United States Environmental Protection Agency Office of Prevention, Pesticide and Toxic Substance (7501C) r/EPA Pesticide Fact Sheet Name of Chemical: Fluopicolide Reason for Issuance: New Chemical Date Issued: December 19, 2007 Description of Chemical Generic Name: Common Name: EPA Chemical Code: Chemical Class: Chemical Abstracts Service (CAS) Number: Registration Status: Pesticide Type: U.S. Producer: 2,6-dichloro-jV-[[3-chloro-5-(trifluoromethyl)-2- pyridinyljmethyl] benzamide Fluopicolide 027412 benzamide Pyridine 239110-15-7 New Chemical Registration Fungicide ValentU.S. Corporation ------- Use Pattern and Formulations Fluopicolide is a new fungicide approved for foliar use on grape; grape, raisin; vegetable, cucurbit, group 9; vegetable fruiting, group 8; vegetable, leafy, except Brassica, group 4; and vegetable, tuberous and corm (except potato), subgroup ID. Non-food uses for turf and ornamentals are also approved. Fluocopicolide belongs to the benzamide class and the pyridine class. The mode of action of fluopicolide has not been determined; however, it is a mode of action unlike the known modes of action of other registered fungicides. Fluopicolide is a mesosystemic fungicide; it translocates toward the stem tips via the xylem but it does not translocate toward the roots. Fluopicolide is effective at low application rates against a wide range of Oomycete (Phycomycete) diseases including downy mildews (Plasmopara, Pseudoperonospara, Peronospora, Bremia), late blight (Phytophthora), and some Pythium species. Fluopicolide is formulated as a suspension concentrate. There are four end use products and one technical proposed for registration in the U.S. Fluocopicolide Technical is for formulating use only. Two of these products: V-10161 VPP for turfgrass and ornamental use, and V-10161 4 SC for cucurbit vegetables, fruiting vegetables, grapes, leafy vegetables, and sweet potatoes are both formulated as 39.5% fluocopicolide. While the other two products: V-10162 Premix for cucurbit vegetables, fruiting vegetables, Lettuce (head and leaf), and V-10162 VPP for turf, and ornamental are both formulated as 5.54% Fluocopicolide and 55.40% Propamocarb Hydrochloride. There is a previously existing tolerance for residues of fluopicolide on imported grapes. Three foliar applications are to be made to grapes in Europe at the maximum seasonal application rate of 0.36 Ib ai/A. Minimum retreatment intervals of 10 days and a preharvest interval of 21 days are to be observed. 2,6-Dichlorobenzamide (BAM) is a metabolite and/or environmental degradate of both fluopicolide and dichlobenil. For use on imported grapes BAM was not included in the risk assessment however, both parent fluopicolide and BAM were included in risk assessments for uses of fluopicolide on domestic crops since more exposure to BAM is expected with domestic uses. No Codex, Canadian, or Mexican MRLs have been established for fluopicolide. ------- SCIENCE FINDINGS Structure and Nomenclature Table 1 Fluopicolide Nomenclature. Chemical structure Empirical Formula Common name Company experimental name IUPAC name CAS name CAS Registry Number End-use products (EPs) Chemical Class Known Impurities of Concern F3C\^'^/-C1 C 1 I H V^Nx 'Y*\ /^^ 3 Cl Ci4H8Cl3F3N20 Fluopicolide AE C638206 2,6-dichloro-A^-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide 2,6-dichloro-Ar-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide 239110-15-7 1. V-10161 VPP 2. V-10161 4 SC 3. V-10162Premix 4. V-10162VPP 5. Fluopicolide Technical Fungicide None Physical and Chemical Properties The physical/chemical properties of fluopicolide as they affect inhalation or dermal exposure are not relevant for an imported crop. Table 2. Physicochemical Properties of Fluopicolide. Parameter Molecular Weight Melting point/range pH Density Water solubility (20 °C) Solvent solubility (g/L at 20 °C) Vapor pressure at 25 °C Value 383.59 149 °C 6.5 at 22.0 °C 1.65 g/cc 2.86 mg/L at pH 4 2.80 mg/L at pH 7 2.80 mg/L at pH 9 n-Hexane: Ethanol: Toluene: Ethyl acetate: Acetone: Die hloro methane : Dimethyl sulfoxide: 0.20 19.2 20.5 37.7 74.7 126 183 S.OSxlO'7 Pa Reference MRID 46474015 MRID 46474013 MRID 46474016 MRID 46474021 MRID 46474022 MRID 46474023 ------- Table 2. Physicochemical Properties of Fluopicolide. Parameter Dissociation constant (pKa) Octanol/water partition coefficient Log(Kow) UV/visible absorption spectrum Value No evidence of ionization in the pH range of 1.9 to 9.8 Log Pow = 3.26 at pH 7.8 and 22 ± 1 °C Log POW = 2.9 at pH 4.0, 7.3 and 9. 1 and 40 °C Absorption maxima wavelengths (nm): In methanol: 203 and 27 1 In methanol/HCl: 202 and 270 In methanol/NaOH : 2 1 9 and 27 1 Reference MRID 46474017 MRID 46474018 MRID 46474019 MRID 46474014 Hazard Characterizations The toxicology database for fluopicolide (AC 638206) is complete and deemed adequate for hazard assessment and for FQPA evaluation. Fluopicolide is a fungicide that is effective in controlling plant disease caused by Oomycetes. The biological activity is mesosystemic in that it controls pathogens on contact through translocation toward the stem tips and not the roots. The exact mode of action of disease control has not been fully determined. The test substance is mostly used on grapes and raisins. The toxicity database is complete for fluopicolide and is adequate for risk assessment evaluations and determination of FQPA. All studies evaluated were deemed acceptable and met guideline criteria except for one reverse gene mutation study. This study was unacceptable because purity of the test material was not provided; however, there were enough adequate studies for gene mutation that this does not constitute a data gap. The studies that are available and were considered (animal, human, general literature) for Fluopicolide (AC638206) are as follows: Acute- oral, dermal, inhalation, eye irritation, skin irritation, dermal sensitization Sub chronic- oral 90-day rat, oral 90-day mouse (2 studies), oral 90-day dog Chronic- oral rat (combined chronic/carcinogenicity) and oral dog Reproductive/developmental- oral developmental rat and rabbit, rat reproduction/fertility Other- acute and subchronic rat neurotoxicity, oral mouse carcinogenicity, mutagenicity studies (in vitro and in vivo), metabolism/pharmacokinetics studies and phenobarbital 28-day hepatotoxicity mouse studies (2 studies) Toxicology Acute Toxicity: Fluopicolide has moderate toxicity with no deaths noted in male or female rats at doses of > 2000 mg/kg when given orally, and > 4000 mg/kg dermally. Following inhalation exposure, an LCso of >1.789 to < 5.16 mg/L was calculated. Toxicity was observed primarily in the inhalation studies and included a decrease in body weight, decrease in mean body temperature and signs of irritation (piloerection, hunched ------- posture, reddened nostrils). Moderate eye irritation occurred in the form of chemosis and corneal opacities, but all effects were gone by 72 hours. Slight dermal irritation occurred, but the test substance was not a skin sensitizer. Subchronic Toxicity: The most common effect observed in the 90 day studies was a decrease in body weight gain. Weight gain was markedly decreased in male and female rats in a subchronic study at doses that exceeded the limit dose (1668-1673 mg/kg/day), and male and female rats in a subchronic neurotoxicity study had reduced body weight gain at doses of 780.6 and 125.2 mg/kg/day, respectively. There was no effect on weight gain in dogs or mice in subchronic studies. Besides effects on body weight and body weight gain, no definitive cross-species target organ was identified in subchronic studies with fluopicolide. No organ lesions were found in dogs administered up to 1000 mg/kg/day for 90 days. Male rats had hypertrophy of the zona glomerulosa in the adrenal gland, trabecular hyperostosis of the bone joint, and decreased bone marrow cellularity after exposure to 1668 mg/kg/day for 90 days. Similar lesions in the adrenal gland and bone marrow were found in female rats administered 119 mg/kg/day for 90 days. In mice, females administered 965 mg/kg/day showed an increased incidence of hepatic oval cell proliferation. Chronic Toxicity: As in the subchronic studies, the main effect in the chronic studies was a decrease in body weight gain with no definitive cross-species target organ identified. Male dogs had reduced weight gain after exposure to 1000 mg/kg/day for one year; body weight of females was not affected. Mice had severely decreased body weight and body weight gain with administration of 551.0 and 772.3 mg/kg/day to males and females, respectively, for 18 months. Male and female rats had decreased weight gain after exposure to 109.4 and 142.2 mg/kg/day for 2 years, respectively. No organ lesions were found in dogs administered up to 1000 mg/kg/day for 52 weeks. Thyroid cystic follicular hyperplasia was seen in male rats after 109.4 mg/kg/day for two years. In mice, altered liver cell foci were seen in males and females given 551.0 or 772.3 mg/kg/day, respectively, for 18 months. Carcinogenicity: No evidence for carcinogenicity was seen in rats administered fluopicolide in food for 24 months. Treatment of rats did not result in an increase in overall tumor incidence or an increase in the incidence of any specific type of tumor. In contrast, mice had an increased incidence of hepatocellular adenoma following administration of 3200 ppm in the diet for 18 months (551.0 and 772.3 mg/kg/day for males and females, respectively). Neurotoxicity: No evidence of neurotoxicity was seen in acute or subchronic oral rat neurotoxicity studies with fluopicolide. A transient decrease in body temperature was the only finding in male and female rats given a single dose of 2000 mg/kg. Brain weight, brain morphometry, and neuropathology were not affected by treatment. Developmental Toxicity: In developmental toxicity studies, maternal toxicity was clearly evident only in rabbits as increased mortality, abortion, and decreased body weight gain at 60 mg/kg/day, the highest dose tested. Minimal maternal toxicity was observed in rats dosed with 700 mg/kg/day; slightly reduced body weight gain did not result in lower ------- absolute body weight. At the same dose affecting the dam, 700 mg/kg in rats and 60 mg/kg in rabbits, fetal growth was affected in both species and observed as decreases in body weight and crown-rump length. Also, at 700 mg/kg, delays in fetal ossification and increased incidence of skeletal malformations were observed in rat fetuses, with neither of these effects seen in rabbit fetuses. No external or visceral abnormalities were observed in either species. In rats the adverse effect was judged to be greater in the fetus than in the dam, suggesting a greater susceptibility in the fetus compared to that of the dam. Reproductive Toxicity: Reproductive performance was not affected in a two-generation reproduction toxicity study in which fluopicolide was administered to male and female rats at nominal dietary concentrations of 0, 100, 500, or 2000 ppm (0, 7.4-8.8, 36.4-43.7, 144.6-179.9 mg/kg/day, respectively, for males and 0, 8.1-9.4, 41.0-46.9, 159.7-193.9 mg/kg/day, respectively, for females). Evidence of parental toxicity in the high-dose groups included decreased body weight gain in FO females and kidney toxicity in FO and FI males and females. Kidney lesions consisted of cortical tubular basophilia or dilation, medullary granular casts, cortical scarring, interstitial inflammation, and/or corticomedullary mineralization. Body weight of the high-dose FI and F2 pups was significantly less than that of the controls beginning on lactation day 14. The high-dose pups had decreased weight gain throughout the 28-day lactation interval. Overall weight gain during lactation was decreased by 8-9% of the control level in the high-dose FI male and female pups and by 11-14% in the high-dose 72 male and female pups. No other effects on offspring growth or survival were noted in either generation. Dermal toxicity: Acute dermal toxicity studies showed that fluopicolide was only a slight dermal irritant (Tox. Category IV). A dermal subchronic toxicity study showed no systemic or local effects at the limit dose. Toxicologicol Endpoints Table 3. Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Dietary and Non-Occupational Human Health Risk Assessments Exposure/ Scenario Acute Dietary (All Populations) Chronic Dietary (All Populations) Point of Departure None Maternal NOAEL=20 mg/kg/day Uncertainty/FQPA Safety Factors None UFA=10x UFH=10x FQPA SF = IX RfD, PAD, Level of Concern for Risk Assessment None Chronic RfD = 0.2 mg/kg/day cPAD = 0.2 mg/kg/day Study and Toxicological Effects An endpoint attributable to a single dose was not identified from the available data. Developmental Toxicity Study in Rabbits LOAEL = 60 mg/kg/day based on death, abortions/ premature deliveries, decreased food ------- Incidental Oral Intermediate-Term (1-6 months) Dermal Short- Intermediate- and Long-Term (1-30 days and 1-6 months) Inhalation Short- Intermediate- and Long-term (1-30 days and 1-6 months) Cancer (oral, dermal, inhalation) maternal NOAEL = 20 mg/kg/day maternal NOAEL = 20 mg/kg/day maternal NOAEL = 20 mg/kg/day UFA=10x UFH=10x FQPA SF = IX UFA=10x UFH=10x FQPA SF = IX UFA=10x UFH=10x FQPA SF = IX MOE = 100 (occupational) MOE = 100 (residential) MOE = 100 (occupational) MOE = 100 (residential) MOE = 100 (occupational) MOE = 100 (residential) consumption, decreased body weight gain. Developmental Toxicity Study in Rabbits LOAEL = 60 mg/kg/day based on death, abortions/ premature deliveries, decreased food consumption, decreased body weight gain. Developmental Toxicity Study in Rabbits LOAEL = 60 mg/kg/day based on death, abortions/ premature deliveries, decreased food consumption, decreased body weight gain. Developmental Toxicity Study in Rabbits LOAEL = 60 mg/kg/day based on death, abortions/ premature deliveries, decreased food consumption, decreased body weight gain. 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 (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long- term risk assessment. UFDB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOG = level of concern. N/A = not applicable. ------- Food Quality Protection Act Considerations FQPA Safety Factor The Agency has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to IX for fluopicolide. That decision is based on the following findings: (1) The toxicity database for fluopicolide is complete. (2) There is no indication that fluopicolide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. (3). Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of fluopicolide. The degree of concern for pre-and/or postnatal toxicity is low. (4) There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential SOPs were used to assess post- application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluopicolide. EPA is retaining the 10X FQPA SF for BAM for those exposure scenarios that do not rely on dichlobenil toxicity data. These scenarios are acute dietary for the general population including infants and children, females 13-49 years of age, chronic dietary, and incidental oral non-dietary. This is due to the incompleteness of the data base with regard to the systemic neurotoxic potential of BAM, including olfactory toxicity via the oral route of exposure. For the dermal and inhalation routes of exposure, for which the Agency is relying on dichlobenil toxicity data, the Agency has reduced the FQPA SF for BAM toxicity to IX. The reasons for this are that, based on a comparison of toxicity via the intraperitoneal route of exposure, higher doses of BAM are needed to induce levels of olfactory toxicity that are similar to those caused by dichlobenil, and olfactory toxicity was the endpoint chosen for these exposure scenarios. Dietary Exposure and Risk Dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03, which uses food consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. A dietary exposure assessment was conducted for residues of fluopicolide in food and drinking water. A second assessment was conducted for combined residues of BAM in food and drinking water from uses of both fluopicolide and dichlobenil. Acute: An acute dietary assessment was not conducted because an endpoint attributable to a single dose was not identified from the available data for fluopicolide. ------- Chronic: The chronic dietary (food and drinking water) exposure to fluopicolide is below the Agency's level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 6% cPAD for the general U.S. population and 9% cPAD for children 1-2 years old, the most highly exposed subgroup. A conservative chronic dietary exposure assessment for the metabolite of fluopicolide, BAM was conducted using maximum residues from field trials and 100% crop treated. The chronic dietary exposure estimates for BAM are 29% of the chronic cPAD for the general U.S. population and 93% cPAD for all infants (< year old), the most highly exposed group which is not of concern to the Agency. Cancer: Fluopicolide has been classified as "not likely to be carcinogenic to humans", and is thus not expected to pose a cancer risk. Residential Handler, Postapplication and Occupational Exposures Total MOEs for residential handlers are well above the LOG of 100, and are not of concern. Residential postapplication exposure via the dermal route is likely for adults and children entering treated lawns. The short-/intermediate-term MOEs for each scenario are above the LOG of 100, and are not of concern. The results of the handler and postapplication occupational exposure indicate that risks are not of concern. The total MOEs range from 100 to 19,000. Aggregate Risk The Agency does not expect that fluopicolide will pose an aggregate acute risk because an endpoint attributable to a single dose was not identified from the available data for fluopicolide. The acute dietary exposure estimates for BAM at the 99.9th percentile of the exposure distribution are 11% of the acute aPAD for the general U.S. population and 28% aPAD for all infants <1 year old, the most highly exposed group. The chronic dietary exposure estimates for fluopicolide are 6% cPAD for the general U.S. population and 9% cPAD for children 1-2 years old, the most highly exposed subgroup. The chronic dietary exposure estimates for BAM are 29% of the chronic cPAD for the general U.S. population and 93% cPAD for all infants (< year old), the most highly exposed group which is not of concern to the Agency. Based on the use pattern, chronic residential exposure to residues of fluopicolide is not expected. Fluopicolide is proposed for registration of uses that could result in short-term residential exposure. The Agency has concluded that food, water and residential exposures result in aggregate MOEs greater than the LOG of 100 for all population groups, and the aggregate short-term estimates for fluopicolide are below the Agency's level of concern. Also, short-term exposures for fluopicolide's metabolite BAM, may occur as a result of activities on treated turf. Incidental oral exposures related to turf activities have been combined with chronic dietary exposure estimates to assess short- term aggregate exposure for BAM. Since aggregate MOEs for BAM are greater than the ------- LOG, they represent risk estimates that are below the Agency's level of concern. The intermediate-term aggregate risk for fluopicolide and BAM is the same as calculated for the short-term aggregate risk. In examining long-term aggregate risk, the Agency has assumed that the only pathway of exposure relevant to that time frame is dietary exposure. Therefore, the long-term aggregate risk is composed of exposures to fluopicolide residues in food and drinking water and is equivalent to the chronic dietary risk. The chronic risk estimates are below the Agency's level of concern for all population subgroups. Cumulative Risk Fluopicolide and the herbicide dichlobenil can form the common metabolite, BAM. To support existing tolerances and to establish new tolerances for fluopicolide, EPA conducted a human health risk assessment for exposure to BAM resulting from the use of all current and pending uses of fluopicolide and dichlobenil. This risk assessment is conservative in terms of potential dietary and non-dietary exposures. The assessment includes evaluations of risks for various subgroups, including those composed of infants and children. For this assessment the Agency retained the additional tenfold (10X) FQPA safety factor (SF) for the protection of infants and children. ENVIRONMENTAL RISK ASSESSMENT Fate Characterization Fluopicolide will not volatilize from soil or aqueous solution. Neither photolysis nor hydrolysis is expected to be a significant degradation pathway for the dissipation of fluopicolide. Photolysis does, however, enhance the degradation of fluopicolide soil degradates. The primary pathway for dissipation of fluopicolide is by microbial or mineral-catalyzed degradation in soil. Fluopicolide is unlikely to leach in soil but its moderate water solubility suggests the potential for runoff in storm or irrigation water. The range of BCFs for edible tissue, nonedible tissue, and whole fish indicate a low potential for bioconcentration in fish and living organisms. The 2,6-Dichlorobenzamide (BAM) is the major potential toxic degradation product from aerobic soil metabolism, aquatic photolysis and soil photolysis studies. Guideline fate studies for BAM were not available, therefore, literature data were used to assess its fate properties. Risk Assessment A screening-level (Level I) risk assessment, based on proposed uses was completed. The calculated RQs for most groups are well below 1.0. The highest RQs (eg., 3.95) were determined from the small mammal ornamentals/short grass consumption scenarios. For the food and turf uses, there are no acute or chronic LOCs exceeded for any of the aquatic organisms. Acute LOCs are not exceeded for aquatic organisms exposed to the degradate, BAM (2,6-dichlorobenzamide) based on the scenario with the highest EEC, Florida nursery. There were no chronic LOCs exceeded 10 ------- for the turf or food uses. There are no avian acute LOCs exceeded for the food uses. There were no acute or chronic dietary-based mammalian LOCs exceeded for BAM for any of the proposed uses. DATA NEEDS AND LABEL REQUIREMENTS Label Requirements • Sufficient rotational crop data is not available to support the proposed rotational crop restrictions. The label must be modified to state that rotation is limited only to those crops on the current label. Data Requirements • Additional storage stability data are needed for celery and spinach reflecting a storage interval of 38 months. One study should be conducted on any representative leafy vegetable. Government Performance Results Act Registration of fluopicolide will meet objectives of 6 PRA title 3.1.1 by assuring new pesticides enter the market are safe for humans and the environment. Contact Person at USEPA: Janet Whitehurst Environmental Protection Agency Office of Pesticide Programs Registration Division Fungicide Branch 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001 Office Location and telephone number: 7873, Potomac Yard South 2777 South Crystal Dr. Arlington V.A. 22202 703-305-6129 11 ------- 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. APPENDIX I: GLOSSARY OF TERMS AND ABBREVIATIONS ADNT a.i. aPAD ARI BCF CAS ChE ChEI cPAD %CT DAT DEEM-FCID DNA DNT DIT DWLOC EC EEC EPA FQPA GLC GLN LCso Acute delayed neurotoxicity Active Ingredient Acute Population Adjusted Dose Aggregate Risk Index Bioconcentration Factor Chemical Abstracts Service Cholinesterase Cholinesterase inhibition Chronic Population Adjusted Dose Percent crop treated Days after treatment Dietary Exposure Evaluation Model - Food Consumption Intake Database Deoxyribonucleic acid Developmental neurotoxicity Developmental immunotoxicity Drinking Water Level of Comparison. Emulsifiable Concentrate Formulation Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. U.S. Environmental Protection Agency Food Quality Protection Act Gas Liquid Chromatography Guideline Number 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. 12 ------- LD50 LOAEL LOAEC LOC LOD LOQ mg/kg/day mg/L MOE MRID MTD NA NOEC NOEL NOAEL NOAEC NPDES OP OPP OPPTS PAD PAG PAM PHED PHI ppb PPE ppm PRZM/ EXAMS RAC RBC RED REI RfD SCI-GROW SF TGAI UF ug ug/L uL/g 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. Lowest Observed Adverse Effect Level Lowest Observed Adverse Effect Concentration Level of Concern Limit of Detection Limit of quantitation Milligram Per Kilogram Per Day Milligrams Per Liter Margin of Exposure Master Record Identification (number), EPA's system of recording and tracking studies submitted Maximum tolerated dose Not Applicable No Observable Effect Concentration No Observed Effect Level No Observed Adverse Effect Level No Observed Adverse Effect Concentration National Pollutant Discharge Elimination System Organophosphate EPA Office of Pesticide Programs EPA Office of Prevention, Pesticides and Toxic Substances Population Adjusted Dose Pesticide Assessment Guideline Pesticide Analytical Method Pesticide Handler's Exposure Data Preharvest Interval Parts Per Billion Personal Protective Equipment Parts Per Million Tier II Surface Water Computer Model Raw Agriculture Commodity Red Blood Cell Reregistration Eligibility Decision Restricted Entry Interval Reference Dose Tier I Ground Water Computer Model Safety Factor Technical Grade Active Ingredient Uncertainty Factor micrograms Micrograms Per Liter Microliter per gram 13 ------- USDA WPS United States Department of Agriculture Worker Protection Standard APPENDIX II: Citations Considered to be Part of the Data Base Supporting the Registration of Fluopicolide Study Information For Ingredient 027472 / 239110-15-71 Fluopicolide MRID 46474000 j Citation I j Bayer CropScience LP (2005) Submission of Product Chemistry and j Residue Data in Support of the Petition for Tolerance of Fluopicolide. j Transmittal of 45 Studies. Receipt Date 07-Feb- 2005 Smith, C. (2004) Fluopicolide (AE C638206) Technical: Product Chemistry 46474001 Data Summary to Support a Tolerance in/on Imported Commodities. Unpublished study prepared by Bayer Ag, Institute of Product Info. 7 p. 07-Feb- 2005 t 46474002 46474003 I™™ 46474004 \ Smith, C. (2004) Fluopicolide (AE C638206) Technical: Product Identity j and Composition, Description of Materials Used to Produce the Product, | Description of the Production Process, Discussion of Formation of j Impurities, and Certified Limits. Unpublished study prepared by Bayer Ag, Institute of Product Info. 108 p. j Bowen, T. (2004) Material Accoutability of AE C638206 Technical: | Analytical Profile of Five Representative Batches and the Batch Used in \ the Long Term Toxicological Testing. Project Number: PA/04/001 , | C040168. Unpublished study prepared by Bayer Cropscience Gmbh. 37 p. j Smith, C. (2004) Analytical Method: Determination of AEC638206 in AE | CC638206 Technical Materials by HPLC; Validation of the Analytical | Method AM000103FP1 for the Determination of AEC638206 in AE CC638206 Technical Materials; Analytical Method: Determination of j Group 1 Impurities in AE CC638206 Technical Materials by HPLC; j Validation of the Analytical Method AM000203FP1 for the Determination | of Group 1 Impurities in AE CC638206 Technical Materials; Analytical 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 14 ------- Method: Determination of Group 2 Impurities in AE CC638206 Technical Materials by HPLC; Validation of the Analytical Method AM000303FP1 for the Determination of Group 2 Impurities in AE CC638206 Technical Materials. Project Number: C033933, C033934, C033936. Unpublished study prepared by Bayer Ag, Institute of Product Info. 14 p. Bowen, T. (2003) Analytical Method: Determination of AE C638206 in AE 46474005 i C638206 Technical Materials by HPLC. Project Number: AM000103FP1, i C033933. Unpublished study prepared by Bayer Cropscience Gmbh. 10 p. 07-Feb- 2005 j Bowen, T. (2003) Validation of the Analytical Method AM000103FP1 for ^tne Determiation of AE C638206 in AE C638206 Technical Materials. | project Number: AF03/005, C033934, AM000103FP1. Unpublished study j prepared by Bayer Cropscience Gmbh. 39 p. 46474007 Bowen, T. (2003) Analytical Method: Determination of Group 1 Impurities in AE C638206 Technical Materials by HPLC. Project Number: AM000203FP1, C033936. Unpublished study prepared by Bayer Cropscience Gmbh. 16 p. r~ 46474008 | Bowen, T. (2003) Validation of the Analytical Method AM000203FP1 for | the Determiation of Group 1 Impurities in AE C638206 Technical I Materials. Project Number: AF03/007, C033937, AM000203FP1. j Unpublished study prepared by Bayer Cropscience Gmbh. 39 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474009 46474010 46474011 j Bowen, T. (2003) Analytical Method: Determination of Group 2 Impurities in AE C638206 Technical Materials by HPLC. Project Number: C033938, j AM000303FP1. Unpublished study prepared by Bayer Cropscience j Gmbh. 16 p. Bowen, T. (2003) Validation of the Analytical Method AM000303FP1 for the Determiation of Group 2 Impurities in AE C638206 Technical Materials. Project Number: AF03/008, C033940. Unpublished study prepared by Bayer Cropscience Gmbh. 35 p. Muehleberger, B.; Eyrich, U. (2003) AE C638206 Technical: Physical Characteristics, Color, Appearance and Odor. Project Number: C031788, PA/02/091. Unpublished study prepared by Bayer Cropscience Gmbh. 11 { Franke, J. (2004) AE C638206 Technical: Thermal Stability in the ^ Presence of Iron and Iron Ions at Ambient and Elevated Temperatures. I Project Number: C040784, 20040010/01. Unpublished study prepared by | Siemens Axiva GmbH & Co. KG. 21 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 Muehlberger, B.; Eyrich, U. (2003) Determination of the pH-Value of AE 46474013 | C638206. Project Number: PA02/092, C031789. Unpublished study j prepared by Bayer Cropscience Gmbh. 11 p. 07-Feb- 2005 46474014 46474015 Muehlberger, B. (2003) AE C638206 Spectral Data (UV/VIS, IR, (Hydrogen-l)-NMR, (Carbon-13)-NMR, MS) and Molar Extinction Coefficient. Project Number: PA02/088, C034149. Unpublished study prepared by Bayer Cropscience Gmbh. 42 p. Smeykal, H. (2003) AE C638206 Technical: Melting Point/ Melting Range. Project Number: 20030348/01, C033115. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 12 p. 07-Feb- 2005 07-Feb- 2005 15 ------- 1 46474016 _,_ 46474017 __ 46474018 46474019 46474020 _.. 46474021 r~~ 46474022 ! Smeykal, H. (2003) AE C638206 (Pure): Relative Density. Project I Number: C034154, 20030755/03. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 10 p. I r I Bright, A. (2000) AE C638206 (99.6% w/w): Dissociation Constant. Project I Number: C008405, CHR/00/026, 00040604. Unpublished study prepared ! by Aventis Cropscience UK Ltd. 17 p. i Bright, A. (2000) AE C638206 (99.6% w/w): Partition Coefficient. Project | Number: CHR/00/025, 00040603, C008404. Unpublished study prepared j by Aventis Cropscience UK Ltd. 22 p. 1 | Muehlberger, B. (2003) AE C638206: Partition Coefficient 1- | Octanol/Water (HPLC-Method). Project Number: PA03/005, C032556. j Unpublished study prepared by Bayer Cropscience Gmbh. 29 p. \ Comb, A. (1999) AE C638206 (99.6% w/w): Water Solubility. Project ! Number: C006351 , AGV/278/994204, AGV/278. Unpublished study prepared by Huntingdon Life Sciences Ltd. 23 p. I Muehlberger, B. (2003) Water Solubility of AE C638206 at pH 4, pH 7 and pH 9 (Column-Elution Method). Project Number: C034161, PA02/089. Unpublished study prepared by Bayer Cropscience Gmbh. 25 p. j Muehlberger, B. (2003) AE C638206: Solubility in Organic Solvents. | Project Number: PA02/090, C031136. Unpublished study prepared by | Bayer Cropscience Gmbh. 28 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 ! Bright, A. (2000) AE C638206 (99.6% w/w): Vapour Pressure. Project 46474023 j Number: CHR/00/027, 00040605, C008406. Unpublished study prepared i by Aventis Cropscience UK Ltd. 30 p. 07-Feb- 2005 j Smith, C. (2005) Fluopicolide (AE C638206): Residue Chemistry Data j Summary to Support the Petition for Tolerances in/on Imported Grapes 46474024 j and Raisins, Including Directions for Use, Proposed Tolerances, and { Submittal of Samples. Project Number: B004860, 00782, C024784. { Unpublished study prepared by Bayer Ag, Institute of Product Info. 43 p. 07-Feb- 2005 46474025 Smith, C. (2004) Metabolism of [U-(Carbon-14)-Phenyl]- and [2,6-(Carbon- 14)-Pyridinyl]-AE C638206 in Vines (Amended Report Replacing Report CU99E503, Document B004329). Project Number: B004860, CU99E503, CU99E503A. Unpublished study prepared by Bayer Ag, Institute of Product Info. 17 p. 07-Feb- 2005 46474026 Rupprecht, J. (2004) Metabolism of [U-(Carbon-14)-Phenyl]- and [2,6- (Carbon-14)-Pyridinyl]-AE C638206 in Vines (Amended Report Replacing Report CU99E503, Document B004329). Project Number: CU99E503, CU99E503A, B004860. Unpublished study prepared by Agrevo USA Co. 108 p. 07-Feb- 2005 46474027 { Smith, C. (2005) Determination of the Residues of AE C638206 and ! Metabolites in Wheat (Straw and Grain), Grapes and Cabbage Using | LC/MS/MS: Method Validation; Modification M001 of the Residue J Analytical Method 00782 for the Determination of the Residues of AE I C638206 and Metabolites AE C657188 and AE C653711 in/on Grape and j Potato by HPLC-MS/MS; Validation of the Modification M002 to the j Analytical Method 00782 for the Determination of the Residues of AE I C638206 and Metabolites AE C657188, AE C653711 and AE 1344122 07-Feb- 2005 16 ------- in/on Wheat by HPLC-MS/MS; Modification MOOS of the Analytical Method 00782 for the Determination of the Residues of AE C657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC-MS/MS; Progress Report: ILV of Analytical Method 00782 Modification M002 and MOOS for the Determination of the Residues of AE C638206 and Metabolites AEC657188, AEC653711, AE1344122 and C065. Project Number: C024784, 00782, C031433. Unpublished study prepared by Bayer Ag, Institute of Product Info. 15 p. j Zietz, E. (2002) Determination of the Residues of AE C638206 and | Metabolites in Wheat (Straw and Grain), Grapes and Cabbage Using 46474028 | LC/MS/MS: Method Validation. Project Number: 00782, IF/101/05424/00, j 01/009. Unpublished study prepared by Institut Fresenius Chemische und j Biologische. 74 p. 46474029 j Schoening, R.; Billian, P. (2003) Modification M001 of the Residue j Analytical Method 00782 for the Determination of Residues of AE C638206 and its Metabolites AE C657188 and AE C653711 in/on Grape j and Potato by HPLC-MS/MS. Project Number: C031433, 00782/M001, j MR/336/02. Unpublished study prepared by Bayer Ag, Institute of Product j Info. 56 p. 46474030 Schoening, R.; Billian, P. (2003) Validation of the Modification M002 to the Analytical Method 00782 for the Determination of Residues of AE C638206 and its Metabolites AE C657188, AE C653711 and AE 134412 in/on Wheat by HPLC-MS/MS. Project Number: C038955, 00782/M002, MR/071/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. 69 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474031 Schoening, R.; Billian, P. (2003) Modification MOOS of the Analytical Method 00782 for the Determination of Residues of AE C657378 (3-OH- BAM) in/on Cereals (Wheat) by HPLC-MS/MS. Project Number: C038960, 00782/M003, MR/148/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. 39 p. 46474032 Grant, J. (2004) Progress Report: Independent Laboratory Validation of "Validation of the Modification M002 to the Analytical Method 00782 for the Determination of Residues of AE C638206 and it Metabolites AE C657188, AE C653711 and AE 1344122 in/on Wheat by HPLC-MS/MS" for Tomatoes and "Modification MOOS to the Analytical Method 00782 for the Determination of Residues of AE C657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC-MS/MS" for Wheat Forage According to PR Notice 96- 1, OPPTS 860.1340 Guidelines, and SANCO/825/00 Rev. 7. Project Number: RAACX098, 49181. Unpublished study prepared by ABC Laboratories. 61 p. 07-Feb- 2005 07-Feb- 2005 46474033 Reiner, H. (2004) Extraction Efficiency (Radiovalidation) of the Residue Method for the Determination of AE C638206 Residues in Plant Samples Using Aged Radioactive Residues. Project Number: C046034, M/9991415/8, MEF/04/506. Unpublished study prepared by Bayer Ag, Institute of Product Info. 60 p. 46474034 Smith, C. (2005) Progress Report: PAM I Multiresidue Protocol Testing for AE C638206 (Fluopicolide) and its Metabolites AE C653711 (BAM), AE C657378 (BAM-OH), AE C657188 (PCA), and AE 1344122 (P1X). Project Number: 1551, RAACX039, A. Unpublished study prepared by Bayer Ag, Institute of Product Info. 8 p. 07-Feb- 2005 07-Feb- 2005 17 ------- ! Ford, C. (2004) Progress Report: RAM 1 Multif residue Protocol Testing for j AE C638206 (Fluopicolide) and its Metabolites AE C65371 1 (BAM), AE 16474035 | C657378 (BAM-OH), AE C657188 (PCA), and AE 1344122 (P1X). Project j Number: 1551 , RAACX039, A. Unpublished study prepared by Pyxant j Labs Inc. 230 p. j Smith, C. (2004) Determination of the Storage Stabulity of AE C638206 j and the Metabolites AE C65371 1 (BAM) and AE C657188 (PCA) in 16474036 j Grape, Potato, Cabbage and Wheat Grain. Project Number: C045739, j IF/02/0004949, 02/19. Unpublished study prepared by Bayer Ag, Institute j of Product Info. 14 p. Zeitz, E. (2004) Determination of the Storage Stability of AE C638206 and the Metabolites AE C65371 1 (BAM) and AE C657188 (PCA) in Grape, 16474037 Potato, Cabbage and Wheat Grain. Project Number: C045739, IF/02/00004949, 02/19. Unpublished study prepared by Institut Fresenius Chemische und Biologische. 87 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474038 Smith, C. (2004) Fluopicolide: Crop Field Trials. Project Number: C0282420, C032071, C028236. Unpublished study prepared by Bayer Ag, Institute of Product Info. 27 p. 07-Feb- 2005 j Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71 j Formulation: Residue Behaviour in Grapevine: European Union (Northern 46474039 | Zone) 2001. Project Number: 01R284, C028242. Unpublished study { prepared by Bayer Cropscience Gmbh, Bayer Ag, Institute of Product Info. { and Aventis Cropscience, Centre de Recherche de La Dargoire. 138 p. 07-Feb- 2005 46474040 Sender, K. (2003) 4.44%AE C638206 + 66.7% Fosetyl-Aluminum WG71 Formulation: Residue Behaviour in Grapevine: European Union (Northern Zone) 2002. Project Number: 02R288, C032071. Unpublished study prepared by Bayer Cropscience Gmbh, Bayer Ag, Institute of Product Info. and Aventis Cropscience, Centre de Recherche de La Dargoire. 113 p. j Sender, K. (2003) AEC638206 SE10 Formulation: Residues at Harvest in j Grapevine: European Union (Northern Zone) 2001. Project Number: 46474041 j 01R280, C028236. Unpublished study prepared by Bayer Cropscience J Gmbh, Bayer Ag, Institute of Product Info, and Aventis Cropscience, Centre de Recherche de La Dargoire. 65 p. 07-Feb- 2005 07-Feb- 2005 46474042 Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71 Formulation: Residue Behaviour in Table Grapes and Wine Grapes: European Union (Southern Zone) 2001 (Including Amendments No.1). Project Number: C028243, C033415, 01R285. Unpublished study prepared by Bayer Cropscience Gmbh. 147 p. 46474043 Sender, K. (2003) 4.44% AE C638206 + 66.7% Fosetyl-Aluminum WG71 Formulation: Residue Behaviour in Grapevine: European Union (Southern Zone) 2002. Project Number: C032072, 02/R/289. Unpublished study prepared by Bayer Cropscience Gmbh. 116 p. 07-Feb- 2005 07-Feb- 2005 ! Sender, K. (2003) AEC638206 SE10 Formulation: Residues at Harvest in ! Table Grapes and Wine Grapes: European Union (Southern Zone) 2001. 46474044 j Project Number: 01R281, C028237, 01R281/1. Unpublished study { prepared by Bayer Cropscience Gmbh and Bayer Ag, Institute of Product { Info. 66 p. 46474045 ! Zietz, E. (2003) AE C638206 SE10 Formulation: Determination of the 07-Feb- 2005 07-Feb- 18 ------- Residues in Red Grapes Following Three Treatments under Field Conditions in Southern Europe 2000: Final Report. Project Number: C031908, IF/100/10689/00, DR/OO/EUS/003. Unpublished study prepared by Institut Fresenius Chemische und Biologische, Agrologia S.L., and Promo-Vert S.A. 148 p. Bayer CropScience LP (2005) Submission of Residue and Toxicity Data in 46474100 i Support of the Petition for Tolerance of Fluopocolide on Grapes and Raisins. Transmittal of 48 Studies. 2005 07-Feb- 2005 46474101 Kaethner, M. (2004) Evaluation of Residue Decline Data from European Field Residue Trials of Grapes Treated with AE C638206 and Harvested 0-28 Days After the Last Treatment. Project Number: C043671. Unpublished study prepared by Bayer Ag, Institute of Product Info. 8 p. 46474102 Smith, C. (2004) C638206 SE10 Formulation: Determination of the Residues in Processed Fractions Derived from Red Grapes Following Three Treatments Under Field Conditions in Southern Europe 2000. Project Number: OOS041R, OORF021/2, OOF/VI/FR/P04. Unpublished study prepared by Bayer Ag, Institute of Product Info. 17 p. r~ 46474103 ! Zietz, E. (2003) AE C638206 SE10 Formulation: Determination of the | Residues in Processed Fractions Derived from Red Grapes Following Three Treatments Under Field Conditions in Southern Europe 2000: (Final I Report). Project Number: DR/OO/EUS/056, IF/100/19787/00, C035551. j Unpublished study prepared by Institut Fresenius Chemische und j Biologische. 111 p. I Smith, C. (2004) C638206 SE10 Formulation: Determination of the j Residues in Processed Fractions Derived from White Grapes Following j Four Treatments Under Field Conditions in Northern Europe 2000 46474104 j (Including AE C638206: Determination of the Residues in White Grapes j Following Four Treatments Under Field conditions in Northern Europe | 2000). Project Number: C037343, C034684, IF/100/18377/00. j Unpublished study prepared by Bayer Ag, Institute of Product Info.. 18 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474105 Zietz, E.; Schram, M. (2003) AE C638206 SE10 Formulation: Determination of the Residues in Processed Fractions Derived from White Grapes Following Four Treatments Under Field Conditions in Northern Europe 2000 (Including Field Report): (Final Report). Project Number: DR/OO/EUN/057, IF/100/18377/00, DR/OO/EUN/002. Unpublished study prepared by Institut Fresenius Chemische und Biologische. 