United States Prevention, Pesticides EPA 738-R-95-038
Environmental Protection And Toxic Substances July 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Methyl Nonyl Ketone
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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
reregistration eligibility review and decisions on the pesticide chemical case methyl nonyl
ketone. 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 reregistration. The RED includes the data
and labeling requirements for products for reregistration. 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 are due 90 days from
the date of this letter. The second set of required responses are 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 Special Review and Reregistration Division representative
Franklin Rubis at (703) 308-8184. Address any questions on required generic data to the
Special Review and Reregistration Division representative Paul Lewis at (703) 308-8018.
Sincerely yours,
Lois Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); 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 data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. 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 reregi strati on) separately. You may
delete uses which the RED says are ineligible for reregi strati on. 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
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. 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)
By 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
METHYL NONYL KETONE
LISTC
CASE 3094
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
METHYL NONYL KETONE REREGISTRATION ELIGIBILITY DECISION TEAM
i
EXECUTIVE SUMMARY
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 5
D. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Developmental Toxicity 7
d. Mutagenicity 8
e. Toxicology Conclusion 8
2. Exposure Assessment 8
a. Occupational and Residential 8
3. Risk Assessment 9
a. Dietary 9
b. Occupational and Residential 9
C. Environmental Assessment 9
1. Ecological Toxicity Data 9
a. Toxicity to Terrestrial Animals 10
(1) Birds: Acute and Subacute Toxicity 10
(2) Mammals 11
b. Toxicity to Aquatic Animals 11
(1) Freshwater Fish 11
(2) Freshwater Invertebrates 12
2. Environmental Fate 12
a. Environmental Fate and Transport 12
(1) Hydrolysis 12
(2) Aerobic Soil Metabolism 13
(3) Leaching-Adsorption/Desorption 13
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b. Environmental Fate and Ground Water Assessment 14
3. Exposure and Risk Characterization 15
a. Exposure and Risk to Nontarget Terrestrial Animals .... 15
(1) Birds 15
(2) Mammals 16
b. Exposure and Risk to Nontarget Aquatic Animals 16
c. Endangered Species 16
d. Exposure and Risk to Ground and Surface Water 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 16
A. Determination of Eligibility 16
B. Determination of Eligibility 17
1. Eligibility Decision 17
2. Eligible and Ineligible Uses 17
C. Regulatory Position 18
V. ACTIONS REQUIRED OF REGISTRANTS 19
1. Manufacturing-Use Products 19
a. Additional Generic Data Requirements 19
2. End-Use Products 19
a. Additional Product-Specific Data Requirements 19
3. Existing Stocks 21
VI. APPENDICES 23
APPENDIX A. Table of Use Patterns Subject to Reregistration 24
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 33
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Methyl Nonyl Ketone 42
APPENDIX D. Product Specific Data Call-In 65
Attachment 1. Chemical Status Sheets 78
Attachment 2. Product Specific Data Call-in Response Forms (Form
A inserts) Plus Instructions 79
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 81
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 88
Attachment 5. List of All Registrants Sent This Data Call-In Notice
(insert) 93
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 94
APPENDIX E. List of Available Related Documents 101
APPENDIX F. Fact Sheet 102
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METHYL NONYL KETONE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Doug Sutherland
Art Grube
Gabe Patrick
Environmental Fate and Effects Division
Larry Liu
Renee Costello
Karen Angulo
Health Effects Division
Winston Dang
Alan Levy
Kathryn Boyle
Registration Division
Beth Edwards
Shyam Mathur
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Toxicology Branch II
Risk Characterization and Analysis Branch
PM 14
Registration Support Branch
Special Review and Reregi strati on Division
Paul Lewis
Mark Wilhite
Carol Stangel
Office of Compliance Monitoring
Beverly Updike
Office of General Counsel
Kevin Lee
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Planning and Reregi strati on Branch
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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
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic 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
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
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
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.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as the "Agency" or
"EPA") has completed its reregistration assessment of the available information on the pesticidal
active ingredient methyl nonyl ketone. The active ingredient has pesticidal activity as a dog and
cat repellant/training aid and as an iris borer deterrent. Use sites include household/domestic
dwelling contents, vegetable gardens, ornamental shade trees, ornamental herbaceous plants,
ornamental lawns and turf, ornamental woody shrubs and vines, paths/patios and refuse/solid
waste containers. The Agency has reviewed the available data for methyl nonyl ketone and has
determined that products registered for the uses described in this reregistration eligibility decision
document as currently registered will not cause unreasonable risk to humans or the environment
and that these products are eligible for reregistration.
Before reregistering the products containing methyl nonyl ketone, the Agency is requiring
that product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will be
eligible for reregistration only when the other active ingredients are determined to be eligible for
reregistration.
v
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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 methyl nonyl ketone. The document consists of six sections. Section I is
the introduction. Section II describes methyl nonyl ketone, 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 methyl
nonyl ketone. Section V discusses the reregistration requirements for methyl nonyl ketone.
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 is covered by this Reregistration Eligibility
Decision:
• Common Name: Methyl nonyl ketone
• Chemical Name: 2-Undecanone
• Chemical Family: Aliphatic ketone
• CAS Registry Number: 112129
• OPP Chemical Code: 44102
• Empirical Formula: CnH220
• Basic Manufacturer: McLaughlin Gormley King Company
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 methyl nonyl ketone
is in Appendix A.
Type of Pesticide:
dog and cat repellent/training aid and iris borer deterrent
Use Sites:
Indoor Residential
household/domestic dwellings contents
Outdoor Residential
household/domestic dwellings outdoor premises
paths/pations
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solid waste containers (garbage cans and bags)
Terrestrial Nonfood Crop
ornamental and/or shade trees
ornamental herbaceous plants
ornamental lawns and turf
ornamental woody shrubs and vines
around perimeters of vegetable plantings
paths/patios
refuse/solid waste containers (garbage cans and bags)
Target Pests:
dog, cat and iris borer
Formulation Types Registered:
pressurized liquid: 1.9% methyl nonyl ketone + 0.1% related compounds; 2.0%
methyl nonyl ketone
granular: 1.9% methyl nonyl ketone + 0.1% related compounds; 0.08% methyl
nonyl ketone + 0.42% cinnamaldehyde; 6.25% thiram, 6.25% methyl nonyl
ketone and 5.50% castor oil (USP)
liquid ready-to-use (pump/sprayer): 1.8-1.9% methyl nonyl ketone + 0.1% related
compounds; 2.0% methyl nonyl ketone
solid (crystalline): 1.8% methyl nonyl ketone + 0.1% related compounds
liquid for reformulating use only: 63.33% methyl nonyl ketone and 3.34% related
compounds
Method of application:
Outdoor:
granular and crystals: band or broadcast to soil or ground as perimeter or
border treatment, between rows or around base of ornamental plants and objects.
pressurized liquid or liquid ready-to-use: apply to bark of trees and base of
shrubs. For surface treatments, spray a piece of cloth and attach it to item to be
protected. The item may or may not be dry.
Indoor:
for a spot treatment, spray a piece of cloth and attach it to item to be
protected. The item may or may not be dry.
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Application equipment:
granular formulation: fertilizer spreader and by hand
pressurized liquid and liquid ready-to-use: pump sprayer and aersol can
Application timing:
Dog and cat:
granular and crystals: repels cats and dogs up to seven to ten days. Repeat
until undesirable animal habits are broken. Repeat after rain. With crystal
formulation, apply at three to four day intervals.
pressurized liquid or liquid ready to use: repels cats and dogs for 12-24
hours. Apply every day or two or as needed.
Iris borer:
spray in the spring, midsummer and at time of transplanting. Spray leaves
after sunset or on cloudy days and soil around plants and between rows. Spray
rhizomes when transplanting and the ground into which new rhizomes are set.
Reapply if weather is cold or rain results in new growth of the host.
Application rate:
granular and crystalline formulation: sprinkle/scatter 4 lbs/1000 sq. ft. (1.28 oz.
a.i.) or 1-2 cupfuls/100 sq. ft. on soil or ground area.
pressurized liquid and liquid ready-to-use: apply until surface is slightly moistened.
Use Practice Limitations:
Do not apply directly to ornamental or other plants unless instructed to because
some vegetation may be damaged.
Pressurized liquid and liquid ready-to-use formulations may stain or soften some
fabrics or plastics.
Do not use in commercial food processing or preparation areas.
Do not contaminate food or feedstuffs. Cover exposed food, food processing areas
and food processing utensils.
Do not apply to food crops.
Do not apply to soft stemmed bodied plants.
Do not apply directly to water.
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Estimated Usage of Pesticide
Due to a lack of usage for methyl nonyl ketone, the Agency cannot estimate the
volume of use of this pesticide. However, it assumes the volume is relatively low.
C. Data Requirements
A Data Call-In was issued in 1992 for methyl nonyl ketone requiring the
submission of additional product chemistry data.
D. Regulatory History
Methyl nonyl ketone was first registered in the United States in 1966 for use as a
dog and cat repellant. Currently, there are 48 products registered to 65 companies. The
Appendix B of this document includes all data requirements identified by the Agency for
currently registered uses needed to support reregi strati on.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Common name: Methyl nonyl ketone
Empirical
formula: CnH22O
Molecular weight: 170.29
TGAI: Methyl nonyl ketone
Color: Colorless
Physical state: Clear liquid at room temperature
Odor: Slight acrid odor
Melting point: 11-14°C
Boiling point: 233-234° C
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Density:
Solubility:
Vapor pressure:
Octanol/water
partition
coefficient:
Stability:
Storage
stability:
Viscosity:
Corrosion
characteristics:
0.827g/mlat20°C
in water: 18. Ox 10'3g/l
in organic solvents: is completely miscible with acetone,
methanol, isopropanol, petroleum ether, vista LPA, Cyclo
Solv (aromatic), and chloroethene.
4.49 x 10-2Torrat25°C
koc= 16,601
Stable at room temperature. Slight discoloration was
observed over an extended period of time.
One year of storage at room temperature did not produce
any significant change regarding purity, color, specific
gravity, and refractive index.
7.5cpsat22°C
Methyl nonyl ketone is considered non-corrosive after 12
months of storage at room temperature.
B. Human Health Assessment
1. Toxicology Assessment
The methyl nonyl ketone toxicological data base is adequate and will
support reregi strati on eligibility.
a. Acute Toxicity
Table 1 below describes the acute toxicity of methyl nonyl ketone.
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Table 1: Acute Toxicity
TEST
Oral LD50 - rat
Dermal LD50 - rabbit
Inhalation LC50 - rat
Eye irritation - rabbit *
Dermal irritation - rabbit *
Dermal sensitization -
guinea pig *
MRID
41904101
41904102
43163801
41904103
41904104
41904105
41904106
RESULTS
>5,000 mg/kg males and
females
>2,000 mg/kg males and
females
>5.43 mg/L
mild conjunctival irritant
mild erythema/eschar and
edema
weak sensitizer
CATEGORY
IV
III
IV
III
III
N/A
* study is not required on technical grade active ingredient. Data are provided for informational
purposes
In an eye irritation study, methyl nonyl ketone was observed to
cause conjunctival irritation in 6/6 New Zealand white rabbits through 24
hours, 4/6 at 48 hours, 2/6 at 72 hours, 1/6 at 4 days and 0/6 at 7 days. In
a dermal irritation study in New Zealand white rabbits, erythema and
eschar formation were present in 6/6 animals through 72 hours and 3/6 at
7 days; edema was noted in 5/6 at 30-60 minutes, 2/6 at 24-72 hours and
0/6 at 7 days. There was the appearance of weak skin sensitization during
the challenge phase of a dermal sensitization study in guinea pigs.
b. Subchronic Toxicity
In a 21-day dermal toxicity study, methyl nonyl ketone was
administered at doses of 0, 30, 100, or 300 mg/kg/day (21 consecutive
days) to young adult male and female New Zealand white rabbits. The
systemic NOEL was equal to or greater than 300 mg/kg/day with the
LOEL being greater than 300 mg/kg/day. The NOEL for dermal irritation
was 100 mg/kg/day with the LOEL being 300 mg/kg/day based on
moderate to severe dermal irritation (MRID 43110301).
c. Developmental Toxicity
In a developmental toxicity (teratology) study, methyl nonyl ketone
was administered at doses of 0, 100, 300, or 1,000 mg/kg/day by gavage
7
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to Charles River Crl:CD BR albino rats on gestation days 6 through 15.
