United States Environmental Protection Agency Office of Chemical Safety and Pollution Prevention (7505P) A S7 Pesticide Fact Sheet Name of Chemical: Reason for Issuance: Fluxapyroxad Registration of New Active Ingredient Date Issued: May 2, 2012 I. DESCRIPTION OF CHEMICAL Common Name Company Experimental Name IUPAC Name CAS Name Year of Initial Registration Chemical Abstracts Service (CAS) Number EPA Chemical Code Pesticide Type Chemical Class Company Mode of Action: Fluxapyroxad BAS 700 F 3 -(difluoromethyl) -1 -methyl -iV-(3 ',45' -trifluorobiphenyl -2 - yl)pyrazol e-4 -carb oxami de 3-(difluoromethyl)-l -methyl -N-(3 ',4',5'-trifluoro[l,r- bi phenyl ] -2 -y 1) - li7-pyrazol e-4 -carb oxami de 2012 907204-31-3 138009 Fungicide Carboxamide BASF Corporation Inhibition of succinate dehydrogenase in complex II of the mitochondrial respiratory chain 1 ------- Chemical Structure: IL USE PATTERN AND FORMULATIONS Fluxapyroxad is a new active ingredient (a.i.) developed by BASF Corporation to control a broad spectrum of fungal diseases. Fluxapyroxad belongs to the carboxamide class of chemicals and its mode of action is inhibition of succinate dehydrogenase in complex II of the mitochondrial respiratory chain, which results in inhibition of spore germination, germ tubes, and mycelial growth within the fungus target species. The review of fluxapyroxad was done jointly with Australia, Canada, and New Zealand (peer review only by New Zealand). Fluxapyroxad is formulated as an emulsifiable concentrate (EC) or suspension concentrate (SC) and is registered for both foliar and seed treatment uses on a wide range of crops (cereal grains, legume vegetables, oil seed crops, peanuts, pome fruit, stone fruit, root and tuber vegetables, fruiting vegetables, and cotton). Crop applications may begin at emergence, but typical applications begin as plants touch across rows. Maximum single application rates range from 0.09 to 0.18 lb ai/acre. Maximum seasonal application rates range from 0.18 to 0.36 lb ai/acre. Pre-harvest intervals (PHIs) range from 0 to 21 days. A 365-day plant-back interval (PBI) is required for all crops that are not on the label. Applications may be made using groundboom, airblast, aerial, and standard slurry or mist-type seed treatment equipment. There are no fluxapyroxad products for homeowner use and there are no products for application to residential areas. TTT. HUMAN HEALTH RISK ASSESSMENT Acute Toxicity Technical fluxapyroxad is of low acute toxicity by the oral, dermal and inhalation routes and is not irritating to the eyes and skin. Subchronic, Chronic, Other Toxicity The primary target organ for fluxapyroxad exposure via the oral route is the liver with secondary toxicity in the thyroid for rats only. Liver toxicity was observed in rats, mice, and dogs, with rats as the most sensitive species for all durations of exposure. In rats, adaptive effects of hepatocellular hypertrophy and increased liver weights and changes in liver enzyme activities 2 ------- were first observed. As the dose or duration of exposure to fluxapyroxad increased, clinical chemistry changes related to liver function also occurred, followed by hepatocellular necrosis, neoplastic changes in the liver, and tumors. Thyroid effects were observed only in rats. These effects were secondary to changes in liver enzyme regulation, which increased metabolism of thyroid hormone, resulting changes in thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and thyroid tumor formation. Tumors were not observed in species other than rats or in organs other than the liver and thyroid. Carcinogenicity In accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), fluxapyroxad is classified as "Not likely to be Carcinogenic to Humans" based on convincing evidence that carcinogenic effects are not likely below a defined dose range: • No treatment-related tumors were seen in male or female mice when tested at doses that were adequate to assess carcinogenicity (including the Limit Dose); • Treatment-related liver tumors were seen in male rats at doses > 250 ppm (11 mg/kg/day) and in female rats at doses > 1500 ppm (82 mg/kg/day); • Treatment-related thyroid follicular cell tumors were seen in male rats only at doses^ 1500 ppm (68 mg/kg/day); • There is no mutagenicity concern from in vivo or in vitro assays; • The hypothesized mode of action (i.e., a non-genotoxic) for each tumor type (i.e., the liver and thyroid) was supported by adequate studies that clearly identified the sequence of key events, dose-response concordance and temporal relationship to the tumor types. The mode of action met the criteria established by the Agency. The Agency has determined that the chronic population adjusted dose (PAD) will adequately account for all chronic effects, including carcinogenicity that could result from exposure to fluxapyroxad. Food Quality Protection Act (FQPA) Safety Factor EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to IX. This reduction is based on the availability of a complete toxicity database with clear NOAELs for characterizing neurotoxicity and sensitivity during development, supplemental studies that characterize the effects of fluxapyroxad on thyroid hormones, and no residual uncertainties in the exposure database. Neurotoxicity: Neither the acute nor the subchronic neurotoxicity studies indicated specific neurotoxicity responses to fluxapyroxad. Although treatment-related effects of decreased rearing and motor activity were observed in the acute neurotoxicity study on the day of dosing, these effects are equivocal as they may indicate transient and reversible neurotoxicity and/or general malaise. The Agency considered the potential for fluxapyroxad to cause developmental neurotoxicity as a result of thyroid hormone disruption, which is more sensitive than the endpoints used in a developmental neurotoxicity study. Based on its evaluation of thyroid hormone data submitted by the registrant and the ontogeny of thyroid hormone metabolism, the Agency has determined that adverse thyroid hormone disruptions in the young are unlikely to occur at dose levels similar to the points of departure chosen for risk assessment. The Agency has low concern for neurotoxic effects of fluxapyroxad at any life stage. 3 ------- Prenatal Developmental/Reproductive Toxicity: No evidence of quantitative susceptibility was observed in a reproductive and developmental toxicity study in rats or in developmental toxicity studies in rats and rabbits. Developmental effects observed in both rats and rabbits occurred at the same doses as those that caused adverse effects in maternal animals, indicating no quantitative susceptibility. Since the maternal toxicities of thyroid hormone perturbation in rats and systemic toxicity in rabbits likely contributed to the observed developmental effects there is low concern for qualitative susceptibility. The observed effects were of low severity, were likely secondary to maternal toxicity, and demonstrated clear NOAELs. Based on the available data and the selection of risk assessment endpoints that are protective of developmental effects, there are no residual uncertainties with regard to pre- and/or postnatal toxicity. Human Exposure and Risk To assess the potential risks to human health from the proposed uses and associated tolerances, toxicological points of departure (POD) and levels of concern (LOC) were identified. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the "no-observed-adverse- effect- level," or NOAEL) and the lowest dose at which adverse effects of concern are identified (the "lowest- observed-adverse-effect-level," or LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level - generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) - and a safe margin of exposure (MOE). PODs were selected for dietary and occupational exposure scenarios. Acute and chronic RfDs and PADs [PAD = RfD/FQPA SF] were selected for assessment of food and drinking water exposures. An uncertainty factor of 100X was applied to PODs selected for all exposure routes (10X for interspecies extrapolation, 10X for intraspecies variation). Acute Dietary: The acute PAD (aPAD) of 1.25 mg/kg/day was based on the observation of decreased motor activity and decreased rearing in the rat acute neurotoxicity study at a LOAEL of 500 mg/kg/day [NOAEL = 125 mg/kg/day]. Chronic Dietary Exposure: The chronic PAD (cPAD) of 0.021 mg/kg/day was based on the observation of non-neoplastic changes in the liver (foci and masses) in the chronic toxicity/carcinogenicity study in rats at a LOAEL of 11 mg/kg/day [NOAEL = 2.1 mg/kg/day]. Cancer: Fluxapyroxad is classified as "Not Likely to be Carcinogenic to Humans" based on convincing evidence that carcinogenic effects are not likely below a defined dose range. A full panel of in vitro and in vivo studies that showed no evidence of genotoxicity, together with mechanistic studies in the liver and thyroid of rats that satisfied stringent criteria for establishing tumorgenic modes of action were used for this determination. The Agency has determined that the cPAD will adequately account for all chronic effects, including carcinogenicity, likely to result from exposure to fluxapyroxad. 4 ------- Aggregate Exposure and Risk In accordance with the FQPA, the Agency must consider aggregate pesticide exposures and risk estimates from three major routes: oral, dermal, and inhalation. In an aggregate assessment, exposures from relevant sources (food, drinking water, and residential uses) are added together and compared to quantitative estimates of hazard (e.g., aNOAEL or PAD), or the risks themselves can be aggregated. To evaluate dietary exposure to fluxapyroxad, the Agency considered exposure that individuals could receive through food consumption and drinking water. The acute and chronic dietary analysis assumed 100% crop treated for all commodities, tolerance-level residues adjusted to account for metabolites of concern and/or highest average field-trial residues. DEEM default and empirical processing factors were also used. The Agency used screening-level water exposure models in the dietary exposure analysis for fluxapyroxad in drinking water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. Acute Dietary: The acute risk estimate is 6 % of the aPAD for children 1 -2 years old, the population subgroup with the highest exposure. The risk estimate for the general U.S. population is 2 % of the aPAD. Chronic Dietary: The chronic risk estimate is 48 % of the cPAD for children 1 -2 years old, the population subgroup with the highest exposure. The risk estimate for the general U.S. population is 14 % of the cPAD. Fluxapyroxad uses are not expected to result in residential exposures. Therefore, the acute and chronic exposure estimates represent aggregate exposure. All risk estimates are below the Agency's level of concern. Occupational Exposure and Risk There is a potential for short- and intermediate-term occupational exposure to fluxapyroxad during mixing, loading, application, commercial seed treatments, planting activities and post- application activities. Chronic exposures are not expected from fluxapyroxad use patterns. Only short- and intermediate-term inhalation exposures were assessed for occupational handlers and post-application activities, with a target LOC or MOE of 100. Dermal exposures were not assessed because PODs for dermal exposure were not selected as no effects of concern were identified from the toxicity database. Worker exposures were assessed based on the product labels prescribed uses and expected exposure durations. For all exposure scenarios the MOEs are greater than 100. Therefore, occupational risks from fluxapyroxad uses are not of concern. IV. ECOLOGICAL RISK ASSESSMENT Environmental Fate Persistence: The available fate data indicate that fluxapyroxad degrades slowly in soil and aquatic systems. Fluxapyroxad is stable to hydrolysis at pH values of 5, 7 and 9, and is stable to both soil and aqueous photolysis. Fluxapyroxad does not readily undergo aerobic or anaerobic 5 ------- degradation in soil (half-lives ranging from 213 to 1,827 days) or in aquatic systems (half-lives ranging from 420 to 731 days), and therefore may persist in soil, water, and in benthic sediment once transported or partitioned to these environmental compartments. Transport: Fluxapyroxad has a moderate potential to reach aquatic environments, including surface and ground water, for several months or more following terrestrial application. The available fate data indicate that fluxapyroxad is likely to dissipate to some extent through various mechanisms, including runoff, erosion, and leaching to ground water. Fluxapyroxad is classified as moderately to slightly mobile (FAO soil mobility classification) with adsorption Koc values ranging from 496 to 1,424 mL/g0C. Freundlich soil partitioning coefficients (KF) for adsorption ranged from 4.3 to 17.9 ml/g. Based on its mobility and environmental persistence, fluxapyroxad has the potential to leach to ground water, particularly where high water tables are present, high rainfall/irrigation occurs, and where sandy soils with low organic matter exist. Fluxapyroxad is not expected to volatilize (vapor pressure of 6.1 x 10"11 Torr at 25° C). Bioaccumulation: Fluxapyroxad is not likely to bioaccumulate. A bioconcentration in fish (BCF) laboratory study involving bluegill sunfish showed that after 28 days of exposure to fluxapyroxad, the whole fish BCF was less than or equal to 93 |ig/kg-ww per |ig/L. The time to reach 90% depuration was approximately 2.5 days. Ecological Risk The potential risks to nontarget organisms from the use of pesticides are evaluated by comparing the toxicity endpoints from ecological toxicity data to estimated environmental concentrations (EECs). The EEC values are based on environmental fate characteristics, soil and water chemistry, and pesticide use data. Risk Quotients (RQs), are calculated from the ratio of the EECs to the most sensitive toxicity endpoint values (such as the LC50 or the median lethal concentration). The calculated RQs represent a screening-level assessment. Since screening- level assessments are based on conservative assumptions, the highest EECs and the lowest toxicity values are always used. RQ values are then compared to levels of concern (LOCs), which indicate whether a pesticide, when used as labeled, has the potential to cause adverse effects on nontarget organisms. When the RQ exceeds the LOC for a particular category, the Agency presumes a potential risk of concern to that category. The following table describes the Agency's LOCs and its respective risk presumptions. Agency's LOCs and Risk Presumptions Risk Presumptions LOC Terrestrial Animals LOC Aquatic Animals LOC Plants (Terrestrial, Semi- aquatic, and Aquatic) Acute Risk >0.5 >0.5 >1 Chronic Risk >1 >1 N/A N/A = not applicable 6 ------- Risks to Aquatic Organisms: Exposure to the fluxapyroxad technical grade active ingredient (TGAI) is not expected to result in acute or chronic risk to aquatic organisms, including fish, amphibians, and plants in aquatic habitats. Despite the absence of chronic ecotoxicity data for estuarine/marine organisms, a comparison of the relatively low surface water EECs to the available chronic toxicity data for freshwater species suggests that risk is low. Estuarine/marine animals were similarly or less sensitive to the TGAI than freshwater animals in the acute studies; and when considered in the context of the relatively low EECs, new data would be unlikely to change the screening-level risk assessment conclusions. The likelihood of adverse effects to sediment-dwelling invertebrates and aquatic plants is considered low as RQ values do not approach or exceed the Agency's LOCs. There is acute risk to aquatic animals based on endpoints for the fluxapyroxad formulations that contain the a.i. pyraclostrobin (which is evaluated in a separate risk assessment) and spray drift- only EECs. When the toxicity endpoints for freshwater fish and invertebrates are adjusted for the percentage of pyraclostrobin in each product, they are similar to toxicity endpoints for the pyraclostrobin TGAI, indicating that the enhanced toxicity of the dual active ingredient formulations appears to be driven by pyraclostrobin. Based on this screening-level assessment, there is acute risk to estuarine/marine species when dual a.i. formulations of fluxapyroxad are applied in areas that may result in spray drift to the estuarine/marine environment. Risks to Terrestrial Organisms: Fluxapyroxad exhibits low acute toxicity to mammals by all exposure routes. Fluxapyroxad is practically non-toxic to birds on an acute oral exposure basis and ranges from slightly to practically nontoxic to birds on a subacute dietary exposure basis. Foliar and seed treatment uses of fluxapyroxad are not expected to result in acute risk of mortality to birds (and therefore reptiles and terrestrial-phase amphibians, for which birds serve as surrogates) or mammals based on a comparison of the available effects data to terrestrial EECs. The screening-level risk assessment shows that uses of fluxapyroxad may result in chronic risk to mammals (dose-based RQ>1.0), including mammals that consume treated seed (estimated dose- based RQs range from 0.01 - 4.46). Despite the exceedances on some of the chronic RQs for mammals, EPA believes the potential for unreasonable chronic effects is low. The chronic RQs reflect risk at the site of application following applications at a maximum use rate. It is also assumed that mammals forage for food exclusively on the treated area and they consume a single food type (e.g., short grass or seed). For most mammals and birds, neither assumption is likely to be true. EPA also notes that the models used to estimate concentrations of fluxapyroxad in the environment are screening models, designed to provide high-end (i.e., protective) exposure estimates, further reducing the likelihood of actual risks. Chronic risk to birds, reptiles, and amphibians in the terrestrial environment cannot be precluded because slight but statistically significant effects on growth were observed at all treatment levels in an avian reproduction study; therefore, EPA was unable to establish a lower threshold for this effect. This treatment-related effect was uniform across all test concentrations and is consistent with effects on body weight and body weight gain in rat pups (NOAEC=l 12 mg/kg diet) in a two- generation reproduction study. In the absence of a definitive NOAEC value for chronic effects on birds, and by proxy, for chronic effects on reptiles and terrestrial-phase amphibians, the Agency's presumes chronic risk to these taxa based on the slight, transient effect on hatchling body weight. Although a lower threshold for this effect was not established, additional data are not being 7 ------- requested because such data would be unlikely to change the screening level risk conclusions. For example, in order to preclude chronic risk (i.e., RQ<1), a chronic toxicity study (i.e., avian reproduction) would need to establish that no adverse effects are observed at concentrations up to and including 80 mg/kg diet, based on EECs for fluxapyroxad uses. However, the existing study demonstrated that effects were observed at concentrations ranging from 100 to 1,000 mg/kg diet. Given the flat concentration response for the effect on hatchling body weight, an additional study would be unlikely to yield a NOAEC between 80 and 100 mg/kg diet and