UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Pesticide Fact Sheet Name of Chemical: Metconazole Reason for Issuance: Registration Date Issued: September, 2007 1. Description of Chemical Chemical Name: 5-[(4-Chlorophenyl)methyl]-2,2-dimethyl-l-(l//-l,2,4-triazol-l- ylmethyl)cyclopentanol Common Name: Metconazole Chemical Formula: cis-Metconazole trans-Metconazole ------- EPA PC Code: 125619 Chemical Abstracts Service (CAS) Number: Year of Initial Registration: Pesticide Type: Chemical Class: U.S. Producer: 125116-23-6 2007 Fungicide Sterol biosynthesis inhibitor - DMI-Fungicide Kureha Corporation and Valent USA II. Use Patterns and Formulations Application Sites: Turf and ornamentals Types of Formulations: Metconazole Technical (72078-1) V-10116 VPP Fungicide (59639-144) Application Methods And Rates: Metconazole may be applied at an application rate of 0.25 to 0.6 Ib a.i./A per year. It may be applied by ground spray only. III. Physical and Chemical Properties: Table 1 - Physical and Chemical Properties of Metconazole Table 1. Physicochemical Properties of the Technical Grade Metconazole Parameter Molecular Weight Melting point/range PH Relative density (20°C) Water solubility (20°C) Value 319.837 100.0-108.4°C (using Electrothermal Digital Melting Point Apparatus) (AC900,768 technical grade) No data were submitted. 1.14 (relative density to water at 4 deg C, using capillary- stoppered, density-specific gravity bottle) (Lot No. AC 8879-140B) Using shake flask method: 18.7±1.0 mg/L (cw-isomer, WL148271, KNF-S-474m) 13.6±1.7 mg/L (trans-isomer, WL148271, KNF-S-474m) Reference 44721503 44721505 44721505 44721505 ------- Table 1. Physicochemical Properties of the Technical Grade Metconazole Parameter Solvent solubility (g/L) at 20°C Vapor pressure (20°C) Dissociation constant (pKa) Octanol/water partition coefficient Log (Kow) UV/visible absorption spectrum Value hexane: 1.40 toluene: 103 2-propanol: 132 ethyl acetate: 260 dichloromethane:481 methanol: 403 acetone: 363 Using gas-saturation method at 20°C: < 1.23xlO'5 Pa or 9.23 x 10'8 mm Hg (AC 900,768) < 1.04xlO'5 Pa or 7.80 x 10'8 mm Hg (cw-isomer, CL 354,801) < 1.96X10'6 Pa or 1.47 x 10'8 mm Hg (trans-isomer, CL 354,802) 11.38±0.03 and 1.06±0.03 (in water using spectrophotometric method) (Lot No. AC 8879-140B) Kow (log Kow) = 7090±989 (3.85) (using flask shaking method) (Lot No. AC 8879-140B) (TGAI) KOW (log KOW) = 7150±803 (3.85) (using flask shaking method) (cw-isomer, CL 354,801) KOW (log KOW) = 6800±1700 (3.8) (using flask shaking method) (/raws-isomer, CL 354,802) Not required for TGAI; required for pure active ingredient Reference 44721505 44721505 44721505 44721505 IV. HUMAN HEALTH RISK ASSESSMENT A. Toxicity 1. Acute Toxicity: Metconazole has low or minimal acute toxicity via the oral (Category III-IV), dermal (Category III), and inhalation routes of exposure (Category IV). It is moderately irritating to the eye (Category III), and minimally irritating to the skin (Category IV); it is not a skin sensitizer. Table 2 - Acute Toxicity Table A.2 Acute Toxicity Profile - Metconazole Technical Guideline No. 870.1100 870.1100 870.1100 Study Type Acute oral [mouse] Acute oral [rat] Acute oral [rat] MRID(s) 44721512 44721512 44721513 Results LD50 = >566 mg/kg LD50 = >566 mg/kg LD50 = >1459 mg/kg Toxicity Category III III III ------- 870.1100 870.1200 870.1200 870.1200 870.2400 870.2500 870.2600 Acute oral [rat] Acute dermal [rat] Acute dermal [rabbit] Acute inhalation [rat] Acute eye irritation [rat] Acute dermal irritation [rabbit] Skin sensitization [guinea pig] 44721514 44721512 44721512 44721512 44721513 44721513 44721513 LD50 = >5000 mg/kg Dermal LDso > 2000 Dermal LDso > 2000 LD50 = >5.6 mg/L moderate irritant mild irritant neg. IV III III IV III IV ------- 2. Subchronic Toxicity: A 28-day oral toxicity study in rats showed decreased body weight gain and food consumption at 1000 and 3000 ppm, as well as effects on blood cells, increased liver enzyme levels, decreased glucose and decreased cholesterol levels at 3000 ppm. Increased liver, spleen, and kidney weights were observed at 1000 and 3000 ppm. Increased fatty vacuolation and hepatocellular hypertrophy at 1000 and 3000 ppm were also observed, indicating that the liver is the primary target organ for metconazole toxicity. 90-day oral toxicity studies in rat and mouse showed similar effects, with hisotpathological changes again demonstrating that the liver is the primary target organ for metconazole. A 90-day oral toxicity study in dogs showed a decrease in food consumption at 600 ppm in females, and at 6000 ppm in males, with a corresponding decrease in body weight gain. All dogs at the high (6000 ppm) dose had cataracts by the end of the study. Effects on blood cells were observed in males at 600 ppm, and in both sexes at 6000 ppm. High dose animals also showed histopathological changes in the liver, kidney, and spleen. Subchronic dermal exposure in rats (21 days) did not result in effects on body weight gain, food consumption, eyes, hematology, or blood chemistry. Liver weights were increased in females at 500 ppm, and in both sexes at 1000 ppm, as well as decreased thymus weights in males at 500 and 1000 ppm, but these were not considered adverse since the histopathology of these organs was normal. 3. Chronic Toxicity: A chronic toxicity study in rats showed increased liver weights in males at 12 months and in females at 24 months, as well as an increase in females' spleen weights at 24 months at doses of 13.1 mg/kg/day in males and 53.8 mg/kg/day in females. Increased hepatocellular lipid vacuolation and centrilobular hypertrophy in both males and females at these doses. A chronic toxicity study in dogs showed a decrease in body weight gain during the first 13 weeks in males, increased incidence of Kupffer cell pigmentation in females, and increased alkaling phosphatase activity in both sexes at 38.5 and 36.8 mg/kg/day in males and females, respectively. 4. Carcinogenicity: There were no treatment-related increases in tumors in rat and mouse carcinogenicity studies after exposure to metconazole. 5. Developmental Toxicity/Developmental Neurotoxicity: A pre-natal development study in rats showed reduced maternal food consumption at 30 and 75 mg/kg/day, correlating with poor weight gain, but no increase in pre-implantation loss. Post- implantation loss was significantly increased at 75 mg/kg/day, and an increase in fetal visceral abnormalities was also seen at this level. An increase in skeletal abnormalities, including extra lumbar ribs, cervical ribs and extra pre-sacral vertebrae, was observed at 30 and 75 mg/kg/day. A pre-natal development study in rabbits showed a reduction in maternal body weight gain at 40 mg/kg/day, again corresponding to a decrease in food consumption. An increase in maternal liver weight was also seen at that dose, along with decreased red blood cell parameters and increased alkaline phosphatase levels. The 40 mg/kg/day dose also showed increased fetal resorptions and a slight decrease in fetal body weight. There was no evidence of neurotoxicity observed in the toxicology database. ------- 6. Reproductive Toxicity: An acceptable new two-generation reproduction study in rats (MRID 46808447) using cis/trans metconazole was submitted and reviewed by HED. This study replaces the two-generation reproduction study with cis-only metconazole (MRID 44721608) that was used in the human health risk assessment for proposed tolerance on imported bananas (Memo Date: 7/06/06). In the new study, parental systemic toxicity was evident at 750 ppm, and included decreased body weight and decreased weight gain in male and female parental animals, increased incidence of fatty hepatocyte change in male parental animals, and increased incidence of spleen congestion in FI parental females. Offspring toxicity was also evident at 750 ppm as decreased viability index on lactation day 0 and reduced body weight in F2 offspring. Reproductive toxicity was evident at 750 ppm as prolonged duration of gestation and decreased gestation index driven by dystocia (maternal deaths during delivery). Available evidence (two developmental toxicity studies and one two-generation reproductive toxicity study) suggest there is no concern for pre- and/or post-natal toxicity resulting from exposure to metconazole, because the pre and postnatal effects observed in rats and rabbits occurred only at maternally toxic dose levels. 7. Metabolism: Metabolism studies in rats indicated that metconazole is excreted primarily in the feces with greater than 90% of the administered dose excreted by three days post-dosing. Biliary excretion is the major route of elimination. Plasma kinetic studies show a low potential for bioaccumulation following single or multiple dosing regimens and the plasma half-life of low- and high-dose rats was slightly shorter in males than females. In an experiment in which the triazole ring was labeled, a single high (200 mg/kg) dose of metconazole showed approximately 5% of the parent compound was excreted as free triazole. 8. Mutagenicity: There is no mutagenicity concern for metconazole. When the genotoxic potential of metconazole was tested in several in vitro and in vivo mutagenicity assays, all tests were negative with the exception of the chromosomal aberration assay (in the presence of S-9 mix (metabolic activation)). Overall, metconazole is considered to be non-genotoxic. 9. Toxicology Profile: The toxicological profile for metconazole is discussed in Table 3 below: Table 3 - Toxicology Profile Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. 870.3100 Study Type MRID No. (year)/ Classification /Doses 44721515(1990) Results NOAEL(M/F) = 9.1/10.1 ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. 870.3100 870.3100 870.3150 870.3150 Study Type 28-Day oral toxicity rodents (rat) 90-Day oral toxicity rodents (rat) 90-Day oral toxicity rodents (mouse) 28-Day oral toxicity non-rodents (dog) 90-Day oral toxicity non-rodents MRID No. (year)/ Classification /Doses M/F: 0, 30, 100, 1000, 3000 ppm M:0, 2.7, 9.1,90.5, 261.1 mg/kg/day F: 0,3.1, 10.1,97,287.4 mg/kg/day Acceptable/guideline 44721517(1991) M/F: 0, 30, 100, 300, 1000, 3000 ppm M:0, 1.94,6.4, 19.2, 64.3, 192.7 mg/kg/day F:0, 2.1,7.2, 22.1,71.4, 208.0 mg/kg/day Acceptable/guideline 44721519(1991) M/F: 0, 30, 300, 3000 (wkl)/2000(wk2-13) ppm M:0, 9.58, 50.5, 341.1 mg/kg/day F: 0, 6.94, 60.7, 438.5 mg/kg/day Acceptable/guideline 44721520(1991) M/F: 0, 100, 1000, and 7000-10000 ppm in diet Unacceptable/non- guideline (some preliminary test data provided) 44721521 (1991) M/F: 0, 60, 600, 6000 Results mg/kg/day LOAEL (M/F) = 90.5/97 mg/kg/day based on depression of body weight in M, liver and kidney weight increases with associated histopathological effects (hypertrophy and fatty vacuolation) in liver only. NOAEL (M/F) = 6.4/7.2 mg/kg/day LOAEL (M/F) = 19.2/22.1 mg/kg/day based on increased spleen weight in females and hepatic vacuolation in males. NOAEL (M/F) = 9.58/6.94 mg/kg/day LOAEL (M/F) = 50.5/60.7 mg/kg/day based on increase in absolute and relative liver weights, hepatocellular hypertrophy and vacuolation, and increase in relative spleen weight (F), elevated AST and ALT activity. NOAEL (M/F) = 100 ppm in diet LOAEL (M/F) = 1000 ppm in diet (increase in relative and absolute thyroid wt. in one/two females) Deficiencies: low n (2M/2F per dose); decrease in food consumption means low exposure to test compound; actual dose received per dose group not provided. NOAEL (M/F) = 2.5/2.6 mg/kg/day ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. Study Type MRID No. (year)/ Classification /Doses Results (dog) ppm in diet M: 0, 2.5, 24.4, 225.2 mg/kg/day F: 0, 2.6, 24.3, 206.6 mg/kg/day Acceptable/guideline LOAEL (M/F) = 24.4/24.3 mg/kg/day based on decreased food consumption and body weight gain in females and elevated platelets and reticulocytes in males. 