 h after dosing,
saflufenacil residues remaining in tissues
were very low, and occurred mainly in
carcass, liver, skin, and gut contents.
Saflufenacil was metabolized by three
major transformation steps:
demethylation of the uracil ring system,
degradation of the 7V-methyl-7V-isopropyl
group to NH2, and cleavage of the uracil
ring, forming a sulfonylamide group.
The predominant metabolites were
M800H01, M800H03, M800H07 and the
parent compound. Other minor
metabolites were M800H05, M800H16,
M800H17, M800H18, M800M19, and
M800M20. There were no significant
sex differences in metabolic profiles.
870.7600
Dermal penetration
(rat)
47128214 (2007)
Acceptable/guideline
1.1723 mg/cm2, 0,1172 mg/cm2
and0.0117mg/cm2
11.723, 1.172 and 0.117 mg/rat
Dermal absorption is 3%.
Comparative
Bioavailability/Toxicity Study
(rat)
47128133 (2005)
Acceptable/non-guideline
0 or 1350 ppm
The bioavailability and toxicity potential
of the hydrated and anhydrated forms of
saflufenacil were similar.
Mechanistic study - total
porphyrin analysis in rat
47128132 (2006)
Acceptable/non-guideline
0, 10, 50, or 1000 ppm ($ = 0,
0.8,4.1,80.6; $=0,0.9,4.6,
89.5 mg/kgbw/day, respectively)
- 11 -
Total porphyrins in feces and liver
provided the most reliable and sensitive
data. Statistically significant effects on
porphyrin metabolism could be detected
at exposure concentrations well below
those associated with adverse
hematological effects.
NOAEL=4.1mg/kg/day
LOAEL = 80.6 mg/kg/day based on
-------
decreased hemoglobin, Ht, MCV, MCH,
and MCHC.
Mechanistic study-porphyrin
analysis supplementary (rat)
47128131(2005)
Acceptable/non-guideline
0, 1, 5, or 25 ppm (c? = 0,0.1,
0.4,2.0; $ =0,0.1,0.5,2.3
mg/kg bw/day
Dietary administration of saflufenacil at
25 ppm caused an increase in porphyrin
in feces of male (237%) and female
(61%) rats, while saflufenacil at 5 ppm
caused an increase in fecal porphyrin
only in males. There were no effects on
hematology parameters.
10. FQPA Safety Factor for Infants and Children: 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 adequate to assess the pre- and postnatal toxicity of
saflufenacil. In accordance with Part 158 Toxicology Data requirements, an
immunotoxicity study (870.7800) is required for saflufenacil. In the absence of
specific immunotoxicity studies, EPA has evaluated the available saflufenacil
toxicity data to determine whether an additional database uncertainty factor is
needed to account for potential immunotoxicity. An increase in spleen weight, an
organ of the immune system, was seen in rats in the 90-day oral toxicity study.
This effect is attributable to an increased clearance of defective RBCs (i.e,
defective hemoglobin synthesis) and is thus an indication of toxicity to the
hematopoietic system rather than to the immune system. There were no other
effects on immune system organs observed in toxicity studies with saflufenacil,
and saflufenacil does not belong to a class of chemicals (e.g., the organotins,
heavy metals, or halogenated aromatic hydrocarbons) that would be expected to
be immunotoxic. Based on these considerations, EPA does not believe that
conducting immunotoxicity testing will result in a point of departure lower than
those already selected for saflufenacil, and an additional database uncertainty
factor is not needed to account for the lack of this study.
• There is no indication that saflufenacil is a neurotoxic chemical and there is no
need for a developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
• There is evidence of increased quantitative and qualitative susceptibility of
offspring in the developmental and reproduction studies for saflufenacil; however,
the degree of concern is low and the Agency did not identify any residual
uncertainties after establishing toxicity endpoints and traditional UFs to be used
in the risk assessment of saflufenacil. The degree of concern is low and there are
no residual uncertainties for the increased susceptibility since: 1) clear
NOAELs/LOAELs were established for the developmental effects seen in rats
and rabbits as well as for the offspring effects seen in the two-generation
reproduction study; 2) dose-response relationships for the effects of concern are
well characterized; 3) none of the effects in the developmental or reproduction
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studies were attributable to a single exposure and, therefore, are not of concern
for acute risk assessment; 4) the dose used to evaluate chronic dietary risks (4.6
mg/kg/day) is lower than the NOAELS for fetal/offspring effects in the
developmental and reproduction studies (5 mg/kg/day in the rat developmental
study, 50 mg/kg/day in the rabbit developmental study, and 15 mg/kg/day in the
rat reproduction study) and is, therefore, protective of the developmental and
offspring effects observed in these studies; and 5) residential exposures are not
expected, since there are no residential uses proposed for saflufenacil.
• There are no residual uncertainties with respect to exposure data:
• The dietary food exposure assessment utilizes proposed tolerance-level
residues and 100% crop treated (CT) information 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 utilizes values generated by model
and associated modeling parameters which are designed to provide
conservative, health-protective, high-end estimates of water
concentrations.
• There are no registered or proposed uses of saflufenacil which would
result in residential exposure.
b. FQPA Safety Factors for General Population - An UF of 100 was applied to acute
and chronic RFD calculations to account for interspecies extrapolation (10X) and
intraspecies variation (10X). The acute population-adjusted dose (aPAD) and chronic
PAD (cPAD) are equal to the acute and chronic RFDs, respectively, divided by the
FQPA SF (IX).
11. Toxicological Endpoints: A summary of the toxicological endpoints are shown
below:
Table . Summary of Toxicological Doses and Endpoints for Saflufenacil for Use in Dietary
Human-Health Risk Assessments.
Exposure/
Scenario
Acute Dietary
(General
Population,
including
Infants and
Children)1
Point of
Departure
NOAEL =
500 mg/kg
bw
Uncertainty/
FQPA SFs
UFA=10X
UFH=10X
FQPA SF = IX
RfD, PAD,
LOG for
Risk
Assessment
Acute RfD =
5.0 mg/kg
aPAD = 5.0
mg/kg
Study and Toxicological Effects
Acute Neurotoxicity Study
NOAEL = 500 (M) and 2000 (F) mg/kg
bw.
LOAEL was 2000 mg/kg bw (males)
based on the decreased motor activity
representing mild and transient systemic
toxicity.
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Table . Summary of Toxicological Doses and Endpoints for Saflufenacil for Use in Dietary
Human-Health Risk Assessments.
Chronic
Dietary (All
Populations)2
Cancer (oral,
dermal,
inhalation)
NOAEL =
4.6
mg/kg/day
UFA=10X
UFH=10X
FQPA SF = IX
Chronic RfD
= 0.046
mg/kg/day
cPAD =
0.046
mg/kg/day
LOAEL was not established for females.
Chronic/Carcinogenicity (mouse)
NOAEL = 4.6 mg/kg bw/d (males) and
18.9 mg/kg bw/d (females).
LOAELs =13.8 mg/kg bw/d (males) and
38.1 mg/kg bw/day (females) based on
decreased red blood cells, hemoglobin,
and Ht and porphyria observed in the
satellite group.
Classification: Not likely carcinogenic to humans based on the lack of tumors in the mouse
and rat carcinogenicity studies and lack of mutagenicity.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and
used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human
exposures. NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF =
uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD =
population-adjusted dose (a = acute, c = chronic). RfD = reference dose.
1 Not harmonized with Canada and Australia
2 Harmonized with Canada and Australia.
B. Dietary Exposure and Risk
1. Dietary Exposure and Risk 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 assessments,
drinking water was incorporated into the dietary assessment. For the acute dietary risk
assessment, the 1-in-10-year peak ground water concentration generated by the Tier II
PRZM (Pesticide Root Zone Model)-GW (ground water) model (180 ppb) was used to
assess the contribution to drinking water. For the chronic dietary risk assessment,
drinking water was incorporated directly into the dietary assessment using the 1-in-10-
year annual mean ground water concentration generated by the Tier II PRZM
(Pesticide Root Zone Model)-GW (ground water) model (173 ppb).
3. Aggregate Exposure Risk Assessments: There are no uses of saflufenacil that are
expected to result in residential exposures. Therefore, the aggregate exposure
assessment takes into consideration dietary food + water exposure only. A cancer
aggregate-risk assessment was not performed because saflufenacil is not a carcinogen
and cancer risk is therefore not a concern.
4. Acute Aggregate Risk: The resulting acute dietary (food + water) risk estimates
were < 1% of the aPAD for the general U.S. population and <1% of the aPAD for the
most highly exposed population subgroup, all infants (<1 year old).
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5. Chronic Aggregate Risk: The chronic dietary risk assessment shows that for all
included commodities, the chronic dietary risk estimates are not of concern (i.e.,
<100% cPAD). For the U.S. population, the exposure for food and water utilized
8.8% of the cPAD. The chronic dietary risk estimate for the highest reported exposed
population subgroup, all infants (<1 year old), is 28% of the cPAD.
6. Cancer Aggregate Risk: Saflufenacil is classified as "not likely carcinogenic to
humans." Therefore, cancer risk is not a concern for this chemical.
Table 4. Summary of Dietary (Food and Drinking Water) Exposure Risk for Saflufenacil.
Population Subgroup
General U.S. Population
All Infants (<1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Youth 13-19 years old
Adults 20-49 years old
Adults 50+ years old
Females 13-49 years old
Acute Dietary
(95th Percentile)
Dietary Exposure
(mg/kg/day)
0.010051
0.036991
0.016375
0.014835
0.010181
0.008192
0.009009
0.008151
0.009122
%aPAD
<1
<1
<1
<1
<1
<1
<1
<1
<1
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.004043
0.012951
0.006895
0.006176
0.004141
0.003002
0.003672
0.003821
0.003659
% cPAD
8.8
28
15
13
9.0
6.5
8.0
8.3
8.0
*The values for the highest exposed population for each type of risk assessment are bolded.
7. Cumulative Risk: Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding as to Saflufenacil and any other substances, and
Saflufenacil does not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has not assumed that
Saflufenacil has a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found
to have a common mechanism on EPA's website at
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http://www.epa.gov/pesticides/cumulative/.
C. Handler and Worker Risk Assessments
1. Occupational Exposure/Risk to Mixer/Loader and Applicators: Saflufenacil
can be applied by aerial, chemigation, groundboom and rights-of-way equipment.
In addition, applications can be made via dry bulk fertilizer. Based upon the
proposed use pattern, EPA expects handler exposure and risk from open
mixing/loading liquids and dry flowables for aerial, chemigation, groundboom, and
rights-of-way applications; impregnating liquids onto dry bulk fertilizer in
commercial and on-farm settings; applying sprays via aerial, groundboom, and
rights-of-way applications; applying impregnated dry bulk fertilizer with
commercial equipment or with grower-owned equipment; and open
mixing/loading/applying via low-pressure handwand.
Handler exposure is expected to be short- or intermediate-term based on
information provided on product labels. In addition, the short- and intermediate-
term toxicological endpoints are the same; therefore, the estimates of risk for short-
term duration exposures are protective of those for intermediate-term duration
exposures. Long-term exposures are not expected; therefore, a long-term
assessment was not conducted.
No chemical-specific data were available to assess potential exposure to pesticide
handlers. The estimates of exposure to pesticide handlers are based upon surrogate
study data available in the Pesticide Handler's Exposure Database (PHED)
Surrogate Exposure Guide (August, 1998). The saflufenacil product labels direct
applicators and other handlers to wear: long-sleeve shirt, long pants, chemical-
resistant gloves, shoes plus socks and protective eyewear.. There are no data to
assess impregnating liquids onto dry bulk fertilizer in commercial settings. The
assumptions that the amount of saflufenacil handled per day in commercial settings
(500-960 tons) make it unlikely that open mixing/loading is used. Therefore, as a
reasonable surrogate for impregnation of dry bulk fertilizer in commercial settings,
unit exposure values from PHED for engineering controls (closed mixing/loading)
are used.
The Agency has determined that there are no risks of concern for occupational handlers
associated with the use of saflufenacil, provided workers wear protective gloves as
recommended on the label.
Table 5. Occupational Handler Dermal and Inhalation Exposures and Risks.
Exposure Scenario
Application
ratea
(Ib ai/acre)
Dermal and
Inhalation Unit Exposures
(mg/lb ai)
Area
Treated
Daily
(acres)b
Combined Doses
(mg/kg/day)c
Total MOEd
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Table 5. Occupational Handler Dermal and Inhalation Exposures and Risks.
Exposure Scenario
Application
ratea
(Ib ai/acre)
Dermal and
Inhalation Unit Exposures
(mg/lb ai)
Area
Treated
Daily
Combined Doses
(mg/kg/day)c
Total MOEd
Mixer/Loaders
Mixing/Loading
Liquids for Aerial
Applications
(PHED)
Mixing/Loading
Liquids for
Chemigation
Applications
(PHED)
Mixing/Loading
Liquids for
Groundboom
Applications
(PHED)
Mixing/Loading
Liquids to Support
Rights of Way
Mixing/Loading
Liquids for
Impregnation of
Dry Bulk
Fertilizers (PHED
eng control for
M/L liquids)
Mixing/Loading
Liquids for
Impregnation of
Dry Bulk
Fertilizers (PHED
eng control for
M/L liquids)
Mixing/Loading
Liquids for On-
farm Impregnation
of Dry Bulk
Fertilizers (PHED
M/L liquids)
0.111
0.35
0.35
1.341b
ai/ton
1.341b
ai/ton
0.134
Dermal
Baseline6: 2.9 (HC)1
Single layer w/glovesg:
0.023 (HC)
Inhalation
Baselinef: 0.0012(HC)
Engineering control:
0.0086
Inhalation
Engineering control:
0 000083
Engineering control:
0.0086
Inhalation
Engineering control:
0 000083
Baseline: 2.9 (HC)1
Inhalation
Baseline: 0.0012(HC)
350
200
80
960 tons
500 tons
160
Baseline Dermal +
Baseline Inhalation:
0 6200
Single layer w/gloves
dermal + Baseline
Inhalation: 0.013
Baseline Dermal +
Baseline Inhalation:
0.0570
Single layer w/gloves
dermal + Baseline
Inhalation: 0.0012
Baseline Dermal +
Baseline Inhalation:
0.100
Single layer w/gloves
dermal + Baseline
Inhalation: 0.0022
Baseline Dermal +
Baseline Inhalation:
0.041
Engineering control
dermal + inhalation:
0.0073
Engineering control
dermal + inhalation:
0.0038
Baseline Dermal +
Baseline Inhalation:
0.032
Baseline Dermal + Baseline
Inhalation: 8.1
Single layer w/gloves
dermal + Baseline
Inhalation' 380
Baseline Dermal + Baseline
Single layer w/gloves
dermal + Baseline
Inhalation: 4,200
Baseline Dermal + Baseline
Inhalation: 49
Single layer w/gloves
dermal + Baseline
Inhalation: 2,300
Baseline Dermal + Baseline
Engineering control dermal
+ inhalation: 680
Engineering control dermal
+ inhalation: 1,300
Baseline Dermal + Baseline
Inhalation: 160
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Table 5. Occupational Handler Dermal and Inhalation Exposures and Risks.
Exposure Scenario
Mixing/Loading
Liquids for On-
farm Impregnation
of Dry Bulk
Fertilizers (PHED
M/L liquids)
Mixing/Loading
Dry Flowables for
Aerial
Applications
(PHED)
Mixing/Loading
Dry Flowables for
Groundboom
Applications
(PHED)
Application
ratea
(Ib ai/acre)
0.134
0.022
0.044
Dermal and
Inhalation Unit Exposures
(mg/lb ai)
Dermal
Baseline: 2.9 (HC)1
Inhalation
Baseline: 0.0012(HC)
Dermal
Baseline: 2.9 (HC)1
Inhalation
Baseline: 0.0012(HC)
Dermal
Baseline: 2.9 (HC)1
Inhalation
Baseline: 0.0012(HC)
Area
Treated
Daily
(acres)b
80
1,200
80
Combined Doses
(mg/kg/day)c
Baseline Dermal +
Baseline Inhalation:
0.016
Baseline Dermal +
Baseline Inhalation:
0.0012
Baseline Dermal +
Baseline Inhalation:
0.0002
Total MOEd
Baseline Dermal + Baseline
Inhalation: 320
Baseline Dermal + Baseline
Inhalation: 4,100
Baseline Dermal + Baseline
Inhalation: 31,000
Applicators
Applying Sprays
via Aerial
Equipment
(PHED)
Applying Sprays
via Groundboom
Equipment
(PHED)
Applying Sprays
via Rights of Way
Equipment
(PHED)
Commercial
Application of Dry
Bulk Fertilizers
(PHED tractor-
drawn granular
spreader data)
On-farm
Applications of
Dry Bulk
Fertilizers (PHED
tractor-drawn
granular spreader
data)
0.35
0.35
0.35
0.134
0.134
Dermal
Eng control11: 0.005 (MC)
Inhalation
Eng control11: 0.000068
(MC)
Dermal
Baseline: 0.014 (HC)
Inhalation
Baseline: 0.00074 (HC)
Dermal
Baseline: 1.3(LC)
Inhalation
Baseline: 0.0039 (HC)
Dermal
Baseline: 0.0099 (LC)
Inhalation
Baseline: 0.0012 (LC)
Dermal
Baseline: 0.0099 (LC)
Inhalation
Baseline: 0.0012 (LC)
1,200
200
80
320
160
160
80
Eng control Dermal +
Inhalation: 0.0015
Baseline Dermal +
Baseline Inhalation:
0.0014
Baseline Dermal +
Baseline Inhalation:
0.02
Baseline Dermal +
Baseline Inhalation:
0.0011
Baseline Dermal +
Baseline Inhalation:
0.0005
Baseline Dermal +
Baseline Inhalation:
0.0005
Baseline Dermal +
Baseline Inhalation:
0.0003
Eng control Dermal +
Inhalation: 3,300
Baseline Dermal + Baseline
Inhalation: 3,700
Baseline Dermal + Baseline
Inhalation: 250
Baseline Dermal + Baseline
Inhalation: 4,700
Baseline Dermal + Baseline
Inhalation: 9,300
Baseline Dermal + Baseline
Inhalation: 9,300
Baseline Dermal + Baseline
Inhalation: 19,000
Flaggers
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Table 5. Occupational Handler Dermal and Inhalation Exposures and Risks.
