United States Office of Prevention, Pesticides Environmental Protection and Toxic Substances Agency (7501C) vvEPA Pesticide Fact Sheet Name of Chemical: Fluoxastrobin Reason for Issuance: New Chemical Date Issued: NOVEMBER 2005 L DESCRIPTION OF CHEMICAL Generic Name: Fluoxastrobin ((2E)-(2-[6-(2-chlorophenoxy)-5-fluoro-4- pyrimidinyljoxy phenyl)-(5,6-dihydro-l,4,2-dioxazin-3- yl)methanone O-methyloxime) Common Name: Fluoxastrobin Trade Name: HEC 480 SC Chemical Class: strobilurins, methoxyacrylates EPA Chemical Code: 028869 Chemical Abstracts Service (CAS) Number: 361377-29-9 Year of Initial Registration: 2005 Pesticide Type: Fungicide U.S. Producer: Bayer CropScience ------- Chemical Structure: ci CH 2. USE PATTERN AND FORMULATIONS Pests/Application Sites: Types of Formulations: Types and Methods: Application Rates: Fluoxastrobin is a new strobilurin-type fungicidal active ingredient (a.i.) for the control of fungal diseases such as early blight, late blight, leaf spots, leaf rust, and Rhizoctonia solani. Fluoxastrobin has been registered for foliar use on peanuts, tuberous and corm vegetables, leaf petiole vegetables, fruiting vegetables, and turf, as well as seed treatment for potato, peanut and turf. Turf applications are labeled for professional pest control operators only, not for homeowners. Fluoxastrobin will be marketed in its technical form (94.8% a.i., a white crystalline solid) for use in formulations, and as the formulation HEC 480 SC Fungicide (40.3% a.i., an off- white suspension concentrate). FIEC 480 SC Fungicide can be applied by chemigation or by ground or aerial spray, post-emergence. For seed treatment it is applied by slurry or mist type equipment. For foliar treatment of agricultural crops, HEC 480 SC fungicide can be applied up to 4 - 6 times per season at rates of 0.12 to 0.18 Ib a.i./A, 7- to 14-day application intervals, and a maximum seasonal application rate of 0.72 Ib a.i./A (including seed treatment use); PHIs range from 3 to 14 days. For turf, FIEC 480 SC fungicide is applied up to 4 times per season at application rates of 0.27 to 0.55 Ib a.i./A, a minimum 21-day application interval, and a maximum seasonal application rate of 2.2 Ib a.i./A. For seed treatment on peanuts and potato seed pieces, HEC 480 SC is applied using slurry or mist-type equipment at a rate ofuptoO.OlOlba.i./CWT. Carrier: Water ------- ;L SCIENCE FINDINGS Fluoxastrobin is a broad-spectrum strobilurin fungicide that has been proposed for use on peanuts, tuberous (potato) and corm vegetables, leaf petiole vegetables, fruiting vegetables, turf, and for seed treatment of potato, peanut and turf. The HEC 480 SC Fungicide label-suggests rotating, alternating, or tank-mixing with products having different modes of action and/or limiting the total number of applications per season in an effort to delay the development of resistance in plant pathogen populations. PHYSICAL AND CHEMICAL PROPERTIES Technical fluoxastrobin is a white, crystalline solid. It is essentially insoluble in water (solubility of 0.0023 g/L in water at pH 7), but is highly soluble in dichloromethane, polyethylene glycol 400, acetone, ethyl acetate, acetonitrile, and dimethylsulfoxide. Technical fluoxastrobin has a melting point of 103-105° C, and a log Pow of 2.85 at 20° C. It does not dissociate in water at pH 4 to 9 and has a vapor pressure of 5.63xlO"10 Pa at 20° C. HAZARD CHARACTERIZATION Acute Toxicity Fluoxastrobin technical has a low order of acute toxicity based on its classification in Toxicity Category III (LD50 > 2000 mg/kg) via the oral and dermal routes, and Toxicity Category IV by the inhalation route of exposure. Fluoxastrobin is a moderate eye irritant (Toxicity Category III), but is neither a dermal irritant nor a sensitizer. The end use product HEC 480 SC Fungicide is an emulsifiable concentrate. This product has a very low order of acute toxicity based on its classification in Acute Toxicity Category IV for all exposure routes. This product is presently classified as a dermal sensitizer but not due to the active ingredient. Subchronic and Chronic Toxicity Fluoxastrobin has a mild or low toxicity following repeated administration in the rat and mouse but higher toxicity in the dog. In both the 90-day and one-year oral feeding dog studies, there was liver toxicity in the form of cholestasis as evidenced by hepatocytomegaly and cytoplasmic granular changes associated with increased liver weight and increased serum liver alkaline phospatase (ALP). The no observed adverse effect level (NOAEL) of 1.5 mg/kg/day in the one year dog study was used for setting the chronic reference Dose (RfD). In the 90-day oral toxicity study in rats, the urinary system in males was a target organ as evidenced by increased kidney weight and histopathology findings in kidneys, urinary bladder, and urethra including the presence of calculi in the urethra and kidneys. The adrenal glands seem ------- to be another target organ in males of the 90-day rat study where vacuolation was seen in the zona fasciculate of the adrenal cortex. The adrenal changes are not likely to be endocrine related effects. In the 90-day oral toxicity in mice, increases in liver and kidney weights were observed. Developmental and Reproductive Toxicity In the rat and rabbit developmental toxicity studies and the two-generation reproduction rat study, there was no increased susceptibility to prenatal or postnatal exposure to fluoxastrobin and no effects on reproduction. Neurotoxicity Fluoxastrobin is not acutely neurotoxic in rats up to a single high dose of 2000 mg/kg/day or by repeated dietary feeding in the rat subchronic neurotoxicity screening study where the top dose was nearly half the limit dose of 1000 mg/kg/day. There were no treatment- related neurotoxicity findings in dogs. Immune System Toxicity Fluoxastrobin is not immunotoxic based on repeated dosing studies in rats and mice. Carcinogenicity The carcinogenic potential of fluoxastrobin was adequately tested in rats and mice of both sexes. There was no evidence of carcinogenicity in rats or mice. Mutagenicity Fluoxastrobin and its major metabolites gave negative results in a battery of genotoxicity tests. DOSE RESPONSE ASSESSMENT AND FOOD QUALITY PROTECTION ACT (FOPA) CONSIDERATION Dose Response Assessment Based on submitted data, the Agency determination of the acute and chronic Reference Doses (RfDs), toxicological endpoint selections, and appropriate margins of exposure (MOEs) for use as appropriate in occupational/residential exposure risk assessments, is summarized below: ------- Acute Dietary Reference Dose (aRfD): No acute toxicity endpoint was identified for either females age 13-49 years or the general population. There was no endpoint noted in the database from a single dose exposure that could be used for risk assessment. This included the acute neurotoxicity (tested to the limit dose) and developmental studies as well as the other short- and long-term studies. Chronic Dietary Reference Dose (cRfD): Fluoxastrobin has a mild or low toxicity following repeated administration in all tested species other than the dog. The dog appears to be the most sensitive species. For all populations, the dose and endpoint for establishing a cRfD is a LOAEL of 7.7 mg/kg/day (NOAEL for females) from the one year toxicity study in dogs. The NOAEL is 1.5 mg/kg/day (NOAEL for females) based on body weight reductions and liver toxicity (cholestasis) in both sexes. An uncertainty factor (UF) of 100 was selected (lOx inter-species extrapolation, lOx intra-species variability) and the cRfD is 0.015mg/kg/day. Incidental Oral Short-Term (1-30 Days) Exposure: The dose and endpoint chosen is the NOAEL of 3.0 mg/kg/day from the 90-day oral toxicity study in the dog. The UF is 100. Incidental Oral Intermediate-Term (1-6 Months) Exposure: The dose and endpoint chosen is the NOAEL of 3.0 mg/kg/day based on 90 day-oral toxicity studies in the dog. TheUFis 100. Dermal Absorption Factor: A dermal absorption factor of 2.3% was chosen by the Agency based on a study which was conducted using five male rhesus monkeys. Dermal Short-Term (1-30 Days) Exposure: There was no systemic or localized hazard noted in a 28-day dermal toxicity study in the rat and there are no developmental or reproductive toxicity concerns, therefore this risk assessment is not necessary. Dermal Intermediate-Term (1-6 Months) Exposure: The dose and endpoint chosen is the NOAEL of 3.0 mg/kg/day based on 90-day oral toxicity tests in the dog.. Dermal Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the NOAEL of 1.5 mg/kg/day based on a chronic oral toxicity study in the dog. Inhalation Short- (1-30 Days) & Intermediate-Term (1-6 Months) Exposure: The dose and endpoint chosen is the NOAEL of 3.0 mg/kg/day based on 90-day oral toxicity studies in the dog. Inhalation Long-Term (>6 Months) Exposure: The dose and endpoint chosen is the NOAEL of 1.5 mg/kg/day based on a chronic oral toxicity study in the dog. ------- Margins of Exposure: Table 1 presents a summary of target Margins of Exposure (MOEs) for risk assessment. MOE's less than 100 are considered to be of concern. Table 1 Summary of the Margins of Exposure That Are Used in Risk Assessment Route ^s^"^ ^^^ Duration Short-Term (1-30 Days) Intermediate-Term (1 - 6 Months) Long-Term (> 6 Months) Occupational (Worker) Exposure Dermal Inhalation N/A 100 100 100 100 100 Residential (Non-Dietary) Exposure Oral Dermal Inhalation 100 N/A 100 100 100 100 N/A 100 100 The MOEs for occupational and residential exposures are based on the conventional uncertainty factor of 100X (10X for intraspecies variation and 10X for interspecies extrapolation.) FQPA Decisions Special FQPA Safety Factor The toxicology database for fluoxastrobin is adequate to support the reduction of the special FQPA SF to IX because there are no/low concerns and no residual uncertainties with regard to pre- and/or postnatal toxicity. Endocrine disruption In the available toxicity studies on fluoxastrobin, there was no estrogen, androgen, and/or thyroid mediated toxicity. The findings of increased incidences of uterine adenocarcinoma and thyroid follicular cell adenoma in the rat chronic toxicity/carcinogenicity study were determined to be unrelated to treatment. These observations, which were found within random occurrence in this strain of rats, are not treatment-related and, henceforth, are not indicative of possible endocrine disruption. When additional appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, fluoxastrobin may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption. 