vvEPA
United States Prevention, Pesticides EPA 739-R-07-007
Environmental Protection and Toxic Substances September 2007
Agency (75 IOC)
Reregistration
Eligibility Decision for
Trimethoxysilyl Quaternary
Ammonium Chloride Compounds
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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 trimethoxysilyl quaternary ammonium chloride compounds
(trimethoxysilyl quats). The Reregistration Eligibility Decision (RED) was approved and signed
on September 25, 2007.
Based on the Agency's review of the trimethoxysilyl quats, the Reregistration Eligibility
Decision (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 the trimethoxysilyl quats will be available to the
public in EPA's Pesticide Docket EPA-HQ-OPP-2007-0831 at http://www.reeailations.gov
Please note that the attached RED document pertains only to the trimethoxysilyl quats
compounds and presents the Agency's conclusions on risks associated with the uses of these
compounds. Based on the information contained in our files, these compounds have been
identified as low risk chemicals. This document also identifies generic and product-specific data
for which the Agency intends to issue Data Call-Ins (DCIs). As part of the RED, the Agency has
determined that the trimethoxysilyl quats are eligible for reregistration.
If you have questions pertaining to this document, please contact Melba Morrow at (703)
308-2716. Note that DCIs with all pertinent instructions will be sent to the registrant at a later
date. Additionally, 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. For questions regarding product reregistration please
contact Velma Noble at (703) 308-6233.
Sincerely,
Frame T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY DECISION
for
Trimethoxysilyl Quaternary Ammonium Chloride Compounds
ListC
Case No. 3148
Approved By:
Frarfk T. Sanders
Director, Antimicrobials Division
September 25, 2007
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TABLE OF CONTENTS
Trimethoxysilyl Quaternary Ammonium Chloride Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract v
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
III. Summary of Trimethoxysilyl Quat Risk Assessment 5
A. Human Health Risk Assessment 5
1. Toxicity of Trimethoxysilyl quats 5
2. Food Quality Protection Act (FQPA) Safety Factor 7
3. Population Adjusted Dose (PAD) 7
4. Dietary and Residential Risk Assessment 7
5. Aggregate Risk 7
6. Occupational Exposure 8
7. Human Incident Data 8
B. Environmental Risk Assessment 8
1. Environmental Fate and Transport 8
2. Ecological Risk 8
a. Toxicity (Hazard) Assessment 9
b. Risk to Threatened and Endangered Species 9
IV. Risk Management, and Reregistration Decision 10
A. Determination of Reregistration Eligibility 10
B. Public Comments and Responses 10
C. Regulatory Position 10
1. Food Quality Protection Act (FQPA) Findings 10
2. Endocrine Disrupter Effects 11
3. Cumulative Risks 11
D. Regulatory Rationale 12
1. Listed Species Considerations 12
a. The Endangered Species Act 12
b. General Risk Mitigation 13
2. Labeling 13
a. Label Amendment 13
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V. What Registrants Need to Do 14
A. Manufacturing-Use Products 16
1. Additional Generic Data Requirements 16
B. End-Use Products 16
1. Additional Product-Specific Data and Efficacy Requirements 16
2. Labeling for End-Use Products 18
VI. Appendices 20
A. Table of Use Patterns for Trimethoxysilyl Quats 21
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 32
C. Technical Support Documents 38
D. Bibliography Citations 39
E. Generic Data Call-In 77
F. Product-Specific Data Call-In 78
G. Batching of End-Use Products 79
H. List of All Registrants Sent the Data Call-In 80
I. List of Available Forms 81
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Trimethoxysilyl Quaternary Ammonium Chloride Reregistration Team
Health Effects Risk Assessment
Timothy McMahon, Ph.D.
Chemical Manager
Melba Morrow, DVM
Diane Isbell
Registration Support
Tracy Lantz
Jacqueline Campbell-McFarland
Product Chemistry
Najm Shamim, Ph.D.
Environmental Fate
James Breithaupt
Ecological Hazard and Environmental Risk
Genevieve Angle
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE
AD
ADTC
a.i.
aPAD
AR
ARC
BCF
CAS
CI
CNS
cPAD
CSF
CFR
CSFII
DCI
DEEM
DFR
ORES
DWEL
DWLOC
EC
EDSP
EDSTAC
EEC
EP
EPA
EPISUIT
FAO
FDA
FFDCA
FIFRA
Fl. oz.
FOB
FQPA
FWS
G
GENEEC
GLC
GLN
GM
GRAS
HA
HAFT
HOT
HPV
IDS
IR
LC50
Acid Equivalent
Antimicrobials Division
Antimicrobials Division Toxicology Endpoint Selection Committee
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Anticipated Residue Contribution
Bioconcentration Factor
Chemical Abstracts Service
Cation
Central Nervous System
Chronic Population Adjusted Dose
Confidential Statement of Formula
Code of Federal Regulations
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific
(i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects
are not anticipated to occur.
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Endocrine Disrupter Screening Program
Endocrine Disrupter Screening and Testing Advisory Committee
Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Environmental Protection Agency, Estimation Program Interface Suite
Food and Agriculture Organization
Food and Drug Administration
Federal Food, Drug, and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
Fluid Ounces
Functional Observation Battery
Food Quality Protection Act
United States Fish and Wildlife Services
Granular Formulation
Tier I Surface Water Computer Model
Gas Liquid Chromatography
Guideline Number
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities
and other organizations when emergency spills or contamination situations occur.
Highest Average Field Trial
Highest Dose Tested
High Production Volume
Incident Data System
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a substance that
11
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LD50
LEL
LOC
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NMFS
NOEC
NOEL
NOAEL
NPDES
NPTN
NR
OP
OPP
OPPTS
Pa
PAD
PCC
PADI
PAG
PAM
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRN
PRZM/
EXAMS
Qi*
RAC
RBC
RED
REI
RfD
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
National Marine Fishery Service
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
National Pesticide Telecommunications Network
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Pascal, the pressure exerted by a force of one newton acting on an area of one square
meter.
Population Adjusted Dose
National Poison Control Center
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
in
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RQ
RS
RUP
SAP
SAR
SCI-GROW
SF
SLC
SLN
TC
TD
TEP
TGAI
TLC
TMRC
torr
TRR
UF
ug/g
ug/L
USDA
USGS
UV
WHO
WP
WPS
Risk Quotient
Registration Standard
Restricted Use Pesticide
Science Advisory Panel
Structure Activity Relationship Assessment
Tier I Ground Water Computer Model
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard
conditions.
Total Radioactive Residue
Uncertainty Factor
Micrograms Per Gram
Micrograms Per Liter
United States Department of Agriculture
United States Geological Survey
Ultraviolet
World Health Organization
Wettable Powder
Worker Protection Standard
IV
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed its human
health and environmental review for the reregi strati on case 3148; Trimethoxysilyl Quaternary
Ammonium Chloride Compounds, and is issuing its risk management decision. There are
currently 30 active products for this group of compounds. This includes chemical codes 107401,
107403,107409 and 169160. Chemical code 107403 is a trihydroxysilyl quat compound that has
been included in this action. The decision to include this compound is based on the finding that
when exposed to water, the trimethoxysilyl quats undergo a chemical reaction which leads to the
formation of trihydroxysilyl quats.
The following Reregi strati on Eligibility Decision (RED) addresses the use of the
trimethoxysilyl and trihydroxysilyl quats as bacteriastatic and fungistatic treatments in human
clothing and bedding, household areas, carpets and upholstery. These products are also used as
material preservatives in the manufacturing of paints, coatings, and concrete. Collectively, these
compounds will be referred to as trimethoxysilyl quats.
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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 (a.i.), 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 human health and environmental effects; and to determine whether or
not the pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment. The Agency has decided that, for
those chemicals that have tolerances and are undergoing reregi strati on, the tolerance
reassessment will be initiated through this reregi strati on process. The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safely finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's human health and ecological risk assessments and the Reregi strati on Eligibility
Decision (RED) for the trimethoxysilyl quats.
As active ingredients trimethoxysilyl quats are used as materials preservatives for, paints
(in can), coatings, textiles (such as those used in human bedding, footwear, clothing/apparel,
upholstery, diapers and carpet), sails, ropes, fire hose, concrete additive, roofing materials, filter
media and polyurethane foam and cellulose products and cleaning buffers. The chemical is also
formulated to provide residual fungistatic activity in household and domestic dwellings on hard
non-porous surfaces, bathroom premises (hard non-porous surfaces), and in garbage cans.
The Agency has concluded that the FQPA Safety Factor for the trimethoxysilyl quats
should be reduced to 3X based on: (1) the potential for significant contact of infants and children
through the proposed homeowner uses for this active ingredient and (2) no evidence of increased
susceptibility in the prenatal developmental study in rats nor is there evidence of neurotoxicity to
the offspring.
Risks summarized in this document are those that result from the use of the active
ingredients octadecanaminum-N-N-dimethyl(3-trimethoxysilyl)propyl chloride;
octadecanaminum-N-N dimethyl(3 trihydroxy silyl)propyl chloride; tetradecanaminum-N-N
dimethyl (3trimethoxysilyl)propyl chloride; and didecyl N-methyl-
(3trimethoxysilyl)propanaminum chloride. The chemicals have been grouped as trimethoxysilyl
quaternary ammonium compounds for the purpose of reregi strati on.
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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 that would occur at 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
the trimethoxysilyl quats and any other substances. The trimethoxysilyl quats do not appear to
produce a toxic metabolite produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that the trimethoxysilyl quats have a common mechanism of
toxicity with other substances. 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.
This document presents the Agency's decision regarding the reregi strati on eligibility of the
registered uses of the trimethoxysilyl quats. In an effort to simplify the RED, the information
presented herein is summarized from more detailed information which can be found in the
technical supporting documents for the trimethoxysilyl quats referenced in this RED. The risk
assessments and related addenda are not included in this document, but are available in the
Public Docket at http://www.regulations.gov (EPA-HQ-OPP-2007-0831).
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 the trimethoxysilyl quats and the regulatory
history. Section III, Summary of Trimethoxysilyl Quats Risk Assessment, gives an overview of
the human health and environmental assessments, based on the information available to the
Agency. Section IV, Risk Management, and Reregi strati on 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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II. CHEMICAL OVERVIEW
A. Regulatory History
The trimethoxysilyl quats are registered as active ingredients as bacteriastatic, algaestatic
and fungistatic compounds. The first products containing a trimethoxysilyl quat were registered
in January 1960. There are currently a total of 30 registered products for PC Codesl07401,
169160, 107403 and 107409. The Agency has determined that the Reregi strati on Eligibility
Decision (RED) will include all of the aforementioned products, which includes a trihydroxysilyl
quat (107403). This decision is supported by the finding that when the methoxysilyl quat
compounds are exposed to water, there is a reaction which leads to the formation of hydroxysilyl
quat compounds.
Trimethoxysilyl quat and trihydroxysilyl quat containing products are currently used as a
material preservative treatment for materials such as those used in human clothing and bedding,
carpets and upholstery. The trimethoxysilyl quats are used as surface treatments in household
areas and bathroom areas. These products are also used in the manufacturing of paints, coatings,
and in concrete. There are no inert uses or tolerances for this reregi strati on case.
B. Chemical Identification:
Table 1 contains information on the chemicals included in this RED.
Table 1: Physical and Chemical Properties
Chemical
name
Empirical
Formula
CAS#
OPP
Chemical
Code
Molecular
Weight
Physical
State
Color
Melting
Point
Boiling
Point
Specific
Gravity
Vapor
Pressure
1-Octadecanaminium-
N,N-dimethyl-N-{3-
(trimethoxysilyl)propyl}-
chloride
C26H58ClNO3Si
27668-52-6
107401
496.30
liquid
Pale yellow to off
white
267 C
617 C
0.99
5.8xlO'14mmHg
1-tetradecanaminium,
N,N-dimethyl-N-(3-
(trimethoxysilyl)propyl)-
chloride
C22H5oClNO3Si
41591-87-1
107409
440.31
liquid
Clear yellowish
245 C
570 C
1.012
1.7X10'12
l-Decanaminium,N-
Didecyl-N-methyl-N-{3-
(trimethoxysilyl)propyl)-
chloride
C27H6oClNO3Si
6895920-6
169160
510.3
liquid
Light to dark amber
272 C
628 C
0.85
2.4 x 10'14
1-ocatdecananminium-
N,N-dimethyl-N-(3-
(trihydroxysilyl)propyl)-
chloride
C23H52ClNO3Si
199111-50-7
107403
454
liquid
clear
306 C
702 C
1.0
1.85xlO'21
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Basic Manufacturers: Aegis Environmental Mgt, Inc., Sishield Technologies Inc., Sanitized
Inc., Microbioguard, International Biochemical Industries, Inc.
C. Use Profile
The following section provides information on the currently registered uses of the
trimethoxysilyl quat products. Included is an overview of the use sites and application methods
for these compounds. Please refer to appendix A for a comprehensive table of uses of the
trimethoxysilyl quats that are eligible for reregi strati on.
Type of Pesticide: Material preservatives, b acted astatic, fungistatic, antimicrobial and
algaestatic treatments
Use Sites: Trimethoxysilyl quats are used in industrial, commercial,
institutional and residential premises.
Use Classification: Trimethoxysilyl quats are general use pesticides.
Formulation Types: Trimethoxysilyl quats are formulated as a soluble concentrate for
both manufacturing and end use products and as a ready to use
solution for end use products.
Application Rates/Methods: As a materials preservative and surface treatment,
trimethoxysilyl quats are applied by open pour methods or by
spraying, dipping or soaking, depending upon the material that is
being treated. The application rates vary based on product and
use site. A complete list can be found as part of Appendix A.
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III. SUMMARY OF RISK ASSESSMENT for TRIMETHOXYSILYL QUATS
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 trimethoxysilyl quats. While the risk assessments and related addenda are
not included in this document, they are available from the OPP Public Docket and may also be
accessed on the Agency's website at http//www.regulations.gov(EPA-HO-OPP-2007-0831).
Hard copies of these documents may be found in the OPP public docket under docket number
OPP-2007-0831. The OPP public docket is located in Room S-4400, One Potomac Yard (South
Building) 2777South Crystal Drive, Arlington, VA, and is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
A. Human Health Risk Assessment
1. Toxicity of Trimethoxysilyl Quats
A brief overview of the toxicity of the trimethoxysilyl quats is presented below. Further
information on the toxicity of this compound can be found in Appendix C in a risk
characterization document dated February 2, 2000.
The Agency has reviewed all toxicity studies submitted for the trimethoxysilyl quats and
has determined that the toxicological database is sufficient for reregistration. The toxicological
database for trimethoxysilyl quats is currently comprised of unpublished studies submitted to the
Agency; however, limited data are available for these compounds. The data matrix for
trimethoxysilyl quats includes acute toxicity studies, a subchronic dermal toxicity study, one
subchronic oral study in rats, one developmental toxicity study in rats, and six mutagenicity
studies (four of which have been classified as being acceptable).
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Table 2. Toxicity of Trimethoxysilyl Quats
Test
Oral LD50
Dermal LD50
Inhalation LC50
Eye Irritation
Dermal Irritation
Subchronic dermal toxicity
Subchronic oral toxicity
Developmental Toxicity
Ames Salmonella Assay
In-vitro Reverse Mutation Assay
In-vitro Forward Mutation Assay
Chromosome Aberration
Mouse Micronucleus
Unscheduled DNA Synthesis
Species
Rat
Rabbit
Rat
Rat
Rabbit
Rat
Rat
Rat
Salmonella
Salmonella, E-coli
Salmonella, E-coli
Chinese hamster
cells
Mouse
Hepatocytes
Results
>5000 mg/kg
(Toxicity Category IV)
>2000 mg/kg
(Toxicity Category III)
>2.0 mg/L (1-Hour)
(Toxicity Category IV)
Severe Ocular Toxicity
(Toxicity Category I)
Severe dermal toxicity
(Toxicity Category I)
Dermal and Systemic NOAEL^ 1000 mg/kg/day
NOAEL > 240 mg/kg/d (HOT)
Maternal NOAEL > 1000 mg/kg/day
Developmental NOAEL^ 1000 mg/kg/day
No increase in number of revertant colonies
(unacceptable study)
No evidence of induced mutant colonies
No evidence of mutagenicity
No association with the induction of structural
chromosome aberrations
No evidence of compound induced cytotoxicity
Unacceptable study
MRID
40385201
40385201
Not available*
403385201
Not available*
41339403
46280411
41438003
40385211
46280412
46280413
46280414
41296803
41296804
* These studies are summarized in the data base for the trimethoxysilyl quats, however,
accession/MRID numbers were not included on the study reviews.
General Toxicity Observations
Upon reviewing the available toxicity information, the Agency has concluded that there are
no endpoints of concern for repeated oral or dermal exposure to the trimethoxysilyl quats. This
conclusion is based on low toxicity observed in acute, Subchronic and developmental studies
conducted with the trimethoxysilyl quat compounds. The risk from inhalation exposure has not
been characterized and an additional study designed to assess inhalation toxicity over time may
be needed. In addition, severe toxicity has been observed with regard to skin and eye irritation.
Carcinogenicity Classification
There are no concerns for carcinogenicity for the trimethoxysilyl quats based on the results
of the mutagenicity studies and the lack of any systemic toxicity being observed in the toxicity
data base; therefore, no carcinogenic analysis is required.
