United States
Environmental Protection
Agency
Office of Prevention, Pesticides
and Toxic Substances
(7501C)
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Fenpropimorph
New Chemical
Tolerance Established
March 2006
Description of Chemical
Generic Name:
Common Name:
Trade Name:
Chemical Class:
EPA Chemical Code:
Chemical Abstracts
Service (CAS) Number:
Registration Status:
Pesticide Type:
U.S. Producer:
re/-(2tf,6S)-4-[3-[4-(l,l-dimethylethyl)phenyl]-2-
methylpropyl]-2,6-dimethylmorpholine
Fenpropimorph
VOLLEY™ 88OL (foreign)
Morpholine Fungicide
121402
67564-91-4
Not Registered; Import Tolerance Established
Fungicide
BASF Corporation
Agricultural Products Division
26 Davis Drive, P.O. Box 13528
Research Triangle Park, NC 27709
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Tolerance Established
Tolerances were established for fenpropimorph in the 40 CFR §180.616 for imported bananas at
2.0 ppm.
Use Pattern and Formulations
Fenpropimorph is a systemic morpholine fungicide which controls Sigatoka diseases
(Mycosphaerella spp.) in bananas and plantains imported into the U.S. Fenpropimorph provides
protectant and eradicant activity by inhibiting ergosterol biosynthesis. The fungicide, known as
VOLLEY™ 880L Fungicide, is proposed for registration in Mexico, Guatemala, Belize, El
Salvador, Honduras, Columbia, Nicaragua, Costa Rica, and Panama. There are currently no U.S.
tolerances established for residues of fenpropimorph in plant or animal commodities and BASF is
not proposing any uses for fenpropimorph on bananas grown in the U.S.
TABLE 1 Summary of Current Foreign Use Directions for Fenpropimorph on Imported
Bananas 1.
End-Use Product
(EUP)
VOLLEY™ 88OL
Foliar broadcast spray
to underside of leaves
(ground equipment) or
to foliage canopy
(aerial equipment)
Applications
Timing 2
[Application
Sequence]
[1] Raceme
formation
[2] Raceme
development
[3] Raceme
development
[4] Mature mats
Maximum Single
Rate/Seasonal Rate2
(kg ai/ha)
single rate = 0.44
maximum seasonal rate -
1.76 applied 4 times per
season
RTI3(Days)
NA5
12
44
12
PHI4
(Days)
0
1. There are no current uses for fenpropimorph in the US.
2. Not specified in the current use directions, but supported by the field trials.
3. RTI = Re-Treatment Interval; not specified in the current use directions, but supported by the field trials.
4. PHI = Pre-Harvest Interval.
5. NA = Not Applicable.
-------
Science Findings
Available product chemistry and toxicology data supporting the proposed tolerance are
summarized below.
Physical/Chemical Structure:
CH3
C—C —C—N
H R
CH,
0
TABLE 1 Physico chemical Properties.*
Parameter
Melting Point/Range (°C)
pH
Density at 20°C (g/cm3)
Water Solubility at 20°C, pH 7 (mg/L)
Solvent Solubility at 20 °C (g/100 ml)
Vapor Pressure at 20°C (Pa)
Dissociation Constant (pKa)
Octanol/Water Partition Coefficient at 22°C, pH 7 (Log [Kow])
UV/Visible Absorption
Value
Liquid at STP
Not available
0.933 [technical material]
4.32
Acetone
Ethyl Acetate
Toluene
Dichloromethane (DCM)
n-Heptane
ACN
Methanol
Iso-propanol
Octanol
760.35
777.95
764.60
774.20
725.35
772.70
789.15
816.70
770.50
3.5x 10'3
Does not dissociate
4.1
Not available
* References: PP#7E4874 administrative materials (MRIDs #44323902, 45857201, 46097501).
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Table 3a: Acute Toxicity for Fenpropimorph Technical (91%)
GDLN
870.1100
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral - rat
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation - rat
Acute Eye Irritation - rabbit
Acute Dermal Irritation -
rabb it
Dermal Sensitization - guinea
Pig
MRID
No.