4. HUMAN HEALTH EXPOSURE AND RISK ASSESSMENT ------- Residue Profile Following multiple foliar applications, detectable combined residues of fluoxastrobin and its Z-isomer are likely to be present in/on tomato, pepper, and trimmed celery at up to 0.6 ppm. Residues on peanut hay are likely to be much higher (up to 17 ppm), but non-detectable (<0.01 ppm) in peanut nutmeats and tuberous and corm vegetables. The residue of concern in/on primary and rotated plant commodities for tolerance setting and risk assessment purposes are fluoxastrobin and its Z-isomer. The residues of concern for livestock for tolerance setting and risk assessment purposes are fluoxastrobin, its Z-isomer, and the phenoxy-hydroxypyrimidine metabolite. Based upon the results of the poultry metabolism study, EPA concludes that the proposed uses do not require tolerances for poultry commodities because there is no reasonable expectation of finite residues in poultry commodities. Dietary Exposure and Risk The dietary exposure and risk estimates for fluoxastrobin are summarized in Table 2. Table 2 Chronic Dietary Exposure and Risk Estimates for Fluoxastrobin. Population Subgroup U.S. Population All infants (< 1 yr) Children 1-2 yrs Children 3 -5 yrs Children 6-12 yrs Youth 13-19 yrs Adults 20-49 yrs Adults 50+ yrs Females 13 -49 yrs cPAD, mg/kg/day 0.015 0.015 0.015 0.015 0.015 0.015 0.015 0.015 0.015 DEEM-FCID Exposure, mg/kg/day 0.0015 0.00091 0.0037 0.0031 0.0021 0.0014 0.0013 0.0013 0.0012 % cPAD 10% 6.0% 25% 20% 14% 9.2% 8.7% 8.7% 8.3% Lifeline Exposure, mg/kg/day 0.0014 0.00085 0.0033 0.0027 0.0018 0.0013 0.0013 0.0013 0.0014 % cPAD 9.5% 5.6% 22% 18% 12% 8.4% 8.6% 8.5% 9.6% * cPAD = chronic PAD, is reported to 2 significant figures, and % cPAD = (Exposure + cPAD) x 100%. **The values for the population with the highest risk for each type of risk assessment are bolded. A drinking water assessment for fluoxastrobin was conducted for fluoxastrobin used according to proposed labeling for HEC 480 SC Fungicide. The results from the use of these models are summarized in Table 3. ------- Table 3 Summary of Estimated Surface Water and Groundwater Concentrations of Fluoxastrobin Exposure Duration Acute (peak) Chronic (average of yearly means) Fluoxastrobin and its Zrisomer Surface Water Cone., ppb a 28 14 Ground Water Cone., ppb b <1 a From the Tier 2 PRZM-EXAMS - Index Reservoir model. Input parameters are based on the turf use (4 ground applications of 0.55 Ibs ai/A per application with a 21-day interval), which generates the highest EDWCs b From the Tier 1 SCIGROW model, also based on turf use (4 ground applications of 0.55 Ibs ai/A per application with a 21-day interval) Residential Exposure Estimates Proposed use of fluoxastrobin on turf may result in individuals of varying ages potentially being exposed from activities in areas that have been treated. Potential routes of exposure include dermal (adults and children) and incidental oral ingestion (toddlers only). While it is assumed that most residential use will result in short-term (1 to 30 days) postapplication exposures, it is also believed that intermediate-term exposures (> 30 days to 180 days) are possible, albeit unlikely. Recreational exposures to turf are expected to be similar to, or in many cases less than those evaluated for Home Uses, so they were not evaluated separately. The resulting risks for children, which are lower than those for adults, are presented in Table 4. Table 4 Children's Residential Combined Risk from Turf Treated with Fluoxastrobin Scenario High Contact Activities (HCA) Hand-to-Mouth (HTM) Object-to-Mouth (OTM) Soil Ingestion (SI) Duration Intermediate-Term Short-Term Short-/Intermediate-Term Short-/Intermediate-Term Route Dermal Oral Oral Oral Daily Dose (mg/kg/day) 0.00246 0.00821 0.00205 0.000028 MOE 1200 365 1500 110000 Total MOE1 235 1 Total MOE = 1 / (1/MOEHCA+ 1/MOEHTM + 1/MOEOTM + 1/MOESI) The total MOE for children's combined risk from activities on treated turf is larger than 100, and therefore does not exceed EPA's level of concern. Other (Spray Drift, etc.) Fluoxastrobin can be directly applied to residential turf by non-resident professional applicators, and does not result in exposures of concern. Based on this assessment, EPA believes that it is unlikely there is a higher potential for risk of exposure to spray drift from residential uses versus agricultural uses of this chemical. ------- Aggregate Risk As per FQPA, 1996, when there are potential residential exposures to the pesticide, aggregate risk assessment must consider exposures from three major sources: oral, dermal and inhalation exposures. The toxicity endpoints selected for these routes of exposure may be aggregated as follows: For short-term aggregate exposure assessment, incidental oral and inhalation cannot be combined due to differences in the endpoint, i.e. neurotoxicity for incidental oral and decreases in body weight for inhalation. No quantification of dermal risk is required. For intermediate-term aggregate exposure, oral and dermal and inhalation endpoints can be aggregated because of the use of a common endpoint (decreased body weight gain). For long-term aggregate exposure, incidental oral and dermal and inhalation endpoints can be aggregated because of the use of oral equivalents and a common endpoint (decreased thymus weight). Short and Intermediate-Term Aggregate Risk There is potential short- and intermediate-term exposure to fluoxastrobin via the dietary (which is considered background exposure) and residential (which is considered primary) pathways. For adults, these pathways lead to exposure via the oral (background) and dermal (primary) routes. For children these pathways lead to exposure via the oral (background), and incidental oral and dermal (primary) routes. Chronic Aggregate Risk Assessment (Food and Drinking Water) There is potential chronic exposure to fluoxastrobin via food and drinking water, i.e., the dietary route. DWLOCs were calculated to determine if aggregate chronic risks are of concern. The chronic DWLOCs are much greater than the EDWCs; thus, chronic aggregate risks do not trigger the Agency's concern. Cumulative Risk Characterization/Assessment EPA has not made a common mechanism of toxicity finding as to fluoxastrobin and any other substances, and fluoxastrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fluoxastrobin has a common mechanism of toxicity with other substances. Occupational Exposure/Risk Pathway There is potential for occupational handler exposure from the application of fluoxastrobin on both food and non-food use sites resulting from handling fluoxastrobin products (i.e., ------- mixer/loaders and applicators); and there is potential for occupational postapplication exposure resulting from entering areas previously treated with fluoxastrobin. Occupational handlers may be exposed by the dermal route and by the inhalation route during mixing, loading and application of fluoxastrobin for both short- and intermediate-term durations. Only one occupational handler scenario related to seed treatment triggered the agency's concern. Although the combined MOE (accounting for both dermal and inhalation exposures) was below 100, the risk estimate is probably not a real risk concern, for the following reasons: First, the inhalation component of the risk estimate is driving the low MOE, but this component was calculated using surrogate data from a dust formulation, and fluoxastrobin is a liquid formulation, which is less prone to be available in the air (if the fluoxastrobin liquid formulation is aerosolized, then inhalation exposure could be a concern). Additionally, at the chemical level, fluoxastrobin is not volatile. Also, the dermal component of the combined MOE is also a conservative screening level estimate, because it is an intermediate-term estimate, while actual exposures are short- and intermediate term in duration (a short term dermal endpoint was not identified). Short-/Intermediate-Term Postapplication Risk Fluoxastrobin has been proposed for both food (i.e., agricultural) and non-food (i.e., residential and commercial) use sites. Agricultural postapplication exposures may occur from a variety of activities following treatment of peanut, leafy vegetable, fruiting vegetable and potato and tuber vegetable crops. Use sites with potential residential exposures include golf course turf, turf farms, recreational turf, and residential lawns. The MOEs for all occupational/agricultural postapplication activities exceed 100 on the day of treatment (i.e., day 0) for all reentry tasks for all proposed use sites, and therefore, do not exceed the Agency's level of concern. The reentry interval (REI) of 12 hours appearing on the proposed fluoxastrobin end use label is acceptable. Non-occupational Off-Target Exposure Based on this assessment and required label restrictions, the Agency believes it is unlikely that there is higher potential for risk of exposure to spray drift from residential uses of this chemical than have been assessed for direct agricultural applications. 5. ENVIRONMENTAL EXPOSURE AND RISK 10 ------- The slow biodegradation, compounded with low mobility in soils, low water solubility, and a relatively low octanol/water partition coefficient suggest that fluoxastrobin may have limited potential for runoff and low bioaccumulation. The low vapor pressure and low Henry's Law Constant suggest that this compound is not expected to volatilize from water or soils in natural environments. Fluoxastrobin's soil degradates, HEC 5725-E-des-chlorophenyl (HEC 7155) and HEC5725-carboxylic acid (HEC 7180) have higher mobilities than does fluoxastrobin. Environmental Fate Characteristics Biodegradation under aerobic conditions could take several months to several years, depending on the soil texture (half life of 29.4 days in sandy loam to 393 days in loamy sand; average half-life of 141 days). Fluoxastrobin is expected to have low to medium mobility, as it absorbs strongly to all tested soils. Fluoxastrobin could persist for several months in non-sand soils to several years in sandy type soils. Under field conditions of intended use areas in the US, fluoxastrobin was shown to persist for over a year but did not seem to leach underground. Fluoxastrobin (E + Z isomers, 98:2 isomer ratio) is stable toward abiotic hydrolysis in sterile buffered solutions at pH 4, 7, and 9 at 50° C. In contrast, direct aqueous photodegradation under laboratory conditions is rapid, with an average half life of 4.1 days (24 hour irradiation) and formation of HEC5725-oxazepine. This laboratory half-life corresponds to a predicted environmental half life of 20.1 summer sunlight in Phoenix, Arizona (33° N) and 28.3 days in Edmondton, Alberta, Canada (53°N). However, aqueous photolysis with the formation of HEC5725-oxazepine was not observed under field conditions since photodegradation in turbid and/or deeper waters may be limited by the attenuation of sunlight due to unfavorable conditions. Photodegradation on soils is much slower at a predicted environmental rate of 146 days. Ecological Effects and Risk Terrestrial Animals Toxicity Based on submitted acute and reproduction data using bobwhite quail, rats, honeybees, and earthworms, fluoxastrobin is classified as practically non-toxic to terrestrial animals. Exposure The calculated mean residue EECs ranged up to 170 ppm for short turf grass. Birds and mammals in the field may be exposed to seed treated with pesticides by ingesting material directly with the diet. They also may be exposed by other routes, such as 11 ------- incidental ingestion of contaminated soil, dermal contact with treated seed surfaces and soil during activities in the treated areas, preening activities, and ingestion of drinking water contaminated with pesticide. Risk Birds Fluoxastrobin is classified as practically non-toxic to birds on an acute exposure basis. All calculated avian acute and chronic RQs using bobwhite quail were less than LOCs, with acute values ranging from <0.002 to <0.06 and chronic values ranging from 0.02 to 0.68 respectively. Mammals All calculated mammalian acute RQs were less than LOCs with the exception of small mammal (15-g) consumption of predicted maximum residue levels of fluoxastrobin on short grass following the maximum application rate for turf (i.e., 4 times per year). The RQ value for a 15-g mammal, based on consumption of short grass at the maximum residue level (314 mg/kg diet) following the maximum application rate for turf, is <0.15. A definitive LD50 was not established for laboratory rats because the available acute toxicity data show no mortality at the highest doses tested. The RQ value of <0.15 is based on an acute mammalian LD50 value of >2000 mg/kg. Although the acute endangered LOG is exceeded for the 15-g mammal (based on maximum short grass residue and maximum application rates for turf), there is uncertainty associated with the RQ value because it based on the highest dose tested where no mortality was observed. In addition, RQ values for the 15-g mammal do not exceed the acute endangered species LOG of 0.1, based on consumption of mean residue levels of short grass (RQ <0.08) or reduction in the application rate of turf from 4 to 2 times per year (RQ < 0.10). Furthermore, use of the >5000 mg/kg LD50 value for the TEP (40.5% fluoxastrobin) results in RQ values well below acute LOCs. Therefore, acute mammalian risks associated with exposure to fluoxastrobin on short grass are unlikely. All calculated mammalian chronic RQs were less than LOCs, with chronic values ranging from 0.01 to 0.31. Mammalian RQ values based on exposure to treated seeds were also well below levels of concern. Non-Target Insects An appropriate label statement is required to protect foraging honeybees if the LD50 is < 11 jig/bee. Based on the acute contact toxicity study to honeybees, the LD50 for fluoxastrobin is >200 