United States Prevention, Pesticides EPA 739-R-07-004
Environmental Protection and Toxic Substances September 2007
Agency (7510P)
Reregistration
Eligibility Decision
(RED)forAlkyl
trimethylenediamines
(Case 3014)
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ATMD RED
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (EPA) has completed its
review of the available data on the antimicrobial, alkyl trimethylenediamines (ATMD). The
Reregistration Eligibility Decision (RED) was approved on September 26, 2007.
Based on the Agency's review of alkyl trimethylenediamines (ATMD), the RED and
supporting documentation are now being published. A Notice of Availability will be published in
the Federal Register announcing the publication of the RED. The RED and supporting
documents for alkyl trimethylenediamines (ATMD) will be available to the public in EPA's
Pesticide Docket EPA-HQ-OPP-2007-0537 at http://www.regulations.gov.
Please note that the attached RED document pertains only to alkyl trimethylenediamines
and presents the Agency's conclusions on the residential, occupational and ecological risks
posed by exposure to ATMD alone. This document also identifies product-specific data for
which the Agency intends to issue Data Call-Ins (DCIs). Note that DCIs, with all pertinent
instructions, will be sent to registrants at a later date. At this time, generic confirmatory data are
required. For product-specific DCIs, the first set of required responses will be due 90 days from
the receipt of the DCI letter. The second set of required responses will be due eight months from
the receipt of the DCI letter.
As part of the RED, the Agency has determined that alkyl trimethylenediamines (ATMD)
is eligible for reregistration. Sections IV and V of this RED document describe product-specific
and generic data requirements.
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ATMD RED
If you have questions pertaining to this document, please contact the Chemical Review
Manager, ShaRon Carlisle, at (703) 308-6427. For questions regarding product reregistration
and or the product DCI that accompanies this document, please contact Marshall Swindell at
(703)308-6341.
Sincerely,
?<££-^/A
Frank Sanders, Director
Antimicrobials Division (751 OP)
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ATMD RED
REREGISTRATION ELIGIBILITY
DECISION
for
Alkyl trimethylenediamines (ATMD),
Case Number 3014
Approved by:
Fran€ T. Sander^ Director
Antimicrobials Division
Date
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ATMDRED
TABLE OF CONTENTS
ATMD Reregistration Team 7
Glossary of Terms and Abbreviations 8
I. Introduction 11
II. Chemical Overview 13
A. Regulatory History 13
B. Chemical Identification 13
C. Use Profile 16
III. Summary of Alkyl Trimethylenediamines Risk Assessments 18
A. Human Health Risk Assessment 18
1. Toxicity of Alkyl Trimethylenediamines 18
2. FQPA Safety 20
3. Dietary Exposure and Risk Assessment 20
4. Residential Exposure and Risk 21
5. Aggregate Risk 21
6. Occupational Exposure 21
a. Occupational Handler Exposure 21
b. Occupational Post-Application Exposure 22
7. Human Incident Data 22
B. Environmental Risk Assessment 23
1. Environmental Fate and Ecotoxicity 23
2. Ecological Exposure and Risk 23
3. Ecological Risk Tables 24
4. Listed Species Consideration 29
a. The Endangered Species Act 31
31
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision...
A. Determination of Reregistration Eligibility 31
B. Public Comments and Responses 32
C. Regulatory Position 32
1. Food Quality Protection Act Considerations 32
2. Endocrine Disrupter Effects 32
3. Cumulative Risks 32
D. Regulatory Rationale 33
1. Endangered Species Considerations 33
a. The Endangered Species Act 33
b. General Risk Mitigation 33
V. What Registrants Need to Do 35
A. Manufacturing Use-Products 36
1. Additional Generic Data Requirements 36
2. Labeling for Technical and Manufacturing-Use Products 36
5
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ATMDRED
B. End-Use Products 37
1. Additional Product Specific Data Requirements 37
2. Labeling for End-Use Products 37
a. Label Changes Summary Table 38
VI. Appendices 39
A. Table of Use Patterns for ATMD 40
B. Table of Generic Data Requirements and Studies Use to Make the 43
Reregistration Decision
C. Technical Support Documents 50
D. Bibliography Citations 51
E. Generic Data Call-In 60
F. Product Specific Data Call-In 61
G. Batching of End-Use Products 62
H. List of All Registrants Sent the Data Call-In 63
I. List of Available Forms 63
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ATMDRED
Alkyl trimethylenediamines (ATMD), Reregistration Team
Antimicrobials Division
Science Team
SanYvette Williams-Foy, D. V.M.,
Talia Lindheimer, Chemist
Genevieve Angle, Ecotoxicity
Cassi Walls, PhD, Chemist
Srinivas Gowda, Microbiologist/Chemist
Steve Malish, PhD. Toxicologist
Johnathan Chen, PhD., Toxicologist
Risk Management
ShaRon Carlisle
Diane Isbell
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ATMDRED
Glossary of Terms and Abbreviations
aPAD
APHIS
ARTF
BCF
CDC
CDPR
CFR
ChEI
CMBS
cPAD
CSFII
CWS
DCI
DEEM
DL
Active Ingredient
Acute Population Adjusted Dose
Animal and Plant Health Inspection Service
Agricultural Re-entry Task Force
Bioconcentration Factor
Centers for Disease Control
California Department of Pesticide Regulation
Code of Federal Regulations
Cholinesterase Inhibition
Carbamate Market Basket Survey
Chronic Population Adjusted Dose
USDA Continuing Surveys for Food Intake by Individuals
Community Water System
Data Call-In
Dietary Exposure Evaluation Model
Double layer clothing {i.e., coveralls over SL}
D WLOCDrinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
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
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause death
in 50% of test animals, usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg orppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals when
administered by the route indicated (oral, dermal, inhalation), expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MPJD Master Record Identification (number). EPA's system of recording and tracking studies submitted.
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ATMDRED
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NTP National Toxicology Program
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RAC Raw Agricultural Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
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ATMDRED
Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for alkyl trimethylenediamines (ATMD) and is
issuing its risk management decision. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of currently
registered products and discussions with the registrant. As a result of this review, EPA has
determined that ATMD containing products are eligible for reregi strati on, provided that labels
are amended accordingly. That decision is discussed fully in this document.
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ATMDRED
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency. Reregi strati on involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess
the potential risks 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 or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
This document presents the EPA decision regarding the reregi strati on eligibility of the
registered uses of the alkyl trimethylenediamines (ATMD). There are five active ingredients in
the the alkyl trimethylenediamines case: Alkyl -1,3-propylenediamine (PC Code 067301); N-
Alkyl*-l,3-propylenediamine acetate *(as in fatty acids of coconut oil) (PC Code 067302); 1-
(Coco alkylamino)-3-aminopropane hydroxyacetate Cocodiamine salt (PC Code 067309);
Alkyl*-l,3-propylenediamine *(42%C12, 26%C18, 15%C14, 8%C16, 5%C10, 4%C8) (PC Code
067310); and l-(alkyl* amino)-3-aminopropane diacetate (PC Code 067310).
The alkyl trimethylenediamines are used primarily as a microbicide, bactericide, or
molluscide. Use sites for ATMD include the following industrial processes and water systems:
oilfield/petrochemical injection water systems; industrial recirculating water cooling systems;
non-potable industrial waters; other industrial processing water systems; petroleum transport
systems, storage systems and subsurface equipment; natural gas well gathering systems and
pipelines; and well completion, packer, stimulation and work over fluids. There are currently
twelve registered products for oilfield uses and three registered products for industrial
recirculating water cooling tower.
Any risks summarized in this document are those that result only from the use of the active
ingredients in the ATMD case. FQPA requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that
have a common mechanism of toxicity." The reason for consideration of other substances is due
to the possibility that low-level exposures to multiple chemical substances that cause a common
toxic effect by a common toxic mechanism could lead to the same adverse health effect as would
a higher level of exposure to any of the substances individually. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common mechanism of toxicity,
EPA has not made a common mechanism of toxicity finding for alkyl trimethylenediamines. For
information regarding EPA's efforts to determine which chemicals have a common mechanism
of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
In an effort to simplify the RED, the information presented herein is summarized from
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ATMDRED
more detailed information, which can be found in the technical supporting documents for ATMD
referenced in this RED. The risk assessments are not included in this document, but are
available in the EPA's Pesticide Docket EPA-HQ-OPP-2007-0537 at
http://www.regulations.gov.
This document consists of six sections. Section I is the introduction. Section II provides a
chemical overview, a profile of the use and usage of ATMD and its regulatory history. Section
III, Summary of ATMD risk assessment, gives an overview of the human health and
environmental assessments, based on the information available to the Agency. Section IV, Risk
Management, Reregi strati on and Tolerance Reassessment, presents the reregi strati on eligibility
and risk management decisions. Section V, What Registrants Need to Do, summarizes the
necessary label changes based on the risk mitigation measures outlined in Section IV. Finally,
the Appendices list all use patterns eligible for reregi strati on, bibliographic information, related
documents and how to access them, and Data Call-In (DCI) information.
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ATMDRED
II. CHEMICAL OVERVIEW
A. Regulatory History
The alkyl trimethylenediamines, case 3014, consists of five active ingredients (PC codes:
067301, 067302, 067309, 067310, and 067313). One of these active ingredients was registered
in June of 1955. ATMD is currently an active ingredient in 14 products. End use products are
approved for use in industrial processes and water systems such as oilfield injection water
systems. There are no tolerances for these chemicals.
B. Chemical Identification
The ATMD group is comprised of the five compounds shown in Table 1 and the physical
chemistry is shown in Table 2 below. The alkyl indicates fatty acids of coconut oil, which
contain one long alkyl chain, primarily Cu. Each chemical is identified by an individual CAS
number, so as a result, product chemistry information is provided for each. The values presented
have been obtained from the best available data and the Agency believes it is adequate to make
an assessment. However, the information can be further refined with input from the registrants
involved in this RED case.