There was no evidence of maternal toxicity or developmental toxicity.
Therefore, both the maternal and developmental NOELs were set at > 1,000
mg/kg/day (the highest dose tested) (MRID 42225901, 42225902).
d. Mutagenicity
In a mouse lymphoma cell forward mutation study, dosing levels
of 0, 0.0032, 0.0042, 0.0056, 0.0075, 0.010, 0.013, 0.018, 0.024, 0.032, or
0.042 //L/mL in the absence of S9, and 0, 0.013, 0.018, 0.024, 0.032,
0.042, 0.056, 0.075, 0.10, or 0.13 //L/mL in the presence of S9 were tested.
The cultures were exposed to the methyl nonyl ketone for 4 hours. There
was no evidence of induced forward mutation at the TK locus at any of the
doses tested with or without the S9 activation (MRID 41740001).
In a Chinese hamster ovary study, dosing levels of 0, 0.0065, 0.013,
0.025, 0.05 or 0.10 //L/mL with and without S9 activation were tested.
There was no evidence of induced chromosomal aberrations over the
control values at any of the doses tested with or without the S9 activation
(MRID 41783101).
In an unscheduled DNA synthesis (UDS) assay, primary rat
hepatocytes were exposed to dosing levels of 0, 0.003, 0.01, 0.03, 0.1, or
0.3 //L/mL for 18 - 20 hours in the presence of tritiated thymidine. There
was no evidence of UDS induction as measured by the incorporation of
tritiated thymidine into DNA (autoradiography) (41774401).
e. Toxicology Conclusion
Based on available information, no toxicological endpoints of
concern (such as short term or intermediate term) were identified.
2. Exposure Assessment
a. Occupational and Residential
An occupational and/or residential exposure assessment is required
for an active ingredient if certain toxicological criteria are met and if there
is potential exposure to handlers (mixers, loaders, applicators) during use
or to persons entering treated sites after application is complete.
Handler (Mixer/Loader/Applicators) Exposures
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There is a potential for exposure to mixer/loader/applicators during
the use-patterns associated with methyl nonyl ketone, specifically potential
exposures arising from applying granulars by hand and lawn spreaders,
and applying liquid sprays to ornamentals, furniture, and rugs.
Post-Application Exposures
There is a potential for exposure to persons entering treated sites
after application of methyl nonyl ketone is complete, specifically potential
post-application exposure arising from re-entering treated lawns, gardens,
and residences.
Need for Assessment
While there is a potential for exposure to handlers as well as post-
application exposure, an occupational and/or residential exposure
assessment for methyl nonyl ketone is not required because there are no
toxicological endpoints of concern.
3. Risk Assessment
a. Dietary
Based on the current use patterns and exposure profiles for methyl
nonyl ketone, residues in/on food and/or feed are not expected to occur.
Therefore, a dietary risk characterization is not required.
b. Occupational and Residential
As stated previously, no appropriate endpoints for short term or
intermediate term occupational or residential risk assessment were
identified. Therefore, a risk characterization is not required.
C. Environmental Assessment
The Agency has adequate data to assess the risk of methyl nonyl ketone to
nontarget terrestrial organisms.
1. Ecological Toxicity Data
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a. Toxicity to Terrestrial Animals
(1) Birds: Acute and Subacute Toxicity.
In order to establish the acute and subacute toxicity
of methyl nonyl ketone to birds, the following tests were
required using the technical grade of the active ingredient
(a.i.): one avian single-dose oral (LD50) study on one
species (preferably mallard or bobwhite quail) and subacute
dietary studies (LC50) on one species of waterfowl
(preferably the mallard duck) and one species of upland
game bird (preferably bobwhite quail).
The results of the studies summarized in Tables 2
and 3 below indicate that methyl nonyl ketone is practically
nontoxic to avian species on an acute oral (Table 2) and
subacute dietary (Table 3) basis. The guideline
requirements for both the avian acute oral LD50 and the
avian subacute dietary LD50 studies have been met.
Table 2. Avian Acute Oral Toxicity
SPECIES
TESTED
Northern
Bobwhite
Mallard
% A.I.
100
100
LD5o
(mg/kg)
> 2,250
> 2,250
MRID
41986501
41986502
CONCLUSION
Practically
nontoxic
Practically
nontoxic
Table 3: Avian Subacute Dietary Toxicity
SPECIES
TESTED
Northern
Bobwhite
Mallard
% A.I.
100
100
LC,n (ppm)
> 5,620
> 5,620
MRID
41947901
41947902
CONCLUSIO
N
Practically
nontoxic
Practically
nontoxic
10
-------
(2) Mammals
Wild mammal testing is required on a case-by-case
basis, depending on the results of the lower tier studies such
as acute and subacute testing, intended use pattern, and
pertinent environmental fate characteristics. Under the
conditions of a range-finding and developmental toxicity
study done for the Agency, as summarized in the Human
Health Assessment, doses up to 1,000 mg/kg/day produced
no apparent related maternal or developmental effects on
rats. Based on these conclusions, wild animal testing was
not required for methyl nonyl ketone.
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of methyl nonyl
ketone to freshwater fish, the minimum data required on the
technical grade of the active ingredient are two freshwater
fish toxicity studies. One study should use a coldwater
species (preferably the rainbow trout), and the other should
use a warmwater species (preferably the bluegill sunfish).
The results of the acute toxicity studies summarized
in Table 4 below indicate that methyl nonyl ketone is
moderately toxic to both cold and warmwater fish. The
guideline requirements for the freshwater fish toxicity
studies have been met.
11
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Table 4: Freshwater Fish Acute Toxicity
SPECIES
TESTED
Rainbow trout
Bluegill sunfish
% A.I.
100
100
LC50 (ppm)
3.0
2.1
MRID
41909603
41909602
CONCLUSION
Moderately toxic
Moderately toxic
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of
methyl nonyl ketone to freshwater invertebrates is a freshwater
aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or
midges.
The results of the freshwater aquatic invertebrate toxicity
study summarized in Table 5 below indicate that there is sufficient
information to characterize methyl nonyl ketone as highly toxic to
aquatic invertebrates. The guideline requirement for the freshwater
aquatic invertebrate toxicity study has been met.
Table 5: Freshwater Invertebrate Toxicity
SPECIES
TESTED
Daphnia
magna
% A.I.
97.9
ECsn (ppm)
0.54
MRID
41909604
CONCLUSION
Highly toxic
2.
Environmental Fate
a. Environmental Fate and Transport
(1) Hydrolysis
In a study addressing the hydrolysis of methyl nonyl ketone,
the data indicated that the pesticide does not undergo hydrolysis.
Methyl nonyl ketone did not hydrolyze in sterile buffered aqueous
12
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solutions (pH 5, 7, and 9) incubated in the dark at 25° C for 30
days. At the end of the study, methyl nonyl ketone was 84.7-
98.9%, 94.0-103.1%, and 90.7-101.5% of the applied for the pH 5,
pH 7, and the pH 9 buffered test solutions, respectively. Material
balances ranged from 87.5 to 100.8% of the applied radioactivity.
Therefore, the study was acceptable to support the Hydrolysis data
requirement (MRID 41986401).
(2) Aerobic Soil Metabolism
The degradation of methyl nonyl ketone in soil appears to
be microbiologically mediated under aerobic conditions (with a
half-life of 0.5 day). In an aerobic soil metabolism study, methyl
nonyl ketone, at 10 ppm, degraded with a half-life of
approximately 0.5 days in sandy loam soil incubated aerobically at
25° ± 1° C. The major degradate was CO2, which totalled 48.7% of
the applied at 30 days. Other metabolites of methyl nonyl ketone
were: 4-hydroxy-2-undecanone; 10-hydroxy-2-undecanone; 2,4-
undecanone; 2,10-undecanone and; 4-hydroxypentanoic acid.
None of these metabolites were present more than 3% of the
applied at any sampling period. Therefore, the study was
acceptable to support the Aerobic Soil Metabolism data
requirement (MRID 42497201).
(3) Leaching-Adsorption/Desorption
In a Leaching-Adsorption/Desorption study, methyl nonyl
ketone was observed to be relatively immobile in soil and have a
low potential to leach into ground water or move offsite into
surface water. Methyl nonyl ketone was determined to be
relatively immobile in sodium azide-sterilized sandy loam, clay
loam, sand, and silt loam soils (Kads=18; Koc=2,480). Therefore, the
study was found to be acceptable to support the Leaching-
Adsorption/Desorption data requirement.
Although the leaching-adsorption/desorption data
requirement is satisfied, the Agency has concerns about the use of
sodium azide as a chemical inhibitor for sterilization of soils. The
Agency believes that physical or chemical sterilization (such as
autoclaving or use of sodium azide) may subtly alter the soil
chemistry, thus complicating the interpretation of the results
obtained in the batch equilibrium studies. The Agency
13
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acknowledges the difficulty of conducting a scientifically-sound
batch equilibrium study for methyl nonyl ketone because it is
unstable under aerobic conditions. Thus, no additional data are
required (MRID 42208301).
b. Environmental Fate and Ground Water Assessment
Due to the low relative mobility and the rapid degradation
of methyl nonyl ketone in soils, its low volume use, and use
patterns, the Agency concludes that the potential for methyl nonyl
ketone to leach into ground water or move offsite into surface
water would be very low.
Methyl nonyl ketone is not very soluble in water (solubility
in water is 18 ppm). It is not susceptible to hydrolysis at pH 5, 7,
and 9 in the absence of light. Because of its extremely high vapor
pressure (4.49xlO"2torr at 25°C), volatilization from soils will be an
important route of dissipation. The high octanol/water partition
coefficient (Kow= 16,218) suggests that methyl nonyl ketone will
have a high tendency to accumulate in fish. However, since methyl
nonyl ketone products are not applied to surface or ground water
and the current use patterns of methyl nonyl ketone products,
exposure of the pesticide to fish is not anticipated.
Results from an aerobic soil metabolism study showed that
methyl nonyl ketone degraded very rapidly in sandy loam soil
(half-life=0.5 day). The major degradate was CO2, which totalled
49% of applied at 30 days. Other nonvolatile metabolites identified
at low concentrations were 4-hydroxy-2-undecanone, 10-hydroxy-
2-undecanone, 2,4-undecanone, 2,10-undecanone, and 4-
hydroxypentanoic acid. None of these degradates were present at
more than 3% of the applied at any sampling period.
Methyl nonyl ketone is expected to be relatively immobile
in the environment (Kads=18; or Koc=2,480).
Based on these properties, the Agency concludes that
methyl nonyl ketone is expected to be relatively immobile and not
persistent in the environment. The major routes of dissipation are
volatilization (vapor pressure=4.49xlO"2 torr) and biotic
degradation under aerobic conditions (half-life=0.5 day).
14
-------
3. Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Terrestrial Animals
(1) Birds
There is some concern that birds may ingest the granular
formulation of methyl nonyl ketone while feeding. Therefore, a
risk assessment on the granular product is included here.
As summarized in Table 6 below, the maximum application
rate for the granular formulation is 49.5 Ibs a.i. per acre. For
broadcast applications, the LD50/ft2 for the northern bobwhite is 1.3
and for the mallard it is 0.21.