therefore would be unlikely to change the screening level risk conclusions. Therefore, additional avian reproduction data are not being requested at this time. Fluxapyroxad is practically non-toxic on an acute exposure basis to terrestrial invertebrates. The available data show that fluxapyroxad and its formulated end-use products are practically non- toxic to the young adult honey bee (Apis mellifera) on both an acute contact and acute oral exposure basis. Foliar uses and some seed treatment uses of fluxapyroxad may result in risk to federally-listed threatened and endangered species (listed) dicotyledonous (dicot) terrestrial and semi-aquatic plants. RQ values based on seed treatment uses exceed the Agency's LOC for the highest use rate evaluated for listed species of dicot plants in semi-aquatic areas, but are below the LOC for all other nontarget plants. The risk conclusion for seed treatment uses is dependent on parameters such as incorporation depth of the seeds and seeding rate; in cases where seeds are incorporated greater than or equal to one inch, exposure via runoff is expected to be reduced, and risk would not exceed the LOC. Risk to monocot plants and nonlisted dicot plants is not expected to exceed the LOC. Co- Formulated Products Formulated fluxapyroxad is in some cases more toxic than the TGAI to aquatic organisms. Exposure to dual active ingredient formulations of fluxapyroxad as a result of spray drift is expected to result in risk of acute mortality that exceeds the LOC for aquatic animals. The greater toxicity of the dual active ingredient formulations to fish and invertebrates, when compared to the fluxapyroxad TGAI and solo formulations, appears to be driven by pyraclostrobin. Ecotoxicity data indicate that fluxapyroxad is practically non-toxic to young adult honey bees on an acute oral and contact exposure basis. However, the fluxapyroxad end-use products that are co-formulated with pyraclostrobin are similar in that respect to the BASF-registered product Pristine®, which contains the similarly structured (carboxamide) fungicide boscalid (25.2%) and pyraclostrobin (12.8%). Risk assessments for boscalid have described uncertainties regarding potential effects of Pristine® on development of honey bee brood, based on incident reports and communications with beekeepers. The available toxicity data indicate that neither fluxapyroxad, any of its end-use products, nor boscalid or Pristine® are acutely toxic to young adult honey bees. In addition, submitted semi-field studies with fluxapyroxad and with Pristine® demonstrated no overall effects on honey bee brood. However, in response to concerns raised by beekeepers regarding Pristine®, BASF is currently planning and conducting further tests to evaluate the potential for effects on larval honey bee development and queen cell production and survival. The structural similarities between boscalid and fluxapyroxad and the similarities in active ingredient content of Pristine®, Merivon® Xemium® brand fungicide, and Priaxor® Xemium® 8 ------- brand fungicide suggest that information from these forthcoming honey bee studies may be relevant to all three products. V. REGULATORY DECISION EPA has determined that the available data provide adequate information to make the determinations required by FIFRA Sec. 3(c)(5) to grant unconditional registrations to fluxapyroxad formulated as a manufacturing-use product (Xemium Fungicide Technical) and the following end-use products : Imbrex™ Xemium® brand fungicide (5.96% a.i.) for a range of agricultural uses; Xemium® 2.78 fungicide ST (28.78% a.i.) for a range of seed treatment uses; Xemium® 2.72 fungicide ST (28.70%> a.i.) for a range of seed treatment uses; Sercadis™ Xemium® brand fungicide (26.55%) a.i.) for a range of agricultural uses; Merivon® Xemium® brand fungicide (21.26% fluxapyroxad and 21.26% pyraclostrobin), for a range of agricultural uses; and Priaxor™ Xemium® brand fungicide (14.33%) fluxapyroxad and 28.58%) pyraclostrobin), for a range of agricultural uses. Human Health: The human health risk assessment concluded that the database for fluxapyroxad is adequate to support the registration of the subject fluxapyroxad products and that there is a reasonable certainty that no harm will result from dietary and occupational exposures to fluxapyroxad. There are no additional data needs associated with the subject uses for fluxapyroxad. Environmental Fate and Effects: There are no data gaps related to environmental fate effects. There are no acceptable chronic toxicity data for estuarine/marine fish or aquatic invertebrates. The data submitted were classified as invalid and/or supplemental based on meaningful guideline deviations and/or uncertainty regarding the study results. However, based on the maximum use rates, the potential for exposure to fluxapyroxad at a level that is likely to cause direct acute or chronic effects on aquatic organisms is considered low. Therefore, the Agency is not requesting additional data at this time because such data would be unlikely to impact the screening-level risk conclusions of the risk assessment. There is uncertainty regarding chronic effects on birds because a NOAEC was not established in the avian reproduction study with bob white quail. Effects on hatchling body weight, although transient, were observed at all treatment concentrations. However, given the flat concentration- response for this effect, an additional study would likely only provide confirmatory data and would be unlikely to change the screening level risk conclusions. Based on the conservative nature of the screening level risk assessment, and since it is unlikely that birds would forage exclusively on the treated area and for an extended period of time, the likelihood of actual chronic risk to birds is not expected to be above the levels of concern. Therefore, additional data are not being requested at this time. 9 ------- Potential risks to listed terrestrial plants are mitigated by the spray drift precautions on the products labels. These instructions are intended to keep the pesticide on the treatment area, thereby reducing the potential for non-target exposures. Specific information on the studies received, the nature of the adverse effects caused by fluxapyroxad, and the Agency's human health and environmental risk assessments can be found in the following documents at http:/'/www.regulations, gov in docket ID number EPA-HQ-OPP-2010-0421: - "Fluxapyroxad. Human Health Risk Assessment for Use of New Active Ingredient on Cereal Grains, Legume Vegetables (Succulent and Dry), Oil Seed Crops (Canola and Sunflower), Peanuts, Pome Fruit, Stone Fruit, Root and Tuber Vegetables (Potatoes and Sugar Beets), Fruiting Vegetables, and Cotton, " dated February 22, 2012. -"Environmental Fate and Ecological Risk Assessment for Foliar and Seed Treatment Uses of the New Fungicide Fluxapyroxad (BAS 7OOF)," dated March 5, 2012. CONTACT PERSON AT USEPA Olga Odiott Registration Division (7505P) Office of Chemical Safety and Pollution Prevention Environmental Protection Agency 1200 Pennsylvania Avenue NW Washington, D.C. 20460 E-mail: odiott.olga@epa.gov DISCLAIMER: The information in this Pesticide Fact Sheet is for information only and is not to be used to satisfy data requirements for pesticide registration. The information is believed to be accurate as of the date on the document. 10 ------- APPENDIX I - Summary of Physical and Chemical Properties I'ammck \ aluc Melting point/range 156.8 °C pH of 1% solution in water 5.S Density 1.47 Water solubility (20°C) 3.88 mg/L at pH 5.8 (not buffered) 3.78 mg/L at pH 4 3.44 mg/L at pH 7 3.84 mg/L atpH 9 Solvent solubility (g/L at 20°C) acetone acetonitrile dichloro methane ethylacetate methanol toluene n-octanol n-heptane >250 167.6 ±0.2 146.1 ±0.3 123.3 ±0.2 53.4 ±0.0 20.0 ±0.0 4.69 ±0.01 0.106 ±0.001 i.l x lO^Pa Vapor pressure at 25 °C Dissociation constant (pKa) 12. 58 (calculated) Octanol/water partition coefficient Log(K0w) 3.08 (deionized water) 3.09 at pH 4 3.13 atpH7 3.09 at pH 9 UV/visible absorption spectrum pH Xmax 8 1.4 199 35913 230 24137 290 1145 5.9 193 44100 230 24010 290 978 12.2 215 23227 229 23473 290 2405 s: molar absorption coefficient, [L mol"1 cm"1] 11 ------- APPENDIX II - Toxicity Data A. Acute Toxicity A. 1 Acute Toxicity Profile - Fluxapyroxad Guideline No. Study Type Results Toxicity Category 870.1100 Acute oral - rat (females) LD50 = >2000 mg/kg III 870.1200 Acute dermal - rat LD50 >2000 mg/kgM & F III 870.1300 Acute inhalation - rat LC50 >5.1 mg/LM&F IV 870.2400 Acute eye irritation - rabbit Slightly irritating IV 870.2500 Acute dermal irritation - rabbit Slightly irritating IV 870.2600 Dermal sensitization - guinea pig No sensitization - A.2 Acute Toxicity Profile - Fluxapyroxad Metabolites Guideline No. Study Type Results Toxicity Category 870.1100 Acute oral - rat (females) M-l LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) M-3 LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) M-25 LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) M-28 LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) 1-3 LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) 1-4 LD50 = >2000 mg/kg III 870.1100 Acute oral - rat (females) 1-5 LD50 = >2000 mg/kg III B. Subchronic, Chronic, Other Toxicity Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results 870.3050 28 day dietary in rats 47923564 (2009) Acceptable, guideline 0, 100, 500, 2000, 6000 ppm 0/0, 9/9.4, 43.7/47.8, 176/183, 530/531, mkd M/F Males NOAEL=100 ppm ( 9.0 mkd) LOAEL 500 ppm (176 mkd) based on thyroid follicular hypertrophy/hyperplasia and clinical chemistry changes Females NOAEL=500 ppm (47.8 mkd) LOAEL=2000 ppm (531 mkd) based on decreased prothrombin time and clinical chemistry changes Non-Guideline Thyroid hormone levels - 28 days-rat 47923594 (2009) Acceptable, non- guideline 0, 50, 250, 1500, 3000 ppm (0/0, 3.5/4.4, 19/20, 105/117, 214/237 mkd) Increased TSH, decreased T4 in males only at 3000 ppm only days 14 through 28. Accompanied by increased absolute and relative liver and thyroid weights. Supports hypothesis that an increased conjugation and elimination of circulating thyroxine (T4) leads to compensatory release of thyroid stimulating hormone (TSH) from the pituitary, secondary to BAS 700 F liver enzyme induction. Non-Guideline Perchlorate discharge study-28 days rat 47923595 (2009) Acceptable, non- guideline The similarities in the behavior of BAS 700 F to phenobarbitol in this perchlorate discharge assay support the hypothesis that BAS 700 F causes increases in thyroid hormones by an 12 ------- Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results 0, 3000 ppm 0/0, 283/247 mkd indirect mechanism Non-Guideline Enzyme induction 47923599 (20210) Acceptable, non- guideline 50 ppm Mechanistic investigations of enzyme induction (thyroid and liver). Non-Guideline Enzyme induction 47923593 (2010) Acceptable, non- guideline 0, 250, 1500, 3000 ppm 0/0, 16/19, 96/126, 192/234 mkd Mechanistic investigations of enzyme induction (thyroid and liver). Non-Guideline S-phase induction 1-3-7-14 days 47923598 (2010) Acceptable, non- guideline 0, 50, 250, 1500, 3000 ppm Mechanistic Investigations of hepatocellular proliferation. Non-Guideline S-phase induction 7-28-91 days 47923597 (2010) Acceptable, non- guideline 50 ppm only Mechanistic Investigations of hepatocellular proliferation. 870.3050 28 day dietary in mice 47923565 (2009) Acceptable, guideline 0, 500, 2500, 7000 ppm Males NOAEL=2500 ppm (552 mkd) LOAEL =7000 ppm (1452 mkd) based on hematological changes. 0/0, 112/150, 552/746, 1452/2100 mkd M/F Females NOAEL=7000 ppm (2100 mkd) LOAEL=Not observed No EPA guideline, OECD 407 -28 day dietary in dogs 47923566 (2009) Acceptable/non-EPA guideline 0, 2500, 7500, 20000 ppm 0/0, 74/85,211/230, 521/503 mkd M/F NOAEL=2500 ppm (74/85 mkd M/F) LOAEL-=7500 ppm (211/230 mkd M/F) based on vomiting (M/F) and clinical chemistry changes 870.3100 90-day dietary in mice 47923568 (2009) Acceptable/guideline 0, 100, 400, 2000, 6000 ppm Males NOAEL=2000 ppm (390 mkd) LOAEL 6000 ppm (1136 mkd) based on decreased body weight and body weight gain and multifocal necrosis in the liver 0/0,21/32, 77/128, 390/610, and 1136/1657 mkd (M/F) Females NOAEL=6000 ppm (1657 mkd) LOAEL=Not observed. 13 ------- Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results 870.3100 90-Day dietary in rats 47923567 (2009) Acceptable, guideline NOAEL = 500 ppm (31.2 mkd) males; 100 ppm (7.3 mkd) females 0, 100, 500, 2000, 6000 ppm 0/0,6.1/7.3,31.2/35.1, 126/144, and 407/424 mkd (M/F) LOAEL = 2000 ppm (126 mkd) males; 500 ppm (35.1 mkd females) based on changes in thyroid hormone levels and thyroid follicular hypertrophy/hyperplasia 870.3150 90-Day Oral Toxicity Feeding-dog 47923569 (2009) Acceptable/guideline 0, 300, 1500, 10000/7500 (M/F) 0/0, 9/10, 45/51, 295/238 mkd M/F NOAEL= 1500 ppm (45/51 mkd M/F) LOAEL=10000 ppm (295 mkd) males, 7500 ppm (238 mkd) females based on vomiting and clinical chemistry changes 870.3200 28-Day Dermal Toxicity-rat 47923571(2009) Acceptable, guideline 0, 100, 300, 1000 mkd NOAEL=1000 mkd LOAEL=not observed 870.3465 90-Day Inhalation Still required, data gap 870.3700a Prenatal Developmental- rat 47923603 (2009) Acceptable, guideline 0, 25, 200 and 1000 mkd (gavage in CMC) Maternal NOAEL=200 mkd LOAEL =1000 mkd based on increased absolute and relative thyroid weights and thyroid hypertrophy/hyperplasia Offspring NOAEL=1000 mkd LOAEL =Not observed 870.3700b Prenatal Developmental- rabbit 47923604 (2009) Acceptable, guideline 0, 10, 25 and 60 mkd Maternal NOAEL=25 mkd LOAEL =60 mkd based on decreased body weight Offspring NOAEL=25 mkd LOAEL =60 mkd based on decreased fetal body weights and increased incidence of paw hyperflexion 870.3800 Reproduction and Fertility Effects-rat 47923602 (2009) Acceptable, guideline 0, 10, 50 and 300 mkd Parental NOAEL=10 mkd LOAEL =50 mkd based on thyroid follicular hypertrophy/hyperplasia Fertility/Reproductive Performance NOAEL=300 mkd LOAEL =Not observed. Offspring NOAEL=10 mkd LOAEL =50 mkd decreased pup body weight/body weight development 870.4100 Chronic Toxicity-dog 47923570 (2009) Acceptable/guideline Females NOAEL=300 ppm( 9 mkd) LOAEL =1500 ppm (43 mkd) based on hepatic fibrosis and 14 ------- Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results 0, 300, 1500, 12000/9000 ppm(M/F) 0/0, 8/9, 39/43, 335/257 mkdM/F clinical chemistry changes Males NOAEL=1500 ppm( 39mkd) LOAEL=12000 ppm (335 mkd) based on vomiting, heptaic fibrosis and cirrhosis, and clinical chemistry changes (liver enzyme elevation) 870.4300 Chronic toxicity/carcinogenicity in rats 47923591 (2009) Acceptable, guideline 0, 50, 250, 1500, 3000 ppm Chronic toxicity NOAEL=50 ppm (2.1/2.7 mkd in males/females) LOAEL =250 ppm (11/1 mkd) based on neoplastic changes in the liver (foci, masses). 0/0,2.1/2.7, 11/14, 68/82, 145/182 mkd (M/F) Carcinogenicity-see CARC report Classified as" not likely to be carcinogenic to humans" at doses below those that cause liver enzyme induction in rats. 870.4300 Chronic toxicity/carcinogenicity in mice 47923592 (2009) Acceptable, guideline 0, 150, 750, 3000, 6000 ppm 0/0, 21/33, 107/158, 468/652, 996/1307 mkd (M/F) Chronic toxicity NOAEL=750ppm (158/107 mkd M/F) LOAEL =3000 ppm (468/652) mkd M/F based on decrease body weight. Carcinogenicity NOAEL=6000 ppm (996/1307 mkd M/F) LOAEL =Not observed Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923572 (2008) Acceptable, guideline 0, 20, 100, 500, 2500, 5000 ng/plate ±S9 Not mutagenic in the reverse mutation assay in Salmonella typhimurium or Escherichia coli with or without metabolic activation. Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923579 (2007) Acceptable, guideline 0-100 ng/ml ±S9 Does not induce forward mutations in CHO cells with or without metabolic activation. Cytogenetics 870.5375 In vitro Mammalian Cytogenetics Chromosomal Aberration Assay- human peripheral blood lymphocytes 47923577 (2008) Acceptable, guideline 0-400 ng/ml ±S9 Does not cause clastogenic effects in V79 cells with or without metabolic activation. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923584 (2006) Acceptable, guideline 0, 500, 1000, 2000 mkd Did not lead to any increase in polychromatic erythrocytes. 870.6200a Acute Neurotoxicity-rat 47923605 (2009) Acceptable, guideline 0, 125, 500, 2000 mkd NOAEL (neurotoxicity) =125 mk LOAEL (neurotoxicity)=500 mk based on decreased motor activity (both sexes) and decreased rearing (males only). 15 ------- Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results 870.6200b Subchronic Neurotoxicity-rat 47923606 (2009) Acceptable, guideline 0, 200, 100, and 5000 ppm 0, 11.5/13.4, 57.7/67.2, 302.2/337.7 mkdM/F NOAEL (neurotoxicity)=5000 ppm(302/338 mkdM/F) LOAEL (neurotoxicity) =Not observed 870.7485 Metabolism and Pharmacokinetics-rat 47923555 (2009) 47923556 (2009) The times to maximum plasma levels (TMax) were 24 hours (500 mg/kg bw), 8 hours (50 mg/kg bw), and 1 hour (5 mg/kg bw) in both sexes. No sex differences in the rate or extent of absorption was observed. AUCs scaled with dose, indicating that absorption was not saturated. Radioactivity was widely distributed in both sexes with a similar pattern: the highest concentrations were found in the gut contents and stomach contents. However, lower concentrations were found in numerous other organs/tissues, including the liver, thyroid, adrenal glands, kidney, pancreas, testes/uterus, and brain. For males and females, radioactivity declined in all tissues over time. The time course of the amount of radioactivity found in urine and feces indicated the excretion occurred predominantly within three days after dosing. Bile duct cannulation experiments showed that the bile was a major route of excretion. The main biotransformation steps of BAS 700 F in rats are hydroxylation at the biphenyl ring system, N-demethylation at the pyrazole ring system, loss of a fluorine atom at the biphenyl ring system, and conjugation with glucuronic acid or with glutathione derivatives. A further, but negligible transformation route is cleavage at the amide bond between the pyrazole ring system and the biphenyl ring system 870.7600 Dermal penetration 47923632 (2010) Acceptable, guideline 5.6, 33,4, 1670 ng/cm2 for 8 h exposure and 24 and 120 h termination *In a formulation with pyraclostrobin (BAS 500 F) The dermal absorption factor is 8.38%. 870.7800 Immunotoxicity-mice (male) 47923633 (2009) Acceptable, guideline 0, 500, 2000 and 6000 ppm 0, 106, 450 and 1323 mg/kg/d Not immunotoxic. Non-guideline 47923598 (2009) Cell proliferation in both sexes was dose-dependent at 16 ------- Table B.l Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Fluxapyroxad (BAS 700F) Guideline No Study Type MRID/Classification Doses Results S-phase Response Liver 1, 3, 7, 14 days-rat 0, 50, 250, 1500 and 3000 ppm maximal at Day 7 (males) and Days 7& 14 (females). Non-guideline S-phase Response Liver 7, 28, 91 days-rat 47923596 (2009) 0, 50 ppm (nominal)- Acceptable, non- guideline 47923596 (2009) Acceptable, non- guideline 0. 