45857208
45857209
45857210
45857211
45857212
45857213
b
Results
LD50: M = 2830 mg/kg
F = 1670 mg/kg
combined = 2230 mg/kg
LD50: M = 36 50 mg/kg
F = 3425 mg/kg
combined =3515 mg/kg
LD50: M = >4000 mg/kg
F = > 4000 mg/kg
combined = > 4000 mg/kg
LC50: M = 3.7 mg/L
F = >2.2,<2.4 mg/L
combined = 2.9 mg/L
Redness (no observations between 72
hr and day 8)
Severely irritating after 1-hr exposure
b
Toxicity
Category
III
III
III
IV
Ha
I
N/A
a = no worse than Category II
b = study not provided
N/A = not applicable
Table 3b: Acute Toxicity for End-Use Product (5.4%)
GDLN
870.1100
870.1200
870.1300
870.2400
Study Type
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation - rat
Acute Eye Irritation - rabbit
MRID
45857203
45857204
45857205
45857206
Results
LD50: M = >2 000 mg/kg
F = > 2000 mg/kg
combined = > 2000 mg/kg
LD50: M = > 2000 mg/kg
F = > 2000 mg/kg
combined = > 2000 mg/kg
LC50: M = 3.62 mg/L
F = 1.52 mg/L
combined not reported
severely irritating
Toxicity
Category
III
III
III
I
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Table 3b: Acute Toxicity for End-Use Product (5.4%)
GDLN
870.2500
870.2600
Study Type
Acute Dermal Irritation -
rabb it
Dermal Sensitization - guinea
Pig
MRID
45857207
a
Results
severely irritating and irreversible
damage
a
Toxicity
Category
I
N/A
a = study not provided
N/A = not applicable
Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.1100
870.6100
Acute oral toxicity
and acute delayed
neurotoxicity of
organopho spho rus
substances - Hens
(gavage)
92.5%
44323909 (1980)
Acceptable/guideline
Acute oral study single
dose: 250, 500, 1000,
2000, or 4000 mg/kg
(with or without
pretreatment with
atropine sulfate and
PAM)
Acute delayed study
single dose: 425, 850 or
1700 mg/kg (pretreated
with atropine sulfate and
PAM)
10 hens treated with
fenpropimorph at 1700
mg/kg
ACUTE ORAL STUDY
Oral LD50: Unprotected = 1,600 mg/kg
Protected = 1,700 mg/kg
Toxicity Category = III
ACUTE DELAYED STUDY
NOAEL = >1700 mg/kg (HOT)
LOAEL = not observed for delayed neurotoxicity
870.3100
90-Day dietary
toxicity - Rat
91.1%
44380103 (1979)
Acceptable/guideline
ppm=0, 6.25, 12.5 or 25
M=0, 0.382,0.768 or
1.54 mg/kg/day
F=0, 0.465, 0.915 or 1.80
mg/kg/day
NOAEL= M: 0.768 mg/kg/day
F: 0.915 mg/kg/day
LOAEL= M: 1.54 mg/kg/day based on increased relative
liver weights and increase incidence of liver single cell
necrosis
F: 1.80 mg/kg/day based on increased absolute
and relative liver weights and increase incidence of liver
single cell necrosis
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Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.3100
870.6200
90-Day dietary
toxicity and
neurotoxicity - Rat
94.3%
44380105 (1997)
Acceptable/guideline
ppm=0, 1, 10, 100 or
1000
M=0, 0.1, 0.7, 7.1 or 71.0
mg/kg/day
F= 0,0.1, 0.8, 8.5 or 77.7
mg/kg/day
[FOB & motor activity
days-7, 22, 50,85;
5/sex/group profused
neurohistology exams]
SYSTEMIC
NOAEL=M: 0.7 mg/kg/day
F: 0.8 mg/kg/day
LOAEL=M: 7.1 mg/kg/day based on I BW & BWG,
T absolute & relative liver wt
F: 8.5 mg/kg/day based on I BW & BWG,
T relative liver wt
NEUROTOX
NOAEL= M: 7.1 mg/kg/day
F: 8.5 mg/kg/day
LOAEL= M: 71.0 mg/kg/day based on differences in
landing foot splay values
F: 77.0 mg/kg/day based on differences in
landing foot splay values
870.3150
90-Day dietary
toxicity - Dog
91.1%
44380104 (1980)
Acceptable/guideline
ppm=0, 50, 100, 200 or
400
M=0, 1.46,2.96,6.40 or
11.63 mg/kg/day
F=0, 1.77, 3.69, 7.92 or
14.64 mg/kg/day
NOAEL= M: 11.63 mg/kg/day
F: 14.64 mg/kg/day
LOAEL= M: not established
F: not established
870.3200
28-Day dermal
toxicity - Rat
96.6%
45868902 (2001)
Acceptable/guideline
M=0, 0.2,0.6 or 2.0
mg/kg/day
F= 0,0.2, 0.6 or 2.0
mg/kg/day
NOAEL = M: 2.0 mg/kg/day
F: 2.0 mg/kg/day
LOAEL = M: not established
F: not established
NOTE: from a range-finding study, the material was tested
at the maximum dose that would not produce severe skin
irritation
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Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.3700
Developmental
toxicity - Rat
(gavage)
92.5%
44380108 (1978)
