United States
                  Environmental Protection
                  Agency	
                      Prevention, Pesticides
                      And Toxic Substances
                      (7508W)	
EPA-738-F-97-002
February 1997
                  R.E.D.   FACTS
     Pesticide
Reregistration
    Use Profile
Oil   of  Citronella
     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 3105, oil of citronella.

     Oil of citronella is  a biopesticide (biochemical) with a non-toxic mode
of action. It is registered as an insect repellent/feeding depressant and as an
animal repellent. Oil of citronella is the volatile oil obtained from the steam
distillation of freshly cut or partially dried grasses,  (Cymbopogon nardus
(Rendal) and Cymbopogon winterianus (Jowitt). Two varieties of citronella
oil exist commercially — "Ceylon type" (derived from C. nardus) and "Java
type" (derived from C. winterianus).
                      Formulation Types Registered:
                      Liquid-ready to use, impregnated material, pellated/tableted,
                      impregnated collar/tag.
                      Methods and Rates of Application:
                      Oil of citronella may be applied by hand-held sprayer, cloth wipe-on,
                      candles, cartridge, rub-on, scent-post application, sprinkle by hand,
                      and flea collar.

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                 Use practice limitations:
                      End-use products formulated from "Ceylon type" oil with use
                      directions for dermal applications:

                      "CAUTION: For external use only. Avoid contact with eyes.
                      Discontinue if irritation or rash appears. Prolonged or frequent
                      repeated skin contact may cause allergic reactions in some
                      individuals. Use on children under 6 months only with the
                      advice of a physician."

                      End-use products formulated from "Java type" oil containing
                      sunscreen ingredients with use directions for dermal
                      applications:

                      "CAUTION: For external use only. Avoid contact with eyes.
                      Discontinue if irritation or rash appears. Use on children under
                      months of age only with the advice of a physician.
                 The insect repellent, oil of citronella was initially registered in the
History   United States in 1948 as McKesson's® oil of citronella (EPA Reg. No. 385-
            32) for human applications (body, hair, clothing, and footwear while being
            worn) to repel gnats (adult) and mosquitoes (adult). Oil of citronella is a
            biochemical pesticide which has a non-toxic mode of action. It is registered
            as an insect repellent (feeding inhibitor) and as an animal repellent.

                 On February 28, 1996, the Agency issued a rule exempting certain
            pesticides, including oil of citronella, from regulation under FIFRA. In
            order to be eligible for this exemption (under FIFRA Section 25(b)), the oil
            of citronella products must meet all of the  criteria listed below:

            1.    The product must only contain inert  ingredients listed in the most
                 current List 4A. [This list is updated periodically and is publish in the
                 Federal Register. The most current list may be obtained by writing to
                 the Registration Support Branch (4A Inert List),  Registration Division
                 (7505C), Office of Pesticide Programs, Environmental Protection
                 Agency, 401 M St., SW, Washington, DC 20460].

            2.    The product must bear a label identifying the name and percentage
                 (by weight) of each active  ingredient and the name of each inert
                 ingredient.

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3.    The product must not bear claims either to control or mitigate
     microorganisms that pose a threat to human health, including but not
     limited to, disease transmitting bacteria or viruses, or claims to control
     insects, rodents carrying specific diseases, including, but not limited
     to, ticks that carry Lyme disease.

4.    The product must not include any false and misleading labeling
     statements, including those listed in 40 CFR 156.10 (a)(5)(i) through
     (viii).

     Citronella products that do not met the criteria listed above, must
comply with the provisions of reregi strati on set forth in this RED.

     During Phase 4 of Reregi strati on, the database for oil of citronella was
evaluated and determined to be inadequate in satisfying certain
requirements for biochemical pesticides. The following were identified as
outstanding data gaps and a DCI was issued in September 1992:

          Guideline No.              Study
Product Chemistry:
          151B-10      Product Identity
          151B-11     Manufacturing Process
          151B-12      Discussion of formation of unintentional
                   ingredients
          151B-13      Analysis of samples
          151B-15      Certification of limits
          151B-16      Analytical methods
          151B-17(a-p)   Physical/Chemical properties

     Mammalian Toxicity:
          152B-10      Acute oral toxicity
          152B-11      Acute dermal toxicity
          152B-12      Acute inhalation toxicity
          152B-13      Primary eye irritation
          152B-14      Primary dermal irritation
          152B-15      Dermal  sensitization
          152B-16      Hypersensitivity
          152B-17      Mutagenicity battery
          152B-18      Immunotoxicity
          152B-21      90-Day  dermal  - rat

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                                   152B-22      90-Day inhalation-rat
                                   152B-23      Teratogenicity
    Human Health
      Assessment
Toxicity
     In studies using laboratory animals, oil of citronella generally has
been shown to be of low acute toxicity. The acute oral toxicity for oil of
citronella derived from "Ceylon type" (LD50 > 5000 mg/kg) places it in
Toxicity Category IV, while the acute oral toxicity for oil of citronella
derived from  "Java type" (LD50 > 4380 mg/kg) is in Toxicity Category III.
The dermal toxicity for oil of citronella (LD50 > 2000mg/kg — both "Ceylon
type" and "Java type") is in Toxicity Category III. Acute inhalation (LC50 >
5000mg/kg - "Ceylon type" and LC50 > 3.1 mg/1 - "Java type") is in
Toxicity Category IV. Eye irritation ("Ceylon type" - irritation cleared in 72
hrs. and "Java type" - irritation cleared within 7 days or less) is in Toxicity
Category III. Dermal irritation is in Toxicity Category III (Refer to Section
III for additional  information). Oil  of citronella derived from "Ceylon type"
oil is a weak dermal sensitizer while citronella oil derived from "Java type"
is a non-sensitizer.
                        [NOTE: For acute oral, dietary, mammalian/avian/aquatic toxicity:
                                  Category I = very highly or highly toxic
                                  Category II = moderately toxic
                                  Category III = slightly toxic
                                  Category IV = practically non-toxic]
   Environmental        Based on a review of all available ecological data, exposure
      Assessment   information, and oil of citronella's non-toxic mode of action, the Agency
                        expects that the currently registered uses of oil of citronella will pose
                        minimal risk to nontarget wildlife and fish.

                             Environmental fate studies for biochemicals are not imposed unless
                        adverse effects are anticipated. The Agency will not, at this time, impose
                        any environmental fate data requirements for currently registered uses of oil
                        of citronella.
Product Labeling        The Agency has reexamined the toxicological data base for oil of
           ChanqeS   citronella and concluded that the current precautionary labeling for certain
          Red UJred   Pr°ducts must be upgraded. EPA is requiring that a revised Confidential
                        Statement of Formula (CSF) and specific product labeling pertaining to

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                 dermal sensitization and maintenance of effectiveness (efficacy) be
                 submitted for reregi strati on. Refer to Section V.
 Regulatory
Conclusion
   For More
Information
     The Agency has determine that, based on available data, the use of
currently registered products containing oil of citronella in accordance with
their approved labeling will not pose unreasonable risks or adverse effects
to humans or the environment.  Therefore, all currently registered uses of
these products are eligible for reregi strati on.
     Oil of citronella products will be reregistered once the required
revised Confidential Statements of Formula, and revised product labeling
pertaining to dermal sensitization and maintenance of effectiveness are
received and accepted by EPA.

     EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for oil of Citronella 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 oil of citronella 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  oil of citronella RED, or reregi strati on of individual products containing
oil of citronella, 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-

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free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.

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