United States
Environmental Protection
Agency
Office of Prevention, Pesticides
and Toxic Substances
(7505 P)
SEPA
Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Pyriofenone
New Chemical; Import
Tolerances Established
March 2012
Year Issued:
DESCRIPTION OF CHEMICAL
Generic Name:
Common Name:
EPA Chemical Code:
Chemical Abstracts
Service (CAS) Number:
Registration Status:
Pesticide Type:
Chemical Class:
U.S. Producer:
(5-chloro-2-methoxy-4-methyl-3-pyridinyl)2,3,4-
trimethoxy-6-methylphenyl)methanone
Pyriofenone
028828
688046-61-9
Not Registered; Import Tolerances Established
Fungicide
Aryl phenyl ketone
ISK Biosciences Corporation
7470 Auburn Road, Suite A,
Concord, Ohio 44077
Page lofl3
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Tolerances Established
Import tolerances were established (without U.S. registrations) for residues of pyriofenone,
including its metabolites and degradates, in the 40 CFR §180.660 in or on grape at 0.30 ppm and
grape, raisin at 0.50 ppm.
Use Pattern and Formulations
Pyriofenone is an aryl phenyl ketone fungicide that is under consideration for registration in
Europe to control powdery mildew (Erysiphe necator) on grape vines. There are currently no
MRLs established by CODEX in Canada and Mexico for pyriofenone.
ISK Biosciences Corporation is supporting import tolerances on grape and grape, raisin.
Pyriofenone is not registered for use on any crops in the U.S. The proposed foreign use of
pyriofenone on grapes specifies a maximum of three foliar spray applications using a suspension
concentrate (SC) formulation at 0.08 lb ai/A per application (90 g ai/ha per application) with a
retreatment interval of 14 days. The total application rate on the proposed European label is 0.24
lb ai/A (270 g ai/ha). The proposed preharvest interval (PHI) is 28 days. The SC formulation
may be applied at any crop growth stage.
Science Findings
Available product chemistry data supporting the use of pyriofenone are summarized
below in Tables 1 and 2.
Table 1. Nomenclature of Pyriofenone
Compound
Chemical Structure
0
N O O J O
I Q
Common name
Pyriofenone
Company
experimental name
IKF-309
IUPAC name
(5-chloro-2-methoxy-4-methyl-3-pyridyl)(2,3,4-trimethoxy-6-
methylphenyl)ketone
CAS name
(5-chloro-2-methoxy-4-methyl-3-pyridinyl)2,3,4-trimethoxy-6-
methylphenyl)methanone
CAS registry
number
688046-61-9
End-use product
(EP)
300 g/L suspension concentrate (SC; Property 300 SC®)
Page 2 of 13
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Table 2. Phvsicochemical Properties of Pvriolenone.
Parameter
Value
Melting point/range
93-95 °C
pH
3.1
Density
1.36
Water solubility (at 20°C)
1.56 mg/L
Solvent solubility (g/L)
n-heptane 10-20
xylene >250
1,2-dichloroethane >250
Acetone >250
Methanol 20-50
n-octanol 2-5
ethyl acetate >250
Vapor pressure at 25°C
1.9 x 10"6 Pa
Dissociation constant (pKa)
No dissociation constant in environmental pH range of pH
4 to 10
Octanol/water partition
coefficient Log(K0w)
3.2
UV/visible absorption spectrum
Not available
Toxicology Summary
Based on the proposed use pattern, exposure to pyriofenone for the general public can occur via
dietary exposure (food) only. Chronic dietary exposure was assessed for all population
subgroups. Acute dietary exposure was not assessed because no toxicological study indicated the
possibility of an effect of concern occurring as a result of a 1-day or single exposure. For the
chronic assessment, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the
dose which the Environmental Protection Agency (the Agency) has concluded will results in no
unreasonable adverse health effects). This dose is referred to as the population adjusted dose
(PAD). The PAD is equivalent to the point of departure (POD) (endpoint) divided by the
required uncertainty and/or safety factors. For non-cancer chronic exposures, estimated dietary
risk that are less than 100% of the PAD are not of concern. There are no drinking water,
occupational or residential exposures associated with the establishment of the import tolerances.
