United States Prevention, Pesticides EPA 739-R-07-008
Environmental Protection and Toxic Substances September 2007
Agency (751 OP)
Reregistration Eligibility Decision
for 2-Octyl-3 (2H)-isothiazolone
(OIT)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial 2-octyl-3 (2H)-
isothiazolone (OIT) . The Reregi strati on Eligibility Decision (RED) for OIT was approved on
September 28, 2007. Public comments and additional data received were considered in this
decision.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for OIT and its associated human health and environmental risks.
A Notice of Availability will be published in the Federal Register announcing the publication of
the RED.
The RED and supporting risk assessments for OIT are available to the public in EPA's
Pesticide Docket EPA-HQ-OPP-2007-0414 at: www.regulations.gov.
The OIT RED was developed through EPA's public participation process, published in
the Federal Register on June 13, 2007, which provides opportunities for public involvement in
the Agency's pesticide tolerance reassessment and reregi strati on programs. The public
participation process encourages robust public involvement starting early and continuing
throughout the pesticide risk assessment and risk mitigation decision making process. The
public participation process encompasses full, modified, and streamlined versions that enable the
Agency to tailor the level of review to the level of refinement of the risk assessments, as well as
to the amount of use, risk, public concern, and complexity associated with each pesticide. Using
the public participation process, EPA is attaining its strong commitment to both involve the
public and meet statutory deadlines.
Please note that the OIT risk assessment and the attached RED document concern only
this particular pesticide. This RED presents the Agency's conclusions on the dietary, drinking
water, occupational and ecological risks posed by exposure to OIT alone. This document also
contains both generic and product-specific data that the Agency intends to require in Data Call-
ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to registrants at a later
date. Additionally, for product-specific DCIs, the first set of required responses will be due 90
days from the receipt of the DCI letter. The second set of required responses will be due eight
months from the receipt of the DCI letter.
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As part of the RED, the Agency has determined that OIT will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measure outlined in Section IV of the document. Sections
IV and V of this RED document describe the labeling amendments for end-use products and data
requirements necessary to implement this mitigation measure. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by OIT. Where the
Agency has identified any unreasonable adverse effect to human health and the environment, the
Agency may at any time initiate appropriate regulatory action to address this concern. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, K. Avivah Jakob, at (703) 305-1328.
For questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703)-308-6341.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
2-Octyl-3 (2H)-isothiazolone (OIT)
ListB
CASE 2475
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
September 28, 2007
Attachment
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Table of Contents
OIT Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
III. Summary of OIT Risk Assessments 6
A. Human Health Risk Assessment 6
1. Toxicity of OIT 6
2. FQPA Safety Factor 9
3. Dietary Exposure Assumptions & Dietary Risk Assessment... 9
a. Dietary Risk from Drinking Water 9
4. Residential Risk Assessment 10
a. Residential Toxicity 10
b. Residential Handlers 12
i. Exposure Assessment 12
ii. Risk Assessment 15
c. Residential Post-Application 17
i. Exposure Assessment 17
ii. Risk Assessment 18
8. Aggregate Risk 19
a. Short-term Aggregate Risk 21
9. Occupational Risk 21
a. Occupational Toxicity 22
b. Occupational Handler Exposure 22
c. Occupational Handler Risk Summary 25
d. Occupational Post-application Risk Summary 31
9. Human Incident Data 31
B. Environmental Risk Assessment 31
1. Environmental Fate and Transport 32
2. Ecological Risk 33
a. Environmental Toxicity 33
b. Ecological Exposure and Risk 38
c. Risk to Listed Species 40
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 43
A. Determination of Reregistration Eligibility 43
B. Public Comments and Responses 43
C. Regulatory Position 44
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a. Determination of Safety to U.S. Population 44
b. Determination of Safety to Infants and Children 45
c. Endocrine Disrupter Effects 46
d. Cumulative Risks 46
D. Regulatory Rationale 46
1. Human Health Risk Management 47
a. Dietary (Food) Risk Mitigation 47
b. Drinking Water Risk Mitigation 47
c. Residential Risk Mitigation 47
i. Handler Risk Mitigation 47
ii. Post-Application Risk Mitigation 48
d. Occupational Risk Mitigation 49
i. Handler Risk Mitigation 49
ii. Post-Application Risk Mitigation 50
2. Environmental Risk Management 51
3. Other Labeling Requirements 52
4. Listed Species Considerations 52
a. The Endangered Species Act 52
b. General Risk Mitigation 53
V. What Registrants Need to Do 55
A. Manufacturing-Use Products 57
1. Additional Generic Data Requirements 57
2. Labeling for Technical and Manufacturing Use Products 59
B. End-Use Products 59
1. Additional Product-Specific Data Requirements 59
2. Labeling for End-Use Products 60
a. Label Changes Summary Table 61
VI. Appendices 62
A. Table of Use Patterns for OIT 63
B. Table of Generic Data Requirements and Studies Used to Make the 71
Reregistration Decision
C. Technical Support Documents 77
D. Bibliography Citations 78
E. Generic Data Call-In 88
F. Product Specific Data Call-In 89
G. Batching of End-Use Products 90
H. List of All Registrants Sent the Data Call-In 91
I. List of Available Forms 92
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OIT Reregistration Team
Health Effects Risk Assessment
Talia Lindheimer
Jonathan Chen
Steven Malish
Tim McMahon
Cassi Walls
Timothy Leighton
Ecological Risk Assessment
Richard Petrie
Najm Shamim
Environmental Fate Risk Assessment
Najm Shamim
Risk Management
K. Avivah Jakob
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
ii
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N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protection factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for 2-Octyl-3 (2H)-isothiazolone (OIT) and is issuing
its risk management decision and tolerance reassessment. The risk assessments, which are
summarized below, are based on the review of the required target database supporting the use
patterns of currently registered products and additional information received through the public
docket. After considering the risks identified in the revised risk assessments, comments
received, and mitigation suggestions from interested parties, the Agency developed its risk
management decision for uses of OIT that pose risks of concern. As a result of this review, EPA
has determined that OIT-containing products are eligible for reregi strati on, provided that risk
mitigation measures are adopted and labels are amended accordingly. That decision is discussed
fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration 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 the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. The Act also required that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's revised human health and ecological risk assessments and the Reregistration Eligibility
Decision (RED) for 2-Octyl-3 (2H)-isothiazolone (OIT).
OIT is currently registered as an industrial mildewcide, microbiocide, fungicide and
bacteriocide. The primary use sites for octhilinone are as a material preservative (e.g., fabrics,
textiles, coatings, sealants, adhesives, rubbers, plastics, leather preservation), as an industrial
mildewcide for cooling tower and air washer water systems (e.g., air washer water, flow-thru
cooling towers), and as a wood preservative (e.g., antisapstain drench).
The Agency has concluded that the FQPA Safety Factor for OIT should be removed
(equivalent to IX) based on: (1) the toxicology data base is complete with respect to assessing
the increased susceptibility to infants and children as required by FQPA for OIT; (2) there is no
concern for developmental neurotoxicity resulting from exposure to OIT in the rat and rabbit
prenatal developmental studies and 2-generation reproduction study; (3) there is no evidence of
increased susceptibility to the fetus following in utero exposure in the prenatal developmental
toxicity studies or to the offspring when adults are exposed in the two-generation reproductive
study; and (4) the risk assessment does not underestimate the potential exposure for infants and
children.
Risks summarized in this document are those that result only from the use of the active
ingredient, OIT. The Food Quality Protection Act (FQPA) requires that the Agency consider
available information concerning the cumulative effects of a particular pesticide's residues and
other substances that have a common mechanism of toxicity. The reason for consideration of
other substances is due to the possibility that low-level exposures to multiple chemical
substances that cause a common toxic effect by a common toxic mechanism could lead to the
1
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same adverse health effect that would occur at a higher level of exposure to any of the substances
individually. Unlike other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding for OIT and any other substances. OIT does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action, therefore, EPA has not assumed
that OIT has a common mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of OIT. In an effort to simplify the RED, the information presented herein is
summarized from more detailed information which can be found in the technical supporting
documents for OIT referenced in this RED. The revised risk assessments and related addenda
are not included in this document, but are available in the Public Docket at
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-0414).
This document consists of six sections. Section I is the introduction. Section II provides a
chemical overview, a profile of the use and usage of OIT and its regulatory history. Section III,
Summary of OIT Risk Assessments, gives an overview of the human health and environmental
assessments, based on the data available to the Agency. Section IV, Risk Management,
Reregi strati on, and Tolerance Reassessment Decision, presents the reregi strati on eligibility and
risk management decisions. Section V, What Registrants Need to Do, summarizes the necessary
label changes based on the risk mitigation measures outlined in Section IV. Finally, the
Appendices list all use patterns eligible for reregi strati on, bibliographic information, related
documents and how to access them, and Data Call-In (DCI) information.
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II.
Chemical Overview
A. Regulatory History
OIT was first registered as an active ingredient by the United States Environmental
Protection Agency (EPA) in 1971. OIT is currently registered as an industrial mildewcide,
microbiocide, fungicide and bacteriocide. OIT is largely used as a material preservative, as an
industrial mildewcide for cooling tower and air washer water systems and as a wood
preservative. Currently there are 36 active product registrations containing OIT as an active
ingredient.
B.
Chemical Identification
Technical OIT
XNN-^CH
CH, CH, CH, CH, CHi
Figure 1. Molecular Structure of OIT
Common name: OIT or Octhilinone
Chemical name: 2-Octyl-3(2H)-isothiazolone
Chemical family: Thiazole, Ketone
Empirical formula: CnHggONS
CAS Registry No.: 26530-20-1
Case number: 2475
OPP Chemical Code: 099901
Molecular weight: 213.34 g/mol
Other names: Kathon; RH-893; 2-n-Octyl-4-isothiazolin-3-one; 3(2H)-
Isothiazolone, 2-octyl-; Microbicide M-8
Basic manufacturers: Rohm & Haas Co.; Lonza Inc.; Thor GMBH
Chemical properties: OIT is a yellow liquid with a mild odor and is stable when stored
in ambient conditions. OIT has a specific gravity of 1.03; a water
solubility of 0.525 g/L; a vapor pressure of 3.68 ~X 10"5 mm Hg @
25 C°; and a viscosity of 48.04 mm2/s at 20 EC and 17.94 mm2/s at
3
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40 °C. The log Kow of OIT is 3.42 and its pH is 3.4. OIT has a half
life of 3.3 hours in air.
C. Use Profile
The following information is a description of the currently registered uses of OIT
products and an overview of use sites and application methods. A detailed table of the uses of
OIT eligible for reregi strati on is contained in Appendix A.
Type of Pesticide: Mildewcide, Microbiocide, Fungicide and Bacteriocide
Summary of Use:
Target Pests:
Materials Preservative:
As a materials preservative, OIT is used in industrial premises. There are
no residential use sites for octhilinone as an active ingredient. However,
octhilinone is used as a materials preservative in various end-use products,
some of which can be handled and used in residential settings. Some
examples of the types of treated materials that a residential user can come
into contact with are paints, carpets, vinyl floors, mattresses,
rubber/polymer products, and textiles (e.g. clothing and linens). Examples
of materials that are treated with OIT include: fabrics and textiles
(furniture, auto upholstery, footwear, carpet, carpet backing, tents,
awnings, canvas, linens, wall and window coverings, dust towels, bedding,
mattresses, pet bedding, pool liners, automotive trim, roof liners, marine
upholstery, pond liners, synthetic brooms, mops, air filter media), coatings
(walls, paints, plasters, stuccos), sealants (grouts, caulks, joint cements),
adhesives (wallpaper pastes, gelatin and starch based), rubber and plastics
(latex, acrylic, styrene, butadiene, polyvinyl chloride, polymethane, vinyl,
foams), leather preservation (wet processes), metalworking fluid
preservation and hydraulic fluid preservation.
Wood Preservative:
OIT is used to control sapstain and mold on wood via high pressure spray
to logs that are processed to formulate plywood
Industrial Processes and Water Systems:
For use in industrial process and water systems including air washer water
and once-thru cooling towers.
Deterioration/spoilage bacteria; fungi (coatings, leather, metal working
coolants); mildew; mold; no pest; algae; animal pathogenic bacteria (g-
and g+ vegetative); yeasts; ammonia-producing bacteria; dust mites;
bacteria (unspecified); slime-forming fungi (paper mills/water systems);
fungal rot/decay; bacteria (causing rot or decay); fungus growths; algae;
barnacles; marine fouling organisms; tubeworms; sapstain.
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Formulation Types: Formulation intermediate, soluble concentrate, ready to use, emulsifiable
concentrate, pelleted tableted.
Methods and Rates of Application:
Equipment for Antimicrobial Use:
OIT end use products are added during the manufacturing
process of treated articles and materials. Examples specific to materials
preservation include: incorporation into the formulation of end use
products; OIT is added at the beginning of the formulation process while
mixing of the final product; OIT is incorporated with products during the
manufacturing process; OIT is added to the final product prior to mixing;
OIT is added to final rinse of fabric; OIT is incorporated into the tanning
process; OIT is dispensed directly into metalworking concentrate; OIT is
dispensed directly into the hydraulic concentrate using a metered pump for
hydraulic fluid preservation. OIT is also applied via spray for wood
preservation.
Application Rates: For details about specific use sites for OIT, refer to Appendix A.
Concentrations of OIT in registered products (including both end use
products and manufacturing use products) range from 1.29% to 99.4%
OIT.
The concentrations of OIT as an active ingredient in registered end-use
products range from 1.29%-46.5%.
Use Classification: General use
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III. Summary of OIT Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for OIT. While the risk assessments and related addenda are not included in
this document, they are available from the OPP Public Docket EPA-HQ-OPP-2007-0414, and
may also be accessed from www.regulations.gov. Hard copies of these documents may be found
in the OPP public docket. The OPP public docket is located in Room S-4900, One Potomac
Yard, 2777 South Crystal Drive, Arlington, VA 22202, and is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The Agency's use of human studies in the OIT 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
1. Toxicity of OIT
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 1. Further details on the toxicity of OIT can be found in
the "Evaluation of Toxicology Database for the Reregi strati on Eligibility Decision Document
Disciplinary Chapter," dated August 13, 2007. This document is available on the Agency's
website in the EPA Docket at: http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-
0414).
The Agency has reviewed all toxicity studies submitted for OIT and has determined that
the toxicological database is sufficient for reregi strati on. The studies have been submitted to
support guideline requirements. Major features of the toxicology profile are presented below.
Table #1. Summary of Acute Toxicity Data for OIT
Guideline
No.
Study Type
MRID #(s)
Results
Toxicity
Category
Acute Toxicity
870.1100
870.1200
870.1300
870.2400
870.2500
Acute oral toxicity
Acute dermal toxicity
Acute inhalation toxicity
Acute eye irritation
Acute dermal irritation
00070456
00070456
00070456
00070456
00063214
LD50 = 794 mg/kg (M)
LD50=681mg/kg(F)
LD50= 1.83 gm/kg* (combined)
LC50 >200 mg/kg
Severely Irritating
Corrosive
III
II
III
I
I
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Guideline
No.
870.2600
Study Type
Skin sensitization
MRID #(s)
41482505,
41482507,
010809
Results
Sensitizer
Toxicity
Category
Notes: Octhilinone has a density of 1.03 gm/mL. = LD50 = 1.83 gm/kg
A dietary exposure assessment was not conducted for OIT and therefore, acute and
chronic reference doses (RfDs) were not required. Based on the current labelled use patterns for
OIT there are no dietary uses. Dietary exposure is not expected.
General Toxicity Observations
Acute Toxicity
OIT exhibits moderate oral, dermal, and inhalation toxicity (toxicity category III). For
primary eye irritation, OIT is moderately irritating (toxicity category III). OIT is corrosive to the
skin and is a dermal sensitizer. OIT is not mutagenic in activated and non-activated conditions
and there is no evidence of a geno-toxic effect.
Acute and Chronic Reference Dose (RfDs)
Dietary exposure to OIT is not expected. Therefore, acute and chronic dietary endpoints
were selected.
Incidental Oral Exposure
For the short-term (< 30 days) and intermediate-term (30 days - 6 months) incidental oral
exposures, a NOAEL of 5 mg/kg/day was selected. The NOAEL was based on systemic effects
in maternal rats (mortality, decreased body weight gain, decreased food consumption) observed
at 30 mg/kg/day in a developmental rat toxicity study (MRID 41482508). The target margin of
exposure (MOE) is 100 for short-term (ST) durations and 300 for intermediate-term (IT)
durations.
Dermal Exposure
For short-term (ST) dermal exposures, a NOAEL of 10 mg/kg/day (equivalent to 0.0674
mg/cm2) was selected from a 14 day dermal toxicity study in rats (MRID 43935705) based on
dermal irritation in both sexes of rats. The target MOE is 10 for the ST dermal duration. While a
MOE of 100 is usually applied, an MOE of 10 is used for this assessment for the following
reasons (3x inter-species variation, 3x intra-species variation). The known short-term duration of
dermal irritation and the use of a semi-occlusive dressing in the study support reducing the
standard MOE. For intermediate-term (IT) dermal exposures, a NOAEL of 5.95 mg/kg/day was
selected from a 90-day dermal toxicity study in rats (MRID 42007301) based on systemic effects
(decreases in HGB, GCT, RBC, albumin, and total protein and a decrease in body weight gain in
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male rats). The target MOE for IT dermal exposure is 100. There are no long-term dermal
endpoints selected for OIT.
Inhalation Exposure
For short- and intermediate-term inhalation exposures, aNOAEL of 0.64 mg/m3 was
selected (equivalent to 0.18 mg/kg/day) from a 90-day inhalation study in rats (MRTD
41544701). Effects observed at the LOAEL of 6.39 mg/m3 (NOAEL is 0.64 mg/m3) included
clinical signs (rales, dyspnea) decreases in body weight gain, fluid in uterus and pulmonary and
nasal cavity pathology. For the OIT risk assessment, human equivalent concentrations (HECs)
were calculated using the regional deposited dose ratio (RDDR) for nonhygroscopic particles and
the study NOAEL of 0.64 mg/m3. These values are: 2 hr HEC: 0.29 mg/m3, 4 hr HEC: 0.15
mg/m3, 6 hr HEC: 0.10 mg/m3 and 8 hr HEC: 0.073 mg/m3. The target MOE for inhalation
exposures is 30. An uncertainty factor of 30 is employed (3x for interspecies extrapolation, lOx
for human variability). A 3x for interspecies extrapolation is used in place of the standard lOx
factor as calculation of the RGDR (Regional Gas Dose Ratio) incorporates dosimetric
adjustments and, therefore, accounts for pharmacokinetic differences between animals and
humans, leaving the 3x pharmacodynamic uncertainty component.
Carcinogenicity
The available carcinogenicity data (TRID 4701030204/MRIDs 00139417, 00139419,
00139484) are unacceptable and do not satisfy the guideline requirements for a carcinogenicity
study in rodents. The metal working fluid use of OIT triggers the need for carcinogenicity data in
the rat and mouse.
Mutagenicity Potential
OIT was found to be negative in the reverse mutation assay with Ames Salmonella
(MRID 43935708), in a mouse bone marrow chromosomal aberration test (MRID 43935710),
and in a mammalian cell in culture gene mutation assay (MRID 43935709). OIT is not
mutagenic in activated and non-activated conditions and there is no evidence of genotoxic effect.
Therefore, OIT is not mutagenic or genotoxic.
Endocrine Disruption Potential
The EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as
amended by FQPA, to develop a screening program to determine whether certain substances
(including all pesticide active and other ingredients) "may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as
the Administrator may designate." Following recommendations of its Endocrine Disrupter and
Testing Advisory Committee (EDSTAC), the EPA determined that there was a scientific basis
for including, as part of the program, the androgen and thyroid hormone systems, in addition to
the estrogen hormone system. The EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. For pesticide chemicals, the EPA
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will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance
may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the
science develops and resources allow, screening of additional hormone systems may be added to
the Endocrine Disrupter Screening Program (EDSP). When the appropriate screening and/or
testing protocols being considered under the Agency's Endocrine Disrupting Screening Program
(EDSP) have been developed, OIT may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. OIT is not used in food and therefore,
the toxicological database is considered to be complete with respect to assessing the increased
susceptibility to infants and children as required by FQPA. There are no food tolerances for OIT
and the use patterns considered for the reregi strati on eligibility decision (RED) document do not
involve dietary exposure. As a result, an FQPA safety finding is not applicable.
3. Dietary Exposure Assumptions & Dietary Risk Assessment
A dietary risk assessment was not conducted for OIT and therefore, acute and chronic
reference doses (RfDs) were not required. Based on the current use patterns for OIT, there are
no dietary uses. However, there are several product labels that incorporate OIT as a materials
preservative in adhesives during the manufacturing processes. These products are restricted from
food contact.
