UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case Oil of citronella
which includes the active ingredient Oil of citronella. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of these chemicals, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregi strati on. The RED includes the data and labeling requirements for products for
reregi strati on. It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the date of
this letter. Complete and timely responses will avoid the Agency taking the enforcement action
of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the reregi strati on representative for the Biopesticides and Pollution
Prevention Division, Richard King at (703) 308-8052.
Sincerely yours,
Janet Andersen, Director
Biopesticide and Pollution
Prevention Division (7501W)
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90
days of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National
Technical Information Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
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You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If
you choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
OilofCitronella
LISTC
CASE 3105
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
BIOPESTICIDES AND POLLUTION
PREVENTION DIVISION
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TABLE OF CONTENTS
OIL OF CITRONELLA REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Mammalian Toxicity 7
b. Mutagenicity 9
c. Subchronic Toxicity 10
d. Immunotoxicty, Developmental Toxicity, and 90-Day Dermal
Toxicity, and 90-Day Inhalation Toxicity
10
2. Exposure Assessment 10
a. Occupational and Residential 10
C. Environmental Assessment 11
1. Ecological Toxicity Data 11
2. Environmental Fate 12
D. Product Performance (Efficacy) Assessment 12
E. Other Considerations
12
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 13
A. Determination of Eligibility 13
B. Determination of Eligibility Decision 13
1. Eligibility Decision 13
2. Eligible and Ineligible Uses 14
C. Regulatory Position 14
1. Tolerance Reassessment 14
2. Labeling Rationale 14
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3. Product Performance (Efficacy) Reassessment 15
V. ACTIONS REQUIRED OF REGISTRANTS 15
A. Manufacturing-Use Products 15
1. Additional Generic Data Requirements 15
2. Labeling Requirements for Manufacturing-Use Products 15
B. End-Use Products 16
1. Additional Product-Specific Data Requirements 16
2. Labeling Requirements for End-Use Products 16
C. Existing Stocks 17
VI. APPENDICES 19
APPENDIX A. Table of Use Patterns Subject to Reregistration 20
APPENDIX B. Table of the Generic Data Requirements andStudies Used to
Make the Reregistration Decision 26
APPENDIX C.Citations Considered to be Part of the Data Base Supporting tfi
Reregistration of Oil of Citronella 31
APPENDIX D. List of Available Related Documents 54
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OIL OF CITRONELLA REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Steve Jarboe
Biopesticides and Pollution Prevention Division
Frank W. Ellis, Jr.
Philip Hutton
Richard King
J. Thomas McClintock
Sheryl Reilly
William Schneider
Roy Sjoblad
John Tice
Freshteh Toghrol
Robert Torla
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Page Intentionally Blank
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Mg/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks associated with the pesticidal uses oil of citronella.
Oil of citronella is a biopesticide (biochemical) with a non-toxic mode of action. It is
registered as an animal repellent and as an insect repellent/feeding depressant. 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 the
citronella oil exist commercially — "Ceylon type" (derived from C. nardus) and "Java type"
derived from C. winterianus).
This reregi strati on eligibility document includes a comprehensive reassessment of the
required data for all of the use patterns of currently registered products containing oil of
citronella, which do not meet the exemption criteria listed below.
On February 28, 1996 the Agency issued a rule under the provisions of FIFRA Section
25(b) exempting certain pesticides, including oil of citronella, from regulation. In order to be
exempt from regulation, products containing oil of citronella must meet the following criteria:
1. Products must contain only inert ingredients listed in the most current List 4A.
[The most current List 4A may be obtained by writing to Registration Support
Branch (4A Inert List), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M Street SW, Washington, DC
20460].
2. Products must bear labeling identifying the name and percentage (by weight) of
each active ingredient and the name of each inert ingredient.
3. Products must not bear label claims either to control or mitigate microorganisms
that pose a threat to human health, including but not limited to disease transmitting
bacteria or virus, or claims to control insects or rodents carrying specific diseases,
including but not limited to ticks that carry Lyme disease.
4. Products must not include any false and misleading labeling statements, including
those listed in 40 CFR 156.10(a)(5)(i) through (viii).
A number of currently registered oil of citronella products do not qualify for the 25(b)
exemption, because they contain inert ingredients which are not on the List 4A (refer to #1
above). Therefore, the Agency is issuing a reregi strati on decision for oil of citronella.
Before reregistering the products containing oil of citronella (i.e., those which do not meet
the criteria stipulated in the exemption above), the Agency is requiring that a revised Confidential
v
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Statement of Formula (CSF) and revised product labeling statements relating to dermal
sensitization and product performance (maintenance of efficacy) be submitted within eight
months of the issuance of this document. After reviewing this information and finding it
acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product.
Those products that contain oil of citronella in combination with other active ingredients will be
eligible for reregi strati on only when the other active ingredient(s) are determined eligible for
reregi strati on.
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregi strati on process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of oil of citronella. The document consists of six sections. Section I is the
introduction. Section II describes oil of citronella, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for oil of citronella.
Section V discusses the reregistration requirements for oil of citronella. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details concerning
the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregi strati on Eligibility
Decision:
• Common Name: Oil of citronella "Ceylon type", and oil of citronella "Java
type".
• Chemical Name: Oil of citronella — An essential oil made up of more than 80
compounds of closely related terpenic hydrocarbons,
alcohols, and aldehydes.
• CAS Registry Number: 8000-29-1
• OPP Chemical Code: 021901
• Basic Manufacturers:
American Candle Company Inc. Bug Master Products
Candle Corp. of America Cardinal Laboratories Inc.
Empire Manufacturing Co. Farnam Companies
Fiebing Chemical Company Flintlock Ltd
General Wax & Candle Co. Kameyama U.S.A., Inc.
L.R. Wilson Enterprises Lamplight Farms Inc.
Natural Research People Inc. PJ. Maxwell Co. Inc.
Perycut-Chemie AG Plantabbs Corp.
Primavera Laboratories Inc. Quantum Inc.
S.C. Johnson & Sons Inc. Tender Corporation
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of oil of citronella is in
Appendix A.
For oil of citronella
Type of Pesticide: Biochemical — insect and animal repellent
Use Sites: Indoor nonfood: Animal treatment — horse-show/race/special,
ponies.
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Indoor residential: Human body/clothing while being worn
(insect control); skin contact treatment; animal treatment (flea
collar).
Outdoor residential: Household/domestic dwellings outdoor
premise use.
Terrestrial non-food + outdoor residential: Ornamental and/or
shade trees: ornamental herbaceous plants; ornamental woody
shrubs and vines.
Target Pests: biting midges, biting flies, black flies, bugs, cats, deer flies,
deer ticks, dogs, face flies, fleas, flies, flying insects, gnats,
horn flies, horse flies, house flies, insects, mosquitoes, "no-
see-ums", stable flies.
Formulation Types Registered: Liquid-ready to use, impregnated material,
pelleted/tableted, impregnated collar/tag.
Method and Rates of Application:
Types of treatment: Hand-held sprayer, cloth wipe-on, candle, cartridge,
rub-on, scent-post application, sprinkle by hand, flea
collar.
Method and Rate - Refer to Appendix A.
Timing - As needed.
Use Practice Limitations: None
C. Estimated Usage of Pesticide
This section summarizes the amounts of citronella estimated for the
pesticide uses of oil of citronella. These estimates are derived from a variety of
published and proprietary sources available to the Agency. The data, reported on
an aggregate and site basis, reflect annual fluctuations in use patterns as well as
the variability in using data from various information sources.
Based on pesticide survey usage information for the years 1991 through
1992, annual citronella domestic usage ranged approximately from 33,000 to
48,000 pounds active ingredient (a.i.) for four sites (domestic dwelling;
ornamentals and dumps; human face, skin, and clothing; and manufacturing). Oil
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of citronella is an insect repellent with its largest markets, in terms of total pounds
active ingredient, allocated to human face, skin, and clothing (56% to 74%);
domestic dwelling [outdoor] (22% to 41%); and ornamentals and dumps (1.5% to
2.0%). The balance is for manufacturing use.
TABLE I: Oil of citronella usage analysis
Site
Domestic dwelling
(outdoor)
Ornamentals and
dumps
Human face, skin,
and clothing
Manufacturing use
Total
Annual Amount (Ibs. ai)
7,084- 19,690
676 - 744
24,500 - 27,500
350 - 400
33,000 - 48,000
Product formulation
Insect repellent
candles
Twist-ons and pellets
Insect repellent sprays and
lotions
oil of citronella
All of the above
D. Data Requirements
In Phase 4 of the Reregi strati on process, data gaps for oil of citronella were
identified and a DCI was issued in September, 1992 for studies on product chemistry and
mammalian toxicity. These data were required to support the currently registered uses of
oil of citronella. Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregi strati on.
E. Regulatory History
The insect repellent, oil of citronella was initially registered in the 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.