Toxicity Endpoints
In risk assessments for import commodities, endpoints are typically selected for dietary exposure
only. Endpoints for incidental oral, dermal and inhalation exposures are not selected for import
tolerances due to lack of potential occupational or residential exposure. A summary of the
toxicological endpoints for pyriofenone used for human risk assessment is shown in Table 3.
Acute Dietary: Quantitative acute dietary exposure and risk assessments are performed for a
food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern
occurring as a result of a 1-day or single exposure. No such effects were identified in the
toxicological studies for pyriofenone; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
Page 3 of 13
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Chronic Dietary: The chronic population adjusted dose (cPAD) is derived from the 2-year
carcinogenicity study in rats, which had a LOAEL of 46 mg/kg/day based on increased incidence
of chronic nephropathy and a NOAEL of 9 mg/kg/day was selected from the same study. Since
the active ingredient is not registered or proposed for use in the United States, endpoints for
occupational and residential exposures have not been determined. An uncertainty factor of 100X
was applied to the chronic point of departure (POD) selected for oral exposure routes (10X for
interspecies extrapolation, 10X for intraspecies variation).
Short- and Intermediate-Term Dermal and Inhalation: Dermal toxicity, inhalation toxicity,
and ocular irritation studies are not available because these exposure routes are not applicable to
non-domestic uses.
Carcinogenicity: EPA classified pyriofenone as "Not Likely to be Carcinogenic to Humans"
based on lack of evidence for carcinogenicity in male and female mice and rats in chronic
toxicity studies. This classification is supported by the lack of mutagenic potential both in vivo
and in vitro. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is
not necessary.
Neurotoxicity: There was no evidence of neurotoxicity in the pyriofenone hazard database,
which included acute and subchronic neurotoxicity studies.
Developmental Toxicity: There was no evidence of increased quantitative or qualitative
susceptibility to the fetus or to offspring. No developmental toxicity occurred in the rat
developmental toxicity study. Abortions and premature delivery were attributed to maternal
stress because they were associated with decreased maternal body weight gain and food
consumption, occurred late in gestation, and were therefore attributed to maternal distress.
Reproductive Toxicity: No reproductive toxicity occurred in the 2-generation reproduction
study. Parental effects at the high dose included liver and kidney pathology and decreased
hematological parameters; the only offspring effect was decreased spleen weight at the high dose.
Dermal Toxicity: Dermal toxicity studies are not available because these exposure routes are
not applicable to non-domestic uses.
Table 3. Summary of Toxicological Doses and Endpoints for Pyriofenone for Dietary
Human Health Risk Assessments
Exposure/
Scenario
Point of
Departure
(POD)
Uncertai nty/F Q PA
Safety Factors
RfD, PAD,
Level of
Concern
for Risk
Assessment
Study and Toxicological Effects
Acute
Dietary
An acute dietary endpoint was not selected because toxicity from a single dose
was not identified in the hazard database.
Chronic
Dietary (All
NOAEL=
9
UFa= IOx
UFh= IOx
Chronic
RfD = 0.09
Chronic toxicity/ carcinogenicity
study- rat
Page 4 of 13
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Table 3. Summary of Toxicological Doses and Endpoints for Pyriofenone for Dietary
Human Health Risk Assessments
Exposure/
Scenario
Point of
Departure
(POD)
Uncertai nty/F Q PA
Safety Factors
RfD, PAD,
Level of
Concern
for Risk
Assessment
Study and Toxicological Effects
Acute
Dietary
An acute dietary endpoint was not selected because toxicity from a single dose
was not identified in the hazard database.
Populations)
mg/kg/day
FQPA SF= lx
mg/kg/day
cPAD =
0.09
mg/kg/day
NOAEL = 9 mg/kg/day based on
increased nephropathy seen in
female rats at LOAEL = 46
mg/kg/day.