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Mutagenicity Potential
The mutagenicity of the trimethoxysilyl quats is fully characterized. For all of the
compounds covered under this RED, there are a total of four acceptable mutagenicity studies, all
of which demonstrate that the trimethoxysilyl quats are negative for mutagenicity.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) 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, residential exposures,
or to compensate for an incomplete database. The FQPA Safety Factor has been reduced to 3X
based on: (1) the potential for significant contact of infants and children through the proposed
homeowner uses for this active ingredient and (2) no evidence of increased susceptibility in the
prenatal developmental study in rats nor is there evidence of neurotoxicity to the offspring. It
should be pointed out that at this time, there are no risks of concern which would require the use
of a FQPA safety factor.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A risk
estimate that is less than 100% of the acute or chronic PAD is not of concern. Since toxicological
endpoints for the risk assessment were not identified based on the available data, RfDs and PADs
have not been calculated for trimethoxysilyl quats. In addition there does not appear to be oral
exposure to this chemical based on use patterns.
4. Dietary and Residential Risk Assessment
There are currently no dietary exposure scenarios for the trimethoxysilyl quats. Although
there are residential uses for trimethoxysilyl compounds, there are no toxicological endpoints of
concern based on the available toxicity data.
5. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act
require "that there is a reasonable certainty that no harm will result from aggregate exposure to
pesticide chemical residue, including all anticipated dietary exposures and other exposures for
which there are reliable information"(FFDCA, Section 408(b)(2)(A)(ii)). Aggregate exposure
will typically include exposures from food, drinking water, residential uses of a pesticide and
other non-occupational sources of exposure. Residential exposure to the trimethoxysilyl quats is
likely; however there are no toxicological endpoints of concern. An aggregate risk assessment
was therefore not conducted for this chemical.
7
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6. Occupational Exposure
The occupational exposure assessment for the trimethoxysilyl quats addresses potential
exposures and risks to humans who may be exposed in "occupational settings." An occupational
risk assessment is required for an active ingredient if certain toxicological criteria are triggered
and there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to
persons entering treated sites after application is complete. For the trimethoxysilyl quats there is
potential for exposure; however, there are no toxicological endpoints of concern according to a
review of the available toxicity data.
7. Human Incident Data
EPA consulted the following sources of information for human poisoning incidents related
to the trimethoxysilyl quats: (1) OPP Incident Data System (IDS), (2) California Department of
Pesticide Regulation (1982-2004) and (3) National Pesticide Information Center (NPIC). There
were no human incidents reported for the trimethoxysilyl quats in these data bases.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. The
following risk characterization is based on the use sites for the trimethoxysilyl quats and any
associated uncertainties. For further information concerning all aspects about the environmental
risk assessment refer to the product chemistry, environmental fate and ecological toxicology in
the trimethoxysilyl quats risk assessment available on the Agency's website in the EPA Docket
at http://www.regulations.gov.
1. Environmental Fate and Transport
The Agency has conducted an environmental fate assessment dated September 19, 2007 for
the trimethoxysilyl quats. The hydrolysis data indicate that the trimethoxysilyl quats are soluble
but not stable in water. Environmental fate studies for the trimethoxysilyl quats consist of only a
hydrolysis study and it was concluded by the Agency that no further fate studies would be
required because of the instability of the compounds and the formation of an insoluble silane
degradate. The trimethoxysilyl quats are not expected to contaminate surface or ground water
due to rapid degradation by hydrolysis.
2. Ecological Risk
The Agency expects exposure to the trimethoxysilyl quats to be minimal to avian, fresh
water estuarine/marine aquatic organisms and plants based on the registered indoor use patterns.
-------
a. Toxicity (Hazard) Assessment
The results from the avian acute toxicity and dietary studies and from the freshwater
invertebrate acute toxicity studies for the trimethoxysilyl quats are summarized in Table 3. The
trimethoxysilyl quats are characterized as practically non-toxic to birds and based on the data in
the Agency's files, the chemical is considered highly toxic to freshwater invertebrates in acute
studies. The trimethoxysilyl quats are classified as being moderately toxic to coldwater fish
species.
Table 3: Ecological Acute Toxicity Studies
Test and Organism
Acute Toxicity LCso
Rainbow Trout
Single Dose Oral
LD50 Mallard Duck
Dietary LCso
Mallard Duck
Eight -day Dietary
LCso
Bob white Quail
Acute Toxicity LCso
Freshwater Daphnids
Chemical PC Code
169160
107401
107401
169160
169160
Results
96hourLC50= 1.73
mg/L
LD50> 1590mg/kg
LC50 > 5620 mg/L
LC50 > 5620 mg/L
LC50=0.18mg/L
Toxicity Category
Moderately toxic
Practically non-toxic
Practically Non-toxic
Practically Non-toxic
Highly toxic
b. Risk to Threatened and Endangered Species
It is expected that the proposed uses for the trimethoxysilyl quats will involve minimal
environmental exposure from registered use patterns. However, an endangered species effect
determination has not been made at this time because a more refined assessment that would
include direct, indirect and habitat effects, has not been conducted.
-------
IV RISK MANAGEMENT AND REREGISTRATION DECISION
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 reregi strati on of products containing the
trimethoxysilyl quats as an active ingredient. The Agency has completed its review of the
generic data and has determined that the data are sufficient to support reregi strati on of products
containing the trimethoxysilyl quats.
The Agency has completed its assessment of the dietary, occupational and ecological risks
associated with the use of pesticide products containing trimethoxysilyl quats as the active
ingredient. Based on a review of the data and other available information for the active
ingredient, the Agency has concluded that there is sufficient information on the human health
and ecological effects of the trimethoxysilyl quats to make decisions as part of the reregi strati on
process under FIFRA, as amended by FQPA. The Agency has determined that products
containing trimethoxysilyl quats are eligible for reregi strati on provided that current data gaps and
confirmatory data needs are addressed. Appendix A summarizes the uses of the trimethoxysilyl
quats that are eligible for reregi strati on. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregi strati on eligibility of the
trimethoxysilyl quats 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 the evaluation of the trimethoxysilyl quats, the Agency has determined there are
no human health or ecological risks of concern.
B. Public Comments and Responses
Risk assessments for the trimethoxysilyl quats were not issued for public comment per the
Agency's public participation process because no toxicological endpoints were identified, and as
such, these assessments were qualitative in nature. To ensure that an opportunity is presented to
the public to comment on the risk assessments and risk management decisions for the
trimethoxysilyl quats, the Agency will implement a 60-day comment period on this RED.
C. Regulatory Position
1. Food Quality Protection Act Findings
An FQPA Safety Factor of 3X was recommended for the trimethoxysilyl quat
compounds. Although there are no food uses for these compounds, it is likely that infants and
children will be exposed to these compounds through the existing uses. The FQPA Safety Factor
was reduced to 3X, based on the findings that there was no evidence of increased susceptibility
in the prenatal developmental study in rats and there was no evidence of neurotoxicity to the
10
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offspring. There is a lack of a second developmental toxicity study in a second species for this
active ingredient and a lack of a two-generation reproduction study.
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 appropriate screening and testing protocols that are currently being considered
under the Agency's EDSP have been developed, the trimethoxysilyl quats may be subjected 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 the
triemthoxysilyl quats. The Food Quality Protection Act (FQPA) requires that the Agency
consider "available information" concerning the cumulative effects of a particular pesticide's
residue 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 the EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, the EPA has not made a common mechanism of
toxicity finding for the trimethoxysilyl quats. For further information regarding the 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 statement 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/.
11
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D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
the trimethoxysilyl quats as an active ingredient. The Agency believes there is reasonable
certainty of no harm resulting from exposure to the trimethoxysilyl quats as an active ingredient
to the general population and to infants and children in particular. This is based on the existing
toxicity data which supports the finding that these products did not elicit a toxic response when
administered to laboratory animals at the limit dose level. In addition, in conducting a human
health hazard assessment, the Agency found that there were no endpoints of concern for the oral
and dermal routes of exposure.
The Agency believes that the trimethoxysilyl quats have minimal potential to cause human
health or environmental risks and has determined that a qualitative approach to assessing human
health and ecological risks from exposure to the trimethoxysilyl quats is appropriate. Therefore,
no risk mitigation measures are necessary at this time.
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)
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.
12
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For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment and are considered to fall under a "no effect" determination. Due to the low
likelihood of exposure and the low toxicity of the trimethoxysilyl quats, the Agency expects no
effects to listed species; however, an endangered species no effect determination has not been
made at this time because an assessment has not been made which includes direct, indirect and
habitat effects.
b. General Risk Mitigation
Trimethoxysilyl quat end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing
trimethoxysilyl quats 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.
2. Labeling
a. Label Amendment
Currently, no label amendments are necessary in order for trimethoxysilyl quat products to
be eligible for reregi strati on.
13
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V. WHAT REGISTRANTS NEED TO DO
The Agency has determined that the trimethoxysilyl quats are eligible for reregi strati on
provided that additional data are submitted to confirm this decision. In the near future, the
Agency intends to issue Data Call-In Notices (DCIs) requiring product-specific data and
additional generic (technical grade) data. Generally, registrants will have 90 days from receipt of
a DCI to complete and submit response forms or to request time extension and or waiver requests
with a full written justification. For product-specific data, the registrant will have eight months to
submit data and amended labels. For generic data, due dates can vary depending on the specific
studies being required.
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 Melba Morrow at (703) 308-2716 with questions regarding generic
reregi strati on.
By US mail:
Document Processing Desk (DCI/AD)
Melba Morrow
US EPA (751 OP)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/AD)
Melba Morrow
Office of Pesticide Programs (751 OP)
One Potomac Yard (South Building)
2777 South Crystal Drive
Arlington, VA 22202
14
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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 (i.e., 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.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (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 13 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 Velma Noble at (703) 308-6233 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:
Document Processing Desk (PDCI/PRB)
Velma Noble
US EPA (75IOC)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (PDCI/PRB)
Velma Noble
Office of Pesticide Programs (75 IOC)
Room 266A, Crystal Mall 2
1801 South Bell Street
Arlington, VA 22202
15
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A. Manufacturing-Use Products
There are currently no registered manufacturing-use products for the trimethoxysilyl quats;
therefore, the end-use manufacturer is responsible for the submission of any generic data
requirements requested by the Agency.
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of the trimethoxysilyl quats for the
above eligible uses has been reviewed and determined to be substantially complete. However,
the following additional data requirements have been identified by the Agency and are included
in the generic DCI for this RED.
Table 4: Data Requirements for the Reregistration Eligibility Decision for
the Trimethoxysilyl Quats
Guideline Study Name
Fresh Water Fish Acute Toxicity Study with TGAI
Fresh Water Invertebrate Acute Toxicity Study with TGAI
New OPPTS
Guideline No.
850.1075
850.1010
Old
Guideline No.
72-1
72-2
B. End-Use Products
1. Additional Product-Specific Data and Efficacy 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, the study MRTD numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product.
The Agency intends to issue a separate Product-Specific Data Call-In (PDCI), outlining
specific data requirements at a later date. Products which include claims for residual sanitizing
activity as well as residual claims against certain non-public health organisms, including mold,
will be required to submit efficacy data to support these claims. If a product label includes a
disinfection claim; the appropriate efficacy data must be submitted to support the claim. The
efficacy studies the Agency intends to call-in are listed in Table 5 below.
16
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Table 5. Efficacy Data Requirements for Reregistration
Claim
Disinfectant
Residual Self-
Sanitizing
Use Pattern
Hard inanimate
surfaces
Materials
Preservative
Guideline Study Name
AOAC Use Dilution Test (Hard
water and organic soil)
or
AOAC Germicidal Spray Test
or
AOAC Hard Surface Carrier Test
(Distilled water only)
Need to submit protocol for
review
New OPPTS
Guideline No.
810.2100
(c), (d), (e)
Old Guideline
No.
91-2 (b),
(c), (d)
17
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2. Labeling for End-Use Products
No specific labeling changes are necessary to implement measures outlined in Section IV, above. However, to ensure
compliance with FIFRA, end -use product labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies.
Description
Declaration of amount of
Methanol in product.
Required for products
containing Methanol > 4%
Precautionary Statements
(Language Required by RED
based on acute toxicity)
Physical and Chemical Hazards
Products classified as corrosive
Residual Self Sanitizing Claim
Nonpublic Health Claims
Application Method
Amended Labeling Language
Contains % Methanol1 .
Danger. Poison. Skull and Crossbones Symbol
Danger. Corrosive. Causes irreversible eye damage and skin burns. Methanol may cause
blindness. May be fatal if inhaled. May be harmful if swallowed or absorbed through the skin.
Do not get in eyes, on skin, or on clothing. Do not breathe vapor or spray mist. Wear a
NIOSH approved respirator with any N, R, P, or HE filter. Appropriate measures must be
taken to prevent the accumulation of hazardous concentrations of methanol vapors in the work
area. Wear goggles or faceshield, rubber gloves, and protective clothing when handling. Wash
thoroughly with soap and water after handling and before eating, drinking, chewing gum, or
using tobacco. Remove contaminated clothing and wash before reuse.
Combustible. Do not use or store near heat or open flame. Deactivation can be achieved by the
addition of anionic surfactant (soap, sulfonates, sulfates) in quantity equivalent to that of
product.
Probable mucosal damage may contraindicate the use of gastric lavage.
Delete Residual Self Sanitizing Activity claim against Trichophyton mentagrophytes in socks.
Protocol and data is needed to support this type of claim.
Effective against odor causing bacteria, bacteria which causes staining and discoloration, fungi
(mold/mildew), and algae as a static agent. Can be used as a final bacteriastatic finish to impart
bacteriastatic/fungistatic (mold/mildew activity)
Delete Fogging Application
Placement on Label
Below the Ingredients
Statement
Signal Word
Precautionary
Statements
Physical and Chemical
Hazards Statements
Note to Physician
Directions for Use
Directions for Use
Directions for Use
18
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Description
Use Surface Deletion
Mold Remediation/Prevention
(Water/Smoke restoration/
Sewer backup/river flood
cleanup/clean water source)
Amended Labeling Language
Delete Polyurethane and cellulose foam for household, industrial, and institutional sponges.
This active ingredient is not cleared for use on food contact surfaces.
Should any of the materials to be treated have prior mold or moisture contamination, add the
appropriate remediation directions for use on the label as per the website below:
Refer to http.//www.epa.gov/mold/mold_remediation Table 1 and 2 for Remediation Directions
for Use
Placement on Label
Directions for Use
Directions for Use
19
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VI. APPENDICES
20
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Trimethoxysilyl Quats
Table of Use Patterns for Trimethosysilyl Quats (Appendix A)
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Residential and Public Access areas
Household and Domestic
Dwellings, hard non
porous surfaces
Soluble
Concentrate
75174-2
75497-1
Ready to Use
64881-6
70087-1
75497-4
75497-5
75497-8
4822-484
79652-1
Soluble
Concentrate
64881-3
75497-2
75497-3
82077-2
82077-3
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Spray (pump or
commercial),
dip or soak
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 2. 5-128 ounces of
product per gallon of
water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Soak:
Use enough of product to
completely submerge item.
21
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Use Site
Bathroom Premises, hard
non porous surfaces
Formulation
Soluble
Concentrate
75174-2
75497-1
Ready to Use
64881-6
70087-1
75497-4
75497-5
75497-8
4822-484
79652-1
Soluble
Concentrate
64881-3
75497-2
75497-3
82077-2
82077-3
Method of
Application
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Spray (pump or
commercial),
dip or soak
Application Rate/ No. of
applications
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 2. 5-128 ounces of
product per gallon of
water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Soak:
Use enough of product to
Use Limitations
22
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Use Site
Human Bedding
Human Bedding
Human Footwear
Formulation
Soluble
Concentrate
75174-2
75497-1
Ready to Use
64881-6
70087-1
75497-4
75497-5
79652-1
Soluble
Concentrate
75174-2
75497-1
Ready to Use
70087-1
Method of
Application
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Application Rate/ No. of
applications
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
Use Limitations
23
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Use Site
Human Clothing/ Apparel
Human Clothing/ Apparel
Formulation
75497-4
75497-5
79652-1
Soluble
Concentrate
75174-2
75497-1
Ready to Use
70087-1
75497-4
Ready to Use
75497-5
79652-1
Method of
Application
Dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Dip or soak
Application Rate/ No. of
applications
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry.
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
Use Limitations
24
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Use Site
Upholstery
Formulation
Soluble
Concentrate
75174-2
75497-1
Ready to Use
64881-6
70087-1
75497-4
75497-5
Soluble
Concentrate
64881-3
Method of
Application
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Application Rate/ No. of
applications
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry.
Add 2.5 ounces of product
per gallon of water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Soak:
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Use Limitations
25
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Use Site
Diapers
Carpets
Formulation
Ready to Use
75497-4
75497-5
Soluble
Concentrate
75174-2
75497-1
Ready to Use
64881-6
70087-1
75497-4
75497-5
79652-1
Soluble
Concentrate
64881-3
75497-2
75497-3
82077-2
82077-3
Method of
Application
Spray (pump or
commercial),
dip or soak
Dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
Spray (pump or
commercial),
dip or soak
Application Rate/ No. of
applications
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry.
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry. One gallon
treats 200 square feet.
