v>EPA
United States Office of Prevention, Pesticides EPA 739-RO-8009
Environmental Protection And Toxic Substances September 2008
Agency (751 OP)
Reregistration Eligibility
Decision for Triclosan
ListB
Case No. 2340
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Reregistration Eligibility Decision (RED) Document
for
Triclosan
Approved by:.
Frank T. Sanders
Director
Antimicrobials Division
Date:
September 18, 2008
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TABLE OF CONTENTS
ABSTRACT 7
I. Introduction 8
II. Chemical Overview 9
A. Regulatory History 9
B. Chemical Identification 9
C. Use and Usage 11
III. Summary of Triclosan Risk Assessments 12
A. Human Health Risk Assessment 12
1. Toxicity Profile 12
2. Dietary Exposure and Risk from Food and Drinking Water 15
3. Residential Exposure and Risk 17
4. Aggregate Exposure and Risk 23
5. Occupational Exposure and Risk 26
6. Incident Reports 27
B. Environmental Fate and Ecological Hazard Assessment 28
1. Environmental Fate 28
2. Ecological Hazard 29
3. Risk to Listed Species 32
IV. Reregistration and Risk Management Decisions 34
A. Determination of Reregistration Eligibility 34
1. Reregistration Eligibility Decision 34
2. Regulatory Rationale 36
B. Risk Management Decision 39
1. Risk Mitigation Measures 39
2. Product Label Amendments 40
3. Antimicrobial Resistance 40
4. Post-Red Activities 41
V. What Registrants Need to Do 42
A. Manufacturing Use Products 42
1. Generic Data Requirements 42
B. End-Use Products 45
1. Product Specific Data Requirements 45
2. Labeling for End-Use Products 46
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Triclosan Reregistration Team
Office of Pesticide Programs:
Environmental Fate and Effects Risk Assessment
Genevieve Angle
Srinivas Gowda
Patricia Jennings
Rick Petrie
Health Effects Risk Assessment
Jonathan Chen
Vicki Dellarco
Timothy Leighton
Tim McMahon
A. Najm Shamim
Risk Management
Heather Garvie
Diane Isbell
Office of General Counsel
Philip Ross
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
EC
EDWC
EEC
EPA
EXAMS
EUP
FCID
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LD
50
LOC
LOD
LOAEL
mg/kg/day
mg/L
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Emulsifiable Concentrate Formulation
Estimated Drinking Water Concentration
Estimated Environmental Concentration
Environmental Protection Agency
Exposure Analysis Modeling System
End-Use Product
Food Commodity Intake Database
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of
a substance that can be expected to cause death in 50% of test animals.
It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
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.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
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MOE
MRID
MUP
NA
NAWQA
NPDES
NR
NOAEL
OP
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
WPS
Margin of Exposure
Master Record Identification (number). EPA's system of recording
and tracking studies submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by EPA's
Cancer Risk Model
Raw Agriculture Commodity
Reregi strati on Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for 5-Chloro-2-(2,4-
dichlorophenoxy)phenol (triclosan) and is issuing its reregi strati on eligibility and risk
management decisions. The risk assessments, which are summarized in this document, are
based on review of registrant-submitted data supporting the use patterns of currently
registered products, citations from the open literature, and additional information received
through the public docket. The risk assessments have been revised, as needed, according to
information received since they were first made available to the public in May 2008. After
considering the risk assessments and risk mitigation options, the Agency developed its
reregi strati on eligibility and risk management decisions for uses of triclosan. As a result of
this review, EPA has determined that all uses of triclosan are eligible for reregi strati on, with
the exception of the paint use, provided that the risk mitigation and data requirements
outlined in this document are fully implemented. The reregi strati on eligibility decision is
discussed fully in this document. The Agency is aware that research is ongoing regarding
triclosan. The outcomes of this further research may require the Agency to revisit this
decision in the future. Further, given the rapidly developing scientific database for triclosan,
the Agency intends to accelerate the schedule for the registration review process for this
chemical. Currently, the Agency intends to begin that process in 2013, ten years earlier than
originally planned.
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I. Introduction
This document is the Environmental Protection Agency's (EPA or "the Agency")
Reregi strati on Eligibility Decision (RED) for all currently registered uses of 5-Chloro-2-(2,4-
dichlorophenoxy)phenol (triclosan). This document also summarizes the human health and
environmental exposure and associated risks used to make the reregi strati on eligibility
decision.
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, and amended again by the Food Quality Protection Act of 1996 (FQPA)
and the Pesticide Registration Improvement Act of 2003 (PRIA) to set time frames for the
issuance of Reregi strati on Eligibility Decisions. FIFRA calls for the development and
submission of data to support the reregi strati on of an active ingredient, as well as a review of
all data submitted to the U.S. Environmental Protection Agency (EPA or "the 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 hazards arising
from the currently registered uses of a pesticide, to determine the need for additional data on
health and environmental effects, and to determine whether or not the pesticide meets the "no
unreasonable adverse effects" criteria of FIFRA.
The Agency made its reregi strati on eligibility decision for triclosan based on the
required data, the current guidelines for conducting acceptable studies to generate such data,
and published scientific literature. The Agency has found that currently registered uses of
triclosan, with the exception of the use as a materials preservative in paint (which has been
requested to be voluntarily cancelled by the registrants), are eligible for reregi strati on
provided the conditions and requirements for reregistration identified in this reregi strati on
eligibility decision (RED) are implemented.
This document consists of six sections: Section I contains the regulatory framework
for reregistration reassessment; Section II provides an overview of the chemical, including a
profile of its use and usage; Section III gives an overview of the human health and ecological
risk assessments; Section IV presents the Agency's reregistration eligibility and risk
management decisions; Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV; and Section VI includes the appendices, related
supporting documents, and Data Call-In (DCI) information. The revised risk assessment
documents and related addenda are not included in this document, but are available in the
Public Docket at http://www.regulations.gov under docket number EPA-HQ-OPP-2007-
0513.
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II. Chemical Overview
A. Regulatory History
Triclosan is regulated by both the U.S. EPA and the U.S. Food and Drug
Administration (FDA). The EPA regulates the antimicrobial uses of triclosan when used as a
bacteriostat, fungistat, mildewstat, and deodorizer. EPA-registered products containing
triclosan as the active ingredient are formulated as ready-to-use, pelleted/tableted,
emulsifiable concentrate, soluble concentrate, and impregnated materials. Triclosan is used
in commercial, institutional and industrial premises and equipment; residential and public
access premises; and as a material preservative. Commercial, institutional and industrial
premises and equipment uses include conveyor belts, fire hoses, dye bath vats and ice making
equipment. As a material preservative, triclosan is used in many products including
adhesives, fabrics, vinyl, plastics (toys, toothbrushes), polyethylene, polyurethane,
polypropylene, floor wax emulsions, textiles (footwear, clothing), caulking compounds,
sealants, rubber, and latex paints. There are a multitude of residential and public access
premises uses including direction application to HVAC coils (limited to commercial
applicators), and use as a materials preservative in toys, paints, mattresses, clothing, brooms,
mulch, floors, shower curtains, awnings, tents, toilet bowls, urinals, garbage cans, refuse
container liners, insulation, concrete mixtures, grouts, and upholstery fabrics. The FDA-
regulated uses include hand soaps, toothpaste, deodorants, laundry detergent, fabric
softeners, facial tissues, antiseptics for wound care, and medical devices.
No direct food use is associated with triclosan; therefore, no tolerance or tolerance
exemption has been established. However, dietary exposure and risk were assessed for the
indirect food uses of triclosan involving pulp and paper use, ice-making equipment,
adhesives, cutting boards, conveyor belts, and counter top use.
B.
Chemical Identification
Triclosan Molecular Structure:
OH
Common Name:
Cl
2,4,4'-Trichloro-2'-hydroxydiphenyl ether
Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-
5-Chloro-2-(2,4-dichlorophenoxy)phenol
Irgasan DP-300R
IrgaguardBlOOO
VIV-20
OPP Chemical Codes: 054901
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CAS Registry No.:
Case Number:
Molecular Formula:
3380-34-5
2340
Ci2H7Ci302
Chemical Characteristics for Technical Grade Active Triclosan:
Molecular Weight
Color
Physical State
Specific Gravity
Dissociation Constant
PH
Stability
Melting Point
Boiling Point
Water Solubility
Octanol-Water Partition constant ( LogK0w)
Vapor Pressure
289.541
White crystals
White crystalline powder
1.55xl03kg/m3at22°C
pKa=8.14at20°C
N/A
Stable at normal conditions
56.5 ° C
N/A
0.012 g/1 at 20°C
4.8at25°C
5.2E-6mmHgat25°C
2.2E-6 mm Hg at 20°C
Manufacturers:
Highest Percent of
Active Ingredient:
Ciba Corporation and Har-Met International, Inc.
99%
Formulation Types Registered: ready-to-use, pelleted/tableted, emulsifiable concentrate,
soluble concentrate, and impregnated materials
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C. Use and Usage
Triclosan was first registered by the EPA in 1969, and currently there are 20
antimicrobial registrations. A detailed table of the uses of triclosan eligible for reregi strati on
can be found in Appendix A.
Type of Pesticide: Fungicide, Bacteriostat
Use Sites for EPA Registrations:
Commercial, institutional and industrial premises and equipment:
conveyor belts, fire hoses, dye bath vats and ice making
equipment.
As a material preservative: adhesives, fabrics, vinyl, plastics
(toys, toothbrushes), polyethylene, polyurethane, polypropylene,
floor wax emulsions, textiles (footwear, clothing), caulking
compounds, sealants, rubber, and latex paints.
Residential and public access premises: direction application to
HVAC coils (limited to commercial applicators), use as a
materials preservative in toys, paints, mattresses, clothing,
brooms, mulch, floors, shower curtains, awnings, tents, toilet
bowls, urinals, garbage cans, refuse container liners, insulation,
concrete mixtures, grouts, and upholstery fabrics.
Target Pests:
Formulations:
Application Methods:
Bacteria, fungi
EPA-registered products containing triclosan as the active
ingredient are formulated as ready-to-use, pelleted/tableted,
emulsifiable concentrate, soluble concentrate, and impregnated
materials.
Direct application of triclosan in a manufacturing setting via
closed system, open pour or metered pump; direct application to
HVAC coils (spray); residential and occupational handler
painting using brush or airless sprayer (using end-use product
where triclosan is used as the materials preservative)
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III. Summary of Triclosan Risk Assessments
The purpose of this section is to summarize EPA's human health and ecological risk
conclusions for triclosan to help the reader better understand EPA's risk management
decisions. 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 triclosan. The full risk assessments and related supporting documents are
available at http://www.regulations.gov under docket number EPA-HQ-OPP-2007-0513.
Hard copies of these documents may be found in the OPP public docket which is 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.
EPA developed this RED for triclosan through a modified, 4-Phase public
participation process. The Agency uses public participation processes to involve the public
in developing pesticide reregi strati on decisions. EPA released its preliminary risk
assessments for 60-day public comment in May 2008. Comments were incorporated into the
final risk assessments which were used to make this reregi strati on eligibility decision.
The Agency is aware of recent research conducted by the Office of Research and
Development on the effects of triclosan on thyroid homeostasis in the rat (US EPA, 2008).
These data were considered in selection of the incidental oral endpoint, but the current
endpoint was retained, as further investigation is needed on the effects of triclosan on the
thyroid. The Agency will continue to monitor the toxicity profile of triclosan and will amend
the assessment as needed.
The Agency's use of human studies in the triclosan risk assessment is in accordance
with the Agency's Final Rule promulgated on January 26, 2006, related to Protections for
Subjects in Human Research, which is codified in 40 CFR Part 26.
A. Human Health Risk Assessment
EPA has conducted a human health risk assessment for triclosan to support the
reregi strati on eligibility decision. EPA evaluated the submitted toxicology, product and
residue chemistry, and occupational/residential exposure studies as well as available open
literature and determined that the data are adequate to support this reregi strati on eligibility
decision. A summary of the human health risk assessment findings and conclusions is
provided below.
1. Toxicity Profile
The toxicological database for triclosan is adequate to support a reregi strati on
eligibility decision. Major features of the toxicology profile are presented below. Detailed
information is available in the 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan):
Toxicology Chapter for the Reregistration Eligibility Decision (RED) Document, dated
August 29, 2008.
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a. Acute Toxicity Profile
Triclosan has low acute toxicity via the oral and dermal routes (Category IV) and
moderate acute toxicity via the inhalation route (Category II). It is moderately irritating to
the eye (Category II), is a moderate to mild dermal irritant (Category III), and not a skin
sensitizer. Table 1 presents the acute toxicity profile for triclosan.
Guideline
Number
870.1100
(§81-1)
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
Table 1. Acute
Study Type/
Test substance (% a.i.)
Acute Oral- Rat
Triclosan (99.7% a.i.)
Acute Dermal- Rabbit
Triclosan (97% a.i.)
Acute Inhalation- Rat
Triclosan (100.5% a.i.)
Primary Eye Irritation-
Rabbit
Triclosan (97% a.i.)
Primary Dermal
Irritation- Rabbit
Triclosan (% a.i. not
provided)
Dermal Sensitization-
Guinea Pig
Triclosan (99.7% a.i.)
Toxicity Profile for Triclosan
MRID Number/ _ ..
„., ,. Results
Citation
43206901 LD50: >5000 mg/kg
94044 LD50: >9300 mg/kg
42306902, T_ ... _ _ n
43310501 LC50:>0.15mg/L
94045 moderately irritating
42306903 PII: 3.5 at 72 hours
43206502 Not a Sensitizer
Toxicity
Category
IV
IV
II
II
III
N/A
b. Toxicological Endpoints
The toxicological endpoints used in the human health risk assessment are
presented in Table 2. The uncertainty and safety factors used to account for interspecies
extrapolation, intraspecies variability, and for completeness of the database are also
presented. The Agency is aware of recent research conducted by the Office of Research and
Development on the effects of triclosan on thyroid homeostasis in the rat (US EPA, 2008).
These data were considered in selection of the incidental oral endpoint, but the current
endpoint was retained, as further investigation is needed on the effects of triclosan on the
thyroid. The Agency will continue to monitor the toxicity profile of triclosan and will amend
the assessment as needed.
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Table 2. Summary of Triclosan Toxicological Endpoints
Exposure
Scenario
Acute Dietary
(general
population)
Chronic Dietary
(all populations)
Short- Term/
Intermediate-
Term Incidental
Oral (1-30 days;
30 days- 6
months)
Dermal (short-
term)
Dermal
(intermediate
term)
Dermal (long-
term)
Dose Used in
Risk Assessment
NOAEL = 30
mg/kg
arid = 0.3
mg/kg/day
NOAEL = 30
mg/kg
crud = 0.3
mg/kg/day
NOAEL = 30
mg/kg
NOAEL = 0.6
mg/animal (100
|ig/cm2)
NOAEL = 40
mg/kg
NOAEL = 40
mg/kg
Uncertainty
factors for Risk
Assessment
Interspecies = lOx
Intraspecies = lOx
DBSS = Ix
UF = 100
Interspecies = lOx
Intraspecies = lOx
DBSS = Ix
UF = 100
Interspecies = lOx
Intraspecies = lOx
DBSS = Ix
UF = 100
Interspecies = 3x
Intraspecies = 3x
DBSS=lx
MOE = 10
Interspecies = lOx
Intraspecies = lOx
DBSS=lx
MOE = 100
Interspecies = lOx
Intraspecies = lOx
DBSS =3x (lack of
chronic dermal study)
MOE =300
Study and Toxicological
Effects
Chronic Toxicity study in Baboons
MRID 133230
LOAEL =100 mg/kg/day, based on
clinical signs of toxicity such as
vomiting, failure to eat and diarrhea
Chronic Toxicity study in Baboons
MRID 133230
LOAEL =100 mg/kg/day, based on
clinical signs of toxicity such as
vomiting, failure to eat and diarrhea
Chronic Toxicity study in Baboons
MRID 133230
LOAEL =100 mg/kg/day, based on
clinical signs of toxicity
14-day dermal toxicity study in the
mouse
MRID 443 89708
LOAEL =1.5 mg/kg/day, based
on treatment-related dermal
irritation at the treatment site and
on increased liver weights
90-day Dermal Toxicity in Rats
MRID 43328001
LOAEL = 80 mg/kg/day, based on
increased incidence occult blood in
the urine.
90-day Dermal Toxicity in Rats
MRID 43328001
LOAEL = 80 mg/kg/day, based on
increased incidence occult blood in
the urine.
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Table 2. Summary of Triclosan Toxicological Endpoints
Exposure
Scenario
Inhalation (all
durations)
Cancer (oral)
Dose Used in
Risk Assessment
LOAEL = 3.21
mg/kg/day
Uncertainty
factors for Risk
Assessment
MOE= 1000a
Study and Toxicological
Effects
21 -Day Inhalation Toxicity study in
the rat
MRID 0087996
LOAEL = 3.21 mg/kg/day [males],
based on increased total leucocyte
count and increased serum
alkaline phosphatase
In accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment (March 29, 2005), the HED CARC classified triclosan as "Not
Likely to be Carcinogenic to Humans".
LTF = uncertainty factor, BBSS = database uncertainty [special sensitivity] factor, NOAEL = no observed adverse effect
level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOG = level of concern, NA = Not Applicable
aMOE of 1000 was applied to the inhalation endpoint. The inhalation toxicity study lacked sufficient data with which to
convert the animal doses to human equivalent concentrations (HECs) in accordance with Agency policy. A LOAEL value
was selected as the endpoint for inhalation risk assessment; therefore, the use of the LOAEL value from the animal study
and uncertainty in determination of what the HEC would be warrants the MOE of 1000.
2. Dietary Exposure and Risk from Food and Drinking Water
Dietary exposure and risk were assessed for the indirect food uses of triclosan
involving pulp and paper use, ice-making equipment, adhesives, cutting boards, conveyor
belts, and counter top use. As no residue chemistry data were submitted to the Agency for
triclosan, the standard methods developed by the FDA were used to estimate the potential
migration of residues. A detailed explanation is found within the Dietary Risk Assessment
for Triclosan, dated August 11, 2008. None of the individual scenarios for the various
indirect food uses for triclosan presented risks of concern for either adults or children.