Cancer
(oral,
dermal,
inhalation)
Classification: "Not likely to be Carcinogenic to Humans"
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and
used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human
exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF =
uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = potential variation in sensitivity
among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose.
Food Quality Protection Act Considerations
FQPA Safety Factor: The proposed use pattern for pyriofenone may result in dietary exposure
to infants and children. Thus, FQPA hazard considerations were addressed in the Agency's
evaluation of the toxicology database. The Agency recommends that the lOx FQPA Safety
Factor (for the protection of infants and children) be reduced to lx. The toxicological database
for pyriofenone is complete with regard to pre-and postnatal toxicity, neurotoxicity, and
immunotoxicity; there are no residual uncertainties. Additionally, the dietary exposure
assessment is based on conservative, health-protective assumptions that ensure that exposures to
pyriofenone are not underestimated.
Exposure Assessment
Dietary Exposures Assessment: The Agency conducted screening-level chronic dietary risk
assessments using the Dietary Exposure Evaluation Model with the Food Commodity Intake
Database (DEEM-FCID™). Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide. For chronic dietary assessments, the risk is expressed as a percentage of a
maximum acceptable dose (i.e., the dose which EPA has concluded will result in no
unreasonable adverse health effects). This dose is referred to as the population adjusted dose
(PAD). The PAD is equal to the POD divided by all pertinent safety factors, including the FQPA
SF. For acute and chronic exposures, the Agency is concerned when estimated dietary risk
Page 5 of 13
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exceeds 100% of the PAD.
A conservative chronic dietary (food only) exposure analysis was performed for the general U.S.
population and standard population subgroups. The assumptions of these unrefined assessments
were tolerance level residues for grapes and raisins, 100% crop treated, and no processing factors
for any other commodities as concentration was not observed in juice or wine. Chronic dietary
risk estimates are not of concern for the general population or any other population subgroup.
The most highly exposed population subgroup is children (1-2 years old), with exposures
resulting in estimated risks of 1% of the cPAD. Exposures were 1% or less of the cPAD for all
population subgroups
Table 4. Summary ol* Chronic Dietary (loot! Only) Kxposurc and Kisk lor I'yriorenone
Population Subgroup
Dietary l-\posuiv
(mu kg day)
"..dwn1
General U.S. Population
0.000158
-------
Aggregate Exposure: As stated previously, there are no existing or proposed US registrations
of pyriofenone and the only route of exposure is via dietary ingestion from imported grape
commodities. Therefore, aggregate exposure and risk estimates are equivalent to the dietary
exposures and risk estimates.
Cumulative Risk
EPA does not have, at this time, available data to determine whether pyriofenone has a common
mechanism of toxicity with other substances. Unlike other pesticides for which the Agency has
followed a cumulative risk approach based on a common mechanism of toxicity, the Agency has
not made a common mechanism of toxicity finding as to pyriofenone and any other substances
and pyriofenone does not appear to produce a toxic metabolite produced by other substances
which have tolerances in the U.S. For the purposes of this action, therefore, the Agency has not
assumed that pyriofenone has a common mechanism of toxicity with other substances.
CONTACT PERSON AT EPA
Mailing Address:
Heather Garvie
Fungicide Branch
Registration Division (7505P)
Office of Pesticide Programs
Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Office Location and Telephone Number:
One Potomac Yard
2777 Crystal Drive
S-7263
Arlington, VA 22202
E-mail: garvie.heather@epa.gov
Phone Number: 703-308-0034
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 or
reregi strati on.
Page 7 of 13
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APPENDIX I
Citations Considered to be Part of the Data Base Supporting the Establishment of
Pyriofenone Import Tolerances
MRU)
i Citation
48112800
| ISK Biosciences Corporation (2010) Submission of Product Chemistry,
| Residue, Fate and Toxicity Data in Support of the Petition for Tolerance of
j Pyriofenone for Use in/on Grapes. Transmittal of 36 Studies.