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ATMDRED
Table 1 Active Ingredients in the Cluster Identified by Alkyl Trimethylenediamines (ATMD) (a-e)
PC
Chemical
Code
CAS
Number
Chemical Name
Structure
Common Name
067301
61791-63-7
Alkyl -1,3-
propylenediamine
(a)
R-NH(CH2)3NH2
R = derived from alkyl groups found in
coconut oil
N-(coco alkyl)
trimethylenediamine
067302
61791-64-8
N-Alkyl -1,3-
propylenediamine
acetate *(as in fatty
acids of coconut
oil)
(b)
[RNH2-[CH2]3-NH3] + 2[CH3COO]
R = derived from fatty acids of coconut oil
l-(Alkyl amino)-3-
aminopropane monoacetate
*(as in fatty acids of coconut
oil)
067309
68155-43-1
l-(Coco
alkylamino)-3-
aminopropane
hydroxyacetate
Cocodiamine salt
(c)
[RNH2-[CH2]3-NH3] + [OHCH2COO]
R = derived from fatty acids of coconut oil
l-(Alkyl amino)-3-
aminopropane
hydroxyacetate
067310
68155-37-3
Alkyl -1,3-
propylenediamine
*(42%C12,
26%C18, 15%C14,
8%C16, 5%C10,
4%C8)
(d)
/Cn
H3C
NH
"NH,
l-(Alkyl amino)-3-
aminopropane * (42%C12,
26%C18, 15%C14, 8%C16,
5%C10, 4%C8)
n= (42%C12, 26%C18, 15%C14, 8%C16,
5%C10, 4%C8)
067313
61791-64-8
1-(alkyl* amino)-3-
aminopropane
diacetate (e)
l-(Alkyl amino) -3-
aminopropane diacetate
n= (42%C12, 26%C18, 15%C14, 8%C16,
5%C10, 4%C8)
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ATMDRED
Table 2. Physical/Chemical Properties for Alkyl trimethylenediamines (ATMD)
Parameter
Molecular
Weight
Specific
Gravity
Physical State
Boiling Point
Solubility
Density
Vapor
Pressure
Melting Point
KOW
pK
PC Codes
067301(a)
139 g/mol
0.836 @ 25 °C
Not Available
572 °F
0.086 g/100 mL
water which equals
0.00086 g/mL of
water. Insoluble in
water; miscible in
organic solvents.
Not Available
<0.1 mmHg
@20°C
62 °F
Not Available
Not Available
067302 (b)
276 g/mol
Not Available
Solid @ 20 °C
180-250 °C
99.2 g/100 mL
water, which
equals 0.992
g/mL of water
0.83-0.87
<5mm Hg @
20 °C
Not required
since the end-
use
formulation is
liquid at room
temperature
Not required
because the
active
ingredient and
end-use
formulations
are soluble in
water and
therefore polar
6.42 - 8.77 for
a product with
47% a.i.
067309 (c)
338 g/mol -478
g/mol. Average
weight is 394
g/mol, and
variable
distribution in
weight is based
on varying alkyl
chain
Not Available
Not available
81 °C
50.5 g/100 mL
water which
equals 0.505
g/mL water
0.9588 g/mL
<4.27 x 10"7 mm
Hg @ 25 °C
Not Available
Not Available
Not Available
067310 (d)
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
067313 (e)
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
Not
Available
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ATMDRED
16
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C. Use Profile
The following section provides information on the currently registered uses of alkyl trimethylenediamines shown in Table 3
below. Included is an overview of the use sites and application methods. Please refer to Appendix A for a comprehensive table of uses
of ATMD eligible for reregi strati on.
Table 3. Use Profile for Alkyl trimethylenediamines (ATMD)
Parameter
Type of
Pesticide
Target
Organisms
Use Sites
Formulation
Types
Application
Rates/Methods
PC Codes
067301(a)
Antimicrobial
Bacteriocide, Molluscide
Industrial Processes and
Water Systems
Secondary Oil Recovery
Injection Water
Industrial Processing
Water, not including
fresh water cooling tower
systems
Soluble solution
Slug Method:
12 ounces of product per
1000 gallons of water.
(95ppm.)
067302 (b)
Antimicrobial
Microbicide, Bacteriocide
Industrial Processes and
Water Systems
Oilfield and
petrochemical water
injection systems
Cooling water
recirculating systems
Soluble concentrate,
ready to use solution
Oilfield and
petrochemical water
injection systems:
Slus Treatment: 1-2 pints
067309 (c)
Antimicrobial
Microbicide
Industrial
Processes and
Water Systems
Oilfield Injection
water systems
Soluble concentrate
Continuous
injection:
1 part product to
5,000-10,000 parts
067310 (d)
Antimicrobial
Microbicide
Industrial Processes and
Water Systems
Oilfield injection water
systems
Packer and workover fluids
Soluble concentrate
Waterfloods and salt water
disposal systems:
Continuous injection: 0.4-
2.0 gallons of product per
067313 (e)
Antimicrobial
Microbicide
Industrial Processes
and Water Systems
Oilfield injection water
systems
Industrial recirculating
water cooling towers
Well completion and
workover fluids.
Soluble concentrate
Oilfield injection water
systems:
Slug Treatment:
One pint to 2 quarts of
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ATMDRED
Table 3. Use Profile for Alkyl trimethylenediamines (ATMD)
Parameter
PC Codes
067301(a)
Continuous:
12 ounces of product per
1000 gallons of water.
(95ppm.), then 0.5-2.5
oz. per 100 gals
1 to 4 pints of product for
each 120,000 gallons of
water.
067302 (b)
of product per 1000
gallons of water.
Continuous Treatment: YA-
1/2 pint of product per
1000 gallons of water.
Cooling water
recirculatins systems:
Slug Treatment:
40 gallons of product per
1000 gallons of water.
Continuous Treatment: 1-
8 gallons of product per
1000 gallons of water.
067309 (c)
water when
noticeably fouled.
1 part product to
10,000-20,000
parts water to
maintain control.
Batch treatment: \
part product to
5,000-10,000 parts
water over a period
of six (6) hours,
several times a
week.
067310 (d)
1000 barrels of water
Batch treatment:
2-8 gallons of product per
1000 barrels of water.
Packer and workover
fluids:
5-10 gallons of product per
1000 barrels
067313 (e)
product per 1000
gallons of water.
Continuous Treatment:
YA pint of product per
1000 gallons of water.
Slug Treatment:
21 gallons of product
per 1000 barrels of
water.
Continuous Treatment:
4.2-8.4 gallons of
product per 1000
barrels of water.
Industrial recirculatins
water cooling towers:
One pint to 2 quarts of
product per 1000
gallons of water.
Well completion, work
over and packer fluids:
4.2-8.4 gallons of
product per 1000
barrels of water.
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ATMDRED
III. SUMMARY OF ALKYL TRIMETHYLENEDIAMINES (ATMD) RISK ASSESMENTS
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments, and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for alkyl trimethylenediamines. While the risk assessments and related
addenda are not included in this document, they are available from the OPP Public Docket,
located at http://www.regulations.gov, under docket number EPA-HQ-OPP-2007-0537. Hard
copies of these documents may be found in the OPP public docket under this same docket
number. The OPP public docket is located in Room S-4400, One Potomac Yard (South
Building), 2777 South Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
A. Human Health Risk Assessment
The human health risk assessment for ATMD incorporates potential exposure and risks
from all sources, which include food, drinking water, residential (if applicable), and occupational
scenarios. Aggregate assessments combine food, drinking water, and any residential or other
non-occupational (if applicable) exposures to determine potential exposures to the U.S.
population. The Agency's human health assessment is protective of all U.S. populations,
including infants and young children. For information on the ATMD human health risk
assessment, see ATMD Risk Assessment, dated May 8, 2007, available at www.regulations.gov
(EPA-HQ-OPP-2007-0537).
1. Toxicity of Alkyl trimethylenediamines
A brief overview of the toxicity of ATMD is presented below. The Agency has reviewed all
toxicity studies submitted for ATMD and has determined that the toxicological database is sufficient
for reregistration. For more details on the toxicity and carcinogenicity of the ATMD, see the Alkyl
trimethylenediamines Toxicology Disciplinary Chapter, dated April 5, 2007, which is available under
docket number EPA-HQ-OPP-2007-0537 at www.regulations.gov.
The Agency has not established toxicity endpoints for ATMD. ATMD is being reevaluated
qualitatively as a low exposure chemical. The classification as low exposure is based on the limited
use patterns and low potential for occupational exposure. There are no non-occupational uses of
ATMD.
Available acute toxicity data show that ATMD is toxic (Toxicity category n) in acute oral
studies in rats, less toxic (Toxicity category in) in an acute dermal toxicity study in rabbits, highly
corrosive (Toxicity category I) in a primary eye irritation study in rabbits and extremely irritating
(Toxicity category I) in primary dermal irritation studies in rabbits. No acute inhalation or dermal
sensitization is available. The acute toxicity of technical grade ATMD is summarized below in Table
4.
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ATMDRED
Table 4. Acute Toxicity Studies with l-Alkyramino-3-aminopropane [* as derived from coconut oil
fatty acids] Case Number 067310
Guideline
Number
870.1100
870.1100
870.1200
870.1300
870.2400
870.2500
870.2500
870.2600
Study Type
Acute Oral Toxicity (Rat)
Acute Oral Toxicity (Rat)
Acute Dermal (Rabbit)
Acute Inhalation
Primary Eye Irritation (Rabbit)
Primary Skin Irritation (Rabbit)
Primary Skin Irritation (Rabbit)
Dermal sensitization
MRID
Number/Citation
240231210
0658-040-03
240231210
n/a
0658-040-03
FDRL 81-080*
0658-040-03
n/a
Results
LD50 =
147.5 mg/kg
LD50 =app.