Table 6: Comparison of LD50/ft2 to the LOG for granular formulation
MAXIMUM
APPLICATION
RATE Ibs a.i./A
49.5
49.5
APPLICATION
METHOD
Broadcast
Broadcast
SPECIES
(LD50/ft2)
Northern bobwhite
(1.3)
Mallard (0.21)
LOC
High Risk > 0.5
Restricted use > 0.2
Endangered species > 0.1
The LD50/ft2 shown in Table 6 are not based on a definitive
LD50 value for birds. Both the bobwhite and the mallard studies
failed to determine an LD50 because there was not 50% mortality at
any of the test levels, including the highest. The information
gained from both studies is that the LD50 is above 2,250 mg/kg.
The LD50/ft2, the calculation being based upon an LD50 being equal
to 2,250 ppm, are considered to be much greater than the actual
acute values (which are unknown) and thus are overly
conservative. These values should be viewed as the upper limit of
what the actual values could be; the actual LD50/ft2 are unknown
and could be much less. Thus, values greater than the LOC for
high risk, restricted use, and endangered species do not necessarily
mean that risk is presumed, but rather that acute risk to avian
species, including endangered species, cannot be ruled out based
on the limited information available. If product labeling is strictly
adhered to, the likelihood of avian species being adversely
impacted is minimized.
15
-------
(2) Mammals
Methyl nonyl ketone is used as a dog and cat repellant.
Because of the repellent nature of the product, mammals are not
likely to ingest it directly. Also, according to the above range-
finding and developmental toxicity study, doses up to 1,000
mg/kg/day produced no apparent related maternal or developmental
effects on rats. Therefore, if mammals were to ingest the product,
it would have to be in an amount greater than 1,000 mg/kg/day to
have an adverse impact, and this is not likely.
b. Exposure and Risk to Nontarget Aquatic Animals
Methyl nonyl ketone displays moderate to high toxicity to
most aquatic organisms tested to date. However, the use of methyl
nonyl ketone is not likely to adversely impact aquatic organisms
because this chemical is neither persistent nor mobile in the
environment.
c. Endangered Species
The acute risk to endangered avian species cannot be
dismissed because the use rate (49.5 Ibs a.i./A) results in an LD50/ft2
that exceeds the endangered species LOG. However, based on the
application method (broadcast by hand) it is unlikely that
endangered avian species would be adversely impacted. Product
labeling must be strictly adhered to in order to minimize adverse
impacts to endangered avian species.
d. Exposure and Risk to Ground and Surface Water
Taking into account the relative immobility, the rapid
dissipation in soils, and the use patterns, it is unlikely that methyl
nonyl ketone will leach into groundwater or move offsite into
surface water.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
16
-------
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 reregi strati on. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing methyl nonyl ketone 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 methyl nonyl ketone.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of methyl nonyl ketone, 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 methyl nonyl ketone and to determine that methyl nonyl ketone can
be used without resulting in unreasonable adverse effects to humans and the environment.
The Agency therefore finds that all products containing methyl nonyl ketone 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 methyl nonyl ketone 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 methyl nonyl ketone, 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
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient methyl
nonyl ketone, the Agency has sufficient information on the health effects of
methyl nonyl ketone and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency has determined that methyl nonyl
ketone products, labeled and used as specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, the Agency concludes that products containing methyl
nonyl ketone for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
17
-------
The Agency has determined that all uses of methyl nonyl ketone are
eligible for reregi strati on.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for methyl
nonyl ketone. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Personal Protective Equipment (PPE) for Handlers (Mixer/Loader/
Applicators)
At this time there are no engineering control requirements, such as closed
systems, currently required on labeling for methyl nonyl ketone products.
For each end-use product, PPE requirements for pesticide handlers will be
set during reregi strati on in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, the PPE for pesticide handlers will be established based on
the acute toxicity of the end-use product. For occupational-use products, PPE
will be established using the process described in PR Notice 93-7 or more
recent EPA guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects:
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most occupational
end-use products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the end-use
product.
Since there are no special toxicological concerns about methyl nonyl ketone,
the establishment of active-ingredient-based handler PPE requirements is not
warranted. PPE requirements, if appropriate, will be established based on the acute
toxicity of the end-use product.
18
-------
2. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered bird
species to methyl nonyl ketone as discussed in the above environmental assessment.
However, based on the application method of the pesticide, it is unlikely that
endangered avian species would be adversely impacted.
The Endangered Species Protection Program is expected to become final in
1995. Limitations in the use of methyl nonyl ketone may be required to protect
endangered and threatened species, but these limitations have not been defined and
may be formulation specific. EPA anticipates that a consultation with the Fish and
Wildlife Service will be conducted in accordance with the species-based priority
approach described in the Program. After completion of the consultation,
registrants will be informed if any required label modifications are necessary. Such
modifications would most likely consist of the generic label statement referring
pesticide users to use limitations contained in county Bulletins.
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.
1. Manufacturing-Use Products
a. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of methyl nonyl ketone for the
above eligible uses has been reviewed and determined to be complete.
2. End-Use Products
a. 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 product specific data requirements are listed in Appendix G, the Product Specific
Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet current
EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new
19
-------
studies. If a registrant believes that previously submitted data meet current testing
standards, then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
2. Entry Restrictions
The Agency is establishing minimum entry restrictions for all methyl nonyl ketone
end-use products, as required for all pesticides, as described below.
a Entry Requirements:
Labeling for sole-active ingredient end-use products that contain methyl nonyl
ketone must be revised to adopt the entry restrictions set forth in this section.
Any conflicting entry restrictions on their current labeling must be removed.
The Agency is establishing the following entry restrictions for all homeowner
uses of methyl nonyl ketone end-use products.
For liquid applications:
"Do not allow persons or pets to enter the treated area until sprays have dried."
For dry applications:
"Do not allow persons or pets to enter the treated area until dusts have settled."
Placement on labeling — Place these statements near the beginning of the
Directions for Use section of the labeling.
b. Application Requirements:
"Do not apply this product in a way that will contact any person or pet,
either directly or through drift. Keep people and pets out of the area
during application."
Placement on labeling — Place this statement near the beginning of the
Directions for Use section of the labeling.
20
-------
c. User Safety Requirements:
• "Follow manufacturer's instructions for cleaning/maintaining personal
protective equipment. If no such instructions for washables, use detergent and
hot water. Keep and wash personal protective equipment separately from other
laundry."
Placement on labeling — Place this statement near the beginning of the
Directions for Use section of the labeling.
d. User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets on or inside
clothing. Then wash thoroughly with detergent and hot water separately from
other laundry and put on clean clothing."
• "Users should remove personal protective equipment immediately after
handling this product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly and change into clean clothing."
Placement on labeling — Place these statements near the beginning of the
Directions for Use section of the labeling.
3. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (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 methyl nonyl ketone
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
21
-------
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
22
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VI. APPENDICES
23
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24
-------
Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS
Soil treatment., When needed., Product RTU
container.
Spot treatment., When needed., Aerosol PRL
can.
Spot treatment., When needed., Pump spray RTU
bottle.
Spot treatment., When needed., Sprayer. RTU
Spray., When needed., Aerosol can.
Spray., When needed., Pump spray bottle. RTU
Spray., When needed., Sprayer.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Spray., When needed., Aerosol can. PRL
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Broadcast., When needed., By hand. G
G
Perimeter treatment., When needed., PRL
Aerosol can.
Soil broadcast treatment., When needed., G
Shaker can.
Soil treatment., When needed., Pump spray RTU
bottle.
Soil treatment., When needed., Sprayer. RTU
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
PRL
PRL
RTU
RTU
RTU
PRL
PRL
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
UC
UC
UC
UC
UC
UC
UC
* 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
NS
NS
NS
NS
NS
NS
NS
1
AN
0.5
AN
AN
1
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
.08 Ib IK sq.ft * NS NS NS
.08 Ib IK sq.ft * NS NS NS
UC * NS NS NS
.08 Ib IK sq.ft
NS NS
NS
UC * NS
UC * NS
NS AN
NS AN
NS 1
NS AN
NS
NS
NS
25
-------
Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 2
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES (con't)
Spray., When needed., Aerosol can. PRL
Sprinkle., When needed., By hand. G
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Spray., When needed., Aerosol can. PRL
ORNAMENTAL AND/OR SHADE TREES
Broadcast., When needed., By hand.
Broadcast., When needed., Spreader.
Soil treatment., When needed., Aerosol
can.
G
G
PRL
Bark treatment., When needed., Aerosol PRL
can.
Bark treatment., When needed., Pump spray RTU
bottle.
Bark treatment., When needed., Sprayer. RTU
Soil band treatment., When needed., Not FM/S
on label.
Soil broadcast treatment., When needed., G
By hand.
Soil broadcast treatment., When needed., G
Shaker can.
Soil broadcast treatment., When needed., G
Spreader.
Soil treatment., When needed., Aerosol PRL
can.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS NS NS
1.136 Ib IK sq.ft * NS NS NS NS AN NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.08 Ib IK sq.ft * NS NS NS NS NS NS
.08 Ib IK sq.ft * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
UC
NS NS
UC * NS NS
.025 Ib IK linear * NS NS
ft
.08 Ib IK sq.ft * NS NS
.08 Ib IK sq.ft * NS NS
.08 Ib IK sq.ft * NS NS
.08 Ib IK sq.ft * NS NS
.08 Ib IK sq.ft * NS NS
UC * NS NS
NS
NS
NS
NS AN NS
NS NS AN NS
NS NS AN NS
NS AN NS
NS NS AN NS
NS NS AN NS
NS AN NS
NS NS AN NS
NS NS 0.5 NS
C93
C93
26
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Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 3
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL AND/OR SHADE TREES (con't)
Soil treatment., When needed., Product
container.
Soil treatment., When needed., Pump spray RTU
bottle.
Soil treatment., When needed., Sprayer. RTU
Sprinkle., When needed., By hand.
ORNAMENTAL HERBACEOUS PLANTS
Broadcast., When needed., By hand.
Broadcast., When needed., Spreader.
Soil treatment., Foliar., Mist sprayer. RTU
Soil treatment., When needed., Aerosol
can.
Spray., Fall., Mist sprayer.
Spray., Foliar., Mist sprayer.
Spray., Rhizome., Mist sprayer.
Spray., Spring., Mist sprayer.
Spray., Transplant., Mist sprayer.
Perimeter treatment., When needed., PRL
Aerosol can.
Perimeter treatment., When needed., Not FM/S
on label.
Soil band treatment., When needed., Not FM/S
on label.
PRL
RTU
RTU
RTU
RTU
G
G
G
RTU
PRL
RTU
RTU
RTU
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS AN NS
UC * NS NS NS NS 3 NS
UC
NS
NS
NS
NS 0.5
UC * NS NS
UC * NS NS
1.136 Ib IK sq.ft * NS NS
NS NS AN
NS NS AN
NS NS AN
Use Group: TERRESTRIAL NON-POOD CROP
.08 Ib IK sq.ft * NS NS NS NS NS
.08 Ib IK sq.ft * NS NS NS NS NS
UC * NS NS NS NS NS
UC * NS NS NS NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * 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 NS
Use Group: TERRESTRIAL NON-POOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS 1 NS
.025 Ib IK linear
ft
.025 Ib IK linear
ft
NS AN NS
NS AN NS
C93
C93
C67
C67
C67
C67
C67
C67
27
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Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 4
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil broadcast treatment., When needed., G
By hand.
Soil broadcast treatment., When needed., G
Shaker can.
Soil broadcast treatment., When needed., G
Spreader.
Soil treatment., When needed., Aerosol
can.
Soil treatment., When needed., Product
container.
Soil treatment., When needed., Pump spray RTU
bottle.
Soil treatment., When needed., Sprayer.
Sprinkle., When needed., By hand.
ORNAMENTAL LAWNS AND TURF
Broadcast., When needed., By hand.
Broadcast., When needed., Spreader.
Spray., When needed., Aerosol can.
Soil broadcast treatment., When needed., G
By hand.