870.3200 21-day Dermal Toxicity 46808439 (2006) 0, 250, 500, 1000 mg/kg/day Acceptable/guideline NOAEL: lOOOmg/kg LOAEL: > 1000 mg/kg No evidence of dermal toxicity 870.6200 Subchronic (13- week) Oral Neurotoxicity- rat 46808440(2002) 0,50, 170, 500 ppm M: 0,4.84, 15.69,47.08 mg/kg/day F: 0,5.10, 17.62,49.82 mg/kg/day Acceptable/Non- guideline Systemic NOAEL (M/F) = 4.84/5.10 mg/kg/ Systemic LOAEL (M/F) = 15.69717.62 mg/kg/ based on decreases in body weight and food consumption. Neurotoxicity NOAEL (M/F) > 47.08/49.82 mg/kg/day 870.3700 Prenatal development in rodents (rat) 44721522(1991) 0, 12, 30, 75 mg/kg/day Gavage Acceptable/Guideline Maternal NOAEL =12 mg/kg/day LOAEL = 30 mg/kg/day based on decrease in body weight gain. Developmental NOAEL = 12 mg/kg/day LOAEL = 30 mg/kg/day based on increased incidence of skeletal variations (predominantly lumbar ribs). 870.3700 Prenatal development in rodents (rat) 46808443(2002) 0, 1,4, 16, 64 mg/kg/day Gavage Acceptable/Guideline Maternal NOAEL= 16 mg/kg/day LOAEL= 64 mg/kg/day based on decreased body weight and food consumption, increased placental weight and increased incidence of swollen placentae ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. Study Type MRID No. (year)/ Classification /Doses Results Developmental NOAEL= 16 mg/kg/day LOAEL= 64 mg/kg/day based on based on an increase in early and late resorptions, decreased fetal body weight and increased incidence of incomplete ossification of sternebrae. 870.3700 Prenatal developmental in non-rodents (rabbit) Definitive Study 44721602 (1997) 0, 5, 10, 20, 40 mg/kg/day gavage Acceptable/Guideline Maternal NOAEL = 20 mg/kg/day LOAEL = 40 mg/kg/day based on reductions in body weight gain, food consumption, and changes in various hematology parameters (reductions in hematocrit, hemoglobin, mean corpuscular volume and increases in platelet counts and alkaline phosphatase activity). Developmental NOAEL = 20 mg/kg/day LOAEL = 40 mg/kg/day based on increases in post-implantation losses. 870.3700 Prenatal developmental in non-rodents (rabbit) 44721603 (1991) 0, 4, 10, 25, 62.5 mg/kg/day (Exp. #1) 0,2,4, 10 mg/kg/day (Exp. #2) Acceptable/Guideline Maternal NOAEL = 25 mg/kg/day LOAEL = 62.5 mg/kg/day based on body weight changes and slight clinical signs (anorexia/reduced or altered fecal output, cold ears). Developmental NOAEL = 4 mg/kg/day LOAEL = 10 mg/kg/day based on examining data from the two experiments. Effects at 62.5 mg/kg/day show total litter loss, decreased live fetuses, increased early and late resorptions. ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. Study Type MRID No. (year)/ Classification /Doses Results Effects at 25 mg/kg/day show some malformations: hydrocephaly (4 fetuses from 4 different litters, but NOT seen at 62.5 mg/kg/day) and limb effects (2 fetuses from 2 different litters, with one fetus with same effect at 62.5 mg/kg/d). Hydrocephaly and limb effects were observed at 10 mg/kg/day in Experiment #2, but not at that same dose in Experiment #1. 870.3800 Reproduction and fertility effects 2-generation- rat 46808447(2002) 0,30, 150 and 750 ppm M/F: 0/0, 2/2, 10.8/10.6, 53.2/53.0 mg/kg/day Acceptable/Guideline Parental/Systemic NOAEL (M/F) = 9.8/10.8 mg/kg/day LOAEL (M/F) = 49.4/53.2 mg/kg/day based on: decreased body weight and decreased weight gain in male and female parental animals, increased incidence of fatty hepatocyte change in male parental animals, and increased incidence of spleen congestion in Fl parental females. Reproductive NOAEL (M/F) = >49.4/ 10.8 mg/kg/day LOAEL (M/F) = 53.2 mg/kg/day based on increased gestation length and decreased gestation index driven by dystocia (difficult labor). Offspring NOAEL (M/F) = 9.8/10.8 mg/kg/day LOAEL (M/F) = 49.4/53.2 mg/kg/day based decreased viability on lactation day 0 and decreased body weight in F2 offspring. 870.4100a Chronic toxicity rodents (rat) 44721609(1992) 0, 10, 100, 300, 1000 NOAEL = (M/F) = 4.3/16.0 mg/kg/day 10 ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. Study Type MRID No. (year)/ Classification /Doses Results ppm M: 0, 0.44, 4.3, 13.1, 43.9mg/kg/day F: 0,0.52,5.3, 16.0,53. mg/kg/day Acceptable/Guideline LOAEL = (M/F) = 13.1/ 53.8 mg/kg/day based on an increase in mean adjusted liver weights at 12 months (M) and 24 months (F), increase in spleen weights at 24 months (F), and increased hepatocellular lipid vacuolation (M/F) and centrilobular hypertrophy (M/F). 870.4100b Chronic toxicity- dog 44721610 0, 30, 300, 1000, 3000 ppm in diet M:0, 1.1, 12.0,38.5, 110.0 mg/kg/day F:0, 1.1, 10.3,36.8, 113.7 mg/kg/day Acceptable/Guideline NOAEL (M/F) = 12.0/10.3 mg/kg/day LOAEL (M/F) = 38.5/36.8 mg/kg/day based on decreased body weight gain weeks 1-13 (males), increased alkaline phosphatase activity (both sexes) and increased incidence of Kupffer cell pigmentation (females). 870.4200 Carcinogenicity rat 44721611 (1992) 0, 100,300, 1000 ppm M: 0,4.6, 13.8,46.5 mg/kg/day F: 0, 5.5, 16.6, 56.2 mg/kg/day Acceptable/Guideline Non-neoplastic findings at (M/F) 13.8/56.2 mg/kg/day: increased incidence of hepatocellular lipid vacuolation (M/F), centrilobular hypertrophy (M/F), liver pigment deposition (M), histiocytic foci in the spleen (M/F),and increase in severity of chronic renal nephropathy (M). Evidence of mononuclear cell leukemia (F). 870.4300 Carcinogenicity- mouse 44721612(1992) 0,30,300, 1000 ppm M:0, 4.5, 39.5, 166.9 mg/kg/day F:0, 5.9, 58.1, 195.5 mg/kg/day Acceptable/Guideline Non-neoplastic findings at (M/F) 166.9/58.1 mg/kg/day: increase in vacuolation, hypertrophy, splenic atrophy and adrenal corticomedullary pigmentation, sinusoidal hypercellularity/single cell necrosis. Neoplastic findings: increase in liver cell 11 ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. 870.5500 870.5300 870.5375 870.5395 870.5550 Study Type Salmonella typhimurium and Escherichia coll Reverse Mutation Assay In vitro Mouse Lymphoma Mutagenesis Assay WL136184* *cis only isomer In vitro Cytogenetics Test In vivo Mammalian Erythrocyte Micronucleus Test: Mouse In vivo/in vitro Mammalian UDS test MRID No. (year)/ Classification /Doses 44721613 (1990) Up to limit dose of 5000 ug/ plate (S. typhimurium) and (E. coli) in the presence and absence of metabolic activation (+S9) Acceptable/Guideline 44721615(1991) Six doses up to 125 ug/ml (toxicity was observed above that dose) in the presence and absence of metabolic activation (±S9) Acceptable/Guideline 44721616(1991) From 6.25 to 400 ug/ml, with and without metabolic activation (+ S9) Acceptable/Guideline 44721618(1995) Up to the limit dose of 2000 mg/kg Acceptable/Guideline 44721620 (1995) Up to the limit dose of 2000 mg/kg Results tumors at high dose (M/F): Increased incidence of hepatocellular adenomas in males and hepatocellular carcinomas in females. Test material was not cytotoxic with or without S9 activation in five S. typhimurium strains and one strain of E. coli, and did not induce a genotoxic response in any strain. There was no evidence of biologically significant induction of mutant colonies. Weakly positive (induced chromosome aberrations in Chinese hamster ovary cells) in the presence of S9 activation, negative without S9 activation. There was no statistically significant increase in the frequency of mi cr enucleated polychromatic erythrocytes in mouse bone marrow at any dose or collection time. Negative for unscheduled DNA synthesis. 12 ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. 870.7485 870.7485 870.7485 870.7485 870.7485 870.7485 Study Type Rat Metabolism and pharmacokinetics: rat Metabolism and pharmacokinetics: rat Metabolism and pharmacokinetics: rat Metabolism and pharmacokinetics: rat WL136184* *cis only isomer Metabolism and pharmacokinetics: rat WL136184* *cis only isomer Metabolism and pharmacokinetics: rat MRID No. (year)/ Classification /Doses Acceptable/Guideline 44721622 (1992) single high dose: 164 mg/kg Radiolabel: (cyclopentyl-14C) Acceptable/Guideline 44721622 (1992) single high dose: 164 mg/kg Radiolabel: (cyclopentyl-14C ) Acceptable/Guideline 44721623 (1991) single low dose: 2 mg/kg Radiolabel: (cyclopentyl-14C) Acceptable/Guideline 44721624(1991) single high dose: 200 mg/kg (males only) Radiolabel: (Triazole - 14C) Acceptable/Guideline 44721625 (1991) single low dose: 2 mg/kg Radiolabel: (Cyclopentyl - 14C) Acceptable/Guideline 46808449 (2002) male/female rat single low dose: 2 mg/kg single high dose: 200 mg/kg repeated dose: 2 mg/kg Results Approximately 94% of radioactivity in excreta after five days: feces (males - 81.3%, females - 65.5%) and urine (males - 13.6%, females - 28.4%) Approximately 94% of radioactivity in excreta after five days: feces (males - 81.3%, females - 65.5%) and urine (males - 13.6%, females - 28.4%) Approximately 94% of radioactivity in excreta after 72 hrs: feces (males - 80%, females - 67%) and urine (males - 14.8%, females - 26%). Metabolite information presented. Approximately 96% of radioactivity in excreta after seven days: feces (76%) and urine (20%). Metabolite information presented. Excretion/retention in bile-duct cannulated rats. Approximately 80% of radioactivity was excreted in the bile after 48 hrs: males (78.7%) and females (83.3%). Low potential for bioaccumulation following single or multiple dosing regimen. The time to maximum plasma concentration for male and female rats treated with either 2 mg/kg or 200 mg/kg was the 13 ------- Table 3. Subchronic, Chronic and Other Toxicity Profile for Metconazole Technical1 Guideline No. 870 748S O / \J . 1 T"O~J 870.7600 Study Type Effects on rat/mice liver enzymes WL136184* *cis only isomer 14-day Mechanistic Study In Vivo Dermal Penetration Study MRID No. (year)/ Classification /Doses Acceptable/Non- guideline 44721626(1991) 0, 300 ppm in diet (mice) and 0, 1000 ppm in diet (rats) for seven or 28 days Acceptable/Non- guideline 46665402 (2005) 0, 30, 300, 1000 ppm in diet (mice) for 14 days. F: 4.5, 48, 151 mg/kg/day Acceptable/TVow- guideline 46808450 (1990) Acceptable/Non- guideline Results earliest sampling interval, 0.25 hours and 4 hours, respectively The plasma half-life of low- and high-dose rats was slightly shorter in males than females, -20-25 hours and -34 hours, respectively. Increased liver weight, cytochrome P450, ethoxycoumarin O-deethylase, ethylmorphine N-demethylase, and lauric acid 1 1-hydroxylase in both rats and mice. No effect on ethoxyresorufm O-deethylase, palmitoyl-CoA oxidation, or peroxisome proliferation (in terms of peroxisome number or morphology). Increased liver weight (300 and 1000 ppm); increased hepatic drug metabolizing enzymes (300 and 1000 ppm) after 7 days; enlarged livers (1000 ppm) at days 3, 7 and 14; hepatic hypertrophy and vacuolation (300 and 1000 ppm) at day 14; increased ALT and AST activities at 1000 ppm (day 14); increased lipid peroxide (300 and 1000) at day 14; increased PCNA labeling at 1000 ppm at day 3 and 7. Dermal absorption= 16% (72 hrs) 1 cis/trans ratio is 85:15. All studies used cis/trans mixture unless otherwise noted. 