United State* Office of Pesticides and Toxic Substances Environmental Protection Office of Pestiade Programs (TS-766C) Agency Washington, DC 20460 &EPA Pesticide Fact Sheet Name of Chemical: PSEUDOMONAS FLUORESCENS EG-1053 Reason for Issuance: New chemical Date Issued: 3/3/88 FacTSheet Number: 160 1. Description of Chemical Generic Name: Pseudomonas fluorescens EC-1053 Trade Name: DAGGER™ EPA Shaughnessy Code: 064188 Year of Initial Registration 1988 Pesticide Type: Biofungicide U.S. and Foreign Producers: Ecogen Inc. 2005 Cabot Boulevard West Langhorne, PA 19047-1810 2. Use Patterns and Formulations; Application Sites: Pseudomonas fluorescens is proposed for use on cotton for control of Pythium/Rhizoctonia. Types of formulations: 20% Granular End-Use Product Types and methods application: End-use product is applied in the furrow at planting time with use of a granular pesticide applicator. Application rates: The proposed application rate is 15 pounds per acre. Usual carrier: Water ------- —2— 3. Science Findings Sunm ry Science Statement : The biofungicide was not toxic to test animels when administered via the oral, derrnal, or pulmonary routes. The active ingredient, P. fluorescens was not infective or pathogenic for test animels when administered via the oral, puirronary, or intravenous routes. Dagger tm G biofungicide did not elicit a delayed type hypersensitivity reaction in guinea pigs. The formulated product was mildly irritating to the eye. All toxicology studies were considered acceptable. Avian testing on the active ingredient, P. fluorescens , by both the oral and injection route showed no adverse effects at levels of 6.9 x i0 6 and 4.6 x 106 colony forming units per bird. The Agency believes that there will not be any adverse effects to avian species through the use of Dagger tm on cotton. Likewise, injection studies using mice show no pathogenic or toxic signs attributable to P. fluorescens . Therefore, the Agency believes that use of this product will not cause adverse effects to feral mamn ls. The n jor concern in aquatic systems is fish. P. fluorescens has been associated with disease in fish. The Agency is not aware of disease occurrences with Pseudononas in aquatic invertebrates. Because no acceptable fish studies have been submitted, the Agency cannot complete an aquatic risk assessment at this time. Testing on nontarget plants showed that, in rrost cases, the active ingredient in Dagger tm caused an increase in growth after germination. The exceptions were cabbage, which showed a significant decrease in seedling height, and lettuce, which showed a significant decrease in fresh weight at the end of four weeks. No phytotoxic effects were seen in any of the species tested. The data taken as a whole indicate that Dagger tm should not pose a threat to nost plants. The Agency does not feel that there will be a “mey effect” situation for endangered terrestrial wildlife, ------- —3— insects or plants through the use of Dagger tm on cotton. A final determination of “may affect” can be made for endangered fish when the Agency receives a pathogenicity study for fish. Chemical Characteristics Color: Light tan (MUP) Charcoal grey (EP) Physical State: Aqueous cell suspension (NIUP) Granular solid (EP) ()ior: Slight musty (MUP) Earthy—like (EP) Density/specific gravity: 1.01 at 20 C (t4UP) f1: 6.9—7.1 Stability: Stable for 77 days in distilled water ( 6.6) (rlrJP) Storage stability: Loses 60—71% of viability within 1 month at 40—50 F and 1000—fold loss within 5 months Thxicology Characteristics Acute effects Acute oral toxicity/pathogenicity (rat): P. fluorescens was not toxic to, or infective in, or pathogenic to rats when administered orally in a single dose at 5 x i08 colony forming units (CPU) per anim3l Dagger tm G biofungicide is not toxic to, or infective in, or pathogenic for rats when administered at 2 x RJ/anioal in a single oral dose. Acute intravenous toxicity/pati-ogenicity (mouse): P. fluorescens was not toxic to, or infective in, or pathogenic for mice when administered at 5 x 106 CR3/animal by the intravenous route. Acute pulmonary toxicity/pathogenicity(rat): P. fluorescens was not toxic to, or infective in, or pathogenic for rats when administered to rats at 1.5 x 108 CR3/animal via the pulmonary route. Dagger tm G biofungicide was not toxic to, or infective in, or pathogenic for rats when administered at 5 x 10 7 /animal via the pulmonary route. Acute dermal toxicity (rabbit): P. fluorescens was not toxic to rabbits when applied to the skin at 2.8 x 108 CFU/anirral. The bacterium ------- —4— also was not a skin irritant. Dagger tm G biofungicide was not toxic to rabbits when applied at the skin at a dose level of 1 gram/animal. The test substance also was not a skin irritant. Primary eye irritation (rabbit): Dagger G biofungicide is a mild eye irritant when applied to the eye of rabbits at 0.1 g/eye. Irritation signs observed were slight to n derate redness, and slight cheriDsis and discharge associated with the con junctivae. Hypersensitivity study (guinea pig): Dagger tm G biofungicide is not a skin sensitizer in guinea pigs. Ecological Characteristics Avian Injection PatFogenicity test (Mallard Duck): The administration of TGAI PseudorTonas strain 1053 at a dose of 10,000 mg/Kg by intraperitoneal injection showed no apparent pathogenicity or effect on the s ±vival of young mallards. Avian Acute Oral LD 50 Pathogenicity test (Mallard Duck): The administration of AI—Pseudononas Strain 1053 (Washed) at a dose of 15,000 mg/Kg showed no pathogenicity or effect on survival of young mallards. 4. Benefits Dagger G, a dry granular formulation is applied at planting time for controlling cotton seedling disease. 5. Tolerance Assessment Pseudononas fluorescens is exempt from the requirement of a tolerance in or on the raw agricultural comrrodities cottonseed and cotton forage. ------- —5— 6. Summery of Major Data Gaps Data required for conditional registration: Tine Generally Allowed for Guideline Nunber Study Response to Data Request Ecological Effects 154—20 Toxicity/Pathogenicity 9 n nths to Freshwater Aquatic Invertebrates 154—19 Freshwater fish testing 9 nonths 121—1 Target Area Phytotoxicity 9 onths Tests (2) [ The previously submitted tests mey be upgraded to core if the percent active ingredient is reported and the test microorganism is confirmed as the same one registered.] 122—1 Seedling Germination/Vegetative 9 ntnths Vigor — Tier I. [ The previously submitted test mey be upgraded to core if the microorganism under test is confirmed as the same as the one registered]. 123—1 Seed Germination/Seedling 9 rronths Emergence - Contact Person at EPA Lois A. Rossi Product Manager (21) Registration Division (TS—767C) Ehvironmental Protection Agency 401 M Street SW. Washington, D.C. 20460 DISCLAIMER: The informetion presented in this Pesticide Fact Sheet is for infornational purposes only and nay not be used to fulfill data requirements for pesticide registration and reregistration. ------- |