Product performance guidelines (efficacy standards) for pesticides used as insect
repellents were first published in the Pesticide Assessment Guidelines, Subdivision G,
Product Performance in October 1982. The Guidelines required efficacy testing for all
pesticides that were used to control microbes or other pests that impact public health. For
mosquito repellents, these guidelines state, products "must generally provide a minimum
of 2 -3 hours protection time based upon first confirmed bite field tests, depending upon
biting pressure evidenced in the testing. If the product provides longer protection times,
then this may be stated on the label." For ticks, fleas and mites, the products must provide
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100% control of the pest infestation through a killing or repelling action when tested
under simulated or actual conditions. Or, the product must provide the protection time (in
hours) which is justified by the supporting data and appears on the label. For ticks, fleas
and mosquitoes, the minimum acceptable protection time is one hour, when using first
confirmed bite methodology, or sock testing.
After these standards were published in 1982, the Agency became aware of
medical incidents implicating other active ingredients (e.g., DEBT). In an effort to
encourage the registration of other less toxic active ingredients for repelling insects, the
Agency relaxed the 2-3 hour standard. Because citronella products protected humans from
mosquito, tick and flee bites for at least one hour, and they provided a relatively non-toxic
alternative, the Agency adopted one hour as a new standard. In the interest of public
safety, the Agency will only consider products eligible for registration if they are
efficacious for at least one hour and the user is provided instructions on how to maintain
effective protection.
On February 28, 1996, the Agency issued a rule exempting certain pesticide active
ingredients, 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 active ingredients listed in the FIFRA 25(b)
Exemption.
2. 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].
3. The product must bear a label identifying the name and percentage (by
weight) of each active ingredient and the name of each inert ingredient.
4. 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.
5. The product must not include any false and misleading labeling statements,
including those listed in 40 CFR 156.10 (a)(5)(i) through (viii).
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Citronella products that do not meet the criteria listed above, must comply with the
provisions of reregi strati on set forth in this RED.
During Phase 4 of Reregistration, the database for oil of citronella was evaluated
and determined to be inadequate in satisfying certain requirements for biochemical
pesticides, which include certain insect and animal repellents. The following were
identified as outstanding data gaps and a DCI was issued in September 1992:
Product Chemistry:
Guideline No.
151B-10
151B-11
151B-12
151B-13
151B-15
151B-16
151B-17(a-p)
Mammalian Toxicitv:
152B-10
152B-11
152B-12
152B-13
152B-14
152B-15
152B-16
152B-17
152B-18
152B-21
152B-22
152B-23
Product Identity
Manufacturing Process
Discussion of formation of
unintentional ingredients
Analysis of samples
Certification of limits
Analytical methods
Physical/Chemical properties
Acute oral toxicity
Acute dermal toxicity
Acute inhalation toxicity
Primary eye irritation
Primary dermal irritation
Dermal sensitization
Hypersensitivity
Mutagenicity battery
Immunotoxicity
90-Day dermal - rat
90-Day inhalation -rat
Teratogenicity
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Oil of citronella is obtained from the steam distillation of the freshly cut or
partially dried cultivated grasses, C. nardus and C. winterianus. Oil of citronella is an
essential oil made up of more than 80 compounds of closely related terpenic
hydrocarbons, alcohols, and aldehydes. Two varieties of citronella oil exist commercially
— "Ceylon type" (extracted from C. nardus) and "Java type" (extracted from C.
winterianus). The "Java type oil" is produced in larger quantities and is characterized by
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containing higher concentrations of (the aldehyde) citronellal than the "Ceylon type oil".
"Java type oil" contains not less than 35% citronellal versus 7-15% citronellal for the
"Ceylon type oil". However, based on available product chemistry data, the Agency has
concluded that oil of citronella is a single substance and that "Java oil" and the "Ceylon
oil" are "substantially similar" compounds. The product chemistry data base for oil of
citronella is adequate and satisfies the requirements set forth in 40 CFR 158.690 —
Biochemical Pest Control Agents (Table II: MRID 41785703)
TABLE II: Physical and chemical characteristics for oil of citronella (technical
Guideline No. 151B-17
Color
Physical state
Odor
Melting point
Boiling point
Density
Solubility
Vapor pressure
(Major components)
Flammability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
Octanol/Water Partition
Coefficient
Characteristic/ Description
Light yellow/yellowish brown
Liquid
Sweet-floral/grassy /camphoraceous
Not applicable
170°C
0.891 -0.901 r@25°Cl
Very soluble in water 20 °C
Camphene 3.0/Limonene 1.4/Geraniol 0.02
Citronellal 0.23/Citronellol 0.015
Flashpoint 170°C (TCC)
Stable under normal conditions
Not known
Not to be diluted w/petroleum solvents
Non-corrosive
Very large, because of high solubility in octanol
B. Human Health Assessment
1. Toxicology Assessment
Adequate mammalian toxicology data on oil of citronella are available and
will support a RED.
a. Mammalian Toxicity
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Certain mammalian toxicity studies conducted with oil of citronella
have been submitted to the Agency and adequately satisfy the requirements
as set forth in 40 CFR 158.690 -- Biochemical Pest Control Agents. (See
Table III).
TABLE III: Acute mammalian toxicity requirements for oil of
citronella as technical grade active ingredient
Guideline
1 52B-1 0 Acute oral tox.(rat)
1 52B-1 1 Acute dermal tox.
(rabbit)
152B-12 Acute inhalation (rat)
152B-13 Primary eye irritation
(rabbit)
152B-14 Primary dermal irritation
(rabbit)
152B-15 Dermal sensitization
(Guinea Pig)
152B-16 Hypersensitivity
Test Material
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
Citronella oil
100% (Ceylon)
Citronella oil
1 00% (Java)
All products
Results
LD 50 > 5000mg/kg
LD 50 > 4380mg/kg
LD 50 > 2000mg/kg
LD 50 > 2000mg/kg
LC 50 > 5000 mg/kg
4 hr. exposure
LC 50 > 3.1 mg/l
Irritation cleared in 72
hours
Irritation cleared
within 7 days or less
Irritation present at 21
days
All irritation resolved
by 48 hrs. Citronella
mild irritant.
Sensitizer
(BuehlerTest)
Non-sensitizer
(BuehlerTest)
All incidents must be
reported to the Agency
Toxicity
Category
IV
III
III
III
IV
IV
III
III
II
III
Not applicable
Not applicable
MRIDNo.
41 747402
43179401
41 747403
43167101
41 747404
43167102
41 747405
43167103
41 747406
43167104
41 747407
43167105
In the evaluation of the toxicity data base for the reregi strati on
eligibility decision for oil of citronella, the primary dermal irritation study
(MRID 41747406) was re-evaluated. If solely based on the criterion of
mild to slight irritation at 72 hours, the technical oil of citronella would be
Toxicity Category IV. However, very slight to well defined erythema (and
slight edema) persisted in one test animal (rabbit) until study termination,
hence the Toxicity Category II designation.
-------
The Agency has concluded that an overall Toxicity Category III
designation with attendant labeling precautions for skin irritation for all
products containing oil of citronella may be more appropriate than a
Toxicity Category II designation, as suggested by the results of the acute
battery conducted with the "Ceylon type" oil. This decision is based on the
following factors: in the dermal irritation test conducted with "Ceylon
type" oil, very slight to well defined erythema was noted until test
termination (i.e., well defined erythema in one animal, while very slight
erythema was noted in the other five test animals); in the dermal irritation
study conducted with "Java type" oil, there was no irritation present in the
six test animals at the 48 hours or 72 hours scoring points; and the results
of the primary eye irritation studies conducted with both "Ceylon type" oil
and "Java type" oil are similar (Toxicity Category III - all irritation cleared
within 7 days).
The dermal sensitization studies conducted with "Ceylon type" oil
(MRID 41747407) and "Java type" oil (MRID 43167105) were re-
evaluated as part of the RED. The "Ceylon type" oil was determined to be
a sensitizer while the "Java type" oil was determined to be a non-sensitizer
. Therefore, the Agency is requiring additional precautionary label
language about dermal sensitization for end-use products formulated from
"Ceylon type" oil. Refer to Section V for further information. However, it
should be noted that this additional precautionary label language regarding
dermal sensitization does not preclude the precautionary label language
about irritations and rashes required by FDA for certain sunscreen products
that are formulated from either "Java type" oil, or "Ceylon type" oil.
b. Mutagenicity
Oil of citronella was tested in a Salmonella/Mammalian Microsome
Reverse Mutation Assay with a confirmatory assay (with and without S9
activation, MRID 417585701) was negative for inducing reverse gene
mutation in various Salmonella test strains up to cytotoxic levels (1000
//g/plate/-S9 ; 3300 //g/plate/+S9).