Acceptable/guideline
(PRE-GLP)
2000 - Supplemental
submission of data
concerning test article
preparation, solubility &
stability (no MRID #)
mg/kg/day=0, 2.5, 10, 40
or 160
MATERNAL
NOAEL= 40 mg/kg/day
LOAEL= 1 60 mg/kg/day based on clinical signs of toxicity
(vaginal bleeding) and 1BW & BWG
DEVELOPMENTAL
NOAEL= 40 mg/kg/day
LOAEL= 160 mg/kg/day based on l# live fetuses/dam, T
resorptions, T% postimplantation loss, Tincidence of cleft
palate 14/274 fetuses (7/24 litters) with 0 in controls
870.3700
Developmental
toxicity - Rat
(gavage)
92.5%
44323912 (1979)
Acceptable/non-guideline
(dosing during gestation
& lactation; partial
developmental
neurotox thru PND 21)
2000 - Supplemental
submission of data
concerning test article
preparation, solubility &
stability (no MRID #)
mg/kg/day=0, 2.5, 10,40
or 160
MATERNAL
NOAEL=10 mg/kg/day
LOAEL=40 mg/kg/day based on iBWG
DEVELOPMENTAL
NO AEL= 10 mg/kg/day
LOAEL= 40 mg/kg/day based on 1# live fetuses/dam, T%
postimplantation loss, I mean litter size & # live pups, 1
survival indices
NEUROTOXICITY
NOAEL=10 mg/kg/day
LOAEL= 40 mg/kg/day based on i F grip strength
NOTE: no visceral or skeletal examinations of fetuses/pups
870.3700
Prenatal
Developmental -
Rabbit (gavage)
95.6%
44323914 (1993)
Acceptable/guideline
mg/kg/day=0, 7.5, 15 or
30
MATERNAL
NO A EL = 15 mg/kg/day
LOAEL = 30mg/kg/day based on clinical signs (9/20
swelling of anus GD 15-29)
DEVELOPMENTAL
NO A EL = 15 mg/kg/day
LOAEL = 30 mg/kg/day based on cleft palate 4/116 fetuses
(2/20 litters), 0 in control; anomalies
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Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.3700
Prenatal
Developmental -
Rabbit (gavage)
92.5%
44323913 (1980)
Acceptable/guideline
mg/kg/day=0, 2.4, 12 or
60 (mortality at 60)
supplementary:
mg/kg/day=0 or 36
MATERNAL
NOAEL = 12 mg/kg/day
LOAEL = 36 mg/kg/day based on mortality, abortions and
clinical signs of toxic ity
DEVELOPMENTAL
NOAEL = 12 mg/kg/day
LOAEL = 36 mg/kg/day based on increased incidence of
resorptions, external anomalies and skeletal
variations/retardations.
870.3800
2-Generation
reproduction study -
Rat, diet
92.5%
44323915 (1982)
Acceptable/non-guideline
ppm=0, 6.25, 12.5 or 25
M=0, 0.51, 1.03 or2.04
mg/kg/day
F=0, 0.71, 1.46 or 2.79
mg/kg/day
PARENTAL
NOAEL=M: 2.04 mg/kg/day
F: 2.79 mg/kg/day
LOAEL =M: not attained
F: not attained
REPRODUCTION
NOAEL=M:2.04 mg/kg/day
F: 2.79 mg/kg/day
LOAEL=M: not attained
F: not attained
OFFSPRING
NOAEL=M: 2.04 mg/kg/day
F: 2.79 mg/kg/day
LOAEL=M: not attained
F: not attained
NOTE: animals not dosed high enough; 25 ppm based on T
relative liver wts in 3-month rat study
870.4300
114-Week
chronic/carcino-
genicity dietary study
-Rat
92.5%
44380106 (1982)
Acceptable/guideline
ppm=0, 5, 10, 50 or 250
M=0,0.2, 0.3, 1.7 or 8.8
mg/kg/day
F=0,0.2, 0.4, 2.1 or 11.2
mg/kg/day
NOAEL =M: 1.7 mg/kg/day
F: 2.1 mg/kg/day
LOAEL =M: 8.8 mg/kg/day based on histopathological
liver findings
F: 11.2 mg/kg/day based on histopathological
liver findings
NO EVIDENCE OF CARCINOGENICITY
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Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.4100
12-Month dietary
toxicity - Dog, diet
>94.7%
44323911 (1990)
Acceptable/guideline
ppm=0, 25, 100 or 400
M= 0,0.8, 3.2 or 12.3
mg/kg/day
F=0,0.8, 3.2 or 13.2
mg/kg/day
NOAEL=M: 3.2 mg/kg/day
F: 3.2 mg/kg/day
LOAEL=M: 12.3 mg/kg/day based on T blood enzyme
activity >200% (ALT, liver)
F: 13.2 mg/kg/day based on T blood enzyme
activity >200% (ALT, liver)
870.4200
Carcinogenicity
study - Mouse, diet
92.5%
44380107 (1982)
Acceptable/guideline
ppm=0, 5, 30, 150 or
1000
M=0, 0.5,3.0, 16 or 106
mg/kg/day
F=0, 0.5, 3.5, 17 or 118
mg/kg/day
treatment=95 wks;
10/sex/group terminated
wk 52 & wk 95; survivors
untreated until wk
103/104
NOAEL=M: 16 mg/kg/day
F: 118 mg/kg/day
LOAEL=M: 106 mg/kg/day based on I BWG
F: not attained
NO EVIDENCE OF CARCINOGENICITY
870.5100
Reverse Gene
Mutation Assay
(Salmonella
typhimurium)
95.6%
44323917 (1994)
Acceptable/guideline
No evidence of induced mutant colonies over background.