Exposure Scenario
Flagging for Aerial
Sprays
Applications
(PHED)
Application
ratea
(Ib ai/acre)
0.35
Dermal and
Inhalation Unit Exposures
(mg/lb ai)
Dermal
Baseline: 0.01 1 (HC)
Inhalation
Baseline: 0.00035 (HC)
Area
Treated
Daily
(acres)b
350
Combined Doses
(mg/kg/day)c
Baseline Dermal +
Baseline Inhalation:
0.0014
Total MOEd
Baseline Dermal + Baseline
Inhalation: 3,600
Mixer/Loader/Applicators
Mixing/Loading/
Applying Liquids
with Low Pressure
Handwand
(PHED)
0.35
Dermal
Baseline: 100 (LC)
Inhalation
Baseline: 0.03 (MC)
2
Baseline Dermal +
Baseline Inhalation:
0.0350
Baseline Dermal + Baseline
Inhalation: 140
a. Application rates based on proposed uses on labels for saflufenacil. Units = Ib ai/acre unless noted otherwise.
b. ExpoSAC Policy #9.1.
c. Combined Dose (mg/kg/day) = Dermal + Inhalation doses. Dose = daily unit exposure (mg/lb ai) x application rate (Ib ai/acre) x acres treated x
absorption factor (dermal: 3%; inhalation: 100%) / body weight (60-kg adult female).
d. Total MOE = NOAEL (5 mg/kg/day) / Combined Dose (mg/kg/day).
e. Baseline Dermal: long-sleeve shirt, long pants, and no gloves.
f Baseline Inhalation: no respirator.
g. Single layer w/ gloves: Baseline plus chemical-resistant gloves.
h. Engineering control for applying sprays via aerial equipment: enclosed cockpit.
i. Data confidence: HC = high confidence; MC = medium confidence; LC = low confidence
2. Postapplication Handler Risk Assessment: Most of the proposed uses for saflufenacil are
soil-directed preplant or preemergent uses where no crop foliage is present. The proposed labels
indicate that crop injury will result if the products are applied postemergent (over the top) to any
crop. Currently, HED has no transfer coefficients or other data to assess postapplication dermal
exposures to soil by occupational workers. In general, such exposures are considered to be
negligible. Therefore, for the proposed soil-directed uses, postapplication dermal exposures and
risks to occupational workers were not assessed. For the use on sunflowers as a dessicant,
postapplication exposure is expected to be minimal since harvesting of sunflowers is typically
done by machine.
The proposed labels have 12- and 24-hour REIs. The technical material has a Toxicity Category
III for acute oral, acute dermal, and acute eye irritation. It has a Toxicity Category IV for acute
inhalation and acute dermal irritation. Per the Worker Protection Standard (WPS), a 12-hour
REI is required for chemicals classified under Toxicity Categories III and IV. Technical-grade
Imazethapyr and Dimethenamid, which are used in conjunction with saflufenacil in the Optill™
and Integrity™ formulations, respectively, also have REFs of 12 hours Therefore, an REI of 12
hours is in compliance with the WPS for all products..
3. Residential Exposure: Currently there are no proposed residential uses for saflufenacil.
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V. ENVIRONMENTAL RISK ASSESSMENT
A. Environmental Fate Characterization: Saflufenacil is nonvolatile, hydrophilic,
and mobile to highly mobile in soil. The solubility of the compound is pH-
dependent; at environmentally relevant pH values, saflufenacil is expected to be
ionic. The compound dissipates in the environment through both abiotic and biotic
degradation and by leaching. It is not expected to persist in aerobic soils (half-life 1 -
5 weeks) or alkaline water bodies (half-life < 1 week), but may be moderately
persistent in acidic to neutral water bodies (half-life 4-10 weeks). Terrestrial field
dissipation study results are relatively consistent with those of the laboratory studies,
showing that the chemical dissipates by degradation and leaching, with dissipation
half-lives ranging from 1 to 36 days.
B. Ecological Effects Characterization: Saflufenacil is classified as practically non-
toxic to fish and freshwater invertebrates, and moderately toxic to estuarine/marine
invertebrates on an acute exposure basis. No sublethal effects were observed in any
of the acute aquatic animals studies for saflufenacil. Available acute toxicity data for
the BAS 781 02H formulation ("Integrity" herbicide), which is a co-formulation with
dimethenamid-p, show that it is 3 - 7 times more toxic than saflufenacil technical to
freshwater fish, invertebrates, and aquatic vascular and non-vascular plants.
Available data indicate that this increase in toxicity is due to the dimethenamid-p.
Chronic exposure to saflufenacil resulted in a 5% reduction in embryo survival in fish
and decreased parental survival (30% reduction) and growth (5% reduction) of
invertebrates. Sediment toxicity testing indicates that the compound does not
partition to sediment, but remains associated with the water column. Exposure of
benthic invertebrates resulted in a 17% reduction in emergence rate. All available
aquatic toxicity data show that the M07 and M08 degradates are less toxic to aquatic
animals and plants than parent saflufenacil.
Saflufenacil is practically non-toxic to avian species on an acute oral and subacute
dietary basis. The lowest NOAEC in an avian reproduction study (96 mg a.i./kg diet)
was based on a reduction in bobwhite quail hatchling body weight. Saflufenacil is
also practically non-toxic to mammals on an acute oral basis. A two-generation
reproduction study in rats resulted in a NOAEL of 15 mg a.i./kg-bw/day based on
increased pup mortality, reduced weight gain, and anemia. No sublethal effects were
observed in any of the acute terrestrial animal studies; however it is important to note
that sublethal effects, including anemia and hematologic effects, which are consistent
with the light-dependent peroxidizing herbicide (LDPH)mode of action, were
observed in the chronic mammalian study. Saflufenacil is classified as practically
non-toxic to non-target terrestrial insects.
Results of Tier II terrestrial plant studies indicate that dicot plant species are more
sensitive to saflufenacil than monocots, but both do exhibit adverse effects when
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treated with saflufenacil formulations.
C. Exposure Modeling: For the aquatic assessment, estimated environmental
concentrations (EECs) in surface water were calculated using the Tier II
PRZM/EXAMS models and employing maximum proposed application rates for
saflufenacil usage on non-crop areas. This was the only use pattern modeled, as it
resulted in the highest estimated aquatic exposure of all proposed uses, and the
resulting risk estimates were low, precluding the need for further modeling. The
California rights-of-way scenario was used to model the non-agricultural use pattern
because, based on a comparison of results, it was the most vulnerable of the nine
available non-agricultural PRZM/EXAMS scenarios.
For the terrestrial animal assessment, the T-REX model was used to calculate dietary
and dose-based EECs of saflufenacil residues on food items via broadcast spray
applications for mammals and birds. The model simulates a 1-year time period for
exposure to birds and mammals, using different feeding strategies and size
classes.The non-agricultural areas maximum single-application rate (0.356 Ib a.i./A)
was used.
Exposure to terrestrial plants was estimated using the TerrPlant model, which
estimates exposure to plants in areas near the application area. Exposure calculations
are based on the amount of pesticide present in soil as a function of drift, and loading
via drift to dry, non-target adjacent areas is assumed to occur from one acre of
treatment to one acre of the non-target area. Spray drift is also considered as a source
of loading to non-target areas.
D. Potential Risks to Non-Target Plants: LOCs were not exceeded for listed or non-
listed aquatic plants. LOCs were exceeded for non-listed (dicot RQ = 1.52 to 40.9,
depending on formulation; monocot 1.93 to 25.4, depending on formulation) and
listed terrestrial plants (dicot RQ = 6.60 to 178, depending on formulation; monocot
73.3 to 1978, depending on formulation) in dry areas. LOCs were exceeded for non-
listed (dicot RQ = 12.9 to 225, depending on formulation; monocot RQ = 8.01 to 140,
depending on formulation) and listed (dicot RQ = 56.1 to 979 depending on
formulation; monocot RQ = 623 to 10,878, depending on formulation) terrestrial
plants in semi-aquatic areas. Terrestrial plants are also at risk from drift (non-listed
dicot RQ = 2.20 to 178, depending on formulation; non-listed monocot RQ 1.61 to
12.7, depending on formulation; listed dicot RQ = 3.33 to 270, depending on
formulation; listed monocot RQ 12.2 to 989 depending on formulation). Mitigative
language on the label reduces these risks.
The Agency's strategy to mitigate these risks involves 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
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responsibilities and offers specific techniques to reduce the possibility of spray drift.
Buffer zones are also required, and are dependent upon application method and rate.
In addition, the use of vegetative buffer strips is required in the surface water
advisory language, which may further reduce possible exposure to non-target plants.
D. Potential Risks to Non-Target Animals: No acute LOCs were exceeded for
terrestrial or aquatic animals. Chronic LOCs were exceeded for certain categories of
non-listed and listed mammals for the non-agricultural use scenario, which uses the
highest application rate (0.356 Ib a.i./A) (RQs that exceed the LOG range from 1.13
to 2.47). The LOG exceedances were based on a reproductive NOAEL of 15 mg
a.i./kg-bw/day; increased stillborn pups, increased pup mortality, reduced pup weight,
and anemia were observed at the next highest treatment level. Chronic RQs
associated with application rates < 0.143 Ib a.i./A are below the LOG. Because there
are direct effects to plants, any listed species depending on these taxa may experience
indirect effects. Mitigating the risks to non-target animals involves label language
that is intended to keep the pesticide on the intended treatment area (see Potential
Risk to Non-Target Plants). The maximum allowable application rate (0.356) for
non-crop areas was lowered to 0.143 Ib ai/A for most use sites, and the maximum rate
is now only for selective stem applications to wilding pine. This greatly reduces the
exposure of nontarget mammals and plants, and brings the chronic RQs for mammals
below the LOG for most non-crop uses.
VI. PROPOSED REGULATORY DECISION
A. Conditional Registration: A conditional registration is recommended for
saflufenacil.
1. Conditional Data (Confirmatory)
• Fish early-life stage toxicity for LDPH chemicals; BASF is a member of the
LDPH task force which is currently developing a protocol for this study, which
will evaluate the potential effect of UV light on the toxicity of surrogate LDPH
chemicals. Based on the results of this study, an appropriate toxicity adjustment
factor will be derived and applied to risk assessments for LDPH chemicals. For
the saflufenacil risk assessment, an adjustment factor of 29X was applied, based
on data from a study on the LDPH oxyfluorfen. The resulting risk estimates were
below the Agency's Level of Concern.
• Submission of an analytical reference standard for saflufenacil and its
metabolites M800H11 and M800H35 to the National Pesticide Standards
Repository [Note: This has been completed].
• 850.3020: Honeybee acute contact study using the BAS 781 02H formulation
-22-
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("Integrity" herbicide). [Note: This study has been submitted to the Agency and
is currently under review (MRID #477962-01).]
• 860.1500: (Crop field trial on sunflower conducted with the SC formulation as
bridging data for earlier field trials conducted with WG formulation.
2. Data Requirements for Future New Uses
• 850.2100: Avian acute oral toxicity using a passerine species. This is a new
requirement under 40 CFR Part 158. Due to the low avian risk assessed for
the currently proposed uses, this study is not required as a condition of this
registration, but will be required for future uses of saflufenacil. A protocol for
conducting the study should be approved by the Agency prior to study
initiation.
• 870.7800: Immunotoxicity study. This is a new requirement under 40 CFR Part
158.
3. Public Interest Finding: A conditional registration under FIFRA Section
3(c)(7)(C) may be granted only 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 pesticide is in the public interest.
B. TOLERANCES
1. Tolerance Levels: The proposed uses and the submitted data support the
following permanent tolerances for the combined residues of saflufenacil,
including its metabolites and degradates, in or on the commodities in the table
below:
Table 6. Tolerance Summary for Saflufenacil.
Commodity
Vegetable, legume,
group 06
Vegetable, foliage of
legume, group 07
Fruit, citrus, group 10
Fruit, pome, group 1 1
Fruit, stone, group 12
Nut, tree, group 14
Pistachio
Almond, hulls
Proposed
Tolerance
(ppm)
0.03
0.1
0.03
0.03
0.03
0.03
-
0.2
Recommended
Tolerance (ppm)
0.03
0.10
0.03
0.03
0.03
0.03
0.03
0.10
Correct Commodity
Definition/Comments
Vegetable, legume, group 6
Vegetable, foliage of legume,
group 7
Translated from tree nuts
-23-
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Table 6. Tolerance Summary for Saflufenacil.
Commodity
Grain, cereal, group 15
Grain, cereal, forage,
fodder and straw group
16
Sorghum stover
Cotton, undelinted seed
Cotton, gin byproducts
Sunflower, seed
Grape
Animal - Kidney
Animal - Liver
Milk
Cattle, meat
Cattle, fat
Cattle, liver
Cattle, meat byproducts,
except liver
Goat, meat
Goat, fat
Goat, liver
Goat, meat byproducts,
except liver
Hog, meat
Hog, fat
Hog, liver
Hog, meat byproducts,
except liver
Sheep, meat
Sheep, fat
Sheep, liver
Sheep, meat byproducts,
except liver
Horse, meat
Horse, fat
Horse, liver
Horse, meat byproducts,
Proposed
Tolerance
(ppm)
0.03
0.1
0.1
0.03
0.03
0.7
0.03
0.02
0.8
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Recommended
Tolerance (ppm)
0.03
0.10
-
0.03
0.10
1.0
0.03
-
-
0.01
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
0.01
0.01
0.80
0.02
Correct Commodity
Definition/Comments
Included in crop group 16
Individual tolerances required
for each species
-24-
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Table 6. Tolerance Summary for Saflufenacil.
Commodity
except liver
Proposed
Tolerance
(ppm)
Recommended
Tolerance (ppm)
Correct Commodity
Definition/Comments
2. International MRLs: There are no Codex, Canadian, or Mexican
maximum residue limits (MRLs) established for residues of saflufenacil in crops or
livestock commodities. The residue definition and proposed tolerances were
harmonized with Canada and Australia.
C. REQUIRED LABEL STATEMENTS: End use products containing saflufenacil as
an active ingredient will be required to have the following protective language on the
product labeling:
1. Environmental Hazards:
a. Ground Water Advisory: "This chemical has properties and characteristics
associated with chemicals detected in ground water. This chemical may
leach into ground water if used in areas where soils are permeable,
particularly where the water table is shallow."
b. Surface Water Advisory: "This product may impact surface water due to
runoff of rain water. This is especially true for poorly draining soils and
soils with shallow ground water. This product is classified as having high
potential for reaching surface water via runoff for several weeks after
application. 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 loading of this chemical from
runoff water and sediment. Runoff of this product will be reduced by
avoiding applications when rainfall is forecast to occur within 48 hours."
D. Contact Person at EPA
Jim Tompkins
Product Manager 25
Herbicide Branch
Registration Division (7505P)
Office of Pesticide Programs
Environmental Protection Agency
Aerial Rios Building
1200 Pensylvania Ave., NW
Washington, DC 20460
-25-
-------
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.
-26-
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VII. BIBLIOGRAPHY
61-1 Chemical Identity
MRID Citation Reference
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
61-2 Description of Beginning Materials and Manufacturing Proces
MRID Citation Reference
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
62-1 Preliminary Analysis
MRID Citation Reference
47127803 Genari, G. (2007) Preliminary Analysis of Five Batches BAS 800 H TGAI.
Project Number: 2007/1022325, 132476/1. Unpublished study prepared by
BASF Aktiengesellschaft. 40 p.
47127804 Dotzer, R. (2007) Identification of Active Substance BAS 800 H (Reg. No.
4054449) and Minor Components in Technical-Grade Material. Project
Number: 2007/1057829. Unpublished study prepared by BASF
Aktiengesellschaft. 24 p.
62-2 Certification of limits
MRID Citation Reference
47127806 Brunt, S.; Genari, G. (2007) BAS 800 H Technical Grade Active Ingredient:
Composition and Certified Limits. Project Number: 2007/7013642. Unpublished
study prepared by BASF Corporation and BASF Aktiengesellschaft. 27 p.
62-3 Analytical Method
MRID Citation Reference
-27-
-------
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
47127807 Distler, 1; Genari, G. (2005) Analytical Method APL0498/01: Determination of
BAS 800 H Technical Grade Active Ingredient TGAI by HPLC. Project
Number: 2005/1018447, APL0498/01. Unpublished study prepared by BASF
Aktiengesellschaft. 15 p.
47127808 Genari, G. (2005) Validation of Analytical Method APL0498/01: Determination
of BAS 800 H Technical Grade Active Ingredient TGAI by HPLC. Project
Number: 132491/2, 2005/1018448. Unpublished study prepared by BASF
Aktiengesellschaft. 16 p.
47127809 Rieger, V. (2007) Analytical Method APL0525/01: Determination of Impurities
in BAS 800 H Technical Grade Active Ingredient TGAI. Project Number:
2006/1027567, APL0525/01. Unpublished study prepared by BASF
Aktiengesellschaft. 35 p.
47127810 Genari, G. (2007) Validation of Analytical Method APL0525/01: Determination
of Impurities in BAS 800 H Technical Grade Active Ingredient TGAI. Project
Number: 2006/1027568, 132491/3. Unpublished study prepared by BASF
Aktiengesellschaft. 46 p.
47128402 Walker, A. (2007) Analytical Method AFL0747/01: Determination of BAS 800
H in BAS 800 04 H. Project Number: AFL0747/01, 2007/1035627. Unpublished
study prepared by Battelle UK Ltd. 16 p.
47128403 Walker, A. (2007) Validation of Analytical Method AFL 0747/01 for the
Determination of BAS 800 H in BAS 800 04 H. Project Number: MX070191,
2007/1035712. Unpublished study prepared by Battelle UK Ltd. 29 p.
47128602 Polowy, K. (2007) GLP Validation of Analytical Method AFR0067/01 and
Certification of BAS 804 00 H: Formulation Lot Number 1641-22: Final Report.
Project Number: 2007/7012430, F200711. Unpublished study prepared by
BASF Agro Research. 61 p.
63-2 Color
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
-28-
-------
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-3 Physical State
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-4 Odor
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-7 Density
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47127821 Kroehl, T. (2005) BAS 800 H - Reg. No. 4054449: Physical Properties of the
Pure Active Ingredient. Project Number: 132464/1, 2005/1026464. Unpublished
-29-
-------
study prepared by BASF Aktiengesellschaft. 15 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-9 Vapor Pressure
MRID
Citation Reference
47127821 Kroehl, T. (2005) BAS 800 H - Reg. No. 4054449: Physical Properties of the
Pure Active Ingredient. Project Number: 132464/1, 2005/1026464. Unpublished
study prepared by BASF Aktiengesellschaft. 15 p.
47127822 Paulick, R. (2007) Determination of the Henry's Law Constant for BAS 800 H at
25 Degrees Celsius. Project Number: 2007/7013512. Unpublished study
prepared by BASF Corporation. 8 p.
63-12 pH
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-14 Oxidizing/Reducting Action
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
-30-
-------
63-15 Flammability
MRID Citation Reference
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
63-16 Explodability
MRID Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
63-18 Viscosity
MRID Citation Reference
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
71-1 Avian Single Dose Oral Toxicity
MRID Citation Reference
47127911 Zok, S. (2006) BAS 800 H - Acute Toxicity in the Bobwhite Quail (Colinus
virginianus) After Single Oral Administration (LD50). Project Number:
11W0414/015141, 2005/1029868. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 52 p.