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)
.08 Ib IK sq.ft
NS AN NS
G
G
G
G
PRL
PRL
RTU
RTU
RTU
RTU
G
G
G
PRL
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.08 Ib IK sq.ft *
.08 Ib IK sq.ft *
.08 Ib IK sq.ft *
.08 Ib IK sq.ft *
UC *
UC *
UC *
UC *
UC *
UC *
1.136 Ib IK sq.ft *
Use Group
.08 Ib IK sq.ft *
.08 Ib IK sq.ft *
UC *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -POOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
AN
AN
AN
AN
0.5
AN
3
0.5
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.08 Ib IK sq.ft * NS NS NS NS AN NS
C93
C93
.08 Ib IK sq.ft
NS
NS
NS
NS AN
NS
28
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Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL LAWNS AND TURF (con't)
Soil broadcast treatment., When needed., G
Shaker can.
Soil broadcast treatment., When needed., G
Spreader.
G
Soil treatment., When needed., Aerosol PRL
can.
Soil treatment., When needed., Product RTU
container.
Soil treatment., When needed., Pump spray RTU
bottle.
Soil treatment., When needed., Sprayer. RTU
Sprinkle., When needed., By hand.
ORNAMENTAL NONFLOWERING PLANTS
Broadcast., When needed., By hand.
Broadcast., When needed., Spreader.
Soil broadcast treatment., When needed.,
By hand.
Soil broadcast treatment., When needed.,
Spreader.
Soil treatment., When needed., Aerosol
can.
ORNAMENTAL WOODY SHRUBS AND VINES
Broadcast., When needed., By hand.
Broadcast., When needed., Spreader.
Soil treatment., When needed., Aerosol
can.
G
G
PRL
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)
.08 Ib IK sq.ft * NS NS NS NS AN NS
.08 Ib IK sq.ft * NS NS
.08 Ib IK sq.ft * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS
1.136 Ib IK sq.ft * NS
Use Group: TE
.08 Ib IK sq.ft * NS
.08 Ib IK sq.ft * NS
.2 Ib IK sq.ft * NS
NS
NS
NS
NS AN
NS AN
NS AN
.04 Ib IK sq.ft
NS
UC * NS
NS
NS
NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
Ib IK sq.ft * NS NS NS NS NS
Ib IK sq.ft * NS NS NS NS NS
UC * NS NS NS NS NS
NS
NS
NS
NS
NS
:STRD
NS
NS
NS
NS
NS
\L NON -FOOD
NS
NS
NS
NS
NS
CROP
NS
NS
NS
AN
AN
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
C93
C93
C93
C93
C93
C93
29
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Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 6
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Soil band treatment., When needed., Not FM/S
on label.
Soil broadcast treatment., When needed.,
By hand.
Soil broadcast treatment., When needed.,
Shaker can.
Soil broadcast treatment., When needed.,
Spreader.
Soil treatment., When needed., Aerosol
can.
Soil treatment., When needed., Product
container.
Soil treatment., When needed., Pump spray RTU
bottle.
Soil treatment., When needed., Sprayer.
Sprinkle., When needed., By hand.
PATHS/PATIOS
Soil treatment., When needed., Sprayer. RT
PAVED AREAS (PRIVATE ROADS/SIDEWALKS)
Sprinkle., When needed., By hand. G
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS)
Sprinkle., When needed., By hand. G
G
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
FM/S
G
G
G
G
G
PRL
PRL
RTU
RTU
RTU
RTU
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.025 Ib IK linear
ft
.08 Ib IK sq.ft
.08 Ib IK sq.ft
.08 Ib IK sq.ft
.08 Ib IK sq.ft
.08 Ib IK sq.ft
UC
UC
UC
UC
UC
UC
1.136 Ib IK sq.ft
* 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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
AN
AN
AN
0.5
AN
3
0.5
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
Use Group: OUTDOOR RESIDENTIAL
1.136 Ib IK sq.ft * NS NS NS NS AN NS
Use Group: INDOOR RESIDENTIAL
.08 Ib IK sq.ft * NS NS NS NS AN NS
.2 Ib IK sq.ft * NS NS NS NS NS NS
C93
C93
30
-------
Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS) (con't)
Surface treatment., When needed., Aerosol PRL NA
can.
Use Group: INDOOR RESIDENTIAL (con't)
UC * NS NS NS NS NS NS
Use Group: OUTDOOR RESIDENTIAL
Spray., When needed., Aerosol can.
Spray., When needed., Sprayer.
Sprinkle., When needed., By hand.
Surface treatment., When needed., Aerosol
can.
PRL
RTU
G
G
G
PRL
NA
NA
NA
NA
NA
NA
UC * NS
UC * NS
.08 Ib IK sq.ft * NS
.08 Ib IK sq.ft * NS
.2 Ib IK sq.ft * NS
UC * NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
C93
C93
VEGETABLES (UNSPECIFIED)
Perimeter treatment., When needed., Not
on label.
FM/S
.025 Ib IK linear * NS
ft
Use Group: TERRESTRIAL NON-FOOD CROP
NS NS NS AN
Perimeter treatment., When needed.,
Product container.
Perimeter treatment., When needed., Pump
spray bottle.
UC * NS
UC * NS NS
NS AN NS
31
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Report Run Date: 07/26/95
PRD Report Date: 06/16/95
) Time 12:54
APPENDIX A ) CASE 3094, [Methyl nonyl ketone] Chemical 044102 [Methyl nonyl ketone]
LUIS 2.1) Page 8
LEGEND
444444
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)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : 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"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date : 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
FM/S : FORM NOT IDENTIFIED/SOLID
G : GRANULAR
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : 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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
U : Unknown whether PPM is given by weight or by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ". 0001234"
USE LIMITATIONS CODES
C67 : Do not broadcast product over crops grown for food, feed or other purposes.
C93 : Do not apply directly to water.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
32
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Methyl Nonyl Ketone covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Methyl Nonyl Ketone 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
0 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.
33
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisifed
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisifed
Satisfied
34
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Stability all
Oxidizing/Reducing Action all
Flammability all
Explodability all
Storage stability all
Viscosity all
Miscibility all
CITATION(S)
Satisified
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
Satisfied
ECOLOGICAL EFFECTS
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
71-4B
71-5A
71-5B
Acute Avian Oral - Quail/Duck C,I,M
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail C,I,M
Avian Dietary - Duck C,I,M
Wild Mammal Toxicity C , I , M
Avian Reproduction - Quail
Avian Reproduction - Duck
Simulated Field Study
Actual Field Study
41986501 and 41986502
41947901
41947902
42225902
35
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN CITATION(S)
72-1A Fish Toxicity Bluegill
72-IB Fish Toxicity Bluegill - TEP
72-1C Fish Toxicity Rainbow Trout
72-ID Fish Toxicity Rainbow Trout- TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
72-3D Estuarine/Marine Toxicity Fish-
TEP
72-3E Estuarine/Marine Toxicity Mollusk
-TEP
72-3F Estuarine/Marine Toxicity Shrimp
-TEP
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
72-5 Life Cycle Fish
72-6 Aquatic Organism Accumulation
72-7A Simulated Field - Aquatic
Organisms
C.I.M
C.I.M
C.I.M
41909602
41909603
41909604
36
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN CITATION(S)
72-7B Actual Field - Aquatic Organisms
122-1A Seed Germination/Seedling
Emergence
122-IB Vegetative Vigor
122-2 Aquatic Plant Growth
123-1A Seed Germination/Seedling
Emergence
123-IB Vegetative Vigor
123-2 Aquatic Plant Growth
124-1 Terrestrial Field
124-2 Aquatic Field
141-1 Honey Bee Acute Contact
141-2 Honey Bee Residue on Foliage
141-5 Field Test for Pollinators
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
41904101
41904102, 43163801
41904103
41904104
41904105
41904016
37
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN
81-7
82-1A
82-1B
82-2
82-3
82-4
82-5A
82-5B
83-1A
83-1B
83-2A
83-2B
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
2 1 -Day Dermal - Rabbit/Rat C,I,M
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
Chronic Feeding Toxicity - Rodent C,I,M
Chronic Feeding Toxicity - C,I,M
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Oncogenicity - Mouse
Developmental Toxicity - Rat C,I,M
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat C,I,M
Gene Mutation (Ames Test) C,I,M
Structural Chromosomal C,I,M
Aberration
Other Genotoxic Effects C , I , M
General Metabolism
CITATION(S)
43110301
Waived
Waived
42225902
Waived
41740001
41783101
Waived
38
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN
85-2
86-1
Dermal Penetration
Domestic Animal Safety
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A
132-1B
133-3
133-4
231
232
233
234
Foliar Residue Dissipation C,I,M
Soil Residue Dissipation C,I,M
Dermal Passive Dosimetry C,I,M
Exposure
Inhalation Passive Dosimetry C,I,M
Exposure
Estimation of Dermal Exposure at C,I,M
Outdoor Sites
Estimation of Inhalation Exposure C,I,M
at Outdoor Sites
Estimation of Dermal Exposure at C,I,M
Indoor Sites
Estimation of Inhalation Exposure C,I,M
at Indoor Sites
Satisfied
Waived
Waived
Waived
Waived
Waived
Waived
Waived
ENVIRONMENTAL FATE
160-5
161-1
161-2
161-3
161-4
Chemical Identity C.I.M
Hydrolysis C,I,M
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
41986401
39
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT USE PATTERN CITATION(S)
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
163-2 Volatility - Lab
163-3 Volatility - Field
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
164-3 Forest Field Dissipation
164-5 Long Term Soil Dissipation
165-1 Confined Rotational Crop
165-2 Field Rotational Crop
165-3 Accumulation - Irrigated Crop
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic
NonTarget
166-1 Ground Water - Small Prospective
166-2 Ground Water - Small
Retrospective
166-3 Ground Water - Irrigated
Retrospective
C.I.M
42497201
C.I.M
42208301
40
-------
Data Supporting Guideline Requirements for the Reregistration of Methyl Nonyl Ketone
REQUIREMENT
201-1
202-1
RESIDUE
171-4A
171-4B
171-4C
171-4D
171-4E
171-4F
171-4G
171-4H
171-41
171-4J
171-4K
171-4L
171-5
171-6
Droplet Size Spectrum
Drift Field Evaluation
CHEMISTRY
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method -
Animal
Storage Stability
Magnitude of Residues - Potable
H2O
Magnitude of Residues in Fish
Magnitude of Residues - Irrigated
Crop
Magnitude of Residues - Food
Handling
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials
Processed Food
Reduction of Residues
Proposed Tolerance
USE PATTERN
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
C.I.M
CITATION(S)
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
Waived
41
-------
GUIDE TO APPENDIX C
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 Reregistration 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.
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.
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.
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.
42
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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.
(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.