870.5375
In vitro Chinese
hamster lung cells
95.6%
44323919 (1995)
Acceptable/guideline
There were no treatment-related increases in total
aberration frequency at any dose level with or without
metabolic activation.
870.5395
In vivo mammalian
cytogenetics -
micronucleus assay
in mice
95.6%
44323918 (1994)
Acceptable/guideline
No significant increase in the frequency of micronucleated
polychromatic erythrocytes in bone marrow at any dose at
any sampling time.
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Table 4 Acute, Subchronic, Chronic and Other Toxicity Profile
Guideline No./
Study Type
MRID No. (year)/
Classification/Doses
RESULTS
870.5550
Unscheduled DNA
synthesis in primary
rat hepatocytes
94.7%
44323916 (1988)
Acceptable/guideline
There was no evidence that unscheduled DNA synthesis, as
determined by radioactive tracer procedures, was induced.
870.6200
Acute neurotoxicity
screening battery - rat
94.3%
44323910 (1997)
Acceptable/guideline
M=0, 100, 500 or 1500
mg/kg (single gavage
dose)
NOAEL=M: 500 mg/kg
F: 500 mg/kg
LOAEL=M: 1500 mg/kg based on piloerection
observations during the clinical examinations and FOB and
neuropathy (one had slight dilation of ventricles in the
frontal lobe, parietal lobe and the midbrain)
F: 1500 mg/kg based on piloerection observations
during the clinical examinations and FOB and decreased
overall motor activity
870.6200
Subchronic toxicity
and neurotoxicity -
Rat, diet
[See 870.3100]
44380105 (1997)
Acceptable/guideline
NOTE: for doses, see
870.3100
NOTE: for results, see 870.3100
Toxicological Endpoints
Table 5 Fenpropimorph - Summary of Toxicological Doses and Endpoints for Chemical for Use in Human
Health Risk Assessments
Exposure
Scenario
Acute Dietary
(females 13-49)
Acute Dietary
(general population)
Dose Used in Risk
Assessment, UF
NOAEL= 15
mg/kg/day
Total UF= 100X
Acute RfD =
0.15 mg/kg/day
Special FQPA SF
and Level of Concern
for Risk Assessment
FQPASF= IX
aPAD = Acute RfD
FQPA SF
aPAD = 0.15 mg/kg/day
Study and Toxicological Effects
Rabbit Developmental Study
Developmental LOAEL = 30
mg/kg/day based on cleft palates
No toxico logical endpoint attributable to a single exposure was identified in the available
toxicity studies
10
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Chronic Dietary
(all populations)
Cancer (oral,
dermal, inhalation)
NOAEL = 3.2
mg/kg/day
Total UF = 100X
Chronic RfD =
0.032 mg/kg/day
FQPA SF = IX
cPAD =Chronic RfD
FQPA SF
cPAD = 0.032
mg/kg/day
One- Year Dog and
Chronic/Carcinogenicity Rat Studies
[Co-critical studies for endpoint
selection].
LOAEL of 9-1 1 mg/kg/day, based on
liver histopathology
Classification: "Not likely to be carcinogenic to humans." No increased incidences in
tumors in a chronic/carcinogenicity rat study or a carcinogenicity mouse study.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level,
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD =
reference dose, MOE = margin of exposure, LOG = level of concern, NA = Not Applicable
Food Quality Protection Act Considerations:
FQPA Safety Factor:
There is a complete toxicity database and the Special FQPA Safety Factor was removed, reduced
to IX, because: 1) there is a low degree of concern for the qualitative susceptibility in
developmental rat and rabbit studies, because the fetal effects were observed only in the presence
of maternal toxicity; and 2) there is no concern for pre/post natal toxicity since no off-spring
toxicity was seen in the 2-generation reproduction study; 3) the endpoints of concern are
addressed in this risk assessment; and 4) the dietary exposure assessment assumed tolerance level
residues and 100% crop treated.