The Agency addressed the possibility of indirect food contact resulting from adhesives
preserved with OIT. It was determined that dietary exposure resulting from possible indirect
food contact is not expected and a complete dietary assessment was not needed. All labels with
the adhesive use pattern contain language that either specify the type of adhesive (e.g., wallpaper
adhesive); or, the labels state that the products are for non-food use contact. Therefore, it is
unlikely that treated adhesives will end up in food packaging materials.
a. Dietary Risk from Drinking Water
A drinking water assessment was not conducted for OIT because there are no registered
outdoor uses for OIT, with the exception of the antisapstain wood preservative use. A dietary
risk assessment was not conducted for the once-through cooling tower use because the registrant
has indicated that they will voluntarily cancel this use. In order to be eligible for reregi strati on,
this use must be removed from all product labels. Therefore, OIT it is not expected to contact
fresh water environments. Octhilinone is stable and persistent in water under abiotic conditions,
but shows a tendency to biodegrade in biotic environments. Also, a soil migration study
supports that OIT is not expected to be prominent or migrate into water runoff since it binds
strongly to the surfaces of soils. OIT does have a tendency to remain on the surface of soils.
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However, the potential for contamination of surface water, as a result of rainfall, is unlikely to
occur because of OIT's tendency to biodegrade in soils and its minimal outdoor uses.
The Agency acknowledges that there is a very small chance that the antisapstain use of
OIT, could potentially result in leaching and runoff when freshly treated wood is stored outdoors.
This risk can potentially be mitigated with precautionary antisapstain label language. For further
information regarding the drinking water assessment please refer to the "Revised Octhilinone
Risk Assessment for the Reregi strati on Eligibility Decision (RED) Document," dated September
20, 2007; the "Environmental Fate Assessment of Octhilinone," dated March 30, 2007; and the
"Transmittal of Octhilinone (OIT) RED Ecological Hazard and Environmental Risk Assessment
Chapter-Case Number 2475," dated March 7, 2007.
4. Residential Risk Assessment
There are no residential use sites for OIT as an active ingredient. However, OIT is used
as a materials preservative in various end-use products, some of which can be handled and used
in residential settings. Residential exposure to OIT can occur from contact with end-use
products treated with OIT. Some examples of the types of treated materials that a residential
user can come into contact with are paints, carpet, vinyl floors, mattresses, rubber/polymer
products, and textiles (e.g., clothing and linens).
The residential exposure assessment considered all potential pesticide exposure, other
than exposure due to residues in food and drinking water. Each route of exposure (oral, dermal,
inhalation) was assessed, where appropriate, and risk was expressed as a Margin of Exposure
(MOE). The MOE is the ratio of estimated exposure to an appropriate No Observed Effect Level
(NOAEL) dose.
a. Residential Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential and occupational risks for OIT are listed in Table 6.
The target Margin of Exposure (MOE) varies by route and duration of exposure. For OIT,
the target MOE for incidental oral exposure is 100 for short-term (ST) and 300 for intermediate-
term (IT) durations. For dermal exposures leading to irritation, the target MOE is 10 for ST and
100 for IT duration. For inhalation exposures, the target MOE is 30 for both short- and
intermediate-term exposure durations.
10
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Table #2. Residential and Occupational Toxicological Doses and Endpoints for PIT
Exposure
Scenario
Incidental Oral,
Short-Term;
Intermediate-Term
(1-30 days; 30 days-
6 months)
Dermal Exposure,
Short-Term
(1-30 days)
[5 x 7 cm application
area]
Dermal Exposure,
Intermediate-Term
(30 days - 6 months)
[4 x 5 cm application
area]
Dermal Exposure,
Long-Term
(>6 months)
Inhalation
Short-Term;
Intermediate-Term
(0-30 days)/ (30 days
to 6 months)
Dose Used in Risk
Assessment
(mg/kg/day)
Systemic
NOAEL= 5 mg/kg/day
Dermal Irritation
NOAEL= 10 mg/kg/day
(0.0674 mg/cm2)
Systemic
NOAEL= 5.95
mg/kg/day
Not Selected
2hrHEC:0.29mg/m3
4hrHEC:0.15mg/m3
6hrHEC:0.10mg/m3
8hrHEC:0.073mg/m3
MOE = 30b
Target MOEs for
Risk Assessment
MOE= 100 (ST)
(lOx inter-species
variation; lOx
intra-species
variation)
MOE= 300 (IT)
(lOx inter- species
variation; lOx
intra-species
variation; 3x for
extrapolation to
intermediate-term
from short-term
endpoint)
Dermal Irritation
MOE= 10 (ST)a
(3x inter-species
variation; 3x intra-
species variation)
MOE= 100 (IT)
(lOx inter-species
variation; lOx
intra-species
variation)
Not Selected
MOE= 30 (ST/IT)
Study and Toxicological Effects
Developmental toxicity study (MRID
41482508)
Systemic: Mortality, decreased body weight
and body weight gain, decreased food
consumption.
14 Day Dermal Study (MRID 43935705)
Dermal: Dermal irritation in both sexes.
Systemic: No systemic effects.
90 Day Dermal Study (MRID 42007301)
Systemic: Decreases inHGB, HCT, RBC,
albumin, and total protein. Decrease in body
weight gain in the male.
Not Selected
90 Day Inhalation Toxicity
(MRID 41544701)
Clinical signs (rales, dyspnea) decreases in
body weight gain, fluid in uterus and
pulmonary and nasal cavity pathology.
a The use of dermal irritation is applied only for the short-term dermal exposure scenario. A margin of exposure (MOE) of 10 is used for the
short-term assessment (3x inter-species variation, 3x intra-species variation).
b Human Equivalent Concentrations (HECs) were calculated using the Regional Deposited Dose Ratio (RDDR) for
nonhygroscopic particles and the study NOAEL of 0.64 mg/m3 Where, HEC = RDDR x NOAEL x (6hr (rats
exposure time in study) / hr (worker exposure time))
Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, LOG = level of
concern, MOE = margin of exposure
11
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b.
Residential Handlers
i. Exposure Assessment
Based on examination of product labels describing uses for OIT, it has been determined
that exposure to handlers can occur in a variety of residential environments. Although no
products containing OIT are labeled for residential use, residents may be exposed to household
items that have been treated with OIT through material preservation (e.g., carpet, paints, and
plastics). For the residential exposure risk assessment the EPA selected high-end exposure
scenarios that are considered to be representative of all OIT residential handler exposure
scenarios. The representative scenarios selected by the Agency were evaluated using maximum
application rates as stated on the product labels. To assess the handler and post-application
exposures and risks, the Agency used standard assumptions, surrogate unit exposure data (from
the Chemical Manufacturers Association (CMA) antimicrobial exposure study, the Pesticide
Handlers Exposure Database (PHED), 2005 Human and Environmental Risk Assessment on
Ingredients of Household Cleaning Products (HERA), and EPA's Health Effects Division's
(HED) Standard Operating Procedures (SOPs) for Residential Exposure Assessments). Table 3
identifies the representative exposure scenarios assessed.
Table #3. Representative Uses Associated with Residential Exposure
Representative Use
Using treated paints
Using treated carpet
Using treated vinyl
floor
Using treated textiles
(e.g., clothing and
linen)
Using treated mattress
covers
Using treated
plastic/polymer
Exposure
Scenario
ST handler: dermal
(irritation) and
inhalation (aerosol)
ST and IT post-app:
child incidental
ingestion and dermal
ST and IT post-app:
child incidental
ingestion and dermal
ST post-app: child
incidental ingestion
and dermal
ST and IT post-app:
child dermal
ST post-app:
infant/child
Application
Method
brush/ roller
airless sprayer
NA
NA
NA
NA
NA
Registration
#
67071-31
67071-6
67071-43
67071-6
81348-8
81348-8
Application Rate
0.23% a.i. by weight
(16.84% a.i. x 13.8 Ib
product/1000 Ib paint)
0. 12% a.i. by weight
(0.25% product by weight
of material x 46.5% a.i. in
product)
0.37% a.i. by weight (4%
product by weight of
material x 9.3% a.i. in
product)
0.12% a.i. by weight
(0.25% product by weight
of material x 46.5% a.i. in
product)
0.4% a.i. by weight (2%
product by weight of
material x 20% a.i. in
product)
0.4% a.i. by weight (2%
product by weight of
material x 20% a.i. in
12
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Representative Use
products
Exposure
Scenario
incidental ingestion
Application
Method
Registration
#
Application Rate
product)
a Exposure to OIT as a preservative for fabrics/textiles is assumed to also represent exposure to leather processed
using OIT preserved products.
Short-term inhalation and dermal residential painter exposures were assessed and are
considered to be representative of all other residential handler exposures. Only short-term
exposure durations (1 to 30 days) were estimated because it was assumed that a homeowner or
do-it-yourself painter would typically paint on an intermittent basis (i.e., once or twice a year).
Inhalation Exposure
Residential handlers using preserved treated paint may have inhalation exposures to both
aerosols and vapors. In the case of OIT, the vapor pressure is relatively low therefore the vapor
phase did not required evaluation. Only inhalation exposure to paint aerosols was quantitatively
assessed.
There are no chemical-specific exposure data to assess paint application via paint brush,
roller, or airless sprayer. Therefore, inhalation exposure was assessed for these scenarios using
surrogate data. The surrogate data are based on the Pesticide Handler Exposure Database
(PHED) and National Paints and Coatings Associate (NCPA) data for painters wearing no
respiratory protection.
For the brush/roller scenario, the PHED inhalation unit exposure value for a residential
handler applying a pesticide using a paint brush was used. The test subjects were painting a
bathroom with a paint brush. This unit exposure value (0.28 mg/lb a.i.) represents a handler
wearing no respiratory protection.
For the airless sprayer scenario, the PHED inhalation unit exposure value for a residential
handler applying a pesticide using an airless sprayer was used. The test subjects were staining
the outside of a house with an airless sprayer. Although these exposures may differ slightly from
exposures of painters to OIT persevered products, these data are judged to be adequately
representative. The inhalation unit exposure value for the airless sprayer application was
available in terms of an air concentration (mg/m3/% a.i.) as well as, in terms of amount handled
(mg/lb a.i.). Since the inhalation toxicity endpoint was determined from an inhalation study (as
opposed to an oral study), the endpoint units are given in terms of an air concentration (mg/m3).
Therefore, in order to estimate inhalation risks (MOEs), it was appropriate to use the unit
exposure value in terms of an air concentration (mg/m3/% a.i.) rather than amount handled
(mg/lb a.i.). The inhalation unit exposure value of 0.68 mg/m3/% a.i was used for baseline (i.e.,
no respirator) exposures.
For the airless sprayer scenario, the OIT Task Force provided an additional exposure
study to supplement the existing PHED data. The purpose of this study, conducted by the
13
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National Paints and Coatings Association (NPCA) (Reinhardt and Fendick, 2000), was to
estimate exposure to crystalline silica while spray painting or sanding three different
formulations of latex paint in an indoor environment. Although the study was conducted to
specifically evaluate crystalline silica exposure, respirable aerosol paint concentrations were
measured during airless spraying activities. Each of the three paint formulations was applied by
a professional painter on three consecutive days resulting in nine samples of respirable aerosol
paint concentrations. The test worker painted the walls and ceilings of rooms measuring 8 feet
high, 10 feet wide, and 12 feet long. A daily painting exposure test (i.e., 8 hour work day)
required painting five to eight standard rooms while each room took 17-34 minutes to
complete. The results showed that the average respirable aerosol breathing zone concentration
during airless spraying of paint was 3.67 mg/m3. The NPCA study suggests that the respirable
aerosol mass in the breathing zone was no more than 16% of the total mass measured.
Therefore, because the endpoint was based on nasal irritation, the respirable aerosol paint
concentration of 3.67 mg/m3 was adjusted up by 16% to estimate the inhalable aerosol paint
concentration (i.e., air concentration up to 100 microns) of 22.91 mg/m3. These data were used
to further characterize the airless sprayer inhalation exposure even though the following were
identified as uncertainties or limitations in the NCPA study:
The study did not provide raw data to support the statement that the respirable
aerosol mass in the breathing zone was no more than 16% of the total mass
measured;
The particle sizes were not actually measured;
No cut point was provided for the size of respirable or inhalable aerosols
Based on these limitations, an additional study is needed to determine aerosol size
distribution that is less than 100 microns. Furthermore, there is insufficient information on the
distribution on the aerosol size/diameter from the PFtED data using the 2L/min sampling pump
with sampling cassettes facing downwards to adjust total aerosols to inhalable particle size (i.e.,
100 microns). Without this data, the air concentrations estimates using the PHED data can not be
adjusted down to estimate only inhalable for the aerosol size distribution, as suggested by the
OIT Task Force.
The inhalation unit exposure value for the brush/roller technique is reported as unit
exposures (UE), which is expressed as mg/lb of active ingredient handled. The inhalation unit
exposure for the airless sprayer technique was provided in terms of an air concentration
(mg/m3/% a.i.) as well as in terms of amount handled (mg/lb a.i.). Since the inhalation toxicity
endpoint was determined from an inhalation study (as opposed to an oral study), the endpoint
units are given in terms of an air concentration (mg/m3). Therefore, in order to more accurately
estimate inhalation risks (MOEs), it was appropriate to use the unit exposure value in terms of an
air concentration (mg/m3/% a.i.) rather than amount handled (mg/lb a.i.) for the airless sprayer
application method. The inhalation unit exposure value of 0.68 mg/m3/% a.i was used for
baseline (i.e., no respirator) exposures.
14
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To assess residential handler exposure, the quantities handled/treated were estimated
based on information from various sources and assumptions (e.g., maximum application rates,
related use information, etc.) For the brush/roller in-can paint applications, it was assumed that
20 Ibs (approximately 2 gallons) of treated paint will be used. This is based on the 90th
percentile value of 8 gallons of latex paint used per year divided by the mean frequency of 4
painting events/year. It was assumed that it could take residential applicators 2, 4, or 6 hours to
apply paint using a brush/roller or airless sprayer.
Dermal Exposure
To estimate the potential for dermal irritation, a dermal exposure based on surface area
was calculated. Because the short-term (ST) dermal toxicological endpoint is based on skin
irritation and not systemic effects; and because the endpoint is provided in terms of body surface
area, the exposure was calculated in terms of body surface area (i.e., mg a.i. per cm2 exposed
skin surface area). Dermal irritation is a relevant toxicological endpoint for ST dermal
exposures.
The percent active ingredient was calculated using information from the product label that results
in the maximum exposure to OIT (EPA Reg. No. 67071-31, with 16.84% a.i.). For short-term
dermal irritation effects, the film thickness of the paint on the hands was assumed to be 10.3
mg/cm2. This film thickness value is based on a measurement where a worker completely
immersed both hands into mineral oil and allowed no wiping (US EPA 1992). Using this film
thickness may result in an underestimate of exposure because the actual film thickness of paint is
potentially higher than the film thickness of mineral oil. A more accurate assessment would
require a dermal irritation study using paint as the test substance.
The "paint matrix effect" parameter pertains to the observation that OIT is essentially
"bound" within the paint matrix thereby reducing the potential dermal exposure. The OIT Task
Force submitted a study that evaluated the amount of OIT that was available on the skin for
exposure when used in a paint matrix (DiDonato and Hazelton, 1990). The percentages of radio-
labeled OIT formulated in solvent systems (ethanol and acetone) and paints (a water-based paint
and a solvent-based stain) remaining on guinea pig skin were compared after 3 hours of
exposure. The 3 hour duration was selected as the worst case to ensure that the paint would be
wet (a dry film would further bind the OIT to the paint).
By taking into account the ratios of the amount of OIT from paint to the amount of OIT
from the solvent (i.e., 4/36 to 8/29), it appears that OIT is available for dermal exposure in the
range of 11% - 28% when formulated in the paint matrix as compared to a solvent. Based on
these results, 28% was used for the paint matrix effect parameter.
ii. Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments. A MOE greater than or equal to 30 is considered
15
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adequately protective for the residential inhalation exposure assessment. A MOE greater than
or equal to 10 is considered adequately protective for the residential dermal exposure
assessment.
For the residential handler inhalation exposure assessment, the short-term inhalation
MOEs estimated for use of a brush/roller are above the target MOE of 30 and, therefore, are not
of concern. However, the short-term inhalation MOEs estimated for the airless sprayer use
scenarios are below the target MOE of 30. Therefore, there are inhalation risks of concern for the
application of paint via airless sprayer. A summary of the inhalation exposures and risks for
residential painters can be found in tables 4 & 5.
Table #4. Short-term Inhalation Exposure and MOE for Residential Painter Using a Brush
or Roller
Method of
Application
Brash/roller
Inhalation
Unit
Exposure
(mg/lb a.i.)
0.28
0.28
0.28
App.
Rate
(% ai)
0.23%
0.23%
0.23%
Quantity
Handled
(Ib/day)
201bs
(2 gal)
201bs
(2 gal)
201bs
(2 gal)
Daily Dose
(mg/kg/day) a
0.00018
0.00018
0.00018
Air Cone.
(mg/m3)b
0.0016
0.0016
0.0016
HEC
(mg/m3)
0.29 at 2 hrs
0.15at4hrs
0.10 at 6 hrs
MOE (ST) c
180
90
60
a Inhalation Daily Dose (mg/kg/day) = inhalation unit exposure (mg/lb a.i.) x application rate x quantity
handled / body weight (70 kg).
b Air conc.(mg/m3) = Dose (mg/kg/day) x BW (70 kg) x Light activity inhalation rate (day/8m3)
c Inhalation MOE = HEC (mg/m3) / Air cone. (mg/m3). Target inhalation MOE is 30.
Table #5. Short-term Inhalation Exposures and MOEs for Residential Painter Using an
Airless Sprayer
Method of
Application
Airless Sprayer
(PHED)
Airless Sprayer
(NPCA)
App.Rate
(% a.i.)
0.23%
0.23%
0.23%
0.23%
0.23%
0.23%
Inhalation Unit
Exposure
PHFD
(mg/m3/%ai)
NPCA (mg/m3)
0.681
0.681
0.681
22.91
22.91
22.91
Air Cone.
(mg/m3)a
0.16
0.16
0.16
0.0053
0.0053
0.0053
HEC
(mg/m3)
0.29 at 2 hrs
0.15 at 4 hrs
0.10 at 6 hrs
0.29 at 2 hrs
0.15 at 4 hrs
0.10 at 6 hrs
Route Specific
MOE (ST) b
2
1
1
6
3
2
a Air cone (mg/m3) = App Rate (%ai) x PHED UE (mg/m3/%ai)
(Note that the %ai incorporated the PHED UE is in terms of whole numbers, not fraction (i.e., 0.23 not 0.0023), therefore the App rate is used as
a whole number in the Air cone, estimate)
Air cone (mg/m3) = App Rate (%ai) x NPCA UE (mg/m3)
(Note that the App rate is used as a weight fraction in the Air cone, estimate (i.e., 0.0023)
b Inhalation MOE = HEC (mg/m3) / Air cone. (mg/m3). Target inhalation MOE is 30.
16
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For the residential handler dermal exposure assessment, the short-term dermal MOE for a
painter applying treated paint is 10. There are no residential dermal risks of concern because the
calculated MOE of 10 is not below the target MOE of 10. A summary of the residential handler
dermal exposures and risks is presented in Table 10 below.
Table #6. Short-term Dermal Exposures & MOEs for Residential Painter
Exposure
Scenario
Painter
%ai
0.23%
Film thickness
(mg/cm2)
10.3
Paint Matrix
Effect (%)
28%
Exposure
(mg/cm2)
0.0067
Dermal MOE
(Target MOE is 10) a
10
a MOE = NOAEL (mg/cm ) / Potential exposure (mg/cm ) [Where: NOAEL for short-term dermal irritation =
0.0674 mg/cm2, Table 3.2].
c. Residential Post-application
i. Exposure Assessment
Post-application scenarios have been selected that encompass multiple products. These
selected scenarios represent high-end exposures and include: contacting treated carpets and vinyl
floors (dermal and incidental oral exposure to children), wearing treated clothing (dermal
exposure to children and adults), using treated mattresses (dermal exposure to children and
adults), mouthing treated textiles such as clothing and blankets (incidental oral exposure to
children), and mouthing treated plastic toys (incidental oral exposure to children). It should be
noted that because OIT has a relatively low vapor pressure, post-application inhalation exposures
were not assessed.
Data sources and methodologies utilized for both the handler and post-application
residential risk assessment include: the HED Residential Standard Operating Procedures (SOPs)
(USEPA, 1997a), the USEPA Exposure Factors Handbook (USEPA 1997b), Recommended
Revisions to the Residential SOPs (USEPA, 2001), and the Human and Environmental Risk
Assessment (HERA) Guidance Document (2003).