Add 2.5 ounces of product
per gallon of water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Use Limitations
26
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Use Site
Toweling
Garbage Cans
Formulation
Soluble
Concentrate
75174-2
75497-1
Ready to Use
75497-4
75497-5
Soluble
Concentrate
75174-2
75497-1
Ready to Use
75497-4
75497-5
75497-8
Method of
Application
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Application Rate/ No. of
applications
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Remove filter from unit.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry.
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Use Limitations
Materials Preservative
Adhesives
Paints (In Can)
Soluble
Concentrate
75174-2
75497-1
75497-2
75497-3
82077-2
82077-3
Soluble
Concentrate
75174-2
Open pour
Open pour
Add 5 pounds of product
per 100 pounds of
adhesive.
Add 5 pounds of product
per 100 pounds of paint
27
-------
Use Site
Coatings
Textiles, sails, ropes, fire
hose
Formulation
75497-1
75497-2
75497-3
82077-2
82077-3
Soluble
Concentrate
75174-2
75497-1
75497-2
75497-3
82077-2
82077-3
Soluble
Concentrate
75174-2
75497-1
Ready to Use
75497-4
75497-5
Ready to Use
75497-4
75497-5
Method of
Application
Open pour
Spray (pump or
commercial),
Dip, soak
Spray (pump or
commercial)
Dip, soak
Application Rate/ No. of
applications
Add 5 pounds of product
per 100 pounds of coatings
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry.
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Use Limitations
28
-------
Use Site
Concrete Additive
Roofing Materials
(shingles, felt, synthetic
overcoats)
Formulation
Soluble
Concentrate
75497-4
75497-5
Soluble
Concentrate
75174-2
75497-1
Soluble
Concentrate
75497-2
75497-3
82077-2
82077-3
Soluble
Concentrate
64881-3
Soluble
Concentrate
75174-2
75497-1
Ready to Use
70087-1
75497-4
Method of
Application
Open pour
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Application Rate/ No. of
applications
40 ounces per cubic foot of
concrete
Add water before adding to
concrete.
6 ounces per 500 cubic
feet. Add water before
adding to concrete.
6-16 ounces per cubic yard.
Add water before adding to
concrete.
Add 2.5 ounces of product
per gallon of water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 6-
12" from surface until
completely covered. Let
Use Limitations
29
-------
Use Site
Air Filters (vacuum, A/C
units, automobiles,
aquariums)
Air Filters (vacuum, A/C
Formulation
75497-5
Soluble
Concentrate
64881-3
Soluble
Concentrate
75174-2
75497-1
Ready to Use
70087-1
75497-4
75497-5
79652-1
Soluble
Method of
Application
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
Application Rate/ No. of
applications
stand until dry.
Add 2.5 ounces of product
per gallon of water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Remove filter from unit.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Add 2.5 ounces of product
Use Limitations
30
-------
Use Site
units, automobiles,
aquariums)
Polyurethane foam and
cellulose products,
cleaning buffers
Formulation
Concentrate
64881-3
Soluble
Concentrate
75174-2
75497-1
Ready to Use
70087-1
75497-4
75497-5
79652-1
Method of
Application
commercial),
dip or soak
Spray (pump or
commercial),
dip or soak
Spray (pump or
commercial)
Application Rate/ No. of
applications
per gallon of water.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Soak:
Use enough of product to
completely submerge item.
Soak item for 3 minutes.
Remove item and wring
excess liquid. Dry treated
articles before use at a
temperature of up to 160
degrees (a clothes dryer).
Add 8 ounces of product
per gallon of water. Then
apply as in ready to use.
Spray entire surface area 4-
6" from surface until
completely covered. Let
stand until dry or let stand
3 minutes and wipe dry.
Use Limitations
31
-------
APPENDIX B: Trimethoxysilyl Quats (3148)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of trimethoxysilyl Quats. These
requirements apply to trimethoxysilyl Quats in 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.
32
-------
DATA REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
61-1
61-2 A
61-2 B
62-1
62-2
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
101490
105186
105988
128481
130316
164909
41438002
42456501
42456508
101490
105186
105988
128481
130316
164909
42456502
101490
105186
105988
128481
130316
164909
42456502
41959401
42456507
41959401
105988
41959401
33
-------
DATA REQUIREMENT
New Guideline
Number
830.1800
830.6302
830.6303
830.6304
830.7220
830.7300
Old
Guideline
Number
62-3
63-2
63-3
63-4
63-6
63-7
Study Title
Analytical Method
Color
Physical State
Odor
Boiling Point
Density
Use Pattern
CITATION(S)
MRID Number
105988
101490
128481
41959401
42456504
42456506
130316
105988
101490
128481
70190
129655
130316
105988
70190
129655
130316
105988
101490
128481
105988
101490
128481
70191
129565
130316
105988
101490
128481
70191
123565
130316
34
-------
DATA REQUIREMENT
New Guideline
Number
830.7840
830.7860
830.7950
830.7370
830.7000
830.6313
830.6315
830.6317
830.6318
830.6320
830.6321
Old
Guideline
Number
63-8
63-9
63-10
63-12
63-13
63-15
63-17
63-18
63-20
63-21
Study Title
Solubility
Vapor Pressure
Dissociation in Water
pH
Stability
Flammability
Storage Stability
Viscosity
Corrosion Characteristics
Dielectric Breakdown Voltage
Use Pattern
CITATION(S)
MRID Number
43589401
105988
101490
42469601
41276601
42469601
105988
101490
128481
70191
130316
41276601
70191
130316
42456509
105988
101490
128481
42456510
105988
101490
128481
105988
101490
128481
ECOLOGICAL EFFECTS
850.2100
71-1 A
Avian Acute Oral Toxicity Test - Quail/duck
40385218
35
-------
DATA REQUIREMENT
New Guideline
Number
850.2200
850.2200
850.1075
850.1075
850.1010
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
Old
Guideline
Number
71-2 A
71-2 B
72-1 A
72-1 D
72-2 A
81-1
81-2
81-3
81-4
81-5
81-6
82-3
Study Title
Avian Acute Dietary - Quail
Avian Acute Dietary - Duck
Fish Acute Toxicity - Bluegill
Fish Acute Toxicity - Rainbow Trout
Acute Aquatic Invertebrate Toxicity
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Acute Eye Irritation
Acute Dermal Irritation
Skin Sensitization
90-Day Dermal
Use Pattern
CITATION(S)
MRID Number
101491
40385217
105187
105187
40385201
41948702
40385201
41948701
43219901
126471
41157803
93218038
40385201
40385201
41157801
41157802
41977901
42456513
86703
42197401
41339403
TOXICOLOGY
870.3700
83-3 A
Prenatal Developmental Toxicity - Rat
41438003
36
-------
DATA REQUIREMENT
New Guideline
Number
870.5100
870.5380
870.5385
870.5395
870.6300
870.7485
870.7600
Old
Guideline
Number
84-2 A
84-2 B
84-4
85-1
85-2
Study Title
Mutation
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
Use Pattern
CITATION(S)
MRID Number
105185
128480
41353301
42456517
41296802
40385213
41296804
130319
40385216
57346
*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
43578601
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
875.2400
875.2500
133-3
133-4
Dermal Exposure
Inhalation Exposure
41412201
41761201
41412201
37
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov (EPA-HQ-OPP-2007-0831).
These documents include:
3-(Trimethoxysilyl) propyl dimethyl octadecyl ammonium chloride (AEM 5700
Antimicrobial): Risk Characterization for non-food use, dated February 2, 2000.
38
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration Decision
(Bibliography)
1. MRID Studies
28989 Isquith, A.J.; White, W.C.; Malek, J.R.; et al. (1976) Durability of Dow CorningA(R)I 5700 Antimicrobial Agent on Textiles.
In- eludes method CTM 0824 dated Jan 29, 1976. (Unpublished study received Nov 7, 1979 under 34292-1; submitted by
Dow Corning Corp., Midland, Mich.; CDL:241924-A)
28990 Schechtman, L.M.; Beard, S.F.; Sinsky, P.M. (1979) Activity of T1482 in~in vitro-Mammalian Cell: Transformation Assay in
the Absence of Exogenous Metabolic Activation. Final Rept. (Unpub- lished study received Sep 19, 1979 under 34292-1;
prepared by Microbiological Associates, submitted by Dow Corning Corp., Mid- land, Mich.; CDL:241925-A)
29136 Dow Corning Corporation (1977?) Dow CorningA(R)I5700 Antimicrobial Agent: Durability Study. (Unpublished study
received Feb 27, 1980 under 34292-1; prepared in cooperation with Litton Bione- tics Laboratory Products; CDL:241856-A)
29137 Isquith, A.J.; White, W.C.; Malek, J.R.; et al. (1961?) Durability of Dow CorningA(R)I5700 Antimicrobial Agent on Textiles.
(Un- published study received Feb 27, 1980 under 22780-1; submitted by Dow Corning Corp., Midland, Mich.; CDL:241856-
B)
29138 Dow Corning Corporation (1952?) Acute Oral Toxicity. (Unpublished study received Feb 27, 1980 under 34292-1;
CDL:241856-C)
29139 Groh, C.L. (1972) Acute Dermal Toxicity-Albino Rats. (Unpublished study received Feb 27, 1980 under 34292-1; submitted
by Dow Corning Corp., Midland, Mich.; CDL:241856-D)
29140 Lukes, T.; Paa, H. (1973) Report to Dow Corning Corporation: 28-Day Subacute Dermal Toxicity Study with Treated Fabrics
in Albino Rabbits: IBT No. 601-04030. (Unpublished study received Feb 27, 1980 under 34292-1; prepared by Industrial Bio-
Test Laborato- ries, submitted by Dow Corning Corp., Midland, Mich.; CDL: 241856-E)
39
-------
29141 Lukes, T.H.; Paa, H.; Kopplin, R.P. (1974) Addendum Report to Dow Corning Corporation: 28-Day Subacute Dermal
Toxicity Study with Treated Fabrics in Albino Rabbits: IBT No. 601-04030. (Unpub- lished study received Feb 27, 1980
under 34292-1; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Dow Corning Corp., Midland, Mich.;
CDL:241856-F)
31557 Mogul Corporation (1973) ?Study of Dow CorningA(R)I Q9-5700 Antimi- crobial Agent. (Unpublished study received
Mar 25, 1980 under 8591-EX-2; CDL:242184-A)
31558 Mogul Corporation (1978) Laboratory Study: Pilot Plant Study: Field Trials. (Unpublished study received Mar 25, 1980
under 8591-EX- 2; CDL:242184-B)
57346 Siddiqui, W.H.; Malek, J.R.; Shells, E. (1981) Percutaneous Absorp- tion of Dow CorningA(R)I 5700 Antimicrobial Agent
in Rabbits. (Unpublished study received Jan 13, 1981 under 34292-1; submit- ted by Dow Corning Corp., Midland, Mich.;
CDL:244089-A)
58099 Morgan, M.; Smith, S.H. (1977) Report to Dow Corning Corporation: Teratogenic Study with TX 1348 in Albino Rats:
IBT No. 8533- 10126. (Unpublished study received May 6, 1977 under 34292-1; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Dow Corning Corp., Midland, Mich.; CDL:232330-A)
58118 Salamon, C.; Smith, S. (1977) Report to Dow Corning Corporation: Host-Mediated Assay for Detection of Mutations
Induced by TX- 1347: IBT No. 8533-10127. (Unpublished study received May 9, 1977 under 34292-1; submitted by Dow
Corning Corp., Midland, Mich.; CDL:232331-A)
59237 Burlington Industries, Incorporated (1974) ?Human Wear Tests with Dow Corning X9-5700 Treated Socks|. (Compilation;
unpublished study received Apr 8, 1976 under 34292-1; submitted by Dow Corn- ing Corp., Midland, Mich.;
CDL:227218-A)
67672 Oshita, G.; Richter, W.R. (1976) Report to Burlington Hosiery Company, Division of Burlington Industries: Three-week
vaginal Irritation Study with Treated Panty Hose Fabric (Cotton and Nylon) in Beagle Dogs: IBT No. 8531-08440.
(Unpublished study received Sep 18, 1978 under 34292-1; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Dow Corning Corp., Midland, Mich.; CDL:235110-A)
67983 Reno, F.E. (1979) Acute Oral LDI50A in Bobwhite Quail: Triforine Technical: Addendum to Final Report: Project No.
920-102. (Un- published study received Jun 3, 1980 under 21137-6; prepared by Hazleton Laboratories America, Inc.,
submitted by EM Laborato- ries, Inc., Elmsford, N.Y.; CDL:242629-A)
40
-------
70190 Dow Corning Corporation (1976) Information about Antimicrobial Agents. Midland, Mich.: Dow Corning. (New product
informa- tion bulletin 19-015; also~In~unpublished submission received Jul 20, 1977 under 8591-EX-l; submitted by
Mogul Corp., Chagrin Falls, Ohio; CDL:233331-A)
85296 Dow Corning Corporation (1952) ?Toxicity of Dow CorningA(R)I X-9- 5700 to Rats|. (Unpublished study received Sep
18, 1974 under 34292-1; CDL:140129-A)
86702 William G. Roessler (1981) Leaching of aNew Chemical from Treated Fabrics. (Compilation; unpublished study received
Oct20, 1981 under 46620-1; CDL:246194-A)
86703 Shelanski, M. V. (1978) Evaluation of Potential Hazards by Dermal Conduct: PI-19-05-311. (Unpublished study received
Oct 20, 1981 under 46620-1; prepared by Product Investigations, Inc., submit- ted by William G. Roessler, Frederick, Md.;
CDL:246194-B)
86704 United States Testing Company, Incorporated (1977) Acute Dermal Toxicity, Rabbit: No. 02266-3. (Unpublished study
received Oct 20, 1981 under 46620-1; submitted by William G. Roessler, Fred- erick, Md.; CDL:246194-C)
86705 United States Testing Company, Incorporated (1977) Skin Sensitiza- tion Test, Guinea Pig Assay: No. 02266-2.
(Unpublished study received Oct 20, 1981 under 46620-1; submitted by William G. Roessler, Frederick, Md.;
CDL:246194-D)
86706 United States Testing Company, Incorporated (1977) Acute Oral Tox- icity, Single Dose LD50: No. 0226-1. (Unpublished
study re- ceived Oct 20, 1981 under 46620-1; submitted by William G. Roes- sler, Frederick, Md.; CDL:246194-E)
101490 William G. Roessler (1981) ?Chemical and Physical Properties of Trimethoxysilylpropyldidecylmethylammonium
Chloride (TPDMC)|. (Compilation; unpublished study received Dec 17, 1981 under 46620-1; CDL:247268-A)
101491 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1982) Final Report: Eight-day Dietary LCI50A-Bobwhite Quail: Requat
Antimicrobial 1977 Liquid: Project No. 180-101. (Unpublished study received Mar 26, 1982 under 46620-1; prepared by
Wildlife International Ltd., submitted by William G. Roessler, Frederick, Md.; CDL: 247269-A)
104765 Myers, T.W. (1975) Report to Dow Corning Corporation: Acute Vapor Inhalation Toxicity Study with Dow CorningA(R)I
X 9-5700 (Dow Corning Q 9-5700) in Albino Rats: IBT No. 663-06493. (Unpub- lished study received Mar 7, 1975 under
34292-1; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Dow Corning Corp., Midland, Mich.;
CDL:140138-A)
41
-------
105185 Lavelle, G.; Entrup, M. (1982) The Salmonella / Microsomal Assay for Bacterial Mutagenic Activity of Requat
Antimicrobial 1977 Liquid with 50% Methanol: Project N. 82-0671-21. (Unpublished study received Jun 17, 1982 under
46620-1; prepared by Hill Top Research, Inc., submitted by William G. Roessler, Frederick, MD; CDL:247708-A)
105186 Cantor, L. (1982) Formal Report of Analysis for N-Nitroso Com-pounds: Report No. 5450-3611. (Unpublished study
received Jun 17, 1982 under 46620-1; prepared by Thermo Electron Corp., submitted by William G. Roessler, Frederick,
MD; CDL:247709-A)
105187 Grim, J. (1982) Acute, Static LC50 Bioassays: Daphnia magna-48 Hour; Rainbow Trout-96 Hour; Material: PSX-018
Sanitized, Inc. (Unpublished study received Jun 17, 1982 under 46620-1; prepared by Northeastern Biologists, Inc.,
submitted by William G. Roessler, Frederick, MD; CDL:247710-A)
105988 William G. Roessler (1982) ?Chemical Study of PSX018|. (Compila- tion; unpublished study received Jun 30, 1982 under
46620-1; CDL:247783-A)
109274 William G. Roessler (1982) ?Leaching Study of Cotton and Nylon Fab- rics Treated with Dow Corning 5700 and Requat
1977 after Extrac- tion with Distilled Water and Synthetic Sweat). (Compilation; unpublished study received Jul 23, 1982
under 46620-1; CDL: 247899-A)
110418 Isquith, A.; Malek, J.; McGee, J.; et al. (1961) Durability of Dow Corning 5700 Antimicrobial Agent on Textiles.
(Unpublished study received Aug 12, 1982 under 34292-1; submitted by Dow Corning Corp., Midland, MI; CDL:248113-
A)
126470 Roessler, W.; Kofmel, U.; Mebes, B. (1982) Leaching Experiment of Requat 1977 Treated Samples—Analyses of Leachate
Solutions. (Unpublished study received Jan 12, 1983 under 46620-1; prepared by Sanitized Laboratory, Switz., submitted
by William G. Roes- sler, Frederick, MD; CDL:249725-A)
126471 Rothstein, E. (1982) ?Toxicity: Requat Antimicrobial 1977 Liquid). (Unpublished study received Jan 12, 1983 under
46620-1; prepared by Leberco Laboratories, submitted by William G. Roessler, Frderick, MD; CDL:249726-A)
128480 Conine, D. (1982) Supplemental Information for the Evaluation of Requat Antimicrobial 1977 Liquid with 50% Methanol
in the Salmo- nella/microsomal Mutagenicity Assay: Ref. 82-0671-21. Unpub- lished study; 2 p.
