United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-034
August 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Regulatory
History
Alkyl Imidazoline
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 before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
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 reregi strati on, EPA explains the basis
for its decision in a Reregi strati on Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 3010, Alkyl Imidazoline.
Alkyl imidazoline (l-(2-Hydroxyethyl)-2-alkyl*-2-imidazoline) is a
microbiocide/microbiostat used in fuel and oil storage tank bottom water. It
prevents the growth of slime-forming bacteria and fungi which might
interfere with the use and quality of oils and fuels in storage tanks.
Formulations include two soluble concentrate liquid products, one with
1.19% and the other with 25.0% active ingredient. Products are loaded and
applied through a closed delivery system that has a proportioning pump or
siphon-type feeder to meter the pesticide product directly from its container
into the fuel oil as it is pumped into storage tanks. Products are not
intended for homeowner use or for use in or around residences.
Products containing alkyl imidazoline were registered in the United
States in 1970. Currently, 2 products are registered for use as a
microbiocide in fuel oil.
Human Health Toxicity
AsS6SSm6nt In studies using laboratory animals, alkyl imidazoline generally has
been shown to be of mild acute toxicity via oral and dermal routes. It has
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been placed in Toxicity Category III (indicating the next to lowest degree of
acute toxicity) for these effects. However, alkyl imidazoline is highly
corrosive and a severe eye and skin irritant. It is placed in Toxicity
Category I (indicating the highest degree of acute toxicity) for these
effects.
The appropriate toxicological endpoint for assessing short-term or
intermediate-term occupational risk for alkyl imidazoline is maternal
toxicity. Developmental toxicity studies using rats showed decreased body
weight gain, decreased food consumption, and decreased food efficiency.
Dietary Exposure
Alkyl imidazoline has no registered food uses. Application is via a
closed delivery system in industrial sites only. No dietary exposure is
expected.
Occupational and Residential Exposure
Minimal occupational and no residential exposure are expected from
the current uses of alkyl imidazoline. These products are loaded and applied
through a closed delivery system that has a proportioning pump or siphon-
type feeder to meter the pesticide product directly from the product
container into the fuel oil as it is pumped into storage tanks. Products are
used in industrial sites and are not intended for homeowner use or for use in
or around residences.
Human Risk Assessment
No significant human health risk is expected from the use of alkyl
imidazoline. Based on the exposure assessment and the toxicological
endpoint of concern (developmental toxicity), the calculated risks to
handlers are well within the boundaries that the Agency considers
reasonable. Furthermore, post-application exposure to workers should be
minimal because of the dilution of the product in fuel oil bottom water and
precautions that are used to minimize exposure to fuel oil.
Environmental Environmental Fate
AsSGSSITIGnt EPA has not required environmental fate testing to support the
reregi strati on eligibility decision for alkyl imidazoline. Because of the
pesticides limited use pattern, only in fuel storage tanks, high dilution rate,
and use only in closed systems, alkyl imidazoline is expected to result in
minimal exposure to the environment when used according to directions on
the label. Also, alkyl imidazoline has chemical properties that suggest it will
remain in the organic phase (fuel/oil) of any mixture with water.
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Ecological Effects
Due to its indoor non-food use pattern, use only in closed systems,
high dilution rates, and the high probability that it will remain in the fuel
portion of any mixture with water, EPA expects minimal environmental
exposure and has not required extensive studies on the ecotoxicology of
these alkyl imidazoline products. However, the Agency is requiring acute
toxicity studies on birds, fish, and aquatic invertebrates. The Agency will
use these data to characterize alkyl imidazoline's acute toxicity to these non-
target species in case of accidents and to determine appropriate
environmental labeling for products.
Risk Mitigation
Ecological Effects Risk Assessment
EPA has not conducted an ecological risk assessment for alkyl
imidazoline because it is only used inside fuel storage tanks. Exposure to
the environment is expected to be negligible. If contaminated water is
pumped from tanks holding fuel treated with alkyl imidazoline, the
pesticide concentration in the water should be very low due to its high
dilution rate and its affinity to the organic (fuel) phase of the mixture.
Treated fuel must be disposed of in accordance with U.S. EPA's Resource
Conservation and Recovery Act (RCRA).
To lessen the human health risks posed by alkyl imidazoline, EPA is
requiring the following risk mitigation measures.
o Use of PPE, personal protective equipment; and
° Continued use of closed delivery systems (historically used).
No environmental risk mitigation measures are being imposed for
alkyl imidazoline because exposure to the environment is expected to be
negligible.
Additional Data
Required
The generic data base supporting the reregi strati on of alkyl
imidazoline has been reviewed and determined to be substantially complete.
The registrant must submit three acute ecotoxicity studies to characterize
alkyl imidazoline's toxicity to fish, birds, and aquatic invertebrates. This
information is required for labeling in case of an accident or misuse of the
pesticide product or technical material.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
Product Labeling All alkyl imidazoline end-use products must comply with EPA's
Changes Required current pesticide product labeling requirements and with the following. For
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a comprehensive list of labeling requirements, please see the Alkyl
Imidazoline RED document.
Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be
contained in an effluent discharged to the waters of the United States
or municipal sewer systems must bear the effluent discharge labeling
statements as described in PR Notice 93-10.
Labeling Requirements for End-Use Products
Handler (Mixer. Loader. Applicator) PPE
The Agency is imposing minimum personal protective
equipment (PPE), long-sleeve shirt, long pants, chemical-resistant
gloves, shoes, and socks for the application of the currently registered
alkyl imidazoline products and is not imposing post-application entry
restrictions. If the end-use product is classified as toxicity category I
or II for eye irritation potential, protective eyewear is also required.
The requirements are based on the absence of significant toxicological
concerns for alkyl imidazoline. However, the Agency may find that
imposing the use of more protective PPE and/or other restrictions
could be necessary upon the review of toxicity data for the end-use
products during product reregi strati on.
Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing alkyl imidazoline that are
intended primarily for industrial or occupational use.
"Do not apply this product in a way that will contact workers or other
persons. Only protected handlers may be in the area during
application."
Engineering Controls:
"Since handlers must use closed metering systems, the handler
requirements are reduced to long-sleeve shirt, long pants, chemical-
resistant gloves, shoes, and socks."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
there are no such instructions for washables, use detergent and hot
water. Keep and wash PPE separately from other laundry."
User Safety Recommendations:
"Users should remove clothing immediately if pesticide gets inside.
Users should wash thoroughly and put on clean clothing."
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Regulatory
Conclusion
For More
Information
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Application Method Timing and Equipment:
"The registrant must state when the preservative is added. For
example: ' Alkyl imidazoline products are loaded and applied through
a closed delivery system that has a proportioning pump or siphon-type
feeder to meter the pesticide product directly from the container into
the fuel oil as it is pumped into storage tanks'."
Effluent Discharge Labeling Statements:
Refer to Labeling Requirements for Manufacturing-Use Products
above for labeling requirements for effluent discharge.
The use of currently registered products containing alkyl imidazoline
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregi strati on.
Alkyl imidazoline products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for alkyl imidazoline 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 Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using FTP on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.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 Alkyl Imidazoline RED document
also will be available from the National Technical Information Service
(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
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For more information about EPA's pesticide reregi strati on program,
the Alkyl Imidazoline RED, or reregi strati on of individual products
containing alkyl imidazoline, please contact the Special Review and
Reregi strati on 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 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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