The Agency evaluated the following post-application scenarios, which are considered to be
representative of all possible post-application residential exposure scenarios:
Contact with treated carpets by children (ST & IT incidental oral and dermal
exposure to children);
Contact with treated vinyl by children (ST & IT incidental oral and dermal
exposure to children);
Treated mattress covers (ST & IT dermal exposure to children and adults);
Treated clothing/textiles (ST dermal exposure to children & adults, ST incidental
oral exposures to children );
Mouthing treated plastic toys (ST incidental oral exposure to children).
17
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There is potential for exposure to occur for greater than 30 days, assuming that OIT has a
relatively long half life indoors, from treated carpet, treated vinyl, and treated mattress covers.
Therefore, both short- and intermediate-term exposure durations were assessed for the treated
carpet, vinyl, and mattress cover scenarios. A long-term residential exposure assessment was not
conducted for OIT. Typically the Agency does not conduct long-term residential exposure
assessments, other than for dietary and drinking water exposures, because residential use of
treated materials is expected to be intermittent. Even with a relatively high half-life, the Agency
does not expect long-term exposure of residents to treated materials. Therefore, a long-term post-
application residential exposure assessment was not conducted for OIT.
For treated textiles, it was assumed that not all clothing is treated with OIT and the
clothing that is treated will not be worn everyday. Therefore, exposure would occur
intermittently. It was also assumed that not all plastic toys are treated with OIT and the toys that
are treated will not be used everyday, resulting in intermittent exposure. Therefore, only short-
term exposure durations were assessed for treated textiles and toys (plastics).
ii. Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
residential handler post-application dermal and incidental oral exposure assessments. The
residential post-application risk assessment identifies short-term (1-30 days) and intermediate-
term (1-6 months) exposure doses. A MOE greater than or equal to 10 is considered adequately
protective for short-term (ST) dermal exposure to OIT; and an MOE of 100 is considered
adequately protective for intermediate-term (IT) dermal exposures. For incidental oral exposure,
a MOE greater then or equal to 300 is considered adequately protective for intermediate-term
(IT) durations; and a MOE of 100 is considered adequately protective for ST incidental oral
durations. A MOE greater then or equal to 30 is considered to be adequately protective for
ST/IT inhalation exposure.
For the residential post-application risk assessment, MOEs are above the respective target
MOEs (10 for ST dermal exposures, 100 for IT dermal exposures, 30 for ST/IT inhalation
exposures, 100 for ST incidental ingestion exposures, and 300 for IT incidental ingestion
exposures) for all scenarios except for the following. The following residential post-application
exposure scenarios are of concern:
ST dermal exposure of children to treated carpet: MOE5o/otransfer = 9
IT dermal exposure of children to treated carpet: MOE5o/0transfer = 6
ST incidental ingestion exposure of children to treated carpet: MOE5o/otransfer = 6
IT incidental ingestion exposure of children to treated carpet: MOE5o/otransfer =13
IT dermal exposure of children to treated mattresses:
MOE5o/0 transfer = 73 (MOEiQO% transfer = 4)
ST dermal exposure of adults and children to treated mattresses:
MOE5o/otransfer= 67 (MOE 100%transfer = 3)
18
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The following residential post-application exposure scenarios are of concern at a 100%
transfer factor; however, they are not of concern with a 5% transfer factor. Therefore,
confirmatory data are required to verify the 5% transfer factor.
ST dermal exposure of adults & children to treated clothing:
MOEioo%transfer= 6; MOE5o/0transfer = H6
IT dermal exposure of adults to treated mattresses:
MOEiQO%transfer = 5; MOEso/,,transfer = HO
Table 7 presents a summary of the short-term and intermediate-term residential post-application
exposures and risk estimates.
Table #7. Short- and Intermediate-term Residential Post-application Risks for Adults &
Children
Exposure Scenario
Child contacting treated carpet (ST)
Child contacting treated carpet (IT)
Child contacting treated vinyl (ST)
Child contacting treated vinyl (IT)
Treated Clothing for Children and
Adults (ST)
Treated Mattress Covers - Children &
Adults (ST)
Treated Mattress Covers - Children (IT)
Treated Mattress Covers - Adults (IT)
Treated Plastics (ST) - Children
mouthing toys
Dermal MOE
Target MOE 10 (ST)
Target MOE 100 (IT)
9 @ 5% transfer
6 @ 5% transfer
5,200 @ 10% transfer
6,300 @ 10% transfer
6 @ 100% transfer
1 16 @ 5% transfer
3 @ 100% transfer
67 @ 5% transfer
4 @ 100% transfer
73 @ 5% transfer
5 @ 100% transfer
1 10 @ 5% transfer
NA
Incidental Ingestion
MOE
Target MOE 1 00 (ST)
Target MOE 300 (IT)
6 @ 5% transfer
13 @ 5% transfer
7,200 @ 10% transfer
15,000 @ 10% transfer
130 (for children)
NA (for adults)
NA
NA
NA
152
NA= Not applicable
8. Aggregate Risk Assessment
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information." Aggregate
exposure typically includes exposures from food, drinking water, residential uses of a pesticide,
and other non-occupational sources of exposure.
19
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The aggregate risk assessment is designed to provide estimates of risks likely to result
from exposures to the pesticide or pesticide residues in food, water, and from residential (or
other non-occupational) pesticide uses. Acute and chronic dietary aggregate assessments were
not conducted because there are no uses for OIT attributable to these routes of exposures.
Inhalation exposures were not considered in the aggregate risk assessment because there are no
inhalation post-application scenarios to be considered. To reiterate, OIT has a low vapor
pressure and, therefore, any potential exposures to OIT vapors were not necessary to assess.
Since the endpoint for each route of exposure was based on a route specific study
resulting in different effects, separate route specific aggregate assessments were conducted. The
use patterns of the products and probability of co-occurrence were taken into account when
selecting use scenarios for the aggregate assessment. Because most of the OIT products are used
as a materials preservative in the manufacturing of various materials and exposure to some of
these materials (e.g., mattresses, carpets, vinyl tiles) can occur on a continuous basis, they were
included in the aggregate assessments. It should be noted that based on the probability of co-
occurrence of the uses that have intermediate-term exposure potential, it was determined that an
adult intermediate-term aggregate assessment was not necessary to conduct.
Table 8 summarizes the use scenarios that were assessed for the short-term (non-dietary,
non-occupational) aggregate assessment.
Table #8. Short-term Aggregate Exposure Use Scenarios
Adults
Children
Dermal:
exposure
exposure
Dermal:
exposure
exposure
exposure
Oral:
exposure
exposure
exposure
to
to
to
to
to
to
to
to
ST
residues
residues
residues
residues
residues
residues
residues
residues
Aggregate Exposure Scenarios
in fabrics/clothing preserved during manufacturing
in mattresses preserved during manufacturing
in fabrics/clothing preserved during manufacturing
in mattresses preserved during manufacturing
in vinyl tiles preserved during manufacturing
in fabrics/clothing preserved during manufacturing
in polymers (toys) preserved during manufacturing
in vinyl tiles preserved during manufacturing
Quantitative assessments were not conducted for use scenarios that have individual risks
of concerns, such as dermal exposures to treated carpets. Dermal post-application exposures to
OIT carpet residues, alone, are of concern to the Agency. An aggregate assessment would only
reflect the previously identified individual risks of concern and incorporation of this scenario in
the aggregate assessment would result in risks of concern. Therefore, the carpet scenario was not
incorporated in the aggregate assessment. If these exposures did not result in individual risks of
concern, then they would have been included in the aggregate assessments instead of exposures
to vinyl floors.
20
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a. Short-Term Aggregate Risk
The endpoint for each route of exposure was based on a route specific study resulting in
different effects and therefore, separate route specific aggregate assessments were conducted.
The total MOE method outlined in the OPP guidance for aggregate risk assessment (September
1, 2000, Standard Operating Procedure (SOP) for Incorporating Screening Level Estimates of
Drinking Water Exposure into Aggregate Risk Assessments) was utilized. This method was used
because the oral, dermal and inhalation endpoints have the same uncertainty factors or target
MOEs. The target MOE for all ST dermal exposure is 10 and ST oral is 100.
Tables 9 and 10 present the MOEs for the short-term dermal and short-term oral
aggregate assessments. The short-term dermal aggregate MOEs for adults and children were
above the target MOE of 10 and, therefore, are not of concern. However, the short-term oral
aggregate MOE for children was below the target MOE of 100 and, therefore, indicates a risk of
concern.
Table #9. Short-term Dermal Aggregate Assessments
Exposure Route
Adults Dermal
Children Dermal
MOEs
Vinyl
NA
5,200
Clothing
116
116
Mattress
67
67
Aggregate
42
42
Target MOE
10
10
a: Aggregate MOE = l/((l/MOEvinyl) + (1/MOEclothing) + (1/MOEmattress))
Table #10. Short-term Oral Aggregate Assessments
Exposure Route
Children Incidental Oral
MOEs
Vinyl
7,200
Clothing
130
Toys
150
Aggregate
69
Target MOE
100
a: Aggregate MOE = l/((l/MOEvinyl) + (1/MOEclothing) + (1/MOEtoys))
9. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. OIT is used as a materials preservative, as an industrial
mildewcide for cooling tower and air washer water systems, and as a wood preservative.
Potential occupational handler exposures can occur during the preservation of materials that are
used for institutional and industrial uses. The "preservation of materials" refers to the scenario of
a worker adding the preservative to the material being treated (metalworking fluid, paint, textiles,
etc.) through either liquid pour or liquid pump methods. In addition, there is the potential for
occupational handlers to come into contact with treated products such as metalworking fluids,
paints, treated wood, etc.
Occupational handlers of OIT include handlers applying OIT treated paint via airless
sprayer or paint brush/roller; handlers pouring OIT liquid preservative for the preservation of
paints, plastics, vinyl, leather, textiles, and metal working fluids; handlers pumping OIT liquid
preservative for preservation of metalworking fluids, paints, plastics, vinyl, leather (metering
21
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pump), textiles, and mattresses (mechanical metering pump); and wood preservative application
via high pressure spray.
An exposure assessment was not conducted for the industrial processes and water
systems use (water system biocide use). The water system uses are only listed on one
manufacturing use product (MUP) label (Reg. #707-308), which does not provide application or
use rates. Since there are no end-use product (EUP) labels containing water system uses, these
uses were not assessed. The water systems use should be canceled and manufacturing use
product labels need to be updated. If this use is not cancelled, new end-use product labels need
to be formally submitted and reviewed by the Agency.
a. Occupational Toxicity
The toxicological endpoints used in the occupational handler assessment of OIT can be
found in Table 6, "Residential and Occupational Toxicological Doses and Endpoints for OIT", of
this document.
b. Occupational Handler Exposure
Occupational risk for all potentially exposed populations is measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from toxicological studies. Occupational risk is
assessed for exposure at the time of application (termed "handler" exposure). Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site and by the
application rate required to achieve an efficacious dose.
Potential occupational handler exposures can occur during the preservation of materials
that are used for institutional and industrial uses, along with the use of cooling water tower
biocides and wood preservatives. The "preservation of materials" refers to the scenario of a
worker adding the preservative to the material being treated (metalworking fluid, paint, textiles,
leather, etc.) through either liquid pour or liquid pump methods. Liquid pour refers to
transferring the antimicrobial product from a small container to an open vat. Liquid pump refers
to transferring the preservative by connecting/disconnecting a chemical metering pump from a
tote or by gravity flow.
The Agency evaluated representative occupational handler scenarios to assesses and
determine dermal and inhalation exposures. To assess occupational handler risk, the Agency
used surrogate unit exposure data from both the proprietary Chemical Manufacturers Association
(CMA) Antimicrobial Exposure Study (USEPA 1999: DP Barcode D247642) 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.
The duration of occupational handler exposure to OIT is expected to be intermediate-term
(IT) for dermal exposures and short- and intermediate-term for inhalation exposures. Short-term
dermal exposures were not assessed for most of the occupational handler scenarios because the
22
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endpoint is based on dermal irritation. Instead, dermal irritation exposures and risks are
mitigated, for most short-term dermal exposure uses, through the use of default personal
protective equipment (PPE) based on the toxicity of the end-use products. To minimize dermal
exposures, the minimum PPE required for mixers, loaders, and others exposed to end-use
products that result in classification of category I, II, or III for skin irritation potential is a long-
sleeve shirt, long pants, shoes, socks, chemical-resistant gloves, and a chemical-resistant apron.
Chemical-resistant gloves and a chemical-resistant apron can be eliminated for applicators and
others exposed to OIT if, once diluted, the concentration in the diluted solution results in a
toxicity category IV for skin irritation potential. Note that chemical-resistant eyewear is required
if the end-use product is classified as toxicity category I or II for eye irritation potential.
As previously mentioned the use of PPE, specifically gloves, can reduce the risks for the
majority of the occupational uses with short-term and intermediate-term dermal exposure.
However, gloves are not a viable mitigation option for in-can preservative products, such as
paints, because it is not feasible to label the end-use product with the biocide information. Short-
and intermediate-term durations were assessed for dermal exposure to workers painting with in-
can paint preservative products. Furthermore, gloves are not a viable mitigation option for
machinists using biocide treated metalworking fluids. Short-, intermediate-, and long-term
exposures were assessed for machinists working with metal working fluids. Typically the
Agency does not conduct short-term dermal exposure assessments for handlers, when an
irritation endpoint is selected, because the addition of PPE (gloves) generally mitigates risks of
concern. However, because gloves (PPE) are not a viable mitigation option for workers painting
with in-can preservative paint products and machinists working with metal working fluids, short-
term dermal exposure assessments were conducted for these scenarios.
For intermediate-term dermal exposures (resulting in the potential for systemic effects),
the PPE used by occupational users were assumed, at a minimum, to be a long-sleeve shirt, long
pants, shoes, socks, chemical-resistant gloves, and goggles or face shield. For the professional
painter scenario, no intermediate-term exposures were assessed because it is assumed that
painters will not use OIT-preserved paint on a continuous basis.
Total MOEs (i.e., that account for combined exposures via dermal and inhalation routes)
were not calculated for occupational use scenarios because the toxicological endpoints for
dermal and inhalation exposures are different.
For more information on the assumptions and calculations for potential risks to
occupational handlers refer to Section 8.0, Occupational Exposure and Risk, in the "Revised
Octhilinone Risk Assessment for the Reregi strati on Eligibility Decision (RED) Document,"
dated September 20, 2007 and the "Revised Occupational and Residential Exposure Chapter for
Octhilinone (OIT) for the Reregistration Eligibility Decision (RED) Document (Case 2475),"
dated September 17, 2007. Based on the representative use patterns of OIT, the exposure
scenarios in Table 11 were assessed:
23
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Table #11. PIT Representative Occupational Handler Exposure Scenarios
Representative
Use
Method of
Application
Exposure
Scenario
Registration #
Application Rate
Material Preservatives
Metalworking
fluid
Paint1
Plastics and
vinyl2
Leather
Textiles
Mattresses
Liquid pour
Liquid
pump
Use of
treated
metalworkin
g fluid
Preservation of
paint
Liquid pour
Liquid
pump
Professional
painter
Brush/roller
Airless
sprayer
Liquid pour
Liquid
pump
Liquid pour
Metering
pump
Liquid pour
Liquid
pump
Mechanical
metering
pump
Handler (worker
pouring preservative
into fluid being
treated): IT dermal;
ST and IT inhalation
Machinist: ST and
IT dermal and
inhalation
Handler: IT dermal;
ST and IT inhalation
Professional Painter:
ST dermal and
inhalation
Handler: IT dermal;
ST and IT inhalation
Handler: IT dermal;
ST and IT inhalation
Handler: IT dermal;
ST and IT inhalation
Handler: IT dermal;
ST and IT inhalation
67071-6
67071-31
81348-8
707-121
67071-6
81348-8
0.0075% a.i. by weight (75
ppm a.i.)
0.23% a.i. by weight (13.8 Ib
product/ lOOOlb paint x
16.84% a.i. in product)
0.4% a.i. by weight (2%
product by weight of
material treated x 20% a.i. in
product)
0.019% a.i. by weight hides
(3,530 ppm product in hides
(wet weight) x 5.5% a.i. in
product)
0.12% a.i. by weight (0.25%
product by weight of
material treated x 46.5% a.i.
in product)
0.4% a.i. by weight (2%
product by weight of
material x 20% a.i. in
product)
Industrial Processes and Water Systems
Cooling tower
waters3
N/A
N/A
707-100
N/A
24
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Representative
Use
Method of
Application
Exposure
Scenario
Registration #
Application Rate
Wood Preservatives
Wood
preservative
High
Pressure
Spray
Handler: IT dermal;
ST and IT inhalation
73612-1
0.096% a.i. solution (80 liters
product/ 1000 liters water x
1.2% a.i. in product)
1 Preservation of paint is assumed to be representative of various exposures related to the incorporation of OIT into
liquid substances during production (including sealants, adhesives, and other viscous materials) as well as addition
of OIT to solid products where addition of product occurs during manufacture; e.g., carpets, molded goods, etc.).
2 Assumed to be representative of exposures related to addition of OIT to plastics, polymers, vinyl, and similar
products during the manufacturing process.
3 Use directions on label are described for manufacturing use product only; no end uses are provided. Therefore, no
exposure assessment was conducted for this scenario.
c. Occupational Handler Risk Summary
The occupational handler risk assessment included both inhalation and dermal exposure
scenarios. The target MOE for short- and intermediate-term inhalation exposures is 30. For
dermal exposures, the target intermediate-term MOE is 100.
As previously mentioned, short-term dermal exposures were not assessed for most of the
occupational uses because dermal irritation via short-term exposures is mitigated with the use of
chemical resistant gloves (PPE). However, the Agency can not require the use of gloves (PPE)
on in-can paint preservative labels. Therefore, a short-term risk assessment was conducted for in-
can paint application by professional handlers.
Materials Preservation & Wood Preservation Uses
The MOEs for the occupational handler use scenarios for materials preservation and
wood preservation were above their target MOEs (target MOE of 100 for IT dermal; target MOE
of 30 for ST/IT inhalation exposures) except for the following scenarios:
Preservation of Plastics & Vinyl: Liquid Pour
(IT dermal MOE = 39) (ST/IT inhalation MOE = 2)
Preservation of Plastics & Vinyl: Liquid Pump
(IT dermal MOE = 83)
(ST/IT inhalation MOE = 2)
Paint Preservation: Liquid Pour
(IT dermal MOE = 67)
(ST/IT inhalation MOE = 4)
25
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Paint Preservation: Liquid Pump
(ST/IT inhalation MOE = 3)
Textiles Preservation: Liquid Pour
(ST/IT inhalation MOE = 14)
For further information regarding the short- and intermediate-term risks to occupational
handlers exposed to OIT materials preservatives and wood preservatives, refer to Table 12.
Table #12. Short- and Intermediate-Term Exposures & Risks Associated with
Occupational Handlers (Materials & Wood Preservation)
Exposure
Scenario
Preservation
of
metalworking
fluid
Preservation
of plastics
and vinyl
Preservation
of paint
Preservation
oftextiles
Preservation
of mattresses
Application
of paint by
professionals
Method of
Application
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pump
Brush/ roller
Unit Exposure
(mg/lb a.i.)
Dermal"
0.184
0.312
0.135
0.00629
0.135
0.00629
0.135
0.00629
0.00629
NCb
Inhalation
0.0085
0.00348
0.00346
0.000403
0.00346
0.000403
0.00346
0.000403
0.000403
0.28
App.
Rate
0.0075%
a.i. by
weight
0.0075%
a.i by
weight
0.4% a.i.
by
weight
0.4% a.i.
by
weight
0.23%
a.i. by
weight
0.23%
a.i. by
weight
0.12%
a.i. by
weight
0.12%
a.i. by
weight
0.4% a.i.
by
weight
0.23%
a.i. by
weight
Quantity
Handled/
Treated
per day
2,502 Ibs
(300 gal)
2,502 Ibs
(300 gal)
20,000
Ibs
(2,000
gal)
200,000
Ibs
(20,000
gal)
20,000
Ibs
(2,000
gal)
200,000
Ibs
(20,000
gal)
10,000
Ibs
10,000
Ibs
2,860 Ibs
(1,300
kg)
50 Ibs
(5 gal)
Absorbed Daily Dose
(mg/kg/day)
0.00049
0.00084
0.15
0.072
0.090
0.041
0.023
0.0011
0.0010
NC
ST/IT
Inhalation
c
mg/kg/day
2.3E-05
9.3E-06
0.0040
0.0046
0.0023
0.0026
0.00059
6.9E-05
6.6E-05
0.00046
ST/IT
Air
Cone"
mg/m3
0.000199
0.000082
0.034600
0.040300
0.019895
0.023173
0.005190
0.000605
0.000576
0.004025
MOEe
IT Dermal
(Target
MOE =
100)
12,000
7,100
39
83
67
140
260
5,500
5,800
NC
ST/IT
Inhalation
(Target MOE
= 30)
370
890
2
2
4
3
14
120
130
25
26
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Exposure
Scenario
Mixing,
loading, and
applying
wood
preservative
solution
Method of
Application
High
pressure/high
volume
spray
Unit Exposure
(mg/lb a.i.)