128481 William G. Roessler (1982) ?Chemistry of Requat 1977|. (Compila- tion; unpublished study received Apr 21, 1983 under
46620-1; CDL:250167-A)
42
-------
128546 DeVries, C.; Siddiqui, W. (1983) Acute Oral Toxicity Study with Dow Corning X9-6346 (Dow Corning 5772
Antimicrobial Agent). (Unpublished study received May 23, 1983 under 34292-2; sub- mitted by Dow Corning Corp.,
Midland, MI; CDL:250353-A)
128547 DeVries, C.; Siddiqui, W. (1983) Acute Dermal Toxicity Study of Dow Corning X9-6346 (Dow Corning 5772
Antimicrobial Agent). (Unpublished study received May 23, 1983 under 34292-2; sub- mitted by Dow Corning Corp.,
Midland, MI; CDL:250353-B)
128548 DeVries, C.; Siddiqui, W. (1983) An Acute Eye Irritation Study of Dow Corning X9-6346 (Dow Corning 5772
Antimicrobial Agent). (Unpublished study received May 23, 1983 under 34292-2; sub- mitted by Dow Corning Corp.,
Midland, MI; CDL:250353-C)
128549 DeVries, C.; Siddiqui, W. (1983) Acute Dermal Irritation Study of Dow Corning X9-6346 (Dow Corning 5772
Antimicrobial Agent). (Unpublished study received May 23, 1983 under 34292-2; submit- ted by Dow Corning Corp.,
Midland, MI; CDL:250353-D)
129564 Stauffer Chemical Co. (1983) A Two-year Dietary Study with R-29148 (2,2,5-Trimethyl-3-dichloroacetyl-l,3-oxazolidine)
in Rats, 24 Month Interim Report. (Compilation; unpublished study received Jun 15, 1983 under 8F2115; CDL:071763-A)
129565 Dow Corning Corp. (1978) ?Efficacy of Q9-5700 Antimicrobial Agent. (Compilation; unpublished study received Sep 7,
1978 under 34292-1; CDL:241926-A)
130316 Dow Corning Corp. (1976) ?Chemistry of Dow Corning Q9-5700|. (Com- pilation; unpublished study received Aug 25,
1980 under 34292-1; CDL:243105-A)
130317 Dow Corning Corp. (1976) ?Efficacy of Dow Corning Q9-5700|. (Com- pilation; unpublished study received Aug 25,
1980 under 34292-1; CDL:243105-B)
130318 Hobbs, E.; Saunders, F.; Isquith, A.; et al. (1972) Acute Toxico- logic Properties and Industrial Handling Hazards of Dow
Corning Q9-5700 Fluid, a Potential Antimicrobial Agent: File No. 1853- 1. (Unpublished study received Aug 25, 1972
under 34292-1; sub- mitted by Dow Corning Corp., Midland, MI; CDL:243105-C)
130319 Hobbs, E. (1973) Acute Toxicologic Properties of Dow Corning Q9- 5700. (Unpublished study received Aug 25, 1980
under 34292-1; submitted by Dow Corning Corp., Midland, MI; CDL:243105-D)
130320 Groh, C.; Saunders, F. (1972) Eye and Skin Irritation Potential of Diluted Dow Corning Q9-5700, a Potential Biocide: File
43
-------
No. 1853- 2. (Unpublished study received Aug 25, 1980 under 34292-1; sub- mitted by Dow Corning Corp., Midland, MI;
CDL:243105-E)
130321 Rausina, G. (1972) Report to ...: Four-day Static Fish Toxicity Studies with TX-793 in Rainbow Trout and Bluegills: IBT
No. A1904. (Unpublished study received Aug 25, 1980 under 34292-1; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Dow Corning Corp., Midland, MI; CDL:243105-F)
130322 May, R. (1972) Report to ...: Human Repeated Insult Patch Test with TX-793: IBT No. F1905. (Unpublished study
received Aug 25, 1980 under 34292-1; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Dow Corning
Corp., Midland, MI; CDL:243105-G)
130323 Myers, T. (1975) Report to ...: Acute Vapor Inhalation Toxicity Study with Dow Corning Q9-5700 in Albino Rats: IBT
No. 663- 06493. (Unpublished study received Aug 25, 1980 under 34292-1; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Dow Corning Corp., Midland, MI; CDL:243105-1)
130324 Oshita, G. (1976) Report to Burlington Hosiery Company, Division of Burlington Industries: Three-week Vaginal
Irritation Study with Treated Panty Hose Fabric (Cotton and Nylon) in Beagle Dogs: IBT NO. 8531-08440. (Unpublished
study received Aug 25, 1980 under 34292-1; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Dow
Corning Corp., Midland, MI; CDL:243105-K)
130325 Carpenter, J.; Walters, P. (1974) 32-Day Human Wear Test with Dow Corning Q9-5700 Treated Socks. (Unpublished
study received Aug 25, 1980 under 34292-1; prepared by Burlington Industries, Inc., submitted by Dow Corning Corp.,
Midland, MI; CDL:243105-L)
130326 Carpenter, J.; Walters, P. (1974) Three-month Human Wear Test with Dow Corning Q9-5700 Treated Athletic Socks.
(Unpublished study received Aug 25, 1980 under 34292-1; prepared by Burlington Industries, Inc., submitted by Dow
Corning Corp., Midland, MI; CDL:243105-M)
164909 Dow Chemical U.S.A. (1977) Physical and Chemical Properties [of Dow Corning X9-5700]. Unpublished compilation. 34
P-
164910 Dow Corning Corp. (19??) [Efficacy Data for Dow Corning X-9-5700]. Unpublished study. 5 p.
164911 Hobbs, E. (1972) Acute Toxicologic Properties and Industrial Handl- ing Hazards of Dow Corning X-9-5700 Fluid, A
Potential Anti- microbial Agent. Unpublished study prepared by Dow Corning Corp. 5 p.
44
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164912 Hobbs, E. (1973) Acute Toxicologic Properties of Dow Corning X-9- 5700: TX-793; Series No. 1-0005-0129. Unpublished
study pre- pared by Dow Corning Corp. 21 p.
164913 Dow Corning Corp. (1973) Biological and Chemical Methods [Efficacy Data]. Unpublished compilation. 94 p.
40385200 Dow Corning Corp. (1987) Submission of Data in Response to Data Call-In Notice for Q9-5700 Antimicrobial Agent:
Toxicology Data. Transmittal of 19 studies.
40385201 Hobbs, E. (1973) Acute Toxicologic Properties of Dow Corning Q9-5700: Laboratory Project ID: AD-0003. Unpublished
compila- tion prepared by Dow Corning Corp. 23 p.
40385202 Rausinn, G. (1972) Four-day Static Fish Toxicity Studies with Dow Corning Q9-5700 in Rainbow Trout and Bluegills:
Laboratory Proj- ect ID: A-1904. Unpublished study prepared by Industrial Bio-Test Laboratories, Inc. 25 p.
40385204 Lukes, T.; Paa, H. (1973) Report to ... 28-Day Subacute Dermal Tox- icity Study with Treated Fabrics in Albino Rabbits:
IBT No. 601-04030. Unpublished study prepared by Industrial Bio-Test Laboratories, Inc. 37 p.
40385211 Isquith, A. (1978) Mutagenicity Evaluation of Dow Corning 5700 Antimicrobial Agent: Laboratory Project ID: 1853-13.
Unpublish- ed study prepared by Dow Corning Corp. 13 p.
40385213 Schechtman, L.; Beard, S.; Sinsky, P. (1979) Activity of T1483 in in vitro Mammalian Cell Transformation Assay in the
Presence of Exogenous Metabolic Activation: Final Report: Laboratory Project ID: T1483. Unpublished study prepared by
Micrbiological Assoc- iates. 28 p.
40385214 Isquith, A. (1980) Durability of Dow Corning 5700 Antimicrobial Agent on Textile: Laboratory Project ID: 1853.
Unpublished stu- dy prepared by Dow Corning Corp. 23 p.
40385215 Annelin, R. (1978) Acute Toxicity of Dow Corning 5700 Antimicrobial Agent to Daphnia magna in a Static System:
Laboratory Project ID: TX1682. Unpublished study prepared by Dow Corning Corp. p.
40385216 Siddiqui, W. (1981) Percutaneous Absorption of Dow Corning 5700 Antimicrobial Agent in Rabbits: Laboratory Project
ID: TX1966. Unpublished study prepared by Dow Corning Corp. 29 p.
40385217 Beavers, J. (1981) Eight-Day Dietary LC50~Mallard Duck: Dow Cor- ning 5700 Antimicrobial Agent: Final Report:
Laboratory Project ID: TX81-9411-03. Unpublished study prepared by Wildlife Inter- national Ltd. 17 p.
40385218 Beavers, J. (1981) Acute Oral LD50~Mallard Duck: Dow Corning 5700 Antimicrobial Agent: Final Report: Laboratory
45
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Project ID: TX81-9411-03. Unpublished study prepared by Wildlife Interna- tional Ltd. 17 p.
40385219 Hess, C.; White, W.; Weaver, M. (1987) Determination of Respirable Particle Size During Spray Application of Sylgard
Antimicrobial Treatment: Laboratory Project ID: CH010. Unpublished study pre- pared by Dow Corning Corp. 13 p.
40517300 Dow Corning Corporation (1988) Submission of Efficacy Data on Dow Corning 5700 Antimicrobial Agent (EPA Reg. No.
34292-1) in Response to EPA Letter for Amendment dated 09/10/84. Transmittal of 1 study.
40517301 Gettings, R. (1987) Efficacy Data on Trichophyto mentagrophytes (Athlete's Foot Fungus): Dow Corning 5700
Antimicrobial Agent: Laboratory Project ID 9010. Unpublished study prepared by Dow Corning Corporation. 8 p.
41157800 Dow Corning Corp. (1989) Submission of Toxicity and Risk Assesment Data in Support of Q9-5700 Fluid and 5772
Compound. Transmittal of 3 studies.
41157801 Hobbs, E. (1972) Acute Toxicoloic Properties and Industrial Hand- ling Hazards of Dow Corning X-9-5700 Fluid, A
Potential Micro- Bial Agent: File No. 1853-1. Unpublished study prepared by Dow Corning Corp. 6 p.
41157802 Groh, C. (1972) Eye and Skin Irritation Potential of Diluted Dow Corning X-9-5700, A Potential Biocide: File No. 1853-2.
Unpub- lished study prepared by Dow Corning Corp. 4 p.
41157803 Kolesar, G.; Siddiqui, W.; Staton, E. (1985) An Acute Aerosol Inha- lation Toxicity Study with Dow Corning 5772
Compound in Rats: Report No. 1312. Unpublished study prepared by Dow Corning Corp. 35 p.
41276600 Sanitized Inc. (1989) Submission of Stability Data in Support of Registration Standard of Requat Antimicrobial 1977
Liquid. Transmittal of 1 study.
41276601 Williams, D. (1989) N,N-didecyl-N-methyl-3-(trimethoxysilyl) Propanaminium Chloride: 1 Year Storage Stability: Lab
Project Number: PSX/018. Unpublished study prepared by Huls America Inc. 6 p.
41296800 Dow Corning Co. (1989) Submission of studies in support of regis- tration of Dow Corning 5700 Antimicrobial
Treatment: Mutagen- icity tests. Transmittal of 4 studies.
41296801 Young, R. (1989) Mutagenicity Test on DC 5700 Hydrolysate in the L5178Y TK+/- Mouse Lymphoma Forward Mutation
Assay: Final Report: HLA Study No. 10864-0-431; 20989; 431. Unpublished study prepared by Hazleton Laboratories
America, Inc. 36 p.
46
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41296802 Ivett, J. (1989) Single Acute Exposure Dose Selection Study on DC 5700 Hydrolysate, Reference # E6653-8: Final Report:
HLA Study No. 10864-0-459-PO; 10864-0-459; 20996. Unpublished study prepared by Hazleton Laboratories America,
Inc. 13 p.
41296803 Ivett, J. (1989) Mutagenicity Test on DC 5700 Hydrolysate Ref. #E6653-8 In vivo Mouse Micronucleus Assay: Final
Report: HLA Study No. 10864-0-455; 20996; 455. Unpublished study prepared by Hazleton Laboratories America, Inc. 26
P-
41296804 Cifone, M. (1989) Mutagenicity Test on Dow Corning 5700 Hydrolysate in the Rat Primary Hepatocyte Unscheduled
DNA Synthesis Assay: Final Report: HLA Study No. 10864-0-447; 20991; 447. Unpublished study prepared by Hazleton
Laboratories America, Inc. 28 p.
41339400 Dow Corning Corp. (1989) Submission of data in support of registra- tion of Dow Corning 5700 Hydrolysate and Q9-5700
Hydrolysate: Toxicity data. Transmittal of 3 studies.
41339401 York, R. (1989) Range-finding Developmental Toxicity Study in Rats: Dow Corning 5700 Hydrolysate: Lab Project ID
No. 416-067. Unpublished study prepared by International Research and Devel- opment Corp. 29 p.
41339402 King, D.; Dwane, M.; Siddiqui, W. (1989) A 14-Day Rangefmding Dermal Toxicity Study with Dow Corning Q9-5700
Hydrolysate in Rats: File No. 3933-18; Ref. No. TX-89-0200-05; Series No. 1-0005-2597. Unpublished study prepared by
Dow Corning Corp., Toxicology Dept. 15 p.
41339403 Dwane, M.; King, D.; Siddiqui, W.; et al. (1989) A 90-day Subchronic Dermal Toxicity Study of Dow Corning 5700
Hydrolysate in Rats: File No. 3933-19; Ref No. 89-0200-05; Series No. 1-5000-2610. Unpublished study prepared by Dow
Corning Corp. 87 p.
41353300 Dow Corning Corp. (1989) Submission of Supplemental Toxicity Data in Support of Dow Corning (R) 5700 Antimicrobial
Treatment. Transmittal of 2 studies.
41353301 Young, R. (1989) Mutagenicity Test on DC 5700 Hydrolysate in the L5178Y TK+/- Mouse Lymphoma Forward Mutation
Assay: Confirmation Study: Lab Project Number: 10864/0/431: 20989. Unpublished stu- dy prepared by Hazleton
Laboratories America, Inc. 32 p.
47
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41353302 Young, R. (1990) Supplemental Studies to the Mutagenicity Test on DC 5700 Hydrolysate in the L5178Y TK+/- Mouse
Lymphoma Forward Mutation Assay: Lab Project Number: 10864/0/43 I/SUP: 20989. Un- published study prepared by
Hazleton Laboratories America, Inc. 29 p.
41391100 Dow Corning Corp. (1990) Submission of Efficacy Data in Support of Amendment Application for Use of Dow Corning
5700 Antimicro- bial in Sock Fabric for Control of Athlete Foot Fungus. Trans- mittal of 1 study.
41391101 Gettings, R. (1987) Efficacy Data on Trichophyton mentagrophytes (Athlete's Foot Fungus): Dow Corning 5700
Antimicrobial Agent 3- (Trimethoxysilyl)propyldimethyl-octadecyl Ammonium Chloride ...: Lab Project Number: 9010.
Unpublished study prepared by Dow Corning Corp. 8 p.
41412200 Chemical Manufacturers Association Biocides Panel Antimicrobial Exposure Task Force (1990) Submission of
Antimicrobial Exposure Assessment Data in Support of Data Call-in Notice. Transmittal of 1 study.
41412201 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial Exposure Assessment
Study: Lab Project ID: Q626. Unpublished study prepared by Univ. of Iowa, Insti- tute of Agricultural Medicine and
Occupational Health. 209 p. Has different statistics when compared to 41742601 and 41761201.
41438000 Dow Corning Corp. (1990) Submission of Data in Response to Anti- microbial Data Call-In Phase II Reregi strati on for
Dow Corning 5700 Antimicrobial Treatment: Developmental Toxicity Stuides. Transmittal of 3 studies.
41438001 Popendorf, W. (1990) Chemical Manufacturers Association Antimicro- bial Exposure Assessment Study: Lab Project
Number: Q626. Un- published study prepared by The University of Iowa, Institute of Agricultural Medicine and
Occupational Health. 209 p. Statistics vary from those in 41742601 & 41761201.
41438002 York, R. (1989) Range-finding Developmental Toxicity Study in Rats: Dow Corning 5700 Hydrolysate: Lab Project
Number: 416- 067. Unpublished study prepared by International Research and Development. 29 p.
41438003 York, R. (1989) Developmental Toxicity Study in Rats: Dow Corning 5700 Hydrolysate: Lab Project Number: 416-068.