500 mg/kg
LD50 > 2000
mg/kg
n/a
Corrosive
Extremely
Irritating
Corrosive
n/a
Toxicity
Category/
Acceptable
(Yes or No)
II/Yes
[Readability issues]
II/Yes
Ill/Yes
n/a
I/Yes
[1% formulation]
I/Yes
[Readability issues]
I/Yes
n/a
Food and Drug Research Laboratories ID Number
As discussed in Chapter II, the uses include oilfield/petrochemical injection water
systems; industrial recirculating water cooling systems; non-potable industrial waters and other
industrial processing water systems. All applications of ATMD are commercial; there are no
residential applications for this chemical. As discussed in the Occupational Handler Exposure
section below, all applications of ATMD are made through closed delivery and loading systems
that result in negligible or minimal exposure to the applicator, depending on the application
equipment. No post-application exposure is anticipated. Additional information can be found in
the Occupational Handler Exposure, Section 7a of this document.
The toxicology database for ATMD is fairly limited, subchronic and chronic toxicity data
for these chemicals are not available. However, EPA believes that the available data is
representative of all the active ingredients in this case. In addition, the Agency conducted a
Structural Activity Relationship (SAR) analysis to determine if there was data available on any
structurally similar chemicals. The Agency determined that Propanediamine, N-Octyl Diacetate
(CAS 030619-57-9) is structurally similar and can be used to evaluate the relative toxicity of
ATMD in this RED.
For the structurally similar Propanediamine, N-Octyl Diacetate, the Agency reviewed a
13 week dermal study in rabbits that indicated potential reproductive concerns such as decreased
testicular weight and disturbance in spermatogenesis. These effects are shown in both low and
high treatment groups in the study. The study concluded that these effects are treatment related.
However, these effects are not seen in a typical, dose-responsive manner. Specifically, the study
indicates a greater effect in the study group that received a lower dose. In addition, other signs
of systemic effects including decreased body weight, inflation of internal organs, increased brain
weight were noted in the study. The study indicates that these effects may be related to an
infection in the test animals and are not treatment related.
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ATMDRED
Because the currently registered use patterns are not expected to result in appreciable
exposure to workers, the Agency does not intend to require additional data at this time based on
the SAR analysis. However, if additional uses are registered for ATMD, the Agency would
require additional data to support the registrations. These studies would be intended to address
potential systemic and reproductive concerns and include, but are not limited to: a subchronic
(90-day) toxicity study; a developmental toxicity study; and a mutagenicity study.
Carcinogenicity Classification
ATMD has not been assessed for carcinogenic potential. However, based on the limited
exposure of the registered use patterns, it is not believed that there is potential for long-term
exposure to ATMD.
Mutagenicity Potential
Two mutagenicity studies were submitted for ATMD. The Ames Salmonella test where
ATMD was negative for reverse mutations in the absence or presence of microsomal S9 in five
Salmonella strains up to cytotoxic concentrations. In a mouse bone marrow chromosomal
aberration test, ATMD was negative for inducing micronuclei in the polychromatic erythrocytes
of mice treated orally at doses up to clinical and cytotoxic levels (125 mg/kg).
Although both studies are considered acceptable and meet the current guidelines, the
database for mutagenicity of N-Coco-1, 3-diaminepropane is considered incomplete. As
mentioned earlier, the Agency conducted a Structural Activity Relationship (SAR) analysis to
determine if there was data available on any structurally similar chemicals. The Agency
determined that the data for Propanediamine, N-Octyl Diacetate (CAS 030619-57-9) is
structurally similar and can be used to evaluate the relative toxicity of ATMD in this RED.
Based on the results of the data from the SAR analysis, the Agency will require another
mutagenicity study if additional use patterns for ATMD are registered in the future. If required,
this study would be used to confirm that the effects noted were not treatment related
2. FQPA Safety Factor Considerations
The FQPA Safety Factor (as required by FQPA) is intended to provide an additional 10-
fold safety factor (10X), to protect for special sensitivity in infants and children to specific
pesticide residues in food, drinking water, or residential exposures, or to compensate for an
incomplete database. However, because ATMD is a non-food use chemical, this risk assessment
is not required.
3. Dietary Exposure and Risk Assessment
Based on the labeled use patterns for ATMD (oil field and recirculating cooling water
21
-------
ATMDRED
towers), the active ingredient is not expected to contact food. Although alkyl TMD is used in
cooling water tower systems, which can discharge the water into potential drinking water
sources, the label restricts the use to recirculating systems. It is anticipated that the biocides used
in recirculating systems are degraded and the concentrations are diluted by the time any
discharge actually occurs. Therefore, the Agency has determined that it is not necessary to
conduct dietary or drinking water assessments for ATMD use in recirculating cooling water
towers.
4. Residential Exposure and Risk
There are no registered residential uses for the alkyl trimethylenediamines. Therefore,
residential exposures are not expected and an assessment is not required.
5. Aggregate Risk
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures
and other exposures for which there is reliable information." Aggregate exposure will typically
include exposures from food, drinking water, residential uses of a pesticide, and other non-
occupational sources of exposure. No exposure from food, drinking water and residential
sources is expected. Therefore, this risk assessment is not required.
6. Occupational Exposure
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational risk assessed for exposure at the time of
application is termed "handler" exposure. Post-application occupational exposures occur when
worker re-enter sites treated with a pesticide. Application parameters used in the risk assessment
are generally defined by the physical nature of the formulation (e.g., formula and packaging), by
the equipment required to deliver the chemical to the use site and by the application rate required
to achieve an efficacious dose.
a. Occupational Handler Exposure
Since ATMD active ingredients have extremely low vapor pressures, respiratory
protection is not required. The Agency believes that the use of labeled personal protective
clothing (PPE) and closed loading and delivery systems results in negligible or minimal
exposure, depending on the application equipment. Therefore, the Agency has determined that it
is not necessary to perform quantitative exposure and risk assessments for these active
ingredients. However, the current labels must be revised, if necessary, to ensure the use of PPE
including gloves and specific closed delivery and loading systems such as dry coupling (i.e.,
drips no more than 2 ml) and/or metering pumps, as appropriate.
22
-------
ATMDRED
Closed loading systems are engineering controls that are " ...designed to prevent human
exposure and should not require human intervention to eliminate exposure " (CDPR 2003) *.
Closed transfer systems that require the worker to open pour the concentrate into a transfer
system are not considered under this definition of closed loading systems because the initial
exposure for the open pour will require a quantitative assessment. Although closed loading and
delivery systems are designed to prevent or eliminate exposure, zero exposure is difficult to
obtain. Although analytical techniques can measure residues at extremely low levels, for
practical purposes, these residues are considered to be negligible or minimal.
Negligible exposure can be considered to result from the use of systems that are designed
to drip less than 2 mL per coupling as in dry coupling or metering pumps that are closed on both
ends. The second category, minimal exposure, has been established because some closed
systems are not entirely enclosed or have not been engineered to reduce drips to 2 ml, but for
practical purposes effectively reduce exposure such that risks are not of concern. Minimal
exposure can be considered to result from closed systems that are designed to prevent or
eliminate inhalation and dermal exposure but are not engineered to a specification (e.g., volume
expected to be discharged).
In the case of ATMD products, the Agency expects that occupational exposures will be
negligible or minimal, assuming that the appropriate PPE (i.e., long pants, long-sleeved shirts,
and chemical resistant gloves) and label-specified closed delivery and loading systems such as
dry coupling and/or metering pumps, as appropriate, are consistently utilized. Therefore, a
quantitative exposure and risk assessment is not warranted and the risks can be considered not a
concern.
b. Occupational Post-application
Occupational post-application exposure is not expected based on the currently registered
use patterns for the alkyl trimethylenediamines. Therefore postapplication exposures where not
accessed.
7. Human Incident Data
The Agency reviewed the following sources of information for human poisoning incidents
related to ATMD use: (1) OPP Incident Data System (IDS) - The Office of Pesticide Programs
(OPP) Incident Data System contains reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies and individual consumers,
submitted to OPP since 1992; (2) California Department of Pesticide Regulation (1982-2004) -
The California Department of Pesticide Regulation pesticide poisoning surveillance program
consists of reports from physicians of illness suspected of being related to pesticide exposure
since 1982. (3) National Pesticide Information Center (NPIC) - NPIC is a toll-free information
service supported by OPP that provides a ranking of the top 200 active ingredients for which
1 Fong, H.R. 2003. An Overview of Closed System Use in California 2001-2002. Report HS-1849. California
Environmental Protection Agency, Department of Pesticide Regulation, Worker Health and Safety Branch. June2003.
23
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ATMDRED
telephone calls were received during calendar years 1984-1991. (4) National Poison Control
Centers (PCC) (1993-1996). In the numerous data bases that have been reviewed and searched,
there are no reported incidents associated with alkyl trimethylenediamines.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. The
following risk characterization is intended to describe the magnitude of the estimated
environmental risks for ATMD use sites and any associated uncertainties. For a detailed
discussion of all aspects of the environmental risk assessment, see the document "Environmental
Hazard and Risk Assessment," dated March 6, 2006 at http://www.regulations.gov.
1. Environmental Fate and Ecotoxicity Assessment/Characterization
The alkyl trimethylenediamines compound, 1-(alkyl* amino)-3-aminopropane diacetate
(applied as Duomeen-C Diacetate, 51.9% a.i. in isopropanol), has been shown to be
hydrolytically stable under abiotic and buffered conditions over the pH 5-9 range and under
abiotic and unbuffered conditions (deionized water, pH ca. 6.2) over a 30-day incubation period.
2. Ecological Exposures and Risk
For the registered uses of ATMD, the potential for exposure to ecological organisms is
expected to be low. Although the Agency has not performed label hazard or ecological risk
assessments, the Agency expects to need ecological toxicity studies for the active ingredient
and/or any of its metabolic and/or hydrolytic transformation products identified to be of potential
concern.
24
-------
ATMDRED
3. Ecological Risk
The ecotoxicological endpoints for ATMD are provided in tables 5-9 below.
Table 5. Acute Avian Toxicity Data for Alkyl trimethylenediamines
Species
Bobwhite quail
(Colinus
virginianus)
Bobwhite quail
(Colinus
virginianus)
Bobwhite quail
(Colinus
virginianus)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Chemical,
% Active
Ingredient (a.i.)