Dermal"
2.5
Inhalation
0.12
App.
Rate
0.096%
a.i.
Quantity
Handled/
Treated
per day
2,195 Ibs
(263 gal)
Absorbed Daily Dose
(mg/kg/day)
0.048
ST/IT
Inhalation
mg/kg/day
0.00036
ST/IT
Air
Cone"
nig/m3
0.0032
MOEe
IT Dermal
(Target
MOE =
100)
130
ST/IT
Inhalation
(Target MOE
= 30)
200
ST = short-term, IT = intermediate-term, NC = Not conducted
a With the exception of the scenario for application of paint, all dermal unit exposure estimates used for occupational handler scenarios
represent exposures incurred assuming the use of PPE (at least a long-sleeve shirt and long pants plus gloves), as specified on the
product labels. For the application of paint by professional painters, dermal exposures were calculated for baseline dermal exposures
(long-sleeve shirt, long pants, and no gloves).
b NC = not conducted. Short-term dermal exposures during the application of paint resulting in the potential for dermal irritation are
evaluated in Section 6.5. Intermediate-term dermal exposures during the application of paint are not assessed because it was assumed
that professional painters will not use OIT-preserved paint on a continuous basis.
c Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb ai) * application rate (%a.i. by weight) * quantity treated or handled
(Ib/day) / Body weight (70 kg).
d Air cone (mg/m3) = dose (mg/kg/day) x 70 kg x light activity inhalation rate (day/ 8m3)
e MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where IT dermal NOAEL = 5.95 mg/kg/day and the ST/IT inhalation 8 hr HEC
= 0.073 mg/m3 and ST/IT inhalation 6 hr HEC = 0.098 mg/m3 for professional painter]
Leather Processing
The potential for occupational exposure, resulting from leather processing, was based on
the loading of the product by open pouring or connecting/disconnecting a metering pump.
Chemical-specific exposure data were not submitted to support leather processing. Therefore, a
screening-level assessment was developed using surrogate data to determine the potential risks
associated with leather processing.
The most representative exposure data available for industrial uses are the monitoring
data from the CMA Antimicrobial Exposure Assessment Study (US EPA 1999: DP Barcode
D247642). The liquid open pour and liquid pump data from the preservative loading were used
to develop the screening-level assessment. The dermal UEs of 0.135 mg/lb a.i. for liquid open
pour and 0.00629 mg/lb a.i. for liquid pump are both based on only 2 replicates where the test
subjects were wearing a single layer of clothing and chemical resistant gloves (UE are not
available for the "no glove" scenarios). The inhalation UEs are based on the same 2 replicates.
The inhalation UE for open pour is 0.00346 mg/lb a.i. and the UE for liquid pump is 0.000403
mg/lb a.i. Although these exposure scenarios are based on minimal replicates, the exposure
values are similar to those found in PHED for similar scenarios.
Table 13 presents the potential, non-cancer, dermal and inhalation risks for the leather
processing use of OIT. The dermal and inhalation handler MOEs for leatherworking are not of
concern.
27
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Table #13. Short and Intermediate-term Dermal and Inhalation Risks Associated With
Occupational Handling of PIT in Leatherworking
Equipment
Raceway
Mixer
Tanning
dram
Exposure
Scenario
Open
pour-
liquid
Metering
pump
Open
pour-
liquid
Metering
pump
Open
pour-
liquid
Metering
pump
Unit Exposures
(nig/ Ib a.i.)
Dermal
0.135
0.00629
0.135
0.00629
0.135
0.00629
Inhal.
0.00346
0.000403
0.00346
0.000403
0.00346
0.000403
Amount
Handled
(Ibs
a.i./day)
2.36
12.6
(ST)
3.8 (IT)
2.36
2.62
2.36
5.0
Daily Dose
(mg/kg/day)
IT
Dermal
a
0.0046
0.00034
0.0046
2.3E-04
0.0046
4.5E-04
ST/IT
Inhal Dose
b
1.2E-04
7.3E-05
(ST)
2.2E-05
(IT)
1.2E-04
1.5E-05
1.2E-04
2.9E-05
ST/IT Inhal
Air Conc.c
0.0010
0.00064 (ST)
0.00019 (IT)
0.0010
0.00013
0.0010
0.00025
MOEd
IT
Dermal
Target
MOE=
100
1,300
17,000
1,300
25,000
1,300
13,000
ST/IT
Inhalation
Target
MOE= 30
72
120 (ST)
380 (IT)
72
560
72
290
a Dermal Dose (mg/kg/day) = Dermal UE (mg/lb ai) x amount handled (Ib ai/day) / 70kg .
b Inhalation Dose (mg/kg/day) = Inhalation UE (mg/lb ai) x amount handled (Ib ai/day) / 70kg .
c Air cone (mg/m3) = Inhal dose (mg/kg/day) x 70 kg x Inhal rate (day /8m3)
d MOE = NOAEL / Dose. Where IT dermal NOAEL = 5.95 mg/kg/day, and ST and IT inhalation HEC =
0.073 mg/m3.
Professional Painter
The metal working fluids (machinist) and professional painter scenarios were assessed
and are discussed separately because of the route of exposure that is applicable to these uses, and
because it is not feasible to mitigate these risks with personal protective equipment (PPE)
restrictions. The handler is assumed to be coming into contact with these materials after they
have been preserved with OIT.
There is the potential for dermal and inhalation exposures to professional painters
handling paint that has been preserved with OIT. The methods of application include painting
with a brush or roller as well as airless spraying. For the professional painter scenario,
intermediate-term exposures were not assessed because it was assumed that painters will not use
OIT-preserved paint on a continuous basis.
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Dermal Exposure (Irritation)
The potential for short-term (ST) dermal exposure during professional painting activities
to OIT resulting in dermal irritation was assessed. Intermediate-term (IT) exposures were not
assessed for the professional painter because it was assumed that not all of the paint used by a
professional on an intermediate-term basis is treated with OIT.
The short-term exposure estimate based on surface area (i.e., as mg a.i. per cm2 of skin
area exposed) was derived using the same approach presented previously in Section 4.b.i of this
document for the residential painter. Because the inputs for the professional painter are identical
to those used for the residential painter, the estimated exposure and MOE for brush/roller and
airless spray applicators are also the same. There are no risks of concern for short-term dermal
exposure because the calculated MOE is 10 (target MOE = 10).
Table #14. Short-term Dermal Exposures & MOEs for Occupational Painter
Exposure
Scenario
Painter
%ai
0.23%
Film thickness
(mg/cm2)
10.3
Paint Matrix
Effect (%)
28%
Exposure
(mg/cm2)
0.0067
Dermal MOE
(Target MOE is 10) a
10
a MOE = NOAEL (mg/cm2) / Potential exposure (mg/cm2) [Where: NOAEL for short-term dermal irritation =
0.0674 mg/cm2, Table 3.2].
Inhalation Exposure (via brush/roller)
The application of paint via brush/roller is presented in table X, above. The MOE for the
application of paint via brush/roller is below the target MOE of 30 (MOE =25), indicating a risk
of concern.
Inhalation Exposure (via airless sprayer)
The Agency used the same exposure data (PHED & NPCA) and assumptions as
described in the Residential Inhalation Exposure portion of this document (Section 4.b. 1) to
determine the inhalation MOEs for paint application via an airless sprayer. It was assumed that it
could take professional applicators 6 hours to apply paint using an airless sprayer.
The inhalation exposure MOEs for paint application via airless sprayer, in which PPE are
not feasible, are below the target MOE of 30 (MOE = 1 using PHED data; MOE = 2 using
NPCA data). Therefore, paint application via airless sprayer poses as an inhalation risk of
concern to occupational handlers.
Table 15 provides further information on the inhalation doses and MOEs for professional
painter exposure via airless sprayer.
29
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Table #15. Short-term Inhalation Exposures and MOEs for Professional Painter Using an
Airless Sprayer
Method of
Application
Airless Sprayer
(PHED)
Airless Sprayer
(NPCA)
App.Rate
(% a.i.)
0.23%
0.23%
Inhalation Unit
Exposure
PHED (mg/m3/%ai)
NCPA (mg/m3)
0.681
22.91
Air Cone.
(mg/m3)a
0.16
0.053
HEC
(mg/m3)
0.10at6hrs
0.10at6hrs
Route Specific
MOE (ST) b
1
2
A Air con (mg/m3) = App Rate (%ai) x UE (mg/m3/%ai)
(Note that the %ai in the PHED UE is in terms of whole numbers, not fraction (i.e., 0.23 not 0.0023)
Air con (mg/m3) = App Rate (%ai) x UE (mg/m3i)
(Note that the %ai using the NCPA UE is in terms of fraction (i.e., 0.0023)
b Inhalation MOE = HEC (mg/m3) / Air cone. (mg/m3). Target inhalation MOE is 30.
Metal Working Fluids (machinists)
The metal working fluids (machinist) and professional painter scenarios were assessed
and are discussed separately because of the route of exposure that is applicable to these uses, and
because it is not feasible to mitigate these risks with personal protective equipment (PPE)
restrictions. The handler is assumed to be coming into contact with these materials after they
have been preserved with OIT.
There is the potential for dermal and inhalation exposure when a worker handles treated
metalworking fluids. This route of exposure occurs after the chemical has been incorporated into
the metalworking fluid and the machinist is using/handling the treated end use product. Tables
16 and 17 provide further information on the dermal and inhalation doses and MOEs for
machinist exposure to metalworking fluids. The MOE values are above the target MOEs and
therefore, neither dermal or inhalation risks of concern.
Table #16. Short- and Intermediate-term Dermal Exposures and MOEs for Machinist
Exposure to Metalworking Fluids
Exposure
Scenario
Machinist - two
hand immersion
%ai
0 0075%
Hand
Surface Area
(cm2/event)
N/A
840
Film
thickness
(mg/cm2)
10.3 for ST
1.75 for IT
Frequency
(event/
day)
N/A
1
Exposure a
7.7E-4 mg/cm2
0.0016 mg/kg/day
Dermal MOE
(Target MOE is
10 for ST and
100 for IT) b
87
3,800
For ST, exposures are calculated as a.i. per area of skin exposed (mg/cm2) = (% active ingredient x film thickness
mg/cm2 (10.3 for ST exposure). For IT, exposures are calculated as an Absorbed Daily Dose normalized to body
weight (mg/kg/day) = [(% active ingredient x hand surface area (cm2/event) x film thickness (mg/cm2) x Frequency
(event/day)] / Body weight (70 kg).
MOE = NOAEL (mg/kg/day) / exposure, where exposure is a.i. per skin area (mg/cm2) for ST and Absorbed Daily
Dose (mg/kg/day) for IT. [Where: short-term NOAEL = 0.0674 mg/cm2 and intermediate-term NOAEL = 5.95
mg/kg/day for dermal exposures, Table 3.2.]
30
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Table #17. Short- and Intermediate-term Inhalation Exposures and MOEs- Exposure to
Metalworking Fluids treated with PIT (Machinist)
Exposure
Scenario
Machinist
% a.i.
0.0075%
OSHA PEL
(mg/m3)
5
ST/IT Daily Exposure3 (mg/m3)
0.000375
ST/IT Inhalation MOE
(Target MOE = 30) b
200
a Daily exposure or air concentration (mg/m3) = % active ingredient x OSHA PEL (mg/m3).
b MOE = 8 hr HEC (0.073 mg/m3) / air concentration (mg/m3)
d. Occupational Post-application Risk Summary
No occupational post-application exposures are assumed to occur for the occupational
handler use scenarios summarized in Table 12. Any post-application exposures from these uses
are expected to occur in a residential setting, which are described in the residential exposure
portion of this document.
9. Human Incident Data
The Agency reviewed available sources of human incident data for incidents relevant to
OIT. EPA consulted the following sources of information for human poisoning incidents related
to OIT use: (1) OPP Incident Data System (IDS)- The Office of Pesticide Programs (OPP)
Incident Data System contains reports of incidents from various sources, including registrants,
other federal and state health and environmental agencies and individual consumers, submitted to
OPP since 1992; (2) California Department of Pesticide Regulation (1982-2004)- The California
Department of Pesticide Regulation pesticide poisoning surveillance program consists of reports
from physicians of illness suspected of being related to pesticide exposure since 1982; (3)
National Pesticide Information Center (NPIC)- NPIC is a toll-free information service supported
by OPP That provides a ranking of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991.; and (4) Published Incident Reports- Some incident
reports associated with OIT related human health hazard are published in scientific literature.
Dermal exposure is the primary exposure route for all of the reported incidences and most
are related to irritation and/or an allergic type reaction. The most common symptoms reported
for cases of dermal exposure were skin irritation/burning, rash, itching, redness and blistering.
Allergic contact dermatitis has also been reported.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. The
majority of the uses for OIT are considered indoor and to have minimal to no environmental
exposure potential following product use, with the exception of the antisapstain wood treatment
use and the once-through cooling tower use. However, an ecological risk assessment was not
conducted for the once-through cooling tower use because the registrant has indicated that they
will voluntarily cancel this use. In order to be eligible for reregi strati on, the once-through
cooling tower use must be removed from all product labels. An environmental risk assessment is
needed for the antisapstain wood treatment use because this use has a high potential for
31
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environmental exposure. However, an environmental risk assessment could not be conducted
because of outstanding data that are required to conduct a complete antisapstain wood treatment
risk assessment. A Tier I, "down-the-drain" model was preformed to simulate industrial process
wastewater releases, resulting from the uses of OIT as a material preservative.
The following risk characterization is intended to describe the magnitude of the estimated
environmental risks for OIT use sites and any associated uncertainties. For a detailed discussion
of all aspects of the environmental risk assessment, refer to Section 9.0, Environmental Fate, and
Section 10.0, Environmental Risk, in the "Revised Octhilinone Risk Assessment for the
Reregi strati on Eligibility Decision (RED) Document," dated August 20, 2007; the
"Environmental Fate Assessment of Octhilinone," dated March 30, 2007; and the "Transmittal of
Octhilinone (OIT) RED Ecological Hazard and Environmental Risk Assessment Chapter-Case
Number 2425," date March 7, 2007.
1. Environmental Fate and Transport
The environmental fate assessment for OIT was based on guideline data and reports
required by the Agency for an environmental fate assessment; conclusions and values provided
from the Environmental Protection Agencies Office of Water (OW) "down-the-drain" modeling;
and the Environmental Protection Agencies Estimation Programs Interface (EPI) Suite. For
additional information on the environmental fate assessment, please refer to the "Environmental
Fate Assessment of Octhilinone," dated March 30, 2007.
Based on the out-put values from the EPI Suite model and additional resources, the
octanol/water partition coefficient is fairly low (Kow = 3.62). Therefore, OIT is not likely to bio-
accumulate in various aquatic organisms. OIT is stable and persistent in water under abiotic
conditions with a half life of greater than 30 days. OIT does not migrate much and the chemical
binds strongly with soil. Therefore, OIT is expected to remain on surface soils, which may result
in contamination of surface water. OIT's degradation pathway appears to be through microbial
biodegradation in surface soils under aerobic and anaerobic conditions within 120 days. These
values suggest that OIT is expected to biodegrade fairly fast in the environment and any
contamination would be short lived. The vapor pressure of OIT is low (3.68 x 10"5 mm Hg @ 25
0 C) and the vapor is not likely to be persistent in air (air half life = 3.3. hours).
The data that were available and reviewed by the Agency addressed various properties of
OIT such as the stability in water, biodegradation, leaching and behavior in soils. Based on the
results of these studies, when OIT is in water it is likely to be stable and persistent (MRID
44723201) and biodegrade slower than it would in soils (Technical Report 23-17-4). OIT is
immobile in soils and, therefore, is not likely to contaminate groundwater (Technical Reports 23-
72-3 and 3923-74-38). In addition, based on the data provided in a leaching and soil metabolism
study, OIT is not likely to migrate into groundwater. OIT biodegrades in soil medium to less
than 50% over the course of 120 days (Technical Report 3923-75-11).
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2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data. A summary of the submitted data is provided below.
a. Environmental Toxicity
Toxicity to Birds
Available data indicate that OIT is slightly toxic to birds on an acute oral basis and
slightly to relatively non-toxic to birds on a sub-acute dietary basis. Therefore, an avian
environmental hazard statement for birds is not required on manufacturing use product labels.
Toxicity to Terrestrial Animals
Based on the results of mammalian studies conducted to meet human toxicity data
requirements, OIT exhibits moderate oral, dermal, and inhalation toxicity (toxicity category III).
For primary eye irritation, OIT is moderately irritating (toxicity category III). OIT is corrosive
to the skin and is a dermal sensitizer.
Toxicity to Aquatic Animals
On an acute basis OIT is very highly toxic to rainbow trout, estuarine/marine
invertebrates, shrimp & oysters; and is highly toxic to bluegill sunfish, freshwater invertebrates,
and estuarine/marine fish.
Because acute toxicity values to fish, aquatic invertebrate, estuarine/marine aquatic fish,
mollusk and shrimp are <1.0 mg/L, the environmental hazard section of OIT labels must state,
"This pesticide is toxic to fish, aquatic invertebrates, oysters and shrimp."
The guideline requirement for a chronic fish early life stage toxicity study (OPPTS
850.14007 72-4) is not fulfilled due to missing raw data (MRID 41909301). Also, the guideline
requirement for chronic aquatic invertebrate data has not been fulfilled because the maximum
allowable toxicant concentration (MATC) could not be determined (>0.074 mg/L) (MRID
41909401). Additional chronic aquatic toxicity studies are not required to be repeated at this
time, but are held in reserve pending the results of the Tier I risk assessment for the treated
lumber antisapstain use.
Toxicity to Plants
For toxicity to plants, non-target plant phytotoxicity testing is required for pesticides
when certain conditions of use and environmental fate apply. The use of OIT as an antisapstain
wood treatment may result in chemical leachate from treated wood into the aquatic environment.
The guideline requirements for testing toxicity to plants are partially fulfilled for the green algae
33
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toxicity test in which growth inhibition was shown. However, confirmatory data are required to
conduct a Tier I risk assessment for the treated lumber antisapstain use.
A summary of the submitted acute ecological toxicity data, avian sub-acute dietary
toxicity data, chronic freshwater fish toxicity data and aquatic plant toxicity data for OIT are
provided in Tables 18, 19, 20 and 21, respectively.
Table #18. Acute Ecological Toxicity
Species
Chemical,
% Active
Ingredient
(a.i.)
Tested
Endpoint
(mg/kg)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
(MRID No.)
Birds (Acute Oral Toxicity)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Octhilinone
98.5%
Octhilinone
95.9%
Octhilinone
88.7%
Octhilinone
RH-893
(% purity
unknown)
Octhilinone
RH-893
(% purity
unknown)
LD50 = 660
NOAEL = ND
, . .
(a.i.)
LD50 = 384
NOAEL= 171
(a.i.)
LD50 = 346
(a.i.)
LD50 = 565 (M)
and 498 (F)
LD50 > 1000
Slightly toxic
Moderately
toxic
Moderately
toxic
Slightly
toxic
Slightly
toxic
Yes
-2 1-day test
duration
- 19 weeks of age
Yes
- 14-day test
duration
- 21 weeks of age
Yes
No
No
416080-01
448590-01
00026809
86-
870001877
(Ecotox data)
86-
870001877
(Ecotox data)
Freshwater Fish (Acute Toxicity)
Rainbow Trout Octhilinone
(Oncorhynchus 93 5%
mykiss)
LC50 = 0.047
NOAEC = 0.023
.
(a.i.)
Very highly
toxic
Yes
- 96-hr test
duration
- flow-through test
system
416080-05
34
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Rainbow Trout
(Qncorhynchus
mykiss .formerly
Salmo gairdneri)
Bluegill sunfish
(Lepomis
macrochirus)
Fathead minnow
(Pimephales
promelas)
Golden shiner
(Notemigonus
crysoleucas)
Octhilinone
96%
Octhilinone
90%
Octhilinone
98.5%
Octhilinone 96%
Octhilinone
90%
Octhilinone
90%
Octhilinone
90%
Octhilinone
90%
LC50 = 0.05
LOEC = 0.05
NOEC = < 0.05
(a.i.)