250, 1500, 3000 ppm (nominal) Cell proliferation in males was maximal at Day 7 and was nearly absent by Day 28. Cell proliferation in females was maximal at Day 7 declined Days 28 and 91, but was still above controls in higher dose groups. All effects were dose- dependent. Reversibility investigated at 28 days treat/28 days recovery. Non-guideline Enzyme induction (Phase I and Phase II) with Thyroid Hormone Levels-14 days 47923593 (2009) Acceptable, non- guideline 0, 250, 1500, 3000 ppm 1/1, 16/19, 96/126, 192/234 mkd Dose-dependent increase in Phase I and Phase II enzymes in both sexes and increased liver and thyroid weights with correlating histopathology. Effects partially (thyroid histopathology) to totally (all other effects) reversible in 4 week recovery group. Non-OPPTS guideline, OECD 486 47923589 (2009) Acceptable, non- guideline 0,1000,2000 mkd Does not induce unscheduled DNA synthesis. Table B.2 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F001 Guideline No Study Type mrii) Classification Doses Results 870.3100 90-Day dietary in rats 47923608 (2009) Acceptable, -guideline 0/0, 94.6/98.8, 285.7/295.1, 953.6/983.1 mkdM/F NO AEL=953.6/983.1 mkdinM/F LOAEL=Not observed 870.3700b Prenatal Developmental- rabbit 47923613 (2009) Acceptable, guideline 0, 40, 100, and 250 mkd Maternal NOAEL=250 mkd LOAEL =Not observed. Offspring NOAEL=250 mkd LOAEL =Not observed Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923609 (2009) Acceptable, guideline Not mutagenic. Gene Mutation 870.5300 In vitro Mammalian 47923611 (2009) Acceptable, guideline Not mutagenic. 17 ------- Table B.2 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F001 Guideline No Study Type mrii) Classification Doses Results Cells Gene Mutation (Chinese Hamster Ovary Cells) Cytogenetics 870.5375 In vitro Mammalian Cytogenetics Chromosomal Aberration Assay- human peripheral blood lymphocytes 47923610 (2009) Acceptable, guideline Not clastogenic. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923612 (2009) Acceptable, guideline O, 500, 1000, 2000 mkd Did not lead to any increase in polychromatic erythrocytes. Table B.3 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F002 Guideline No Study Type MRII) Classification Doses Results 870.3050 28 day dietary in rats 47923615 (2009) Acceptable, guideline 0/0, 113/113.4, 275.9/394.8, 1164.8/1253.3 mkd NOAEL= 1164.8/1253.3mkd in M/F LOAEL=Not observed 870.3100 90-Day dietary in rats 47923616 (2009) Acceptable, -guideline 0/0, 113/113.4, 275.9/394.8, 1164.8/1253.3 mkd 0/0, 95.1/98.0, 285.3/299.5, 958.4/928.7 mkdM/F NOAEL=958.4/928.7 mkgM/F LOAEL=not observed 870.3700b Prenatal Developmental- rabbit 47923622 (2000) Acceptable, -guideline 0, 100, 300, 1000 mkd Maternal NOAEL=300 mkd LOAEL =1000 mkd based on increased mortality and abortions. Offspring NOAEL=1000 mkd LOAEL =Not observed Gene Mutation 870.5100 In vitro Bacterial Gene 47923617 (2007) Acceptable, guideline Not mutagenic. 18 ------- Table B.3 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F002 Guideline No Study Type mrii) Classification Doses Results Mutation Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923619 (2008) Acceptable, -guideline Not mutagenic. Cytogenetics 870.5375 In vitro Mammalian Cytogenetics Chromosomal Aberration Assay- human peripheral blood lymphocytes 47923618 (2008) Acceptable, -guideline Not clastogenic. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923620 (2009) Acceptable, guideline O, 375,750,1500 mkd Did not lead to any increase in polychromatic erythrocytes. Non-OPPTS guideline, OECD417 47923621(2009) Acceptable, non- guideline 1000 mkd, oral (gavage) M700F002 is systemically bioavailable and its presence in the bone marrow and blood after an oral application is confirmed. Table B.4 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F048 Guideline No Study Type MRII) Classification Doses Results 870.3050 28 day dietary in rats 47923624 (2009) Acceptable, guideline\ 0, 50, 200, 1000 mkd (nominal) 0/0, 47.1/51.4, 189.3/208.2, not calculable/1477.8 M/F NOAEL=47.1/51.4 mkd in males, 1477.8 mkd females. LOAEL= 189.3 in mkd males based on decreased absolute and realtive monocyte counts. The LOAEL was not observed in females. 870.3700b Prenatal Developmental- rabbit 47923631 (2009) Acceptable, guideline 0, 10, 30 and 100 mg/kg bw/d Maternal NOAEL=30 mkd LOAEL = 100 mkd based on mortality, abortions, and resorptions Offspring NOAEL=30 mkd LOAEL =100 mkd based on incresed aborptions and late 19 ------- Table B.4 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Metabolite M700F048 Guideline No Study Type mrii) Classification Doses Results resorptions. Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923625 (2009) Acceptable, guideline Not mutagenic. Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923627(2009) Acceptable, guideline Not mutagenic. Cytogenetics 870.5375 In vitro Mammalian Cytogenetics Chromosomal Aberration Assay- human peripheral blood lymphocytes 47923626 (2009) Acceptable, guideline Clastogenic with metabolic activation. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923628 (2009) Acceptable, guideline 0, 500, 1000, 2000 mkd Did not lead to any increase in polychromatic erythrocytes. 870.7485 Metabolism and Pharmacokinetics-rat 47923557 (2009) Acceptable, guideline In both sexes, the major route of excretion was the feces (85.47% in males and 86.4% in females) with maximum excretion within 12-24 hours after dosing. The minor route of excretion was in the urine (2.4% in males and 6.8% in females). Non-OPPTS guideline, OECD417 47923630 (2009) Acceptable, non- guideline 1000 mkd, oral (gavage) M700F048 is 5077265 is systemically bioavailable and its presence in the bone marrow, blood and liver after an oral application is confirmed. Non-OPPTS guideline, OECD 486 47923629 (2009) Acceptable, non- guideline 0,1000,2000 mkd Does not induce unscheduled DNA synthesis. Table B.5 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Artificial Batch Guideline No Study Type MRII) Classification Doses Results Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923573 (2009) Acceptable, guideline No evidence of mutagenicity. 20 ------- Table B.5 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Artificial Batch Guideline No Study Type MRU) Classification Doses Results Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923580 (2009) Acceptable, guideline No evidence of forward mutations. Cytogenetics 870.5375 In vitro Mammalian Cytogenetics Chromosomal Aberration Assay- human peripheral blood lymphocytes 47923578 (2009) Acceptable, guideline Clastogenic in V79 cells in the presence or absence of metabolic activation. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47023585 (2009) Acceptable, guideline 0, 500, 1000, 2000 mkd Did not lead to any increase in polychromatic erythrocytes Non-OPPTS guideline, OECD 486 47923590 (2009) Acceptable, non- guideline 0, 2.5, 5 mkd Does not induce unscheduled DNA synthesis. Table B.6 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Impurity B Guideline No Study Type MRU) Classification Doses Results Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923574 (2009) Acceptable, guideline Not mutagenic. Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923581 (2009) Acceptable, guideline Not mutagenic. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923586 (2009) Acceptable, guideline 0, 15, 30, 60 mkd Did not lead to any increase in polychromatic erythrocytes. Table B.7 Subchronic, Chronic and Other Toxicity Profile Toxicity Profile for Impurity C 21 ------- Guideline No Study Type mrii) Classification Doses Results Gene Mutation 870.5100 In vitro Bacterial Gene Mutation 47923576 (2008) Acceptable, guideline Not mutagenic. Gene Mutation 870.5300 In vitro Mammalian Cells Gene Mutation (Chinese Hamster Ovary Cells) 47923583 (2008) Acceptable, guideline Not mutagenic. Cytogenetics-other 870.5395 In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus-mouse 47923588 (2008) Acceptable, guideline 0, 500, 1000, 2000 mkd Did not lead to any increase in polychromatic erythrocytes. 22 ------- APPENDIX III - Data Base Supporting Fluxapyroxad MRID Citation BASF Corporation (2010) Submission of Product Chemistry. Efficacy. Toxicity and 47923500 j Residue Data in Support of the Application for Registration of Xemium Fungicide 1 Technical. Transmittal of 99 of 280 Studies. O'Bvrnc. D. (2010) BAS 700 F: Applicant Information. Project Number: 2010/7003 734/OCR. Unpublished study prepared by BASF Corporation. 10 p. I Koradin, C.; Mayer, K. (2009) Product Identity and Composition of BAS 700 F. Project | 47923502 j Number: 2009/1079882/OCR. Unpublished study prepared by BASF Aktiengesellschaft. 105 p. Doct/cr. R.: Dcppcrmann. N. (2009) Confirmation of Identity of Minor Components in 47923503 Technical-Grade BAS 700 F. Project Number: 2009/1091108/OCR. Unpublished study prepared by BASF Aktiengesellschaft. 47 p. I j Bentz, A. (2009) Chemical Analysis of Five Batches BAS 700 F Technical Grade Active [ 47923504 j Ingredient. Project Number: 2009/1049717/OCR, 275605/1/OCR. Unpublished study prepared by BASF Aktiengesellschaft. 133 p. Krochl. T. (2006) Physical Properties: Pure Active Ingredient. Project Number: 47923505 2006/1036276/OCR. 267469/1/OCR. Unpublished study prcparcd by BASF Aktiengesellschaft. 20 p. I j Kroelil, T. (2008) Physical and Chemical Properties of BAS 700 F TC: Accelerated Storage | 47923506 j Stability up to 2 Weeks at 54 Degrees Celsius. Project Number: 2008/1014896/OCR, 275716/1/OCR. Unpublished study prcparcd by BASF Aktiengesellschaft. 21 p. ,7()9-, _Brcm. G. (2008) Henry's Law Constant for BAS 700 F: Supplement. Project Number: 2008/1070047/OCR. Unpublished study prcparcd by BASF AkticngcscHschafl. 4 p. Krochl. T. (2008) Spectra (UV-VIS. NMR. IR. MS) of BAS 700 F PAI. Project Number: 47923508 2008/1066533/OCR. 267490/1/OCR. Unpublished study prcparcd by BASF Aktiengesellschaft. 22 p. i Wilfmgcr, W. (2008) Water Solubility of BAS 700 F at 20 Degrees Celsius. Project | 47923509 j Number: 2007/1056999/OCR, 267487/1EXT/OCR, 20071489/01/PCSB. Unpublished study prcparcd by Eurofins-GAB GmbH. 53 p. Wilfingcr. W. (2008) Solubility of BAS 700 F in Organic Solvents. Project Number: 47923510 2007/1057003/OCR. 20071490/01/PSBO/OCR. 267472/1 EXT. Unpublished study prcparcd bv Eurofins-GAB GmbH. 55 p. I Wilfingcr, W. (2008) Partition Coefficient of BAS 700 F (HPLC Method). Project Number: | 47923511 | 2007/1057001/OCR, 20071489/01/PCPC/OCR, 267475/1EXT. Unpublished study prepared by Eurofins - GAB GmbH. 42 p. Hassink. J. (2009) BAS 700 F: Aqueous Hydrolysis at Four Different pH Values. Project | 47923512 j Number: 2009/1049061/OCR, 324301/OCR. Unpublished study prepared by BASF | | Aktiengesellschaft. 17 p. 1 47923513 1 Hassink. J. (2009) Aqueous Photolysis of BAS 700 F. Project Number: 2009/1031228/OCR. 23 ------- 314718/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 26 p. Wilfingcr. W. (2008) Dissociation Constant ofBAS 700 F in Water. Project Number: | 47923514 | 2007/1057000/OCR, 267478/1EXT/OCR, 20071489/01/PCDC. Unpublished study prepared 1 by Eurofins - GAB GmbH. 30 p. Hassink. J. (2009) Photochemical Oxidative Degradation ofBAS 700 F (QSAR Estimates). 47923515 Project Number: 2009/1070299/OCR. 314737/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 11 p. Lochr. S. (2008) Evaluation of Physical and Chemical Properties According to Directive | 47923516 j 94/37/EC (67/548/EC Annex V). Project Number: 2008/1070100/OCR, 1 S1K/NR//08/2251/OCR. Unpublished study prepared by BASF Akticngcscllschaft. 17 p. Yacoub. R. (2010) BAS 700 F (TGAI): Determination of Oxidation/Reduction: Final 47923517 Report. Project Number: 2010/7003376/OCR. 375474/20/OCR. Unpublished study prepared bv BASF Agricultural Research Center. 13 p. Krochl, T. (2010) BAS 700 F (TC/TGAI): Storage Stability and Corrosion Characteristics in | | Commercial Type Containers when Stored for up to 2 Weeks at 54 Degrees Celsius: (Final 1 Report). Project Number: 2010/1007161/OCR. 275719/2/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 15 p. 47923519 ^cnl/" (2009) BAS 700 F TGAI: Storage Stability. Project Number: 2009/1075862/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 8 p. , Krochl, T. (2008) UV/VIS Spectra of Metabolite M700F001 ofBAS 700 F. Project j 47923520 | Number: 2008/1037028/OCR, 350095/1/OCR. Unpublished study prepared by BASF ' Aklicngcscllschafl. 14 p. Wilfingcr. W. (2008) Water Solubility of Metabolite M700F001 ofBAS 700 F at 20 47923521 Degrees Celsius. Project Number: 2008/1084086/OCR. S08/02531/L1/PCSB/OCR. 350092/1 EXT. Unpublished study prepared by Eurofins - GAB GmbH. 47 p. , Wilfingcr, W. (2008) Partition Coefficient of Metabolite M700F001 of BAS 700 F (HPLC | 47923522 | Method). Project Number: 2008/1090847/OCR, 350094/1EXI70CR, S08/03171. Unpublished study prepared by Eurofins - GAB GmbH. 42 p. Wilfingcr. W. (2008) Dissociation Constant of Metabolite M700F001 ofBAS 700 F in 47923523 Walcr.Vrojcct Number: 2008/1090848/OCR. S08/03172/L1/PCDC/OCR. S08/03172. Unpublished study prepared by Eurofins - GAB GmbH. 30 p. , ( Krochl, T. (2008) UV/VIS Spectra of Metabolite M700F002 of BAS 700 F. Project | 47923524 J Number: 2008/1037029/OCR, 350096/1/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 14 p. Wilfingcr. W. (2008) Water Solubility of Metabolite M700F002 ofBAS 700 F at 20 47923525 Degrees Celsius. Project Number: 20()8/1084088/OCR. S08/02532/L1/PCSB/OCR. S08/02532. Unpublished study prepared by Eurofins - GAB GmbH. 47 p. , Wilfingcr, W. (2008) Partition Coefficient of Metabolite M700F002 of BAS 700 F (HPLC j 47923526 j Method). Project Number: 2008/1090849/OCR, 311302/1EXI7OCR, S08/03173/L1/PCPC. Unpublished study prepared by Eurofins - GAB GmbH. 42 p. Wilfingcr. W. (2008) Dissociation Constant of Metabolite M700F002 ofBAS 700 F in 47923527 Watcr.Vrojccl Number: 2008/1090850/OCR. 311301/1 EXT/OCR. S08/03174. Unpublished study prepared by Eurofins - GAB GmbH. 30 p. 47923528 Eulcr. K. (2009) Water Solubility of Metabolite M700F007 ofBAS 700 F at 20 Degrees 24 ------- Celsius. Project Number: 2009/1099046/OCR. 09L00156/OCR. Unpublished study prepared by BASF SE. GKA Competence Center Analytics. 30 p. Eulcr. K. (2009) Partition Coefficient of Metabolite M700F007 ofBAS 700 F (HPLC- 47923529 Method). Project Number: 2009/1099047/OCR. 09L00157/OCR. Unpublished study prepared by BASF SE. GKA Competence Center Analytics. 19 p. , Kacppcl, N. (2009) Dissociation Constant of Metabolite M700F007 of BAS 700 F in Water. [ 47923530 | Project Number: 2009/1099048/OCR, 09L00158/OCR. Unpublished study prepared by BASF SE. GKA Competence Center Analytics. 18 p. Strathmann. S. (2009) Fungicidal Efficacy ofBAS 700 F Metabolites: M700F001. 47923531 M700F002. M700F007. Project Number: 2009/1108856/OCR. Unpublished study prepared bv BASF Aklicngcscllschafl. 14 p. , Anonymous (2010) Safety Data Sheet: XcmiumFungicide Technical. Project Number: | 47923532 | 2010/7003318/OCR, VERSION/1/O/OCR. Unpublished study prepared by BASF Corporation. 11 p. Anonymous (2009) Safety Data Sheet: BAS 700 F Tcchn. Project Number: 47923533 2009/1106724/OCR. VERSION/l/l/OCR. Unpublished study prcparcd by BASF Akticngcscllschafl. 13 p. i Voclkcr, E. (2008) Possible Procedures for the Decontamination of Water fromB AS 700 F. | 47923534 | Project Number: 2008/1044643/OCR, 080717/BAS/700/F/OCR. Unpublished study prcparcd by BASF Akticngcscllschafl. 6 p. Dcmirci. F. (2006) Determination of the Active Ingredient in BAS 700 F TGAI by RP- [ 47923535 j HPLC. Project Number: 2006/1034133/OCR, 264256/1. Unpublished study prepared by BASF Akticngcscllschafl. 10 p. | | Demirci, F. (2006) Validation of HPLC Method APL0530/01; Determination of the Active j 47923536 j Ingredient in BAS 700 F TGAI by RP-HPLC. Project Number: 2006/1034134/OCR, 264256/1/OCR. Unpublished study prcparcd by BASF Akticngcscllschafl. 14 p. Bent/.. A. (2009) Analytical Method APL0557/02: Determination of the Impurities in BAS 47923537 700 F TGAI (Technical Grade Active Ingredient). Project Number: 2009/1071710/OCR. APL0557/02. Unpublished study prcparcd by BASF Akticngcscllschafl. 71 p. 1 [ Benlz, A. (2009) Validation of Analytical Method APL0557/01: Determination of | | Impurities in BAS 700 F Technical Grade Active Ingredient (TGAI) (Including Amendment | | no. 1). Project Number: 2009/7006438/OCR, 264256/2/OCR. Unpublished study prepared ' 1 by BASF Akticngcscllschaft. 88 p. Bent/.. A. (2009) Supplement of the Development and Validation of the Analytical Method , , APL0557/02 with the Title: Determination of Impurities in BAS 700 F Technical Grade | | Active Ingredient (TGAI). Project Number: 2009/1049716/OCR, 264256/5/OCR. Unpublished study prcparcd by BASF Akticngcscllschafl. 20 p. Bent/.. A.: Sicbcckcr. M. (2009) Determination of Toluene in BAS 700 F TGAI and 47923540 Formulation by GC/MS Hcadspacc. Project Number: 2009/1116594/OCR. APL0594/01. Unpublished study prcparcd by BASF Akticngcscllschafl. 28 p. , Bcnla, A.; Sicbcckcr, M. (2010) Validation of Analytical Method APL0594/01: 4799^41 ! Determination of Toluene in BAS 700 F TGAI and Formulation by GC/MS Headspace. Project Number: 2009/1116595/OCR, 264256/6/OCR. Unpublished study prepared by BASF Aktiengesellschaft. 31 p. 47923542 Hopf, B.; Mackenroth, C. (2009) Validation of BASF Method No. 535/3 (L0076/03) for 25 ------- BAS 700 F in Plant Matrices. Project Number: 2009/1074615/OCR. 315766/OCR. Unpublished study prepared by BASF Aklicngcscllscha.fi. 109 p. Lchmann. A.: Mackenroth. C. (2009) Validation of BASF Method No. L0137/01 in Plant 47923543 Matrices. Project Number: 2009/1074617/OCR. 324238/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 237 p. , Class, T.; Jooss, S. (2009) BAS 700 F: Independent Laboratory Validation (1LV) of BASF j Method Number L0137/01 and L0140/02 for the Determination of BAS 700 F in Plant Materials and Animal Matrices by LC/MS/MS. Project Number: 2009/1074618/OCR, P/B/1766/G/OCR, 315767/1. Unpublished study prepared by PTRL Europe Gmbh. 77 p. | Class, T.; Jooss, S. (2009) M700F002 (Metabolite of BAS 700 F): Independent Laboratory | i Validation (ILV) of BASF Method Numbers L0137/01 and L0140/02 for the Determination 1 47923545 | of M700F002 inPlant Material and Animal Matrices by LC/MS/MS. Project Number: 1 2009/1074614/OCR. 315767/2/OCR. P/B/1767/G/OCR. Unpublished study prepared by PTRL Europe Gmbh. 76 p. , ( Class, T.; Jooss, S. (2009) M700F008 (Metabolite of BAS 700 F): Independent Laboratory | j Validation (ILV) of B ASF Method Number L013 7/01 and L0140/02 for the Determination | 47923546 j of M700F008 inPlant Material and Animal Matrices by LC/MS/MS. Project Number: I 1 2009/1091115/OCR. P/B/1832/G/OCR. 315764/3/OCR. Unpublished study prepared by PTRL Europe Gmbh. 77 p. Hopf, B.; Mackenroth, C. (2009) Validation of the Analytical Method L0140/02: Method 1 j for the Determination of BAS 700 F and its Metabolites M700F002, M700F008 and 4 /9zJj4 / i M700F048 jn Anim.,i Matrices. Project Number: 2009/1074613/OCR. 315793/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. 110 p. i Macdougall, J. (2009) Independent Laboratory Validation of Analytical Method No. | j L0140/01 for the Determination of BAS 700 F, M700F048, M700F008 and M700F002 in 1 47923548 j Egg, Bovine Milk, Liver and Muscle by HPLC-MS/MS. Project Number: 1 2009/1074797/OCR. 30301/OCR. 215157/OCR. Unpublished study prepared by Charles River Laboratories . 358 p. , Pcrc/, R.; Tarkalanov, N.; Pcrc/, S. (2009) Evaluation of BAS 700 F and Metabolites FDA | 47923549 | Multiresidue Method (MRM) Testing. Project Number: 2009/7006274/OCR, 319741/OCR, 1 ADPEN/2K9/0707BAS. Unpublished study prepared bv ADPEN Laboratories. Inc. 124 p. Pcrc/.. S.: Pcrc/.. R. (2009) Independent Laboratory Validation of BASF Analytical Method i ( D0903: Determination of BAS 700 F and its Metabolites, M700F001 and M700F002 in Soil I | atLOQ 0.001 mg/kg. Project Number: 2009/7003274/OCR, 374091, ADPEN/2K9/903/374091. Unpublished study prepared by ADPEN Laboratories. Inc. 83 p. Saha. M. (2010) Method Validation of BASF Analytical Method D0903: Determination of 1 | Residues of BAS 700 F and its Metabolites, M700F01 and M700F002 in Soil at LOQ 0.001 1 | mg/kg: Amended Final Report. Project Number: 2010/7003181/OCR, 369563/OCR. Unpublished study prepared by BASF Agro Research. 