43
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BIBLIOGRAPHY
MRID
CITATION
00029517 Hotham, G.A. (1980) Efficacy Data for Hefty Dog/Cat Repellent. (Unpublished
study including U.S. National Bureau of Standards special publication 412,
received Apr 8, 1980 under 41847-1; prepared by Lasar Holography, Inc.,
submitted by Mobil Chemical Co., Macedon, N.Y.; CDL:242170-A)
00029519 Mobil Chemical Company (1979) Efficacy Data for Dog/Cat Repellents.
(Unpublished study received Apr 8, 1980 under 41847-1; CDL:242171-A)
00049042 Voluntary Purchasing Group, Incorporated (19??) Examples of Performance.
(Unpublished study received Dec 9, 1975 under 7401-285; CDL:229931-A)
00049043 Voluntary Purchasing Group, Incorporated (19??) Toxicology: Methyl nonyl
ketone. (Unpublished study received Dec 9, 1975 under 7401-285;
CDL:229931-B)
00049044 Voluntary Purchasing Group, Incorporated (19??) Miscellaneous Information.
(Unpublished study received Dec 9, 1975 under 7401-285; CDL:229931-C)
00058129 Sterner, W.; Grahwit, G.; Chibanguza, G. (1977) Effect of MGK Dog and Cat
Repellent, Lot 6623 on the Embryonic Development of Rats after Oral
Applikation: Project No. 5-4-165-76. (Unpublished study received March 25,
1977 under 1021-873; prepared by International Bio-Research, Inc., West
Germany, submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.;
CDL:228757-A)
00060056 Herco Chemical Products Company (19??) Efficacy: Dog-Gon. (Unpublished
study received Jan 26, 1971 under 11459-1; CDL:226784-A)
00071315 Vilkas, A.G.; Seminara, J. (1980) The Acute Toxicity of Sample # 12117902
MCTR-319-79 to the Rainbow Trout, Salmo gairdneri Richardson: UCES
Project No. 11506-05-19. (Unpublished study received Jan 13, 1981 under
41847-1; prepared by Union Carbide Corp., submitted by Mobil Chemical Co.,
Macedon, N.Y.; CDL:244140-A)
00076140 Armour Industrial Chemical Company (19??) Unsymmetrical Ketones.
Philadelphia, Pa.: Armour. (Product data bulletin; also In unpublished
submission received Mar 22, 1966 under unknown admin, no.; submitted by
McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:102947-A)
44
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BIBLIOGRAPHY
MRID
CITATION
00076141 Wisconsin Alumni Research Foundation (1966) Assay Report: WARF #
5122135. (Unpublished study received Mar 22, 1966 under unknown admin.
no.; submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.;
CDL:102947-B)
00076142 Wisconsin Alumni Research Foundation (1966) Assay Report: WARF No.
5122134. (Unpublished study received Mar 22, 1966 under unknown admin.
no.; submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.;
CDL:102947-C)
00086697 Wo, C.; Shapiro, R. (1981) Acute Oral Toxicity: Report No. T-1794.
(Unpublished study received Oct 27, 1981 under 46624-1; prepared by Nutrition
International, Inc., submitted by Market-Tech Industries, Ltd., Plainview, N.Y.;
CDL:246168-A)
00086698 Shapiro, R.; Wo, C. (1981) Acute Dermal Toxicity: Report No. T-1795.
(Unpublished study received Oct 27, 1981 under 46624-1; prepared by Nutrition
International, Inc., submitted by Market Tech Industries, Ltd.; Plainview, N.Y.;
CDL:246168-B)
00086699 Wo, C.; Shapiro, R. (1981) Primary Skin Irritation: Report No. T- 1796.
(Unpublished study received Oct 27, 1981 under 46624-1; prepared by Nutrition
International, Inc., submitted by Market Tech Industries, Ltd., Plainview, N.Y.;
CDL:246168-C)
00086700 Wo, C.; Shapiro, R. (1981) Modified Eye Irritation: Report No. T-1785.
(Unpublished study received Oct 27, 1981 under 46624-1; prepared by Nutrition
International, Inc., submitted by Market Tech Industries, Ltd., Plainview, N.Y.;
CDL:246168-D)
00086701 Wo, C.; Shapiro, R. (1981) Acute Inhalation Study: Report No. T-1797.
(Unpublished study received Oct 27, 1981 under 46624-1; prepared by Nutrition
International, Inc., submitted by Market-Tech Industries,L Ltd., Plainview,
N.Y.; CDL:246168-E)
00087093 ATI, Incorporated (1978) Confidential Statement of Formula. (Unpublished
study received May 4, 1978 under 41847-EX-l; submitted by Mobil Chemical
Co., Macedon, N.Y.; CDL:233840-A)
45
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BIBLIOGRAPHY
MRID
CITATION
00087095 Armak Company (1966) Methyl Nonyl Ketone. (Unpublished study received
May 4, 1978 under 41847-EX-l; submitted by Mobil Chemical Co., Macedon,
N.Y.; CDL:233840-C)
00087098 Mobil Chemical Company (1978) Toxicity Tests: Summary. Summary of studies
233840-H through 233840-J. (Unpublished study received May 4, 1978 under
41847-EX-l; CDL:233840-F)
00087099 Cooper, D.; Terrell, Y. (1978) Report on Oral LD50 in Rats: Laboratory No.
8E-0141. (Unpublished study received May 4, 1978 under 41847-EX-l;
prepared by Cannon Laboratories, Inc., submitted by Mobil Chemical Co.,
Macedon, N.Y.; CDL:233840-G)
00087100 Imlay, P. (1978) Report on Primary Dermal Irritation Study in Rabbits:
Laboratory No. 8E-0144. (Unpublished study received May 4, 1978 under
41847-EX-l; prepared by Cannon Laboratories, Inc., submitted by Mobil
Chemical Co., Macedon, N.Y.; CDL:233840-H)
00087101 Zeigler, R.L.; Taylor, B., Jr. (1978) Acute Inhalation Toxicity Study of Animal
Repellant Mobil #9B Concentrate, Code 259-25A: Laboratory No. 8E-0145.
(Unpublished study received May 4, 1978 under 41847-EX-l; prepared by
Cannon Laboratories, Inc., submitted by Mobil Chemical Co., Macedon, N.Y.;
CDL:233840-I)
00087102 Imlay, P. (1978) Report on Dermal LD50 in Rabbits: Laboratory No. 8E-0143.
(Unpublished study received May 4, 1978 under 41847-EX-l; prepared by
Cannon Laboratories, Inc., submitted by Mobil Chemical Co., Macedon, N.Y.;
CDL: 233840-J)
00087104 Freeman, S.K., inventor; International Flavors & Fragrances, Inc., assignee
(1969) Repelling animals with ketone. U.S. patent 3,474,176. Oct 21. 3p. Cl.
424-311; Int. Cl. A611 23/00. (Published study; CDL:233840-L)
00126742 Birch, M. (1970) Toxicological Investigation of Santicizer 97 A: Monsanto
Project No. Y-70-112. (Unpublished study received Mar 30, 1983 under
41847-3; prepared by Younger Laboratories, Inc., submitted by Mobil Chemical
Co., Macedon, NY; CDL: 249890-A)
46
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BIBLIOGRAPHY
MRID
CITATION
00126743 Mobil Chemical Co. (1979) Hefty Animal Guard Bags. (Unpublished study
Received Mar 30, 1983 under 41847-4; CDL:249892-A)
00126744 Daleo, C.; Cruzan, G. (1983) Skin Irritation of Hefty Odor Guard Plastic Bags
after a Single Application to Albino Rabbits: Study No. 21313. (Unpublished
study received Mar 30, 1983 under 41847-4; submitted by Mobil Chemical Co.,
Macedon, NY; CDL: 249892-B)
00126745 Daleo, C.; Cruzan, G. (1983) Skin Irritation of Hefty Dog and Cat Repellent
Concentrate (New) after a Single Application to Albino Rabbits: Study No.
21312. (Unpublished study received Mar 30, 1983 under 41847-4; submitted by
Mobil Chemical Co., Macedon, NY; CDL:249892-C)
00126746 Daleo, C.; Cruzan, G. (1983) Primary Eye Irritation of Hefty Dog and Cat
Repellent Concentrate (New) in Albino Rabbits: Study No. 21311. (Unpublished
study received Mar 30, 1983 under 41847-4; submitted by Mobil Chemical Co.,
Macedon, NY; CDL: 249892-D)
00132565 Ventec Laboratories, Inc. (1983) Pet Repellent Device: Controlled Release of
Methyl Nonyl Ketone. (Unpublished study received Nov 16, 1983 under
50959-1; CDL:251816-A)
00133719 Wisconsin Alumni Research Foundation (1966) Assay Report: WARF 5122135.
(Unpublished study received Mar 18, 1966 under 1021-873; submitted by
McLaughlin Gormley King Co., Minneapolis, MN; CDL:102945-A)
00133720 Wisconsin Alumni Research Foundation (1966) Assay Report: Technical Methyl
Nonyl Ketone: WARF No. 5122134. (Unpublished study received Mar 18, 1966
under 1021-873; submitted by McLaughlin Gormley King Co., Minneapolis,
MN;CDL:102945-B)
00134161 Wisconsin Alumni Research Foundation (1966) Assay Report: Methyl Nonyl
Ketone. Toxicity to Dogs and Rabbits. (Unpublished study received Jul 5, 1966
under 1021-873; submitted by McLaughlin Gormley King Co., Minneapolis,
MN; CDL:051061-A)
00134162 Wisconsin Alumni Research Foundation (1966) Acute Oral Toxicity:Rats: WARF
No. 5122135. (Unpublished study received Jul 5, 1966 under 1021-873;
47
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BIBLIOGRAPHY
MRID
CITATION
submitted by McLaughlin Gormley King Co., Minneapolis, MN;
CDL:051061-B)
00134163 McLaughlin Gormley King Co. (1966) Analytical Procedures for Methyl Nonyl
Ketone. (Unpublished study received Jul 5, 1966 under 1021-873;
CDL:051061-C)
00134169 Mobil Chemical Co. (1977) CMethyl Nonyl Ketone: Chemical and Physical
Properties. (Compilation; unpublished study received Jun 26, 1979 under
41847-1; CDL:238688-A)
00134170 Cooper, D.; Terrell, Y. (1978) Oral LD50 of Animal Repellant, Mobil #9B
Concentrate (Code 259-25A), in Rats: Laboratory No. 8E-0141. Unpublished
study received Jun 26, 1979 under 41847-1; prepared by Cannon Laboratories,
Inc., submitted by Mobil Chemical Co., Macedon, NY; CDL:238688-B)
00134171 Imlay, P. (1978) Report on Dermal LD50 in Rabbits: Animal Repellent Mobil
#9B Concentrate, Code 259-25A: Laboratory No. 8E-0143. (Unpublished study
received Jun 26, 1979 under 41847-1; prepared by Cannon Laboratories, Inc.,
submitted by Mobil Chemical Co., Macedon, NY; CDL:238688-E)
00134172 Mobil Chemical Co. (1979)
-------
BIBLIOGRAPHY
MRID
CITATION
101-205. Unpublished study prepared by Hazleton Laboratories America, Inc.
lip
00143609 Zoetis, T. (1983) Primary Eye Irritation Study in Rabbits: AHR-4827 (Sergeant's
Indoor Dog & Cat Repellent): Final Report: Project No. 101-202. Unpublished
study prepared by Hazleton Laboratories America, Inc. 17 p.
00145542 A. H. Robins Co., Inc. (1984) Product Chemistry: Sergeant's Indoor Dog and
Cat Repellent. Unpublished compilation. 16 p.
00145543 Wolfe, G. (1984) Acute Oral Toxicity Study in Rats: AHR-4827 (Sergeant's
Indoor Dog & Cat Repellent): Final Report: Project No. 101-200. Unpublished
study prepared by Hazleton Laboratories America, Inc. 10 p.
00145544 Wolfe, G. (1984) Acute Dermal Toxicity Study in Rabbits Using AHR-4827
(Sergeant's Indoor Dog & Cat Repellent): Final Report: Project No. 101-201.
15p.
00145545 Wolfe, G. (1984) Primary Dermal Irritation Study in Rabbits with AHR-4827
(Sergeant's Indoor Dog & Cat Repellent): Final Report: Project No. 101-203.
Unpublished study prepared by Hazleton Laboratories America, Inc. 12 p.
00145546 Wolfe, G. (1984) Dermal Sensitization with AHR-4827 (Sergeant's Indoor Dog
& Cat Repellent) in Guinea Pigs: Buehler's Technique Modified (1): Final
Report: Project No. 101-204. Unpublished study prepared by Hazleton
Laboratories America, Inc. 16 p.
00148462 Precision Valve Corp. (1985) Particle Size Data on Sergeants Indoor Repellant
Units. Unpublished study. 10 p.
00149982 McLaughlin Gormley King Co. (19??) GLC Method of Analysis for Methyl
Nonyl Ketone. Unpublished study. 2 p.
00150551 Farnam Companies, Inc. (1985) Product Chemistry Data Requirements: Farnam
B'Have Dog & Cat Repellent. Unpublished compilation. 21 p.
00150552 Farnam Companies, Inc. (1985) Product Chemistry Data Requirements: Farnam
Menoke Indoor-Outdoor Dog and Cat Repellent Spray. Unpublished
compilation. 21 p.