Unpublished study prepared by International Research and Development Corp. 101 p.
41742600 Chemical Manufacturers Association (1991) Submission of Replacement Antimicrobial Exposure Assessment Study to
Support Registration of DCI. Transmittal of 1 study.
41742601 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial Exposure Assessment:
Lab Project Number: Q626. Unpublished study prepared by The Univ. of Iowa. 209 p.
48
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41761200 Chemical Manufacturers Association (1991) Submission of Replacement Antimicrobial Exposure Data in support of
Antimicrobial Pesti- cide Active Ingredient Data Call-in Notice. Transmittal of 1 study.
41948700 Sanitized Inc. (1991) Submission of Data To Support Reregi strati on Phase 3 for Requat Antimicrobial 1977 Liquid:
Toxicology Data. Transmittal of 2 studies.
41948701 Barbera, J. (1991) Acute Dermal Toxicity of (...): Requat Anti- microbial 1977 Liquid: Lab Project Number: 911322.
Unpublished study prepared by Leberco Testing, Inc. 13 p.
41948702 Barbera, J. (1991) Acute Oral Toxicity Testing of (...): Requat Antimicrobial 1977 Liquid: Lab Project Number: 911321.
Unpub- lished study prepared by Leberco Testing, Inc. 14 p.
41959400 Sanitized Inc. (1991) Submission of product chemistry data in supp- ort of registration of Requat. Transmittal of 1 study.
41959401 Steinmetz, J. (1991) Manufacturing Use Product Chemistry Data: Req- uat (Trimethoxysilyl-
propyldidecylmethylammoniumchloride). Un- published study prepared by Huls America, Inc. 16 p.
41977900 Sanitized Inc. (1991) Submission of toxicity data in support of reregi strati on of Requat Antimicrobial 1977 Liquid.
Transmittal of 1 study.
41977901 Barbera, J. (1991) Primary Dermal Irritation: Requat Antimicrobial 1977 Liquid: Lab Project Number: 91812.
Unpublished study prep- ared by Leberco Testing Inc. 10 p.
42197400 Dow Corning Corporation (1992) Submission of toxicology data in support of registration of Dow Corning 5700.
Transmittal of 1 study.
42197401 Hoffman, R. (1992) A Skin Sensitization Study of Dow Corning 5700 Hydrolysate in Guinea Pigs: Lab Project Number:
1992-10000-36929. Unpublished study prepared by Dow Corning Corporation. 23 p.
42203200 Sanitized Inc. (1992) Submission of product chemistry data in supp- ort of a change in percent of active ingredient due to
more sophisticated technique used for analysis for Requat Antimicro- bial 1977 Liquid. Transmittal of 1 study.
42203201 Steinmetz, J. (1991) Manufacturing Use Product Chemistry Data: Requat. Unpublished study prepared by Huls America,
Inc. 16 p.
42204200 Dow Corning Corporation (1992) Submission of preliminary results of an in vivo test on an impurity present in Dow
Coming's Antimi- crobials pursuant to FIFRA Section 6(a)(2). Transmittal of 1 study.
49
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42204201 Stark, F. (1992) Letter Sent to Document Processing Desk, OPP, EPA, February 13, 1992: ?Preliminary results from a 28-
day vapor inhalation toxicity study on a chemical substance that is present as an impurity in Dow Coming's antimicrobial
pro- ducts|. Prepared by Dow Corning Corp. 4 p.
42334100 Dow Corning Corp. (1992) Submission of FIFRA 6(a)(2) Data To Support Supplementary Information to MRID
#42204201: Toxicology study. Transmittal of 1 study.
42334101 Stark, F. (1992) Letter Sent to Office of Pesticide Programs dated May 15, 1992: ?Regarding chemical substance that is
present as impurity in 34292-1,-2,-3,-5,-6|. Prepared by Dow Corning Corp. 3 p.
42456500 Dow Corning Corp. (1992) Submittal of product chemistry and mutagenicity data in support of Dow Corning 5700
Hydrolysate reregi strati on data call-in. Transmittal of 19 studies.
42456501 Abbott, E. (1992) Phase 3 Submission of Dow Corning 5772 Antimicrobial Agent Registration Correspondance.
Unpublished study prepared by Dow Corning Corp. 28 p.
42456502 Abbott, E. (1992) Phase 3 Submission of Dow Corning 5772 Antimicrobial Agent Registration Correspondance.
Unpublished study prepared by Dow Corning Corp. 8 p.
42456503 Malek, J. (1990) Phase 3 Submission of Supplimental Materials: Corporate Test Method 0230, 0680A, and 0680B: Dow
Corning 5700 Hyrolysate. Unpublished study prepared by Dow Corning Corp. 22 p.
42456504 White, W. (1990) Phase 3 New Submission; Analysis for N,N-Dimethylnitrosamine in Dow Corning Q9-5700
Antimicrobial Agent. Unpublished study prepared by Dow Corning Corp. lip.
42456505 White, W. (1990) Phase 3 New Submission; Nitrosamine Analysis: Dow Corning 5700 Antimicrobial Agent. Unpublished
study prepared by Dow Corning Corp. 12 p.
42456506 Malek, J. (1990) Phase 3 New Submission: Chemical Review of Dow Corning 5700 Antimicrobial Agent Impurities.
Unpublished study prepared by Dow Corning Corp. 8 p.
42456507 Malek, J.; Robinson, R. (1978) Phase 3 New Submission Supplimental Materials: Batch Analysis Report for Dow Corning
5700 Antimicrobial Agent and Dow Corning 5772 Antimicrobial Agent. Unpublished study prepared by Dow Corning
Corp. 19 p.
50
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42456508 Abbott, E. (1992) Phase 3 New Submission of ?Revision of] MRID 00071090 Product Bulletin: Information About
Antimicrobial Agents Dow Corning Q9-5700 Antimicrobial Agent. Unpublished study prepared by Dow Corning Corp. 15
P-
42456509 Malek, J. (1977) Phase 3 New Submission of Supplimental Data: Shelf Stability of Dow Corning 5700 Antimicrobial
Agent. Unpublished study prepared by Dow Corning Corp. 8 p.
42456510 Gardner, J. (1984) Phase 3 New Submission of Supplimental Data: Storage Stability Data for Dow Corning 5700
Antimicrobial Agent. Unpublished study prepared by Dow Corning Corp. 12 p.
42456511 Devries. C.; Siddiqui, W. (1983) Phase 3 New Submission: Acute Oral Toxicity of Dow Corning 5700 Antimicrobial
Agent: Project X9-6346. Unpublished study prepared by Dow Corning Corp. 9 p.
42456512 King, D.; Dwane, M.; Siddiqui, W. (1989) Phase 3 New Submission of ?Revision of] MRID 41339402: A 14-Day
Rangefinding Dermal Toxicity Study with Dow Corning Q9-5700 Hydrolysate in Rats. Unpublished study prepared by
Dow Corning Corp. 5 p.
42456513 Devries, C.; Siddiqui, W. (1983) Phase 3 New Submission: Acute Dermal Irritation Study of Dow Corning 5700
Antimicrobial Agent: Lab Project Number: X9-6346. Unpublished study prepared by Dow Corning Corp. 10 p.
42456514 York, R. (1989) Range-Finding Developmental Toxicity Study in Rats ?Revision of MRID 41438002): Dow Corning 5700
Hydrolysate: Lab Project Number: 416-067. Unpublished study prepared by International Research and Development
Corp. 29 p.
42456515 York, R. (1989) Developmental Toxicity Study in Rats ?Revision of MRID 41438003): Dow Corning 5700 Hydrolysate:
Lab Project Number: 416-068. Unpublished study prepared by International Research and Development Corp. 101 p.
42456516 Isquith, A. (1987) Phase 3 New Submission: Mutagenicity Test on Dow Corning 5700 Antimicrobial Agent in the
Bacterial Reverse Mutation Assay. Unpublished study prepared by Dow Corning Corp. 31 p.
42456517 Ivett, J. (1989) Mutagenicity Test on DC 5700 Hydrolysate Ref. #E6653-8 in vivo Mouse Micronucleus Assay: (Revision
of MRID 41296803): HLA Study Number 10864-0-455. Unpublished study prepared by Hazleton Laboratories America,
Inc. 26 p.
42456518 Young, R. (1989) Mutagenicity Test on DC 5700 Hydrolysate in the L5178Y TK+/-Mouse Lymphoma Forward Mutation
Assay: ?Revision of MRID 41296801 : Lab Project Number: 10864-0-431. Unpublished study prepared by Hazleton
51
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Laboratories America, Inc. 36 p.
42456519 Isquith, A. (1987) Phase 3 New Submission: Mutagenicity Test on Dow Corning 5700 Antimicrobial Agent in the
Bacterial Reverse Mutation Assay. Unpublished study prepared by Dow Corning Corp. 31 p.
42496900 Dow Corning Corp. (1990) Submittal of Revised Product Chemistry Data for Dow Corning 5700 Hydrolysate Data Call-
in: Phase 3 Response. Transmittal of 1 study.
42496901 White, C. (1990) Phase 3 ?Revision of] Summary of MRID 00070190 and Related MRID 00130316 and Supplemental
Data: ?Dow Corning 5700 Hydrolysate|: Physical and Chemical Characteristics. Unpublished study prepared by Dow
Corning Corp. 73 p.
42511800 Dow Corning Corp. (1992) Submission of supplemental toxicity data under FIFRA 6(a)2 to support DC 1-2366
registration. Transmittal of 1 study.
42511801 Bey, A. (1992) Letter Sent to OPP, USEPA dated Sept. 23, 1992: Dow Corning 1-2366 Silane: Supplemental Toxicity
Data, including Confidential Attachment. 110 p.
42587500 Chemical Manufacturers Association (1992) Submission of second replacement antimicrobial exposure data in support of
registra- tion for antimicrobial pesticide active ingredients data call-in notice. Transmittal of 1 study.
42587501 Popendorf, W.; Selim, M.; Kross, B. (1992) Chemical Manufacturers Association Antimicrobial Exposure Assessment
Study: Second Replacement to MRID 41761201: Lab Project Number: Q626. Unpublished study prepared by The
University of Iowa. 316 p.
43219900 Dow Corning Corp. (1994) Submittal of Acute Dermal Toxicity Data in Support of Reregi strati on of DOW CORNING
X9-6346 (DOW CORNING 5772 Antimicrobial Agent). Transmittal of 1 study.
43219901 DeVries, C.; Siddiqui, W. (1983) Acute Dermal Toxicity Study of DOW CORNING X9-6346 (DOW CORNING 5772
Antimicrobial Agent): Lab Project Number: 4211-3. Unpublished study prepared by DOW CORNING CORP. 10 p.
43578600 Dow Corning Corp. (1995) Submission of Environmental Fate Data in Support of Trimethoxysilyl Quats Reregi strati on.
Transmittal of 1 Study.
43578601 Gorman, M. (1995) Hydrolysis of DC-5772 as a Function of pH: Final Report: Lab Project Number: 42160: 8253.
Unpublished study prepared by ABC Labs, Inc. 164 p.
52
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43589400 Dow Corning Corp. (1994) Submission of Product Chemistry Data in Support of the Reregi strati on of Trimethyoxysilyl
quats. Transmittal of 1 Study.
43589401 Angelotti, N. (1994) Solubility of Q9-6346 Silane: (Same as Dow Corning 5772 Antimicrobial Agent): Lab Project
Number: LIMS 9402992. Unpublished study prepared by Dow Corning Corp. 5 p.
43811200 Dow Corning Corp. (1995) Submission of Environmental Fate Data in Support of the Reregi strati on of Trimethoxysilyl
Quats. Transmittal of 1 Study.
43811201 Gorman, M. (1995) Hydrolysis of DC-5772 as a Function of pH: Amended Final Report: Lab Project Number: 42160:
8253. Unpublished study prepared by ABC Labs, Inc. 202 p.
44129300 Coating Systems (1996) Submission of Product Chemistry Data in Support of the Application for Registration of
Zoonocide. Transmittal of 1 Study.
44129301 Wright, T. (1996) Product Chemistry Information: Zoonocide. Unpublished study prepared by Wright Corp. and Coating
Systems. 10 p.
44186000 S.C. Johnson & Son, Inc. (1996) Submission of Product Chemistry, Toxicity, and Efficacy Data in Support of the
Application for Registration of BD 1. Transmittal of 17 Studies.
44186001 Gueldenzopf, T. (1996) Product Chemistry Data for Bathroom Duck, Formula Numbers 7217H121, 7217H120, and
7217H140: Lab Project Number: ARTM-W-105627A. Unpublished study prepared by S.C. Johnson and Son, Inc. 91 p.
44186002 Siepler, R. (1994) Physical and Chemical Characteristics of Bathroom Duck, Formula Number 7217H121: Lab Project
Number: 201: 7217H121-A1: 8308. Unpublished study prepared by S.C. Johnson and Son, Inc. 14 p.
44186003 Weiss, C. (1994) Amendment to Twelve Month Room Temperature Storage-Stability Study for Bathroom Duck Formula
Number 7217H121: Lab Project Number: 201: 7217H121-A12. Unpublished study prepared by S.C. Johnson and Son, Inc.
21 p.
44186004 Glaza, S. (1993) Acute Oral Toxicity Study of Raid BD493/n-Alkyl (60% C14, 30% C16, 5% C12, 5% CIS) Dimethyl
Benzyl Ammonium Chloride/n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride/3-
(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H121) in Rats: Final Report: Lab Project
Number: HWI 21103437. Unpublished study prepared by Hazleton Wisconsin, Inc. 29 p. \
53
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44186005 Glaza, S. (1993) Acute Dermal Toxicity Study of Raid BD493/n-Alkyl (60% C14, 30% C16, 5% C12, 5% CIS) Dimethyl
Benzyl Ammonium Chloride/n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride/3-
(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H121) in Rabbits: Final Report: Lab Project
Number: HWI 21103438. Unpublished study prepared by Hazleton Wisconsin, Inc. 39 p.
44186006 Glaza, S. (1993) Primary Eye Irritation Study of Raid BD493/n-Alkyl (60% C14, 30% C16, 5% C12, 5% CIS) Dimethyl
Benzyl Ammonium Chloride/n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride/3-
(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H121) in Rabbits: Final Report: Lab Project
Number: HWI 21103440. Unpublished study prepared by Hazleton Wisconsin, Inc. 36 p.
44186007 Glaza, S. (1993) Primary Dermal Irritation Study of Raid BD493/n-Alkyl (60% C14, 30% C16, 5% C12, 5% CIS)
Dimethyl Benzyl Ammonium Chloride/n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride/3-
(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H121) in Rabbits: Final Report: Lab Project
Number: HWI 21103439. Unpublished study prepared by Hazleton Wisconsin, Inc. 25 p.
44186008 Glaza, S. (1993) Dermal Sensitization Study of Raid BD493/n-Alkyl (60% C14, 30% C16, 5% C12, 5% CIS) Dimethyl
Benzyl Ammonium Chloride/n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride/3-
(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H120) in Guinea Pigs—Closed Patch Technique:
Final Report: Lab Project Number: HWI 21103442. Unpublished study prepared by Hazleton Wisconsin, Inc. 36 p.
44186009 Falbo, D. (1996) Efficacy Testing of Disinfectant Bathroom Duck—No Fragrance: Amended Report: Lab Project Number:
8308: 106750: 201. Unpublished study prepared by S.C. Johnson Wax, Inc. 133 p.
44186010 Falbo, D. (1996) Efficacy Testing of Disinfectant Bathroom Duck-No Fragrance: Formula 7217H121 (ETC 2125M)
Active Ingredient: Quaternary Ammomium Compound Fungistatic Claims 201M2: Amended Report: Lab Project
Number: 8308: 106750: 201. Unpublished study prepared by S.C. Johnson Wax, Inc. 20 p.
44186011 Miles, S. (1996) Efficacy Testing of Disinfectant Bathroom Duck-No Fragrance: Formula 7217H121 (ETC 2125M)
Virucidal Claims 201M3: Amended Report: Lab Project Number: 8308: 105697: 201M3. Unpublished study prepared by
S.C. Johnson Wax, Inc. 39 p.
44186012 Falbo, D. (1996) Efficacy Testing of Disinfectant Bathroom Duck-Spring Fresh Scent: Formula 7217H120 (ETC
2125M): Amended Report: Lab Project Number: 8308: 106751: 200. Unpublished study prepared by S.C. Johnson Wax,
Inc. 50 p.
54
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44186013 Falbo, D. (1996) Efficacy Testing of Disinfectant Bathroom Duck-Country Garden: Formula 7217H140 (ETC 2125M):
Amended Report: Lab Project Number: 8308: 106394: 212. Unpublished study prepared by S.C. Johnson Wax, Inc. 46 p.
44186014 Falbo, D. (1996) Residual Antibacterial Test for Bathroom Duck: 7217H12-MUP Active Ingredients: Quaternary
Ammonium Compound DC 5772 MUP: Lab Project Number: 289M1: GLP 289M1: A041. Unpublished study prepared by
S.C. Johnson Wax, Inc. 72 p.
44186015 Brady, C. (1996) One Minute Inactivation of Human Immunodeficiency Virus Type 1 (HIV-1) by 7217H121-MUP: Lab
Project Number: 2395. Unpublished study prepared by ViroMed Laboratories, Inc. 9 p.