LC50 = 0.0655
(a.i.)
LC50 = 0.18
(ai)
LC50 = 0.16
NOAEC = 0.07
(a.i.)
LC50 = 0.196
(a.i.)
LC50 = 0.203
(a.i.)
LC50 = 0.140
(a.i.)
LC50 = 0.154
(a.i.)
Very highly
toxic
Very Highly
toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
Highly toxic
No
- 96-hr test
duration
- static renewal test
system
- toxic effects and
death at all
treatment levels
- small aquaria
No
- 96-hr test
duration
- static test system
Yes
- 96-hr
- flow-through test
system
Yes
- 96-hr test
duration
- static renewal test
system
No
- 96-hr test
duration
- static test system
No
- 96-hr test
duration
- static test system
No
- 96-hr test
duration
- static test system
No
- 96-hr test
duration
- static test system
439357-02
00026805
416080-04
439357-03
00026805
00026805
00026805
00026805
35
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Freshwater Invertebrates (Acute Toxicity)
Waterflea
(Daphnia magna)
Octhilinone
98.5%
Octhilinone
96%
Octhilinone
88.7%
EC50=0.32
NOAEC = 0.21
(a.i.)
EC50= 0.107
NOAEC = 0.055
(a.i.)
LC50 = 0.18
(a.i.)
Highly toxic
Highly toxic
Highly toxic
Yes
- 48-hr test duration
- flow-through test
system
No
- 48-hr test duration
- static test system
- total hardness
above guideline
- small test aquaria
Yes
- 48-hr test
duration
- static test system
416080-06
439357-04
00026806
(Ecotox data
No. 86-
870001884)
Estuarine & Marine Organisms (Acute Toxicity)
Sheepshead
minnow
(Cyprinodon
variegatus)
Mysid shrimp
(Mysidopsis
bahia)
Eastern oyster
(Crassostrea
virginicd)
Octhilinone
98.5%
Octhilinone
98.5%
LC50=0.16
NOAEC =
0.0.054
(a.i.)
LC50= 0.071
NOAEC = <0.034
(a.i.)
Octhilinone
98.5%
Highly toxic
Very highly
toxic
Very highly
toxic
Yes
- 96-hr test
duration
- flow-through test
system
Yes
- 96-hr test
duration
- flow-through test
system
Yes
- 96-hr test
duration
- flow-through test
system
416080-07
416080-08
417007-01
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Table #19. Sub-acute Oral Toxicity of Octhilinone to Birds
Species
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Chemical,
% Active
Ingredient
Tested
Octhilinone
98.5%
Octhilinone
96%
Octhilinone
88.7%
Octhilinone
98.5%
Octhilinone
88.7%
Endpoint
(mg/kg)
LC50(diet) =
>3267
NOAEC = 1288
(a.i.)
LC50 (diet) =
2542
NOAEC = 3 10
.
(a.i.)
LC50 (diet)
>5620
(a.i.)
LC50 (diet) =
1215
NOAEC = ND
(a.i.)
LC50 (diet) =
>5620
Toxicity
Category
Slightly toxic
Slightly toxic
Relatively
nontoxic
Slightly toxic
Relatively
nontoxic
Satisfies Guidelines/
Comments
Yes
- 8-day test duration
- 1 1 weeks of age
No
- 12-day test duration
- 10 days of age
- control mortality
20%
- inadequate housing
Yes
- 8-day test duration
Yes
- 8-day test duration
- 5 days of age
Yes
Reference
(MRID No.)
416080-02
439357-01
00026808
416080-03
00026807
Table #20. Chronic Toxicity of Octhilinone to Freshwater Organisms
Species
Fathead Minnow
(Pimephales promelas)
Waterflea
(Daphnia magna)
Chemical,
% Active
Ingredient
Tested
Octhilinone
98.5%
Octhilinone
98.5%
Endpoint
(mg/L)
LOAEC = ND
NOAEC = ND
MATC >8.5 and
< 0.018; 0.012
geo. Mean
(a.i.)
NOAEC = 0.074
(a.i.)
Satisfies Guidelines/
Comments
No
- 3 5 -day test duration
- early-life stage
- flow-through test
system
-relative S.D. for fish
weight in one control
replicate unacceptable
(53%)
No
- 21 -day test
Reference
(MRID No.)
419093-01
419094-01
37
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Species
Chemical,
% Active
Ingredient
Tested
Endpoint
(mg/L)
Satisfies Guidelines/
Comments
duration
- life-cycle
- flow-through test
system
- MATC could
not be
determined
- raw data missing
Reference
(MRID No.)
Table #21. Toxicity of Octhilinone to Aquatic Plants
Species
Green alga
(Selenastrum
capricornutum)
Chemical,
% Active
Ingredient
Tested
Octhilinone
99.2%
Endpoint
(mg/L)
EC50 (120-hour, cell
density) = 0.0 15)
NOEC (120-hour
cell density) =
0.011
Satisfies Guidelines/
Comments
YES
- growth inhibition
- 120-hr test duration
- static test system
Reference
(MRID No.)
440710-01
b. Ecological Exposure and Risk
The Agency has evaluated the industrial processes wastewater releases (resulting from
the use of OIT as a materials preservative) and antisapstain wood preservative uses being
considered for reregi strati on. The majority of OIT uses are classified as "indoor" and to have
minimal or no environmental impact; therefore, an ecological risk assessment was not needed for
the majority of these uses. However, a Tier I down-the-drain risk assessment was needed to
simulate industrial process wastewater releases. A Tier I ecological risk assessment is also
required for the treated lumber antisapstain use. However, the antisapstain ecological risk
assessment could not be conducted as a result of data deficiencies and unavailable data
endpoints.
Industrial Waste Water Releases
The high stability of OIT in water and its long aerobic and anaerobic half lives triggered
the need for Tier I "down-the-drain" modeling and a "down-the-drain" risk assessment. The
"down-the-drain" model was utilized to provide expected environmental concentrations (EEC's)
for OIT that may be flushed down-the-drain following use of materials treated with OIT and
38
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following industrial applications of OIT treated materials. The "down-the-drain" model
provided the following environmental concentrations (EEC's):
Acute - 0.006 ppb (0.000006 ppm)
Chronic - 0.080 ppb (0.00008 ppm)
The expected EEC's are worst-case estimates assuming that 100% of OIT, produced for
antimicrobial use, is discharged down-the-drain. The worst-case scenario was used for the Tier I
assessment to generate risk quotients. The model does not account for formulation dilution of
active ingredient or for reduced efficacy following use. Table 22 provides the generated risk
quotients and Table 23 provides the risk presumption categories for terrestrial animals, aquatic
organisms, and terrestrial and aquatic plants.
Table #22. Risk Quotients for OIT Industrial Processes and Waste Water Releases using
the Down-the-Drain Model
Species
Rainbow trout
Daphnia magna acute
chronic
Sheepshead minnow
Mysid shrimp
Eastern oyster
Green algae
Toxicity Value (ppm)
0.05 LC50
0.18 EC50
0.07 NOAEC
0.16 LC50
0.07 EC50
>0.06 EC50
0.02 EC50
RQ
0.0016
0.0004
0.00009
0.0005
0.0014
0.0013
0.0040
Table #23. Risk Presumption Categories
Risk Presumption for Terrestrial Animals
Acute: Potential for acute risk for all non-target organisms
Acute Restricted Use: Potential for acute risk for all non-target organisms, but may be mitigated
through restricted use classification
Acute Endangered Species: endangered species may be adversely affected by use
Chronic Risk: potential for chronic risk may warrant regulatory action
Risk Presumption for Aquatic Organisms
Acute: Potential for acute risk for all non-target organisms
Acute Restricted Use: Potential for acute risk for all non-target organisms, but may be mitigated
through restricted use classification
Acute Endangered Species: endangered species may be adversely affected by use
Chronic Risk: potential for chronic risk may warrant regulatory action
Risk Presumption for Terrestrial and Aquatic Plants
Potential for risk for all non-endangered and endangered plants
LOC
>0.5
>0.2
>0.1
>1
LOC
>0.5
>0.1
>0.05
>1
LOC
>1
39
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No acute, chronic, or endangered species level of concerns (LOCs) are exceeded for
aquatic animals and green algae. However, the risk assessment is incomplete due to missing
non-target plant ecotoxicity endpoints. Plants are the most sensitive species tested. Therefore,
the full compliment of plant toxicity tests are required to evaluate toxicity to other non-target
plant groups. Terrestrial animals are not expected to be exposed to residues greater than those
predicted by the "down-the-drain" model.
Antisapstain Wood Treatment Use
As previously mentioned, an antisapstain wood treatment ecological risk assessment for
terrestrial and aquatic organisms could not be conducted for OIT as a result of data deficiencies.
Soil Koc and wood leaching rate data are required in order to conduct the Tier I antisapstain
environmental risk assessment. It is important to note that surface water monitoring data, that
can obtain expected environmental concentrations (EECs), may be submitted in lieu of an
antisapstain model. Due to the high toxicity of OIT to aquatic organisms, chronic fish and
aquatic invertebrate studies are needed. However these studies will be held in reserve pending
the results of the Tier I antisapstain risk assessment. Outstanding plant toxicity studies and
confirmatory ecological toxicity data must be submitted to the Agency in order to conduct an
antisapstain wood treatment risk assessment. These data needs are outlined in Chapter V, Table
X of this document.
Non-target Insects (Honeybee)
Honeybees could potentially be exposed to pesticide residues if treated wood is used to
construct hives or hive components. These residues may be toxic to the bees or result in residues
in honey or other hive products intended for human use/consumption. Therefore, a special
honeybee study is required for all wood preservative uses unless a statement prohibiting the use
of treated wood in hive construction is added to the label such as, "Wood treated with OIT shall
not be used in the construction of beehives." This study is a combination of Guidelines 171-4
and 850.3030 (see information regarding residue data requirements for uses in beehives in the
residue chemistry section of 40 CFR part 158). Numbers of bees used in this study and methods
for collection/introduction of bees into hives, feeding, and observations for toxicity and mortality
should be consistent with those described in OPPTS Guideline 850.3030, "Honey Bee Toxicity
of Residues on Foliage." The toxicity portion of this study is in lieu of the honeybee contact
LD50 test.
c. 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
40
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listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species" (50 C.F.R. ' 402.02).
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly 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. The active ingredient
uses of OIT, with the exception of the industrial waste water discharges and the antisapstain
wood preservation uses, fall into this category.
Risks to aquatic animals and green algae were not identified, using Tier I "down-the-
drain" modeling to assess potential exposure from industrial waste water discharges. However,
the industrial waste water discharges assessment is considered to be incomplete due to missing
non-target plant eco-toxicity endpoints. The full compliment of plant toxicity tests are required to
confirm that green algae is the most sensitive non-target plant species. Terrestrial animals are
not expected to be exposed to residues greater than those predicted by the "down-the-drain"
model. A No Effect determination is made for terrestrial and aquatic animal species from
"indoor" OIT uses. However, the Agency defers making an endangered species determination
for terrestrial and aquatic plants from "indoor" uses, as a result of the industrial waste water
treatment use, of OIT until after receipt of outstanding data.
A Tier I antisapstain model to assess potential exposure from treated antisapstain wood
was not conducted due to the lack of OIT wood leaching rate data and soil Koc's. An
environmental monitoring study of runoff from antisapstain treatment facilities is suggested to
address the potential risks and to provide EECs for a risk assessment as an alternative to the
antisapstain Tier I model. The Agency defers making an endangered species determination for
41
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the antisapstain use of OIT until additional data and modeling refinements are available. At that
time, an environmental exposure assessment of the antisapstain use of OIT will be conducted,
and the risks to Listed Species will be considered.
42
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing OIT as an active ingredient. The Agency has completed its review of
these generic data and has determined that the data are sufficient to support reregi strati on of all
supported products containing OIT.
The Agency has completed its assessment of the dietary, occupational, drinking water,
and ecological risks associated with the use of pesticide products containing the active ingredient
OIT. Based on a review of these data and on public comments on the Agency's assessments for
the active ingredient OIT, the Agency has sufficient information on the human health and
ecological effects of OIT to make decisions as part of the tolerance reassessment process under
FFDCA and reregi strati on process under FIFRA, as amended by FQPA. The Agency has
determined that OIT-containing products are eligible for reregi strati on provided that: (i) current
data gaps and confirmatory data needs are addressed; (ii) the risk mitigation measure outlined in
this document is adopted; and (iii) label amendments are made to reflect this measure. Label
changes are described in Section V. Appendix A summarizes the uses of OIT 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 OIT and lists the submitted studies that
the Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of OIT, the Agency has determined that OIT products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA.
Accordingly, should a registrant fail to implement the risk mitigation measures identified in this
document, the Agency may take regulatory action to address the risk concerns from the use of
OIT. If all changes outlined in this document are incorporated into the product labels, then all
current risks for OIT will be substantially mitigated for the purposes of this determination. Once
an Endangered Species assessment is completed, further changes to these registrations may be
necessary as explained in Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, the EPA worked with stakeholders
and the public to reach the regulatory decision for OIT. During the public comment period,
which closed on August 17, 2007, the Agency received comments from the OIT Task Force
Committee, in response to the EPA's draft OIT risk assessment (RA) and supporting science
documents. The comments included suggestions for using AMEM exposure modeling for the
vinyl flooring assessment; and, the submission of additional paint exposure data to further
characterize the airless sprayer exposure assessment. The task force also suggested the use of a
chemical specific dermal bioavailability data/matrix effect study which impacted the painter
dermal MOEs found in the draft OIT Risk Assessment. Other comments included suggestions
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for additional personal protection equipment (PPE) to reduce possible exposure risks to wood
treatment workers. The Agency's response to these comments has been incorporated, as
necessary, into the revised OIT Risk Assessment and revised supporting science chapters. These
revised documents are available on the U.S. Federal Government's web docket at:
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-0414). A Response to Comment
document will be made available on the public docket in the future. In addition, comments
received by the registrants during the Phase I, Error Only Comments Period, of the RED process
are available on the docket. The Agency is providing a 60-day public comment period on this
RED document.
C. Regulatory Position
a. Determination of Safety to U.S. Population
The Agency has determined that the tolerances for OIT, with amendments and changes
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of OIT. In reaching this conclusion, the
Agency has considered all available information on the toxicity, use practices and exposure
scenarios, and the environmental behavior of OIT.
An acute/chronic dietary risk assessment and an aggregate dietary exposure and risk
assessment were not conducted for OIT because the use patterns are not expected to result in
acute or chronic dietary exposure and toxicity endpoints were not identified. The Agency did
address the possibility of indirect food contact resulting from adhesives preserved with OIT. It
was determined that dietary exposure resulting from possible indirect food contact is not
expected and that a complete dietary assessment was not needed. All labels with the adhesive
use pattern contain language that either specify the type of adhesive (e.g., wallpaper adhesive);
or, the labels state that the products are for non-food use contact. Therefore, there are no indirect
food contact dietary risks of concern. A dietary risk assessment was not conducted for the once-
through cooling tower use because the registrant has indicated that they will voluntarily cancel
this use. In order to be eligible for reregi strati on, this use must be removed from all product
labels.
For adults and children, an aggregate assessment of incidental oral, dermal, and
inhalation exposures was not performed across routes of exposure because toxicity endpoints of
concern were derived from separate toxicity studies. However, the Agency did aggregate route
specific exposures for incidental oral scenarios for children, and dermal scenarios for children
and adults. An aggregate assessment was conducted for dermal exposures of adults to clothing
and mattresses. The total aggregate MOE for dermal exposure to adults (MOE = 42) is above the
target MOE of 10 and is not of concern. An aggregate assessment was also conducted for dermal
exposures of children to treated clothing, mattresses, and vinyl tiles. The total aggregate MOE
for dermal exposures to children (MOE = 42) was above the target of 10 and is not of concern.
An aggregate assessment was also conducted for incidental oral exposures of children mouthing
treated textiles, polymers (plastic toys), and vinyl tiles. The total aggregate MOE for incidental
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oral exposure to children (MOE = 69) is below the target MOE of 100 and, therefore is of
concern. To mitigate the incidental oral aggregate risks of concern for children, the OIT Task
Force has agreed to prohibit the use of OIT preserved plastics to manufacture children's toys.
Product labels with this use must be amended to prohibit the use of OIT preserved plastics to
manufacture children's toys. By removing the toy scenario, the MOE becomes 128 for the
aggregated incidental oral assessment, eliminating aggregate risks of concern for children.
A drinking water assessment was not conducted for OIT because there are no registered
outdoor uses for OIT, with the exception of the antisapstain wood preservative use. OIT is stable
and persistent in water under abiotic conditions, but shows a tendency to biodegrade in biotic
environments. Also, a soil migration study supports that OIT is not expected to be prominent or
migrate into water runoff since it binds strongly to the surfaces of soils. OIT does have a
tendency to remain on the surface of soils. However, the potential for contamination of surface
water, as a result of rainfall, is unlikely to occur because of OIT's tendency to biodegrade in soils
and its minimal outdoor uses. Therefore, OIT it is not expected to contact fresh water
environments.
The Agency acknowledges that there is a very small chance that the antisapstain use of
OIT could potentially result in leaching and runoff when freshly treated wood is stored outdoors.
To mitigate the possible risk that antisapstain treated wood, when stored outside, could
potentially result in leaching and runoff, precautionary antisapstain label language is required on
all antisapstain products. Also, a dietary/drinking water risk assessment was not conducted for
the once-through cooling tower use because the registrant has indicated that they will voluntarily
cancel this use. In order to be eligible for reregi strati on, the once-through cooling tower use
must be removed from all product labels.
b. Determination of Safety to Infants and Children
The EPA has determined that the currently registered uses of OIT, with changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers factors of the toxicity, use
practices, and environmental behavior noted above for the general population, but also takes into
account the possibility of increased susceptibility to the toxic effects of OIT residues in this
population subgroup.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from OIT residues, the Agency considered the completeness of the database for developmental
and reproductive effects, the nature of the effects observed, and other information. The FQPA
Safety Factor has been removed (i.e., reduced to IX) for OIT based on: (1) the toxicology
database is complete with respect to assessing the increased susceptibility to infants and children
as required by FQPA; (2) there is no concern for developmental neurotoxicity resulting from
exposure to OIT in the rat and rabbit prenatal developmental studies and the 2-generation
reproduction study; (3) there is no evidence of increased susceptibility to the fetus following in
utero exposure in the prenatal developmental toxicity studies or to the offspring when adults are
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exposed in the two-generation reproductive study; and (4) the risk assessment does not
underestimate the potential exposure for infants and children.
c. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
d. Cumulative Risks
Risks summarized in this document are those that result only from the use of OIT. The
Food Quality Protection Act (FQPA) requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that
have a common mechanism of toxicity." The reason for consideration of other substances is due
to the possibility that low-level exposures to multiple chemical substances that cause a common
toxic effect by a common toxic mechanism could lead to the same adverse health effect as would
a higher level of exposure to any of the substances individually. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common mechanism of toxicity,
EPA has not made a common mechanism of toxicity finding for OIT. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
D. Regulatory Rationale
The Agency has determined that OIT is eligible for reregi strati on provided that additional
required data confirm this decision, the risk mitigation measures outlined in this document are
adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the uses
of OIT. Where labeling revisions are warranted, specific language is set forth in the summary
tables of Section V of this document.
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1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
An acute/chronic dietary risk assessment and an aggregate dietary exposure and risk
assessment were not conducted for OIT because the use patterns are not expected to result in
acute/chronic dietary exposure and toxicity endpoints were not identified. Therefore, there are
no dietary or indirect food contact dietary risks of concern for OIT. No mitigation is needed at
this time.
b. Drinking Water Risk Mitigation
There are no registered outdoor uses for OIT, with the exception of the antisapstain wood
preservative use. Therefore, the Agency did not conduct a drinking water exposure assessment
because OIT is not expected to come into contact with or be exposed to drinking water. Also, a
dietary/drinking water assessment was not conducted for the once-through cooling tower use
because the registrant has indicated that they will voluntarily cancel this use. In order to be
eligible for reregi strati on, the once-through cooling tower use must be removed from all product
labels.