253 p. j Smith, C. (2004) AE C638206 SE10 Formulation: Determination of the | Residues in Red Grapes Following Three Treatments under Field 46474106 I Conditions in Southern Europe 2000. Project Number: C031908, i IF/100/10689/00, OOR021/1. Unpublished study prepared by Bayer Ag, ! Institute of Product Info. 15 p. 07-Feb- 2005 07-Feb- 2005 46474107 Lemke, V. (2004) Evaluation of Acute and Chronic Dietary Exposure to Fluopicolide and Assessment of Potential Risk - Proposed Import Tolerances for Grapes. Project Number: RAACX105, B004787. Unpublished study prepared by Bayer Corp. 35 p. 07-Feb- 2005 46474108 Payraudeau, V.; Smith, C. (2004) Fluopicolide (AE638206): Toxicology Data Summary for the EPA Import Tolerance: Acute, Subchronic, Chronic, Teratology, Reproduction and Neurotoxicity Studies. Project Number: C008135, C009846, C008274. Unpublished study prepared by Bayer Ag, 07-Feb- 2005 19 ------- Institute of Product Info. 15 p. j Smith, C. (2004) AE C638206: Rat Acute Oral Toxicity. Project Number: 46474109 j C008135, TOX/283/15, TOX/99324. Unpublished study prepared by Bayer ! Ag, Institute of Product Info. 6 p. r~ i McRae, L. (2000) AE C638206: Rat Acute Oral Toxicity. Project Number: 46474110 | 015/003096/AC, TOX/99324, TOX/00/283/15. Unpublished study j prepared by Huntingdon Life Sciences, Ltd. 19 p. 07-Feb- 2005 07-Feb- 2005 46474111 Smith, C. (2004) AE638206: Rat 90-Day Dietary Toxicity Study with 4 Week Off-Dose Period. Project Number: C008603, TOX/00/283/4, TOX/99198. Unpublished study prepared by Bayer Ag, Institute of Product Info. 25 p. r~ 46474112 j Mallyon, B. (2000) AE C638206: Rat 90-Day Dietary Toxicity Study with 4 j Week Off-Dose Period. Project Number: TOX/00/283/4, TOX/99198, j C008603. Unpublished study prepared by Aventis Cropscience UK Ltd. I 442 p. 07-Feb- 2005 07-Feb- 2005 46474113 Smith, C. (2004) AE C638206: Mouse 90-Day Dietary Toxicity Study. Project Number: C008604, TOX/00/283/5, TOX/99216. Unpublished study prepared by Bayer Ag, Institute of Product Info. 15 p. r~ 46474114 46474115 Mallyon, B. (2000) AE C638206: Mouse 90-Day Dietary Toxicity Study. Project Number: TOX/00/283/5, TOX/99216, C008604. Unpublished study prepared by Aventis Cropscience UK Ltd. 272 p. Smith, C. (2004) AE C638206: 90-Day Toxicity Study in the Mouse by Dietary Administration. Project Number: C01838, 605303, SA/00363. Unpublished study prepared by Bayer Ag, Institute of Product Info. 14 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474116 46474117 Wason, S. (2001) AE C638206: 90-Day Toxicity Study in the Mouse by Dietary Administration. Project Number: SA/00363, 605303, C018138. Unpublished study prepared by Aventis Cropscience. 343 p. Smith, C. (2004) AE C638206: Dog 90-Day Oral Toxicity Study. Project Number: C010655, TOX/00/283/25, TOX/99292. Unpublished study prepared by Bayer Ag, Institute of Product Info. 11 p. j Mallyon, B. (2000) AE C638206: Dog 90-Day Oral Toxicity Study. Project 46474118 | Number: TOX/00/283/25, TOX/99292, C010655. Unpublished study j prepared by Aventis Cropscience UK Ltd. 303 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474119 r~ 46474120 Smith, C. (2004) AE C638206: Rat Oral Developmental Toxicity (Teratogenicity) Study (Including Addendum). Project Number: C016312, C044366, TOX99195. Unpublished study prepared by Bayer Ag, Institute of Product Info. 16 p. Hofmann, T. (2004) AE C638206: Rat Oral Developmental Toxicity (Teratogenicity) Study (Including Addendum). Project Number: 2000/0858, 99/0566, TOX99195. Unpublished study prepared by Aventis Pharma Deutschland Gmbh. 239 p. 07-Feb- 2005 07-Feb- 2005 46474121 Smith, C. (2004) AE C368206: Rabbit Oral Developmental Toxicity (Teratogenicity) Study (Including Addendum). Project Number: C016495, 99/0567. Unpublished study prepared by Bayer Ag, Institute of Product Info. 14 p. 07-Feb- 2005 20 ------- 46474122 Hofmann, T. (2004) AE C638206: Rabbit Oral Developmental Toxicity (Teratogenicity) Study (Including Addendum). Project Number: C016495, C044368, 2000/0859. Unpublished study prepared by Aventis Pharma Deutschland Gmbh. 217 p. r~ 46474123 Smith, C. (2004) AE C638206: Study of Reproductive Performance in CD Rats Treated Continuously Through Two Successive Generations by Dietary Administration; AE C638206: Additional Microscopic Examination to a Study of Reproductive Performance in CD Rats Treated Continuously Through Two Successive Generations by Dietary Administration. Project Number: C033054, C04/3545, AES/056. Unpublished study prepared by Bayer Ag, Institute of Product Info.. 43 p. 07-Feb- 2005 07-Feb- 2005 Blee, M. (2003) AE C638206: Study of Reproductive Performance in CD Rats Treated Continuously Through Two Successive Generations by 46474124 Dietary Administration. Project Number: C033054, AES/056/023443, AES/056. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 960 p. 46474125 Blee, M. (2004) AE C638206: Additional Microscopic Examination to a Study of Reproductive Performance in CD Rats Treated Continuously Through Two Successive Generations by Dietary Administration. Project Number: BAG/391043545, BAG/391 A. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 450 p. 07-Feb- 2005 07-Feb- 2005 46474126 Blee, M. (2002) AE C638206: Preliminary Study of Effects on Reproductive Performance in CD Rats by Dietary Administration. Project Number: C023472, 049/013609, AES/049. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 217 p. j Smith, C. (2004) AE C638206: 52-Week Toxicity Study by Oral Route 46474127 j (Gavage) in Beagle Dogs. Project Number: C029194, 20961/TCC. ! Unpublished study prepared by Bayer Ag, Institute of Product Info. 13 p. 46474128 Chevalier, G. (2002) AE C638206: 52-Week Toxicity Study by Oral Route (Gavage) in Beagle Dogs. Project Number: C029194, 20961/TCC. Unpublished study prepared by Centre International de Toxicologie. 785 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46474129 j Smith, C. (2004) AE C638206: Carcinogenicity Study by Oral Route j (Dietary Admixture) in C57BL/6 Mice. Project Number: C038732, j 21557/TCS. Unpublished study prepared by Bayer Ag, Institute of Product | Info. 21 p. 46474130 Chevalier, G. (2003) AEC638206: Carcinogenicity Study by Oral Route (Dietary Admixture) in C57BL/6 Mice. Project Number: C038732, 21557/TCS. Unpublished study prepared by Centre International de Toxicologie. 2242 p. 07-Feb- 2005 07-Feb- 2005 46474131 Smith, C. (2004) AE C638206: 28-Day Explanatory Toxicity Study in the C57BL/6 Female Mouse. Project Number: C040806, 99/0567. Unpublished study prepared by Bayer Ag, Institute of Product Info. 18 p. \ Langrand-Lerche, C. (2004) AE C638206: 20-Day Explanatory Toxicity 46474132 j Study in the C57BL/6 Female Mouse . Project Number: C040806, | SA/03313. Unpublished study prepared by Aventis Cropscience. 217 p. 1R.741,, | Langrand-Lerche, C. (2002) Phenobarbitol: 28-Day Hepato-Toxicity Study j jn the C57BL/6 MouSe. Project Number: C026075, SA/02013, 605655. 07-Feb- 2005 07-Feb- 2005 21 ------- 46474134 Unpublished study prepared by Aventis Cropscience. 204 p. Langrand-Lerche, C. (2004) Phenobarbital and Clofibric Acid: Reference 28-Day Study for the Hepatotoxicity in the C57BL/6 Mouse. Project Number: C042531, SA/03310. Unpublished study prepared by Aventis Cropscience. 466 p. r~ j Frith, C.; Highman, B.; Burger, G.; et. al. (1983) Spontaneous Lesions in 46474135 Virgin and Retired Breeder Balb/C and C57BL/6 Mice. Laboratory Animal j Science 33(3): 273-286. 07-Feb- 2005 07-Feb- 2005 46474136 Cunningham, M. (1996) Role of Increased DMA Replication in the Carcinogenic Risk of Nonmutagenic Chemical Carcinogens (Phenobarbital, Oxazepam, Methapyrilene, Saccharin). Mutation Research 365: 59-69. r~ 46474137 Ito, N.; Hasegawa, R.; Imaida, K.; et. al. (1992) Pathological Markers for Non-Genotoxic Agent-Associated Carcinogens (Clofibrate, DEHP, DEHA, TCA, PB, Alachlor). Toxicology Letters 64/65: 613-620. 07-Feb- 2005 07-Feb- 2005 46474138 r~ 46474139 Smith, C. (2004) AE C638206: Combined Carcinogenicity and Toxicity Study by Dietary Administration to CD Rats for 104 Weeks. Project Number: C038733, AES/024/032124, AES/024. Unpublished study prepared by Bayer Ag, Institute of Product Info. 35 p. Cooper, S. (2003) AE C638206: Combined Carcinogenicity and Toxicity Study by Dietary Administration to CD Rats for 104 Weeks. Project Number: C038733, AES/024/032124, AES/024. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 3517 p. 07-Feb- 2005 07-Feb- 2005 46474140 Payraudeau, V.; Smith, C. (2004) Fluopicolide (AE C638206): Genotoxicity Data Summary. Project Number: C008172, C012560, C012562. Unpublished study prepared by Bayer Ag, Institute of Product Info. 9 p. 07-Feb- 2005 46474141 Smith, C. (2004) AE C638206: Bacterial Reverse Mutation Test. Project Number: C008172, TOX/99189, TOX/00/283/7. Unpublished study prepared by Bayer Ag, Institute of Product Info. 10 p. r~ 46474142 Stammberger, I. (2004) AE C639206: Bacterial Reverse Mutation Test (Including Amendment 2). Project Number: C008172, C045895, TOX/99189. Unpublished study prepared by Aventis Pharma Deutschland Gmbh. 54 p. 07-Feb- 2005 07-Feb- 2005 I Smith, C. (2004) AE C638206 00 1C96 0002 (OP 2050045): Reverse j Mutation Assay in Four Histidine-Requiring Strains of Salmonella 46474143 I typhimurium and One Trytophan-Requiring Strain of Escherichia coli. j Project Number: C012560, 1849/6. Unpublished study prepared by Bayer ! Ag, Institute of Product Info. 12 p. Ballantyne, M. (2001) AE C638206 00 1C96 0002 (OP 2050045): Reverse i Mutation in Four Histidine-Requiring Strains of Salmonella typhimurium 46474144 and One Trytophan-Requiring Strain of Escherichia coli. Project Number: j C012560, 1849/6, 1849/6/D6171. Unpublished study prepared by j Covance Laboratories, Ltd. 64 p. 07-Feb- 2005 07-Feb- 2005 46474145 Smith, C. (2004) AE C638206 00 1C99 0005: Reverse Mutation Assay in Four Histidine-Requiring Strains of Salmonella typhimurium and One 07-Feb- 2005 22 ------- Trytophan-Requiring Strain of Escherichia coli. Project Number: C012562, 1849/5. Unpublished study prepared by Bayer Ag, Institute of Product Info. 12 p. i Ballantyne, M. (2001) AE C638206 00 1C99 0005: Reverse Mutation in ! Four Histidine-Requiring Strains of Salmonella typhimurium and One 46474146 J Trytophan-Requiring Strain of Escherichia coli. Project Number: C012562, j 1849/5/D6171, 1849/5. Unpublished study prepared by Covance i Laboratories, Ltd. 57 p. 07-Feb- 2005 f Smith, C. (2004) AE C638206 00 1B96 0002 (R001737): Reverse Mutation Assay in Four Histidine-Requiring Strains of Salmonella 46474147 | typhimurium and One Trytophan-Requiring Strain of Escherichia coli. j Project Number: C012564, 605201. Unpublished study prepared by Bayer | Ag, Institute of Product Info. 12 p. 46474148 Ballantyne, M. (2001) AE C638206 00 1B99 0002 (ROO1737): Reverse Mutation in Four Histidine-Requiring Strains of Salmonella typhimurium and One Trytophan-Requring Strain of Escherichia coli. Project Number: C012564, 1849/8/D6171, 1849/8. Unpublished study prepared by Covance Laboratories, Ltd. 60 p. 07-Feb- 2005 07-Feb- 2005 j Bayer CropScience LP (2005) Submission of Toxicity, Pesticide Fate and 46474200 j Product Chemistry Data in Support of the Petition for Tolerance of j Fluopicolide in/on Imported Grapes and Raisins. Transmittal of 47 Studies. 07-Feb- 2005 j Smith, C. (2004) AE C638206 00 1C96 0001 (OP2050046): Reverse j Mutation Assay in Four Histidine-Requiring Strains of Salmonella 46474201 | tymphimurium and One Tryptophan-Requiring Strain of Escherichia coli. | Project Number: C012566, 1849/7, 605202. Unpublished study prepared { by Bayer Ag, Institute of Product Info. 12 p. | j Ballantyne, M. (2001) AE C638206 00 1C96 0001 (OP2050046): Reverse { i Mutation in Four Histidine-Requiring Strains of Salmonella tymphimurium I 46474202 j and One Tryptophan-Requiring Strain of Escherichia coli. Project Number: | j 1849/7/D6171, 1849/7, TOX/20135. Unpublished study prepared by { j Covance Laboratories, Ltd. 64 p. 07-Feb- 2005 07-Feb- 2005 46474203 46474204 Smith, C. (2004) AE C638206: In Vitro Chinese Hamster Lung V79 Cell HPTR Mutation Test. Project Number: C026130, TOX99190. Unpublished study prepared by Bayer Ag, Institute of Product Info. 13 p. Stammberger, I.; Graeser, D. (2005) AE C638206: In Vitro Chinese Hamster Lung V79 Cell HPTR Mutation Test (Including Amendment 2). Project Number: 2000/0333, TOX99190, C026130. Unpublished study prepared by Aventis Pharma Deutschland Gmbh and Aventis Pharma Deutschland Gmbh. 56 p. 07-Feb- 2005 07-Feb- 2005 46474205 Smith, C. (2004) AE C638206: In Vitro Chinese Hamster Lung V79 Cells Chromosome Aberration Assay. Project Number: C008174, TOX99191. Unpublished study prepared by Bayer Ag, Institute of Product Info. 12 p. j Stammberger, I.; Graeser, H. (2004) AE C638206: In Vitro Chinese j Hamster Lung V79 Cells Chromosome Aberration Assay (Including 46474206 j Amendment No. 1). Project Number: 2000/0315, 2000/1301, C008174. ! Unpublished study prepared by Aventis Pharma Deutschland Gmbh and I Aventis Pharma Deutschland Gmbh. 53 p. 07-Feb- 2005 07-Feb- 2005 23 ------- 46474207 Smith, C. (2004) AE C638206: In Vitro Mammalian Chromosome Aberration Test in Human Lymphocytes. Project Number: C011815, 605137. Unpublished study prepared by Bayer Ag, Institute of Product Info. 10 p. r~ 46474208 j Allais, L. (2001) AE C638206: In Vitro Mammalian Chromosome | Aberration Test in Human Lymphocytes. Project Number: j AES/031/004381, AES/031, 605137. Unpublished study prepared by j Huntingdon Life Sciences, Ltd. 30 p. 07-Feb- 2005 07-Feb- 2005 j Smith, C. (2004) AE C638206: Mouse Erythrocyte Micronucleus Test. 46474209 j Project Number: C008175, TOX/99192. Unpublished study prepared by | Bayer Ag, Institute of Product Info. 8 p. 07-Feb- 2005 j Roth, T. (2005) AE C638206: Mouse Erythrocyte Micronucleus Test. 46474210 j Project Number: 2000/0263, TOX/99192, TOX/00/283/10. Unpublished j study prepared by Aventis Pharma Deutschland Gmbh. 33 p. 07-Feb- 2005 Smith, C. (2004) AE C638206: Induction of Micronucles in the Bone 46474211 Marrow of Treated Mice. Project Number: C035885, 2014/70. Unpublished study prepared by Bayer Ag, Institute of Product Info. 10 p. 07-Feb- 2005 46474212 r~ 46474213 Whitwell, J. (2003) AE C638206: Induction of Micronuclei in the Bone Marrow of Treated Mice. Project Number: 2014/70/D6172, 2014/70, C035885. Unpublished study prepared by Covance Laboratories, Ltd. 58 P- 07-Feb- 2005 Smith, C. (2004) AE C638206: Micronucleus Test on the Male Mouse. Project Number: C037549, T/3072923. Unpublished study prepared by Bayer Ag, Institute of Product Info. 11 p. 07-Feb- 2005 j Herbold, B. (2003) AE C638206: Micronucleus-Test on the Male Mouse. 46474214 j Project Number: AT00749, T/3072923, C037549. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 47 p. 07-Feb- 2005 Smith, C. (2004) AE C638206: In Vivo Rat Liver Unscheduled DNA Synthesis (DNA Repair) Test (Including Addendum). Project Number: C008141, C010494, TOX/00/283/21. Unpublished study prepared by Bayer Ag, Institute of Product Info. 10 p. 07-Feb- 2005 46474216 46474217 46474218 1 46474219 j Mason, C.; Bright, J. (2000) AE C638206: In Vivo Rat Liver Unscheduled j DNA Synthesis (DNA Repair) Test (Including First Addendum). Project j Number: AES/002/003189, TOX/99330, TOX/00/283/21. Unpublished j study prepared by Huntingdon Life Sciences, Ltd. and Aventis j Cropscience UK Ltd. 44 p. j Smith, C. (2004) AE C638206: Neurotoxicity Study by a Single Gavage j Administration to CD Rats Followed by a 14-Day Observation Period. ! Project Number: C019695, AES/046/013157. Unpublished study prepared j by Bayer Ag, Institute of Product Info. 25 p. j Cooper, S. (2002) AE C638206: Neurotoxicity Study by a Single Oral j Gavage Administration to CD Rats Followed by a 14-Day Observation | Period. Project Number: AES/046/013157, AES/046, 013157. j Unpublished study prepared by Huntingdon Life Sciences, Ltd. 360 p. I Cooper, S. (2002) AE C638206: Dose Range and Time to Peak Effect in j Rats by Acute Oral Administration. Project Number: AES045/12582, 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 24 ------- AES/045, 012582. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 244 p. Smith, C. (2004) AE C638206: Neurotoxicity Study by Dietary 46474220 ! Administration to CD Rats for 13 Weeks. Project Number: C019700, | AES/051. Unpublished study prepared by Bayer Ag, Institute of Product ! Info. 22 p. 07-Feb- 2005 46474221 Cooper, S. (2002) AE C638206: Neurotoxicity Study by Dietary Administration to CD Rats for 13 Weeks. Project Number: AES/0517014550, AES/051, 014550. Unpublished study prepared by Huntingdon Life Sciences, Ltd. and Huntingdon Life Sciences Ltd. 396 p. 07-Feb- 2005 j Bolton, N. (2002) Further Validation of Neurotoxicity Procedures Following | Oral Gavage Administration of D-Amphetamine or Diisopropyl 46474222 | Fluorophosphate to CD Rats to Meet EPA FIFRA Requirements. Project | Number: HLS027/982493, C045769, HLS/027. Unpublished study j prepared by Huntingdon Life Sciences Ltd. 199 p. 07-Feb- 2005 Blacker, A. (2004) Justification for Waiving a Developmental Neurotoxicity 46474223 Study of Fluopicolide (AE C638206). Project Number: AMB/11/04, B004879. Unpublished study prepared by Bayer CropScience LP. 7 p. 07-Feb- 2005 46474224 46474225 Fisher, P.; Smith, C. (2004) Fluopicolide (AE C638206): Metabolism and Pharmokinetics Data Summary. Unpublished study prepared by Bayer Ag, Institute of Product Info. 11 p. Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206 and [Pyridyl-2,6- (Carbon 14)]-AE C638206: Rat Blood and Plasma Kinetics Study. Project Number: C036987, SA/02012. Unpublished study prepared by Bayer Ag, Institute of Product Info. 16 p. 07-Feb- 2005 07-Feb- 2005 46474226 Fisher, P.; Vinck, K. (2003) [Phenyl-U-(Carbon 14)]-AE C638206 and [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Blood and Plasma Kinetics Study. Project Number: SA/02012, C036987. Unpublished study prepared by Bayer Cropscience. 69 p. 07-Feb- 2005 46474227 j D'Souza, R. (2000) [Carbon 14]-AE C638206: Preliminary Toxicokinetic Studies in the Rat. Project Number: TOX/00/283/24, TOX/99217, HFL1063. Unpublished study prepared by Aventis Cropscience UK Ltd. and HFL. 175 p. 46474228 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Tissue Kinetic Study. Project Number: C036983, SA/02094. Unpublished study prepared by Bayer Ag, Institute of Product Info. 26 p. 07-Feb- 2005 07-Feb- 2005 46474229 46474230 | Fisher, P. (2003) [Phenyl-U-(Carbon 14)]-AE C638206 Rat Tissue Kinetic j Study. Project Number: SA/02094, C036983. Unpublished study prepared | by Bayer Cropscience. 168 p. Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Single High & Low Dose Rat A.D.E. Study; [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism Following Administration of a Single Oral Low Dose (Including Amendment No. 1); [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism Following Administration of a Single Oral High Dose (Including Amendment No. 1). Project Number: C017703, C039583, C039582. Unpublished study prepared by Bayer Ag, Institute of Product Info. 51 p. 07-Feb- 2005 07-Feb- 2005 25 ------- I Totis, M. (2001) [Phenyl-U-(Carbon 14)]-AE C638206: Single High & Low 46474231 j Dose Rat A.D.E. Study. Project Number: SA/00398, 605306, C017703. Unpublished study prepared by Aventis Cropscience. 78 p. r~ 46474232 j Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism | Following Administration of a Single Oral Low Dose (Including | Amendment No. 1). Project Number: SA/00581, C039583. Unpublished j study prepared by Aventis Cropscience and Bayer Cropscience. 160 p. 07-Feb- 2005 07-Feb- 2005 46474233 i Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Metabolism Following Administration of a Single Oral High Dose (Including j Amendment No. 1). Project Number: SA/01157, C039582. Unpublished study prepared by Bayer Cropscience. 142 p. 07-Feb- 2005 46474234 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Repeat Oral Low Dose A.D.M.E. Study in the Rat (Including Amendment No. 1). Project Number: C039584, SA/01288. Unpublished study prepared by Bayer Ag, ! Institute of Product Info. 35 p. | Fisher, P. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Repeat Oral Low j Dose A.D.M.E. Study in the Rat (Including Amendment No. 1). Project | Number: SA/01288, C039584. Unpublished study prepared by Bayer j Cropscience. 210 p. 07-Feb- 2005 07-Feb- 2005 46474236 Smith, C. (2004) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Bile Excretion Study. Project Number: C021984, SA/01383, 605513. Unpublished study prepared by Bayer Ag, Institute of Product Info. 14 p. j Totis, M. (2002) [Phenyl-U-(Carbon 14)]-AE C638206: Rat Bile Excretion 46474237 | Study. Project Number: SA/01383, 605513, C021984. Unpublished study j prepared by Aventis Cropscience. 64 p. 07-Feb- 2005 07-Feb- 2005 j Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Tissue 46474238 j Kinetic Study. Project Number: C036980, SA/02370. Unpublished study prepared by Bayer Ag, Institute of Product Info. 17 p. 07-Feb- 2005 46474239 Fisher, P. (2003) [2,6-Pyridyl-(Carbon 14)]-AE C638206: Rat Tissue Kinetic Study. Project Number: SA/02370, C036980. Unpublished study prepared by Bayer Cropscience. 63 p. r~ 46474240 Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low Dose Rat A.D.E. Study (Including Amendment No. 1); [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Metabolism Following Administration of a Single Oral Dose (Including Amendment No. 1). Project Number: C012385, C012989, C039580. Unpublished study prepared by Bayer Ag, Institute of Product Info. 42 p. 07-Feb- 2005 07-Feb- 2005 46474241 46474242 Le Lain, R. (2001) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low Dose Rat A.D.E. Study (Amended). Project Number: SA/00477, 605088, C012385. Unpublished study prepared by Aventis Cropscience. 55 p. Fisher, P. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Rat Metabolism Following Administration of a Single Oral Low Dose (Including Amendment No. 1). Project Number: SA/00550, C039580. Unpublished study prepared by Bayer Cropscience. 193 p. 07-Feb- 2005 07-Feb- 2005 46474243 Smith, C. (2004) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low Dose Rat Bile Excretion Study. Project Number: C032181, SA02157. 07-Feb- 2005 26 ------- Unpublished study prepared by Bayer Ag, Institute of Product Info. 13 p. 46474244 r~ 46474245 46474246 Gutierrez, L. (2003) [Pyridyl-2,6-(Carbon 14)]-AE C638206: Single Oral Low Dose Rat Bile Excretion Study. Project Number: SA/02157, 605761, C032181. Unpublished study prepared by Bayer Cropscience. 48 p. Cousin, J.; Smith, C. (2004) Summary of Test Substance Batches Used on the Mammalian Toxicology Studies Submitted to Support the U.S. Tolerance Petition for Residues in/on Imported Grapes and Raisins. Unpublished study prepared by Bayer Ag, Institute of Product Info. 5 p. Gomez, C.; Tassel, J-P. (2000) AE C638206: Determination by HPLC Analysis in Ground Rodent Diet. Project Number: R&D/CRSA/ANL/00/054, ANL/235/OOE, 604941. Unpublished study prepared by Aventis Cropscience. 18 p. r~ Gomez, C.; Brousse, I.; Oullier, J-P.; et. al. (2000) AE C638206: 4R474P47 ! Determination by HPLC Analysis in Ground Rodent Diet. Project Number: j R&D/CRSA/ANL/00/075, ANL/235/OOE/E/, 605022. Unpublished study j prepared by Aventis Cropscience. 19 p. 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 07-Feb- 2005 46708400 r~ 46708401 Valent U.S.A. Corp. (2005) Submission of Product Chemistry, Residue, Environmental Fate and Fate Data in Support of the Petition for Tolerance of Fluopicolide for Use on Grapes and the Application for Registration of Fluopicolide Technical, V-10161 4 SC, V-10161 VPP Fungicide, V-10162 Premixand V-10162 VPP Fungicide. Transmittal of 49 Studies. Hewitt, A. (2005) Atomization Droplet Size Spectra for Fluopicolide AG. Project Number: UQ/792B, 200500281. Unpublished study prepared by University of Queensland Centre for Pesticide Application. 132 p. 08-Dec- 2005 08-Dec- 2005 j Muhlberger, B.; Lemke, G. (2005) AE C0638206 Storage Stability. Project 46708402 j Number: PA3/069, 200501004. Unpublished study prepared by Bayer | Cropscience Gmbh. 18 p. 46708403 r~ 46708404 46708405 46708406 Smeykal, H. (2005) AE C638206: Thermal Stability in the Presence of Aluminum and Aluminum Ions at Ambient and Elevated Temperatures. Project Number: 20050498/01, 200500260. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 21 p. Muhlberger, B.; Lemke, G. (2004) AE C638206 Oxidizing or Reducing Potential Code: AC C638206 00 1C99 0007. Project Number: PA3/070, 200501005. Unpublished study prepared by Bayer Cropscience Gmbh. 12 P- 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00 j 1C96 0001: Oxidizing Properties. Project Number: 20030348/06, j 08-Dec- 200500835. Unpublished study prepared by Siemens Axiva GmbH & Co. I 2005 KG. 10 p. j mammmmmm^^ Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00 1C96 0001: Autp-Flammability (Solids-Determination of Relative Self- 08-Dec- Ignition Temperature). Project Number: 20030348/05, 200500834. 2005 Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 10 p. Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00 46708407 | 1C96 0001: Flammability (Solids). Project Number: 20030348/03, j 200500832. Unpublished study prepared by Siemens Axiva GmbH & Co. 08-Dec- 2005 27 ------- I KG. 9 p. 46708408 Smeykal, H. (2003) AE C638206; Substance, Technical AE C638206 00 1C960001: Explosive Properties. Project Number: 20030348/04, 200500833. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 11 p. r~ 46708409 Bowen, T. (2005) Corrosion Characteristics of Fluopicolide Technical Grade Active Ingredient (AE C638206). Project Number: AF04/097, 200501006. Unpublished study prepared by Bayer Cropscience Gmbh. 11 P- 08-Dec- 2005 08-Dec- 2005 46708410 46708411 Franke, J. (2004) AE C638206; Substance, Techncial AE C638206 00 1C99 0015 Particle Size Distribution. Project Number: 20040728/01, 200500261. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 12 p. Queyrel, I.; Rosati, D. (2001) AE C638206 and its Metabolites: AE C657188 (PCA), AE C653711 (BAM), and RPA 427967 (hydroxyl): Analytical Method for the Determination of the Residues in Soil. Project Number: 200500871, 0115425, 01/03. Unpublished study prepared by Aventis Cropscience, Centre de Recherche de La Dargoire. 46 p. 08-Dec- 2005 08-Dec- 2005 46708412 Krebber, R. (2005) Analytical Method 00924 for the Determination of AE C638206 and its Metabolites AE C657188 (PCA) and AE C653711 (BAM) in Drinking and Surface Water by HPLC-MS/MS. Project Number: MR/005/05, 200500874, 00924. Unpublished study prepared by Bayer Ag, .44 p. 46708413 Queyrel, I.; Rosati, D. (2003) Analytical Method AR-307-03 for the Determination of AE C638206 and its Metabolites AE C653711 and AE C657177 in Water. Project Number: 200500873, 0315132, AR/307/03. Unpublished study prepared by Bayer Cropscience. 44 p. 08-Dec- 2005 08-Dec- 2005 46708414 46708415 Rose, A. (2005) Environmental Fate and Ecological Risk Assessment for Fluopicolide Use on Turf, Vegetables, and Grapes. Project Number: VP/29735, 200500284. Unpublished study prepared by Valent U.S.A. Corporation. 142 p. Godfrey, T. (2000) Soil: Analytical Method for the Determination of Residues of AE C638206. Project Number: DGM/CO1/00/0, 200500870. Unpublished study prepared by Aventis Cropscience UK Ltd. 31 p. I Peronne, H.; Rosati, D. (2005) Storage Stability of Residues of AE j C638206 and its Metabolites: BAM (AE C653711), PCA (AE C657188) 46708416 j and RPA 427967 (AE 0608000) in Soils During Deep Freeze Storage for { at Least 24 Months. Project Number: 0415034, 200500875. Unpublished | study prepared by Bayer Cropscience. 48 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 { 46708417 j Mills, E.; Simmonds, M. (2003) (Carbon 14)-AE C657188: Adsorption to | and Desorption from Three Soils. Project Number: CX/03/032, j 200500845. Unpublished study prepared by Battelle Agrifood, Ltd. 88 p. i Billian, P.; Schoning, R. (2004) Storage Stability of AE C638206 and its j Metabolites AE C657378 (3-OH_BAM), AE C553711 (BAM) and AE 46708418 1344122 (P1X) in/on Cereals (Rest of Plant, Grain, Straw) for 24 Months. j Project Number: MR/177/04, 200500286, BCS/RD/D/ROCS. Unpublished j study prepared by Bayer Ag. 47 p. 08-Dec- 2005 08-Dec- 2005 28 ------- 46708419 _,_ 46708420 __ 46708421 46708422 ! Jacob, O.; Fitzmaurice, M. (2003) (Carbon 14)-AE C653711: Hydrolysis at j pH 4, 5, 7 and 9. Project Number: CX/03/03, 200500852. Unpublished j study prepared by Battelle Agrifood, Ltd. 67 p. ! Shepler, K.; Runes, H. (2002) Hydrolysis of (Carbon 14)-AE C638206 at I pH 4, 5, 6, 7 and 9. Project Number: 1 124W, 200500851 . Unpublished ! study prepared by PTRL West, Inc. 87 p. i Sur, R. (2004) AE 0608000: Hydrolytic Degradation. Project Number: | M1 11 1405/3, 200500853, MEF/04/369. Unpublished study prepared by j Bayer Ag. 68 p. I | Shepler, K.; Runes, H. (2003) Photolysis and Quantum Yield of (Carbon | 14)-AE C638206 in Buffered Aqueous Solution. Project Number: 1119W, | 200500854. Unpublished study prepared by PTRL West, Inc. 1 13 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 { Hellpointner, E. (2004) Phototransformation of [pyridyl-2,6-(Carbon 14)]AE 46708423 \ C638206 in Sterile Water Buffered at pH 7. Project Number: M1121324/4, 200500855, MEF/043/04. Unpublished study prepared by Bayer Ag. 54 p. 08-Dec- 2005 46708424 Mackie, J. (2005) [Benzene Ring-U-(Carbon 14)]-AE C638206: Soil Photolysis. Project Number: 200500856, 394309, 398240. Unpublished study prepared by Inveresk Research International. 