United States Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances (7501P) ?/EPA Pesticide Fact Sheet Name of Chemical: Reason for Issuance: Date Issued: Prothioconazole New Chemical Tolerances Established March 14,2007 Description of Chemical Generic Name: Common Name: Trade Name: Chemical Class: EPA Chemical Code: CAS Number: Registration Status: Pesticide Type: U.S. Producer: Tolerances Established Prothioconazole (2-(2-(l-chlorocyclopropyl)-3-(2- chlorophenyl)-2-hydroxypropyl)-1,2-dihydro-3#- l,2,4-triazole-3-thione) Prothioconazole PROLINE ® 480 SC Fungicide Triazolinthione 113961 178928-70-6 New Chemical Registration Fungicide Bayer CropScience 2 T. W. Alexander Drive Research Triangle Park, NC 27709 Tolerances were established for prothioconazole in the 40 CFR §180.626 section as summarized below: Tolerances for combined residues of prothioconazole and its desthio metabolite: Barley, grain 0.35 ppm Barley, hay 7.0 ppm Barley, straw 4.0 ppm Grain, aspirated grain fractions 11 Pea and bean, dried shelled, except soybean, subgroup 6C 0.90 ppm Peanut, nutmeat 0.02 ppm ------- Peanut, hay 6.0 ppm Rapeseed, seed 0.15 ppm Wheat, grain 0.07 ppm Wheat, forage 6.0 ppm Wheat, hay 4.5 ppm Wheat, straw 5.0 ppm Tolerances for prothioconazole, the desthio metabolite, and conjugates convertible to these compounds by acid hydolysis, calculated as parent: Cattle, fat 0.1 ppm Cattle, meat 0.02 ppm Cattle, meat byproducts 0.20 ppm Goat, fat 0.1 ppm Goat, meat 0.02 ppm Goat, meat byproducts 0.20 ppm Hog, meat byproducts 0.05 ppm Horse, fat 0.1 ppm Horse, meat 0.02 ppm Horse, meat byproducts 0.20 ppm Milk 0.02 ppm Poultry, liver 0.02 ppm Sheep, fat 0.1 ppm Sheep, meat 0.02 ppm Sheep, meat byproducts 0.20 ppm Use Patterns and Formulations Prothioconazole is a broad-spectrum systemic fungicide produced by Bayer CropScience for the control of diseases caused by ascomycetes, basidiomycetes, and deuteromycetes. Prothioconazole may be applied alone or as a tank mix with other fungicides, insecticides, or herbicides. Application through any type of irrigation system is prohibited. EPA and the Pest Management Regulatory Agency (PMRA) of Canada jointly reviewed prothioconazole. The crops proposed for joint review include barley, canola, chickpeas, the oilseed crop group, the dried shell and bean subgroup, lentils and wheat. Uses on peanuts were proposed for the U.S. only. Prothioconazole is formulated as a 4 Ib/gal suspension concentrate (equivalent to a flowable concentrate; F1C) formulation (Proline® 480 SC Fungicide, 41% active ingredient). The product is applied as broadcast post emergence foliar or soil sprays (application to soil for peanuts only) using ground or aerial equipment at 0.088-0.178 Ib ai/A/application (0.100-0.200 kg ai/ha/application). The proposed maximum seasonal rates range 0.285-0.713 Ib ai/A (0.320- 0.800 kg ai/ha), and the proposed retreatment intervals are 5-21 days. The PHIs range from 7 days for dried shelled peas and beans to 36 days for oilseed crops. The directions for use of prothioconazole are summarized in Table 1. PROTHIOCONAZOLE FACT SHEET - Page 2 of 5 5 ------- Table 1. Summary of Directions for Use of Prothioconazole Applic. Timing, Type, and Equip. Applic. Rate (Ib ai/A) [fl oz/A] Max. No. Applic. per Season Retreatment Interval (days) Max. Seasonal Applic. Rate (Ib ai/A) [fl oz/A] PHI (days) Use Directions and Limitations Barley (for Fusarium Head Blight) Broadcast foliar spray; Ground or aerial 0.134-0.178 [4.3 - 5.7] 2 7 to 14 0.293 [9.37] 32 Apply as a preventative foliar spray within the time period when 70 to 100% of the barley heads on the main stem are fully emerged when weather conditions are favorable for disease development and up to 3 to 5 days after full head emergence. Barley (for Leaf and Stem Diseases) Broadcast foliar spray; Ground or aerial 0.0875-0.134 [2.8-4.3] 2 7 to 14 0.269 [8.6] 32 Apply as a preventative foliar spray when the earliest disease symptoms appear on the leaves or stems. Chickpea Broadcast foliar spray; Ground or aerial 0.134-0.178 [4.3 - 5.7] 3 10 to 14 0.534 [17.1] 7 Apply at first sign of disease. Use higher use rate when conditions are favorable for severe disease pressure and/or when growing less disease resistant varieties. Dried Shelled Peas and Beans Subgroup, except Soybean (Grain, Sweet, White and White Sweet lupins; Field, Kidney, Dry lima, Pinto and Tepary beans; Adzuki bean, Blackeyed pea, Catjang, Cowpea, Crowder pea, Moth bean, Mung bean, Rice bean, Southern pea and Urd bean; Dry broad bean; Guar; Lablab bean; Pea [including Field pea] and Pigeon pea) Broadcast foliar spray; Ground or aerial Broadcast foliar spray; Ground or aerial Broadcast foliar spray; Ground or aerial 0.134-0.178 [4.3-5.7] 0.134-0.178 [4.3-5.7] 0.134-0.178 [4.3-5.7] 3 3 Rapes 2 5 to 14 10 to 14 eed (Canola), 5 to 7 0.534 [17.1] Lentils 0.534 [17.1] ndian rapeseed, 0.356 [11.4] 7 7 and Cran 36 Apply at the first sign of disease. Use higher use rate when conditions are favorable for severe disease pressure and/or when growing less disease resistant varieties. Apply at early flower or at the first sign of disease. Use higher use rate when conditions are favorable for severe disease pressure and/or when growing less disease resistant varieties. ibe Apply when the crop is 20 to 50% bloom stage (not after the 50% bloom stage). Utilize higher rate for fields with history of heavy disease pressure or for dense crop stands. Peanut PROTHIOCONAZOLE FACT SHEET - Page 3 of 5 5 ------- Table 1. Summary of Directions for Use of Prothioconazole Applic. Timing, Type, and Equip. Broadcast foliar spray; Ground or aerial Applic. Rate (Ib ai/A) [fl oz/A] 0.156-0.178 [5.0-5.7] Max. No. Applic. per Season 4 Retreatment Interval (days) 14 to 21 Max. Seasonal Applic. Rate (Ib ai/A) [fl oz/A] 0.713 [22.8] PHI (days) 14 Use Directions and Limitations Use higher rate when conditions are favorable for severe disease pressure and/or when growing less disease resistant varieties. Wheat (spring, durum and winter; for Fusarium Head Blight) Broadcast foliar spray; Ground or aerial 0.134-0.178 [4.3-5.7] 2 7 to 14 0.293 [9.37] 30 Apply within the time period from when at least 75% of the wheat heads on the main stem are fully emerged to when 50% of the heads on the main stem are in flower. Optimal timing of application may be at or around 15% flower. Wheat (spring, durum and winter; for Leaf and Stem Diseases) Broadcast foliar spray; Ground or aerial 0.134-0.156 [4.3 - 5.0] 2 7 to 14 0.293 [9.37] 30 Apply as a preventative foliar spray or when the earliest disease symptoms appear on the leaves or stems. Science Findings The Agency has completed a human health risk assessment for the uses of the new active ingredient prothioconazole. For the approved crops, the risk estimates from acute and chronic dietary (food + water) exposures do not exceed the Agency's LOG. The toxicology database is extremely large, especially the number of complex toxicology studies. The toxicity database for prothioconazole (and its metabolites) is considered complete and deemed adequate for endpoint selection for exposure and risk assessment, for FQPA evaluation, and to support the approved uses and tolerances. With respect to cancer, EPA has concluded prothioconazole and its metabolites are not carcinogenic, and are classified "Not likely to be Carcinogenic to Humans." Available product chemistry and toxicology data supporting the proposed tolerance are summarized below. PROTHIOCONAZOLE FACT SHEET - Page 4 of 5 5 ------- Physical/Chemical Structure: Prothioconazole - Prothioconazole-Desthio - OH Cl Table 2. Prothioconazole Nomenclature. Empirical Formula Common name Company experimental name IUPAC name CAS name CAS registry number End-use product/EP Chemical Class Known Impurities of Concern C14H15C12N3OS Prothioconazole JAU 6476 2-[(2RS)-2-(l-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2ff-l,2,4-triazole- 3(4//)-thione 2-[2-( 1 -Chlorocyclopropyl)-3 -(2-chlorophenyl)-2-hydroxypropyl]- 1 ,2-dihydro- 3H- l,2,4-triazole-3 -thione 178928-70-6 PROLINE ® 480 SC Fungicide Triazolinthione None The physical and chemical properties of prothioconazole are summarized in Table 3. Table 3. Physicochemical Properties of the Technical-Grade Prothioconazole. Parameter Molecular Weight Melting point Density (g/ml at 20°C) Value 344.26 g/mol 139.1- 144.5 °C 1.36 (pure active ingredient) 1.17 at 20 °C (end use product) Reference MRID 46246003 MRID 46246003 MRID 46246003 PROTHIOCONAZOLE FACT SHEET- Page 5 of 55 ------- Table 3. Physicochemical Properties of the Technical-Grade Prothioconazole. Parameter Water solubility (g/L) Solvent solubility at 20 °C (g/L) Vapor pressure (Pa at 20 or 25 °C) Dissociation constant, pKa Octanol/water partition coefficient, Log(K0w) UV/visible absorption spectrum Value 5.0 pH 4 buffer at 20 °C 0.3 pH 8 buffer at 20 °C 2.0 pH 9 Buffer at 20 °C g/L at room temp acetone >250 acetonitrile 10-100 dichloromethane 100-250 dimethylsulfoxide 100-250 ethyl acetate <250 n-heptane <0.1 1-octanol 10-100 polyethylene glycol >250 2-propanol 10-100 xylene 1-10 <4 x 10'7 6.9 at 20 °C unbuffered: Kow = 11300; log Kow = 4.05 pH4:Kow=14600;log = 4.16 pH7:Kow = 6600;log=3.82 pH9:Kow=100;log = 2.00 Peak maxima at 275 nm. No absorption at >300 nm. Reference MRID 46246003 MRID 46246003 MRID 46246003 MRID 46246003 MRID 46246003 MRID 46246003 Toxicological Characteristics In addition to prothionconazole^er se, the major metabolite prothioconazole-desthio is of toxicological interest. Residues of prothioconazole-desthio, the major metabolite/degradate in plants, together with residues of its 4-hydroxy metabolites, may also be found in edible ruminant tissues and milk. Because of the toxicological significance of the parent prothioconazole and prothioconazole-desthio, this Fact Sheet provides summaries of the available toxicity information for both compounds. Table 4. Acute Toxicity of Prothioconazole Technical Guideline No. 870.1100 870.1200 870.1300 870.2400 Study Type Acute oral toxicity (rat) Acute dermal toxicity (rat) Acute inhalation toxicity (rat) Primary eye irritation (rabbit) MRID No. 46246230 46246244 46246246 46246249 T. ix Toxicity Results „ x J Category LD50 >= 6200 mg/kg (M, F) LD50 >= 2000 mg/kg (M,F) LC50 >= 4.99 mg/L (M,F) Not an irritant IV PROTHIOCONAZOLE FACT SHEET- Page 6 of 55 ------- Table 4. Acute Toxicity of Prothioconazole Technical Guideline No. 870.2500 870.2600 Study Type Primary skin irritation (rabbit) Dermal sensitization (Guinea pig) MRID No. 46246302 46246305 T. ix Toxicity Results „ x J Category Not an irritant IV Not a sensitizer Negative Table 5. Acute Toxicity of Prothioconazole-desthio Guideline No. 870.1100 870.1100 870.1200 870.1300 870.2400 870.2500 870.2600 Study Type Acute oral toxicity (rat) Acute oral toxicity (mouse) Acute dermal toxicity (rat) Acute inhalation toxicity (rat) Primary eye irritation (rabbit) Primary skin irritation (rabbit) Dermal sensitization (Guinea pig) MRID No. 46246231 46246242 46246243 46246247 46246250 46246250 46246304 Results LD50 = 2806 mg/kg (M, F) (approximate) LD50 = 2235 mg/kg (M) LD50 = 3459 mg/kg (F) LD50 >= 5000 mg/kg (M,F) LC50 >= 5.077 mg/L (M,F) Slight irritant (iritis, discharge) Not an irritant Not a sensitizer Toxicity Category III III IV IV III IV Negative Table 6. Toxicity Profile for Prothioconazole Technical Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3700a Prenatal develop- mental in rats - oral 46246316(1996) 0, 80, 500, 1000 mg/kg/day Acceptable/Guideline Maternal Toxicity NOAEL = 80 mg/kg/day LOAEL = 500 mg/kg/day based on increased urination and water consumption, and decreased body weight gain. Developmental Toxicity NOAEL = 80 mg/kg/day LOAEL = 500 mg/kg/day based on increased incidence of delayed ossification, increased incidence of dysplastic pubic bone, and increased incidence of left punctiform 14th rib. PROTHIOCONAZOLE FA CT SHEET - Page 7 of 55 ------- Table 6. Toxicity Profile for Prothioconazole Technical Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3700a Prenatal develop- mental in rats - oral 46246317(2002) 0, 40, 200, 1000 mg/kg/day Acceptable/Nonguideline Range finding study for above, no endpoints were determined. 870.3700a Prenatal develop- mental in rodents (rat) - dermal 46246323 (2001) 0, Technical 1000 mg/kg/day, 62.5 mg/kg/day diluted EC 250 formulation, 250 mg/kg/day EC 250 formulation Acceptable/Nonguideline Maternal Toxicity NOAEL > 1000 mg/kg/day LOAEL > 1000 mg/kg/day Developmental Toxicity NOAEL = 1000 mg/kg/day LOAEL > 1000 mg/kg/day 870.3700a Prenatal develop- mental in rats - oral 46923601 (2004) 0, 20, 80, 750 mg/kg/day Acceptable/Nonguideline Maternal Toxicity NOAEL = 80 mg/kg/day LOAEL = 750 mg/kg/day based on increased water consumption, decreased food consumption and decreased body weight gain. Developmental Toxicity NOAEL = 80 mg/kg/day LOAEL = 750 mg/kg/day based on increased incidence of rudimentary ribs (comma-shaped). 870.3700b Prenatal develop- mental in nonrodents (rabbit) 46246330 (1997) 0, 80, 100, 300, 480 mg/kg/day pilot study Acceptable/Nonguideline Maternal Toxicity NOAEL < 80 mg/kg/day LOAEL = 80 mg/kg/day based on reduced food consumption and body wts. Developmental NOAEL = 300 mg/kg/day LOAEL = 480 mg/kg/day based on decreased body wt, and small fetuses. 870.3700b Prenatal develop- mental in nonrodents (rabbit) 46246328 (1998) 0, 10, 30, 80, 350* mg/kg/day * Additional group added after start of study Acceptable/Guideline Maternal Toxicity NOAEL = 80 mg/kg/day LOAEL = 350 mg/kg/day based on decreased body wt and decreased food consumption. Developmental Toxicity NOAEL = 80 mg/kg/day LOAEL = 350 mg/kg/day based on abortions, total resorptions, and lower fetal body weight 870.4100a Chronic toxicity rodents (rat) 46246335 (2000) 0, 5, 50, 750 mg/kg/day Rat, 53 weeks Acceptable/Guideline NOAEL = 50 mg/kg/day LOAEL = 750 mg/kg/day based on decreased body weight and body weight gain, alterations in hematology and clinical chemistry parameters indicative of liver and kidney damage, increased liver and kidney weights, and accompanying histopathological alterations in the liver, kidney and urinary bladder. FOB conducted at 27 and 52 weeks. PROTHIOCONAZOLE FACT SHEET - Page 8 of 5 5 ------- Table 6. Toxicity Profile for Prothioconazole Technical Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.4 lOOb Chronic toxicity non-rodent (dog) 46246336 (2001) 0, 5, 40, 125 mg/kg/day one year Acceptable/Guideline NOAEL = 5 mg/kg/day LOAEL = 40 mg/kg/day based on decreased T3 and T4 thyroid hormones, increased urine volume, and increased incidence of chronic inflammation and pigmentation in the kidneys of the male animals, and decreased T4 thyroid hormone, increased spleen weight, increased incidence of spleen pigmentation, and increased incidence of crystals present in the kidneys of the female animals. 870.4200 Carcinogenicity rats 46246338 (2001) M: 0, 5, 50, 750/500 mg/kg/day F: 0,5,50,750/625 mg/kg/day 106 weeks Unacceptable/Guideline for Carcinogenicity because dose levels too high. NOAEL = 50 mg/kg/day LOAEL = 500/625 (M/F) mg/kg/day based on increased mortality and decreased body weight/body weight gain, changes in clinical chemistry (APh, creatinine, urea) and hematological parameters, increased liver and kidney weights, and liver (hypertrophy and eosinophilic/clear cell focus) and kidney/urinary bladder pathology. 870.4300 Carcinogenicity mice 46246339 (2001) 0, 10, 70, 500 mg/kg/day 80 weeks Acceptable/Guideline NOAEL = 10 mg/kg/day LOAEL = 70 mg/kg/day based on kidney (tubular degeneration/regeneration in males) effects. no evidence of Carcinogenicity Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665) Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3700a Prenatal develop- mental in rodents (rat) - dermal 46246326 (1991) 0, 30 mg/kg/day Pilot study, used with 46246325 Acceptable/Nonguideline Discussed in appendix 1 of MRID 46246325 Maternal Toxicity NOAEL = 30 mg/kg/day LOAEL > 30 mg/kg/day Developmental Toxicity NOAEL = 30 mg/kg/day LOAEL > 30 mg/kg/day 870.3700a Prenatal develop- mental in rodents (rat) - dermal 46246325 (1991) 0, 100, 300, 1000 mg/kg/day Acceptable/Guideline When combined with 46246326 Maternal Toxicity NOAEL = 1000 mg/kg/day LOAEL > 1000 mg/kg/day Developmental Toxicity NOAEL = 30 mg/kg/day LOAEL =100 mg/kg/day based on structural alterations (14th rib) 870.3700a Prenatal develop- mental in rodents (rat) - oral 46246322 (1991) 0, 1, 3 mg/kg/day Acceptable/Nonguideline results combined with 46246321 Maternal Toxicity NOAEL = 3 mg/kg/day LOAEL > 3 mg/kg/day Developmental Toxicity NOAEL = 3 mg/kg/day LOAEL > 3 mg/kg/day Combined with 46246321 PROTHIOCONAZOLE FACT SHEET - Page 9 of 5 5 ------- Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665) Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.3700a Prenatal develop- mental in rodents (rat) - oral 46246321 (1991) 0, 10, 30, 100 mg/kg/day Acceptable/Guideline results combined with 46246322 Maternal Toxicity NOAEL = 30 mg/kg/day LOAEL = 100 mg/kg/day based on decreased body weight gains, increased liver weight with histopathology Developmental Toxicity NOAEL < 10 mg/kg/day LOAEL < 10 mg/kg/day based on structural alterations (supernumery ribs) and incomplete/delayed ossification at all levels. Combined with 46346322 870.3700a Prenatal develop- mental in rodents (rat) - oral 46246320 (1990) 0, 100 mg/kg/day Acceptable/Nonguideline Maternal Toxicity NOAEL = 100 mg/kg/day LOAEL > 100 mg/kg/day Developmental Toxicity NOAEL <100 mg/kg/day LOAEL = 100 mg/kg/day based on developmental delays 870.3700a Prenatal develop- mental in rodents (rat) - oral 46246319(1992) 0, 30 mg/kg/day oral Acceptable/Nonguideline Maternal Toxicity No NOAEL or LOAEL were determined Developmental Toxicity No NOAEL or LOAEL were determined, observations included structural abnormalities, developmental delays, death, shows 14th rib not completely reversible afterbirth. Follow up of MRID 46246320, 46246321. 870.3700b Prenatal developmental in nonrodents (rabbit) - oral 46246327, (1991) 0, 2, 10, 50 mg/kg/day Acceptable/Guideline Maternal Toxicity NOAEL = 10 mg/kg/day LOAEL = 50 mg/kg/day based on decreased body wt gain, decrease food consumption, increased resorptions, decreased number of fetuses, liver histopathology. Developmental Toxicity NOAEL = 2 mg/kg/day LOAEL =10 mg/kg/day based on structural alterations including malformed vertebral body and ribs, arthrogryposis, and other multiple malformations. 