Exposures can occur where there is the possibility of indirect food migration
(including paper/pulp use, use in ice-making equipment, adhesives, cutting boards, counter
tops, and conveyer belts). The National Health and Nutrition Surveys (NHANES) are a
series of U.S. national surveys of the health and nutrition status of the non-institutionalized
civilian population conducted by the Centers for Disease Control and Prevention. The
NHANES data are believed to be a more accurate predictor of aggregate exposure because
not only are the data triclosan specific, they are also based on actual consumer use of the
various triclosan products as they co-occur in practice (see the Residential Post
Application/Bystander Risk Summary section of this RED document for a full explanation of
the NHANES data). The NHANES data accounts for indirect dietary and water exposures
more effectively than the use of standard models that the Agency normally would use to
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estimate the potential migration of residues. We are presenting the dietary model results as
additional information regarding the pathways of exposure.
EPA-registered products containing triclosan are largely used indoors as a materials
preservative. However, there is potential for effluents from EPA-registered products
containing this chemical to contact fresh water environments. Triclosan was detected in both
raw and finished drinking water in Southern California at levels of 56 and 49 ng/L,
respectively (Loraine and Pettigrove, 2006). Using the assumption of 2L consumption per
day for adults, the intake of triclosan is estimated at 98 ng/person/day or 1.4 ng/kg/day for a
70 kg adult. Comparing this intake value to the selected reference dose for triclosan (0.3
mg/kg/day or 300,000 ng/kg/day), the intake of triclosan in drinking water using the
measured value from Loraine and Pettigrove study does not present a risk of concern.
Triclosan degrades with an average half-life value of 5.2 + 1.7 days. Therefore, based on the
EPA use patterns, and the relatively short half-life, the potential for effluents from EPA-
registered products to impact drinking water sources is negligible. Therefore a quantitative
drinking water assessment was not conducted. For additional information see the Dietary
Risk Assessment for Triclosan, dated August 11, 2008.
Non-cancer dietary risk is expressed as a percentage of a level of concern. The level
of concern is the dose at or below which no unreasonable adverse health effects to any
human population subgroup are expected to occur. This dietary level of concern is termed
the population adjusted dose (PAD), which reflects the reference dose (RfD), either acute or
chronic, adjusted for (divided by) any database uncertainty (special sensitivity) factor. In the
case of triclosan, the special sensitivity factor is Ix (estimated risks that are less than 100%
of the PAD are below EPA's level of concern). The acute PAD (aPAD) is the highest
predicted dose to which a person could be exposed on a single day with no expected adverse
health effect. The chronic PAD (cPAD) is the highest predicted dose to which a person
could be exposed over the course of a lifetime with no expected adverse health effect.
Using conservative assumptions, the Agency estimated dietary exposure to triclosan
when used in adhesives, pulp and paper, ice-making equipment, countertops and cutting
boards and conveyer belts (see Table 3 below). Because the aPAD and cPAD are well below
100%, dietary exposure does not exceed the Agency's level of concern. For additional
information on these calculations please see the Dietary Risk Assessment for Triclosan, dated
August 11,2008.
Table 3. Dietary Exposure to Triclosan
Use % aPAD % cPAD (cPAD = 0.30 mg/kg/day)
(aPAD = 0.30 mg/kg/day)
Adhesive Adult: Adult:
0.0003/0.30 x 100) = 0.10% 0.0003 mg/kg/day/0.3 mg/kg/day
xlOO = 0.10%
Child: Child:
0.0007/0.30 xlOO = 0.23% 0.0007 mg/kg/day70.30 mg/kg/day
x 100 =0.23%
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Pulp and
Paper
Adult: Adult:
0.00039 mg/kg/day 70.30 mg/kg/day x 0.00039 mg/kg/day/0.3 0 mg/kg/day
100 Adult: 0.00039 mg/kg/day/0.30 x 100 = 0.13%
mg/kg/day x 100 = 0.13%
Child:
Child:
0.00092 mg/kg/day70.37 mg/kg/day 0.00092 mg/kg/day / 0.037
= 0.30%
Ice-Making Adult:
Equipment 1.13 xlO"8 mg/kg/day/0.30
mg/kg/day = 0.30%
Adult:
l.lSxlO'8 mg/kg/day/0.30
mg/kg/day = 3.76 x 10'5 x 100 = 3.76 mg/kg/day = 3.76 x 10'5 x 100 =
xlO6 %
3.76 x 10 ° %
Child:
Child:
2.65 x 10'' mg/kg/day 70.30 2.65 x 10'' mg/kg/day 70.30
mg/kg/day = 8.83 x 10'8 x 100 = 8.83 mg/kg/day = 8.83 x 10'8 x 100 =
x 10 6 % 8.83 x 10 6 %
Countertops Adult: Adult:
and cutting 0.0286 mg/kg/day/ 0.30 mg/kg/day = 0.0286 mg/kg/day/ 0.30 mg/kg/day
boards 9.53% = 9.53%
Conveyer
Belt Use
Child:
0.1333 mg/kg/day/ 0.3 mg/kg/day x
100 = 44.3%
Adult:
Child:
0.1333 mg/kg/day/ 0.3 mg/kg/day x
100 = 44.3%
Adult:
0.0000123 mg/kg/day/0.30 mg/kg/day 0.0000123 mg/kg/day/0.30
x 100 = 0.041 % mg/kg/day x 100 = 0.041 %
Child: 0.000057 mg/kg/day / 0.30
mg/kg/day x 100 = 0.019%
Child: 0.000057 mg/kg/day / 0.30
mg/kg/day x 100 = 0.019%
3. Residential Exposure and Risk
To assess residential handler risks, the Agency used surrogate unit exposure data
from the Chemical Manufacturers Association (CMA) antimicrobial exposure study and the
Pesticide Handlers Exposure Database (PHED) (the NHANES data most likely do not
capture intermittent uses of triclosan such as home owners using paint that has been
preserved with triclosan because the NHANES sampling is from a discrete sampling
timeframe). Residential post-application/bystander exposures were assessed using the
NHANES biological monitoring data from the general population for ages 6+ years old as
well as bounding estimates for infant exposure using EPA's standard assumptions In
addition, the post-application assessment looked at the potential for incidental dermal
irritation as well as systemic dermal exposure as there is the potential for adults and children
to contact impregnated textiles and fabrics such as clothing items and mattresses. Although
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the contribution of dermal exposure to the aggregate exposure is represented in the NHANES
data, a post-application screening-level clothing assessment to represent exposure to treated
textiles and fabrics is provided. Infant-specific pathways of exposure were also assessed, as
the NHANES data do not take into account the potential exposure pathways of triclosan-
treated products for younger children such as putting objects and/or hands into their mouths.
There are no EPA-registered products containing triclosan that can be applied by a
homeowner in a residential setting. However, triclosan can be used as an in-can preservative
for latex paint, and articles treated with triclosan in an occupational setting also have the
potential for post-application residential exposure (e.g. as a materials preservative in
mattresses, clothing, tooth brush bristles, plastic toys, garbage bags, paper, playground
equipment, sponges, furniture, footwear, etc.). Triclosan can also be used by service
contractors to control, prevent, and inhibit the growth of fungi, mildew, mold, and bacteria
on coils in residential heating, ventilating, and air conditioning (HVAC) systems.
Residential non-cancer risk estimates are typically expressed as a margin of exposure
(MOE) which is a ratio of the dose from a toxicological study selected for risk assessment,
typically a NOAEL, to the predicted exposure (MOE = dose + exposure). Estimated MOEs
are then compared to the "target MOE" which represents the dose selected for risk
assessment and uncertainty factors (UF) applied to that dose (target MOE = dose *
uncertainty factors). The standard UF is lOOx, which includes lOx for interspecies
extrapolation (to account for differences between laboratory animals and humans) and lOx
for intraspecies variation (to account for differences within the same species). Additional
uncertainty or safety factors may also be applied.
There is the potential for individuals in residential settings to be exposed to triclosan
following application of products containing triclosan. Table 4 presents the representative
scenarios used to estimate residential risk from products containing triclosan.
Table 4. Representative Uses Associated with Residential Exposure to Triclosan
Representative Use
Application
Method
Example Registration
Number
Application Rate
Paint (Latex)
• Brush and
airless
sprayer
42182-1
0.1 Ib a.i./gallon
[up to 1% product x 99% a.i. x 10 Ib/gal paint
density = 0.099 Ib a.i./gallon of paint]
Textiles
(exposures to treated
articles are
represented by
exposure to mattress
and clothing)
• N/Aa
70404-5
Round to 2% a.i. in finished textiles and
mattresses.
(Rates range up to the finished product
containing 2% formulated product by weight.
Triclosan product contains 99% a.i..)
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Table 4. Representative Uses Associated with Residential Exposure to Triclosan
Representative Use
Plastic
(exposures to plastic
treated articles are
represented by
plastic toys)
Application
Method
• N/Aa
Example Registration
Number
42182-1
Application Rate
0.5% a.i.
(0. 1% to 0.5% product x 99% a.i.)
(a) The handler's scenarios were not assessed because the products can only be applied occupationally
a. Residential Handler Risk Summary
Handler exposures were assessed for the in-can preservative use in paint. Dermal
exposures for the short-term duration were not assessed because no systemic dermal toxicity
was observed. Dermal irritation was observed in the toxicity study using a test substance
containing 99 percent active ingredient (a.i.). Residential uses are at or below 1 to 2 percent
a.i. are not expected to cause irritation. For additional information, please see the Revised
Triclosan Occupational and Residential Exposure Assessment, dated September 8, 2008.
The estimated risk from exposure to triclosan in residential settings does not exceed
the Agency's level of concern for inhalation during the paint brush application (MOE=
4,000; target MOE = 1000). However, the estimated risk from exposure to triclosan in
residential settings is of concern during the airless sprayer application (MOE= 180; target
MOE = 1000). Personal protective equipment (PPE) such as respirators is not a viable
mitigation option for residential paint uses for an in-can preservative. Mitigating with PPE is
only a viable option for pesticide-labeled products (i.e., a label is needed to inform workers
to wear PPE). Therefore, the Agency can direct workers using pesticide-labeled products
(concentrated form) at the manufacturing setting to wear PPE to mitigate dermal irritation.
Conversely, for in-can material preservatives there is no pesticide label that goes with the
preserved product to inform the workers/painters that PPE is needed (i.e., there is no
pesticide label on a can of paint). However, a request has been received by the Agency from
the registrants to voluntarily cancel the paint use (inclusive of stains and coatings). Once the
action to terminate the paint use is completed, any risks associated with triclosan-treated
paint will be mitigated. For additional information on how the residential assessment was
conducted see the Revised Triclosan Occupational and Residential Exposure Assessment,
dated September 8, 2008.
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Table 5. Triclosan Short-Term Residential Handler Inhalation Exposures and MOEs
Exposure
Scenario
Application
Method
Painting
Application
Method
Paint brush
Airless sprayer
Application Rate
O.llba.i./gal
Quantity
Handled/ Treated
per day
2 gallons
15 gallons
Unit
Exposure
(mg/lb a.i.)
0.28
0.83
Daily Dose
(mg/kg/day)°
0.0008
0.018
MOEd
(Target
MOE =
1000)
4,000
180
Application rates are the maximum application rates determined from EPA registered labels for triclosan.
Amount handled per day values are estimates or label instructions.
Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x application rate (% a.i. weight or Ib a.i./gal) x quantity
treated (Ib/day or gal/day) x absorption factor (1.0 for inhalation)]/ Body weight (70 kg for inhalation).
MOE = LOAEL / Daily Dose. [Where short-term inhalation LOAEL = 50 mg/m3 or a dose of 3.21 mg/kg/day].
Target MOE = 1000.
b. Residential Post Application/Bystander Risk Summary
For EPA-registered products, triclosan may be used as an active ingredient in textiles
and fabrics (e.g., mattresses and clothing/bibs) and plastic products (e.g., toys, cutting boards,
etc). Exposures can occur where there is the possibility of indirect food migration, including
paper/pulp use, use in ice-making equipment, adhesives, cutting boards, counter tops, and
conveyer belts. In addition to EPA-regulated uses, the residential post-application
assessment also includes an aggregate assessment of the FDA uses such as toothpaste, hand
soaps, and deodorants. The aggregate assessment includes both EPA- and FDA-registered
uses because the biological monitoring methodology, NHANES, used to collect the samples
from the general population does not allow for separation of the contribution of individual
products to total exposure. Although the aggregate exposure/risk assessment using the
NHANES data provides an encompassing review of all triclosan-treated products, it does not
include exposures to children under the age of 6 years old. Children under the age of 6 years
exhibit unique activities that do not occur at older ages. Therefore, a separate assessment for
children under 6 years old has been conducted. In addition, dermal and inhalation route-
specific assessments were also conducted.
The following information has been excerpted from Cohen (2008). NHANES are a
series of US national surveys of the health and nutrition status of the non-institutionalized
civilian population conducted by the Centers for Disease Control and Prevention. As part of
the 2003-2004 NHANES, urinary concentrations (ug/L) of triclosan (2,4,4'-trichloro-2'-
hydroxydiphenyl ether) were measured on a random sample of 2,517 participants of ages 6
and over. These measurements represent concentrations in spot urine samples. The
corresponding human dose (mg/kg/day) was not measured or estimated by NHANES. The
NHANES urinary metabolite concentration data collection efforts were not designed to
directly determine the dose and CDC has not reported dose estimates for triclosan based on
NHANES measurement data. The NHANES 2003-2004 data were obtained from the
NHANES website: www.cdc.gov/nchs/nhanes.htm See the Triclosan Occupational and
Residential Exposure Assessment, dated September 8, 2008 for more details on NHANES.
The NHANES results are believed to be representative of a range of acute to chronic
exposures to children and adults because of the relatively short half-life of triclosan in urine
Page 20 of 98
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(i.e., 11 hours) and the often daily use of triclosan products such as hand soaps and tooth
paste. The upper range of exposures is important because of the uncertainties in converting
the spot urine concentrations to a dose; because the pharmacokinetic data appears to be
highly variable for triclosan; and because the use of triclosan by the NHANES population is
unknown. Interpreting the NHANES data for triclosan as representing a range of acute to
chronic exposures is also supported by the fact that the 2,517 samples selected for analyses of
triclosan were randomly selected from the total NHANES random population of 9,643, and
therefore, " ...the representative design of the survey was maintained" (Calafat et al 2007).
Given the uncertainties in aggregating screening-level single use exposure estimates and
assumptions on co-occurrence of uses, the NHANES data are viewed to be a reasonable data
set to use for predicting aggregate risks.
The Agency used conservative assumptions assessing the spot urine concentrations to
err on the side of overestimating the potential dose. Conservative assumptions used in the
assessment include: 1) assumptions used by Cohen (2008) for the dose conversion (e.g., 95th
percentile of urinary volume assumed for all individuals); 2) the characterization of the risks
if one were to assume the pharmacokinetics of triclosan at the lowest (most conservative)
urinary excretion (urinary excretion ranged from 24 to 83 percent with a median of 54
percent); and 3) the inclusion of these conservative assumptions even at the upper percentile
of exposure. Future refinements to using the NHANES data for the triclosan risk assessment
should focus on refining these parameters.
The residential post-application assessment is protective of long-term exposure. The
results of the NHANES aggregate risks using the most conservative methodology option
assessed for those 6+ years old indicate mean MOEs ranging from 4,700 to 19,000. At the
99th percentile the MOEs range from 260 to 1,700. For infants 6 to 12 months old, the mean
NHANES 6-11 year old MOEs combined with bounding estimates for infant-specific
activities for nursing, object-to-mouth, and hand-to-mouth exposures indicate an aggregate
MOE of 390. At the 99th percentile NHANES distribution combined with the infant-specific
activities indicate a MOE of 290. Including exposures to the FDA-regulated soaps and
toothpaste for 6-11 year olds is a conservative assessment of exposure from these products to
6 to 12 month olds.
Based on the low vapor pressure of triclosan and the lack of aerosol generation over
time by the application methods (excluding bystanders in the vicinity of airless spraying of
paint which triggers risks of concern), inhalation exposure is expected to be minimal. This
expectation is confirmed by the MOEs estimated to be in the millions for breathing triclosan-
contaminated dust. The potential for dermal irritation to occur from direct contact with
products treated at low concentrations of triclosan are expected to be minimal. See the
Revised Triclosan Occupational and Residential Exposure Assessment., dated September 8,
2008, for more detailed information.
Dermal Irritation
The potential for dermal irritation to occur from incidental dermal exposures from
products (impregnated textiles, fabrics such as clothing items and mattresses) treated at low
concentrations of triclosan are expected to be minimal.
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Dermal Systemic
There is the potential for dermal-specific route of exposure to adults and children
contacting impregnated textiles and fabrics such as clothing items and mattresses. The
contribution of dermal exposure to the aggregate exposure is represented in the NHANES
data. Nonetheless, a post-application screening-level clothing assessment to represent
exposure to treated textiles and fabrics is provided. The route-specific dermal toxicological
endpoint for the intermediate-term exposure duration is used to represent all textile uses.
Long-term duration was not assessed because transferable triclosan residues from treated
textiles and fabrics are not expected to be available continuously at the levels used in this
screening-level assessment.
The dermal MOEs for adults and toddlers are equal to or above the target MOE of
100. The calculations of the intermediate-term post-application dermal doses and MOEs for
adults and toddlers wearing treated clothing are shown in Table 4.9 of the Revised Triclosan
Residential and Occupational Risk Assessment., dated September 8, 2008.
Infant-Specific Exposure Pathways
While NHANES data are measured exposures that represent the real world co-
occurrence of triclosan-treated products, it is necessary to use screening-level deterministic
assessments as well as to make assumptions of potential co-occurrence of triclosan-treated
products for younger children. An assessment of infants in the 6 to 12 month old age group
has been selected to represent the high end of exposure activities of children less then six
years old to triclosan-treated products. This age group is considered the high end of
exposure based on the characteristics discussed in Table 2 presented in USEPA (2005) and
the likelihood of these activities co-occurring. USEPA (2005) indicates that this age group
includes behaviors that would lend themselves to potentially expose children to triclosan-
treated products. Characteristics of children at this age that potentially exposes children to
triclosan that would not have been captured by the 6-11 year old age category in NHANES
include nursing, increasingly likely to mouth nonfood items, and "development of personal
dust clouds" as a characteristic relevant to inhalation exposure.