49
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BIBLIOGRAPHY
MRID
CITATION
00155093 Four Paws Products Ltd. (1985) Four Paws Keep-off Outdoor Dog and Cat
Repellent: Product Chemistry. Unpublished compilation, lip.
00156737 CSA Limited, Inc. (1985) CSA Liquid Dog & Cat Repellent: Product Chemistry.
Unpublished study. 5 p.
00157025 McLaughlin Gormley King Co. (19??) Laboratory Report: Product Chemistry
Data for TL-1853, 1854, 2040, 2041, & 2042 Containing Methyl Nonyl Ketone.
Unpublished compilation. 7 p.
00157554 Costello, B. (1986) Summary of Results of a Guinea Pig Dermal Sensitization
Studies: 85-4903A: Guinea Pig Dermal Sensitization Modified Buehler Method.
Unpublished study prepared by Biosearch Inc. 16 p.
00159984 McLaughlin Gormley King Co. (1985) GLC Analysis for Methyl Nonyl Ketone:
Keep-Off Outdoor Dog & Cat Repellent Granules. Unpublished compilation. 5
P-
00164721 Meinen, V. (1986) Farnam B'have: Dog and Cat Repellent Spray, Results from
One Year Storage Stability Test. Unpublished study prepared by McLaughlin
Gormley King Co. 1 p.
0290700 The Fuller Brush Co. (1987) Submission of Product Chemistry Data for the
Product, Off Limits Dog & Cat Repellent. Transmittal of 3 studies.
40290701 Gray, L.; Dayton, W. (1987) Product Chemistry: Product Identity and
Composition (for) Off Limits Dog & Cat Repellent: Laboratory Product # 1278.
Unpublished study prepared by The Fuller Brush Co. 7 p.
40290702 Gray, L.; Dayton, W. (1987) Product Chemistry: Analysis and Certification of
Limits (for) Off Limits & Cats Repellents: Laboratory Project # 1278.
Unpublished study prepared by The Fuller Brush Co. 6 p.
40290703 Gray, L.; Dayton, W. (1987) Product Chemistry: Physical and Chemical
Characteristics for Off Limits Dog & Cat Repellent: Laboratory Project # 1278.
Unpublished study prepared by The Fuller Brush Co. 10 p.
50
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BIBLIOGRAPHY
MRID
CITATION
40353900 McLaughlin Gormley King Co. (1987) Submission of Product Chemistry Data
To Support the Registration of MGK Dog & Cat Repellent Concentrate 1769.
Transmittal of 1 study.
40353901 Carlson, D. (1987) MGK Dog & Cat Repellent Concentrate 1769: Storage
Stability Study—End-Use Aerosol. Unpublished study prepared by McLaughlin
Gormley King Co. 4 p.
40516100 Hilo Products Inc. (1987) Submission of Chemistry Data in Support of Methyl
Nonyl Ketone. Transmittal of 1 study.
40516101 Canton, D. (1987) Product Chemistry: Hilo Outdoor Dog and Cat Repellent:
Laboratory Project ID: Prestorage Analysis. Unpublished study prepared by
McLaughlin Gormley King Co. 8 p.
40741600 Nationwide Chemical Products Inc. (1988) Submission of Chemistry Data in
Support of Dog & Cat Repellent Spray. Transmittal of 1 study.
40741601 Valentine, D. (1988) Dog & Cat Repellent Granular: Product Chemistry.
Unpublished study prepared by Nationwide Chemical Products, Inc. 6 p.
40741700 Nationwide Chemical Products, Inc. (1988) Submission of Chemistry Data in
Support of Dog & Cat Repellent Liquid. Transmittal of 1 study.
40741701 Valentine, D. (1988) Dog & Cat Repellent Liquid: Product Chemistry.
Unpublished study prepared by Nationwide Chemical Products, Inc. 6 p.
40741800 Nationwide Chemical Products, Inc. (1988) Submission of Chemistry Data in
Support of Dog & Cat Repellent. Transmittal of 1 study.
40741801 Valtentine, D. (1988) Dog & Cat Repellent: Product Chemistry. Unpublished
study prepared by Nationwide Chemical Products, Inc. 6 p.
40953200 Grant Laboratories (1988) Submission of Chemistry Data to Support the
Registration for Grant's Dog & Cat Repellent. Transmittal of 1 study.
40953201 Wall, R. (1988) Product Chemistry Data for: Grant's Dog & Cat Repellent.
Unpublished study prepared by Grant Laboratories. 7 p.
51
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BIBLIOGRAPHY
MRID
CITATION
41153500 Bonide Products Co., Inc. (1989) Submission of Product Chemistry Data in
Support of Registration of Dogzix. Transmittal of 1 study.
41153501 Wurz, J. (1989) Product Chemistry for Bonide Dogzix: Lab Project ID: Product
Chemistry—Dogzix. Unpublished study prepared by Bonide Products Co., Inc.
in cooperation with Utica College of Syracuse University. 17 p.
41459200 Tiro Industries, Inc. (1990) Submission of Chemistry, Toxicity and Efficacy Data
in Support of Iris Guard Registration. Transmital of 8 studies.
41459201 Ashton, D. (1989) Product Chemistry Data Requirements for Iris Guard.
Unpublished study prepared by Tiro Industries, Inc. 14 p.
41459202 Hershman, R. (1988) Alila Iris Borer Repellent: Acute Inahlation Toxicity,
Single Level, 4 Hour Exposure-Rats: Lab Project Number 87-5976A.
Unpublished study prepared by Biosearch, Inc. 13 p.
41459203 Gabriel, D. (1988) Alila Iris Borer Repellent: Acute Oral Toxicity, Single
Level-Rats: Lab Project Number: 87-5976. Unpublished study prepared by
Biosearch, Inc. 8 p.
41459204 Reilly, C. (1988) Alila Iris Borer Repellent: Acute Dermal Toxicity, Single
Level-Rabbits: Lab Project Number: 87-5976A. Unpublished study prepared by
Biosearch, Inc. 8 p.
41459205 Kregers, K. (1988) Alila Iris Borer Repellent: Primary Skin Irritation-Rabbits:
Lab Project Number: 87-5976A. Unpublished study prepared by Biosearch, Inc.
9 p.
41459206 Reilly, C. (1988) Alila Iris Borer Repellent: Primary Eye Irritation - Rabbits:
Lab Project Number: 87-5976A. Unpublished study prepared by Biosearch, Inc.
lip.
41459207 Reilly, C. (1988) Alila Iris Borer Repellent: Guinea Pig Dermal Sensitization -
Modified Buehler Method: Lab Project Number: 87-5976A. Unpublished study
prepared by Biosearch, Inc. 8 p.
41459208 Wadekamper, J. (1983) Iris Borer Repellent Study Using Iris Guard.
Unpublished study prepared by Tiro Industries, Inc. 13 p.
52
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BIBLIOGRAPHY
MRID
CITATION
1740000
41740001
41774400
41774401
41774402
41783100
41783101
41833800
41833801
41833802
McLaughlin Gormley King Co. (1990) Submission of Data To Support
Registration of Methyl Nonyl Ketone (MGK Dog & Cat Repellent):Toxicology
Study. Transmittal of 1 study.
San, R.; Clarke, J. (1990) L5178Y TK (-
Assay: Lab Project Number: T9487.701.
Microbiological Associates, Inc. 29 p.
•/-) Mouse Lymphoma: Mutagenesis
Unpublished study prepared by
MGK Co. (1991) Submission of Toxicity Data in Support of the Methyl Nonyl
Ketone Registration Standard. Transmittal of 2 studies.
Curren, R. (1991) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
MGK Methyl Nonyl Ketone: Lab Project Number: T9487.380. Unpublished
study prepared by Microbiological Associates, Inc. 27 p.
San, R.; Shelton, B. (1991) Salmonella/Mammalian-Microsome Plate
Incorporation Mutagenicity Assay (Ames Test): MGK Methyl Nonyl Ketone: Lab
Project Number: T9487.501. Unpublished study prepared by Microbiological
Associates, Inc. 50 p.
McLaughlin Gormley King Co. (1991) Submission of Mutagenicity data in
support of Methyl Nonyl Ketone Registration. Transmittal of 1 study.
Putman, D.; Morris, M. (1990) Final Report: Chromosome Aberrations in
Chinese Hamster Ovary (CHO) Cells: Lab Project Number: T9487. 337.
Unpublished study prepared by Microbiological Associates, Inc. 29 p.
Rudducks USA, Inc. (1991) Resubmission of Data To Support Registration of
Get Off My Garden, Dog and Cat Repellant: Toxicology Studies. Transmittal of
4 studies.
Gabriel, D. (1989) Get Off My Garden-Dog and Cat Repellant: Acute Dermal
Toxicity, Single Level-Rabbits: Lab Project No: 89-6774A. Unpublished study
prepared by Biosearch Inc. 9 p.
Gabriel, D. (1989) Get Off My Garden-Dog and Cat Repellant: Acute Oral
Toxicity, Single Level-Rats: Lab Project Number: 89-6774A. Unpublished study
prepared by Biosearch Inc. 8 p.
53
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BIBLIOGRAPHY
MRID
CITATION
41833803 Gabriel, D. (1989) Get Off My Garden-Dog and Cat Repellant: Primary Skin
Irritation - Rabbits: Lab Project Number: 89-6774A. Unpublished study
prepared by Biosearch Inc. 9 p.
41833804 Bielucke, J. (1989) Get Off My Garden-Dog and Cat Repellant:Primary
Irritation-Rabbits: Lab Project Number: 89-6774A. Unpublished study prepared
by Biosearch Inc. lip.
41871500 Rudducks USA, Inc. (1991) Submission of Data to Support the Registration of
"Get Off My Garden, Dog & Cat Repellant": Efficacy Data. Transmittal of 1
Study.
41871501 Campbell, G. (1991) Get Off My Garden, Dog & Cat Repellant EPA Reg.No.
(...): Urination/Dog Repellant Study. Unpublished Study prepared by Ontario
Nutri Lab. 24 p.
41904100 MGK (1991) Submission of Data to Support the Registration of Methyl Nonyl
Ketone; MGK Dog & Cat Repellent: Toxicology Data. Transmittal of 6 Studies.
41904101 Gabriel, D. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone)-Code
#(...): Acute Oral Toxicity, Single Level-Rats: Lab Project Number: 91-7236A.
Unpublished study prepared by Biosearch Inc. 10 p.
41904102 Gabriel, D. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone)-Code
#(...): Acute Dermal Toxicity, Single Level-Rabbits: Lab Project Number:
91-7236A. Unpublished study prepared by Biosearch Inc. 12 p.
41904103 Hershman, R. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone) -Code
#(...): Acute Inhalation Toxicity, LC50, 4-Hour Exposure-Rats: Lab Project
Number: 91-7236A. Unpublished study prepared by Biosearch Inc. 70 p.
41904104 Bielucke, J. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone) -Code
#(...): Primary Eye Irritation-Rabbits: Lab Project Number: 91-7236A.
Unpublished study prepared by Biosearch Inc. 13 p.
41904105 Romanelli, P. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone)-Code
#(...): Primary Skin Irritation-Rabbits: Lab Project Number: 91-7236A.
Unpublished study prepared by Biosearch Inc. 10 p.
54
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BIBLIOGRAPHY
MRID
CITATION
41904106 Romanelli, P. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone)-Code
#(...): Guinea Pig Dermal Sensitization-Modified Buehler Method: Lab Project
Number: 91-7236A. Unpublished study prepared by Biosearch Inc. 20 p.
41905100 Ruddocks USA, Inc. (1991) Submission of efficacy study concerning the ability
of " Get off My Garden " cat repellant to discourage cats from using the litter to
which it has been applied. Transmittal of 1 study.
41905101 Campbell, G. (1991) Get off My Garden: Spray Repellant to Discourage Cats
from Using Litter: Lab Project Number: RE 0190. Unpublished study prepared
by Ontario Nutri Lab. 23 p.