47127912 Zok, S. (2006) BAS 800 H - Acute Toxicity in the Mallard Duck (Anas
platyrhynchos) After Single Oral Administration. Project Number:
13W0414/015145, 2005/102866. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 54 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
-31 -
-------
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
71-2 Avian Dietary Toxicity
MRID
Citation Reference
47127913
47127914
47127929
Zok, R. (2006) BAS 800 H - Avian Dietary LC50 Test in Chicks of the
Bobwhite Quail (Colinus virginianus). Project Number: 31W0414/015139,
2005/1029867. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 45 p.
Zok, R. (2006) BAS 800 H - Avian Dietary LC50 Test in Chicks of the Mallard
Duck (Anas platyrhynchos). Project Number: 32W0414/015140, 2005/1029869.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 42 p.
Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
71-4 Avian Reproduction
MRID
Citation Reference
47127915 Zok, R. (2006) BAS 800 H - 1-Generation Reproduction Study on the Bobwhite
Quail (Colinus virginianus) by Administration in the Diet. Project Number:
71W0414/015148, 2006/1035447. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 349 p.
47127916 Zok, R. (2006) BAS 800 H - 1-Generation Reproduction Study on the Mallard
Duck (Anas platyrhynchus) by Administration in the Diet. Project Number:
72W0414/015149, 2006/1035448. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 343 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
72-1 Acute Toxicity to Freshwater Fish
MRID
Citation Reference
-32-
-------
47127904 Jatzek, R. (2005) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus
mykiss) in a Static System over 96 hours. Project Number: 12F0414/015146,
2005/1029784. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 40 p.
47127905 Jatzek, R. (2005) BAS 800 H: Acute Toxicity Study on the Bluegill Sunfish
(Lepomis macrochirus) in a Static System Over 96 Hours. Project Number:
14F0414/015147, 2005/1029929. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 39 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
72-2 Acute Toxicity to Freshwater Invertebrates
MRID Citation Reference
47127901 Bergtold, M.; Janson, G. (2006) Acute Toxicity of BAS 800 H to Daphnia
magna Straus in a 48 Hour Static Test: Final Report. Project Number: 132860,
2006/1004506. Unpublished study prepared by BASF Aktiengesellschaft. 20 p.
72-3 Acute Toxicity to Estuarine/Marine Organisms
MRID Citation Reference
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study
MRID Citation Reference
47127907 Weltje, L.; Bergtold, M. (2007) Chronic Toxicity of BAS 800 H to Daphnia
magna Straus in a 21-Day Semi-Static Test (Including Amendment No. 1).
Project Number: 132863, 2007/7013579. Unpublished study prepared by BASF
Ag Research Station. 33 p.
47127908 Zok, S. (2007) BAS 800 H - Early Life-Stage Test on the Fathead Minnow
(Pimephales promelas) in a Flow Through System (Including Amendment
No.l). Project Number: 51F0414/015150, 2007/7002034. Unpublished study
-33-
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prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 107 p.
47127929 Holmes, C.; Jackson, S. (2008) HAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
81-1 Acute oral toxicity in rats
MRID
Citation Reference
47128101 Leibold, E.; Gamer, A. (2005) HAS 800 H - Acute Oral Toxicity Study in Rats.
Project Number: 10A0414/011124, 2005/1014960, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
47128208 Gamer, A.; Landsiedel, R. (2007) BAS 800 01 H - Acute Oral Toxicity Study in
Rats. Project Number: 10A0320/061117, 2007/1020183. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology.
23 p.
47128306 Rokh, N. (2007) BAS 800 02 H - Acute Oral Toxicity Study in Rats: "Acute
Toxic Class Method". Project Number: 10A0812/059038, 2007/1035031.
Unpublished study prepared by Centre International de Toxicologie. 40 p.
47128406 Wolf, T. (2007) BAS 800 04 H: Acute Oral Toxicity Study with Rats (Acute
Toxic Class Method). Project Number: 10AO175/069086, BAS21,
2007/1044694. Unpublished study prepared by Austrian Research Center
(ARC). 37 p.
47128506 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Acute Oral Toxicity Study in
Rats. Project Number: 10A0520/071058, 2007/1053309. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
47128606 Wolf, T. (2007) BAS 804 00 H - Acute Oral Toxicity Study with Rats (Acute
Toxic Class Method). Project Number: BAS 17, 10AO174/069081. Unpublished
study prepared by Austrian Research Center (ARC). 38 p.
81-2 Acute dermal toxicity in rabbits or rats
MRID Citation Reference
47128102 Gamer, A.; Leibold, E. (2005) BAS 800 H - Acute Dermal Toxicity Study in
Rats. Project Number: 11A0414/011125, 2005/1014961, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 24 p.
47128108 Kaspers, U.; Strauss, V.; Kaufmann, W. et al. (2007) BAS 800 H - Range
Finding Study in Wistar Rats Administration in the Diet 4 Weeks. Project
-34-
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Number: 30S0414/01147, 2007/1028946, RTP/NC/27709. Unpublished study
prepared by BASF Aktiengesellschaft. 367 p.
47128209 Gamer, A.; Landsiedel, R. (2007) BAS 800 01 H - Acute Dermal Toxicity Study
in Rats. Project Number: 11A0320/061126, 2007/1020184. Unpublished study
prepared by BASF Corporation. 28 p.
47128307 Rokh, N. (2007) BAS 800 02 H - Acute Dermal Toxicity in Rats. Project
Number: 11A0812/059039, 2007/1035032. Unpublished study prepared by
Centre International de Toxicologie. 32 p.
47128407 Wolf, T. (2007) BAS 800 04 H: Acute Dermal Toxicity Study with Rats. Project
Number: 11A0175/069087, BAS22, 2007/1044695. Unpublished study prepared
by Austrian Research Center (ARC). 28 p.
47128507 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Acute Dermal Toxicity Study
in Rats. Project Number: 11A0520/071059, 2007/1053310. Unpublished study
prepared by BASF Aktiengesellschaft. 27 p.
47128607 Wolf, T. (2007) BAS 804 00 H - Acute Dermal Toxicity Study with Rats.
Project Number: BASIS, 11AO174/069080, 2007/1044693. Unpublished study
prepared by Austrian Research Center (ARC). 28 p.
81-3 Acute inhalation toxicity in rats
MRID
Citation Reference
47128103 Ma-Hock, L.; Leibold, E. (2005) BAS 800 H - Acute Inhalation Toxicity Study
in WistarRats. Project Number: 1310414/017021, 2005/1016432,
RTP/NC/27709. Unpublished study prepared by BASF Aktiengesellschaft. 23 p.
47128210 Hock, L.; Landsiedel, R. (2007) BAS 800 01 H -Acute Inhalation Toxicity
Study in Wistar Rats 4-hour Dust Exposure. Project Number: 1310320/067021,
2007/1039534. Unpublished study prepared by BASF Aktiengesellschaft,
Experimental Toxicology and Ecology. 33 p.
47128308 Ma-Hock, L.; Landsiedel, R. (2007) BAS 800 02 H - Acute Inhalation Toxicity
Study in Wistar Rats: 4-Hour Liquid Aerosol Exposure. Project Number:
1310812/057024, 2007/1016466. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 73 p.
47128408 Ma-Hock, L.; Landsiedel, R. (2007) BAS 800 04 H: Acute Inhalation Toxicity
Study in Wistar Rats: 4-Hour Liquid Aerosol Exposure. Project Number:
1310175/067017, 2007/1057667. Unpublished study prepared by BASF
Aktiengesellschaft, Experimental Toxicology and Ecology. 40 p.
47128508 Ma-Hock, L.; Landsiedel, R. (2007) BAS 781 02 H: Acute Inhalation Toxicity
Study in Wistar Rats: 4-hour Liquid Aerosol Dust Exposure. Project Number:
-35-
-------
1310520/077006, 2007/1057668. Unpublished study prepared by BASF
Aktiengesellschaft. 50 p.
47128608 Muller, P. (2007) BAS 804 00 H: 4-hour Acute Inhalation Toxicity Study in
Rats. Project Number: 1310174/069090, B55978, 2007/1053326. Unpublished
study prepared by RCC Ltd. 28 p.
81-4 Primary eye irritation in rabbits
MRID
Citation Reference
47128104 Remmele, M.; Leibold, E. (2005) BAS 800 H - Acute Eye Irritation in Rabbits.
Project Number: 11H0414/102297, 2005/1005765, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 22 p.
47128105 Remmele, M.; Landsiedel, R. (2007) BAS 800 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0414/012309, 2007/1011575, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 25 p.
47128211 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0320/062236, 2007/1020186. Unpublished study
prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 23 p.
47128309 Remmele, M.; Landsiedel, R. (2007) BAS 800 02 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0812/052187, 2005/1029892. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology
23 p.
47128409 Remmele, M.; Landsiedel, R. (2007) BAS 800 04 H: Acute Eye Irritation in
Rabbits. Project Number: 11HO175/062291, 2007/1053323. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology.
23 p.
47128509 Remmele, M.; Landsiedel, R. (2007) BAS 781 02 H: Acute Eye Irritation in
Rabbits. Project Number: 11H0520/072105, 2007/1050806. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
47128609 Remmele, M.; Landsiedel, R. (2007) BAS 804 00 H: Acute Eye Irritation in
Rabbits. Project Number: 11HO174/062285, 2007/1052012. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
81-5 Primary dermal irritation
MRID
Citation Reference
47128106 Remmele, M.; Leibold, E. (2005) BAS 800 H - Acute Dermal Irritation /
Corrosion in Rabbits. Project Number: 18H0414/102293, 2005/1005766,
-36-
-------
RTP/NC/27709. Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
47128212 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18H0320/062235,
2007/1020185. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 21 p.
47128310 Rokh, N. (2007) BAS 800 02 H - Acute Dermal Irritation in Rabbits. Project
Number: 18H0812/059040, 2007/1035033. Unpublished study prepared by
BASF Aktiengesellschaft, Toxicology and Ecology. 31 p.
47128410 Remmele, M.; Landsiedel, R. (2007) BAS 800 04 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18HO175/062290,
2007/1053325. Unpublished study prepared by BASF Aktiengesellschaft,
Experimental Toxicology and Ecology. 21 p.
47128510 Remmele, M.; Landsiedel, R. (2007) BAS 781 02 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 2007/1057258,
18H0520/072139. Unpublished study prepared by BASF Aktiengesellschaft. 21
P-
47128610 Remmele, M.; Landsiedel, R. (2007) BAS 804 00 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18HO174/062284,
2007/1052011. Unpublished study prepared by BASF Aktiengesellschaft. 22 p.
81-6 Dermal sensitization
MRID
Citation Reference
47128107 Gamer, A.; Leibold, E. (2005) BAS 800 - Maximization Test in Guinea Pigs.
Project Number: 30H0414/012302, 2005/1014962, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 37 p.
47128213 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 33H0320/062237, 2007/1020187.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 33 p.
47128311 Rokh, N. (2007) BAS 800 02 H - Skin Sensitization Test in Guinea Pigs
(Modified Buehler Test: 9 Inductions). Project Number: 33H0812/059041,
2007/1035034. Unpublished study prepared by Centre International de
Toxicologie. 40 p.
47128411 Gamer, A.; Landsiedel, R. (2007) BAS 800 04 H: Modified BUEHLER Test (9
Inductions) in Guinea Pigs. Project Number: 33H0175/062292, 2007/1053322.
Unpublished study prepared by BASF Aktiengesellschaft, Experimental
Toxicology and Ecology. 32 p.
-37-
-------
47128511 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 2007/1057259, 33H0520/072140.
Unpublished study prepared by BASF Aktiengesellschaft. 32 p.
47128611 Gamer, A.; Landsiedel, R. (2007) BAS 804 00 H: Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 33HO174/062286, 2007/1052013.
Unpublished study prepared by BASF Aktiengesellschaft. 33 p.
81-8 Acute neurotoxicity screen study in rats
MRID Citation Reference
47128127 Kaspers, U.; Kaufmann, W.; Van Ravenzwaay, B. (2007) BAS 800 H - Acute
Oral Neurotoxicity in Wistar Rats: Administration Via Gavage (Including
Amendment No. 1). Project Number: 61S0414/01208, 2007/7009438.
Unpublished study prepared by BASF Aktiengesellschaft. 391 p.
47128128 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Repeated
Dose 90-day Oral Neurotoxicity Study in Wistar Rats: Administration in the
Diet. Project Number: 63S0414/01198, 2006/1024382. Unpublished study
prepared by BASF Aktiengesellschaft. 510 p.
82-1 Subchronic Oral Toxicity: 90-Day Study
MRID Citation Reference
47128109 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 - Repeated Dose
90-Day Oral Toxicity in Wistar Rats - Administration in the Diet. Project
Number: 2005/1012914, RTP/NC/27709. Unpublished study prepared by BASF
Aktiengesellschaft. 390 p.
47128111 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Repeated
Dose 90-day Oral Toxicity Study in C57BL/6NCrl Mice Administration in the
Diet. Project Number: 51S0414/01161, 2005/1015755, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 297 p.
82-2 21-day dermal-rabbit/rat
MRID Citation Reference
47128110 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Range
Finding Study in C57BL/6NCrL Mice - Administration in the Diet for 4 Weeks.
Project Number: 31S0414/01148, 2005/1011556, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 231 p.
-38-
-------
47128114 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2006) Repeat Dose 28-days
Dermal Toxicity Study in Wistar Rats. Project Number: 33S0414/01193,
2006/1022422, RTP/NC/27709. Unpublished study prepared by BASF Ag
Research Station. Slip.
83-1 Chronic Toxicity
MRID Citation Reference
47128118 Hempel, K.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Chronic Oral
Toxicity in Beagle Dogs: Administration Via Gelatin Capsules for 12 Months.
Project Number: 43D0414/01196, 2007/1032051. Unpublished study prepared
by BASF Aktiengesellschaft. 523 p.
83-2 Oncogenicity
MRID Citation Reference
47128119 Kamp, H.; Strauss, V.; Kuttler, K.; et al. (2007) BAS 800 H - Carcinogenicity
Study in C57BL/6NCrl Mice: Administration Via the Diet Over 18 Months.
Project Number: 87C0414/01177, 2007/1005067. Unpublished study prepared
by BASF Aktiengesellschaft. 2172 p.
83-3 Teratogenicity ~ 2 Species
MRID Citation Reference
47128115 Schneider, S.; Strauss, V.; Fabian, E.; et al. (2007) BAS 800 H - Prenatal
Developmental Toxicity Study in Wistar Rats Oral Administration (Gavage) .
Project Number: 30R0414/01178, 2007/1008481, RTP/NC/27709. Unpublished
study prepared by BASF Ag Research Station. 380 p.
47128116 Schneider, S.; Deckardt, K.; Hellwig, J.; et al. (2006) BAS 800 H - Prenatal
Developmental Toxicity Study in Himalayan Rabbits Oral Administration
(Gavage). Project Number: 40R0414/01173, 2005/1029151, RTP/NC/27709.
Unpublished study prepared by BASF Ag Research Station. 319 p.
83-4 2-generation repro.-rat
MRID Citation Reference
47128117 Schneider, S.; Strauss, V.; Kuettler, K.; et al. (2007) BAS 800 H - Two-
-39-
-------
Generation Reproduction Toxicity Study in Wistar Rats Administration via the
Diet. Project Number: 70R0414/01200, 2007/1043413, RTP/NC/27709.
Unpublished study prepared by BASF Ag Research Station. 1214 p.
84-2 Interaction with Gonadal DNA
MRID
Citation Reference
47128121 Engelhardt, G.; Leibold, E. (2005) Salmonella typhimurium / Escherichia coli
Reverse Mutation Assay (Standard Plate Test and Preincubation Test) with BAS
800 H. Project Number: 40M0414/014210, 2005/1006704. Unpublished study
prepared by BASF Aktiengesellschaft. 53 p.
47128122 Engelhardt, G.; Leibold, E. (2005) Salmonella typhimurium / Escherichia coli
Reverse Mutation Assay (Standard Plate Test and Preincubation Test) with BAS
800 H - Anhydrate. Project Number: 40M0267/054031, 2005/1023109.
Unpublished study prepared by BASF Aktiengesellschaft. 53 p.
47128123 Engelhardt, G.; Liebold, E. (2005) In vitro Gene Mutation Test with BAS 800 H
in CHO Cells (HPRT Locus Assay). Project Number: 50M0414/014213,
2005/1014963. Unpublished study prepared by BASF Aktiengesellschaft. 58 p.
47128124 Engelhardt, G.; Liebold, E. (2005) In vitro Chromosome Abberation Assay with
BAS 800 H in V79 Cells. Project Number: 32M0414/014214, 2005/1023788.
Unpublished study prepared by BASF Aktiengesellschaft. 116 p.
47128125 Engelhardt, G.; Liebold, E. (2005) Cytogenetic Study in vivo with BAS 800 H
in the Mouse Micronucleus Test: Single Oral Administration. Project Number:
25M0414/014211, 2005/1014070. Unpublished study prepared by BASF
Aktiengesellschaft. 51 p.
47128126 Engelhardt, G.; Liebold, E. (2005) In vivo Unscheduled DNA Synthesis (USD)
Assay with BAS 800 H in Rat Hepatocytes: Single Oral Administration. Project
Number: 2005/1020111, 80M0414/014212. Unpublished study prepared by
BASF Aktiengesellschaft. 50 p.
85-1 General metabolism
MRID
Citation Reference
47128129 Fabian, E.; Landsiedel. R. (2007) (Carbon 14)-BAS 800 H: Study on the
Biokinetics in Rats. Project Number: 02B0627/046008, 2007/1033929.
Unpublished study prepared by BASF Aktiengesellschaft. 91 p.
-40-
-------
122-2 Aquatic plant growth
MRID Citation Reference
47127923 Hoffmann, F. (2007) Effect of BAS 800 H (Reg. No. 4054449) on the Growth of
the Green Alga Pseudokirchneriella subcapitata (Including Amendment No. 1):
Final Report. Project Number: 132848, 2007/7013577. Unpublished study
prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 34 p.
47127925 Hoffmann, F. (2007) Effect of BAS 800 H (Reg. No. 405449) on the Growth of
the Blue-Green Alga Anabaena flos-aquae (Including Amendment No. 1): Final
Report. Project Number: 132851, 2007/7013576. Unpublished study prepared
by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 36 p.
123-1 Seed germination/seedling emergence and vegitative vigor
MRID Citation Reference
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47560308 Stromel, C.; Brockman, A.; Teresiak, H. (2008) Effect of Metabolite of BAS
800 H, M800H08 with Incorporation into Soil on Seedling Emergence and
Seedling Growth of Ten Species of Terrestrial Plants. Project Number:
2008/1036946/US/OCR, AC/BASF/08/12, 31/44/69. Unpublished study
prepared by Agro-Check. 132 p.