14 ------- 10. FQPA Hazard Considerations: The toxicology risk assessment team addressed the potential enhanced sensitivity to infants and children as required by FQPA, in accordance with the 2002 OPP lOx Guidance document, and recommended reducing the 10X FQPA Safety Factor to IX for the dietary and residential risk assessments. The recommendation is based on the following: • There is no evidence of susceptibility following in utero exposure in the rat and rabbit developmental toxicity studies and following both in utero and post-natal exposure in the two-generation rat reproduction study. • There is no evidence of increased susceptibility in the offspring based on the result of the two-generation reproduction study. • The residue levels used in the dietary assessment were the established tolerance levels for banana, soybean commodities, and livestock commodities, and assumed 100% crop treated (actions completed previously). Therefore, the acute and chronic dietary, food only, exposure is considered an upper bound conservative estimate. The contribution from drinking water is minimal. The Agency concludes that the acute and chronic exposure estimates in this analysis are unlikely to underestimate actual exposure. • The drinking water component of the dietary assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. • While there is potential for postapplication residential exposure, the best data and approaches currently available were used in the metconazole residential assessment. The Agency used the current conservative approaches for residential assessment. The Agency believes that the calculated risks represent conservative estimates of exposure because maximum application rates are used to define residue levels upon which the calculations are based. Exposures are unlikely to be under estimated because the assessment was a screening level assessment. 11. Toxicological Endpoints: A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios for dietary and occupational human health risk assessments is provided in the table below. The conventional interspecies extrapolation (10X) and intraspecies variation (10X) uncertainty factors were applied for all exposure scenarios. As stated above, the FQPA SF for increased susceptibility was reduced to IX for all exposures scenarios. A summary of the toxicological endpoints are shown below in Table 4: 15 ------- Tables 4a and 4b ~ Summary of Toxicological Doses and Endpoints for Metconazole for Use in Human Health Risk Assessments Table 4a. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and Non-Occupational Human Health Risk Assessments Exposure/ Scenario Acute Dietary (General Population, including Infants and Children) Acute Dietary (Females 13-49 years of age) Chronic Dietary (All Populations) Incidental Oral Short-Term (1- 30 days) Incidental Oral Intermediate- Term (1-6 months) Dermal Short- Term (1-30 days) Dermal Point of Departure Uncertainty/FQ PA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects An appropriate dose/endpoint attributable to a single dose was not observed in the available oral toxicity studies reviewed. NOAEL= 12 mg/kg/day NOAEL= 4.3 mg/kg/day NOAEL= 9.1 mg/kg/day NOAEL= 6.4 mg/kg/day UFA= 10x UFH= 10x FQPA SF= Ix UFA=10x UFH= 10x FQPA SF= Ix UFA= 10x UFH=10x FQPA SF= Ix UFA= 10x UFH=10x FQPA SF= Ix Acute RfD = 0.12 mg/kg/day aPAD=0.12 mg/kg/day Chronic RfD = 0.04 mg/kg/day cPAD = 0.04 mg/kg/day Residential LOC for MOE = 100 Residential LOC for MOE = 100 Developmental toxicity in rats: LOAEL= 30 mg/kg/day based on increases in skeletal variations. Chronic oral toxicity study in rats: LOAEL =13.1 mg/kg/day based on increased liver (M) weights and associated hepatocellular lipid vacuolation (M) and centrilobular hypertrophy (M). Same effects seen in F at 54 mg/kg/day, plus increased spleen wt. 28-Day oral toxicity study in rats: LOAEL = 90.5 mg/kg/day based on decreased body weight (M), increased liver and kidney weight and hepatocellular hypertrophy and vacuolation (M/F). 90-Day oral toxicity study in rats: LOAEL = 19.2 based on increased spleen wt (F) and hepatic vacuolation (M). Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the Limit Dose in a 21 -day dermal toxicity study in the rat and the lack of target organ toxicity, neurotoxicity, developmental or reproductive toxicity. 16 ------- Table 4a. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Dietary and Non-Occupational Human Health Risk Assessments Exposure/ Scenario Intermediate- Term (1-6 months) Inhalation Short- Term (1-30 days) Inhalation Intermediate- Term (1-6 months) Cancer (oral, dermal, inhalation) Point of Departure Uncertainty/FQ PA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects NOAEL= 9.1 mg/kg/day NOAEL= 6.4 mg/kg/day UFA= 10x UFH=10x FQPA SF= Ix UFA= 10x UFH=10x FQPA SF= Ix Residential LOC for MOE = 100 Residential LOC for MOE = 100 28-Day oral toxicity study in rats: LOAEL = 90.5 mg/kg/day based on decreased body weight (M), increased liver and kidney weight and hepatocellular hypertrophy and vacuolation (M/F). 90-Day oral toxicity study in rats: LOAEL =19.2 mg/kg/day based on increased spleen wt (F) and hepatic vacuolation (M). Classification: "Not likely to be Carcinogenic to Humans" Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFs=use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key date (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. LOC = level of concern. N/A = not applicable. Table 4b. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Occupational Human Health Risk Assessments Exposure/ Scenario Dermal Short- Term (1-30 days) Dermal Intermediate - Term (1-6 months) Inhalation Short- Term (1-30 days) Point of Departure Uncertainty Factors Level of Concern for Risk Assessment Study and Toxicological Effects Quantification of dermal risk is not required due to lack of systemic or dermal toxicity at the Limit Dose in a 21-day dermal toxicity study in the rat and the lack of target organ toxicity, neurotoxicity, developmental or reproductive toxicity. NOAEL=9.1 mg/kg/day UFA=10x UFH=10x Occupational LOC for MOE =100 28-Day oral toxicity study in rats: LOAEL = 90.5 mg/kg/day based on decreased body weight (M), increased liver and kidney weight and hepatocellular hypertrophy and 17 ------- Table 4b. Summary of Toxicological Doses and Endpoints for Metconazole for Use in Occupational Human Health Risk Assessments Exposure/ Scenario Inhalation Intermediate- term (1-6 months) Cancer (oral, dermal, inhalation) Point of Departure NOAEL=6.4 mg/kg/day Uncertainty Factors UFA=10x UFH=10x Level of Concern for Risk Assessment Occupational LOC forMOE=100 Study and Toxicological Effects vacuolation (M/F). 90-Day oral toxicity study in rats: LOAEL =19.2 mg/kg/day based on increased spleen wt (F) and hepatic vacuolation (M). Classification: "Not Likely to be Carcinogenic to Humans" Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = potential variation in sensitivity among members of the human population (interspecies). 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 date (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not applicable. B. Dietary Exposure and Risk 1. Dietary Exposure from Food and Drinking Water: Acute and chronic dietary (food and drinking water) exposure assessments were conducted for the proposed uses on turf and ornamentals, and all registered food uses (imported bananas, and Section 18 on soybeans), and drinking water. The residue levels used in the assessment were the established tolerance levels for banana, soybean commodities, and livestock commodities, and assumed 100% crop treated. Therefore, the dietary, food only, exposure is considered an upper bound conservative estimate. Estimated concentrations of metconazole in drinking water from the proposed uses on turf and ornamentals were provided by EFED and incorporated directly into the acute and chronic assessments. A Tier II drinking water assessment for the proposed uses on turf and ornamentals was performed using PRZM/EXAMS modeling with index reservoir (IR) scenarios and percent cropped area (PCA) adjustment factors. For the acute assessment the 1 in 10 year annual peak concentration of metconazole in drinking water was used, and is not expected to exceed 45.48 ug /L. For the chronic assessment, the 1 in 10 year annual average concentration of metconazole in drinking water was used, and is not expected to exceed 31.25 ug /L. 2. Aggregate Risk Exposures: Based on the proposed uses on turfgrass, and that fact that common toxicity endpoints exist for the incidental oral, and acute and chronic dietary routes of exposure, then acute, chronic, and short-term aggregate exposure and risk assessments are required. 3. Acute Aggregate Risk: Acute aggregate exposures include food plus drinking water exposures. The acute dietary exposure estimate at the 95th percentile is 2% aPAD for 18 ------- females 13-49 years old, the only population subgroup of concern, which is below the Agency's level of concern. 4. Chronic Aggregate Risk: Chronic aggregate exposures include food plus drinking water exposures. The chronic dietary (food and drinking water) exposure to metconazole is below the Agency's level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 4% cPAD for the general U.S. population and 10% cPAD for all infants (<1 year old), the most highly exposed population subgroup. 5. Short- and Intermediate Term Aggregate Risk: Dietary, incidental oral and inhalation routes of exposure have the same toxicity endpoints, and therefore, can be aggregated. The short- and intermediate-term aggregate risk assessments take into account average (chronic) exposure estimates from dietary consumption of metconazole (food and drinking water) and non-occupational/residential use on turf (dermal for adults, and dermal plus incidental oral for children). Postapplication exposures from the use on turf are considered predominantly short-term (1-30 days). Although exposures are expected via the dermal route, quantification of dermal risk is not required, since a dermal endpoint was not identified for short-, or intermediate- term exposures. Therefore, short- and intermediate-term postapplication aggregate risk assessments were conducted only for average dietary and incidental oral exposures to toddlers. The short-and intermediate-term aggregate MOEs from dietary exposure (food + drinking water) and non-occupational/residential handler exposure (inhalation) for adults are 3,000 and 2,900, respectively; which are not of concern, since they are greater than the level of concern MOE of 100. The short-and intermediate-term aggregate MOEs from dietary exposure (food + drinking water) and non- occupational/residential exposure (incidental oral) for children 1-2 years old are 470 and 520, respectively; which are not of concern, since it is greater than the level of concern MOE of 100. These aggregate exposure assessments are considered conservative estimates, that should not underestimate risks, because of the following inputs: 1) dietary inputs used crop specific (turf) screening level drinking water modeling data (i.e., Tier II surface water model); 2) maximum application rates and minimum application intervals were used; and 3) conservative SOPs and upper level estimates of exposure were employed. 6. Cancer Aggregate Risk: There were no treatment-related tumors observed in carcinogenicity studies in rats and mice. As a result, a cancer assessment was not conducted. 