41909600 McLaughlin Gormley King Company (1991) Submission of method validation
and acute toxicity studies in response to the data requiremants for Methyl Nonyl
Ketone. Transmittal of 4 studies.
41909601 Bussard, J. (1991) Method Validation for the Analysis of Methyl Nonyl Ketone
in Aquatic Test Water: Lab Project Number: 39197. Unpublished study prepared
by ABC Laboratories, Inc. 192 p.
41909602 Sword, M.; Herzig, R. (1991) Acute Flow-Through Toxicity of Methyl Nonyl
Ketone to Bluegill (Lepomis macrochirus): Lab Project Number: 391198.
Unpublished study prepared by ABC Laboratories, Inc. 278 p.
41909603 Sword, M.; Herzig, R. (1991) Acute Flow-Through Toxicity of Methyl Nonyl
Ketone to Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: 39199.
Unpublished study prepared by ABC Laboratories, Inc. 299 p.
41909604 Blasberg, J.; Herzog, D.; Herzig, R.; (1991) Acute Toxicity of Methyl Nonyl
Ketone to Daphnia magna Under Flow-Through Conditions: Lab Project
Number: 39200. Unpublished study prepared by ABC Laboratories, Inc. 283 p.
41932100 MGK (1991) Submission of Data to Support the Reregistration of Methyl Nonyl
Ketone: Product Chemistry Data. Transmittal of 1 Study.
41932101 Lawson, P. (1991) Methyl Nonyl Ketone (MNK): Description of Each Beginning
Material in Manufacturing Process. 8 p.
55
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BIBLIOGRAPHY
MRID
CITATION
41947900 MGK (1991) Submission of Data to Support the Registration of Methyl Nonyl
Ketone: Toxicology Data. Transmittal of 2 Studies.
41947901 Beavers, J.; Grimes, J.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): A Dietary LC50 Study with the Northern Bobwhite: Lab Project
Number: 163-114. Unpublished study prepared by Wildlife International Ltd.
24 p.
41947902 Beavers, J.; Grimes, J.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): A Dietary LC50 Study with the Mallard: Lab Project Number:
163-115. Unpublished study prepared by Wildlife International Ltd. 24 p.
41972100 MGK (1991) Submission of product chemistry data in support of registration of
MGK Dog and Cat Repellent. Transmittal of 3 studies
41972101 Meinen, V.; Sundquist, D. (1990) Product Identity and Composition of Methyl
Nonyl Ketone: Lab Project Number: GLP-242/61. Unpublished study prepared
by MGK Co. 91 p.
41972102 Meinen, V.; Sundquist, D. (1991) Analysis and Certification of Product
Ingredients for Methyl Nonyl Ketone: Lab Project Number:GLP-242/62.
Unpublished study prepared by MGK Co. 44 p.
41972103 Sundquist, D.; Meinen, V. (1991) Product Chemistry of Methyl Nonyl Ketone:
Physical and Chemical Characteristics: Lab Project Number: GLP-240/226.
Unpublished study prepared by MGK Co. 35 p.
41986400 MGK Co. (1991) Submission of environmental fate data to support the
reregistration of methyl nonyl ketone. Transmittal of 1 study.
41986401 Gorman, M. (1991) Hydrolysis of Methyl Nonyl Ketone as a Function of pH at
25C: Final Report: Lab Project Number: 39313. Unpublished study prepared by
ABC Labs. 41 p.
41986500 MGK Co. (1991) Submission of toxicity data to support the registration standard
for methyl nonyl ketone. Transmittal of 4 studies.
41986501 Campbell, S.; Lynn, S.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): An Acute Oral Toxicity Study with the Northern Bobwhite: Lab
56
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BIBLIOGRAPHY
MRID
CITATION
Project Number: 163-116. Unpublished study prepared by Wildlife International
Ltd. 29 p.
41986502 Campbell, S.; Lynn, S.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): An Acute Oral Toxicity Study with the Mallard: Lab Project
Number: 163-117. Unpublished study prepared by Wildlife International Ltd.
28 p.
41986503 Pesselman, R. (1991) Water Solubility Determination of Methyl Nonyl Ketone:
Final Report: Lab Project Number: HWI 6001-709. Unpublished study prepared
by Hazleton Wise. Inc. 33 p.
41986504 Pesselman, R. (1991) Octanol/Water Partition Coefficient Determination of
Methyl Nonyl Ketone: Draft Report: Lab Project Number: HWI 6001-710.
Unpublished study prepared by Hazleton Wise. Inc. 36 p.
41999600 MGK Co. (1991) Submission of product chemistry data in support of end use
registration of a granular repellent made form MGK dog and cat repellent.
Transmittal of 1 study.
41999601 Carlson, D. (1991) Storage Stability Data: Granular Repellent made from MGK
Dog & Cat Repellent. Unpublished study prepared by MGK Co. 9 p.
42003900 McLaughlin Gormley King Co. (1991) Submission of Data To Support
Reregistration of Methyl Nonyl Ketone (MGK Dog & Cat Repellent): Product
Chemistry Study. Transmittal of 1 study.
42003901 Stashick, J.; McGowan, N. (1991) "Vapor Pressure at 25(degrees)C of Methyl
Nonyl Ketone": Final Report: Lab Project No: 39314. Unpublished study
prepared by ABC Labs., Inc. 19 p.
42013600 MGK Co. (1991) Submission of product chemsitry data in support of
reregistration of methyl nonyl ketone. Transmittal of 1 study.
42013601 Stashick, J. (1991) Vapor Pressure at 25 C of Methyl Nonyl Ketone: Lab Project
Number: 39314. Unpublished study prepared by ABC Labs, Inc. 19 p.
57
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BIBLIOGRAPHY
MRID
CITATION
42057500 McLaughlin Gormley King Co. (1991) Submission of product chemistry data in
support of reregistration of MGK Dog and Cat Repellent (Methyl Nonyl Ketone).
Transmittal of 1 study.
42057501 Meinen, V. (1991) Product Chemistry of Methyl Nonyl Ketone: Physical and
Chemical Characteristics (Supplemental Information): Lab Project Number:
GLP-226. Unpublished study prepared by McLaughlin Gormley King Co. 20 p.
42161000 McLaughlin Gormley King Co. (1992) Submission of Data in Response to Data
Requirements for Methyl Nonyl Ketone: Environmental Fate (Soil) Study.
Transmittal of 1 study.
42161001 Williams, M. (1991) "Soil/Sediment Adsorption-Desorption of carbon 14-Methyl
Nonyl Ketone": Final Report: Lab Project Number: 39436. Unpublished study
prepared by ABC Laboratories, Inc. 49 p.
42208300 MGK Co. (1992) Submission of environmental fate data in support of
reregistration of Methyl Nonyl Ketone. Transmittal of 1 study.
42208301 Williams, M. (1992) Soil/Sediment Adsorption-Desorption of Methyl Nonyl
Ketone: Lab Project Number: 39436. Unpublished study prepared by ABC
Labs., Inc. 51 p.
42225900 McLaughlin Gormley King Co. (1992) Submission of Data To Support
Registration of Methyl Nonyl Ketone (MGK Dog & Cat Repellent): Toxicology
Studies. Transmittal of 2 Studies.
42225901 Irvine, L. (1991) Methyl Nonyl Ketone (MNK): Rat Teratology Dose Ranging
Study: Lab Project Number: MCA/3/R. Unpublished study prepared by Toxicol
Labs, Ltd. 65 p.
42225902 Irvine, L. (1992) Methyl Nonyl Ketone (MNK): Rat Development Toxicity
(Teratology) Study: Lab Project Number: MCA/5/R. Unpublished study
prepared by Toxicol Labs, Ltd. 173 p.
42241300 Hartz Mountain Corp. (1992) Submission of Data To Support FIFRA Section
6(a)(2) Requirements for Hartz 2 in 1 Pesticide Products. Transmittal of 1 study.
58
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BIBLIOGRAPHY
MRID
CITATION
42241301 Perlberg, W. (1992) Letter Sent to G. LaRocca and R. Mountfort dated March
11, 1992: Summarizing alleged adverse reports for period 10/1/91 through
12/31/91: Hartz 2 in 1 Pesticide Products. Prepared by Hartz Mountain Corp.
89 p.
42497200 McLaughlin Gormley King Co. (1992) Submittal of Soil Metabolism Data in
Support of the Methyl Nonyl Ketone Reregistration. Transmittal of 1 study.
42497201 Williams, M. (1992) Aerobic Soil Metabolism of Methyl Nonyl Ketone: Lab
Project Number: 39430. Unpublished study prepared by ABC Laboratories, Inc.
46 p.
42549700 MGK (1992) Submission of toxicity and product chemistry data in support of the
registration of MGK Dog & Cat Repellent Emulsifiable 2598. Transmittal of 7
studies.
42549701 Gabriel, D. (1992) Acute Oral Toxicity LD50-Rats: MGK Dog and Cat
Repellent Emulsifiable 2598: Lab Project Number: 92-7471A. Unpublished study
prepared by Biosearch Incorporated. 23 p.
42549702 Gabriel, D. (1992) Acute Dermal Toxicity Single Level-Rabbits: MGK Dog and
Cat Repellent Emulsifiable 2598: Lab Project Number: 92-7471A. Unpublished
study prepared by Biosearch Incorporated. 15 p.
42549703 Hershman, R. (1992) Acute Inhalation Toxicity LC50-4-hour Exposure-Rats:
MGK Dog and Cat Repellent Emulsifiable 2598:Lab Project Number: 92-7471A.
Unpublished study prepared by Biosearch Incorporated. 57 p.
42549704 Moore, G. (1992) Primary Eye Irritation-Rabbits: MGK Dog and Cat Repellent
Emulsifiable 2598: Lab Project Number: 92-7471A. Unpublished study prepared
by Biosearch Incorporated. 13 p.
42549705 Romanelli, P. (1992) Primary Skin Irritation-Rabbits: MGK Dog and Cat
Repellent Emulsifiable 2598: Lab Project Number: 92-7471A. Unpublished
study prepared by Biosearch Incorporated, lip.
42549706 Moore, G. (1992) Guinea Pig Dermal Sensitization-Modified Buehler Method:
MGK Dog and Cat Repellent Emulsifiable 2598:Lab Project Number: 92-7471A.
Unpublished study prepared by Biosearch Incorporated. 23 p.
59
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BIBLIOGRAPHY
MRID
CITATION
42549707 Carlson, D. (1992) Storage Stability: MGK Dog and Cat Repellent Emulsifiable
2598 and MGK Dog and Cat Repellent 2599: Lab Project Number: GLP NO.
322. Unpublished study prepared by McLaughlin Gormley King Company. 9 p.
42762500 Dexol Industries (1993) Submission of product chemistry data in support of
registration for Dexol Dog & Cat Repellent. Transmittal of 1 study.
42762501 Prues, J. (1993) Dexol Dog & Cat Repellent: Product Chemistry Data.
Unpublished study prepared by Dexol Industries. 10 p.
42850700 MGK Co. (1993) Submission of toxicity data in support of the registration for
MGK Dog and Cat Repellent emulsifiable 1770. Transmittal of 6 studies.
2850701 Gabriel, D. (1993) Acute Oral Toxicity, Single Level-Rats: MGK Dog and Cat
Repellent Emulsifiable 1770: Lab Project Number: 93-7803A: AOT-210.
Unpublished study prepared by Biosearch Inc. lip.
42850702 Gabriel, D. (1993) Acute Dermal Toxicity, Single Level-Rabbits: MGK Dog
and Cat Repellent Emulsifiable 1770: Lab Project Number: 93-7803A:
ADT-210. Unpublished study prepared by Biosearch Inc. 15 p.
42850703 Hershman, R. (1993) Acute Inhalation Toxicity, Single Level, 4-Hour
Exposure—Rats: MGK Dog and Cat Repellent Emulsifiable 1770: Lab Project
Number: 93-7803A: AIT-214. Unpublished study prepared by Biosearch Inc.