Tested
Alkyl
trimethylenediamines
100%
Alkyl
trimethylenediamines
% purity unknown
Alkyl
trimethylenediamines
23.5%
Alkyl
trimethylenediamines
22%
Alkyl
trimethylenediamines
22%
Endpoint
(mg/kg)
LD50 = 0.24
NOAEL =
0.1
LD50 = 492.5
(M)and
366.8 (F)
LD50 = 681
LD50 = 500
LD50 = 3,200
Toxicity
Category
Very highly
toxic
Moderately
toxic
Slightly
toxic
Moderately
toxic
Relatively
nontoxic
Satisfies
Guidelines/
Comments
Yes
(supplemental)
- 14-day test
duration
- >16 weeks of
age
Yes
(supplemental)
- 14-day test
duration
- 17 weeks of
age
Yes
(supplemental)
-21 -day test
duration
- Adult
Yes
(supplemental)
-21 -day test
duration
-Young adult
Yes
(supplemental)
-14-day test
duration
-Young adult
Reference
(MRID or
ACC No.)
470013023
97534
134550
106859
110384
These acceptable acute oral toxicity studies on the mallard duck and bobwhite quail
indicate that ATMD is very highly toxic to relatively nontoxic to birds on an acute oral basis
depending on the concentration of active ingredient. The guideline requirement OPPTS
850.21007(71-1) is satisfied.
25
-------
ATMDRED
Table 6. Subacute Avian Toxicity Data for Alkyl trimethylenediamines
Species
Bobwhite quail
(Colinus
virginianus)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Mallard duck
(Anas
platyrhynchos)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylenedi
amines 100%
Alkyl
trimethylenedi
amines 0.03%
Alkyl
trimethylenedi
amines 0.03%
Alkyl
trimethylenedi
amines %
purity
unknown
Alkyl
trimethylenedi
amines %
purity
unknown
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 50%
Endpoint
(ppm)
LC50(diet) =
6,400
NOAEC = 800
LC50 (diet) =
100,000
NOAEC =
100,000
LC50 (diet) =
100,000
NOAEC =
100,000
LC50 (diet) =
5,000
LC50 (diet) =
5,000
NOAEC = 500
LC50(diet) =
6,400
NOAEC =
3,200
LC50(diet) =
6,400
LC50 (diet) =
5000
Toxicity
Category
Relatively
nontoxic
Relatively
nontoxic
Relatively
nontoxic
Slightly
toxic
Slightly
toxic
Relatively
nontoxic
Relatively
nontoxic
Slightly
toxic
Satisfies Guidelines/
Comments
Yes (core)
- 8-day test duration
- 17 days of age
Yes (core)
- 8-day test duration
Yes (core)
- 8-day test duration
Yes (supplemental)
- 8-day test duration
- 1 1 days of age
Yes (supplemental)
- 8-day test duration
- 10 days of age
Yes (supplemental)
- 8-day test duration
- 10 days of age
Yes (core)
- 8-day test duration
- 16 days of age
Yes (core)
-8-day test duration
-10 days of age
Reference
(MRID or
ACC No.)
470013024
123864
123863
97516
97535
470013025
40062405
133266
The results from eight acceptable studies indicate that alkyl trimethylenediamines is
slightly toxic to relatively non-toxic to avian species through subacute dietary exposure. These
studies fulfill guideline requirements OPPTS 850.21007 (71-2a - Bobwhite quail and 71-2b -
Mallard duck).
26
-------
ATMDRED
The Agency requested that aquatic toxicity studies be conducted with alkyl
trimethylenediamines since under typical use conditions; it may be introduced into the aquatic
environment.
Table 7. Acute Toxicity of Alkyl trimethylenediamines to Freshwater Fish
Species
Bluegill sunfish
(Lepomis
macrochirus)
Rainbow trout
(Qncorhynchus
mykiss)
Bluegill sunfish
(Lepomis
macrochirus)
Rainbow trout
(Qncorhynchus
mykiss)
Rainbow trout
(Qncorhynchus
mykiss)
Redear sunfish
(Lepomis
microlophus)
Rainbow trout
(Qncorhynchus
mykiss)
Bluegill sunfish
(Lepomis
macrochirus)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylene
diamines
32%
Alkyl
trimethylene
diamines
32%
Alkyl
trimethylene
diamines
0.03%
Alkyl
trimethylene
diamines
0.03%
Alkyl
trimethylene
diamines %
purity
unknown
Alkyl
trimethylene
diamines %
purity
unknown
Alkyl
trimethylene
diamines
32%
Alkyl
trimethylene
diamines
32%
Endpoint
(mg/L)
LC50 = 0.30
(a.i.)
LC50 = 0.12
(a.i.)
LC50 =1,390
NOAEC =
1,000
LC50 = 1,300
NOAEC =
1,000
LC50=1.58
NOAEC=1.0
LC50 = 3.63
NOAEC= 1.4
LC50 = 0.87
NOAEC = 0.39
LC50 = 0.96
NOAEC = 0.72
Toxicity
Category
Highly toxic
Highly toxic
Relatively
nontoxic
Relatively
nontoxic
Moderately
toxic
Moderately
toxic
Highly toxic
Highly toxic
Satisfies
Guidelines/
Comments
Yes (supplemental)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (supplemental)
- 96-hr test duration
- static test system
Yes (supplemental)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Reference
(MRID or
ACC No.)
41786601
41786606
123862
123862
97518
97519
41786606
41786601
27
-------
ATMDRED
Table 7. Acute Toxicity of Alkyl trimethylenediamines to Freshwater Fish
Species
Bluegill sunfish
(Lepomis
macrochims)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylene
diamines
50%
Endpoint
(mg/L)
LC50 = 0.3
NOAEC = 0.1
Toxicity
Category
Highly toxic
Satisfies
Guidelines/
Comments
Yes (core)
- 96-hr test duration
- static test system
Reference
(MRID or
ACC No.)
133265
Freshwater acute toxicity tests indicate that alkyl trimethylenediamines is relatively
nontoxic to highly toxic to freshwater fish on an acute basis depending on the concentration of
active ingredient. These studies fulfill the guideline requirement for freshwater fish species
under OPPTS 850.1075 (72-la&b). Because acute toxicity to fish is < 1.0 mg/L the
environmental hazard section of ATMD labels must state: "This pesticide is toxic to fish."
Table 8. Acute Toxicity of Alkyl trimethylenediamines to Freshwater Invertebrates
Species
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylenedia
mines 32%
Alkyl
trimethylenedia
mines 32%
Alkyl
trimethylenedia
mines 32%
Alkyl
trimethylenedia
mines % purity
unknown
Endpoint
(mg/L)
EC50=0.0512
(a.i.)
EC50= 0.160
NO AEC = 0.130
EC50= 0.104
NOAEC = 0.050
LC50 = 0.12
NOAEC = 0.1
Toxicity
Category
Very
highly
toxic
Highly
toxic
Highly
toxic
Highly
toxic
Satisfies
Guidelines/
Comments
Yes (core)
- 48-hr test duration
- static test system
Yes (core)
- 48-hr test duration
- static test system
Yes (core)
- 48-hr test duration
- static test system
Yes (supplemental)
- 48-hr test duration
- static test system
Reference
(MRID or
ACC No.)
41786602
41786602
40062409
97521
The results of these studies indicate that alkyl trimethylenediamines is very highly toxic
to highly toxic to freshwater invertebrates. These studies fulfill guideline requirement OPPTS
850.1010 (72.2a). Because the acute aquatic invertebrate toxicity value is < 1.0 mg/L, the
environmental hazard section of ATMD labels must state: "This pesticide is toxic to aquatic
28
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ATMDRED
invertebrates."
Table 9. Acute Toxicity of Alkyl trimethylenediamines to Estuarine and Marine Organisms
Species
Quahog clam
(Mercenaria
mercenaria)
Atlantic
silverside
(Menidia
menidia)
Mysid shrimp
(Mysidopsis
bahia)
Pink shrimp
(Penaeus
duorarum)
Fiddler crab
(Uca pugilator)
Blue crab
(Callinectes
sapidus)
Atlantic
silverside
(Menidia
menidia)
Mysid shrimp
(Mysidopsis
bahia)
Quahog clam
(Mercenaria
mercenaria)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 0.03%
Alkyl
trimethylenedi
amines 0.03%
Alkyl
trimethylenedi
amines %
purity
unknown
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Endpoint
(mg/L)
EC50= 0.019
(a.i.)
LC50= 0.155
(a.i.)
LC50 = 0.061
(a.i.)
LC50 = 1000
LC50 = 1000
LC50 = 387
NOAEC = 274
LC50 = 0.577
NOAEC = 0.22
LC50 = 0.19
NOAEC = 0.1 3
LC50 = 0.059
NOAEC=
0.045
Toxicity
Category
Very highly
toxic
Highly toxic
Very highly
toxic
Relatively
nontoxic
Relatively
nontoxic
Relatively
nontoxic
Highly toxic
Highly toxic
Very highly
toxic
Satisfies
Guidelines/
Comments
Yes (core)
- 48-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (supplemental)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static -renewal test
system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 48-hr test duration
- static test system
Reference
(MRID or
ACC No.)
41786603
41786604
41786605
123866
123866
97520
41786604
41786605
41786603
29
-------
ATMDRED
Table 9. Acute Toxicity of Alkyl trimethylenediamines to Estuarine and Marine Organisms
Species
White shrimp
(Penaeus
setiferus)
Eastern oyster
(Crassostrea
virginica)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Alkyl
trimethylenedi
amines 32%
Alkyl
trimethylenedi
amines 32%
Endpoint
(mg/L)
LC50 = 2.39
NOAEC = 1
EC50 = 720
NOAEC = 300
Toxicity
Category
Moderately
toxic
Relatively
nontoxic
Satisfies
Guidelines/
Comments
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Reference
(MRID or
ACC No.)