870.3700b Prenatal developmental in nonrodents (rabbit) - dermal 46246329 (1991) 0, 100, 300, 1000 mg/kg/day dermal pilot study Acceptable/Nonguideline Maternal Toxicity NOAEL = 300 mg/kg/day LOAEL = 1000 mg/kg/day based on local dermal toxicity Developmental Toxicity NOAEL = 1000 mg/kg/day LOAEL > 1000 mg/kg/day 870.4 lOOb Chronic toxicity dogs 46246337 (2001) 0, 40, 300, 2000 ppm 0, 1.35/1.55, 10.1/11.1, 69.9/77.1 (M/F) mg/kg/day 30 weeks Unacceptable/Guideline Not tested at high enough doses GLP deficiencies NOAEL = 69.9/77.1 (M/F) mg/kg/day LOAEL > 69.9/77.1 (M/F) mg/kg/day PROTHIOCONAZOLE FACT SHEET - Page 10 of 55 ------- Table 7. Toxicity Profile for Prothioconazole-Desthio (SXX0665) Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results 870.4200 Carcinogenicity rats 46246342 (1999) 0, 20, 140, 980 ppm 0, 1.1/1.6,8.0/11.2, 51.6111A (M/F) mg/kg/day Acceptable/Guideline NOAEL = 1.1/1.6 (M/F) mg/kg/day LOAEL = 8.0/11.2 (M/F) mg/kg/day based on clinical chemistry, histopathology (liver). no evidence of carcinogenicity 870.4300 Carcinogenicity mice 46246340 (2000) 46246341 (2001) 0, 12.5, 50, 200 ppm 0,3.1/5.1, 12.8/20.3, 51.7/80.0 (M/F) mg/kg/day 105 weeks Acceptable/Guideline NOAEL =12.8/20.3 (M/F) mg/kg/day LOAEL = 51.7/80.0 (M/F) mg/kg/day based on decreased body weight gain in males, decreased triglyceride levels in both sexes, decreased cholesterol levels in males, changes in glucose levels in males, increased liver weights in both sexes, increased incidence of histopathological findings in the liver hepatocytes in both sexes, decreased blood urea levels in females, increased kidney weights in females, and increased incidence of eosinophilic droplets in the cortical tubules of the kidneys of females. no evidence of carcinogenicity 870.6300 Developmental neurotoxicity rats 46246418 (2004) 0, 40, 160, 500 ppm 0,3.6, 15.1,43.3 mg/kg/day during gestation 0,8.1,35.7, 104.6 during lactation Acceptable/Nonguideline Maternal Toxicity NOAEL =15.1 mg/kg/day LOAEL = 43.3 mg/kg/day based on dystocia Developmental Toxicity NOAEL = 3.6 mg/kg/day LOAEL =15.1 mg/kg/day based on deviated snout and malocclusion Offspring Neurotoxicity potential could not be determined - Brain morphometric changes and increased incidence of peripheral nerve lesions were observed at high dose level, but not measured at mid- and low-dose levels. Toxicological Endpoints Table 8. Summary of Toxicological Doses and Endpoints for Prothioconazole desthio for Use in Human Health Risk Assessments Exposure/ Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects Dietary and Non-Occupational Human Health Risk Assessments Acute Dietary (Females 13-49) Acute Dietary (General Population, including infants and children) NOAEL = 2.0 mg/kg/day None UFA=10x UFH=10x FQPASF=10x (UFDB) None Acute RfD = 0.002 mg/kg/day aPAD = 0.002 mg/kg/day None Developmental Toxicity study in rabbits LOAEL =10 mg/kg/day, based on structural alterations including malformed vertebral body and ribs, arthrogryposis, and multiple malformations. An appropriate study was not identified PROTHIOCONAZOLE FACT SHEET - Page 11 of 5 5 ------- Table 8. Summary of Toxicological Doses and Endpoints for Prothioconazole desthio for Use in Human Health Risk Assessments Chronic Dietary (All Populations) Incidental Oral Short- and Intermediate-Term (1-30 days and 1-6 months) Dermal Short- and Intermediate-Term (1-30 days and 1-6 months) Inhalation Short- and Intermediate- term (1-30 days and 1-6 months) Cancer (oral, dermal, inhalation) NOAEL=1.1 mg/kg/day N/A N/A N/A UFA=10x UFH=10x FQPASF=10x (UFDB) N/A N/A N/A Chronic RfD = 0.001 mg/kg/day cP AD = 0.001 mg/kg/day N/A N/A N/A Chronic/Oncogenicity study in rats LOAEL = 8.0 mg/kg/day based on liver histopathology (hepatocellular vacuolation and fatty change (single cell, centrilobular, andperiportal)). Incidental oral exposure endpoint not identified because residential exposure is not anticipated. Dermal endpoints are not applicable because residential exposure is not anticipated. Inhalation endpoints are not applicable because residential exposure is not anticipated Classification: "Not likely to be Carcinogenic to Humans" based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. Occupational Human Health Risk Assessments Dermal Short- and Intermediate-Term (1-30 days and 1-6 months) Inhalation Short- and Intermediate- term (1-30 days and 1-6 months) Cancer (oral, dermal, inhalation) NOAEL=30 mg/kg/day NOAEL=2.0 mg/kg/day Inhalation absorption are assumed to be 100% UFA=10x UFH=10x UFDB = 10x UFA=10x UFH=10x UFDB = 10x Occupational LOCforMOE = 1000 Occupational LOCforMOE = 1000 Dermal developmental study in rats LOAEL =100 mg/kg/day based on an increased incidence of supernumerary rib (14th rib). Developmental Toxicity study in rabbits LOAEL =10 mg/kg/day, based on structural alterations including malformed vertebral body and ribs, arthrogryposis, and multiple malformations. Classification: "Not likely to be Carcinogenic to Humans" based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. For acute and chronic dietary (food and water) risk assessments, the lOx FQPA SF (lOx) for the lack of NOAEL and a LOAEL from the developmental neurotoxicity (peripheral nerve lesions and brain morphometrics). has been retained in the form of an UFdb study, regarding some neurotoxic endpoint Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = potential variation in sensitivity among members of the human population (interspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOG = level of concern. N/A = not applicable. The LOG for occupational exposure to prothioconazole desthio is based on the conventional uncertainty factor of lOOx (UFA = lOx and UFH = lOx) and an additional UFDB (lOx) for the lack of NOAEL and a LOAEL from the developmental neurotoxicity study, regarding some neurotoxic endpoint (peripheral nerve lesions and brain morphometrics). PROTHIOCONAZOLE FACT SHEET - Page 12 of 5 5 ------- Food Quality Protection Act Considerations: There are adequate data in the prothioconazole (including metabolites) database to characterize the potential for pre-natal or post-natal risks to infants and children: two-generation reproduction studies in rats; developmental studies in rats and rabbits; and a developmental neurotoxicity study in rats. The effects seen in these studies suggest that pups are more susceptible: pup effects were seen at levels below the LOAELs for maternal toxicity and, in general, were of comparable or greater severity compared to the effects observed in adults. In addition, since the developmental effects seen in the developmental neurotoxicity study were investigated at the high dose level only, there is uncertainty concerning the LOAEL/NOAEL for developmental effects in this study. Thus, the FQPA factor is retained at 10X. EPA is currently regulating at doses lower than the lowest dose in the DNT. It is unlikely that the lowest dose tested in the DNT will be a LOAEL. Exposure Assessment: Acute Dietary Exposure and Risk: A moderately refined acute dietary exposure assessment was conducted for prothioconazole using empirical processing factors (PFs), livestock maximum residues, and 100 percent crop treated (%CT). An acute endpoint was identified only for females, 13-49 years of age. Dietary risk estimates were determined considering exposures from food plus upper bound surface water EDWC point estimates based on the bean application scenario. The dietary exposure analyses result in acute dietary risk estimates that are below the Agency's level of concern for food and drinking water. The most conservative exposure estimate, using upper bound water residues from the bean application scenario resulted in exposure estimates at the 95th percentile of 0.001192 mg/kg/day, which utilized 60% of the aPAD for females 13-49 years of age. Chronic Dietary Exposure and Risk: A moderately refined chronic dietary exposure assessment assumed empirical processing factors, average residues, livestock maximum residues, and 100%CT. Dietary risk estimates were determined considering exposures from food plus upper bound surface water EDWC point estimates based on the bean application scenario. The dietary exposure analysis results in chronic dietary risk estimates that are below the Agency's level of concern for food plus drinking water. The highest exposure and risk estimates were for all infants and children 1-2 years old. The highest exposure and risk estimates for food plus upper bound water were for the all infants population subgroup, with an estimated exposure of 0.000948 mg/kg/day, which utilized 86% of the cPAD. Cancer Exposure and Risk: The available toxicology studies in the mouse and rat showed no increase in tumor incidence, and therefore the Agency concluded that prothioconazole or its metabolites are not carcinogenic, and classified "Not Likely to be Carcinogenic to Humans" according to the 2005 Cancer Guidelines. Therefore, a dietary cancer assessment was not performed. PROTHIOCONAZOLE FACT SHEET - Page 13 of 55 ------- Residential Exposure and Risk: Residential exposures are not expected, since there are no proposed residential uses. Aggregate Exposure and Risk: In accordance with the FQPA, the Agency must consider aggregate pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. Consequently, an aggregate assessment adds together exposures from relevant sources and compares the resulting estimate of total exposure to numerical estimates of hazard (e.g., a NOAEL or PAD); alternatively, the risks themselves can be aggregated. When aggregating exposures and risks from various sources, the Agency considers both the route and duration of exposure. Based on the Section 3 food crop uses, dietary aggregate exposures (i.e. food plus drinking water) are expected. The Agency does not expect residential exposures at this time because no residential uses have been proposed. Therefore, dietary (food plus drinking water) exposures sufficiently define aggregate exposures for assessment of risks from the use of prothioconazole. Estimates of pesticide residues in drinking water were incorporated directly into the dietary exposure analysis to assess aggregate acute and chronic risk. Cumulative Exposure and Risk: Prothioconazole is a member of the triazole-containing class of pesticides, often referred to as the conazoles. EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. At this time, there is not sufficient evidence to determine whether conazoles share common mechanisms of toxicity. Without such understanding, there is no basis to make a common mechanism of toxicity finding for the diverse range of effects found. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative. To support existing tolerances and to establish new tolerances for conazole pesticides, including prothioconazole, EPA conducted human health risk assessments for exposure to 1,2 4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of triazole-containing pesticides (as of 9/1/05), including prothioconazole. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with the common metabolites (e.g., use of maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). Acute and chronic aggregate risk estimates associated with these compounds are below the Agency's level of concern for all durations of exposure and for all population subgroups, including those of infants and children. The Agency's risk assessment for these common metabolites is available in the propiconazole reregi strati on docket at http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-0497. Occupational Exposure and Risk: Occupational exposure to prothioconazole is limited to use of the formulation PROLINE® 480 SC Fungicide, which is for application on barley, oilseed crops, dried bean and pea crops, peanuts, and wheat. Short- and intermediate-term dermal and inhalation exposures are expected from handler activities, and short- and intermediate-term dermal exposures are expected from postapplication activities. The short- and intermediate-term dermal exposure scenarios are assessed using the NOAEL of 30 mg/kg/day from the dermal PROTHIOCONAZOLE FACT SHEET - Page 14 of 5 5 ------- developmental toxicity study in the rat. The short- and intermediate-term inhalation exposure scenarios are assessed using the NOAEL of 2 mg/kg/day from the rabbit developmental toxicity study. EPA did not use a submitted prothioconazole-specific handler exposure study because the unit exposure information was inappropriate for estimating exposure, the small scale of the study, the choice of activity, and the use of Bayer employees as study subjects. An ethics review of this study was completed (K.Sherman, 9/27/06) concluded that the study does not violate current ethical standards. Although it was considered scientifically valid for qualitative purposes, the study not meet HED's scientific standards for quantitative use in risk assessment Short-/Intermediate-Term Handler Risk: Handlers are assumed to have potential short- (1-30 consecutive days) and intermediate-term (31-180 consecutive days) dermal and inhalation exposure to prothioconazole and its degradates when mixing, loading and applying PROLINE® 480 SC Fungicide. Short- and intermediate-term risk is not of concern if the MOE attains or exceeds the LOC of 1000. PROLINE® 480 SC is applied aerially and by ground equipment. MOEs for mixers and loaders reached or exceeded the LOC of 1000 for all scenarios except for wheat for aerial application, even when engineering controls/PPE were applied (closed system and gloves). The LOC of 1000 was reached for mixers/loaders for groundboom application with single-layer PPE plus gloves. Representative handler exposure scenarios include mixing and loading (M/L) for aerial and groundboom equipment, application with aerial and groundboom equipment, and flagging for aerial applications. Total MOEs range from 870 (closed M/L for aerial application to wheat) to 5,000. The MOE of 870 is not considered a significant departure from the target LOC of 1000. Aerial and groundboom application exposure scenarios reach MOEs of 1000 with baseline clothing and no gloves. With appropriate PPE and engineering controls (for aerial M/L activities), the target MOE of 1000 is attained or exceeded for all handler activities. Short-/Intermediate-Term Postapplication Risk: Postapplication workers are assumed to have potential short- and intermediate-term dermal exposure (but not inhalation exposure) from the uses of PROLINE® 480 SC Fungicide in low- to medium-height crops from activities such as scouting, irrigation, hand weeding and hand harvesting. The quantitative hazard estimate of 30 mg/kg/day (LOAEL from the dermal developmental study in the rat) as used in the handler assessment (see previous section) is used in the postapplication assessment. Postapplication Risk: Currently available exposure and toxicity data support an interim 48 hour REI for all crops; therefore, the postapplication worker risk assessment indicates no risk concerns for scouting and irrigation. The interim 48 hour REI could change based on the requested brain morphometric data from lower doses of the DNT. Environmental Fate Characteristics/Ecological Effects Environmental Fate Summary: Environmental risk assessments utilized environmental fate and toxicity data for prothioconazole and two primary degradates; the prothioconazole-desthio and prothioconazole-S-methyl. Risks were estimated using a total toxics residue approach for exposure levels for aquatic organisms and to derive estimated concentrations in drinking water. PROTHIOCONAZOLE FACT SHEET - Page 15 of 5 5 ------- In addition, for characterization purposes, unbound residues alone were used to estimate exposures. The lowest available toxicity endpoint among prothioconazole and the two primary degradates was used to evaluate risk. Prothioconazole possesses a potential for direct adverse acute effects to non-target fresh- and saltwater non-vascular plants, freshwater vascular plants, and saltwater invertebrates other than mollusks at some of the proposed application rates. The results also indicate a potential for adverse effects associated with chronic exposures to mammals for all proposed uses of prothioconazole and a potential for adverse effects to semi-aquatic plant species. Overall, potential risks appear to be greatest for estuarine/marine invertebrates, nonvascular plants, and terrestrial mammals. Estimated risks may translate to reduced survival, reproduction, or growth in affected species with subsequent effects at higher levels of biological organization. Aquatic exposure estimated assuming ground application is 8 - 27 percent lower than when the pesticide is applied aerially, which does not alter the overall risk conclusions. For listed species, acute risk levels of concern were exceeded for estuarine/marine invertebrates, semi-aquatic plants, aquatic plants, and freshwater fish. Listed species chronic risk levels of concern were exceeded for mammals. Because aquatic plant risk quotients are above the endangered species level of concern, the Agency considers this indicative of a potential for adverse effects to those listed species that rely on a specific plant species (plant species obligate). However, given the uncertainties in the screening level assessment, the levels of exceedance are not deemed significant. a. Hydrolysis Prothioconazole is stable to hydrolysis at environmentally relevant pH's and temperatures. In a study conducted in darkness for 7 days at 50°C, radio-labeled prothioconazole did not hydrolyze in sterile aquatic buffer solutions (pH 7 and 9); radio-labeled prothioconazole was hydrolyzed with a half-life of 120 days in sterile pH 4 aqueous buffer solution. Extrapolating from these results, the half-life of prothioconazole at 25°C at pH 4 was estimated as between 679 days and >10 years. No major transformation products were detected in any pH solution. The metabolite prothioconazole-desthio is stable to hydrolysis at environmentally relevant pH's and temperatures. In a study conducted in darkness for 30 days at 25°C, radio-labeled prothioconazole-desthio did not hydrolyze in sterile pH 5, 7 and 9 aqueous buffer solutions. b. Photolysis Aqueous - Prothioconazole is rapidly photodegraded to prothioconazole-desthio in water under favorable light conditions; however, prothioconazole-desthio is persistent under further irradiation. Radio-labelled prothioconazole photodegrades with a half-life of approximately 9.7 days in sterile pH 7 aqueous buffered solution maintained at 25°C and irradiated with the equivalent of 93 days of summer sunlight. Together, prothioconazole and prothioconazole- desthio photodegrade with a half-life of 101.9 days. Prothioconazole-desthio, together with two other