jig/bee. Therefore, the label statement is not required. Fluoxastrobin is classified as practically non-toxic to honeybees. Earthworms 12 ------- Earthworm exposures to fluoxastrobin and its degradates in soil are not expected to be an exposure route of concern because acute and subchronic LC50 toxicity values for both the parent and fluoxastrobin degradates are relatively high at >1000 mg/kg, and no significant mortality and/or sublethal effects were observed in any of the treatment groups. Terrestrial Plants Toxicity Fluoxastrobin is not likely to cause adverse effects to non-target terrestrial plants, based on data from emergence and vegetative vigor tests on 10 different species of plants, after application of the formulated product at a single concentration of 0.54 Ibs ai/A. This concentration is equal to the maximum application rate for fluoxastrobin. In both the seedling emergence and vegetative vigor tests, no monocot or dicot species were significantly affected by the treatment, and no reductions exceeded 25%. The respective NOAEC and EC25 values were 0.54 and >0.54 Ibs ai/A for all test species. Exposure At the maximum label application rate for fluoxastrobin, no non-target monocot or dicot species were significantly affected by the treatment, and no growth reductions exceeded 25%. If use directions for approved uses are followed, non-target exposures are expected to be minimal. Risk All acute non-endangered and endangered RQs for non-target terrestrial and semi-aquatic plants are less than LOCs, with acute non-endangered values ranging from <0.04 to <0.45 and acute endangered species values ranging from 0.04 to 0.45, respectively. Aquatic Animals Toxicity On an acute basis, Fluoxastrobin is moderately toxic to estuarine/marine fish; highly toxic to freshwater fish and invertebrates; and very highly toxic to estuarine/marine invertebrates. Chronic LOCs are also exceeded for estuarine/marine invertebrates and mollusks. Chronic effects for estuarine/marine invertebrates include reduced survival and reductions in wet weight of surviving adults following a 28-day exposure duration. No data were available to assess the chronic toxicity of fluoxastrobin to estuarine/marine mollusks. Therefore, the NOAEC value was estimated based on the acute-to-chronic ratio for mysid shrimp. 13 ------- Exposure Surface water concentrations ranging from 4.3 to 32.9 ppb resulting from fluoxastrobin application to selected crops were predicted with the Tier II models PRZM-EXAMS. Peak EECs were then compared to acute toxicity endpoints to derive acute RQs. The 60-day EECs were compared to chronic toxicity endpoints (NOAEC values) to derive chronic RQs for freshwater and estuarine/marine fish, and 21-day EECs were compared to chronic toxicity endpoints for freshwater and estuarine/marine invertebrates. Risk The ecological risks to fish and invertebrates are considered conservative estimates because they are based on worst case exposure and use scenarios. Nonetheless, because of the potential for exposure and possible adverse effects of fluoxastrobin to endangered and non- endangered fish and invertebrates, the registrant is required to provide information on the proximity of Federally listed freshwater fish and invertebrates to the fluoxastrobin use sites. This requirement may be satisfied in one of three ways: 1) having membership in the FIFRA Endangered Species Task Force (Pesticide Registration [PR] Notice 2000-2); 2) citing FIFRA Endangered Species Task Force data; or 3) independently producing these data, provided the information is of sufficient quality to meet FIFRA requirements. The information will be used by the OPP Endangered Species Protection Program to develop recommendations to avoid and mitigate adverse effects to listed species. Risk quotients (RQs) were calculated from the ratio of estimated environmental concentrations (EECs) to ecotoxicity values. Peak EECs were compared to acute ecotoxicity endpoints to derive acute RQs for aquatic animals. Chronic RQs were derived by comparing 60- day EECs to NOAEC values (chronic toxicity endpoints) for freshwater organisms and 21-day EECs to NOAEC values for estuarine/marine organisms. The RQs are then compared to the Agency's levels of concern (LOCs) to indicate when a pesticide's use as directed on the label has the potential to cause adverse effects on non-target organisms. These LOCs are part of the Agency's interpretive policy and are used to analyze potential risk to non-target organisms and the need to consider regulatory action. Acute and chronic RQs for freshwater organisms are summarized in Table 15. Estimates of benthic sediment exposure to pesticides can be provided by PRZM/EXAMS but this assessment was not performed for fluoxastrobin because toxicity data related to sediment exposure are not available. Therefore, acute (10-day) and chronic (28-day) sediment toxicity testing, as described in the OPPTS 850.1735 and 850.1740 protocols, are required in order to reduce uncertainties and evaluate risks to freshwater and estuarine/marine sediment-dwelling organisms. 14 ------- Table 5 Acute and Chronic Risk Quotients for Freshwater Fish and Invertebrates Exposed to Fluoxastrobin. Crop Application Rate (State - application type) [# of apps.] Potatoes (ID - aerial) 0.12 [6] Potatoes (ID - ground) 0.12 [6] Potatoes (ME - aerial) 0.12 [6] Potatoes (ME - ground) 0.12 [6] Tomatoes (CA) 0.18 [4] Tomatoes (FL) 0.18 [4] Peppers 0.18 [4] Peppers 0.18 [4] no drift Cabbage 0.18 [4] Peanuts 0.18 [4] EECs Peak/ 21-day Average/ 60-day Average (Hg/L) 8.8 8.6 8.4 4.3 4.1 3.9 32.9 31.9 30.8 28.7 27.8 26.7 8.4 8.0 7.6 21.0 20.0 18.3 25.2 23.6 18.5 24.6 22.9 17.9 12.8 12.3 11.1 19.7 19.2 18.5 Acute Risk Quotients Freshwater Fish3 LC50 = 435 Hg/L 0.02 0.01 0.08f 0.07f 0.02 0.05f 0.06f 0.06f 0.03 0.05f Freshwater Invertebrateb LC50 = 120 Hg/L 0.07f 0.04 0.27e 0.24e 0.07f 0.18e 0.21e 0.21e 0.1P 0.16e Chronic Risk Quotients Freshwater Fish3 NOAEC = 55.7 Hg/L 0.15 0.07 0.55 0.48 0.14 0.33 0.33 0.32 0.20 0.33 Freshwater Invertebrate0 NOAEC = 180 Hg/L 0.05 0.02 0.18 0.02 0.04 0.11 0.13 0.13 0.07 0.11 15 ------- Crop Application Rate (State - application type) [# of apps.] Turf(FL) 0.55 [4] Turf(FL) 0.55 [2] Turf (PA) 0.55 [4] Turf (PA) 0.55 [2] EECs Peak/ 21-day Average/ 60-day Average (Hg/L) 20.9 19.6 18.5 9.4 8.9 8.4 21.5 20.7 19.8 10.4 10.0 9.6 Acute Risk Quotients Freshwater Fish3 LC50 = 435 jig/L 0.05f 0.02 0.05f 0.02 Freshwater Invertebrateb LC50 = 120 Hg/L 0.17e 0.08f 0.18e 0.09f Chronic Risk Quotients Freshwater Fish3 NOAEC = 55.7 Hg/L 0.33 0.15 0.36 0.17 Freshwater Invertebrate0 NOAEC = 180 Hg/L 0.11 0.05 0.12 0.06 a Rainbow trout (Oncorhynchus mykiss) b Amphipod (Gammarus pulex) 0 Water flea (Daphnia magna) d exceeds acute high risk (RQ > 0.5), restricted use (RQ > 0.1)1 and endangered species level of concern (RQ >0.05) e exceeds acute restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05) f exceeds acute endangered species level of concern (RQ >0.05) g exceeds chronic level of concern (RQ > 1.0) For the current application rates modeled on major crops where fluoxastrobin is applied, acute endangered species LOCs are exceeded for freshwater fish (in Maine potatoes, Florida tomatoes, peppers, peanuts, and turf at the maximum application rate of 4x/year) and freshwater invertebrates (in all crops with the exception of ground application of potatoes in Idaho). Acute RQ values range from 0.01 to 0.08 for freshwater fish, and from 0.04 to 0.27 for freshwater invertebrates. Chronic RQs for freshwater fish (0.07 to 0.55) and invertebrates (0.02 to 0.18) are less than chronic LOCs. The acute and chronic RQs for estuarine and marine animals are summarized in Table 16. 16 ------- Table 6 Acute and Chronic Risk Quotients for Estuarine/Marine Fish and Invertebrates Exposed to Fluoxastrobin. Crop Application Rate (State - application type) [# of apps] Potatoes (ID - aerial) 0.12 [6] Potatoes (ID - ground) 0.12 [6] Potatoes (ME - aerial) 0.12 [6] Potatoes (ME - ground) 0.12 [6] Tomatoes (CA) 0.18 [4] Tomatoes (FL) 0.18 [4] Peppers 0.18 [4] Peppers 0.18 [4] no drift Cabbage 0.18 [4] Peanuts 0.18 [4] EECs Peak/ 21-day Average/ 60-day Average (ng/L) 8.8 8.6 8.4 4.3 4.1 3.9 32.9 31.9 30.8 28.7 27.8 26.7 8.4 8.0 7.6 21.0 20.0 18.3 25.2 23.6 18.5 24.6 22.9 17.9 12.8 12.3 11.1 19.7 19.2 18.5 Acute Risk Quotients Estuarine/ Marine Fish a LC50 = >1374 Hg/L 0.01 O.003 O.02 <0.02 <0.01 0.02 0.02 0.02 0.01 O.01 Estuarine/ Marine Invertebrate" LC50 = 51.6 Hg/L 0.17e 0.08f 0.64d 0.56d 0.16e 0.41e 0.49e 0.48e 0.25e 0.38e Chronic Risk Quotients Estuarine/ Marine Fish c NOAEC = 176 Hg/L 0.05 0.02 0.18 0.15 0.04 0.10 0.11 0.10 0.06 0.11 Estuarine/ Marine Invertebrateb NOAEC = 0.61 jig/L 14g 6.7g 52g 46g 13g 33g 39g 38g 20g 31g 17 ------- Crop Application Rate (State - application type) [# of apps] Turf(FL) 0.55 [4] Turf(FL) 0.55 [2] Turf (PA) 0.55 [4] Turf (PA) 0.55 [2] EECs Peak/ 21-day Average/ 60-day Average (H.S/L) 20.9 19.6 18.5 9.4 8.9 8.4 21.5 20.7 19.8 10.4 10.0 9.6 Acute Risk Quotients Estuarine/ Marine Fish a LC50 = >1374 O.02 - ~ O.01 - ~ 0.02 - ~ 0.01 - ~ Estuarine/ Marine Invertebrate" LC50 = 51.6 jig/L 0.41e - ~ 0.18e - ~ 0.42e - ~ 0.20e - ~ Chronic Risk Quotients Estuarine/ Marine Fish c NOAEC = 176 ~ 0.11 .. ~ 0.05 .. ~ 0.11 .. ~ 0.05 Estuarine/ Marine Invertebrate" NOAEC = 0.61 Hg/L 32g - .. 15g ~ .. 34g ~ .. 16g ~ a Sheepshead minnow (Cyprinodon variegatus) b Mysid shrimp (Mysidopsis bahia) 0 Estimated on the assumption that acute to chronic ratio for estuarine/marine fish is the same as freshwater fish d exceeds acute high risk (RQ > 0.5), restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05) e exceeds acute restricted use (RQ > 0.1) and endangered species level of concern (RQ >0.05) f exceeds acute endangered species level of concern (RQ >0.05) g exceeds chronic level of concern (RQ > 1.0) Acute LOCs for estuarine/marine fish are not exceeded; peak EECs for all major crops are well below the NOAEC value (RQ range: <0.003 to <0.02). No estuarine/marine chronic fish data were submitted, so a NOAEC value was estimated based on the assumption that the acute-to- chronic NOAEC ratio for estuarine/marine fish is the same as for freshwater fish. Based on the estimated NOAEC value, chronic RQ values for estuarine/marine fish, ranging from 0.02 to 0.18, are less than the chronic LOCs. Acute and chronic LOCs for estuarine/marine invertebrates are exceeded for all major crops modeled (acute RQ range: 0.08 to 0.64; chronic RQ range: 6.7 to 52). Estuarine/marine invertebrates appear to be much more sensitive to fluoxastrobin, with acute and chronic RQs approximately two and 290 times higher than their freshwater counterparts. Aquatic Plants Toxicity Based on data using duckweed, and freshwater green algae, fluoxastrobin and its degradates are classified as practically non-toxic to non-target aquatic plants. 