Exposure Assessment:
Fenpropimorph is proposed for use only on imported bananas. Since there are no registered
(neither agricultural, occupational nor residential) uses associated with fenpropimorph in the U.S.,
the only route of exposure is dietary (food only). Dietary exposure will be limited to residues
from imported bananas. With no proposed U.S. registrations, there is no expectation that
fenpropimorph residues would occur via water consumption or residential use. Therefore, neither
a residential, water or aggregate exposure is expected.
Acute: An acute dietary dose and an endpoint attributable to a single dose were identified
for only one subpopulation, females ages 13 through 49. The acute exposure estimate of
approximately 0.004 mg/kg/day corresponds to 2.6 % of the aPAD. An appropriate
endpoint attributable to a single exposure was not identified for the general population nor
any of the other population subgroups.
Chronic: The chronic exposure estimate for the most highly exposed population subgroup
(children 1-2 years old) was approximately 0.004 mg/kg/day, or 11 % of the cPAD. Risks
for the general U.S. population and all other population subgroups were lower. Based on
11
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the dietary exposure analyses conducted, there are no dietary risk concerns for
fenpropimorph.
Cancer: Fenpropimorph has been classified as not likely to be carcinogenic to humans,
and therefore it is not expected to pose a cancer risk.
DATA GAP
Requested additional acceptable method validation recovery data using either BASF
Method 456/0, the Dutch or the German Multiresidue Method.
Contact person at USEPA
Mailing address:
Mary L. Waller
Product Manager (21)
Environmental Protection Agency
Office of Pesticide Programs
Registration Division (7505C)
Fungicide Branch
1200 Pennsylvania Avenue NW
Washington, D.C. 20460
Office location and telephone number:
Room 249, Crystal Mall #2
1801 S. Bell St.
Arlington, VA 22202
703-308-9354
DISCLAIMER: The information in this Pesticide Fact Sheet is for information only and is not to
be used to satisfy data requirements for pesticide registration. The information is believed to be
accurate as of the date on the document.
12
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APPENDIX I:
GLOSSARY OF TERMS AND ABBREVIATIONS
ADNT Acute delayed neurotoxicity
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
ARI Aggregate Risk Index
BCF Bioconcentration Factor
BW Body Weight
BWG Body Weight Gain
CAS Chemical Abstracts Service
ChE Cholinesterase
ChEI Cholinesterase inhibition
cPAD Chronic Population Adjusted Dose
%CT Percent crop treated
DAT Days after treatment
DEEM-FCID Dietary Exposure Evaluation Model - Food Consumption Intake Database
DNA Deoxyribonucleic acid
DNT Developmental neurotoxicity
DIT Developmental immunotoxicity
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EPA U.S. Environmental Protection Agency
FOB Functional Observation Battery
FQPA Food Quality Protection Act
GLC Gas Liquid Chromatography
GLN Guideline Number
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed as
the weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg
or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral,
dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LOAEL Lowest Observed Adverse Effect Level
LOAEC Lowest Observed Adverse Effect Concentration
LOC Level of Concern
LOD Limit of Detection
LOQ Limit of quantitation
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
13
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MRID Master Record Identification (number), EPA's system of recording and tracking
studies submitted
MTD Maximum tolerated dose
NA Not Applicable
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NOAEC No Observed Adverse Effect Concentration
NPDES National Pollutant Discharge Elimination System
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/
EXAMS Tier II Surface Water Computer Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
TGAI Technical Grade Active Ingredient
UF Uncertainty Factor
jig micrograms
Hg/L Micrograms Per Liter
jiL/g Microliter per gram
USDA United States Department of Agriculture
WPS Worker Protection Standard
wt(s) weight(s)
t Increase
1 Decrease
14
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Appendix II
Citations Considered to be Part of the Data Base Supporting the Registration of
Fenpropimorph
MRID
44323900
44323901
44323902
44323903
44323904
44323905
44323906
44323907
44323908
44323909
44323910
Citation
BASF Corp. (1997) Submission of Product Chemistry, Toxicology, Nature of Residue in
Plants and Animals, and Residue in Plants Data in Support of the Import Tolerance Petition
for Fenpropimorph in/on Bananas. Transmittal of 32 Studies.
Tobia, A. (1997) FQPA Informative Summary: Fenpropimorph Import Tolerance for
Bananas: Lab Project Number: 97/5276. Unpublished study prepared by BASF Corp. 12 p.
Ohnsorge, U. (1997) Product Identity and Composition of Fenpropimorph TGAI: Lab
Project Number: 97/10567. Unpublished study prepared by BASF Aktiengesellschaft. 40 p.
