United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-029
September 1994
R.E.D. FACTS
Piperalin
Pesticide
Registration
Use Profile
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3114, piperalin.
Piperalin is a fungicide used to control powdery mildew on
ornamental plants, shrubs, vines and trees grown in commercial green
houses. It is formulated as a soluble concentrate/liquid, and is applied as a
foliar spray using a high-volume high-pressure sprayer. Use practice
limitations include a recommendation to use with three specific surfactants,
and prohibitions against entering treated areas without personal protective
equipment (PPE) for 12 hours, applying the pesticide through any type of
irrigation system, applying directly to water or wetlands, and contaminating
water, food or feed.
Regulatory Piperalin was first registered as a pesticide in the U.S. in 1964.
History Currently, only one product is registered which contains this active
ingredient. The product contains 84.4% piperalin and is used only to
control powdery mildew on ornamentals grown in commercial greenhouses.
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Human Health
Assessment
Environmental
Assessment
Toxicity
In studies using laboratory animals, piperalin generally has been
shown to be of relatively low acute toxicity. It causes only slight dermal
toxicity and has been placed in Toxicity Category IV (indicating the lowest
degree of acute toxicity) for this effect. It also is not a skin sensitizer.
Piperalin is slightly toxic through the oral and inhalation routes, causes mild
eye irritation, and causes moderate to severe skin irritation; it has been
placed in Toxicity Category III for each of these effects.
Piperalin caused no systemic toxicity in a subchronic dermal toxicity
study using rabbits. In a developmental toxicity study using rats, piperalin
caused excessive salivation, soiled fur, decreased body weight and decreased
food consumption in the mothers. The lowest observed effect level (LOEL)
was the highest dose tested, based on decreased fetal body weight. A third
mutagenicity test is required to confirm the Agency's finding so far that
piperalin is not mutagenic.
Dietary Exposure
Piperalin has no registered food uses, so dietary exposure is not a
concern.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to piperalin
during and after application in greenhouses. However, piperalin is of
sufficiently low toxicity that an exposure assessment was not conducted.
Human Risk Assessment
Piperalin has no registered food uses so no dietary risks are posed.
Even though applicators can be exposed to significant amounts of piperalin,
this pesticide poses little toxicity concern. Workers' exposure will be
minimized through product labeling requirements.
Environmental Fate
Piperalin hydrolyzes very rapidly at pH 9 forming two degradates,
DCBA or dichlorobenzoic acid and 3-(2-methylpiperidino)propyl alcohol.
Microbially-mediated and chemical hydrolysis are the most significant
degradative processes. In soil metabolism studies, the parent compound
decreased over time while the two degradates increased.
Piperalin is immobile in several types of soil. However, additional
information is needed to confirm the identity and determine the leaching
potential of piperalin's degradates.
Ecological Effects
While additional studies are needed to determine its acute toxicity to
birds, piperalin is practically nontoxic to birds on a subacute dietary basis.
Because piperalin is only used indoors (inside greenhouses), avian
reproduction studies are not required. Piperalin is highly toxic to fish and
moderately toxic to aquatic invertebrates.
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Additional Data
Required
Product Labeling
Changes Required
Ecological Effects Risk Assessment
Piperalin is practically nontoxic to birds, highly toxic to fish, and
moderately toxic to aquatic invertebrates. However, birds and mammals
will not be significantly exposed to piperalin through consumption of insect
and plant food containing residues of this pesticide. Exposure to fish and
aquatic invertebrates also is not expected to occur since piperalin is used
only inside greenhouses, and since labeling prohibits use practices that
would contaminate water. No significant risks to birds, fish or aquatic
invertebrates are expected. Similarly, no significant risks to endangered
species are expected from the use of piperalin.
EPA is requiring the following additional generic data for piperalin to
confirm its regulatory assessments and conclusions: an additional
mutagenicity study, data confirming the identity of the major degradates,
studies to determine the leaching potential of the two major hydrolytic
degradates.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, a revised Confidential Statement of
Formula (CSF) and revised labeling for reregistration.
The registered piperalin end-use product must comply with EPA's
current pesticide product labeling requirements, and with the following:
Personal Protective Equipment (PPE) for Mixers/Loaders/ Applicators
There are no special toxicological concerns that warrant the
establishment of active-ingredient-based PPE requirements for pesticide
handlers.
Early Entry PPE
Since piperalin is of relatively low acute toxicity and the Agency has
no special concerns about other adverse effects, the PPE required for early
entry is coveralls, chemical-resistant gloves, shoes, and socks.
Restricted Entry Interval (REI)
The interim REI established for piperalin under the Worker Protection
Standard (WPS) was 24 hours because data at that time indicated that
piperalin was in Toxicity Category II for skin irritation potential. In
reviewing the data, EPA determined that piperalin should be in Toxicity
Category III for skin irritation potential. Therefore, piperalin must have
only a 12-hour REI.
Environmental Hazard Labeling Statement
The following statement is required on end-use product labeling:
"This product is toxic to fish. 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 washwaters."
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Regulatory
Conclusion
For More
Information
Use of the currently registered product containing piperalin in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of the
product are eligible for reregistration.
This product will be reregistered once the required product-specific
data, revised Confidential Statement of Formula and revised labeling are
received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for piperalin during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224, and also can be reached on the Internet via
FEDWORLD.GOVand EPA's gopher server, EARTH1.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the piperalin RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the piperalin RED, or reregistration of individual products containing
piperalin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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