18 ------- All acute non-endangered and endangered species RQs are less than LOCs for both vascular and non-vascular plants. The range of RQ values for both vascular and non-vascular aquatic plants is 0.004 to 0.43. Exposure The exposure data that were used for aquatic animals were also used for aquatic plants. Risk Aquatic plant risk to non-vascular plants was evaluated based on marine diatom (S. capricornatum) toxicity studies using fluoxastrobin and its degradates HEC 7155 and HEC 7180. Vascular plant risk was based on duckweed (L. gibba) toxicity studies performed using fluoxastrobin technical only. For aquatic vascular and non-vascular plants, peak EECs were compared to acute EC50 and NOAEC toxicity endpoints to derive acute non-endangered and endangered species RQs, respectively. The acute non-endangered and endangered species RQs that were calculated for aquatic vascular and non-vascular plants are summarized in Table 18. Table 7 Acute Non-Endangered and Endangered Species Risk Quotients for Aquatic Vascular and Non- Vascular Plants Exposed to Fluoxastrobin Crop Application Rate (# of apps) Potatoes (ID - aerial) 0.12(6) Potatoes (ID - ground) 0.12(6) Potatoes (ME - aerial) 0.12(6) Potatoes (ME - ground) 0.12(6) Tomatoes (CA) 0.18(4) EECs Peak (Hg/L) 8.8 4.3 32.9 28.7 8.4 Acute Non-Endangered Risk Quotients Vascular plant a EC50 = 1200 Hg/L 0.01 0.004 0.03 0.02 0.01 Non-vascular Plant" EC50 = 260 Hg/L 0.03 0.13 0.03 0.11 0.03 Acute Endangered Species Risk Quotients Vascular plant a NOAEC = 160 Hg/L 0.06 0.03 0.21 0.18 0.05 Non-vascular Plant" NOAEC = 76 Ug/L 0.12 0.06 0.43 0.38 0.11 19 ------- Crop Application Rate (# of apps) Tomatoes (FL) 0.18(4) Peppers 0.18(4) Peppers 0.18 (4) no drift Cabbage 0.18(4) Peanuts 0.18(4) Turf(FL) 0.55 (4) Turf(FL) 0.55 (2) Turf (PA) 0.55 (4) Turf (PA) 0.55 (2) EECs Peak (Hg/L) 21 25.2 24.6 12.8 19.7 20.9 9.4 21.5 10.4 Acute Non-Endangered Risk Quotients Vascular plant a EC50 = 1200 jig/L 0.02 0.02 0.02 0.01 0.02 0.02 0.01 0.02 0.01 Non-vascular Plant11 EC50 = 260 Hg/L 0.08 0.1 0.09 0.05 0.08 0.08 0.04 0.08 0.04 Acute Endangered Species Risk Quotients Vascular plant a NOAEC = 160 jig/L 0.13 0.16 0.15 0.08 0.12 0.13 0.06 0.13 0.07 Non-vascular Plantb NOAEC = 76 Hg/L 0.28 0.33 0.32 0.17 0.26 0.28 0.12 0.28 0.14 a Duckweed (Lemna gibba) b Green algae (Selenastrum capricornutum) 0 exceeds acute high risk (RQ > 1.0) and endangered species level of concern (RQ > 1.0) All of the fluoxastrobin acute non-endangered or endangered species RQs are less than the LOCs for vascular and non-vascular aquatic plants, so no level of concern is reached. The range of RQ values for both vascular and non-vascular aquatic plants is 0.004 to 0.43. Aquatic EECs for all major crops were well below available toxicity endpoint values for the fluoxastrobin degradates HEC 7155 and HEC 7180, as well. Therefore, fluoxastrobin degradates are not a concern for aquatic organisms and plants. Risk to Endangered Species The preliminary risk assessment for endangered species indicates that fluoxastrobin exceeds the endangered species LOCs for the following combinations of analyzed uses and species: 20 ------- • Use of fluoxastrobin on the following crop scenarios indicate an exceedance of the endangered species LOG for freshwater fish: Maine potatoes (ground and aerial application), Florida tomatoes, peanuts, and turf (at the maximum application rate of 4 times per year). • Use of fluoxastrobin on Idaho potatoes (aerial application only), Maine potatoes (ground and aerial application), tomatoes, peppers, cabbage, peanuts, and turf (at maximum [4x/year] and reduced [2x/year] application rates) indicate endangered LOG exceedances for endangered freshwater invertebrates. Use of fluoxastrobin on Idaho and Maine potatoes (aerial and ground application), tomatoes, peppers, cabbage, peanuts, and turf (at maximum [4x/year] and reduced [2x/year] application rates) indicate endangered acute and chronic LOG exceedances for estuarine/marine invertebrates. • Use of fluoxastrobin on Maine potatoes (ground and aerial application), Florida tomatoes, peppers, cabbage, peanuts, and turf in Florida (at maximum [4x/year] application rates only) and Pennsylvania (for applications of both 4 and 2x/year) indicate chronic LOG exceedances for estuarine/marine mollusks. The list of endangered/threatened freshwater fish species where potatoes, tomatoes, peppers, and peanuts are grown is comprised of 84 different species representing 36 States. The three States with the largest number of endangered/threatened freshwater fish species include California, Washington, and Oregon. Within these States, the majority of endangered/threatened fish species are salmon and steel head (Orcorhynchus sp.). The predominant endangered fish species in Florida and North Carolina, where tomatoes, peppers, and peanuts are grown, is the sturgeon (Acipenser sp.). The list is of freshwater invertebrates is primarily comprised of bivalves (70% of all listed invertebrates; present in 20 States), crustaceans (i.e., amphipods, crayfish, and shrimp) (-19 of all listed invertebrates; present in 6 States), and snails (~11% of all listed invertebrates; present in 2 States). While the majority of listed freshwater invertebrates are bivalves, the amphipod (Gammarus acherondytes) was listed as endangered in Illinois. The identification of an endangered amphipod is a factor because this species was identified as the most sensitive freshwater invertebrate from the available effects data. It appears, however, that the endangered amphipods in Illinois are present only in caves, where pesticides are not likely to be present in water at concentrations that would cause adverse effects. The Agency's levels of concern for endangered and threatened freshwater fish and invertebrates and estuarine/marine invertebrates and mollusks are exceeded for the use of fluoxastrobin. However, the Agency recognizes that there are no Federally listed estuarine/marine invertebrates/mollusks. The registrant must provide information on the proximity of Federally listed freshwater fish and invertebrates to the fluoxastrobin use sites. This requirement may be satisfied in one of 21 ------- three ways: 1) having membership in the FIFRA Endangered Species Task Force (Pesticide Registration [PR] Notice 2000-2); 2) citing FIFRA Endangered Species Task Force data; or 3) independently producing these data, provided the information is of sufficient quality to meet FIFRA requirements. The information will be used by the OPP Endangered Species Protection Program to develop recommendations to avoid adverse effects to listed species. The registrant has satisfied this requirement using option #1 above. 7. SUMMARY OF REGULATORY POSITION AND RATIONALE Available data provide adequate information to support the conditional registration of fluoxastrobin technical and the proposed end-use product. Fluoxastrobin technical has a relatively low toxicity fungicide, and there is reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to the proposed uses on peanuts, tuberous and corm vegetables, leaf petiole vegetables, fruiting vegetables, turf and seed treatment (potato, peanut and turf). The results of the risk assessment suggest the potential for direct effects to endangered freshwater fish, and both endangered and non-endangered freshwater invertebrates, estuarine/marine invertebrates, and mollusks. In addition, in order to reduce the uncertainties associated with the risk assessments, additional studies and data will be required as a condition of registration. Although fluoxastrobin is a member of the strobilurin group that includes already marketed active ingredients, the Agency believes that growers would benefit from a new active ingredient that can be an effective disease management tool for both curative and preventative purposes. In many cases, the efficacy of fluoxastrobin will be comparable to others currently on the market. However, diverse qualities of strobilurin fungicides suggest that there can be a valuable place for this strobilurin active ingredient for some important diseases. In addition, new chemicals, especially with similar attributes, increase competition and should lower price. Thus, growers will receive benefits through lower production costs which, presumably, would be passed on to the consumer. Therefore, the registration of fluoxastrobin is considered to be in the public interest. 8. SUMMARY OF CONFIRMATORY DATA REQUIREMENTS Available data provide adequate information to support the conditional registration of fluoxastrobin and establishment of the associated tolerances for residues. However, in order to reduce the uncertainties associated with the risk assessments, the following studies or data will be required as a condition of registration: • Submit additional information concerning the mouse immunotoxicity subacute feeding study. Sediment-bound fluoxastrobin is persistent (half-life = 141 days), and concentrations in suspended or bottom sediments are likely to be higher than those of the sediment interstitial pore water and/or water column. Given the potential risks to freshwater and estuarine/marine invertebrates based on fluoxastrobin concentrations in the water column, 22 ------- acute (10-day) and chronic (28-day) sediment toxicity testing, as described in the OPPTS 850.1735 and 850.1740 protocols, will be required in order to reduce uncertainties and evaluate risks to freshwater and estuarine/marine sediment dwelling organisms. 860.1300 Nature of the Residue - Livestock - provide comparison of chromatograms for goat metabolism study 860.1340 Residue Analytical Method - Plant and Livestock Commodities - Provide revisions to include instructions for analysis of all crops and specification of the additional ions to be monitored. 860.1380 Storage Stability - Provide raw data and other background parameters. 860.1500 Crop Field Trials - Provide summaries of weather conditions during each trial. 860.1520 Processed Food and Feed - A new peanut study must be submitted. 860.1650 Submittal of Analytical Reference Standards - As is required for all new chemicals. 860.1900 Field Accumulation in Rotational Crops- Provide weather conditions and soil characteristics. Labeling Restrictions The Restricted Entry Interval (REI) is 12 hours. Directions for Use "Not for use by residential users." "Do not use in greenhouses." "Maximum seasonal application rate for turf includes turf seed treatment." 9. CONTACT PERSON AT EPA Mail Address: Tony Kish, Acting Product Manager (22) Fungicide Branch Registration Division (7505C) Office of Pesticide Programs Environmental Protection Agency Washington, DC 20460 Office Location and Telephone Number: 23 ------- Room 249 1801 South Bell Street Arlington, VA 22202 Phone: 703-308-9443 email: kish.tony@epa.gov 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 ai ARTF CAS CFR cPAD CSFII DEEM-FCID DFR DWLOC EC50 EDSP EDSTAC EDWC EEC EPA FFDCA FIFRA FQPA HED hr Kow Ib LC50 LD 50 Active Ingredient Agricultural Reentry Task Force Chemical Abstracts Service Code of Federal Regulations Chronic Population Adjusted Dose Continuing Surveys of Food Intakes by Individuals Dietary Exposure Evaluation Model - Food Consumption Intake Database Dislodgeable Foliar Residue Drinking Water Level of Concern Effective Concentration - concentration of chemical in water at which an effect is seen in 50% of the exposed population Endocrine Disrupter Screening Program Endocrine Disrupter and Testing Advisory Committee Estimated Drinking Water Concentration Estimated Environmental Concentrations United States Environmental Protection Agency Federal Food, Drug and Cosmetic Act Federal Insecticide, Fungicide and Rodenticide Act Food Quality Protection Act Health Effects Division, Office of Pesticide Programs Hour Octanol/Water Partition Coefficient pound 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/L, mg/kg or ppm. 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 24 ------- LOAEL LOAEC LOG m3 mg/kg/day mg/L MOE MTD NA NOEC NOEL NOAEL NOAEC OPP OPPTS PAD PHED PHI ppb PPE ppm PRZM/EXAMS REI RfD RQ SCI-GROW SF SOP TC TGAI TTR UF Hg Hg/L USDA WPS 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 cubic meter milligrams per kilogram (body weight) per day Milligrams per Liter Margin of Exposure Maximum Tolerated Dose Not Applicable No Observed Effect Concentration No Observed Effect Level No Observed Adverse Effect Level No Observed Adverse Effect Concentration EPA Office of Pesticide Programs EPA Office of Prevention, Pesticides and Toxic Substances Population Adjusted Dose Pesticide Handler's Exposure Data Preharvest Interval Parts Per Billion Personal Protective Equipment Parts Per Million Tier II Surface Water Computer Model Restricted Entry Interval Reference Dose Risk Quotient Tier I Ground Water Computer Model Safety Factor Standard Operating Procedure Transfer Coefficient Technical Grade Active Ingredient Turf Transferable Residue Uncertainty Factor Micrograms Micrograms per Liter United Stated Department of Agriculture Worker Protection Standard 25 ------- FLUOXASTROBIN BIBLIOGRAPHY MRID 45865300 45865301 45865302 45865303 45865304 45865305 45865306 Citation Receipt Date Bayer CropScience (2003) Submission of Product Chemistry, Environmental Fate 04-Feb-2003 and Residue Data in Support of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin for Use on Peanut, Tuber and Corm Vegetables, Leaf Petioles, Fruiting Vegetables and Seed Treatments. Transmittal of 35 of 165 Studies. Fontaine, L. (2003) Product Chemistry of HEC 480 SC Fungicide: Lab Project 04-Feb-2003 Number: 200452: 200028: G200413. Unpublished study prepared by Bayer CropScience. 