44186016 Bennett, M. (1996) The Evaluation of the Efficacy of 7217H121-MUP Against Escherichia coli (0157:H7): Lab Project
Number: 2403. Unpublished study prepared by ViroMed Laboratories, Inc. 8 p.
44186017 Bennett, M. (1996) The Evaluation of the Efficacy of 7217H121-MUP Against Vancomycin Resistant Enterococcus
faecalis: Lab Project Number: 2402. Unpublished study prepared by ViroMed Laboratories, Inc. 10 p.
44218900 S.C. Johnson & Son, Inc. (1996) Submission of Toxicity Data in Support of the Application for Registration of Raid BD 1.
Transmittal of 1 Study.
44218901 Hoffman, G. (1997) An Acute (4-Hour) Inhalation Toxicity Study of Raid BD493 / n-Alkyl (60% C14, 30% C16, 5% C12,
5% CIS) Dimethyl Benzyl Ammonium Chloride / n-Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium
Chloride / 3-(Trimethoxysily) Propyl Dimethyl Octadecyl Ammonium Chloride (7217H121) in the Rat via Nose-Only
Exposure: Revised Final Report: Lab Project Number: 92-5125: 925125. Unpublished study prepared by Huntingdon Life
Sciences. 90 p.
44279400 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Applications for
Registration for AM 500 I and AM 500. Transmittal of 4 Studies.
44279401 BioShield Technologies, Inc. (1997) Product Identity and Composition of AM 500 I and AM 500. Unpublished study. 14
P-
44279402 BioShield Technologies, Inc. (1997) Description of Beginning Materials and the Manufacturing Process of AM 500 I and
AM 500. Unpublished study. 24 p.
44279403 Berkner, J. (1997) Discussion of Formation of Impurities in AM 500 I and AM 500. Unpublished study prepared by
BioShield Technologies, Inc. 4 p.
55
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44279404 Wells, D. (1997) AMSOO-Conducting Product Chemistry Studies for an End-Use Product Following Product Properties
Test Guidelines: Final Report: Lab Project Number: 97-3-6913: 13637.1196.6100.880. Unpublished study prepared by
Springborn Laboratories, Inc. 44 p. (OPPTS 830.6302, 830.6303, 830.6304, 830.7300, 830.7100, & 830.7000}
44351900 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Applications for
Registration for BioShield AM 500 and BioShield AM 500 I. Transmittal of 1 Study.
44351901 Jellinek, Schwartz & Connolly, Inc. (1997) Preliminary Analysis, Certification of Ingredient Limits, and Analytical
Method for Enforcement of Limits for BioShield AM 500 and BioShield AM 500 I: Lab Project Number:
13637.0497.6102.250: 102196/830.6317/BIOSHIELD. Unpublished study prepared by Springborn Laboratories, Inc. 13 p.
44376000 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Protectant Concentrate C15. Transmittal of 3 Studies.
44376001 BioShield Technologies, Inc. (1997) Product Identity of BST Protectant Concentrate C15. Unpublished study. 23 p.
44376002 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Protectant Concentrate C15: Lab Project Number: 102196/830.6317/BIOSHIELD. Unpublished study. 11 p.
44376003 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Protectant Concentrate C15. Unpublished
study. 4 p.
44376200 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Registration of BST
Protectant 50. Transmittal of 3 Studies.
44376201 BioShield Technologies, Inc. (1997) Product Identity of BST Protectant 50. Unpublished study. 23 p.
44376202 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Protectant 50. Unpublished study, lip.
44376203 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Protectant 50. Unpublished study. 4 p.
44379400 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of Application for the Registration
of BST Protectant 75. Transmittal of 3 Studies.
44379401 BioShield Technologies, Inc. (1997) Product Identity of BST Protectant 75. Unpublished study. 23 p.
56
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44379402 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Protectant 75. Unpublished study, lip.
44379403 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Protectant 75. Uupublished study. 4 p.
44385100 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Kleen Air 05. Transmittal of 3 Studies.
44385101 BioShield Technologies, Inc. (1997) Product Identity of BST Kleen Air 05. Unpublished study. 31 p.
44385102 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Kleen Air 05: Lab Project Number: 102196/830.6317/BIOSHIELD. Unpublished study. 12 p.
44385103 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Kleen Air 05. Unpublished study. 4 p.
44385200 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Fabric Softener 175. Transmittal of 3 Studies.
44385201 BioShield Technologies, Inc. (1997) Product Identity of BST Fabric Softener 175. Unpublished study. 67 p.
44385202 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Fabric Softener 175. Unpublished study. 12 p.
44385203 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Fabric Softener 175. Unpublished study. 4
P-
44385300 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Carpet and Upholstery Cleaner Aerosol 25. Transmittal of 3 Studies.
44385301 BioShield Technologies, Inc. (1997) Product Identity of BST Carpet and Upholstery Cleaner Aerosol 25. Unpublished
study. 41 p.
44385302 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Carpet and Upholstery Cleaner Aerosol 25. Unpublished study, lip.
44385303 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Carpet and Upholstery Cleaner Aerosol 25.
Unpublished study. 4 p.
57
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44385600 Bioshield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Mold and Mildew Remover and All Purpose Cleaner 25. Transmittal of 3 Studies.
44385601 BioShield Technologies, Inc. (1997) Product Identity of BST Mold and Mildew Remover & All Purpose Cleaner 25.
Unpublished study. 68 p.
44385602 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Mold and Mildew Remover & All Purpose Cleaner 25. Unpublished study. 12 p.
44385603 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Mold and Mildew Remover & All Purpose
Cleaner 25. Unpublished study. 4 p.
44385700 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Carpet and Upholstery Concentrate C15. Transmittal of 3 Studies.
44385701 BioShield Technologies, Inc. (1997) Product Identity of BST Carpet and Upholstery Cleaner Concentrate C15.
Unpublished study. 47 p.
44385702 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Carpet and Upholstery Cleaner Concentrate C15: Lab Project Number: 102196/830.6317/BIOSHIELD. Unpublished
study. 12 p.
44385703 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Carpet and Upholstery Cleaner Concentrate
C15. Unpublished study. 4 p.
44386000 BioShield Technologies, Inc. (1997) Submission of Product Chemistry Data in Support of the Application for Registration
of BST Carpet and Upholstery Cleaner 25. Transmittal of 3 Studies.
44386001 BioShield Technologies, Inc. (1997) Product Identity of BST Carpet and Upholstery Cleaner 25. Unpublished study. 37 p.
44386002 BioShield Technologies, Inc. (1997) Certification of Limits and Analytical Method for Enforcement of Limits for BST
Carpet and Upholstery Cleaner 25: Lab Project Number: 102196/830.6317/BIOSHIELD. Unpublished study. 11 p.
44386003 BioShield Technologies, Inc. (1997) Physical and Chemical Properties of BST Carpet and Upholstery Cleaner 25.
Unpublished study. 4 p.
58
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44507000 Atlantic Mills, Inc. (1998) Submission of Product Chemistry and Efficacy Data in Support of the Application for
Registration of Kerri-Klean Microbe Guard. Transmittal of 2 Studies.
44507001 Griffin, H. (1998) Product Chemistry: Kerri-Klean Microbe Guard: Lab Project Number: 287. Unpublished study prepared
by NAMSA. 34 p.
44507002 Griffin, H. (1998) Dow Corning Shake Flask: Kerri Klean Microbeguard: Lab Project Number: 287. Unpublished study
prepared by NAMSA. 59 p.
44553500 BioShield Technologies, Inc. (1998) Submission of Toxicity Data in Support of the Application for Registration of
BioShield AM 500 and BioShield 500 I. Transmittal of 1 Study.
44553501 Kuhn, J. (1998) Primary Eye Irritation Study in Rabbits: AM500: Final Report: Lab Project Number: 4263-98.
Unpublished study prepared by Stillmeadow Inc. 21 p.
44649600 S.C. Johnson & Son, Inc. (1998) Submission of Efficacy Data in Support of the Registration of BD1. Transmittal of 3
Studies.
44649601 Falbo, D. (1998) Residual Antibacterial Efficacy of BD1: Lab Project Number: GLP 368M1: 368M1: 132247.
Unpublished study prepared by S.C. Johnson Wax, Inc. 20 p.
44649602 Falbo, D. (1998) Residual Mold and Mildew Efficacy of BD1-7 Days: Lab Project Number: GLP 368M2: A124: 132246.
Unpublished study prepared by S.C. Johnson Wax, Inc. 20 p.
44649603 Falbo, D. (1998) Residual Mold and Mildew Efficacy of BD1-14 Days: Lab Project Number: GLP 368M3: A124: 132246.
Unpublished study prepared by S.C. Johnson Wax, Inc. 20 p.
44789800 BioShield Technologies, Inc. (1999) Submission of Toxicity Data in Support of the Application for Registration of BST
Protectant 50. Transmittal of 1 Study.
44789801 Kuhn, J. (1999) Primary Eye Irritation Study in Rabbits: AM 500: Final Report: Lab Project Number: 4842-98.
Unpublished study prepared by Stillmeadow, Inc. 17 p. (OPPTS 870.2400}
44789900 BioShield Technologies, Inc. (1999) Submission of Toxicity Data in Support of the Application for Registration of BST
Protectant Concentrate C15. Transmittal of 1 Study.
59
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44789901 Kuhn, J. (1999) Primary Eye Irritation Study in Rabbits: (BST Protectant Concentrate CIS): Final Report: Lab Project
Number: 4841-98. Unpublished study prepared by Stillmeadow, Inc. 17 p. (OPPTS 870.2400}
44876600 BioShield Technologies, Inc. (1999) Submission of Product Chemistry Data in Support of the Application for Registration
ofBioShield AMS 1860. Transmittal of 3 Studies.
44876601 Wells, D. (1999) AMS 1860-Preliminary Analysis: Lab Project Number: 13637.6119: 4.3.07(2). Unpublished study
prepared by Springborn Laboratories, Inc. 51 p. {OPPTS. 830.1700}
44876602 Damico, J. (1999) AMS 1860-Certified Limits. Unpublished study prepared by BioShield Technologies, Inc. 4 p. {OPPTS.
830.1750}
44876603 Wells, D. (1999) AMS 1860-Product Chemistry Testing for an End-Use Product Following Product Properties Test
Guidelines, Series 830: Lab Project Number: 13637.6118. Unpublished study prepared by Springborn Laboratories, Inc. 47
p. {OPPTS. 830.6302, 830.6303, 830.6304, 830.6315, 830.7300, 830.7100, 830.7000}
44885900 Bioshield Technologies, Inc. (1999) Submission of Product Chemistry Data in Support of the Application for Registration
of Bioshield AMS 1860. Transmittal of 2 Studies.
44885901 Damico, J. (1999) Product Identity and Disclosure of Ingredients, Description of Beginning Materials and Manufacturing
Process, and Discussion of the Formation of Impurities: AMS-1860. Unpublished study prepared by SciReg, Inc. 73 p.
{OPPTS 830.1550, 830.1620, 830.1670}
44885902 Wells, D. (1999) AMS 1860-Determination of the Boiling Point: Lab Project Number: 13637.6120. Unpublished study
prepared by Springborn Laboratories. 25 p. {OPPTS 830.7200}
44914500 S.C. Johnson & Son, Inc. (1999) Submission of Product Chemistry, Toxicity, and Efficacy Data in Support of the
Application for Registration of Raid 500. Transmittal of 14 Studies.
44914501 Grissmeyer, J. (1999) Product Chemistry Data for Raid 500, Formula Number 15194D48: Lab Project Number:
15194D109: ARTM-W-132013C: ARTM-W-132013B. Unpublished study prepared by S.C. Johnson and Son, Inc. 118 p.
{OPPTS 830.1550, 830.1600, 830.1620, 830.1650, 830.1670, 830.1700, 830.1750, 830.1800}
44914502 Smith, G. (1999) Physical and Chemical Characteristics of Raid 500, Formula Number 15194D48: Lab Project Number:
15194D48-A2: 409A2: P-4. Unpublished study prepared by S.C. Johnson and Son, Inc. 21 p. {OPPTS 830.6303,
830.6303, 830.6304, 830.7300, 830.7000, 830.6315}
60
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44914503 Bonnette, K. (1999) An Acute Oral Toxicity Study in Rats with Raid 500 Intermediate: Lab Project Number: 3068.198:
349. Unpublished study prepared by Springborn Laboratories, Inc. 26 p. (OPPTS 870.1100}
44914504 Bonnette, K. (1999) An Acute Dermal Toxicity Study in Rabbits with Raid 500 Intermediate: Lab Project Number:
3068.199: 349. Unpublished study prepared by Springborn Laboratories, Inc. 33 p. {OPPTS 870.1200}
44914505 Bonnette, K. (1999) An Acute Nose-Only Inhalation Toxicity Study in Rats with Raid 500 Intermediate: Final Report: Lab
Project Number: 3068.200: 349. Unpublished study prepared by Springborn Laboratories, Inc. 54 p. {OPPTS 870.1300}
44914506 Bonnette, K. (1999) A Primary Eye Irritation Study in Rabbits with Raid 500: Aerosol Dosing Method: Amended Final
Report: Lab Project Number: 3068.201: 409. Unpublished study prepared by Springborn Laboratories, Inc. 29 p. {OPPTS
870.2400}
44914507 Bonnette, K. (1999) A Confirmatory Primary Eye Irritation Study in Rabbits with Raid 500: Aerosol Dosing Method: Final
Report: Lab Project Number: 3068.230: 409. Unpublished study prepared by Springborn Laboratories, Inc. 30 p. {OPPTS
870.2400}
44914508 Bonnette, K. (1999) A Primary Skin Irritation Study in Rabbits with Raid 500 Intermediate: Final Report: Lab Project
Number: 3068.202: 349. Unpublished study prepared by Springborn Laboratories, Inc. 29 p. {OPPTS 870.2500}
44914509 Bonnette, K. (1999) A Dermal Sensitization Study in Guinea Pigs with Raid 500 Intermediate: Modified Buehler Design:
Amended Final Report: Lab Project Number: 3068.203: 349. Unpublished study prepared by Springborn Laboratories, Inc.
63 p. {OPPTS 870.2600}
44914510 Falbo, D. (1999) Efficacy Testing of Raid 500: Amended Report: Lab Project Number: A0257: 409M1: 409. Unpublished
study prepared by S.C. Johnson & Son, Inc. 19 p.
44914511 Falbo, D. (1999) Efficacy Testing of Raid 500: Amended Report: Lab Project Number: A0257: 409M2. Unpublished study
prepared by S.C. Johnson & Son, Inc. 18 p.
44914512 Falbo, D. (1999) Raid 500-Efficacy Study: Amended Report: Lab Project Number: A0257: 409M3. Unpublished study
prepared by S.C. Johnson & Son, Inc. 14 p.
44914513 Falbo, D. (1999) Raid 500-Efficacy Study: Amended Report: Lab Project Number: A0257: 409M4. Unpublished study
prepared by S.C. Johnson & Son, Inc. 14 p.
61
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44914514 Falbo, D. (1999) Efficacy Testing ofRaid 500-F1: Lab Project Number: A0257: 411M1. Unpublished study prepared by
S.C. Johnson & Son, Inc. 20 p.
44929100 BioShield Technologies, Inc. (1999) Submission of Product Chemistry Data in Support of the Application for Registration
of AMS 1860. Transmittal of 1 Study.
44929101 Ward, T.; Rondon, C.; Boeri, R. (1999) AMS 1860: Determination of Stability at Normal and Elevated Temperatures and
in the Presence of Metals and Metal Ions: Lab Project Number: 1853-BS. Unpublished study prepared by T.R. Wilbury
Labs., Inc. 40 p. (OPPTS 830.6313}
44969200 S.C. Johnson and Son, Inc. (1999) Submission of Efficacy Data in Support of the Application for Registration ofRaid 500.
Transmittal of 3 Studies.
44969201 Onstad, B. (1999) EPA Hard Surface Mildew-Fungistatic Test (Raid 500): Final Study Report: Lab Project Number: 7488.
Unpublished study prepared by Viromed Biosafety Labs. 9 p.
44969202 Ramm, K. (1999) Virucidal Efficacy of Disinfectants for use on Environmental Surfaces: Virus: Influenza Virus type A2
(Raid 500): Final Study Report: Lab Project Number: 7538: JW011899.FLU. Unpublished study prepared by Viromed
Biosafety Labs. lip.
44969203 Ramm, K. (1999) Virucidal Efficacy of Disinfectants for use on Inanimate Environmental Surfaces: Virus: Rhinovirus
type 39 (Raid 500): Final Study Report: Lab Project Number: 7539: JW021699.R39. Unpublished study prepared by
Viromed Biosafety Labs. lip.
44972400 BioShield Technlogies, Inc. (1999) Submission of Product Chemistry Data in Support of the Application for Registration
of BSTI 1860. Transmittal of 1 Study.
44972401 Damico, J. (1999) BSTI 1860: Product Identity and Disclosure of Ingredients, Description of Beginning Materials and
Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by SciReg, Inc. 43 p.
{OPPTS 830.1550, 830.1620,830.1620, 830.1670, 830.1750}
45121300 BioShield Technologies, Inc. (2000) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of AM 3651PI. Transmittal of 8 Studies.