Infant-specific activities resulting in potential exposures that are not accounted for
by the 6-11 year old age group in NHANES that are likely to co-occur include:
• Nursing (i.e., triclosan-contaminated breast milk);
• Object-to-mouth exposures (e.g., mouthing of plastic items such as toys,
combs & brushes, playground equipment);
• Hand-to-mouth exposure (e.g., residues in dust stuck to children's hands);
and;
• Inhalation of triclosan-contaminated dust.
Other potential exposure pathways for infants in the 6 to 12 month old age group
that are captured - and overestimated for the 6 to 12 month olds — by the NHANES age
groups 6-11 years old include:
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• Brushing teeth with triclosan-treated tooth paste;
• Washing hands with triclosan-treated antibacterial soap;
• Exposure to impregnated fabrics and textiles such as clothing/sportswear,
blankets, mattresses, tooth brush bristles, etc. that may be treated with
triclosan; and
• Exposure to impregnated polymers and plastics such as food contact
surfaces (e.g., cutting boards, conveyor belts, counter and table tops).
The MOEs for each of the infant-specific exposure pathways are listed below. See
the Revised Triclosan Occupational and Residential Exposure Assessment, dated September
8, 2008 for the details of this assessment including MOE calculations.
Nursing
The daily dose for an infant 6 to 12 months old is estimated to be 0.005 mg/kg/day. The
MOE is 6000 (i.e., chronic NOAEL of 30 mg/kg/day / daily dose 0.005 mg/kg/day) which is
above the target MOE of 100 and therefore indicate no risks of concern.
Object-to-mouth
The MOE of 430 is above the target MOE of 100 and is not of concern.
Hand-to-mouth
The calculation of the short- and intermediate-term oral doses (toxicological endpoint
selected is also protective of the long-term duration) and the oral MOEs are shown in Table
4.6 of i}\Q Revised Triclosan Residential and Occupational Risk Assessment, dated September
8, 2008. The oral MOEs are above the target MOE of 100 (short-term MOE = 1E+6 and the
intermediate- and long-term MOE = 6.7E+6).
Dust Inhalation
The resulting route-specific inhalation MOEs are in the millions, with a target MOE =
1,000. Therefore, inhalation to triclosan-contaminated dust is considered to be negligible.
4. Aggregate Exposure and Risk
The Agency performed an assessment of the aggregate exposure to triclosan.
Aggregate exposure is the total exposure to a single chemical (or its residues) that may occur
from dietary (i.e., food and drinking water), residential, and other non-occupational sources
including triclosan FDA uses such as hand soaps and toothpaste, and from all known or
plausible exposure routes (oral, dermal, and inhalation). An aggregate risk assessment was
conducted using the single selected toxicological endpoint for acute dietary, short-term (1-30
days), intermediate-term (1-6 months), and chronic (several months to lifetime) exposure
durations. Inhalation aggregate risks are minimal based on the low vapor pressure of triclosan
Page 23 of 98
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and uses such as tooth paste, hand soap, and impregnated textiles that do not involve
inhalation as the primary route of exposure. Further discussion of inhalation exposure can be
found in the Revised Triclosan Occupational and Residential Exposure Assessment, dated
September 8, 2008.
In performing aggregate exposure and risk assessments, the Office of Pesticide
Programs has published guidance outlining the necessary steps to perform such assessments
(General Principles for Performing Aggregate Exposure and Risk Assessments, November
28, 2001; available at http://www.epa.gov/pesticides/trac/science/aggregate.pdf). Steps for
deciding whether to perform aggregate exposure and risk assessments are listed, which
include: identification of toxicological endpoints for each exposure route and duration;
identification of potential exposures for each pathway (food, water, and/or residential);
reconciliation of durations and pathways of exposure with durations and pathways of health
effects; determination of which possible residential exposure scenarios are likely to occur
together within a given time frame; determination of magnitude and duration of exposure for
all exposure combinations; determination of the appropriate technique (deterministic or
probabilistic) for exposure assessment; and determination of the appropriate risk metric to
estimate aggregate risk.
In the case of triclosan, population-based biological monitoring data are available to
assess the co-occurrence of uses to develop an aggregate exposure assessment. The
population-based biological monitoring data are believed to be a more accurate predictor of
aggregate exposure because not only are the data triclosan specific, they are also based on
actual consumer use of the various triclosan products as they co-occur in practice. Although
the aggregate exposure/risk assessment using the NHANES data provides an encompassing
review of all triclosan-treated products, it does not include exposures to children under the
age of 6 years old. Children under the age of 6 years exhibit unique activities that do not
occur at older ages. Therefore, a separate assessment for children under 6 years old has been
included. The potential dermal-specific route of exposure to adults and children contacting
impregnated textiles and fabrics such as clothing items and mattresses is represented in the
NHANES data.
a. Aggregate Risk for Children (6 years) to Adults
All exposure durations were assessed using the selected oral NOAEL of 30
mg/kg/day with a target MOE of 100. The oral endpoint was selected to represent the
various oral exposure scenarios that are expected from antimicrobial exposure to triclosan.
The calculated MOEs are representative of all exposure durations. The NHANES data show
that 74.6% of the samples had detectable levels of total (free plus conjugated) triclosan.
Tables 5.1 and 5.2 in the 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan) Risk
Assessment for the Reregistration Eligibility Decision (RED) Document., dated September 15,
2008 provide the mean and 99th percentiles, respectively, of the spot urine concentration to
dose conversion prior to correcting for the 54% triclosan urinary excretion (in units of
ug/kg/day); the pharmacokinetic 54% corrected daily dose converted to units of mg/kg/day;
and the MOEs (for each of the three basic concentration to dose conversion methods).
Aggregate exposures and risks are presented for the following age groups and
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subpopulations: all age groups; ages 6-11; ages 12-19; ages 20-59; ages >=60; males;
females, Mexican-American; White, non-Hispanic; and Black, non-Hispanic.
The results of the aggregate risks at both the mean and 99th percentile do not trigger
risks of concern. The mean MOEs range from 4,700 to 19,000 (target MOE = 100). The
MOEs at the 99th percentile of the dose range from 260 to 1,700 (target MOE = 100). The
MOE is 120 when applying the lowest and most conservative percent urinary excretion from
the results of the pharmacokinetic data (i.e., 24 percent) to the most conservative dose
conversion method (i.e., Geigy's 95th percentile of daily urine volumes). In conclusion, even
with the reliance of conservative assumptions in estimating risks to account for the
considerable uncertainties in converting spot urine concentration to dose, the NHANES data
as analyzed for triclosan sufficiently characterize the aggregate risks as meeting the
definition of not resulting in unreasonable adverse effects.
b. Aggregate Risk for Infants
While NHANES data are measured exposures that represent the real world co-
occurrence of triclosan-treated products, it is necessary to use screening-level deterministic
assessments as well as to make assumptions of potential co-occurrence of triclosan-treated
products for younger children. USEPA (2005) Guidance on Selecting Age Groups for
Monitoring and Assessing Childhood Exposures to Environmental Contaminants, an
internally and externally scientific peer reviewed document, provides the basis of the age
group selection. The age group of 6 to 12 months old was selected to represent behavioral
activities of children younger than 6 years old that are exposed to triclosan-treated products.
Characteristics of children at this age that potentially exposes children to triclosan that would
not have been captured by the 6-11 year old age category in NHANES include nursing,
increasingly likely to mouth nonfood items (e.g., toys, combs & brushes, playground
equipment), and "development of personal dust clouds" as a characteristic relevant to
inhalation exposure. The aggregate risks for infants 6 to 12 months old have been estimated
by combining the mean NHANES distribution with the infant-specific bounding risks, with
the exception of the inhalation risks as they were considered negligible (MOEs in the
millions and therefore these risks do not effect the aggregate results). See the Revised
Triclosan Residential and Occupational Risk Assessment, dated September 8, 2008 for more
information on the infant-specific exposure pathways. The aggregate MOE from the
measured mean of the 6-11 year old NHANES subjects combined with the bounding risks
from nursing, object-to-mouth, and hand-to-mouth indicate a long-term MOE of 390 (target
MOE = 100). The 99th percentile of the NHANES dose (when using the 95% urine volume
to estimate the 99th percentile dose) is combined with the infant-specific bounding risks and
indicates a long-term MOE of 290 (target MOE = 100). See the Triclosan Residential and
Occupational Exposure Assessment, dated September 8, 2008 for more information regarding
the infant aggregate exposure assessment.
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5. Occupational Exposure and Risk
Because triclosan is currently registered for use in occupational settings (including
HVAC coil spray applications, as a materials preservative in paints and in industrial
processes and water systems for pulp and paper), occupational handlers have the potential to
be exposed to triclosan through mixing, loading or applying a pesticide or following
application of products containing triclosan. Table 6 presents the representative occupational
uses assessed for triclosan. Occupational non-cancer risks are presented as margins of
exposure (MOE).
Table 6. Representative Exposure Scenarios Associated with Occupational Exposures to
Triclosan
Representative Use
Method of
Application
Exposure Scenario
Example
Registration #
Application Rate
Commercial/Industrial/Institutional Premises (Use Category III)
HVAC coil
applications
Painting
(commercial
painters)
Airless sprayer
Paint brush,
Airless sprayer
ST/IT Handler:
Inhalation
ST/IT Handler:
Inhalation
82523-1
42182-1
6.1E-41bai/10ft2
(0.85 pints/10 ft2 x 1 gal/8
pts x 8.34 Ib/gal x 0.69% ai)
O.llba.i./gallon
[up to 1% product x 99% a.i.
x 10 Ib/gal paint density =
0.099 Ib a.i./gallon of paint]
Material Preservatives (Use Category VII)
Paint
Liquid pour,
Powder
ST/IT Handler:
inhalation
42182-1
0.1 Ib a.i./gallon
[up to 1% product x 99% a.i.
x 10 Ib/gal paint density =
0.099 Ib a.i./gallon of paint]
Industrial processes and water systems (Use Category VIII)
Pulp and Paper
Metered pump
ST/IT Handler:
Inhalation
70404-5
2% a.i. by weight of paper
product
(2% product by weight x
99% a.i. for paper mulch )
Note : other labels for paper
and paper board have lower
rates, 42182-1 and 3090-165)
To assess handler risk, the Agency used surrogate unit exposure data primarily from
the proprietary Chemical Manufacturers Association (CMA) Antimicrobial Exposure Study
(USEPA 1999) and the Pesticide Handlers Exposure Database (PHED) (USEPA 1998). For
the occupational scenarios in which CMA data were insufficient, other data and methods
were applied. For additional information, please see the Revised Triclosan Residential and
Occupational Exposure Assessment, dated September 8, 2008.
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Using conservative assumptions, most estimated risks from exposure to triclosan in
occupational settings did not exceed the Agency's level of concern during application.
However, Table 7 presents the application occupational risks for triclosan that exceeded
EPA's level of concern. The calculated dermal MOEs were below the target MOE of 100 for
the commercial painters (both applying by brush and airless sprayer) and the application
during pulp & paper manufacture. The inhalation MOEs are below the target MOE of 1000
for the airless sprayer (paint), the paint manufacturing, and the pulp and paper. However, a
request has been received by the Agency from the registrants to voluntarily cancel the paint
use (inclusive of stains and coatings). Once the action to terminate the paint use is
completed, any risks associated with triclosan-treated paint will be mitigated. See Section IV
of this document for EPA's triclosan risk management strategy.
Table 7. Short- and Intermediate-Term Inhalation and Intermediate-Term Dermal Risks
Associated with Occupational Handlers
Exposure
Scenario
Method of
Application
Unit Exposure
(mg/lb a.i.)
Inhalation
Dermal
Application
Rate
Quantity
Handled/
Treated per
day
Daily Dose
(mg/kg/day)a
Inhalation
Dermal
MOEb
(Target MOEs = 1000
for inhalation; 100 for
dermal)
Inhalation
Dermal
Commercial, Institutional and Industrial Premises and Equipment (Use Site Category HI )
HVAC
Painting
(commercial)
Airless sprayer
Paint brush
Airless sprayer
0.83
0.26
0.83
38
180
38
6.1E-41b
ai/10ft2
0.1 Ib
a.i./gal
Large
building
1000 ft2
5 gallons
50 gallons
0.00072
0.002
0.059
0.033
1.3
2.7
4,500
1,600
54
1,200
31
1
Material Preservatives (Use Site Category VII)
Paint
(manufacturing
process)
Liquid pour
Liquid pump
0.00346
0.000403
0.135
(gloves)
0.00629
(gloves)
0.99% a.i.
20,000 Ibs
200,000 Ibs
0.0098
0.011
0.38
0.18
330
290
110
220
Industrial Processes and Water Systems (Use Site Category VIII)
Pulp and Paper
Metering pump
0.000403
0.00629
(gloves)
2% a.i.
500 tons
0.115
1.8
Require closed loading
systems to mitigate the
exposure/risk
a Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption factor (1 for inhalation and 1 for dermal) x application rate x quantity
treated / body weight (70 kg).
b MOE = LOAEL or NOAEL (mg/kg/day) / daily dose [Where inhalation LOAEL = 3.21 mg/kg/day for all inhalation exposure durations
and the IT dermal NOAEL is 40 mg/kg/day from a dermal route-specific study]. Target MOE = 1000 for inhalation and 100 for dermal.
Occupational post-application dermal and inhalation exposures are assumed to be
negligible based on the use patterns.
6. Incident Reports
There are no incident reports associated with exposure to end-use products containing
triclosan.
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B. Environmental Fate and Ecological Hazard Assessment
The Agency has conducted an environmental fate assessment and an ecological
hazard assessment for triclosan to support the reregi strati on eligibility decision. It should be
noted that an ecological risk assessment is not ordinarily conducted when the registered use
patterns are considered to be "indoor use" because of the limited potential for these use
patterns to result in environmental exposure. However, triclosan has been detected in natural
waterways; therefore, the Agency believes it is prudent to conduct a qualitative risk
assessment using surface water monitoring data.
The following risk characterization is intended to describe the magnitude of the
estimated ecological hazards and environmental risks associated with the use of EPA-
registered triclosan products. The Agency evaluated the submitted environmental fate and
ecological studies as well as available open literature and determined that the data are
adequate to support a reregi strati on eligibility decision. In addition, a Tier 1, Down-the-
Drain (DTD) module and & Probabilistic Dilution Model (PDM) was performed to simulate
industrial process wastewater releases, resulting from the uses of triclosan as a material
preservative. The Down-the-Drain (DTD) module estimates concentrations of triclosan
found in surface water to which aquatic organisms may be exposed as a result of potential
releases of triclosan from consumer uses and the Probabilistic Dilution Model (PDM)
estimates the number of days per year that the concentration of triclosan in surface water
exceeds the concentration of concern for aquatic organisms. For detailed discussions of all
aspects of the environmental risk assessment, see the Revised Environmental Fate
Assessment of Triclosan for the Issuance of the Reregistration Eligibility Decision Document.,
dated September 11, 2008, and the Revised Ecological Hazard and Environmental Risk
Assessment of Triclosan for the Reregistration Eligibility Decision (RED) Document, dated
September 11,2008.
1. Environmental Fate
a. Hydrolysis
Triclosan [5-chloro-2-(2,4-dichlorophenoxy)phenol] is a white crystalline powder
with low solubility in water (12 ppm). Triclosan is hydrolytically stable under abiotic and
buffered conditions over the pH 4-9 range based on data from a preliminary test at 50°C.
Photolytically, triclosan degrades rapidly under continuous irradiation from artificial light at
25°C in a pH 7 aqueous solution, with a calculated aqueous photolytic half-life of 41
minutes. One major degradation product has been identified, DCP (2,4-dichlorophenol),
which was a maximum of 93.8-96.6% of the applied triclosan at 240 minutes post-treatment.
In soil, triclosan is expected to be immobile based on an estimated Koc of 9,200.
Triclosan is not expected to volatilize from soil (moist or dry) or water surfaces based on an
estimated Henry's Law constant of 1.5 x 10"7 atm-mVmole. Triclosan exists partially in the
dissociated form in the environment based on a pKa of 7.9, and anions do not generally
adsorb more strongly to organic carbon and clay than their neutral counterparts. In aquatic
environments, triclosan is expected to adsorb to suspended solids and sediments and may
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bioaccumulate (Kow 4.76), posing a concern for aquatic organisms. There is a low to
moderate potential for bioconcentration in aquatic organisms based on a BCF range of 2.7 to
90.
b. Biodegradability
Hydrolysis is not expected to be an important environmental fate process due to the
stability of triclosan in the presence of strong acids and bases. However, triclosan is
susceptible to degradation via aqueous photolysis, with a half-life of <1 hour under abiotic
conditions, and up to 10 days in lake water. An atmospheric half-life of 8 hours has also
been estimated based on the reaction of triclosan with photochemically produced hydroxyl
radicals. Additionally, triclosan may be susceptible to biodegradation based on the presence
of methyl-triclosan following wastewater treatment.
2. Ecological Hazard
As mentioned previously, the Agency used surface water monitoring data to evaluate
the ecological risks associated with the antimicrobial uses of triclosan. In addition, the
Agency used toxicity endpoints from ecological toxicity studies to estimated environmental
concentrations based on environmental fate characteristics and pesticide use data. The
toxicity endpoints used in the ecological hazard assessment were obtained from guideline
toxicity studies conducted for wildlife, aquatic organisms, and plants (40 CFR §158.2060).
A summary of the submitted data is provided below.
a. Environmental Toxicity
Toxicity to Birds
One available acute oral study on the bobwhite quail indicates that triclosan is only
slightly toxic to birds (LDso of 825 mg/kg). A subacute dietary study using the TGAI may
be required on a case-by-case basis depending on the results of lower-tier ecological studies
and pertinent environmental fate characteristics in order to establish the toxicity of a
chemical to avian species. The preferred-test species is either the mallard duck or bobwhite
quail. The results of these two acceptable studies indicate that triclosan is relatively nontoxic
to avian species through subacute dietary exposure (LCso of >5000 ppm).
Toxicity to Terrestrial Animals
Refer to the 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Risk Assessment
for the Reregistration Eligibility Decision (RED) Document dated September 15, 2008 for
details on the available acute mammalian toxicity studies submitted for human health
assessment and for information on triclosan's potential as an endocrine disrupter.
Toxicity to Aquatic Animals
One acute toxicity study is required to establish the toxicity of triclosan to freshwater
fish. The preferred test species is either the rainbow trout (Oncorhynchus mykiss\ a
coldwater fish, or the bluegill (Lepomis macrochirus), a sunfish. For triclosan, acute studies
are available for the rainbow trout and the bluegill and for the fathead minnow (Pimephales
promelas). The acute toxicity values from these studies categorize triclosan as being highly
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toxic to freshwater fish (96-hr LCso of 0.26 - 0.288 mg/L). A precautionary label statement
is required.