{OPPTS 830.1600, 830.1620, 830.1670}
Bross, M. (1993) Preliminary Analysis: Composition of Five Batches of
Fenpropimorph. ..Technical: Lab Project Number: 93/10078: PCP02250. Unpublished study
prepared by BASF Aktiengesellschaft. 41 p. {OPPTS 830.1700}
Kastel, R. (1994) Physical and Chemical Properties Report for Fenpropimorph. ..TGAI: Lab
Project Number: 94/10392: PCF 01296. Unpublished study prepared by BASF
Aktiengesellschaft. 9 p. {OPPTS 830.6313, 830.7300, 830.7000, 830.7220, 830.6315,
830.7100, 830.6302, 830.6303, 830.6304}
Ohnsorge, U. (1997) Storage Stability Data for Fenpropimorph TC: Lab Project Number:
97/10577. Unpublished study prepared by BASF Aktiengesellschaft. 4 p. {OPPTS
830.6317}
Bross, M. (1992) Determination of Fenpropimorph in Technical Fenpropimorph by
Capillary GC: Analytical Method CP No. 149/1: Lab Project Number: 92/11989.
Unpublished study prepared by BASF Aktiengesellschaft. 9 p. {OPPTS 830.1800}
Bross, M. (1 992) Determination of Impurities in Technical Fenpropimorph by Capillary GC:
Analytical Method CP No. 179: Lab Project Number: 92/11988. Unpublished study
prepared by BASF Aktiengesellschaft. 32 p. {OPPTS 830.1800}
Bross, M. (1993) Validation of GC-Methods CP 149/1 and CP 179: Determination of Active
Ingredient and Impurities in Fenpropimorph Technical: Lab Project Number: 93/10190:
PCP02195. Unpublished study prepared by BASF Aktiengesellschaft. 44 p.
Robert, N.; Fairley, C.; Prentice, D.; et al. (1980) The Acute Oral Toxicity (LD50) and
Neurotoxic Effects of Fenpropimorph.. .to the Domestic Hen: Lab Project Number: 80/0204:
BSF 336/80382: BSF/336. 40 p.
Mellert, W.; Kaufmann, W.; Hildebrand, B. (1997) Acute Oral Neurotoxicity of
Fenpropimorph. ..in Wistar Rats: Lab Project Number: 97/10592: 20C0047/93061.
Unpublished study prepared by BASF Aktiengesellschaft. 420 p.
15
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44323911
Hellwig (1990) Report on the Study of Fenpropimorph...in Beagle Dogs—Administration via
the Diet over 12 Months: Lab Project Number: 90/0172: 33D0133/87021. Unpublished
study prepared by BASF Aktiengesellschaft. 842 p.
44323912
Hoffmann, T.; Merkle, J. (1979) Study of the Perinatal and Postnatal Toxicity of
Fenpropimorph...in Rats: Lab Project Number: 79/10164: T282R. Unpublished study
prepared by BASF Aktiengesellschaft. 344 p.
44323913
Zeller, H.; Merkle, J. (1 980) Study to Determine the Prenatal Toxicity of Fenpropimorph...in
Rabbits: Lab Project Number: 80/0109: T316K. Unpublished study prepared by BASF
Aktiengesellschaft. 258 p.
44323914
Marty, J. (1993) CGA 101 031 (Fenpropimorph) Technical: Rabbit Oral Teratogenicity:
(Final Report): Lab Project Number: 93/11016: 923154. Unpublished study prepared by
Ciba-Geigy Ltd. 263 p.
44323915
Merkle, J. (1982) Report on a Reproduction Study with Fenpropimorph...in Rats After Oral
Administration (Feeding): 2-Generation Study: Lab Project Number: 82/079. Unpublished
study prepared by BASF Aktiengesellschaft. 1152 p.
44323916
Cifone, M. (1988) Report on the Mutagenicity Test on Fenpropimorph in the Rat Primary
Hepatocyte Unscheduled DNA Synthesis Assay: (Revised Final Report): (Includes Phase 3
Summary): Lab Project Number: 88/0210: 10001-0-447: 61M0133/879008. Unpublished
study prepared by Hazleton Labs America, Inc. 37 p.
44323917
Engelhardt, G. (1994) Report on the Study of Fenpropimorph in the Ames Test
(Salmonella/Mammalian-Microsome Mutagenicity Test—Standard Plate Test and
Preincubation Test): Lab Project Number: 94/10180: 40M0047/934047: 934047.
Unpublished study prepared by BASF Aktiengesellschaft. 40 p.