74 p. Zangmcistcr. W. (2009) Validation of Analytical Method L0092: Determination of the | j Active Ingredient and its Metabolites in Soil by HPLC/MS-MS. Project Number: ' i 2008/1063799/OCR. 266245/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. 128 p. , Zangmcistcr, W. (2009) Validation of Analytical Method L0143/01: Determination of BAS j 47g9^„ | 700 F and its Metabolites M700F001, M700F002 and M700F007 in Water by HPLC/MS- MS. Project Number: 2009/1069396/OCR. 314720/OCR. Unpublished study prepared by BASF Aklicngcscllscha.fi. 85 p. 26 ------- Zangmcislcr. W. (2009) Validation of BASF Method L0142/01: Determination of B AS 700 47923554 F in Air. Project Number: 2009/1069395/OCR. 314739/OCR. Unpublished study prepared bv BASF Aklicngcscllschaft. 68 p. Fabian, E.; Landsiedel, R. (2009) Carbon 14-BAS 700 F: Study on the Biokinelics in Rats. 47923555 Project Number: 2009/1074879/OCR, 02B0759/066004/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 104 p. Schopfcr. C: Labib. S. (2009) The Metabolism of Carbon 14-BAS 700 F in Wistar Rats. 47923556 Project Number: 2009/1019789/OCR, 267316/OCR. Unpublished study prepared by BASF Aktiengesellschaft. 467 p. Griesser, M. (2009) Excretion and Metabolism of Carbon 14-M700F048 After Oral 47923557 Administration in Rats. Project Number: 2009/1074686/OCR, 366577/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. 89 p. Sire. G. (2008) BAS 700 F: Acute Oral Toxicity in Rats: Acute Toxic Class Method. Project 47923558 (Number: 2008/1002441/OCR, 10A0683/059045/OCR, 34746/TAR. Unpublished study • prepared by Centre International de Toxicologic. 29 p. Sire. G. (2008) BAS 700 F: Acute Dermal Toxicity in Rats. Project Number: 47923559 2008/1002442/OCR. 11A0683/059048/OCR. 34747/TAR. Unpublished study prepared by Centre International dc Toxicologic. 30 p. Ma-Hock. L.: Landsiedel. R. (2008) BAS 700 F: Acute Inhalation Toxicity Study in Wistar 47923560 ^ ^als: ^ Hour Dust Exposure. Project Number: 2008/1074154/OCR, 13I0683/057032/OCR. ' Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 35 p. , Rcmmclc, M.; Hcllwig, J. (2008) LS 5094351: Acute Dermal Irritation/Corrosion in Rabbits j (Including Amendment No. 1). Project Number: 2008/7020134/OCR, ' 18H0683/052209/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 28 p. I Bauer, B.; Landsiedel, R. (2008) BAS 700 F: Acute Eye Irritation in Rabbits. Project 47923562 | Number: 2008/1014225/OCR, 11H0683/052354/OCR. Unpublished study prepared by BASF Aklicngcscllscha.fi. Experimental Toxicology and Ecology. 25 p. Gamer. A.: Landsiedel. R. (2008) BAS 700 F: Maximization Test in Guinea Pigs. Project 47923563 Number: 2008/1014226/OCR. 30H0683/052352/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 41 p. j Kamp, H.; Fabian, E.; Strauss, V.; et al. (2009) BAS 700 F: Repeated Dose Toxicity Study | in Wistar Rats: Administration in the Diet for 4 Weeks (Including Amendment no. 1). | Project Number: 2009/7006273/OCR, 30C0683/05060/OCR. Unpublished study prepared 1 by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 356 p. Kamp. H.: Strauss. V.: Groclcrs. S.: cl al. (2009) BAS 700 F: Repealed Dose Toxicity Study , in C57BL/6 J Rj Mice: Administration in the Diet for 4 Weeks. Project Number: | 2007/1005068/OCR, 31C0683/05067/OCR. Unpublished study prepared by BASF Aklicngcscllscha.fi. Experimental Toxicology and Ecology. 198 p. Hcmpcl. K.: Strauss. V.: Grolcrs. S.: cl al. (2009) BAS 700 F: Repealed Dose 28-Day Oral j Toxicity Study in Beagle Dogs: Administration in the Diet. Project Number: 1 2007/1052660/OCR, 30D0683/05077/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 284 p. 47923567 Strauss. V.: Groclcr. S.: cl al. (2009) BAS 700 F: Repealed Dose 90-Day Oral Toxicity Study in Wistar Rats: Administration in the Diet. Project Number: 27 ------- 2007/1005069/OCR. 50C0683/05I 164/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 448 p. Kamp. H.: Strauss. V.: Groelers. S.: el al. (2009) BAS 700 F: Repealed Dose 90-Day Oral I 47090^0 ( Toxicity Study in C57BL/6 J Rj Mice Administration in the Diet. Project Number: I 1 2007/1018641/OCR, 51C0683/05070/OCR. Unpublished study prepared by BASF Akticngcscllscha.fi. Experimental Toxicology and Ecology. 292 p. Hcmpcl. K.: Strauss. V.: Grotcrs. S.: cl al. (2009) BAS 700 F: Repeated Dose 90-Day Oral 1 I Toxicity Study in Beagle Dogs: Administration in the Diet. Project Number: 1 | 2008/1013661/OCR. 31D0683/05084/OCR. Unpublished study prepared by B ASF Aklicngcscllscha.fi. Experimental Toxicology and Ecology. 357 p. Hcmpcl. K.; Strauss. V.; Groelers. S.; cl al. (2009) BAS 700 F: Chronic Toxicity Study in | j Beagle Dogs: Administration in the Diet for 12 Months. Project Number: 1 1 2008/1090458/OCR. 33D0683/05088/OCR. Unpublished study prepared by BASF Aklicngcscllscha.fi. Experimental Toxicology and Ecology. 563 p. , ( Kaspcrs, U.; Strauss, V.; Moreno, M.; ct al. (2009) BAS 700 F: Repeated Dose 28-Day | j Dermal Toxicity Study in Wistar Rats. Project Number: 2009/1072489/OCR, | | 33S0683/05104/OCR, 311316. Unpublished study prepared by BASF Aktiengesellschaft, 1 1 Experimental Toxicology and Ecology. 323 p. Schulz. M.: Landsicdcl. R. (2008) BAS 700 F: Salmonella lyphimurium/Eschcrichia coli ¦ 7()9^ Reverse Mutation Assay (Standard Plate Test and Preincubation Test). Project Number: I 4 /9233 n | 2008/1028479/OCR, 40M0683/054184/OCR. Unpublished study prepared by BASF 1 Aktiengesellschaft. Experimental Toxicology and Ecology. 52 p. Schulz. M.: Landsicdcl. R. (2009) BAS 700 F: Salmonella typhimurium/ Escherichia coli , .7q_, | Reverse Mutation Assay (Standard Plate Test and Preincubation Test). Project Number: | 4 /923315 | 2009/1080768/OCR, 40M0683/054204/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 52 p. Schulz. M.: Landsicdcl. R. (2009) 3.4.5-Trifluoro-biphcnyl-2-ylaminc: Salmonella I j typhimurium / Escherichia coli Reverse Mutation Assay (Standard Plate Test and Prival | 47923574 j Preincubation Test). Project Number: 2009/1072516/OCR, 40M0316/074191/OCR. | | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and ' Ecology. 63 p. Schulz. M.: Landsicdcl. R. (2008) Technical Impurity of BAS 700 F: Salmonella I lyphimurium/Eschcrichia coli Reverse Mutation Assay (Standard Plate Test and | 47923575 | Preincubation Test). Project Number: 2007/1054448/OCR, 40M0625/074093/OCR. | | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and 1 1 Ecology. 57 p. Schulz. M.: Landsicdcl. R. (2008) Technical Impurity of BAS 700 F) - Salmonella , lyphimurium/Eschcrichia coli Reverse Mutation Assay (Standard Plate Test and | 47923576 j Preincubation Test). Project Number: 2007/1054385/OCR, 40M0621/074092/OCR. | | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and | | Ecology. 54 p. | j Schulz, M.; Landsiedel, R. (2008) BAS 700 F: In vitro Chromosome Aberration Assay in I 47923577 j V79 Cells. Project Number: 2007/1023153/OCR, 32M0683/054166/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 92 p. Schulz. M.: Landsicdcl. R. (2009) BAS 700 F: In Vitro Chromosome Aberration Assav in ' 47923578 ' V79 Cells. Project Number: 2009/1078662/OCR. 32M0683/054203/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 104 p. 28 ------- Scliul/.. M.: Landsiedel. R. (2007) In vitro Gene Mutation Test in CHO Cells (HPRT Locus 47923579 Assay). Project Number: 2007/1020715/OCR. 50M0683/054167/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 57 p. I i Schulz, M.; Landsiedel, R. (2009) BAS 700 F: In Vitro Gene Mutation Test in CHO Cells | 47923580 | (HPRT Locus Assay). Project Number: 2009/1078663/OCR, 50M0683/054205/OCR. | | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and 1 1 Ecology. 57 p. Schulz. M.: Landsiedel. R. (2009) 3.4.5-Tririuoro-biphcnyl-2-ylaminc: In Vitro Gene , . , Mutation Test in CHO Cells (HPRT Locus Assay). Project Number: 2009/1072518/OCR, | | 50M0316/074184/OCR. Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 56 p. Schulz. M.: Landsiedel. R. (2008) Technical Impurity of BAS 700 F: In vitro Gene I j Mutation Test in CHO Cells (HPRT Locus Assay). Project Number: 2008/1068014/OCR, | | 50M0625/074150/OCR. Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 58 p. Schulz. M.: Landsiedel. R. (2008) Technical Impurity of BAS 700 F: In Vitro Gene | ( Mutation Test in CHO cells (HPRT Locus Assay). Project Number: 2008/1068013/OCR, 1 50M0621 /074151 /OCR. Unpublished study prepared by B ASF Aktiengesellschaft. Experimental Toxicology and Ecology. 58 p. ( Schulz, M.; Landsiedel, R. (2006) Cytogenetic Study in vivo with LS 5094351 in the Mouse | . j Micronucleus Test After Two Oral Administrations. Project Number: 2006/1032708/OCR, 1 26M0683/054160/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 51 p. I Schulz, M.; Landsiedel, R. (2009) BAS 700 F: Micronucleus Test in Bone Marrow Cells of | 47923585 j the Mouse. Project Number: 2009/1072522/OCR, 26M0683/054188/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 51 p. Schulz. M.: Landsiedel. R. (2009) 3.4.5-Tririuoro-biphcnyl-2-ylaminc: Micronucleus Test in [ j Bone Marrow Cells on the Mouse. Project Number: 2009/1072517/OCR, I 1 26M0316/074194/OCR. Unpublished study prepared by BASF Aktiengesellschaft. Experimental Toxicology and Ecology. 51 p. Schulz. M.: Landsiedel. R. (2008) Technical Impurity of BAS 700 F: Micronucleus Test in 1 „„7 | Bone Marrow Cells of the Mouse (Including Amendment No. 1). Project Number: 1 4 | 2008/7020156/OCR. 26M0625/074091/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 56 p. t Schulz, M.; Landsiedel, R. (2008) Technical Impurity of BAS 700 F: Micronucleus Test in | 47q9t«oo j Bone Marrow Cells of the Mouse. Project Number: 2008/1002421/OCR, 26M0621/074090/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 51 p. I ( Schulz, M.; Landsiedel, R. (2008) BAS 700 F: hi vivo Unscheduled DNA Synthesis (UDS) | j Assay in Rat Hepatocytes (Including Amendment No. 1). Project Number: j | 2008/7020135/OCR, 80M0683/054165/OCR. Unpublished study prepared by BASF 1 Aktiengesellschaft. Experimental Toxicology and Ecology. 54 p. Schulz. M.: Landsiedel. R. (2009) BAS 700 F: In Vivo Unscheduled DNA Synthesis (UDS) 1 47923590 1 ^ssa-v 'n ^al Hepatocytes. Project Number: 2009/1078661/OCR, 80M0683/054198/OCR. | | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 49 p. 47923591 Bucsscn. R.: Strauss. V.: Groctcrs. A.: el al. (2009) BAS 700 F: Combined Chronic 29 ------- Toxicity/Carcinogenicity Study in Wislur Ruts: Administration Via the Diet up to 24 Months. Project Number: 2009/1072490/OCR. 80C0683/05071/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Labor fiicr Ockotoxicologic. 1779 p. ( Buesen, R.; Strauss, V.; Kuettler, K.; et al. (2010) BAS 700 F: Carcinogenicity Study in | C57BL/6 J Rj Mice: Administration Via the Diet Over 18 Months (Including Amendment | Nq Projecl Number: 2010/7003500/OCR, 87C0683/05082/OCR. Unpublished study 1 prepared by BASF Akticngcscllschaft. Experimental Toxicology and Ecology. 2182 p. Bucsscn. R.: Strauss. V: Fabian. E.: et al. (2009) BAS 700 F: Enzyme Induction in Liver of , Wistar Rats: Administration in the Diet Over 2 Weeks and Recovery Period of About 4 | Weeks. Project Number: 2009/1072495/OCR, 48C0683/05098/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 228 p. Bucscn. R.: Strauss. V.: Fabian. E.: cl al. (2009) BAS 700 F: Thyroid Hormone Study: j Repeated Dose Oral Toxicity Study in Wistar Rats: Administration Via the Diet for 4 | Weeks project Number: 2009/1072497/OCR, 48C0683/05115/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 279 p. Bucscn. R.: Fabian. E.: Ravcn/.waay. B. (2009) BAS 700 F: Thyroid Function Test in j Wistar Rats Using Perchlorate Discharge as a Diagnostic Test: Administration Via the Diet i Over 2 Weeks. Project Number: 2009/1072501 /OCR. 48C0683/05110/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 103 p. Bucscn, R.; Kauffmann, W.; Fabian, E.; cl al. (2010) BAS 700 F: S-Phasc Response Study j in Wistar Rats Administration in the Diet for 7, 28 and 91 Days. Project Number: i 2009/1072498/OCR. 40C0683/05099/OCR. Unpublished study prcparedby BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 425 p. I Bucscn, R.; Kaufmann, W.; Fabian, E.; ct al. (2010) BAS 700 F: S-Phasc Response Study in j Wistar Rats: Administration in the Diet for 7, 28 and91 Days. Project Number: I 2009/1072499/OCR, 40C0683/05111/OCR. Unpublished study prepared by BASF ' Aktiengesellschaft. Experimental Toxicology and Ecology. 207 p. Bucscn. R.: Kaufmann. W.: Fabian. E.: cl al. (2010) BAS 700 F: S-Phasc Response Study in , Wistar Rats: Administration via the Diet for 1, 3, 7 and 14 Days. Project Number: | 2009/1072500/OCR, 40C0683/05114/OCR. Unpublished study prepared by BASF ' Aklicngcscllschaft. Experimental Toxicology and Ecology. 502 p. Bucscn. R.: Fabian. E.: Groclcrs. S.: cl al. (2010) BAS 700 F: Enzyme Induction in Liver of ( Wistar Rats: Administration in the Diet Over 2 Weeks. Project Number: | 2009/1072496/OCR, 48C0683/05113/OCR. Unpublished study prepared by BASF Aklicngcscllschaft. Experimental Toxicology and Ecology. 155 p. BASF Corporation (2010) Submission of Residue. Environmental Fate. Fate and Toxicity 47923600 Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 99 of 280 Studies. i Doi, A. (2010) Evaluation of a Mode of Action for Liver Tumor Induction by BAS 700 F. 47923601 j Project Number: 2010/7003345/OCR, 2010/7003345. Unpublished study prepared by BASF Corporation. 19 p. Schneider. S.: Strauss. V.: Groclcrs. S.: cl al. (2009) BAS 700 F - Two-Gcncralion j Reproduction Toxicity Study in Wistar Rats - Administration via the Diet. Project Number: | 2009/1072491/US/OCR. EU/70R0683/05092. 70R0683/05092. Unpublished study prepared by BASF SE. 971 p. 47923603 Bucscn. ^ - Strauss. V.: Kaufmann. W.: cl al. (2009) BAS 700 F - Prenatal Developmental | Toxicity Study in Wistar Rats - Oral Administration (Gavage). Project Number: 30 ------- 2009/1072492/US/OCR. EU/30R0683/05094. 2009/1072492. Unpublished study prepared by BASF SE. 385 p. Bucscn. R.: Fabian. E.: Raven/.waay. B. (2009) BAS 700 F - Prenatal Developmental I _i 7()9 ^( Toxicity Study in Himalayan Rabbits - Oral Administration (Gavage). Project Number: I | 2009/1072493/US/OCR, 40R0683/05089, 2009/1072493. Unpublished study prepared by BASF SE. 279 p. Kaspcrs. U.: Kaufmann. W.: Fabian. E.: el al. (2009) BAS 700 F - Acute Oral Neurotoxicity 1 47923605 in Wistar Rats; Administration via Gavage. Project Number: 2009/1065774/US/OCR, | 61S0683/05102, 2009/1065774. Unpublished study prepared by BASF SE. 379 p. | Kaspers, U.; Strauss, V.; Kaulmann, W.; et al. (2009) BAS 700 F - Repeated Dose 90-Day | 4709-a()a Neurotoxicity Study in Wistar Rats; Administration in the Diet (Including Amendment I | No. 1). Project Number: 2009/7006263/OCR, 63S0683/05090, 2009/7006263. Unpublished ' 1 study prepared by B ASF SE. 424 p. Cords. S.: Lammcr. E. (2009) Rcg.No. 5069089 (Metabolite of BAS 700 F): Acute Oral , 47923607 l Toxicity Study in Rats. Project Number: 2009/1072502/US/ocr, 9//EU/10A0451/079119, [ | 10A0451/079119. Unpublished study prepared by Bioassay Labor fuerBiologische Analvtik GmbH. 24 p. Kaspcrs. U.: Strauss. V.: Groctcrs. S.: et al. (2009) Reg.No. 5069089 (Metabolite of BAS I j 700 F) - Repeated Dose 90-Day Oral Toxicity Study in Wistar Rats; Administration in the I | Diet. Project Number: 2009/1072503/US/OCR, 50S0451/07119, 2009/1072503. Unpublished study prepared by BASF SE. 411 p. Schulz. M.: Landsicdcl. R. (2009) Rcg.No. 5069089 (Metabolite of BAS 700 F) - | 47q9ofinq i Salmonella typhimurium/ Escherichia coli Reverse Mutation Assay (Standard Plate Test ' 1 and Preincubation Test). Project Number: 2009/1072504/US/ocr. 40M0451/074195. 2009/1072504. Unpublished study prepared bv BASF SE. 54 p. ( Schulz, M.; Landsicdcl, R. (2009) Rcg.No. 5069089 (Metabolite of BAS 700 F) - In Vitro 1 47923610 | Chromosome Aberration Assay in V79 Cells. Project Number: 2009/1072505/US/OCR, 1 3 2M0451 /074158. 2009/1072505. Unpublished study prepared by BASF SE. 90 p. Schulz. M.: Landsicdcl. R. (2009) Rcg.No. 5069089 (Metabolite of 700 F) - In Vitro Gene 1 1 1 Mutation Test in CHO Cells (HPRT Locus Assay) (Including Amendment No. 1). Project I I Number: 2009/7006288/ocr, 50M0451/074157, 2009/7006288. Unpublished study prepared ' by BASF SE. 62 p. Schulz. M.: Landsicdcl. R. (2009) Rcg.No. 5069089 (Metabolite of BAS 700 F): I 17(19-^ 19 f Micronucleus Test in Bone Marrow Cells of the Mouse. Project Number: I 1 2009/1072506/US/ocr. EU/26M0451/074181. 2009/1072506. Unpublished study prepared by BASF SE. 51 p. Schneider. S.: Fabian. E.: Mcllcrt. W. (2009) Rcg.No. 5069089 (Metabolite of BAS 700 F) - | 47090^1 o i Prenatal Developmental Toxicity Study in New Zealand White Rabbits - Oral ' 1 Administration (Gavage). Project Number: 2009/1072507/US/ocr. EU/40R0451/07118. 2009/1072507. Unpublished study prepared by BASF SE. 568 p. , , Cords, S.; Lammcr, E. (2009) Rcg.No. 5435595 (Metabolite of BAS 700 F) - Acute Oral | 470^^14 1 Toxicity Study in Rats. Project Number: 2009/1018501/US/ocr, 9//EU/10A0441/079106, 09/BF/OT009. Unpublished study prepared by Bioassay Labor fucr Biologischc Analvtik GmbH. 24 p. I Kaspers, U.; Strauss, V.; Groters, S.; et al. (2008) Reg.No. 5435595 (Metabolite of BAS 700 1 47923615 F) - Repeated Dose 28-Day Oral Toxicity Study in Wistar Rats; Administration in the Diet: j 1 Final Report. Project Number: 2008/1052054/US/ocr, EU/30S0441/07048, 2008/1052054. 31 ------- Unpublished study prepared by BASF SE. 193 p. Kaspcrs. U.: Strauss. V.: Groters. S.: el al. (2009) Rcg.No. 5435595 (Metabolite ofBAS 700 1 , | F) - Repeated Dose 90-Day Oral Toxicity Study in Wistar Rats; Administration in the Diet. ' 1 Project Number: 2009/1012026/US/ocr. EU/50S0441/07091. 2009/1012026. Unpublished study prepared by BASF SE. 347 p. , , Schulz, M.; Landsicdcl, R. (2007) Rcg.No. 5435595 (Metabolite of BAS 700 F) - 1 ,. _ j Salmonella typhimurium/ Escherichia coli Reverse Mutation Assay (Standard Plate Test | ' and Preincubation Test). Project Number: 2007/1051931/US/OCR, EU/40M0441/074079, | 2007/1051931. Unpublished study prepared by BASF SE. 52 p. | Schulz, M.; Landsiedel, R. (2008) Reg.No. 5435595 (Metabolite ofBAS 700 F) - In Vitro 1 47923618 Chromosome Aberration Assay in V79 Cells. Project Number: 2008/1002741/US/ocr, EU/32M0441/074074. 2008/1002741. Unpublished study prepared by BASF SE. 116 p. Schulz. M.: Landsicdcl. R. (2008) Rcg.No. 5435595 (Metabolite ofBAS 700 F) - In Vitro 1 . (. j Gene Mutation Test in CHO Cells (HPRT Locus Assay). Project Number: ¦ 1 2008/1014199/US/ocr. EU/50M0441/074075. 2008/1014199. Unpublished study prepared by BASF SE. 62 p. ( Schulz, M.; Landsicdcl, R. (2009) Rcg.No. 5435595 (Metabolite ofBAS 700 F): 1 1 Micronucleus Test in Bone Marrow Cells of the Mouse. Project Number: 1 I 2009/1072508/US/ocr. EU/26M0441/074180. Unpublished study prepared by BASF SE. 51 P- I Fabian, E.; Landsicdcl, R. (2009) [Carbon 14J-Rcg.No. 5435595 (Metabolite of BAS 700 | 47923621 | F): Study on the Kinetics in Mice. Project Number: 2009/1098042/US/ocr, EU/02B0092/096007. 