123-2 Aquatic plant growth
MRID Citation Reference
47127922 Backfisch, K. (2007) Effect of BAS 800 H on the Growth of Lemna gibba
(Including Amendment No. 1): Final Report. Project Number: 134222,
2007/7013578. Unpublished study prepared by BASF Corporation. 37 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
141-1 Honey bee acute contact
MRID Citation Reference
-41 -
-------
47127929 Holmes, C.; Jackson, S. (2008) HAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47445903 Kling, A. (2008) Assessment of Side Effects of BAS 800 01 H to the Honey
Bee, Apis mellifera L. in the Laboratory. Project Number: 2008/1000141,
317342, 20071545/S I/BLEU. Unpublished study prepared by Eurofms - GAB
GmbH. 26 p.
161-1 Hydrolysis
MRID Citation Reference
47127823 Panek, M. (2006) Hydrolysis of (Carbon 14)-BAS 800 H: Final Report. Project
Number: 2005/7004259, 132680. Unpublished study prepared by BASF
Corporation. 155 p.
161-2 Photodegradation-water
MRID Citation Reference
47127824 Ta, C.; Trollinger, J. (2007) Aqueous Photolysis of (Carbon 14)-BAS 800 H:
Final Report. Project Number: 2007/7009413, 132683. Unpublished study
prepared by BASF Corporation. 126 p.
47699901 Ta, C.; Trollinger, J. (2009) Aqueous Photolysis of (Carbon 14)-BAS 800 H:
Final Report. Project Number: 2009/7000140/OCR, SUBNO/200711/09/02,
132683. Unpublished study prepared by BASF Agro Research. 141 p.
161-3 Photodegradation-soil
MRID Citation Reference
47127825 Ta, C. (2007) BAS 800 H: Soil Photolysis: Amended Final Report. Project
Number: 2007/7007647, 132653. Unpublished study prepared by BASF
Corporation. 115 p.
162-1 Aerobic soil metabolism
MRID Citation Reference
-42-
-------
47127826 Singh, M. (2007) Aerobic Soil Metabolism of (Carbon 14)-BAS 800 H on US
Soils: Final Report. Project Number: 2006/7007173, 132650. Unpublished study
prepared by BASF Corporation. 217 p.
162-2 Anaerobic soil metabolism
MRID Citation Reference
47611201 Pyles, A.; Panek, M. (2008) Anaerobic Soil Metabolism of 14C-BAS 800 H:
Final Report. Project Number: 2008/7015021, 812/05/01//US/332554, 332554.
Unpublished study prepared by BASF Corporation. 124 p.
162-3 Anaerobic aquatic metab.
MRID Citation Reference
47127828 Panek, M. (2007) Anaerobic Aquatic Metabolism of (Carbon 14)-BAS 800 H.
Project Number: 132647, 2006/7009997. Unpublished study prepared by BASF
Corporation and Agvise Laboratories. 185 p.
162-4 Aerobic aquatic metab.
MRID Citation Reference
47127827 Malinsky, D. (2008) Aerobic Aquatic Metabolism of (Carbon 14) BAS 800 H
Under Dark and Light Conditions. Project Number: 133487, 2007/7009863.
Unpublished study prepared by BASF Corporation and Agvise Laboratories.
205 p.
163-1 Leach/adsorp/desorption
MRID Citation Reference
47127829 Ta, C.; Varner, J. (2007) Adsorption/Desorption of BAS 800 H on Soils: Final
Report. Project Number: 132674, 2006/7007148. Unpublished study prepared
by BASF Corporation. 70 p.
47127830 Ta, C. (2007) Adsorption/Desorption of the Major Metabolites (M800H01,
M800H02, M800H07, M800H08, M800H15, and M800H22) of BAS 800 H on
Soils: Final Report. Project Number: 2007/7009870, 132677. Unpublished study
prepared by BASF Corporation. 243 p.
-43-
-------
164-1 Terrestrial field dissipation
MRID
Citation Reference
47127831 Saha, M. (2007) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Soil Using LC/MS/MS": Final Report. Project Number: 132659, 2005/5000071.
Unpublished study prepared by BASF Agro Research. 197 p.
47127832 Perez, S.; Perez, R. (2007) Independent Laboratory Validation of BASF
Analytical Method D0503: The Determination of Residues of BAS 800 H and
its Metabolites in Soil Using LC/MS/MS. Project Number: 132662,
ADPEN/2K7/903/132662, 2007/7012422. Unpublished study prepared by
ADPEN Laboratories, Inc. 203 p.
47128234 Jordan, J.; Saha, M.; Warren, R. (2007) Terrestrial Field Dissipation of BAS 800
H in Pine/Vegetation Management use Patterns. Project Number: 2007/700986.
132665. Unpublished study prepared by BASF Corporation, Agvise, Inc. and
ROI. 375 p.
47560309 Saha, M.; Gooding, R. (2008) Freezer Storage Stability of BAS 800 H and the
Relevant Metabolites in Soil Samples. Project Number: 2008/7012718/OCR,
132671. Unpublished study prepared by BASF Corporation. 344 p.
47699902 Saha, M. (2009) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites, in
Soil Using LC/MS/MS": Final Report. Project Number: 2009/700132I/OCR,
711/17/02//US/132659, 2009/7001321. Unpublished study prepared by BASF
Agro Research. 200 p.
164-2 Aquatic field dissipation
MRID
Citation Reference
47523802 Saha, M. (2008) Method Validation of BASF Analytical Method D0502
Entitled: " The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS"- Amended Final Report. Project Number: 132692,
2008/7013814, D0502. Unpublished study prepared by BASF Agro Research.
187 p.
47523803 Smith, M.; Perez, R. (2008) Independent Laboratory Validation of BASF
Analytical Method D0502: The Determination of Residues of BAS 800 H and
its Metabolites, in Water using LC-MS/MS. Project Number:
ADPEN/2K8/903/351551, 2008/7012014. Unpublished study prepared by
ADPEN Laboratories, Inc. 223 p.
-44-
-------
47699903 Saha, M. (2009) Method Validation of BASF Analytical Method D0502
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS: Final Report. Project Number: 2009/7000172/OCR,
US/132692. Unpublished study prepared by BASF Agro Research. 197 p.
165-1 Confined rotational crop
MRID Citation Reference
47128017 Veit, P.; Glabgen, W. (2007) Rotational Crop Study with (Carbon-14)-BAS 800
H . Project Number: 132587, 2007/1016303, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 330 p.
165-4 Bioaccumulation in fish
MRID Citation Reference
47127909 Hafemann, C. (2007) Bioaccumulation and Metabolism of BAS 800 H in
Bluegill Sunfish (Lepomis macrochirus): Final Report. Project Number: 132626,
2007/1056242. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 83 p.
171-4B Residue Analytical Methods
MRID Citation Reference
47128005 Fabian, E.; Landsiedei, R. (2006) (Carbon-14)-BAS 800 H - Absorption,
Distribution and Excretion After Repeated Oral Administration in Lactating
Goats. Project Number: 2006/1030265, RTP/NC/27709, 02B0627/046013.
Unpublished study prepared by BASF Aktiengesellschaft. 45 p.
47128007 Rabe, U.; Glabgen, W. (2007) The Metabolism of (Carbon-14)-BAS 800 H in
Laying Hens. Project Number: 132623, 2006/1007338, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 143 p.
171-4C Magnitude of the Residue [by commodity]
MRID Citation Reference
47128216 Kleppe, C. (2007) Bridging Rationale for BAS 800 H Formulations Used in
Field Crop Residue Program. Project Number: 2007/7013524. Unpublished
study prepared by BASF Corporation. 8 p.
-45-
-------
47445905 Thiaener, I; Hafemann, C. (2007) Extractability Study on Soybean Matrices
after Application with 14C-BAS 800 H. Project Number: 2007/1056933, LC03,
132/581. Unpublished study prepared by BASF Aktiengesellschaft. 46 p.
171-4A1 Characterization of Total Terminal Residue
MRID Citation Reference
47128001 Hafemann, C.; Hoefs, R.; Helfrich, P. (2007) Metabolism of BAS 800 H in
Corn. Project Number: 132584, 2006/1024287, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 184 p.
47128002 Rabe, U.; Glabgen, W. (2007) Metabolism of BAS 800 H in Soybean. Project
Number: 132581, 2006/1036209, RTP/NC/27709. Unpublished study prepared
by BASF Aktiengesellschaft. 229 p.
47128003 Hafemann, C.; Kloppner, U. (2007) Metabolism of (Carbon-14)-BAS 800 H in
Tomato. Project Number: 142727, 2007/1018206, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 142 p.
47128004 Kleppe, C. (2007) Request for Waiver of Plant Metabolism Study in Support of
Sunflower Harvest Aid / Desiccation Use with BAS 800 H. Project Number:
2007/7013487. Unpublished study prepared by BASF Corporation. 34 p.
47128006 Hafemann, C.; Glabgen, W. (2007) The Metabolism of (Carbon-14)-B AS 800 H
in Lactating Goats. Project Number: 2006/1010563, 132620, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 206 p.
830.1000 Background for product properties test guidelines
MRID Citation Reference
47128239 Oostlander, M.; Killins, R.; Barton, W.; et. al. (2008) BAS 800 H Herbicide:
Application for BAS 800 H Applied Pre-Seed/Pre-emerge and to Chemfallow,
Pre-plant to Soybean, and Pre-Plant or Pre-plant Incorporated to Corn-Field and
Sweet Corn. Daco Data Requirement - part 10 Value. Project Number:
2008/7002707. Unpublished study prepared by BASF Canada, Inc. 300 p.
830.1550 Product Identity and composition
MRID Citation Reference
47127801 Kleppe, C. (2007) Compulsory Data for the Evaluation of the Active Substance
BAS 800 H: EPA Guideline Numbers: OPPTS 830. Supplemental (Registrant
-46-
-------
Information, Product Identity and Further Information). Project Number:
2007/7013522. Unpublished study prepared by BASF Corporation. 11 p.
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
47749001 Genari, G. (2008) Product Identity and Composition of BAS 800 H (Including
Amendment No. 1). Project Number: 2008/7019767/OCR, 2008/7019769.
Unpublished study prepared by BASF Aktiengesellschaft. 197 p.
830.1600 Description of materials used to produce the product
MRID Citation Reference
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
-47-
-------
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
47749001 Genari, G. (2008) Product Identity and Composition of BAS 800 H (Including
Amendment No. 1). Project Number: 2008/7019767/OCR, 2008/7019769.
Unpublished study prepared by BASF Aktiengesellschaft. 197 p.
830.1620 Description of production process
MRID Citation Reference
47127802
47128202
47128301
47128401
47128501
47128601
47749001
Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
Genari, G. (2008) Product Identity and Composition of BAS 800 H (Including
Amendment No. 1). Project Number: 2008/7019767/OCR, 2008/7019769.
Unpublished study prepared by BASF Aktiengesellschaft. 197 p.
-48-
-------
830.1650 Description of formulation process
MRID
Citation Reference
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
830.1670 Discussion of formation of impurities
MRID Citation Reference
47127802 Genari, G. (2007) Product Identity and Composition of BAS 800 H. Project
Number: 2007/1022324. Unpublished study prepared by BASF
Aktiengesellschaft. 194 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
-49-
-------
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
47749001 Genari, G. (2008) Product Identity and Composition of BAS 800 H (Including
Amendment No. 1). Project Number: 2008/7019767/OCR, 2008/7019769.
Unpublished study prepared by BASF Aktiengesellschaft. 197 p.
830.1700 Preliminary analysis
MRID
Citation Reference
47127803 Genari, G. (2007) Preliminary Analysis of Five Batches BAS 800 H TGAI.
Project Number: 2007/1022325, 132476/1. Unpublished study prepared by
BASF Aktiengesellschaft. 40 p.
47127804 Dotzer, R. (2007) Identification of Active Substance BAS 800 H (Reg. No.
4054449) and Minor Components in Technical-Grade Material. Project
Number: 2007/1057829. Unpublished study prepared by BASF
Aktiengesellschaft. 24 p.
47127805 Hsieh, T. (2007) BASF Proposal to Commercially Produce the Anhydrate Form
of BAS 800 H Technical: Final Report. Project Number: 2007/7013587.
Unpublished study prepared by BASF Agro Research. 8 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
-50-
-------
47749002 Doetzer, R. (2007) Confirmation of Identity of Active Substance BAS 800 H
and Related Minor Components. Project Number: 2007/1057532/US/OCR,
2007/1057532. Unpublished study prepared by BASF Aktiengesellschaft. 20 p.
47796101 Genari, G. (2009) Preliminary Analysis of Five Batches Saflufenacil (BAS 800
H) TGAI. Project Number: 147899/1, 2009/1074772, 2003/1023211.
Unpublished study prepared by BASF SE. 75 p.
47796102 Peterson-Thiery, M. (2009) Saflufenacil - Documentation of Equivalency and
Qualification of Technical Grade Active Ingredient Produced by the Source:
CBW (Chemie GmbH - Bitterfeld-Wolfen). Project Number: 2009/1078541,
2009/1074772, 2007/1022325. Unpublished study prepared by BASF SE. 19 p.
830.1750 Certified limits
MRID
Citation Reference
47127805 Hsieh, T. (2007) BASF Proposal to Commercially Produce the Anhydrate Form
of BAS 800 H Technical: Final Report. Project Number: 2007/7013587.
Unpublished study prepared by BASF Agro Research. 8 p.
47127806 Brunt, S.; Genari, G. (2007) BAS 800 H Technical Grade Active Ingredient:
Composition and Certified Limits. Project Number: 2007/7013642. Unpublished
study prepared by BASF Corporation and BASF Aktiengesellschaft. 27 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
-51 -
-------
830.1800 Enforcement analytical method
MRID
Citation Reference
47127807 Distler, 1; Genari, G. (2005) Analytical Method APL0498/01: Determination of
HAS 800 H Technical Grade Active Ingredient TGAI by HPLC. Project
Number: 2005/1018447, APL0498/01. Unpublished study prepared by BASF
Aktiengesellschaft. 15 p.
47127808 Genari, G. (2005) Validation of Analytical Method APL0498/01: Determination
of BAS 800 H Technical Grade Active Ingredient TGAI by HPLC. Project
Number: 132491/2, 2005/1018448. Unpublished study prepared by BASF
Aktiengesellschaft. 16 p.
47127809 Rieger, V. (2007) Analytical Method APL0525/01: Determination of Impurities
in BAS 800 H Technical Grade Active Ingredient TGAI. Project Number:
2006/1027567, APL0525/01. Unpublished study prepared by BASF
Aktiengesellschaft. 35 p.
47127810 Genari, G. (2007) Validation of Analytical Method APL0525/01: Determination
of Impurities in BAS 800 H Technical Grade Active Ingredient TGAI. Project
Number: 2006/1027568, 132491/3. Unpublished study prepared by BASF
Aktiengesellschaft. 46 p.
47127811 Stegmaier, W. (2007) Gas Chromatographic Determination of Dimethyl Sulfate
in BAS 800 H and Validation of the GC/MS Method AM/01011/0 le. Project
Number: 2007/7013933. Unpublished study prepared by BASF AG. 20 p.
47128202 Cannan, T. (2008) BAS 800 01 H Group A - Product Identity, Composition, and
Analysis. Project Number: FR0739, 2007/7013548, AFR0064/01. Unpublished
study prepared by BASF Corporation. 74 p.
47128203 Polowy, K.; Hartman, M. (2007) Validation of Analytical Method AFR0064/01
and GLP Certification of BAS 800 01 H Formulation Lot 1641-87 and BAS 800
02 H Lot 1631-22: Final Report. Project Number: F200717, 2007/7012410,
AFR0064/01. Unpublished study prepared by BASF Corporation. 63 p.
47128301 Aldridge, T. (2008) SHARPEN Herbicide (120 g/L BAS 800 H EC): Group A -
Product Identity, Composition and Analysis. Project Number: FR0742,
2007/7013630. Unpublished study prepared by BASF Corporation. 83 p.
47128302 Polowy, K.; Hartman, M. (2007) Validation of Analytical Method AFR0064/01
and GLP Certification of BAS 800 01 H Formulation Lot 1641-87 and BAS 800
02 H Lot 1631-22: Final Report. Project Number: F200717, 2007/7012410.
Unpublished study prepared by BASF Corporation. 63 p.
47128401 Cannan, T. (2008) BAS 800 04 H: Group A - Product Identity, Composition,
and Analysis. Project Number: FR0741, 2007/7013550. Unpublished study
prepared by BASF Corporation. 102 p.
-52-
-------
47128402 Walker, A. (2007) Analytical Method AFL0747/01: Determination of BAS 800
H in BAS 800 04 H. Project Number: AFL0747/01, 2007/1035627. Unpublished
study prepared by Battelle UK Ltd. 16 p.
47128403 Walker, A. (2007) Validation of Analytical Method AFL 0747/01 for the
Determination of BAS 800 H in BAS 800 04 H. Project Number: MX070191,
2007/1035712. Unpublished study prepared by Battelle UK Ltd. 29 p.
47128501 Aldridge, T. (2008) BAS 781 02 H (68 g/L BAS 800 H + 600 g/L
Dimethenamid-P EC): Group A - Product Identity, Composition and Analysis.
Project Number: FR0744, 2007/7013645, AFR0068/01. Unpublished study
prepared by BASF Corporation. 101 p.
47128502 Polowy, K. (2007) Validation of Analytical Methods AFR0068/01 and
AFR0069/01, and the GLP Certification of BAS 781 01 H Formulation Lot
1632-15, BAS 781 UN H Formulation Lot 1632-35-7, and BAS 781 UO H
Formulation Lot 1632-38: Final Report. Project Number: F200712,
2007/7006972. Unpublished study prepared by BASF Agro Research. 128 p.
47128601 Cannan, T. (2008) BAS 804 00 H: Group A - Product Identity, Composition,
and Analysis. Project Number: 2007/7013549, FR0740, AFR0067/01.
Unpublished study prepared by BASF Corporation. 77 p.
47128602 Polowy, K. (2007) GLP Validation of Analytical Method AFR0067/01 and
Certification of BAS 804 00 H: Formulation Lot Number 1641-22: Final Report.
Project Number: 2007/7012430, F200711. Unpublished study prepared by
BASF Agro Research. 61 p.
47749003 Czajkowska, T. (2006) Validation of Analytical Method AFR0050/01 and
Certification of BAS 800 00 H Formulation, Lot Number 1609-13: Final Report.
Project Number: 2006/7001026/OCR, F200529, 2006/7001026. Unpublished
study prepared by BASF Agro Research. 44 p.
47749004 Czajkowska, T. (2005) Validation of Analytical Method AFR0027/01 and
Certification of BAS 800 UCH and TGAI: Final Report. Project Number:
2005/7003446/OCR, 133079, 2005/7003446. Unpublished study prepared by
BASF Agro Research. 47 p.