One study is required to establish the acute toxicity (ECso) of triclosan to freshwater
invertebrates. The preferred test species is Daphnia magnet, a water flea. Two studies
categorize triclosan as being highly toxic to freshwater invertebrates (48-hr LCso of 0.39-
0.42 mg/L) and therefore a precautionary label statement is required. However, neither study
satisfied the guideline requirement (OPPTS 850.1010) for current uses.
Acute toxicity testing with estuarine and marine organisms is required when an end-
use product is intended for direct application to the marine/estuarine environment or the
active ingredient is toxic to aquatic organisms and is expected to reach this environment via
other transport pathways. At this time this testing is not required for triclosan, but is
dependent upon the results of environmental modeling and monitoring which are required to
support reregi strati on of triclosan (see Revised Ecological Hazard and Environmental Risk
Assessment Science Chapter for the Triclosan Reregistration Eligibility Decision (RED)
Document, dated September 11, 2008).
Chronic toxicity testing (fish early life stage and aquatic invertebrate life cycle) is
required for pesticides when certain conditions of use and environmental fate apply. The
preferred freshwater fish test species is the fathead minnow. At this time this testing is not
required for triclosan, but is dependent upon the results of environmental modeling and
monitoring which are required to support reregi strati on of triclosan (see Revised Ecological
Hazard and Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11, 2008).
Toxicity to Plants
Non-target plant phytotoxicity testing is required for pesticides when certain
conditions of use and environmental fate apply. At this time this testing is not required for
triclosan, but is dependent upon the results of environmental modeling and monitoring which
are required to support reregi strati on of triclosan (see Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan Reregistration Eligibility
Decision (RED) Document, dated September 11, 2008).
Testing has been conducted with triclosan on several aquatic plant species. Testing is
normally conducted with one species of aquatic vascular plant (Lemna gibba) and four
species of algae: (1) freshwater green alga, Selenastrum capricornutum, (2) marine diatom,
Skeletonema costatum, (3) freshwater diatom, Naviculapelliculosa, and (4) bluegreen
cyanobacteria, Anabaenaflos-aquae. The rooted aquatic macrophyte rice (Oryza saliva) is
also tested in seedling emergence and vegetative vigor tests.
Four studies that evaluate the toxicity of triclosan to freshwater aquatic plants have
been submitted. Results of these studies are presented in Table 6 of the Revised Ecological
Hazard and Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11, 2008. Note that in
a search of the available data on triclosan, the U.S. EPA's Office of Water found an ECso as
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low as 0.0007 mg/L for the green alga Scenedesmus subspicatus and an Ł€25 as low as
0.00067 mg/L for the blue-green alga Anabaenaflos-aquae (U.S. EPA, 2007).
The guideline requirement for an algal toxicity test (850.5400, 123-2) is partially
fulfilled. One additional algal toxicity test under 850.5400 is outstanding: a test with the
freshwater green alga, Selenastrum capricornutum. The other non-target aquatic plant
toxicity requirement, floating freshwater aquatic macrophyte duckweed (Lemna gibba),
guideline 850.4400, is satisfied. Studies on the rooted freshwater macrophyte rice (Oryza
sativa), 850.4225 and 850.4250 (2 tests on seedling emergence and vegetative vigor) have
not been submitted.
Toxicity to Honeybees
Honeybee toxicity data are not needed based on the current uses of triclosan.
b. Ecological Exposure and Risk
An ecological risk assessment is not typically conducted for the types of triclosan
uses registered with the EPA because of the limited potential for ecological exposure.
However, since triclosan has been detected in natural waters, a qualitative environmental risk
assessment was performed using monitoring levels of triclosan found in waterways and
toxicity values from the tables in section I of the Ecological Hazard and Environmental Risk
Assessment Science Chapter for the Triclosan Reregistration Eligibility Decision (RED)
Document, dated September 11, 2008 to develop risk quotients (RQs) and compare them to
levels of concern (LOCs) for triclosan. LOCs were not exceeded for fish but were exceeded
for aquatic plants. The RQs were based on published literature, submitted data and USGS
monitoring data. A meta-analysis of literature, plus exposure modeling was used to conduct
a probabilistic assessment of triclosan. This analysis sheds light on the difficulties associated
with relating laboratory data to field effects and concludes that additional studies may be
needed to refine scientific knowledge of metabolites and degradates, bioaccumulation
factors, endocrine-related effects, and community level impacts. There were no acceptable
acute toxicity studies for freshwater invertebrates or estuarine and marine organisms nor
were there any acceptable chronic toxicity studies available for aquatic organisms.
Therefore, risk to these species could not be assessed at this time. The hazard assessment
will be used to meet current labeling needs and to determine hazard endpoints for ecological
organisms potentially exposed in the event of a spill or other potential environmental
releases.
In addition, the Agency performed consumer environmental modeling for triclosan.
See the Appendix to the Revised Ecological Hazard and Environmental Risk Assessment
Science Chapter for the Triclosan Reregistration Eligibility Decision (RED) Document,
dated September 11, 2008 titled Estimates of Exposures and Risks To Aquatic Organisms
from Releases of Triclosan to Surface Water as a Result of Uses Under EPA 's Jurisdiction,
and the Revised Environmental Fate Science Chapter for the Triclosan Reregistration
Eligibility Decision (RED) Document, dated September 11, 2008. The consumer
environmental modeling (DTD module and PDM) assumed that all triclosan used in the
manufacture of the antimicrobial uses is released into surface waters. After adjustments,
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these models concluded that estimated concentrations of triclosan in surface water do not
exceed concentrations of concern for acute risk presumptions for any of the aquatic
organisms and plants (vascular and non-vascular). As discussed in the Revised Ecological
Hazard and Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11, 2008, only acute
concentrations of concern were evaluated for aquatic organisms since acceptable chronic
aquatic data are not available. However, considering the low probability of triclosan being
released into household wastewater and surface waters from the antimicrobial uses, the
Agency also concludes that chronic aquatic risks are unlikely from consumer uses of
triclosan-treated plastic and textile items. Therefore, Agency can reasonably conclude that
the antimicrobial uses of triclosan (e.g., triclosan-treated plastic and textile items in
households) are unlikely to contribute significant quantities of triclosan into household
wastewater and eventually to surface water.
As discussed in the Revised Environmental Fate Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11, 2008, little is
known about how much, if any, triclosan is released from industrial sites (where triclosan is
incorporated into plastic and textile items) into effluents and the environment (e.g., surface
waters). Considering this, the Agency is requiring that the technical registrants perform
environmental modeling and monitoring to address this issue. Until the Agency receives
these data it is unable to calculate risk quotients specific to these industrial scenarios.
However, the Agency does not anticipate risks of concern. The confirm this, the modeling
and monitoring data will be required. In the event a new risk of concern is identified, the
Agency will revisit the issue. The registrants are required to sample effluents from such
facilities and receiving (surface) waters adjacent to these facilities, determining the extent
and duration of triclosan and major degradates/metabolites (e.g., triclosan methyl).
Depending on the results of this monitoring, further ecological effects data may be required.
In addition, four studies to address bioaccumulation potential will also be called-in. See
Chapter V. of this RED document and the Revised Ecological Hazard and Environmental
Risk Assessment Science Chapter for the Triclosan Reregistration Eligibility Decision (RED)
Document, dated September 11, 2008, for more information on the potential ecological
effects data to be called in.
3. Risk to Listed Species
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 CFR §402.02).
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To facilitate compliance with the requirements of the Endangered Species Act
subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly reduce appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or distribution of any listed
species (U.S. EPA 2004). After the Agency's screening-level risk assessment is performed,
if any of the Agency's Listed Species LOG Criteria are exceeded for either direct or indirect
effects, a determination is made to identify if any listed or candidate species may co-occur in
the area of the proposed pesticide use. If determined that listed or candidate species may be
present in the proposed use areas, further biological assessment is undertaken. The extent to
which listed species may be at risk then determines the need for the development of a more
comprehensive consultation package as required by the Endangered Species Act.
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. This
preliminary analysis indicates that there is a potential for triclosan use to overlap with listed
species and that a more refined assessment is warranted, to include direct, indirect and habitat
effects.1 The more refined assessment should involve clear delineation of the action area
associated with proposed use of triclosan and best available information on the temporal and
spatial co-location of listed species with respect to the action area. This analysis has not been
conducted for this assessment and therefore an endangered species effect determination will
not be made at this time. The refined endangered species assessment will be performed
under the Registration Review program (see
http://www.epa.gov/oppsrrdl/registration_review/ for more information) and will include a
species by species analysis.
1 The Agency is making this statement because triclosan and triclosan transformation products are being
detected in various environmental components (see Revised Environmental Fate Science Chapter for the
Triclosan Reregistration Eligibility Decision (RED) Document, dated September 11, 2008).
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IV. Reregistration and Risk Management Decisions
A. Determination of Reregistration Eligibility
1. Reregistration Eligibility Decision
Section 4(g)(2)(A) of FIFRA calls for EPA 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. EPA has previously identified and required the submission of
the generic (i.e., active ingredient-specific) data required to support reregi strati on of products
containing triclosan as an active ingredient. The Agency has reviewed these generic data,
and has determined that the data are sufficient to support a reregi strati on eligibility decision
for all products containing triclosan.
The Agency completed its assessment of the residential, occupational, indirect dietary
and ecological risks associated with the use of pesticide products containing the active
ingredient triclosan. The Agency has determined that most triclosan containing products are
eligible for reregi strati on provided that: 1) all risk mitigation measures are implemented; 2)
current data gaps and confirmatory data requirements are addressed; and 3) label
amendments are made as described in Section V. Use as a materials preservative in paint
(inclusive of stains and coatings) has been requested to be voluntarily cancelled by the
registrants and is not eligible for reregi strati on. Appendix A summarizes the uses of triclosan
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 triclosan 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.
The Agency considered the available information and has determined that the uses of
triclosan that appear in Appendix A of this document will not pose unreasonable risks to
humans or the environment if the conditions and requirements for reregi strati on outlined in
this document are implemented. Unless labeled and used as specified in this document,
triclosan would present risks inconsistent with FIFRA. Accordingly, should a registrant fail
to implement any of the conditions and requirements for reregi strati on identified in this
document, the Agency may take regulatory action to address the potential risk concerns from
the use of triclosan.
a. Endocrine Disruption Effects
Under the Federal Food Drug and Cosmetic Act (FFDCA), as amended by FQPA, the
Agency is required 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 such endocrine
effects as the Administrator may designate." Following the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA
determined that there was scientific basis for including, as part of the program, the androgen
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and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted
EDSTAC's recommendation that the Program include evaluations of potential effects in
wildlife. For pesticide chemicals, 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 has
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).
There is some evidence that triclosan disrupts thyroid hormone homeostasis and
interacts with the androgen and estrogen receptors. The available evidence is summarized in
the 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Toxicology Chapter for the
Reregistration Eligibility Decision (RED) Document, dated August 29, 2008. The Agency is
aware that research is ongoing regarding endocrine effects of triclosan, and this further
research may require future modification to the risk assessment and the RED for triclosan.
The EPA process of regulating pesticides allows for reevaluation at any time if new
information becomes available.
b. Cumulative Risks
Risks summarized in this document are those that result only from the use of
triclosan. The Food Quality Protection Act (FQPA) requires that, when considering whether
to establish, modify, or revoke a tolerance, 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." 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 as to triclosan. The Agency
acknowledges that triclocarban has been detected along with triclosan in the environment.
Although there may be some structural similarity between triclosan and triclocarban, these
chemicals belong to two different classes (hydroxyphenylether and hydroxyphenylurea
respectively). Further, there is not necessarily a relationship between the mechanism of
antimicrobial activity and mechanism of toxicity in mammals. As defined in the Office of
Pesticide Programs' 2002 document "Guidance on Cumulative Risk Assessment of Pesticide
Chemicals that Have a Common Mechanism of Toxicity," available at:
http://www.epa.gov/pesticides/trac/science/cumulative guidance.pdf, common mechanism of
toxicity refers to "two or more pesticide chemicals or other substances that cause a common
toxic effect by the same, or essentially the same, sequence of major biochemical events..."
There is currently insufficient evidence characterizing major biochemical events between
triclosan and triclocarban to suggest that these two chemicals share a common mechanism of
toxicity.
c. Public Comments and Response
Through EPA's public participation process, EPA worked with stakeholders and the
public to reach the regulatory decisions for triclosan. During the public comment period on
the risk assessments, which closed on July 7, 2008, the Agency received multiple comments
from the technical registrants, members of the public, and various environmental groups.
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All comments are available at http://www.regulations.gov under docket number EPA-HQ-
OPP-2007-0513. The Agency's official responses will also be posted in the public docket.
2. Regulatory Rationale
With the exception of the paint use which has been requested to be voluntarily
cancelled by the registrants, the Agency has determined that triclosan is eligible for
reregi strati on provided that the risk mitigation and data requirements outlined in this
document are fully implemented. A summary of EPA's rationale for reregistering and
managing risks associated with triclosan is presented below. Where labeling revisions are
warranted, specific language is set forth in the summary tables of Section V. of this
document.
a. Performing Residential Activities
There are no EPA registered products containing triclosan that can be applied directly
by the homeowner. However, there is a homeowner application of triclosan when it is used
as an in-can preservative for latex paint. To estimate the potential risks associated with this
exposure, the Agency assessed handler exposures for the in-can preservative use in paint.
The calculated inhalation MOEs are above the target MOE of 1000 for the paint brush
scenario but below the target MOE for the airless sprayer scenario (i.e., MOE = 180).
Because the estimated risks associated with treated paints exceeded EPA's level of concern
by such a large degree - in some cases by more than several orders of magnitude - the
Agency believes that this use does not meet the "no unreasonable adverse effects" criteria of
FIFRA. Personal protective equipment (PPE) such as respirators is not a viable mitigation
option for residential paint uses for an in-can preservative. The paint use (inclusive of stains
and coatings) has been requested to be voluntarily cancelled by the registrants and is not
eligible for reregi strati on. Once the action to terminate the paint use is completed, any risks
associated with triclosan-treated paint will be mitigated.
Based on the aggregate risk assessment, the Agency believes that certain other
residential uses of triclosan (see Appendix A) result in significantly lower exposure and risk.
Therefore, residential uses other than paints, stains, and coatings meet the "no unreasonable
adverse effects" criteria of FIFRA and are eligible for reregi strati on.
b. Performing Occupational Activities
There is the potential for workers to be exposed to triclosan during the application of
triclosan products in an occupational setting (handler exposure). However, occupational post-
application exposures are assumed to be negligible based on the use patterns. To estimate the
potential risks associated with occupational handler exposure, the Agency assessed
representative application scenarios including treated paints and the industrial processes and
water systems use for pulp and paper.
Short-term dermal irritation exposures and risks were not estimated for occupational
handler exposures. Instead, dermal irritation exposures and risks will be mitigated using
default PPE requirements based on the toxicity of the end-use products. For occupational
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uses dermal irritation risks are mitigated by requiring the user to wear PPE (e.g., chemical
resistant gloves and clothing). Mitigating with PPE is only a viable option for pesticide-
labeled products (i.e., a label is needed to inform workers to wear PPE). Therefore, the
Agency often requires workers using pesticide-labeled products (concentrated form) in the
manufacturing setting (where workers are applying the active ingredient to the paint itself) to
wear PPE to mitigate dermal irritation. Conversely, for in-can material preservatives there is
no pesticide label that goes with the preserved product to inform the workers/painters that
PPE is needed (there is no pesticide label on a can of paint). Thus PPE is only a viable
option in an occupational setting where triclosan is being applied to the paint, but not a viable
option when occupational handlers are actually applying the paint itself.
For the intermediate-term dermal risks, the MOEs were above the target MOE of 100,
and therefore, not of concern except for the commercial painter and material preservative
uses for pulp and paper. The intermediate-term MOEs for using a paint brush/roller and an
airless sprayer are 31 and 1, respectively (target MOE = 100). Again, because triclosan is
used as a material preservative in the paint, the use of chemical resistant gloves on the label
is impractical. However, the paint use (inclusive of stains and coatings) has been requested to
be voluntarily cancelled by the registrants. Once the action to terminate the paint use is
completed, any risks associated with triclosan-treated paint will be mitigated. For the pulp
and paper use, dermal risks will be mitigated by requiring the use of a closed delivery
system.
For the occupational handler inhalation exposure and risk assessment, the MOEs were
below the target MOE for all scenarios except for the brush application for paints. The
inhalation MOE for commercial use of an airless sprayer for paints is 54 (target MOE =
1000), for liquid pour and liquid pump during paint manufacturing 330 and 290 (target MOE
= 1000), respectively. The paint use (inclusive of stains and coatings) has been requested to
be voluntarily cancelled by the registrants. Once the action to terminate the paint use is
completed, any risks associated with triclosan-treated paint will be mitigated. For the pulp
and paper use, inhalation risks can be mitigated by requiring the use of a closed delivery
system.
However, the Agency believes that certain other occupational uses of triclosan (see
Appendix A) result in significantly lower exposure and risk. Therefore, occupational uses
other than paints, stains, and coatings meet the "no unreasonable adverse effects" criteria of
FIFRA and are eligible for reregi strati on provided the mitigation measures and associated
label changes presented in Table 8 and Table 10 are implemented.
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c. Ecological Risk Management
A qualitative environmental risk assessment was performed using monitoring levels
of triclosan found in waterways and toxicity values from the tables in section I of the
Ecological Hazard and Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11, 2008 to develop
risk quotients (RQs) and compare them to levels of concern (LOCs) for triclosan. LOCs
were not exceeded for fish but were exceeded for aquatic plants. In addition, the Agency
performed consumer environmental modeling for triclosan. The consumer environmental
modeling assumed that all triclosan used in the manufacture of the antimicrobial uses is
released into surface waters. After adjustments, these models concluded that estimated
concentrations of triclosan in surface water do not exceed concentrations of concern for acute
risk presumptions for any of the aquatic organisms and plants (vascular and non-vascular).
Considering the low probability of triclosan being released into household wastewater and
surface waters from the antimicrobial uses, the Agency also concludes that chronic aquatic
risks are unlikely from consumer uses of triclosan-treated plastic and textile items.