An in vitro cytogenicity assay measuring chromosomal aberration
frequencies in Chinese hamster ovary (CHO) cells (MRID 41785702) was
conducted with oil of citronella. Test results were negative up to cytotoxic
levels (75.5 //g/ml/-S9 ; 150 //g/ml/+S9).
An unscheduled DNA synthesis (UDS) study in rat hepatocytes
(MRID 41747408) conducted with oil of citronella was negative for
-------
increasing nuclear labeling (a measure of UDS) at moderate levels of
cytotoxicity (30-50 //g/ml).
c. Subchronic Toxicity
The Agency has waived the requirement for a subchronic oral
toxicity based on the lack of adverse effects observed in the acute oral
toxicity study (MRID 41747402), and the currently registered non-food
uses of oil of citronella.
d. Immunotoxicty, Developmental Toxicity, and 90-Day Dermal
Toxicity, and 90-Day Inhalation Toxicity
The immunotoxicity (152B-18), 90-Day dermal toxicity (152B-21),
and developmental toxicity 152B-23) guideline requirements for oil of
citronella have been waived based on: (1) the submitted acute mammalian
toxicology studies (MRIDs 41747402, 41747403, and 41747404), which
show no significant adverse effects (Toxicity Categories III & IV) for
various routes of exposure (i.e., oral, dermal, and inhalation); (2) negative
results observed in the battery of mutagenicity studies (MRIDs 41785701,
41785702, and 417474408); (3) the current GRAS status of oil of
citronella (21 CFR 182.2, 182.6, and 172.515); (4) no reports of
hypersensitivity (FIFRA Section 6(a)(2)) of adverse effects following oral
and dermal exposure; and (5) the rationales used to develop and support
an exemption under Section 25(b).
The Agency has waived the requirements for 90-day inhalation
toxicity based on the lack of significant adverse effects observed in the
acute inhalation study (MRID 41747404), and long term use with no
adverse effects reported.
2. Exposure Assessment
a. Occupational and Residential
Based on the application methods listed in the use directions on
labels of currently registered oil of citronella products, the potential for
oral, eye, dermal and inhalation exposure exists. However, the lack of
significant acute mammalian toxicity does not trigger additional
requirements for evaluation of exposure over that mitigated by the
precautionary labeling statements currently proposed for certain products
formulated from oil of citronella (refer to Section V).
10
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c.
Environmental Assessment
There are no outstanding data requirements. The available data is sufficient for the
Agency to make an assessment of the environmental effects for the currently registered
uses of oil of citronella.
1. Ecological Toxicity Data
All of the ecological effects data requirements have been
adequately addressed. The candle, lotion, and indoor spray formulations
of citronella pose minimal or nonexistent exposure situations for avian,
aquatic, and nontarget species. While the ornamental and dump uses pose
the greatest potential for exposure, these uses represent only two percent
of the total use of oil of citronella. These data (Table IV), in light of the
use patterns and estimated usage, indicate that adverse effects in avian,
aquatic, or insect species are not likely.
Table IV: Environmental Expression - Tier I Guideline Requirements for
oil of citronella
Guideline
No.
154B-6
154B-7
154B-8
154B-9
154B-10
154B-11
Study
Avian acute oral
(bobwhite quail)
Avian subacute
dietary
Fish toxicity
(rainbow trout)
Invertebrate toxicity
(Daphnia magna )
Nontarget plants
Nontarget insects
Results
LC50 > 2,250 mg/kg; practically non-toxic;
NOEL= 1,350 mg/kg
Waived because of low avian acute toxicity (MRID
41747409) and no mortality observed at upper test
limits.
LC50 > 17.3 mg/L (based on nominal
concentration); slightly toxic.
Minimal exposure to aquatic sources. Study will
adequately fulfill data requirements for currently
registered uses.
EC50 > 26.4 mg/L (based on nominal
concentration); slightly toxic.
Minimal exposure to aquatic invertebrate species.
Study will adequately fulfill data requirements for
currently registered uses.
Waived because exposure to nontarget plants will
be minimal.
Waived because exposure to nontarget insects will
be minimal. Additionally, any exposure to
nontargets should result in the insects being
repelled.
MRID
41747409
N/A
41747410
41747411
N/A
N/A
11
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2. Environmental Fate
Environmental fate studies are not required for biochemical pesticides unless
adverse effects on nontarget species are observed as a result of acute testing (Tier I) for
ecological effects. No adverse effects are suggested by the data as described in Table
IV above.
D. Product Performance (Efficacy) Assessment
Because of numerous public inquires regarding the effectiveness (efficacy) of oil of
citronella lotions, the Agency examined efficacy data associated with oil of citronella
insect repellent lotion products and determined that product effectiveness diminishes
rapidly overtime; on the average, reasonable effectiveness (efficacy) lasts for 1 to 2 hours.
Therefore inorder to maintain a reasonable degree of effectiveness, the Agency is requiring
all oil of citronella products with label claims for repelling ticks and mosquitoes to bear
a statement pertaining to the maintenance of effectiveness.
E. Other Considerations
On August 3, 1996, the Food Quality Protection Act (FQPA) was signed into law
requiring EPA to consider new factors when making regulatory decisions regarding
pesticide registration, reregistration, petitions for tolerances, and tolerance exemptions. The
Agency must now consider specific factors relevant to children's exposure to pesticides.
In this case these include: special sensitivity; aggregate exposure; cumulative effects; and
endocrine disruption effects. Although the new standards in FQPA are clearly applicable
to food use pesticides, the Agency believes that it is prudent to also apply a similar
standard to actions involving non-food use pesticides, which may pose significant non-
dietary risks to infants and children.
The principle uses of oil of citronella have been identified as insect repellent sprays and
lotions with human applications. The Agency acknowledges that such uses may result in
exposures for children. Based on the mammalian toxicity, oil of citronella (derived from
"Ceylon type" oil) may cause dermal irritation and sensitization in some individuals. To
reduce this risk, the Agency is requiring the labels of all products with dermal applications
to include a special precautionary statement pertaining to dermal irritation and
sensitization. It is the Agency's opinion that this proposed precautionary label language
may also mitigate special sensitivity risks to children.
Oil of citronella has been in continuous use as an insect repellent with human
applications for almost 50 years without any adverse incidents being reported to EPA. This
12
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long use history without adverse incidents combined with the low acute mammalian
toxicity indicates that oil of citronella is not likely to cause adverse effects resulting from
aggregate exposures or cumulative effects. Further, the Agency is not aware of any
evidence relevant to the possibility that oil of citronella may have endocrine disrupter
effects, individually or in combination with another chemical.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and required
the submission of the generic data required to support reregistration of products containing
oil of citronella technical active ingredients. The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support reregistration of all
products containing oil of citronella. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregistration eligibility of oil of
citronella, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of oil of citronella and to determine that oil of citronella can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing oil of citronella as the active ingredients are
eligible for reregistration. The reregistration of particular products is addressed in Section V
of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that all uses of oil of citronella are eligible for reregistration,
it should be understood that the Agency may take appropriate regulatory action, and/or
require the submission of additional data to support the registration of products containing
oil of citronella, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients oil of citronella as
non-food use, the Agency has sufficient information on the health effects of oil of
13
-------
citronella and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that oil of citronella products, labeled and used
as specified in this Reregi strati on Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, the Agency concludes that
products containing oil of citronella for all non-food uses are eligible for reregi strati on.
2. Eligible and Ineligible Uses
The Agency has determined that all currently registered uses of oil of citronella are
eligible for reregi strati on. (Refer to Appendix A).
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for oil of citronella.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Oil of citronella is a non-food use biochemical and therefore tolerance requirements are
not applicable.
2. Labeling Rationale
Potential Risks for Dermal Irritation and Sensitivity
Oil of citronella formulated from "Ceylon type" oil has been determined to be a weak
dermal sensitizer in guinea pigs (Buehler Test), while oil of citronella formulated from
"Java type" oil is not (Refer to Section III). Under FIFRA, 40 CFR 156.10, products
known to be dermal sensitizers are required to have precautionary labeling mitigating
dermal sensitization risks. Thus, all products made from "Ceylon type" oil with directions
for dermal applications must be labeled with the appropriate label precautions.
Additionally, the FDA requires all products containing sunscreens to display specific label
language pertaining to dermal irritation and dermal sensitivity (21 CFR 352.10). The net
result is that all oil of citronella products containing sunscreens and those formulated from
"Ceylon type" oil that have use directions for dermal applications must bear special
precautionary labeling relating to dermal sensitization.
Potential Risks to Infants and Children
The FQPA significantly amended both FIFRA and FFDCA to permit increased
protection for infants and children. Since the principal uses of Oil of citronella have been
identified as insect repellent sprays and lotions, which may result in exposure for children,
14
-------
the Agency is requiring special precautionary labeling relating to dermal sensitization and
irritation for all product with use directions for dermal applications. Refer to Section V.