115 p. r~ 46708425 Lowrie, C.; Keirs, D. (2001) [Pyridyl-2. 6-(Carbon 14)] Labelled AE C638206: Photodegradation on Sandy Loam Soil. Project Number: 396814, 20050857. Unpublished study prepared by Inveresk Research International. 44 p. 08-Dec- 2005 08-Dec- 2005 | Allan, J. (2003) Route and Rate Degradation of (2,6-(Carbon 14)-pyridinyl] I and [U-(Carbon 14)-benzoyl]-AE 638206 in European Sandy Loam Under 46708427 j Laboratory Aerobic Conditions at 20 (Degrees) C and Determination of j Aged in situ Kd Values at 25 C. Project Number: CU99E506, 200500858. Unpublished study prepared by Bayer Cropscience LP. 87 p. 08-Dec- 2005 j Allan, J. (2003) The Route and Rate of Degradation of [2,6-(Carbon 14)- j pyridinyl] and [U-(Carbon 14)-benzoyl]-AE C638206 in Two Soils Under 46708428 j Laboratory Aerobic Conditions at 25 (Degrees) C. Project Number: | CUOOE509, 200500860. Unpublished study prepared by Bayer { Cropscience LP. 105 p. j Rupprecht, J.; Harbin, A. (2005) Degradation of [2,6 (Carbon 14)-pyridinyl] j and [U-(Carbon 14)-benzoyl]-AE C638206 in a Sediment/Water System 46708429 J Under Laboratory Anaerobic Conditions at 20 (Degress)C. Project j Number: CUOOE513, 200500868. Unpublished study prepared by Bayer j Cropscience LP. 66 p. 08-Dec- 2005 08-Dec- 2005 j Norris, F. (2005) AE C638206: Terrestrial Soil Dissipation Under 46708430 j Agricultural Field Conditions. Project Number: 01CU27801, 200500869, j AR/265/01. Unpublished study prepared by Bayer Cropscience LP. 436 p. 08-Dec- 2005 46708431 Bright, A. (2000) Homogeneity and Stability in Solvents AE C638206 99.6% w/w. Project Number: CHR/00/024, 200500918. Unpublished study prepared by Aventis Cropscience UK Ltd. 30 p. 08-Dec- 2005 { Wetton, P.; Mullee, D. (2001) 2,6-dichlorobenzamide (BAM): Acute 46708432 | Toxicity to Daphnia magna. Project Number: 1133/008, 200500877. | Unpublished study prepared by Safepharm Laboratories, Ltd. 41 p. 08-Dec- 2005 29 ------- 46708433 Young, B.; Abedi, J. (2003) The 48 Hour Acute Toxicity to the Water Flea, Daphnia magna, in a Static System AE C638206 Technical 971% w/w. Project Number: 02CU28564, 200500876. Unpublished study prepared by Bayer Cropscience LP. 43 p. r~ 46708434 Young, B.; Abedi, J. (2003) The 48 Hour Acute Toxicity to the Water Flea, Daphnia magna, in a Static System AE C638206 Technical 97.1% w/w. Project Number: 02CU28564, 200500876. Unpublished study prepared by Bayer Cropscience LP. 43 p. 08-Dec- 2005 08-Dec- 2005 46708435 46708436 j Dionne, E. (2003) AE C638206 - Acute Toxicity to Eastern Oysters j (Crassostrea virginica) Under Flow-Through Conditions. Project Number: | 200500879, 13798/6122. Unpublished study prepared by Springborn j Smithers Laboratories. 54 p. Caferella, M. (2003) AE C638206 - Acute Toxicity to Mysids (Americamysis bahia) Under Static Conditions. Project Number: 200500880, 13798/6121. Unpublished study prepared by Springborn Smithers Laboratories. 53 p. r~ 46708438 Young, B.; Abedi, J. (2003) The 96 Hour Acute Toxicity to the Rainbow Trout, Oncorhyncus mykiss, in a Static System AC C638206 Technical 97.1% w/w. Project Number: 02CU20827, 200500882. Unpublished study prepared by Bayer Cropscience LP. 53 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour Static 4R7no4oq Acute Toxicity Test with the Common Carp (Cyprinus carpio). Project | Number: 149A/162, 200500887. Unpublished study prepared by Wildlife ! International, Ltd. 42 p. 46708440 Blankinship, A.; Palmer, S.; Kendall, T.; et. al. (2003) AE C638206: A 96- Hour Static Acute Toxicity Test with the Ricefish (Oryzial latipes). Project Number: 149A/164, 200500885. Unpublished study prepared by Wildlife International, Ltd. 42 p. 08-Dec- 2005 08-Dec- 2005 46708441 Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour Static Acute Toxicity Test with the Zebra Fish (Brachydanio rerio). Project Number: 200500884, 149A/163. Unpublished study prepared by Wildlife International, Ltd. 40 p. AK70KAAK Meyer, B.; Young, B. (2003) Bioaccumulation and Metabolism of [2,6- (Carbon i4).pyrjdiny|]-AE C638206 in Bluegill Sunfish, Lepomis 08-Dec- 2005 46708442 46708444 46708445 { Cafarella, M. (2003) AE C638206: Acute Toxicity to Sheepshead Minnow ! (Cyprinodon variegatus) Under Static Conditions. Project Number: 1 13798/6120, 200500889. Unpublished study prepared by Springborn j Smithers Laboratories. 48 p. I Young, B.; Abedi, J. (2003) Effects on the Life-Cycle of the Water Flea, j Daphnia magna, in a Static Renewal System AC C638206 Technical | 97.7% w/w. Project Number: 02CU34046, 200500891. Unpublished study | prepared by Bayer Cropscience LP. 82 p. | Palmer, S.; Kendall, T.; Krueger, H. (2003) AE C638206: An Early Life- j Stage Toxicity Test with the Fathead Minnow (Pimephales promelas) j Under Flow-Through Conditions. Project Number: 149A/141A, j 200500892. Unpublished study prepared by Wildlife International, Ltd. 77 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 30 ------- i macrochirus, In a Flow-Through System. Project Number: 604CU, | 200500893. Unpublished study prepared by Bayer Cropscience LP. 104 p. Gallagher, S.; Beavers, J. (2001) AE C638206 Technical: An Acute Oral 46708447 i Toxicity Study with the Mallard. Project Number: 512/113, 200500895. i Unpublished study prepared by Wildlife International, Ltd. 31 p. r~ 46708448 Gallagher, S.; Beavers, J. (2001) AE C638206 Technical: An Acute Oral Toxicity Study with the Northern Bobwhite. Project Number: 512/112, 200500896. Unpublished study prepared by Wildlife International, Ltd. 31 P- 08-Dec- 2005 08-Dec- 2005 46708449 Gallagher, S.; Beavers, J.; Martin, K. (2002) AE C638206 Technical: A Dietary LC50 Study with the Mallard. Project Number: 512/115, 200500889. Unpublished study prepared by Wildlife International, Ltd. 54 P- 46708500 Valent U.S.A. Corporation (2005) Submission of Toxicity, Fate, Residue and Environmental Fate Data in Support of the Applications for Registration of Fluopicolide Technical, V-10161 4 SC, V-10161 VPP Fungicide, V-10162 Premixand V-10162 VPP Fungicide, and the Petition for Tolerance of Fluopicolide for Use on Grapes. Transmittal of 48 Studies. 08-Dec- 2005 08-Dec- 2005 46708501 Gallagher, S.; Grimes, J.; Beavers, J.; et. al. (2002) AE C38206 Technical: A Dietary LC50 Study with the Northern Bobwhite. Project Number: 512/114, 200500898. Unpublished study prepared by Wildlife International, Ltd. 54 p. j Temple, D.; Martin, K.; Beavers, J.; et. al. (2003) AE C638206 Technical: 4R7nocno | A Reproduction Study with the Mallard. Project Number: 149/186, I 200500902. Unpublished study prepared by Wildlife International, Ltd. 165 46708503 46708504 Waltersdorfer, A. (2001) Contact Toxicity (LD50) to Honey Bees (Apis | mellifera L.) Substance Pure: AE C638206 00 1B99 0002. Project | Number: CWOO/065, 200500904. Unpublished study prepared by Aventis i Crop Science. 16 p. 46708505 Sabbert, T. (2004) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Using AE C638206 SC40. Project Number: 200721, 200500906, A6451402. Unpublished study prepared by Bayer Corp. 86 p. 08-Dec- 2005 08-Dec- 2005 Temple, D.; Martin, K.; Beavers, J.; et. al. (2003) AE C638206 Technical: j A Reproduction Study with the Northern Bobwhite. Project Number: ! 149/185, 200500901. Unpublished study prepared by Wildlife | International, Ltd. 167 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 46708507 Hoberg, J. (2003) AE C638206 - 7-Day Toxicity Test with Duckweed (Lemna gibba). Project Number: 13798/6125, 2005500908, EBACX/085. Unpublished study prepared by Springborn Smithers Laboratories. 61 p. 46708508 j Young, B.; Abedi, J. (2003) Effect to Anabaena flos-aquae (Blue-green j Alga) in a Growth Inhibition Test AE C638206 Technical 97.1% w/w. j Project Number: 02CU28566, 200500911. Unpublished study prepared by j Bayer CropScience LP. 51 p. 08-Dec- 2005 08-Dec- 2005 46708509 j Desjardins, D.; Kendall, T.; Krueger, H. (2003) AE C638206: A 96-Hour 08-Dec- ------- Toxicity Test with the Freshwater Alga (Selenastrum capricornutum). Project Number: 149A/166A, 200500915. Unpublished study prepared by Wildlife International, Ltd. 56 p. 46708510 Hoberg, J. (2003) AE C638206 - Acute Toxicity to the Marine Diatom, Skeletonema costatum Under Static Conditions. Project Number: 13798/6124, 200500917, EBACX/008. Unpublished study prepared by Springborn Smithers Laboratories. 66 p. 2005 08-Dec- 2005 46708512 Aufderheide, J.; Hughes, C. (2002) Acute Toxicity of AE C638206 Technical to the Earthworm, Eisenia fetida. Project Number: 47063, 200500268. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 20 p. 08-Dec- 2005 46708513 Fichera, L. (2005) Independent Laboratory Validation of Bayer Crop Science Analytical Method Entitled "Analytical Method AR 307-03 for the Determination of AE C638206 and its Metabolites AE C653711 and AE C657188 in Water". Project Number: VP/29639, 200500262, 050203. Unpublished study prepared by Golden Pacific Laboratories, LLC (GPL). 130 p. 08-Dec- 2005 46708514 Needham, D. (2003) (Carbon 14)-AE C638206: Absorption, Distribution, Metabolism and Excretion Following Repeated Oral Administration to the Lactating Cow. Project Number: 2014/040, 200500925. Unpublished study prepared by Covance Laboratories, Ltd. 200 p. 08-Dec- 2005 46708515 Needham, D. (2003) (Carbon 14)-AE C638206: Absorption, Distribution, Metabolism and Excretion Following Repeated Oral Administration to the Laying Hen. Project Number: 2014/004, 200500923. Unpublished study prepared by Covance Laboratories, Ltd. 226 p. I Cavaille, C.; Rosati, D. (2003) AE C638206 and its Metabolites AE j C653711 (BAM) and AE C657188 (PCA): Analytical Method AR 303-02 46708516 j for the Determination of Residues in Foodstuffs of Animal Origin. Project Number: C035414, 200500924, 02/125. Unpublished study prepared by j Bayer Cropscience. 85 p. 08-Dec- 2005 08-Dec- 2005 46708517 Wustner, D. (2005) Determination of the Analytes and the Definition of the Regulated Residues (of Fluopicolide): In/On Raw Agricultural Commodities and Rotational Crops, and in Processed Commodities and Secondary Residues in Meat, Milk, Poultry and Eggs. Project Number: V/DWRES/1, 200500285. Unpublished study prepared by Valent U.S.A. Corporation. 31 p. 46708518 Gedik, L.; McCombe, W. (2003) The Distribution and Metabolism of (Carbon 14)-AE C638206 in the Lactating Cow. Project Number: 201123, 200500922, 21582. Unpublished study prepared by Inveresk Research International. 200 p. 08-Dec- 2005 08-Dec- 2005 I 46708519 i~~ 46708520 Gedik, L.; McCombe, W. (2003) The Distribution and Metabolism of (Carbon 14)-AE C638206 in the Laying Hen. Project Number: 201500, 200500921, 21552. Unpublished study prepared by Inveresk Research International. 186 p. i j Rupprecht, J. (2004) Metabolism of [U-(Carbon 14)-phenyl] and [2,6- j (Carbon 14) pyridinyl]-AE C638206 in Lettuce (Amended Report j Replacing Report 505CU, Document B004330). Project Number: 505CUA, I 200500920, F9951 4/001 . Unpublished study prepared by Agrevo USA Co. 08-Dec- 2005 08-Dec- 2005 32 ------- and A & L Great Lakes Laboratories. 93 p. j Rupprecht, J. (2004) Metabolism of [U-(Carbon 14)-phenyl] and [2,6- | (Carbon 14) pyridinyl]-AE C638206 in Potatoes (Amended Report 46708521 j Replacing Report 502CU, Document B004328). Project Number: 502CUA, j 200500919, F99514/001. Unpublished study prepared by Agrevo USA Co. | and A & L Great Lakes Laboratories. 136 p. 08-Dec- 2005 46708522 Grant, J. (2005) Independent Laboratory Validation of "Validation of the Modification M002 to the Analytical Method 00782 for the Determination of Residues of AEC638206 and its Metabolites AEC657188, AEC653711 and AE 344122 in/on Wheat by HPLC-MS/MS" for Tomatoes and "Modification MOOS to the Analytical Method 00782 for the Determination of Residues of AEC657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC- MS/MS" for Wheat Forage According to PR Notice 96-1, OPPTS 860- 1340 Guideline, and SANCO/825/00 Rev. 7. Project Number: 49181, 200500277, RAACX098. Unpublished study prepared by Analytical Bio- Chemistry Labs., Inc. 129 p. 46708523 Grant, J. (2004) Independent Laboratory Validation of "Validation of the Modification M002 to the Analytical Method 00782 for the Determination of Residues of AE C638206 and its Metabolites AE C657188, AE C653711 and AE 1344122 in/on Wheat by HPLC-MS/MS" for Tomatoes and "Modification MOOS to the Analytical Method 00782 for the Determination of Residues of AEC657378 (3-OH-BAM) in/on Cereals (Wheat) by HPLC- MS/MS" for Wheat Forage According to PR Notice 96-1, OPPTS 860- 1340 Guidelines, and SANCO/825/00 Rev. 7. Project Number: 49181, 200500277, RAACX098. Unpublished study prepared by Analytical Bio- Chemistry Labs., Inc. 61 p. 08-Dec- 2005 08-Dec- 2005 46708524 i Schreier, T. (2005) Tolerance Enforcement Method for the Analysis of j Residues of Fluopicolide in/on Crops: Method RM-43C-1. Project Number: | FLUOPICOLIDE/002, 200500282, RM/43C/1. Unpublished study prepared { by Valent U.S.A. Corporation. 18 p. 46708525 Ford, C. (2005) PAM I Multiresidue Protocol Testing for AE C638206 (Fluopicolide) and its Metabolites AE C653711 (BAM), AE C657378 (BAM-OH), AE C657188 (PCA) and AE 1344122 (PIX). Project Number: 1551, 200500927, RAACX039. Unpublished study prepared by Pyxant Labs Inc. 327 p. 08-Dec- 2005 08-Dec- 2005 46708526 Green, C. (2005) Extrapolation of 30-Month Storage Stability Data for Fluopicolide and Degradates BAM and PCA in Crop Samples to 48 Months. Project Number: 29815, 200500259. Unpublished study prepared by Valent U.S.A. Corporation. 