7. Cumulative Risk: Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information concerning the cumulative effects" of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike 19 ------- other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to metconazole and any other substances. For the purposes of this action, therefore, EPA has not assumed that metconazole has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. B. Handler and Worker Risk Assessments 1. Occupational: Short- (1 - 30 days) and intermediate-term (1-6 months) exposures are possible for occupational metconazole handlers. Only inhalation toxicity endpoints were identified for these anticipated exposure durations. A Margin of Exposure (MOE) > 100 is adequate to protect occupational pesticide handlers. All metconazole occupational handler MOEs are estimated to be > 100 for the proposed uses, and therefore, do not cause concern for FED. There is the possibility for agricultural workers to have postapplication exposure to metconazole following its use on commercially grown ornamentals in nurseries and greenhouses, as well as golf course turf. However, because dermal toxicity endpoints for the appropriate durations of exposure were not identified, and because inhalation exposure is considered to be insignificant for postapplication exposures, no occupational postapplication exposure assessment was conducted. 2. Residential: There is potential adult short-term dermal and inhalation exposure to metconazole from its proposed use on turf and ornamentals. However, because dermal toxicity endpoints for the appropriate duration of exposure were not identified, only residential handler inhalation exposures/risks have been assessed. An MOE > 100 is adequate to protect residential pesticide handlers. All metconazole residential handler MOEs are estimated to be > 100 for the proposed uses, and therefore, do not cause concern. Adults, adolescents and toddlers may be exposed to metconazole from its proposed residential uses. Adults and adolescents may experience short- and intermediate-term dermal exposure from golfing and other activities on treated turf, as well as from tending treated ornamentals. Toddlers may experience short- and intermediate-term dermal and incidental oral exposure from activities on treated turf. Because dermal toxicity endpoints for the appropriate durations of exposure were not identified, and because inhalation exposure is considered to be insignificant for postapplication exposures, only toddler incidental oral postapplication exposures have been assessed. Chemical-specific turf transferable residue studies were submitted for use in estimating postapplication 20 ------- exposures. Postapplication risks to toddlers following the application of metconazole to home lawns were calculated for short- and intermediate-term exposures. All MOEs for the toddler lawn exposure scenarios were >100, and therefore, are not of concern. In addition the total MOE for combined toddler exposures (i.e., hand-to-mouth, object-to-mouth, and incidental ingestion of soil) is >100, and therefore, is not of concern. III. ENVIRONMENTAL RISK ASSESSMENT A. Environmental Fate Characterization: Metconazole is stable to hydrolysis under environmental conditions. It is moderately to slightly degradable by direct photolysis in water. However, photodegradation in water is not expected to be a major route of dissipation in aquatic systems as metconazole has been shown to partition rapidly to the sediment (DT50 in water ranged from 1-15 days) and slowly degrade while in sediment (DT50 for total system ranged from 116-814 days). Aerobic soil metabolism is the only significant route of degradation of metconazole. Based on three aerobic soil metabolism studies, the half-life values are in the range of 192.5 days to 660 days. In a soil photolysis study, metconazole degraded with an estimated half-life of 72 days. Field dissipation studies indicate that metconazole dissipated with a DT50 ranging from 33 to 138 days. Adsorption/desorption studies of metconazole in four soils (pH 5.8-7.6, 0.74-2.29 % OC) produced Koc values ranging between 1026 and 2723 ml/g. This Koc range suggests the chemical is slightly mobile (FAO Classes). The ranges of BCFs for edible tissue, nonedible tissue, and whole fish indicate a low potential for bioconcentration in fish. Also, given the relative short depuration time, it is considered that the risk for bioaccumulation of metconazole in fish is low. B. Exposure Characterization: Metconazole has potential to reach surface water via run- off and spray drift and to reach ground water via leaching. However, the submitted terrestrial field dissipation studies show no significant leaching of metconazole, and ground water modeling estimate a concentration of less than 1 ppb. Estimated environmental concentrations (EECs) in surface water were calculated for metconazole using the Tier II PRZM/EXAMS models and employing maximum application rates for metconazole usage on turf, small grains, soybeans, sugar beets, peanuts, stone fruits, and tree nuts. The peak (l-in-10 year) surface water EECs were between 2.89 and 88.19 |ig/L (dependent on scenario and application method). For the terrestrial assessment, EECs for metconazole were calculated using the terrestrial Tier I model T-REX using the maximum application rate for the evaluated uses. Upper bound dietary EECs ranged from approximately 1.53 ppm for metconazole residues on fruits, pods, seeds, and large insects for soybean application to 446 ppm on short grass for turf application. C. Effects Characterization: Results of acute toxicity studies in freshwater and estuarine/marine fish indicate that metconazole is moderately toxic on an acute basis. 21 ------- The LC50 = 1.71 mg ai/L for freshwater fish (28-day study, OECD204) and the LC50 = 6.3 mg ai/L for estuarine/marine fish. The NOAEC for freshwater fish was 0.00291 mg ai/L based on dry and wet weights and length. For the eastern oyster, the ECso = 2.0 mg ai/L based on shell growth. Acceptable or supplemental toxicity data for estuarine/marine fish (chronic) and for invertebrates (freshwater and estuarine/marine, acute and chronic) were not provided to the Agency. In lieu of these data, toxicity data from other conazole pesticides were use to characterize the risks, assuming that metconazole toxicity was similar to the other conazoles. Metconazole is classified as slightly toxic to birds based on gavage (LDso = 777 mg ai/kg-bwt) and dietary (LC50 1078 mg ai/kg-diet) studies in bobwhite quail. Adverse effects were observed in a reproduction study using bobwhite quail (reduction in live 3- week embryos, hatching success, chick survival, chick body weights, and adult female body weight gain), resulting in a NOAEC of 58 mg ai/kg-diet. the acute toxicity tests for mammals produced definitive LD50s (combined for males and females) of 566, 660, and 1459 mg ai/kg-bwt as well as one non-definitive LDso of >5000 mg ai/kg-bwt (no mortalities). The parental, offspring, and reproductive NOAEC for the 2-generation rat study was 150 mg ai/kg-diet. Significant effects were categorized as parental, reproductive, and offspring. Parental effects include decreased body weight and decreased weight gain in male and female parental animals, increased incidence of fatty hepatocyte change in male parental animals, and increased incidence of spleen congestion in Fl parental females. Reproductive effects included increased gestation length and decreased gestation index driven by dystocia. Offspring effects included decreased viability on lactation day 0 and decreased body weight in F2 offspring. Results of available toxicity studies indicate that metconazole is practically non-toxic to honey bees on an acute contact basis. Seedling emergence studies and vegetative vigor studies were conducted for ten species using two different end-use products (Caramba and Metconazole 50 WDG). The studies with Caramba did not provide any definitive EC25S (all were > 0.097 Ibs ai/acre, the highest concentration tested). For the seedling emergence study conducted with Metconazole 50 WDG, the most sensitive monocot was ryegrass (EC25 = 0.78 Ibs ai/acre and NOAEC = 0.30 Ibs ai/acre), and the most sensitive dicot was the radish (EC25 = 0.15 Ibs ai/acre and NOAEC = 0.075 Ibs ai/acre). For the vegetative vigor study conducted with Metconazole 50 WDG, there were no reductions in growth parameters based on the EC25 (> 0.60 Ibs ai/acre) and NOAEC (0.60 Ibs ai/acre) in the four tested monocots, and the most sensitive dicot was radish (EC25 = 0.44 Ibs ai/acre, NOAEC < 0.038 Ibs ai/acre, and EC05 = 0.0036 Ibs ai/acre). Contact toxicity studies on the effects of metconazole to honey bees indicate that there are no effects at concentrations less than 95.3 jig ai/bee. The most sensitive ECso values for aquatic vascular plants and non-vascular plants are 0.022 and 0.081 mg ai/L, respectively. The respective NOAECs are 0.00051 and 0.031 mg ai/L. 22 ------- D. Potential Risks to Non-Target Organisms: 1. Aquatic: Based on this analysis, direct toxic exposure is expected for estuarine/marine fish (chronic), and freshwater and estuarine/marine invertebrates (acute and chronic). Available toxicity data for aquatic plants coupled with the results of this screening-level assessment show that use of metconazole is likely to result in direct toxic exposure to vascular aquatic plants (proposed application to turf and ornamentals only) and to non-vascular aquatic plants (proposed application to ornamentals only). Labeling restrictions limiting number of applications and requiring a buffer zone will reduce these risks. The specific labeling language addressing these concerns is provided below. 2. Terrestrial: Results of this screening-level assessment using available toxicity data suggest that use of metconazole is likely to result in toxic exposure to birds and mammals on an acute basis and to mammals on a chronic basis. ). Labeling restrictions limiting number of applications will reduce these risks. The specific labeling language addressing these concerns is provided below. The Tier I terrestrial plant model, TERRPLANT, was used to assess risks to terrestrial and semi-aquatic plants. Results of this screening-level assessment suggest that use of metconazole is likely to result in toxic exposure to semi-aquatic dicots. ). Labeling restrictions limiting number of applications and requiring a buffer zone will help reduce these risks. The specific labeling language addressing these concerns is provided below. The results of this risk assessment suggest that the patterns of metconazole use are such that they coincide in time and space to areas frequented by avian and mammalian wildlife. These areas have been of demonstrated use by wildlife as sources of food and cover. The potentially problematic wildlife food items suggested by this risk assessment are likely to be present in and around the treated areas. In addition, there is potential for indirect effects to all taxonomic groups due to changes in habitat caused by vegetation changes. A considerable uncertainty in this assessment comes from the fact that metconazole (94% purity used in formulation) comprises two geometric isomers; cis andirons, with a typical ratio of 85:15 cis:trans. The technical grade material is 94 % pure with a minimum of 80 % cis isomer. The submitted data do not provide information on the differences in degradation rates between the two geometric isomers or the relative contribution of each isomer to the total amount of residues identified in each of the environmental fate studies. Therefore, the environmental concentrations presented in this risk assessment assume fate properties and degradation rates are the same for both isomers. Estimated levels of metconazole in the environment, when compared with minimum toxicity values, are likely to result in direct risks to Federally Listed Threatened and Endangered ("listed") and non-listed species from several different taxa. Indirect risks are also identified for listed and non-listed species. Labeling restrictions limiting number of applications and requiring will reduce these risks. The specific labeling language addressing these concerns is provided below. 