Therefore, Agency can reasonably conclude that the antimicrobial uses of triclosan (e.g.,
triclosan-treated plastic and textile items in households) are unlikely to contribute significant
quantities of triclosan into household wastewater and eventually to surface water.
Environmental modeling and monitoring specific to plastic and textile facilities,
where triclosan is incorporated into these items, is required. The technical registrants will be
required via the DCI to sample effluents from such facilities and receiving (surface) waters
adjacent to these facilities, determining the extent and duration of triclosan and major
degradates/metabolites (e.g., triclosan methyl). Prior to beginning the environmental
monitoring the registrants must submit a protocol to the Agency for approval. Depending
upon the results of this modeling and monitoring effort, the following ecological effects data
may be required (these studies are held in reserve):
1) Freshwater invertebrate acute study (850.1010) [Technical Grade Active
Ingredient (TGAI)];
2) Estuarine/marine fish acute study (850.1075) (TGAI)];
3) Estuarine/marine shrimp acute study (850.1035) (TGAI);
4) Estuarine/marine mollusk acute study (850.1025) (TGAI);
5) Fish early life-stage (freshwater) study (850.1400) (TGAI);
6) Aquatic invertebrate (freshwater) life-cycle study (850.1300) (TGAI);
7) Fish life-cycle study (850.1500) (TGAI);
8) Acute sediment toxicity to freshwater invertebrates (850.1735) (TGAI);
9) Acute sediment toxicity to estuarine invertebrates (850.1740) (TGAI); and
10) Additional plant toxicity testing: an additional algal toxicity test (850.5400) with
the freshwater green alga, Selenastrum capricornutum; and studies on the rooted
freshwater macrophyte, rice (Oryza saliva) - 850.4225 and 850.4250 (2 tests on
seedling emergence and vegetative vigor)
11) Oyster bioconcentration study - BCF (850.1710) (major degradate/metabolite of
triclosan - e.g., methyl triclosan)
12)Fish bioconcentration study -BCF (850.1730) (major degradate/metabolite of
Page 3 8 of 98
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triclosan - e.g., methyl triclosan)
13) Chironomid sediment toxicity test (850.1790) (major degradate/metabolite of
triclosan - e.g., methyl triclosan)
14) Aquatic food chain transfer (850.1850) (major degradate/metabolite of triclosan -
e.g., methyl triclosan)
15) Chronic sediment toxicity to freshwater and/or estuarine invertebrates (no
guideline number) (TGAI)
In addition, four studies to address bioaccumulation potential will also be required via
the DCI (850.1850; 850.1710; 850.1730; and 850.1790). Prior to conducting these studies,
the registrants must submit protocols to the Agency for approval.
B. Risk Management Decision
Triclosan uses presented in Appendix A are eligible for reregi strati on provided that
registrants comply with the requirements outlined in this document including implementing
risk mitigation measures, amending product labels, and submitting required confirmatory
data. In addition, the Agency is aware of recent research conducted by the Office of
Research and Development on the effects of triclosan on thyroid homeostasis in the rat (US
EPA, 2008). These data were considered in selection of the incidental oral endpoint, but the
current endpoint was retained, as further investigation is needed on the effects of triclosan on
the thyroid. The Agency will continue to monitor the toxicity profile of triclosan and will
amend the assessment as needed. Further, given the rapidly developing scientific database
for triclosan, the Agency intends to accelerate the schedule for the registration review process
for this chemical. Currently, the Agency intends to begin that process in 2013, ten years
earlier than originally planned.
1. Risk Mitigation Measures
Products containing triclosan are eligible for reregi strati on provided that the
registrants implement the risk mitigation measures presented in Table 8. Specific label
language to implement these measures is presented in Table 10. In the future, registrants
may request that the Agency remove or reduce certain restrictions or mitigation measures
upon submission of acceptable toxicity and exposure studies that demonstrate to the Agency
that risk exposure to triclosan is below the Agency's level of concern.
Table 8. Risk Mitigation Measures for Triclosan
Use Site
Paints, Stains, and
Coatings
Risk(s) of Concern
Residential handler inhalation
exposure to triclosan in paint when
applying paint
Mitigation Measures
• A request has been received
by the Agency from the
registrants to voluntarily
Page 3 9 of 98
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Occupational handler dermal and
inhalation exposure to triclosan
when applied to paint in
manufacturing setting
Occupational handler inhalation
exposure to triclosan when applying
paint
Pulp and Paper
Occupational handler inhalation and
dermal exposure to triclosan when
applied during pulp and paper
manufacturing (used in the
industrial water processing systems)
Closed systems must be used
2. Product Label Amendments
Manufacturing-Use Products and End-Use Products are to be amended to reflect the
mitigation measures presented in Table 8 and the label amendments presented in Table 10
(see Section V).
3. Antimicrobial Resistance
Antimicrobial resistance differs from antibiotic resistance, the latter of which can be a
concern in hospital or medical settings. There is currently some research attempting to
demonstrate a connection between antimicrobial resistance and antibiotic resistance in regard
to triclosan, but the linkage has not been expressly proven. The Agency continues to look
into the issue of antimicrobial resistance and its links to antibiotic resistance through review
of current literature and membership in the Interagency Task Force on Antimicrobial
Resistance. The Task Force has a number of goals stated in the Public Health Action Plan to
Combat Antimicrobial Resistance
(http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf). Though none of the goals
are associated with a specific active ingredient, many of the activities are expected to further
our understanding of the processes involved with antimicrobial resistance, which may
subsequently further our understanding of any potential resistance from the use of triclosan.
Some of the goals are as follows:
• Evaluate the benefits and risks incorporating antimicrobial, disinfectant, or antiseptic
chemicals into consumer products (e.g., soap, toys, kitchen utensils, clothes, paints,
plastics, and film preservatives) and of applying disinfectants and sanitizers to hard,
non-porous surfaces such as food-contact surfaces, hospital premises, bathrooms, etc.
Consider whether they have any efficacy in reducing infection and/or may play a role
in promoting drug resistance;
• Convene an expert group to consider how to incorporate antimicrobial resistance
(AR) issues into regulations governing the registration and use of antimicrobials and
antibiotic pesticides. Invite external experts, stakeholders, and the public to provide
input;
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• Determine which organisms and susceptibility to specific antimicrobial drugs should
be under surveillance and create a mechanism for periodic updating of this list;
• Develop and implement procedures for monitoring antimicrobial use in human
medicine, agriculture, veterinary medicine, and consumer products;
• Conduct pilot studies to assess the extent of environmental contamination by
antimicrobial drug residues and drug-resistant organisms that enter the soil or water
from human and animal wastes. If contamination is detected, conduct appropriate
surveillance in waste, surface and ground water, and soil from agricultural areas in
which waste is used for fertilizer, and conduct studies to determine potential impact
on human and animal health;
• Gather information on the relationship between antimicrobial pesticide and herbicide
use and the emergence of drug-resistance by monitoring;
• Establish an ongoing mechanism to obtain periodic input from external experts on AR
issues. This process will include ensuring from stakeholders and partners in
developing and reviewing federal efforts to address antimicrobial resistance
4. Post-RED Activities
The Agency recognizes that there is a considerable amount of ongoing research
regarding triclosan. The Agency will track the progress of these studies and, as new
scientific data becomes available, will review this data. The Agency will then determine
what, if any, changes to the risk assessment and risk management decision are necessary.
The Agency will also continue to participate actively in the Interagency Task Force on
Antimicrobial Resistance described above and evaluate information that results from that
activity. Further, given the rapidly developing scientific database for triclosan, the Agency
intends to accelerate the schedule for the registration review process for this chemical.
Currently, the Agency intends to begin that process in 2013, ten years earlier than originally
planned
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V. What Registrants Need to Do
The Agency has determined that triclosan is eligible for reregi strati on provided that
the conditions and requirements for reregi strati on identified in this RED are implemented
(see Section IV). The registrants will also need to amend product labeling for each product.
The database supporting the reregi strati on of triclosan has been reviewed and
determined to be adequate to support a reregi strati on eligibility decision. However,
additional confirmatory data are required to support continued registration.
A. Manufacturing Use Products
1. Generic Data Requirements
The generic database supporting the reregistration of triclosan for currently registered
uses has been reviewed and determined to be adequate to support a reregi strati on eligibility
decision. However, the confirmatory data presented in Table 9 are required. CMA, PHED,
environmental fate and surface water monitoring studies are all required. The ecological
studies are being held in reserve pending the outcome of the surface water monitoring
studies. Specific deadlines are set forth in the generic data call-in (GDCI), including those
for submission of initial responses and/or request for time extensions or data waivers as well
as for other required steps. Deadlines for submitting generic data are also set forth in the
GDCI.
Table 9. Generic Data Required to Support Triclosan Registrations
EPA Guideline
Number
Requirement Name
Ecological Studies
Special Study for Surface
Water Modeling
850.1710
850.1730
850.1850
850.1790
Environmental modeling and monitoring specific to plastic and
textile facilities where triclosan is incorporated into these items
Oyster Bioconcentration Test
Fish Bioconcentration Test
Aquatic Food Chain Transfer
Chironomid sediment toxicity test
Environmental Fate Study
835.4400
Anaerobic Aquatic Metabolism
Confirmatory CMA and PHED Studies
875.1700
875.2700
875.2800
875.12001
875.14002
875.2300
875.1600
Product Use Information (applicator)
Product Use Information (post-applicator)
Description of Human Activity
Dermal Indoor Exposure
Inhalation Indoor Exposure
Indoor Surface Residue Dissipation (infant assessment for
mouthing toys)
Applicator Exposure Monitoring Data Reporting
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Table 9. Generic Data Required to Support Triclosan Registrations
EPA Guideline
Number
875.2900
Requirement Name
Data Reporting and Calculations
Studies to be Held in Reserve Pending Outcome of Surface Water Monitoring Data
850.1010
850.1075
850.1035
850.1025
850.1300
850.1400
850.1500
850.1735
850.1740
850.4225
850.4250
850.5400
850.1710
850.1730
850.1790
850.1850
No current guideline
number
Aquatic invertebrate acute toxicity, test, freshwater daphnids
Fish acute toxicity test, marine
Mysid acute toxicity test
Oyster acute toxicity test (shell deposition)
Daphnid chronic toxicity test
Fish early-life stage toxicity test
Fish life cycle toxicity
Whole sediment acute toxicity invertebrates, freshwater
Whole sediment acute toxicity invertebrates, marine
Seedling emergence, Tier II
Vegetative vigor, Tier II
Acute Algal Dose-Response Toxicity - Green Algae
(Selenastrum Capricornutum)
Oyster bioconcentration study - BCF (major
degradate/metabolite of triclosan - e.g., methyl triclosan)
Fish bioconcentration study - BCF (major degradate/metabolite
of triclosan - e.g., methyl triclosan)
Chironomid sediment toxicity test (major degradate/metabolite
of triclosan - e.g., methyl triclosan
Aquatic food chain transfer (major degradate/metabolite of
triclosan - e.g., methyl triclosan)
Chronic sediment toxicity to freshwater and/or estuarine
invertebrates (no guideline number) (TGAI)
1 & 2 These studies are required for all manufacturing settings where "liquid pour" is the application method of
triclosan
Environmental modeling and monitoring specific to plastic and textile facilities,
where triclosan is incorporated into these items, is required. The technical registrants are
required to sample effluents from such facilities and receiving (surface) waters adjacent to
these facilities, determining the extent and duration of triclosan and major
degradates/metabolites (e.g., triclosan methyl). Prior to beginning the environmental
monitoring the registrants must submit a protocol to the Agency for approval. Depending
upon the results of this modeling and monitoring effort, the above aforementioned ecological
effects data may be required (these studies are held in reserve).
Four studies to address bioaccumulation potential will also be called-in (850.1850;
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850.1710; 850.1730; and 850.1790). Prior to conducting these studies, the registrants must
submit protocols to the Agency for approval.
Surrogate dermal and inhalation unit exposure values were taken from the proprietary
Chemical Manufacturers Association (CMA) antimicrobial exposure study or from the
Pesticide Handler Exposure Database (PHED). Since the CMA data are of poor quality, the
Agency requires that confirmatory data be submitted to support the occupational scenarios
assessed in this document. The quantities handled/treated were estimated based on
information from various sources, including HED's Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA, 2000 and 2001), and personal
communication with experts. The individuals contacted have experience in these operations
and their estimates are believed to be the best available without undertaking a statistical
survey of the uses. In certain cases, no standard values were available for some scenarios.
Assumptions for these scenarios were based on AD estimates and could be further refined
from input from registrants.
For triclosan technical grade active ingredient products, the registrant is required 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 Heather Garvie at (703) 308-0034 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Heather Garvie Heather Garvie
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
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B. End-Use Products
1. Product Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made. The
registrant must review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product. The Agency intends to issue a separate product-
specific data call-in (PDCI) outlining specific data requirements.
The PDCI will set forth specific deadlines including those pertaining to submission of
response forms or requests for time extensions and/or waivers as well as for other required
steps. Deadlines for submitting product-specific data will also be provided.
For end-use products containing the active ingredient triclosan, 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
17 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.
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Please contact Emily Mitchell at (703) 308-8583 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Emily Mitchell Emily Mitchell
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement
measures outlined in Section IV. Specific language to incorporate these changes is presented
in Table 10. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this RED. However,
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors. Refer to "Existing Stocks
of Pesticide Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26,
1991.
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Table 10. Required Label Changes for Manufacturing and End-Use Products Containing Triclosan
Description
Triclosan: Required Labeling Language
Placement on Label
Manufacturing-Use Products
For all Manufacturing
Use Products
One of these statements
may be added to a label
to allow reformulation of
the product for a specific
use or all additional uses
supported by a formulator
or user group.
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
For all Manufacturing
Use Products that have
toys as a use site
For all Products that state
paint as a use site on the
label
For all Manufacturing
Use Products
"Only for formulation as a preservative for the following use(s) [fill blank
only with those uses that are being supported by MP registrant]."
"This product may be used to formulate products for specific use(s) not listed
on the MP label if the formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not
listed on the MP label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding support of such use(s)."
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements
of a National Pollution Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do
not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of the EPA."
"When used for formulation as a materials preservative for toys, the active
ingredient amount must be limited to no more than 0.5%."
The paint use site must be removed from the label.
"When used in industrial process waters for the manufacture of pulp and
paper, a closed delivery systems must be used."
Directions for Use
Directions for Use
Precautionary Statements
Directions for Use
Directions for Use
Directions for Use
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VI. APPENDICES
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Triclosan Appendix A: Use Patterns Eligible for Reregistration
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Commercial, institutional and industrial premises and equipment
Air Conditioning Heat
Exchange Coils
82523-1
Spray (Fine
Mist)
0.85USpts./10sqft. (400
ml/ m2) based on a 4" (100
mm) deep coil at 12 FPL
For application by a service contractor
Residential and public access premises
Air Conditioning Heat
Exchange Coils
82523-1
Spray (Fine
Mist)
0.85USpts./10sqft. (400
ml/ m2) based on a 4" (100
mm) deep coil at 12 FPL
For application by a service contractor
Materials preservatives
Personal Care Products:
bristles & Handles of
brushes (tooth, hair)
combs, incontinence care
products, razors
Textiles & Fibers
Sanitizer (natural and
Synthetic in contact with
Human Skin)
42182-1
83884-9
3090-165
Incorporated
into
production of
end use
product
incorporated
in the
fiber/textile or
applied
directly to it
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
.1% - 1% a.i. based on
weight of finished product
0.7 to 1.0% of product
based on weight of finished
product
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Not for use in diapers
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
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Use Site
Home Furnishings:
blankets, cloths,
countertops, curtains,
draperies, linens, napkins
Textiles
Formulation
42182-1
83884-9
6390-25
10466-42
10466-24
3090-215
Method of
Application
Incorporated
into
production of
end use
product
incorporated
in the
fiber/textile or
applied
directly to it
Padding or
Exhaustion
Application
directly to the
textile
Exhaustion,
padding or co-
treatment with
resins and
softeners
Incorporation
Application Rate/ No. of
applications
.1% - 1% a.i. based on
weight of finished product
.1% - 1% a.i. based on
weight of finished product
Apply to leave 0.25% -
1.0% of product on the dry
weight of the fiber.
Apply 1%- 1.5% of the
product based on weight of
material being treated
Add at 1 to 3.5% on weight
of material being treated
0.1% to .5% of product
Use Limitations
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Not for use in diapers
For manufacturing use only.
None Listed
Do not use for any applications involving
direct or indirect food contact or human or
animal drinking water contact applications.
Do not use in the manufacture or treatment of
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Use Site
Formulation
10466-27
10466-42
10466-38
83884-7
42182-1
Method of
Application
into fiber
Padding or
Exhaustion
Incorporation
into textiles
Incorporated
into PVC used
in coated or
laminated
textiles
Incorporation
into textiles
Incorporated
into
Application Rate/ No. of
applications
based on the weight of
material being treated
1 to 5% based on fabric
weight and durability
requirements. Inclusive of
air filters, cleaning cloths,
non-woven wipes
1%-1.5% based on weight
of finished product
0.05% - 0.3% based on
weight of finished product
Up to 5% of the product
based on weight of the
finished product
.1% - 1% a.i. based on
weight of finished product
Use Limitations
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
Not to be used on food contact surfaces
Distributors of products containing the
additive may not make claims of
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
production of
end use
product
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
3090-165
Pad, jig or
dyeback
0.7 to 1.0% of Product; can
also be used for paper and
leather
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
70404-5
Incorporation
into product
or applied as
finish
. l%-2% based on weight of
finished product
Not for use in diapers
83884-10
Incorporation
into product
or applied as
finish
. l%-2% based on weight of
finished product
Not for use in diapers
83884-9
incorporated
in the
fiber/textile or
applied
directly to it
.1% - 1% a.i. based on
weight of finished product
Not for use in diapers
Carpets & Rugs
42182-1
Incorporated
into
.1% - 1% a.i. based on
weight of finished product
Distributors of products containing the
additive may not make claims of
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Use Site
Shoe & Boot Spray
PVC (foils, films,
coatings, artificial leather,
plastisols, extruded and
injection moulded articles,
PVC tiles and fibers)
Plastics
Formulation
10466-27
83884-9
10466-42
3090-219
2829-139
Method of
Application
production of
end use
product
Padding;
exhaustion
incorporated
in the
fiber/textile or
applied
directly to it
Spray
Incorporated
into
production of
end use
product
Incorporated
into
production of
end use
product
Application Rate/ No. of
applications
1-4% based on weight of
finished product
.1% - 1% a.i. based on
weight of finished product
1%-1.5% based on weight
of finished product
Apply such that the
finished product contains
0.5% to 1.4% by weight of
the additive
Up to 2.5% a.i.