161 p. {OPPTS 830.1550, 830.1600, 830.1670, 830.1800, 830.6302, 830.6303, 830.6317, 830.6320, 830.7000, 830.7100, 830.7300} Fontaine, L. (2003) Product Chemistry of Fluoxastrobin Technical: Lab Project 04-Feb-2003 Number: VB1-2005-0011201-00: 2001-05-23: PF-F/PB-A. Unpublished study prepared by Bayer CropScience. 266 p. {OPPTS 830.1550, 830.1620, 830.1670, 830.1700, 830.1750, 830.1800} Fontaine, L. (2003) Product Chemistry of Fluoxastrobin Technical: Lab Project 04-Feb-2003 Number: BR 2254: PF-E/FT-EA: 14 0120 0966. Unpublished study prepared by Bayer CropScience. 141 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6313, 830.6314, 830.6315, 830.6316, 830.6317, 830.6320, 830.7000, 830.7050, 830.7200, 830.7220, 830.7300, 830.7370, 830.7520, 830.7560, 830.7840, 830.7950} Hellpointner, E. (1999) Hydrolysis of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) 04-Feb-2003 HEC 5725 in Sterile Aqueous Buffer Solutions: Lab Project Number: M 1110904-6: MR-058-99: PF-E/MR. Unpublished study prepared by Bayer AG. 44 p. rumhard, B. (2001) Aqueous Hydrolysis of HEC5725 Under Conditions of 04-Feb-2003 Processing Studies: Lab Project Number: M1771 136-6: MR-426-01: PF-E/MR. Unpublished study prepared by Bayer AG. 34 p. Stupp, H. (2001) Photolysis of HEC 5725 in Aqueous Solution: Lab Project 04-Feb-2003 Number: MR 072-00: M 1120905-8. Unpublished study prepared by Bayer AG. 81 p. 26 ------- 45865307 45865308 45865309 45865310 45865311 45865312 45865313 45865314 45865315 Hellpointner, E. (2001) Determination of the Quantum Yield and Assessment of the 04-Feb-2003 Environmental Half-Life of the Direct Photogradation in Water of HEC 5725: Lab Project Number: M1430940-1: MR 540/00. Unpublished study prepared by Bayer AG. 3 9 p. Hellpointner, E. (2001) Photolysis of HEC 5725 on Soil Surface: Lab Project 04-Feb-2003 Number: Ml 130939-6: MR 347/00. Unpublished study prepared by Bayer AG. 92 p. Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation of (Methoxyiminotolyl- 04-Feb-2003 Ring-UL-(Carbon 14)) HEC 5725 in Soil Laacher Hof AXXa: Lab Project Number: M 125 0886-O: MR 230/01: THS 4727. Unpublished study prepared by Bayer AG. 58 p. Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation and Metabolism of 04-Feb-2003 (Methoxyiminotolyl-Ring-UL-(Carbon 14)-and (Pyrimidine-2-(Carbon 14) HEC 5725 inThre Soils: Lab Project Number: M 125 0894-9: MR-231/01: MR-23 l-O 1. Unpublished study prepared by Bayer Ag. 124 p. Stupp, H. (2002) HEC 2725 Carboxylic Acid: Degradation of HEC 5725 C 04-Feb-2003 Carboxylic Acid (HEC71 SO) in Three Soils Under Aerobic Conditions: Lab Project Number: M125 1146-O: MR522/01. Unpublished study prepared by Bayer Ag. 54 p. Hellpointner, E. (2002) Anaerobic Aquatic Degradation and Metabolism of HEC 04-Feb-2003 5725: Lab Project Number: M152006-3: MR-406/01: HPO-225. Unpublished study prepared by Bayer Ag. 76 p. Brumhard, B.; Oi, M. (2002) Aerobic Degradation and Metabolism of 04-Feb-2003 (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 5725 in the Water/Sediment System: Lab Project Number: M15 1 0903-9: MR-396/01: M151 0903-9. Unpublished study prepared by Bayer Ag. 75 p. Hein, W. (2000) Adsorption/Desorption of (Phenyl-UL-(Carbon 14)) HEC 7155 04-Feb-2003 (Deschlorophenyl HEC 5725) on Four Different Soils: Lab Project Number: BAY33: FM776. Unpublished study prepared by Staatliche Lehr-und Forschungsanstalt fuer Landwirtschaft. 44 p. Pent, G. (1998) Adsorption/Desorption of (Methoxyiminotolyl-Ring-UL- 04-Feb-2003 (Carbon 14)) HEC 5725 on Four Different Soils: Lab Project Number: BAY27: FM767. Unpublished study prepared by Staatliche Lehr-und Forschungsanstalt fuer Landwirtschaft. 46 p. 27 ------- 45865316 45865317 45865318 45865319 45865320 45865321 45865322 45865323 45865324 Stupp, H. (2001) Adsorption and Desorption of HEC 5725-Carboxylic Acid in 04-Feb-2003 Soil: Lab Project Number: MR411-01: M1311123-2: MR41 1/01. Unpublished study prepared by Bayer Ag. 63 p. Schramel, O. (2001) Dissipation of HEC 5725 (100 EC) in Soil under Field 04-Feb-2003 Conditions: France, Germany, Great Britain, Italy: Lab Project Number: R812390: R812404: R812412. Unpublished study prepared by Bayer Ag. 184 p. Bauer, M; Andre, I; Zielinski, C. (2002) Terrestrial Field Dissipation of 04-Feb-2003 HEC 5725 in California Soil, 1999: Final Report: Lab Project Number: AG990009: F99568-001: 99.109. Unpublished study prepared by Battelle Memorial Institute and Plant Services, Inc. 236 p. Bauer, M.; Andre, I; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in Georgia Soil, 1999: Final Report: Lab Project Number: AG990010: F99541-001: HC022102. Unpublished study prepared by Battelle Memorial Institute and Bayer Research Farm. 197 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in New York Soil, 1999: Final Report: Lab Project Number: AG990011: F99565-001: AR99352. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 241 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in New York Soil, 1999: Final Report: Lab Project Number: HC022104: 200217: AG990012. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 174 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in Washington Soil, 1999: Final Report: Lab Project Number: AG990013: F99538-001: 99-40. Unpublished study prepared by Battelle Memorial Institute and Quails Agricultural Laboratories, Inc. 191 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in California Turf, 1999: Final Report: Lab Project Number: AG990014: HC022701: 200219. Unpublished study prepared by Battelle Memorial Institute and Plant Sciences, Inc. 253 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in New York Turf, 1999: Final Report: Lab Project Number: AG990015: F99565-001: HC022702. Unpublished study prepared by Battelle Memorial Institute and A.C.D.S. Research, Inc. 261 p. 04-Feb-2003 28 ------- 45865325 45865326 45865327 45865328 45865329 45865330 45865331 45865332 Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in Manitoba Soil, 1999: Final Report: Lab Project Number: AG990024: F99559-001: HC022107. Unpublished study prepared by Battelle Memorial Institute and Enviro-Quest. 188 p. Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field Dissipation of HEC 04-Feb-2003 5725 in Prince Edward Island Soil, 1999: Final Report: Lab Project Number: AG990025: F99564-001: HC022106. Unpublished study prepared by Battelle Memorial Institute and Atlantic AgriTech. 173 p. Stupp, H. (20) Photolysis of HEC5725 in Water/Sediment Systems: Lab Project 04-Feb-2003 Number: MR 322/01: M 112 1135-4: PF-E/MR. Unpublished study prepared by Bayer AG. 54 p. Schramel, O. (2001) Residue Analytical Method 00611 (MR-645/99) for the 04-Feb-2003 Determination of HEC 5725-E-Isomer, HEC 5725-Z-Isomer, HEC-5725-E-Des-Chlorophenyl and HEC 5725-E/Z-Carboxylic Acid in Soil by HPLC-MS/MS: Lab Project Number: P 60190031: MR-645/99: 00611. Unpublished study prepared by Bayer AG. 74 p. {OPPTS 850.7100} Bauer, M. (2002) Independent Laboratory Validation of Bayer Method 00611 04-Feb-2003 "Residue Analytical Method for the Determination of HEC 5725-E-Isomer, HEC 5725-Z-Isomer, HEC-5725-E-Des-Chlorophenyl and HEC 5725-E/Z-Carboxylic Acid in Soil by HPLC-MS/MS": Lab Project Number: AG000082: HC112101: 200317. Unpublished study prepared by Battelle. 85 p. {OPPTS 850.7100} Sommer, H. (1999) Method for Determination of HEC 5725 and HEC 7155 in 04-Feb-2003 Test Water from Aquatic Toxicity Test by HPLC: Lab Project Number: P 604 97052: 109230: 00579. Unpublished study prepared by Bayer Ag. 15 p. Sommer, H. (2001) Enforcement Methods for Determination of HEC 5725 in 04-Feb-2003 Drinking and Surface Water by HPLC-MS/MS: Lab Project Number: P 684 017047: MR-201/01: 00692. Unpublished study prepared by Bayer Ag. 27 p. {OPPTS 840.1400} Schramel, O. (2001) Determination of the Storage Stability of HEC 5725- 04-Feb-2003 E-isomer HEC 5725-Z-Isomer, HEC5725-E-Des-Chlororphenyl and HEC 5725-E/Z-Carboxylic Acid in Soil After a Storage Period of 14 Months: Lab Project Number: P64190032: MR-646199: MR-646-99. Unpublished study prepared by Bayer Ag. 85 p. 29 ------- 45865333 45865334 45865335 45865400 Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 5725- 04-Feb-2003 amide on Soil Using High Performance Liquid Chromatography (HPLC): Lab Project Number: M 138 1128-4: MR314-01: 314/01. Unpublished study prepared by Bayer Ag. 35 p. Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 5725- 04-Feb-2003 hydroxyphenyl on Soil Using High Performance Liquid Chromatography (HPLC): Lab Project Number: M 138 1127-3: MR313-01: 313/01. Unpublished study prepared by Bayer Ag. 35 p. Schafer, H. (2001) Calculation of DT50 Values of HEC 5725 Metabolite HEC 04-Feb-2003 7155 in Soil: Lab Project Number: P668 01 6557: MR-552-01. Unpublished study prepared by Bayer Ag. 21 p. Bayer CropScience (2003) Submission of Environmental Fate, Fate, and Toxicity 04-Feb-2003 Data in Support of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin on Peanuts, Tuberous and Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and Seed Treatments. Transmittal of 32 of 165 Studies. 45865401 45865402 45865403 45865404 45865405 Sommer, H. (2001) Estimation of the Adsorption Coefficient (Koc) of HEC 04-Feb-2003 5725-Carboxylic Acid on Soil Using High Performance Liquid Chromatography (HPLC): Lab Project Number: M 138 1130-7: 247/01: MR247-01. Unpublished study prepared by Bayer Ag. 34 p. Schafer, H. (2001) Calculation of Temperature Referenced First Order DT50 04-Feb-2003 Values HEC 5725 Based on Field Dissipation Studies Conducted in Europe: Lab Project Number: MR-562-01: P 668 01 6561. Unpublished study prepared by Bayer Ag. 33 p. Schafer, H. (2001) Calculation of a DT-50 Value of HEC 5725 Metabolite 04-Feb-2003 Oxazepine Generated by Photolysis in Aqueous Solution: Lab Project Number: MR-262/0 1: MR262-01: P 668 01 6521. Unpublished study prepared by Bayer Ag. 16 p. Schafer, H. (2001) Predicted Environmental Concentration of HEC 5725 and its 04-Feb-2003 Metabolite HEC 7155 in Ground Water Recharge Based on PELMO: Use in Winter Cereals in Northern and Southern Europe: Lab Project Number: P 668 01 6558: MR-545/01. Unpublished study prepared by Bayer Ag. 20 p. Malekani, K. (2003) Fate of HEC 5725 in the Environment (Summary): Lab 04-Feb-2003 Project Number: 200415. Unpublished study prepared by Bayer CropScience. 99 P- 30 ------- 45865406 45865407 45865408 45865409 45865410 45865411 45865412 45865413 45865414 Heimbach, F. (1999) Acute Toxicity of HEC 5725 (tech.) to Water Fleas 04-Feb-2003 (Daphnia magna): Lab Project Number: HBF/DM 211: E 320 1674-3. Unpublished study prepared by Bayer Ag. 47 p. {OPPTS 850.1010} Dorgerloh, M; Sommer, H. (2002) Acute Toxicity of HEC 5725 (E:Z; 65:35) to 04-Feb-2003 Water Fleas (Daphnia magna): Lab Project Number: E 320 2187-3: DOMA 21071. Unpublished study prepared by Bayer Ag. 51 p. {OPPTS 850.1010} Hendel, B.; Sommer, H. (2001) Acute Toxicity of HEC 5725-Carboxylic Acid 04-Feb-2003 (Tech) to Water Fleas (Daphnia magna): Lab Project Number: E 320 1976-8: HDB/DM 249. Unpublished study prepared by Bayer Ag. 26 p. {OPPTS 850.1010} Hendel, B. (2000) Acute Toxicity of HEC 5725-Deschlorophenyl to Water Fleas 04-Feb-2003 (Daphnia magna): Lab Project Number: E 320 1800-4: HDB/DM 227. Unpublished study prepared by Bayer Ag. 24 p. {OPPTS 850.1010} Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 5725: A 96-Hour Shell Deposition 04-Feb-2003 Test with the Eastern Oyster (Crassostrea virginica): Lab Project Number: 99-B-133: HC831501: 2357-BR. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 30 p. Boeri, R.; Wyskiel, D.; Ward, T. (2002) HEC 5725: A 96-Hour Flow-Through 04-Feb-2003 Acute Toxicity Test with the Saltwater Mysid, (Americamysisbahia): Lab Project Number: 99-B-131: HC833101: 2358-BR. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 31 p. Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Bluegill (Lepomis 04-Feb-2003 macrochirus) in a Static Test: Lab Project Number: E 252 1696-1: DOMA 99089: 00579. Unpublished study prepared by Bayer Ag. 48 p. {OPPTS 850.1075} Dorgerloh, M. (2000) HEC 5725 Acute Toxicity (96 Hours) to Common Carp 04-Feb-2003 (Cyprinus carpio) in a Static Test: Lab Project Number: DOMA 20011: E 28601782-4. Unpublished study prepared by Bayer Ag. 37 p. {OPPTS 850.1075} Dorgerloh, M. (1999) HEC 5725 Acute Toxicity (96 Hours) to Rainbow Trout 04-Feb-2003 (Oncorhynchus mykiss) in a Static Test: Lab Project Number: E 250 1605-9: DOMA 99065: 00579. Unpublished study prepared by Bayer Ag. 48 p. {OPPTS 45865415 Dorgerloh, M.; Sommer, H. (2001) HEC 5725-Carboxylic Acid-Acute Toxicity (96 Hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test (Limit Test): Lab Project Number: E 280 2104-7: DOMA 21020: 00683. Unpublished study prepared by Bayer Ag. 41 p. {OPPTS 850.1075} 04-Feb-2003 ------- 45865416 45865417 45865418 45865419 45865420 45865421 45865422 45865424 45865425 Dorgerloh, M. (2000) HEC 5725-Deschlorophenyl-Acute Toxicity (96 Hours) to 04-Feb-2003 Rainbow Trout (Oncorhynchus mykiss) in a Static Test: Lab Project Number: E 280 1761-5: DOMA 20012: 00579. Unpublished study prepared by Bayer Ag. 46 p. {OPPTS 850.1075} Kern, M.; Woodard, D.; Mattern, G. (2002) Acute Toxicity of HEC 5725 04-Feb-2003 (Technical) to the Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions: Lab Project Number: HC830901: 110322. Unpublished study prepared by Bayer CropScience. 30 p. Hendel, B. (2000) Influence of HEC 5725 (tech.) on the Reproduction Rate of 04-Feb-2003 Water Fleas (Daphnia magna): Lab Project Number: E 321 1798-1: HDB/RDM 64. Unpublished study prepared by Bayer Ag. 80 p. {OPPTS 850.1300} Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 5725: A Flow-Through Life Cycle 04-Feb-2003 Toxicity Test with the Saltwater Mysid (Americamysis bahia): Lab Project Number: 99-B-132: HC843101: 2359-BR. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 48 p. Scheerbaum, D. (2001) HEC 5725-Fish (Rainbow Trout), Early-Life Stage 04-Feb-2003 Toxicity Test, Under Flow-Through Conditions: (Final Report): Lab Project Number: 991028BD: FSR69122. Unpublished study prepared by Dr. U. Noack-Laboratorium. 84 p. {OPPTS 850.1400} Dorgerloh, M.; Weber, E. (2001) (Carbon 14)-HEC 5725-Bioconcentration and 04-Feb-2003 Biotransformation in Bluegill (Lepomis macrochirus) under Flow-Through Conditions: Lab Project Number: DOM 20032: E 244 1857-1: DOMA 20032. Unpublished study prepared by Bayer Ag. 160 p. {OPPTS 850.1730} Barfknecht, R. (2000) HEC 5725 Techn. Ai: Acute Oral Toxicity for Bobwhite 04-Feb-2003 Quail: Lab Project Number: E 292 1560-5: BAR/LD032. Unpublished study prepared by Bayer Ag. 38 p. {OPPTS 850.2100} 04-Feb-200345865423Barfknecht, R. (2001) HEC 5725 Techn.: 5-Day Dietary LC50 for Bobwhite Quail (Colinus virginianus): Lab Project Number: E 295 1558-5: BAR/LC007. Unpublished study prepared by Bayer Ag. 34 p. {OPPTS 850.2200} Barfknecht, R. (2001) HEC 5725 Techn.: 5-Day Dietary LC50 for Mallard Duck 04-Feb-2003 (Anas platyrhynchos): Lab Project Number: E 297 1559-8: BAR/LC 009. Unpublished study prepared by Bayer Ag. 35 p. {OPPTS 850.2200} Frieling, W. (2001) Reproduction Study in Bobwhite Quail with HEC 5725 04-Feb-2003 Techn: (By Dietary Admixture): Lab Project Number: 259774. Unpublished study prepared by NotoxB.V. 211 p. {OPPTS 850.2300} 32 ------- 45865426 45865427 Bowers, L.; Stoughton, t> (2003) Effect of Technical HEC 5725 on Mallard 04-Feb-2003 Reproduction: Lab Project Number: HC740801: 200084. Unpublished study prepared by Bayer CropScience. 129 p. Bruhnke, C. (2000) HEC 5725 A.I.-Acute Effects on the Honeybee Apis 04-Feb-2003 melifera (Hymenoptera, Apidae); Limit Test: Lab Project Number: 990222BN: IBA64041. Unpublished study prepared by Noack-Laboratorium. 30 p. {OPPTS 45865428 45865429 45865430 45865431 45865432 45865500 Bowers, L. (2003) Tier 1 Seedling Emergence and Vegetative Vigor Nontarget 04-Feb-2003 Phytotoxicity Study Using HEC 5725 SC 480: Lab Project Number: 200313: HC451601: HC451602. Unpublished study prepared by Bayer CropScience. 97 p. Dorgerloh, M. (2001) HEC 5725-Toxicity (7 Days) to Lemna gibba G3: Lab 04-Feb-2003 Project Number: E 412 1602-6: DOM 20017: MR-238/00. Unpublished study prepared by Bayer Ag. 31 p. {OPPTS 850.4400} Kern, M.; Lam, C. (2002) Toxicity of HEC 5725 Technical to Duckweed (Lemna 04-Feb-2003 gibba G3): Lab Project Number: HC883701: 200340. Unpublished study prepared by Bayer CropScience. 36 p. {OPPTS 850.4400} Dorgerloh, M. (2000) HEC 5725-Influence on the Growth of the Green Alga, 04-Feb-2003 Selenastrum capricornutum: Lab Project Number: E 323 1609-4: DOM 99061. Unpublished study prepared by Bayer Ag. 38 p. {OPPTS 850.5400} Dorgerloh, M.; Sommer, H. (2001) HEC 5725-Carboxylic Acid-Influence on the 04-Feb-2003 Growth of the Green Alga, Selenastrum capricornutum: Lab Project Number: E 323 1878-2: DOM 20061: MR-110/01. Unpublished study prepared by Bayer Ag. 47 p. {OPPTS 850.5400} Bayer CropScience (2003) Submission of Fate, Toxicity, and Residue Data in 04-Feb-2003 Support of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin on Peanut, Tuber and Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and Seed Treatments. Transmittal of 34 of 165 Studies. 45865501 Dorgerloh, M. (2000) HEC 5725~Deschlorophenyl~Influence on the Growth of the Green Alga, Selenastrum capricornutum: Lab Project Number: E 323 1756-7: DOM 20015: MR-245/00. Unpublished study prepared by Bayer Ag. 30 p. {OPPTS 850.5400} 04-Feb-2003 33 ------- 45865502 45865503 45865504 45865505 45865506 45865507 45865508 45865509 45865510 Meisner, P. (2000) Acute Toxicity of HEC 5725 Techn. Ai: to Earthworms 04-Feb-2003 (Eisenia fetida): Lab Project Number: E 310 1771-0: MPE/RG 318/00. Unpublished study prepared by Bayer Ag. 19 p. Meisner, P. (2000) Acute Toxicity of HEC 5725-Deschlorophenyl to Earthworms 04-Feb-2003 (Eisenia fetida): Lab Project Number: E 310 1759-6: MPE/RG 335/00. Unpublished study prepared by Bayer Ag. 19 p. Luehrs, U. (2002) HEC 5725-Deschlorophenyl: Effects on Reproduction and 04-Feb-2003 Growth of Earthworms (Eisenia fetida) in Artificial Soil: Lab Project Number: 14661022. Unpublished study prepared by Ibacon GmbH. 36 p. Hendel, B. (2000) Influence of HEC 5725 (tech.) on Developement and 04-Feb-2003 Emergence of larvae of Chironomus riparius in a Water Sediment System: Lab Project Number: E 416 1774-0: HDB/CH 41: MR-277/00. Unpublished study prepared by Bayer Ag. 45 p. Dorgerloh, M.; Sommer, H. (2001) Influence of HEC 5725-Carboxylic Acid 04-Feb-2003 on Developement and Emergence of Larvae of Chironomus riparius in a Water Sediment System: Lab Project Number: E 416 2091-3: DOM 21061: 00683. Unpublished study prepared by Bayer Ag. 56 p. Koester, I; Weber, H. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14))HEC 04-Feb-2003 5725: Absorption, Distribution, Excretion and Metabolism in the Lactating Goat: Lab Project Number: M 21819094: MR-142/01: M 181 9094-2. Unpublished study prepared by Bayer Ag. 415 p. {OPPTS 860.1300} Koester, I; Weber, H. (2001) (Chlorophenyl-UL-(Carbon 14))HEC 5725: 04-Feb-2003 Absorption, Distribution, Excretion and Metabolism in the Lactating Goat: Lab Project Number: MR-143/01: M 51819097: MO-02-002409. Unpublished study prepared by Bayer Ag. 290 p. {OPPTS 860.1300} Klempner, A.; Weber, H. (2001) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: 04-Feb-2003 Absorption, Distribution, Excretion and Metabolism in Laying Hens: Lab Project Number: M 31819103: MR-405/01: HEC4. Unpublished study prepared by Bayer Ag. 331 p. {OPPTS 860.1300} Klempner, A.; Weber, H. (2002) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 04-Feb-2003 5725: Absorption, Distribution, Excretion and Metabolism in Laying Hens: Lab Project Number: M 91819073: MO-02-014542: MR-404/01. Unpublished study prepared by Bayer Ag. 412 p. {OPPTS 860.1300} 34 ------- 45865511 45865512 45865513 45865514 45865515 45865516 45865517 45865518 45865519 Reiner, H. (2001) Metabolism of (Chlorophenyl-UL-(Carbon 14)) HEC 5725 in 04-Feb-2003 Tomatoes: Lab Project Number: M1731026-0: MR 128/01. Unpublished study prepared by Bayer CropScience. 71 p. {OPPTS 860.1300} Reiner, H. (2001) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) 04-Feb-2003 HEC 5725 in Tomatoes: Lab Project Number: M1731027-1: MR 129/01. Unpublished study prepared by Bayer CropScience. 70 p. {OPPTS 860.1300} Stork, A. (2001) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 04-Feb-2003 5725 in Spring Wheat: Lab Project Number: M173 0927-9: MR 005/00. Unpublished study prepared by Bayer CropScience. 265 p. {OPPTS 860.1300} Stork, A. (2001) Metabolism of (Chlorophenyl-UL-(Carbon 14)) HEC 5725 in 04-Feb-2003 Spring Wheat: Lab Project Number: 0173 0934-7: MR-125/01: BD0402G. Unpublished study prepared by Bayer Ag. 183 p. {OPPTS 860.1300} Stork, A. (2001) Metabolism of (Pyrimidine-2-(Carbon 14)) HEC 5725 in Spring 04-Feb-2003 Wheat: Lab Project Number: M1730911-2: MR-126/01. Unpublished study prepared by Bayer Ag. 206 p. {OPPTS 860.1300} Stork, A. (2001) Residues of HEC 5725 in Spring Wheat after Seed Dressing: Lab 04-Feb-2003 Project Number: M173 0901-1: MR-379/01. Unpublished study prepared by Bayer Ag. Ill p. {OPPTS 860.1300} Stork, A. (2002) Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 04-Feb-2003 5725 in Peanuts: Lab Project Number: M173 0935-8: MR-531/01: MO-02-017618. Unpublished study prepared by Bayer CropScience Ag. 196 p. {OPPTS 860.1300} Stork, A. (2002) Metabolism of (Pyrimidine-2-(Carbon 14))HEC 5725 in Peanuts: 04-Feb-2003 Lab Project Number: M173 0936-9: MO-03-000144: MR-532/01. Unpublished study prepared by Bayer CropScience Ag. 183 p. {OPPTS 860.1300} Heinemann, O. (2001) Analytical Determination of Residues of the Fungicide 04-Feb-2003 HEC 5725 in/on Cereals, Cereal Processed Products and Vegetables by HPLC-MS/MS: Lab Project Number: P60293003: MR-507/99: 00604. Unpublished study prepared by Bayer Ag. 136 p. {OPPTS 860.1300, 860.1340, 45865520 Preu, M. (2001) Analytical Method 00649 for the Determination of Residues of HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS: Lab Project Number: P 602001007: MR-508/00: 00649. Unpublished study prepared by Bayer Ag. 208 p. {OPPTS 860.1300, 860.1340, 860.1360} 04-Feb-2003 35 ------- 45865521 45865522 45865523 45865524 45865525 45865526 45865527 Reiner, H. (2001) Extraction Efficiency Testing of the Residue Method 00604 04-Feb-2003 for the Determination of HEC 5725 Residues in Spring Wheat and Tomatoes Using Radioactive Residues: Lab Project Number: M 9991050-3: MR-127/01: 00604. Unpublished study prepared by Bayer Ag. 52 p. {OPPTS 860.1340} Preu, M. (2001) Extraction Efficiency of Method 00604 for Incurred Residues 04-Feb-2003 of HEC 5725 in Samples of Wheat Ear-Comparison of ASE with MethanoI/Water (4/1,/v/v) and ASE with Methanol/Water (1/1, v/v): Lab Project Number: P 602011001: MR-023/01: 00604. Unpublished study prepared by Bayer Ag. 36 p. {OPPTS 860.1340} Bauer, M. (2002) Independent Laboratory Validation of the ASE Extraction 04-Feb-2003 Method as Described in Bayer Method 00604: "Analytical Determination of Residues of the Fungicide HEC 5725 in/on Cereals, Cereal Processed Products and Vegetables by HPLC-MS/MS.": Lab Project Number: 200319: AG000083: HC111602. Unpublished study prepared by Battelle Memorial Institute. 43 p. {OPPTS 860.1340} South, N. (2002) Independent Laboratory Validation of the Microwave Extraction 04-Feb-2003 Method as Described in "Analytical Method 00649 for the Determination of Residues of HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS.": Lab Project Number: AG020018: HC111603: 200256. Unpublished study prepared by Battelle Memorial Institute. 51 p. {OPPTS 860.1340} Schoening, R. (2001) Residue Analytical Method 00691 for the Determination of 04-Feb-2003 Residues of HEC 5725 (E+Z~Isomer) and HEC 7154 in Animal Tissues by HPLC with Electrospray MS/MS~Detection: Lab Project Number: P 602014706: MR-194/01: 00691. Unpublished study prepared by Bayer Ag. 152 p. {OPPTS 860.1340} Koester, J. (2001) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Extraction 04-Feb-2003 Efficiency Testing of the Residue Method for the Determination of HEC 5725 in Animal Tissues Using Aged Radioactive Residues: Lab Project Number: M 9991134-6: MR-542/01: HEC 5. Unpublished study prepared by Bayer Ag. 74 p. {OPPTS 860.1340} Schoening, R. (2001) Modification and Independent Laboratory Validation of 04-Feb-2003 Residue Analytical Method 00691 for the Determination of Residues of HEC 5725 (E+Z~Isomer) and HEC 7154 in Animal Tissues: Lab Project Number: 110897: HC110201: 00691. Unpublished study prepared by Bayer Corporation. 