48112802
| Turner, B. (2010) Product Chemistry Studies for Technical Pyriofenone:
| Preliminary (Five Batch) Analysis. Project Number: IB/2010/MG/002/01,
j JSM0057. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 68
|p-
48112803
f
j Turner, B. (2009) Product Chemistry Studies for Technical Pyriofenone.
[ProjectNumber: IB/2010/MG/001/01, ISK0392, ISK0399. Unpublished study
| prepared by Huntingdon Life Sciences, Ltd. 180 p.
48112804
| Crowe, A. (2009) IKF-309: Metabolism in Grapes. Project Number: ISK0299.
| Unpublished study prepared by Huntingdon Life Sciences, Ltd. 82 p.
48112805
| Haynes, L. (2010) IKF-309: Metabolism in Lactating Goats. Project Number:
| ISK0297. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 169
lp'
48112806
i
j Brewin, S. (2008) IKF-309: Validation of Methodology for the Determination
| of Residues in Wheat (Grain and Straw) and Grapes. Project Number:
| ISK/0341, ISK/0341/074208. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 45 p.
48112807
Gemrot, F. (2009) Independent Laboratory Validation of IKF-309: Analytical
| Method in Grapes, Wheat Grain and Straw. Project Number: S09/02866.
Unpublished study prepared by Eurofins/ADME Bioanalyses. 79 p.
48112808
Schaufele, M. (2008) IKF-309: Residue Study (Decline) with IKF-309 300 SC
| (IBE 3985) Applied to Wine Grapes in Germany and Southern France in 2007.
| Project Number: ISK0301, LGV07/RE01. Unpublished study prepared by
| Huntingdon Life Sciences, Ltd. 68 p.
48112809
| Schaufele, M. (2009) IKF-309: Residue Study (at Harvest) with IKF-309 300
| SC (IBE 3985) Applied to Wine Grapes in Southern France in 2008. Project
1 Number: ISK0383, LGV08/RE03. Unpublished study prepared by Huntingdon
| Life Sciences, Ltd. 44 p.
48112810
| Schaufele, M. (2010) IKF-309 300 SC: Residue Study (Processing and Decline
1 with IKF-309 300 SC (IBE 3985)) Applied to Wine Grapes in Germany, Spain
and Italy in 2008. Project Number: ISK0381, LGV08/RE01, LGV08/RE02.
Page 8 of 13
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Unpublished study prepared by Huntingdon Life Sciences, Ltd. 169 p.
48112811
Schaufele, M. (2009) IKF-309 300 SC: Residue Study (at Harvest and
Processing) with IKF-309 300 SC (IBE 3985) Applied to Wine Grapes in
Northern and Southern France in 2008. Project Number: ISK0382,
LGV08/RE04, LGV08/RE05. Unpublished study prepared by Huntingdon Life
Sciences, Ltd. 138 p.
48112812
Schaufele, M. (2010) IKF-309 300 SC: Residue Study (at Harvest) with IKF-
309 300 SC (IBE 3985) Applied to Wine Grapes and Table Grapes in Northern
France, Spain and Italy in 2009. Project Number: JSM0015, LGV09/RE03.
Unpublished study prepared by Huntingdon Life Sciences, Ltd. 77 p.
48112813
Rockwell, D. (2010) PAM 1 Multiresidue Protocol Testing for IKF-309 in
Grapes. Project Number: 2125, IB/2010/JLW/009/01. Unpublished study
prepared by Pyxant Labs, Inc. 82 p.
48112814
Moore, E. (2008) IKF-309 Technical: Acute Oral Toxicity to the Rat (Acute
Toxic Class Method). Project Number: ISK0313. Unpublished study prepared
by Huntingdon Life Sciences, Ltd. 28 p.
48112815
Moore, E. (2009) IKF-309: Toxicity Study by Dietary Administration to CD-I
Mice for 13 Weeks. Project Number: ISK0291. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 268 p.