830.6302 Color
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128204 Yacoub, R. (2007) BAS 800 01H: Determination of Physical State, pH, Bulk
-53-
-------
Density, and Explodability: Final Report. Project Number: 2007/7002967,
143705. Unpublished study prepared by BASF Corporation, lip.
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
47128603 Yacoub, R. (2007) BAS 804 00 H: Determination of Physical State, pH,
Explodability, and Density: Final Report. Project Number: 2007/7007982,
313731. Unpublished study prepared by BASF Agro Research, lip.
830.6303 Physical state
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47127816 Yacoub, R. (2006) BAS 800 H: Physical State and Melting Point of Pure Active
Ingredient (PAI): Final Report. Project Number: 2005/5000147, 132467.
Unpublished study prepared by BASF Corporation, lip.
47128204 Yacoub, R. (2007) BAS 800 01H: Determination of Physical State, pH, Bulk
Density, and Explodability: Final Report. Project Number: 2007/7002967,
143705. Unpublished study prepared by BASF Corporation, lip.
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
-54-
-------
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
47128603 Yacoub, R. (2007) BAS 804 00 H: Determination of Physical State, pH,
Explodability, and Density: Final Report. Project Number: 2007/7007982,
313731. Unpublished study prepared by BASF Agro Research, lip.
830.6304 Odor
MRID
Citation Reference
47127812
47128207
47128404
830.6313
ions
MRID
Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
Stability to sunlight, normal and elevated temperatures, metals, and metal
Citation Reference
-55-
-------
47127813 Yacoub, R. (2007) BAS 800 H (TGAI): Stability to Normal and Elevated
Temperature, Metal and Metal Ions: Final Report. Project Number:
2007/7007671, 132488. Unpublished study prepared by BASF Corporation. 12
P-
830.6314 Oxidizing or reducing action
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128205 Yacoub, R. (2007) BAS 800 01 H: Determination of Oxidation/Reduction: Final
Report. Project Number: 143711, 2007/7002963. Unpublished study prepared
by BASF Corporation. 13 p.
47128304 Yacoub, R. (2007) BAS 800 02 H: Determination of Oxidation/Reduction: Final
Report. Project Number: 2007/7002962, 133076. Unpublished study prepared
by BASF Agro Research. 13 p.
47128405 Yacoub, R. (2007) BAS 800 04 H: Determination of Oxidation/Reduction: Final
Report. Project Number: 313823, 2007/7007978. Unpublished study prepared
by BASF Agro Research. 13 p.
47128504 Yacoub, R. (2007) BAS 781 02 H: Determination of Oxidation/Reduction: Final
Report. Project Number: 2007/7013454, 133181/20. Unpublished study
prepared by BASF Agro Research. 13 p.
47128604 Yacoub, R. (2007) BAS 804 00 H: Determination of Oxidation/Reduction: Final
Report. Project Number: 2007/7007979, 313732. Unpublished study prepared
by BASF Agro Research. 13 p.
830.6315 Flammability
MRID
Citation Reference
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
-56-
-------
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) HAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
830.6316 Explodability
MRID
Citation Reference
47127812 Yacoub, R. (2007) HAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47128204 Yacoub, R. (2007) BAS 800 01H: Determination of Physical State, pH, Bulk
Density, and Explodability: Final Report. Project Number: 2007/7002967,
143705. Unpublished study prepared by BASF Corporation, lip.
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
47128603 Yacoub, R. (2007) BAS 804 00 H: Determination of Physical State, pH,
Explodability, and Density: Final Report. Project Number: 2007/7007982,
313731. Unpublished study prepared by BASF Agro Research, lip.
830.6317 Storage stability of product
MRID
Citation Reference
47127814 Genari, G. (2007) BAS 800 H TGAI: Storage Stability and Corrosiveness.
Project Number: 2007/1054373. Unpublished study prepared by BASF
Aktiengesellschaft. 8 p.
47128206 Yacoub, R. (2007) BAS 800 01 H: Storage Stability and Corrosion. Project
Number: 2007/7004158. Unpublished study prepared by BASF Corporation. 11
P-
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
-57-
-------
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128305 Yacoub, R. (2007) BAS 800 02 H: Storage Stability and Corrosion in
Commercial Containers. Project Number: 2007/7009807. Unpublished study
prepared by BASF Agro Research, lip.
47128505 Yacoub, R. (2007) BAS 781 02 H: Storage Stability. Project Number:
2007/7013520. Unpublished study prepared by BASF Agro Research. 11 p.
47128605 Yacoub, R. (2007) BAS 804 00 H: Accelerated Storage Stability. Project
Number: 2007/7009806. Unpublished study prepared by BASF Agro Research.
12 p.
830.6320 Corrosion characteristics
MRID
Citation Reference
47127814 Genari, G. (2007) BAS 800 H TGAI: Storage Stability and Corrosiveness.
Project Number: 2007/1054373. Unpublished study prepared by BASF
Aktiengesellschaft. 8 p.
47128206 Yacoub, R. (2007) BAS 800 01 H: Storage Stability and Corrosion. Project
Number: 2007/7004158. Unpublished study prepared by BASF Corporation. 11
P-
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128305 Yacoub, R. (2007) BAS 800 02 H: Storage Stability and Corrosion in
Commercial Containers. Project Number: 2007/7009807. Unpublished study
prepared by BASF Agro Research, lip.
830.7000 pH of water solutions or suspensions
MRID Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
-58-
-------
47128204 Yacoub, R. (2007) BAS 800 01H: Determination of Physical State, pH, Bulk
Density, and Explodability: Final Report. Project Number: 2007/7002967,
143705. Unpublished study prepared by BASF Corporation, lip.
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
47128603 Yacoub, R. (2007) BAS 804 00 H: Determination of Physical State, pH,
Explodability, and Density: Final Report. Project Number: 2007/7007982,
313731. Unpublished study prepared by BASF Agro Research, lip.
830.7050 UV/Visible absorption
MRID
Citation Reference
47127815 Beery, J. (2007) BAS 800 H: Spectroscopic Characterization by NMR, MS, IR
and UV/Vis: Final Report. Project Number: F200523, 2005/7004339.
Unpublished study prepared by BASF Corporation. 32 p.
830.7100 Viscosity
MRID
Citation Reference
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
-59-
-------
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
830.7200 Melting point/melting range
MRID
Citation Reference
47127816 Yacoub, R. (2006) BAS 800 H: Physical State and Melting Point of Pure Active
Ingredient (PAI): Final Report. Project Number: 2005/5000147, 132467.
Unpublished study prepared by BASF Corporation, lip.
830.7300 Density/relative density
MRID
Citation Reference
47127812 Yacoub, R. (2007) BAS 800 H (MP): Determination of Oxidation/Reduction,
Physical State, pH, Bulk Density, Explodability, and Odor: Amended Final
Report. Project Number: 132485, 2007/7009479. Unpublished study prepared
by BASF Corporation. 14 p.
47127821 Kroehl, T. (2005) BAS 800 H - Reg. No. 4054449: Physical Properties of the
Pure Active Ingredient. Project Number: 132464/1, 2005/1026464. Unpublished
study prepared by BASF Aktiengesellschaft. 15 p.
47128204 Yacoub, R. (2007) BAS 800 01H: Determination of Physical State, pH, Bulk
Density, and Explodability: Final Report. Project Number: 2007/7002967,
143705. Unpublished study prepared by BASF Corporation, lip.
47128207 Kroehl, T. (2008) Physical and Chemical Properties of BAS 800 01 H (BAS 800
H 70% WG) - Accelerated Storage Stability Up to 2 Weeks at 54 Degrees
Celsius and 8 Weeks at 40 Degrees Celsius. Project Number: 143747/1,
2008/1002621. Unpublished study prepared by BASF Aktiengesellschaft, BASF
Agricultural Center. 26 p.
47128303 Yacoub, R. (2007) BAS 800 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 2007/7002966, 133073. Unpublished study prepared by BASF
Agro Research. 12 p.
-60-
-------
47128404 Kroehl, T. (2007) Physical and Chemical Properties of BAS 800 04 H (BAS 800
H 342 g/L SC) - Accelerated Storage Stability up to 2 Weeks at 54 Degrees
Celsius. Project Number: 313821/1, 2007/1039740. Unpublished study prepared
by BASF Aktiengesellschaft, Ecology and Environmental Analytics. 19 p.
47128503 Yacoub, R. (2007) BAS 781 02 H: Determination of Physical State, pH,
Explodability, Flammability, Relative Density, and Viscosity: Final Report.
Project Number: 133178/20, 2007/7013453. Unpublished study prepared by
BASF Agro Research. 12 p.
47128603 Yacoub, R. (2007) BAS 804 00 H: Determination of Physical State, pH,
Explodability, and Density: Final Report. Project Number: 2007/7007982,
313731. Unpublished study prepared by BASF Agro Research, lip.
830.7370 Dissociation constant in water
MRID
Citation Reference
47127817 Beery, J. (2007) BAS 800 H: Dissociation Constant: Amended Final Report.
Project Number: 2007/7002007, F200524, 2005/7004342. Unpublished study
prepared by BASF Corporation. 17 p.
830.7570 Partition coefficient (n-octanol/water), estimation by liquid chromatography
MRID Citation Reference
47127818 Vanhook, C. (2005) BAS 800 H: Partition Coefficient (n-Octanol/Water)
Estimation by High Performance Liquid Chromatography: Final Report. Project
Number: 132458, 2005/7004256. Unpublished study prepared by BASF
Corporation. 17 p.
830.7840 Water solubility: Column elution method, shake flask method
MRID Citation Reference
47127819 Vanhook, C. (2005) BAS 800 H: Water Solubility at 20 Degrees Celsius by
Shake Flask Method: Final Report. Project Number: 2005/7003391, 132452A.
Unpublished study prepared by BASF Corporation. 20 p.
830.7950 Vapor pressure
MRID
Citation Reference
-61 -
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47127821 Kroehl, T. (2005) BAS 800 H - Reg. No. 4054449: Physical Properties of the
Pure Active Ingredient. Project Number: 132464/1, 2005/1026464. Unpublished
study prepared by BASF Aktiengesellschaft. 15 p.
835.0001 Background for Environmental Fate, Transport, and Drift
MRID Citation Reference
47445904 Paulick, R.; Warren, R. (2008) Environmental Fate Summary for BAS 800 H.
Project Number: 2008/7009261, D0503, 2007/7013512. Unpublished study
prepared by BASF Corporation. 20 p.
835.1230 Sediment and soil absorption/desorption for parent and degradates
MRID Citation Reference
47127829 Ta, C.; Varner, J. (2007) Adsorption/Desorption of BAS 800 H on Soils: Final
Report. Project Number: 132674, 2006/7007148. Unpublished study prepared
by BASF Corporation. 70 p.
835.1240 Soil column leaching
MRID Citation Reference
47127830 Ta, C. (2007) Adsorption/Desorption of the Major Metabolites (M800H01,
M800H02, M800H07, M800H08, M800H15, and M800H22) of BAS 800 H on
Soils: Final Report. Project Number: 2007/7009870, 132677. Unpublished study
prepared by BASF Corporation. 243 p.
835.2120 Hydrolysis of parent and degradates as a function of pH at 25 C
MRID Citation Reference
47127823 Panek, M. (2006) Hydrolysis of (Carbon 14)-BAS 800 H: Final Report. Project
Number: 2005/7004259, 132680. Unpublished study prepared by BASF
Corporation. 155 p.
835.2210 Direct photolysis rate in water by sunlight
MRID Citation Reference
-62-
-------
47127824 Ta, C.; Trollinger, J. (2007) Aqueous Photolysis of (Carbon 14)-BAS 800 H:
Final Report. Project Number: 2007/7009413, 132683. Unpublished study
prepared by BASF Corporation. 126 p.
47699901 Ta, C.; Trollinger, J. (2009) Aqueous Photolysis of (Carbon 14)-BAS 800 H:
Final Report. Project Number: 2009/7000140/OCR, SUBNO/200711/09/02,
132683. Unpublished study prepared by BASF Agro Research. 141 p.
835.2410 Photodegradation of parent and degradates in soil
MRID Citation Reference
47127825 Ta, C. (2007) BAS 800 H: Soil Photolysis: Amended Final Report. Project
Number: 2007/7007647, 132653. Unpublished study prepared by BASF
Corporation. 115 p.
835.4100 Aerobic soil metabolism
MRID
Citation Reference
47127826 Singh, M. (2007) Aerobic Soil Metabolism of (Carbon 14)-BAS 800 H on US
Soils: Final Report. Project Number: 2006/7007173, 132650. Unpublished study
prepared by BASF Corporation. 217 p.
47445901 Singh, M. (2008) Aerobic Soil Metabolism of (Carbon 14) C-BAS 800 H on US
Soils. Project Number: 2008/7009234, 132650, AR05/153. Unpublished study
prepared by BASF Agro Research. 220 p.
835.4200 Anaerobic soil metabolism
MRID
Citation Reference
47611201
Pyles, A.; Panek, M. (2008) Anaerobic Soil Metabolism of 14C-BAS 800 H:
Final Report. Project Number: 2008/7015021, 812/05/01//US/332554, 332554.
Unpublished study prepared by BASF Corporation. 124 p.
835.4300 Aerobic aquatic metabolism
MRID
Citation Reference
47127827 Malinsky, D. (2008) Aerobic Aquatic Metabolism of (Carbon 14) BAS 800 H
Under Dark and Light Conditions. Project Number: 133487, 2007/7009863.
Unpublished study prepared by BASF Corporation and Agvise Laboratories.
-63-
-------
205 p.
835.4400 Anaerobic aquatic metabolism
MRID Citation Reference
47127828 Panek, M. (2007) Anaerobic Aquatic Metabolism of (Carbon 14)-BAS 800 H.
Project Number: 132647, 2006/7009997. Unpublished study prepared by BASF
Corporation and Agvise Laboratories. 185 p.
835.6100 Terrestrial field dissipation
MRID
Citation Reference
47127831 Saha, M. (2007) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Soil Using LC/MS/MS": Final Report. Project Number: 132659, 2005/5000071.
Unpublished study prepared by BASF Agro Research. 197 p.
47128235 Jordan, 1; Saha, M.; Warren, R. (2008) Terrestrial Field Dissipation of BAS 800
H in Row Crop Use Patterns: Final Report. Project Number: 132668,
2007/7009867. Unpublished study prepared by BASF Agro Research. 532 p.
47128236 Jordan, J.; Saha, M.; Warren, R. (2007) Terrestrial Field Dissipation of BAS 800
H in Orchard and Vineyard use Patterns: Final Report. Project Number: 134549,
2007/7009868. Unpublished study prepared by Agvise Inc., Vaughn
Agricultural Research Serv., Ltd. and Research for Hire. 619 p.
47128237 Gooding, R.; Saha, M. (2008) Freezer Storage Stability of BAS 800 H and the
Relevant Metabolites in Soil Samples: Final Report. Project Number: 132671,
2007/7013581. Unpublished study prepared by BASF Corporation. 290 p.
47128238 Sotack, G. (2008) BAS 800 UC H: Tank Mix Uniformity of an EC Formulation
in a Simulated Spray Tank: Final Report. Project Number: F200714,
2007/7007879. Unpublished study prepared by BASF Corporation. 19 p.
47560309 Saha, M.; Gooding, R. (2008) Freezer Storage Stability of BAS 800 H and the
Relevant Metabolites in Soil Samples. Project Number: 2008/7012718/OCR,
132671. Unpublished study prepared by BASF Corporation. 344 p.
47699902 Saha, M. (2009) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites, in
Soil Using LC/MS/MS": Final Report. Project Number: 2009/700132I/OCR,
711/17/02//US/132659, 2009/7001321. Unpublished study prepared by BASF
Agro Research. 200 p.
-64-
-------
835.6200 Aquatic field dissipation
MRID
Citation Reference
47523802 Saha, M. (2008) Method Validation of BASF Analytical Method D0502
Entitled: " The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS"- Amended Final Report. Project Number: 132692,
2008/7013814, D0502. Unpublished study prepared by BASF Agro Research.
187 p.
47523803 Smith, M.; Perez, R. (2008) Independent Laboratory Validation of BASF
Analytical Method D0502: The Determination of Residues of BAS 800 H and
its Metabolites, in Water using LC-MS/MS. Project Number:
ADPEN/2K8/903/351551, 2008/7012014. Unpublished study prepared by
ADPEN Laboratories, Inc. 223 p.
47699903 Saha, M. (2009) Method Validation of BASF Analytical Method D0502
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS: Final Report. Project Number: 2009/7000172/OCR,
US/132692. Unpublished study prepared by BASF Agro Research. 197 p.
835.7100 Ground water monitoring
MRID
Citation Reference
47523802 Saha, M. (2008) Method Validation of BASF Analytical Method D0502
Entitled: " The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS"- Amended Final Report. Project Number: 132692,
2008/7013814, D0502. Unpublished study prepared by BASF Agro Research.
187 p.
47523 803 Smith, M.; Perez, R. (2008) Independent Laboratory Validation of BASF
Analytical Method D0502: The Determination of Residues of BAS 800 H and
its Metabolites, in Water using LC-MS/MS. Project Number:
ADPEN/2K8/903/351551, 2008/7012014. Unpublished study prepared by
ADPEN Laboratories, Inc. 223 p.
47699903 Saha, M. (2009) Method Validation of BASF Analytical Method D0502
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Water Using LC-MS/MS: Final Report. Project Number: 2009/7000172/OCR,
US/132692. Unpublished study prepared by BASF Agro Research. 197 p.
850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids
MRID Citation Reference
-65-
-------
47127901 Bergtold, M.; Janson, G. (2006) Acute Toxicity of BAS 800 H to Daphnia
magna Straus in a 48 Hour Static Test: Final Report. Project Number: 132860,
2006/1004506. Unpublished study prepared by BASF Aktiengesellschaft. 20 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.1025 Oyster acute toxicity test (shell deposition)
MRID Citation Reference
47127902 Palmer, S.; Kendall, T.; Krueger, H.; et al. (2007) BAS 800 H: A 96-Hour Shell
Deposition Test with the Eastern Oyster (Crassostrea virginica). Project
Number: 147A/214, 132884, 2007/7009823. Unpublished study prepared by
Wildlife International, Ltd. 41 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.1035 Mysid acute toxicity test
MRID
Citation Reference
47127903 Blankinship, A.; Kendall, T.; Krueger, H.; et al. (2007) BAS 800 H: A 96-Hour
Flow-Through Acute Toxicity Test with the Saltwater Mysid (Americamysis
bahia) . Project Number: 147A/212C, 132881, 2007/7009955. Unpublished
study prepared by Wildlife International, Ltd. 43 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47560303 Minderhout, T. ; Kendall, T.; Krueger, H.; Holmes, C. (2008) BAS 800 H
Metabolite M07: A 96-Hour Static Acute Toxicity Test with the Saltwater
Mysid (Americamysis bahia). Project Number: 2008/7015130/OCR, 147A/246,
356246. Unpublished study prepared by Wildlife International Ltd. 38 p.
-66-
-------
850.1075 Fish acute toxicity test, freshwater and marine
MRID Citation Reference
47127904 Jatzek, R. (2005) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus
mykiss) in a Static System over 96 hours. Project Number: 12F0414/015146,
2005/1029784. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 40 p.