40062411
40062412
The results of the studies indicate that alkyl trimethylenediamines is highly toxic to
estuarine/marine fish and very highly toxic to relatively nontoxic to estuarine/marine
invertebrates on an acute basis. These studies fulfill the guideline requirements OPPTS
850.1075/(72-3a), OPPTS 850.1035/(72-3c) and OPPTS 850.1025/(72-3b). Because
estuarine/marine aquatic fish, mollusk, and shrimp acute toxicity values are < 1.0 mg/L, the
environmental hazard section of ATMD labels must state: "This pesticide is toxic to
clams/oysters and shrimp."
Chronic toxicity testing and non-target plant phytotoxicity is required for pesticides
when certain conditions of use and environmental fate apply. Neither of these test are required
for alkyl trimethylenediamines.
4. Listed Species Consideration
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. 402.02
30
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ATMDRED
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
This approach, will allow the Agency to determine whether ATMD use has "no effect" or
"may affect" federally listed threatened or endangered species (listed species) or their designated
critical habitat. If the assessment indicates that ATMD "may affect" a listed species or its
designated critical habitat, the assessment will be refined. The refined assessment will allow the
Agency to determine whether use of ATMD is "likely to adversely affect" the species or critical
habitat or "not likely to adversely affect" the species or critical habitat. When an assessment
concludes that a pesticide's use "may affect" a listed species or its designated critical habitat, the
Agency will consult with the U.S. Fish and Wildlife Service and National Marine Fisheries
Service (Services), as appropriate. The Agency has not conducted and Endangered Species Risk
Assessment for ATMD.
-------
ATMDRED
IV. RISK MANAGEMENT, REREGISTRATION AND TOLERANCE
REASSESMENT DECSION
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient are
eligible for reregi strati on. The Agency has previously identified and required the submission of
generic (i.e., active ingredient-specific) data to support reregistration of products containing
ATMD as an active ingredient. The Agency has completed its review of the generic data and has
determined that the data are sufficient to support reregistration of all products containing alkyl
trimethylenediamines.
The Agency has completed its assessment of the dietary, residential, occupational and
ecological risks associated with the use of pesticide products containing the active ingredient
alkyl trimethylenediamines. Based on a review of the data from the SAR analysis and other
available information for the active ingredient, alkyl trimethylenediamines, the Agency has
sufficient information on the human health and ecological effects and exposure potential of
ATMD to make decisions as part of the tolerance reassessment process under FFDCA and
reregistration process under FIFRA, as amended by FQPA. The Agency has determined that
ATMD containing products are eligible for reregistration. Appendix A summarizes the uses of
ATMD that are eligible for reregistration. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of ATMD and
lists the submitted studies that the Agency found acceptable. Data gaps are identified as generic
data requirements that have not been satisfied with acceptable data.
Based on its evaluation of alkyl trimethylenediamines, the Agency has determined that
ATMD products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency may take regulatory action to
address the risk concerns from the use of alkyl trimethylenediamines. If all changes outlined in
this document are incorporated into the product labels, then all current risks for ATMD will be
substantially mitigated for the purposes of this determination. Once an Endangered Species
assessment is completed, further changes to these registrations may be necessary as explained in
Section III of this document.
B. Public Comments and Responses
Risk assessments for ATMD were not issued for public comment per the Agency's public
participation process because a risk assessment was not required based on the negligible
potential for human health or ecological exposures. To ensure that an opportunity is presented to
the public to comment on the risk assessments and risk management decisions for alkyl
trimethylenediamines, the Agency will provide a 60-day public comment period on the ATMD
RED document.
32
-------
ATMDRED
C. Regulatory Position
1. Food Quality Protection Act Findings
Based on the labeled use patterns for ATMD, the active ingredient is not expected to
contact food. Therefore ATMD is considered a non-food use chemical. A risk assessment is not
required.
2. Endocrine Disrupter Effects
EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act (FQPA), to develop a screening program to determine
whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other
endocrine effects as the Administrator may designate." Following recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined
that there was a scientific basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that EPA include evaluations of potential effects in wildlife. For pesticides,
EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.
As the science develops and resources allow, screening of additional hormone systems may be
added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, ATMD may be subject to additional screening and/or
testing to better characterize effects related to endocrine disruption.
3. Cumulative Risks
Risks summarized in this document are those that result only from the use of alkyl
trimethylenediamines. The Food Quality Protection Act (FQPA) requires that the Agency
consider "available information" concerning the cumulative effects of a particular pesticide's
residues and "other substances that have a common mechanism of toxicity." The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect, as would a higher level of exposure to any of the substances
individually. Unlike other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding for alkyl trimethylenediamines. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at
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ATMDRED
http://www.epa.gov/pesticides/cutnulative/.
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
ATMD as an active ingredient. The Agency feels there is reasonable certainty of no harm
resulting from exposure to ATMD as an active ingredient to the general population and to infants
or children in particular.
Because of the minimal potential for exposure to workers or the environment from
ATMD use, the Agency has determined that a qualitative approach to assessing human health
risks and ecological risks from exposure to these chemicals is appropriate. The chemicals in the
ATMD case have extremely low vapor pressures, resulting in very low potential for inhalation
exposure. In addition, the use of personal protective equipment (PPE) along with closed loading
and delivery systems will result in negligible or minimal exposure to workers.
In Section 7a, the Agency presented information on the Structural Activity Analysis that
was conducted for ATMD. This analysis indicated potential reproductive concerns such as
decreased testicular weight and disturbance in spermatogenesis. However, the currently
registered use patterns are not expected to result in significant exposure to workers; therefore, the
Agency does not intend to require additional risk mitigation or data at this time. However, if
additional uses are registered for ATMD, the Agency would require additional data to support
the registrations. These studies would be intended to address potential systemic and reproductive
concerns and include, but are not limited to: a two generation reproduction study; a subchronic
(90-day) toxicity study; a developmental toxicity study; and a mutagenicity study.
1. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species" (50 C.F.R. § 402.02).
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2), the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may (directly or indirectly)
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ATMDRED
significantly reduce the likelihood of both the survival and recovery of a listed species in the
wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA
2004). After the Agency's screening-level risk assessment is performed, if any of the Agency's
Listed Species LOG Criteria are exceeded for either direct or indirect effects, a determination is
made to identify if any listed or candidate species may co-occur in the area of the proposed
pesticide use. If it is determined that listed or candidate species may be present in the proposed
use areas, further biological assessment is undertaken. The extent to which listed species may be
at risk determines the need for the development of a more comprehensive consultation package
as required by the Endangered Species Act.
The future Endangered Species Assessment will allow the Agency to determine whether
ATMD uses have "no effect" or "may affect" federally listed threatened or endangered species
(listed species) or their designated critical habitat. If the assessment indicates that ATMD "may
affect" a listed species or its designated critical habitat, the assessment will be refined. The
refined assessment will allow the Agency to determine whether use of ATMD is "likely to
adversely affect" the species or critical habitat or "not likely to adversely affect" the species or
critical habitat. When an assessment concludes that a pesticide's use "may affect" a listed species
or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service
and National Marine Fisheries Service (Services), as appropriate.
b. General Risk Mitigation
ATMD end-use products (EPs) may also contain other registered pesticides. Although the
Agency is not proposing any mitigation measures for products containing ATMD specific to
federally listed threatened and endangered species, the Agency needs to address potential risks
from other end-use products. Therefore, the Agency requires that users adopt all threatened and
endangered species risk mitigation measures for all active ingredients in the product. If a
product contains multiple active ingredients with conflicting threatened and endangered species
risk mitigation measures, the more stringent measure(s) should be adopted.
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V. WHAT REGISTRANTS NEED TO DO
The Agency has determined that ATMD are eligible for reregi strati on provided that: (i)
additional data that the Agency intends to require confirm this decision; and (ii) the label
amendments are made to reflect these measures. The registrants must amend their product
labeling to incorporate the label statements set forth in the Label Changes Summary Table in
Section B below. The additional data requirements that the Agency intends to obtain will
include, among other things, submission of the following:
For ATMD technical grade active ingredient products, the registrant needs to submit the
following items:
Within 90 days from receipt of the generic data call in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and,
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact ShaRon Carlisle at (703) 308-6427 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk (DCI/AD) Document Processing Desk (DCI/AD)
ShaRon Carlisle ShaRon Carlisle
US EPA (751 OP) Office of Pesticide Programs (751 OP)
1200 Pennsylvania Ave., NW One Potomac Yard (South Building),
Washington, DC 20460 2777 South Crystal Drive
Arlington, VA 22202
For end use products containing the active ingredient alky! trimethylenediamines, the registrant
needs to submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (PDCI response form and requirements status
and registrant's response form); and,
2. Submit any time extension or waiver requests with a full written justification.
36
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ATMDRED
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (CSF) (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in Table 15
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and,
6. The product-specific data responding to the PDCI.
Please contact Marshall Swindell at (703) 308-6341 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Marshall Swindell (PM-33) Marshall Swindell (PM-33)
US EPA (751 OP) Office of Pesticide Programs (751 OP)
1200 Pennsylvania Ave., NW One Potomac Yard (South Building),
Washington, DC 20460 2777 South Crystal Drive
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of ATMD has been reviewed and
determined to be substantially complete. Based on the currently registered use patterns, the
Agency is not requiring additional data at this time. However, if additional uses are registered
for ATMD, the Agency would require additional data to support the registrations. These studies
would be intended to address potential systemic and reproductive concerns and include, but are
not limited to: a two generation reproduction study; a subchronic (90-day) toxicity study; a
developmental toxicity study; and a mutagenicity study.
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing use product (MP) labeling
37
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ATMDRED
should be revised to comply with all current EPA regulations, PR Notices and applicable policies.
The Technical and MP labeling should bear the labeling contained in Table 6, Label Changes
Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in, outlining specific acute toxicity data requirements, will
follow this RED at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 6.
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 document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in 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.