48112816
Ohtsuka, R. (2010) IKF-309 Technical: Repeated Dose 90-Day Oral Toxicity
Study in Rats. Project Number: IET/06/0015. Unpublished study prepared by
Institute of Environmental Toxicology. 423 p.
48112817
Nakashima, N. (2010) IKF-309 Technical: Repeated Dose 90-Day Oral
Toxicity Study in Dogs. Project Number: IET/06/0109. Unpublished study
prepared by Institute of Environmental Toxicology. 301 p.
48112818
Nakashima, N. (2010) IKF-309 Technical: Repeated Dose 1-Year Oral
Toxicity Study in Dogs. Project Number: IET/06/0110. Unpublished study
prepared by Institute of Environmental Toxicology. 369 p.
48112819
Ohtsuka, R. (2010) IKF-309 Technical: Carcinogenicity Study in Rats. Project
Number: IET/06/0086. Unpublished study prepared by Institute of
Environmental Toxicology. 696 p.
48112820
Moore, E. (2010) IKF-309 Carcinogenicity Study by Dietary Administration to
CD-I Mice for 78 Weeks. Project Number: ISK0305. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 1870 p.
48112821
Takahashi, K. (2010) IKF-309 Technical: Teratogenicity Study in Rabbits
Preliminary Study: Final Report. Project Number: IET/06/0115. Unpublished
study prepared by Institute of Environmental Toxicology. 104 p.
48112822
Takahashi, K. (2009) IKF-309 Technical: Teratogenicity Study in Rabbits.
Page 9 of 13
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| Project Number: IET/06/0116. Unpublished study prepared by Institute of
Environmental Toxicology. 125 p.
Hojo, H. (2009) IKF-309 Technical: A Teratogenicity Study in Rats: A Dose
48112823 [Range-Finding Study. Project Number: IET/06/0113. Unpublished study
| prepared by Institute of Environmental Toxicology. 105 p.
j Hojo, H. (2010) IKF-309 Technical: A Teratogenicity Study in Rats. Project
48112824 | Number: IET/06/0114. Unpublished study prepared by Institute of
Environmental Toxicology. 137 p.
Hojo, H. (2009) IKF-309 Technical: A Reproduction Toxicity Study in Rats:
48112825 | A Dose Range-Finding Study. Project Number: IET/06/0111. Unpublished
j study prepared by Institute of Environmental Toxicology. 284 p.
| Hojo, H. (2009) IKF-309 Technical: A Reproduction Toxicity Study in Rats.
48112826 | Project Number: IET/06/0112. Unpublished study prepared by Institute of
| Environmental Toxicology. 552 p.
j May, K. (2007) IKF-309 Technical: Bacterial Reverse Mutation Test. Project
48112827 | Number: ISK/0311/073744. Unpublished study prepared by Huntingdon Life
| Sciences, Ltd. 35 p.
j Hynes, L. (2008) IKF-309 Technical: in vitro Mutation Test Using Mouse
48112828 | Lymphoma L5178Y Cells. Project Number: ISK/0310. Unpublished study
j prepared by Huntingdon Life Sciences, Ltd. 41 p.
| Pritchard, L. (2008) IKF-309 Technical in vitro Mammalian Chromosome
48112829 | Aberration Test in CHL Cells. Project Number: ISK/0322. Unpublished study
| prepared by Huntingdon Life Sciences, Ltd. 50 p.
j Hynes, G. (2028) IKF-309 Technical: Mouse Micronucleus Test. Project
48112830 | Number: ISK/0327. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 39 p.
| Powell, L. (2009) IKF-309: Dose Range and Time to Peak Effect in Rats by
48112831 | Acute Oral Administration. Project Number: ISK0408. Unpublished study
j prepared by Huntingdon Life Sciences, Ltd. 114 p.
| Powell, L. (2010) IKF-309: Neurotoxicity Study by a Single Oral Gavage
48112832 1 Administration t0 CD Rats followed by a 14 Day Observation Period. Project
| Number: ISK0407. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 323 p.
| Arrowsmith, W. (2010) IKF-309: Neurotoxicity Study by Dietary
48112833 1 Administration to CD Rats for 13 Weeks. Project Number: JSM0027.