major degradates, prothioconazole-thiazocine and 1,2,4-triazole, have maximum PROTHIOCONAZOLE FACT SHEET- Page 16 of 55 ------- concentrations of 55.7%, 14.1%, and 11.9% of the applied, observed on the 11th, 5th, and 18th day of incubation, respectively. No significant information was obtained for six minor transformation products or several unidentified compounds. Photodegradation is expected to be a potential route of dissipation for prothioconazole and prothioconazole-desthio together in the environment when the compounds are present in clear, shallow surface water. Soil - Prothioconazole together with prothioconazole-desthio are considered stable to photodegradation on loamy sand soil. Prothioconazole photodegradation on soil is insignificant compared to metabolism. The major transformation product detected in both dark and irradiated samples is prothioconazole-desthio. Prothioconazole and prothioconazole-desthio were added together in the half-life calculations. Apparently, no significant transformation products are specifically generated by phototransformation on soil surfaces. Photodegradation on soil is not expected to be a potential route of dissipation for prothioconazole and prothioconazole-desthio in the environment. c. Metabolism Aerobic soil metabolism -Prothioconazole rapidly dissipates from aerobic soil systems. Relatively high amounts of prothioconazole-desthio and unextracted material were observed in environmental fate studies, and are assumed to have similar toxicities. It is possible that toxic, unextracted residues will become bioavailable in the environment. Calculated aerobic biotic degradation of prothioconazole and prothioconazole-desthio was very slow in silt, loamy sand, silty loam, and silty clay loam soils, with half-lives ranging from 533 to 1386 days. When incubated in darkness for up to one year at 20 °C, maintained at 75% of 1/3 bar moisture, prothioconazole degraded to prothioconazole-desthio, prothioconazole-S-methyl, 1,2,4-triazole, prothioconazole-sulfonic acid, prothioconazole-triazolinone, prothioconazole-3, 4, 5, and 6- hydroxy-desthio, 2-chlorobenzoic acid, and CC>2. However, the estimates of the aerobic soil metabolism half-lives are uncertain given the assumptions associated with the unextracted residues. Consequently, the Agency's estimates of prothioconazole's persistence in the soil may be overestimated. Aerobic aquatic metabolism - The aerobic aquatic metabolism of prothioconazole can not be calculated adequately because prothioconazole quickly degrades to prothioconazole-desthio. Furthermore, both chemicals are of similar toxicity and there is considerable unextracted material in the studies. In addition to prothioconazole-desthio, prothioconazole degrades to prothioconazole-S-methyl, 1,2,4-triazole, prothioconazole-triazolinone, prothioconazole- triazolylketone, and CC>2. Prothioconazole-desthio appears to degrade more quickly in aerobic water/sediment systems than in aerobic soil alone; half-lives in various water/sediment systems range from 17.4 to 75.3 days. The Agency believes that the unextracted residues may consist of parent and may be bioavailable in the environment. The Agency's calculations are conservative because of the uncertainty associated with these unextracted residues. Thus, the Agency's estimate of the persistence of prothioconazole and prothioconazole-desthio may be overstated. Anaerobic aquatic metabolism - Prothioconazole and prothioconazole-desthio degraded slowly, with half-lives ranging from 61.9 to 231 days in an anaerobic pond/sandy clay loam sediment system. Prothioconazole degraded extensively in this system to prothioconazole-S-methyl. PROTHIOCONAZOLE FA CT SHEET - Page 17 of 55 ------- d. Adsorption/Desorption Prothioconazole's rapid degradation made it impossible to calculate adsorption coefficients. Nonetheless, prothioconazole-desthio is expected to be mobile in most soils, although it might bind to some benthic sediments in aquatic environments. Soil binding is strongly correlated to the soil organic carbon content. Prothioconazole-S-methyl, another significant degradate of prothioconazole, is expected to have low to slight mobility, as indicated from high sorption coefficients (Kd of 15.6-64.1 mg/L, K0c of 1973-2995 mL/goc). Mobility may be greater in relatively coarse-grained, well-drained soils. Prothioconazole may be mobile in typical agricultural soils. e. Mobility Prothioconazole's rapid degradation makes it impossible to determine its soil-water partition coefficient. Qualitatively, however, prothioconazole may exhibit low potential of leaching, likely to its rapid degradation. In contrast, prothioconazole-desthio has soil-water coefficients ranging from 4.13 to 13.38 mg/L in four different soils, indicating moderate to high mobility. Prothioconazole-desthio has a Kd less than 5 in some soils and is persistent (hydrolysis half-life greater than 25 weeks). Furthermore, its photolysis half-life is greater than 1 week, aerobic soil metabolism half-life is greater than 2-3 weeks, it is not volatile, and shows movement to 45 cm during field dissipation studies. Together, these parameters indicate potential for groundwater contamination. f. Terrestrial Field Dissipation In three terrestrial field dissipation studies, prothioconazole alone dissipated from the top layer of soil with a DT50 of less than 2 or 3 days, but prothioconazole-desthio dissipated from the top layer of soil with extremely variable DT50 of 28-422 days. Moderate amounts of prothioconazole-S-methyl were detected above the level of quantitation (LOQ) in 0-15 cm soil, and 1,2,4-triazole was detected at all soil depths, albeit not above the LOQ. Prothioconazole was not detected below 15 cm in any of the three fields in California, Georgia or New York. In contrast, prothioconazole-desthio was detected at levels above the LOQ down to 30 cm and at levels above the minimum detection limit [MDL] but below the LOQ down to 45 cm in one replicate in the California field study, and at levels below the LOQ at one to two sampling times in the Georgia and New York field studies g. Aquatic Field Dissipation In three aquatic field dissipation studies, prothioconazole and prothioconazole-desthio dissipated with long half-lives in sediment (203.9 days, 121.6 days, and 90.0 days in California, Arkansas, and Arkansas cropped aquatic fields, respectively). Dissipation half-lives in paddy water were extremely short (1.7 days, 0.9 days, and 0.6 days in California, Arkansas, and Arkansas cropped aquatic fields, respectively), likely more due to adsorption than degradation. Prothioconazole was detected in only three sampling intervals below LOQ but above the MDL in sediment below 3 inches. Prothioconazole-desthio was detected at 3-6 inch deep sediment through 28 DAT in the PROTHIOCONAZOLE FACT SHEET - Page 18 of 5 5 ------- Arkansas flooded field and through 60 DAT in the Arkansas flooded and cropped field. h. Bioaccumulation Bioaccumulation factors (BCF) for prothioconazole and prothioconazole-desthio could not be definitively calculated due to lack of clear accumulation plateaus. Nonetheless, there is minimal uncertainty in the conclusion that neither chemical bioaccumulates. Despite prothioconazole's very hydrophobic octanol-water partition coefficient (unbuffered log K0w of 4.05), significant bioaccumulation in aquatic organisms is not anticipated due to its quick degradation. The octanol-water partition coefficient for prothioconazole-desthio is unknown. The BCFs in fish for prothioconazole and prothioconazole-desthio can not be definitively quantified; however, the studies indicate that it is likely that prothioconazole-desthio does not bioaccumulate. Exposure Characterization: Prothioconazole degrades rapidly to prothioconazole-desthio via most degradation processes, and prothioconazole-desthio has a similar toxicological profile to that of its parent. Therefore, this assessment is conducted considering prothioconazole and prothioconazole-desthio jointly as the toxic moiety. Based on registrant-submitted environmental fate data, prothioconazole is expected to degrade quickly to prothioconazole- desthio, which is expected to be persistent with moderate mobility in the soil. Prothioconazole- desthio is stable to hydrolysis, very slowly degraded by aerobic soil metabolism, anaerobic aquatic metabolism, and aqueous photolysis, and moderately degraded by aerobic aquatic metabolism. Transport to surface water of prothioconazole residues is predicted, and, in some soils, transport to groundwater is also predicted, particularly in areas with porous soil of low organic carbon content. Effects Characterization: Prothioconazole and the prothioconazole-desthio are practically non- toxic to birds, mammals, and honeybees under acute exposure conditions and only slightly toxic to fish and freshwater aquatic invertebrates. Prothioconazole-desthio is very highly toxic to aquatic plants and estuarine/marine invertebrates following acute exposure. Prothioconazole- desthio is slightly more toxic to birds and mammals under chronic exposure conditions compared to the parent compound based on the respective study-determined effect levels. In birds, chronic exposure to prothioconazole-desthio did not cause any significant effects in adults or offspring. In mammals, chronic effects of prothioconazole-desthio included decreased viability of offspring and decreased offspring body weights. Ecological Risk Summary: Overall, potential risks appear to be greatest for estuarine/marine invertebrates and nonvascular plants, and terrestrial mammals. Functionally, estimated risks may translate to reduced survival, reproduction, or growth in affected species with subsequent effects at higher levels of biological organization. Aquatic exposure estimated assuming ground application is 8 - 27 percent lower than when the pesticide is applied aerially. The exposure estimates associated with ground application would not alter overall risk conclusions although for some specific combination of crop and taxa, risk quotients may be below the LOG. For listed species, acute risk levels of concern were exceeded for estuarine/marine invertebrates, semi-aquatic plants, aquatic plants, and freshwater fish. Listed species chronic risk levels of concern were exceeded for mammals. Because aquatic plant risk quotients are above the PROTHIOCONAZOLE FACT SHEET - Page 19 of 5 5 ------- endangered species level of concern, the Agency considers this to be indicative of a potential for adverse effects to those listed species that rely on a specific plant species (plant species obligate). Because of the national extent of the proposed uses of prothioconazole, there is a potential to affect some listed plant species and the species which depend upon listed or non-listed plant species. Indirect effects in this case may not be limited to aquatic species as terrestrial animals that rely on aquatic food items have potential to be affected indirectly. Conclusions: Prothioconazole degrades rapidly to prothioconazole-desthio via most degradation processes, and prothioconazole-desthio has a similar toxicological profile to that of its parent. Prothioconazole-desthio is expected to be persistent with moderate mobility in the soil. Prothioconazole-desthio is stable to hydrolysis, very slowly degraded by aerobic soil metabolism, anaerobic aquatic metabolism, and aqueous photolysis, and moderately degraded by aerobic aquatic metabolism. Transport to surface water of prothioconazole residues is predicted, and, in some soils, transport to groundwater is predicted, particularly in areas with porous soil of low organic carbon content. Prothioconazole and the prothioconazole-desthio are practically non-toxic to birds, mammals, and honeybees under acute exposure conditions and only slightly toxic to fish and freshwater aquatic invertebrates. Prothioconazole-desthio is very highly toxic to aquatic plants and estuarine/marine invertebrates following acute exposure. Prothioconazole-desthio is slightly more toxic to birds and mammals under chronic exposure conditions compared to the parent compound based on the respective study-determined effect levels. In birds, chronic exposure to prothioconazole-desthio did not cause any significant effects in adults or offspring. In mammals, chronic effects of prothioconazole-desthio included decreased viability of offspring and decreased offspring body weights. a. Risk to Aquatic Organisms Regarding freshwater fish, aquatic-phase amphibians, and freshwater invertebrates potentially exposed to prothioconazole for uses on wheat, bean, canola, and peanut, the RQs do not exceed non-listed or listed species acute or chronic risk LOCs. For estuarine/marine fish and invertebrates potentially exposed to prothioconazole for uses on wheat, canola, bean, and peanuts, the RQs for estuarine/marine fish do not exceed any acute risk LOCs with all RQs less than 0.01; chronic toxicity data were not available for a representative fish species so RQs could not be calculated. The RQs for estuarine/marine mollusks similarly did not exceed any acute risk LOCs with all RQs<0.01. Based on mysid shrimp toxicity data, the listed species acute risk LOG of 0.05 is exceeded for estuarine/marine invertebrates for all modeled scenarios while the acute non-listed species LOG of 0.5 is exceeded for use on beans and peanuts (RQs = 0.55 & 0.57, respectively). Chronic RQ values were only calculated for non-molluskan invertebrates since this was the only taxa with chronic toxicity data. The listed and non-listed species chronic risk LOG (RQ>1.0) for estuarine marine invertebrates is exceeded for all modeled uses with RQs ranging from 2.4 to 6.4. These risks are summarized in Table 9. PROTHIOCONAZOLE FACT SHEET - Page 20 of 55 ------- Table 9. Risk Quotients for Estuarine/Marine Fish and Invertebrates Exposed to Prothioconazole Use Wheat Canola Bean Peanut Application Rate Ibs ai/A (#app/ interval (d)) 0.178 (2/7) 0.178 (2/5) 0.178 (3/5) 0.178 (4/14) EECs (PPb) Peak 20.5 12.8 33.2 34.4 21- day 20.2 12.5 32.7 33.3 60- day 19.8 12.0 32.2 32.2 Fish RQs LCso = >10300 NOAEC = N/A Acute <0.01 <0.01 <0.01 <0.01 Invertebrate RQs LC50 = 60 NOAEC = 5.2 Acute 0.34* 0.21* 0.55** 0.57** Chronic 3.94 2.40 6.29 6.40 Mollusk RQs ECso= 3000 Acute <0.01 <0.01 <0.01 <0.01 *Exceeds the listed species acute risk LOC (RQXX05) **Exceeds the non-listed species acute risk LOC (RQ>0.50) and the listed species acute risk LOC Bolded chronic RQs exceed the listed and non-listed species chronic risk LOC (RQ>1.0) For both vascular and non-vascular aquatic plants, the listed species acute risk LOC of 1.0 is exceeded for all scenarios, with RQs ranging from 1.20 to 5.9 (Table 10). Table 11 lists the RQs for estuarine/marine non-vascular plants potentially exposed to prothioconazole. These RQs exceed the listed species acute risk LOC for all uses (1.8 to 4.7) and exceed or equal the non-listed species acute risk LOC at all proposed application rates except canola (1.0 to 1.6). Table 10. Risk Quotients for Freshwater Aquatic Plants Exposed to Prothioconazole Use Wheat Application Rate Ibs a.i./A (#app/interval (d)) 0.178 (2/7) EECs (PPb) Peak 20.5 Vascular Plant RQs EC50 = 35 NOAEC = 5.8 Acute 0.59 Acute Listed Species 3.5 Non-Vascular Plant RQs EC50 = 0.074 EC05 = 0.011 Acute 0.28 Acute Listed Species 1.9 PROTHIOCONAZOLE FACT SHEET - Page 21 of 5 5 ------- Table 10. Risk Quotients for Freshwater Aquatic Plants Exposed to Prothioconazole Use Canola Bean Peanut Application Rate Ibs a.i./A (#app/interval (d)) 0.178 (2/5) 0.178 (3/5) 0.178 (4/14) EECs (PPb) Peak 12.8 33.2 34.4 Vascular Plant RQs EC50 = 35 NOAEC = 5.8 Acute 0.37 0.95 0.98 Acute Listed Species 2.2 5.7 5.9 Non-Vascular Plant RQs EC50 = 0.074 EC05 = 0.011 Acute 0.17 0.45 0.46 Acute Listed Species 1.2 3.0 3.1 Aquatic plant acute risk LOG (RQ > 1.0); applies to non-listed and listed species Table 11. Risk Quotients for Estuarine/Marine Non- Vascular Plants Exposed to Prothioconazole Use Wheat Canola Bean Peanut Application Rate Ibs ai/A (#app/interval (d)) 0.178 (2/7) 0.178 (2/5) 0.178 (3/5) 0.178 (4/14) EECs (PPb) Peak 20.5 12.8 33.2 34.4 Non- Vascular Plant RQs EC50 = 21 NOAEC = 7.3 Acute 1.0 0.62 1.6 1.6 Acute Listed Species 2.9 1.8 4.5 4.7 Aquatic plant acute risk LOG (RQ > 1.0); applies to non-listed and listed species b. Risk to Avian Species (Acute/Chronic) No RQs exceed non-listed or listed species acute risk LOCs with RQs ranging from <0.01 to 0.05. No acute or chronic LOCs are exceeded for any proposed uses. Acute dietary-based RQs range from <0.01 to 0.01 and dietary-based chronic RQs ranged from 0.01 to 0.18. PROTHIOCONAZOLE FACT SHEET - Page 22 of 5 5 ------- c. Risk to Mammalians (Acute/Chronic) For mammals, no acute risk LOCs are exceeded with RQs ranging from <0.01 to 0.01. Table 12 summarizes the chronic mammalian RQs for the proposed uses of prothioconazole. The non- listed and listed species chronic risk LOG (RQ>1.0) is exceeded for all proposed uses of prothioconazole. However, LOG exceedances are specific to food item with no exceedances associated with mammals that consume seeds or fruits/pods/large insects with RQs ranging from 0.01 to 0.23. For all other food items, the chronic risk LOCs are exceeded, particularly for smaller mammals. The highest RQs are for mammals that consume short grass with RQs ranging from 1.0 to 3.8 followed by mammals that consume broadleaf plants/small insects (RQs = 0.56 to 2.1) and tall grass (RQs = 0.45 to 1.7). Table 12. Mammalian Dose-Based Chronic RQ Values for Uses of Prothioconazole; Based on Rat NOAEL of 9.5 mg/kg bw and Upper-Bound Kenaga Residues Use Barley/ Wheat (Fusariu mhead blight) Application Rate Ibs ai/A #app/interval (d) 0.178 (2/7) Body Weight (g) 15 35 1000 Avian Acute RQs for Specified Food Items Short Grass 2.9 2.4 1.3 Tall Grass 1.3 1.1 0.60 Broadleaf Plants/Small Insects 1.6 1.4 0.74 Fruits/Pods / Lg Insects 0.18 0.15 0.08 Seeds 0.04 0.03 0.02 Barley (leaf& stem) 0.134 (2/7) 15 35 1000 2.2 1.8 0.99 0.99 0.85 0.45 1.2 1.0 0.56 0.13 0.12 0.06 0.03 0.03 0.01 Canola & Oilseed crop 0.178 (2/5) 15 35 1000 3.1 2.6 1.4 1.4 1.2 0.65 1.7 1.5 0.80 0.19 0.16 0.09 0.04 0.04 0.02 Chickpe a& Lentils 0.178 (3/10) 15 35 1000 2.8 2.4 1.3 1.3 1.1 0.60 1.6 1.4 0.73 0.18 0.15 0.08 0.04 0.03 0.02 Peanut 0.178 (4/14) 15 35 1000 2.5 2.1 1.1 1.2 0.98 0.52 1.4 1.2 0.64 0.16 0.13 0.07 0.03 0.03 0.02 Dried shell peas & beans 0.178 (3/5) 15 35 1000 3.8 1.7 3.2 1.5 1.7 0.79 2.1 1.8 0.97 0.23 0.20 0.11 0.05 0.04 0.02 Wheat 0.156 15 2.5 1.2 1.4 0.16 0.03 PROTHIOCONAZOLE FACT SHEET - Page 23 of 55 ------- Table 12. Mammalian