62
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45121301 Smith, F. (2000) AM 3651PI: Product Identity and Composition, Description of Beginning Materials, Description of
Formula Process, Discussion of the Formation of Impurities, and Certified Limits. Unpublished study prepared by SciReg,
Inc. 40 p. (OPPTS 830.1550, 830.1600, 830.1650, 830.1670, 830.1750}
45121302 Wells, D. (1999) AM 3651PI-Determination of Storage Stability: Lab Project Number: 13637.0897.6107.865:
13637.6107. Unpublished study prepared by SpringbornLabs., Inc. 36 p. {OPPTS 830.6317}
45121303 Kuhn, J. (1999) AM 3651PI: Acute Oral Toxicity Study in Rats: Final Report: Lab Project Number: 4850-98. Unpublished
study prepared by Stillmeadow, Inc. 24 p. {OPPTS 870.1100}
45121304 Kuhn, J. (1999) AM 365 IP: Acute Dermal Toxicity Study in Rabbits: Final Report: Lab Project Number: 4851-98.
Unpublished study prepared by Stillmeadow, Inc. 22 p. {OPPTS 870.1200}
45121305 Bennick, J. (1999) AM 365 IP: Acute Inhalation Toxicity Study in Rats: Final Report: Lab Project Number: 4852-98.
Unpublished study prepared by Stillmeadow, Inc. 36 p. {OPPTS 870.2400}
45121306 Kuhn, J. (1999) AM 365 IP: Primary Dermal Irritation Study in Rabbits: Final Report: Lab Project Number: 4854-98.
Unpublished study prepared by Stillmeadow, Inc. 13 p. {OPPTS 870.2400}
45121307 Kuhn, J. (1999) AM 365 IP: Primary Dermal Irritation Study in Rabbits: Final Report: Lab Project Number: 4854-98.
Unpublished study prepared by Stillmeadow, Inc. 13 p. {OPPTS 870.2500}
45121308 Kuhn, J. (1999) AM 365 IP: Dermal Sensitization Study in Guinea Pigs: Final Report: Lab Project Number: 4855-98.
Unpublished study prepared by Stillmeadow, Inc. 18 p. {OPPTS 870.2600}
45347600 Bioshield Technologies, Inc. (2001) Submission of Efficacy Data in Support of the Application for Registration AM
365IP. Transmittal of 2 Studies.
45347601 Snyder, A. (1999) AOAC Use-Dilution Method: AM 365 IP: Final Study Report: Lab Project Number:
7361/SRC021099.UD: 7669/SRC061099.UD. Unpublished study prepared by ViroMed Biosafety Labs. 15 p.
45347602 Onstad, B. (2000) Germicidal and Detergent Sanitizing Action of Disinfectants: AM 365 IP: Final Study Report: Lab
Project Number: 7457: SRC050699.SAN. Unpublished study prepared by ViroMed Biosafety Labs. 10 p.
45810100 Goulston Technologies, Inc. (2002) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of AM-7 Antimicrobial. Transmittal of 3 Studies.
63
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45810101 Miller, L. (2002) Goulston Technologies AM-7 Antimicrobial: Product Identity and Composition, Description of Materials
Used to Produce the Product, Description of Formulation Process, Discussion of Formation of Impurities, Certified Limits,
Enforcement Analytical Method, Submittal of Samples: Lab Project Number: GT-AM7-830: GC-09-00: ALTM040.DOC.
Unpublished study prepared by Biologic, Inc. 101 p. (OPPTS 830.1550, 830.1600, 830.1650, 830.1670, 830.1750,
830.1800,830.1900}
45810102 Miller, L. (2002) Goulston Technologies AM-7 Antimicrobial: Physical and Chemical Properties: Lab Project Number:
GT-AM7-83001. Unpublished study prepared by Biologic, Inc. 6 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6315,
830.7000, 830.7100, 830.7220, 830.7300, 830.7840, 830.7950}
45810103 Cerven, D. (2002) Acute Eye Irritation in Rabbits: M 18001: Lab Project Number: MB 02-10168.04: 1200-01.
Unpublished study prepared by MB Research Laboratories. 10 p. {OPPTS 870.2400}
46022700 SisShield Technologies, Inc. (2003) Submission of Product Chemistry Data in Support of the Application for Registration
of SiS 7200. Transmittal of 3 Studies.
46022701 Haynes, D. (2003) SiS 7200: Product Identity and Disclosure of Ingredients, Description of the Beginning Materials and
Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by SiShield
Technologies, Inc. 46 p.
46022702 Fung, K.; Leung, H.; Roesch, E. (2003) Preliminary Analysis of Chemical Composition: SIS 7200 Alternative
Formulation. Project Number: 3002. Unpublished study prepared by Ortec Inc. 20 p.
46022703 Haynes, D. (2003) SiS 7200 Certified Limits. Unpublished study prepared by SiShield Technologies, Inc. 4 p.
46023000 SiShield Technologies, Inc. (2003) Submission of Product Chemistry Data in Support of the Application for Registration
of SiS Am 500 and SiS AM500I. Transmittal of 3 Studies.
46023001 Haynes, D. (2003) SiS AM 500 and SiS AM500I: Product Identity and Disclosure of Ingredients, Description of the
Beginning Materials and Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study
prepared by SisShield Technologies, Inc. 40 p.
46023002 Haynes, D. (2003) SiS AM500 and AM500I Certified Limits. Unpublished study prepared by SiShield Technologies, Inc.
4 p.
64
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46023003 Fung, K.; Leung, H.; Roesch, E. (2003) Determination of Quaternary Ammonium Chloride Content in SiS AM 500 and
SiS AM 500 Alternative. Project Number: 3003. Unpublished study prepared by Ortec, Inc. 14 p.
46054800 Marinize Products Corp (2003) Submission of Product Chemistry Data in Support of the Application for Registration of
Miltrol. Transmittal of 3 Studies.
46054801 Sinning, D. (2003) Preliminary Analysis and Enforcement Analytical Method: Miltrol. Project Number: 3030/01.
Unpublished study prepared by Case Consulting Laboratories, Inc. 8 p.
46054802 Sinning, D. (2003) Physical and Chemical Characteristics of Miltrol: Physical State, Oxidation/Reduction, Flammability,
pH, Viscosity and Relative Density. Project Number: 3030/02. Unpublished study prepared by Case Consulting
Laboratories, Inc. 7 p.
46054803 Loder, E. (2003) Submission of Chemistry, Manufacturing Process and Confidential Statement of Formula: Miltrol.
Project Number: MILTROL/1. Unpublished study prepared by Maranize Products, Corp. 4 p.
46279600 Marinize Products, Corp. (2004) Submission of Product Chemistry Data in Support of the Application for Registration of
Miltrol. Transmittal of 1 Study.
46279601 Loder, E. (2004) Chemistry Data: Miltrol. Project Number: MITROL/1. Unpublished study prepared by Marinize
Products, Corp. 31 p.
46341100 Jennico2, Inc. (2004) Submission of Product Chemistry Data in Support of the Application for Registration of Pine
Cleaner. Transmittal of 2 Studies.
46341102 Sinning, D. (2004) Physical and Chemical Characteristics of MILTROL: Storage Stability and Corrosion Characteristics.
Project Number: 3030/03. Unpublished study prepared by Case Consulting Laboratories, Inc. 9 p.
46579200 Marinize Products Corp. (2005) Submission of Efficacy Data in Support of the Amended Registration of Miltrol.
Transmittal of 1 Study.
46579201 Loder, E. (2005) Efficacy of Organosilane On the Acute Mortality of American House Dust Mites: Final Report.
Unpublished study prepared by Marinize Products, Inc. 32 p.
46693800 Aegis Environmental Management, Inc. (2005) Submission of Product Chemistry and Toxicity Data in Support of the
Application for Registration of Aegis 444-02 RTU Antimicrobial. Transmittal of 8 Studies.
65
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46693801 Welch, C. (2005) Aegis 444-02 RTU Antimicrobial: Product Identity, Composition and Analysis (Group A). Project
Number: AEM/44402/2005/1. Unpublished study prepared by ChemReg International, LLC. 36 p.
46693802 Sinning, D. (2005) Physical and Chemical Characteristics of AEGIS Antimicrobial 2% RTU: Flammability, pH, Viscosity
and Relative Density: Final Report. Project Number: 3270/01. Unpublished study prepared by Case Consulting
Laboratories, Inc. 7 p.
46693803 Kuhn, J. (2005) Acute Oral Toxicity Study (UDP) in Rats: Aegis Exp-201: Final Report. Project Number: 8989/05.
Unpublished study prepared by Stillmeadow, Inc. lip.
46693804 Kuhn, J. (2005) Acute Dermal Toxicity Study in Rabbits: Aegis Exp-201: Final Report. Project Number: 8990/05.
Unpublished study prepared by Stillmeadow, Inc. 12 p.
46693805 Kuhn, J. (2005) Acute Dermal Irritation Study in Rabbits: Aegis Exp-201: Final Report. Project Number: 8993/05.
Unpublished study prepared by Stillmeadow, Inc. lip.
46693806 Kuhn, J. (2005) Skin Sensitization Study in Guinea Pigs: Aegis Exp-201: Final Report. Project Number: 8994/05.
Unpublished study prepared by Stillmeadow, Inc. 18 p.
46693807 Carter, L. (2005) Acute Inhalation Toxicity Study in Rats: Aegis Exp-201: Final Report. Project Number: 8991/05.
Unpublished study prepared by Stillmeadow, Inc. 20 p.
46693808 Kuhn, J. (2005) Acute Eye Irritation Study in Rabbits: Aegis Exp-201: Final Report. Project Number: 8992/05.
Unpublished study prepared by Stillmeadow, Inc. 17 p.
46714500 SiShield Technologies, Inc. (2005) Submission of Product Chemistry Data in Support of the Application for Registration
of SiS 7200 WB. Transmittal of 3 Studies.
46714501 Weeden, D. (2005) SiS 7200 WB: Product Identity and Disclosure of Ingredients Description of the Beginning Materials
and Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by SiShield
Technologies, Inc. 49 p.
46714502 Fung, K.; Leung, H.; Roesch, E. (2003) Preliminary Analysis of Chemical Composition: SiS 7200. Project Number: 3002.
Unpublished study prepared by Ortec, Inc. 20 p.
46714503 Weeden, D. (2005) SiS 7200 WB Certified Limits. Unpublished study prepared by SiShield Technologies, Inc. 4 p.
66
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46731000 Microbe Guard, Inc. (2006) Submission of Product Chemistry Data in Support of the Application for Registration of
Nanoguard. Transmittal of 3 Studies.
46731001 Weeden, D. (2006) NanoGuard: Product Identity and Disclosure of Ingredients, Description of the Beginning Materials
and Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by Microbe Guard
Inc. 54 p.
46731002 Allred, G.; Su, M. (2006) Preliminary Analysis of Chemical Composition: Nanoguard. Project Number: MGI/1201.
Unpublished study prepared by Synthonix. 19 p.
46731003 Weeden, D. (2006) Nanoguard Certified Limits. Unpublished study prepared by Microbe Guard Inc. 4 p.
46755000 Microbe Guard, Inc. (2006) Submission of Product Chemistry Data in Support of the Application for Registration of
DuraLast-I (MUP) and DuraLast (EUP). Transmittal of 3 Studies.
46755001 Weeden, D. (2006) DuraLast and DuraLast-I: Product Identity and Disclosure of Ingredients, Description of the Beginning
Materials and Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by
Microbe Guard, Inc. 25 p.
46755002 Allred, G.; Su, M. (2006) Determination of % Quaternary Ammonium Chloride by Biphasic Titration: Duralast. Project
Number: MGI/1202, 101. Unpublished study prepared by Synthonix. 10 p.
46755003 Weeden, D. (2006) DuraLast-I and DuraLast Certified Limits. Unpublished study prepared by Microbe Guard, Inc. 4 p.
46916800 Marinize Products, Inc. (2006) Submission of Product Chemistry Data in Support of the Application for Registration of
Marquat 72 MUP. Transmittal of 1 Study.
46916801 Sinning, D. (2006) Physical and Chemical Characteristics of Marquat: Physical State, Oxidation/Reduction, Flammability,
pH, Viscosity and Relative Density. Project Number: 3490/01. Unpublished study prepared by Case Consulting
Laboratories, Inc. 12 p.
46921200 Biosafe, Inc. (2006) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of
HM4100 Antimicrobial. Transmittal of 7 Studies.
46921201 Sinning, D. (2006) Physical and Chemical Characteristics of HM-4100: Physical State, Oxidation/Reduction, pH, and Bulk
Density. Project Number: 3450/01. Unpublished study prepared by Case Consulting Laboratories, Inc. 7 p.
67
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46921202 Kuhn, J. (2006) Skin Sensitization: Local Lymph Node Assay in Mice: HM-4100: Amended Final Report. Project
Number: 9671/06. Unpublished study prepared by Stillmeadow, Inc. 13 p.
46921203 Carter, L. (2006) Acute Inhalation Toxicity Study in Rats: HM-4100: Final Report. Project Number: 9668/06. Unpublished
study prepared by Stillmeadow, Inc. 18 p.
46921205 Kuhn, J. (2006) Acute Oral Toxicity Study (UDP) in Rats: HM-4100: Final Report. Project Number: 9666/06.
Unpublished study prepared by Stillmeadow, Inc. lip.
46921206 Kuhn, J. (2006) Acute Dermal Irritation Study in Rabbits: HM-4100: Amended Final Report. Project Number: 9670/06.
Unpublished study prepared by Stillmeadow, Inc. 12 p.
46921207 Kuhn, J. (2006) Acute Dermal Toxicity Study in Rabbits: HM-4100: Amended Final Report. Project Number: 9667/06.
Unpublished study prepared by Stillmeadow, Inc. 14 p.
46923900 Piedmont Chemical Industries I, Inc. (2006) Submission of Product Chemistry Data in Support of the Application for
Registration of Ztrex 72 Antimicrobial MUP. Transmittal of 2 Studies.
46923901 Sinning, D. (2006) Ztrex 72 Antimicrobial Agent MUP: Preliminary Analysis and Enforcement Analytical Method. Project
Number: 3500/01. Unpublished study prepared by Case Consulting Laboratories, Inc. 8 p.
46923902 Sinning, D. (2006) Physical and Chemical Characteristics of Ztrex 72 Antimicrobial Agent MUP: Color, Physical State,
Odor, Oxidation/Reduction, Flammability, pH, Viscosity and Relative Density. Project Number: 3500/02. Unpublished
study prepared by Case Consulting Laboratories, Inc. 7 p.
46942800 Biosafe, Inc. (2006) Submission of Toxicity Data in Support of the Application for Registration of HM4100 Antimicrobial.
Transmittal of 1 Study.
46942801 Kuhn, J. (2006) Acute Eye Irritation Study in Rabbits: HM-4100: Amended Final Report. Project Number: 9669/06.
Unpublished study prepared by Stillmeadow, Inc. 18 p.
46965100 American MoldGuard, Inc. (2006) Submission of Product Chemistry Data in Support of the Application for Registration of
AMG-X40. Transmittal of 1 Study.
46965101 Jacoby, H. (2006) Product Chemistry in Support of AMG-X40: Group A Product Identity and Composition. Project
Number: 292/001/02. Unpublished study prepared by Acta Group, L.L.C. 17 p.
68
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47023900 Microbe Guard Inc. (2006) Submission of Product Chemistry Data in Support of the Application for Registration of Mold
Shield. Transmittal of 3 Studies.
47023901 Weeden, D. (2006) Mold Shield: Product Identity and Disclosure of Ingredients, Description of the Beginning Materials
and Manufacturing Process, and Discussion of the Formation of Impurities. Unpublished study prepared by Microbe Guard
Inc. 36 p.
47023902 Allred, G.; Su, M. (2006) Mold Shield: Determination of % Quaternay Ammonium Chloride by Biphasic Tiltration.
Project Number: MG/0505. Unpublished study prepared by Synthonix. lip.
47023903 Weeden, D. (2006) Mold Shield: Certified Limits. Unpublished study prepared by Microbe Guard Inc. 4 p.
47042500 Biosafe, Inc. (2007) Submission of Product Chemistry Data in Support of the Application for Registration of HM4100
Antimicrobial. Transmittal of 1 Study.
47042501 Getman, G. (2007) Product Chemistry Data of HM 4100: Group A-Product Identity, Composition, and Analysis. Project
Number: 11282006/02. Unpublished study prepared by Biosafe, Inc. 35 p.
47050000 Marinize Products, Inc. (2007) Submission of Product Chemistry Data in Support of the Application for Registration of
Marquat 72 MUP. Transmittal of 1 Study.
47050001 Sinning, D. (2006) Marquat: Preliminary Analysis and Enforcement Analytical Method. Project Number: 3490/03.
Unpublished study prepared by Case Consulting Laboratories, Inc. 15 p.
47053600 Piedmont Chemical Industries ILLC (2007) Submission of Product Chemistry Data in Support of the Application for
Registration of Ztrex 72 Antimicrobial Agent MUP. Transmittal of 5 Studies.
47053601 Bralkowski, M. (2007) Ztrex 72 Antimicrobial Agent MUP: Product Properties Test Guideline Submission. Project
Number: 830/1550. Unpublished study prepared by Piedmont Chemical Industries I, LLC. 6 p.