Unpublished study prepared by Huntingdon Life Sciences, Ltd. 323 p.
48112834 L- (2010) IKF-309: Metabolism in Rats. Project Number: ISK0281.
I Unpublished study prepared by Huntingdon Life Sciences, Ltd. 256 p.
Page 10 of 13
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48112835
| Laurent, M. (2010) IKF-309: 4-Week Dietary Immunotoxicity Study in the
j Female Mouse. Project Number: JSM0036. Unpublished study prepared by
| Huntingdon Life Sciences, Ltd. 118 p.
48112836
| Chambers, P. (2010) IKF-309: 4-Week Dietary Immunotoxicity Study in the
| Female Rat. Project Number: JSM0037. Unpublished study prepared by
j Huntingdon Life Sciences, Ltd. 122 p.
48125900
j ISK Biosciences Corporation (2010) Submission of Toxicity and Residue
| Data in Support of the Petition for Tolerance of Pyriofenone for Use in or on
| Grapes. Transmittal of 2 Studies.
48125901
| Ohtsuka, R. (2010) IKF-309 Technical: Repeated Dose 1-Year Oral Toxicity
| Study in Rats. Project Number: IET/06/0085. Unpublished study prepared by
j Institute of Environmental Toxicology. 608 p.
48125902
| Brewin, S. (2010) IKF-309, 3HDPM and 4HDPM: Storage Stability in Wheat
| (Grain and Straw) and Grapes for a Period of 18 Months: Interim Report,
j Project Number: ISK0353. Unpublished study prepared by Huntingdon Life
| Sciences, Ltd. 48 p.
48279100
| ISK Biosciences Corporation (2010) Submission of Residue and Toxicity
| Data in Support of the Petition for Tolerance of Pyriofenone for Use on
j Grapes. Transmittal of 3 Studies.
48279101
| Brewin, S. (2010) IKF-309, 3HDPM and 4HDPM: Storage Stability in Wheat
| (Grain and Straw) and Grapes for a Period of 18 Months: Final Report. Project
j Number: ISK0353. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 57 p.
48279102
f
j Cooper, S. (2007) Validation of Neuropathology Procedures Neurotoxicity
| Study by Oral Gavage Administration of Acrylamide or Triethyltin Bromide to
1 Male CD Rats. Project Number: HLS/367/053352. Unpublished study
| prepared by Huntingdon Life Sciences, Ltd. 191 p.
48279103
| Cooper, S. (2010) Further Validation of Neurotoxicity Procedures Following
| Oral Gavage Administration of D-Amphetamine or Di-isopropyl
| Fluorophosphate to CD Rats. Project Number: HLS0384/062633. Unpublished
| study prepared by Huntingdon Life Sciences, Ltd. 281 p.
48295700
| ISK Biosciences Corporation (2010) Submission of Product Chemistry Data in
j Support of the Petition for Tolerance of Pyriofenone for Use In or On Grapes.
| Transmittal of 7 Studies.
48295701
| Turner, B. (2010) IKF-309: Method Validation for Determination of Related
| Impurities Detected by HPLC. Project Number: JSM0030. Unpublished study
' prepared by Huntingdon Life Sciences, Ltd. 73 p.
48295702
Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
Page 11 of 13
-------
1
| Number: ISK0335. Unpublished study prepared by Huntingdon Life Sciences,
'Ltd. 41 p.
48295703
Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
j Number: ISK0336. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 39 p.
48295704
f
j Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
| Number: ISK0337. Unpublished study prepared by Huntingdon Life Sciences,
1 Ltd. 38 p.
48295705
| Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
| Number: ISK0338. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 38 p.