2009/1098042. Unpublished study prepared by BASF SE. 30 p. Schneider. S.: Fabian. E.: Mcllcrt. W. (2009) Rcg.No. 5435595 (Metabolite of BAS 700 F) - I 47090^99 i Prenatal Developmental Toxicity Study in New Zealand White Rabbits - Oral I 1 Administration (Gavage). Project Number: 2009/1072509/US/ocr, EU/40R0441/07117, 2009/1072509. Unpublished study prepared bv BASF SE. 356 p. Cords. S.: Lammcr. E. (2009) Rcg.No. 5570265 (Metabolite ofBAS 700 F) - Acute Oral | 47g236?3 1 Toxicity Study in Rats. Project Number: 2009/1018496/US/ocr, 9//EU/10A0008/099001, ' 09/BF/OT029. Unpublished study prepared by Bioassav Labor fuer Biologische Analvtik GmbH. 24 p. , ( Kaspcrs, U.; Strauss, V.; Groctcrs, S.; ct al. (2009) Rcg.No. 5570265 (Metabolite of BAS 1 i 700 F) - Repeated Dose 28-Day Oral Toxicity Study in Wistar Rats; Administration in the . Dic(. Fin})] Rcpor( Projccl Number: 2009/1072510/US/ocr. EU/30S0008/09005. 2009/1072510. Unpublished study prepared by BASF SE. 402 p. I j Schulz, M.; Landsiedel, R. (2009) Reg.No. 5570265 (Metabolite of BAS 700 F): Salmonella 1 | typhimurium/ Escherichia coli Reverse Mutation Assay (Standard Plate Test and I | Preincubation Test). Project Number: 2009/1072511/US/ocr, EU/40M0008/094079, 1 2009/1072511. Unpublished study prepared by B ASF SE. 52 p. Schulz. M.: Landsicdcl. R. (2009) Rcg.No. 5570265 (Metabolite ofBAS 700 F): In Vitro 47923626 Chromosome Aberration Assay in V79 Cells. Projccl Number: 2009/1072512/US/ocr. EU/32M0008/094198. 2009/1072512. Unpublished study prepared by BASF SE. 96 p. Schulz. M.; Landsicdcl. R. (2009) Rcg.No. 5570265 (Metabolite ofBAS 700 F) in vitro 1 | Gene Mutation Test in CHO Cells (HPRT Locus Assay). Project Number: | 4 iviibl | 2009/1072513/US/ocr, EU/50M0008/094054, 2009/1072513. Unpublished study prepared I I by BASF SE. 52 p. 32 ------- Scliul/.. M.: Landsicdcl. R. (2009) Rcg.No. 5570265 (Metabolite ofBAS 700 F): ! Micronucleus Test in Bone Marrow Cells of the Mouse. Project Number: I 2009/1072514/US/ocr. EU/26M0008/094005. 2009/1072514. Unpublished study prepared by BASF SE. 51 p. Schulz. M.: Liindsicdcl. R. (2009) Rcg.No. 5570265 (Metabolite ofBAS 700 F): In Vivo 4799^699 I Unscheduled DNA Synthesis (UDS) Assay in Rat Hepatocytes (Including Amendment no. 1 1): Final Report. Project Number: 2009/7006262/ocr. EU/80M0008/094199. 2009/7006262. Unpublished study prepared by BASF SE. 54 p. ( Fabian, E.; Landsicdcl, R. (2009) [Carbon 14J-Rcg.No. 5570265 (Metabolite ofBAS 700 F) 47923630 | - Study on the Kinetics in Mice. Project Number: 2009/1098044/US/ocr, EU/02B0250/096008. 2009/1098044. Unpublished study prepared by BASF SE. 30 p. Schneider. S.: Fabian. E.: Mcllcrt. W. (2010) Rcg.No. 5570265 (Metabolite of B AS 700 F) - 479,,,, . j Prenatal Developmental Toxicity Study in New Zealand While Rabbits Oral Administration | (Gavage) project Number: 2009/1072515/US/ocr, EU/40R0008/09008, 2009/1072515. Unpublished study prepared by BASF SE. 458 p. Fabian. E.: Landsicdcl. R. (2010) (Carbon 14)-BAS 703 02 F - In-Vivo Dermal Absorption 47923632 j in the Rat. Project Number: 2010/1009626/US/ocr, EU/01B0651/096010, 2010/1009626. I Unpublished study prepared by BASF SE. 46 p. Kaspcrs. U.: Strauss. V.: Groctcrs. S.: cl al. (2009) BAS 700 F - Inimunoloxicilv Study in .7g7,,,, Male C57BL/6 J Rj Mice; Administration in the Diet for 4 Weeks. Project Number: | 2009/1072494/US/ocr, 683/05105//EU/352759, 43S0683/05105. Unpublished study 1 prepared by BASF SE. 169 p. , Doi. A. (2010) Toxicology Summary for BAS 700 F: Final Report. Project Number: 1 " 2010/7003555/ocr. 2010/7003555. Unpublished study prepared by BASF Corporation. 25 p. Goodling. R. (2010) Freezer Storage Stability ofBAS 700 F and its Relevant Metabolites in 47923635 Soil Samples: Final Report. Project Number: 2009/7005955/ocr. SUBNO/201002/41/01. 2009/7005955. Unpublished study prepared bv BASF Agricultural Research Center. 145 p. Zangmcistcr. W. (2010) Storage Stability ofBAS 700 F and its Metabolites Rcg.No. 47923636 1 5069089 (M700F001), Reg.No. 5435595 (M700F002) andReg.No. 5410775 (M700F003) ' in Soil Samples Under Frozen Conditions. Project Number: 2010/1011375/US/ocr. EU/266248. 2010/1011375. Unpublished study prepared by BASF SE. 23 p. , Radzom, M.; Mackcnrotli, C. (2010) Investigation of the Storage Stability of BAS 700 F in 47923637 j Plant Matrices. Project Number: 2010/1009624/US/ocr, EU/315768, 2010/1009624. ' Unpublished study prepared by BASF SE. 51 p. Radzom M.: Mackcnrotli. C. (2009) Investigation of the Storage Stability of the BAS 700 F 47923638 Metabolite M700F002 in Plant Matrices. Project Number: 2009/1072398/US/ocr. EU/324239. 2009/1072398. Unpublished study prepared by BASF SE. 38 p. , Rodzom, M.; Mackcnrotli, C. (2009) Investigation of the Storage Stability of the BAS 700 F ,79,, ,,q j Metabolite M700F048 in Plant Matrices and Processed Commodities. Project Number: 1 2009/1072399/US/ocr. EU/362486. 2009/1072399. Unpublished sludv prcparcdbv BASF SE. 49 p. | Lehmann, A.; Mackenroth, C. (2009) Investigation of the Storage Stability of M700F008 in 47923640 1 Plant Matrices. Project Number: 2009/1072400/US/ocr, EU/370501, 2009/1072400. Unpublished study prepared by BASF SE. 31 p. .-yo-j-Y 11 Rabc. U.: Kulinkc. G. (2009) Metabolism ofBAS 700 F in Tomatoes. Project Number: 4 / JZ.104 2009/1017901 /US/ocr. EU/315734. 2009/1017901. Unpublished study prcparcd by BASF 33 ------- SE. 129 p. Brcl/.. M.: Ockcrl. M.: Glacssgcn. W. (2009) Metabolism of B AS 700 F in Soybean. Project 47923642 | Number: 2009/1017387/US/ocr, EU/315733, 2009/1017387. Unpublished study prepared by 'BASF SE. 318 p. Bross. M.: Kulinke. G. (2009) Metabolism of |Carbon 14|-BAS 700 F in Wheal After Foliar 47923643 Treatment. Project Number: 2009/1048403/US/ocr. EU/315732. 2009/1048403. Unpublished study prepared by BASF SE. 372 p. Fabian. E.; Landsicdcl. R. (2009) (Carbon 14)-BAS 700 F: Absorption. Distribution and | Excretion After Repeated Oral Administration in Laying Hens. Project Number: I 2009/1065025/US/ocr. EU/02B0440/076006. 2009/1065025. Unpublished study prepared by BASF SE. 40 p. I Hafcmann, C.; Klocppncr, U. (2009) The Metabolism of (Carbon 14)-BAS 700 F in Laying 47923645 | Hens. Project Number: 2009/1069223/US/ocr, EU/315779, 2009/1069223. Unpublished study prepared by BASF SE. 201 p. Grosshans. F.: Glacssgcn. W.: Lutz. T. (2010) The Metabolism of (Carbon 14)-M700F002 47923646 1 (Metabolite ofB AS 700 F) in Laying Hens. Project Number: 2009/1078621/US/ocr. EU/366569. 2009/1078621. Unpublished study prepared bv BASF SE. 110 p. t Grosshans, F.; Lutz, T. (2010) The Metabolism of (Carbon 14)-M700F048 (Metabolite of 47923647 j BAS 700 F) in Laying Hens. Project Number: 2009/1111646/US/ocr, EU/366571, 2009/1111646. Unpublished study prepared by BASF SE. 124 p. Fabian. E.: Landsicdcl. R. (2009) (Carbon 14)-BAS 700 F - Absorption. Distribution and j Excretion After Repeated Oral Administration in Lactating Goats. Project Number: I 2009/1065024/US/ocr. EU/02B0440/076005. 2009/1065024. Unpublished study prepared by BASF SE. 56 p. Grosshans. F.: Bret/.. M.: Lutz. T.: cl al. (2009) Metabolism of (Carbon 14)-BAS 700 F 47923649 j ((Carbon 14)-Reg.No. 5094351) in Lactating Goat. Project Number: 2009/1074074/US/ocr, 1 EU/315778. 2009/1074074. Unpublished study prepared by BASF SE. 290 p. Grosshans. F. (2009) The Metabolism of (Carbon 14)-M700F002 (Metabolite of BAS 700 47923650 , F) in Lactating Goats. Project Number: 2009/1074682/US/ocr, EU/362496, 2009/1074682. Unpublished study prepared by BASF SE. 135 p. Grosshans. F.: Kuhnkc. G.: Klocppncr. U. (2010) The Metabolism of (Carbon 14)- . j M700F048 (Metabolite of BAS 700 F) in Lactating Goats. Project Number: 1 2009/1116609/US/ocr. EU/366572. 2009/1116609. Unpublished study prepared by BASF Aklicngcscllscha.fi. 137 p. , While, M. (2010) Magnitude of BAS 700 F Residues in Raw Agricultural Commodities of j the Cereal Grains and Forage, Fodder and Straw of Cereal Grains Crop Groups Following 47923652 j Applications of BAS 700 AEF. Project Number: 2010/7003693/ocr, 1 SUBNO/201003/08/02. 2010/7003693. Unpublished study prepared by B ASF Agricultural Research Center. 660 p. Allen. K. (2010) Determination of Residues of BAS 700 in Wheal and Barley (Forage, j Grain and straw) Following Two Foliar Applications of BAS 700 00 F. Project Number: i 2010/7003123/ocr. US/B ASF/0802. 2010/7003123. Unpublished study prepared by Pcracto Ply. Ltd. 97 p. I Erdmann, H. (2009) Study on the Residue Behaviour of BAS 700 F in Wheat and Trilicalc 47923654 j After Application of BAS 700 00 F, Under Field Condition in France, Italy, Spain, UK and Germany. 2008. Project Number: 2009/1012126/US/ocr. ASF/08/02//EU/315849. 34 ------- 2009/1012126. Unpublished study prepared bv Agro-Check. Dr. Tcrcsiak & Erdmann GbR. 59 p. Erdmann. H. (2009) Study on the Residue Behaviour of B AS 700 F in Wheal and Trilicalc ( After Application of Fa 5094351 18 F Under Field Condition in France, UK, Spain and | 2007. Project Number: 2007/1050092/US/ocr, ASF/07/11//EU/284416, 2007/1050092. Unpublished study prepared by Agro-Check. 73 p. Erdmann. H. (2009) Study on the Residue Behaviour of B AS 700 F in Barley After j Application of BAS 700 00 F, Under Field Condition inFrance, Italy, Spain, UK, Greece, 1 Netherlands and Germany. 2008. Project Number: 2009/1012125/US/ocr. 50//EU/AC/B ASF/08/03. 315850. Unpublished study prepared by Agro-Check. 71 p. Erdmann. H. (2009) Study on the Residue Behaviour of BAS 700 F in Barley After j Application of Fa 5094351 18F Under Field Condition in France, UK, Spain and Germany, I 2007 Projcct Numbcr: 2007/1050093/US/ocr. 10//EU/AC/B ASF/07/12. 284410. Unpublished study prepared by Agro-Check. 72 p. j Johnston, R. (2009) The Magnitude of BAS 700 F Residues in Raw Agricultural j Commodities of the Legume Vegetables (Succulent and Dry) and Foliage of Legume 47923658 j Vegetables crop Groups Following Applications of BAS 700 AE F. Project Number: 1 2009/7003589/ocr. //SubNo/200910/12/03. 347435. Unpublished study prepared by BASF Agricultural Research Center. 401 p. Johnston, R. (2010) Magnitude of BAS 700 F Residues in Oil Seed Crops (Canola and 47923659 j Sunflower). Project Number: 2009/7003064/ocr, SubNo/200909/72/02, 347437. 1 Unpublished study prepared by BASF Agricultural Research Center. 145 p. Becker. J. (2010) Magnitude of Residue of BAS 700 in/on Peanut RAC Treated with BAS 47923660 700 AE F. Project Number: 2009/7006381/ocr. SUBNO/201002/42/02. ARA/08/09/04. Unpublished study prepared by Ag Research Associates. 318 p. (Jordan, J. (2009) Magnitude of BAS 700 F in Pomcfruit Following Applications of BAS 47923661 j 700 AE F. Project Number: 2009/7003135/ocr, SUBNO/200909/10/02, 347441. ' Unpublished study prepared by BASF Agricultural Research Center. 130 p. Jordan. J. (2010) Magnitude of BAS 700 F Residues in Stoncfruit Following Applications of 47923662 BAS 700 AE F. Project Number: 2009/7003328/ocr. 911/14/02//US/347443. 347443. Unpublished study prepared by BASF Agricultural Research Center. 262 p. , Johnston, R. (2010) Magnitude of BAS 700 F Residues in Raw Agricultural Commodities | of Potatoes and Sugar Beets Following Applications of BAS 700 AE F. Project Number: i 2009/7003643/ocr. /03/01/01//US/347445. 347445. Unpublished study prepared by BASF Agricultural Research Center. 236 p. While, M. (2010) Magnitude of BAS 700 F Residue in Fruiting Vegetables Following 47993664 i Applications of BAS 700 AEF: Final Report. Project Number: 2009/7006207/ocr, | //SubNo/201002/55/01,2009/7006207. Unpublished study prepared by BASF Agricultural 1 Research Center. 234 p. Jordan. J.: Gordon. B. (2010) Magnitude of Residue of BAS 700 F in Cotton RAC and , Processed Fractions After Seed Treatment with BAS 700 AC F. Project Number: | 2010/7003260/ocr, 909/09/02//US/347447, 347447. Unpublished study prepared by BASF Agricultural Research Center. 197 p. MacDougall. J. (2010) Magnitude of Residues in Eggs and Tissues of Laying Hens 47993666 I Following Multiple Oral Administration of BAS 700 F and M700F002 (Including | Amendment no. 1). Project Number: 2010/7003614/ocr, /EU/214965//EU/30467, 315796. | Unpublished study prepared by Charles River Laboratories . 501 p. 35 ------- 47923667 47923668 47923669 47923670 47923671 47923672 47923673 Hassink. J. (2009) BAS 700 F: Hydrolysis at 90 Degree Celsius. 100 Degree Celsius and | 120 Degree Celsius: Final Report. Project Number: 2009/1049060/US/ocr, EU/324302, 1 2009/1049060. Unpublished study prepared by BASF SE. 17 p. Johnston. R.: Saha. M. (2009) Magnitude of BAS 700 F Residues in Processed Fractions , and/or Aspirated Grain Fractions of the Cereal Grain Wheat Following Applications of BAS | 700 AEF: Final Report. Project Number: 2009/7003065/ocr, 315760, 2009/7003065. Unpublished study prepared by BASF Agricultural Research Center. 240 p. Johnston. R.: Saha. M. (2009) Magnitude of BAS 700 F Residues in Processed Fractions of I the Cereal Grain Barley Following Applications of BAS 700 AE F. Project Number: 1 2009/7003177/ocr, 909/08/02//US/315759, 2009/7003177. Unpublished study prepared by BASF Agricultural Research Center. 229 p. Johnston. R.: Saha. M. (2010) Magnitude of BAS 700 F Residues in Processed Fractions | and/or Aspirated Grain Fractions of the Cereal Grains Corn, Sorghum and Rice Following | Applications of BAS 700 AE F. Project Number: 2010/7003485/ocr, | 911/03/02//US/347434,2010/7003485. Unpublished study prepared by BASF Agricultural Research Center. 391 p. Johnston. R.: Saha. M. (2010) Magnitude of BAS 700 F Residues in Processed Fractions j and/or Aspirated Grain Fractions of Soybean Following Applications of BAS 700 AE F: 1 Final Report. Project Number: 2009/7003178/ocr, 315747, 2009/7003178. Unpublished study prepared by BASF Agricultural Research Center. 234 p. Johnston. R. (2010) The Magnitude of BAS 700 F Residues in Oil Seed Crop Processed | Fractions (Canola and Sunflower): Final Report. Project Number: 2009/7003097/ocr, 1 //SubNo/201002/58/01. 2009/7003097. Unpublished study prepared by BASF Agricultural Research Center. 209 p. , Becker, J. (2010) Magnitude of Residue of BAS 700 in/onPcanut Processed Fractions After 47923674 j Treatment with BAS 700 AEF. Project Number: 2009/70063 82/ocr, /08/09/05//US/347440, 1 2009/7006482. Unpublished study prepared bv Ag Research Associates. 267 p. 47923675 47923676 47923677 47923678 Jordan. J.: Saha. M. (2009) Magnitude of BAS 700 F Residues in Apple Processed Fractions i Following Applications of BAS 700 AE F: Final Report. Project Number: | 2009/7003644/ocr, SUBNO/200912/02/01, 2009/7003644. Unpublished study prepared by BASF Agricultural Research Center. 219 p. Jordan. J. (2010) Magnitude of BAS 700 F Residues in Plum Processed Fractions Following | Applications of BAS 700 AE F: Final Report. Project Number: 2009/7006075/ocr, 1 //SubNo/201002/51/01. 2009/7006075. Unpublished study prepared by BASF Agricultural Research Center. 160 p. Johnston. R.: Saha. M. (2010) Magnitude of BAS 700 F Residues in Root and Tuber j Processed Fractions Following Applications of BAS 700 AE F. Project Number: 1 2009/7003454/ocr. //SubNo/201002/45/01. 2009/7003454. Unpublished study prepared by- BASF Agricultural Research Center. 303 p. , White, M.; Saha, M. (2010) Magnitude of BAS 700 F Residues in Tomato Process | Fractions: Final Report. Project Number: 2009/7006206/ocr, 002/53/01//US/353001, 2009/7006206. Unpublished study prepared by BASF Agricultural Research Center. 252 p. 47923679 Schopfcr. C: Kuhnkc. G.: Labib. S.: el al. (2009) Confined Rotational Crop Study with 36 ------- 14C-BAS 700 F (Pyra/.ole Lubcl). Project Number: 2009/1074683/US/ocr. EU/267319. 2009/1074683. Unpublished study prepared bv BASF SE. 345 p. Schopfer. C: Glaessgen. W.: Lut/.. T.: el al. (2009) Confined Rotational Crop Study with 47923680 14C-BAS 700 F (Aniline Label). Project Number: 2009/1074684/US/ocr. EU/315741. 2009/1074684. Unpublished study prepared by BASF SE. 408 p. , Norris, F.; Salia, M. (2009) The Magnitude of BAS 700 F Residues in Wheat, Lettuce and j Radishes Planted as Rotational Crops Following Applications of BAS 700 00 F to Bare Soil 47923681 | (Plant Back Intervals of 30, 60, 90 and 120 Days): Final Report. Project Number: 1 2009/7004936/ocr. 910/14/01 //US/319643. 2009/7004936. Unpublished study prepared by BASF Agricultural Research Center. 181 p. Erdmann. H. (2009) Interim Report: Field Rotational Crop Study with BAS 700 00 F. j Containing 62.5 g/L Reg.No. 5094351, Applied to Bare Soil at 365, 120 and 30 Days Prior 47923682 | to Planting of Four Rotational Crops in Spain, Italy, Greece and Germany, 2008 - 2009. I Project Number: 2009/1074616/US/ocr, ASF/08/01//EU/315743, 2009/1074616. Unpublished study prepared by Agro-Check. 138 p. Schopfer. C: Panck. M.: Daussin. F. (2010) BAS 700 F: Plant and Animal Residue i Chemistry Overview Including Proposed Tolerances/MRLs and Dietary Risk Assessment: | Fjna] Report Project Number: 2010/7003645/ocr. SubNo/201003/12/01. 2010/7003645. Unpublished study prepared by BASF Corporation. 205 p. Malinsky, D. (2010) Aerobic Soil Metabolism of (Carbon 14)-BAS 700 F on US Soils: 47923684 | Final Report. Project Number: 2009/7003246/ocr, 002/57/01//US/319649, 2009/7003246. 1 Unpublished study prepared by BASF Agricultural Research Center. 139 p. Bayer. H.: Unold. M. (2009) Aerobic Soil Metabolism of BAS 700 F. Project Number: 47923685 2009/1050247/US/ocr. EU/314701. 2009/1050247. Unpublished sludv prepared bv BASF SE. 157 p. , Staudenmaier, H.; Unold, M. (2009) Aerobic Soil Metabolism of (Carbon 14)- 47923686 j Trifluorophenyl-Labeled BAS 700 F. Project Number: 2009/1069339/US/ocr, EU/347044, ' 2009/1069339. Unpublished study prepared by BASF SE. 69 p. Bayer. H.: Unold. M. (2009) Degradation of M700F003 (Reg.No. 5410775) in Aerobic Soil. 47923687 Project Number: 2009/1070323/US/ocr. EU/347043. 2009/1070323. Unpublished study prepared by BASF SE. 37 p. t Malinsky, D. (2010) Anaerobic Soil Metabolism of (Carbon 14)-BAS 700 F on US Soil: 47923688 | Final Report. Project Number: 2009/7003247/ocr, //SubNo/201002/56/01, 2009/7003247. Unpublished study prepared by BASF Agricultural Research Center. 131 p. Staudenmaier. H. (2009) The Anaerobic Soil Metabolism of BAS 700 F. Project Number: 47923689 2008/1067408/US/ocr. EU/314702. 2008/1067408. Unpublished sludv prepared bv BASF SE. 79 p. 47<)9-Y90 Hassink. J. (2009) Soil Photolvsis of BAS 700 F. Project Number: 2009/1013342/US/ocr. EU/314704. 2009/1013342. Unpublished study prepared by BASF SE. 42 p. Ta. C. (2010) Rate of Degradation of BAS 700 F in Soils: Final Report. Project Number: 47923691 j 2009/7006123/ocr, //SubNo/201002/37/01, 209/7006123. Unpublished study prepared by 1 BASF Agricultural Research Center and Agvisc. Inc. 133 p. Ebert. D. (2009) Rate of Degradation of BAS 700 F in Various Soils Under Aerobic 47923692 Conditions. Project Number: 2009/1004083/US/ocr. EU/314703. 2009/1004083. Unpublished study prepared by BASF SE. 91 p. 37 ------- Bavcr. H.: Unold. M. (2009) Rale of Degradation of M700F001 (Metabolite ofBAS 700 F) 47923693 in Aerobic Soil. Project Number: 2009/1070321/US/ocr. EU/354642. 2009/107321. Unpublished study prepared by BASF SE. 104 p. I i Bayer, H.; Unold, M. (2009) Rate of Degradation of M700F002 (Metabolite ofBAS 700 F) I 47923694 (in Aerobic Soil. Project Number: 2009/1070322/US/ocr, EU/314705, 2009/1070322. Unpublished study prepared by BASF SE. 120 p. Jordan. J.: Warren. R. (2010) Terrestrial Field Dissipation ofBAS 700 F Following | j Applications ofBAS 700 AC F in Legumes. Project Number: 2009/7006030/ocr, I 1 //SubNo/201003/03/01. 2009/7006030. Unpublished study prepared by B ASF Agricultural Research Center. 293 p. Jordan. J.; Warren. R. (2010) Terrestrial Field Dissipation ofBAS 700 F Following | j Applications ofBAS 700 AC F or BAS 700 AE F in Vegetable Use Patterns. Project 1 1 Number: 2009/7006032/ocr. //SubNo/201003/02/01. 