101 p. {OPPTS 860.1340} 36 ------- 45865528 45865529 45865530 45865531 45865532 45865533 45865534 45865600 Anderson, C. (2002) Multiresidue Method Testing for HEC 5725 E-and Z- 04-Feb-2003 Isomers and HEC 7154 According to PAM I, Appendix II, as Updated January, 1994: Lab Project Number: HC161601: 47115: 200292. Unpublished study prepared by ABC Laboratories, Inc. 116 p. {OPPTS 860.1340} De Haan, R. (2001) HEC 5725-A 29-Day Dairy Cattle Feeding Study: Lab 04-Feb-2003 Project Number: HC060401: 110888: BJ060401. Unpublished study prepared by Bayer Corporation and Southwest Biolabs, Inc. 168 p. {OPPTS 860.1480} Krolski, M. (2002) HEC 5725 480 SC-Magnitude of the Residues on Celery: Lab 04-Feb-2003 Project Number: US19CE01: 200228: AG000013. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 135 p. {OPPTS 860.1500} Beedle, E. (2002) HEC 5725 480 SC and 50 WP-Magnitude of the Residue in 04-Feb-2003 Tomatoes and Peppers (Crop Group 8~Fruiting Vegetables, Except Curcurbits: Lab Project Number: US19TO01: US19PP01: 200164. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 238 p. {OPPTS 860.1500} Duah, F. (2002) HEC 5725 480 SC-Magnitude of the Residue in/on Peanuts: Lab 04-Feb-2003 Project Number: HC19PE01: 200348: HC057-OOD. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 198 p. {OPPTS 860.1500} Krolski, M. (2003) HEC 5725 480 SC and 50 WP-Magnitude of the Residue in 04-Feb-2003 Potatoes: Lab Project Number: US19PO01: 200227: US024-OOH. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 195 p. {OPPTS 860.1500} Beedle, E. (2002) HEC 5725 480 SC-Magnitude of the Residue in Tomato 04-Feb-2003 Processed Commodities: Lab Project Number: US19TO02: 200237: US19TO01. Unpublished study prepared by Bayer CropScience, The National Food Laboratory, Inc. and Battelle-AgriFood. 168 p. {OPPTS 860.1520} Bayer CropScience (2003) Submission of Residue and Toxicity Data in Support 04-Feb-2003 of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin on Peanut, Tuber and Corm Vegetables, Leaf Petioles, Fruiting Vegetables, and Seed Treatments. Transmittal of 34 of 165 Studies. 45865601 Keffer, C. (2002) HEC 5725 480 SC-Magnitude of the Residue in Potato 04-Feb-2003 Processed Commodities: Lab Project Number: US19PO02: 200276: US006-01P. Unpublished study prepared by Bayer CropScience, The National Food Laboratory, Inc., and Battelle-AgriFood. 159 p. {OPPTS 860.1520} 37 ------- 45865602 45865603 45865604 45865605 45865606 Keffer, C. (2003) HEC 5725 480 SC-Magnitude of the Residue in Peanut 04-Feb-2003 Processed Commodities: Lab Project Number: US19PE01: 200406: US005-01P. Unpublished study prepared by Bayer CropScience, Texas A&M University, and Battelle-AgriFood. 136 p. {OPPTS 860.1520} Neumann, B. (2001) Confined Rotational Crop Study with (Pyrimidine-2- 04-Feb-2003 (Carbon 14)) HEC5725: Lab Project Number: M 130 0930-6: MR-124/01. Unpublished study prepared by Bayer Ag. 214 p. {OPPTS 860.1850} Neumann, B. (2001) Confined Rotational Crop Study with (Methoxyiminotolyl- 04-Feb-2003 Ring-UL-(Carbon 14)) HEC 5725: Lab Project Number: M1300900-3: MR 086/01: IS4530A. Unpublished study prepared by Bayer CropScience. 215 p. {OPPTS 860.1850} Neumann, B. (2001) Confined Rotational Crop Study with (Chlorophenyl-UL- 04-Feb-2003 (Carbon 14)) HEC5725: Lab Project Number: M1300933-9: MR 392/00: BD0302G. Unpublished study prepared by Bayer CropScience. 207 p. {OPPTS 860.1850} Krolski, M. (2003) HEC 5725 480 SC-Magnitude of the Residues in Rotational 04-Feb-2003 Crops: Lab Project Number: HC19RC01: HC19RC02: HC19RC03. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 374 p. {OPPTS 45865607 45865608 45865609 45865610 Beedle, E.; Ying, S. (2002) HEC 5725 480 SC~Magnitude of the Residue in 04-Feb-2003 Rotational Crop of Cotton: Lab Project Number: US19CT01: 200311: US218-OOR. Unpublished study prepared by Bayer CropScience, Texas A&M University, and Battelle-AgriFood. 194 p. {OPPTS 860.1900} Beedle, E. (2002) HEC 5725 480 SC~Magnirude of the Residue in Legume 04-Feb-2003 Vegetables (Crop Group 6) and Foliage of Legume Vegetables (Crop Group 7) WhenPlanted as Rotational Crops: Lab Project Number: US19BP01: US19BL01: US19BY01. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 623 p. {OPPTS 860.1900} Beedle, E.; Ying, S. (2002) HEC 5725 480 SC~Magnitude of the Residue in a 04-Feb-2003 Rotational Crop of Alfalfa: Lab Project Number: US19AL01: 200282: US195-OOR. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 170 p. {OPPTS 860.1900} Lenz, C. (2003) HEC 5725 480 SC~Magnitude of the Residue in Rotational Crop 04-Feb-2003 Grasses (Crop Group 7-17): Lab Project Number: US19GS01: 200368: US 148-OORA. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 174 p. {OPPTS 860.1900} 38 ------- 45865611 45865612 45865613 45865614 45865615 45865616 45865617 45865618 45865619 45865620 Krolski, M. (2003) HEC 5725 480 SC-Magnitude of the Residue in Rotational 04-Feb-2003 Crops of Corn, Rice, Sorghum, and Wheat (Crop Groups 15 and 1): Lab Project Number: US19CO01: US19RI01: US19SO01. Unpublished study prepared by Bayer CropScience and Battelle-AgriFood. 751 p. {OPPTS 860.1900} Krotlinger, F. (1996) HEC 5725: Study for Acute Oral Toxicity in Rats: Lab 04-Feb-2003 Project Number: 25231: T8060660: 109158. Unpublished study peparedby Bayer Ag. 29 p. {OPPTS 870.1100} Andrews, P. (1998) HEC 5725 N: Study for Acute Oral Toxicity in Rats: Lab 04-Feb-2003 Project Number: 27685: T 2062383: 109159. Unpublished study prepared by Bayer Ag. 25 p. {OPPTS 870.1100} Krotlinger, F. (2000) HEC 5725-Phenoxy-Hydroxypyrimidine (Metabolite of 04-Feb-2003 HEC 5725): Study for Acute Oral Toxicity in Rats: Lab Project Number: 305919: T1070086. Unpublished study prepared by Bayer Ag. 27 p. {OPPTS 870.1100} Eigenberg, D. (2003) An Acute Oral LD50 Study in the Rat with HEC 5725 04-Feb-2003 480 SC: Lab Project Number: 02-A12-NE: 200396. Unpublished study prepared by Bayer CropScience LP. 22 p. {OPPTS 870.1100} Krotlinger, F. (1998) HEC 5725: Study for Acute Dermal Toxicity in Rats: Lab 04-Feb-2003 Project Number: 27025: T9069103: 109161. Unpublished study prepared by Bayer Ag. 29 p. {OPPTS 870.1200} Eigenberg, D. (2003) An Acute Dermal LD50 Study in the Rat with HEC 5725 04-Feb-2003 480 SC: Lab Project Number: 02-A22-NF: 200395. Unpublished study prepared by Bayer CropScience LP. 20 p. {OPPTS 870.1200} Pauluhn, J. (1999) HEC 5725: Study on Acute Inhalation Toxicity in Rats: Lab 04-Feb-2003 Project Number: PH-28952: T8067483: 109268. Unpublished study prepared by Bayer Ag. 78 p. {OPPTS 870.1300} Pauluhn, J. (2003) HEC 5725 SC 480: Study on Acute Inhalation Toxicity in Rats: 04-Feb-2003 Lab Project Number: AT00190: T3072202. Unpublished study prepared by Bayer Ag. 72 p. {OPPTS 870.1300} Leuschner, P. (1999) Acute Eye Irritation Study of HEC 5725 by Instillation into 04-Feb-2003 the Conjunctival Sac of Rabbits: Lab Project Number: R 6504 A: T5060144: 9301/44/95. Unpublished study prepared by LPT Laboratory of Pharmacology and Toxicology. 22 p. {OPPTS 870.2400} 39 ------- 45865621 45865622 45865623 45865624 45865625 45865626 45865627 45865628 45865629 45865630 Merkel, D. (2003) Primary Eye Irritation Study in Rabbits: HEC 5725 480 SC: 04-Feb-2003 Lab Project Number: 02C-I35-NG: 200445: P324 BAY. Unpublished study prepared by Product Safety Labs. 17 p. {OPPTS 870.2400} Leuschner, P. (1999) Acute Skin Irritation Test (Patch Test) of HEC 5725 in 04-Feb-2003 Rabbits: Lab Project Number: R 6503 A: T5060144: 9300/44/95. Unpublished study prepared by LPT Laboratory of Pharmacology and Toxicology. 20 p. {OPPTS 870.2500} Merkel, D. (2003) Primary Skin Irritation Study Rabbits: HEC 5725 480 SC: Lab 04-Feb-2003 Project Number: 02C-I25-NH: 200449: 12875. Unpublished study prepared by Product Safety Labs. 18 p. {OPPTS 870.2500} Stropp, G. (1996) HEC 5725: Study for the Skin Sensitization Effect in Guinea 04-Feb-2003 Pigs (Guinea Pig Maximization Test According to Magnusson and Kligman): Lab Project Number: 25304: T4060666: 109164. Unpublished study prepared by Bayer Ag. 28 p. {OPPTS 870.2600} Merkel, D. (2003) Dermal Sensitization Study in Guinea Pigs (Buehler Method): 04-Feb-2003 HEC 5725 480 SC: Lab Project Number: 02C-I24-NI: 200450: 12876. Unpublished study prepared by Product Safety Labs. 26 p. {OPPTS 870.2600} Bomhard, E.; Hartmann, E. (1998) HEC 5725: Study on Subchronic Toxicity in 04-Feb-2003 CD-I Mice (Dietary Administration Over 3 Months): Lab Project Number: 27916: T1061888: 109167. Unpublished study prepared by Bayer Ag. 210 p. {OPPTS 870.3100} Bomhard, E.; Hartmann, E. (1998) HEC 5725: Study on Subchronic Toxicity in 04-Feb-2003 Wistar Rats (Dietary Administration Over 3 Months with a Subsequent Recovery Period of 1 Month): Lab Project Number: 27918: T1061662: 109168. Unpublished study prepared by Bayer Ag. 465 p. {OPPTS 870.3100} Jones, R.; Hastings, T. (2001) Technical Grade HEC 5725: A Low-Dose 04-Feb-2003 Subchronic Toxicity Feeding Study in the Beagle Dog: Lab Project Number: 99-S76-FS: 110819. Unpublished study prepared by Bayer Corporation. 568 p. {OPPTS 870.3150} Jones, R.; Elcock, L. (2001) Technical Grade HEC 5725: A Subchronic Toxicity 04-Feb-2003 Feeding Study in the Beagle Dog: Lab Project Number: 99-S76-AK: 111012. Unpublished study prepared by Bayer Corporation. 690 p. {OPPTS 870.3150} Krotlinger, F.; Popp, A. (2000) HEC 5725: Study for Subacute Dermal Toxicity in 04-Feb-2003 Rats (4-Week Treatment Period): Lab Project Number: PH-30471: T1069312: 30471. Unpublished study prepared by Bayer Ag. 207 p. {OPPTS 870.3200} 40 ------- 45865631 45865632 45865633 45865634 45865700 Becker, H.; Biedermann, K.; Leutkemeier, H. (1997) Developmental Toxicity 04-Feb-2003 Study with HEC 5725 in the Rat: Lab Project Number: R6886: T2054292: 627884. Unpublished study prepared by Research and Consulting Company Ag. 338 p. {OPPTS 870.3700} Holzum, B. (1999) HEC 5725: Developmental Toxicity Study in Rabbits After 04-Feb-2003 Oral Administration: Lab Project Number: PH-29148: T6062099: 109407. Unpublished study prepared by Bayer Ag. 502 p. {OPPTS 870.3700} Young, A. (2001) A Pilot Reproductive Study with HEC 5725 in the Wistar Rat: 04-Feb-2003 Lab Project Number: 98-972-VI: 109086. Unpublished study prepared by Bayer Corporation. 316 p. {OPPTS 870.3800} Young, A.; Christenson, W. (2001) A Two-Generation Reproductive Toxicity 04-Feb-2003 Study with HEC 5725 in the Wistar Rat: Lab Project Number: 99-R72-BW: 110249. Unpublished study prepared by Bayer Corporation and Pathology Associates International. 1473 p. {OPPTS 870.3800} Bayer CropScience (2003) Submission of Toxicity, Product Chemistry, Residue, 04-Feb-2003 Environmental Fate, Risk and Exposure Data in Support of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide and the Petition for Tolerance of Fluoxastrobin for Use on Peanuts, Tuber and Corm Vegetables, Leaf Petioles, Fruiting Vegetables and Seed Treatments. Transmittal of 30 of 165 Studies. 