23 ------- IV. PROPOSED REGULATORY DECISION A. Unconditional Registration: We recommended registration of metconazole for control of diseases in turfgrass and ornamentals. 1. Conditional Data: 850.1075/72-la,c: Freshwater fish LCso, both cold and warm water fish 850.1010/72-2a: Freshwater invertebrate LC50 850.1055/72-3c: Estuarine/marine invertebrate LCso 850.1300/72-4a: Fish early life stage (estuarine/marine) 850.1400/72-4b: Aquatic invertebrate Life cycle Freshwater and Estuarine/marine 850.1735: Whole Sediment Acute Toxicity invertebrates, freshwater B. Tolerances: No tolerances are required for the proposed non-food uses of metconazole on turf and ornamentals. C. Required Label Statements: End use products containing metconazole as an active ingredient will be required to add the following protective language on the product labeling: 1. Environmental Hazards: "Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. " 2. Directions for Use: - "Do not make more than three applications per year (2 Ibs active ingredient/year)." 24 ------- Contact Person at EPA Mary Waller Product Manager Fungicide Branch Registration Division (7505P) Office of Pesticide Programs Environmental Protection Agency Aerial Rios Building 1200 Pennsylvania Ave., NW Washington, DC 20460 DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and reregi strati on. 25 ------- Bibliography Study Information For Product Registration - Section 3 59639-RUU MRID Citation Valent U.S.A. Corp. (2006) Submission of Product Chemistry, 46805800 Environmental Fate and Toxicity Data in Support of the Application for Registration of V-10116 VVP Fungicide. Transmittal of 9 Studies. Taylor, E. (2006) Metconazole 50 WDG: Product Identity and Composition, Description of Materials Used to Produce the Product, Description of Production Process, Description of Fomulation Process, 46805801 Discussion of Fomation of Impurities, Preliminary Analysis, Certified Limits, Enforcement Analytical Method, Submittal of Samples. Project Number: 200600078, 2006/10116/001, VAM/27B/001. Unpublished study prepared by Valent Dublin Laboratory. 142 p. Ha, S. (2006) Physical and Chemical Properties of Metconazole 50 WDG. 46805802 Project Number: 200600068, V/06/30023A, VA/030/01. Unpublished study prepared by Valent Dublin Laboratory. 50 p. Receipt Date 05-Apr- 2006 05-Apr- 2006 46805803 46805804 Hewitt, A. (2005) Metconazole (KNF-S-474m): Atomization Droplet Size Spectra for the 50 WDG Formulation. Project Number: 200600023, UQ/792B. Unpublished study prepared by University of Queensland Centre for Pesticide Application. 168 p. Rodabaugh, D. (2006) An Acute Oral Toxicity Study in Rats with V- 10116 50 WP (Up/Down Study Design). Project Number: 200600055, VP/29421, ODV00039. Unpublished study prepared by Charles River Laboratories, Inc. 71 p. Rodabaugh, D. (2006) An Acute Dermal Toxicity Study in Rats with V- 46805805 10116 50 WP. Project Number: 200600059, VP/29468, ODV00040. Unpublished study prepared by Charles River Laboratories, Inc. 56 p. 46805806 46805807 Rodabaugh, D. (2006) An Acute Nose-Only Inhalation Toxicity Study in Rats With V-10116 50 WP. Project Number: 200600073, VP/29474, ODV00041. Unpublished study prepared by Charles River Laboratories, Inc. 75 p. Rodabaugh, D. (2006) A Primary Eye Irritation Study in Rabbits With V- 10116 50 WP. Project Number: 200600060, ODV00042, VP/29479. 05-Apr- 2006 05-Apr- 2006 05-Apr- 2006 05-Apr- 2006 05-Apr- 2006 05-Apr- 2006 26 ------- Unpublished study prepared by Charles River Laboratories, Inc. 45 p. Rodabaugh, D. (2006) A Primary Skin Irritation Study in Rabbits With V- 46805808 10116 50 WP. Project Number: 200600061, VP/29495, ODV00043. Unpublished study prepared by Charles River Laboratories, Inc. 45 p. 46805809 Total Rows: 10 Study Information For Product Registration - Section 3 72078-R 05-Apr- 2006 Rodabaugh, D. (2006) A Dermal Sensitization Study in Guinea Pigs with V-10116 50 WP: Modified Buehler Method. Project Number: 200600062, 05-Apr- ODV00044, 999/233. Unpublished study prepared by Charles River 2006 Laboratories, Inc. 67 p. MRID Citation ValentU.S.A. Corp. (2006) Submission of Environmental Fate, Toxicity, 46805100 Exposure and Risk Data in Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 12 Studies. Fichera, L. (2006) Independent Laboratory Validation of ValentU.S.A. Corporation Analytical Method "Determination of Metconazole and its 46805101 Metabolites Mil, M21 & M30 in Soil" . Project Number: VP/29516, 200600074, 050197. Unpublished study prepared by Golden Pacific Laboratories, LLC (GPL). 142 p. 46805102 Dix, M. (2005) Metconazole (KNF-S-474m): Independent Laboratory Validation (ILV) - Determination of Metconaole Residues in Water. Project Number: 200600026, 12709/6227, RM/41/W1. Unpublished study prepared by Springborn Smithers Laboratories. 61 p. Porch, J.; Krueger, H.; Martin, K. (2006) Metconazole: A Tier II Toxicity Test to Determine the Effects of the Test Substance on Seedling 46805103 Emergence of Ten Species of Plants. Project Number: 200600070, VP/28601, 263/152. Unpublished study prepared by Wildlife International, Ltd. 149 p. 46805104 Porch, J.; Krueger, H.; Martin, K. (2006) Metconazole: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Receipt Date 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 27 ------- 46805105 Species of Plants. Project Number: 263/153, 200600046, VP/28609. Unpublished study prepared by Wildlife International, Ltd. 169 p. Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole on Turfgrass in Georgia. Project Number: 200600066, V/27271, V/04/27271. 03-Apr- Unpublished study prepared by Valent Dublin Laboratory and Agriscope, 2006 LLC. 381 p. 46805106 Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole on Turfgrass in New Jersey. Project Number: 200600065, V/27254, RM/41V. Unpublished study prepared by Valent Dublin Laboratory and Crop Management Strategies, Inc. 397 p. Stearns, J. (2005) Transferable Turf Reside of Metconazole on Turfgrass. 46805107 Project Number: V/25718, 200600025, V/03/25718. Unpublished study prepared by Valent Dublin Laboratory and Agriscope, LLC. 113 p. Stearns, J. (2005) Transferable Turf Residue of Metconazole on Turfgrass. 46805108 Project Number: 200600024, V/27246, V/04/27246. Unpublished study prepared by Valent Dublin Laboratory and Agsearch. 109 p. 46805109 Rose, A.; Leggett, M.; Assaf, N. (2006) Environmental Fate and Ecological Risk Assessment For Metconazole Use on Turf and Ornamentals. Project Number: 200600092, VP/30526. Unpublished study prepared by Valent U.S.A. Corporation. 62 p. 46805110 46805111 46805112 46808400 Kureha Corporation (2006) Submission of Product Chemistry, Environmental Fate, and Toxicity Data in Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 52 Studies. Wustner, D. (2006) Physical and Chemical Properties of Metconazole 46808401 Fungicide Technical. Project Number: 200600080, V/06/281/MET. Unpublished study prepared by Valent U.S.A. Corporation. 41 p. 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 Creek, M. (2006) Metconazole (KNF-S-474m): Toxicology Data Summary and Toxicity Endpoint Selection Justification. Project Number: 03-Apr- 200600089, MRC/2006/02. Unpublished study prepared by Valent U. S. A. 2006 Corporation. 26 p. Assaf, N. (2006) Aggregate Human Health Risk Assessment Associated with Metconazole Professional Prduct Use on Turf Grass and Ornamental 03-Apr- Plants. Project Number: 200600084, VP/30513. Unpublished study 2006 prepared by Valent U.S.A. Corporation. 23 p. Driver, J.; Ross, J. (2006) Worker Risk Estimates for Metconazole When Used as an Ornamental and Turf Fungicide. Project Number: 200600086, 03-Apr- VALENT/001/06. Unpublished study prepared by Infoscientific.com. 18 2006 P- 03-Apr- 2006 03-Apr- 2006 28 ------- 46808402 Yacoub, R. (2006) BAS 555 F: (TGAI): Stability to Normal and Elevated Temperature, Metal and Metal Ions and pH: Final Report. Project Number: 200600087, 2006/7006764, 238696. Unpublished study prepared by BASF Agro Research. 12 p. Ha, S. (2006) UV/vis Absorption of Metconazole. Project Number: 46808403 200600091, V/30023C. Unpublished study prepared by Valent U.S.A Corporation. 49 p. Fisk, P. (1991) WL148271 (KNF-S-474m): Hydrolysis as a Function of 46808404 pH. Project Number: 200300392, SBGR/90/308. Unpublished study prepared by Sittingbourne Research Center. 39 p. van der Gaauw, A. (2002) [T-14-Carbon]-KNF-474m: Aqueous 46808405 Photolysis. Project Number: 842052, 200300086. Unpublished study prepared by RCC Umweltchemie Ag. 63 p. Lentz, N. (2005) Metconazole (KNF-S_474m): Photodegradation on Soil. 46808406 Project Number: 200600041, 017961/1. Unpublished study prepared by Ricerca Biosciences, LLC. 124 p. Rose, A. (2006) Data Waiver: Photodegradation in Air. Project Number: 46808407 200600090, VP/30577. Unpublished study prepared by Valent U.S.A. Corporation. 4 p. Assaf, N. (2006) Metconazole (KNF-S-474m): Degradation Under 46808408 Aerobic Conditions in Soil. Project Number: 200600095, VP/28329. Unpublished study prepared by Valent U.S.A. Corporation. 200 p. 46808409 Gedik, L.; Keirs, D.; Fang, C. (2001) Metconazole (BAS 555F): Degradation in Soil Under Anaerobic Conditions. Project Number: 200400117, 399019. Unpublished study prepared by Inveresk Research International. 93 p. Gohre, K. (2006) Metconazole (KNF-S-474m): Metabolism Under 46808410 Anaerobic Aquatic Conditions. Project Number: 200600083, VP/28311. Unpublished study prepared by Valent U.S.A. Corporation. 209 p. Gohre, K. (2006) Metconazole (KNF-S-474m): Soil 46808411 Absorption/Desorption. Project Number: 200600082, VP/28612. Unpublished study prepared by Valent U.S.A. Corporation. 137 p. 46808412 Maurer, J. (2006) Estimation of Adsorption Coefficient (Koc) of Metconazole Degradate M30 by High Performance Liquid Chromatography. Project Number: 200600085, VP/29431. Unpublished study prepared by Valent U.S.A. Corporation. 42 p. Johnson, A.; Gillham, A.; Ahmed, S. (1998) Metconazole 85:15 cis:trans, 46808413 Metconazole 95% cis, A Comparative Acute Oral Toxicity (LD50) Study with Northern Bobwhite. Project Number: 200600028, CYD/621/984073. 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 29 ------- Unpublished study prepared by Valent U.S.A. Corporation. 62 p. 46808414 46808415 46808416 46808417 46808418 Hakin, B.; Rodgers, M.; Andersons, A.; et. al. (1991) Dietary Toxicity (LC50) of WL148271 to the Bobwhite Quail. Project Number: 200300447, SLL/184/901426. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 31 p. Hakin, B.; Rodgers, M.; Anderson, A.; et. al. (1991) Dietary Toxicity (LC50) of WL148271 to the Mallard Duck. Project Number: 200300449, SLL/185/901427. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30 p. Johnson, A.; Ahmed, S. (1999) Metconazole 85:15 cis:trans, Assessment to Determine the Effects on Reproduction in the Northern Bobwhite. Project Number: 200600029, CYD/622/984096. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 335 p. Temple, D.; Martin, K.; Beavers, J.; et. al. (2005) Metconazole (KNF-S- 474m): A Reproduction Study with the Mallard. Project Number: 200600045, 556/102. Unpublished study prepared by Wildlife International, Ltd. 153 p. Toy, R. (1990) WL 148271 (KNF-S-474m): Acute Toxicity to Salmo gairdneri, Daphnia Magna and Selenastrum capricormutum. Project Number: 200300453, SBGR/89/188. Unpublished study prepared by Sittingbourne Research Center. 