United States Environmental Protection Agency Office of Pesticides and Toxic Substances Office of Pesticide Programs (TS-766C) Washington. DC 20460 54Q/FS~91-118 PR # 91-110528 • 4>EPA Pesticide Fact Sheet Name of Chemical: Giiociadium virens 01-21 Reason for Issuance: Registration of New Biological Pesticide Date Issued: Fact Sheet Number: November 1990 217 1. Description Generic Name: Trade Names: EPA Shaughnessy Code: Year of Initial Registration: Pesticide Type: U.S. and Foreign ' Producers: Giiociadium virens GL-21 WRC-GL-21 and WRC-AP-1 128900-8 1990 Biofungicide W.R. Grace & Co. 7379 Route 32 Columbia, MD 21044 2. Use Patterns and Formulations Application sites: The manufacturing use product (MP) is for use only in the formulation of fungicides. The end-use product (EP) is for use in the control of damping-off diseases, particularly those caused by Pythium and Rhizoctonia, of greenhouse ornamental and food crops. Types of formulations: A liquid MP containing 20% active ingredient and a granular EP containing 12% active ingredient. Types and methods of application: The EP is blended with soil or soilless plant growing media at least 3 days prior to planting or incorporated into the media surface in plant beds prior to or at planting. Printed on Recycled Paper ------- -2- Application rate: The EP is applied at the rate of 1-1 1/4 ounces/cubic foot of media when blended or at the rate of 3/4 - 1 ounce/square foot of bed surface. 3. Science Findings Summary Science statement: The toxicological data which were submitted for this active ingredient included reports of an acute oral toxicity/ pathogenicity study, an acute pulmonary toxicity/pathogenicity study and an acute intravenous toxicity/pathogenicity study. The studies were performed using rats. All studies were classified as acceptable. The review of these studies indicates that the biofungicide is not toxic to, infective in, or pathogenic to rats by oral or pulmonary routes of exposure and not infective or pathogenic to rats by intravenous injection. Mycelium of the fungus was used for the injections and was found to be acutely toxic and lethal to test animals due to mechanical clogging of capillaries, however, these mortalities were not considered to be relevant in this case since injection is not a normal route of exposure and the product consists of chlamydospores rather than mycelium. Acute dermal toxicity testing was not required for this biofungicide based on the facts that the end-use product consists of large pellets, the label will require that gloves be worn when handling the product and application will be by soil incorporation. A primary eye irritation study was not required since protective eye covering must be worn. The inert materials in the product have been exempted from the requirement for a tolerance in §180.1001 and no indications of toxicity were reported in workers following 1-2 years of working with the organism. Although Gliocladium strains are known to produce certain toxins, data were submitted which showed that only one of the known toxins (gliotoxin) was produced in detectable amounts. Since gliotoxin is sensitive to oxidation, the levels that may exist in the product are not considered to be of toxicological significance since the toxin will be rapidly degraded. This conclusion is supported by the demonstrated lack of toxicity in the oral and pulmonary studies conducted on rats. Data requirements for evaluating adverse effects on birds, wild mammals, freshwater fish, freshwater aquatic ------- -3- requirement for tests on aquatic birds was waived because it is not expected that the fungus will enter the aquatic environment since its only use is as a seed treatment. Data requirements for evaluating adverse effects on freshwater fish and invertebrates, estuarine and marine organisms, nontarget plants and insects and honey bees were waived. The seed treatment use pattern makes it unlikely that Trichoderma would enter aquatic environments, contact nontarget plant species or that honey bees or other insects would be exposed to the organism. Because only minimal exposure, if any, to nontarget organisms may occur from the use of this biofungicide as a seed treatment, there is not expected to be a "may effect" situation with regard to endangered species. Data for environmental fate (Tier II) are not required for this biofungicide because no more than negligible environmental exposure associated with the seed treatment use is likely and the initial (Tier I) tests were waived or not required. Chemical Characteristics: Property MP and EP Color yellow-green Physical state powder Odor vinegar Density/bulk density fluffed - 28.8 Ibs/cu ft. packed - 43.6 Ibs/cu ft. pH 6.17 Storage stability 184 days at 20°C Viscosity N/A Miscibility N/A Corrosion characteristics N/A Toxicological Characteristics: Acute effects: Data were submitted for acute toxicity/ pathogenicity as determined in oral, pulmonary and intravenous tests. Data were classified acceptable. The tests indicated that the product was not toxic to, infective in or pathogenic to rats. Other toxicity information: Information was submitted which demonstrated that no human or animal pathogens were detected during the manufacturing process. Information was included on the history of the production process, a summary of sources of operator exposure and number of exposure hours for a typical ------- -4- employee. No hypersensitivity or other toxicological effects attributable to working with the organism were reported. Ecological Effects; Data on the ecological effects of the biofungicide were included only for an avian oral pathogenicity/toxicity study on bob white quail. The test organism was practically nontoxic to terrestrial avian species by ingestion. Data requirements for all other ecological effects testing were waived based on the nature of the fungus and the facts that it is unlikely that the organism will enter aquatic environments and minimal exposure would be likely due to the seed treatment use pattern. 4. Benefits The use of the end-use product will be beneficial in the control of damping-off and seed rot diseases of seedling plants which may be a source of economic loss by reducing the stand of plants in the field. The availability of a biological fungicide would provide a less toxic alternative to the currently registered chemical seed treatments. 5. Tolerance Assessment An exemption from the requirement for a tolerance for residues of Trichoderma harzianum Rifai Strain KRL-AG2 on beans, (green and dry), cabbage, corn (field and sweet), cotton, cucumbers, peanuts, potatoes, sorghum, soybeans, sugar beets, and tomatoes when used as a seed treatment in accordance with good agricultural practices was requested. Since testing of the biofungicide showed not evidence of effects which would be of toxicological concern, an exemption will t>e granted. 6. Summary of Major Data Gaps No data gaps exist for this active ingredient. Contact Person at EPA Susan T. Lewis Product Manager (21) Fungicide-Herbicide Branch Registration Division (H-7505C) Environmental Protection Agency 401 M St.", SW. 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 reregistration.. ------- ------- ;>EPA United States Environmental Protection Agency Office of Pesticide Program (H7504C) PMSD, Information Services Branch 401 M Street. SW Washington. DC 20460 First-Class Postage and Fees Paid EPA Permit No G-35 Official Business Penalty for Private Use S300 US EPA, REGION V LIBRARY 230 SOUTH DEARBORN STREET ROOM 1420 CHICAGO IL 60604 ------- |