45865701 45865702 45865703 45865704 Jones, R.; Hastings, T. (2002) Technical Grade HEC 5725: A Chronic Toxicity 04-Feb-2003 Feeding Study in the Beagle Dog: Lab Project Number: 99-C76-BD: 110920-1. Unpublished study prepared by Bayer Corp. 1047 p. {OPPTS 870.4100} Eiben, R. (2001) HEC 5725 Oncoogenicity Study on CD-I Mice: (Dietary 04-Feb-2003 Administration Over 18 Months): Lab Project Number: 31353: T5067480: 20028 HJC. Unpublished study prepared by Bayer AG. 1206 p. {OPPTS 870.4200} Schladt, L.; Ruhl-Fehlert, C. (2001) HEC 5725 Combined Study on Chronic 04-Feb-2003 Toxicity and Carcinogenicity in Wistar Rats: (Dietary Administration for 2 Years): Lab Project Number: PH 31357: 31357: T4062600. Unpublished study prepared by Bayer AG. 3759 p. {OPPTS 870.4300} Herbold, B. (1996) HEC 5725 Salmonella/Microsome Test Plate Incorporation 04-Feb-2003 and Preincubation Method: Lab Project Number: 25186: 109098: 2053707. Unpublished study prepared by Bayer Ag. 58 p. {OPPTS 870.5100} 41 ------- 45865705 45865706 45865707 45865708 45865709 45865710 45865711 45865712 45865713 Herbold, B. (1998) HEC 5725 N Salmonella/Microsome Test Plate Incorporation 04-Feb-2003 and Preincubation Method: Lab Project Number: 27260: T 0061472: 109099. Unpublished study prepared by Bayer AG. 54 p. {OPPTS 870.5100} Herbold, B. (2000) HEC 5725-Phenoxy-Hydroxypyrimidine Special Study Ames 04-Feb-2003 Test Screening: Lab Project Number: 30476: T 1069925. Unpublished study prepared by Bayer AG. 46 p. {OPPTS 870.5100} Herbold, B. (2001) HEC 5725-Phenoxy-Hydroxypyrimidine Salmonella/ 04-Feb-2003 Microsome Test Plate Incorporation and Preincubation Method: Lab Project Number: 30960: T 8069922. Unpublished study prepared by Bayer AG. 50 p. {OPPTS 870.5100} Herbold, B. (2001) HEC 5725-Dihydroxypyrimidine Special Study Ames Test 04-Feb-2003 Screening: Lab Project Number: 31123: T 8070506. Unpublished study prepared by Bayer AG. 47 p. {OPPTS 870.5100} Brendler-Schwaab, S. (1997) HEC 5725 Mutagenicity Study for the Detection of 04-Feb-2003 Induced Forward Mutations in the V79-HPRT Assay in Vitro: Lab Project Number: 25785: T 2053716: 109155. Unpublished study prepared by Bayer AG. 36 p. {OPPTS 870.5300} Herbold, B. (1996) HEC 5725 In Vitro Mammalian Chromosome Aberration Test 04-Feb-2003 with Chinese Hamster V79 Cells: Lab Project Number: 25187: T 0053705: 109156. Unpublished study prepared by Bayer AG. 35 p. {OPPTS 870.5375} Herbold, B. (1999) HEC 5725 Micronucleus Test on the Mouse: Lab Project 04-Feb-2003 Number: 28393: T 9059870: 109157. Unpublished study prepared by Bayer AG. 41 p. {OPPTS 870.5395} Sheets, L.; Gilmore, R.; Stuart, B. (2001) An Acute Oral Neurotoxicity Screening 04-Feb-2003 Study with Technical Grade HEC 5725 in Wistar Rats: Lab Project Number: 98-412-WG: 110509: 393-029. Unpublished study prepared by Bayer Corp. and Experimental Pathology Laboratories Inc. 449 p. {OPPTS 870.6200} Gilmore, R.; Hastings, T. (2002) A Subchronic Neurotoxicity Screening Study 04-Feb-2003 with Technical Grade HEC 5725 in Wistar Rats: Lab Project Number: 01-N72-CZ: 200366. Unpublished study prepared by Bayer Corp. 479 p. {OPPTS 45865714 Klempner, A. (2002) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Rat Metabolism Part 1 of 2: Toxicokinetic Behaviour and Metabolism in the Rat: Lab Project Number: M 71819099: MR-136/01: M 181 9099-7. Unpublished study prepared by Bayer AG. 314 p. {OPPTS 870.7485} 04-Feb-2003 42 ------- 45865715 45865716 45865717 45865718 45865719 45865721 45865722 45865723 Neumann, B.; Weber, E. (2002) (Chlorophenyl-UL-(Carbon 14)) HEC 5725: Rat 04-Feb-2003 Metabolism Part 2 of 2: Distribution of the Radioactivity in Male and Female Rats Determined by Quantitative Whole Body Autoradiography: Lab Project Number: M71819099: MR 332/01: M 181 9099-7. Unpublished study prepared by Bayer CropScience. 113 p. Klempner, A. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 5725: Rat 04-Feb-2003 Metabolism Part 1 of 2: Toxicokinetic Behaviour and Metabolism in the Rat: Lab Project Number: M 21819076: MR-135/01: M 181 9076-2. Unpublished study prepared by Bayer AG. 412 p. {OPPTS 870.7485} Neumann, B.; Weber, E. (2001) (Methoxyiminotolyl-ring-UL-(Carbon 14)) HEC 04-Feb-2003 5725: Rat Metabolism Part 2 of 2: Distribution of the Radioactivity in Male and Female Rats Determined by Quantitative Whole Body Autoradiography: Lab Project Number: M21819076: MR 334/01: M 181 9076-2. Unpublished study prepared by Bayer AG. 94 p. {OPPTS 870.7485} Neumann, B. (2001) (Pyrimidine-2-(Carbon 14)) HEC 5725: Rat Metabolism: 1 04-Feb-2003 Part 1 of 2: Toxicokinetic Behaviour and Metabolism: Lab Project Number: M 61819098: MR 404/00: M 181 9098-6. Unpublished study prepared by Bayer AG. 156 p. {OPPTS 870.7485} Neumann, B.; Weber, E. (2001) (Pyrimidine-2-(Carbon 14)) HEC 5725: Rat 04-Feb-2003 Metabolism: Part 2 of 2: Distribution of the Radioactivity in Male and Female Rats Determined by Quantitative Whole Body Autoradiography: Lab Project Number: M61819098: MR 333/01: M 181 9098-6. Unpublished study prepared by Bayer CropScience. 114 p. {OPPTS 870.7485} Leser, K.; Hartmann, E. (2001) HEC 5725 Study on Subchronic Toxicity in 04-Feb-2003 Wistar Rats (Dietary Administration Over Two Months): Lab Project Number: PH-31124: T3062320: 31124. Unpublished study prepared by Bayer AG. 494 p. {OPPTS 870.3100} Jones, R.; Jensen, T. (2000) The Homogenicity and Stability of HEC 5725 04-Feb-2003 Technical in Canine Ration: Lab Project Number: 98-876-VB: 109067. Unpublished study prepared by Bayer Corp. 13 p. Jones, R.; Jensen, T. (2001) The Homogenicity and Stability of HEC 5725 04-Feb-2003 Technical in Rodent Ration Using Purina Mills Certified Rodent 5002 Meal: Revised Final Version: Lab Project Number: 98-872-WI: 109608. Unpublished study prepared by Bayer Corp. 14 p. 43 ------- 45865724 45865725 45865726 45865727 45865728 45865729 45865730 45873900 45873901 45911500 45911501 Krotlinger, F.; Romeike, A. (1997) HEC 5725 Study for Subacute Oral 04-Feb-2003 Toxicity oin Rats (Feeding Study Over 4 Weeks): Lab Project Number: 26541: T9060661: 109166. Unpublished study prepared by Bayer AG. 246 p. Krotlinger, F.; Hartmann, E. (2001) HEC 5725 N: Study for Subacute Oral 04-Feb-2003 Toxicity in Rats (Feeding Study Over 4 Weeks): Lab Project Number: PH-29147: T2062329: 29147. Unpublished study prepared by Bayer AG. 250 p. Andrews, P.; Vohr, H. (2001) HEC 5725 Study for Subacute Oral Toxicity in 04-Feb-2003 Mice (Feeding Study for 5 Weeks-Immunotoxicity Investigations): Lab Project Number: PH 31405: 31405: T 7070398. Unpublished study prepared by Bayer AG. 43 p. Andrews, P. (2002) HEC 5725 and HEC 5725 A Comparative Study for Subacute 04-Feb-2003 Oral Toxicity in Rats (Feeding Study for 4 Weeks): Lab Project Number: 31817: T 7070811: 06007 SAN. Unpublished study prepared by Bayer AG. 481 p. Sabbagh, G. (2003) Drinking Water Exposure and Risk Assessment for HEC 04-Feb-2003 5725: Lab Project Number: 200361. Unpublished study prepared by Bayer CropScience. 72 p. Sabbagh, G. (2003) Aquatic Exposure Assessment for HEC 5725: Lab Project 04-Feb-2003 Number: 200362. Unpublished study prepared by Bayer CropScience. 67 p. Lemke, V. (2002) Evaluation of Dietary Exposure to HEC 5725 and Assessment 04-Feb-2003 of Potential Risk: Lab Project Number: 200416. Unpublished study prepared by Bayer CropScience. 35 p. Bayer CropScience (2002) Submission of Risk and Exposure Data in Support of 10-Mar-2003 the Application for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide. Transmittal of 1 Study. Standart, V. (2003) Non-Dietary Exposure & Risk Assessment of HEC 5725 10-Mar-2003 480 SC During Use in Peanuts, Vegetables, Seed Treatment, and Turf: Lab Project Number: 200470. Unpublished study prepared by Bayer CropScience. 34 P- Bayer CropScience (2003) Submission of Toxicity Data in Support of the 17-Apr-2003 Applications for Registration of Fluoxastrobin Technical and HEC 80 SC Fungicide. Transmittal of 2 Studies. Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of 17-Apr-2003 Elimination of HEC 5725 when Administered Intravenously or Dermally to Male Rhesus Monkeys: Final Report: Lab Project Number: VCBZ-102-03-16: 44 ------- VCBZ-102: 02C-P29-LT. Unpublished study prepared by Charles River Laboratories. 118 p. {OPPTS 870.7600} 45911502 Sebesta, C. (2003) A Study to Determine the Dermal Absorption of (Carbon 14) HEC 5725 in EC 100 Formulation when Administered Dermally to Male Rhesus Monkeys: Final Report: Lab Project Number: 200478: VCBZ-0105: 02C-B29-NJ. Unpublished study prepared by Charles River Laboratories. 111 p. {OPPTS 870.7600} 17-Apr-2003 46044200 Bayer CropScience (2003) Submission of Public Interest Finding Data in Support of the Applications for Registration of Fluoxastrobin Technical and HEC 480 SC Fungicide. Transmittal of 1 Study. Ol-Aug-2003 46044201 46080400 Beedle, E.; Hall, T.; Malakani, K.; et. al. (2003) Public Interest Document for Ol-Aug-2003 Fluoxastrobin Fungicide. Project Number: 200642. Unpublished study. 75 p. Bayer CropScience (2003) Submission of Toxicity Data in Support the FIFRA 25-Sep-2003 6(a)(2) Data Requirements for Fluoxystrobin. Transmittal of 2 Studies. 46080401 46080402 van Wijngaarden, R. (2003) Screening Studies on the Effects of Fluoxastrobin to 25-Sep-2003 Freshwater Invertebrates. Project Number: F03069. Unpublished study prepared by Alterra, Green World Research. 12 p. van Wijngaarden, R.; (2003) Acute Toxicity of Fluoxastrobin to Freshwater 25-Sep-2003 Invertebrates: Final Report. Project Number: ALT/RW/2003/1, ALTERRA/RW/2003/1. Unpublished study prepared by Alterra, Green World Research. 93 p. 46216600 Bayer CropScience (2004) Submission of Toxicity Data in Support of the Application for Registration of Fluoxastrobin and HEC 480 SC Fungicide. Transmittal of 4 Studies. 05-Mar-2004 46216601 Sturdivant, D. (2004) Summary of Toxicological End Points for HEC 5725. Project Number: 200959. Unpublished study prepared by Bayer CropScience LP. 6 p. 05-Mar-2004 46216602 Sturdivant, D. (2004) Overview of Toxicology and Risk Assessment for HEC 5725 (Tier 3). Project Number: 200960. Unpublished study prepared by Bayer CropScience LP. 12 p. 05-Mar-2004 46216603 Sturdivant, D. (2004) Summary of Individual Toxicology and Metabolism Studies for HEC 5725 (Tier 2). Project Number: 200961. Unpublished study prepared by Bayer CropScience LP. 108 p. 05-Mar-2004 45 ------- 46216604 46397900 Sturdivant, D. (2004) Summary of Toxicology Studies on HEC 480 SC Fungicide 05-Mar-2004 Containing the Active Ingredient Fluoxastrobin. Project Number: 200962. Unpublished study prepared by Bayer CropScience. 13 p. Bayer CropScience (2004) Submission of Product Chemistry Data in Support of 04-Nov-2004 the FIFRA 6(a)(2) Data Requirements for Fluoxastrobin Technical. Transmittal of 1 Study. 46397901 46404900 46404901 46486100 46486101 46486102 Fontaine, L. (2004) Product Chemistry of Fluoxastrobin Technical. Project 04-Nov-2004 Number: BR/2361, 15/920/2213, ANR/20404. Unpublished study prepared by Bayer Cropscience LP and Bayer Ag, Institute of Product Info. 455 p . Bayer CropScience LP (2004) Submission of Toxicity Data in Support of the 16-Nov-2004 FIFRA 6(a)(2) Data Requirements for Fluoxastrobin. Transmittal of 1 Study. Liebig, M. (2003) A Long-Term Indoor Microcosm Study on the Toxicity of 16-Nov-2004 Fluoxastrobin (EC 100) to the Amphipod Gammarus pulex L. in a Natural Water-Sediment System. Pro-ject Number: P1MG. Unpublished study prepared by ECT Oekotoxikologie Gmbh. 135 p. Bayer CropScience LP (2005) Submission of Residue Data in Support of the 03-Mar-2005 Application for Registration of Fluoxastrobin. Transmittal of 4 Studies. Beedle, E. (2005) Addendum 1: Incorporation of Internal Standard and a List of 03-Mar-2005 Additional Crop Matrices Analyzed by Method 00604 (US Submission); Analytical Determination of Residues of the Fungicide HEC 5725 in/on Cereals, Cereal Process Products and Vegetables by HPLC-MS/MS. Project Number: MR/507/99/1, 00604/1, P60293003. Unpublished study prepared by Bayer Corp. 54p. Beedle, E. (2005) Addendum 1: Additional Crop Matrices Analyzed by Method 03-Mar-2005 00649 (US Submission); Analytical Method 00649 for the Determination of Residues of HEC 5725 in/on Matrices of Plant Origin by HPLC-MS/MS. Project Number: P602001007, MR/508/00/1, 00649/1. Unpublished study prepared by Bayer Corp. 7 p. 46486103 De Haan, R. (2005) Addendum 1: Additional Information of Independent Laboratory Validation; Modification and Independent Laboratory Validation of Residue Analytical Method 00691 for the Determination of Residues of HEC 5725 (E + Z Isomer) and HEC 7154 in Animal Tissues. Project Number: HC110201, 110897/1. Unpublished study prepared by Bayer Corp. lOp. 03-Mar-2005 46 ------- 46486104 Schramel, O. (2001) Independent Laboratory Validation of Method 00691 for the 03-Mar-2005 Determination of Residues of HEC 5725 (E + Z-Isomer) and HEC7154 in Matrices of Animal Origin by HPLC-MS/MS. Project Number: MR/475/01, P613010040. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 30 p. 46569700 Bayer CropScience LP (2005) Submission of Product Chemistry Data in Support 13 -Jun-2005 of the Application for Registration of Fluoxastrobin Technical. Transmittal of 1 Study. 46569701 Andre, J. (2005) Freezer Storage Stability of HEC 5725 and Relevant Metabolites 13-Jun-2005 on Soil from California, Washington, Georgia, New York, Manitoba, and Prince Edward Is- land. Project Number: 201275, AGO 10002. Unpublished study prepared by Battelle. 102 p. 47 ------- |