3. Product Performance (Efficacy) Reassessment
The Agency has an established policy, 40 CFR 158.640 — Pesticide Assessment
Guidelines, Subdivision G — Product Performance, that the submission of efficacy data
may be waived, unless the pesticide bears a claim to control pest microorganisms that pose
a threat to human health and whose presence cannot be readily observed by the user
including but not limited to, microorganisms infectious to man in any area of the inanimate
environment. However, each registrant must ensure through testing that his products are
efficacious when used in accordance with the label directions and commonly accepted pest
control practices. The Agency reserves the right to require, on a case-by-case basis,
submission of efficacy data for any pesticide registered or proposed for
regi strati on/reregi strati on.
In this case, the registrants of all oil of citronella topical products with label claims to
repel fleas, ticks and mosquitoes are required to either submit/cite product performance
(efficacy) data, or delete label claims for repelling fleas, ticks and mosquitoes. Additional,
all oil of citronella lotion products which bear claims for repelling fleas, ticks and
mosquitoes must also have a statement pertaining to maintenance of effectiveness
(efficacy). Refer to Section V (B)(2).
2
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of
both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of oil of citronella for the above
eligible uses has been reviewed and determined to be substantially complete. At this time
no additional data are being required. However, the Agency is requiring that a revised
Confidential Statement of Formula (CSF) and revised product labeling be submitted within
eight months of the issuance of this document for all products.
2. Labeling Requirements for Manufacturing-Use Products
At this time, no changes are required for the current precautionary labeling of
manufacturing-use products containing oil of Citronella.
15
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The
database supporting the reregi strati on of the above eligible uses of oil of citronella is
substantially complete and no additional product specific data is being required at this
time. However, the Agency is requiring that a revised CSF and revised product labeling
be submitted within 8 months of issuance of this document for all products.
2. Labeling Requirements for End-Use Products
Dermal Sensitivity:
Based on the results of the acute mammalian toxicity in Section III and the provisions
of FQPA, the current precautionary statements on the labels of certain end-use products
containing oil of citronella must be revised to include a special statement pertaining to
dermal sensitivity listed in Table V.
TABLE V -- Precautionary label language for dermal sensitivity
Type of
Formulation
"Ceylon type" oil
"Ceylon type" oil
"Java type" oil
"Java type" oil
"Java type" oil
Application
Dermal
Non-dermal
Dermal ,
containing
sunscreen
ingredients*
Dermal, w/o
sunscreen
ingredients
Non-dermal
Precautionary Statement
regarding Dermal Sensitivity
"Discontinue if irritation or rash
appears. Prolonged or frequent skin
contact may cause allergic reactions
in some individuals. Use on children
under 6 months of age only with the
advice of a physician."
None required
"For external use only. Avoid
contact with eyes. Discontinue if
irritation or rash appears. Use on
children under 6 months of age only
with the advice of a physician."
"Discontinue if irritation or rash
appears. Use on children under 6
months of age only with the advice
of a physician. "
None required.
"Statements required by FDA (21 CFR 352.52 -- Labeling of sunscreen drug
products).
Product Performance (Efficacy):
16
-------
Based on the review of available product performance data, the Agency is requiring all oil
of citronella products with label claims for repelling mosquitoes, fleas and ticks to have
specific instructions pertaining to maintenance of effective repellent activity (i.e., protection
time). The minimum acceptable protection time is one hour. The following statement
pertaining to maintenance of repellent activity must appear in the direction for use.
"For maximum repellent effectiveness of this product, repeat applications at 1 hour intervals."
A label statement identical to the one listed above except with a protection time longer one
hour may be permitted, provided it can be supported by product performance data showing
an acceptable level of repellent activity. Refer to the Pesticide Assessment Guidelines,
Subdivision G - Product Performance for further information regarding acceptable levels of
repellent activity.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this RED. Persons other than the registrant may
generally distribute or sell such products for 50 months from the date of the issuance of this
RED. However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer to
"Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register. Volume 56,
No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell oil of citronella
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from the
date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
17
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Page Intentionally Blank
18
-------
VI. APPENDICES
19
-------
Page Intentionally Blank
20
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Report Run Date: 05/14/97 ) Time 14:14
Report Date: 09/04/96
APPENDIX A REPORT
Case 3105 [Oil of citronella] Chemical 021901 [Oil of citronella]
LUIS 4.0 - Page:
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
14444444444444444444444444444444444444444444444444444444444444444
Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
HORSES (SHOW/RACE/SPECIAL/PONIES)
Animal treatment (spray), When needed,
Sprayer
Animal treatment, When needed, Cloth
Enclosed premise treatment, When needed, RTU
Sprayer
Wipe-on/wiper treatment, When needed,
Cloth
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Premise treatment, Not on label, Not on RTU
label
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Citronella candle, Not on label, By hand IMPR
Use Group: INDOOR NON-FOOD
UC * NS NS NS
NS 1 NS
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
UC * NS NS
.001047 Ib *
animal
.001047 Ib * NS NS
animal
UC * NS NS
.001047 Ib *
animal
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
.001047 Ib *
animal
.001047 Ib * NS NS
animal
NS NS AN NS
NS NS AN NS
NS NS NS NS
NS NS 1 NS
NS NS AN NS
NS NS NS NS
NS NS AN NS
NS NS AN NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
C93, CAG, CAL
C93, CAG, CAL
21
-------
Report Run Date: 05/14/97 ) Time 14:15
PRD Report Date: 09/04/96
LUIS 4.0 - Page:
APPENDIX A REPORT
Case 3105 [Oil of citronella] Chemical 021901 [Oil of citronella]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES (con't)
Citronella candle, When needed, By hand IMPR
Citronella cartridge, When needed, By RTU
hand
Outdoor treatment, Not on label, Package IMPR
applicator
Rub-on, When needed, By hand
Scent post application, When needed, By IMPR
hand
Sprinkle, When needed, By hand
HUMAN BODY/CLOTHING WHILE BEING WORN (INSECT CONTROL)
Clothing treatment, Not on label, By hand IMPR
Clothing treatment, When needed, Not on RTU
label
Clothing treatment, When needed, Sprayer PRL
Skin contact treatment, Not on label, By IMPR
hand
Skin contact treatment, When needed, By IMPR
hand
Use Group: OUTDOOR RESIDENTIAL (con't)
IMPR
RTU
IMPR
IMPR
IMPR
P/T
NA
NA
NA
NA
NA
NA
!CT CONTROL)
IMPR
RTU
PRL
RTU
IMPR
RTU
IMPR
PRL
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
NS
AN
AN
AN
NS
NS
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
22
-------
Report Run Date: 05/14/97 ) Time 14:15
PRD Report Date: 09/04/96
LUIS 4.0 - Page:
APPENDIX A REPORT
Case 3105 [Oil of citronella] Chemical 021901 [Oil of citronella]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HUMAN BODY/CLOTHING WHILE BEING WORN (INSECT CONTROL) (con't)
NA
Skin contact treatment, When needed, Not RTU
on label
Skin contact treatment, When needed, RTU
Sprayer
ORNAMENTAL AND/OR SHADE TREES
Scent post application, When needed, By IMPR
hand
Sprinkle, When needed, By hand
ORNAMENTAL HERBACEOUS PLANTS
P/T
Scent post application, When needed, By IMPR
hand
ORNAMENTAL LAWNS AND TURF
Sprinkle, When needed, By hand
ORNAMENTAL WOODY SHRUBS AND VINES
P/T
Scent post application, When needed, By IMPR
hand
Sprinkle, When needed, By hand
P/T
NA
Use Group: INDOOR RESIDENTIAL (con't)
UC * NS NS NS NS AN NS
UC * NS NS
NS
NS AN NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
UC * NS NS NS NS 10 NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS 10 NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
UC * NS NS
NS
NS 10 NS
23
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Report Run Date: 05/14/97 )
PRD Report Date: 09/04/96
Time 14:15
LUIS 4.0 - Page:
APPENDIX A REPORT
Case 3105 [Oil of citronella] Chemical 021901 [Oil of citronella]
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Soil Tex. Max. Dose
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Re-Entry Intv.
PRD Report Date
Minimum Interval between Applications (days)
Reentry Intervals
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
Non-specific
C Coarse
M Medium
F Fine
O Others
FORMULATION CODES
IMPR IMPREGNATED MATERIAL
P/T PELLETED/TABLETED
PRL PRESSURIZED LIQUID
RTU LIQUID-READY TO USE
ABBREVIATIONS
AN
NA
NS
UC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to
24
-------
Report Run Date: 05/14/97
PRD Report Date: 09/04/96
) Time 14:15
LUIS 4.0 - Page:
APPENDIX A REPORT
Case 3105 [Oil of citronella] Chemical 021901 [Oil of citronella]
J44444444444444444444444444
USE LIMITATIONS CODES
C93 : Do not apply directly to water.