29 p.
42850704 Moore, G. (1993) Primary Eye Irritation-Rabbits: MGK Dog and Cat Repellent
Emulsifiable 1770: Lab Project Number: 93-7803A:PEI-206. Unpublished study
prepared by Biosearch Inc. 15 p.
42850705 Moore, G. (1993) Primary Skin Irritation-Rabbits: MGK Dog and Cat Repellent
Emulsifiable 1770: Lab Project Number: 93-7803A:PSI-206-037. Unpublished
study prepared by Biosearch Inc. 12 p.
42850706 Romanelli, P. (1993) Guinea Pig Dermal Sensitization-Modified Buehler
Method: MGK Dog and Cat Repellent Emulsifiable 1770:Lab Project Number:
93-7803A: GPS-210. Unpublished study prepared by Biosearch Inc. 23 p.
60
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BIBLIOGRAPHY
MRID
CITATION
42872900 RocCorp, Inc. (1993) Submission of product chemistry data in support of the
Me-Too registration for HiLo Dog & Cat Repellent/Trainer. Transmittal of 1
study.
42872901 Donze, W. (1993) Product Chemistry: HiLo Dog & Cat Repellant/Trainer: Lab
Project Number: IN HOUSE QUALITY CONTROL. Unpublished study
prepared by RocCorp, Inc. lip.
42907700 Daniel R. Freeman (1993) Submission of Product Chemistry, Toxicology and
Efficacy Data in Support of Registration of Repel Plus Dog and Cat Repellent.
Transmittal of 8 Studies.
42907701 Shapiro, R. (1993) EPA Acute Oral Toxicity Limit Test (with Rats): Lot #43
(Repel Plus Dog and Cat Repellent): Lab Project Number: T-2435. Unpublished
study prepared by Product Safety Labs. 16 p.
42907702 Shapiro, R. (1993) EPA Acute Dermal Toxicity Limit Test (with Rabbits): Lot
#43 (Repel Plus Dog and Cat Repellent): Lab Project Number: T-2438.
Unpublished study prepared by Product Safety Labs. 15 p.
42907703 Shapiro, R. (1993) EPA Primary Dermal Irritation Test (with Rabbits):Lot #43
(Repel Plus Dog and Cat Repellent): Lab Project Number: T-2437. Unpublished
study prepared by Product Safety Labs. 15 p.
42907704 Shapiro, R. (1993) EPA Primary Eye Irritation: Animal Repellent Lot #43
(Repel Plus Dog and Cat Repellent): (with Rabbits): Lab Project Number:
T-2196. Unpublished study prepared by Product Safety Labs. 21 p.
42907705 Shapiro, R. (1993) EPA Guinea Pig Sensitization (Buehler): Lot #43 (Repel Plus
Dog and Cat Repellent): Lab Project Number:T-2439. Unpublished study
prepared by Product Safety Labs. 22 p.
42907706 Savage, J. (1993) REPEL Animal Repellent Chemical and Physical Properties:
Lab Project Number: 93009. Unpublished study prepared by Genesis Labs. 24
P-
42907707 Savage, J. (1993) REPEL Animal Repellent: Purity Analysis: Lab Project
Number: 93001. Unpublished study prepared by Genesis Labs. 30 p.
61
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BIBLIOGRAPHY
MRID
CITATION
42907708 Freeman, D. (1993) Repel Plus Dog and Cat Repellent: Efficacy. Unpublished
study prepared by Rancho Mirage in cooperation with the University of Southern
California. 10 p.
43090600 McLaughlin Gormley King Co. (1993) Submission of toxicity data in support of
registration of MGK Dog and Cat Emulsifiable 2598. Transmittal of 1 study.
43090601 Gabriel, D. (1993) Acute Dermal Toxicity, Single Level-Rabbits (MGK Dog and
Cat Emulsifiable 2598): Lab Project Number: 93/7929A. Unpublished study
prepared by Biosearch Inc. 15 p.
43110300 McLaughlin Gormley King Co. (1994) Submission of Toxicity Data for Methyl
Nonyl Ketone in Support of Registration for MGK Dog and Cat Repellent.
Transmittal of 1 Study.
43110301 Husband, R. (1994) Methyl Nonyl Ketone: 21 Day Dermal Toxicity Study in the
Rabbit: Lab Project Number: MCA/20/C: MCA/20/93. Unpublished study
prepared by Toxicol Labs. Limited. 153 p.
43163800 McLaughlin Gormley King Co. (1994) Submittal of Acute Dermal Toxicity Data
in Support of Registration of MGK Dog and Cat Repellent Technical. Transmittal
of 1 study.
43163801 Gabriel, D. (1994) Acute Dermal Toxicity, Single Level-Rabbits: MGK Dog
and Cat Repellent, Code #10-94: Lab Project Number: 93-7954A. Unpublished
study prepared by Biosearch Inc. 15 p.
43299100 Daniel R. Freeman (1994) Submission of efficacy data in support of registration
of Repels Plus Dog and Cat Repellent. Transmittal of 1 study.
43299101 Fisher, C. (1994) Efficacy: Repels Plus Dog and Cat Repellent: Lab Project
Number: DOG/AND/CAT/REPELLENCY/TEST. Unpublished study. 27 p.
43338300 GRO Tec, Inc. (1994) Submission of product chemistry data in support of
registration of Dog & Cat Repellent (methyl nonyl ketone). Transmittal of 1
study.
43338301 H. R. McLane, Inc. (1994) Dog & Cat Repellent: (Product Chemistry and
Physical and Chemical Characteristics): Lab Project Number:
62
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BIBLIOGRAPHY
MRID CITATION
EPA\PENN\59REPPC1\PM4. Unpublished study prepared in cooperation with
GRO Tec, Inc. 5 p.
93148000 Me Laughlin Gormley King Co. (1990) Reregistration Phase 3 Response: Methyl
nonyl ketone.
93148999 Me Laughlin Gormley King Co. (1990) Reregistration Phase 3 Response: Methyl
nonyl ketone. Correspondence and Supporting Material.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
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all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
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as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
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extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
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that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
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clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA. You
must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
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must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
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to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
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Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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METHYL NONYL KETONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Methyl Nonyl Ketone.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of Methyl
Nonyl Ketone. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this Methyl Nonyl Ketone Product Specific Data
Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Methyl Nonyl Ketone
are contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on Methyl Nonyl Ketone are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Methyl Nonyl Ketone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Methyl Nonyl Ketone, please
contact Paul Lewis at (703) 308-8018.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Frank Rubis at (703) 8184.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Frank Rubis
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Methyl Nonyl Ketone
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSERT PART A OF THE DCI HERE
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
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committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-in Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
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completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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THE EPA'S BATCHING OF PRODUCTS CONTAINING METHYL NONYL KETONE AS
THE ACTIVE INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS
FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient Methyl
Nonyl Ketone, the Agency has batched products that can be considered similar in terms of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., liquid, powder,
aerosol, granular, etc.), and labeling (e.g., signal word, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products within a
batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is
the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so if the data base is
complete and valid by today's standards (see acceptance criteria attached), the formulation tested is
considered by the EPA to be similar for acute toxicity, and the formulation has not been significantly
altered since submission and acceptance of the acute toxicity data. Regardless of whether new data
is generated or existing data is referenced, submissions must identify the test material by its
EPA registration number. If more than one confidential statement of formula (CSF) exists for a
product, the registrant must indicate the formulation actually tested by identifying the corresponding
CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms that are to be completed and submitted to the Agency within 90
days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the
data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).
If a registrant does not want to participate in a batch, the choices are Options 1, s4, 5 or 6.
88
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However, a registrant should know that choosing not to participate in a batch does not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Table 1 displays the batches for the active ingredient Methyl Nonyl Ketone.
Table 1, Batched Products:
Batch
1
Reg. No.
4-356
15-8
16-153
192-182
270-293
572-209
769-599
1663-30
5887-78
11715-256
49585-23
59144-19
65636-85
Active Ingredients
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 0.42%
Cinnamaldehyde ...0.08%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Form
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
89
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2
2A
769-879
1769-362
2596-27
2596-28
7056-135
8220-17
10806-2
10900-77
11715-13
13799-1
44446-52
769-603
65636-53
65846-8
68688-37
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 2.0%
Methyl Nonyl Ketone ... 2.0%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
aerosol
pump spray
pump spray
pump spray
pump spray
3
2596-53
2596-56
Methyl Nonyl Ketone ... 2.0%
Methyl Nonyl Ketone ... 2.0%
pump spray
pump spray
90
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4
10370-271
46515-33
59578-1
59578-2
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
pump spray
pump spray
pump spray
pump spray
5
5A
2915-63
5887-64
11715-199
11715-285
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
aerosol
aerosol
non-aerosol spray
non-aerosol spray
6
270-230
43591-4
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
Methyl Nonyl Ketone ... 1.9%
Related Compounds ... 0.1%
spray
spray
It is felt that data from another product within the same batch, or, better yet, the actual registration
product are most representative of the potential acute toxicity of a product. However, the Agency
will accept acute toxicity data conducted on the technical product (99.2% active ingredient) cited in
the HED chapter of the Methyl Nonyl Ketone RED (see the Hazard Assessment) in support of the
following products:
All products in batches 1, 2, sub-batch 2A, 3. Registration numbers 1021-873, and 4941-18.
It is felt that the inert ingredients contained in the above products are of low enough toxicity or in
such low concentrations that they will not change the acute toxicity profile of the technical product.
91
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Products in sub-batch 2A may cite either acute toxicity data conducted on a product from batch 2,
sub-batch 2A or the technical. Either way, these products must cite a primary eye irritation study
conducted on a product from sub-batch 2. Products in sub-batch 5A may cite either data conducted
on a product from batch 5 or sub-batch 5A. However, products in sub-batch 5A must cite a primary
eye irritation study conducted on a product of sub-batch 5A.
Table 2 lists the products the Agency was unable to batch. These products were not considered to
be similar to other products for purposes of batching. With the exception of registrations 1021-873
and 4941-18, the registrant may only cite acute toxicity data conducted on that product itself and no
other product in this RED. Registrations 1021-873 and 4941-18 may cite acute toxicity data from
the technical product in HED's chapter of the RED. If the registrant of 1021-873 or 4941-18 choses
not to cite the data on the technical, he/she must cite data conducted on the registration product.
Table 2, No Batch Group:
EPA Reg.
No.
1021-872
1021-873
1021-1637
4941-18
11715-286
20215-6
28293-26
63660-1
Active Ingredient
Methyl Nonyl Ketone .
Related Compounds
Methyl Nonyl Ketone .
Methyl Nonyl Ketone .
Related Compounds
Methyl Nonyl Ketone .
Related Compounds ..
Methyl Nonyl Ketone .
Related Compounds ..
Methyl Nonyl Ketone .
Thiram
Castor Oil
Methyl Nonyl Ketone .
Related Compounds ..
Methyl Nonyl Ketone .
Related Compounds ..
. 63.33%
.. 3.34%
. 95.00%
. 31.67%
.. 1.67%
. 1.9%
. 0.1%
. 1.9%
. 0.1%
. 6.25%
... 6.25%
... 5.50%
. 1.9%
. 0.1%
. 1.9%
. 0.1%
Formulation Type
liquid
liquid
liquid
aerosol
aerosol
powder
aerosol
spray
92
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Attachment 5. List of All Registrants Sent This Data Call-In Notice (insert)
93
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must also
be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams.
In no case will volumes be accepted. Do not mix English and metric system units
(i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure
active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become
obsolete for that specific formulation.
94
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95
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96
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product \arnc
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
97
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98
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
|
o
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
99
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100
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The following is a list of available documents related to Methyl Nonyl Ketone. It's purpose
is to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Methyl Nonyl Ketone and are included in the EPA's
Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Methyl Nonyl Ketone RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
101
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