2009/7006032. Unpublished study prepared by BASF Agricultural Research Center. 756 p. j Jordan, J. (2010) Terrestrial Field Dissipation ofBAS 700 F Following Applications of BAS | 4709^97 ! ^ f7 in Orchard and Vineyard Use Patterns. Project Number: 2009/7006033/ocr, | | //SubNo/201002/60/01,2009/7006033. Unpublished study prepared by BASF Agricultural 1 1 Research Center. 505 p. Bayer. H. (2009) Field Soil Dissipation Study ofBAS 700 F in the Formulation LAB 47973698 < ' F-N on Bare Soil at Six Different Locations In Europe, 2007-2008. Project 1 | Number: 2009/1070324/US/ocr, EU/266242, 2009/1070324. Unpublished study prepared by ' 'BASF SE. 371 p. Hardy. I. (2009) BAS 700 F: Kinetic Modelling Analysis of Data From Field Soil Residue , , Studies Conducted in Europe. Project Number: 2009/1071711/US/ocr, | 4 /92 Jb99 | 9/005//EU/JL/09/0Q5B 2009/1071711. Unpublished study prepared by Battelle UK, Ltd. 54 P- BASF Corporation (2010) Submission of Fate. Environmental Fate. Fate in Animals. 47923700 Product Chemistry and Toxicity Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 82 of 280 Studies. I Hardy, 1. (2009) BAS 700 F: Timcstcp Normalisation Analysis of Data from Field Soil | 47923701 | Residue Studies Conducted in Europe. Project Number: 2009/1093280/OCR, 2009/1093280. JL/09/005A. Unpublished study prepared by Battelle Agrifood. Ltd. 116 p. Bayer. H.: Unold. M.: Zangmcister. W. (2009) Field Soil Dissipation Study of M700F002 1 | (Metabolite ofBAS 700 F) in the Formulation EXP 5435595 F on Bare Soil at Four ! 1 Different Locations in Europe. 2008-2009. Project Number: 2009/1070325/OCR. 2009/1070325. 347041. Unpublished study prepared bv BASF Aklicngcscllscha.fi. 289 p. Hardy. I. (2009) BAS 700 F: Kinetic Modelling Analysis of M700F002 Data from Field | 47923703 | Soil Residue Studies Conducted in Europe. Project Number: 2009/1071712/OCR, 1 2009/1071712. JL/09/006D. Unpublished study prepared by Battelle Agrifood. Ltd. 42 p. Hardy. I. (2009) BAS 700 F: Timcstcp Normalisation Analysis of M700F002 Data from 47923704 Field Soil Residue Studies Conducted in Europe. Project Number: 2009/1093281/OCR. 2009/1093281. JL/09/006C. Unpublished study prepared by Battelle Agrifood. Ltd. 63 p. Bayer. H.; Zangmcister. W. (2010) Accumulation Behaviour of BAS 700 F in Soil under | | Field Conditions in United Kingdom following Repeated Application onto Winter Wheat | I over Several Years. Project Number: 2010/1009655/OCR, 2010/1009655, 314711. | | Unpublished study prepared by BASF Aktiengesellschaft. 181 p. 38 ------- Bavcr. H.: Zangmcislcr. W. (2010) Accumulation Behaviour of B AS 700 F in Soil under | Field Conditions in Germany following Repeated Application onto Winter Barley over I Several Years. Project Number: 2010/1009654/OCR. 2010/1009654. 324237. Unpublished study prepared by BASF Aklicngesellschafl. 106 p. Hassink. J.: Slephan. A. (2009) Determination of the Adsorplion/Dcsorplion Behaviour of 47923707 | BAS 700 F on Different Soils. Project Number: 2009/1065633/OCR, 2009/1065633, 1 314706. Unpublished study prepared by BASF Aktiengesellschaft. 78 p. Hassink. J.: Slephan. A. (2009) Determination of the Adsorplion/Dcsorplion Behaviour of i M700F001 (Metabolite of BAS 700 F) on Different Soils. Project Number: | 2009/1070295/OCR, 2009/1070295, 314708. Unpublished study prepared by BASF Aklicngesellschafl. 61 p. Hassink. J.: Slephan. A. (2009) Determination of the Adsorplion/Dcsorplion Behaviour of j M700F002 (Metabolite of BAS 700 F) on Different Soils. Project Number: 1 2009/1070296/OCR, 2009/1070296, 314707. Unpublished study prepared by BASF Aklicngesellschafl. 63 p. Hassink. J. (2009) M700F007 (Metabolite of BAS 700 F): Aqueous Hydrolysis at Four 47923710 j Different pH Values. Project Number: 2009/1070297/OCR, 2009/1070297, 367713. I Unpublished study prepared by BASF Aktiengesellschaft. 18 p. Hassink. J. (2009) Photolysis of M700F007 (Metabolite of BAS 700 F) in Sterile Natural 47923711 Water. Project Number: 2009/1070298/OCR. 2009/1070298. 367714. Unpublished study prepared by BASF Aklicngesellschafl. 20 p. Schwarz. H. (2008) BAS 700 F: Determination of the Biodcgradabilily in the C02- 47923712 | Evolution Test. Project Number: 2008/1028082/OCR, 2008/1028082, 22G0683/053365. ' Unpublished study prepared by BASF Aktiengesellschaft. 28 p. Ebcrl. D. (2009) Degradation of BAS 700 F in Walcr/Scdimcnl Systems under Aerobic 47923713 Conditions. Project Number: 2009/1004082/OCR. 2009/1004082. 314715. Unpublished study prepared by BASF Aklicngesellschafl. 151 p. Ta. C. (2010) BAS 700 F: Anaerobic Aquatic Metabolism Project Number: 47923714 [ 2009/7006124/OCR, 2009/7006124, 319648. Unpublished study prepared by BASF Agro 1 Research and Agvise Laboratories. Inc. 105 p. Zok. S. (2008) BAS 700 F - Acute Toxicity in the Bobwhilc Quail (Colinus virginianus) 47o9-?71 * , ^cr Single Oral Administration (LD50). Project Number: 2007/1054365/OCR, | 2007/1054365, 11W0683/055077. Unpublished study prepared by BASF ' Aklicngesellschafl. 63 p. Zok. S. (2008) BAS 700 F - Acute Toxicity in the Mallard Duck (Anas plalyrhvnchos) after 47923716 Single Oral Administration (LD50). Project Number: 2008/1003797/OCR. 2008/1003797. 13W0683/055082. Unpublished study prepared bv BASF Aklicngesellschafl. 64 p. , Zok, S. (2009) BAS 700 F - Acute Toxicity in the Zebra Finch (Tacniopygia guttata) after 47923717 j Single Oral Administration (LD50). Project Number: 2009/1050338/OCR, 2009/1050338, 15W0683/055095. Unpublished study prepared by BASF Aklicngesellschafl. 69 p. Zok. S. (2009) BAS 700 F - Avian Dietary LC50 Test in Chicks of the Bobwhilc Quail 4709-571 o | (Colinus virginianus) (Including Amendment No. 1). Project Number: 2009/7006256/OCR, | 2009/7006256, 31W0683/055090. Unpublished study prepared by BASF Aklicngesellschafl. 72 p. Zok. S. (2008) BAS 700 F - Avian Dietary LC50 Test in Ducklings of the Mallard Duck (Anas plalyrhvnchos). Project Number: 2008/1037447/OCR. 2008/1037447. 39 ------- 32W0683/055091. Unpublished study prepared bv BASF Aklicngcscllschafl. 63 p. Zok. S. (2009) BAS 700 F - 1-Generation Reproduction Study on the Bobwhite Quail | (Colinus virginianus) by Administration in the Diet (Including Amendment No. 1 and 1 Amendment No. 2). Project Number: 2009/7006257/OCR. 2009/7006257. 71W0683/055080. Unpublished study prepared by BASF Aklicngcscllschafl. 367 p. , Zok, S. (2009) BAS 700 F - 1-Gcncralion Reproduction Study on the Mallard Duck (Anas . j platyrhynchus) by Administration in the Diet (Including Amendment No. 1). Project Number: 2009/7006258/OCR, 2009/7006258, 72W0683/055081. Unpublished study prepared by BASF Aktiengesellschaft. 368 p. Zok, S. (2007) BAS 700 F - Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss) in a Static System Over 96 Hours. Project Number: 2007/1057974/OCR, 1 2007/1057974, 12F0683/053363. Unpublished study prepared by BASF Aktiengesellschaft. 1 55 p. Salinas. E. (2008) BAS 700 F - Acute Toxicity Study with the Blucgill Sunfish (Lcpomis 47923723 macrochirus). Project Number: 2008/1010605/OCR. 2008/1010605. 14F0683/055084. Unpublished study prepared by BASF Aklicngcscllschafl. 49 p. Salinas, E. (2009) BAS 700 F - Acute Toxicity Study with the Fathead Minnow (Pimcphalcs 47923724 | promelas). Project Number: 2009/1025414/OCR, 2009/1025414, 15F0683/055093. 1 Unpublished study prepared by BASF Aklicngcscllschafl. 49 p. Yoshivasu. T. (2008) Acute Toxicity Study of (BAS 700 F) to Carp (Cvprinus carpio). 47923725 Project Number: 2008/1064998/OCR. 2008/1064998. 508050252. Unpublished study prepared by Japan Food Research Laboratories. 32 p. ( Nicr/.cdska, E. (2009) M700F001 (Metabolite of BAS 700 F): Acute Toxicity for Rainbow 47923726 | Trout. Project Number: 2009/1021591/OCR, 2009/1021591, W/09/09. Unpublished study prepared by Institute of Organic Industry. 34 p. Zmijowski. G. (2009) M700F002 (Metabolite of BAS 700 F): Acute Toxicity for Rainbow 47923727 Trout. Project Number: 2009/1021595/OCR. 2009/1021595. W/15/09. Unpublished study prepared by Institute of Organic Industry. 35 p. , Rzodeczko, H. (2009) M700F007 (Metabolite of BAS 700 F): Acute Toxicity for Rainbow 47923728 j Trout. Project Number: 2009/1026001/OCR, 2009/1026001, 314071. Unpublished study ' prepared by Institute of Organic Industry. 34 p. Zok. S. (2009) BAS 700 F - Early Life-Stage Toxicity Test on the Fathead Minnow j (Pimepliales promelas) in a Flow Through System Project Number: 2008/1090791/OCR, | 2008/1090791, 51F0683/055085. Unpublished study prepared by BASF Aktiengesellschaft. 106 p. Hafcmann. C.: Klocppncr. U. (2009) Bioconccntration and Metabolism of BAS 700 F in 47923730 Blucgill Sunfish (Lcpomis macrochirus). Project Number: 2009/1012801/OCR. 2009/1012801. 315780. Unpublished study prepared by BASF Aklicngcscllschafl. 163 p. Janson, G. (2009) Acute Toxicity of BAS 700 F to Daphnia magna STRAUS in a 48 Hour 47923731 Static Test. Project Number: 2008/1028252/OCR, 2008/1028252, 312497. Unpublished study prepared by BASF Aklicngcscllschafl. 22 p. Nicr/.cdska. E. (2009) M700F001 (Metabolite of BAS 700 F): Daphnia magna. Acute 47923732 ' Immobilization Test. Project Number: 2009/1021592/OCR, 2009/1021592, W/10/09. Unpublished study prepared by Institute of Organic Industry. 30 p. 47923733 i Zmijowski, G. (2009) M700F002 (Metabolite of BAS 700 F): Daphnia magna, Acute 40 ------- Immobilisation Test. Project Number: 2009/1021596/OCR. 2009/1021596. W/16/09. Unpublished study prepared by Institute of Organic Industry. 31 p. R/.odcc/.ko. H. (2009) M700F007 (Metabolite ofBAS 700 F): Daphnia magna. Acute 47923734 Immobilisation Test. Project Number: 2009/1026002/OCR. 2009/1026002. 314070. Unpublished study prepared by Institute of Organic Industry. 33 p. , Minderliout, T.; Kendall, T.; Krucgcr, H.; cl al. (2010) BAS 700 F: A Flow-Through Lifc- 1 j Cycle Toxicity Test with the Saltwater Mysid (Americamysis bahia). Project Number: | ' 2009/7006424/OCR, 2009/7006424, 147A/254. Unpublished study prepared by Wildlife | International, Ltd. 88 p. | Janson, G. (2009) Chronic Toxicity ofBAS 700 F to Daphnia magna STRAUS in a 21 Day 1 47923736 Semi-Static Test. Project Number: 2008/1055084/OCR, 2008/1055084, 312500. Unpublished study prepared by BASF Aklicngcscllscha.fi. 35 p. Hoffmann. F. (2010) Effect ofBAS 700 F on the Growth of the Green Alga | j Pseudokirchneriella subcapitata (Including Amendment No. 1 and Amendment No. 2). 1 1 Project Number: 2009/7003353/OCR. 2009/7003353. 312496. Unpublished study prepared by BASF Akticngcscllschafl. 38 p. Nicr/.cdska, E. (2009) M700F001 (Metabolite ofBAS 700 F): Pseudokirchneriella 1 j subcapitata SAG.61.81 - Growth Inhibition Test (Including Amendment No. 1). Project i 4/9Li UK i Numbcr. 2009/7006254/OCR. 2009/7006254. 314066. Unpublished study prepared by Institute of Organic Industry. 41 p. I Zmijowski, G. (2009) M700F002 (Metabolite of BAS 700 F): Pseudokirchneriella | 47923739 j subcapitata SAG.61.81 Growth Inhibition Test. Project Number: 2009/1021597/OCR, 2009/1021597. 314063. Unpublished study prepared bv Institute of Organic Industry. 38 p. R/.odcc/.ko. H. (2009) M700F007 (Metabolite ofBAS 700 F): Pseudokirchneriella [ j subcapitata SAG.61.81 - Growth Inhibition Test (Including Amendment No. 1). Project I 1 Number: 2009/7006255/OCR. 2009/7006255. 314069. Unpublished study prepared by Institute of Organic Industry. 40 p. Hoffmann. F. (2009) Effect ofBAS 700 F on the Growth of the Blue-Green Alga Anabacna 47923741 j flos-aquae. Project Number: 2009/1079883/OCR, 2009/1079883, 319810. Unpublished 1 study prepared by BASF Aktiengesellschaft. 33 p. Hoffmann. F. (2009) Effect ofBAS 700 F on the Growth of the Fresh Water Diatom 47923742 Navicula pclliculosa. Project Numbcr: 2009/1079885/OCR. 2009/1079885. 319811. Unpublished study prepared by BASF Akticngcscllschafl. 32 p. Hoffmann. F. (2009) Effect ofBAS 700 F on the Growth of the Marine Diatom | 47923743 j Skeletonema costatum. Project Number: 2009/1079884/OCR, 2009/1079884, 319816. 1 Unpublished study prepared by BASF Aktiengesellschaft. 35 p. Thomas. S.: Kendall. T.: Krucgcr. H.: cl al. (2010) BAS 700 F: A 10-Day Survival and , 47q9o7zU t Growth Toxicity Test with the Freshwater Ampliipod (Hyalclla aztcca) using Spiked j | Sediment. Project Number: 2010/7003236/OCR, 2010/7003236, 147A/255B. Unpublished study prepared by Wildlife International. Ltd. 80 p. Thomas. S.: Kendall. T.: Krucgcr. H.: cl al. (2009) BAS 700 F: A 10-Day Whole Sediment I 4-709-374« j Toxicity Test with Leptocheirus plumulosus using Spiked Sediment. Project Number: I 1 2009/7006265/OCR, 2009/7006265, 147A/25. Unpublished study prepared by Wildlife International. Ltd. 72 p. i7o2',74c Backfisch. K.: Wclljc. L. (2009) Chronic Toxicity ofBAS 700 F to the Non-Biting Midge 1 ' Chironomus riparius - A Spiked Sediment Study. Project Numbcr: 2009/1037085/OCR. 41 ------- 2009/1037085. 319818. Unpublished study prepared by BASF Aklicngcscllschafl. 39 p. Hoffmann. F. (2009) Effect of BAS 700 F on the Growth of Lcmna gibba. Project Number: | 47923747 | 2009/1086122/OCR, 2009/1086122, 319808. Unpublished study prepared by BASF ' 1 Akticngcscllschaft. 36 p. Schmitzcr. S. (2008) Effects of BAS 700 F (Acute Contact and Oral) on Honey Bees (Apis . 47923748 i mcllifcra L.) in the Laboratory. Project Number: 2008/1010703/OCR, 2008/1010703, | | 41711035. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 33 p. Schmil/.cr. S. (2009) Study on the Effect of BAS 700 00 F on Honey Bee Brood (Apis I 4709^740 j mellifera L.) under Semi-Field Conditions - Tunnel Test. Project Number: 1 1 2009/1037123/OCR, 2009/1037123, 314110. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 86 p. Fricdrich. S. (2009) Acute Toxicitv of BAS 700 F to the Earthworm Eiscnia fetida in | 47923750 [ Artificial Soil with 5% Peat. Project Number: 2009/1072245/OCR, 2009/1072245, 1312513/1. Unpublished study prepared by Biochem Agrar. Labor fuer Biologische und Chcmischc. 25 p. ( Witle, B. (2009) Acute Toxicity (14 Days) of (Metabolite of BAS 700 F, M700F001) to the | j Earthworm Eisenia fetida in Artificial Soil. Project Number: 2009/1050216/OCR, 1 2009/1050216. 314078. Unpublished study prepared bv Institut fuer Biologische Analytik und Consulting IBACON. 28 p. 1 j Witte, B. (2009) Acute Toxicity (14 Days) of (Metabolite of BAS 700 F, M700F002) to the | j Earthworm Eisenia fetida in Artificial Soil. Project Number: 2009/1072244/OCR, | | 2009/1072244, 314074/1. Unpublished study prepared by Institut fuer Biologische Analytik ' und Consulting IBACON. 28 p. Wolf. A. (2008) Effects of (M700F001. Metabolite of BAS 700 F) on Growth and , , Reproduction of Earthworms (Eiscnia fetida) in Artificial Soil. Project Number: | 4 riii /3 j | 2008/1033932/OCR, 2008/1033932, 314079. Unpublished study prepared by BASF ' Akticngcscllschaft. 28 p. Wolf. A. (2008) Effects of (M700F002. Metabolite of BAS 700 F) on Growth and 1 | Reproduction of Earthworms (Eiscnia fetida) in Artificial Soil. Project Number: j | 2008/1017010/OCR, 2008/1017010, 314075. Unpublished study prepared by BASF Aklicngcscllschafl. 28 p. Schulz. L. (2008) Effects of BAS 700 F on the Activity of Soil Microflora (Nitrogen | 47923755 ! Transformation Test). Project Number: 2008/1065108/US, 2008/1065108, 08/10/48/065/N. 1 1 Unpublished study prepared by Biochem Agrar. Labor fuer Biologische und Chemische. 28 P- Scluilz. L. (2009) Effects of (Metabolite of BAS 700 F. M700F001) on the Activity of Soil | | Microflora (Nitrogen Transformation Test). Project Number: 2008/1065121/OCR, 1 2008/1065121. 08/10/48/066/N. Unpublished study prepared by Biochem Agrar. Labor fuer Biologische und Chcmischc. 30 p. , , Schulz, L. (2009) Effects of (Metabolite of BAS 700 F, M700F002) 011 the Activity of Soil | j Microflora (Nitrogen Transformation Test). Project Number: 2009/1004145/OCR, 2009/1004145. 314073. Unpublished study prepared by Biochem Agrar. Labor fuer Biologische und Chcmischc. 31 p. 1 1 Schulz, L. (2008) Effects of BAS 700 F on the Activity of Soil Microflora (Carbon | 47923758 j Transformation Test). Project Number: 2008/1065107/OCR, 2008/1065107, | | 08/10/48/065/C. Unpublished study prepared by Biochem Agrar, Labor fuer Biologische 42 ------- und Chcmischc. 27 p. Schulz. L. (2009) Effects of (Metabolite of BAS 700 F. M700F001) on the Activity of Soil | | Microflora (Carbon Transformation Test). Project Number: 2008/1065120/OCR, 1 2008/1065120. 08/10/48/066/C. Unpublished study prepared by Biochcm Agrar. Labor fucr Biologischc und Chcmischc. 28 p. , , Schulz, L. (2009) Effects of (Metabolite of BAS 700 F, M700F002) on the Activity of Soil | 4700^760 ! Microflora (Carbon Transformation Test). Project Number: 2009/1004144/OCR, | 2009/1004144, 314072. Unpublished study prepared by Biochem Agrar, Labor fuer | Biologische und Chemische. 30 p. | Gallagher, S.; Kendall, T.; Krueger, H. (2009) BAS 700 F: A 96-Hour Static Acute Toxicity 1 47923761 Test with the Saltwater Mysid (Americamysis bahia). Project Number: 2009/7000069/OCR, 2009/7000069. 147A/231. Unpublished study prepared bv Wildlife International. Ltd. 45 p. Gallagher. S.: Kendall. T.: Krucgcr. H. (2009) BAS 700 F: A 96-Hour Shell Deposition Test 47923762 j with the Eastern Oyster (Crassostrea virginica). Project Number: 2009/7000165/OCR, 1 2009/7000165. 147A/233. Unpublished study prepared by Wildlife International. Ltd. 47 p. Gallagher. S.: Kendall. T.: Krucgcr. H.: cl al. (2009) BAS 700 F: A 96-Hour Sialic Acute ¦ 7()9^7 Toxicity Test with the Shccpshcad Minnow (Cyprinodon varicgatus). Project Number: | 4 /92 j /bi | 2008/7015417/OCR, 2008/7015417, 147A/232A. Unpublished study prepared by Wildlife 1 International. Ltd. 44 p. Porch. J.: Krucgcr. H.: Kendall. T.: cl al. (2009) BAS 700 01 F: A Toxicity Test to . 470907^4 j Determine the Effects of the Test Substance 011 Vegetative Vigor of Ten Species of Plants. | | Project Number: 2009/7006203/OCR, 2009/7006203, 147/238. Unpublished study prepared by Wildlife International. Ltd. 169 p. Porch. J.: Krucgcr. H.: Kendall. T.: cl al. (2009) BAS 700 01 F: A Toxicity Test to I j Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of | 4 /92 j /to | plants pr0ject Number: 2009/7006202/OCR, 2009/7006202,147/237. Unpublished study prepared by Wildlife International. Ltd. 120 p. Cords. S.: Lammcr. E. (2009) (Metabolite of BAS 700 F): Acute Oral Toxicity Sludv in | 47923766 | Rats. Project Number: 2009/1084176/OCR, 2009/1084176, 10A0432/099058. Unpublished 1 study prepared by Bioassav Labor fuer Biologische Analvtik GmbH. 25 p. Hammer. S. (2009) BAS 700 F: Determination of the Inhibition of Oxygen Consumption in , (the Activated Sludge Respiration Inhibition Test. Project Number: 2009/1110679/OCR, I I 2009/1110679, 08G0683/053372. Unpublished study prepared by BASF Aktiengesellschaft. ' 24 p. Rover. S. (2009) Effect of (Metabolite of BAS 700 F. M700F002) on the Reproduction of 1 470907^0 l the Collembola Folsomia Candida in Artificial Soil with 5% Peat. Project Number: I | 2009/1045472/OCR, 2009/1045472, 365782. Unpublished study prepared by BASF Aktiengesellschaft. 23 p. Krucck. S. (2009) Field Study to Evaluate Effects of BAS 701 00 F on Earthworms. Project 47923769 Number: 2009/1000121/OCR. 2009/1000121. 08/10/48/005/F. Unpublished study prepared by Biochcm Agrar. Labor fucr Biologischc und Chcmischc. 159 p. I j Royer, S.; Obermann, M. (2009) Effect of BAS 701 00 F on the Organic Matter 1 | Decomposition under Field Conditions (Litter Bag Method). Project Number: j | 2009/1067172/OCR, 2009/1067172, 314115. Unpublished study prepared by BASF 1 ' Aktiengesellschaft. 