38
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ATMDRED
a. Label Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 6. Labeling Changes Summary Table
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Product
PPE
All labels must state long pants, long sleeved shirt,and chemical resistant gloves must be worn
when handling the product and it must be applied using a closed delivery system such as a dry
coupling and/or metering pump.
Precautionary
Statements
Ecological Effects Language
Required by the RED and PR
Notice 93-10 and 95-1
"This product is toxic to fish, aquatic invertebrates, oysters, and shrimp. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters
unless in accordance with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Environmental Hazard
Statements
For industrial water systems, all labels must limit use to closed systems. Use in once-through
industrial water systems is prohibited.
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ATMDRED
VI. APPENDICES
40
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Alkyl trimethylenediames Appendix A
ATMDRED
Use Site
Formulation/
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Industrial processes and water systems.
Oilfield Injections Water
Systems
Oilfield Injections Water
Systems
Oilfield Injections Water
10707-5
(Ready-to use)
10707-6
(Soluble
concentrate)
10707-33
Continuous
Injections
Batch Treatment
None Listed
Slug Treatment
Continuous Injections:
Add product at 1 part per 10,000
parts water (4 gallons per 1,000
bbl water) when system is
noticeably fouled. Product per
10,000 parts water (4 gallons per
1,000 bbl water) to maintain
control.
Batch Treatment: Add product at
1 part 10,000 parts water
(4gallons per 1,000 bbl water)
over a period of 6 hour several
times per weeks
Continuous Injections:
Add product at 1 part per 5,000
parts water (9 gallons per 1,000
bbl water) when system is
noticeably fouled. Product per
10,000 parts water (4 gallons per
1,000 bbl water) to maintain
control.
Batch Treatment: Add product at
1 part 5,000 parts water
(9gallons per 1,000 bbl water)
over a period of 6 hour several
times per weeks.
Dosages may vary from 500
None Listed
None Listed
None Listed
41
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ATMDRED
Use Site
Systems (Continued)
Oil Well Completions,
workover, stimulation fluids,
petroleum transportation
systems, storage systems and
surface equipment
Natural Gas Wells, Gathering
Systems and Pipelines
Packer Fluids and Workover
Fluids
Formulation/
Reg No.
(Ready -to use)
34688-55
(Formulation
Intermediate)
68708-8
(Ready -to use)
68708-6
(Ready -to use)
34688-67
(Ready -to use)
10707-55
(Formulation
Intermediate)
68708-6
(Ready -to use)
Method of
Application
Closed Delivery
system
Slug Treatment/
Continuous
injections
Slug, Batch and
Continuous
Treatment
None stated
Slug Treatment or
continuous
application
Injection via
chemical pump
Application Rate/ No. of
applications
ppm in slug applications. To 30
- 50ppm in continuous treatment
(1/4 pint per 1,000 gallons
equals approximately 30ppm.)
30 - 60ppm for badly fouled
systems
Formulation use only
Slug Method: 12 ounces of
product per 1000 gallons of
water. (95ppm.)
Continuous: 12 ounces of
product per 1000 gallons of
water. (95ppm), then 0.5-2.5 oz.
per 100 gallons
Continuous: 10 to 50ppm of
product
Batch or Slug: 50 to 200ppm of
product for up to 16 hours once
or twice a week as needed.
200 to 250ppm concentration
Slug Treatment: 1,000 to 50,000
ppm of product.
Continuous Treatment: 2,000
ppm of product
1200 to 2400ppm product
Use Limitations
Formulation use only
Use with closed delivery systems only.
None Listed
None Listed
None Listed
None Listed
42
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ATMDRED
Use Site
Non potable Industrial Waters
Industrial Re-circulating Water
Cooling Systems
Formulation/
Reg No.
69100-1
(Ready-to use)
10707-33
(Ready-to use)
Method of
Application
Injection into
closed delivery
systems
Apply directly to
system where it
will be uniformly
mixed
Application Rate/ No. of
applications
1 to 4ppm (1 to 4 pints of
product for each 120,000 gallons
of water.
Apply 120 to 500ppm of product
to system when re-growth is first
noticed.
Maintain 30 to 50ppm in system
for system control
Use Limitations
Closed Delivery Systems Only. Not for use in fresh
water cooling tower systems.
None Listed
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ATMDRED
APPENDIX B: ATMD
Appendix B lists the generic (not product specific) data requirements which support the re-registration of ATMD. These
requirements apply to all products, including data requirements for which a technical grade active ingredient is the test substance. The
data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments' premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
(12) will identity each study by a "Master Record Identification (MRID) number. The listed studies are considered "valid" and acceptable for
satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study.
44
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAD CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
61-1
61-2 A
61-2 B
62-1
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
143397
43000801
43132901
43148501
43355601
43355602
43355604
134346
143397
43000801
43132901
43148501
43355601
43355602
43355603
43355604
43132901
43148501
43355601
43355602
43355603
43355604
143397
43029201
43148501
43355601
43355602
43355603
43355604
45
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
830.1750
830.1800
830.6302
830.6303
830.6304
830.7220
Old
Guideline
Number
62-2
62-3
63-2
63-3
63-4
63-6
Study Title
Certification of Limits
Analytical Method
Color
Physical State
Odor
Boiling Point
Use Pattern
CITATION(S)
MRID Number
143397
43029201
43087401
43148501
143397
43029201
43103701
43148501
43355601
43355602
43355603
43355604
43087401
43148501
43406801
43024504
43029202
43087401
43148501
43390601
43406801
43084701
43148501
43406801
43024504
43029202
43090701
43132901
43148501
43390601
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
830.7300
830.7840
830.7860
830.7950
830.7370
830.7000
Old
Guideline
Number
63-7
63-8
63-9
63-10
63-12
Study Title
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
PH
Use Pattern
CITATION(S)
MRID Number
43029202
43090401
43148501
43390601
43024504
43029202
43047301
43090501
43132901
43148501
43390601
43024504
43029202
43132901
43148501
43390601
43460301
43047801
43132901
43148501
43301201
43024504
43029202
43090401
43132901
43148501
43390601
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
830.6313
830.6314
830.6316
830.6317
830.6320
Old
Guideline
Number
63-13
63-14
63-15
63-16
63-17
63-18
63-20
Study Title
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Corrosion Characteristics
Use Pattern
CITATION(S)
MRID Number
43024504
43029202
43132901
43148501
43231501
43390601
43024504
43132901
43148501
43132901
43148501
43024504
43029202
43132901
143397
43132901
43148501
43024504
43132901
43148501
43132901
43148501
ECOLOGICAL EFFECTS
850.2100
71-1 A
Avian Acute Oral Toxicity Test - Quail/duck
97534
106859
110384
134550
40062404
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
850.2200
850.1075
850.1075
850.1010
850.1025?
850.1035?
850.1045?
Old
Guideline
Number
71-2 A
72-1 A
72-1 C
72-2 A
72-3 A
72-3 B
72-3 C
Study Title
Avian Acute Dietary - Quail/duck
Fish Acute Toxicity - Bluegill
Fish Acute Toxicity - Rainbow Trout
Acute Aquatic Invertebrate Toxicity
Estu/Mari tox. Fish
Estu/Mari tox. Mollusk
Estu/Mari tox. Shrimp
Use Pattern
CITATION(S)
MRID Number
97516
97535
123863
123864
133266
40062405
470013023
470013024
470013025
97519
133265
123862
41786601
97518
41786606
97521
41786602
123866
41786604
40062412
41786603
97520
40062411
41786605
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
145463
145464
Data gap
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ATMDRED
DATA REQUIREMENT
New Guideline
Number
870.2400
870.2500
870.2600
870.3700
870.3700
870.5100
870.5375
Old
Guideline
Number
81-4
81-5
81-6
83-3 A
83-3 B
84-2 A
84-2 B
Study Title
Acute Eye Irritation - Rabbit
Acute Skin Irritation - Rabbit
Dermal Sensitization
Prenatal Developmental Toxicity - Rat
Prenatal Developmental Toxicity - Rabbit
Bacterial Reverse Mutation Test - Ames
In Vitro Mammalian Chromosome Aberration Test
Use Pattern
CITATION(S)
MRID Number
145465
145466
Data gap
Data Gap
Data Gap
42594101
42594102
*For guidelines 82-3 and 82-4, at least one is required to be fulfilled; not both (for both food and non-food uses).
**Only required for food use.
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis of Parent and Degradates
40062413
41069001
93034010
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ATMDRED
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room 119, Crystal Mall #2, 1801 Bell Street, Arlington, VA. It is open Monday
through Friday, excluding legal holidays, from 8:30 am to 4 pm.
OPP public docket is located in Room S-4400, One Potomac Yard (South Building), 2777 South
Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday, excluding Federal
holidays, from 8:30 a.m. to 4:00 p.m.
The docket initially contained the (date) preliminary risk assessment and the related
documents. EPA then considered comments on these risk assessments (which are posted to the
e-docket) and revised the risk assessments. The revised risk assessments will be posted in the
docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at www.regulations.gov
These documents include:
• Alkyl trimethylenediamines: Risk Assessment for the Reregistration Eligibility Decision (RED)
Document. PC Codes: 067301, 067302, 067309, 067310, and 067313. Antimicrobials Division,
May 8, 2007, SanYvette Williams-Foy, D.V.M., Risk Assessor
• Alkyl trimethylenediamines: Occupational Risk Assessment of Antimicrobial Uses for the
Reregistration Eligibility Decision (RED) Document. PC Codes: 067301, 067302, 067309,
067310, and 067313, Antimicrobials Division, March 21, 2007, Cassi L. Walls, Ph.D., Chemist.
• Ecological Hazard and Environmental Risk Assessment Chapter for the Alkyl
Trimethylenediamines Reregistration Eligibility Decision (RED) Document (Case No. 3014).
Risk Assessment and Science Support Branch, Antimicrobials Division, January 30, 2007,
Genevieve Angle, Biologist.