GAG : Do not apply where runoff is likely to occur.
CAL : Do not contaminate water, food or feed.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
UNIT DESCRIPTIONS
animal :
Ib : pound
25
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients within the case
Oil of Citronella covered by this Reregi strati on Eligibility Decision Document. It contains generic data requirements
that apply to Oil of Citronella in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR
Part 158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment
Guidelines, which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield,
VA 22161 (703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number
if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study.
26
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Oil of Citronella
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
151B-10
151B-11
151B-12
151B-13
151B-15
151B-17
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(1)
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
PHYSICAL AND CHEMICAL
PROPERTIES:
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
pH
Stability
Flammability
Storage stability
All
All
All
All
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
41785703
27
-------
Data Supporting Guideline Requirements for the Reregistration of Oil of Citronella
REQUIREMENT
(m) Viscosity
(n) Miscibility
(o) Corrosion characteristics
TOXICOLOGY (Tier I)
152B-10 Acute Oral Toxicity
152B-11 Acute Dermal Toxicity -
Rabbit/Rat
152B-12 Acute Inhalation Toxicity -Rabbit
152B-13 Primary Eye Irritation -Rabbit
152B-14 Primary Dermal Irritation -Rabbit
152B-15 Dermal Sensitization - Guinea Pig
152B-16 Hypersensitivity
152B-17 Microbial mutagenicity
152B-18 Immunotoxicity
152B-20 90-Day Oral Toxicity
152B-21 90-Day Dermal Toxicity
152B-23 Develpomental Toxicity
ECOLOGICAL EFFECTS:
154B-6 Avian Acute Oral Toxicity
154B-7 Avian Subacute Dietary Toxicity
154B-8 Fish Toxicity
USE PATTERN
ALL
ALL
ALL
All
All
All
All
All
All
All
All
Waived
Waived
Waived
Waived
All
Waived
All
CITATION(S)
41585703
41785703
41785703
41747402,43179401
41747403,43167101
41747404,43167102
41747405,43167103
41747405,43167104
41747407,43167105
All incidents must be reported.
41785701, 41785702, 41747408
41747409
41747410
28
-------
Data Supporting Guideline Requirements for the Reregistration of Oil of Citronella
REQUIREMENT USE PATTERN CITATION(S)
154B-9
154B-10
154B-11
Invertebrate Toxicity
Nontarget plants
Nontarget insects
All
Waived
Waived
41747411
ENVIRONMENTAL FATE:
PRODUCT PERFORMANCE:
156B-2 Efficacy - Product Specific
Mosquito and Tick
All data requirements have been waived.
00001004,
00059308,
00107683,
41851602,
42151312,
42504601,
42649201,
42821502,
42921303,
43902306,
00001005,
00073787,
00123621,
41851603,
42151313,
42504602,
42821501,
42821503,
43590401,
44010101,
00001145,
00073788,
00134321,
41851604,
42151314,
42507201,
42649201,
42890102,
43725901,
44167301,
00053315,
00093884,
41851601,
42151311,
42151315,
42507202,
42821501,
42921302,
43761601,
44173201
29
-------
Page Intentionally Blank
30
-------
Page Intentionally Blank
31
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA
in arriving at the positions and conclusions stated elsewhere in the Reregi strati on Eligibility Document. Primary
sources for studies in this bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the published literature, in those
instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials,
this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the published article from within the typically larger volumes
in which they were submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional bibliographic citation. The
Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record
Identifier, or "MRID number". This number is unique to the citation, and should be used whenever a specific
reference is required. It is not related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier. These entries are listed
after all MRID entries. This temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest
known submission. Bibliographic conventions used reflect the standard of the American National Standards
Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the
author. When no author or laboratory could be identified, the Agency has shown the first submitter as the
author.
b. Document date. The date of the study is taken directly from the document. When the date is followed by a
question mark, the bibliographer has deduced the date from the evidence contained in the document. When the
date appears as (19??), the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a document title.
Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in
addition to any self-explanatory text) the following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately following the word
"received."
(2) Administrative number. The next element immediately following the word "under" is the registration
number, experimental use permit number, petition number, or other administrative number associated
with the earliest known submission.
32
-------
(3) Submitter. The third element is the submitter. When authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses identifies
the EPA accession number of the volume in which the original submission of the study appears. The
six-digit accession number follows the symbol "CDL," which stands for "Company Data Library."
This accession number is in turn followed by an alphabetic suffix which shows the relative position
of the study within the volume.
33
-------
BIBLIOGRAPHY
MRID
CITATION
00001004 Miller, R.L. (1969) Effect of Repel-a-Gel on Horses: Research Report No.
RLM 69:68. (Unpublished study received Oct 30, 1969 under 134-48;
submitted by Hess & Clark, Research Dept, Div. of Richardson-Merrell,
Inc., Ashland, Ohio; CDL:000603-A)
00001005 Thompson, W.S. (1969) Effect of Repel-A-Gel on Horses: Research Report
No. WST 69:84. (Unpublished study received Oct 30, 1969 under 134-48;
submitted by Hess & Clark, Research Dept.,Div. of Richardson-Merrell,
Inc., Ashland, Ohio; CDL:000603-B)
00001006 Campbell, J.A. (1970) Repel-A-Gel Stability and Package Compatibility:
Research Report No. JAC 70:17. (Unpublished study received Jul 6, 1970
under 134-48; submitted by Hess & Clark Research Dept., Div. of
Richardson-Merrell, Inc., Ashland, Ohio; CDL:000604-A)
00001009 Gunderson, G.R. (1969) Repel-A-Gel Irritation Test on Horses: Research
Report No. GRG 69:73. (Unpublished study received Feb 12, 1969 under
134-48; submitted by Hess & Clark, Research Dept., Div. of
Richardson-Merrell, Inc., Ashland, Ohio; CDL:133550-B)
00001145 Straight Arrow A(R)4 Incorporated (1971) "1971" Study Report on Formula
to be Marketed as "Jungle Jel." (Unpublished study that includes appended
incomplete report AP-105B, received May 16, 1972 under 11314-1;
CDL:013082-A)
00024124 Williamson, H.O.; McDuffie, W.E.; Jasper, R.L. (1971) [Absorbine Fly-Gel:
Toxicity to Rats]. (U.S. Environmental Protection Agency, Chemical and
Biological Investigations Branch, Pharmacology Laboratory, unpublished
report.)
00053315 Tyler, D.B. (1979) Statistical Analyses of a Claim in an Application for
Registration of a Biorational Natural Herbal Flea Collar as a Pesticide.
(Unpublished study received Jul 22, 1980 under 42443-1; submitted by
Natural Research People, Inc., Lavina, Mont.; CDL:243301-A)
00059308 Albert, R.A.; Hoerlein, B.F.; Greene, J.E.; et al. (1964) A Study of the
Efficacy of a Dog Repellent. (Unpublished study received on unknown date
under 8096-1; prepared by Auburn Univ., Small Animal Surgery and
Medicine, submitted by Loumac Chemical Co., Chattanooga, Tenn.;
CDL:231170-A)
00064473 Williamson, H.O.; McDuffie, W.E.; Teeters, W.R. (1974) [Irving's Fly
Dope: Albino Rats]. (U.S. Environmental Protection Agency, Chemical &
34
-------
BIBLIOGRAPHY
MRID
CITATION
Biological Investigations Branch, Technical Services Div.; unpublished
study; CDL:227928-A)
00073787 Whitmire Research Laboratories, Incorporated (1964) [Effectivenessof
Outdoor Dog Away]. (Compilation; unpublished study received Jun 11,
1964 under 499-138; CDL:020041-A)
00073788 Whitmire Research Laboratories, Incorporated (1964) [Effectiveness of
Indoor Dog Away]. (Compilation; unpublished study received Jun 5, 1964
under 499-137; CDL:020042-A)
00093884 Ecosafe Laboratories, Incorporated (1982) Data in Support of Insect Shooo,
Skeeter Shooo Spray & Skeeter Shooo Balm. (Unpublished study received
Jan 19, 1982 under 45220-3; CDL:246625-A)
00096567 Hansen, K.L.; Hewett, T.A.; Beck, L.S.; et al. (1981) Primary Eye Irritation
Study: Wipe-V: Project No. 1712-B. (Unpublished study received Oct 28,
1981 under 270-149; prepared by Elars Bioresearch Laboratories, Inc.,
Phoenix, Ariz.; CDL:246129-A)
00096568 Hansen, K.L.; Hewett, T.A.; Beck, L.S.; et al. (1981) Acute Dermal Toxicity
Study: Wipe-V: Project No. 1712-C. (Unpublished study received Oct 28,
1981 under 270-149; prepared by Elars Bioresearch Laboratories, Inc.,
submitted by Farnam Cos., Inc., Phoenix, Ariz.; CDL:246129-B)
00096569 Hansen, K.L.; Hewett, T.A.; Beck, L.S. (1981) Primary Dermal Irritation
Study: Wipe-V: Project No. 1712-A. (Unpublished study received Oct 28,
1981 under 270-149; prepared by Elars Bioresearch Laboratories, Inc.,
submitted by Farnam Cos., Inc., Phoenix, Ariz.; CDL:246129-C)
00096570 Hansen, K.L.; Hewett, T.A.; Beck, L.S.; et al. (1981) Acute Oral Toxicity
Study: Wipe-V: Project No. 1712-D. (Unpublished study received Oct 28,
1981 under 270-149; prepared by Elars Bioresearch Laboratories, Inc.,
submitted by Farnam Cos., Inc., Phoenix, Ariz.; CDL:246129-D)
00096571 Morgan, J.M.; Horath, L.L.; Sabaitis, C.P.; etal. (1981) Four Hour Acute
Aerosol Inhalation Toxicity Study in Rats of Wipe-V: Toxigenics Study No.