71 p. 47923771 Ta. C: Staab. F. (2010) BAS 700 F (Fluxapyroxad): Summary and Evaluation of 43 ------- Environmental Fate and Ecotoxicological Studies. Project Number: 2010/7002968/OCR. 2010/7002968. Unpublished study prepared bv BASF Corporation. 38 p. Fabian. E.: Landsicdcl. R. (2010) Carbon-14 (Metabolite of B AS 700 F) Absorption. I ( Distribution arid Excretion after Repeated Oral Administration in Laying Hens. Project | 4 /y2- 'L | Number: 2009/1083000/OCR, 2009/1083000, 02B0092/096003. Unpublished study prepared by BASF Aklicngcscllschaft. 38 p. Fabian. E.: Landsicdcl. R. (2010) Carbon 14 (Metabolite ofBAS 700 F) - Absorption. 1 j Distribution and Excretion after Repeated Oral Administration in Laying Hens. Project | Number. 2010/1009631/OCR. 2010/1009631. 02B0250/096005. Unpublished study prepared by BASF Aklicngcscllschaft. 40 p. Fabian. E.; Landsicdcl. R. (2010) Carbon 14 (Metabolite ofBAS 700 F) - Absorption. | . j Distribution and Excretion after Repeated Oral Administration in Lactating Goats. Project 1 1 Number: 2010/1009630/OCR. 2010/1009630. 02B0250/096006. Unpublished study prepared by BASF Aklicngcscllschaft. 42 p. , j Gagnc, J.; Staab, F.; Welter, K. (2010) BAS 700 F: Justification for an Ecologically | -7q9,77„ j Relevant Toxicity Endpoint for Wild Mammal Chronic Risk Assessment. Project Number: | | 2010/7003381/OCR, 2010/7003381. Unpublished study prepared by BASF Corporation. 23 1 lp. Yacoub. R. (2010) BAS 700 F (TGAI): Stability at Normal and Elevated Temperature. 47923776 Metal and Metal Ions: Final Report. Project Number: 2010/7003137/OCR. 2010/7003137. 375474. Unpublished study prepared by BASF Corporation. 12 p. Bent/.. A. (2009) Determination of the Technical Impurities in BAS 700 F TGAI. Batch | 47923777 | 35575/18. Project Number: 2009/1080846/OCR, 2009/1080846, 263299/18. Unpublished ' ' study prepared by BASF Aktiengesellschaft. 20 p. Fries. J. (2009) Certificate of Analysis: Characterization ofBAS 700 F. Batch 35575/18. 47923778 Project Number: 2009/1102151/OCR. 2009/1102151. 263299/17. Unpublished study prepared by BASF Aklicngcscllschaft. 6 p. Bent/.. A. (2009) Determination of the Technical Impurities in Five Different Batches of 47923779 | BAS 700 F TGAI. Project Number: 2009/1080842/OCR, 2009/1080842, 263299/16. 1 Unpublished study prepared by BASF Aktiengesellschaft. 21 p. Fries. J. (2008) Certificate of Analysis: Characterization of Rcg.No. 5094351. Batch No. 47923780 COD-001049. Project Number: 2009/1104581/OCR, 2009/1104581, 263299/10. Unpublished study prepared by BASF Aklicngcscllschaft. 6 p. Fries. J. (2008) Certificate of Analysis: Characterization ofBAS 700 F. Batch COD-001103. | 47923781 j Project Number: 2009/1104580/OCR, 2009/1104580, 263299/11. Unpublished study 1 prepared by BASF Aktiengesellschaft. 6 p. O'Bvrnc. D. (2010) Discussion of Special Batches of BAS 700 F Technical Grade Active 47923782 Ingredient. Project Number: 2010/7003714/OCR. 2010/7003714. Unpublished study prepared by BASF Corporation. 13 p. BASF Corporation (2010) Submission of Product Chemistry. Toxicity. Residue, and | 47923800 | Exposure and Risk Data in Support of the Application for Registration ofBAS 700 01F 1 Fungicide. Transmittal of 37 Studies. O'Bvrnc. D. (2010) BAS 700 01 F: Applicant Information. Project Number: 47923801 2010/7003735/OCR. 2010/7003735. Unpublished study prepared by BASF Corporation. 6 P- 44 ------- Arago. L. (2010) BAS 700 OIF - Group A - Product Identity. Composition and Analysis. 47923802 Project Number: 2010/7003320/OCR. 2010/7003320. AFL0777/01. Unpublished study prepared by BASF SE. 64 p. I j Kroelii, T. (2009) BAS 700 F 62.5 g/L EC - Physical and Chemical Properties of Formula I | BAS 700 01F- Accelerated Storage Stability for up to 2 Weeks at 54 Degrees Celcius in | 4 J80 j | PA/pE.Coextruded Packs prqject Number: 2009/1075206/OCR, EU/360430/1, 1 1 2009/1075206. Unpublished study prepared by BASF SE. 25 p. Yacoub. R. (2010) BAS 700 01 F: Determination of Oxidation/Reduction: Final Report. 47923804 Project Number: 2010/7003375/OCR. 201002/65/01. 2010/7003375. Unpublished study prepared by BASF Agro Research Center. 13 p. Fischer. S. (2009) Evaluation of Physical and Chemical Properties according to Directive | 47923805 j 94/37/EC (67/548/EC Annex V). Project Number: 2009/1043128/OCR, SK/NR/09/0636, 1 2009/1043128. Unpublished study prepared by B ASF Akticngcscllschaft. 12 p. Bent/.. A. (2009) Quantitative Determination of the Active Ingredient Rcg.No. 5094351 in 47923806 BAS 700 01 F by HPLC. Project Number: 2009/1024781/OCR. 2009/1024781. 360432/1. Unpublished study prepared by BASF SE. 16 p. Bent/, A. (2009) Validation of the Analytical HPLC-Mcthod AFL0777/01: Quantitative | 47923807 j Determination of the Active Ingredient BAS 700 F inBAS 700 01 F. Project Number: 1 2009/1024782/OCR. 360432/1. Unpublished study prepared by BASF SE. 20 p. Cords. S.: Lammcr. E. (2009) BAS 700 01F- Acute Oral Toxicity Study in Rats. Project 47923808 Number: 2009/1046045/OCR. 7/10A0929/089105. 10A0929/089105. Unpublished study prepared by Bioassay Labor fucr Biologischc Analvtik GmbH. 25 p. ( Cords, S.; Lammcr, E. (2009) BAS 700 01F- Acute Dermal Toxicity Study in Rats. Project | 47923809 j Number: 2009/1046044/US/OCR, 9104/EU/09/BF/DT028, 2009/1046044. Unpublished study prepared by Bioassay Labor fucr Biologischc Anal vtik GmbH. 26 p. Wittmer. E.: Landsicdcl. R. (2009) BAS 700 01F- Acute Inhalation Toxicity Study in i 47Q9Toin | WistarRats - 4-Hour Liquid Aerosol Exposure (Head-Nose Only) (Including Amendment I | No. 1 and Amendment No. 2). Project Number: 2009/7006577/OCR, EU/13I0929/087028, 2009/7006577. Unpublished study prepared bv BASF SE. 110 p. Bauer. B. (2009) BAS 700 01F- Acute Eve Irritation in Rabbits. Project Number: 47923811 2009/1072579/US/OCR. EU/11H0929/082225. 11H0929/082225. Unpublished study prepared by BASF SE. 24 p. Bauer, B. (2009) BAS 700 01F- Acute Dermal Irritation / Corrosion in Rabbits. Project I 47923812 Number: 2009/1072578/US/OCR, EU/18H0929/082224, 2009/1072578. Unpublished study prepared by BASF SE. 22 p. Ramcllc. M.: Landsicdcl. R. (2009) BAS 700 01F- BUEHLER Test in Guinea Pigs. Project 47923813 Number: 2009/1100354/US/OCR. EU/32H0929/082240. 32H0929/082240. Unpublished study prepared by BASF SE. 30 p. I | Carlez, V. (2010) Handler Exposure and Margin of Safety Assessments during the Foliar | 47090014 1 Application of Fluxapyroxad (BAS 700 F) Formulated in an Emulsifiable Concentrate (BAS | | 700 01 F) to Wheat and Barley in Australia. Project Number: 2010/7003573/OCR, 1 2010/7003573. Unpublished study prepared by BASF Corporation. 22 p. Becker. J. (2010) Dissipation of Dislodgcablc Foliar Residues of BAS 700 F following , 4709001 ^ 1 Applications to Tomato Plants. Project Number: 2010/7003558/OCR, | | 656/US/ARA/09/09/02, 2010/7003558. Unpublished study prepared by Ag Research Associates. LLC and BASF Agro Research Center. 186 p. 45 ------- 47923816 47923817 47923818 47923819 47923821 47923822 47923823 47923824 47923825 47923826 47923827 47923828 47923829 Salinas. P. (2009) BAS 700 01 F: Acute Toxicity Study in the Rainbow Trout (Oncorhvnchus mvkiss). Project Number: 2009/1122060/US/OCR. 7/EU/12F0929/085071. 2009/122060. Unpublished study prepared bv BASF SE. 50 p. I Jaiison, G. (2009) Acute Toxicity of BAS 700 01 F to Daphnia magna Straus in a 48 Hour | Static Test. Project Number: 2009/1117876/US/OCR, EU/366956, 366956. Unpublished study prepared by BASF SE. 21 p. Hoffmann. F. (2009) Effect of BAS 700 01 F on the Growth of the Green Alga Pseudokirchneriella subcapitata: Final Report. Project Number: 2009/1116616/US/OCR, EU/366955, 2009/1116616. Unpublished study prepared by BASF SE. 31 p. Sipos, K. (2009) Effects of BAS 700 01 F (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory. Project Number: 2009/1059195/US/OCR, 12/EU/09/084/116MT. 366992. Unpublished study prepared by LAB Research. Ltd. 34 p. Sipos. K. (2009) Effect of BAS 700 01 F on the Parasitic Wasp (Aphidius rhopalosiphi) in a | Laboratory Trial: Final Report. Project Number: 2009/1077338/US/OCR, I 996/EU/09/084/335FD. 2009/1077338. Unpublished studv prepared bv LAB Research. Ltd. 34 p. Rochlig, U. (2009) Effects of BAS 700 01 F on the Green Laccwing Chrysopcrla carnca | STEPH. under Laboratory Conditions - Rate-Response-Test: Final Report. Project Number: 1 2009/1110757/US/OCR. 3/EU/09/10/48/049/A. 2009/1110757. Unpublished study prepared by Biochcm Agrar. 29 p. , Sipos, K. (2010) Effect of BAS 700 01 F on the Predatory Mite (Typlilodromus pyri) in an | Extended Laboratory Trial: Final Report. Project Number: 2009/1112602/US/OCR, I 66995/EU/1/72/37/71, 2009/1112602. Unpublished study prepared by LAB Research, Ltd. I 32 p. Sipos. K. (2009) Effect of BAS 700 01 F on the Parasitic Wasp (Aphidius rhopalosiphi) in , an Extended Laboratory Trial. Project Number: 2009/1112603/US/OCR, I 74/EU/09/084/351FD, 2009/1112603. Unpublished study prepared by LAB Research, Ltd. '41 p. Schmitzcr. S. (2010) Effects of BAS 700 01 F on the Reproduction of Rove Beetles i Aleocliara bilineata - Extended Laboratory Study: Final Report. Project Number: | 2010/1004001/US/OCR, 81598/EU/1/72/37/77, 2010/1004001. Unpublished study prepared by Instilut fucr Biologischc Analvtik und Consulting IB ACON. 27 p. Witte. B. (2009) Acute Toxicity (14 Days) of BAS 700 01 F to the Earthworm Eiscnia fetida | in Artificial Soil with 5% Peat: Final Report. Project Number: 2009/1089822/US/OCR, I U/366952/EU/1539700. 2009/1089822. Unpublished study prepared by Institut fuer Biologischc Analvtik und Consulting IB ACON. 29 p. Fricdrich. S. (2009) Sublethal Toxicity of BAS 700 01 F to the Earthworm Eiscnia fetida in | Artificial Soil with 5% Peat: Final Report. Project Number: 2009/1106175/US/OCR, 1 2/EU/09/10/48/088/S. 2009/1106175. Unpublished study prepared by Biochcm Agrar. 28 p. Witte. B. (2009) Effects of BAS 700 01 F on Reproduction of the Collcmbola Folsomia , Candida in Artificial Soil willi 5% Peat: Final Report. Project Number: | 2009/1089825/US/OCR, U/1539709/EU/366991, 2009/1089825. Unpublished study prepared by Institut fucr Biologischc Anal vtik und Consulting IB ACON. 27 p. Fcil. N. (2009) Effects of BAS 700 01 F on the Activity of the Soil Microflora in the i Laboratory (Carbon Transformation Test): Final Report. Project Number: | 2009/1089815/US/OCR, U/1539688/EU/366988, 2009/1089815. Unpublished study | prepared by Institut fuer Biologische Analytik und Consulting IB ACON. 48 p. 46 ------- 47923830 Cane/. V. (2010) Handler Exposure and Margin of Safely Assessments during the Foliar | Application of Fluxapyroxad (BAS 700 F) Formulated in an Emulsifiable Concentrate (BAS j 700 01 F) and in Three Suspension Concentrate Formulations (BAS 700 04 F, BAS 703 47923831 j 01F, and BAS 703 02F) to Cereals, Oilseeds, Legume Vegetables, Tuberous and Corm, | Fruiting Vegetables, Stone and Pome Fruit in Canada and the United States . Project 1 Number: 2010/7003574/OCR. 2010/7003574. Unpublished study prepared by B ASF Canada. 23 p. , Staab, F. (2010) BAS 700 F (Fluxapyroxad): Screening Level Ecological Risk Assessment | Including Higher Tiered Steps for Non Target Aquatic and Terrestrial Organisms for 47923832 j Proposed Applications in Several Crops of the United States and Canada. Project Number: 1 2010/7003587/OCR. 2010/7003587. Unpublished study prepared by B ASF Corporation. 24 P- Cane/.. V. (2010) Reentry Exposure and Margin of Safely Assessments following the Foliar .....j.., j Application of Fluxapyroxad (BAS 700 F) Formulated in an Emulsifiable Concentrate (BAS 1 700 01 F) to Wheat and Barley in Australia. Project Number: 2010/7003572/OCR. 2010/7003572. Unpublished study prepared bv BASF Corporation. 12 p. , Cancz, V. (2010) Reentry Exposure and Margin of Safety Assessments Following the Foliar j Application of Fluxapyroxad (BAS 700 F) Formulated in an Emulsifiable Concentrate (BAS j 700 01 F) and in Three Suspension Concentrate Formulations (BAS 700 04 F, BAS 703 47923834 j 01F, and BAS 703 02F) to Cereals, Oilseeds, Legume Vegetables, Tuberous and Corm, | Fruiting Vegetables, Stone and Pome Fruit in Canada and the United States. Project Number: 2010/7003571/OCR, 2010/7003571. Unpublished study prepared by BASF Canada. 24 p. 47923835 47923836 47923837 47923900 47923901 Staab, F.; Jackson, S. (2010) BAS 700 F (Fluxapyroxad): Screening Level Ecological Risk Assessment for Non Target Aquatic and Terrestrial Organisms for Proposed Applications in 1 Cereal Crops of Australia: Final Report. Project Number: 2010/7003586/OCR, 1 2010/7003586. Unpublished study prepared by BASF Corporation. 16 p. Sipos. K. (2009) Effect of BAS 700 00 F on the Predatory Mite (Tvphlodromus pyri) in an , Extended Laboratory Trial: Final Report. Project Number: 2008/1046575/US/OCR, ! 82/EU/08/647/351RAR, 2008/1046575. Unpublished study prepared by LAB Research, Ltd. ' 32 p. Mayer. C. (2009) Evaluation of the Duration of Effects of BAS 700 00 F on the Predatory j Mite Typhlodromus pyri (Acari: Phytoseiidae) - Aged Residue Trial: Final Report. Project I Number: 2009/1069103/US/OCR. EU/314102. 2009/1069103. Unpublished study prepared by BASF SE. 29 p. BASF Corporation (2010) Submission of Product Chemistry. Toxicity, and Exposure and | Risk Data in Support of the Application for Registration of BAS 700 02 F Fungicide Seed 1 Treatment. Transmittal of 10 Studies. Cane/.. V. (2010) Seed Treatment Exposure and Margin of Safety Assessments during the , Commercial Seed Treatment of Soybean Seed with Fluxapyroxad (BAS 700 F) Formulated | as a Flowable Concentrate (FS) (BAS 700 02F and BAS 700 03F) in Canada. Project | Number: 2010/7003698/OCR, 2010/7003698. Unpublished study prepared by BASF | Canada, Inc. 26 p. 47923902 ( Arago, L. (2010) BAS 700 02 F: Group A - Product Identity, Composition and Analysis. 47 ------- Project Number: 2010/7003321/OCR. 2010/7003321. AFL0788/01. Unpublished study prepared by BASF Akticngcscllschafl. 97 p. 47923903 47923904 47923905 47923906 47923907 47923908 47923909 47923910 47924000 Keller. M. (2009) Physical and Chemical Properties ofBAS 700 F 333 g/L FS (BAS 700 02 j F) Including Low Temperature Stability and Accelerated Storage Stability Up to 2 Weeks at 1 54 Degrees Celsius. Project Number: 2009/1099062/OCR, 2009/1099062, 367661/1. Unpublished study prepared by BASF Aklicngcscllscha.fi. 26 p. Yacoub. R. (2010) BAS 700 02 F: Determination of Oxidation/Reduction. Project Number: 2010/7003377/OCR, 2010/700337, 367671. Unpublished study prepared by BASF Corporation. 13 p. Canez, V. (2010) Exposure and Margin of Safety Assessments for Loading and Sowing of Soybean Seeds Treated with Fluxapyroxad (BAS 700 F) Formulated as a Flowable I Concentrate (FS) (BAS 700 02 F and BAS 700 03 F) in Canada. Project Number: 1 2010/7003709/OCR. 2010/7003709. Unpublished study prepared by BASF Canada. Inc. 11 P- , Pr/y wara, B.; Harscli, M. (2009) Quantitative Determination of the Active Ingredient in 1 BAS 700 02 F by HPLC. Project Number: 2009/1084186/OCR, 2009/1084186, AFL0788/01. Unpublished study prepared bv BASF Akticngcscllscha.fi. 17 p. Pr/.v wara. B.: Harscli. M. (2009) Validation of the Analytical HPLC-Mcthod AFL0788/01: j Quantitative Determination of the Active Ingredient BAS 700 F in BAS 700 02 F by HPLC. 1 Project Number: 2009/1084187/OCR, 2009/1084187, 367667/1. Unpublished study prepared by BASF Akticngcscllschaft. 20 p. Cords. S.: Nchrbass. T. (2010) BAS 700 02 F - Acute Oral Toxicity Study in Rats. Project j Number: 2009/1116752/OCR, 2009/1116752, 09/BF/OT100. Unpublished study prepared 1 by Bioassav Labor fuerBiologische Analytik GmbH. 23 p. Cords. S.: Nchrbass. T. (2010) BAS 700 02 F - Acute Dermal Toxicity Study in Rats. Project Number: 2009/1116753/OCR. 2009/1116753. 09/BF/DT101. Unpublished study prepared by Bioassav Labor fucr Biologischc Analytik GmbH. 26 p. Wittmcr. E.: Landsicdcl. R. (2010) BAS 700 02 F - Acute Inhalation Toxicity Study in | Wistar Rats - 4-Hour Liquid Aerosol Exposure (Head-Nose Only). Project Number: 1 2010/1009632/OCR. 2010/1009632. 1310374/097012. Unpublished study prepared by BASF Akticngcscllschaft. Labor fucr Ockotoxicologic. 50 p. . BASF Corporation (2010) Submission of Product Chemistry and Toxicity Data in Support | of the Application for Registration ofBAS 700 03 F Fungicide Seed Treatment. Transmittal of 7 Studies. 47924002 47924003 47924006 47924007 Arago. L. (2010) BAS 700 03 F: Group A - Product Identity. Composition and Analysis. Project Number: 2010/7003333/OCR. 2010/7003333. AFL0789/01. Unpublished study prepared by BASF Akticngcscllschaft. 86 p. . Keller, M. (2009) Physical and Chemical Properties of BAS 700 F 28.7% FS (BAS 700 03 | F) Including Accelerated Storage Stability Up to 2 Weeks at 54 Degrees Celsius. Project Number: 2009/1099063/OCR. 2009/1099063. 351165/1. Unpublished study prepared by BASF Akticngcscllschaft. 19 p. j Pr/y wara. B.; Harsch, M. (2009) Quantitative Determination of the Active Ingredient in (BAS 700 03 F by HPLC. Project Number: 2009/1086676/OCR, 2009/1086676, 351166/1. Unpublished study prepared by BASF Akticngcscllschaft. 17 p. Pr/y wara. B.: Harsch. M. (2009) Validation of the Analytical HPLC-Mcthod AFL0789/01: Quantitative Determination of the Active Ingredient BAS 700 F in BAS 700 03 F by HPLC. 48 ------- Project Number: 2009/1086677/OCR. 2009/1086677. 351166/1. Unpublished study prepared by BASF Aklicngcscllschafl. 20 p. Warcing. B. (2010) BAS 700 03 F - Acute Eve Irritation in Rabbits. Project Number: 47924008 2009/1110765/OCR. 2009/1110765. 11H0371/092066. Unpublished study prepared by BASF Aklicngcscllscha.fi. 23 p. , Warcing, B. (2010) BAS 700 03 F - Acute Dermal Irritation / Corrosion in Rabbits. Project | 47924009 | Number: 2009/1110764/OCR, 2009/1110764, 18H0371/092065. Unpublished study prepared by BASF Aklicngcscllschafl. 21 p. Rcmmclc. M.: Landsicdcl. R. (2010) BAS 700 03 F - BuchlcrTcsl in Guinea Pigs. Project 47924010 Number: 2009/1110763/OCR. 2009/1110763. 32H0371/092067. Unpublished study prepared by BASF Aklicngcscllschafl. 30 p. , BASF Corporation (2010) Submission of Product Chemistry and Toxicity Data in Support | 47924100 j of the Application for Registration of BAS 700 04 F Fungicide Seed Treatment. Transmittal of 17 Studies. Arago. L. (2010) BAS 700 04 F: Group A: Product Identity. Composition and Analysis. 47924102 Project Number: 2010/7003484/OCR. 201003/06/01/OCR. 2009/1096910. Unpublished study prepared by BASF Aklicngcscllschafl. 77 p. j Kroclil, T. (2010) BAS 700 F 300 g/L SC: Physical and Chemical Properties of Formula 1 _i 7()9_i | 1 BAS 700 04 F: Accelerated Storage Stability for up to 2 Weeks at 54 Degrees Celsius in | /y241u | HDPE Packs. Project Number: 2009/1119422/OCR, 360420/1/OCR. Unpublished study ' 1 prepared by BASF Aktiengesellschaft. 25 p. Yacoub. R. (2010) BAS 700 04 F: Determination of Oxidation/Reduction. Project Number: 47924104 2010/7003378/OCR. 002/61/01/OCR. 360421/OCR. Unpublished study prepared by BASF Agro Research. 13 p. Bent/.. A.: Sicbcckcr. M. (2009) Quantitative Determination of the Active Ingredient in BAS 47924105 [ 700 04 F by HPLC. Project Number: 2009/1096910/OCR, 0792/01/OCR, 360422/1/OCR. 1 Unpublished study prepared by BASF Aktiengesellschaft. 16 p. Bent/.. A. (2009) Validation of the Analytical HPLC-Mcthod AFL0792/01: Quantitative • 47994106 ' Determination of the Active Ingredient BAS 700 F inBAS 700 04 F. Project Number: | 4 /9z4t0o | 2009/1096911/OCR, 360422/1/OCR. Unpublished study prepared by BASF ' Aklicngcscllschafl. 