46 p. Toy, R. (1991) WL 148271 (KNF-S-474m): 96 hr Acute Toxicity to 46808419 Pimephales promelas. Project Number: 200300452, SBGR/90/240. Unpublished study prepared by Sittingbourne Research Center. 24 p. 46808420 46808421 46808422 Cafarella, M. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to Eastern Oyster (Crassostrea virginica). Project Number: 200600042, 12709/6235. Unpublished study prepared by Springborn Smithers Laboratories. 54 p. Sayers, L. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to Mysids (Americamysis bahia) Under Static Conditions. Project Number: 200600043, 12709/6233. Unpublished study prepared by Springborn Smithers Laboratories. 41 p. Sayers, L. (2005) Metconazole (KNF-S-474m) - Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Static Conditions. Project Number: 200600044, 12709/6234. Unpublished study prepared by Springborn Smithers Laboratories. 50 p. Cafarella, M. (2006) Metconazole (KNF-S-474m) - Life Cycle Toxicity 46808423 Test with Mysids (Americamysis bahia). Project Number: 12709/6236, 200600069. Unpublished study prepared by Springborn Smithers 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 30 ------- Laboratories. 79 p. Mitchell, G.; Boeri, R.; Kowalski, P.; et. al. (1996) Toxicity of AC 900, 768 (Metconazole) Technical to Rainbow Trout (Onchorynchus mykiss) 46808424 in a Flow-Through Prolonged Toxicity Test. Project Number: 200600027, 954/96/129. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 152 p. 46808425 46808426 46808427 Koa, L. (1996) CL 900, 768 (Metconazole): Bioconcentration and Elimination of [Triazole-3,5-(14Carbon)]CL 900, 768- Derived Residues by Bluegill Sunfish. Project Number: 200300455, MET/96/012. Unpublished study prepared by American Cyanamid Co. 216 p. Harrison, E.; Hillaby, J. (1991) WL148271: KNF-S-474m: Acute Topical and Oral Toxicity to the Honey Bee, Apis mellifera L.. Project Number: 200300450, SBGR/90/230. Unpublished study prepared by Sittingbourne Research Center. 26 p. Hillaby, J.; Harrison, E. (1991) WL 136184 (KNF-S-474c): Toxicity to the Earthworm, Eisenia foetida, in a 14-Day Artificial Soil Test. Project Number: 200300451, SBGR/91/208. Unpublished study prepared by Sittingbourne Research Center. 23 p. Hoberg, J. (2006) Metconazole (KNF-S-474m) - Toxicity to the 46808428 Duckweed, Lemna gibba. Project Number: 12709/6232, 200600076. Unpublished study prepared by Springborn Smithers Laboratories. 81 p. 46808429 46808430 46808431 46808432 46808433 Hoberg, J. (2006) Metconazole (KNF-S-474m) - Acute Toxicity to the Freshwater Green Alga, Pseudokirchneriella subcapitata. Project Number: 200600096, 12709/6228. Unpublished study prepared by Springborn Smithers Laboratories. 56 p. Hoberg, J. (2006) Metconazole (KNF-S-474m) - Acute Toxicity to the Freshwater Blue-Green Alga, Anabaena flos-aquae. Project Number: 200600093, 12709/6230. Unpublished study prepared by Springborn Smithers Laboratories. 62 p. Hoberg, J. (2006) Metconazole (KNF-S-474m) - Toxicity to the Freshwater Diatom, Navicula pelliculosa. Project Number: 200600097, 12709/6229. Unpublished study prepared by Springborn Smithers Laboratories. 57 p. Hoberg, J. (2006) Metconazole (KNF-S-47m) - Acute Toxicity to the Marine Diatom, Skeletonema costatum. Project Number: 200600098, 12709/6231. Unpublished study prepared by Springborn Smithers Laboratories. 57 p. Collins, C. (1990) WL 148271 (KNF-S-474m): Acute Inhalation Toxicity Study - LC50 Rats (4 Hour Exposure). Project Number: 200300398, 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 ------- 579/45. Unpublished study prepared by Springborn Smithers Laboratories. 53 p. Gardner, J. (1990) WL 148271: Skin and Eye Irritancy and Skin 46808434 Sensitization Potential. Project Number: 200300399, SBGR/89/218. Unpublished study prepared by Sittingbourne Research Center. 29 p. Glaza, S. (1995) Dermal Sensitization Study of CL 900, 768 in Guinea 46808435 Pigs - Maximation Test. Project Number: HWI/40804288, 200300400. Unpublished study prepared by Hazleton Wisconsin, Inc. 57 p. 46808436 Creek, M. (2006) Justification for Waiving an Acute Neurotoxicity and a Developmental Neurotoxicity Study with Metconazole Fungicide Technical. Project Number: 200600088, MRC/2006/01. Unpublished study prepared by Valent U.S.A. Corporation. 5 p. Pickersgill, N. (1991) WL 148271: Oral (Capsule) Maximum Tolerated 46808437 Single Dose Study in the Beagle. Project Number: 579/21, 200400248. Unpublished study prepared by Hazleton Uk. 46 p. 46808438 46808439 46808440 46808441 46808442 46808443 Bonnette, K. (2006) A 14-Day Range-Finding Dermal Toxicity Study in Fischer 344 Rats with Metconazole Technical. Project Number: ODV00035, 200600040. Unpublished study prepared by Charles River Laboratories, Inc. 352 p. Bonnette, K. (2006) Metconazole (KNF-S-474m): A 21-Day Dermal Toxicity Study in Fischer 344 Rats. Project Number: 200600094, VP/28361. Unpublished study prepared by Charles River Laboratories, Inc. 297 p. Cooper, S. (2002) KNF-474m: Neurotoxicity Study by Dietary Administration to CD Rats for 4 Weeks. Project Number: 200300088, KRA/068/022386. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 272 p. Cooper, S. (2002) KNF-474m: Preliminary Neurotoxicity Study by Dietary Administration to CD Rats for 2 Weeks. Project Number: 200300087, KRA/065/020005. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 160 p. Fulcher, S. (2002) KNF-474m: Preliminary Teratology Study by Oral Gavage Administration to CD Rats. Project Number: 200300082, KRA/064/020002. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 63 p. Fulcher, S. (2002) KNF-474m: Teratology Study by Oral Gavage Administration to CD Rats. Project Number: 200300084, KRA/069/022919. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 156 p. 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 32 ------- Tesh, J. (1990) An Appraisal of the Effects of WL 148271/KNF-S-474m 46808444 (Technical) Upon Pregnancy in the Rabbit. Proj ect Number: 200400247, QRT/0049. Unpublished study prepared by Life Science Research. 9 p. 46808445 Hoberman, A. (1996) An Oral Development (Embryo-Fetal Toxicity/Teratogenicity) Pilot Study with AC 900, 768 in Rabbits. Project Number: 200300463, ARGUS/101/027P. Unpublished study prepared by Argus Research Laboratories, Inc. 153 p. Willoughby, C. (1991) WL 148271: Preliminary Study to Assess Effects 46808446 on Reproductive Performance in Rats. Proj ect Number: 2003 00426, 91/0109. Unpublished study prepared by Life Science Research. 151 p. Teramoto, S. (2002) KNF-474m: Reproductive Toxicity Study in Rats. 46808447 Project Number: 200400253, IET/00/0146. Unpublished study prepared by Institute of Environmental Toxicology. 425 p. Teramoto, S. (2002) A Measurement Study of Serum Steroid Hormone Concentrations and Hepatic Drug-Metabolizing Enzyme Contents During 46808448 Late Gestation in Rats Fed Diets Containing KNF-474m. Project Number: IET/02/0058, 200400255. Unpublished study prepared by Institute of Environmental Toxicology. 111 p. Yamamoto, E. (2002) Metabolism of KNF-474m in Rats. Proj ect Number: 46808449 200400254, IET/01/8002. Unpublished study prepared by Institute of Environmental Toxicology. 113 p. 46808450 46808451 46808452 46901700 46901702 Cornelissen, K. (1990) KNF-S1474m (WL 148271): A Study of Absorption and Excretion Following Percutaneous Administration to the Rat. Proj ect Number: 200600072, 579/47. Unpublished study prepared by HazletonUk. 142 p. Mann, P. (2002) KNF-474m Validation of an Analytical Method and Dietary Formulation Preparation, Homogeneity and Stability. Project Number: 200300083, KRA/067/014561. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 27 p. Mann, P. (2002) KNF-474m: Validation of an Analytical Method and Liquid Formation Preparation, Homogeneity, and Stability. Project Number: 200300085, KRA/066/014562. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 25 p. ValentU.S.A. Corporation (2006) Submission of Environmental Fate, Residue, Exposure and Risk Data in Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 16 Studies. Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole in Ontario, Canada. Proj ect Number: V/26251, 200600147, V/26251/03/A. 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 03-Apr- 2006 26-Jul- 2006 26-Jul- 2006 33 ------- 46901703 Unpublished study prepared by Valent Dublin Laboratory, Vaughn Agricultural Research Serv., Ltd. and Agvise Inc. 274 p. Stearns, J. (2006) Terrestrial Field Soil Dissipation of Metconazole in Madera, California. Project Number: 200600146, V/26219, V/26219/03/A. Unpublished study prepared by Excel Research Services, Inc. and Valent Dublin Laboratory. 264 p. Fujie, G. (2006) RM-41C-1-1: Determination of cis-Metconazole and 46901704 trans-Metconazole in Crops. Project Number: RM/41C/1/1, RM/41C/4. Unpublished study prepared by Valent Dublin Laboratory. 43 p. Gohre, K. (2006) Radiovalidation of Residue Methodology for 46901705 Metconazole in Animal Tissue. Project Number: VP/30188, 200600145. Unpublished study prepared by Valent Dublin Laboratory. 35 p. 46901706 Noon, P. (2006) Independent Laboratory Validation of the Analytical Method RM-41C-1, Determination of cis-Metconazole and trans- Metconazole in Crops. Project Number: 200600132, 120/010, VP/29874. Unpublished study prepared by North Coast Laboratories, Inc. 105 p. Green, C. (2006) Magnitude of the Residues of Metconazole on Cherries. 46901707 Project Number: 25654, 200600148, V/03/25654. Unpublished study prepared by CMS Inc., Columbia Ag Research, Inc. and Agsearch. 214 p. Green, C. (2006) Magnitude of the Residues of Metconazole on Peaches. 46901708 Project Number: 25662, 200600150, V/25662/05/M. Unpublished study prepared by CMS Inc., Agriscope, LLC and Agsearch. 224 p. 46901709 Green, C. (2006) Magnitude of the Residues of Metconazole on Plums and Dried Plums. Project Number: 25671, 200600149, V/03/25671. Unpublished study prepared by Agsearch, Agsolutions, Inc. and Excel Research Services, Inc. 195 p. 46901710 46901711 Green, C. (2006) Magnitude of the Residues of Metconazole on Pecans. Project Number: 27211, 200600111, V/04/27211. Unpublished study prepared by Agricultural Research Associates, Biological Research Service, Inc. and South Texas Ag Research, Inc. 141 p. Green, C. (2006) Magnitude of the Residues of Metconazole on Peanut Nutmeats and Peanut Processing Fraction. Project Number: 200600181, 46901712 25689, V/04/25689. Unpublished study prepared by Ashgrow Crop Management Systems, Inc., Coastal Ag Research, Inc. and Carolina Ag- Research Service, Inc. 367 p. 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 Green, C. (2006) Magnitude of the Residues of Metconazole on Almonds. Project Number: 25700, 200600153. Unpublished study prepared by 26-Jul- Valent U.S.A. Corporation, Research 2000, Inc. and Excel Research 2006 Services, Inc. 214 p. 26-Jul- 2006 26-Jul- 2006 34 ------- 46901713 46901714 46901715 Green, C. (2006) Dissipation of Dislodgeable Foliar Residues of Metconazole on Peach Leaves. Project Number: 200600075, 29209, 26-Jul- V/05/29209. Unpublished study prepared by Excel Research Services, 2006 Inc. and Valent Dublin Laboratory. 108 p. Rose, A.; Leggett, M. (2006) Environmental Fate and Ecological Risk Assessment for Metconazole Use on Orchards (Tree Nuts and Stone Fruit) 26-Jul- and Peanuts. Project Number: 200600312, VP/30966. Unpublished study 2006 prepared by Valent U.S.A. Corporation. 97 p. Gagne, J. (2006) Metconazole: An Analysis of the Potential Risk to Endangered Species of Mammals Associated with Tree Nuts, Peanuts, and 26-Jul- Stone Fruits. Project Number: 200600311, V/ES/1. Unpublished study 2006 prepared by Valent U.S.A. Corporation. 