There is a very small chance that the use of OIT for antisapstain wood preservation could
potentially result in leaching and runoff when freshly treated wood is stored outdoors. This
possible risk can be mitigated with precautionary antisapstain label language. All OIT product
labels with the use of antisapstain must be updated to include the appropriate antisapstain label
language. Please refer to Table 25 for further information regarding OIT label requirements.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler dermal and inhalation risks were assessed for the application of OIT-
preserved paint via an airless sprayer and a paint brush/roller. Short-term (ST) inhalation risks of
concern were identified for the application of paint via airless sprayer (MOEs = 1-6; target
inhalation MOE = 30). The Agency recognizes that the assumptions used in this risk assessment
are conservative and believe that actual exposures are significantly less that those generated by
the models in this particular case. For instance, the models assume 100% absorption which does
not take into account the significant matrix effect that is likely to bind a significant amount of the
OIT within the paint matrix making it unavailable for absorption. Evidence is available
regarding this matrix effect on dermal availability and more than 70% of the OIT was found to
be bound to the paint three hours after exposure. A chamber study is required to further refine
the assessment and confirm that a significant matrix effect is also pertinent to the inhalation route
of exposure. Further, the study used to derive the toxicological endpoint in the risk assessment
had a significant gap (10X) between the dose for the NOAEL and the dose where the effect was
seen (LOAEL). It is reasonable to assume that the actual NOAEL may be higher than the level
available, based on the dosing range. To better characterize the actual NOAEL the registrants
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intend to conduct a new inhalation toxicity study examining doses between the current NOAEL
and LOAEL to refine the assessment. Finally, the effect on which this assessment was based,
irritation, is not considered to be a severe effect especially when compared to the systemic
effects that may be found for other paint preservatives. Based on this rationale, the Agency
believes that to address the identified inhalation risks of concern for the application of paint via
airless sprayer, the maximum use rate for OIT in paint must be reduced from 0.23% active
ingredient to 0.14% active ingredient. Based on the reduced rate and the likelihood that
exposure is overestimated based on the rationale presented above, the Agency considered the
identified risks to me adequately mitigated and do not pose a risk of concern. The studies
described above are necessary to confirm this determination.
ii. Post-Application Risk Mitigation
For the residential post-application assessment, representative scenarios were assessed for
short- and intermediate-term incidental oral and dermal exposures to treated carpets (children),
treated vinyl (children), and treated mattress covers (children & adults). Post-application
scenarios were also assessed for short-term incidental oral exposures of children and dermal
exposures of children and adults to treated clothing/textiles. Short-term incidental oral exposures
to children mouthing treated plastic toys were also assessed. Post-application inhalation
exposures were not assessed because OIT has a relatively low vapour pressure.
Post-application risks of concern were identified for short- and intermediate-term dermal
and incidental oral exposures of children to treated carpet (ST dermal MOE = 9; IT dermal MOE
= 6; ST incidental oral MOE = 6; IT incidental oral MOE = 13). The OIT Task Force has
indicated that OIT is intended to treat carpet-backing only, not carpet fiber. To address theses
risks of concern the use of OIT to treat carpet fiber must be cancelled and deleted from all
product labels. Also, all product labels must be amended to limit the use of OIT in carpets, to
carpet backing only, by adding limitation language to the labels. As a result of the cancellation
of the use of OIT to treat carpet fibers, and label language limiting the use of OIT to treat carpet
backing only, the Agency has determined that all dermal and incidental oral risks of concern
pertaining to children will be eliminated. The rational for this decision is that the Agency does
not conduct exposure assessments for treated carpet-backing use scenarios because exposures are
unlikely. Therefore, by limiting the use of OIT for carpet to carpet-backing only, dermal and
incidental oral exposures to treated carpet fibers will no longer exist. As a result of this
mitigation measure, oral and dermal risks of concern will no longer exist for the treated carpet
fiber use scenario.
Post-application risks of concern were also identified for intermediate-term dermal
exposures of children and adults to treated mattress covers (IT MOE at 5% transfer rate = 73).
To mitigate the dermal risks of concern, the application rate of OIT in mattress ticking must be
reduced from 0.4% active ingredient to 0.3% active ingredient. Reducing the application rate to
0.3% active ingredient in the mattress ticking scenario changes the intermediate-term dermal
exposure to 0.062 mg/kg/day, resulting in an MOE of 96. Although the MOE of 96 is below the
Agency target of 100, the Agency believes that this use does not pose as a risk of concern
because the risk assessment is based on conservative exposure assumptions and the MOE is very
close to the target of 100. Therefore, the Agency believes that there are no dermal risks of
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concern to children from exposure to treated mattress ticking, at the reduced application rate of
0.3% active ingredient. All product labels with the mattress ticking use scenario must be
amended to reflect the reduced application rate.
For the post-application risk assessment exposures to children and adults from treated
clothing and treated mattresses were conducted using a 5% transfer rate. The short-term dermal
MOE for exposure of children and adults to treated clothing/textiles is above the target MOE of
10 at a 5% transfer rate (MOE @ 5% transfer rate =116). The ST dermal MOE for exposure of
children and adults to treated mattresses is also above the target MOE of 10 at a 5% transfer rate
(MOE @ 5% transfer rate =110); and the IT dermal MOE for exposure to adults to treated
mattresses is above the target MOE of 100 at a 5% transfer rate (MOE @ 5% transfer rate =
110). An Indoor Surface Residue Dissipation study is needed to verify the 5% transfer rate for
treated clothing/textiles and mattresses (GL #875.2300).
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
Inhalation risks of concern were identified without the use of a respirator (PPE) for
plastics/vinyl preservation via liquid pour and liquid pump; paint preservation via liquid pour
and liquid pump; and textile preservation via liquid pour. To mitigate these inhalation risks of
concern, occupational handlers must wear a NIOSH approved respirator with an organic vapor
(OV) cartridge or canister with any N, R, P or HE pre-filter. Please refer to Table 25, in this
document, for guidance on the PPE label language that is required for occupational use of OIT.
The use of a respirator eliminates the inhalation risks of concern by raising the MOEs, assessed
without the use of a respirator 10 fold. For plastics and vinyl preservation via liquid pour and
liquid pump the MOEs are raised to 20 with the addition of a respirator. Although the MOE of
20 is below the Agency's target MOE of 30, the Agency believes that these uses do not pose as
occupational risks of concern with the use of a respirator because the risk assessment is based on
conservative exposure assumptions and the MOE is close to the target of 30. Therefore, the
Agency believes occupational inhalation risks of concern for the preservation of plastics and
vinyl via liquid pour and liquid pump will be mitigated with the use of a respirator. Moreover,
receipt of the inhalation toxicity study will allow further refinement of the risk assessment.
Dermal risks of concern were identified for occupational handler intermediate-term
exposure resulting from plastic & vinyl preservation via liquid pour (MOE = 39) and liquid
pump (MOE = 83); and paint preservation via liquid pour (MOE = 67). Dermal exposures for
these industrial applications were assessed wearing gloves, long sleeve shirts, and long pants.
These risks can be mitigated with the addition of further personal protective equipment (PPE) by
having the handlers wear a face shield and a chemical resistant apron. Currently the Agency does
not have method for quantifying the extra protection of an apron and face shield. However, it is
believed that the addition of this equipment will eliminate dermal risks of concern for workers.
To mitigate the dermal risks of concern for occupational handlers, all product labels for
plastic/vinyl preservation via liquid pour and liquid pump, and paint preservation via liquid pour
must include the following PPE statement: "Occupational handlers must wear chemical-resistant
gloves, face shield, chemical-resistant apron worn over long sleeved shirt and long pants and a
NIOSH approved respirator with an organic vapor (OV) cartridge or canister with any N, R, P or
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HE pre-filter." Please refer to Table 25, in this document, for guidance on the PPE label
language that is required for occupational use of OIT.
Inhalation risks of concern were also identified for the application of paint via a
brush/roller (ST/IT MOE = 25) and via airless sprayer (ST/IT MOE = 1-2). The Agency
recognizes that the assumptions used in this risk assessment are conservative and believe that
actual exposures are significantly less that those generated by the models in this particular case.
For instance, the models assume 100% absorption which does not take into account the
significant matrix effect that is likely to bind a significant amount of the OIT within the paint
matrix making it unavailable for absorption. Evidence is available regarding this matrix effect
on dermal availability and more than 70% of the OIT was found to be bound to the paint three
hours after exposure. A chamber study is required to further refine the assessment and confirm
that a significant matrix effect is also pertinent to inhalation route of exposure. Further, the study
used to derive the toxicological endpoint in the risk assessment had a significant gapping (10X)
between the dose for the NOAEL and the dose where the effect was seen. It is reasonable to
assume that the actual NOAEL may be much higher than the level the Agency chose. To better
characterize the actual NOAEL the registrants intend to conduct a new inhalation toxicity study
examining doses between the current NOAEL and LOAEL to refine the assessment. Finally, the
effect on which this assessment was based, irritation, is not considered to be a severe effect
especially when compared to the systemic effects that may be found for other paint
preservatives. Based on this rationale, the Agency believes that to address the identified
inhalation risks of concern for the application of paint via airless sprayer, the maximum use rate
for OIT in paint must be reduced from 0.23% active ingredient to 0.14% active ingredient.
Based on the reduced rate and the likelihood that exposure is overestimated based on the
rationale presented above, the Agency considered the identified risks to me adequately mitigated
and do not pose a risk of concern. Receipt of previously identified data are needed to confirm
this determination.
An occupational handler exposure assessment was not conducted for the industrial
processes and wastewater systems use (water system biocide use). The water system use is only
listed on one manufacturing use product (MUP) label (Reg. #707-308), which does not provide
application or use rates. Since there are no end-use product (EUP) labels containing water
system uses, these uses were not assessed. The industrial process and wastewater treatment use
must be deleted from all manufacturing use product labels or new end-use product labels need to
be formally submitted and reviewed by the Agency.
ii. Post-Application Risk Mitigation
Occupational post-application exposures are expected to be negligible and, therefore,
there are no occupational post-application risks of concern. Mitigation measures are not
necessary at this time.
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2. Environmental Risk Management
For the industrial processes and wastewater use, the Agency conducted a Tier I "down-
the-drain" risk assessment to simulate industrial process wastewater releases. No acute, chronic,
or endangered species Level of Concerns (LOCs) were exceeded for aquatic animals and green
algae. However, the "down-the-drain" risk assessment is incomplete due to missing non-target
plant eco-toxicity endpoints. Plants are the most sensitive species tested. Therefore, plant
toxicity data are required to evaluate toxicity to other non-target plant groups and to conduct a
complete assessment for the industrial processes and wastewater use pattern. Terrestrial animals
are not expected to be exposed to residues greater than those predicted by the "down-the-drain"
model.
The registrant has indicated that they will voluntarily cancel the once-through cooling
tower use. Therefore, a dietary/drinking water assessment was not conducted for this use. In
order to be eligible for reregi strati on, this use must be removed from all product labels.
The Agency could not conduct an ecological risk assessment for the use of OIT as an
antisapstain wood preservative as a result of major data deficiencies. Such data include a soil
Koc and wood leaching-rate data, which are required before a Tier I antisapstain environmental
risk assessment can be conducted. It is important to note that surface water monitoring data, that
can obtain expected environmental concentrations (EECs), may be submitted in lieu of an
antisapstain model. The need for chronic fish and aquatic invertebrate data has been triggered
due to the high toxicity of OIT to aquatic organisms. However these studies will be held in
reserve pending the results of the Tier I antisapstain risk assessment. The identified outstanding
plant toxicity studies and ecological toxicity data must be submitted to the Agency in order to
conduct the antisapstain wood treatment risk assessment. These data needs are outlined in
Chapter V, Table 24.
The following statement must be added to all product labels because the acute toxicity to
fish, aquatic invertebrates, and estuarine/marine species are less then 1.0 mg/L:
This product is toxic to fish, aquatic invertebrates, oysters and shrimp.
Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of a
National Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA.
Registrants are responsible for amending all OIT antisapstain wood preservative
product labels to incorporate the required antisapstain use label language. The following
statement must be placed on all antisapstain products to decrease leaching risks:
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Treated lumber must be stored under-cover, indoors, or at least 100 feet from
any pond, lake, stream, wetland, or river to prevent possible runoff of the
product into the waterway. Treated lumber stored within 100 feet of a pond,
lake, steam, or river must be either covered with plastic or surrounded by a
berm to prevent surface water runoff into the nearby waterway. If a berm or
curb is used around the site, it should consist of impermeable material (clay,
asphalt, concrete) and be of sufficient height to prevent runoff during heavy
rainfall events.
To address exposure to non-target insects, a special honeybee study is required for all wood
preservative uses unless a statement prohibiting the use of treated wood in hive construction is
added to the label such as, "Wood treated with OIT shall not be used in the construction of
beehives." This study is a combination of Guidelines 171-4 and 850.3030 (see information
regarding residue data requirements for uses in beehives in the residue chemistry section of 40
CFR part 158). Numbers of bees used in this study and methods for collection/introduction of
bees into hives, feeding, and observations for toxicity and mortality should be consistent with
those described in OPPTS Guideline 850.3030, "Honey Bee Toxicity of Residues on Foliage."
The toxicity portion of this study is in lieu of the honeybee contact LD50 test.
3. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing OIT. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
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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. The active ingredient
uses of OIT, with the exception of the industrial waste water discharges and the antisapstain
wood preservation uses, fall into this category.
Risks to aquatic animals and green algae were not identified, using Tier I "down-the-
drain" modeling to assess potential exposure from industrial waste water discharges. However,
the industrial waste water discharges assessment is considered to be incomplete due to missing
non-target plant eco-toxicity endpoints. The full compliment of plant toxicity tests are required to
confirm that green algae is the most sensitive non-target plant species. Terrestrial animals are
not expected to be exposed to residues greater than those predicted by the "down-the-drain"
model. A No Effect determination is made for terrestrial and aquatic animal species from
"indoor" OIT uses. However, the Agency defers making an endangered species determination
for terrestrial and aquatic plants from "indoor" uses (industrial waste water treatment use) of OIT
until after receipt of outstanding data.
A Tier I antisapstain risk assessment model could not be conducted to assess potential
exposure from treated antisapstain wood products due to the lack of OIT wood leaching-rate data
and soil Koc's. An environmental monitoring study of run-off from antisapstain treatment
facilities is suggested to address the potential risks and to provide EECs for a risk assessment as
an alternative to an antisapstain Tier I assessment. Impacts from the antisapstain use could
potentially be mitigated with precautions to prevent leaching and run-off when wood is stored
outdoors (see General Risk Mitigation, below). Due to these circumstances, the Agency defers
making a determination for the antisapstain uses of OIT until additional data and modeling
refinements are available. At that time, the environmental exposure assessment of the
antisapstain use of OIT will be revised, and the risks to Listed Species will be reconsidered.
b. General Risk Mitigation
OIT end-use products (EPs) may also contain other registered pesticides. Although the
Agency is not proposing any mitigation measures for products containing OIT specific to
federally listed species, the Agency needs to address potential risks from other end-use products.
53
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Therefore, the Agency requires that users adopt all listed species risk mitigation measures for all
active ingredients in the product. If a product contains multiple active ingredients with
conflicting listed species risk mitigation measures, the more stringent measure(s) should be
adopted.
54
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V. What Registrants Need to Do
The Agency has determined that OIT is eligible for reregi strati on provided that: (i)
additional data that the Agency intends to require confirm this decision; (ii) the risk mitigation
measure outlined in this document is adopted; and (iii) label amendments are made to reflect this
measure. To implement the risk mitigation measure, the registrants must amend their product
labeling to incorporate the label statement set forth in the Label Changes Summary Table in
Section B below (Table 24). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For OIT technical grade active ingredient products, the registrant needs to submit the
following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding generic
reregi strati on.
By US mail:
Document Processing Desk
K. Avivah Jakob
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
K. Avivah Jakob
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
One Potomac Yard, Room S-4900
2777 South Crystal Drive
Arlington, VA 22202
55
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For end-use products containing the active ingredient PIT, 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 23
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Marshall Swindell at (703) 308-6341 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Marshal Swindell Marshal Swindell
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
56
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of OIT has been reviewed and
determined to be substantially complete. However, the following additional data requirements
have been identified by the Agency as confirmatory data requirements and are included in the
generic data call in (DCI) for this RED.
Residential & Occupational Handler Confirmatory Data
A 21/28-day dermal toxicity study (870.3200) is needed to refine the dermal exposure
estimates for both the residential and occupational painter scenarios. The dermal exposure
estimate for both the residential and occupational painter scenarios, using treated paint, was
based on wet film thickness data from a study where the user's hands were immersed twice in
mineral oil. No information specific to the wet film thickness of paint was identified. The
method employed may result in an underestimate of dermal exposures to paint. Therefore, this
assessment could be refined by conducting a dermal irritation study where OIT treated paint is
the test substance.
An inhalation exposure study (chamber study) (875.2500) is needed to further refine the
residential and occupational handler assessments and to confirm that a significant matrix effect is
also pertinent to the inhalation route of exposure. The Agency recognizes that the assumptions
used in the OIT risk assessment are conservative and believe that actual exposures are
significantly less that those generated by the models in this particular case. For instance, the
models assume 100% absorption which does not take into account the significant matrix effect
that is likely to bind a significant amount of the OIT within the paint matrix making it
unavailable for absorption. Evidence is available regarding this matrix effect on dermal
availability and more than 70% of the OIT was found to be bound to the paint three hours after
exposure. Therefore, an inhalation exposure study is needed to further refine the assessment.
A 90-day inhalation toxicity study (870.3465) is needed to better characterize the
inhalation NOAEL and to refine the residential and occupational exposure assessments. The
study used to derive the toxicological endpoint in the risk assessment had a significant gap (10X)
between the dose for the NOAEL and the dose where the effect was seen. It is reasonable to
assume that the actual NOAEL may be much higher than the level the Agency chose. To better
characterize the actual NOAEL the registrants intend to conduct a new inhalation toxicity study
examining doses between the current NOAEL and LOAEL to refine the assessment.
Surrogate dermal and inhalation unit exposure values were taken from the proprietary
CMA antimicrobial exposure study (USE EPA 1999: DP Barcode D247642). Most of the CMA
data are of poor quality and, therefore, the Agency requests that confirmatory monitoring data be
generated to support the values used in the occupational and residential risk assessments and to
further refine these assessments. The following confirmatory monitoring data are needed: dermal
exposure-indoor & outdoor data (875.1200 & 875.1100, respectively), and inhalation exposure-
57
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indoor & outdoor data (875.1400 & 875.1300, respectively). Product use information (875.1700)
and description of human activity data (875.2800) are also needed to further define the exposure
scenarios being supported and to further refine the assessments.
Residential Post-Application Confirmatory Data
An indoor surface residue dissipation study (GL 875.2300) is needed to verify the 5%
transfer rate from treated clothing/textiles and from treated mattresses.
Environmental Fate and Ecological Exposure Confirmatory Data
Non-target plant toxicity data are needed to further refine and complete the "down-the-
drain" risk assessment for the industrial process and wastewater releases. For the industrial
processes and wastewater use, the Agency conducted a Tier I "down-the-drain" risk assessment
to simulate industrial process wastewater releases. However, the "down-the-drain" risk
assessment is incomplete due to missing non-target plant eco-toxicity endpoints. Plants are the
most sensitive species tested. Therefore, plant toxicity data are required to evaluate toxicity to
other non-target plant groups and to conduct a complete assessment for the industrial processes
and wastewater use pattern.
The OIT Task Force has identified that they wish to cancel the once-through cooling
tower use. However, receipt of this removal has not yet been submitted. Unless the registrant
formally cancels this use, the data requirements for the once-through-cooling tower use will be
applicable.
The Agency could not conduct an ecological risk assessment for the use of OIT as an
antisapstain wood preservative as a result of major data deficiencies. Such data include a soil
Koc and wood leaching-rate data, which are required to conduct a Tier I antisapstain
environmental risk assessment. It is important to note that surface water monitoring data, that
can obtain expected environmental concentrations (EECs), may be submitted in lieu of an
antisapstain model. The need for chronic fish and aquatic invertebrate data has been triggered
due to the high toxicity of OIT to aquatic organisms. However these studies will be held in
reserve pending the results of the Tier I antisapstain risk assessment. The identified outstanding
plant toxicity studies and ecological toxicity data must be submitted to the Agency in order to
conduct the antisapstain wood treatment risk assessment.
Table 24, below, provides an outline of the requested human health and ecological
confirmatory data needs for OIT.