47127905 Jatzek, R. (2005) HAS 800 H: Acute Toxicity Study on the Bluegill Sunfish
(Lepomis macrochirus) in a Static System Over 96 Hours. Project Number:
14F0414/015147, 2005/1029929. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 39 p.
47127906 Palmer, S.; Kendall, T.; Krueger, H.; et al. (2007) BAS 800 H: A 96-Hour Static
Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus).
Project Number: 147A/213, 132878, 2007/7009824. Unpublished study
prepared by Wildlife International, Ltd. 38 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.1300 Daphnid chronic toxicity test
MRID
Citation Reference
47127907 Weltje, L.; Bergtold, M. (2007) Chronic Toxicity of BAS 800 H to Daphnia
magna Straus in a 21-Day Semi-Static Test (Including Amendment No. 1).
Project Number: 132863, 2007/7013579. Unpublished study prepared by BASF
Ag Research Station. 33 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.1350 Mysid chronic toxicity test
MRID
Citation Reference
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
-67-
-------
by BASF Corp. 20 p.
850.1400 Fish early-life stage toxicity test
MRID Citation Reference
47127908 Zok, S. (2007) BAS 800 H - Early Life-Stage Test on the Fathead Minnow
(Pimephales promelas) in a Flow Through System (Including Amendment
No.l). Project Number: 51F0414/015150, 2007/7002034. Unpublished study
prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 107 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.1730 Fish BCF
MRID
Citation Reference
47127909 Hafemann, C. (2007) Bioaccumulation and Metabolism of BAS 800 H in
Bluegill Sunfish (Lepomis macrochirus): Final Report. Project Number: 132626,
2007/1056242. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 83 p.
850.2100 Avian acute oral toxicity test
MRID
Citation Reference
47127911 Zok, S. (2006) BAS 800 H - Acute Toxicity in the Bobwhite Quail (Colinus
virginianus) After Single Oral Administration (LD50). Project Number:
11W0414/015141, 2005/1029868. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 52 p.
47127912 Zok, S. (2006) BAS 800 H - Acute Toxicity in the Mallard Duck (Anas
platyrhynchos) After Single Oral Administration. Project Number:
13W0414/015145, 2005/102866. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 54 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
-68-
-------
850.2200 Avian dietary toxicity test
MRID
Citation Reference
47127913 Zok, R. (2006) BAS 800 H - Avian Dietary LC50 Test in Chicks of the
Bobwhite Quail (Colinus virginianus). Project Number: 31W0414/015139,
2005/1029867. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 45 p.
47127914 Zok, R. (2006) BAS 800 H - Avian Dietary LC50 Test in Chicks of the Mallard
Duck (Anas platyrhynchos). Project Number: 32W0414/015140, 2005/1029869.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 42 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
850.2300 Avian reproduction test
MRID
Citation Reference
47127915 Zok, R. (2006) BAS 800 H - 1-Generation Reproduction Study on the Bobwhite
Quail (Colinus virginianus) by Administration in the Diet. Project Number:
71W0414/015148, 2006/1035447. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 349 p.
47127916 Zok, R. (2006) BAS 800 H - 1-Generation Reproduction Study on the Mallard
Duck (Anas platyrhynchus) by Administration in the Diet. Project Number:
72W0414/015149, 2006/1035448. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 343 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47699904 Zok, S. (2009) BAS 800 H - 1-Generation Reproduction Study on the Bobwhite
quail (Colinus virginianus) by Administration in the Diet (Including
Amendment No. 1). Project Number: 2009/7000198/OCR,
EU/71W0414/015148, 2006/1035447. Unpublished study prepared by BASF
Aktiengesellschaft. 357 p.
-69-
-------
850.3020 Honey bee acute contact toxicity
MRID Citation Reference
47127917 Sinderamnn, A.; Porch, 1; Krueger, H. (2007) BAS 800 H: An Acute Contact
Toxicity Study with the Honey Bee. Project Number: 147/231, 132908,
2007/7012392. Unpublished study prepared by Wildlife International, Ltd. 19 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47445903 Kling, A. (2008) Assessment of Side Effects of BAS 800 01 H to the Honey
Bee, Apis mellifera L. in the Laboratory. Project Number: 2008/1000141,
317342, 20071545/S I/BLEU. Unpublished study prepared by Eurofms - GAB
GmbH. 26 p.
47796201 Kling, A. (2008) BAS 781 02 H - Acute Oral and Contact Toxicity to the Honey
Bee Apis mellifera L. in the Laboratory. Project Number:
2008/1065171/US/OCR, S08/02983//EU/358386, SOS/02983. Unpublished
study prepared by Eurofms - GAB GmbH. 33 p.
850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence)
MRID Citation Reference
47127918 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 02 H: A Toxicity Test
to Determine the Effects of the Test Substance on Seedling Emergence of Ten
Species of Plants. Project Number: 147/228, 147485,2007/7012423.
Unpublished study prepared by Wildlife International, Ltd. 114 p.
47127919 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 01 H: A Toxicity Test
to Determine the Effects of the Test Substance on Seedling Emergence of Ten
Species of Plants. Project Number: 147/226, 147488,2007/7013632.
Unpublished study prepared by Wildlife International, Ltd. 118 p.
850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor)
MRID Citation Reference
47127920 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 02 H: A Toxicity Test
to Determine the Effects of the Test Substance on Vegetative Vigor of Ten
Species of Plants. Project Number: 147/229, 147479,2007/7013634.
Unpublished study prepared by Wildlife International, Ltd. 205 p.
-70-
-------
47127921 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 01 H: A Toxicity Test
to Determine the Effects of the Test Substance on Vegetative Vigor of Ten
Species of Plants. Project Number: 147/227, 147482,2007/7013633.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 205 p.
850.4225 Seedling emergence, Tier II
MRID
Citation Reference
47127918 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 02 H: A Toxicity Test
to Determine the Effects of the Test Substance on Seedling Emergence of Ten
Species of Plants. Project Number: 147/228, 147485,2007/7012423.
Unpublished study prepared by Wildlife International, Ltd. 114 p.
47127919 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 01 H: A Toxicity Test
to Determine the Effects of the Test Substance on Seedling Emergence of Ten
Species of Plants. Project Number: 147/226, 147488,2007/7013632.
Unpublished study prepared by Wildlife International, Ltd. 118 p.
47560304 Stromel, C. ; Brockman, A.; Teresiak, H. (2008) Effect of Metabolite of BAS
800 H, M800H07 with Incorporation into Soil on Seedling Emergence of Ten
Species of Terrestrial Plants (Including Amendment No. 1). Project Number:
2008/7015223/OCR, AC/BASF/08/11. Unpublished study prepared by Agro-
Check. 121 p.
47560308 Stromel, C.; Brockman, A.; Teresiak, H. (2008) Effect of Metabolite of BAS
800 H, M800H08 with Incorporation into Soil on Seedling Emergence and
Seedling Growth of Ten Species of Terrestrial Plants. Project Number:
2008/1036946/US/OCR, AC/BASF/08/12, 31/44/69. Unpublished study
prepared by Agro-Check. 132 p.
850.4250 Vegetative vigor, Tier II
MRID
Citation Reference
47127920 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 02 H: A Toxicity Test
to Determine the Effects of the Test Substance on Vegetative Vigor of Ten
Species of Plants. Project Number: 147/229, 147479,2007/7013634.
Unpublished study prepared by Wildlife International, Ltd. 205 p.
47127921 Porch, I; Krueger, H.; Martin, K.; et al. (2007) BAS 800 01 H: A Toxicity Test
to Determine the Effects of the Test Substance on Vegetative Vigor of Ten
Species of Plants. Project Number: 147/227, 147482,2007/7013633.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
-71 -
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Oekotoxicologie. 205 p.
850.4400 Aquatic plant toxicity test using Lemna spp. Tiers I and II
MRID Citation Reference
47127922 Backfisch, K. (2007) Effect of BAS 800 H on the Growth of Lemna gibba
(Including Amendment No. 1): Final Report. Project Number: 134222,
2007/7013578. Unpublished study prepared by BASF Corporation. 37 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47560302 Porch, I; Kendall, T.; Krueger, H.; Holmes, C. (2008) BAS 800 H Metabolite
M07: A 7-Day Toxicity Test with Duckweed (Lemna gibba G3). Project
Number: 2008/7013852/OCR, 147A/243, 355549. Unpublished study prepared
by Wildlife International Ltd. 50 p.
47560306 Porch, J.; Kendall, T.; Krueger, H.; Holmes, C. (2008) BAS 800 H Metabolite
M08: A 7-Day Toxicity Test with Duckweed (Lemna gibba G3). Project
Number: 2008/701385I/OCR, 147A/245, 355551. Unpublished study prepared
by Wildlife International Ltd. 50 p.
850.5400 Algal toxicity, Tiers 1 and II
MRID
Citation Reference
47127923 Hoffmann, F. (2007) Effect of BAS 800 H (Reg. No. 4054449) on the Growth of
the Green Alga Pseudokirchneriella subcapitata (Including Amendment No. 1):
Final Report. Project Number: 132848, 2007/7013577. Unpublished study
prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 34 p.
47127924 Sindermann, A.; Kendall, T.; Krueger, H.; et al. (2007) BAS 800 H: A 96-Hour
Toxicity Test with the Freshwater Diatom (Navicula pelliculosa). Project
Number: 147A/215, 132854, 2007/7009827. Unpublished study prepared by
Wildlife International, Ltd. 44 p.
47127925 Hoffmann, F. (2007) Effect of BAS 800 H (Reg. No. 405449) on the Growth of
the Blue-Green Alga Anabaena flos-aquae (Including Amendment No. 1): Final
Report. Project Number: 132851, 2007/7013576. Unpublished study prepared
by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 36 p.
47127926 Sindermann, A.; Kendall, T.; Krueger, H.; et al. (2007) BAS 800 H: A 96-Hour
Toxicity Test with the Marine Diatom (Skeletonema costatum). Project Number:
-72-
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147A/216A, 132857, 2007/7009826. Unpublished study prepared by Wildlife
International, Ltd. 47 p.
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
47560301 Porch, I; Kendall, T.; Krueger, H.; Holmes, C. (2008) BAS 800 H Metabolite
M07: A 96-Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella
subcapitata). Project Number: 2008/7013828/OCR, 355548, 147A/242.
Unpublished study prepared by Wildlife International Ltd. 56 p.
47560305 Porch, I; Kendall, T.; Krueger, H.; Holmes, C. (2008) BAS 800 H Metabolite
M08: A 96-Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella
subcapitata). Project Number: 2008/7012761/OCR, 355550, 147A/244.
Unpublished study prepared by Wildlife International Ltd. 56 p.
860.1300 Nature of the residue - plants, livestock
MRID Citation Reference
47128001 Hafemann, C.; Hoefs, R.; Helfrich, P. (2007) Metabolism of BAS 800 H in
Corn. Project Number: 132584, 2006/1024287, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 184 p.
47128002 Rabe, U.; Glabgen, W. (2007) Metabolism of BAS 800 H in Soybean. Project
Number: 132581, 2006/1036209, RTP/NC/27709. Unpublished study prepared
by BASF Aktiengesellschaft. 229 p.
47128003 Hafemann, C.; Kloppner, U. (2007) Metabolism of (Carbon-14)-BAS 800 H in
Tomato. Project Number: 142727, 2007/1018206, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 142 p.
47128004 Kleppe, C. (2007) Request for Waiver of Plant Metabolism Study in Support of
Sunflower Harvest Aid / Desiccation Use with BAS 800 H. Project Number:
2007/7013487. Unpublished study prepared by BASF Corporation. 34 p.
47128005 Fabian, E.; Landsiedei, R. (2006) (Carbon-14)-BAS 800 H - Absorption,
Distribution and Excretion After Repeated Oral Administration in Lactating
Goats. Project Number: 2006/1030265, RTP/NC/27709, 02B0627/046013.
Unpublished study prepared by BASF Aktiengesellschaft. 45 p.
47128006 Hafemann, C.; Glabgen, W. (2007) The Metabolism of (Carbon-14)-B AS 800 H
in Lactating Goats. Project Number: 2006/1010563, 132620, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 206 p.
47128007 Rabe, U.; Glabgen, W. (2007) The Metabolism of (Carbon-14)-B AS 800 H in
-73-
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Laying Hens. Project Number: 132623, 2006/1007338, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 143 p.
47128020 Fabian, E.; Landsiedel, R. (2007) (Carbon-14)-BAS 800 H - Adsorption,
Distribution and Excretion After Repeated Oral Administration in Laying Hens
(Including Amendment No. 1). Project Number: 02B0627/046012,
2007/7013970, RTP/NC/27709. Unpublished study prepared by BASF
Aktiengesellschaft. 51 p.
860.1340 Residue analytical method
MRID
Citation Reference
47127831 Saha, M. (2007) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites in
Soil Using LC/MS/MS": Final Report. Project Number: 132659, 2005/5000071.
Unpublished study prepared by BASF Agro Research. 197 p.
47127832 Perez, S.; Perez, R. (2007) Independent Laboratory Validation of BASF
Analytical Method D0503: The Determination of Residues of BAS 800 H and
its Metabolites in Soil Using LC/MS/MS. Project Number: 132662,
ADPEN/2K7/903/132662, 2007/7012422. Unpublished study prepared by
ADPEN Laboratories, Inc. 203 p.
47128008 Nejad, H. (2007) Method Validation of BASF Analytical Method D0603/02:
Residue Enforcement Method for Determination of Residues BAS 800 H and Its
Metabolites M800H11 and M800H35 in Plant Matrices Using LC/MS/MS:
Final Report. Project Number: 132590, 2007/7009778. Unpublished study
prepared by BASF Agro Research. 144 p.
47128009 Perez, R.; Perez, S. (2007) Independent Method Validation of BASF Analytical
Method D0603/02: Method for Determination of Residue BAS 800 H and its
Metabolites M800H11 and M800H35 in Plant Matrices Using LC/MS/MS.
Project Number: 2007/7013612, 132602, 2K7/132602. Unpublished study
prepared by ADPEN Laboratories, Inc. 291 p.
47128010 Blumenstiel, S.; Grosshans, F. (2007) Technical Procedure: Method for the
Determination of BAS 800 H in Animal Matrices. Project Number: L0073/01,
2007/1051917, RTP/NC/27709. Unpublished study prepared by BASF
Aktiengesellschaft. 14 p.
47128011 Grosshans, F.; Blumenstiel, S. (2007) Validation of BASF Method L0073/01:
Determination of BAS 800 H in Animal Matrices. Project Number:
RTP/NC/27709, 132629, 2006/1039451. Unpublished study prepared by BASF
Aktiengesellschaft. 49 p.
47128012 Rawle, N. (2007) Independent Laboratory Method Validation for the
-74-
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Determination of BAS 800 H in Bovine Milk and Tissue. Project Number:
RTP/NC/27709, CEMR/3684, 2007/1051939. Unpublished study prepared by
CEM Analytical Services, Ltd. 59 p.
47128013 Perez, R.; Tarkalanov, N. (2007) Evaluation of BAS 800 H and Relevant
Metabolites FDA Multi-residue Method (MRM) Testing. Project Number:
A32605, ADPEN/2K7/132605, 2008/7002704. Unpublished study prepared by
ADPEN Laboratories, Inc. 153 p.
47445905 Thiaener, I; Hafemann, C. (2007) Extractability Study on Soybean Matrices
after Application with 14C-BAS 800 H. Project Number: 2007/1056933, LC03,
132/581. Unpublished study prepared by BASF Aktiengesellschaft. 46 p.
47699902 Saha, M. (2009) Method Validation of BASF Analytical Method D0503
Entitled: "The Determination of Residues of BAS 800 H and its Metabolites, in
Soil Using LC/MS/MS": Final Report. Project Number: 2009/700132I/OCR,
711/17/02//US/132659, 2009/7001321. Unpublished study prepared by BASF
Agro Research. 200 p.
47796103 Nejad, H.; Saha, M.; Stewart, J.; et al.; (2009) Residue Enforcement Method for
Determination of BAS 800 H and its Metabolites M800H11 and M800H35
Residues in Plant Matrices using LC/MS/MS. Project Number: D0603/02,
2009/7003376, 2007/7009778. Unpublished study prepared by BASF
Corporation. 39 p.
47796104 Blumenstiel, S. (2009) Technical Procedure: Method for the Determination of
BAS 800 H in Animal Matrices - BASF Method Number L0073/01 Final.
Project Number: L0073/01, 2009/1080927, 2009/1080927/OCR. Unpublished
study prepared by BASF SE. 14 p.
860.1360 Multiresidue method
MRID
Citation Reference
47128013 Perez, R.; Tarkalanov, N. (2007) Evaluation of BAS 800 H and Relevant
Metabolites FDA Multi-residue Method (MRM) Testing. Project Number:
A32605, ADPEN/2K7/132605, 2008/7002704. Unpublished study prepared by
ADPEN Laboratories, Inc. 153 p.
860.1380 Storage stability data
MRID
Citation Reference
47128014 Nejad, H. (2007) Freezer Storage Stability of BAS 800 H and its Metabolites in
Plant Matrices: Final Report. Project Number: 2007/7009893, 132608.
Unpublished study prepared by BASF Agro Research. 108 p.
-75-
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47128015 Rawle, N. (2007) Residues of BAS 800 H in Milk and Edible Tissues Following
Oral Administrations to Lactating Dairy Cattle. Project Number: 132638,
CEMS/3669, 2007/1052659. Unpublished study prepared by CEM Analytical
Services, Ltd. 162 p.
47523801 Nejad, H. (2008) Freezer Storage Stability of BAS 800 H and its Metabolites in
Plant Matrices: Amended Final Report. Project Number: 132608,
2008/7012825. Unpublished study prepared by BASF Agro Research. 217 p.
860.1480 Meat/milk/poultry/eggs
MRID
Citation Reference
47128015 Rawle, N. (2007) Residues of BAS 800 H in Milk and Edible Tissues Following
Oral Administrations to Lactating Dairy Cattle. Project Number: 132638,
CEMS/3669, 2007/1052659. Unpublished study prepared by CEM Analytical
Services, Ltd. 162 p.
47128019 Panek, M. (2008) Justification for Waiving a Feeding/Residue Study in Laying
Hens with BAS 800 H: Final Report. Project Number: 2008/7002706.
Unpublished study prepared by BASF Agro Research. 8 p.