95 p. Assaf, N. (2006) Metconazole Aggregate Human Health Exposure Risk 46901716 Assessment. Project Number: 200600313, VP/30959. Unpublished study prepared by Valent U.S.A. Corporation. 23 p. Wustner, D. (2006) Summary of Metconazole Residue Chemistry Data. 46901717 Project Number: 200600310, V/RES/2. Unpublished study prepared by Valent U.S.A. Corporation. 63 p. Kureha Corporation (2006) Submission of Product Chemistry and Residue 46901900 Data in Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 15 Studies. Wustner, D. (2006) Metconazole Fungicide Technical Particle Size, 46901901 Distribution and Shape. Project Number: V/PC/2, 200600194. Unpublished study prepared by Valent U.S.A. Corporation. 13 p. 46901902 Edwards, V. (1991) [cyclopentyl-(Carbon 14)]WL148271 (KNF-S- 474m): Metabolism in Wheat. Project Number: 200300436, SBGR/91/017. Unpublished study prepared by Sittingbourne Research Center, Biotech. 56 p. Edwards, V. (1991) [triazole-14(Carbon)] WL136184 (KNF-S-474c): 46901903 Metabolism in Wheat. Project Number: 200400092, SBGR/91/016. Unpublished study prepared by Sittingbourne Research Center. 108 p. Kao, L. (1997) CL 900768 (Metconazole): Metabolism of [Triazole-3,5- (Carbon 14)] CL 900768 in Canola Under Field Conditions. Project 46901904 Number: 200600109, MET/97/015, M96P768MPB1. Unpublished study prepared by Excel Research Services, Inc., American Cyanamid Co. and Enviro-Quest. 314 p. Kao, M. (1997) CL 900768 (Metconazole): Metabolism of [p- 46901905 Chlorophenyl-U-(Carbon 14)] CL 900768 in Canola Under Field Conditions. Project Number: 200600107, MET/97/016, M96P768MB2. 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 35 ------- 46901906 Unpublished study prepared by Excel Research Services, Inc., Ag-Quest Inc. and American Cyanamid Co. 350 p. Class, T.; Schluter, H. (2002) Metconazole (BAS 55 F; AC 900768): Metabolism of Carbon-14 Labeled AC 900768 in Peas. Project Number: 200600104, MET/02/006. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS) and PTRL Europe Gmbh. 178 p. Satoh, K. (2002) Metabolic Fate of KNF-474m in Mandarins. Project 46901907 Number: 200400252, IET/01/8005. Unpublished study prepared by Institute of Environmental Toxicology. 280 p. 46901908 46901909 46901910 46901911 46901912 46901913 46901914 46901915 Johnston, A.; Cameron, S.; Young, C. (1992) The Disposition of (Carbon 14)-WL148271 (KNF-S-474M) in the Lactating Goat. Project Number: ffil/143140, 200300446. Unpublished study prepared by Inveresk Research International. 170 p. 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 Jalal, M. (2006) Metconazole (KNF-S-474m): Metabolism by Lactating Goats. Project Number: 200600151, VP/28 111, V/04/28 111. Unpublished 26-Jul- study prepared by Valent Dublin Laboratory and Genesis Midwest 2006 Laboratories. 294 p. Johnston, A.; Cameron, S.; Young, C. (1991) The Disposition of (Carbon 14)-WL136184 (KNF-S-474C) in the Laying Hen. Project Number: 26-Jul- 200400250, IRI/150949. Unpublished study prepared by Inveresk 2006 Research International. 121 p. Johnston, A.; Young, C.; Cameron, S. (1992) The Disposition of (Carbon 14)-WL136184 (KNF-S-474C) in the Laying Hen. Project Number: 26-Jul- 200400251, IRI/151324. Unpublished study prepared by Inveresk 2006 Research International. 76 p. Jalal, M. (2006) Metconazole (KNF-S-474m): Metabolism by Laying Hens. Project Number: 200600176, VP/28337, V/04/28337. Unpublished 26-Jul- study prepared by Genesis Midwest Laboratories, Acorn NMR Inc and 2006 Valent Dublin Laboratory. 453 p. Hill, A.; Standen, M. (1993) Metconazole: Confined Rotational Crop Study Using [Cyclopentyl-(Carbon 14)]- and [Triazole-(Carbon 14)]- 26-Jul- WL148271. Proj ect Number: 200300437, SBGR/92/104. Unpublished 2006 study prepared by Sittingbourne Research Center. 201 p. Green, C. (2006) Magnitude of the Residues of Metconazole in Dairy Cattle Milk and Meat. Proj ect Number: 200600291,29111, V/05/29 111. 26-Jul- Unpublished study prepared by Genesis Midwest Laboratories and Valent 2006 Dublin Laboratory. 401 p. Wustner, D. (2006) Justification for Waiving a Feeding/Residue Study in 26-Jul- Laying Hens with Metconazole Fungicide Technical. Project Number: 2006 36 ------- 200600292, V/RES/1. Unpublished study prepared by Valent U.S.A. Corporation. 19 p. BASF Corporation (2006) Submission of Toxicity, Fate, Residue, Environmental Fate Data in Support of the Applications for Registration 46902200 of Caramba Fungicide, BAS 556 OIF Fungicide, Metconazole Fungicide Technical and the Petition for Tolerance of Metconazole on Crop and Livestock Commodities. Transmittal of 32 Studies. Hassink, J. (2005) Hydrolysis of Metconazole (TGAI Batch 43705). 46902201 Project Number: 209413, 2005/1016371. Unpublished study prepared by BASF Aktiengesellschaft. 17 p. 46902202 Williams, M.; Heim, L. (1996) Determination of the Aqueous Photolysis Rate with AC 900, 768 (WL 148, 271). Project Number: ENV/95/014/01, 42254, MK/324/001. Unpublished study prepared by ABC Laboratories, Inc. 93 p. Bissinger, T. (1996) Photochemical Degradation of Metconazole (CL 46902203 900768) in Soil. Project Number: CFS/1996/076, DELS, MK/620/013. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 52 p. Rice P. (2002) Calculation of DT50 and DT90 Values of Metconazole 46902204 (BAS 555 F) in Five Soils. Project Number: EXA/01/028, MK/620/021. Unpublished study prepared by BASF Agro Research. 18 p. 46902205 46902206 46902207 46902208 Steinfuhrer, T. (1996) (14-Carbon)-Metconazole (CL 900768): Degradation in Water Sediment Systems. Project Number: DES37, CFS/1995/029, MK/630/002. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 122 p. Jackson, S.; White, M.; Nejad, H. (2006) Oklahoma 2004 Metconazole Terrestrial Field Dissipation Study. Project Number: 2006/7007134, 141527. Unpublished study prepared by Crop Guard Research, Inc. and BASF Agro Research and Agvise Laboratories. 212 p. Jackson, S.; White, M.; Nejad, H. (2006) Mississippi 2003 Metconazole Terrestrial Field Dissipation Study. Project Number: 2006/7007133, 141530. Unpublished study prepared by BASF Agro Research, Agvise Laboratories and Valent Dublin Laboratory. 222 p. Jackson, S.; White, M.; Nejad, H. (2006) North Dakota 2003 Metconazole Terrestrial Field Dissipation Study: Final Report. Project Number: 138071, 2006/7007132. Unpublished study prepared by BASF Agro Research, Agvise Laboratories and Valent Dublin Laboratory. 218 p. Nejad, H. (2006) Validation of BASF Method Number D0506 for 46902209 Determination of Metconazole (BAS 555 F) and its Metabolites Ml 1, M21, M30 and Triazol in Soil Using LC/MS/MS. Project Number: 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 37 ------- 138074, 2006/7006766. Unpublished study prepared by BASF Agro Research. 81 p. Ibrahim, A.; Hauser, R. (2006) Independent Method Validation of BASF Analytical Method D0506: Method for Determination of Metconazole 46902210 (BAS 555 F) and its Metabolites Ml 1, M21, M30 and Triazol in Soil Using LC/MS/MS. Project Number: 238588, 2K6/238588, 2006/7007031. Unpublished study prepared by Adpen Labs. 136 p. 46902211 46902212 46902213 Smith, K., Nejad, H. (2006) Freezer Storage Stability of Metconazole and Metabolites in Three Soils for Up to 18 Months. Project Number: 2006/7007139, 257989. Unpublished study prepared by BASF Agro Research and Valent Dublin Laboratory. 84 p. Jatzek, D. (2002) BAS 555 F - Determination of the Chronic Effect on the Reproduction of the Water Flea Daphnia magna Straus. Project Number: 01/0051/51/1, 2002/1004678. Unpublished study prepared by BASF Aktiengesellschaft. 43 p. Zok, S. (2001) BAS 555 F - Early Life-Stage Toxicity Test on the Rainbow Trout (Oncorhynchus mykiss). Project Number: 52F0051/015001, 2001/1015080. Unpublished study prepared by BASF Aktiengesellschaft. 167 p. Porch, I; Krueger, H.; Krip, W.; et. al. (2006) Caramba (BAS 555 01 F): A Toxicity Test to Determine the Effects of the Test Substance on 46902214 Seedling Emergence of Ten Species of Plants. Project Number: 147/223, 238702, 2006/7007216. Unpublished study prepared by Wildlife International, Ltd. 105 p. Porch, I; Krueger, H.; Kendall, T.; et. al. (2006) Caramba (BAS 555 01 F): A Toxicity Test to Determine the Effects of the Test Substance on 46902215 Vegetative Vigor of Ten Species of Plants. Project Number: 147/224, 238705, 2006/7007217. Unpublished study prepared by Wildlife International, Ltd. 137 p. 46902216 Saha, M.; Gooding, R. (2006) The Determination of Residues of Metconazole (BAS 555 F) and its Metabolites in Plant Matrices Using LC/MS/MS: Final Report. Project Number: 2005/5000141, 238522. Unpublished study prepared by BASF Agro Research. 221 p. Perez, R.; Ibrahim, A.; Hauser, R.; et. al. (2006) Independent Method Validation of BASF Analytical Method D0508: The Determination of 46902217 Residuesof Metconazole (BAS 555 F) and Its Metabolites in Plant Matrices Using LC/MS/MS. Project Number: 238582, 2006/7007032, 2K6/238582. Unpublished study prepared by Adpen Labs. 296 p. 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 46902218 Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 38 ------- at < -ISDegrees Celsius in Cereal Grain (Germany, 1995). Project Number: DER31, CFS/1997/001, MK/326/004. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 38 p. Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer 46902219 at < -18 Degrees Celsius in Cereal Green Plant and Straw (Germany, 1996). Project Number: DER43, CFS/1997/022, MK/326/005. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 49 p. Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer 46902220 at < -18 Degrees Celsius in Carrots and Lettuce (Germany, 1996). Project Number: DER48, CFS/1997/060, MK/326/006. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 55 p. 46902221 Kretschmer, S. (2000) Metconazole (CL 900768): Storage Stability of Residues of the Metabolite Triazolylalanine (CL 147267) in Wheat Grain. Project Number: P/342/G, B/342, MK/326/016. Unpublished study prepared by PTRL Europe Gmbh. 37 p. Memmesheimer, H. (1997) Metconazole (CL 900768): Storage Stability of CL 900768 Residues as cis-(CL 354801) and trans-(CL 354802) Isomer 46902222 at < -18 Degrees Celsius in Rape Seed and Rape Oil (Germany, 1996). Project Number: DER49, CFS/1977/061, MK/326/007. Unpublished study prepared by Cyanamid Forshung Gmbh (CFS). 55 p. 46902223 Gooding, R.; Saha, M. (2006) Freezer Storage Stability of BAS 555 F (Metconazole) and its Metabolites in Plant Samples: Amended Final Report. Project Number: 2006/7007240, 138032. Unpublished study prepared by BASF Agro Research. 177 p. White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Wheat: Final Report. Project Number: 46902224 137711, 2006/7006723. Unpublished study prepared by BASF Agro Research, Southeast Ag Research, Inc. and Shoffner Farm Research. 203 P- White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Barley: Final Report. Project Number: 46902225 137714, 2006/7006917. Unpublished study prepared by BASF Agro Research, ACDS Research, Inc. and Alvey Lab & Agr Research Services. 175 p. 46902226 Jordan, J.; Saha, M. (2006) The Magnitude of Metconazole (BAS 555 F) and its Metabolites and Pyraclostrobin (BAS 500 F) Residues in Oats: Final Report. Project Number: 137717, 2006/7006724. Unpublished study prepared by BASF Agro Research, ACDS Research, Inc. and Southeast 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 39 ------- Ag Research, Inc. 255 p. 46902227 Jordan, J.