420-0706. (Unpublished study received Oct 28, 1981 under 270-149;
prepared by Whittaker Corp., submitted by Farnam Cos., Inc., Phoenix,
Ariz.; CDL:246129-E)
00104087 Luy, T.; Peterson, A. (1976) Report on Dietary LC50 in Bobwhite Quail:
[Scent-off Twist-ons]: Laboratory Nos. G-1065-66. (Unpublished study
35
-------
BIBLIOGRAPHY
MRID
CITATION
received Aug 24, 1979 under 5332-8; prepared by Wells Laboratories, Inc.,
submitted by Plantabbs Corp., Timonium, MD; CDL:241053-A)
00107683 Williamson, H.; McDuffie, W.; Teeters, W. (1972) [Top Form Shoo Fly
Wipe-on Insecticidal Repellent: Rat]. (U.S. Pharmacology Laboratory;
unpublished study; CDL:050170-A)
00113301 Campbell, I; Ray, W. (19??) To Determine the Stability and Compatibility
of Wipe 'n Spray in a New Spray Type Plastic Container: Research Report
No. JAC 69:101. (Unpublished study received Dec 2, 1969 under 134-46;
submitted by Hess & Clark, Inc., Ashland, OH; CDL:223007-A)
00123620 Williamson, H.; McDuffie, W.; Jasper, R. (1972) [Pulvex Shun Indoor Use:
Rats]. (Unpublished study received Jan 27, 1972 under 591-42; prepared by
Pharmacology Laboratory, submitted by U.S. Environmental Protection
Agency, Beltsville, MD; CDL: 009007-A)
00123621 Neu-Glo Candles, Inc. (1978) Efficacy Test: Neu-Glo Patio Candles.
(Unpublished study received Jan 4, 1979 under 42700-1; CDL: 237305-A)
00123622 Seis, E. (1978) Letter sent to M. Neuman dated Oct 19, 1978 [Analysis of
Oil Citronella Ceylon]. (Unpublished study received Jan 4, 1979 under
42700-1; prepared by Norda, Inc., submitted by Neu-Glo Candles, Inc.,
Scappoose, OR; CDL:237305-B)
00130230 Baltezore, M.; Shu, H. (1981) Acute Dermal Toxicity Test/Eye Irritation
Test: [Insect Shooo]: ES Unilab #14078. (Unpublished study received Jan
19, 1982 under 45220-3; prepared by ES Unilab Research, Inc., submitted
by Ecosafe Laboratories, Oakland, CA; CDL:246626-A)
00131242 Rosenfeld, G.; Robbins, G. (1983) Acute Oral Toxicity Study in Rats:
[Nature's Own Herbal Flea Repellent Collar]: Study #0646A. (Unpublished
study received Oct 3, 1983 under 270-174; prepared by Cosmopolitan
Safety Evaluation, Inc., submitted by Farnam Cos., Inc., Phoenix, AZ;
CDL:251420-A)
00131243 Rosenfeld, G.; Robbins, G. (1983) Acute Dermal Toxicity and Irritancy
Study-Rabbit LD50: [Nature's Own Herbal Flea Repellent Collar]: Study
#06466. (Unpublished study received Oct 3, 1983 under 270-174; prepared
by Cosmopolitan Safety Evaluation, Inc., submitted by Farnam Cos., Inc.,
Phoenix, AZ; CDL:251420-B)
00131244 Rosenfeld, G.; Robbins, G. (1983) Primary Eye Irritation Study in Rabbits:
36
-------
BIBLIOGRAPHY
MRID
CITATION
[Nature's Own Herbal Flea Repellent Collar]: Study #0646D. (Unpublished
study received Oct 3, 1983 under 270-174; prepared by Cosmopolitan Safety
Evaluation, Inc., submitted by Farnam Cos., Inc., Phoenix, AZ;
CDL:251420-C)
00131245 Boyd, J. (1982) Effectiveness Evaluations on the Herbal Collar, a Repelling
Device, against Fleas on Dogs: Project Report 151. (Unpublished study
received Oct 3, 1983 under 270-174; prepared by P.A.C.E. International,
submitted by Farnam Cos., Inc., Phoenix, AZ; CDL:251420-D)
00134320 Natural Research People, Inc. (1979) [Chemistry of Natural Herbal Flea
Collar]. (Compilation; unpublished study received Oct 4, 1979 under
42443-1; CDL:241133-A)
00134321 Natural Research People, Inc. (1979) [Efficacy of Natural Herbal Flea
Collar]. (Compilation; unpublished study received Oct 4, 1979 under
42443-1; CDL:241133-B)
00134322 Unilab Research (1979) Rat Acute Oral Toxicity Study: Natural Herbal Flea
Collar Ingredients: Laboratory No. 11226. (Unpublished study received Oct
4, 1979 under 42443-1; submitted by Natural Research People, Inc., Lavina,
MT;CDL:241133-C)
00134323 Unilab Research (1979) Rabbit Dermal Toxicity; Rabbit Skin Irritation:
Sample #2: Wax and Oils: Laboratory No. 11226A. (Unpublished study
received Oct 4, 1979 under 42443-1; submitted by Natural Research People,
Inc., Lavina, MT; CDL:241133-D)
00143188 Lacap, L. (1984) Report on Acute Oral LD50 in Rats Using Herbal Oil Flea
and Tick Repellent: Laboratory No. K-4291. Unpublished study prepared
by Wells Laboratories, Inc. 5 p.
00143189 Azevedo, J. (1984) Report on Sensitivity Testing in Guinea Pigs Using
?Herbal Oil Flea and Tick Repellento. Unpublished study prepared by Wells
Laboratories, Inc. 3 p.
00164042 PetGuard, Inc. (1986) Amendment to Application for Registration of
Pesticide: PetGuard Herbal Flea Repellent Collar for Dogs and Cats:
(Product Chemistry Data). Unpublished compilation. 75 p.
00164126 Superior International Laboratories (1986) Product Chemistry Data: Horse
Powero. Unpublished compilation. 16 p.
37
-------
BIBLIOGRAPHY
MRID
CITATION
40147600 Tender Corp. (1987) Submission of Toxicity Data for Insect Repellent
M6984. Transmittal of 4 studies.
40147601 Kukulinski, M. (1987) Eye Irritation TUsing Insect Repellent M6984o:
Project ID: TM-86-724. Unpublished study prepared by Tox Monitor
Laboratories Inc. 6 p.
40147602 Kukulinski, M. (1987) Primary Skin Irritation TUsing Insect Repellent
M69840: Laboratory Project ID: TM-86-724. Unpublished study prepared
by Tox Monitor Laboratories Inc. 8 p.
40147603 Kukulinski, M. (1987) Acute Oral Toxicity TUsing Insect Repellent
M69840: Laboratory Project ID: TM-86-724. Unpublished study prepared
by Tox Monitor Laboratories Inc. 6 p.
40147604 Frentzko, M. (1987) Repeated Insult Patch Test TUsing Insect Repellent
M69840: Laboratory Project ID: M6984. Unpublished study prepared by
Essex Testing Clinic Inc. 10 p.
40220200 Tender Corp. (1987) Submission of Chemistry Data of Natrapel.
Transmittal of 3 studies.
40220201 Grout, E. (1987) Product Chemistry: TNatrapelo. Unpublished study
prepared by Tender Corp. 6 p.
40220202 Herbert V. Shuster Inc. (1987) Analysis & Certification of Product
Ingredients: TNatrapelo: Laboratory Project ID: 101228. Unpublished study.
7 p.
40220203 Grout, E. (1987) Physical & Chemical Properties: TNatrapelo. Unpublished
study prepared by Tender Corp. 5 p.
40295800 Tender Corp. (1987) Submission of Product Chemistry Data in Support of
Application for Registration of Natrapel with Aloe. Transmittal of 2 studies.