• Product Chemistry Chapter for the Alkyl trimethylenediamines Reregistration Eligibility
Decision Document (RED). Antimicrobials Division, February 27, 2007, Talia Lindheimer,
Chemist, Team II.
• Environmental Fate Science Chapter for the Alkyl trimethylenediamines Reregistration Eligibility
Decision (RED) Document Case No. 3014, DP Barcode: 336032. Risk Assessment and Science
Support Branch, Antimicrobials Division, January 30, 2007, Srinivas Gowda,
Microbiologist/Chemist.
• Evaluation of Toxicology Database for the Registration Eligibility Decision Document
Disciplinary Chapter for Alkyl Trimethylenediamines. Risk Assessment and Science Support
Branch, Antimicrobials Division, April 5, 2007, S.L. Malish, Ph.D., Toxicologist.
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Chlorine Dioxide 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.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the
case of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can
stand alone for purposes of review and can be described with a conventional bibliographic
citation. The Agency has also attempted to unite basic documents and commentaries upon them,
treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to the
citation, and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier. These
entries are listed after all MRID entries. This temporary identifying number is also to be used
whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material submitted to
EPA, by a description of the earliest known submission. Bibliographic conventions used reflect
the standard of the American National Standards Institute (ANSI), expanded to provide for
certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could be
identified, the Agency has shown the first submitter as the author.
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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 (1999), the Agency was unable
to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements describing
the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other administrative
number associated with the earliest known submission.
(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.
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1. MRID Studies
MRID# Citation
MRID 106859. Fletcher, D. (1973) Report to Nalco Chemical Company: Acute Oral Toxicity
Study with 32D16 in Bobwhite Quail: IBT No. 651-02892. Unpublished study received Apr 9,
1973 under 1706-126; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Nalco
Chemical Co., Oak Brook, IL; CDL: 051060-D)
MRID 110384. Fletcher, D. (1973) Report to Nalco Chemical Company: Acute Oral Toxicity
Study with 32D16 in Mallard Ducks: IBT No. 651-02893. Unpublished study received Apr 9,
1973 under 1706-126; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Nalco
Chemical Co., Oak Brook, IL; CDL: 051060-C)
MRID 123862. Bentley, R. (1975) Acute Toxicity of Co-op Turbex to Lepomis macrochirus
and Salmo gairdneri. (Unpublished study received Mar 5, 1975 under 1990-372; prepared by
Bionomics, EG&G Environmental Consultants; submitted by Farmland Industries, Inc., Kansas
City, MO; CDL: 110678-A)
MRID 123863. WARF Institute, Inc. (1975) Report: WARF Institute No. 4112599.
(Unpublished study received Mar 5, 1975 under 1990-372; submitted by Farmland Industries,
Inc., Kansas City, MO; CDL: 110680-A)
MRID 123864. WARF Institute, Inc. (1975) Report: WARF Institute No. 4112599.
(Unpublished study received Mar 5, 1975 under 1990-372; submitted by Farmland Industries,
Inc., Kansas City, MO; CDL: 110680-B)
MRID 123866. Heitmuller, T. (1975) Acute Toxicity of Surflo-B15 to Larvae of the Eastern
Oyster (Crassostrea virginicd), Pink Shrimp (Penaeus duoramm), and Fiddler Crab (Uca
pugilator). (Unpublished study received Jun 1, 1975 under 17664-11; prepared by Bionomics—
EG&G, Inc., submitted by Baroid Div., N.L. Industries, Inc., Houston, TX; CDL: 165021-A)
MRID 133265. Thompson, C.; McAllister, W. (1983) Acute Toxicity of EH&S 266 to Bluegill
Sunfish: Static Bioassay Report 30595. (Unpublished study received Oct 25, 1983 under 10349-
14; prepared by Analytical Biochemistry Laboratories, Inc., submitted by Visco, Div. of Nalco
Chemical Co., Sugar Land, TX; CDL: 251787-A)
MRID 133266. Beavers, J.; Jaber, M.; Joiner, G.; et al. (1983) A Dietary LC50 in the Mallard
with EH&S 267: Project No. 187-103. Final Report. (Unpublished study received Oct 25, 1983
under 10349-14; prepared by Wildlife International, Ltd., submitted by Visco, Div. of Nalco
Chemical Co., Sugar Land, TX; CDL: 251788-A)
MRID 134346. Armak Co. (1978) Product Chemistry: Duomeen C. (Compilation; unpublished
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study receive Nov. 23, 1979 under 6922-19; CDL241391-A).
MRID 134550. Fletcher, D. (1972) Report to Esso Research and Engineering Company: Acute
Oral Toxicity Study with MRD 72-10 in Bobwhite Quail: IBT No. J1739. (Unpublished study
received Jul 25, 1972 under 8928-4; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Exxon Chemical Americas, Houston, TX; CDL: 005650-D)
MRID 143397. Welchem, Inc. (19??) Product Chemistry Requirements for Welchem
Microbiocide 56. Unpublished compilation. 18p
MRID 145463. Andresen, M. (1984) Acute Oral Toxicity Study of Microbiocide 56 in Rats:
Final Report: IIRi Project No. L8100: Study No. 887. Un- published study prepared IIT Research
Institute. 20 p.
MRID 145464. Andresen, M. (1984) Acute Dermal Toxicity Study on Microbiocide 56 in
rabbits: Final Report: IITRI Project No. L8100: Study No. 888. Unpublished study prepared by
IIT Research Institute, lip.
MRID 145465. Andresen, M. (1984) Primary Eye Irritation Study of Microbiocide 56 in
rabbits: Final Report: IITRI Project No. L8100: Study No. 886. Unpublished study prepared by
IIT Research Institute. 13 p.
MRID 145466. Andresen, M. (1984) Acute Dermal Irritancy/Corrosivity study of Microbiocide
56 in Rabbits: Final Report: IITRI Project No. 18100: Study No. 885. Unpublished study
prepared by IIT Re- search Institute. 19 p.
MRID 240231210 (ID#). Reagen, E.L. (1981). Acute Oral LD50 Assay in Rats; Study 6874.
Final Report Unpublished study received April 29, 1981; prepared by Food and Drug Research
Laboratories, Inc. submitted by Armak Co, McCook, IL. 3 p.
MRID 240231210 (ID#). Siglin, J.C. (1981). Acute Dermal Toxicity in Rabbits; Study 6874.
Final Report Unpublished study received May 7, 1981; prepared by Food and Drug Research
Laboratories, Inc. submitted by Armak Co, McCook, IL. 1 p.
MRID 40062404. Bisinger, E. (1984) Avian Oral LD50 in Bobwhite Quail: Wildlife and
Aquatic Organism Data Requirements: Armohib B-101: Report No. T-4000: [Supplemental Data
Submitted in Response to EPA's Comments]. Unpublished study prepared by Akzo Chemie
America and Product Safety Labs. 14p.
MRID 40062405. Bisinger, E. (1984) Avian Dietary LC50 in Bobwhite Quail: Wildlife and
Aquatic Organism Data Requirements: Armohib B-101: Report No. T-3995: [Supplemental Data
Submitted in Response to EPA's Comments]. Unpublished study prepared by Akzo Chemie
America and Product Safety Labs. 13p.
MRID 40062411. Bisinger, E. (1984) Acute LC50 in Estuarine and Marine Organisms/96-hour
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LC50 in White Shrimp: Wildlife and Aquatic Organism Data Requirements: Armohib B-101:
Report No. H-8241: [Supplemental Data Submitted in Response to EPA's Comments].
Unpublished study prepared by Akzo Chemie America and MBA Laboratories. 14p.
MRID 40062412. Bisinger, E. (1984) Acute LC50 in Estuarine and Marine Organisms/96-hour
LC50 in Oyster: Wildlife and Aquatic Organism Data Requirements: Armohib B-101: Report
No. H-8241: [Supplemental Data Submitted in Response to EPA's Comments]. Unpublished
study prepared by Akzo Chemie America and MBA Laboratories. 14p.
MRID 40062413. Bisinger, E. (1987?) Hydrolysis Study: Environmental Fate Data
Requirements: Armohib B-101: [Reply to EPA's Comments]. Un- published study prepared by
Akzo Chemie America. 14 p.
MRID 40062609. Bisinger, E. (1984) Acute LC50: Daphnia magna: Wildlife and Aquatic
Organism Data Requirements: Armohib B-101: Report No. H-8241: [Supplemental Data
Submitted in Response to EPA's Comments]. Unpublished study prepared by Akzo Chemie
America and MBA Laboratories. 14p.
MRID 41069001. Bisinger, E. (1989) Hydrolysis of Duomeen-C Diacetate: Environmental Fate
Data Requirements for Armohib B-101. Unpublished study prepared by Akzo Chemicals Inc. 30
P-
MRID 41786601. Surprenant, D. (1988). Acute Toxicity of Microbiocide 56 to Bluegill
Sunfish (Lepomis macrochirus) Under Static Conditions: Lab Project Number: 88-6-2734:
384.1187.6100.00. Unpublished study prepared by Springborn Life Sciences, Inc. 20p.
MRID 41786602. Surprenant, D. (1988). Acute Toxicity of Microbiocide 56 to Daphnids
(Daphnia magna): Lab Project Number: 88-3-2669: 384.1187.6100.110. Unpublished study
prepared by Springborn Life Sciences, Inc. 20p.
MRID 41786603. Surprenant, D. (1988). Acute Toxicity of Microbiocide 56 to Embryo-Larvae
of the Quahog Clam (Mercenaria mercenaria) Under Static Renewal Conditions: Lab Project
Number: 88-5-2712. Unpublished study prepared by Springborn Life Sciences, Inc. 20p.
MRID 41786604. Surprenant, D. (1988). Acute Toxicity of Microbiocide 56 to Silversides
(Menidia menidia) Under Static Renewal Conditions: Lab Project Number: 88-4-2687:
384.1187.6100.501. Unpublished study prepared by Springborn Life Sciences, Inc. 19p.
MRID 41786605. Surprenant, D. (1988). Acute Toxicity of Microbiocide 56 to Mysid Shrimp
(Mysidopsis bahia): Lab Project Number: 88-4-2739: 384.1187.6100.510. Unpublished study
prepared by Springborn Life Sciences, Inc. 20p.