Use Limitations
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Not for use in diapers
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
When used for formulation as a materials
preservative for toys, the active ingredient
amount must be limited to no more than
0.5%.
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
2829-145
3090-215
4822-429
42182-1
Incorporated
into
production of
end use
product
Upto2.5%a.i.
When used for formulation as a materials
preservative for toys, the active ingredient
amount must be limited to no more than
0.5%.
Incorporation
into plastic
0.1% to .5% of product
based on the weight of
material being treated
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
Incorporated
into
production of
end use
product
0.06% a.i.
Impregnated plastic bag; not for use for food
storage
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
(some examples include
toys, cutting boards,
toothbrush bristles &
handles, storage containers,
brooms)
Active concentration is limited to 0.5% for
toys and ice-making equipment; Distributors
of products containing the additive may not
make claims of antimicrobial activity other
than the protection of the product against the
growth of bacteria, mold, mildew and fungi in
or on the treated product.
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Use Site
Synthetic cellulosic
sponges
Polymer Compounds
Formulation
70404-5
83884-10
10466-38
83884-9
10466-27
42182-1
70404-5
Method of
Application
Incorporated
into
production of
end use
product
Incorporation
into product
or applied as
finish
Incorporation
into finished
product
incorporated
in the plastic
or applied
directly to it
Incorporated
into
manufacturing
process
Incorporated
into
production of
end use
product
Incorporated
into
Application Rate/ No. of
applications
.1% - 1% a.i. based on
weight of finished product
. l%-2% based on weight of
finished product
5-10% of product based on
weight of finished product
.15%- 1% a.i. based on
weight of finished product
1-4% based on weight of
finished product
.1% - 1% a.i. based on
weight of finished product
.1% - 1% a.i. based on
weight of finished product
Use Limitations
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Page 55 of 98
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Use Site
Pulp & Paper
Formulation
83884-10
3090-215
83884-9
42182-1
3090-165
Method of
Application
manufacturing
process
Incorporation
into product
or applied as
finish
Incorporation
into polymer
incorporated
in the polymer
or applied
directly to it
Incorporation
into finished
product
Pad, jig or
Application Rate/ No. of
applications
. l%-2% based on weight of
finished product
0.1% to .5% of product
based on the weight of
material being treated
.15%- 1% a.i. based on
weight of finished product
.1% - 1% a.i. based on
weight of finished product
1% of product
Use Limitations
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
When used in industrial process waters for the
manufacture of pulp and paper, a closed
delivery systems must be used; Distributors of
products containing the additive may not
make claims of antimicrobial activity other
than the protection of the product against the
growth of bacteria, mold, mildew and fungi in
or on the treated product.
When used in industrial process waters for the
Page 56 of 98
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
dyeback
manufacture of pulp and paper, a closed
delivery systems must be used.
Do not use in the manufacture or treatment of
items that may come in contact with food. Do
not use for production of baby diapers or
fibers for the production of baby diapers. Do
not use for the production of health care
products or products intended to decrease the
transmission of disease. Finished products
incorporating the product may not make
claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1
Floor coverings (carpets,
rugs, mats, sealer/wax
components
42182-1
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
(for example: adhesives,
caulking, tiles, whirlpools)
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Inks, Dispersions, Pigment
Presscakes
10466-27
Formulation
into end use
products
intended to
treat the
article itself.
1-4% based on weight of
product
Not for use in food-grade inks
Construction & building
materials
42182-1
Incorporated
into
production of
end use
.1% - 1% a.i. based on
weight of finished product
(for example: adhesives,
caulking, tiles, whirlpools)
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
Page 57 of 98
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Use Site
Polyethylene Sleeves for
Buried Conduits
Adhesvies
Polymeric systems
Formulation
10466-38
10466-27
42182-1
10466-42
10466-38
Method of
Application
product
Incorporated
into
production of
end use
product
Incorporated
into
production of
end use
product
Incorporated
into
production of
end use
product
Incorporation
into
production of
end-use
product
Incorporation
into
production of
end-use
product
Application Rate/ No. of
applications
Up to 2% based on weight
of finished product
1-4% based on weight of
product
.1% - 1% a.i. based on
weight of finished product
4%-1.5% based on weight
of goods
0.05% - 3% based on
weight of goods; inclusive
of synthetic fibers, molded
plastics and synthetic
foams
Use Limitations
of bacteria, mold, mildew and fungi in or on
the treated product.
Not for use on food grade adhesives
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product; Not for use on food grade
adhesives
Page 58 of 98
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Vinyl Film: Garment
Bags, Blanket Bags,
Cubicle Curtains
42182-1
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Polyethylene,
Polypropylene, Vinyl,
Nylon, Latex and products
of similar matrix
5383-127
Incorporated
into
production of
end use
product
0.5%-1.0% by weight of
the fabric
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Polypropylene, Nylon and
Acrylic Fibers and blends
of these fibers with cotton
5383-127
Incorporated
into
production of
end use
product
Incorporated at a percent
ranging from 0.1% to 1.5%
by weight of the fabric
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Industrial Materials: air
filters, air filtration media,
janitorial supplies, trays,
wipes, respirator mask
components, conveyor
belts
42182-1
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Ice Making Equipment
42182-1
Incorporated
into
.1% - 1% a.i. based on
weight of finished product
Distributors of products containing the
additive may not make claims of
Page 59 of 98
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
production of
end use
product
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Sporting Goods:
boating/marine equipment,
exercise & gym
equipment, playground
equipment
42182-1
Incorporated
into
production of
end use
product
.1% - 1% a.i. based on
weight of finished product
Distributors of products containing the
additive may not make claims of
antimicrobial activity other than the
protection of the product against the growth
of bacteria, mold, mildew and fungi in or on
the treated product.
Technical Registration
70404-2
73951-1
For
processing or
manufacturing
use only
N/A
Page 60 of 98
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Appendix B: Triclosan (Case 2340)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Triclosan. These
requirements apply to Triclosan 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
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
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.
Page 61 of 98
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DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
42027901
45358501
42027901
45358502
45487201
42027901
42027902
43277802
45358503
45358504
42027902
45358504
42027901
43277802
43533901
45358503
45358505
42027902
45358506
42027902
45358502
42027902
42027902
42027904
N/A
42027904
Page 62 of 98
-------
DATA REQUIREMENT
New Guideline
Number
830.7840
830.7860
830.7950
830.7550
830.7560
830.7570
830.7000
830.6313
Old Guideline
Number
63-8
63-9
63-11
63-12
63-13
Study Title
Solubility
Vapor Pressure
Partition Coefficient (Octanol/Water)
PH
Stability
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
42027904
47261401
47261403
47261404
47261406
47261407
42027904
47261403
47261404
47261406
47261407
42027902
42027904
N/A
42027902
43022601
43277801
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
71-1
71-2
72-1
Avian Acute Oral Toxicity Test, Bobwhite Quail
Avian Acute Oral Toxicity Test, Bobwhite Quail
Avian Acute Oral Toxicity Test, Mallard Duck
Avian Dietary Toxicity Test, Bobwhite Quail
Fish Acute Toxicity - Freshwater, Rainbow Trout
Fish Acute Toxicity - Freshwater, Bluegill Sunfish
3,4,7
3,4,7
3,4,7
41008910
43022602
43022603
41008911
43022604
41008912
43969301
41008913
Page 63 of 98
-------
DATA REQUIREMENT
New Guideline
Number
850.1075
850.1010
850.1025
850.1035
Old Guideline
Number
72-1
72-2
72-3
72-3
Study Title
Estuarine/Marine - Fish Acute Toxicity
Aquatic Invertebrate Acute Toxicity, Daphnia
Oyster acute toxicity test (shell deposition)
Mysid acute toxicity test
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Page 64 of 98
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DATA REQUIREMENT
New Guideline
Number
850.1300
850.1400
850.1500
850.1710
850.1710
850.1730
Old Guideline
Number
72-4
72-4
72-5
72-6
72-6
72-6
Study Title
Daphnia Chronic Toxicity Test
Fish early -life stage toxicity test
Fish life cycle toxicity
Oyster bioconcentration study
Oyster bioconcentration study - BCF (major
degradate/metabolite of triclosan - e.g., methyl triclosan)
Fish bioconcentration study
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Data Gap
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Data Gap
Page 65 of 98
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DATA REQUIREMENT
New Guideline
Number
850.1730
850.1790
850.1790
850.1850
850.1850
850.1735
Old Guideline
Number
72-6
72-6
72-6
none
none
none
Study Title
Fish bioconcentration study - BCF (major degradate/metabolite
of triclosan - e.g., methyl triclosan)
Chironomid sediment toxicity test
Chironomid sediment toxicity test (major degradate/metabolite
of triclosan - e.g., methyl triclosan)
Aquatic food chain transfer
Aquatic food chain transfer (major degradate/metabolite of
triclosan - e.g., methyl triclosan)
Whole sediment acute toxicity invertebrates, freshwater
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Data Gap
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Data Gap
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Page 66 of 98
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DATA REQUIREMENT
New Guideline
Number
850.1740
850.4225
850.4250
850.5400
Old Guideline
Number
none
123-1
123-1
123-2
Study Title
Whole sediment acute toxicity invertebrates, marine
Seedling Emergence, Tier II
Vegetative Vigor, Tier II
Acute algal dose-response toxicity - marine diatom
Acute algal dose-response toxicity - freshwater diatom
Acute algal dose-response toxicity - bluegreen cyanobacteria
Acute algal dose-response toxicity - duckweed
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items) )
44422801
Page 67 of 98
-------
DATA REQUIREMENT
New Guideline
Number
850.5400
No current
guideline number
Special Study for
Surface Water
Monitoring
Old Guideline
Number
123-2
Study Title
Algal toxicity, Tiers 1 and II
Chronic sediment toxicity to freshwater and/or estuarine
invertebrates (TGAI)
Environmental modeling and monitoring specific to plastic and
textile facilities where triclosan is incorporated into these items
Use Pattern
3,4,7
3,4,7
CITATION(S)
MRID Number
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Study being held in reserve pending
outcome of surface water monitoring
(Special Study, Environmental
Modeling and Monitoring Specific to
Plastic and Textile Facilities where
Triclosan is Incorporated into these
Items)
Data Gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
81-1
81-2
81-3
81-4
81-5
81-6
82-la
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90- Day Oral Sub-chronic - Rodent
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
43206901
94044
100178
43206902
43310501
94045
42306903
43206502
133545
43022605
43389707
Page 68 of 98
-------
DATA REQUIREMENT
New Guideline
Number
870.3150
870.3250
870.3465
870.3700
870.3800
870.4100a
870.4 lOOb
870.4200
870.4300
870.5100
870.5300
870.5375
870.5385
870.5500
870.7485
870.7600
Old Guideline
Number
82-1
82-3
82-4
83-3
83-4
83-la
83-lb
83-2
83-5
84-2
84-2
84-2
84-2
84-2
85-1
85-3
Study Title
90- Day Oral Sub-chronic Non-rodent
90-Day Dermal Toxicity - Rat
28/90-Day Inhalation - Rat
Developmental Toxicity -Rat
Developmental Toxicity - Mouse
Developmental Toxicity - Non-rodent
2 Gen. Reproduction and Fertility Effects
Chronic Toxicity - Hamster
Chronic Toxicity - Baboon
Carcinogenicity - Mouse
Chronic/Oncogenicity - Rat
Bacterial Reverse Mutation Test
In vitro Mammalian Cell Gene Mutation Test
In vitro Mammalian Chromosome Aberration Test
Micronucleus Assay
Bacterial DNA Damage or Repair Test
Metabolism and Pharmacokenetics
Dermal Penetration
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
96102
43328001
0087996
43817502
43817503
43817501
43022607
43820401
43787101
40623701
44751101
133230
FDA Review
161332,42047906
44389705
44389704
47276601
43740802
47276602
45307501, 45307502, 45307503
34335
ENVIRONMENTAL FATE
835.2110
161-1
Hydrolysis
3,4,7
42027908
Page 69 of 98
-------
DATA REQUIREMENT
New Guideline
Number
835-2240
835.4100
835.4400
835.4300
Old Guideline
Number
161-2
162-1
162-3
162-4
Study Title
Photodegradation in Water
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Use Pattern
3,4,7
3,4,7
3,4,7
3,4,7
CITATION(S)
MRID Number
43022608
47261401
Data gap
47261402
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
875.1700
875.2700
875.2800
875.1200
875.1400
875.2300
875.1600
875.2900
133-1
233
234
236
134
Product Use Information (applicator)
Product Use Information (post-applicator)
Description of Human Activity
Dermal Indoor Exposure
Inhalation Indoor Exposure
Indoor Surface Residue Dissipation (infant assessment for
mouthing toys)
Applicator Exposure Monitoring Data Reporting
Data Reporting and Calculations
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
3,4,7
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
Page 70 of 98
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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.
The triclosan docket (EPA-HQ-OPP-2007-0513) initially contained the April 17,
2008 preliminary risk assessment and the related supporting science documents. EPA
then considered comments on the risk assessment and revised the risk assessment and
supporting chapters as necessary. The revised risk assessment, supporting science
chapters and Response to Comments document will be posted in the docket at the same
time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov
These documents include:
• Triclosan Preliminary Risk Assessment; Notice of Availability and Risk
Reduction Options, 05/07/2008.
Preliminary Risk Assessment and Supporting Science Documents:
• 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Risk Assessment for the
Reregi strati on Eligibility Decision (RED) Document. Case No 2340. PC Code:
054901, Antimicrobials Division, April 17, 2008.
• Preliminary Ecological Hazard and Environmental Risk Assessment Science
Chapter for the Triclosan Reregi strati on Eligibility Decision (RED) Document.
Case No 2340. PC Code: 054901, February 22, 2008, Genevieve Angle,
Biologist.
• Environmental Fate Science Chapter for the Triclosan Reregi strati on Eligibility
Decision (RED) Document. Case No 2340. PC Code: 054901, February 06,
2008, Srinivas Gowda, Microbiologist/Chemist.
• Product Chemistry Chapter for the Triclosan Reregi strati on Eligibility Decision
(RED) Document. Case No 2340. PC Code: 054901, October 17, 2007, Srinivas
Gowda, Microbiologist/Chemist.
• Dietary Risk Assessment for Triclosan for the RED Process. Case No 2340. PC
Code: 054901, April 5, 2007, A. Najm Shamim, PhD., Chemist
• Triclosan, Occupational and Residential Exposure Assessment. Case No 2340.
PC Code: 054901, Antimicrobials Division, April 17, 2008.
• Revised 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Toxicology
Chapter for the Reregi strati on Eligibility Decision (RED) Document. Case No
Page 71 of 98
-------
2340. PC Code: 054901, May 14, 2008, Tim McMahon, Ph.D., Senior
Toxicologist
Triclosan: Report of the Cancer Assessment Review Committee, Jessica Kidwell,
January 4, 2008
Revised Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
• Reregi strati on Eligibility Decision (RED) Document for Triclosan. Case No 2340.
PC Code: 054901, Antimicrobials Division, September 18, 2008.
• 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Risk Assessment for the
Reregi strati on Eligibility Decision (RED) Document. Case No 2340. PC Code:
054901, September 15, 2008, Tim McMahon, Ph.D., Senior Toxicologist.
• 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Toxicology Chapter for the
Reregi strati on Eligibility Decision (RED) Document. Case No 2340. PC Code:
054901, August 29, 2008, Tim McMahon, Ph.D., Senior Toxicologist.
• Triclosan, Occupational and Residential Exposure Assessment. Case No 2340.
PC Code: 054901, Antimicrobials Division, September 8, 2008.
• Revised Environmental Fate Science Chapter for the Triclosan Reregi strati on
Eligibility Decision (RED) Document. Case No 2340. PC Code: 054901,
September 11, 2008, Srinivas Gowda, Microbiologist/Chemist.
• Revised Ecological Hazard and Environmental Risk Assessment Science Chapter
for the Triclosan Reregi strati on Eligibility Decision (RED) Document. Case No
2340. PC Code: 054901, September 11, 2008, Richard C. Petrie, Agronomist,
Team 3 Leader.
• TRICLOSAN: Revised Report of the Hazard Identification Assessment Review
Committee and Antimicrobial Division Toxicity Endpoint Committee. August 29,
2008, Tim McMahon, Ph.D., Senior Toxicologist.
• Product Chemistry Chapter for the Triclosan Reregi strati on Eligibility Decision
(RED) Document. Case No 2340. PC Code: 054901, October 17, 2007, Srinivas
Gowda, Microbiologist/Chemist.
• Dietary Risk Assessment for Triclosan for the RED Process. Case No 2340. PC
Code: 054901, August 11, 2008, A. Najm Shamim, PhD., Chemist
• Estimates of Exposures and Risks to Aquatic Organism from Releases of
Triclosan to Surface Water as a Result of Uses under the EPA's Jurisdiction. Risk
Assessment and Science Support Branch (RASSB), Patricia Jennings, September
4, 2008
Page 72 of 98
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the triclosan Reregistration Eligibility Document. Primary sources for
studies in this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions. Selections from other
sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each
entry consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency
has chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
Page 73 of 98
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b. Document date. The date of the study is taken directly from the
document. When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers
to create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition number, or
other administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within the
volume.
Page 74 of 98
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1. MRID Studies
MRID# Citation
34335 Stierlin, H. (1968) "Percutaneous Absorption of GP 41 353 in the Rat and
the Rabbit." (Unpublished study; prepared by J.R. Geigy, AG, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000506-M).
43429 Stenger, E.G.; Scharer, (1963) "Local Effects on Rabbit's Eye."
(Unpublished study; prepared by J.R. Geigy, AG, Switzerland, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:108210-J).