860.1500 Crop field trials
MRID
Citation Reference
47128215 Kleppe, C.; Lingard, S. (2006) Proposal for a NAFTA Crop Residue Program
with BAS 800 H, Plus Memorandum of Understanding. Project Number:
2006/7013791. Unpublished study prepared by BASF Corporation. 28 p.
47128216 Kleppe, C. (2007) Bridging Rationale for BAS 800 H Formulations Used in
Field Crop Residue Program. Project Number: 2007/7013524. Unpublished
study prepared by BASF Corporation. 8 p.
47128217 Sotack, G. (2008) BAS 800 OOH: Tank Mix Uniformity of a WG formulation in
a Simulated Spray Tank: Final Report. Project Number: F200713,
2007/7007878. Unpublished study prepared by BASF Corporation. 19 p.
47128218 Jordan, J. (2007) The Magnitude of BAS 800 H Residues in Raw Agricultural
Commodities of the Legume Vegetable (Succulent and Dry) and Foliage of
Legume Vegetables Crop Groups Following Applications of BAS 800 00 H:
Final Report. Project Number: 132980, 2006/7012776. Unpublished study
prepared by BASF Corporation, Agricultural Chemistry Development Services,
Inc. (ACDS) and ICMS, Inc. 242 p.
47128219 Jordan, J.; Saha, M. (2007) Magnitude of BAS 800 H Residues in the Citrus
-76-
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Crop Group Following Applications of BAS 800 00 H: Amended Final Report.
Project Number: 142406. Unpublished study prepared by BASF Corporation,
Glades Crop Care, Inc. and Florida Pesticide Research, Inc. 110 p.
47128220 Jordan, J. (2007) Magnitude of BAS 800 H Residues in Pome Fruits Following
Applications of BAS 800 00 H: Final Report. Project Number: 179902, 139,
2006/7012768. Unpublished study prepared by BASF Corporation, Agsearch,
and Vaughn Agricultural Research Services. 139 p.
47128221 Jordan, J.; Stewart, J. (2007) Magnitude of BAS 800 H Residues in Stonefruit
Following Applications of BAS 800 00 H: Final Report. Project Number:
215320, 163, 2006/7012778. Unpublished study prepared by BASF
Corporation, Agsearch and Excel Research Services, Inc. 163 p.
47128222 Jordan, J.; Nejad, H. (2007) Magnitude of BAS 800 H Residues in Tree Nuts
Following Applications of BAS 800 00 H: Final Report. Project Number:
218911, 2006/7012770. Unpublished study prepared by BASF Corporation,
Research for Hire and South Texas Ag. Research. 117 p.
47128223 Johnston, R. (2008) Magnitude of BAS 800 H Residues in Raw Agricultural
Commodities of the Cereal Grains and Forage, Fodder and Straw of Cereal
Grains Crop Groups Following Applications of BAS 800 00 H: Amended Final
Report. Project Number: 176728, 2008/7002717. Unpublished study prepared
by BASF Corporation, Agriscope, LLC and Shoffner Farm Research. 421 p.
47128224 White, M.; Nejad, H. (2008) The Magnitude of BAS 800 H Residues in/on
Cotton Following Applications of BAS 800 00 H: Final Report. Project
Number: 148700, 2007/7013709. Unpublished study prepared by BASF
Corporation, South Texas Ag Research, Inc. and Great Plains Crop Services.
115 p.
47128225 Jordan, J. (2007) Magnitude of BAS 800 H Residues in Grapes Following
Applications of BAS 800 00 H: Final Report. Project Number: 218920,
2006/7012769. Unpublished study prepared by BASF Corporation, Agsearch
and Agresources, Inc. 152 p.
47128226 Johnston, R.; Saha, M. (2008) Magnitude of BAS 800 H Residues in Sunflower
RAC Following Applications of BAS 800 OOH: Final Report. Project Number:
147617, 2007/7013708. Unpublished study prepared by BASF Corporation,
Diamond Ag Research, Inc. and Agresources, Inc. 105 p.
47128227 Norris, F.; Gooding, R. (2007) The Magnitude of BAS 800 H Residues in
Soybean Aspirated Grain and Processed Fractions: Final Report. Project
Number: 132986, 2006/7012764. Unpublished study prepared by BASF
Corporation and GLP Technologies. 86 p.
860.1520 Processed food/feed
MRID
Citation Reference
-77-
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47128227 Norris, F.; Gooding, R. (2007) The Magnitude of BAS 800 H Residues in
Soybean Aspirated Grain and Processed Fractions: Final Report. Project
Number: 132986, 2006/7012764. Unpublished study prepared by BASF
Corporation and GLP Technologies. 86 p.
47128228 Jordan, 1; Saha, M. (2007) Magnitude of BAS 800 H Residues in Citrus
Processed Fractions Following Applications of BAS 800 00 H: Final Report.
Project Number: 142391, 2006/7011656. Unpublished study prepared by BASF
Corporation. 109 p.
47128229 Jordan, J. (2007) Magnitude of BAS 800 H Residues in Apple Processed
Fractions Following Applications of BAS 800 00 H: Final Report. Project
Number: 142388, 2006/7012767. Unpublished study prepared by BASF
Corporation and Agricultural Chemistry Development Services, Inc. (ACDS).
82 p.
47128230 Jordan, J.; Stewart, J. (2007) Magnitude of BAS 800 H Residues in Plum
Processed Fractions (Prunes) Following Applications of BAS 800 00 H: Final
Report. Project Number: 142385, 2006/7012766. Unpublished study prepared
by BASF Corporation, Excel Research Services, Inc. and University of Idaho,
Cooperative Extension. 83 p.
47128231 Johnston, R.; Saha, M. (2007) Magnitude of BAS 800 H Residues in Processed
Fractions of the Cereal Grain Crop Group (Corn, Wheat, Sorghum and Rice)
Following Applications of BAS 800 00 H: Final Report. Project Number:
133427, 2006/7012771. Unpublished study prepared by BASF Corporation,
Agsearch and Shoffner Farm Research. 172 p.
47128232 Jordan, J.; Nejad, H. (2007) Magnitude of BAS 800 H Residues in Grape
Processed Fractions Following Applications of BAS 800 00 H: Final Report.
Project Number: 142382, 2006/7012765. Unpublished study prepared by BASF
Corporation, Research for Hire and University of Idaho, Cooperative Extension.
80 p.
47128233 Norris, F.; Saha, M. (2007) The Magnitude of BAS 800 H Residues in
Sunflower Processed Fractions Following a Late Season Application of BAS
800 00 H as a Dessicant: Final Report. Project Number: 145547, 2006/7012774.
Unpublished study prepared by BASF Corporation, Northern Plains Ag
Research and GLP Technologies. 106 p.
47445902 White, M.; Nejad, H. (2008) Magnitude of BAS 800 H Residues in Cotton
Processed Fractions Following an Application of BAS 800 00 H. Project
Number: 2008/7005482, 345313, D0603/02. Unpublished study prepared by
BASF Agro Research. 111 p.
-78-
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860.1550 Proposed tolerances
MRID
Citation Reference
47128016 Hafemann, C.; Kleppe, C. (2006) Proposal for the Residue Defination for BAS
800 H Based on Studies for Plant Metabolism and Confined Rotational Crops
Plus Memorandum of Understanding. Project Number: RTP/NC/27709,
2006/7011119. Unpublished study prepared by BASF Corp. 23 p.
47128021 Hafemann, C. (2008) BAS 800 H: Summary of Metabolism in Plants and
Animals. Project Number: 2008/7003585, RTP/NC/27709. Unpublished study
prepared by BASF Agro Research. 15 p.
860.1850 Confined accumulation in rotational crops
MRID Citation Reference
47128017 Veit, P.; Glabgen, W. (2007) Rotational Crop Study with (Carbon-14)-BAS 800
H . Project Number: 132587, 2007/1016303, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 330 p.
860.1900 Field accumulation in rotational crops
MRID Citation Reference
47128018 Norris, F.; Manasi, S. (2007) The Magnitude of BAS 100 H Residue in Wheat,
Lettuce and Radish Planted as Rotational Crops Following an Application of
BAS 800 00 H to Wheat (Plant Back Intervals of 4, 6 and 9 Months): Final
Report. Project Number: 2006/7012775, 132611. Unpublished study prepared
by BASF Agro Research, Southeast Ag Research, Inc. and Agvise Research.
153 p.
870.1100 Acute oral toxicity
MRID
Citation Reference
47128101 Leibold, E.; Gamer, A. (2005) BAS 800 H - Acute Oral Toxicity Study in Rats.
Project Number: 10A0414/011124, 2005/1014960, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
47128208 Gamer, A.; Landsiedel, R. (2007) BAS 800 01 H - Acute Oral Toxicity Study in
Rats. Project Number: 10A0320/061117, 2007/1020183. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology.
-79-
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23 p.
47128306 Rokh, N. (2007) BAS 800 02 H - Acute Oral Toxicity Study in Rats: "Acute
Toxic Class Method". Project Number: 10A0812/059038, 2007/1035031.
Unpublished study prepared by Centre International de Toxicologie. 40 p.
47128406 Wolf, T. (2007) BAS 800 04 H: Acute Oral Toxicity Study with Rats (Acute
Toxic Class Method). Project Number: 10AO175/069086, BAS21,
2007/1044694. Unpublished study prepared by Austrian Research Center
(ARC). 37 p.
47128506 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Acute Oral Toxicity Study in
Rats. Project Number: 10A0520/071058, 2007/1053309. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
47128606 Wolf, T. (2007) BAS 804 00 H - Acute Oral Toxicity Study with Rats (Acute
Toxic Class Method). Project Number: BAS 17, 10AO174/069081. Unpublished
study prepared by Austrian Research Center (ARC). 38 p.
870.1200 Acute dermal toxicity
MRID
Citation Reference
47128102 Gamer, A.; Leibold, E. (2005) BAS 800 H - Acute Dermal Toxicity Study in
Rats. Project Number: 11A0414/011125, 2005/1014961, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 24 p.
47128209 Gamer, A.; Landsiedel, R. (2007) BAS 800 01 H - Acute Dermal Toxicity Study
in Rats. Project Number: 11A0320/061126, 2007/1020184. Unpublished study
prepared by BASF Corporation. 28 p.
47128307 Rokh, N. (2007) BAS 800 02 H - Acute Dermal Toxicity in Rats. Project
Number: 11A0812/059039, 2007/1035032. Unpublished study prepared by
Centre International de Toxicologie. 32 p.
47128407 Wolf, T. (2007) BAS 800 04 H: Acute Dermal Toxicity Study with Rats. Project
Number: 11A0175/069087, BAS22, 2007/1044695. Unpublished study prepared
by Austrian Research Center (ARC). 28 p.
47128507 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Acute Dermal Toxicity Study
in Rats. Project Number: 11A0520/071059, 2007/1053310. Unpublished study
prepared by BASF Aktiengesellschaft. 27 p.
47128607 Wolf, T. (2007) BAS 804 00 H - Acute Dermal Toxicity Study with Rats.
Project Number: BASIS, 11AO174/069080, 2007/1044693. Unpublished study
prepared by Austrian Research Center (ARC). 28 p.
-80-
-------
870.1300 Acute inhalation toxicity
MRID
Citation Reference
47128103 Ma-Hock, L.; Leibold, E. (2005) BAS 800 H - Acute Inhalation Toxicity Study
in WistarRats. Project Number: 1310414/017021, 2005/1016432,
RTP/NC/27709. Unpublished study prepared by BASF Aktiengesellschaft. 23 p.
47128210 Hock, L.; Landsiedel, R. (2007) BAS 800 01 H -Acute Inhalation Toxicity
Study in Wistar Rats 4-hour Dust Exposure. Project Number: 1310320/067021,
2007/1039534. Unpublished study prepared by BASF Aktiengesellschaft,
Experimental Toxicology and Ecology. 33 p.
47128308 Ma-Hock, L.; Landsiedel, R. (2007) BAS 800 02 H - Acute Inhalation Toxicity
Study in Wistar Rats: 4-Hour Liquid Aerosol Exposure. Project Number:
1310812/057024, 2007/1016466. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 73 p.
47128408 Ma-Hock, L.; Landsiedel, R. (2007) BAS 800 04 H: Acute Inhalation Toxicity
Study in Wistar Rats: 4-Hour Liquid Aerosol Exposure. Project Number:
1310175/067017, 2007/1057667. Unpublished study prepared by BASF
Aktiengesellschaft, Experimental Toxicology and Ecology. 40 p.
47128508 Ma-Hock, L.; Landsiedel, R. (2007) BAS 781 02 H: Acute Inhalation Toxicity
Study in Wistar Rats: 4-hour Liquid Aerosol Dust Exposure. Project Number:
1310520/077006, 2007/1057668. Unpublished study prepared by BASF
Aktiengesellschaft. 50 p.
47128608 Muller, P. (2007) BAS 804 00 H: 4-hour Acute Inhalation Toxicity Study in
Rats. Project Number: 1310174/069090, B55978, 2007/1053326. Unpublished
study prepared by RCC Ltd. 28 p.
870.2400 Acute eye irritation
MRID
Citation Reference
47128104 Remmele, M.; Leibold, E. (2005) BAS 800 H - Acute Eye Irritation in Rabbits.
Project Number: 11H0414/102297, 2005/1005765, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 22 p.
47128105 Remmele, M.; Landsiedel, R. (2007) BAS 800 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0414/012309, 2007/1011575, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 25 p.
47128211 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0320/062236, 2007/1020186. Unpublished study
prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 23 p.
-81 -
-------
47128309 Remmele, M.; Landsiedel, R. (2007) BAS 800 02 H - Acute Eye Irritation in
Rabbits. Project Number: 11H0812/052187, 2005/1029892. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology
23 p.
47128409 Remmele, M.; Landsiedel, R. (2007) BAS 800 04 H: Acute Eye Irritation in
Rabbits. Project Number: 11HO175/062291, 2007/1053323. Unpublished study
prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology.
23 p.
47128509 Remmele, M.; Landsiedel, R. (2007) BAS 781 02 H: Acute Eye Irritation in
Rabbits. Project Number: 11H0520/072105, 2007/1050806. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
47128609 Remmele, M.; Landsiedel, R. (2007) BAS 804 00 H: Acute Eye Irritation in
Rabbits. Project Number: 11HO174/062285, 2007/1052012. Unpublished study
prepared by BASF Aktiengesellschaft. 24 p.
870.2500 Acute dermal irritation
MRID
Citation Reference
47128106 Remmele, M.; Leibold, E. (2005) BAS 800 H - Acute Dermal Irritation /
Corrosion in Rabbits. Project Number: 18H0414/102293, 2005/1005766,
RTP/NC/27709. Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
47128212 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18H0320/062235,
2007/1020185. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 21 p.
47128310 Rokh, N. (2007) BAS 800 02 H - Acute Dermal Irritation in Rabbits. Project
Number: 18H0812/059040, 2007/1035033. Unpublished study prepared by
BASF Aktiengesellschaft, Toxicology and Ecology. 31 p.
47128410 Remmele, M.; Landsiedel, R. (2007) BAS 800 04 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18HO175/062290,
2007/1053325. Unpublished study prepared by BASF Aktiengesellschaft,
Experimental Toxicology and Ecology. 21 p.
47128510 Remmele, M.; Landsiedel, R. (2007) BAS 781 02 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 2007/1057258,
18H0520/072139. Unpublished study prepared by BASF Aktiengesellschaft. 21
P-
47128610 Remmele, M.; Landsiedel, R. (2007) BAS 804 00 H: Acute Dermal
Irritation/Corrosion in Rabbits. Project Number: 18HO174/062284,
2007/1052011. Unpublished study prepared by BASF Aktiengesellschaft. 22 p.
-82-
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870.2600 Skin sensitization
MRID
Citation Reference
47128107 Gamer, A.; Leibold, E. (2005) BAS 800 - Maximization Test in Guinea Pigs.
Project Number: 30H0414/012302, 2005/1014962, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 37 p.
47128213 Remmele, M.; Landsiedel, R. (2007) BAS 800 01 H - Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 33H0320/062237, 2007/1020187.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 33 p.
47128311 Rokh, N. (2007) BAS 800 02 H - Skin Sensitization Test in Guinea Pigs
(Modified Buehler Test: 9 Inductions). Project Number: 33H0812/059041,
2007/1035034. Unpublished study prepared by Centre International de
Toxicologie. 40 p.
47128411 Gamer, A.; Landsiedel, R. (2007) BAS 800 04 H: Modified BUEHLER Test (9
Inductions) in Guinea Pigs. Project Number: 33H0175/062292, 2007/1053322.
Unpublished study prepared by BASF Aktiengesellschaft, Experimental
Toxicology and Ecology. 32 p.
47128511 Gamer, A.; Landsiedel, R. (2007) BAS 781 02 H: Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 2007/1057259, 33H0520/072140.
Unpublished study prepared by BASF Aktiengesellschaft. 32 p.
47128611 Gamer, A.; Landsiedel, R. (2007) BAS 804 00 H: Modified Buehler Test (9
Inductions) in Guinea Pigs. Project Number: 33HO174/062286, 2007/1052013.
Unpublished study prepared by BASF Aktiengesellschaft. 33 p.
870.3100 90-Day oral toxicity in rodents
MRID
Citation Reference
47128109 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 - Repeated Dose
90-Day Oral Toxicity in Wistar Rats - Administration in the Diet. Project
Number: 2005/1012914, RTP/NC/27709. Unpublished study prepared by BASF
Aktiengesellschaft. 390 p.
47128110 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Range
Finding Study in C57BL/6NCrL Mice - Administration in the Diet for 4 Weeks.
Project Number: 31S0414/01148, 2005/1011556, RTP/NC/27709. Unpublished
study prepared by BASF Aktiengesellschaft. 231 p.
47128111 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Repeated
Dose 90-day Oral Toxicity Study in C57BL/6NCrl Mice Administration in the
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Diet. Project Number: 51S0414/01161, 2005/1015755, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 297 p.
870.3150 90-day oral toxicity in nonrodents
MRID
Citation Reference
47128112 Kaspers, U.; Deckardt, K.; Kaufmann, W.; et al. (2007) BAS 800 H - Subacute
Oral Toxicity Study in Beagle Dogs Administration via Gelatin Capsules for 4
Weeks: (Including Amendments 1, 2, and 3). Project Number: 40D0414/01164,
2007/7004136, RTP/NC/27709. Unpublished study prepared by BASF
Aktiengesellschaft. 267 p.
47128113 Kaspers, U.; Deckardt, K.; Burkhardt, S.; et al. (2006) BAS 800 H - Repeated
Dose 90-day Oral Toxicity Study in Beagle Dogs Administration via Gelatin
Capsules. Project Number: 41D0414/01182, 2006/1007441, RTP/NC/27709.
Unpublished study prepared by BASF Aktiengesellschaft. 334 p.