40349000 Lamplight Farms, Inc. (1987) Submission of Product Chemistry Data to
Support the Revised Application for Registration of Citronella Outdoor
Liquid Light. Transmittal of 1 study.
40349001 Lamplight Farms, Inc. (1987) Product Chemistry Data Requirements:
Citronella Outdoor Liquid Light. Unpublished study. 8 p.
40445400 Tender Corp. (1987) Submission of Natrapel Spray and Lotion Product
38
-------
BIBLIOGRAPHY
MRID
CITATION
Chemistry Data. Transmittal of 3 studies.
40445401 Herbert V. Shuster, Inc. (1987) Analytical Methodology for Quantitative
Analysis of Insect Repellents: Laboratory Project Identification 102460.
Unpublished study. 10 p.
40445402 Herbert V. Shuster, Inc. (1987) Flammability Test [for Natrapel Insect].
Unpublished study. 4 p.
40445403 Grout, E. (1987) Physical & Chemical Properties ?for Natrapelo.
Unpublished study prepared by Tender Corp. 4 p.
40732500 SCM Glidco Organics Corp. (1988) Product Chemistry Data submitted for
Citronella Java 82-398 registration. Transmittal of 3 studies.
40732501 Von Genk, R. (1988) Product Identity and Composition: Citronella Java
82-398. Unpublished study prepared by SCM Glidco Organics Corp. 9 p.
40732502 Von Genk, R. (1988) Analysis and Certification: Citronella Java 82-398:
Analytical Methods and Quality Control. Unpublished study prepared by
SCM Glidco Organics Corp. 3 p.
40732503 Von Genk, R. (1988) Physical and Chemical Characteristics: Citronella Java
82-398. Unpublished study prepared by SCM Glidco Organics Corp. 3 p.
41122200 Roccorp, Inc. (1989) Submission of Product Chemistry Data in support of
Hilo Flea Repellent Collar Registration Standard. Transmittal of 1 study.
41122201 Donze, W. (1989) Product Chemistry: Hilo Flea Repellent Collar:
Laboratory Project ID: In House Quality Control. Unpublished study
prepared by Roccorp, Inc. 8 p.
41226500 Prentiss Drug and Chemical Co. (1989) Submission of Product Chemistry
Data in Response to the Butoxypolypropylene Data Call-In. Transmittal of 1
study.
41226501 Slocumb, A. (1989) Product Chemistry Data for Prentox(R) Pyronyl Equine
Insect Repellent Insecticide. Unpublished study prepared by Prentiss Drug
and Chemical Co. 9 p.
41639300 Chemical Consultants International, Inc. (1990) Submission of Data To
Support Registration of Coleman Lantern Fuel (Citronella Oil): Product
Chemistry and Toxicology Studies. Transmittal of 7 studies.
39
-------
BIBLIOGRAPHY
MRID
CITATION
41639301 Bellet, E. comp. (1990) Product Chemistry for Coleman Plus Mosquito
Repellent Lantern Fuel. Unpublished study prepared by Chemical
Consultants International, Inc. 36 p.
41639302 Mallory, V.; Mathews, R. (1990) Acute Exposure Oral Toxicity: Coleman
Experimental Fuel [in Rats]: Lab Project Number: PH402-CO-001-89.
Unpublished study prepared by Pharmakon Research International, Inc. 24
P-
41639303 Mallory, V.; Mathews, R. (1990) Acute Exposure Dermal Toxicity:
Coleman Experimental Fuel [in Rabbits]: Lab Project Number:
PH422-CO-001-90. Unpublished study prepared by Pharmakon Research
International, Inc. 22 p.
41639304 Hoffman, G.; Newton, P. (1990) Acute Inhalation Toxicity of Coleman
Experimental Fuel [in Rats]: Lab Project Number: 90-8257. Unpublished
study prepared by Bio/Dynamics, Inc. 55 p.
41639305 Mallory, V.; Mathews, R. (1990) Primary Dermal Irritation Study: Coleman
Experimental Fuel [in Rabbits]: Lab Project Number: PH420-CO-001-90.
Unpublished study prepared by Pharmakon Research International, Inc. 17
P-
41639306 Mallory, V.; Mathews, R. (1990) Primary Eye Irritation (Rabbit): Coleman
Experimental Fuel: Lab Project Number: PH420-CO-001-90. Unpublished
study prepared by Pharmakon Research International, Inc. 19 p.
41639307 Mallory, V.; Mathews, R. (1990) Delayed Contact Hypersensitivity in
Guinea Pigs: Coleman Experimental Fuel: Lab Project Number:
PH424-CO-001-90. Unpublished study prepared by Pharmakon Research
International, Inc. 34 p.
41747400 Candle Corporation of America (1991) Submission of Product Chemistry
and Toxicity Data in Support of List C Reregi strati on of Oil of Citronella.
Trnsmittal of 12 studies.
41747401 Weatherston, I. (1991) Summary of Toxicity Study Data Submitted in
Support of Reregi strati on [of Oil of Citronella]: Lab Project Number: 1/91
CO/RR-1. Unpublished study prepared by Technology Services Group, Inc.
7 p.
41747402 Kuhn, J. (1990) Oil of Citronella: Acute Oral Toxicity Study in Rats: Lab
Project Number: 1/91 CO/RR-2. Unpublished study prepared by
40
-------
BIBLIOGRAPHY
MRID
CITATION
Technology Services Group, Inc. 13 p.
41747403 Kuhn, J. (1990) Oil of Citronella: Acute Dermal Toxicity Study in Rabbits:
Lab Project Number: 1/91 CO/RR-3. Unpublished study prepared by
Technology Services Group, Inc. 14 p.
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42921301 Gil, J. (1993) Product Chemistry: Buzz-Away: Lab Project Number: 002.
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43041301 Primavera Labs, Inc.; Span Medical; Systems, Inc. (1993) TREO SPF
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43041302 Primavera Labs, Inc.; Span Medical; Systems, Inc. (1993) TREO SPF
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Product Comparison Data in Support of Application for Registration of
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43041401 Primavera Labs, Inc.; Span Medical Systems, Inc. (1993) TREO SPF
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43041402 Primavera Labs, Inc.; Span Medical Systems, Inc. (1993) TREO SPF
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43590400 Avon Products, Inc. (1994) Submission of Efficacy Data on Avon's
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43590401 Gerberg, E.; Coler, R.; Choate, P. (1994) Field Test of Mosquito Repellency
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43639400 Primavera Labs, Inc. (1995) Submission of Product Chemistry Data in
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43639401 Primavera Labs, Inc.; Avon Products, Inc. (1995) TREO SPF 8-Alternate
Formula No. 1: Product Chemistry—First of a Series. Unpublished study.
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43639402 Primavera Labs, Inc.; Avon Products, Inc. (1995) TREO SPF 8-Alternate
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43639500 Primavera Labs, Inc. (1995) Submission of Product Chemistry Data in
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43639501 Primavera Labs, Inc.; Avon Products, Inc. (1995) TREO SPF 30-Alternate
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10 p.
43639502 Primavera Labs, Inc.; Avon Products, Inc. (1994) TREO SPF 30-Alternate
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43639700 Primavera Labs, Inc. (1995) Submission of Product Chemistry Data in
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43639702 Primavera Labs, Inc.; Avon Products, Inc. (1995) TREO SPF 8-Alternate
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43640900 Primavera Labs, Inc. (1995) Submission of Product Chemistry Data in
Support of Registration Amendment for TREO SPF 30 Alternate Formula
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43640901 Primavera Labs, Inc.; Avon Products, Inc. (1995) TREO SPF 30-Alternate
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43640902 Primavera Labs, Inc.; Avon Products, Inc. (1994) TREO SPF 30-Alternate
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43725900 Perycut-Chemie Ag (1995) Submission of Efficacy Data in Support of the
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43761600 Bug Master Products (1995) Submission of Efficacy Data in Support of the
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43761601 Hamilton, E. (1995) Citronella Wrist Bands-Product Performance: Lab
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43902301 Garrison, M. (1996) Skin So Soft Moisturizing Outdoor Protection After
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951029. Unpublished study prepared by TKL Research, Inc. 69 p.
43902306 Spero, N. (1995) Evaluation of the Efficacy of a Personal Repellent Against
Mosquitoes in the Field: Lab Project Number: G05995001A044B:
0895-059-0024. Unpublished study prepared by Insect Control & Research,
Inc. 80 p.
43981600 Primavera Laboratories, Inc. (1996) Submission of Product Chemistry Data
in Support of Alternate Formulation No. 3 for TREO SPFs 8, 15 & 30.
Transmittal of 2 Studies.
