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

-------
                     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.

-------
                        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

-------
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."

-------
 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.

-------
     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.

-------