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
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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
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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
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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..
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;>EPA
United States
Environmental Protection Agency
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