43981601 Primavera Labs, Inc.; Imperial Cosmetics Services, Inc. (1996) TREO SPF
8~Alternate Formula No. 3: Product Chemistry—First of a Series: Lab
Project Number: C:\DMS\SRSIEGEL\0011463.WP. Unpublished study. 9
P-
43981602 Primavera Laboratories, Inc.; Imperial Cosmetics Services, Inc. (1996)
TREO SPF 8-Alternate Formula No. 3: Product Chemistry-First of a
Series: Lab Project Number: C:\DMS\SRSIEGEL\0011425.WP.
Unpublished study prepared by Imperial Cosmetics Services, Inc. 4 p.
43990400 Avon Products, Inc. (1996) Submission of Product Chemistry Data in
Support of the Application for Registration of Avon's Skin So Soft
Moisturizing Outdoor Protection After Sun Spray. Transmittal of 2 Studies.
43990401 Garrison, M. (1996) Skin So Soft Moisturizing Outdoor Protection After
Sun Spray Product Chemistry: Second of a Series: (Analysis and
Certification of Ingredients): Lab Project Number: 6975-59. Unpublished
study prepared by Avon Products, Inc. lip.
53
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BIBLIOGRAPHY
MRID
CITATION
43990402 Garrison, M. (1996) Skin So Soft Moisturizing Outdoor Protection After
Sun Spray Product Chemistry: Third of a Series: (Physical and Chemical
Characteristics): Lab Project Number: 6975-60. Unpublished study prepared
by Avon Products, Inc. 6 p.
43991000 Primavera Labs, Inc. (1996) Submission of Product Chemistry Data in
Support of the Amended Registration of TREO SPF 30. Transmittal of 2
Studies.
43991001 Primavera Laboratories, Inc.; Imperial Cosmetics Services, Inc. (1996)
TREO SPF 30-Alternate Formula No. 3: Product Chemistry-First of a
Series: (Manufacturing Process). Unpublished study. 9 p.
43991002 Primavera Laboratories, Inc.; Imperial Cosmetics Services, Inc. (1996)
TREO SPF 30-Alternate Formula No. 3: Product Chemistry-First of a
Series: (Physical and Chemical Characteristics). Unpublished study. 4 p.
44010100 Avon Products, Inc. (1996) Submission of Pesticide Use Data in Support of
Registration of Skin-So-Soft. Transmittal of 1 Study.
44010101 Boisvert, I; Lacoursiere, J. (1995) Field Study Report on the Protection
Offered by Avon's Skin-So-Soft Authentic and Herbal Fresh Lotions against
Mosquito, Black Fly, and Biting Midges. Unpublished study prepared by
Universite du Quebec a Trois-Rivieres. 47 p.
44034100 S.C. Johnson & Son, Inc. (1996) Submission of Product Chemistry Data in
Support of the Amended Registration of Off! Citronella Candle. Transmittal
of 1 Study.
44034101 Lois, R. (1996) Off! Citronella Candle: Formula 7812D47: Product
Chemistry: (Product Identity and Composition): Lab Project Number:
7812D47-C1. Unpublished study prepared by S.C. Johnson & Son Inc. 8 p.
44078200 Spectrum, Div. of United Industries Corp. (1996) Submission of Product
Chemistry Data in Support of the Application for Registration of Cutter
Insect Repellent RDC031RN. Transmittal of 2 Studies.
44078201 Duckworth, C. (1996) Physical and Chemical Properties Determination of
Cutter Insect Repellent RDC031RN: Lab Project Number: 96-06-02.
Unpublished study prepared by United Industries Corp. 9 p.
44078202 Duckworth, C. (1996) Product Identity & Disclosure of Ingredients and
Analysis and Certification of Product Ingredients of Cutter Insect Repellent
54
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BIBLIOGRAPHY
MRID
CITATION
RDC031RN. Unpublished study prepared by United Industries Corp. 9 p.
44103400 Spectrum, Division of United Industries Corp. (1996) Submission of Product
Chemistry Data in Support of Registration of Cutter Insect Repellent
RDC031RN. Transmittal of 1 Study.
44103401 Moutray, R. (1996) Determination of Oil of Citronella in Candle Formulas
Gas Chromatography Method: Lab Project Number: UIGC 058.00.
Unpublished study prepared by United Industries Corp. 16 p.
44133100 Avon Products, Inc. (1996) Submission of Toxicity Data in Support of the
Application for Registration for Skin So Soft Moisturizing Outdoor
Protection. Transmittal of 1 Study.
44133101 MacEachern, L. (1996) Supplement to Primary Ocular Irritancy Test in
Rabbits (MRID #43902303): (Skin So Soft Moisturizing Outdoor
Protection): Lab Project Number: 59-157. Unpublished study prepared by
Avon Products, Inc. 6 p.
44144500 Spectrum Div. of United Industries Corp. (1996) Submission of Product
Chemistry Data in Support of the Application for Registration of Cutter
Insect Repellent Icarus. Transmittal of 2 Studies.
44144501 Schoenberg, P. (1996) Physical and Chemical Properties Determination of
Cutter Insect Repellent Icarus: Lab Project Number: 96-09-01. Unpublished
study prepared by United Industries Corp. 9 p.
44144502 Schoenberg, P. (1996) Product Identity and Disclosure of Ingredients and
Analysis and Certification of Product Ingredients of Cutter Insect Repellent
Icarus. Unpublished study prepared by United Industries Corp. 9 p.
44147400 Avon Products, Inc. (1996) Submission of Particle Size Analysis Data in
Support of the Application for Registration for Skin So Soft Moisturizing
Outdoor Protection. Transmittal of 1 Study.
44147401 MacEachern, L. (1996) Particle Size Analysis of the Spray from Two
Different Pumps (Skin So Soft Moisturizing Outdoor Protection): Lab
Project Number: SR-6211. Unpublished study prepared by Emson, Inc. 11
P-
44167300 Repello Products, Inc. (1996) Submission of Efficacy Data in Support of the
Application for Registration of Repello Products Pleasant Protection Insect
Repelllent. Transmittal of 1 Study.
55
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BIBLIOGRAPHY
MRID
CITATION
44167301 Abraham, C. (1996) Field Evaluation of the Efficacy of Repello's Products
Efficacy Tests—Bite Count (Mosquito Exposure): Repello Products Pleasant
Protection Insect Repellent. Unpublished study prepared by Repello
Products, Inc. 6 p.
44173200 Repello Products, Inc. (1996) Submission of Efficacy Data in Support of the
Registration for Repello Products Insect Repelling Towelette. Transmittal of
1 Study.
44173201 Abraham, C. (1996) Field Evaluation of the Efficacy of Repello Products:
Efficacy Tests—Bite Count (Mosquito Exposure): Repello Products
Insect-Repelling Towelette: Lab Project Number: 8/8/96-EFFICACY
TESTS-BITE COUNT (MOSQUITO EXPOSURE). Unpublished study
prepared by Repello Products, Inc. 6 p.
44178100 S.C. Johnson & Son, Inc. (1996) Submission of Product Chemistry Data in
Support of the Amended Registration for Off! Citronella Candle.
Transmittal of 1 Study.
44178101 Wallace, J. (1996) Storage Stability: Off! Citronella Candle. Unpublished
study prepared by S.C. Johnson & Son, Inc. 7 p.
93165000 Farnam Companies Inc (1990) Reregi strati on Phase 3 Response: Oil of
citronella.
93165999 Farnam Companies Inc (1990) Reregi strati on Phase 3 Response: Oil of
citronella. Correspondence and Supporting Material.
93166000 Plantabbs Corp (1990) Reregi strati on Phase 3 Response: Oil of citronella.
93166999 Plantabbs Corp (1990) Reregi strati on Phase 3 Response: Oil of citronella.
Correspondence and Supporting Material.
93167000 American Candle Company Inc (1990) Reregi strati on Phase 3 Response:
Oil of citronella.
93167999 American Candle Company Inc (1990) Reregi strati on Phase 3 Response: Oil
of citronella. Correspondence and Supporting Material.
93170000 Natural Research People, Inc. (1990) Reregi strati on Phase 3 Response: Oil
of citronella.
56
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93170999 Natural Research People, Inc. (1990) Reregi strati on Phase 3 Response: Oil
of citronella. Correspondence and Supporting Material.
93171000 Tender Corporation (1990) Reregi strati on Phase 3 Response: Oil of
citronella.
93171999 Tender Corporation (1990) Reregi strati on Phase 3 Response: Oil of
citronella. Correspondence and Supporting Material.
93172000 Kameyama U.S.A. Inc. (1990) Reregi strati on Phase 3 Response: Oil of
citronella.
93172999 Kameyama U.S.A. Inc. (1990) Reregi strati on Phase 3 Response: Oil of
citronella. Correspondence and Supporting Material.
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The following is a list of available documents for Oil of Citronella that my further assist
you in responding to this Reregi strati on Eligibility Decision document. These documents
may be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies 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., or contact Richard King at (703)-308-8052.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Oil of Citronella.
The following documents are part of the Administrative Record for Oil of Citronella and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1.Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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