44323918
Engelhardt, G. (1994) Cytogenetic Study in vivo of Fenpropimorph in Mice Micronucleus
Test: Single Intraperitoneal Administration: (Includes Phase 3 Summary): Lab Project
Number: 94/10966: 26M0047/934049. Unpublished study prepared by BASF
Aktiengesellschaft. 72 p.
44323919
Engelhardt, G. (1995) In vitro Chromosome Aberration Assay (with Fenpropimorph in V79
Cells): Lab Project Number: 95/10325: 32M0047/934078. Unpublished study prepared by
BASF Aktiengesellschaft. 93 p.
44323920
van Dijk, A. (1989) (Carbon 14)-RO 14/3169: Absorption, Distribution, Excretion, and
Metabolism after Single Oral Intravenous, Single Oral, and Repeated Oral Administration to
the Rat: Lab Project Number: 89/0315: 063641. Unpublished study prepared by RCC
Umweltchemie AG. 413 p.
44323921
Hawkins, D.; Down, W.; Ballard, S.; et al. (1981) The Effect of Fenpropimorph (BAS 108
406) on Hepatic Drug-Metabolizing Enzyme Activity in the Rat: (Final Report): Lab Project
Number: 81/0367: BSF 368/81203. Unpublished study prepared by Huntingdon Research
Centre. 72 p.
44323922
Hamm, R. (1995) Plant Uptake with (carbon 14)-Fenpropimorph (Phenyl-U-(carbon 14)) in
Banana: Lab Project Number: P94/16867: 95/10710. Unpublished study prepared by BASF
16
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44323924
44323925
44323926
44323927
44323928
44323929
44323930
44323931
44323932
44380100
44380101
44380102
Aktiengesellschaft. 21 p. {OPPTS 860.1300}
Hamm, R. (1995) Plant Uptake with (carbon 14)-Fenpropimorph (Morpholine-2,6-(carbon
14)) in Banana: Lab Project Number: P94/16866: 95/10709. Unpublished study prepared by
BASF Aktiengesellschaft. 28 p. {OPPTS 860.1300}
Tilting, N. (1993) Gaschromato graphic Determination of Fenpropimorph in Banana Fruit,
Peel, and Pulp: Lab Project Number: 93/11464: 241/1. Unpublished study prepared by
BASF Aktiengesellschaft. 69 p. {OPPTS 860.1340}
Shaffer, S. (1997) Specificity Test for BASF Analytical Method No. 241/1, "Gas
Chromatographic Determination of Fenpropimorph in Banana Fruit, Peel, and Pulp": Lab
Project Number: 97/5003: 96122: 10170. Unpublished study prepared by Horizon Labs, Inc.
48 p. {OPPTS 860.1340}
Artz, S.; Malinsky, S. (1997) Independent Method Validation of BASF Analytical Method
No. 241/1, "Gas Chromatographic Determination of Fenpropimorph in Banana Fruit, Peel,
and Pulp" at BASF: Lab Project Number: 97/5077: 96139: 241/1. Unpublished study
prepared by BASF Corp. 35 p. {OPPTS 860.1340}
Zehr, R. (1997) Document Detailing Additional Comments and Procedures Used for the
Conduct of the Independent Laboratory Validation... of BASF Method 241/1: Lab Project
Number: 97/5290: 93/11464: 97/5077. Unpublished study prepared by BASF Corp. 4 p.
{OPPTS 860.1340}
Fomenko, J. (1996) PAM I Multiresidue Testing for BAS 421 F: Lab Project Number:
96/5076: A008.076: 96013. Unpublished study prepared by Maxim Technologies, Inc. 46 p.
{OPPTS 860.1360}
Shaffer, S. (1997) Determination of the Freezer Storage Stability of BAS 421 F in Bananas:
Lab Project Number: 97/5093: 10171: 96123. Unpublished study prepared by Horizon Labs,
Inc. 51 p. {OPPTS 860.1380}
Wofford, J.; Artz, S. (1997) Magnitude of Fenpropimorph Residues in Banana: Lab Project
Number: 97/5004: 95162: A9710. Unpublished study prepared by Horizon Labs, Inc. and
BASF Corp. 335 p. {OPPTS 860.1500}
Sotack, G. (1997) BAS 421 13 F: Tank Mix Stability/Homogeneity Study of Corbel
Fungicide in Oil: Lab Project Number: 97/5165: 97088: FR9729. Unpublished study
prepared by BASF Corp. 16 p.
Burkey, J. (1997) Fenpropimorph Use on Bananas: Residue Chemistry Overview: Lab
Project Number: 97/5288. Unpublished study prepared by BASF Corp. 19 p.
BASF Corp. (1997) Submission of Product Chemistry, Toxicology and Residues Data in
Support of Tolerance Petition for Fenpropimorph in/on Banana. Transmittal of 10 Studies.