MRID 41786606. Surprenant, D. (1990). Acute Toxicity of Microbiocide 56 to Rainbow Trout
(Salmo gairdnerf) Under Static Conditions: Lab Project Number: 88-11-2861:
384.0788.6101.103. Unpublished study prepared by Springborn Life Sciences, Inc. 19p.
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MRID 42594101. Bisinger, E. C. (1990).Evaluation of the Mutagenic Activity of Duomeen C in
the Ames/Salmonella/Microsome Test; Study No. 031444. Final Report Unpublished study
received April 3, 1990; prepared by RCC Notox B.V, s' Hertogen-bosch (The Netherlands),
submitted by Baker Performance Chemicals. 6 p.
MRID 42594102. O' Loughlin, K. G. (1991). Measurement of Micronuclei in bone Marrow
Erythrocytes of Swiss-Webster Mice Treated with Duomeen C; Study No 1924-CO1-90. Final
Report Unpublished study received March 28, 1991; prepared by SRI International, Menlo Park,
CA, submitted by baker Performance Chemicals. 7 p.
MRID 43000801. Doane, B,; Cox, W.; Linton, K. (1993) l-(Alkylamino)-3-aminopropane
hydroxyacetate: Chemical Identity Beginning Materials and Manufacturing Process: Lab Project
Number: 15-056210: 5120-12: 90230000. Unpublished study prepared by Baker Performance
Chemicals, Inc. 61p.
MRID 43024504. Ellison, F. (1993) Physical and Chemical Characteristics of Duomeen O;
Physical State, Boiling Point, Specific Gravity, Solubility, Vapor Pressure, pH, Stability,
Oxidizing or Reducing, Explodability, and Viscosity: Final Report: Lab Project Number: 00459-
002. Unpublished study prepared by Case Consulting Labs, Inc. 19p.
MRID 43029201. Ellison, F. (1993) Duomeen C and Jet Amine DC: Preliminary Analysis and
Precision and Accuracy of Analytical Method Used to Validate Certified Limits: Final Report:
Lab Project Number: 00459-002. Unpublished study prepared by Case Consulting Labs, Inc. 29
P-
MRID 43029202. Ellison, F. (1993) Duomeen C: Physical and Chemical Characteristics of
Duomeen C: Physical State, Boiling Point, Specific Gravity, Solubility, Vapor Pressure, pH,
Stability, Oxidizing or Reducing, Explodability and Viscosity: Final Report: Lab Project
Number: 00459-002. Unpublished study prepared by Case Consulting Labs, Inc. 19 p.
MRID 43087401. Matherly, R.; Baham, G. (1993) Determination of olor, Physical State, and
Odor for Magnacide 434 (Alkyl Trimethylene): Final Report: Lab Project Number: GLP/0005.
Unpublished study prepared by Baker Performance Chemicals, Inc. 53p.
MRID 43090401. Matherly, R.; Baham, G. (1993) Determination of pH and Density for
Magnacide 434: Final Report: Lab Project Number: GLP-0004. Unpublished study prepared by
Baker Performance Chemicals, Inc. 58 p.
MRID 43090501. Matherly, R.; Baham, G. (1993) Determination of Solubility for Magnacide
434: Final Report: Lab Project Number: GLP-0002. Unpublished study prepared by Baker
Performance Chemicals, Inc. 62p.
MRID 43090701. Matherly, R; Baham, G. (1993) Determination of Boiling Point of Magnacide
434: Final Report: Lab Project Number: GLP/0003. Unpublished study prepared by Baker
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Performance Chemicals Inc. 57p.
MRID 43148501. Gibson, P.; Bennett, G.; Doane, B. (1994) l-(alkylamino)-3-aminopropane
diacetate; Chemical Identity, Beginning Materials and Manufacturing Process, Discussion of
Impurities. Unpublished study prepared by Baker Performance Chemicals, Inc. 51p.
MRID 43301201. Blasberg, J. (1994) pK Determination of Magnacide 434/461 EPA
Registration Number 10707-5/10707-6: Final Report: Lab Project Number: 41261. Unpublished
study prepared by ABC Lab., Inc. 119p.
MRID 43355601. Jones, D. (1994) Product Chemistry Requirements for X-CIDE 302 Industrial
Bactericide. Unpublished study prepared by Petrolite Corp. 71p
MRID 43355602. Jones, D. (1994) Product Chemistry Requirements for X-CIDE 320 Industrial
Bactericide. Unpublished study prepared by Petrolite Corp. 91 p.
MRID 43355603. Jones, D. (1994) Product Chemistry Requirements for X-CIDE 420 Industrial
Bactericide. Unpublished study prepared by Petrolite Corp. 101 p.
MRID 43355604. Jones, D. (1994) Product Chemistry Requirements for X-CIDE 56 Industrial
Bactericide. Unpublished study prepared by Petrolite Corp. 61 p.
MRID 43390601. Dsida, P. (1994) Product Chemistry Requirements for l-((Coco
Alkyl)Amino)-3-aminopropane Diacetates. Unpublished study prepared by Chem ADVISOR,
Inc. lOp.
MRID 43406801. Matherly, R.; Baham, G. (1994) Determination of Color, Physical State, and
Odor for Magnacide B-615: Final Report: Lab Project Number: GLP/0012. Unpublished study
prepared by Baker Performance Chemicals Inc. 52 p.
MRID 43407301. Matherly, R.; Baham, G. (1994) Determination of Solubility for Magnacide
B-615: Final Report: Lab Project Number: GLP/0009. Unpublished study prepared by Baker
Performance Chemicals, Inc. 65p.
MRID 43407801. Matherly, R.; Baham, G. (1994) Determination of Dissociation Constants for
Magnicide B-615: Final Report: Lab Project Number: GLP/0014. Unpublished study prepared
by Baker Performance Chemicals, Inc. 56p.
MRID 43460301. Blasberg, J.; Madsen, S. (1994) Vapor Pressure Determination of Magnacide
434/461 at 25 degrees C: Final Report: Lab Project Number: 41260. Unpublished study
prepared by ABC Lab., Inc. 56p.
MRID 470013023. Shapiro, R. (1984) Avian Single Dose LD50 - Bob White Quail: [Armohib
B-101]: Report No. T-4000. Unpublished study prepared by Product Safety Labs. 14p.
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MRID 470013024. Shapiro, R. (1984) Avian Dietary LC50 Study with Bob White Quail:
Armohib B-101: Report No. T-3995. Unpublished study prepared by Product Safety Labs. 6p.
MRID 470013025. Shapiro, R. (1984) Avian Dietary LC50 Study with Mallard Ducks: Armohib
B-101: Report No. T-3998. Unpublished study prepared by Product Safety Labs. 1 Ip.
MRID 65804013. (ID#). Evan, R., Biley, D., Glass, H.G. (1952). Acute Toxicity and Irritation
Studies on Arquad T, Duomeen C Individually and in Combination (no other identification data
included) Final Report Unpublished study received July 1, 1952. 7 p.
MRID 93034010. Rausch, L. (1990) Akzo Chemicals, Inc. Phase 3 Summary of MRID
41069001. Hydrolysis of Dumomeen-C Diacetate. Prepared by Akzo Chemicals Inc. 10 p.
MRID 97516. Casterton, P.L. (1979) Avian Dietary LC50 (Mallard Duck): Laboratory Report
No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2; prepared by
Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco, Tulsa, Okla.;
CDL: 242696-A)
MRID 97518. Reed, D. (1979) Laboratory Test Report: Static LC50: Rainbow Trout:
Laboratory Report No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2;
prepared by Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco,
Tulsa, Okla.; CDL: 242698-A)
MRID 97519. Casterton, P.L. (1979) Fish Acute LC50 (Redear Sunfish): Laboratory Report
No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2; prepared by
Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco, Tulsa, Okla.;
CDL: 242699-B)
MRID 97520. Casterton, P.L. (1979) Laboratory Test Report: (Static LC50: Blue Crab):
Laboratory Report No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2;
prepared by Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco,
Tulsa, Okla.; CDL: 242699-A)
MRID 97521. Kresse, H.J. (1980) Daphnia magna: Acute LC50: Laboratory Report No. K-
5096. (Unpublished study received Jun 16, 1980 under 38231-2; prepared by Microbiological
and Biochemical Assay Laboratories, submitted by C-E Natco, Tulsa, Okla.; CDL: 242698-B)
MRID 97534. Casterton, P.L. (1979) Avian Acute Oral LD50: Bobwhite Quail: Laboratory
Report No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2; prepared by
Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco, Tulsa, Okla.;
CDL: 242695-A)
MRID 97535. Casterton, P.L. (1979) Avian Dietary LC50 (Bobwhite Quail): Laboratory Report
No. K-5096. (Unpublished study received Jun 16, 1980 under 38231-2; prepared by
Microbiological and Biochemical Assay Laboratories, submitted by C-E Natco, Tulsa, Okla.;
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CDL: 242695-B)
MRID NA (ID#). Siglin, J.C. (1981). Primary Skin Irritation in Rabbits; Study 6874. Final
Report Unpublished study received April 30, 1981; prepared by Food and Drug Research
Laboratories, Inc. submitted by Armak Co, McCook, IL. 3 p
2 Open Literature
Citation
1 Fong, H.R. 2003. An Overview of Closed System Use in California 2001-2002. Report HS-
1849. California Environmental Protection Agency, Department of Pesticide Regulation, Worker
Health and Safety Branch. June 2003.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See the V of the RED for a
list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G.
Batching of Alkyl trimethylenediamines Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency intends to complete batching at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprdOO I/forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out
on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by
e-mail at williams.nicole(g),epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-l.pdf
Pesticide Registration Kit
www. epa. gov/pesticides/registrationkit/.
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Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
http://npic.orst.edu .
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The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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