58
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Table #24. Data Requirements for PIT
Guideline Study Name
New OPPTS Guideline Number
Human Health Confirmatory Data
21/28-Day dermal Toxicity Study
Inhalation Exposure Study
90-Day Inhalation Toxicity Study
Indoor Surface Residue Dissipation Study
Dermal exposure-indoor & outdoor data
Inhalation exposure-indoor & outdoor data
Product Use Information
Description of Human Activity Data
870.3200
875.2500
870.3465
875.2300
875. 1200 & 875. 1100
875. 1400 & 875. 1300
875. 1700 & 875.2700
875.2800
Environmental Fate & Ecological Exnosure Confirmatorv Data
Freshwater Diatom
Blue-green Cyanobacteria
Marine Diatom
Freshwater Floating Macrophyte Duckweed
Freshwater Rooted Macrophyte Rice Seedling Emergence
Freshwater Rooted Macrophyte Rice Vegetative Vigor
Soil Koc Study
Wood Leaching Study
Residues in honey^eeswax and toxicity of treated wood residues
to bees
(This test can be waived provided that labels are amended as
outlined for wood preservative use)
850.5400
850.5400
850.5400
850.4225
850.4225
850.4250
835.1220
AWPA Method El 1-06, Standard Method of
Determining the Leachability of Wood
Preservatives Immersed in Water, AWPA,
2006
Combination of Guideline 860. 1500 and
850.3030
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
25, Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
59
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meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in will be issued at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 25, Label Changes Summary
Table.
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.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the OIT RED. The following
table describes how language on the labels should be amended.
60
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Table 25. Labeling Changes Summary Table
Description
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
Amended Labeling Language
"This product is toxic to fish, aquatic invertebrates, oysters and shrimp. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters
unless in accordance with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA. "
Placement on Label
Precautionary
Statements
End Use Products Intended for Occupational Use
PPE Requirements
For all antisapstain end-use
products
"Wear chemical-resistant gloves, goggles, face shield, chemical-resistant apron worn over long
sleeved shirt and long pants and a NIOSH approved respirator with an organic vapor (OV)
cartridge or canister with any N, R, P or HE pre-filter"
"Antisapstain treated lumber must be stored under cover, indoors, or at least 100 feet from any
pond, lake, stream, wetland, or river to prevent possible runoff of the product into the
waterway. Treated lumber stored within 100 feet of a pond, lake, steam, or river must be either
covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby
waterway. If a berm or curb is used around the site, it should consist of impermeable material
(clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall
events."
Immediately
following^elow
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
This language is to be
included in the
Environmental Hazards
section of the label.
Directions For Use
End Use Products Intended for
Plastic Preservation (or treated
plastic products)
End Use Products Intended for
Carpet Treatment
"Treated plastics can not be used to manufacture children's toys"
"Use only to treat carpet-backing. Not for use in carpet fibers."
61
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VI. APPENDICES
62
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Appendix A. Table of Use Patterns for OIT
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Materials preservatives
Coatings: latex and solvent-
based paints, semi-transparent
stains and solid stains.
Paints and Coating Materials
707-100
(Formulation
Intermediate)
707-208
(Soluble
Concentrate)
707-303
(Soluble
Concentrate)
5383-101
5383-102
(Ready to Use)
67071-6
(Ready to Use)
67071-17
(Emulsifiable
Concentrate)
67071-39
(Soluble
Concentrate)
67071-31
(Soluble
Concentrate)
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Added at the
beginning of the
formulation
process while
mixing of the final
product.
Incorporated into
formulation of end
use product
Not listed
Incorporated with
products during the
manufacturing
process
1.0 to 4.0 pounds of product per
100 gallons of coating
formulation.
1.64 to 6.55 pounds of product
per 100 gallons of coating
formulation.
0.25 to 2.0 pounds of product
per 100 gallons of coating
formulation.
(0.2-2.0%) add 2-20 Ibs. (0.9-
9.0kg) of product to each 1000
Ibs. (453 kg.) of paint.
0.1 to 5 pounds of product per
100 gallons of paint.
0.20 to 2.5% (wt/wt) based on
paint or coating used on the
surface.
Add 0.1% to 2.0% of product
based on weight of the
formulation of paint or wood
coating.
None Listed
None Listed
None Listed
None Listed
None Listed
Not for incorporation in products used to paint
swimming pools.
None Listed
63
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Use Site
Plasters & Stuccos
Sealants, caulks and fillers
Concentrates
Building Materials: elastomeric
roof, wall coatings, mastics,
caulks, sealants, joint cements,
spackling, stucco and grouting
Wallpaper Pastes and
Adhesives
Formulation
5383-101
5383-102
(Ready to Use)
5383-101
5383-102
(Ready to Use)
67071-17
(Emulsifiable
Concentrate)
707-100
(Formulation
Intermediate)
707-100
(Formulation
Intermediate)
707-208
(Soluble
Concentrate)
707-303
(Soluble
Concentrate)
707-100
(Formulation
Intermediate)
707-208
(Soluble
Concentrate)
Method of
Application
Added at the
beginning of the
formulation
process while
mixing of the final
product.
Added at the
beginning of the
formulation
process while
mixing of the final
product.
Not listed
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Application Rate/ No. of
applications
((0. 1 - 1.0) add l-101bs. (0.45
- 4.5kg) of product to each 1000
Ibs. (453 kg.) of plasters.
(0.1-1.5%)addl-151bs.
(0.45 - 6.8kg.) of paste to each
1000 Ibs. (453 kg. ) of sealant
filler.
0.20 to 0.75% (wt/wt) based on
formulations
For higher humidity areas: up to
2.5% product may be required
1.0 to 3.0 pounds of product per
100 gallons of coating
formulation.
1.0 to 3.0 pounds of product per
100 gallons of coating
formulation.
5.9 to 8.2 pounds of product per
100 gallons of coating
formulation.
0.25 to 3.0 pounds of product
per 100 gallons of coating
formulation.
0.1 to 415 pounds of product per
100 gallons of coating
formulation.
0.12 to 0.16 pounds of product
per 100 gallons of coating
formulation.
Use Limitations
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
64
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Use Site
Aqueous Adhesive and
Tackifier Preservation
Water based Emulsions/
Adhesives
Fabric Mildewcide
Formulation
707-100
(Formulation
Intermediate)
707-208
(Soluble
Concentrate)
3090-217
(Soluble
Concentrate)
67071-6
(Ready to Use)
10466-42
(Soluble
Concentrate)
707-121
(Ready to Use)
707-208
(Soluble
Concentrate)
707-236
(Ready to Use)
Method of
Application
Incorporated into
formulation of end
use product
Incorporated into
formulation of end
use product
Not Listed
Incorporated into
formulation of end
use product
Add as a
component to final
product prior to
mixing
Add to final rinse
of fabric
Add to final rinse
of fabric
Add to final rinse
of fabric
Application Rate/ No. of
applications
1.0 to 0.20 pounds of product
per 100 gallons of coating
formulation.
0.05 pounds of product per 100
gallons of coating formulation.
Use a concentration of 0.3 to 1.5
of product relative to the total
weight of the material being
treated.
0.1 to 5 pounds of product per
1000 gallons of adhesive.
Apply 0.8 to 1.5% of product by
weight.
1.14 to 2.28 fluid ounces of
product for every 100 gallons of
final rinse.
0.68 to 1.37 fluid ounces of
product for every 100 pounds of
fabric treated
0.27 fluid ounces of product for
every 100 gallons of final rinse.
0.68 to 0. 1 14 fluid ounces of
product for every 100 pounds of
fabric treated.
1 !/4 to 2 1/2 fluid ounces of
product for every 100 gallons of
final rinse.(5-10ppm active
ingredient)
Use Limitations
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
65
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Use Site
Fabric Mildewcide
Fabrics w/ Human Contact:
Mattress Ticking, footwear
fabrics, outerwear, hosiery,
Feathers and Down
Latices: (Polymers, synthetic,
Rubber)
Leather Preservative
Formulation
67071-6
(Ready to Use)
3090-217
10466-42
(Soluble
Concentrate)
3090-217
(Soluble
Concentrate)
707-121
(Ready to Use)
707-236
(Ready to Use)
1448-412
(Soluble
Concentrate)
Method of
Application
Not Listed
Not Listed
Add to the cold
liquor at room
temperature, run
for 5 minutes cold
then raise
temperature to
49C/120Fovera
period of 15
minutes, Maintain
bath at the stated
temperature for a
further 15 minutes.
Not listed
Incorporated in
tanning process
Incorporated in
tanning process
Incorporated in
tanning process
Application Rate/ No. of
applications
3/4 to 1 1/2 fluid ounces of
product for every 100 pounds of
fabric treated (3-6ppm active
ingredient)
0.1 to 0.25% by weight of
product calculated on the
materials weight.
Use a concentration of 1.0 to
2.0% of product relative to the
dry weight of the
fabric/textile/material being
treated
Use a concentration of 0.3 to
1.5% of the product relative to
the total weight of the material
being treated.
1 170ppm to 3530ppm to every
10,000 pounds of wet hide.
1260ppm to 3780ppm to every
10,000 pounds of wet hide.
0.01-0.3% (100 - 10,000ppm)
Use Limitations
None Listed
None Listed
None Listed
None Listed
None Listed
None Listed
66
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Use Site
Chrome
Metalworking Fluid
Preservation
Hydraulic Fluid Preservation
Formulation
67071-6
(Ready to Use)
39967-46
(Soluble
Concentrate)
39967-46
(Soluble
Concentrate)
707-195
67071-6
(Ready to Use)
67071-6
(Ready to Use)
Method of
Application
Not listed
Gradually add to
float or to product
to be preserved
Gradually add to
float or to product
to be preserved
Dispensed directly
into metalworking
concentrate
Dispense directly
into the hydraulic
concentrate using a
metered pump
Application Rate/ No. of
applications
0.014 to 0.045% of product
calculated on the pelt weight.
0.2-0.5% product calculated on
the pelt weight
Dilute with 2-5 parts water.
55 to 167 ppm of product/ 25 to
75 ppm of active ingredient for
final use dilution
initial dose 0.47 to 1.44 pounds
(7 to 21 fluid ounces) of product
per 1000 gallons of emulsion
25-7 5ppm of active ingredient.
Subsequent Dose: 0.09 to 0.58
pounds (1.3 to 8.6 fluid ounces)
of product per 1000 gallons of
emulsion every 4 weeks.
Provides 5 to 30 ppm active
ingredient.
55 to 167 ppm of product/ 25 to
75 ppm of active ingredient for
final use dilution
initial dose 0.47 to 1.44 pounds
(7 to 21 fluid ounces) of product
per 1000 gallons of emulsion
25-7 5ppm of active ingredient.
Subsequent Dose: 0.09 to 0.58
pounds (1.3 to 8.6 fluid ounces)
Use Limitations
None Listed
None Listed
None Listed
None Listed
None Listed
67
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
of product per 1000 gallons of
emulsion every 4 weeks.
Provides 5 to 30 ppm active
ingredient.
Polymer Compounds
707-208
(Soluble
Concentrate)
Incorporated into
formulation of end
use product
0.15 to 0.36 pounds of product
per 100 pounds of compounded
polymer systems.
None Listed
10466-42
(Soluble
Concentrate)
Add product in
post treatment
Apply 0.8 to 1.5% of product by
weight.
None Listed
Polymer Latex Preservation
707-286
(Soluble
Concentrate)
Add latex
2.15 to 4.29 pounds of product
(971 - 1946 grams) to each 1000
pounds (453 kilograms) of fluid
to provide 2143 - 4290 ppm
product 9500 - lOOOppm active
ingredient)
Finished textile articles incorporating this product may
not make any pesticidal claims without obtaining a
pesticide registration. Consult PR Notice 2000 for
allowable claims for treated articles.
Vinyl: shower Curtains, wall
coverings, mattress covers,
interior automotive parts,
coated fabrics for upholstery.
Exterior use Vinyl: landau tops,
exterior automotive trim,
tarpaulins, awnings, ditch and
pond liners, marine upholstery,
swimming pool liners.
2829-127
(Ready to Use)
Incorporated into
formulation of end
use product
3% of product based on total
weight of formulation of items
for interior use.
5% of product based on total
formulation of items subjected to
extended outdoor weathering.
None Listed
2829-133
(Pelleted
Tableted)
Incorporated into
formulation of end
use product
1.2% of product based on total
weight of formulation of items
for interior use.
2.0% of product based on total
formulation of items subjected to
extended outdoor weathering.
None Listed
5383-128
Incorporated into
formulation during
mixing or
compounding
process
Suggested concentrations
between 2 and 5%
Product should not be used in treated articles which are
intended to contact food or drinking water.
68
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
67071-43
(Soluble
Concentrate)
Add 0.5% to 4.0% of product
based on the total weight of the
formulation/ composition.
None Listed
Casein/Resin
3090-217
(Soluble
Concentrate)
Not Listed
Use a concentration of 0.3 to
1.5% of the product relative t the
total weight of the material being
treated.
None Listed
Plasticized PVC Exterior items:
swimming pool liner, roof liner,
lining foils, cable casings,
tarpaulins, tents, garden hoses,
Interior Items: Floor and wall
coverings, coated furniture
fabrics, shower curtains,
awnings.
3090-219
(Soluble
Concentrate)
Incorporated at
various stages of
manufacturing
process
Finished product to contain 0.5
to 1.4% by weight of the
additive
Product is not registered for use as a sanitizer
Do not use in the manufacture or treatment of items
that may come in contact with food. Do not use for the
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 (items regulated by the FDA)
67071-6
(Ready to Use)
Can be introduced
in different phases
of the process
cycle.
Interior products: 0.1 to 0.5% of
product based on total weight of
the formulation/composition.
Exterior products: 0.15% to
0.75% of product based on the
total weight of the formulation/
composition.
Product should never be introduced directly into fillers
and pigments.
Plasticized PVC Exterior items:
swimming pool liner, roof liner,
lining foils, cable casings,
tarpaulins, tents, garden hoses,
Interior Items: Floor and wall
coverings, coated furniture
fabrics, shower curtains,
awnings.
81348-8
(Soluble
Concentrate)
Not listed
Interior: Level of 1.2% product
based on total weight of the final
treated product.
Exterior products: a level of 2%
should be evaluated
Do not use product where treated plastic materials can
come into contact with humans or pets or be used as
food or feed packing materials or as food contact
surfaces.
Human Clothing PVC Items:
Rain wear, protective wear,
shoes, boots, PVC slippers,
3090-219
(Soluble
Concentrate)
Incorporated at
various stages of
manufacturing
Finished product to contain 0.5
to 1.4% by weight of the
additive
Product is not registered for use as a sanitizer.
69
-------
Use Site
gloves.
Formulation
Method of
Application
process
Application Rate/ No. of
applications
Use Limitations
Industrial Processes and Water Systems
Air Washer Water
Cooling Tower Water
707-308
(Formulation
Intermediate)
707-308
(Formulation
Intermediate)
Not Stated
Not Stated
Not Stated
Not Stated
None Stated
None Stated
Antifouling Coating
Boats/ Ships: Wood, fiberglass
or metal
48302-12
(Ready to Use)
Spray, brush or
Roll on
192 sq. ft/gal at 4.0 mils or 960
sq. ft. per container
Do not apply by airless spray. Do not apply more than
one coat of product within 24 hours. Apply only in
outdoor, non-enclosed spaces. Do not launch vessels
before recommended drying time.
Wood Preservation
Debarked logs to be made into
plywood
73612-1
(Soluble
Concentrate)
Spray
40 to 180 liters of product
concentrate per 1,000 liters of
water.
Treated Wood Must not be used where it may contact
food or animal feed.
70
-------
Appendix B: Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide to Appendix B
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Octhilinone. These requirements apply to
Octhilinone 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.
Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
3. product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishment 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
4. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column will
identify 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.
71
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.6302
830.6303
830.6304
830.7220
830.7300
830.7840
830.7860
61-1
6 1-2 A
61-2B
62-1
62-2
63-2
63-3
63-4
63-6
63-7
63-8
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analyses
Certification of Limits
Color
Physical state
Odor
Boiling Point
Density
Solubility
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
43499601
43499601
43499601
43505501
43499601, 43505501
43499602
43499602
43499602
43499603, 43499602
43499605, 43499602
43499606, 43499602
72
-------
DATA REQUIREMENT
New Guideline
Number
830.7950
830.7370
830.7550/830.7570
830.7000
830.6313
830.6317
830.7100
830.6320
Old Guideline
Number
63-9
63-10
63-11
63-12
63-13
63-17
63-18
63-20
Study Title
Vapor Pressure
Dissociation Constant
Partition coefficient (w-octanol/water), shake flask method/Partition
coefficient (w-octanol/water), estimation by liquid chromatography
pH
Stability to normal and elevated temperatures, metals, and metal ions
Storage Stability
Viscosity
Corrosion characteristics
Use Pattern
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
CITATION(S)
MRID Number
41222604,41482501,
43499607, 43499602
43499608, 43499602
43499609, 43499602
43499602
43499610, 43499602
43499611,43499602
43499602
43499602
ECOLOGICAL EFFECTS
850.2100
850.2200
71-1
71-2
Avian acute oral toxicity test - Quail/Duck
Avian dietary toxicity test - Duck/Quail
7, 8, 9, 10
7, 8, 9, 10
00026809,41608002,
41608003, 44859001
00026807, 00026808,
41608001,43935701
73
-------
DATA REQUIREMENT
New Guideline
Number
850.1075
850.1010
850.1025
850.1035
850.1075
850.1085
850.1300
850.5400
Non-Guideline
Non-Guideline
Old Guideline
Number
72-1
72-2
72-3
72-3
72-3
72-4
72-4
123-2
Non-Guideline
Non-Guideline
Study Title
Fish acute toxicity test - Freshwater - Bluegill/Rainbow trout/Daphnia
magna/Oncorhynchus mykiss/Leopomis macrochirus
Aquatic invertebrate acute toxicity test, freshwater daphnids
Oyster acute toxicity test (shell disposition)
Mysid acute toxicity test
Fish acute toxicity test - Estuarine/Marine
Fish acute toxicity mitigated by humic acid
Daphnid chronic toxicity test
Alsal toxicitv. Tiers I and II
Green algae - Selenastmm capricornutum
(Pseudokerscheneria subcapitatum)
Blue-green cyanobacteria -Anabaena flos-aquae
Freshwater diatom - Navicula pelliculosa
Marine diatom - Skeletonema costatum
Acute toxicity to water flea (Daphnia magna)
Acute toxicological evaluations with wildlife
Use Pattern
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
CITATION(S)
MRID Number
41608004,41608005,
41608006,43935702,
43935703
43935704
41700701
41608008
41608007
00026805, 41909301
41909401, 43935704
44071001
Data Gap
Data Gap
Data Gap
00026806
47107013
74
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.3250
870.3465
81-1
81-2
81-3
81-4
81-5
81-6
82-1
81-2
82-2
82-3
82-4
Acute oral toxicity - Rat
Acute dermal toxicity - Rabbit
Acute inhalation toxicity - Rat
Acute eye irritation - Rabbit
Acute dermal irritation
Skin sensitization
90-Day oral toxicity in rodents
90-Day oral toxicity in nonrodents
21/28-Day dermal toxicity
90-Day dermal toxicity
90-Day inhalation toxicity
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
00063214, 00070456
00070456
00063214
00063214
00063214
00063214,41482505,
41482507,
00136524
00136525
00136526
42007301,43935705,
43935706
00136527, 41544701
75
-------
DATA REQUIREMENT
New Guideline
Number
870.4200
870.3700
870.5100
870.5195
870.5550
870.5385
Non-Guideline
Old Guideline
Number
83-2
83-3
84-2
84-2
84-2
84-2
Non-Guideline
Study Title
Carcinogenicity
Prenatal developmental toxicity study
Bacterial reverse mutation test
Mouse biochemical specific locus test
Unscheduled DNA synthesis in mammalian cells in culture
Mammalian erythrocyte micronucleus test
Contact Dermatitis
Use Pattern
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
7, 8, 9, 10
CITATION(S)
MRID Number
00139417,00139419,
00139484
00046403, 00058029,
00136528,41482508,
41482509,43935707,
43944401
43935708
43935709
40647505
43935710
Open Literature
ENVIRONMENTAL FATE
835.2110
161-1
Hydrolysis as a function of pH
7, 8, 9, 10
44723201
76
-------
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 legal holidays, from 8:30 am to 4 pm.