Petersen-Thiery, M. (1997) Certification of Limits for Fenpropimorph: Lab Project Number:
97/10429. Unpublished study prepared by BASF Aktiengesellschaft. 12 p. {OPPTS
830.1750}
Geiger-Jackson, D. (1997) Fenpropimorph: Manufacturing Materials Safety and
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Specifications: Lab Project Number: 97/5275: 97/10581. Unpublished study prepared by
BASF Corp. 97 p.
44380103
Kirsch, P. (1979) Study of the Toxicity of Fenpropimoroph (Reg. No. 108 406) on Rats in a
3-Month Feeding Experiment: Lab Project Number: 79/079. Unpublished study prepared by
BASF Aktiengesellschaft. 738 p.
44380104
Kirsch, P. (1980) Study of the Toxicity of Fenpropimoroph (Reg. No. 108 406) in Beagle
Dogs in a 3-Month Feeding Study: Lab Project Number: 80/0171. Unpublished study
prepared by BASF Aktiengesellschaft. 487 p.
44380105
Mellert, W.; Deckardt, K.; Kaufmann, W. et al. (1997) Subchronic Oral Toxicity and
Neurotoxicity of Fenpropimorph (Reg. No. 108 406) in Wister Rats Administration in the
Diet for 3 Months: Lab Project Number: 97/10591: 50C0047/93057. Unpublished study
prepared by BASF Aktiengesellschaft. 720 p.
44380106
Hunter, B.; Barnard, A.; Hayman, R. et al. (1992) Fenpropimorph (Reg. No. 108 406):
Assessment of Potential Tumorigenic and Toxic Effects in Prolonged Dietary
Administration to Rats: Lab Project Number: BAF/308/81138: 82/092. Unpublished study
prepared by Huntingdon Research Centre. 1974 p.
44380107
Hunter, B.; Heywood, R.; Hayman, R. et al. (1982) Fenpropimorph (Reg. No. 108 406):
Assessment of Potential Tumorigenic Effects in Prolonged Dietary Administration to Mice:
Lab Project Number: BAF/320/81746: 82/142: BSF/320. Unpublished study prepared by
Huntingdon Research Centre. 1201 p.
44380108
Hofmann, H. (1978) Investigation to Determine the Prenatal Toxicity of Fenpropimorph
(Reg. No. 108 406) in Rats: Lab Project Number: 78/043. Unpublished study prepared by
BASF Aktiengesellschaft. 141 p.
44380109
Kirsch, P. (1980) Report on the Study of the Cholinesterase Inhibition of Fenpropimorph
(Reg. No. 108 406) in Rats After a Single Intraperitoneal Administration: Lab Project
Number: 80/0205. Unpublished study prepared by BASF Aktiengesellscaft. 117 p.
44380110
Hamm, R. (1997) Metabolism of (carbon 14)-Fenpropimorph (BAS 421 F) in Banana: Lab
Project Number: 97/10536: 16868. Unpublished study prepared by BASF
Aktiengesellschaft. 150 p.
44835200
BASF Corporation (1999) Submission of Product Chemistry Data in Support of the Petition
for Tolerance of Fenpropimorph in/on Bananas. Transmittal of 1 Study.
44835201
Cannan, T. (1998) BAS 421..F: Stability to Normal and Elevated Temperatures, Metals, and
Metal Ions: Lab Project Number: 98118: FR9864: 98/5182. Unpublished study prepared by
BASF Corporation. 13 p. {OPPTS 830.1630}
46431600
BASF Corporation (2004) Submission of Toxicity Data in Support of the Petition for
Tolerance of Fenpropimorph. Transmittal of 4 Studies.
46431601
Hastings, C. (2004) Fenpropimorph: Response to Agency Questions on Analytical Results
For Test Material in Feed for 3-Month Rat Study MRID 44380103. Project Number:
2004/7009670. Unpublished study prepared by BASF Corporation. 5 p.
18
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Hastings, C. (2004) Fenpropimorph: Response to Agency Questions on Analytical Results
for Test Material in Feed for 3-Month Dog Study MRID 44380104. Project Number:
2004/7009671. Unpublished study prepared by BASF Corporation. 5 p.
46431603
Hastings, C. (2004) Fenpropimorph: Response to Agency Questions on Analytical Results
For Test Material in Feed and Historical Control Data in the Mouse Oncogenicity Study
MRID 44380107. Project Number: 2004/7009672. Unpublished study prepared by BASF
Corporation. 8 p.
46431604
Hastings, C. (2004) Fenpropimorph: Response to Agency Questions on Analytical Results
for Test Material in Feed for 2-Generation Rat Reproduction Study MRID 44323915.
Project Number: 2004/7009673. Unpublished study prepared by BASF Corporation. 5 p.
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