48295706
| Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
j Number: ISK0339. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 37 p.
48295707
{
j Comb, A. (2009) Characterisation of Test Substance: Pyriofenone. Project
| Number: ISK0340. Unpublished study prepared by Huntingdon Life Sciences,
| Ltd. 38 p.
48341300
|
j ISK Biosciences Corporation (2010) Submission of Residue Data in Support
| of the Petition for Tolerance of Pyriofenone for Use on Grapes. Transmittal of
| 1 Study.
48341301
| Brewin, S. (2010) IKF-309: Validation of Methodology for the Determination
j of Residues in Wheat (Grain and Straw) and Grapes: Amendment Report.
| Project Number: ISK/0341. Unpublished study prepared by Huntingdon Life
| Sciences, Ltd. 9 p.
48459600
| ISK Biosciences Corporation (2011) Submission of Residue and Product
| Chemistry Data in Support of the Petition for Tolerance of Pyriofenone for
j Use on Grapes. Transmittal of 4 Studies.
48459601
i
j Gelin, M. (2011) Response to Request for Additional Information for IKF-309
| Metabolism in Grapes (MRID #48112804). Project Number:
| IB/201 l/MG/003/01. Unpublished study prepared by Huntingdon Life
| Sciences, Ltd. 4 p.
48459602
f
j Gelin, M. (2011) Response to Request for Additional Information for
| Independent Laboratory Validation of IKF-309 Analytical Method in Grapes,
| Wheat Grain and Straw (MRID #48112807). Project Number:
| IB/201 l/MG/004/01. Unpublished study prepared by ADME Bioanalyses. 8 p.
48459603
| Gelin, M. (2011) Response to Request for Additional Information for PAM I
| Multiresidue Protocol Testing for IKF-309 in Grapes (MRID #48112813).
| Project Number: IB/201 l/MG/002/01. Unpublished study prepared by Pyxant
Page 12 of 13
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| Labs, Inc. 5 p.
Turner, B. (2009) IKF-309 (PAI) Spectra. Project Number: ISK0393.
Unpublished study prepared by Huntingdon Life Sciences, Ltd. 29 p.
48459604
, 1SK Bioscience Corporation (2011) Submission of Toxicity Data in Support of
48476200 | the Petition for Tolerance of Pyriofenone for Use on Grapes. Transmittal of 5
I Studies.
48476201
48476202
| Gelin, M. (2011) Response to Request for Historical Control Data: IKF-309:
| Toxicity Study by Dietary Administration to CD-I Mice for 13 Weeks. Project
| Number: ISK0291, IB/2011/MG/001/05. Unpublished study prepared by ISK
Bioscience Corporation. 8 p.
Gelin, M. (2011) Response to Request for Historical Control Data: IKF-309
| Technical: Repeated Dose 90-Day Oral Toxicity Study in Rats. Project
(Number: IB/2011/MG/001/06, IET/06/0015. Unpublished study prepared by
I ISK Bioscience Corporation. 13 p.
| Gelin, M. (2011) Response to Request for Historical Control Data: IKF-309
! Technical: Repeated Dose 90-Day Oral Toxicity Study in Dogs. Project
(Number: IB/2011/MG/001/07, IET/06/0109. Unpublished study prepared by
| ISK Bioscience Corporation. 30 p.
[ Gelin, M. (2011) Response to Request for Historical Control Data: IKF-309
| Technical: Repeated Dose 1-Year Oral Toxicity Study in Rats. Project
(Number: IB/2011/MG/001/08, IET/06/0085. Unpublished study prepared by
| ISK Biosciences Corporation. 29 p.
[ Gelin, M. (2011) Response to Request for Historical Control Data: IKF-309
4847^90^ ! Carcinogenicity Study by Dietary Administration to CD-I Mice for 78 Weeks.
| Project Number: IB/201 l/MG/001/09, ISK0305. Unpublished study prepared
j by ISK Bioscience Corporation. 9 p.
48476204
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