30 p. j Gould, T.; Dallstream, K.; Beedle, E. (2005) Storage Stability of AE ! C638206 and Metabolites in Potato, Sugar Beet, Tomato and Wheat j Processed Commodities. Project Number: RAACY001, 200501003. ! Unpublished study prepared by Bayer Corp. 81 p. 08-Dec- 2005 08-Dec- 2005 j Cavaille, C.; Rosati, D. (2004) Residues of AE C638206 and Major j Metabolites in Milk and Edible Cattle Tissues Following 28 Day Dosing of 46708528 j Technical Product to Lactating Cows: 2002. Project Number: 0315145, j 200500928, 02/105. Unpublished study prepared by Bayer Cropscience j and RCC Umweltchemie Ag. 256 p. 46708529 Schreier, T. (2005) Waiver Request: Magnitude of the Residue of 08-Dec- 2005 08-Dec- 33 ------- 1 p__^^ i Fluopicolide in Poultry and Eggs. Project Number: FLUOPICOLIDE/001 , | 200500225. Unpublished study prepared by Valent U.S.A. Corporation. 6 | P. ! Mackie, S. (2004) AE C638206: Magnitude of Residues in/on Bell Pepper ! Resulting from Foliar Application of EXP 11067B (2002). Project Number: | 02CU33132, 200500934, 1501. Unpublished study prepared by Pyxant I Labs Inc., Southeast Ag Research, Inc. and Ag. Consultants Inc. 149 p. | Mackie, S. (2004) AE C638206: Magnitude of Residues in Cantaloupe | Resulting from Foliar Applications of EXP 1 1 067B Under Maximum I ,lR7nRco1 j Proposed Label Specifications (2002). Project Number: 02CU27825, | 4C./U8JDCS j 200500933, 27825-0201 . Unpublished study prepared by Pyxant Labs I \ Inc., Chemtrol Scientific Testing and Alvey Lab & Agr Research Services. | | 149 p. Mackie, S. (2004) AE C638206: Magnitude of Residues in Cucumbers Resulting from Foliar Application of EXP 1 1 067B Under Maximum Proposed Label Specifications (2002). Project Number: 02CU27779, 200500931 , 27779-0201 . Unpublished study prepared by Pyxant Labs I Inc., Agricultural Systems Associates and Ag Research Associates, LLC. 113p. r~ r~ j Mackie, S. (2005) AE C638206: Magnitude of Residues in Head Lettuce j Resulting from Foliar Applications of EXP 1 1 067B Under Maximum I ,,R7nRcoo 1 Proposed Label Specifications (2002). Project Number: 02CU27778, | 4b/U8:Dcscs j 200500936, 27778-0101. Unpublished study prepared by Pyxant Labs { Inc., Agricultural Chemistry Development Services, Inc. (ACDS) and j Glades Crop Care, Inc. 152 p. i-— r— | Mackie, S. (2005) AE C638206: Magnitude of Residues in Leaf Lettuce j Resulting from Foliar Applications of EXP 1 1 067B Under Maximum j Proposed Label Specifications (2002). Project Number: 02CU30473, j 200500937, 30473-0101. Unpublished study prepared by Pyxant Labs j Inc., Agricultural Chemistry Development Services, Inc. (ACDS) and | Glades Crop Care, Inc. 138 p. j Mackie, S. (2004) AE C638206: Magnitude of Residues in/on Chili Pepper I I RAC Resulting from Foliar Application of EXP 1 1 067B (2002). Project | 46708535 | Number: 02CU33133, 200500935, 33133-09801. Unpublished study j prepared by Pyxant Labs Inc., South Texas Ag. Research and Arid Ag j Research, Inc. 110 p. r_,_ _, { Norris, F. (2003) AE C638206: Magnitude of Residues in/on Tomato RAC j Resulting from Foliar Application of EXP 11067B (2001). Project Number: 46708536 j 01CU27776, 200500930, 27776-01. Unpublished study prepared by j Enviro-Test Laboratories (ETL), Lab Services and Carolina Ag-Research I I Service, Inc. 320 p. | | f ™™™™™™*| j Mackie, S. (2004) AE C638206: Magnitude of Residues in Potato Resulting from Foliar Applications of EXP 1 1 067B Under Maximum I ,,R7nRco7 i Proposed Label Specifications (2001). Project Number: 01CU27775, | 4C./U8JDCS/ | 200500929, 27775-0101. Unpublished study prepared by Pyxant Labs j Inc., Crop Management Strategies, Inc. and Agricultural Chemistry j Development Services, Inc. (ACDS). 247 p. r~~ r { 45700530 Mackie, S. (2004) AE C638206: Magnitude of Residues in Squash j Resulting from Foliar Application of EXP 1 1 067B Under Maximum 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 34 ------- i Proposed Label Specifications (2002). Project Number: 02CU27824, | 200500932, 27824-0101. Unpublished study prepared by Pyxant Labs I Inc., Crop Management Strategies, Inc. and Agricultural Systems I Associates. 114 p. ! Kowalsky, J. (2005) Fluopicolide: Magnitude of the Residues in Celery ! Resulting from Foliar Applications of EXP 11067B Under Maximum 46708539 j Proposed Label Specifications. Project Number: 02CU33134, 200500250, j 33134-0301. Unpublished study prepared by Pyxant Labs Inc., Glades ! Crop Care, Inc. and Agsearch. 216 p. 08-Dec- 2005 46708540 Kowalsky, J. (2005) Fluopicolide: Magnitude of Residues in Spinach Resulting from Foliar Applications of EXP 11067B Under Maximum Proposed Label Specifications (2002). Project Number: 02CU33135, 200500249, 33135-0101. Unpublished study prepared by Pyxant Labs Inc., Crop Management Strategies, Inc. and Ashgrow Crop Management Systems, Inc. 212 p. 08-Dec- 2005 46708541 Belyk, M. (2005) Magnitude of Residues on Grapes Treated with Three Applications of the Fungicide EXP 11067B (AE C638206) with a 21 Day PHI. Project Number: 02AC03, 200500938, 02AC03/01. Unpublished study prepared by Enviro-Test Laboratories (ETL), A.C.D.S. Research, Inc. and Vaughn Agricultural Research Serv., Ltd. 239 p. 08-Dec- 2005 46708542 46708543 Zietz, E. (2003) AE C638206 Code AE C638206 00 SE10 A3: Determination of the Residues in Processed Fractions Derived From White Grapes Following Four Treatments Under Field Conditions In Northern Europe 2000. Project Number: IF/100/18377/00, 200500939, BKA/683/00/RES/1. Unpublished study prepared by Institut Fresenius Chemische und Biologische. 130 p. Norris, F. (2003) AE C638206: Determination of the Magnitude of Residues in/on Tomato Processed Fractions Resulting from Foliar Application of EXP 11067B. Project Number: 01CU27782, 200500940, 01/009. Unpublished study prepared by Bayer CropScience LP, California Agricultural Research Inc. and Hulst Research Farm Services. 266 p. 08-Dec- 2005 08-Dec- 2005 Mackie, S. (2004) AE C638206: Magnitude of Residues in Processed Wheat Fractions Resulting from an Exaggerated Rate Application of EXP 46708544 11067Bto Bare Ground (2001). Project Number: 01CU27784, 200500941, 27784/0502. Unpublished study prepared by Pyxant Labs Inc. and Alvey Lab & Agr Research Services. 169 p. 46708545 Mackie, S. (2004) AE C638206: Magnitude of Residues in Processed Potato Fractions Resulting from Exaggerated Rate Applications of EXP 11067B (2001). Project Number: 01CU27781, 200500942, 27781/1101. Unpublished study prepared by Pyxant Labs Inc., Quails Agricultural Laboratories, I and Agsearch. 133 p. 08-Dec- 2005 08-Dec- 2005 46708546 Meyer, B. (2003) Uptake of (Carbon 14) AE C638206 Residues in Soil by Rotational Crops under Confined Conditions (Amended Report Replacing Document No. B003699). Project Number: CU99E501. Unpublished study prepared by Aventis CropScience and Bayer Cropscience Gmbh. 311 p. 08-Dec- 2005 j Mackie, S. (2005) AE C638206: Magnitude of Residues in Wheat when 4R7noc47 Used as a Rotational Crop after Potatoes that have had Foliar Applications of EXP 11067B at the Maximum Proposed Label Specifications (2001). Project Number: 01CU31873, 200500944, 31783- 08-Dec- 2005 35 ------- 0201. Unpublished study prepared by Pyxant Labs Inc., Crop Management Strategies, Inc. and Mid South Agric. Research. 488 p. Creek, M. (2005) Fluopicolide: Toxicology Data Summary and Endpoint 46708548 i Selection Justification. Project Number: 29866, 200500283. Unpublished i study prepared by Valent U.S.A. Corporation. 40 p. r~ 46708600 Valent U.S.A. Corporation (2005) Submission of Product Chemistry, Toxicity, Pesticide Fate, Exposure and Risk Data in Support of the Application for Registrations of Fluopicolide Technical, V-10161 4 SC, V- 10161 VPP Fungicide, V-10162 Premixand V-10162 VPP Fungicide and the Petition for Tolerance of Fluopicolide on Grapes. Transmittal of 51 Studies. 08-Dec- 2005 08-Dec- 2005 j Schungel, M. (2003) AE C638206 - AE C657378 Acute Toxicity in the Rat 46708601 ! After Oral Administration. Project Number: T/4072771. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p. ! Schungel, M. (2003) AE C653711 (Metabolite of AE C638206) Acute 46708602 Toxicity in the Rat After Oral Administration. Project Number: T/4073121. j Unpublished study prepared by Bayer Ag Inst. of Toxicology. 36 p. 08-Dec- 2005 08-Dec- 2005 Coleman, D. (2005) AE C657188 (Plant Metabolite of AE C638206) Rat 46708603 [ Acute Oral Toxicity. Project Number: TOX/20044, AES/018/003625/AC. j Unpublished study prepared by Huntingdon Life Sciences, Ltd. 21 p. 08-Dec- 2005 46708604 Schungel, M. (2003) Project AE C638206 Acute Toxicity in the Rat After Oral Administration. Project Number: T2072634, AE1344122. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p. 08-Dec- 2005 46708605 McRae, L. (2000) Rat Acute Dermal Toxicity AE C638206 Code: AE C638206 00 1C99 0005. Project Number: TOX/99325, 200500953, AGV/306/002691/AC. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 18 p. 08-Dec- 2005 46708606 j__ 46708607 f 46708608 !___ 46708609 1 46708610 r~ 46708611 j Wesson, C. (2000) Rat Acute Inhalation Toxicity AE C638206. Project j Number: TOX/99329, 374/091 , 200500956. Unpublished study prepared j by Safepharm Laboratories, Ltd. 46 p. I McRae, L. (2000) Rabbit Eye Irritancy AE C638206. Project Number: j TOX/99327, 200500959, AGV/308/002879/SE. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 19 p. Coleman, D. (2000) Guinea-Pig Skin Sensitization Study (Magnusson & Kligman Method) AE C638206. Project Number: TOX/99328, 200500965, AGV/309/002587/SS. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30 p. ._ Mallyon, B. (2000) Mouse 28-Day Dietary Toxicity Study AE C638206 j Code: AE C638206 00 1C99 0004. Project Number: TOX/00/283/2, j 200500715. Unpublished study prepared by Aventis Cropscience UK Ltd. | 186 p. | Higgs, P. (2000) Rat 28-Day Dietary Toxicity Study AE C638206 Code: i AE C638206 00 1C99 0003. Project Number: TOX/00/283/1, 200500718. i Unpublished study prepared by Aventis Cropscience UK Ltd. 287 p. | McElligott, A. (2003) AE 1344122 28-Day Toxicity Study in the Rat by j Dietary Administration. Project Number: SA/03054, 200500993. | 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 36 ------- 46708612 Unpublished study prepared by Bayer Cropscience. 357 p. Eiben, R.; Rinke, M. (2003) AE C657378 Subacute Toxicity in Rats (Administration in the Diet for 4 Weeks). Project Number: T1072327, 200500992. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 384 p. r~ j Mallyon, B. (2000) AE C638206 Dog 28-Day Oral Toxicity Study. Project 46708613 | Number: TOX/00/283/3, 200500231. Unpublished study prepared by j Aventis Cropscience UK Ltd. 118 p. 08-Dec- 2005 08-Dec- 2005 { Eigenberg, E.; Stuart, B. (2003) A Subacute Dermal Toxicity Study in Rats 46708614 j with AE C638206. Project Number: 200705, 200500968. Unpublished study prepared by Bayer Corp. 309 p. r~ 46708615 Hofmann, T. (2000) AE C638206 Code: AE C638206 00 1C99 0005 Rat Oral Developmental Toxicity (Tetratogenicity) Range Finding Study. Project Number: 99/0533. Unpublished study prepared by Hoechst Ag Pharma Development Toxicology. 39 p. 08-Dec- 2005 08-Dec- 2005 46708616 Hofmann, T. (2000) Rabbit Oral Developmental Toxicity (Teratogenicity) Range Finding Study AE C638206 Code: AE C638206 00 1C99 0005. Project Number: 2000/0467, T/041/99. Unpublished study prepared by Aventis Pharma Deutschland Gmbh. 89 p. Herbold, B. (2003) AE 1344122 Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: T/5072079. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 56 p. 46708618 Herbold, B. (2004) AE C638206 SC 480 Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: T/7073223, 200500973. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 54 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 Herbold, B. (2003) AE C657378 Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: T/2063319, 200500971. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 53 p. Kitching, J. (2005) Bacterial Mutation Assay AE C657188 (Plant Metabolite of AE C638206). Project Number: TOX/20045, 200500969. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 28 p. 08-Dec- 2005 08-Dec- 2005 f 46708621 !___ 46708622 l_ 46708623 P_ 46708624 T j Koom, J. (1992) Evaluation of the Possible Mutagenic Activity of 2,6- | Dichlorobenzamide in the Ames Salmonella/Microsome Test. Project | Number: 56645/69/92, 200500946. Unpublished study prepared by Solvay JDupharB.V. 23 p. Herbold, B. (2003) Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: T/4072951, 200500972. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 53 p. [ Herbold, B. (2003) AE 1C657188 V79/HPRT - Test in Vitro for the Detection of Induced Forward Mutations. Project Number: T/8072081 , 200500974. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 38 p. j Herbold, B. (2003) AE 1344122 Metabolite of AE C638206 V79/HPRT - j Test in Vitro for the Detection of Induced Forward Mutations. Project 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 37 ------- i Number: T/7072080, 200500975. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 38 p. 46708625 Herbold, B. (2003) AE C653711 Metabolite of AE C638206 V79/HPRT - j Test in Vitro for the Detection of Induced Forward Mutations. Project | Number: T/4072078, 200500976. Unpublished study prepared by Bayer ! Ag Inst. of Toxicology. 38 p. 08-Dec- 2005 46708626 Herbold, B. (2003) AE C657378 V79/HPRT - Test in Vitro for the Detection of Induced Forward Mutations. Project Number: T/4063320, 20050097. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 38 p. 08-Dec- 2005 46708627 Lloyd, M. (2003) AE 1344122 (Metabolite of AE C638206) Induction of Chromosome Aberrations in Cultured Human Peripheral Blood Lymphocytes. Project Number: 2014/67, 200500979. Unpublished study prepared by Covance Laboratories, Ltd. 69 p. 46708628 j Kumaravel, T. (2003) AE C657378: Induction of Chromosome Aberrations | in Cultured Human Peripheral Blood Lymphocytes: Final Report. Project j Number: 2014/69, 200500980. Unpublished study prepared by Covance j Laboratories, Ltd. 69 p. 08-Dec- 2005 08-Dec- 2005 |46708629 i 46708630 | Lloyd, M. (2003) AE C657188 (Metabolite of AE C638206) Induction of j Chromosome Aberrations in Cultured Human Peripheral Blood j Lymphocytes. Project Number: 2014/68, 200500978. Unpublished study j prepared by Covance Laboratories, Ltd. 65 p. Herbold, B. (2003) AE C657378 Micronucleus - Test on the Male Mouse. Project Number: T/3072950, 200500981. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 47 p. 08-Dec- 2005 08-Dec- 2005 46708631 Brendter-Schwaab, S. (2004) AE C657378 (Project AE 638206) Unscheduled DNA Synthesis Test with Rat Liver Cells in Vivo. Project Number: T/3073210, 200500983. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 37 p. 46708632 Weller, O.; Ries, S. (2002) Mass Spectroscopic Identification of Metabolites in Urine Samples of the Rat Metabolism Study Following Administration of a Single Oral Low Dose (Substudy of the Mass { J Spectroscopic Part of Study SA00550). Project Number: SA0055/MS, { { 200500985. Unpublished study prepared by Aventis Crop Science. 165 p. [ | Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711 (BAM): Single | 46708633 Oral High Dose A.D.M.E. Study in the Rat. Project Number: SA/02327, { 200500987. Unpublished study prepared by Bayer Cropscience. 97 p. I | Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711 (BAM): Single | 46708634 j Oral Low Dose A.D.M.E. Study in the Rat. Project Number: SA02156, { | 200500986. Unpublished study prepared by Bayer Cropscience. 83 p. | Gutierrez, L. (2003) (Phenyl-U-(Carbon 14))-AE C653711: Repeat Oral I 46708635 Low Dose A.D.M.E. Study in the Rat. Project Number: SA/03018, { 200500988. Unpublished study prepared by Bayer Cropscience. 94 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 j Gutierrez, L. (2002) (Pyridyl-2,6-(Carbon 14))-AE C657188 (PCA): Single 46708636 | Oral Low Dose Rat A.D.M.E. Study. Project Number: SA/01093, | 200500989. Unpublished study prepared by Bayer Cropscience. 77 p. 08-Dec- 2005 38 ------- 46708637 Cage, S. (2003) (Carbon 14))-EXP 11120A Comparative in Vitro Dermal Penetration Study Using Human and Rat Skin. Project Number: BAG/368/033121, 200500990. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 93 p. r~ 46708638 Kemp, L. (2003) (Carbon 14) - EXP 11120A in Vivo Dermal Absorption in the Male Rat. Project Number: BAG/367/033193, 200500991. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 120 p. 08-Dec- 2005 08-Dec- 2005 46708639 Weller, O.; Ries, S. (2002) Mass Spectroscopic Identification of Three Metabolites in an Urine Sample of the Rat Metabolism Study Following Administration of a Single Oral Dose (Supplementary Substudy of the Mass Spectroscopic Part of Study SA00550). Project Number: SA005500/MS1, 200500984. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 21 p. 46708640 Wustner, D. (2005) Worker Reentry Exposure and Risk Assessment of Fluopicolide Fungicide Applied to Agricultrual Crops and Turf. Project Number: V/RE/1, 200500266. Unpublished study prepared by Valent U.S.A. Corporation. 13 p. r~ I Mackie, S. (2004) AE C638206: Dissipation of Dislodgeable AE C638206 | Foliar Residues from Leaf Lettuce Resulting from Foliar Applications of 46708641 j EXP 11067B Under Maximum Proposed Label Specifications. Project j Number: 200500994, 02CU27806. Unpublished study prepared by Central j California Research Laboratories. 180 p. 08-Dec- 2005 08-Dec- 2005 08-Dec- 2005 46708642 Wustner, D. (2005) Handler Exposure and Risk Assessment of Fluopicolide Fungicide Applied to Agricultural Crops, Ornamentals and Turf. Project Number: V/MLA/1, 200500264. Unpublished study prepared by Valent U.S.A. Corporation. 16 p. Wustner, D. (2005) Reentry Exposure and Risk Assessment of 4R7r)oR4o j Fluopicolide Fungicide After Application to Residential Turf. Project I Number: V/RE/2, 200500265. Unpublished study prepared by Valent j U.S.A. Corporation. 12 p. 08-Dec- 2005 08-Dec- 2005 j Renaud, D. (2003) AE C638206 Henry's Law Constant Calculation Code: 46708644 | AE C638206. Project Number: C/037664, 200501008. Unpublished study I prepared by Bayer Cropscience. 7 p. 46708645 1 46708646 Lechelt-Kunze, C. (2003) AE C638206 Technical: Effects on Survival, Growth and Reproduction on the Earthworm Eisenia fetida Tested with 5% Peat in the Test Substrate. Project Number: E/31 2/2368/5, 200500269. Unpublished study prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p. Assaf, N. (2005) Chronic Dietary and Drinking Water Exposure Analyses for Fluopicolide. Project Number: VP/29591, 200500229. Unpublished study prepared by Valent U.S.A. Corporation. 31 p. 08-Dec- 2005 08-Dec- 2005 46708647 46708648 Repetto-Larsay, M. (2004) Evaluation of Potential Dermal Sensitization in the Local Lymph Node Assay. Project Number: SA/04239, 200500945. Unpublished study prepared by Bayer Cropscience. 41 p. Assaf, N. (2005) Fluopicolide PRZM/EXAMS Modeling. Project Number: VP/29680, 200500230. Unpublished study prepared by Valent U.S.A. Corporation. 227 p. 08-Dec- 2005 08-Dec- 2005 39 ------- 46708649 Young, B.; Abedi, J. (2003) Effect of Pseudokirchneriella subcapitata (Green Alga) in a Growth Inhibition Test AE C638206 Technical 97.1% w/w. Project Number: 02CU28565, 200500910. Unpublished study prepared by Bayer Enivronmental Science. 52 p. r~ j Hungtingdon Life Sciences Ltd. (2000) Rabbit Skin Irritancy AE C638206. 46708650 j Project Number: TOX/99326, 200500962. Unpublished study prepared by | Huntingdon Life Sciences, Ltd. 17 p. 08-Dec- 2005 08-Dec- 2005 | Herbold, B. (2004) AE C638206 SC 480 Micronucleus - Test on the Male 46708651 j Mouse. Project Number: T/8073224, 200500992. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 46 p. 08-Dec- 2005 46709800 Valent U.S.A. Corporation (2005) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of V-10162 Premix. Transmittal of 8 Studies. 08-Dec- 2005 I Taylor, E. (2005) Physical and Chemical Properties of V-10162 Premix. 46709801 | Project Number: 200500274, 2005/10162PM/SC. Unpublished study prepared by Valent U.S.A. Corporation. 11 p. 08-Dec- 2005 46709802 r~ 46709803 Taylor, E. (2005) Product Identity and Composition, Description of Materials Used to Produce the Product, Description of Production Process, Description of the Formulation Process, Preliminary Analysis, Certified Limits, Enforcement Analytical Method, and Submittal of Samples for V-10162 Premix. Project Number: 200500248, 2005/10162PM/001. Unpublished study prepared by Valent U.S.A. Corporation. 75 p. 08-Dec- 2005 Krotlinger, F. (2003) AE B066752 04 SC61 A1-EXP11120B Study for Acute Oral Toxicity in Rats. Project Number: T8072207. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 32 p. 08-Dec- 2005 46709804 46709805 Krotlinger, F. (2003) AE B066752 04 SC61 A1-EXP11120B Amended Study for Acute Dermal Toxicity in Rats. Project Number: 200500955, T/1072219. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 33 p. 08-Dec- 2005 Pauluhn, J. (2003) AE C638206 & Propamocarb SC 62.5 + 625 Study on Acute Inhalation Toxicity in Rats According to OECD No. 403. Project Number: 200500957, T6072223. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 68 p. 08-Dec- 2005 j Griffon, B. (2002) Acute Eye Irritation in Rabbits. Project Number: 46709806 ] 200500960, 24685. Unpublished study prepared by Centre International | de Toxicologie. 19 p. 08-Dec- 2005 j Griffon, B. (2003) Acute Dermal Irritation in Rabbits. Project Number: 46709807 j 200500963, 24684. Unpublished study prepared by Centre International | de Toxicologie. 18 p. 46709808 46709900 46709901 Griffon, B. (2003) Skin Sensitization Test in Guinea Pigs (Modified Buehler Test: 9 Applications). Project Number: 200500966, 246686/TSG. Unpublished study prepared by Centre International de Toxicologie. 36 p. { Valent U.S.A. Corporation (2005) Submission of Product Chemistry and | Toxicity Data in Support of the Application for Registration of V-10161 4 | SC. Transmittal of 8 Studies. f ! Taylor, E. (2005) Physical and Chemical Properties of V-10161 4 SC. 08-Dec- 2005 08-Dec- 2005 08-Dec- 40 ------- Project Number: 2005/01061/SC. Unpublished study prepared by Valent U.S.A. Corporation. 12 p. 46709902 j Taylor, E. (2005) Product Identity and Composition, Description of j Materials Used to Produce the Product, Description of Production j Process, Description of Formulation Process, Preliminary Analysis, j Certified Limits, Enforcement Analytical Method, and Submittal of Samples | for V-10161 4 SC. Project Number: 2005/161/001. Unpublished study | prepared by Valent U.S.A. Corporation. 217 p. 2005 08-Dec- 2005 | Krotlinger, F. (2003) AE C638206 00 SC40 A2-EXP11067B Study for 46709903 | Acute Oral Toxicity in Rats. Project Number: T/6072205. Unpublished j study prepared by Bayer Ag Inst. of Toxicology. 25 p. 08-Dec- 2005 j Krotlinger, F. (2005) AE C638206 00 SC40 A2-EXP11067B Study for 46709904 j Acute Dermal Toxicity in Rats. Project Number: T/9072217. Unpublished I study prepared by Bayer Ag Inst. of Toxicology. 25 p. j Pauluhn, J. (2003) AE C638206 SC 480 Study on Acute Inhalation 46709905 j Toxicity in Rats According to OECD No. 403. Project Number: T/1072200. j Unpublished study prepared by Bayer Ag Inst. of Toxicology. 71 p. 08-Dec- 2005 46709906 < Griffon' B- (2003) Acute Irritation in Rabbits. Project Number: 24679. j Unpublished study prepared by Centre International de Toxicologie. 20 p. 08-Dec- 2005 46709907 Griffon, B. (2003) Acute Dermal Irritation in Rabbits. Project Number: 24678/TAL. Unpublished study prepared by Centre International de Toxicologie. 18 p. j Griffon, B. (2003) Skin Sensitization Test in Guinea Pigs (Modified Buehler 46709908 j Test: 9 Applications). Project Number: 24680TSG. Unpublished study prepared by Centre International de Toxicologie. 32 p. 08-Dec- 2005 46745700 46745701 Valent U.S.A. Corp. (2006) Submission of Toxicity Data in Support of the Petition for Tolerance of Fluopicolide for Use on Grapes and Raisins. Transmittal of 4 Studies. 30-Jan- 2006 Payraudeau, V. (2005) Historical Control Data for Functional Observational Battery (FOB) and Motor Activity in CD Rats. Project Number: VP/02/12/05, 200600004. Unpublished study prepared by Bayer Cropscience and Huntingdon Life Sciences, Ltd. 15 p. 30-Jan- 2006 46745702 Fowles, J. (2005) Historical Control Data for Long-Term Studies in C57bl/6 Mice. Project Number: JRF/24/10/05, 200600003. Unpublished study prepared by Bayer Cropscience. 10 p. 30-Jan- 2006 46745703 j Fowles, J. (2005) Historical Control Data for Neoplasms in Long-Term j Studies in CD Rats. Project Number: JRF/14/10/05, 200600001. j Unpublished study prepared by Bayer Cropscience and Huntingdon Life j Sciences, Ltd. 27 p. 46745704 Fowles, J. (2005) Historical Control Data for Survival in Long-Term Studies in CD Rats. Project Number: JRF/25/10/05, 200600002. Unpublished study prepared by Bayer Cropscience and Huntingdon Life Sciences, Ltd. 9 p. 30-Jan- 2006 30-Jan- 2006 j Valent U.S.A. Corporation (2006) Submission of Product Chemistry, 46821400 | Residue, Environmental Fate and Toxicity Data in Support of the j Registration of Fluopicolide Technical. Transmittal of 1 Study. 24-Apr- 2006 41 ------- 46821401 Council Directive (2005) Report and Proposed Decision of the United Kingdom Made to the European Commission Under Article 8(1) of 91/414/EEC. Project Number: 200600102. Unpublished study prepared by Council Directive. 1321 p. { j Valent USA Corporation and Interregional Research Project No. 4 (2006) { | Submission of Residue Data in Support of the Application for Registration | 47021700 j ofV-10161 4 SC and the Petitions for Tolerance of Fluopicolide for Use on ! j Broccoli, Cabbage, Onion, Radish, Carrot, and Sugar Beet. Transmittal of I ! 7 Studies. 24-Apr- 2006 29-Dec- 2006 47021701 47021702 Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Broccoli RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU33136. Unpublished study prepared by Pyxant Labs Inc. 204 p. Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Cabbage RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU33137. Unpublished study prepared by Pyxant Labs Inc. 221 p. r~ 47021703 Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in Onion RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU27780. Unpublished study prepared by Pyxant Labs Inc. 310 p. 29-Dec- 2006 29-Dec- 2006 29-Dec- 2006 47021704 47021705 Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Radish RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU33129. Unpublished study prepared by Pyxant Labs Inc. 306 p. 29-Dec- 2006 Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Carrot RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU33130. Unpublished study prepared by Pyxant Labs Inc. 211 p. 29-Dec- 2006 47021706 Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in Sugar Beet RAC Resulting from Foliar Applications of EXP 11067B under Maximum Proposed Label Specifications (2002). Project Number: 02CU33131. Unpublished study prepared by Pyxant Labs Inc. 324 p. j Kowalsky, J. (2006) Fluopicolide: Magnitude of Residues in/on Sugar Beet j Processing Fractions Resulting from Foliar Applications of EXP 11067B 47021707 under 5X Maximum Proposed Label Specifications (2002). Project | Number: 02CU34312. Unpublished study prepared by Pyxant Labs Inc. I 312 p. 29-Dec- 2006 29-Dec- 2006 T j Valent USA Corporation. (2007) Submission of Environmental Fate Data 47040400 j in Support of the Application for Registration of Fluopicolide Technical. j Transmittal of 1 Study. 47040401 47073700 Rupprecht, J. (2003) The Adsorption Desorption of AEC638206 in US and European Soils. Project Number: CU99E512, 200500847. Unpublished study prepared by Bayer Cropscience Lp. 77 p. Valent U.S.A. Corporation (2007) Submission of Residue Data in Support of the Application for Registration of Fluopicolide Technical. Transmittal of 1 Study. 29-Jan- 2007 29-Jan- 2007 08-Mar- 2007 42 ------- 47073701 Schreier, T. (2007) Tolerance Enforcement Method for the Analysis of Residues of Fluopicolide in/on Crops: Method RM-43C-2. Project Number: METHOD/RM/43C/2. Unpublished study prepared by Valent U.S.A. Corporation. 22 p. r~ 47240600 j Valent USA Corporation (2007) Submission of Product Chemistry and | Residue Data in Support of the Applications for Registration of j Fluopicolide Technical, V 10161 4 SC, V 10161 VPP Fungicide, V 10162 j Premix, V 10162 VPP Fungicide and the Petition for Tolerance of j Fluopicolide and Propamocarb hydrochloride for Use on Cereals. j Transmittal of 1 Study. 08-Mar- 2007 26-Sep- 2007 47240601 i Billian, P.; Schoning, R. (2007) Storage Stability of AE C638206 and its j Metabolites AE C657378 (3/OH/BAM), AE C653711 (BAM) and AE j 1344122 (P1x) in/on Cereals (Rest of Plant, Grain, Straw) for 25 Months, j Plus 41 Month Addendum. Project Number: 200700330, MR/178/04, | P642034707. Unpublished study prepared by Valent USA Corporation. 58 IP- 26-Sep- 2007 Total Rows: 328 43 ------- 44 ------- 45 ------- |