94044 Ullmann, L. (1980) Report on Acute Dermal LD50 in the Rabbit of FAT
80023/A: Project No. 800761. (Unpublished study received Jan 28, 1982
under 100-502; prepared by Ciba-Geigy Ltd., Switzer- land, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 246688-A)
94045 Ullmann, L. (1980) Report on Eye Irritation in the Rabbit after Single
Application of FAT 80023/A: Project No. 801012. (Unpublished study
received Jan 28, 1982 under 100-502; prepared by Ciba-Geigy Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:246688-B)
96102 Burther, B.R.; Gordon, D.E. (1973) "Report to Ciba-Geigy Corporation:
90-day Subacute Oral Toxicity Study with Irgasan DP-300 in Beagle
Dogs: IBT No. C1435." (Unpublished study; prepared by Industrial Bio-
Test Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.:
CDL:008400-C)
100178 Schoenig, G. (1967) "Report to Geigy Chemical Company: Acute
Dermal Toxicity Study on CH 3565: IBT No. A5460." (Unpublished
study; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000503-D).
130187 Schoenig, G. (1967) "Report to Geigy Chemical Company: Acute
Dermal Toxicity Study on CH 3565: IBT No. A5460." (Unpublished
study; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000503-D)
133545 Goldsmith, L. (1983) 90-Day Oral Toxicity Study in Rats with Fat
80'023/H: LBI Project No. 22188. Final Report. (Unpublished study
received Dec. 23, 1983 under 100-502; submitted by Ciba-Geigy Corp.)
Page 75 of 98
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149464
40623701
41008910
4100891 1
41008912
41008913
41008914
42027901
42027902
42027904
42027906
42027908
Stierlin, H. (1972) Study of Pharmacokinetics and Metabolism in Mouse,
Rat, Rabbit and Dog: GP 41 353: Report No. 33/1972. Un- published
study prepared by Ciba-Geigy Ltd. 31 p.
Morseth, S.L. (1988) "Two-Generation Reproduction Study in Rats with
FAT 80'02390" Hazleton Laboratories America, Inc.
Terrell, Y. 1985. Acute Oral Toxicity Study of Issue Plus II; ID No. 88-
472; Prepared by American Standards Biosciences Corp. for Diversey
Wyandotte Corporation, Wyandotte, Michigan.
Terrell, Y. 1988. Avian Dietary Quaily (Litmus Test) of Issue Plus in
Bobwhite Quail; Project No. 88-471; Prepared by American Standard
Biosciences Corp. for Diversey Wyandotte Corporation, Wyandotte,
Michigan.
Terrell, Y. 1988. The Acute Toxicity Bioassay of Issue Plus on Rainbow
Trout; Project No. 88-474; Prepared by American Standard Biosciences
Corp. for Diversey Wyandotte Corporation, Wyandotte, Michigan.
Terrell, Y. 1988. The Acute Toxicity Bioassay of Issue Plus on Bluegill
Sunfish; Project No. 88-473; Prepared by American Standard Biosciences
Corp. for Diversey Wyandotte Corporation, Wyandotte, Michigan.
Terrell, Y. 1988. Acute Toxicity of Issue Plus onDaphnia magna;
Project No. 88-475; Prepared by American Standard Biosciences Corp. for
Diversey Wyandotte Corporation, Wyandotte, Michigan.
LoMenzo, J. (1991) Irgasan DP 300: Product Identity and Composition.
Unpublished study prepared by Ciba-Geigy Corp.
Basingthwaite, J. (1983) Irgasan DP 300: Batch Analysis and Analytical
Methodology. Unpublished study prepared by Ciba-Geigy Ag.
Vogel, A. (1990) Irgasan 300 DP: Report on Melting Point/Melting
Range. Unpublished study prepared by Ciba-Geigy Ltd.
Study 1 - Yau, E.T. and Green, J.D. (1986) Fat 80' 023 2 Year Oral
Administration to Rats; Study 2 - Parkes, D.G. (1986) Determination of
Fat 80' 023 in Blood and Tissue Samples Taken During a Two- Year
Chronic Oral Toxicity /Oncogenicity Study in Albino Rats (24-month Final
Report). Ciba-Geigy Corporation.
Pointurier, R. 1990. Irgasan® DP 300 - Report on Hydrolysis as a
Function of pH. Unpublished study performed and submitted by Ciba-
Geigy Ltd., Basel, Switzerland.
Page 76 of 98
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42306902 Duchosal F. and Ph. Thevenaz (1990) "4-Hour Acute Inhalation Toxicity
Study with FAT 80'023/Q in Rats" Ciba-Geigy Ltd.
42306903 Sachsse, K.; Ullman, L. (1975) Skin Irritation in the Rabbits after Single
Application of FAT 80'023/A. Unpublished Study Conducted by Ciba
Geigy Ltd., Basel Switzerland. Project No. Siss 4719. Submitted to EPA
by Chemical Division of Ciba Geigy Corp. (9/11/75).
42322101 Boettcher, J. 1990. Report on the Acute Toxicity (96h) of FAT 80, 023/Q
to Zebrafish. Test No. G 069 04. Prepared by Ciba-Geigy, Ltd., D&C
Product Ecotoxicology, Basel, Switzerland. Submitted by Ciba-Giegy
Corporation, Greensboro, North Carolina.
42322102 Wuethrich, V. 1990. 48-Hour Acute Toxicity of FAT 80, 023/Q to
Daphnia magna (OECD-Immobilization Test). Project No. 262923.
Prepared by RCC Umweltchemie AG, Itingen, Switzerland. Submitted by
Ciba-Giegy Corporation, Greensboro, North Carolina.
43022601 Morrissey, M. (1993) Stability Determination of Irgasan DP 300 in the
Presence of Metal: Final Report: Lab Project Number: HWI 6117-246.
Unpublished study prepared by Hazleton Wisconsin, Inc.
43022602 Pedersen, C.A. andB.R. Helsten. 1993. Triclosan (IRGASAN DP300®):
14-Day Acute Oral LD50 Study in Bobwhite Quail. Study performed by
Bio-Life Associates, Ltd., Neillsville, Wisconsin. Laboratory Project No.
102-024-03. Submitted by CIBA-GEIGY Corporation, Greensboro, North
Carolina.
43022603 Pedersen, C.A. andB.R. Helsten. 1993. Triclosan (IRGASANDP300®):
14-Day Acute Oral LD50 Study in Mallard Ducks. Study performed by
Bio-Life Associates, Ltd., Neillsville, Wisconsin. Laboratory Project No.
102-023-04. Submitted by CIBA-GEIGY Corporation, Greensboro, North
Carolina.
43022604 Pedersen, C.A. andB.R. Helsten. 1993. Triclosan (IRGASANDP300®):
8-Day Acute Dietary LCso Study in Bobwhite Quail. Study performed by
Bio-Life Associates, Ltd., Neillsville, Wisconsin. Laboratory Project No.
102-022-01. Submitted by CIBA-GEIGY Corporation, Greensboro, North
Carolina.
43022605 Trutter, Janet A. (1993) "13-Week Subchronic Oral Toxicity Study of
Triclosan in CD-I® Mice." Hazleton Washington, Inc.
43022607 Schroeder, R.E. et al. (1992) "A Segment II Teratology Study in Rabbits
with Irgacare MP" Bio/dynamics Inc.
Page 77 of 98
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43022608 Spare, W. 1993. Aqueous Photolysis of Triclosan. Agrisearch Project
No.: 12208. Unpublished study performed by Agrisearch Inc., Frederick,
MD; and submitted by Ciba-Geigy Corporation, Greensboro, NC.
43046001 Bowman, J.H. 1990. Acute Toxicity of D1063.01 (Triclosan: Irgasan
DP300) to Fathead Minnow (Pimephalespromelas). Laboratory Project
ID No. 38655. Prepared by Analytical Bio-Chemistry Laboratories, Inc,
Columbia, Missouri. Submitted jointly by Proctor and Gamble Company
and Ciba-Geigy Corp.
43046002 Forbis, A.D. and J.G. Muckerman. 1990. Acute Toxicity of D1063.01
(Triclosan: Irgasan DP300) to Daphnia magna. Laboratory Project ID No.
38656. Prepared by Analytical Bio-Chemistry Laboratories, Inc,
Columbia, Missouri. Submitted jointly by Proctor and Gamble Company
and Ciba-Geigy Corp.
43206501 Wnorowski, Gary. (1994) "Acute Toxicity Limit Test for Triclosan
Irgasan® DP 300) Product Safety Labs.
43206502 Wnorowski, G. (1994) Dermal Sensitization Test-Buehler Method for
Triclosan (Irgasan® DP 300) Lot No. 5.2.0211.0. Product Safety Labs;
Study No. 2635. Submitted to EPA by Ciba-Geigy Corp. Unpublished.
43277801 Morrissey, M. (1994) Stability Determination of Irgasan DP300 Exposed
to Metal Ions: Final Report: Lab Project Number: HWI 6117-261.
Unpublished study prepared by Hazleton Wisconsin, Inc.
43277802 Schatowitz, B. (1990) Additional Data Required by the US EPA for the
Results of the Analysis of Irgasan DP300 for Dioxins/Furans: Lab Project
Number: 102290. Unpublished study prepared by Ciba-Geigy Ltd.
43310501 Duchosal F. and Ph. Thevenaz (1990) "4-Hour Acute Inhalation Toxicity
Study with FAT 80'023/Q in Rats" Ciba-Geigy Ltd.
43328001 Trimmer, Gary W. (1994) "90-Day Subchronic Dermal Toxicity Study in
the Rat with Satellite Group with Irgasan DP300 (MRD-92-399)" Exxon
Biomedical Sciences, Inc.
43533301 Jones, E., Wilson, L.A. (1988) "Ames Metabolic Activation Test to
Address the Potential Mutagenic Effect of Triclosan (Irgasan DP 300)"
Huntingdon Research Center, Ltd. Cambridgeshire, England.
43533901 Schatowitz, B. (1995) Additional Data Required by the U.S. EPA for the
Product Analysis of Irgasan DP 300: Lab Project Number: 11995.
Unpublished study prepared by Ciba Research Services.
Page 78 of 98
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43740701 Wuethrich, V. 1990. Influence of FAT 80023/Q (Irgasan DPS 00) on
Reproduction ofDaphnia magna. Project No. 262934. Prepared by RCC
Umweltchemie AG, Itingen, Switzerland. Submitted by Ciba-Giegy AG,
Basel, Switzerland.
43740801 Heidemann, A. (1990) "Chromosome Aberration Assay in Chinese
Hamster V79 Cells In Vitro with FAT 80'023/Q (Irgasan® DP 300);
Cytotest Cell Research GMBH & Co. KG, Federal Republic of Germany;
Study No. 179100. Unpublished.
43740802 Volkner, W. (1991) "Chromosome Aberration Assay in Bone Marrow
Cells of the Rat with FAT 80'023/Q (Irgasan® DP300); Cytotest Cell
Research GMBH & Co. KG, Federal Republic of Germany; Study No.
218305. Unpublished.
43817502 Denning, H.J., Sliwa, S., and Willson, GA. (1992) "Triclosan: Effects on
Pregnancy and Post-Natal Development in Rats: Volume 1, Volume 2 and
Appendices 1-17" Unilever Research, Colworth/Welwyn Lab.
43817503 Denning, H.J., Sliwa, S., and Willson, GA. (1992) "Triclosan: Effects on
Pregnancy and Post-Natal Development in Rats: Volume 1, Volume 2 and
Appendices 1-17" Unilever Research, Colworth/Welwyn Lab.
43820401 Schroeder, R.E. et al. (1992) "A Segment II Teratology Study in Rabbits
with Irgacare MP" Bio/dynamics Inc.
43969301 Sword, M.C. 1996. Static Acute Toxicity of Triclosan to Rainbow Trout.
Study performed by ABC Laboratories, Inc., Columbia, Missouri.
Laboratory Report No. 42997. Sponsored by CIBA Chemical Division,
Greensboro, North Carolina.
44389701 Eldrige, S. (1993) Cell Proliferation in Rodent Liver: (Triclosan): Final
Report: Lab Project Number: 142. Unpublished study prepared by
Pathology Associates, Inc. 14 p.
44389702 Molitor, E., Persohn, E., Thomas, H. "The Effect of FAT 80'023/Q
(Irgasan DP 300) on Selected Biochemical Liver Parameters Following
Subchronic Dietary Administration to Male and Female Mice. Ciba-
Geigy Limited, Switzerland, Report CB 91/18, May 22, 1992.
44389703 Molitor, E.; Persohn, E. (1993) The Effects of FAT 80'023/Q (Irgasan DP
300) on Selected Biochemical and Morphological Liver Parameters
Following Dietary Administration to Male Rats: Lab Project Number: CB
92/28. Unpublished study prepared by Ciba-Geigy Ltd. 70p.
Page 79 of 98
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44389704
44389705
44389706
44389707
44389708
44389710
44422801
44751101
44874001
45307501
Henderson, L.M., et al. (1988) An Assessment of the Mutagenic Potential
of Triclosan Using the Mouse Lymphoma TK Locus Assay. Huntingdon
Research Center Ltd., Huntingdon, Cambridgeshire, PE18 6ES, England.
Study No. ULR 216/88644. Unpublished.
Stankowski, L.F., Jr. et al. (1993) Amended Final Report,
Ames/Salmonella Plate Incorporation Assay on Test Article 39316 (CC
#14663-09). Pharmakon USA, P.O. Box 609, Waverly, PA. Laboratory
Study Report No. PH 301-CP-001-93. Unpublished.
Thomas, Rer. Nat. H. (1994) The Effect of FAT 80'023/Q and the Model
Inducers Phenobarbitone, 3-Methylcholanthrene, Pregnenolone 16 co -
carbonitrile and Nafenopin on Selected Biochemical and Morphological
Liver Parameters in the Syrian Hamster. Study conducted by Ciba-Geigy
Limited. Study number CB 93/40. Unpublished.
Thevenaz, Dr. Phil. (1987) Final Report: FAT 80023: 28-Day Toxicity
Study in Mice (Administration in Feed) with Special Reference to
Histopathology. Ciba-Geigy Ltd., Basle, Switzerland. Unpublished.
Burns, J.M. (1997) 14-Day Repeated Dose Dermal Study of Triclosan in
CD-I Mice. Corning Hazleton Incorporated (CHV), 9200 Leesburg Pike,
Vienna, Virginia. Laboratory Study No. CHV 2763-100. April 29, 1997.
Unpublished.
Burns, J.M. (1997) 14-Day Repeated Dose Dermal Study of Triclosan in
Rats. Corning Hazleton Incorporated (CHV), 9200 Leesburg Pike,
Vienna, Virginia. Laboratory Study No. CHV 6718-102. Unpublished.
Staveley, J.P. and T.L. Williams. 1997. Effects of Triclosan on the
Growth and Reproduction of Aquatic Plants. Study performed by
Carolina Ecotox, Inc., Durham, North Carolina. Laboratory Report ID:
21-02-1. Sponsored by Ciba-Geigy Corporation, Greensboro, North
Carolina.
Chambers, P.R. (1999) "Potential Tumorigenic and Chronic Toxicity
Effects in Prolonged Dietary Administration to Hamsters." Huntingdon
Life Sciences Ltd., Huntingdon, England. CBG 756/972896.
Chambers, P.R. (1999) "Potential Tumorigenic and Chronic Toxicity
Effects in Prolonged Dietary Administration to Hamsters." Huntingdon
Life Sciences Ltd., Huntingdon, England. CBG 756/972896.
Van Dijk, Dr. A. (1994) "14C- Triclosan: Absorption, Distribution,
Metabolism, and Elimination after Single/Repeated Oral and Intravenous
Page 80 of 98
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45307502
45307503
47261401
47261402
47261403
47261404
47261406
47261407
47276601
47276602
Administration to Hamsters." RCC Umweltchemie AG. RCC
Project No. 351707.
Van Dijk, Dr. A. (1994) "14C- Triclosan: Absorption, Distribution,
Metabolism, and Elimination after Single/Repeated Oral and Intravenous
Administration to Hamsters." RCC Umweltchemie AG. RCC Project No.
351707.
Van Dijk, Dr. A. (1995) "14C- Triclosan: Absorption, Distribution,
Metabolism, and Elimination after Single/Repeated Oral and Intravenous
Administration to Mice." RCC Umweltchemie AG. RCC Project No.
337781.
Adam, D. (2007) (Carbon 14)-Triclosan: Degradation and Metabolism in
Three Soils Incubated Under Aerobic Conditions. Project Number:
B1283 5. Unpublished study prepared by RCC Umweltchemie Ag.
Adam, D. (2006) (Carbon 14)-Triclosan: Route and Rate of Degradation
in Aerobic Aquatic Sediment Systems. Project Number: A33300.
Unpublished study prepared by RCC Umweltchemie Ag.
Volkel, W. (2007) The Effects of Triclosan on Soil Nitrification. Project
Number: A89954. Unpublished study prepared by RCC Umweltchemie
Ag.
Volkel, W. (2006) The Effects of Triclosan on Soil Respiration. Project
Number: A88312. Unpublished study prepared by RCC Umweltchemie
Ag.
Christensen, K. (1994) Triclosan - Determination of Anaerobic Aquatic
Biodegradation. Project Number: 93/12/5076. Unpublished study prepared
by Springborn Laboratories Inc.
Christensen, K. (1994) Triclosan - Aerobic Biodegradation in Water.
Project Number: 93/4/4731. Unpublished study prepared by Springborn
Laboratories Inc.
Broker, P.C., Gray, V.M., Howell, A. (1988) "Analysis of Metaphase
Chromosomes Obtained from CHO Cells Cultured in vitro and Treated
with Triclosan." Huntingdon Research Center, Ltd. ULR 214/88731;
Unilever Test #: KC880171. Unpublished.
San Sebastian, J.R., Morgan, J.M. (1993) "Rat Hepatocyte Primary
Culture/DNA Repair Test on 39317" Pharmakon Research International,
Inc. Pharmakon Study #: PH311-CP-001-93. Unpublished.
Page 81 of 98
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2. MRID Studies
Accession # Citation
251773 Drake, J.C. & Buxtorf, A. (1976) 1 Year Oral Toxicity Study in Baboons
with Compound FAT 80 023/A. Geigy Pharmaceuticals, Toxicology
Department, MRID #133230.
3. Open Literature
Citation
Agiiera, A., Fernandez-Alb a, A.R., Luis, P., et al. 2003. Evaluation Of Triclosan And
Biphenylol In Marine Sediments And Urban Wastewaters By Pressurized Liquid
Extraction And Solid Phase Extraction Followed By Gas Chromatography
Mass Spectrometry And Liquid Chromatography Mass Spectrometry. Analytica
Chimica Acta 480: 193-205.