Dose-Based Chronic RQ Values for Uses of Prothioconazole; Based on Rat NOAEL of 9.5 mg/kg bw and Upper-Bound Kenaga Residues Use (leaf& stem) Application Rate Ibs ai/A #app/interval (d) (2/7) Body Weight (g) 35 1000 Avian Acute RQs for Specified Food Items Short Grass Tall Grass 2.2 1.2 0.98 0.53 Broadleaf Plants/Small Insects 1.2 0.65 Fruits/Pods / Lg Insects 0.13 0.07 Seeds 0.03 0.02 Bolded values exceed the chronic risk LOG (RQ>1.0) for non-listed and listed mammalian species Chronic dietary-based mammalian RQs for proposed uses of prothioconazole are based on effects levels associated with chemical concentrations in feed. The dietary-based RQs do not exceed the chronic risk LOCs for any proposed uses of prothioconazole with RQs ranging from 0.02 to 0.51. d. Risk to Terrestrial and Semi-aquatic Plants Risk quotients for terrestrial and semi-aquatic plant (Table 13) for proposed uses of prothioconazole exceed the acute plant risk LOG (RQ>1.0) for semi-aquatic listed plants; no other LOCs are exceeded. Risk quotients for non-listed terrestrial and semi-aquatic plant species are not calculated because an EC25 (>0.272 Ibs a.i./A, highest test level) could not be estimated from the Tier II plant study. Table 13. RQ Values for Listed Terrestrial and Semi-Aquatic Plants Exposed to Prothioconazole Use(s) Barley, Canola, Chickpea, Dried shell peas & beans, Lentils, Oilseed crops, Peanut, Wheat Barley (leaf & stem) Wheat (leaf & stem) Single Application Rate Lbs a.i./A 0.178 0.134 0.156 RQs Based on Tier II Study on Cucumber (EC25>0.272; NOAEC/EC05 = 0.03) Adja Ground spray 0.36 0.27 0.31 icent Aerial spray 0.59 0.45 0.52 Semi-Aquatic Ground spray 3.0 2.3 2.6 Aerial spray 3.3 2.5 2.9 Bolded values exceed listed plant acute risk LOG (RQ>1.0) PROTHIOCONAZOLE FACT SHEET - Page 24 of 5 5 ------- Uncertainties and Data Gaps The major uncertainty in characterizing effects of prothioconazole and/or prothioconazole- desthio is associated with the toxicity of prothioconazole-desthio to estuarine/marine invertebrates and the lack of an acceptable sediment toxicity test. For estuarine/marine invertebrates, toxicity tests for prothioconazole-desthio indicated that both the LCso and the chronic NOAEC are approximately 60 ppb based on mysid shrimp toxicity tests. This suggests that chronic and acute thresholds are the same, a conclusion that is incongruent with typical toxicological patterns. Risks to sediment dwelling invertebrates could not be estimated since the submitted studies did not meet guideline requirements. It is recommended that guideline sediment toxicity tests be submitted. The environmental fate data submitted to the Agency are complete. However, because of the considerable uncertainty surrounding soil extraction procedures, the unextracted material in the aerobic soil, aerobic aquatic, and anaerobic aquatic metabolism studies was added to parent in calculation of half-lives used in environmental fate modeling and fate characterization. Therefore, the persistence and bioavailability of prothioconazole may be overestimated; resulting in conservative estimated aquatic exposure. Importantly, Tier II modeling using the 90th percentile unextracted-material-incorporated half-lives did not change risk estimates for aquatic animals or aquatic plants relative to modeling using upper 90th percentile confidence bounds on the mean half-lives calculated without incorporating unextracted material. In neither case do aquatic concentrations approach levels-of-concern for aquatic animals; however, aquatic concentrations are sufficiently high to result in risk quotients that exceed levels-of-concern for aquatic plants. Finally, the adsorption coefficient (Kd or K0c) of prothioconazole could not be calculated from submitted data because of the chemical's quick degradation in the systems. Therefore, conclusions about the mobility of prothioconazole combined residues of concern are drawn only from degradates. Similarly, bioaccumulation factors (BCF) of prothioconazole and prothioconazole-desthio could not be definitively calculated due to lack of clear accumulation plateaus. Therefore, there is also minimal uncertainty in the conclusion that neither chemical bioaccumulates. DATA GAPS For the Developmental Neurotoxicity Study (MRID 46246418), brain morphometric measurements from the mid and low dose animals must be submitted as well as addressing the other deficiencies listed in the DER to allow the reconsideration of the FQPA database uncertainty factor. Data must be generated and submitted to confirm the degree of stability of the prothioconazole- 4-hydroxy in ruminant fat for a duration of 45 days. The final report of the ongoing storage stability study with prothioconazole and desthio- prothioconazole in plant commodities (interim results for which were reported in MRID 46477701) must be submitted. PROTHIOCONAZOLE FACT SHEET - Page 25 of 5 5 ------- Based on the proposed tolerance expressions and the proposed enforcement methods, analytical reference standards of the following compounds must be provided: • prothioconazole-desthio prothioconazole sulfonic acid potassium salt [triazole-15N-13C]prothioconazole • [triazole-15N-13C]prothioconazole-desthio • [triazole-15N-13C]prothioconazole sulfonic acid Environmental Fate and Effects Repeating the sediment toxicity study following Agency guidelines in which the chemical is first added to the sediment would reduce some uncertainty associated with assessing risks to sediment dwelling invertebrates. Contact person at USEPA Tony Kish, Product Manager (22) Environmental Protection Agency Office of Pesticide Programs Registration Division (7505P) (703)-308-9443 Mailing Address: By U.S. Mail: Document Processing Desk Office of Pesticide Programs (75 IOC) US Environmental Protection Agency 401 M Street SW Washington, DC 20460-0001 By Courier: Document Processing Desk Office of Pesticide Programs(7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, Va.22202-4501 Office Location and Telephone Number - Registration Division Seventh Floor, One Potomac Yard 2777 South Crystal Drive Arlington, Va.22202-4501 PROTHIOCONAZOLE FACT SHEET- Page 26 of 55 ------- (703)305-0025 Disclaimer: The information in this Pesticide Fact Sheet is a summary only and is not to be used to satisfy any data requirements for pesticide registration or reregi strati on. ai ARTF °C CAS CFR cPAD CSFII d DEEM-FCID DFR DWLOC EDSP EDSTAC EDWC EEC EFED EPA F FFDCA FIFRA FQPA g HED Ha hr Kd kg KQW Ib LCso LD5 '50 GLOSSARY OF TERMS AND ABBREVIATIONS Active Ingredient Agricultural Reentry Task Force Degrees Celsius Chemical Abstracts Service Code of Federal Regulations Chronic Population Adjusted Dose Continuing Surveys of Food Intakes by Individuals Day(s) Dietary Exposure Evaluation Model - Food Consumption Intake Database Dislodgeable Foliar Residue Drinking Water Level of Concern Effective Concentration - concentration of chemical in water at which an effect is seen in 50% of the exposed population Endocrine Disrupter Screening Program Endocrine Disrupter and Testing Advisory Committee Estimated Drinking Water Concentration Estimated Environmental Concentrations Environmental Fate and Effects Division, Office of Pesticide Programs United States Environmental Protection Agency Female Federal Food, Drug and Cosmetic Act Federal Insecticide, Fungicide and Rodenticide Act Food Quality Protection Act Gram Health Effects Division, Office of Pesticide Programs Hectare Hour Partition coefficient Kilogram Octanol/Water Partition Coefficient Pound Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/L, mg/kg or ppm. Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation.). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg. PROTHIOCONAZOLE FACT SHEET- Page 27 of 55 ------- LOAEL LOAEC LOG LOD LOQ M m3 mg/kg/day mg/L ml MOE MRID MTD NA NOAEL NOAEC NOEC NOEL OPP OPPTS PAD PHED PHI ppb PPE ppm PRZM/EXAMS REI RfD RQ SCI-GROW SF SOP TC TGAI TTR UF MS ug/L USDA WPS Lowest Observed Adverse Effect Level Lowest Observed Adverse Effect Concentration Level of Concern Limit of Detection Limit of Quantitation Male Cubic meter Milligrams per kilogram (body weight) per day Milligrams per Liter Milliliter Margin of Exposure Master Record Identification Number Maximum Tolerated Dose Not Applicable No Observed Adverse Effect Level No Observed Adverse Effect Concentration No Observed Effect Concentration No Observed Effect Level EPA Office of Pesticide Programs EPA Office of Prevention, Pesticides and Toxic Substances Population Adjusted Dose Pesticide Handler's Exposure Data Preharvest Interval Parts Per Billion Personal Protective Equipment Parts Per Million Tier II Surface Water Computer Model Restricted Entry Interval Reference Dose Risk Quotient Tier I Ground Water Computer Model Safety Factor Standard Operating Procedure Transfer Coefficient Technical Grade Active Ingredient Turf Transferable Residue Uncertainty Factor Micrograms Micrograms per Liter United Stated Department of Agriculture Worker Protection Standard PROTHIOCONAZOLE FACT SHEET - Page 28 of 55 ------- Study Information For Ingredient 113961 / 178928-70-6/Prothioconazole MRID 46246000 46246001 46246002 46246003 46246004 46246005 46246006 46246007 46246008 46246009 46246010 46246011 Citation Bayer CropScience (2004) Submission of Product Chemistry, Efficacy, Toxicity and Fate Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shell Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice, and Wheat. Transmittal of 50 of 298 Studies. Schneider, J. (2001) Physical and Chemical Properties of JAU6476. Project Number: 14/0120/0950. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 298 p. Fontaine, L. (2004) Product Chemistry of Prothioconazole Technical. Project Number: BR/2281, ANR/02904, ANR/03004. Unpublished study prepared by Bayer Corp., Bayer Ag Institut fuer Ruckstands-Analytik and Bayer Ag, Institute of Product Info. 409 p. Fontaine, L. (2004) Product Chemistry of Prothioconazole Technical. Project Number: BR/2282, 14/0210/0950, 2001/08/08. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik, Bayer Corp. and Bayer Ag, Institute of Product Info. 140 p. Frank, J. (2004) Product Chemistry of Proline 480 SC. Project Number: BR/2283, ANR/02804, 200420/1. Unpublished study prepared by Bayer Corp. 202 p. Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse Crops, Cereal Crops, Canola and Rapeseed: Volume 1 - Wheat. Project Number: BYFCAN005, BYFCAN005/1. Unpublished study prepared by Bayer CropScience. 596 p. Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse Crops, Cereal Crops, Canola and Rapeseed: Volume 2 - Barley. Project Number: BYFCAN005, BYFCAN005/2. Unpublished study prepared by Bayer CropScience. 404 p. Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse Crops, Cereal Crops, Canola and Rapeseed: Volume 3 - Canola. Project Number: BYFCAN005, BYFCAN005/3. Unpublished study prepared by Bayer CropScience. 171 p. Bulman, P. (2004) Prothioconazole 480 SC Fungicide for Control of Diseases in Pulse Crops, Cereal Crops, Canola and Rapeseed: Volume 4 - Chickpea, Lentil & Dry Bean. Project Number: BYFCAN005, BYFCAN005/4. Unpublished study prepared by Bayer CropScience. 544 p. Heimbach, F. (2001) Acute Toxicity of JAU6476 (tech.) to Water Fleas (Daphnia magna). Project Number: E/3201675/4, HBF/DM212. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 50 p. Kern, M; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC Formulation to the Waterflea (Daphnia magna) Under Static -Renewal Conditions. Project Number: EBJAX072, J6820701, 200514. Unpublished study prepared by Bayer Corp. 34 p. Heimbach, F. (1990) Acute Toxicity of SXX 0665 (techn.) to Waterfleas (Daphnia magna). Project Number: HBF/DM/95, E/3200404/1. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 28 p. Receipt Date 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 29 of 5 5 ------- 46246012 46246013 46246014 46246015 46246016 46246017 46246018 46246019 46246020 46246021 46246022 46246023 46246024 46246025 Dorgerloh. M; Sommer, H. (2001) Acute Toxicity of JAU6476-S-Methyl to Waterfleas (Daphnia magna). Project Number: E/3202119/8, DOM/21055, 00699/MR/250/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 40 p. Sayers, L. (2004) JAU 6476-Desthio - Acute Toxicity to Crayfish (Promcambarus clarkii) Under Static -Renewal Conditions: Amended Final Report. Project Number: 13798/6147, EBJAY004, J6880601. Unpublished study prepared by Springborn Smithers Laboratories. 49 p. Drottar, K.; Kendall, T.; Krueger, H. (2001) JAU 6476: A 96-Hour Shell Deposition Test with the Eastern Oyster (Crassostreavirginica). Project Number: 149A/127, J6831501, 110956. Unpublished study prepared by Wildlife International, Ltd. 39 p. Kendall, T.; Nixon, W. (2001) Analytical Method Verification for the Determination of JAU-6476 in Saltwater. Project Number: 149C/115, J61 12401, 110957. Unpublished study prepared by Wildlife International, Ltd. 30 p. Drottar, K.; Blankinship, A.; Kendall, T.; et. al. (2002) JAU 6476: A 96-Hour Flow-Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number: 149A/128A, J6833101, 110983. Unpublished study prepared by Wildlife International, Ltd. 38 p. Drottar, K.; Palmer, S.; Kendall, T.; et. al. (2002) Desthio JAU 6476: A 96-Hour Flow- Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number: 149A/129, J6833102, 110979. Unpublished study prepared by Wildlife International, Ltd. 39 P- Dorgerloh, M. (1999) JAU6476 - Acute Toxicity (96 hours) to Rainbow Trout (Oncorhynchus mykiss) in a Static Test. Project Number: E/250 1657/6, DOM/99076. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 5 1 p. Kern, M.; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC to the Rainbow Trout (Oncorhynchus mykiss) Under Static Conditions. Project Number: EBJAX073, J6812201, 200193. Unpublished study prepared by Bayer Corp. 33 p. Grau, R. (1990) SXX 0665 techn.: Acute Toxicity to the Rainbow Trout in a Static Test. Project Number: E/2800441/9, FF/298. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 28 p. Dorgerloh, M.; Sommer, H. (2001) JAU6476-S-Methyl - Acute Toxicity (96 hours) to Rainbow Trout (Oncorhynchus mykiss) in a Semi-Static Test. Project Number: E/2802052/9, DOM/21047, 00699. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 47 p. Dorgerloh, M. (1999) JAU6476 - Acute Toxicity (96 Hours) to Bluegill (Lepomis macrochirus) in a Static Test. Project Number: E/252 1695/0, DOM/99090, 00586. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 48 p. Kern, M.; Lam, C. (2003) Acute Toxicity of JAU 6476 480 SC to the Bluegill (Lepomis macrochirus) Under Static-Renewal Conditions. Project Number: 200599, EBJAX075, J6810301. Unpublished study prepared by Bayer Corp. 34 p. Grau, R. (1991) SXX 0665: Acute Toxicity to Golden Orfe in a Static Test. Project Number: E/2820400/6, FO/1253. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands- Analytik. 29 p. Dorgerloh, M. (2000) JAU6476 - Acute Toxicity (96 hours) to Common Carp (Cyprinus 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET - Page 30 of 55 ------- carpio) in a Static Test. Project Number: E/2861781/3, DOM/20010. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 40 p. 2004 46246026 Kern, M; Lam, C. (2003) Acute Toxicity of JAU 6476-Desthio to the Fathead Minnow (Pimephales promelas) Under Static-Renewal Conditions. Project Number: EBJAZ071, J6811202, 200151. Unpublished study prepared by Bayer Corp. 35 p. 01-Apr- 2004 46246027 Kern, M.; Lam, C. (2004) Acute Toxicity of JAU 6476 Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under Static-Renewal Conditions. Project Number: EBJA2140, J6830901, 200615. Unpublished study prepared by Bayer Corp. 35 p. 01-Apr- 2004 46246028 Hendel, B.; Sommer, H. (2001) Influence of JAU6476 (tech.) on the Reproduction Rate of Water Fleas. Project Number: E/3211982/6, HDB/RDM67. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 79 p. 01-Apr- 2004 46246029 Dorgerloh, M.; Sommer, H. (2001) Influence of JAU6476-Desthio on the Reproduction Rate of Water Fleas in a Static Renewal Laboratory Test System. Project Number: E/3211987/5, DOM/21036. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 73 p. 01-Apr- 2004 46246030 Blankinship, A.; Kendall, T.; Krueger, H. (2003) Desthio JAU-6476: A Flow-Through Life Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number: 149A/130A, J6843101, 200485. Unpublished study prepared by Wildlife International, Ltd. 107 p. 01-Apr- 2004 46246031 Dorgerloh, M.; Sommer, H. (2001) JAU6476 - Early Life Stage Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-through Conditions. Project Number: E/2841699/9, DOM/20028, 00586. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands- Analytik. 102 p. 01-Apr- 2004 46246032 Gries, T.; Dorgerloh, M. (2002) JAU6476-Desthio: Early Life-Stage Toxicity Test with Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions. Project Number: 1022/013/321. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 119 p. 01-Apr- 2004 46246033 Drottar, K.; Kendall, T.; Krueger, H. (2004) Desthio JAU 6476: A Flow-Through Life-Cycle Toxicity Test with the Fathead Minnow (Pimephales promelas). Project Number: 149A/126A, J6851201, 200108. Unpublished study prepared by Wildlife International, Ltd. 130 p. 01-Apr- 2004 46246034 Dorgerloh, M.; Weber, E. (2001) (Carbon 14)-JAU6476-Bioconcentration and Biotransformation in Bluegill (Lepomis macrochirus) Under Flow-Through Conditions. Project Number: E/2442023/7, DOM/21003. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 168 p. 01-Apr- 2004 46246035 Dorgerloh, M.; Weber, E.; Spiegel, K. (2001) (Carbon 14)-JAU6476-Desthio - Bioconcentration and Biotransformation in Bluegill (Lepomis macrochirus) Under Flow- Through Conditions. Project Number: E/2441731/2, DOM/20006. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 131 p. 01-Apr- 2004 46246036 Barkfknecht, R. (1999) JAU6476 techn. ai.: Acute Oral Toxicity forBobwhite Quail (Colinus virginianus). Project Number: 2921561/6, BAR/LD028. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 35 p. 01-Apr- 2004 46246037 Grau, R. (1990) SXX 0665 (Technical Grade): Acute Oral LD50 to Bobwhite Quail. Project Number: E/2920414/2, VB/009. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 36 p. 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 31 of 55 ------- 46246038 Barfknecht, R. (2001) JAU6476 techn.: 5-Day - Dietary LC50 for Bobwhite Quail (Colinus virginianus). Project Number: E/2951563/1, BAR/LC005. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 32 p. 01-Apr- 2004 46246039 Barfknecht, R. (2001) JAU6476-Desthio.: 5-Day - Dietary LC50 for Bobwhite Quail (Colinus virginianus). Project Number: E/2951564/2, BAR/LC011. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 34 p. 01-Apr- 2004 46246040 Barfknecht, R. (2001) JAU6476 techn.: 5-Day - Dietary LC50 to Mallard Duck (Anas platyrhynchos). Project Number: E/2971562/2, BAR/LC010. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 31 p. 01-Apr- 2004 46246041 Martin, K.; Nixon, W. (2001) Analytical Method Verification for the Determination of Desthio JAU 6476 in Avian Diet. Project Number: 149C/113, J6111901, 99/B/203. Unpublished study prepared by Wildlife International, Ltd. 30 p. 01-Apr- 2004 46246042 Frieling, W. (2000) Reproduction Study in Bobwhite Quail with JAU 6476 (by Dietary Admixture). Project Number: 259842, 88353, 259842/MO/OO/010540. Unpublished study prepared by Notox B.V. 231 p. 01-Apr- 2004 46246043 Barfknecht, R. (2002) JAU6476-Desthio techn. ai.: Effects of a Subchronic Dietary Exposure to the Northern Bobwhite Quail Including Effects on Reproduction and Behavior. Project Number: E/2981830/1, BAR/REP006. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 106 p. 01-Apr- 2004 46246044 Frieling, W. (2000) Reproduction Study in Mallard Duck with JAU 6476 (by Dietary Admixture). Project Number: 259919, 88353. Unpublished study prepared by Notox B.V. 207 p. 01-Apr- 2004 46246045 Frey, L.; Martin, K.; Beavers, J.; et. al.; (2001) Desthio JAU-6476: A Reproduction Study with the Mallard (Anas platyrhynchos). Project Number: 149/181, 110617, J6740801. Unpublished study prepared by Wildlife International, Ltd. 200 p. 01-Apr- 2004 46246046 Schmitzer, S. (2004) Effects of JAU 6476 SC 480 (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory. Project Number: 18351035. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON GmbH. 31 p. 01-Apr- 2004 46246047 Moll, M.; Butzler, R. (2004) Effects of JAU SC 480 on the Parasitoid Aphidius rhopalosiphi, Extended Laboratory Study. Project Number: 18352002. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON GmbH. 50 p. 01-Apr- 2004 46246048 Wilhelmy, H. (1999) JAU 6476 a.i.: Acute Effects on the Honeybee Apis mellifera. Project Number: IBA64051, 990222BN. Unpublished study prepared by Dr. U. Noack- Laboratorium fuer Angewandte Biologie. 32 p. 01-Apr- 2004 46246049 Sabbert, T. (2004) Tier 1 Seedling Emergence and Vegeatative Vigor Non-target Phytotoxicity Study Using JAU 6476 480SC. Project Number: J6451601, J6451602, 200951. Unpublished study prepared by Bayer Corp. 84 p. 01-Apr- 2004 46246050 Sabbert, T. (2004) Tier 2 Seedling Emergence Non-target Phytotoxicity Study Using JAU 6476 480SC. Project Number: J6451603, 200952. Unpublished study prepared by Bayer Corp. 57 p. 01-Apr- 2004 46246100 Bayer CropScience (2004) Submission of Environmental Fate and Residue Data in Support of the Applications for Registration of Prothioconazole Technical and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 32 of 55 ------- 46246101 46246102 46246103 46246104 46246105 46246106 46246107 46246108 46246109 46246110 46246111 46246112 46246113 46246114 Subgroup, Peanut, Rice, and Wheat. Transmittal of 50 out of 297 Studies. Kern, M; Banman, C.; Lam, C. (2004) Toxicity of JAU 6476 Technical to Duckweed (Lemna gibba G3) Under Static -Renewal Conditions. Project Number: EBJAY002, J6883701, 200488. Unpublished study prepared by Bayer Corp. 48 p. Kern, M.; Banman, C.; Lam, C. (2003) Toxicity of JAU 6476 480 SC to Duckweed (Lemna gibba G3) Under Static -Renewal Conditions. Project Number: EBJAX189, J6883703, 200672. Unpublished study prepared by Bayer Corp. 48 p. Kern, M.; Roberts, I; De Haan, R. (2004) Toxicity of JAU 6476 Technical to the Blue-green Alga Anabaena flos-aquae. Project Number: EBJAX078, J6883801, 200497. Unpublished study prepared by Bayer Corp. 58 p. Kern, M.; Banman, C.; Lam, C. (2003) Toxicity of JAU 6476-Desthio to Duckweed (Lemna gibba G3) Under Static-Renewal Conditions. Project Number: EBJAX084, J6883702, 200469. Unpublished study prepared by Bayer Corp. 46 p. Dorgerloh, M. (2000) JAU6476 Influence on the Growth of the Green Alga, Selenastrum capricornutum. Project Number: E/3231610/6, DOM/99107. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 49 p. Kern, M.; Lam, C. (2004) Toxicity of JAU 6476 480 SC Formulation to the Green Alga Pseudokirchneriella subcapitata (a.k.a. Selenastrum capricornutum). Project Number: EBJAX075, J6883501, 200602. Unpublished study prepared by Bayer Corp. 51 p. Dorgerloh, M.; Sommer, H. (2001) JAU6476-S-Methyl Influence on the Growth of the Green Alga, Selenastrum capricornutum. Project Number: E/3232061/7, DOM/21028. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 48 p. Heimbach, F. (1990) Growth Inhibition of Green Algae (Scenedesmus subspicatus) by SXX 0665 Technical. Project Number: E/3230401/3, HBF/AL78. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 30 p. Kern, M.; Lam, C. (2004) Toxicity of JAU 6476 Technical to the Freshwater Diatom Navicula pelliculosa. Project Number: EBJAX085, J6883401, 200252. Unpublished study prepared by Bayer Corp. 50 p. Kern, M.; De Harm, R. (2004) Toxicity of JAU 6476 Technical to the Saltwater Diatom Skeletonema costatum. Project Number: EBJAX076, J6883601, 200434. Unpublished study prepared by Bayer Corp. 49 p. Hoogendoorn, G. (2000) An Extended Laboratory Study to Evaluate the Effects of JAU6476 on the Predaceous Mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae). Project Number: B060HAE. Unpublished study prepared by Mitox Stichting Duurzame. 30 p. Anderson, J. (1999) Influence of JAU6476 Technical Ingredient on the Microbial Mineralization of Nitrogen in Soils. Project Number: E/3371710/2, ALO/203199, 2445. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 23 p. Anderson, J. (2000) Influence of the JAU6476 Technical Ingredient on Glucose Stimulated Respiration in Soils. Project Number: E/3301708/2, AJO/203099. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 25 p. Anderson, J. (2000) Influence of the Metabolite JAU6476-Desthio on the Microbial Mineralization of Nitrogen in Soils. Project Number: E/337 1792/2, AJO/209400. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 21 p. 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 33 of 55 ------- 46246115 Anderson, J. (2001) Influence of the Metabolite JAU6476-Desthio on the Microbial Mineralization of Nitrogen in Soils. Project Number: E/3372075/7, AJO/219101. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 21 p. 01-Apr- 2004 46246116 Anderson, J. (1999) Influence of the Metabolite JAU6476-S-Methyl on the Microbial Mineralization of Nitrogen Soils. Project Number: E/3371709/0, AJO/203399. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 23 p. 01-Apr- 2004 46246117 Anderson, J. (1999) Influence of the Metabolite JAU6476-S-Methyl on Glucose Stimulated Respiration in Soils. Project Number: E/3301707/1, AJO/203299. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 25 p. 01-Apr- 2004 46246118 Nienstedt, K. (2002) Reproduction Toxicity Test Exposing Folsomia Candida (Collembola) to JAU6476 Technical. Project Number: 1022/028/641. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 34 p. 01-Apr- 2004 46246119 Moser, T.; Rombke, J. (2001) Acute and Reproduction Toxicity of JAU6476-Desthio to the Collembolan Species Folsomia Candida According to the ISO Guideline 11267 "Soil Quality-Inhibition of Reproduction of Collembola (Folsomia Candida) by Soil Pollutants" (1999). Project Number: P1CR. Unpublished study prepared by ECT Oekotoxikologie Gmbh. 28 p. 01-Apr- 2004 46246120 Nienstedt, K. (2001) Reproduction Toxicity Test Exposing Folsomia Candida (Collembola) to JAU6476-Desthio. Project Number: 1022/020/641. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 36 p. 01-Apr- 2004 46246121 Moser, T.; Scheffczyk, A. (2001) Acute and Reproduction Toxicity of JAU6476-S-Methyl to the Collembolan Species Folsomia Candida According to the ISO Guideline 11267 "Soil Quality-Inhibition of Reproduction of Collembola (Folsomia Candida) by Soil Pollutants" (1999). Project Number: P35CR. Unpublished study prepared by ECT Oekotoxikologie Gmbh. 24 p. 01-Apr- 2004 46246122 Meisner, P. (2000) Acute Toxicity of JAU6476 (tech.) to Earthworms (Eisenia fetida). Project Number: E/3101769/7, MPE/RG326/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 22 p. 01-Apr- 2004 46246123 Meisner, P. (2000) Acute Toxicity of JAU6476 EC 250 to Earthworms (Eisenia fetida). Project Number: E/3101795/6, MPE/RG331/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 18 p. 01-Apr- 2004 46246124 Lechelt-Kunze, C. (2003) Prothioconazole (JAU 6476) SC 480: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artifical Soil with 10% Peat. Project Number: E/3102600/2, LKC/RG/A/16/03. Unpublished study prepared by Bayer Ag, Institute of Product Info. 23 p. 01-Apr- 2004 46246125 Meisner, P. (2000) Acute Toxicity of JAU6476-Desthio to Earthworms (Eisenia fetida). Project Number: E/3101844/1, MPE/RG338/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 20 p. 01-Apr- 2004 46246126 Heimbach, F. (2000) Acute Toxicity of JAU6476-S-Methyl to Earthworms (Eisenia fetida). Project Number: E/3101743/9, HBF/RG321. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 19 p. 01-Apr- 2004 46246127 Meisner, P. (2000) Influence of JAU6476-EC 250 on the Reproduction of Earthworms (Eisenia fetida). Project Number: E/3121753/2, MPE/RG325. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 27 p. 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 34 of 5 5 ------- 46246128 46246129 46246130 46246131 46246132 46246133 46246134 46246135 46246136 46246137 46246138 46246139 46246140 46246141 Meisner, P. (2000) Influence of JAU6476-Desthio on the Reproduction of Earthworms (Eisenia fetida). Project Number: E/3 12 1799/2, MPE/RG3 22/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 24 p. Heimbach, F. (2000) Influence of JAU6476-S-Methyl on the Reproduction of Earthworms (Eisenia fetida). Project Number: E/3 121713/8, HBF/RG3 17. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 24 p. Kunze, L. (2002) JAU6476 EC 250: Effect on the Earthworm Fauna of a Grassland Area in One Year. Project Number: E/3 1 12093/9, LKC/RGF58. Unpublished study prepared by Bayer Ag, Institute of Product Info. 96 p. Hendel, B. (2000) Influence of JAU6476 (tech.) on Developmental and Emergence of Larvae of Chironomus riparius in a Water-Sediment System. Project Number: E/4161775/1, HDB/CH42. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 53 P- Hendel, B. (2000) Influence of SXX 0665 (tech.) on Development and Emergence of Larvae of Chironomus riparius in a Water-Sediment System. Project Number: E/4161808/8, HDB/CH43. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 53 P- Hall, A.; Duah, F. (2002) JAU 6476 480 SC - Magnitude of Residue In/On Wheat Forage, A Potential Wildlife Feed Item. Project Number: J619WH03, 111032, J6122/01W. Unpublished study prepared by Bayer Corp. 148 p. Hall, A.; Duah, F.; Daussin, S. (2004) JAU 6476 480 SC - Magnitude of Residue In/On Turf Grass, A Potential Wildlife Feed Item. Project Number: J619GS01, 200832, J6043/01W. Unpublished study prepared by Bayer Corp. 146 p. Hall, A.; Duah, F.; Daussin, S. (2004) JAU 6476 480 SC - Magnitude of Residue In/On Peanut Forage, A Potential Wildlife Feed Item. Project Number: J619PE03, 200833, J6062/01W. Unpublished study prepared by Bayer Corp. 123 p. Heimbach, F. (2002) Expert Statement Concerning the Evaluation of the Study Results of Study LCK/RgF 58 "JAU6476 EC 250: Effect on the Earthworm Fauna of A Grassland Area in One Year". Project Number: MO/02/014407. Unpublished study prepared by Bayer Ag, Institute of Product Info. 8 p. Rosenkranz, B. (2004) Effects of JAU 6476 SC 480 on the Predatory Mite Typhlodromus pyri, Extended Laboratory Study - Dose Response Test-. Project Number: 18353062. Unpublished study prepared by Institut fuer Biologische Analytik. 42 p. Hall, A. (2004) Environmental Risk Assessment for Prothioconazole. Project Number: 201000. Unpublished study prepared by Bayer CropScience LP. 59 p. Heinemann, O. (2003) 36 Months Storage Stability of Residues of JAU6476 and JAU6476- Desthio During Frozen Storage In/On Wheat Matrices. Project Number: MR/354/01, P64283007. Unpublished study prepared by Bayer Ag, Institute of Product Info. 47 p. Tolliver, M. (2004) Tier II Summaries for Ecotoxicology Studies. Project Number: 201002. Unpublished study prepared by Bayer CropScience LP. 1 12 p. Haas, M.; Bornatsch, W. (2000) Metabolism of JAU 6476 in Spring Wheat (after foliar application). Project Number: M/1730851/5, 110880, MR/198/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 149 p. 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 35 of 5 5 ------- 46246142 Haas, M. (2001) Metabolism of JAU 6476 in Spring Wheat after Seed Dressing. Project Number: M/1730885/2, 110881, MR/467/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 84 p. 01-Apr- 2004 46246143 Duah, F.; Lopez, R. (2004) The Metabolism of [Triazole-3, 5-(Carbon 14)] JAU6476 in Wheat. Project Number: J6041601, 200733. Unpublished study prepared by Bayer Corp. 197 P- 01-Apr- 2004 46246144 Vogeler, K.; Sakamoto, H.; Brauner, A. (1993) Metabolism of SXX 0665 in Summer Wheat. Project Number: M/1730365/5, MR/PF3906, PF/3906. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 114 p. 01-Apr- 2004 46246145 Haas, M. (2001) Metabolism of [Phenyl-UL-(Carbon 14)]JAU6476 in Peanuts. Project Number: M/1730984/2, MR/193/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 130 p. 01-Apr- 2004 46246146 Haas, M. (2003) Metabolism of [trizole-UL-(Carbon 14)]JAU6476 in Peanuts. Project Number: M1731145/2, MR/194/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. 145 p. 01-Apr- 2004 46246147 Beedle, E.; Ying, S. (2004) The Metabolism of [Triazole-UL-(Carbon 14)]JAU6476 in Sugar Beets. Project Number: J6041603, 200467. Unpublished study prepared by Bayer Corp. 91 p. 01-Apr- 2004 46246148 Beedle, E.; Ying, S. (2004) The Metabolism of [Phenyl-UL-(Carbon 14)]JAU6476 in Sugar Beets. Project Number: J6041602, 200466. Unpublished study prepared by Bayer Corp. 86 P- 01-Apr- 2004 46246149 Weber, E.; Weber, H.; Spiegel, K. (2003) [Triazole-UL-(Carbon 14)]JAU6476: Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat. Project Number: M51819114, MR/448/02. Unpublished study prepared by Bayer Ag, Institute of Product Info. 308 p. 01-Apr- 2004 46246150 Weber, H.; Spiegel, K. (2001) [Phenyl-UL-(Carbon 14)]JAU6476: Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat. Project Number: M/91819082, MR/092/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 205 p. 01-Apr- 2004 46246200 Bayer CropScience (2004) Submission of Residue and Toxicity Data in Support of the Application for Registrations of Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Excpet Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 50 of 179 Studies. 01-Apr- 2004 46246201 Weber, H.; Weber, E.; Spiegel, K. (2002) ((Phenyl-UL-(Carbon 14))JAU6476-desthio: Absorption, Distribution, Excretion, and Metabolism in the Lactating Goat Including the Validation of the Residue Analytical Method for the Determination of JAU6476-desthio, JAU6476-3-hydroxy-desthio. Project Number: M91819091, SXX1, SXX2. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 399 p. 01-Apr- 2004 46246202 Weber, H.; Spiegel, K. (2001) ((Phenyl-UL-(Carbon 14))JAU6476: Absorption, Distribution, Excretion, and Metabolism in Laying Hens. Project Number: M/81819090, MR/309/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 142 p. 01-Apr- 2004 46246203 Weber, H.; Justus, K. (2003) ((Triazole-UL-(Carbon 14))JAU6476: Absorption, 01-Apr- Distribution, Excretion, and Metabolism in Laying Hens. Project Number: M/91819118, 2004 PROTHIOCONAZOLE FACT SHEET- Page 36 of 55 ------- 46246204 46246205 46246206 46246207 46246208 46246209 46246210 46246213 46246214 46246215 46246216 46246217 46246218 MEF005/03. Unpublished study prepared by Bayer Ag, Institute of ProductInfo. 157 p. Moore, S. ; Harbin, A. (2003) An Analytical Method for the Determination of JAU 6476, JAU 6476-Desthio and JAU 6476-4-Hydroxy Residues in Various Bovine Matrices by LC- MS/MS. Project Number: 200537. Unpublished study prepared by Bayer Corp. 131 p. Justus, K.; Spiegel, K. (2004) (Triazole-UL-(Carbon 14))JAU6476: Extraction Efficiency of the Residue Analytical Method for the Determination of JAU6476, JAU6476-4-hydroxy and JAU 6476-desthio in Animal Tissues and Milk Using Aged Residues. Project Number: M99912561/1, MEF/020/04. Unpublished study prepared by Bayer Ag, Institute of Product Info. 58 p. Gould, T.; Timberlanke, B.; Krolski, M.; et. al. (2004) Validation of Bayer CropScience Method RPA JA/03/0 1 : JAU6476 : An Analytical Method for the Determination of Total Residues of JAU6476 in Plant Matrices Using LC/MS-MS. Project Number: J61 1 1401, 200799, RPA/JA/03/01. Unpublished study prepared by Bayer Corp. 238 p. Reed, D. (2004) Independent Laboratory Validation for the Determination of JAU6476, JAU6476-Desthio, and JAU6476-4-Hydroxy in Bovine Milk and Liver: Final Report. Project Number: RAYAY004, BAYER/15 17. Unpublished study prepared by Pyxant Labs Inc. 298 p. Gould, T.; Timberlake, B. (2004) Extraction Efficiency of JAU6476 and Metabolites by the Method JA/03/01. Project Number RAYAY01 1. Unpublished study prepared by Bayer Corp. 59 p. Clark, J. (2004) Independent Laboratory Validation of "JAU6476: An Analytical Method for the Determination of Residues of JAU6476 and desthio-JAU6476 in Plant Matrices by LC- MS/MS". Project Number: RAJAY020, 48663. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 77 p. Rodgers, C. (2003) Testing of JAU 6476 Plus Five Metabolites Through the FDA Multiresidue Methods as Described in the FDA Pesticide Analytical Manual (PAM) I, Appendix II, Updated 1/94. Project Number: 200480, J6 162302, 47947. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 133 p. Duah, F. (2004) A 28-Day Feeding Study with JAU6476 in Dairy Cattle. Project Number: 200715, J6060401, 205/003/10. Unpublished study prepared by Bayer Corp. and Genesis Midwest Laboratories. 498 p. Heinemann, O.; Auer, S. (2001) JAU6476-desthio - Dairy Cattle Feeding Study. Project Number: MR/535/00, P/673003007, 2001/03/30. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 262 p. Lemke, V.; Helfrich, K. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Canola. Project Number: J619CN01, RCJAY006, 200464. Unpublished study prepared by Bayer Corp. and ICMS, Inc. 3 54 p. Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Rice. Project Number: J619RI01, RCJAY008, 200468. Unpublished study prepared by Bayer Corp. 501 p. Fischer, D. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Peanuts. Project Number: J619PE01, RCJAY007, 200508. Unpublished study prepared by Bayer Corp., Battelle and Bayer Research Farm. 490 p. Kraai, M. (2004) KAU6476 480 SC - Magnitude of the Residue In/On Wheat Grain, Wheat Aspirated Grain Fractions, and Wheat Processed Commodities. Project Number: J619WH02, 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET- Page 37 of 55 ------- 46246219 46246220 46246221 46246222 46246223 46246224 46246225 46246226 46246227 46246228 46246229 46246230 46246231 RCJAY004, 200521. Unpublished study prepared by Bayer Corp., Texas A & M Research Center and Battelle. 744 p. Lmke, V.; Murphy, J. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Wheat. Project Number: J619WH01, RCJAY009, 200524. Unpublished study prepared by Bayer Corp., Battelle and Vaughn Agricultural Research Serv., Ltd. 1270 p. Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Barley. Project Number: J619BA01, 200806, RCJAY005. Unpublished study prepared by Bayer Corp., Battelle and Agvise Inc. 797 p. Fischer, D. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Dried Peas and Dried Beans (Crop Subgroup 6C - Dried, Shelled Pea and Bean - Except Soybean). Project Number: J619BY02, J619DP02, RCJAX007. Unpublished study prepared by Bayer Corp., Quails Agricultural Laboratories, I and Varco Ag. Research & Consulting. 564 p. Harbin, A. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Rice Grain and Rice Processed Commodities. Project Number: J619R102, RCJAY003, 200493. Unpublished study prepared by Bayer Corp., Texas A & M Food Protein Research & and Battelle. 464 p. Lenz, C. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Peanuts and Peanut Processed Commodities. Project Number: J619PE02, RCJAY002, 200518. Unpublished study prepared by Bayer Corp., Texas A & M Research Center and Battelle. 447 p. Beedle, E. (2004) JAU6476 480 SC - Magnitude of the Residue In/On Canola Seed and Canola Processed Commodities. Project Number: J619CN02, RCJAY001, 200953. Unpublished study prepared by Bayer Corp., Texas A & M Research Center and Battelle. 309 p. Haas, M. (2001) Confined Rotation Crop Study with JAU 6476. Project Number: 1 10882, M1300891/2. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 145 p. Duah, F.; Kraai, M. (2004) The Accumulation of ((Triazole-3,5-(Carbon 14)) JAU6476 in Confined Rotational Crops. Project Number: J6051601, 200623. Unpublished study prepared by Bayer Corp. 324 p. Lemke, V.; Lenz, C.; Murphy, J. (2004) JAU6476 480 SC - Magnitude of the Residue in Field Rotational Crops - Wheat, Mustard Greens, and Turnips. Project Number: 200535, J619RC01, J619RC02. Unpublished study prepared by Bayer Corp., Battelle and Bayer Research Farm. 1202 p. Lemke, V. (2004) Evaluation of Acute and Chronic Dietary Exposure to JAU6476 and Assessment of Potential Risk. Project Number: 200996. Unpublished study prepared by Bayer Corp. 78 p. Bayer CropScience (2004) Tier II Summaries for Residue Chemistry Studies: (JAU 6476- desthio). Project Number: 201004. Unpublished study prepared by Bayer CropScience Lp. 185 p. Andrews, P. (1998) JAU 6476: Study for Acute Oral Toxicity in Rats. Project Number: 27500, T7062252. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Krotilinger, F. (1991) SXX 0665: Study for Acute Oral Toxicity in Rats. Project Number: 20098, T9034877, 109274. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 72 P- 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 38 of 55 ------- 46246232 46246233 46246234 46246235 46246236 46246237 46246238 46246239 46246240 46246241 46246242 46246243 46246244 46246245 46246246 46246247 Eigenberg, D. (2003) An Acute Oral LD50 Study in the Rat with JAU 6476 480 SC. Project Number: 02/A12/NZ. Unpublished study prepared by Bayer Corp. 20 p. Kroetlinger, F. (2002) JAU 6476-Asymmetric Isomer: Study for Acute Oral Toxicity in Rats. Project Number: 32125, T/3071404. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Schungel, M. (2003) JAU 6476 DES-Chloro: Acute Toxicity in the Rat After Oral Administration. Project Number: AT00329, T9072235. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 23 p. Krotlinger, F. (2002) JAU 6476 - Methyl Study for Acute Oral Toxicity in Rats. Project Number: 31997, T6071332. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Krotlinger, F. (2001) JAU 6476-Asymmetric Disulfide: Study for Acute Oral Toxicity in Rats. Project Number: 3 1498, T6070919. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Krotlinger, F. (2000) JAU 6476 - Sulfonic Acid K. Salt: Study for Acute Oral Toxicity in Rats. Project Number: 30237, T3069242. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Krotlinger, F. (2000) JAU 6476 Alpha-Hydroxy-Desthio: Study for Acute Oral Toxicity in Rats. Project Number: 30109, T8069445. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p. Krotlinger, F. (2000) JAU 6476 Alpha-Acetoxy-Desthio Study for Acute Oral Toxicity in Rats. Project Number: 301 10, T8069436. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p. Krotlinger, F. (2000) JAU 6476-Benzylpropyldiol Study for Acute Oral Toxicity in Rats. Project Number: 29898, T9069086. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Krotlinger, F. (2000) JAU 6476 - Triazolinone: Study for Acute Oral Toxicity in Rats. Project Number: 30108, T8069643. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Krotlinger, F. (1991) SXX 0665: Study for Acute Oral Toxicity in Mice. Project Number: 20097, T0034878, 109278. Unpublished study prepared by Berigische Univ. 65 p. Krotlinger, F. (1991) SXX 0665: Study for Acute Dermal Toxicity in Rats. Project Number: 20094, T8034876. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 29 p. Krotlinger, F. (1999) JAU 6476: Study for Acute Dermal Toxicity in Rats. Project Number: 28495, T3067398, 108994. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 27 P- Eigenberg, D. (2003) An Acute Dermal LD50 Study in the Rat with JAU 6476 480 SC. Project Number: 02/A22/OA, 200491. Unpublished study prepared by Bayer Corp. 20 p. Pauluhn, J. (1999) JAU 6476: Study on Acute Inhalation Toxicity in Rats. Project Number: PH/28954, T1067489, 109267. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 77 p. Pauluhn, J. (1992) SXX 0665: Study for Acute Inhalation Toxicity in Rats. Project Number: 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET - Page 39 of 5 5 ------- 46246248 46246249 46246250 46246300 46246301 46246302 46246303 46246304 46246305 46246306 46246307 46246308 46246309 21087, T0034959, T/9034723. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 80 p. Pauluhn, J. (2003) JAU 6476 480 SC: Study on Acute Inhalation Toxicity in Rats. Project Number: AT00332, T5072295. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 69 p. Leuschner, P. (1999) Acute Eye Irritation Study of JAU 6476 by Instillation into the Conjunctiva! Sac of Rabbits. Project Number: R6506A, T7060146, 108997. Unpublished study prepared by Laboratory of Pharmacology & Toxicology. 22 p. Martins, T. (1991) SXX 0665: Study for Eye and Skin Irritation/ Corrosion in Rabbits. Project Number: 19945, T4039651. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 p. Bayer CropScience (2004) Submission of Toxicity Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide and Proline 480 SC Funicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shell Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice, and Wheat. Transmittal of 50 of 298 Studies. Merkel, D. (2003) Primary Eye Irritation Study in Rabbits: JAU 6476 480 SC. Project Number: 02C/I35/NX, 200607, 13229. Unpublished study prepared by Product Safety Labs. 16 p. Leuschner, P. (1999) Acute Skin Irritation Test (Patch Test) of JAU 6476 in Rabbits. Project Number: R/6505A, T7060146, 108998. Unpublished study prepared by Laboratorium fuer Pharmakologie und Tox. 20 p. Merkel, D. (2003) Primary Skin Irritation Study in Rabbits: JAU 6476 480 SC. Project Number: 02C/I25/NY, 200606, 13230. Unpublished study prepared by Product Safety Labs, Food Products Laboratory and Silliker Laboratories of New Jersey, Inc. 15 p. Dreist, M.; Diesing, L. (1991) SXX 0665 Study for Skin-Sensitizing Effects in Guinea Pigs (Buehler Patch Test). Project Number: 20719, T/0039594, 109277. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 35 p. Stropp, G. (1996) JAU 6476: Study for Skin Sensitization Effect in Guinea Pigs (Guinea Pig Maximization Test Method According to Magnusson and Kligman). Project Number: 25027B, 108999, T/5060667. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Vohr, H. (2003) JAU 6476 480 SC: Study for the Skin Sensitization Effect in Guinea Pigs (Guinea Pig Maximization Test According to Magnusson and Kligman). Project Number: AT00397, T/4072294. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Vohr, H. (2002) JAU 6476 Des-Chloro Study for the Skin Sensitization Effect in Guinea Pigs (Guinea Pig Maximization Test According to Magnusson and Kligman). Project Number: AT0003 1, T/3071852. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 26 p. Diesing, L. (1990) l-Chlor-2,4-dinitrobenzol Study for Suitability of Guinea Pig Strain BOR: DHPW for Use in Studies on Skin Sensitizing Effect. Project Number: T/7033948, 193 16. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 43 p. Schladt, L.; Hartmann, E. (1999) SXX 0665: Study on Subchronic Toxicity in Wistar Rats (Dietary Administration Over 14 Weeks with a Subsequent Recovery Period Over 5 Weeks). 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 40 of 5 5 ------- 46246310 46246311 46246312 46246313 46246314 46246315 46246316 46246317 46246318 46246319 46246320 46246321 46246322 46246323 Project Number: 29336, T2037354, 109446. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 545 p. Wirnitzer, U. (1999) SXX 0665: Dose-Range-Finding Study inB6C3Fl Mice (Dietary Administration for About 13 Weeks). Project Number: 29235, T2034753, 109445. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 327 p. Wirnitzer, U.; Hartmann, E. (1999) JAU 6476: Study on Subchronic Toxicity in Wistar Rats (Administration by Gavage Over 14 Weeks with a Subsequent Recovery Period of 4 Weeks). Project Number: 28760, T9062416, 109095. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 559 p. Andrews, P.; Hartman, E. (2001) JAU 6476-Sulfonic Acid K-Salt Study for Subchronic Oral Toxicity in Rats (Feeding Study for 13 Weeks). Project Number: 31441, T/7069877. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 371 p. Jones, R.; Stuart, B. (2001) Technical Grade JAU 6476: A Subchronic Oral Gavage Study in the Beagle Dog. Project Number: 98/116/WH, 109442. Unpublished study prepared by Bayer Corp. 13 14 p. Hofmann, W.; Ruf, J.; Rinke, M. (2000) SXX 0665: Subchronic Toxicity Study in the Beagle Dog (13 Week Feeding Study). Project Number: 29616, T/4039822. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 360 p. Krotlinger, F.; Hartmann, E. (2000) JAU 6476 Study for Subacute Dermal Toxicity in Rats (Four- Week Treatment Period). Project Number: 30115, T/2067397. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 227 p. Stahl, B. (1996) JAU 6476: Developmental Toxicity Study in Rats After Oral Administration. Project Number: 25827, T2060240, 109074. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 671 p. Klaus, A. (2002) JAU 6476-des-chloro: Pilot Developmental Toxicity Study in Rats After Oral Administration. Project Number: AT00172, T0063605. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 228 p. Becker, H.; Marburger, A. (2001) JAU 6476 - Sulfonic Acid K Salt Dose Range-Finding Study to a Prenatal Development Toxicity Study in the Rat. Project Number: R7936, T8068554, 778274. Unpublished study prepared by RCC Umweltchemie Ag. 153 p. Holzum, B. (1992) SXX 0665: Embryotoxicity Study on Postnatal Development of Supernumerary Ribs in Rats Following Oral Administration. Project Number: 21792, T/4039958, 109269. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 177 p. Renhof, M. (1990) SXX 0665: Exploratory Study for Embryotoxic Effects in Rats Following Oral Administration. Project Number: 18661, T/0030368. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 131 p. Becker, H.; Leutkemeier, H.; Biedermann, K.; et. al. (1991) Embryotoxicity Study (Including Teratogenicity) with SXX 0665 Technical in the Rat. Project Number: 236114, R/5426, 108979. Unpublished study prepared by RCC Umweltchemie Ag. 324 p. Becker, H.; Biedermann, K. (1991) Supplementary Study to the Embryotoxicity Study (Including Teratogenicity) With SXX 0665 Technical in the Rat. Project Number: 281518, R5437, T9034679. Unpublished study prepared by RCC Umweltchemie Ag. 193 p. Young, A. (2001) A Dermal Developmental Toxicity Study with (JAU 6476, Technical 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET - Page 41 of 5 5 ------- 46246324 46246325 46246326 46246327 46246328 46246329 46246330 46246331 46246332 46246333 46246334 46246335 46246336 46246337 Material and Products) in the WistarRat. Project Number: 108993, 98/622/QZ. Unpublished study prepared by Bayer Corp. 521 p. Becker, H.; Marburger, A.; Biedermann, K. (2001) JAU 6476 - Sulfonic Acid K Salt Prenatal Developmental Toxicity Study in the Rat. Project Number: 778285, R7997, T9068555. Unpublished study prepared by RCC Umweltchemie Ag. 275 p. Holzum, B. (1991) SXX 0665 Study for Embryotoxic Effects in Rats Following Dermal Exposure. Project Number: 21058, T/6034739, 109280. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 232 p. Bartmann, K. (1991) SXX 0665 Supplementary Study for Embryotoxic Effects in Rats Following Dermal Exposure. Project Number: 20582, T/7037368, 109280. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 178 p. Bartmann, K. (1991) SXX 0665: Study for Embryotoxic Effects in Rabbits Following Oral Administration. Project Number: 21091, T/9037397, 109270. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 191 p. Becker, H.; Biedermann, K. (1998) Developmental Toxicity Study with JAU 6476 in the Rabbit. Project Number: 650981, R7235, T9054299. Unpublished study prepared by RCC Umweltchemie Ag. 369 p. Becker, H.; Biedermann, K. (1991) Dose Range-Finding Embryotoxicity Study (Including Teratogenicity) with SXX 0665 Technical in the Rabbit (Dermal Application). Project Number: 309554, R5425, T1040386. Unpublished study prepared by RCC Umweltchemie Ag. 92 p. Becker, H.; Biedermann, K. (1997) Dose Toleration Study to a Developmental Toxicity Study with JAU 6476 in the Rabbit. Project Number: 650970, R7003, T/5055258. Unpublished study prepared by RCC Umweltchemie Ag. 1 12 p. Freshwater, K. (1999) A Pilot Reproductive Toxicity Study with JAU 6476 Technical in the WistarRat. Project Number: 98/912/TF, 109079. Unpublished study prepared by Bayer Corp. 306 p. Eigenberg, D. (1992) Pilot Study to Establish Dose Levels for a Two-Generation Reproduction Study in Rats Using Technical Grade SXX 0665 Administered via the Diet. Project Number: 90/972/HV, 103274. Unpublished study prepared by Miles Inc. 232 p. Eigenberg, D. (2001) A Two-Generation Dietary Reproduction Study in Rats Using SXX 0665. Project Number: 91/672/KO, 109835. Unpublished study prepared by Bayer Corp. 959 P- Young, A. (2001) A Two-Generation Reproductive Toxicity Study with JAU 6476 in the WistarRat. Project Number: 98/612/VH, 110500. Unpublished study prepared by Bayer Corp. 1441 p. Wirnitzer, U.; Popp, A. (2000) JAU 6476: Study on Chronic Toxicity in Wistar Rats Administration via Gavage Over 1 Year. Project Number: 30536, T6067643. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 75 1 p. Jones, R.; Stuart, B. (2001) Technical Grade JAU 6476: A Chronic Oral Gavage Study in the Beagle Dog. Project Number: 99/C16/BF, 110921. Unpublished study prepared by Bayer Corp. 980 p. Henninger, K.; Wetzig, H.; Popp, A. (2001) SXX 0665 Chronic Toxicity Study in Beagle 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET - Page 42 of 5 5 ------- 46246338 46246339 46246340 46246341 46246342 46246343 46246344 46246345 46246346 46246347 46246348 46246349 46246350 46246400 Dogs (30 Week Feeding Study). Project Number: 31148, T/6044125. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 525 p. Wirnitzer, U.; Hartmann, E. (2001) JAU 6476 Study on Carcinogenicity in Wistar Rats (Administration by Gavage Over 2 Years). Project Number: 31512, T7067644. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 1780 p. Schladt, L. (2001) JAU 6476 Oncogenicity Study in CD-I Mice (Administration via Gavage for 18 Months). Project Number: 31510, T5068083. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 1396 p. Wirnitzer, U.; Rinke, M. (2000) SXX 0665 Oncogenicity Study inB6C3Fl Mice (Dietary Administration Over 2 Years). Project Number: 30045, T307337. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 1326 p. Wirnitzer, U.; Rinke, M. (2002) SXX 0665: Oncogenicity Study in B6C3F1 Mice (Dietary Administration Over 2 Years). Project Number: 30045A, T307337, 30045/1. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 13 p. Schladt, L.; Hartmann, E.; Rinke, M. (1999) SXX 0665: Combined Study on Chronic Toxicity and Carcinogrnicity in Wistar Rats (Dietary Administration Over 2 Years). Project Number: PH/29419, T7037250, 109447. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 1854 p. Herbold, B. (1996) JAU 6476: Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: 24859, T/9053957, 109055. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 57 p. Herbold, B. (1990) SXX 0665: Salmonella/Microsome Test. Project Number: 108970, T/7034730, 19539. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 48 p. Herbold, B. (2003) JAU 6476 Des-chloro: Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: AT00304, T/1071508. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 5 1 p. Herbold, B. (2002) JAU 6476-Methyl Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: 32267, T/90 17782. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 5 1 p. Herbold, B. (2002) JAU 6476-Asymmetric Isomer: Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: 32103, T/9071191. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 5 1 p. Herbold, B. (2001) JAU 6476-Asymmetric Disulfide Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: PH/3 1565, T/6070522, 3 1565. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 51 p. Herbold, B. (2000) JAU 6476-Alpha-hydroxy-desthio Salmonella/Microsome Test Plate Incorporation and Preincubation Method. Project Number: 30086, T/5069118. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 50 p. Herbold, B. (2000) JAU 6476-Triazolinone Salmonella/Microsome Test Plate Incorporation and Preincubation. Project Number: 30063, T/4069153. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 50 p. Bayer CropScience LP (2004) Submission of Toxicity, Environmental Fate, Exposure and Risk Data in Support of the Application for Registrations of Prothioconazole Technical 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 43 of 5 5 ------- 46246401 46246402 46246403 46246404 46246405 46246406 46246407 46246408 46246409 46246410 46246411 46246412 46246413 46246414 Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole for Use on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 50 of 297 Studies. Herbold, B. (2000) JAU 6476-Alpha-acetoxy-desthio Salmonella/ Microsome Test Plate Incorporation and Preincubation Method. Project Number: 30004, T/4069117. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 50 p. Herbold, B. (2000) JAU 6476-Sulfonic Acid K.salt Salmonella/ Microsome Test Plate Incorporation and Preincubation Method. Project Number: 29969, T/3068883. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 48 p. Herbold, B. (2000) JAU 6476-Benzylpropyldiol Salmonella/ Microsome Test Plate Incorporation and Preincubation Method. Project Number: 29700, T/9068870. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 55 p. Brendler-Schwaab, S. (1996) JAU 6476 Mutagenicity Study for the Detection of Induced Forward Mutations in the V79-HPRT Assay in Vitro. Project Number: 25605, T/9053713, 109056. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 38 p. Brendler-Schwaab, S. (1999) SXX 0665 Mutagenicity Study for the Detection of Induced Forward Mutations in the V79-HGPRT Assay in Vitro. Project Number: PH/28965, T/0039189, 109284. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 39 p. Herbold, B. (1996) JAU 6476 In Vitro Mammalian Chromosome Aberration Test with Chinese Hamster V79 Cells. Project Number: PH/25718, T/9053704, T/5053782. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 42 p. Gahlmann, R. (1995) SXX 0665 In Vitro Mammalian Chromosome Aberration Test with Chinese Hamster Ovary (CHO) Cells. Project Number: 24457, T/3039191, 108971. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 35 p. Herbold, B. (2003) JAU 6476 Des-Chloro In Vitro Chromosome Aberration Test with Chinese Hamster V79 Cells. Project Number: AT00321, T/9071506. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 46 p. Herbold, B. (1996) JAU 6476 Micronucleus Test on the Mouse. Project Number: 25572, T/0060969. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 49 p. Herbold, B. (1993) SXX 0665 Micronucleus Test on the Mouse. Project Number: 22089, T/0044129, 108974. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 44 p. Herbold, B. (2003) JAU 6476 Micronucleus-Test on the Male Mouse. Project Number: T/5072907, AT00605. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 50 p. Brendler-Schwaab, S. (1998) JAU 6476 Test on Unscheduled DNA Synthesis in Rat Liver Primary Cell Cultures In Vitro. Project Number: 27417, T/3053852, 109059. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 32 p. Brendler-Schwaab, S. (1999) JAU 6476 Test on Unscheduled DNA Synthesis with Rat Liver Cells In Vivo. Project Number: 28905, T/4061476, T/8059770. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 34 p. Brendler, S. (1992) SXX 0665 Mutagenicity Test on Unscheduled DNA Synthesis in Rat Liver Primary Cell Cultures In Vitro. Project Number: 21187, T/5034729, 108975. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 3 1 p. 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 44 of 5 5 ------- 46246415 Schmidt, U. (1999) JAU 6476 Investigation of the Inhibition of Cytochrome P450 Dependent Monooxygenases in Liver Microsomes (in vitro). Project Number: 28400, 109060. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p. 01-Apr- 2004 46246416 Sheets, L.; Lake, S. (2001) A Subchronic Oral Neurotoxicity Screening Study with Technical Grade JAU 6476 in Wistar Rats. Project Number: 98/412/RY, 109968. Unpublished study prepared by Bayer Corp. 482 p. 01-Apr- 2004 46246417 Sheets, L.; Lake, S. (2000) An Acute Oral Neurotoxicity Screening Study with Technical Grade JAU 6476 in Wistar Rats. Project Number: 98/412/RG, 109250. Unpublished study prepared by Bayer Corp. 439 p. 01-Apr- 2004 46246418 Sheets, L.; Lake, S. (2004) A Developmental Neurotoxicity Screening Study with Technical Grade SXX 0665 in Wistar Rats. Project Number: 03/D72/NW, 200958. Unpublished study prepared by Bayer Corp. 1111 p. 01-Apr- 2004 46246419 Justus, K. (2001) (Carbon 14)JAU6476: Rat Metabolism Part 2 of 2: Distribution of the Total Radioactivity in Rats Determined by Quantitative Whole Body Autoradiography (QWBA) with (Triazole-UL-(Carbon 14))JAU6476. Project Number: M/61819061, MR/437/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 108 p. 01-Apr- 2004 46246420 Klein, O. (1999) (Carbon 14)SXX 0665: Investigation on the Distribution of the Total Radioactivity in the Rat by Whole-Body Autoradiography (Part of the General Rat Metabolism Study). Project Number: M/81819009, PF3554. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 22 p. 01-Apr- 2004 46246421 Justus, K. (2001) (Carbon 14)JAU6476: Rat Metabolism Part 1 of 2: Investigation of the Biokinetic Behaviour and the Metabolism (ADME) in the Rat with [Triazole-UL-(Carbon 14)] and (Phenyl-UL-(Carbon 14))JAU6476. Project Number: M/61819061, MR/251/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 312 p. 01-Apr- 2004 46246422 Koester, J. (2001) [Phenyl-UL-(Carbon 14)]SXX0665: Biokinetic Behaviour and Metabolism in the Rat (pilot study). Project Number: M/81819009, MR/056/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 82 p. 01-Apr- 2004 46246423 Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of Elimination of JAU 6476 When Administered Intravenously or Dermally to Male Rhesus Monkeys: Final Report. Project Number: QEAZ/172, 02C/P29/JW, QEAZ/172/02/370. Unpublished study prepared by Charles River Laboratories. 104 p. 01-Apr- 2004 46246424 Sebesta, C. (2003) An Exploratory Study to Determine the Rate and Route of Elimination of SXX 0665 When Administered Intravenously or Dermally to Male Rhesus Monkeys: Final Report. Project Number: QEAZ/173, 02C/P29/JV, QEAZ/173/02/412. Unpublished study prepared by Charles River Laboratories. 105 p. 01-Apr- 2004 46246425 Sebesta, C. (2003) A Study to Determine the Dermal Absorption of (Carbon 14)SXX 0665 in SC 480 Formulation When Administered Dermally to Male Rhesus Monkeys: Final Report. Project Number: VCBZ/100, 02C/B29/KU, VCBZ/100/02/471. Unpublished study prepared by Charles River Laboratories. 103 p. 01-Apr- 2004 46246426 Weber, H. (1997) (Phenyl-UL-(Carbon 14))JAU 6476 250 EC: Dermal Absorption Pilot Study in the Rat. Project Number: M/187/0840/8, MR/545/97. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 62 p. 01-Apr- 2004 46246427 Wirnitzer, U.; Hartmann, E. (1999) JAU 6476 Dose Range-Finding Study in CD-I Mice 01-Apr- Administration by Gavage Over 14 Weeks). Project Number: PH/28579, T1062643, 2004 PROTHIOCONAZOLE FACT SHEET - Page 45 of 5 5 ------- 46246428 46246429 46246430 46246431 46246432 46246433 46246434 46246435 46246436 46246437 46246438 46246439 46246440 46246441 109063 . Unpublished study prepared by Bayer Ag Inst. of Toxicology. 25 1 p. Andrews, P.; Romeike, A. (1997) JAU 6476: Study for Subacute Oral Toxicity in Rats (Feeding Study for 4 Weeks). Project Number: 26398, T/80603 18, 109061. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 209 p. Andrews, P.; Hartmann, E.; Schmidt, U. (1998) JAU 6476: Study for Subacute Oral Toxicity in Rats (4 Week Study Comparing Different Modes of Administrations). Project Number: PH/28332, T/4062402, 109062. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 198 p. Krotlinger, F.; Hartmann, E. (1992) SXX 0665: Subacute Oral Toxicity Study in Rats. Project Number: 21 173, T/1034716, 109271. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 180 p. Detzer; Rinke (1999) SXX 0665: Subacute Toxicity Study in the Beagle Dog. Project Number: 28890, T/2034799, 109272. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 205 p. Pauluhn, J. (1991) SXX 0665: Orientative Study for Subacute Inhalation Toxicity in the Rat (5x6 Hour Exposures). Project Number: 20368, T/5039580, 109273. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 154 p. Pauluhn, J. (1992) SXX 0665: Aerosol Study for Subacute Inhalation Toxicity in the Rat . Project Number: 21071, T/9040195, 109283. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 321 p. Krotlinger, F. (1991) SXX 0665: Study for Acute Intraperitoneal Toxicity in Rats. Project Number: 20095, T/7034875, 109279. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 62 p. Schmidt, U. (2000) Determination of Enzyme Activities and Concentration of JAU 6476 in the Liver and Kidneys of Dogs in the Subchronic Gavage Study. Project Number: 30260, T/7/067/969, 98/1 16/WH. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 48 P- Freyberger, A. (1996) JAU 6476: Interactions with Thyroid Peroxidase-Catalyzed Reactions In Vitro. Project Number: 25 157. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Enzmann, H.; Watta-Gebert, B. (1991) SXX 0665: Liver Foci Test with Initiation and Regeneration. Project Number: 20900. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 28 p. Kroetlinger, F.; Vohr, H. (2002) JAU 6476: Plaque-Forming Cell Assay in Mice. Project Number: 32090, T/7070695. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 85 p. Weber, H. (2001) (phenyl-UL-(Carbon 14))SXX 0665: Plasma Kinetics in Pregnant Rats Following Oral or Dermal Administration. Project Number: M/61818106, MR/514/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 73 p. Moore, K.; Budzowski, K. (1998) A Liquid Chromatographic Method for the Determination of JAU 6476 in Dose Preparations. Project Number: 98/899/RI, 108384. Unpublished study prepared by Bayer Corp. 16 p. Rinke, M. (200 1) Assessment of Ovarian Findings in Rodents After Treatment with 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- PROTHIOCONAZOLE FACT SHEET- Page 46 of 55 ------- 46246442 46246443 46246444 46246445 46246446 46246447 46246448 46246449 46246450 46246500 46246501 46246502 46246503 SXX0665. Project Number: MO/02/000457. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 15 p. Stropp, G. (1996) Validation of the Magnusson-Kligman Maximization Test Method Used by the Fachbereich Toxlkologie, Bayer AG Performed in Guinea Pigs of the Strain Hsd Poc: DH. Project Number: T/1060339, 24605. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 31 p. Vohr, H. (2002) Validation of the Magnusson-Kilgman Maximization Test Method Used by the Fachbereich Toxikologie, Bayer AG Performed in Guinea Pigs of the Strain Crl:HA with Alpha-Hexylzimtaldehyd. Project Number: T/8071893, AT00083. Unpublished study prepared by Bayer Ag Inst. of Toxicology. 30 p. Moore, K. (1991) A Liquid Chromatographic Method for the Determination of SXX 0665 in Rodent Ration. Project Number: 101258. Unpublished study prepared by Mobay Chemical Corp. 18 p. Tolliver, M. (2004) Tier II Summaries for Toxicology Studies. Project Number: 201003. Unpublished study prepared by Bayer CropScience LP. 474 p. Standart, V. (2004) Occupational Exposure & Safety Assessment for Prothioconazole. Project Number: 200955. Unpublished study prepared by Bayer CropScience LP. 20 p. Maasfeld, W. (2002) Determination of Exposure to JAU 6476 and JAU 6476-desthio (SXX 0665) During Mixing/Loading and Application of JAU 6476 in Cereals. Project Number: P/666/00/1501, MR/036/02. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 1 10 p. Tolliver, M. (2004) Tier II Summaries for Occupational and Residential Exposure Studies. Project Number: 201006, MR/036/02. Unpublished study prepared by Bayer CropScience LP. 6 p. Sommer, H. (200 1) Estimation of the Absorption Coefficient (Koc) of JAU6476 on Soil Using High Performance Liquid Chromatography (HPLC). Project Number: M/138/1079/9, MR/473/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 37 P- Pent, G. (1998) Adsorption/Desorption of (phenyl-UL-(Carbon 14))SXX0665 on Four Different Soils. Project Number: BAY28, FM768. Unpublished study prepared by Staatliche Lehr- und Forschungsanstalt fuer. 46 p. Bayer CropScience (2004) Submission of Environmental Fate Data in Support of the Application for Registrations of Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice, and Wheat. Transmittal of 48 of 297 Studies. Hein, W. (1999) Adsorption/Desroption of S-methyl-JAU6476 on Four Different Soils. Project Number: BAY30, FM/774. Unpublished study prepared by Staatliche Lehr- und Forschungsanstalt fuer. 42 p. Sommer, H. (200 1) Estimation of the Adsorption Coefficient (Koc) of JAU6476-thiazocine on Soil Using High Performance Liquid Chromatography (HPLC). Project Number: M/1381109/3, MR/265/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 34 p. Riegner, K. (1999) Leaching Behavior of JAU6476 Formulated as 250 EC in Soil (Parent 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET- Page 47 of 55 ------- 46246504 46246505 46246506 46246507 46246508 46246509 46246510 46246511 46246512 46246513 46246514 46246515 46246516 46246517 Leaching). Project Number: M/1320961/2, MR/098/99, 4430. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 39 p. Babczinski, P. (2001) Aged Soil Column Leaching of JAU6476. Project Number: M/121 1074/6, MR/364/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 90 p. Riegner, K. (1998) Hydrolysis of [Phenyl-UL-(Carbon-14)]JAU6476 in Sterile Aqueous Buffer Solutions. Project Number: M/l 110902/4, MR/623/98, 4412. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 41 p. Hellpointner, E. (1993) SXX 0655: Hydrolysis in Buffers. Project Number: M/l 110379/2, PF/3882. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 39 p. Gilges, M.; Bornatsch, W. (2001) Photolysis of JAU6476 in Sterile Aqueous Buffer. Project Number: M/l 120917/1, MR/213/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 71 p. Hellpointner, E. (2001) Determination of the Quantum Yield and Assessment of the Environmental Half-life of the Direct Photodegradation in Water of JAU6476. Project Number: M/1430957/9, MR/101/01, 214. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 39 p. Hellpointner, E. (1990) Determination of the Quantum Yield and Assessment of the Environmental Half-life of the Direct Photodegradation of SXX 0665 in Water. Project Number: M/1120358/0, PF3852, ME/24/93. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 32 p. Gilges, M. (2001) Photolysis of JAU6476 on Soil Surface. Project Number: M/1130918/3, MR/242/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 47 P- Hellpointner, E. (2001) Proazolthion (Proposed) [JAU6476]: Degradation and Metabolism of JAU6476 in Aerobic Soils. Project Number: M/1250893/8, MR/104/01, 215. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 101 p. Gilges, M. (2000) Aerobic Degradation of JAU6476 in Two Soils. Project Number: M/1250960/3, MR/549/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 59 p. Gilges, M. (2001) Degradation of JAU6476-desthio (SXX0665) in Four Soils Under Aerobic Conditions. Project Number: M/1251001/0, MR/327/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 58 p. Gilges, M. (2001) Degradation of JAU6476-S-methyl (WAK7861) in Four Soils Under Aerobic Condition. Project Number: M/125 1002/1, MR/340/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 55 p. Brumhard, B.; Oi, M. (2001) Aerobic Degradation and Metabolism of the Active Ingredent JAU6476 in the Water/Sediment System. Project Number: M151/0899/3, MR/395/01, BB J5 1 . Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 95 p. Scholz, K. (2001) Anaerobic Aquatic Metabolism of JAU6476. Project Number: M/1520919/7, MR/275/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 76 p. Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in California Soil, 1999. Project 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01 -Apr- PROTHIOCONAZOLE FACT SHEET - Page 48 of 5 5 ------- 46246518 46246519 46246520 46246521 46246522 46246523 46246524 46246525 46246526 46246527 46246529 46246531 46246534 46246535 Number: J6022102, 200051, F99534/001. Unpublished study prepared by Bayer Corp. and A & L Great Lakes Laboratories. 124 p. Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in Georgia Soil, 1999. Project Number: J6022101, 110799, F99540/001. Unpublished study prepared by Bayer Corp., Bayer Research Farm and A & L Great Lakes Laboratories. 135 p. Wood, S. (2004) Terrestrial Field Dissipation of JAU6476 in New York Soil, 1999. Project Number: J6022103, 200053, F99557/001. Unpublished study prepared by Bayer Corp., A.C.D.S. Research, Inc. and A & L Great Lakes Laboratories. 134 p. Lenz, M. (2004) Terrestrial Field Dissipation of JAU6476 in Saskatchewan Soil, 1999. Project Number: J6022105, 200134, F99573/001. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and AgQuest. 137 p. Lenz, M. (2004) Terrestrial Field Dissipation of JAU6476 in Manitoba Soil, 1999. Project Number: J6022106, 200096, F99560/001. Unpublished study prepared by Bayer Corp., A & L Great Lakes Laboratories and AgQuest. 137 p. Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in a California Rice Field, 2000. Project Number: J6022401, 200060, F005 19/001. Unpublished study prepared by Bayer Corp., Agricultural Advisors, Inc. and A & L Great Lakes Laboratories. 181 p. Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in an Arkansas Rice Field, 2000. Project Number: J6022402, 200067, F00520/001. Unpublished study prepared by Bayer Corp., Shoffner Farm Research and A & L Great Lakes Laboratories. 185 p. Wyatt, D. (2004) Aquatic Field Dissipation of JAU6476 in a Cropped Arkansas Rice Field, 2000. Project Number: J6022403, 200078, F00520/001. Unpublished study prepared by Bayer Corp., Shoffner Farm Research, Battelle and A & L Great Lakes Laboratories. 148 p. Schramel, O. (2001) Determination of the Storage Stability of JAU6476 and the Metabolites JAU6476-desthio and JAU6476-S-methyl in Soil. Project Number: P64190027, MR/644/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 52 p. Schramel, O. (2001) Dissipation of JAU 6476 (250 EC) in Soil Under Field Conditions (France, Germany, Great Britain, Italy). Project Number: RA/2152/98, R812587, R812595. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 15 1 p. Bauer, M. (2003) Independent Laboratory Validation of "Determination of JAU 6476, Desthio (SXX 0665), S-methyl, and Thiazocine in Water by LC/MS/MS". Project Number: AG030004, J6102401, 200484. Unpublished study prepared by Battelle. 62 p. South, N. (2003) Independent Laboratory Validation of "Analysis of JAU 6476, Desthio, S- methyl, and JAU 6476-thiazocine in Soil". Project Number: AG020026, J6102101, 200482. Unpublished study prepared by Battelle. 