20 p. Cords. S.: Lammcr. E. (2009) BAS 700 04 F: Acute Oral Toxicity Study in Rats. Project 47924107 Number: 2009/1046046/OCR. 10A0165/099018/OCR. 09/BF/OT088. Unpublished study prepared by Bioassay Labor fucr Biologischc Analytik GmbH. 23 p. , Cords, S.; Lammcr, E. (2009) BAS 700 04 F: Acute Dermal Toxicity Study in Rats. Project | 47924108 | Number: 2009/1046047/OCR, 09/BF/DT089/OCR, 11A0165/099019. Unpublished study prepared by Bioassay Labor fucr Biologischc Analytik GmbH. 26 p. Wittmcr. E.: Landsicdcl. R. (2010) BAS 700 04 F: Acute Inhalation Toxicity Study in I 47094100 I Wistar Rats: 4-Hour Liquid Aerosol Exposure (Head-Nose Only). Project Number: I | 2010/1014827/OCR, 13I0165/09I001/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 46 p. Wolf. T. (2009) BAS 700 04 F: Acute Eve Irritation/Corrosion in Rabbits. Project Number: | 47924110 2009/1107321/OCR, 11H0165/099101/OCR, BAS70. Unpublished study prepared by | 1 Seibersdorf Labor GmbH. 25 p. | 47924111 Wolf. T. (2009) BAS 700 04 F: Acute Dermal Irritation/Corrosion in Rabbits. Project 49 ------- Number: 2009/1107323/OCR. 18H0165/099100/OCR. BAS71. Unpublished study prepared bv Seibersdorf Labor GmbH. 23 p. 47924112 47924113 Wciss-Fuchs. U. (2010) BAS 700 04 F: Skin Scnsitisation Study (in Guinea Pigs) (Buchlcr test) (Including Amendment no. 1). Project Number: 2010/7003521/OCR, 32H0165/099102/OCR, BAS69. Unpublished study prepared by Seibersdorf Labor GmbH. 38 p. Salinas. E. (2009) BAS 700 04 F: Acute Toxicity Study in the Rainbow Trout (Oncorhynchus mykiss). Project Number: 2009/1120235/OCR, 12F0165/095033/OCR, 374384. Unpublished study prepared by BASF Akticngcscllschaft. Experimental Toxicology and Ecology. 50 p. Janson. G. (2010) Acute Toxicity of BAS 700 04 F to Daphnia magna Straus in a 48 Hour 47924114 | Static Test. Project Number: 2009/1120198/OCR, 374383/OCR. Unpublished study 1 prepared by BASF Akticngcscllschaft. 21 p. 47924115 47924116 47924117 47924118 47924200 47924202 47924203 47924204 47924205 Hoffmann. F. (2010) Effect of BAS 700 04 F on the Growth of the Green Algae Pscudokirchncriclla subcapital: Supplement. Project Number: 2009/1116615/OCR. 374382/OCR. Unpublished study prepared by BASF Akticngcscllschaft. 31 p. Zenker, K. (2009) Acute Toxicity of BAS 700 04 F to the Honeybee Apis mcllifcra L. under I Laboratory Conditions. Project Number: 2009/1098875/OCR, 314334/OCR. 1/49/39/80. 1 Unpublished study prepared by Biochcm Agrar. Labor fucrBiologischc und Chcmischc. 30 P- , Fallowficld, L. (2009) A Rate-Response Laboratory Test to Determine the Effects of BAS j 700 04 F on the Predatory Mite, Typhlodromus pyri (Acari: Phytoseiidae): Supplement. 1 Project Number: 2009/1119430/OCR, 374385/OCR, 1/72/64/89. Unpublished study 1 prepared by Mambo-Tox. Ltd. 26 p. Stevens. J. (2009) A Rate-Response Laboratory Test to Determine the Effects of BAS 700 04 F on the Parasitic Wasp, Aphidius rhopalosiphi (Hymcnoptcra, Braconidac): | Supplement. Project Number: 2009/1119429/OCR, 383347/OCR, 1754821. Unpublished study prepared by Mambo-Tox. Ltd. 26 p. BASF Corporation (2010) Submission of Product Chemistry. Toxicity and Fate Data in Support of the Application for Registration of BAS 703 01 F Fungicide. Transmittal of 19 Studies. , Kroclil, T. (2009) BAS 700 F/Pyraclostrobin 250/250 g/L SC - Physical and Chemical | Properties of Formula BAS 703 01 F- Accelerated Storage Stability for up to 8 Weeks at 40 Degrees Celsius in HDPE Packs. Project Number: 2009/1093207/OCR. 2009/1093207. 346735/1. Unpublished study prepared by BASF Akticngcscllschaft. 27 p. i Yacoub, R. (2010) BAS 703 01F: Determination of Oxidation/Reduction: Final Report. | Project Number: 2010/7003380/OCR, 2010/7003380, 375475. Unpublished study prepared by BASF Corporation. 13 p. Bent/.. A.: Sicbcckcr. M. (2009) Analytical HPLC-Mcthod AFL0783/01 - Quantitative j Determination of the Active Ingredients BAS 700 F, and Pyraclostrobin in BAS 703 01 F by I HPLC. Project Number: 2009/1058626/OCR. 2009/1058626. AFL0783/01. Unpublished study prepared by BASF Akticngcscllschaft. 21 p. Bent/.. A. (2009) Validation of the Analytical HPLC-Mcthod AFL0783/01: Quantitative | Determination of the Active Ingredients BAS 700 F and Pyraclostrobin in BAS 703 01F. | Project Number: 2009/1058627/OCR, 2009/1058627, 346736/1. Unpublished study | prepared by BASF Aktiengesellschaft. 22 p. 50 ------- Cords. S.: Nchrbass. T. (2009) BAS 703 OIF - Acute Oral Toxicity Study in Ruts. Project 47924206 Number: 2009/1058515/OCR. 2009/1058515. 10A0832/089070. Unpublished study prepared by Bioassav Labor fiicr Biologische Analvtik GmbH. 27 p. I Cords, S.; Nelirbass, T. (2009) BAS 703 01 F- Acute Dermal Toxicity Study in Rats. 47924207 ( Project Number: 2009/1058516/OCR, 2009/1058516, 11A0832/089094. Unpublished study prepared by Bioassav Labor fiicr Biologische Analvtik GmbH. 26 p. Witlmcr. E.: Landsicdcl. R. (2009) BAS 703 01F- Acute Inhalation Toxicity Study in 47994908 1 Wistar Rats - 4-Hour Liquid Aerosol Exposure (Head-Nose Only). Project Number: 1 2009/1112581/OCR. 2009/1112581. 1310832/087030. Unpublished study prepared by BASF Akticngcscllscha.fi. 61 p. Rcmmclc. M. (2009) BAS 703 01F- Acute Eve Irritation in Rabbits. Project Number: 47924209 | 2009/1079827/OCR, 2009/1079827, 11H0832/082230. Unpublished study prepared by 1 BASF Akticngcscllschaft. 24 p. Rammclc. M. (2009) BAS 703 01F- Acute Dermal Irritation / Corrosion in Rabbits. Project 47924210 Number: 2009/1079826/OCR. 2009/1079826. 18H0832/082234. Unpublished study prepared by BASF Akticngcscllschaft. 22 p. Rcmmclc, M.; Landsicdcl, R. (2009) BAS 703 01F- BuchlcrTcst in Guinea Pigs. Project 47924211 | Number: 2009/1079828/OCR, 2009/1079828, 32H0832/082235. Unpublished study ' prepared by BASF Akticngcscllschaft. 32 p. Salinas. E. (2009) BAS 703 01 F: Acute Toxicity Study in the Rainbow Trout 47924212 (Oncorhyncluis mykiss). Project Number: 2009/1116843/OCR. 2009/1116843. 12F0832/085067. Unpublished study prepared by BASF Akticngcscllschaft. 53 p. (Janson, G. (2009) Acute Toxicity of BAS 703 01 F to Daphnia magna Straus in a 48 Hour 47924213 | Static Test. Project Number: 2009/1103583/OCR, 2009/1103583, 352390. Unpublished ' study prepared by BASF Akticngcscllschaft. 24 p. Hoffmann. F. (2009) Effect of BAS 703 01 F on the Growth of the Green Alga 47924214 Pscudokirchncriclla subcapital. Project Number: 2009/1096901/OCR. 2009/1096901. 352389. Unpublished study prepared by BASF Akticngcscllschaft. 34 p. , Sipos, K. (2009) Effects of BAS 703 01 F (Acute Contact and Oral) on Honey Bees (Apis 47924215 ® lnc"'^cra L ) in the Laboratory. Project Number: 2009/1059197/OCR, 2009/1059197, | 09/087/116MT. Unpublished study prepared by LAB International Research Centre | Hungary, Ltd. 34 p. j Sipos, K. (2009) Effect of BAS 703 01 F on the Predatory Mite (Typhlodromus pyri) in a 47924216 | Laboratory Trial. Project Number: 2009/1077335/OCR, 2009/1077335, 09/087/335RA. Unpublished study prepared by LAB International Research Centre Hungary. Ltd. 31 p. Sipos. K. (2009) Effect of BAS 703 01 F on the Parasitic Wasp (Aphidius rhopalosiphi) in a 47924217 Laboratory Trial. Project Number: 2009/1077339/OCR. 2009/1077339. 09/087/335FD. Unpublished study prepared by LAB International Research Centre Hungary. Ltd. 34 p. | Porch, J.; Krueger, H.; Kendall, T.; et al. (2009) BAS 703 OLA Toxicity Test to Determine 4.7994.9 is l'1c Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants. Project | Number. 2009/7006348/OCR, 2009/7006348, 147/248. Unpublished study prepared by 1 Wildlife International. Ltd. 169 p. Porch. J.: Krueger. H.: Kendall. T.: cl al. (2009) BAS 703 OLA Toxicity Test to Determine 47994919 i l'1c Effects of the Test Substance on Seedling Emergence of Ten Species of Plants. Project | Number. 2009/7006347/OCR, 2009/7006347, 147/247. Unpublished study prepared by Wildlife International. Ltd. 109 p. 51 ------- Arago. L. (2010) BAS 703 01 F: Group A - Product Identity. Composition and Analysis. 47924220 Project Number: 2010/7003549/OCR. 2010/7003549. AFL0783/01. Unpublished study prepared by BASF Aklicngcscllschafl. 104 p. BASF Corporation (2010) Submission of Product Chemistry, Toxicity and Fate Data in 47924300 Support of the Application for Registration of BAS 703 02 F Fungicide. Transmittal of 19 Studies. Arago. L. (2010) BAS 703 02 F: Group A: Product Identity. Composition and Analysis. 47924302 Project Number: 2010/7003550/OCR, 2009/1072414. Unpublished study prepared by BASF Aktiengesellschaft. 104 p. Kroehl, T. (2010) BAS 700 F/Pyraclostrobin 167/333 g/L SC - Physical and Chemical 479?-T(P ProPcrt'cs of Formula BAS 703 02 F - Accelerated Storage Stability for up to 8 weeks at 40 | Degrees Celsius in HDPE Packs. Project Number: 2010/1007164/OCR, 365678/1/OCR, 1 B AS/703/02/F. Unpublished study prepared by BASF Aktiengesellschaft. 27 p. i7()7_P() I Yacoub. R. (2010) BAS 703 02 F: Determination of Oxidation/Reduction. Project Number: 1 2010/7003379/OCR. 375476. Unpublished study prepared bv BASF Agro Research. 13 p. Bent/.. A.: Sicbcckcr. M. (2009) Analytical HPLC-Mcthod AFL0784/01: Quantitative A-ia-yA-inf. , Determination of the Active Ingredients BAS 700 F and Pyraclostrobin in BAS 703 02 F by | HPLC. Project Number: 2009/1072414/OCR. Unpublished study prepared by BASF ' Aklicngcscllschafl. 21 p. Bent/.. A. (2009) Validation of the Analytical HPLC-Mcthod AFL0784/01: Quantitative . | Determination of the Active Ingredients BAS 700 F and Pyraclostrobin in BAS 703 02 F by | HPLC. Project Number: 2009/1072415/OCR, 365680/1/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 22 p. Cords. S.: Lammcr. E. (2009) BAS 703 02 F: Acute Oral Toxicity Study in Rats. Project 47924308 ' Number: 2009/1072463/OCR. 09/BF/OT051/OCR. 10A0203/099049. Unpublished study prepared by Bioassay Labor fucr Biologischc Analytik GmbH. 28 p. I Cords, S.; Lammer, E. (2009) BAS 703 02 F - Acute Dermal Toxicity Study in Rats. Project 47924309 j Number: 2009/1072464/OCR, 11A0203/099050/OCR, 09/BF/DT/050. Unpublished study prepared by Bioassay Labor fucr Biologischc Analytik GmbH. 26 p. Witlmcr. E.: Landsicdcl. R. (2009) BAS 703 02 F: Acute Inhalation Toxicity Study in 47Q?/nio i Wistar Rats: 4-Hour Liquid Aerosol (Head-Nose Only). Project Number: | 2009/1099680/OCR. 13T0203/097006/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 57 p. Rcmmclc. M. (2009) BAS 703 02 F: Acute Eve Irritation in Rabbits. Project Number: 47924311 | 2009/1093221/OCR, 11H0203/092027/OCR." Unpublished study prepared by BASF 1 Aktiengesellschaft. Experimental Toxicology and Ecology. 24 p. Rcmmclc. M. (2009) BAS 703 02 F: Acute Dermal Irritation / Corrosion in Rabbits. Project 47924312 Number: 2009/1093220/OCR. 18H0203/092034/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. Experimental Toxicology and Ecology. 22 p. Rcmmclc. M. (2009) BAS 703 02 F: BuchlerTcst in Guinea Pigs. Project Number: 47924313 | 2009/1093222/OCR, 32H0203/092035/OCR. Unpublished study prepared by BASF 1 Aktiengesellschaft. Experimental Toxicology and Ecology. 32 p. Salinas. P. (2009) BAS 703 02 F: Acute Toxicity Study in the Rainbow Trout 47924314 1 (Oncorhvncluis mykiss). Project Number: 2009/1114416/OCR, 12F0203/095014/OCR. | Unpublished study prepared by BASF Aktiengesellschaft, Experimental Toxicology and Ecology. 53 p. 52 ------- Janson. G. (2009) Acute Toxicity ofBAS 703 02 F to Daphnia magna Straus in a 48 Hour 47924315 Sialic Test. Project Number: 2009/1103584/OCR. 366975/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 24 p. j Hoffmann, F. (2009) Effect of B AS 703 02 F on the Growth of the Green Alga 47924316 | Pseudokirchneriella subcapitata: Supplement. Project Number: 2009/1096902/OCR, 366974/OCR. Unpublished study prepared by BASF Aklicngcscllschafl. 33 p. Sipos. K. (2009) Effects ofBAS 703 02 F (Acute Contact and Oral) on Honey Bees (Apis 47924317 ® nlc"'^cra L.) in the Laboratory. Project Number: 2009/1075203/OCR, 1/61/85/61/OCR, 1 374397/OCR. Unpublished studv prepared bv LAB International Research Centre Hungary. Ltd. 34 p. Sipos. K. (2009) Effect ofBAS 703 02 F on the Predatory Mite (Typhlodromus pvri) in a 47924318 ! Laboratory Trial: Supplement. Project Number: 2009/1077336/OCR, 374399/OCR, 1 1/61/95/18/OCR. Unpublished study prepared by LAB International Research Centre Hungary. Ltd. 31 p. ( Sipos, K. (2009) Effect of B AS 703 02 F on the Parasitic Wasp (Apliidius rliopalosiplii) in a 47924319 ® laboratory Trial: Supplement. Project Number: 2009/1077340/OCR, 1/61/95/21/OCR, | 374401/OCR. Unpublished study prepared by LAB International Research Centre Hungary, 1 Ltd. 34 p. Porch. J.: Krucgcr. H.: Kendall. T.: cl al. (2009) BAS 703 02 F: A Toxicity Test to A-iQ-yA-i-yt) • Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants. | Project Number: 2009/7006442/OCR, 374396/OCR, 147/246/OCR. Unpublished study 1 prepared by Wildlife International. Ltd. 172 p. Krucgcr. H.: Kendall. T.: Staab. F.: cl al. (2009) BAS 703 02 F: A Toxicity Test to ¦ 7q9 ., | Determine the Effects of the Test Sublancc on Seedling Emergence of Ten Species of | Plants. Project Number: 2009/7006321/OCR, 147/245/OCR, 374395/OCR. Unpublished study prepared by Wildlife International. Ltd. 119 p. 48356300 Corporation (2011) Submission of Toxicity Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 1 Study. Fabian. E.: Landsicdcl. R. (2010) (Carbon 14)-BAS 703 02 F - in-vivo Dermal Absorption 48356301 1 iU tllC RaL Pr°Jcct Nunlbcr: 01B0651/096010, 2010/1009626, 01B0651/096010/OCR. | Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer Oekotoxicologie. 46 P- 48386800 ^^F Corporation (2011) Submission of Environmental Fate Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 1 Study. Bayer. H.: Ta. C. (2010) BASF Response to Deficiency Letter from APVMA Dated 22 48386801 October 2010 on Anacrobicity of Test Systems in BAS 700 F Studies. Project Number: 2010/1185606. Unpublished study prepared by BASF Aklicngcscllschafl. 7 p. 48409100 Corporation (2011) Submission of Environmental Fate Data in Support of the Registration of Xcmium Fungicide Technical. Transmittal of 1 Study. Hassink. J. (2011) BAS 700 F: Aqueous Hydrolysis al Four Different pH Values (Including 48409101 j Amendment No. 1). Project Number: 324301, 2011/7000318. Unpublished study prepared 1 by BASF Aktiengesellschaft. 19 p. BASF Corporation (2011) Submission of Toxicity and Exposure and Risk Data in Support 48475900 of the Applications for Registration of BAS 703 01 F Fungicide and Xcmium Fungicide Technical. Transmittal of 2 Studies. 53 ------- 48475901 48475902 48485300 48485301 48495200 48495201 48514400 48514401 48565300 48565301 48580800 48580801 48580802 48665700 Slaab. F.: Edwards. D. (2011) Assessment of the Potential Effects of Fluxapvroxad (BAS | 700 F) and Co-formulations of Fluxapyroxad and Pyraclostrobin on Brood Development in i Honey Bees. Project Number: 2011/7000789. Unpublished study prepared by BASF Corporation. 21 p. Slaab. F.: Edwards. D. (2011) Response to U.S. EPA's Reduced Risk Decision for | Fluxapyroxad Use on Apples: Aquatic and Sediment Organisms. Project Number: 1 2011/7000790. Unpublished study prepared by BASF Corporation. 9 p. BASF Corporation (2011) Submission of Toxicity Data in Support of the Application for Registration of XcmiumFungicide Technical. Transmittal of 1 Study. Zok, S. (2011) BAS 700 F - Avian Dietary LC50 Test in Chicks of the Bobwhite Quail (Colinus virginianus) (Including Amendment No. 1 and Amendment No. 2). Project I Number: 2011/7000183, 31W0683/055090. Unpublished study prepared by BASF SE. 122 fP- BASF Corp. (2011) Submission of Environmental Fate Data in Support of the Application for Registration of Fluxapyroxad Fungicide (BAS 700F). Transmittal of 1 Study. Pcrc/.. R.: Pcrc/.. S. (2011) Independent Laboratory Validation of BASF Analytical Method L0143/01: Validation of Analytical Method L0143/01: Determination of 700 F and Its | Metabolities M700F001, M700F002 andM700F007 in Water by HPLC/MS-MS: Amended 1 Report. Project Number: 395759. 2K10/ADPEN/903/0817A. 2011/7001254. Unpublished study prepared by ADPEN Laboratories. Inc. 174 p. I BASF Corporation (2011) Submission of Environmental Fate Data in Support of the | Application for Registration of Fluxapyroxad Fungicide (BAS 700F). Transmittal of 1 Study. Warren. R. (2011) Soil Taxonomic Classification Crosswalk for Non-Us Soils Used in j Environmental Fate Studies Supporting the Global Registration Submission of ! Fluxapyroxad (BAS 700 F). Project Number: 2011/70012376. Unpublished study prepared by BASF Agro Research. 22 p. BASF Corporation (2011) Submission of Toxicity Data in Support of the Application for Registration of BAS 700 01 F Fungicide. Transmittal of 1 Study. Sipos. K. (2009) Effects of BAS 700 01 F (Acute Contact and Oral) on Honey Bees (Apis | mellifere L.) in the Laboratory. Project Number: 1059195/US/ocr/ver/l I /12//EU/09/084/116MT 366992. Unpublished study prepared by LAB International Research Centre Hungary. Ltd. 34p. BASF Corporation (2011) Submission of Residue Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 2 Studies. Richtcr. M. (2011) Investigation of the Storage Stability of the BAS 700 F Metabolite M700F048 in Plant Matrices and Processed Commodities. Project Number: 2011/1125600. 362486. Unpublished study prepared by BASF SE. 68p. Lchmann. A.: Mackcnroth. C. (2011) Investigation of the Storage Stability of M700F008 in Plant Matrices. Unpublished study prepared by BASF Aklicngcscllschafl. 24p. , BASF Corporation (2011) Submission of Residue and Environmental Fate Data in Support | of the Application for Registration of Xemium Fungicide Technical. Transmittal of 5 Studies. 48665701 Schoptcr. C. (2011) Fluxapyroxad (BAS 700 F): Evaluation of Frcc/cr Storage Stability 1 Data for Metabolite M700F008. Project Number: 2011/1139629. Unpublished study 54 ------- prepared by BASF Akticngescllschafl. 27p. Schrcincr. D.: Deppermann. N. (2011) Re-Analysis of Samples which were Generated 48665702 j during Wheat and Soybean Metabolism Studies with 14C-BAS 700 F. Project Number: 1 315732/1. 2011/1141383. Unpublished study prepared by BASF Akticngcscllschaft. 60p. 48665703 Erdmann. H. (2011) Field Rotational Crop Study with BAS 700 00 F. Containing 62.5 g/L. Applied to Bare Soil at 365, 120 and 30 Days Prior to Planting of Four Rotational Crops in Spain, Italy, Greece and Germany, 2008-2009. Project Number: 315743, AC/B ASF/08/01, 2010/1144335. Unpublished study prepared bv Agro-Check. 160p. Erdmann. H. (2011) Study on the Residue Behaviour of BAS 700 F in Barley. Wheat and 48665704 Rotational Crops Under Field Condition in UK and Germany. 2009. Project Number: 374090. AC/BASF/09/14. 2010/1159929. Unpublished study prepared by Agro-Check. 60p. ( Erdmann, H. (2011) Field Rotational Crop Study willi BAS 700 00 F, Containing 62.5 g/L, 48665705 I Applied to Bare Soil, with a Nominal Application Rate of 250 g a.i./ha, at 30 Days Prior to | Planting of Oilseed Rape in Spain, Italy and Germany, 2009 - 2010. Project Number: 1 376206. AC/B ASF/09/16. 2010/1159931. Unpublished study prepared by Agro-Check. 71p. 48733000 BASF Corporation (2012) Submission of Environmental Fate Data in Support of the Application for Registration of Xcmium Fungicide Technical. Transmittal of 1 Study. I Erdmann, H. (2011) Study on the Residue Behaviour of BAS 700 F on the Rotational j Crops: Corn, Potato, Sugarbeet (EU-N), Sunflower (EU-S) after One Application (250 g 48733001 j a.i./ha) of BAS 700 00 F to Bare Soil 30 Days Prior Planting, under Field Conditions in | Spain, Italy and Germany, 2010-2011. Project Number: 385154, AC/BASF/10/08, | 2011/1050133. Unpublished study prepared by Agro-Check. 93p. 55 ------- |