Allmyr, M.; McLachlan, MS; Sandborgh-Englund, G.; and Adolfsson-Erici, M. 2006.
Determination of Triclosan as Its Pentafluorobenzoyl Ester in Human Plasma and
Milk Using Electron Capture Negative lonization Mass Spectrometry. Anal.
Chem. 2006, 78, 6542-6546.
Anderson, P.D., D'Aco, V.J., Shanahan, P., et al. 2004. Screening Analysis of Human
Pharmaceutical Compounds in U.S. Surface Waters. Environmental Science and
Technology. 38(3): 838-49.
Bendz, D., Paxeus, N.A., Ginn, .R., et al. 2005. Occurrence and Fate Of
Pharmaceutically Active Compounds In The Environment, A Case Study: Hoje
River In Sweden. Journal of Hazardous Materials. 122: 195-204.
Bester, K. 2003. Triclosan In A Sewage Treatment Process—Balances And Monitoring
Data. Water Research. 37 (16): 3891-6.
Bester, K. 2005. Fate of Triclosan and Triclosan-Methyl in Sewage Treatment Plants and
Surface Waters. Archives of Environmental Contamination and Toxicology. 49
(1): 9-17.
Boyd, G.R., Palmeri, J.M., Zhang, S., et al. 2004. Pharmaceuticals And Personal Care
Products (PPCPs) And Endocrine Disrupting Chemicals (EDCs) In Stormwater
Canals And Bayou St. John In New Orleans, Louisiana, USA. Science of the
Total Environment. 333 : 137-48.
Boyd, G.R., Reemtsma, H., Grimm, D.A., et al. 2003. Pharmaceuticals And Personal
Care Products (PPCPs) In Surface And Treated Waters Of Louisiana, USA And
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Ontario, Canada. Science of the Total Environment (Netherlands). 311 (1-3): 135-
49.
Broker, P.C., Gray, V.M., Howell, A. (1988) "Analysis of Metaphase Chromosomes
Obtained from CHO Cells Cultured in vitro and Treated with Triclosan."
Huntingdon Research Center, Ltd. ULR 214/88731; Unilever Test #: KC880171.
Unpublished.
Cauosa (2007). Determination of Parabens and Triclosan in Indoor Dust Using Matrix
Solid-Phase Dispersion and Gas Chromatography with Tandem Mass
Spectrometry. Anal. Chem. 2007, 79, 1675-1681.
Calafat AM, Ye X, Wong LY, Reidy JA, and Needham LL. 2007. Urinary
Concentrations of Triclosan in the U.S. Population: 2003-2004. Environmental
Health Perspectives. Dated December 7, 2007. Available online at
http://dx.doi.org/
Cohen J. 2008. Computations of Human Triclosan Dose Based On NHANES Urine
Concentrations. Memorandum from Dr. Jonathan Cohen, ICF International to
Tim Leighton, David Miller, Philip Villaneuva, USEPA, dated March 6, 2008.
Contract EP-W-06-091, WA 0-02, TAP CM 19.
Crofton, KM; Paul, KB; DeVito, PB; Hedgea, JH. 2007. Short-term in vivo exposure to
the water contaminant triclosan: Evidence for disruption of thyroxine.
Environmental Toxicology and Pharmacology 24: 194-197.
Dayan AD. 2007. Risk assessment of triclosan [Irgasan] in human breast milk. Food
and Chemical Toxicology 45 (2007) 125-129.
Eldrige, S. (1995) Cell Proliferation in Rodent Liver. Study conducted by Pathology
Associates, Inc. Submitted to EPA (no). Unpublished.
Federle, T.W. andE.L. Schwab. 2003. Triclosan Biodegradation in Wastewater
Treatment Plant Effluent Diluted in Various River Wastes. Abstr. Gen. Meet Am
Soc. Microbiol 103. p. 0-017.
Federle, T.W., Kaiser, S.K., and Nuck, B.A. 2002. Fate and Effects of Triclosan in
Activated Sludge. Environmental Toxicology and Chemistry/SETAC. 21(7):
1330-7.
Flaherty, C.M. and S.I. Dodson. (2005). Effects of pharmaceuticals onDaphnia survival,
growth, reproduction, to be assigned. Chemosphere. 61: 200-207.
Freeman, N , Jimenez M, Reed KJ,Gurunathan S, Edwards RD, Roy A, Adgate JL,
Pellizzari ED, Quackenboss J, Sexton K, Lioy PJ, 2001. Quantitative analysis of
children's microactivity patterns: The Minnesota Children's Pesticide Exposure
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Study. Journal of Exposure Analysis and Environmental Epidemiology. 11(6):
501-509.
Gatidou, G., Thomaidis, N.S., Stasinakis, A.S., et al. 2007. Simultaneous Determination
Of the Endocrine Disrupting Compounds Nonylphenol, Nonylphenol
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Gas Chromatography-Mass Spectrometry. Journal of Chromatography A. 1138:
32-41.
Geigy. 1981. Geigy Scientific Tables, Volume 1. Units of measurement, body fluids,
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Gomez, M.J., Martinez Bueno, M.J., Lacorte, S., et al. 2007. Pilot Survey Monitoring
Pharmaceuticals And Related Compounds In A Sewage Treatment Plant Located
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Hanioka, N. et. al. (1996) effect of 2,4,4'-Trichloro-2'-hydroxyphenyl Ether on
Cytochrome P450 Enzymes in the Rat Liver, to be added. Chemosphere. 34: 719-
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Hovander, L. et. al. (2001). Identification of Hydroxylation PCB Metabolites and Other
Phenolic Halogenated Pollutants in Human Blood Plasma, to be added.
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Hua, W., Bennett, E.R., Letcher, R.J. 2005. Triclosan In Waste And Surface Waters From
the Upper Detroit River By Liquid Chromatography-Electrospray-Tandem
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Takao, Y.; and Arizono, K. 2004. Effects of triclosan on the early life stages and
reproduction of medaka Oryzias latipes and induction of hepatic vitellogenin.
Aquatic Toxicology 67:167-179.
Kanda, R., Griffin, P., and James, H.A., et al. 2003. Pharmaceutical and Personal Care
Products in Sewage Treatment Works. Journal of Environmental Monitoring.
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Klopin, D.W., Furlong, E.T., Meyer, M.T., et al. 2002. Pharmaceuticals, Hormones, and
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Other Organic Wastewater Contaminants in U.S. Streams, 1999-2000: A National
Reconnaissance. Environmental Science and Technology. 36(6): 1202-11.
Lee, H., and Peart, I.E. 2002. Organic Contaminants in Canadian Municipal Sewage
Sludge. Part I. Toxic or Endocrine-disrupting Phenolic Compounds. Water
Quality Research Journal of Canada. 37(4): 681-696.
Lee, H., Peart, I.E., and Svoboda, M.L. 2005. Determination of Endocrine-Disrupting
Phenols, Acidic Pharmaceuticals, and Personal-care Products in Sewage by Solid-
phase Extraction and Gas Chromatography-Mass Spectrometry. Journal of
Chromatography. 1094(1-2): 122-9.
Lee, H., Sarafm, K., and Peart, T.E., et al. 2003. Acidic Pharmaceuticals in Sewage:
Methodology, Stability Test, Occurrence, and Removal from Ontario Samples.
Water Quality Research Journal of Canada. 38(4): 667-682.
Lindstrom, A., Buerge, I.J., Poiger, T., et al. 2002. Occurrence and environmental
behavior of the bactericide triclosan and its methyl derivative in surface waters
and in wastewater. Environmental Science Technology. 36: 2322-2329.
Comment in Environmental Science Technolology. 36 (11): 228A-230A.
Loraine, G.A., Pettigrove, M.E. 2006. Seasonal Variations In Concentrations Of
Pharmaceuticals and Personal Care Products In Drinking Water And Reclaimed
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40(3): 687-95.
Mage D.T., Allen R., Gondy G., Smith W., Barr D.B., Needham L.L. 2004. Estimating
Pesticide Dose from Pesticide Exposure Data by Creatinine Correction in the
Third National Health and Nutrition Examination Survey (NHANES-III). J
Exposure Anal Environ Epidemiol 14:457-465.
Mage D.T., Allen, R.H., Kodali, A. 2007. Creatinine corrections for estimating children's
and adult's pesticide intake doses in equilibrium with urinary pesticide and
creatinine concentrations. J Exposure Sci Environ Epidemiol 1-9.
Matsumura, N.; Ishibashi, H.; Hirano, M.; Nagao, WatanabeN; Shiratsuchi, H; Kai, T;
Nishimura, T.; Kashiwagi, A., and Arizono, K. 2005. Effects of nonylphenol and
triclosan on production of plasma vitellogenin and testosterone in male South
African clawed frogs (Xenopus laevis).Biol. Pharm. Bull. 28: 1748-1751.
McAvoy, D.C., Schatowitz, B., Martin, J., etal. 2002. Measurement Of Triclosan In
Wastewater Treatment Systems. Environmental Toxicology and Chemistry. 21
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McAvoy, D.C., Schatowitz, B., Martin, J., et al. 2002. Measurement Of Triclosan In
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Mezcua, M., Gomez, M.J., Ferrer, I, et al. 2004. Evidence of 2,7/2,8-Dibenzodichloro-/>-
dioxin As A Photodegradation Product Of Triclosan In Water And Wastewater
Samples. Analytica Chimica Acta. 524 (1-2): 241-247.
Morales, S., Canosa, P., and Rodriguez, I, et al. 2005. Microwave Assisted Extraction
Followed by Gas Chromatography with Tandem Mass Spectrometry for the
Determination of Triclosan and Two Related Chlorophenols in Sludge and
Sediments. Journal of Chromatography. 1082: 128-35.
Nakada, N., Toshikatsu, T., and Hiroyuki, S., et al. 2006. Pharmaceutical Chemicals and
Endocrine Disrupters in Municipal Wastewater in Tokyo and their Removal
during Activated Sludge Treatment. Water Research. 40(17): 3297-303.
Palenske, N.M., Dzialowski, E.M (2005). Effects of the Environmental Contaminant
Triclosan on the Physiology of Developing Xenopus Laevis Tadpoles. Integrative
and Comparative Biology. 45(6): 1175. Published.
Paxeus, N., and Gryaab, K. 2004. Removal Of Selected Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs), Gemfibrozil, Carbamazepine, Beta-Blockers, Trimethoprim
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Sabaliunas, D., Webb, S.F., Hauk, A., et al. 2003. Environmental Fate Of Triclosan In
The River Aire Basin, UK. Water Research (England). 37: 3145-54.
Samsoe-Petersen L.,Winther-Nielsen M., Madsen T. Fate and Effects of Triclosan.
San Sebastian, J.R., Morgan, J.M. (1993) "Rat Hepatocyte Primary Culture/DNA
Repair Test on 39317" Pharmakon Research International, Inc. Pharmakon Study
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Sandborgh-Englund G, Adolfsson-Erici M, Odham G, and Ekstrand J. 2006.
Pharmacokinetics of Triclosan Following Oral Ingestion in Humans. Journal of
Toxicology and Environmental Health, Part A, 69:1861-1873, 2006.
Schafer, K.S,, Reeves, M., Spitzer, S., Kegley, S. E. 2004. Chemical Trespass: Pesticides
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Chemicals In Sewage Effluent By Gas Chromatography/Mass Spectrometry.
Biomedical Mass Spectrometry. 12 (2): 86-94.
Singer, H., Muller, S., Tixier, C., et al. 2002. Triclosan: Occurrence and Fate Of A
Widely Used Biocide In The Aquatic Environment: Field Measurements In
Wastewater Treatment Plants, Surface Waters, And Lake Sediments.
Environmental Science and Technology. 36(23): 4998-5004.
Tamura,H., Y. Ishimoto., T. Fujikawa et al. (2006). Use of Structural basis for androgen
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Related compounds with the androgen receptor based on an In vitro reporter gene
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14:7160-7174.
Thomas, P.M., and Foster, G.D. 2004. Determination of Nonsteroidal Anti-inflammatory
Drugs, Caffeine, and Triclosan in Wastewater by Gas Chromatography-Mass
Spectrometry. 2004. Journal of Environmental Science and Health. Part A,
Toxic/Hazardous Substances & Environmental Engineering. 39(8): 1969-78.
Thomas, P.M., and Foster, G.D. 2005. Tracking Acidic Pharmaceuticals, Caffeine, And
Triclosan Through The Wastewater Treatment Process. Environmental
Toxicology and Chemistry. 24 (1): 25-30.
Thompson, A., Griffin, P., and Stuetz, R., et al. 2005. The Fate and Removal of Triclosan
during Wastewater Treatment. Water Environment Research. 77(l):63-67.
Veldhoen, N; Skirrow, RC; Osachoff, H.; Wigmore, H; Clapson, DJ; Gunderson, MP;
Aggelen, GV; Helbing, CC. (2006). The bactericidal agent triclosan modulates
thyroid hormone-associated gene expression and disrupts postembryonic anuran
development. Aquatic Toxicology 80: 217-227.
Waltman, E.L., Venables, B.J., and Waller, W.T. 2006. Triclosan In A North Texas
Wastewater Treatment Plant And The Influent And Effluent Of An Experimental
Constructed Wetland. Environmental Toxicology and Chemistry. 25 (2): 367-72.
Wind, T., Werner, U., Jacob, M., et al. 2004. Environmental Concentrations Of Boron,
LAS, EDTA, NTA and Triclosan Simulated with GREAT-ER in the river Itter.
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Ying, G. and Kookana, R.S. 2007. Triclosan In Wastewaters And Biosolids From
Australian Wastewater Treatment Plants. Environmental International. 33 (2):
199-205.
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4. Website References
Citation
DOE. 1997. Energy Information Administration: Profile of Commercial Buildings in
1995. http://www.eia.doe.gov/emeu/cbecs/char95/profile.html
Estimation Programs Interface (EPI) Suite. Windows based suite of physical/chemical
properties and environmental estimation models developed by the US EPA's
Office of Prevention, Pesticides and Toxic substances (OPPTS) and Syracuse
Research Institute (SRC). Physical properties of Triclosan. EPI Suite Summary
(v3.12). http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm
FDA, 2003, A Guidance For Industry: Preparations of food Contact Notifications and
Food Additive Petitions for Food Contact Substances, Chemistry
Recommendations. Final Guidance, April 2003. http://www.cfsan.fda.gov
FDA, 2003. Sanitizing Solutions: Chemistry Guidance for Food Additive Petitions,
January 2003. http://www.cfsan.fda.gov
Hazard Substances Data Bank (HSDB). A Database of the National Library of
Medicine's TOXNET System. Triclosan: Environmental Fate and Exposure.
http://toxnet.nlm.nih.gov
Guidance on Cumulative Risk Assessment of Pesticide Chemicals that Have a Common
Mechanism of Toxicity, Office of Pesticide Programs, 2002.
http://www.epa.gov/pesticides/trac/science/cumulativeguidance.pdf
Public Health Action Plan to Combat Antimicrobial Resistance. Interagency Task Force
on Antimicrobial Resistance.
http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf
5. Other Supporting Documents
Citation
AD Memo by Tim McMahon to Jess Rowland, Executive Secretary for Agency's
HIARC Committee, 1998.
Calculations reported by Bob Quick in an AD Memo by Bob Quick to Bob Brennis,
1998.Capen, C. Toxic Responses of the Endocrine System. In: Casarett and
Doull's Toxicology: The Basic Science of Poisons, 5th ed., Curtis D. Klaassen,
Ph.D., editor. McGraw-Hill.
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Environment Project No. 861. Copenhagen: Danish Environmental Protection Agency;
2003.
Tox Record No. 001955, 001956 (1968).
Tox Record No. 001968 (1977).
USEPA. 1996. Office of Research and Development, Descriptive Statistics Tables from
a Detailed Analysis of the National Human Activity Pattern (NHAPS) Data;
EPA/600/R-96/148, July 1996. Data Collection Period October 1992 -
September 1994.
USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa. August 1997.
USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from
the Pesticide Handler Exposure Database Version 1.1. Washington, DC: U.S.
Environmental Protection Agency.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial
Exposure Assessment Study (Amended on 8 December 1992). Memorandum
from Siroos Mostaghimi, PH.D., USEPA to Julie Fairfax, USEPA. Dated
November, 4 1999. DP Barcode D247642.
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs, Human Health
Effects Division. Dated April 5, 2000.
USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November
12. Recommended Revisions to the Standard Operating Procedures (SOPs) for
Residential Exposure Assessment, February 22, 2001.
USEPA. 2002. CHILD-SPECIFIC EXPOSURE FACTORS HANDBOOK (INTERIM
REPORT). USEPAEPA-600-P-00-002B. 01 Sep 2002. U.S. Environmental
Protection Agency, Office of Research and Development, National Center for
Environmental Assessment, Washington Office, Washington, DC, 448.
USEPA. 2007. 5-Chloro-2-(2,4-dichlorophenoxy)phenol (triclosan): Toxicology
Chapter for the Reregi strati on Eligibility Decision (RED) document.
USEPA 2008. T. E. Stoker and W. Setzer. The Endocrine Disrupting Effects of
Triclosan, a common pharmaceutical and personal care product: Alteration of the
Thyroid Axis Following a Peri-juvenile Exposure in the Male Wistar Rat.
EPA/600/X-08/010.
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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
triclosan RED for a list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G. Batching of Triclosan Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available
Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat
reader)
Instructions
2.
3.
Print out and complete the forms. (Note: Form numbers that are bolded
can be filled out on your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
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
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
http://www.epa.sov/opprd001/forms/8570-
l.pdf
http://www.epa.sov/opprd001/forms/8570-
4.pdf
http://www.epa.sov/opprd001/forms/8570-
5.pdf
http://www.epa.sov/opprd001/forms/8570-
17.pdf
http://www.epa.sov/opprd001/forms/8570-
25.pdf
http://www.epa.sov/opprd001/forms/8570-
27.pdf
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8570-
28
8570-
30
8570-
32
8570-
34
8570-
35
8570-
36
8570-
37
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.sov/opprd001/forms/8570-
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
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
7pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices
/or98-l.odf
Pesticide Registration Kit
www.epa.sov/pesticides/resistrationkit/.
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
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f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with
Attachments (This document is in PDF format and requires the
Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in
PDF format and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of
Data
e. EPA Form No. 8570-35, Data Matrix
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)
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g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data
(November 27, 1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is
currently in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office of
Pesticide Programs. We anticipate that this publication will become available during the
Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: 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
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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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