870.3200 21/28-day dermal toxicity
MRID
Citation Reference
47128114 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2006) Repeat Dose 28-days
Dermal Toxicity Study in Wistar Rats. Project Number: 33S0414/01193,
2006/1022422, RTP/NC/27709. Unpublished study prepared by BASF Ag
Research Station. 311 p.
870.3700 Prenatal developmental toxicity study
MRID Citation Reference
47128115 Schneider, S.; Strauss, V.; Fabian, E.; et al. (2007) BAS 800 H - Prenatal
Developmental Toxicity Study in Wistar Rats Oral Administration (Gavage) .
Project Number: 30R0414/01178, 2007/1008481, RTP/NC/27709. Unpublished
study prepared by BASF Ag Research Station. 380 p.
47128116 Schneider, S.; Deckardt, K.; Hellwig, I; et al. (2006) BAS 800 H - Prenatal
Developmental Toxicity Study in Himalayan Rabbits Oral Administration
(Gavage). Project Number: 40R0414/01173, 2005/1029151, RTP/NC/27709.
Unpublished study prepared by BASF Ag Research Station. 319 p.
870.3800 Reproduction and fertility effects
MRID Citation Reference
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47128117 Schneider, S.; Strauss, V.; Kuettler, K.; et al. (2007) BAS 800 H - Two-
Generation Reproduction Toxicity Study in Wistar Rats Administration via the
Diet. Project Number: 70R0414/01200, 2007/1043413, RTP/NC/27709.
Unpublished study prepared by BASF Ag Research Station. 1214 p.
870.4100 Chronic toxicity
MRID
Citation Reference
47128118 Hempel, K.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Chronic Oral
Toxicity in Beagle Dogs: Administration Via Gelatin Capsules for 12 Months.
Project Number: 43D0414/01196, 2007/1032051. Unpublished study prepared
by BASF Aktiengesellschaft. 523 p.
870.4200 Carcinogenicity
MRID
Citation Reference
47128119 Kamp, H.; Strauss, V.; Kuttler, K.; et al. (2007) BAS 800 H - Carcinogenicity
Study in C57BL/6NCrl Mice: Administration Via the Diet Over 18 Months.
Project Number: 87C0414/01177, 2007/1005067. Unpublished study prepared
by BASF Aktiengesellschaft. 2172 p.
870.4300 Combined chronic toxicity/carcinogenicity
MRID Citation Reference
47128120 Kaspers, U.; Strauss, V.; Groters, S.; et al. (2007) BAS 800 H - Combined
Chronic Toxicity/Carcinogenicity Study in Wistar Rats: Administration Via the
Diet Up to 24 Months. Project Number: 80S0414/01170, 2007/1018564.
Unpublished study prepared by BASF Aktiengesellschaft. 1788 p.
870.5100 Bacterial reverse mutation test
MRID
Citation Reference
47128121 Engelhardt, G.; Leibold, E. (2005) Salmonella typhimurium / Escherichia coli
Reverse Mutation Assay (Standard Plate Test and Preincubation Test) with BAS
800 H. Project Number: 40M0414/014210, 2005/1006704. Unpublished study
prepared by BASF Aktiengesellschaft. 53 p.
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47128122 Engelhardt, G.; Leibold, E. (2005) Salmonella typhimurium / Escherichia coli
Reverse Mutation Assay (Standard Plate Test and Preincubation Test) with BAS
800 H - Anhydrate. Project Number: 40M0267/054031, 2005/1023109.
Unpublished study prepared by BASF Aktiengesellschaft. 53 p.
870.5300 In vitro mammalian cell gene mutation test
MRID Citation Reference
47128123
Engelhardt, G.; Liebold, E. (2005) In vitro Gene Mutation Test with BAS 800 H
in CHO Cells (HPRT Locus Assay). Project Number: 50M0414/014213,
2005/1014963. Unpublished study prepared by BASF Aktiengesellschaft. 58 p.
870.5375 In vitro mammalian chromosome aberration test
MRID Citation Reference
47128124 Engelhardt, G.; Liebold, E. (2005) In vitro Chromosome Abberation Assay with
BAS 800 H in V79 Cells. Project Number: 32M0414/014214, 2005/1023788.
Unpublished study prepared by BASF Aktiengesellschaft. 116 p.
870.5395 Mammalian erythrocyte micronucleus test
MRID Citation Reference
47128125
Engelhardt, G.; Liebold, E. (2005) Cytogenetic Study in vivo with BAS 800 H
in the Mouse Micronucleus Test: Single Oral Administration. Project Number:
25M0414/014211, 2005/1014070. Unpublished study prepared by BASF
Aktiengesellschaft. 51 p.
870.5550 Unscheduled DNA synthesis in mammalian cells in culture
MRID Citation Reference
47128126 Engelhardt, G.; Liebold, E. (2005) In vivo Unscheduled DNA Synthesis (USD)
Assay with BAS 800 H in Rat Hepatocytes: Single Oral Administration. Project
Number: 2005/1020111, 80M0414/014212. Unpublished study prepared by
BASF Aktiengesellschaft. 50 p.
870.6200 Neurotoxicity screening battery
MRID Citation Reference
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47128127 Kaspers, U.; Kaufmann, W.; Van Ravenzwaay, B. (2007) HAS 800 H - Acute
Oral Neurotoxicity in Wistar Rats: Administration Via Gavage (Including
Amendment No. 1). Project Number: 61S0414/01208, 2007/7009438.
Unpublished study prepared by BASF Aktiengesellschaft. 391 p.
47128128 Kaspers, U.; Strauss, V.; Kaufmann, W.; et al. (2007) BAS 800 H - Repeated
Dose 90-day Oral Neurotoxicity Study in Wistar Rats: Administration in the
Diet. Project Number: 63S0414/01198, 2006/1024382. Unpublished study
prepared by BASF Aktiengesellschaft. 510 p.
870.7485 Metabolism and pharmacokinetics
MRID
Citation Reference
47128129 Fabian, E.; Landsiedel. R. (2007) (Carbon 14)-BAS 800 H: Study on the
Biokinetics in Rats. Project Number: 02B0627/046008, 2007/1033929.
Unpublished study prepared by BASF Aktiengesellschaft. 91 p.
47128130 Grosshans, F. (2007) The Metabolism of (Carbon 14)-BAS 800 H (Reg. No.
4054449) in Rats. Project Number: 132617, 2006/1035461. Unpublished study
prepared by BASF Aktiengesellschaft. 265 p.
870.7600 Dermal penetration
MRID
Citation Reference
47128214 Fabian, E.; Landsiedel, R. (2007) Study on the Dermal Penetration of (Carbon
14)-BAS 800 H in BAS 800 02 H in Rats. Project Number: 01B0627/046022,
2007/1057390. Unpublished study prepared by BASF Aktiengesellschaft, Labor
fuer Oekotoxicologie. 45 p.
850.1790 Chironomid Sediment Toxicity Test
MRID Citation Reference
47127910 Weltje, L. (2007) Chronic Toxicity of BAS 800 H (Reg. No. 4054449) to the
Non-Biting Midge Chironomus riparius Exposed Via Spiked Sediment: Final
Report. Project Number: 132875, 2007/1035748. Unpublished study prepared
by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 38 p.
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850.6200 Earthworm subchronic toxicity test
MRID Citation Reference
47127927 Vertesi, A. (2006) Acute Toxicity of BAS 800 H (Reg. No. 4054449) on
Earthworms (Eisenia fetida) in Artificial Soil with 5% Peat. Project Number:
06/230/125G, 2006/1015846. Unpublished study prepared by BASF
Aktiengesellschaft, Labor fuer Oekotoxicologie. 32 p.
850.7100 Data reporting for environmental chemistry methods
MRID Citation Reference
47127928 Obermann, M. (2005) Validation of Analytical Method APL0500/01:
Determination of Pesticides in Water by HPLC/MS: Final Report. Project
Number: 230119/1, 2005/1026675, APL0500/01. Unpublished study prepared
by BASF Aktiengesellschaft. 41 p.
850.1735 Whole sediment: acute freshwater invertebrates
MRID Citation Reference
47127929 Holmes, C.; Jackson, S. (2008) BAS 800 H: Screening Level Ecological Risk
Assessment for Wildlife, Aquatic Organisms, Nontarget Aquatic Plants, and
Nontarget Insects. Project Number: 2007/7013913. Unpublished study prepared
by BASF Corp. 20 p.
870.3050 Repeated dose 28-day oral toxicity in rodents
MRID Citation Reference
47128108 Kaspers, U.; Strauss, V.; Kaufmann, W. et al. (2007) BAS 800 H - Range
Finding Study in Wistar Rats Administration in the Diet 4 Weeks. Project
Number: 30S0414/01147, 2007/1028946, RTP/NC/27709. Unpublished study
prepared by BASF Aktiengesellschaft. 367 p.
850.7100 Data reporting for environmental chemistry methods
MRID Citation Reference
47523804 Stevens, J. (2008) A Rate-Response Laboratory Test to Determine the Effects of
BAS 800 01 H on the Parasitic Wasp, Aphidius rhopalosiphi (Hymenoptera,
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Braconidae). Project Number: 355425, 2008/1035600. Unpublished study
prepared by Mambo-Tox, Ltd. 25 p.
850.6200 Earthworm subchronic toxicity test
MRID Citation Reference
47560307 Luhrs, U. (2008) Acute Toxicity (14 Days) of Metabolite of BAS 800 H,
M800H08 to the Earthworm Eisenia fetida in Artificial Soil. Project Number:
2008/1036410/US/OCR, 44431021, 355542. Unpublished study prepared by
Institut fuer Biologische Analytik und Consulting IBACON. 26 p.
Non-Guideline Study
MRID
Citation Reference
47127800 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue, and Environmental Fate Data in Support of the Application
for Registration of BAS 800 H Herbicide Technical and the Petition for
Tolerance of BAS 800 H on Various Crop Commodities. Transmittal of 33 of
202 Studies.
47127820 Vanhook, C. (2007) BAS 800 H: Solubility of 800 H in Organic Solvents: Final
Amended Report. Project Number: 2007/7001658, 132461. Unpublished study
prepared by BASF Corporation. 29 p.
47127833 Paulick, R.; Warren, R. (2008) Environmental Fate Summary for BAS 800 H.
Project Number: 2007/7013659. Unpublished study prepared by BASF
Corporation. 16 p.
47127900 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue, and Environmental Fate Data in Support of the Application
for Registration of BAS 800 H Herbicide Technical and the Petition for
Tolerance of BAS 800 H on Various Crop Commodities. Transmittal of 29 of
202 Studies.
47128000 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue, and Environmental Fate Data in Support of the Application
for Registration of BAS 800 H Herbicide Technical and the Petition for
Tolerance of BAS 800 H on Various Crop Commodities. Transmittal of 21 of
202 Studies.
47128100 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue and Environmental Data in Support of the Application for
Registration of BAS 800 H Herbicide Technical and the Petition for Tolerance
of BAS 800 H on Various Crop Commodities. Transmittal of 36 of 202 Studies.
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47128131 Cunha, G.; Mellert, W.; Deckardt, K.; et al. (2005) BAS 800 H - Supplementary
Mechanistic Study in Wistar Rats - Total Porphyrin Analysis: Administration in
the Diet Over 8 Weeks. Project Number: 48C0414/01165, 2005/1026344.
Unpublished study prepared by BASF Aktiengesellschaft. 137 p.
47128132 Cunha, G.; Mellert, W.; Strauss, V.; et al. (2006) Mechanistic Study in Wistar
Rats - Total Porphyrin Analysis: Administration in the Diet for at Least 4 Weeks
(BAS 800 H). Project Number: 30C0414/01150, 2005/1026783. Unpublished
study prepared by BASF Aktiengesellschaft. 185 p.
47128133 Cunha, G; Mellert, W.; Deckardt, K.; et al. (2005) BAS 800 H - Comparative
Bioavailability/Toxicity Study in Male Wistar Rats for the Hydrate and
Anhydrate Crystalline Forms. Project Number: 48C0414/01176, 2005/1006750.
Unpublished study prepared by BASF Aktiengesellschaft. 142 p.
47128134 Sherman, 1; Van Cott, A.; Rice, P. (2006) Health Effects Assessment of
Trifluoroacetic Acid Residues Resulting from Plant Metabolism of BAS 800 H.
Project Number: 2006/7011066. Unpublished study prepared by BASF
Corporation. 17 p.
47128135 Canez, V. (2008) BAS 800 H: Reentry Worker Exposure Assessment Following
Application to Fruit Tree, Nut, and Vine Crops (BAS 800 01 H), for Pine
Plantation and Industrial Vegetation Management (BAS 800 02 H), and to Field
and Row Agricultural Crops (BAS 800 04 H). Project Number: 2008/7002702.
Unpublished study prepared by BASF Corporation. 27 p.
47128136 Canez, V. (2008) BAS 800 H: Mixer/Loader and Applicator Exposure
Assessment Following Application to Fruit Tree, Nut, and Vine Crops (BAS
800 01 H), for Pine Plantation and Industrial Vegetation Management (BAS 800
02 H), and to Field and Row Agricultural Crops (BAS 800 04 H) . Project
Number: 2008/7002703. Unpublished study prepared by BASF Corporation. 38
P-
47128200 BASF Corporation (2008) Submission of Product Chemistry and Toxicity Data
in Support of the Application for Registration of BAS 800 01 H TNV Herbicide.
Transmittal of 39 of 202 Studies.
47128201 Kleppe, C. (2007) Compulsory Data for the Evaluation of the Plant Protection
Product BAS 800 01 H. Project Number: 2007/7013557. Unpublished study
prepared by BASF Corporation. 10 p.
47128300 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue and Environmental Fate Data in Support of the Application
for Registration of SHARPEN Herbicide and the Petition for Tolerance of BAS
800 H on Various Crops. Transmittal of 11 of 202 Studies.
47128400 BASF Corporation (2008) Submission of Product Chemistry, Toxicity, Risk and
Exposure, Residue and Environmental fate Data in Support of the Application
for Registration of SHARPEN Herbicide and the Petition for tolerance of BAS
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800 H on Various Crops. Transmittal of 11 of 202 Studies.
47128500 BASF Corporation (2008) Submission of Product Chemistry and Toxicity Data
in Support of the Application for Registration of BAS 781 02 H Herbicide.
Transmittal of 11 Studies.
47128600 BASF Corporation (2008) Submission of Product Chemistry and Toxicity Data
in Support of the Application for Registration of BAS 804 00 H LegVeg
Herbicide. Transmittal of 11 Studies.
47430800 BASF Corporation (2008) Submission of Environmental Fate and Toxicity Data
in Support of the Application for Registration of BAS 800 H Herbicide
Technical. Transmittal of 3 Studies.
47430801 Schulz, L. (2008) Effects of BAS 800 01 H on the Activity of Soil Microflora
(Carbon Transformation Test). Project Number: 309959, 1/04/21/56,
08/10/48/014/C. Unpublished study prepared by Biochem Agrar, Labor fuer
Biologische und Chemische. 28 p.
47430802 Schulz, L. (2008) Effects of BAS 800 01 H on the Activity of Soil Microflora
(Nitrogen Transformation Test). Project Number: 309960, 1/04/24/23,
08/10/48/014/N. Unpublished study prepared by Biochem Agrar, Labor fuer
Biologische und Chemische Analytik. 29 p.
47430803 Sipos, K. (2008) Effects of BAS 800 01 H on the Predatory Mite
(Typhlodromus pyri) in a Laboratory Trial. Project Number: 326628,
1/05/16/00, 08/640/335RA. Unpublished study prepared by LAB International
Research Centre Hungary Ltd. 28 p.
47445900 BASF Corporation (2008) Submission of Residue, Environmental Fate and
Toxicity Data in Support of the Application for Registration of BAS 800 H
Herbicide Technical. Transmittal of 5 Studies.
47490900 BASF Corporation (2008) Submission of Efficacy Data in Support of the
Application for Registration of BAS 800 H Herbicide Technical. Transmittal of
1 Study.
47490901 Nejad, H.; Hafemann, C. (2008) BAS 800 H (Saflufenacil): Extraction
Efficiency of Incurred Residues. Project Number: 2008/7010227, D0603/02.
Unpublished study prepared by BASF Corporation. 16 p.
47523800 BASF Corporation (2008) Submission of Residue and Environmental Fate Data
in Support of the Application for Registration of BAS 800 Herbicide Technical.
Transmittal of 4 Studies.
47523900 BASF Corporation (2008) Submission of Toxicity Data in Support of the
Application for Registration of BAS 781 02H Herbicide. Transmittal of 2
Studies.
47523901 Stevens, J. (2008) A Rate-Response Laboratory Test to Determine the Effects of
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BAS 781 02 H on the Parasitic Wasp, Aphidius rhopalosiphi (Hymenoptera,
Braconidae). Project Number: 2008/1036407, ASF/08/25//EU/355543, 355543.
Unpublished study prepared by Mambo-Tox Ltd. 25 p.
47523902 Waterman, L. (2008) A Rate-Response Laboratory Test to Determine the
Effects of BAS 781 02 H on the Predatory Mite, Typhlodromus pyri (Acari:
Phytoseiidae). Project Number: 2008/1036408, 355540. Unpublished study
prepared by Mambo-Tox Ltd. 26 p.
47560300 BASF Corporation (2008) Submission of Product Chemistry and Environmental
Fate Data in Support of the Application for Registration of BAS 800 H
Herbicide Technical. Transmittal of 9 Studies.
47611200 Bayer Corporation (2008) Submission of Environmental Fate Data in Support of
the Application for Registration of BAS 800 H Herbicide Technical. Transmittal
of 1 Study.
47667400 BASF Corporation (2008) Submission of Residue Data in Support of the
Application for Registration of BAS 800 H Herbicide Technical. Transmittal of
1 Study.
47667401 Nejad, H.; Thiaener, J. (2008) BASF Response to Canada PMRA Inquiry
Concerning the Acceptability of Radio-Validation of the Plant Residue
Enforcement Methodology: (BAS 800 H Herbicide Technical). Project Number:
2008/7015391. Unpublished study prepared by BASF Corporation. 6 p.
47699900 BASF Corporation (2009) Submission of Residue, Environmental Fate and
Toxicity Data in Support of the Application for Registration of BAS 800 H
Herbicide Technical. Transmittal of 4 Studies.
47749000 BASF Corporation (2009) Submission of Product Chemistry Data in Support of
the Application for Registration of BAS 800 H Herbicide Technical. Transmittal
of 4 Studies.
47796100 BASF Corporation (2009) Submission of Product Chemistry and Residue Data
in Support of the Application for Registration of BAS 800 H Herbicide
Technical. Transmittal of 4 Studies.
47796200 BASF Corporation (2009) Submission of Toxicity Data in Support of the
Application for Registration of BAS 781 02H Herbicide. Transmittal of 1 Study.
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