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Rye: Final Report. Project Number: 26-Jul- 137720, 2006/7006725. Unpublished study prepared by BASF Agro 2006 Research, Southeast Ag Research, Inc. and Midwest Research, Inc. 146 p. 46902228 White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and Its Metabolites in Soybean: Final Report. Project Number: 137726, 2006/7006995. Unpublished study prepared by BASF Agro Research, Southeast Ag Research, Inc. and Agresources, Inc. 213 p. 46902229 46902230 Jordan, J.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Sugar Beet: Final Report. Project Number: 137729, 2006/7006726. Unpublished study prepared by BASF Agro Research, Agresources, Inc. and Agstat. 260 p. White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Wheat Processing Commodities: Final 46902231 Report. Project Number: 137723, 2006/7007147. Unpublished study prepared by BASF Agro Research, Agresources, Inc. and Alvey Lab & Agr Research Services. 236 p. 46902232 White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Wheat Aspirated Grain Fractions. Project Number: 257986, 2006/7007257. Unpublished study prepared by BASF Agro Research. 131 p. BASF Corporation (2006) Submission of Product Chemistry, Toxicity, Residue, Risk and Exposure Data in Support of the Applications for 46902300 Registration of Caramba Fungicide and BAS 556 OIF Fungicide and the Petition for Tolerance of Metconazole on Soybeans, Wheat, Triticale, Rye, Oats, and Sugarbeet. Transmittal of 35 Studies. White, M.; Saha, M. (2006) The Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Soybean Processing Commodities: 46902301 Final Report. Project Number: 137732, 2006/7006996. Unpublished study prepared by BASF Corporation, Agresources, Inc. and Midwest Research, Inc. 208 p. 46902302 Jordan, J.; Saha, M. (2006) Magnitude of Residues of Metconazole (BAS 555 F) and its Metabolites in Sugar Beets and Sugar Beet Processed Fractions Following Applications of BAS 555 OIF: Final Report. Project Number: 137735, 2006/7006727. Unpublished study prepared by BASF 26-Jul- 2006 Leonard, R. (2005) The Magnitude of Metconazole Residues in Soybeans: Final Report. Project Number: 204640, 2004/5000755. Unpublished study 26-Jul- prepared by BASF Agro Research, Southeast Ag Research, Inc. and 2006 Shoffner Farm Research. 113 p. 26-Jul- 2006 26-Jul- 2006 26-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 40 ------- Corporation, Agresources, Inc. and Prairie Agricultural Research, Inc. 206 P- White, M.; Saha, M. (2006) Field Accumulation of Residues of Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from 46902303 Limited Field Trials in Mississippi: Final Report. Project Number: V/04/27131, 2006/7007130. Unpublished study prepared by BASF Corporation. 156 p. White, M.; Saha, M. (2006) Field Accumulation of Residues of Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from 46902304 Limited Field Trials in Ohio: Final Report. Project Number: V/04/27115, 2006/7007127. Unpublished study prepared by BASF Corporation and Ag. Consultants Inc. 150 p. White, M.; Saha, M. (2006) Field Accumulation of Residues of Metconazole (BAS 555 F) and its Metabolites in Rotational Crops from 46902305 Limited Field Trials in California: Final Report. Project Number: V/04/27123, 2006/7007128. Unpublished study prepared by BASF Corporation and Excel Research Services, Inc. 228 p. BASF Corporation (2006) Human Health Risk Assessment for 46902306 Metconazole (BAS 555 F) Use in Various Crops. Project Number: 2006/7007250. Unpublished study prepared by BASF Corporation. 18 p. 46902307 Holmes, C.; Gagne, J.; Van Cott, A.; et. al. (2006) Metconazole: Screening Level Ecological Risk Assessment for Wildlife, Aquatic Organisms, Nontarget Plants, and Nontarget Insects. Project Number: 2006/7008102. Unpublished study prepared by BASF Corporation. 29 p. Jackson, S. (2006) Tier II Drinking Water and Ecological Risk Exposure 46902308 Assessment for the Use of Metconazole. Project Number: 2006/7007247. Unpublished study prepared by BASF Corporation. 26 p. Jackson, S.; Holmes, C. (2006) Metconazole Buffer Distance Requirements for Protection of Endangered Species Including Crops: 46902309 Soybeans, Sugar Beets, Wheat, Barley, Oats, Rye, Tree Nuts, Stone Fruit, Peanuts, Turf and Ornamental Uses. Project Number: 2006/7008097, ELECTRONIC. Unpublished study prepared by BASF Corporation. 24 p. 46902310 46902311 Gagne, J.; Van Cott, A. (2006) Metconazole: An Analysis of the Potential Risk to Endangered Species of Mammals Associated with Soybeans, Sugar Beets, Wheat, Barley, Oats, and Rye. Project Number: 20006/7008095. Unpublished study prepared by BASF Corporation. 97 p. Canez, V. (2006) Metconazole: Agricultural Worker Reentry Exposure Assessment Following Application to Soybeans and Other Low Profile Field Crops. Project Number: 2006/7008091. Unpublished study prepared by BASF Corporation. 29 p. 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 41 ------- 46902312 Canez, V. (2006) Metconazole: Mixer/Loader and Applicator Exposure Assessment Following Application to Soybeans and Other Low Profile Field Crops. Project Number: 2006/7008100. Unpublished study prepared by BASF Corporation. 28 p. Finch, C. (2006) BAS 555 01 F (Caramba) Fungicide: Group A - Product 46902313 Identity, Composition, and Analysis. Project Number: FR0604, 2006/7008138. Unpublished study prepared by BASF Corporation. 46 p. Weatherhead, P. (2000) Method Validation of RLA 12495.00 HPLC Meth°cl for the Determination of Metconazole SL Formulations. Project Number: RGL/4572, MK/220/007. Unpublished study prepared by BASF Agro Research. 32 p. Fries, J. (2004) Supplement to the Method Validation of RLA 12495.00 HPLC Method for the Determination of Metconazole SL Formulations 46902315 (Technical Report No. RLG 4572). Project Number: 180322/1, 2003/1021955. Unpublished study prepared by BASF Ag Research Station. 16 p. Baker, I. (2001) Metconazole 90 g/L SL- Chemical and Physical Stability of Formula RLA 12307 (BAS 555 01 F) when Stored in HOPE Packs - 46902316 208 Week Final Report. Proj ect Number: RGL/4697, 97002/A, 9630/97002/83. Unpublished study prepared by BASF Agro Research. 81 P- Yacoub, R. (2006) BAS 555 01 F: Determination of Oxidizing/Reducing 46902317 Action: Final Report. Project Number: 257980, 2006/7007115. Unpublished study prepared by BASF Corporation. 13 p. Bradley, D. (1997) Oral LD50 Study in Albino Rats with AC 900768 90 46902318 g/L SL (RLF 12307). Project Number: T/0977, A97/87, MK/460/016. Unpublished study prepared by American Cyanamid Co. 22 p. Bradley, D. (1997) Dermal LD50 Study in Albino Rats with AC 900766 46902319 90 g/L SL (RLF 12307). Project Number: T/0978, A97/88, MK/460/017. Unpublished study prepared by American Cyanamid Co. 17 p. Hoffman, G. (1996) Acute Inhalation Toxcity Study with CL 900,768 60 46902320 g/L SL (SF09381) in Rats. Project Number: 96/5283, MK/460/009. Unpublished study prepared by Huntingdon Life Sciences. 100 p. 46902321 46902322 Anonymous (1999) Metconazole (AC 900768) Request to Waive the Requirements for an Acute Inhalation Study with the AC 900768 90 g/L SL Formulation. Proj ect Number: MK/460/028. Unpublished study prepared by BASF Corporation. 8 p. Boczon, L. (1997) Primary Eye Irritation Study (in Rabbits) with AC 900768 90 g/L SL Formulation (RLF 12307). Proj ect Number: T/0975, 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 42 ------- 46902323 A97/86, MK/460/019. Unpublished study prepared by American Cyanamid Co. 15 p. Boczon, L. (1997) Primary Dermal Irritation Study (in Rabbits) with AC 900768 90 g/L SL Formulation (RLF 12307). Project Number: T/0976, A97/85, MK/460/018. Unpublished study prepared by American Cyanamid Co. 15 p. 46902324 Finch, C. (2006) BAS 556 01 F Fungicide: Group A - Product Identity, 46902325 Composition, and Analysis. Project Number: FR0605, 2006/7008139. Unpublished study prepared by BASF Corporation. 62 p. 46902326 46902327 Yacoub, R. (2006) BAS 556 01 F: Determination of Physical State, pH, Explodability, Relative Density, Flammability, and Viscosity: Final Report. Project Number: 138251, 2006/7006656. Unpublished study prepared by BASF Corporation. 12 p. Yacoub, R. (2006) BAS 556 01 F: Determination of Oxidizing/Reducing 46902328 Action: Final Report. Project Number: 138254, 2006/7006762. Unpublished study prepared by BASF Corporation. 13 p. Yacoub, R. (2006) BAS 556 01 F: Accelerated Storage Stability. Project 46902329 Number: 2006/7006763. Unpublished study prepared by BASF Corporation. 13 p. Gamer, A.; Hellwig, J. (2006) BAS 556 UG F - Acute Oral Toxicity 46902330 Study in Rats. Project Number: 10A0515/051035, 2005/1019609. Unpublished study prepared by BASF Aktiengesellschaft. 22 p. Gamer, A.; Hellwig, J. (2006) BAS 556 UG F - Acute Dermal Toxicity 46902331 Study in Rats. Project Number: 11A0515/051060, 2005/1029610. Unpublished study prepared by BASF Aktiengesellschaft. 23 p. 46902332 Hock, L.; Hellwig, J. (2005) BAS 556 UGF - Acute Inhalation Toxicity Study in Wistar Rats 4-hour Liquid Aerosol Exposure. Project Number: 1310515/057008, 2005/1026595. Unpublished study prepared by BASF Aktiengesellschaf. 37 p. Remmele, M.; Hellwig, J. (2006) BAS 556 UG F - Acute Eye Irritation Study in Rabbits. Project Number: 11H0515/052073, 2005/1029612. 24-Jul- 2006 Blanset, D. (1998) Dermal Sensitization Study with AC 900768 90 g/L SL (RLF 12307) in Guinea Pigs - Buehler Method (Nine Inductions). Project 24-Jul- Number: 97/1701, 971/97/153, MK/460/026. Unpublished study prepared 2006 by Huntingdon Life Sciences. 40 p. 24-Jul- 2006 Vanhook, C. (2005) Method AFR0039/01: BAS 556 F: Determination of Metconazole and/or Pyraclostrobin Content in Technical Grade Material 24-Jul- and Formulations by HPLC. Project Number: AFR0039/01, F200511, 2006 2005/5000101. Unpublished study prepared by BASF Corporation. 22 p. 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 24-Jul- 2006 43 ------- 46902334 46902335 Unpublished study prepared by BASF Aktiengesellschaft. 21 p. Remmele, M.; Hellwig, J. (2006) BAS 556 UG F - Acute Dermal Irritation/Corrosion in Rabbits. Project Number: 18H0515/052136, 2005/1029611. Unpublished study prepared by BASF Aktiengesellschaft. 21 p. Gamer, O.; Hellwig, J. (2006) BAS 556 UG F - Modified BUEHLER Test (9 Inductions) In Guinea Pigs. Project Number: 33H0515/052137, 2005/1029613. Unpublished study prepared by BASF Aktiengesellschaft. 32 p. Kureha Corporation (2006) Submission of Environemntal Fate Data in 46955600 Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 2 Studies. 46955601 46955602 Stearns, J. (2006) Transferable Turf Residue of Metconazole on Turf grass Supplement - Detailed Weather Data. Project Number: V/25718, 46805107, 200600461. Unpublished study prepared by Valent U.S.A. Corporation and Agriscope, LLC. 5 p. Stearns, J. (2006) Transferable Turf Residue of Metconazole on Turf grass Supplement - Detailed Weather Data. Project Number: V/27246, 46805108, 200600462. Unpublished study prepared by Valent U.S.A. Corporation and Agsearch. 5 p. Kureha Corporation (2007) Submission of Product Chemistry Data in 47095800 Support of the Application for Registration of Metconazole Fungicide Technical. Transmittal of 1 Study. Wustner, D. (2007) Metconazole Fungicide Technical (KNF-S0474m): Product Chemistry Group A - Composition, Materials, Process and 47095801 Formation of Impurities - Alternate Manufacturing Site. Project Number: V/PC/3, 200700037. Unpublished study prepared by Valent U.S.A. Corporation and BASF Aktiengesellschaft. 51 p. Total Rows: 173 24-Jul- 2006 24-Jul- 2006 13-Oct- 2006 13-Oct- 2006 13-Oct- 2006 02-Apr- 2007 02-Apr- 2007 44 ------- |