47053602 Bralkowski, M. (2007) Ztrex 72 Antimicrobial Agent MUP: Product Properties Test Guideline Submission. Project
Number: 830/1600. Unpublished study prepared by Piedmont Chemical Industries I, LLC. 36 p.
47053603 Bralkowski, M. (2007) Ztrex 72 Antimicrobial Agent MUP: Product Properties Test Guideline Submission. Project
Number: 830/1620. Unpublished study prepared by Piedmont Chemical Industries I, LLC. 7 p.
69
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47053604 Bralkowski, M. (2007) Ztrex 72 Antimicrobial Agent MUP: Product Properties Test Guideline Submission. Project
Number: 830/6316. Unpublished study prepared by Piedmont Chemical Industries I, LLC. 3 p.
47053605 Bralkowski, M. (2007) Ztrex 72 Antimicrobial Agent MUP: Product Properties Test Guideline Submission. Project
Number: 830/6319. Unpublished study prepared by Piedmont Chemical Industries I, LLC. 3 p.
47121600 WM Barr and Company Inc. (2007) Submission of Product Chemistry Data in Support of the Application for Registration
of Maquat 72-MUP. Transmittal of 1 Study.
47121601 Rice, C. (2007) Product Identity and Composition: Maquat-72 MUP. Unpublished study prepared by W.M. Barr & Co. 8
P-
47169200 Coatings Specialist Group (2007) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of Sports-Aide 1000. Transmittal of 7 Studies.
47169201 Sinning, D. (2007) Physical and Chemical Characteristics of Sportsaide 1000: Physical State, Oxidation/Reduction, pH,
Viscosity and Relative Density. Project Number: 3760/01. Unpublished study prepared by Case Consulting Laboratories,
Inc. 7 p.
47169202 Kuhn, J. (2007) Acute Eye Irritation Study in Rabbits: Sportsaide 1000: Final Report. Project Number: 10793/07.
Unpublished study prepared by Stillmeadow, Inc. 17 p.
47169203 Kuhn, J. (2007) Acute Dermal Irritation Study in Rabbits: Sportsaide 1000: Final Report. Project Number: 10794/07.
Unpublished study prepared by Stillmeadow, Inc. lip.
47169204 Kuhn, J. (2007) Skin Sensitization Study in Guinea Pigs: Sportsaide 1000: Final Report. Project Number: 10795/07.
Unpublished study prepared by Stillmeadow, Inc. 18 p.
47169205 Kuhn, J. (2007) Acute Oral Toxicity Study (UDP) in Rats: Sportsaide 1000: Final Report. Project Number: 10790/07.
Unpublished study prepared by Stillmeadow, Inc. lip.
47169206 Kuhn, J. (2007) Acute Dermal Toxicity Study in Rats: Sportsaide 1000: Final Report. Project Number: 10791/07.
Unpublished study prepared by Stillmeadow, Inc. 12 p.
47169207 Crutchfield, V. (2007) Acute Inhalation Toxicity Study in Rats: Sportsaide 1000: Final Report. Project Number: 10792/07.
Unpublished study prepared by Stillmeadow, Inc. 18 p.
70
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93218000 Dow Corning Corp. (1990) Reregi strati on Phase 3 Response: Trimethoxysilyl)propyl dimethyl octadecyl ammonium
chloride.
93218001 White, W. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00130316 and Related MRIDs 00164909, 00070190.
Product Identity and Composition: [Dow Corning 5700 Antimicrobial and Dow Corning 5772 Antimicrobial Agents]. 16
P-
93218004 White, W. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00070190 and Related MRIDs 00130316, 00129565.
Physical and Chemical Characteristics: [Dow Corning 5700 Antimicrobial Agent, Dow Corning 5772 Antimicrobial
Agent, Slygard Antimicrobial Agent]. 14 p.
93218005 Annelin, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385218. Acute Oral LD50 - Mallard Duck: Project
9411-03. Prepared by Wildlife International Ltd. 11 p.
93218006 Annelin, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385217. Eight Day Dietary LC50 - Mallard Duck:
Project 9411-03. Prepared by Wildlife International Ltd. 10 p.
93218007 Annelin, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00130321 and Related MRIDs 40385202. Four-Day
Static Fish Toxicity Studies with Dow Corning 5700 Antimicrobial Agent in Rainbow Trout and Bluegills. Prepared by
Industrial Bio-Test Labs. Inc. lip.
93218008 Hess, C.; White, W.; Weaver, M. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385219. Determination of
Respirable Particle Size during Spray Application of Sylgard Antimicrobial Treatment. Prepared by DOW CORNING
CORP. lip.
93218009 Annelin, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385215. Acute Toxicity of Corning 5700
Antimicrobial Agent to Daphnia magna in a Static System. Prepared by Dow Corning Corp. 10 p.
93218010 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00130318 and Related MRIDs 41157801, 00164911.
Acute Toxicological Properties and Industrial Handling Hazards of Dow Corning Q9-5700 Fluid, a Potential Antimicrobial
Agent. Prepared by Dow Corning Corp. 8 p.
93218011 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00130319 and Related MRIDs 00164912, 40385201.
Acute Toxicological Properties of Dow Corning Q9-5700: Acute Oral Toxicology in the Rat. Prepared by Dow Corning
Corp. 8 p.
71
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93218012 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00130319 and Related MRIDs 00164912, 40385201.
Acute Toxicologic Properties of Dow Corning Q9-5700: Acute Dermal Toxicity in Rabbits. Prepared by Dow Corning
Corp. 9 p.
93218013 Groh, C. (1990) Dow Corning Corp. Phase3 Summary of MRID 40385201 and Related MRIDs 00130318, 00164912.
Acute Toxicologic Properties of Dow Corning Q9-5700. Prepared by Dow Corning. 12 p.
93218014 Kolesar, G. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41157803 and Related MRIDs 00057346, 40385219,
40385216. An Acute Aerosol Inhalation Toxicity Study with Dow Corning 5772 Compound in Rats. Prepared by Dow
Corning Corp. lip.
93218015 Groh, C. (1990) Dow Corning Corp. Phase3 Summary of MRID 41157801 and Related MRIDs 00164911, 00130318.
Acute Toxicological Properties and Industrial Handling Hazards of Dow Corning Q9-5700 Fluid, a Potential Antimicrobial
Agent: Primary Eye Irritation in the Rabbit. Prepared by Dow Corning Corp. 8 p.
93218016 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41157802 and Related MRIDs 00130320. Eye and Skin
Irritation Potential of Diluted Dow Corning Q9-5700, a Potential Biocide: Primary Eye Irritation in the Rabbit. Prepared
by Dow Corning Corp. 10 p.
93218017 Groh, C. (1990) Dow Corning Corp. Phase3 Summary of MRID 40385201 and Related MRIDs 00164912, 00130319.
Acute Toxicologic Properties of Dow Corning Q9-5700: Primary Eye Irritation in the Rabbit. Prepared by Dow Corning
Corp. lip.
93218018 Groh, C. (1990) Dow Corning Corp. PhaseS Summary of MRID 41157801 and Related MRIDs 00164911, 00130318.
Acute Toxicological Properties and Industrial Handling Hazards of Dow Corning Q9-5700 Fluid, a Potential Antimicrobial
Agent: Primary Dermal Irritation Study. Prepared by Dow Corning Corp. 9 p.
93218019 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41157802 and Related MRIDs 00130320. Eye and Skin
Irritation Potential of Diluted Dow Corning Q9-5700, a Potential Biocide. Prepared by Dow Corning Corp. 8 p.
93218020 Groh, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385201 and Related MRIDs 00164912, 00130319.
Acute Toxicologic Properties of Dow Corning Q9-5700: Primary Dermal Irritation Study. Prepared by Dow Corning Corp.
8 p.
93218021 Siddiqui, W. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41339403. A 90-Day Subchronic Dermal Toxicity
Study of Dow Corning 5700 Hydrolysate in Rats. Prepared by Dow Corning Corp. lip.
72
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93218022 Siddiqui, W. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41438003 and Related MRIDs 41438002.
Developmental Toxicity Studies of Dow Corning 5700 Hydrolysate in Rats. Prepared by Dow Corning Corp. 25 p.
93218023 Isquith, A. (1990) Dow Corning Corp. Phase 3 Summary of MRID 00057346 and Related MRID 40385216. Percutaneous
Absorption of Dow Corning 5700 Antimicrobial Agent in Rabbits. Prepared by Dow Corning Corp. 15 p.
93218024 Dwane, M. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41339402. A 14-Day Rangefmding Dermal Toxicity
Study with Dow Corning Q9-5700 Hydrolysate in Rats. Prepared by Dow Corning Corp. 14 p.
93218025 Kolesar, G. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385219. Determination of Respirable Particle Size
During Spray Application of Slygard Antimicrobial Treatment. Prepared by Dow Corning Corp. 9 p.
93218027 Henrich, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41353302 and Related MRIDs 41353301, 41296801.
Mutagenicity Test on Dow Corning 5700 Hydrolysate in the L51784 TK +/- Mouse Lymphoma Forward Mutation Assay -
Supplemental Studies: Project 10864. Prepared by Hazleton Labs. America, Inc. 18 p.
93218028 Henrich, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41296803 and Related MRIDs 41296802.
Mutagenicity Test on Dow Corning 5700 Hydrolysate in vivo Mouse Micronucleus Assay: Project 10864. Prepared by
Hazleton Laboratories America, Inc. 12 p.
93218029 Henrich, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41296802 and Related MRIDs 41296803. Single
Acute Exposure Dose Selection on Dow Corning 5700 Hydrolysate: Project 10864. Prepared by Hazleton Laboratories
America, Inc. 12 p.
93218030 Henrich, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 41296804. Mutagenicity Test on Dow Corning 5700
Hydrolysate in the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: Project 10864. Prepared by Dow Corning
Corp. 15 p.
93218031 Isquith, A. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385216 and Related MRIDs 00057346.
Percutaneous Absorption of Dow Corning 5700 Antimicrobial Agent in Rabbits. Prepared by Dow Corning Corp. 16 p.
93218032 White, C. (1990) Dow Corning Corp. Phase 3 Summary of MRID 40385214 and Related MRIDs 00028989, 00029136,
00029137. Residue Analytical Method: [Dow Corning 5700 Antimicrobial Agent]. Prepared by Dow Corning Corp. 12 p.
93218033 Beavers, J.; Fink, R. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385218. Acute Oral LD50 - Mallard Duck:
Project 9411. Prepared by Wildlife International, Ltd. 16 p.
73
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93218034 Beavers, 1; Fink, R. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385217. Eight Day Dietary LC50 - Mallard
Duck: Project 9411-03. Prepared by Wildlife International Ltd. 16 p.
93218035 Rausina, G. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385202 and Related MRIDs 00130321. Four-day
Static Fish Toxicity Studies with Dow Corning 5700 Antimicrobial Agent in Rainbow Trout and Bluegills: IBT No.
A1904. Prepared by Industrial Bio-Test Laboratories, Inc. 19 p.
93218037 Annelin, R.; Humble, D. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385215. Acute Toxicity of Dow
Corning 5700 Antimicrobial Agent to Daphnia magna in a Static System: Project 1853-14. Prepared by Dow Corning
Corp. 5 p.
93218038 Kolesar, G.; Siddiqui, W.; Stanton, E. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 41157803 and Related
MRIDs 40385216, 00057346. An Acute Aerosol Inhalation Toxicity Study with Dow Corning 5772 Compound in Rats.
Prepared by Dow Corning Co. 33 p.
93218039 Schechtman, L.; Beard, S. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 00028990. Mutagenicity Test on Dow
Corning 5700 Antimicrobial Agent in the in vitro Mammalian Cell Transformation Assay in the Absence of Exogenous
Metabolic Activation: Project No. T1482. Prepared by Microbiological Associates. 28 p.
93218040 Young, R. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 41353302. Supplemental Studies to the Mutagenicity
Test on DC 5700 Hydrolysate in the L5178Y TK+/- Mouse Lymphoma Forward Mutation Assay: Final Report: HLA
Study No. 10864-0-431 SUP. Prepared by Hazleton Laboratories America, Inc. 29 p.
93218041 Siddiqui, W.; Malek, J.; Shells, E. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385216 and Related MRIDs
00057346. Percutaneous Absorption of Dow Corning 5700 Antimicrobial Agent in Rabbits. Prepared by Dow Corning
Corp. 22 p.
93218042 Isquith, A.; Malek, J.; McGee, J. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385214. Durability of Dow
Corning 5700 Antimicrobial Agent on Textiles. Prepared by Dow Corning Corp. 22 p.
93218043 Isquith, A.; Malek, J.; Angelotti, N. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 00028989. Durability of Dow
Corning 5700 Antimicrobial Agent on Textiles. Prepared by Dow Corning Corp. 19 p.
93218044 Carpenter, J.; Walters, P. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385209. Three-month Human Wear
Test with Dow Corning Q9-5700 Treated Athletic Socks. Prepared by Burlington Industries, Inc. 12 p.
74
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93218045 Schechtman, L.; Beard, S. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385213. Mutagenicity Test on Dow
Corning 5700 Antimicrobial Agent in the in vitro Mammalian Cell Transformation Assay in the Presence of Exogenous
Metabolic Activation: Project No. T1483. Prepared by Microbiological Associates. 27 p.
93218046 Carpenter, 1; Walters, P. (1990) Dow Corning Corp. Phase 3 Reformat of MRID 40385208. 32-Day Human Wear Test
with Dow Corning Q9-5700 Treated Socks. Prepared by Burlington Industries, Inc. 18 p.
93218047 Dwane, M. (1990) Dow Corning Corp. Phase 3 Summary of MRID 42456513. Acute Dermal Irritation Study of Dow
Corning 5772 Antimicrobial Agent: Project X9-6346. Prepared by DOW CORNING CORP. 8 p.
93218048 Henrich, R. (1990) Dow Corning Corp. Phase 3 Summary of MRID 42456516. Mutagenicity Test on Dow Corning 5700
Antimicrobial Agent in the Bacterial Reverse Mutation Assay. Prepared by DOW CORNING CORP. 14 p.
93218049 Dwane, M. (1990) Dow Corning Corp. Phase 3 Summary of MRID 42456511. Acute Oral Toxicity of Dow Corning 5772
Antimicrobial Agent: Project X9-6346. Prepared by DOW CORNING CORP. 7 p.
93218999 Dow Corning Corp. (1990) Reregi strati on Phase 3 Response: Trimethoxysilyl)propyl dimethyl octadecyl ammonium
chloride. Correspondence and Supporting Material.
93219000 William G. Roessler (1990) Reregi strati on Phase 3 Response: Didecyl-N-methyl-3-(trimethoxysilyl) propanaminium
chloride.
93219001 Klein, S. (1990) William G. Roessler Phase 3 Summary of MRID 00101490 and Related MRIDs 00128481, 00105988,
00105186. Product Identity and Composition: [Requat]. 17 p.
93219002 Klein, S. (1990) William G. Roessler Phase 3 Summary of MRID 00101490 and Related MRID s 00128481, 00105988.
Physical and Chemical Characteristics: [Requat]. 5 p.
93219003 Klein, S. (1990) William G. Roessler Phase 3 Summary of MRID 00101491. Eight-Day Dietary LC:50 - Bobwhite Quail:
Project No. 180-101. Prepared by Wildlife International, Ltd. 6 p.
93219004 Grim, J. (1990) William G. Roessler Phase 3 Summary of MRID 00105187. Fish Toxicity Rainbow Trout-TEP: [Requat].
Prepared by Northeastern Biologists. 9 p.
93219005 Grim, J. (1990) William G. Roessler Phase 3 Summary of MRID 00105187. Invertebrate Toxicity-TEP Daphnia magna:
[Requat]. Prepared by Northeastern Biologists. 8 p.
75
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93219006 Klein, S. (1990) William G. Roessler Phase 3 Summary of MRID 00086703. Dermal Sensitization: [Requat]. Prepared by
Product Investigations, Inc. 5 p.
93219007 Klein, S. (1990) William G. Roessler Phase 3 Summary of MRID 00086702 and Related MRIDs 00109274, 00126470.
90-Day Dermal - Rodent: [Requat]. Prepared by Sanitized A.G. 6 p.
93219008 Entrup, M. (1990) William G. Roessler Phase 3 Summary of MRID 00105185 and Related MRIDs 00128480. The
Salmonella/Microsomal Assay of Bacterial Activity of Requat 1977 Liquid with 50% Methanol: Study 82-0671-21.
Prepared by Hill Top Research, Inc. 10 p.
93219999 William G. Roessler (1990) Reregi strati on Phase 3 Response: Didecyl-N-methyl-3-(trimethoxysilyl) propanaminium
chloride. Correspondence and Supporting Material.
76
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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 Chapter V of the
trimethoxysilyl quats RED for a list of studies that the Agency plans to require.
77
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In for trimethoxysilyl quats at a
later date.
78
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Appendix G. Batching of Trimethoxysilyl Quats Products for Meeting Acute Toxicity Data
Requirements for Reregistration.
The Agency intends to insert the batching for the trimethoxysilyl quats at a later date.
79
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Appendix H. List of All Registrants Sent the Data Call-In
The Agency intends to insert the list of registrants for the trimethoxysilyl quats at a later
date.
80
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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/opprd001/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 atwilliams.nicole@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
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)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.gov/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
81
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8570-36
8570-37
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/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
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
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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
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
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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:
ace. orst. edu/info/nptn.
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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