62 p. Lam, C. (2004) Analytical Method for the Determination of JAU 6476, Desthio, S-methyl and JAU 6476-thiazocine in Soil and Sediment. Project Number: JA002/S04/01, 200515. Unpublished study prepared by Bayer Corp. 30 p. Sabbagh, G.; Arthur, E. (2004) Soil Adsorption Value (Koc) for JAU 6476. Project Number: 200817. Unpublished study prepared by Bayer Corp. 19 p. Lam, C. (2004) Analytical Method for the Determination of JAU 6476, Desthio, S-methyl, and JAU 6476-thiazocine in Water. Project Number: JA002/W04/01, 200517. Unpublished study prepared by Bayer Corp. 32 p. 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 PROTHIOCONAZOLE FACT SHEET - Page 49 of 5 5 ------- 46246536 46246537 46246539 46246540 46246541 46246542 46246543 46246544 46246545 46246546 46246547 46246548 46270400 46270401 Fisher, J. (2004) Calculation of Temperature Referenced Field Half-lives for JAU6476 and JAU6476-desthio. Project Number: 200731. Unpublished study prepared by Bayer Corp. 27 P- Pugsley, R.; Ritter, A.; Williams, W. (2004) Aquatic Environment and Drinking Water Exposure Assessment of JAU6476 and Major Metabolites Resulting from JAU6476 Use on Rice. Project Number: 746/36, 200840. Unpublished study prepared by Waterborne Environmental, Inc. (WEI). 101 p. Riegner, K. (1999) Leaching Behaviour of JAU 6476 Formulated as 250 EC in Soil (Parent Leaching). Project Number: M/132/0961/2, 109139. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 40 p. Ramanarayanan, T. (2004) Degradation of JAU6476 and Its Major Metabolites in Two Sediment- Water Systems Under Aerobic Conditions: Kinetics Modeling. Project Number: 200841. Unpublished study prepared by Bayer Corp. 33 p. Ramanarayanan, T. (2004) Aquatic Ecological and Drinking Water Exposure Assessment for JAU6476 and its Major Metabolites Resulting from JAU6476 Use on Barley, Canola, Drybean, Peanut and Wheat. Project Number: 200842. Unpublished study prepared by Bayer Corp. 122 p. Hellpointner, E. (2000) Calculation of the Chemical Lifetime of JAU 6476 in the Troposphere. Project Number: HPO/198, MR/323/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. lip. Schramel, O. (2000) Residue Analytical Method 00610 (MR-642/99) for the Determination of JAU 6476 and the Metabolites JAU 6476-S-methyl in Soil by HPLC-MS/MS. Project Number: P60 190026, MR/643/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 61 p. Sommer, H. (2002) Determination of the Storage Stability of JAU6476 and of the Metabolites JAU6476-desthio and JAU6476-S-methyl in Soil. Project Number: P64190027, MR/081/02. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 54 P- Hellpointner, E. (1999) Calculation of the Chemical Lifetime of JAU 6476 in the Troposphere. Project Number: HPO/172, MR/093/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. lip. Schad, T. (200 1) Calculation of Degradation Rates of JAU 6476 Based on Aerobic Soil Degradation Studies. Project Number: P668/01/6773, MR/383/01. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 20 p. Tolliver, M. (2004) Tier II Summaries for Environmental Fate: (JAU 6476). Project Number: 201005. Unpublished study prepared by Bayer CropScience LP. 195 p. Tolliver, M. (2004) Prothioconazole (JAU6476) Tier 3 Summary. Project Number: 201008. Unpublished study prepared by Bayer CropScience LP. 93 p. Bayer CropScience (2004) Submission of Product Chemistry Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole for Use on Barley, Oilseed Crop Group (Except Sunflower and Safflower), Dried Shelled Pea and Bean (Except Soybean) Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 1 Study. Krohn, J. (1992) Octanol/Water Partition Coefficient of SXX 0665. Project Number: 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 01-Apr- 2004 17-May- 2004 17-May- PROTHIOCONAZOLE FACT SHEET - Page 50 of 5 5 ------- 46359100 46359101 46359102 46467300 46467301 46467302 46467303 46467304 46467305 46467306 46467307 46477400 Q/505/0507, 14/505/0507. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. lip. Bayer CropScience (2004) Submission of Fate Data in Support of the Registration of Prothioconazole Technical Fungicide and Proline 480 SC Fungicide and the Petition for Tolerance of Prothioconazole Technical Fungicide for Use on Barley, Oilseed Crop Group, Dried Shelled Pea and Bean Crop Subgroup, Peanut, Rice and Wheat. Transmittal of 2 Studies. Gilges, M. (2001) Photolysis of JAU6476 on Soil Surface. Project Number: M/l 130918/3, MR/242/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 54 P- Gilges, M. (2000) Aerobic Degradation of JAU6476 in Two Soils. Project Number: M/1250960/3, MR/549/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 68 p. U.S. Triazole Task Force (2005) Submission of Toxicity and Residue Data in Support of the Application for Registrations of Prothioconazole Technical Fungicide and Chipco Brand Triton 70 WDG Fungicide, the Registrations of Lynx 45 WG Turf and Ornamental Fungicide, Propiconazole Technical, Folicur 3.6 F Foliar Fungicide, Enable 2F, RH-7592 Technical and Propiconazole EC, and the Petitions for Tolerance of Tebuconazole, Triadimefon, Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 7 Studies. Wahle, B. (2004) A Subacute Toxicity Testing Study in the CD-I Mouse with 1,2,4- Triazole. Project Number: 03/S71/QB, 200808, TZ524901. Unpublished study prepared by Bayer Corp. and Huntingdon Life Sciences. 477 p. Wahle, B. (2004) A Subchronic Toxicity Testing Study in the CD-I Mouse with 1,2,4- Triazole. Project Number: 03/S71/QC, 201052, TZ524902. Unpublished study prepared by Bayer Corp. and Bayer Ag Inst. of Toxicology and Dow Chemical Company. 765 p. Wahle, B.; Sheets, L. (2004) A Combined Subchronic Toxicity / Neurotoxicity Screening Study in the Wistar Rat with 1,2,4-Triazole. Project Number: 03/N72/QA, 201024, T1072994. Unpublished study prepared by Bayer Corp. and Bayer Ag Inst. of Toxicology. 1257 p. Young, A.; Sheets, S.; Elcock, L. (2005) A Two-Generation Reproductive Toxicity Study in the Wistar Rat with 1,2,4-Triazole. Project Number: 03/R72/PZ, 201220, TZ521802. Unpublished study prepared by Bayer Corp. 1570 p. Reed, R. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazolylalanine and Triazolylacetic Acid Residues in Milk: Final Report. Project Number: MLI/03/04, ML03/1088/TTF, METH/160. Unpublished study prepared by Morse Laboratories, Inc. 341 p. Reed, R. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazolylalanine and Triazolylacetic Acid Residues on Grapes: Final Report. Project Number: MLI/03/05, ML03/1092/TTF, METH/160. Unpublished study prepared by Morse Laboratories, Inc. 302 p. Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole Alanine and Triazole Acetic Acid Residues in Bananas. Project Number: 1487, METH/160. Unpublished study prepared by Pyxant Labs Inc. 340 p. Bayer CropScience (2005) Submission of Product Chemistry Data in Support of the 2004 09-Sep- 2004 09-Sep- 2004 09-Sep- 2004 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 09-Feb- 2005 22-Feb- PROTHIOCONAZOLE FACT SHEET - Page 51 of 5 5 ------- 46477401 46477700 46477701 46477702 46477703 46477704 46477705 46477706 46492900 46492901 46492902 46492903 46501400 Application for Registration of Prothioconazole Technical Fungicide. Transmittal of 1 Study. Fontaine, L. (2005) Product Chemistry of Prothioconazole Technical. Project Number: BR/2383, ANR/03 104, ANR/03005. Unpublished study prepared by Bayer Corp., Bayer Ag Institut fuer Ruckstands-Analytik and U.S. Environmental Protection Agency. 182 p. Bayer CropScience LP (2005) Submission of Residue and Efficacy Data in Support of the Application for Registration of Proline 480 SC Foliar Fungicide. Transmittal of 6 Studies. Duah, F. (2005) JAU6476 - Crop Residues Storage Stability Deficiency Study. Project Number: J6131603, RAJAY037, 201262. Unpublished study prepared by Bayer Corp. 138 P- Heinemann, O. (2000) Analytical Determination of Residues of JAU 6476 and Desthio-JAU 6476 in/on Cereals by HPLC-MS/MS. Project Number: P60293002, 00598, MR/401/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 87 p. Heinemann, O. (2000) Analytical Determination of Residues of JAU6476 and JAU6476- Desthio in/on Cereals and Canola by HPLC-MS/MS (Method Modification 00598/M001). Project Number: P60293006, 00598/M001, MR/689/99. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 92 p. Heinemann, O. (2001) Analytical Determination of Residues of JAU6476-3 -Hydro xy Hydroxydesthio, JAU6476-5-Hydroxy-Desthio, and JAU6476-Desthio in/on Matrices of Animal Origin by HPLC-MS/MS. Project Number: P603003006, 00655, MR/537/00. Unpublished study prepared by Bayer Ag Institut fuer Ruckstands-Analytik. 190 p. Bulman, P.; Henry, S. (2005) Proline 480 SC Fungicide (Prothioconazale) Fusarium Head Blight Suppression in Wheat: Deficiency Response. Project Number: BYFCAN005/W, 544/01/03120, FD02NARDVOJB32. Unpublished study prepared by Bayer Cropscience LP. 92 p. Henry, S.; Bulman, P. (2005) Proline 480 SC Fungicide (Prothioconazol) Fusarium Head Blight Suppression in Barley: Deficiency Response. Project Number: BYFCAN005/B, FD02NARDWJBG2, FD02NARDWJLB2. Unpublished study prepared by Bayer CropScience. 80 p. U.S. Triazole Task Force (2005) Submission of Residue and Toxicity Data in Support of Triazole Products and the Petition for Tolerance of Tebuconazole, Triadimefon, Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 3 Studies. Maliani, N. (2004) Validation of the Residue Analytical Method: "Determination of 1,2,4- Triazole, Triazole Alanine and Triazole Acetic Acid Residues in Plant and Animal Matrices". Project Number: MLI/03/03, ML03/1081/TTF. Unpublished study prepared by Morse Laboratories. 234 p. Maliani, N. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazolylalanine and Triazolylacetic Acid Residues in Tomatoes: Final Report. Project Number: MLI/03/06, ML03/1093/TTF. Unpublished study prepared by Morse Laboratories, Inc. 364 p. Hoberman, A. (2005) Oral (Stomach Tube) Developmental Toxicity Study of 1,2,4-Triazole in Rabbits. Project Number: VCB00002. Unpublished study prepared by Argus Research Laboratories, Inc. 393 p. U.S. Triazole Task Force (2005) Submission of Residue, Exposure and Risk Data in Support of the Registrations of Lynx 2 and Lynx 45 WG Turf and Ornamental Fungicide, and the 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 22-Feb- 2005 10-Mar- 2005 10-Mar- 2005 10-Mar- 2005 10-Mar- 2005 18-Mar- 2005 PROTHIOCONAZOLE FACT SHEET - Page 52 of 5 5 ------- 46501401 46501402 46501403 46501404 46553700 46553701 46568300 46568301 46580900 46616400 46616401 Applications for Registration of Chipco Brand Triton Fungicide and Chipco Brand Triton 70 WDG Fungicide, and the Petitions for Tolerance of Tebuconazole, Triademefon, Triadimenol, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 4 Studies. Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole Alanine and Triazole Acetic Acid Residues in Eggs. Project Number: U/S/TRIAZOLE/TASK/FORCE/1490, METH/160, U/S/TRIAZOLE/TASK/FORCE/1478. Unpublished study prepared by Pyxant Labs Inc. and Morse Laboratories, Inc. 35 1 p. Robaugh, D. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazole Alanine and Triazole Acetic Acid Residues in Peanut Butter. Project Number: U/S/TRIAZOLE/TASK/FORCE/1491, METH/160, U/S/TRIAZOLE/TASK/FORCE/1478. Unpublished study prepared by Pyxant Labs Inc. and Morse Laboratories, Inc. 306 p. Maliani, N. (2005) Dietary Exposure Monitoring: Determination of 1,2,4-Triazole, Triazolylalanine and Triazolylacetic Acid Residues in Soybeans. Project Number: MLI/03/07, ML03/1094/TTF, METH/160. Unpublished study prepared by Morse Laboratories, Inc. 332 p. Heard, N. (2004) Triazole Alanine and Triazole Acetic Acid Aggregate Exposure Assessments. Project Number: T022678/04. Unpublished study prepared by U.S. Triazole Task Force. 152 p. U.S. Triazole Task Force (2005) Submission of Toxicity, Residue, Risk and Exposure Data in Support of the Application for Registrations of Propiconazole Technical, Folicur 3.6F Foliar Fungicide, Lynx 45WG Turf and Ornamental Fungicide, Lynx 2, Enable 2F, RH-7592 Technical and Inline, the Registrations of Prothiconazole Technical Fungicide, Chipco (R) Brand Triton (TM) Fungicide and Chipco Brand Triton 70 WD Fungicide, and the Petition for Tolerance of Tebuconazole, Prothioconazole, Triticonazole, Triademefon, Triadimenol, Fenbuconazole, Myclobutanil, Propiconazole, Tetraconazole and Epoxiconazole. Transmittal of 1 Study. Heard, N. (2005) 1,2,4-Triazole Aggregate Exposure Assessment. Project Number: T022748/04. Unpublished study prepared by U.S. Triazole Task Force. 140 p. U.S. Triazole Task Force (2005) Submission of Product Chemistry Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide, Chipco Brand Triton Fungicide and Chipco Brand Triton 70 WDG Fungicide, the Registrations of Propiconazole Technical, Lynx 2, Lynx 45 WG Turf and Ornamental Fungicide, Folicur 3.6F Foliar Fungicide, Enable 2F, RH-7592 Technical and Propiconazole EC, and the Petitions for Tolerance of Difenoconazole, Tebuconazole, Triadimefon, Myclobutanil, Tetraconazole and Epoxiconazole. Transmittal of 1 Study. Memmel, A. (2005) Storage Stability Studies for (3 Triazole Derived Metabolites) in Apples, Wheat Flour, Milk, Peanut Butter and Eggs; Interim Report - Storage Stability Through One Year. Project Number USTTF/15 11, ZOLE/TASK/FORCE/1511, 1511. Unpublished study prepared by Pyxant Labs Inc. 170 p. U.S. Triazole Task Force (2005) Submission of Residue Data in Support of the Petitions for Tolerance of Triazole. Transmittal of 1 Study. U.S. Triazole Task Force (2005) Submission of Toxicity and Product Chemistry Data in Support of the Petitions for Tolerance of 1,2,4-Triazole and the Registrations of Lynx 45 WG Turf and Ornamental Fungicide, Lynx 2, Chipco Brand Triton Fungicide, Chipco Brand Triton 70 WDG Fungicide. Transmittal of 2 Studies. DairOsto, M.; Hess, F.; Juberg, D.; et. al. (2005) Scientific Assessment to Support Waiver 18-Mar- 2005 18-Mar- 2005 18-Mar- 2005 18-Mar- 2005 25-May- 2005 25-May- 2005 08-Jun- 2005 08-Jun- 2005 28-Jun- 2005 08-Aug- 2005 08-Aug- PROTHIOCONAZOLE FACT SHEET - Page 53 of 5 5 ------- 46616402 46714600 46714601 46714602 46714603 46714604 46714605 46714606 46714607 46727700 46727701 46765300 46765301 46841000 Exemptions for an Acute Neurotoxicity Study in the Rat, the Partial Chronic Toxicity/Oncogenicity Studies in the Male Rat and Female Mouse with 1,2,4-Triazole. Project Number: T004225/05. Unpublished study prepared by Isagro S.P.A., BASF Corporation and Bayer CropScience LP. 83 p. Jensen, T. (2004) The Homogeneity and Stability of 1, 2, 4-Triazole Technical in Rodent Ration Using Purina Mills Certified Rodent Diet 5002 Meal. Project Number: 03/H72/RR, 201 185. Unpublished study prepared by Bayer Corp. 15 p. Bayer CropScience LP (2005) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of Provost 433 SC Fungicide. Transmittal of 7 Studies. Frank, J. (2005) Product Chemistry of Provost 433 SC Fungicide. Project Number: BR/244, ANR/22005, ANR/21905. Unpublished study prepared by Bayer Corp. 53 p. Moore, G. (2005) Acute Oral Toxicity Up and Down Procedure in Rats: AE 1344248 01 SC39 Al. Project Number: 181 15, P320/UDP. Unpublished study prepared by Product Safety Laboratories. 15 p. Moore, G. (2005) Acute Dermal Toxicity Study in Rats - Limit Test: AE 1344248 01 SC39 Al. Project Number: 181 16, P322. Unpublished study prepared by Product Safety Laboratories. 15 p. Moore, G. (2005) Acute Inhalation Toxicity Study in Rats - Limit Test: AE 1344248 01 SC39 Al. Project Number: 181 17, P330. Unpublished study prepared by Product Safety Laboratories. 22 p. Moore, G. (2005) Primary Eye Irritation Study in Rabbits: AE 1344248 01 SC39 Al. Project Number: 18118, P324. Unpublished study prepared by Product Safety Laboratories. 16 p. Moore, G. (2005) Primary Skin Irritation Study in Rabbits: AE 1344248 01 SC39 Al. Project Number: 181 19, P326. Unpublished study prepared by Product Safety Laboratories. 16 p. Moore, G. (2005) Dermal Sensitization Study in Guinea Pigs (Buehler Method): AE 1344248 01 SC39 Al. Project Number: 18120, P328. Unpublished study prepared by Product Safety Laboratories. 23 p. Bayer Cropscience LP (2005) Submission of Product Chemistry Data in Support of the Application for Registration of Prosaro 421 SC Fungicide. Transmittal of 1 Study. Frank, J. (2005) Product Chemistry of Prosaro 421 SC Fungicide. Project Number: ANR/21305, ANR/21405, 12980. Unpublished study prepared by Bayer Corp. 268 p. Bayer CropScience LP (2006) Submission of Public Interest Data in Support of the Registrations of Prothioconazole Technical, Proline 480 SC Fungicide, Provost 433 SC Fungicide, Prosaro 421 SC Fungicide. Transmittal of 4 Studies. Nelson, J.; Heintzelman, R.; Kaiser, R.; et. al. (2006) Public Interest Document for Prothioconazole Technical, Proline 480 SC Fungicide, Provost 433 SC Fungicide and Prosaro 421 SC Fungicide. Project Number: PID/BAY05JN15. Unpublished study prepared by ABG, Inc. 74 p. Bayer CropScience (2006) Submission of Residue Data in Support of the Applications for Registration of Prothioconazole Technical Fungicide, Proline 480 SC Fungicide and Provost 433 SC Fungicide and the Petition for Tolerance of Prothioconazole on Soybean. Transmittal 2005 08-Aug- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 19-Dec- 2005 09-Jan- 2006 09-Jan- 2006 22-Feb- 2006 22-Feb- 2006 22-May- 2006 PROTHIOCONAZOLE FACT SHEET - Page 54 of 5 5 ------- 46841001 46841002 46923600 46923601 of 2 Studies. Duah, F.; Harbin, A. (2006) JAU6476 480 SC - Magnitude of the Residue in/on Soybeans. Project Number: RAJAY026, M/270206/01/1. Unpublished study prepared by Bayer CropScience LP and Pyxant Labs Inc. 489 p. Duah, F.; Harbin, A. (2006) JAU6476 480 SC - Magnitude of the Residue in/on Soybean Aspirated Grain Fractions and Soybean Processed Commodities. Project Number: RAJAY027, 1641. Unpublished study prepared by Texas A & M Food Protein Research, GLP Technologies and Pyxant Labs Inc. 524 p. Bayer CropScience LP (2006) Submission of Toxicity Data in Support of the Application for Registrations of Prothioconazole Technical and Proline 480 SC Fungicide. Transmittal of 1 Study. Young, A. (2006) Technical Grade JAU 6476: A Supplementary PreNatal Developmental Toxicity Study in the Wistar Hanover (Crl: WI(HAN) Rat to Investigate Ocular Abnormalities and Supernumerary Ribs. Project Number: 03/T12/UB, 201037, MO/04/004745. Unpublished study prepared by Bayer CropScience LP. 1488 p. 22-May- 2006 22-May- 2006 30-Aug- 2006 30-Aug- 2006 PROTHIOCONAZOLE FACT SHEET - Page 55 of 5 5 ------- |