The docket initially contained the May 25, 2007 preliminary risk assessment and the
related documents. EPA then considered comments on these risk assessments (which are posted
to the e-docket) and revised the risk assessments. The revised risk assessments will be posted in
the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov
These documents include:
Reregi strati on Eligibility Decision (RED) Document:
Reregistration Eligibility Decision for 2-Octyl-3 (2H)-isothiazolone (OIT), 09/28/2007
Preliminary Risk Assessment and Supporting Science Documents:
Revised Octhilinone Risk Assessment for the Reregistration Eligibility Decision (RED)
Document. PC Code: 099901 (active). Case No. 2475. DP Barcode: D337742, 5/25/2007
Revised Occupational and Residential Exposure Chapter for Octhilinone (OIT) for
Reregistration Eligibility Decision (REDO Document (Case 2475), 5/25/2007
Transmittal of Octhilinone (OIT) RED Ecological Hazard and Environmental Risk
Assessment Chapter-Case Number 2475, 3/7/2007
Environmental Fate Assessment of Octhilinone, 3/30/2007
Incident Reports Associated with Octhilinone, 4/5/2007
Product Chemistry of Octhilinone for Reregistration Eligibility Decision (RED), 2/6/2007
Dietary Exposure Assessment of Octhilinone Use of Indirect Food Contact Surfaces,
2/21/2007
Evaluation of Toxicology Database for the Reregistration Eligibility Decision Document
Disciplinary Chapter, 3/5/2007
Revised Risk Assessment and Supporting Science Documents:
Revised Octhilinone Risk Assessment for the Reregistration Eligibility Decision (RED)
Document. PC Code: 099901 (active). Case No. 2475. DP Barcode: D337742,
9/20/2007
Evaluation of Toxicology Database for the Reregistration Eligibility Decision Document
Disciplinary Chapter, 10/31/2007
Revised Occupational and Residential Exposure Chapter for Octhilinone (OIT) for the
Reregistration Eligibility Decision (RED) Document (Case 2475), 9/17/2007
77
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
1. MRID Studies
MRID#
00010890
00026805
00026806
00026807
00026808
00026809
00046403
00058029
Citation
Copley, M. (1994) Octhilinone Waiver Request for a Dermal of
Sensitization Study; Unpublished study prepared by the U.S. EPA,
ID 099901-000707, Apr. 8, 1994.
Hutchinson, C. (1979) Bioassay Report: Acute Toxicity of RH-
893 Technical to Five Species of Freshwater Fishes. Unpublished
data. Conducted by Bionomics, Inc. for Rohm and Haas Company.
Stiefel, C. (1979) Acute Toxicity of RH-893 Technical to the
Water Flea (Daphnia magna). Lab Report No. BW-79-7-503.
Unpublished data. Conducted by Bionomics, Inc. for Rohm and
Haas Company.
Beavers, J.B. et. al. (1979) Eight-day Dietary LC50 - Mallard Duck
RH-893 Technical (79P-251) Final Report. Unpublished data.
Conducted by Wildlife International. Ltd. for Rohm and Haas
Company.
Beavers, J.B. et. al. (1979) Eight-day Dietary LC50 - Bobwhite
Quail RH-893 Technical (79P-253) Final Report. Unpublished
data. Conducted by Wildlife International. Ltd. for Rohm and Haas
Company.
Beavers, J.B. et. al. (1979) Acute Oral LD50 - Bobwhite Quail RH-
893 Technical (79P-252) Final Report. Unpublished data.
Conducted by Wildlife International. Ltd. for Rohm and Haas
Company.
Powers, M.B. (1971) Final Report: Teratology Study-Rats: Project
No. 417-349. (Unpublished study received May 25, 1971 under
unknown admin, no.; prepared by Hazleton Laboratories,
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL: 107967-
A).
Powers, M.B. (1970) Final Report: Teratology Study-Rabbits:
Project No. 417-346. (Unpublished study received Feb 3, 1977
under 984-67; prepared by Hazleton Laboratories, Inc., submitted
78
-------
00063214
00070456
00136524
00136525
00136527
00136528
00139417
by Whitmoyer Laboratories, Inc., Myerstown, Pa.; CDL:229345-
A).
Powers, M.B. (1970) Final Report [for Octhininone]: Acute Oral -
Rats; Draize Eye Irritation - Rabbits; Primary Skin Irritation -
Rabbits; Skin Sensitization - Guinea Pigs; Acute Inhalation
Exposure - Rats: Projects No. 417-323, No. 417-324, No. 417-325,
and No. 417-326, 417-327. (Unpublished study, received Jul 18,
1978 under 707-127; prepared by Hazleton Laboratories, Inc.,
Philadelphia, Pa.; CDL: 234400-C).
Powers, M.B. (1970) Final Report [for Octhininone]: Acute Oral -
Rats; Acute Dermal - Rabbits; Acute Eye Irritation - Rabbits;
Acute Inhalation Exposure - Rats: Projects No. 417-306, No. 417-
307, No. 417-308, and No. 417-310 and 417-310. (Unpublished
study, received April 4, 1978 under 707-143 prepared by TRW,
Inc. submitted by Rohm & Haas Co., Philadelphia, Pa;
CDL:233428-B).
Powers, M.; Kundzin, M.; Ferrell, J. (1970) Three-month Dietary
Ad- ministration-Rats: RH-893 (Technical): Project No. 417-320.
Final report (Unpublished study received Feb 9, 1971 under 707-
100; prepared by Hazleton Laboratories, Inc., submitted by Rohm
& Haas Co., Philadelphia, PA; CDL:004372-H).
Powers, M.; Ferrell, J. (1970) Three-month Dietary
Administration-Dogs: RH-893 (Technical): Project No. 417-334.
Final report (Unpublished study received Feb 9, 1971 under 707-
100; prepared by Hazleton Laboratories, Inc., submitted by Rohm
& Haas Co., Philadelphia, PA; CDL:004372-I).
Hiddem en, J.; Ferrell, J. (1971) Subacute Inhalation Study-Rats:
RH-893-50%: Project No. 417-345. Final report (Unpublished
study received Feb 9, 1971 under 707-100; prepared by Hazleton
Laboratories, Inc., submitted by Rohm & Haas Co., Philadelphia,
PA; CDL:004372-K).
Powers, M. (1970) Teratology Study: Rabbits: RH-893
(Technical): Project No. 417-346. Final report (Unpublished study
received Feb 9, 1971 under 707-100; prepared by Hazleton
Laboratories, Inc., submitted by Rohm & Haas Co., Philadelphia,
PA; CDL: 004372-L).
Piccirillo, V.J.; Smith, J.M.; Larson, P.S.; et al. (1975) Eighteen
Month Study on the Carcinogenic Potential of RH-893 in Mice.
79
-------
00139419
00139484
40647505
(Unpublished study received Jun 4, 1975 under 5F1632; prepared
by Medical College of Virginia, Health Sciences Center, Dept. of
Pharmacology and Medical Univ. of South Carolina, Dept. of
Pathology, submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL: 094944-B).
Hennigar, G.R.; Larson, P.S. (1974) Eighteen-Month Study in
Which RH-893 Is Being Added to the Diet of Mice: Monthly
Reports. (Unpublished study received Jun 4, 1975 under 5F1632;
prepared by Medical Univ. of South Carolina, Dept. of Pathology
and Medical College of Virginia, Health Sciences Center, Dept. of
Pharmacology, submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL: 094944-D).
Piccirillo, V.J.; Smith, J.M. (1975) Eighteen Month Study on the
Carcinogenic Potential of RH-893 in Mice. (Unpublished study
received Feb 3, 1977 under 984-67; prepared by Medical College
of Virginia, Toxicology Research Dept., submitted by Whitmoyer
Laboratories, Inc., Myerstown, Pa.; CDL:229346-A).
Muller, G. (1986) Skane M-8 HQ Microbiocide in vitro
Unscheduled DNA Synthesis Assay: Report 86R-0018.
Unpublished study prepared by Rohm and Haas Co. 29 p.
41222604
Lorence, PJ, and Walls, GE, (1989) Vapor Pressure Determination
of RH-5287, , Rohm and Hass Company, Research Laboratories
727 Norristown Road, Spring House, PA: 19477, Report #: 34-89-
23
41482501
41482505
41482507
Lorence, PJ and Walls, GE, (1989) Vapor Pressure Determination
of RH-293. Rohm and Hass Company, Research Laboratories, 727
Norristown, Spring House, PA: 19477, Report #: 34-98-24.
Murphy, M. Chen, P. (1983) RH-893-A Study of the Concentrated
Dependent Delayed Contact Hypersensitivity study in Guinea
Pigs; Lab Project Number: 83R-143. Unpublished study prepared
by Rohm and Haas Co. 48 p.
Bonin, R; Murphy, M. (1983) RH-893 Process Variation A Study
of the Concentrated-Dependent Delayed Contact Hypersensitivity
study in Guinea Pigs; Lab Project Number: 83R-025. Unpublished
study prepared by Rohm and Haas Co. 36 p.
80
-------
41482508
41482509
41544701
41608001
41608002
41608003
41608004
41608005
41608006
Powers, M. (1970) Teratology Study: Rabbits: RH-893
(Technical): Project No. 417-346. Final report (Unpublished study
received Feb 9, 1971 under 707-100; prepared by Hazleton
Laboratories, Inc., submitted by Rohm & Haas Co., Philadelphia,
PA; CDL: 004372-L).
Solomon, H.; Lutz, M. (1987) Skane M-8 HQ Industrial
Mildewcide: Oral (Gavage) Developmental Toxicity Study in
Rabbits: Lab Project Number: 87R-019: 86P-504. Unpublished
study prepared by Rohm and Haas Co. 178 p.
Hagan, J.; Kulwich, B.; Fisher, J. (1989) Skane M-8 HQ
Microbicide: Thirteen-Week Inhalation Toxicity Study in Rats:
Protocol No. 86P-196: Report No. 87R-013: Lab Project Number:
87R-013: 86P- 196. Unpublished study prepared by Rohm and
Haas Co. 521 p.
Pedersen, C.A.. (1990) Octhilinone - 21-Day Acute Oral LD50
Study in Bobwhite Quail. Rohm and Haas Report No. 90RC-0020.
Unpublished data. Conducted by Bio-Life Associates, Ltd. for
Rohm and Haas Company.
Pedersen, C.A.. (1990) Octhilinone - 8-Day Acute Dietary LC50
Study in Bobwhite Quail. Rohm and Haas Report No. 90RC-0021.
Unpublished data. Conducted by Bio-Life Associates, Ltd. for
Rohm and Haas Company.
Pedersen, C.A.. (1990) Octhilinone - 8-Day Acute Dietary LC50
Study in Mallard Ducklings. Rohm and Haas Report No. 90RC-
0022. Unpublished data. Conducted by Bio-Life Associates, Ltd.
for Rohm and Haas Company.
Sousa, J.V. (1990) Octhilinone - Acute Toxicity to Bluegill
(Lepomis macrochirus) Under Flow-Through Conditions. Lab
Report No. 90-7-3375. Unpublished data. Conducted by
Springborn Laboratories for Rohm and Haas Company.
Sousa, J.V. (1990) Octhilinone - Acute Toxicity to Rainbow
Trout (Oncorhynchus my kiss) Under Flow-Through Conditions.
Lab Report No. 90-7-3367. Unpublished data. Conducted by
Springborn Laboratories for Rohm and Haas Company.
McNamara, P.C. (1990) Octhilinone - Acute Toxicity to Daphnids
(Daphnia magna) During a 48-Hour Flow-Through Exposure. Lab
81
-------
41608007
41608008
41700701
41909301
41909401
Report No. 90-6-3350. Unpublished data. Conducted by
Springborn Laboratories for Rohm and Haas Company.
Sousa, J.V. (1990) Octhilinone - Acute Toxicity to Sheepshead
Minnow (Cypridon variegatus) Under Flow-Through Conditions.
Lab Report No. 90-7-3375. Unpublished data. Conducted by
Springborn Laboratories for Rohm and Haas Company.
Sousa, J.V. (1990) Octhilinone - Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) Under Flow-Through Conditions. Lab Report
No. 90-7-3383. Unpublished data. Conducted by Springborn
Laboratories for Rohm and Haas Company.
Dionne, E. (1990) Mollusc 96-Hour Flow-Through Shell
Deposition Study. Unpublished data. Conducted by Springborn
Laboratories, Inc. for Rohm and Haas Company.
Sousa, J.V. (1991) Octhilinone - Toxicity Test with Fathead
Minnow (Pimephales promelas) Embryos and Larvae. Lab. Report
No. 90-10-3525. Unpublished data. Prepared by Springborn
Laboratories, Inc. for Rohm and Haas Company.
McNamara, P.C. (1991) Octhilinone - The Chronic Toxicity to
Daphnia magna Under Flow-Through Conditions. Lab Report No.
90-09-3473. Unpublished data. Prepared by Springborn
Laboratories for Rohm and Haas Company.
42007301
43499601
43499602
43499603
Bernacki, H.; Hamilton, J. (1991) RH-893 HQ Technical: Three-
Month Dermal Toxicity Study in Rats: Lab Project Number: 90P-
031: 90R- 031. Unpublished study prepared by Rohm and Haas
Co. 374 p.
Rub, B. and Coscia, A.T., (1994) Product Identity and
Composition of Acticide 45 Thor Americas, Inc., 37 North
Avenue, Norwalk, CT 06851, Document ID#: 9302-BR-61.
Rub, B. and Coscia, A.T., (1994) Summary of Physical and
Chemical Characteristics of Acticide 45, Thor Americas, Inc., 37
North Avenue, Norwalk, CT 06851, Document ID#: 9302-BR-63.
Rub, B. and Coscia, A.T., (1993) Boiling Point of Acticide 45-
TGAI, BioChem GmbH, Daimlerstrasse 5b, 7500 Karlsruhe,
Germany, Document ID#: 925040174D.
82
-------
43499605
43499606
43499607
43499608
43499609
43499610
43499611
43505501
43935701
43935702
43935703
Rub, B. and Coscia, A.T., (1992) Density of Acticide 45-TGAI.
BioChem GmbH, Daimlerstrasse 5b, 7500 Karlsruhe, Germany,
Document ID#: 925040174E.
Rub, B. and Coscia, A.T., (1993) Water Solubility of Acticide 45-
TGAI, BioChem GmbH, Daimlerstrasse 5b, 7500 Karlsruhe,
Germany, Document ID#: 925040174G.
Rub, B. and Coscia, A.T., (1993) Vapor Pressure of Acticide 45-
TGAI, BioChem GmbH, Daimlerstrasse 5b, 7500 Karlsruhe,
Germany, Document ID#: 925040525F.
Rub, B. and Coscia, A.T., (1992) Dissociation Constant of
Acticide 45-TGAI, BioChem GmbH, Daimlerstrasse 5b, 7500
Karlsruhe, Germany, Document ID#: 9250401741.
Rub, B. and Coscia, A.T., (1993) Partition Coefficient of Acticide
45-TGAI, BioChem GmbH, Daimlerstrasse 5b, 7500 Karlsruhe,
Germany, Document ID#: 925040174H.
Rub, B. and Coscia, A.T., (1994) Stability of Acticide 45-TGAI,
THOR CHEMIE GMBH, Landwehrstrasse 1, D-67346 Speyer,
Germany, Document ID#: THOR 9302-BR-3.
Rub, B. and Coscia, A.T., (1994) 1 Year Storage Stability of
Acticide 45, THOR CHEMIE GMBH, Landwehrstrasse 1, D-
67346 Speyer, Germany, Document ID#: THOR 9302-BR-63/17.
Rub, B. and Coscia, A.T., (1994) Analysis and Certification of
Product Ingredients Thor Chemie GmbH, Speyer, Germany,
Document ID#: 9302-BR-l.
Wyness, L.E. (1995) N-Octylisothiazolone (OIT): Subacute
Dietary Toxicity LC50 to Bobwhite Quail. Lab Project No.
1154/45. Unpublished data. Conducted by Corning Hazleton
(Europe) for Thor Americas, Inc.
Wyness, L.E. (1995) N-Octylisothiazolone (OIT): Acute Toxicity
to (Oncorhynchus mykiss). Lab Project No. 1154/47.
Unpublished data. Conducted by Corning Hazleton (Europe) for
Thor Chemicals Ltd. (UK).
Wyness, L.E. (1995) N-Octylisothiazolone (OIT): Acute Toxicity
to (Lepomis macrochirus). Lab Project No. 1154/46. Unpublished
83
-------
43935704
43935705
43935706
43935707
43935708
43935709
43935710
data. Conducted by Corning Hazleton (Europe) for Thor
Chemicals Ltd. (UK).
Wyness, L.E. (1995) N-Octylisothiazolone (OIT): Acute Toxicity
to (Daphnia magna). Lab Project No. 1154/48. Unpublished data.
Conducted by Corning Hazleton (Europe) for Thor Chemicals Ltd.
(UK).
Zuehlke, U. (1995) N-Octylisothiazolone (OIT) 96%: 14-Day
Dermal Subacute Toxicity Study in the Rat: Final Report: Lab
Project Number: 1247-1154-052: 1154-052. Unpublished study
prepared by Hazleton Deutschland GmbH. 145 p. 00136526
(MRID) Powers, M.; Kwapien, R. (1970) Three-week Dermal
Application-Rabbits: RH-893-50%: Project No. 417-321. Final
report (Unpublished study received Feb 9, 1971 under 707-100;
prepared by Hazleton Laboratories, Inc., submitted by Rohm &
Haas Co., Philadelphia, PA; CDL:004372-J).
Zuehlke, U. (1995) N-Octylisothiazolone (OIT) 94 +/- 3% 90-Day
Dermal Subchronic Toxicity Study in the Rat: Final Report: Lab
Project Number: 1282-1154-051: 1154-051. Unpublished study
prepared by Corning Hazleton GmbH. 403 p.
Fuchs, A. (1995) N-Octylisothiazolone (OIT) 96%: 14-Day Oral
(Gavage) Dose Range-Finding Study in the Female Rat: Final
Report: Lab Project Number: 1248-1154-050: 1154-050.
Unpublished study prepared by Hazleton Deutschland GmbH. 108
P-
Ballantyne, M. (1995) N-Octylisothiazolone (OIT) 94 +/- 3%:
Reverse Mutation in 5 Histidine-Requiring Strains of Salmonella
typhimurium: Final Report: Lab Project Number: 1154/53.
Unpublished study prepared by Hazleton Europe Ltd. 49 p.
Clements, J. (1995) N-Octylisothiazolone (OIT) 94 +/- 3%:
Mutation at the Thymidine Kinase (TK) Locus of Mouse
Lymphoma L5178Y Cells Using the Microtitre Fluctuation
Technique: Final Report: Lab Project Number: 1154/54.
Unpublished study prepared by Corning Hazleton (Europe). 44 p.
Riley, S. (1995) N-Octylisothiazolone (OIT) 94 +/- 3%: Induction
of Micronuclei in the Bone Marrow of Treated Mice: Final Report:
Lab Project Number: 1154/55. Unpublished study prepared by
Corning Hazleton (Europe). 36 p.
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43944401
44071001
44723201
Fuchs, A. (1995)N-Octylisothiazolone (OIT) 94+/-3%: Oral
(Gavage) Teratogenicity Study in the Rat: Final Report: Lab
Project Number: 1272-1154-049: 1154-049. Unpublished study
prepared by Hazleton Europe GmbH.
Hoberg, J.R. (1996) Octhilinone - Acute Toxicity to the
Freshwater Green Alga, Selenastrum capricornutum. Lab Report
No. 95-12-6255. Unpublished data. Conducted by Springborn
Laboratories, Inc.
Dr. T. Lucas (1999) Hydrolytic Stability Study of Octhilinone (
14C)-Acticie OIT), Submitted by: Acti-Chem Specialties Inc., 56
Quarry Rd., Trumbull, CT: 06611-4816. Performing Laboratory:
Covance Laboratories GmbH, Kesselfeld 29, D-48163 Munster,
Germany. Laboratory Report #: 1509-1154-069.
Rodgers, M. (1999) Acticide OIT: Acute Oral Toxicity (LD50) to
Bobwhite Quail. Lab Project No. THR 053. Unpublished data.
Conducted by Huntingdon Life Sciences, Ltd. For Thor Chemie
GmbH/Acti-Chem Specialties, Inc.
Gough, BJ. and T.E. Shellenberger. (1971) Acute Toxicological
Evaluation of Fungicide with Wildlife. Final Report. Unpublished
Data. Conducted by Gulf South Research Institute for Rohm and
Haas Company.
2. Open Literature
Citation
Andersen, KE; and Veien NK. (1985) Biocide Patch. Contact Dermatitis, Vol. 12, No. 2, pages
99-103
44859001
86-870001877
Emmett, EA; Ng, SK; Levy, MA.; Moss, JN; and Morici, IJ. (1989) The irritancy and
allergenicity of 2-n-octyl-4-isothiazolin-3-one (Skane M-8), with recommendations for
patch test concentration. Contact Dermatitis. 20(l):21-6.
Foussereau, J.; Brandle I.; Boujnah-Khouadja, A. (1984) Allergic contact eczema caused by
isothiazolin-3-one derivatives. Derm Beruf Umwelt. 1984; 32(6):208-211
Mathias, CG, Andersen, KE; and Hamann, K. (1983) Allergic contact dermatitis from 2-n-
octyl-4-isothiazolin-3-one, a paint mildewcide. Contact Dermatitis. Nov; 9(6):507-9.
Oleaga, JM; Aguirre, A.; Landa, N.; Gonzalez, M. and Diaz-Perez, JL (1992) Allergic
contact dermatitis from Kathon 893. Contact Dermatitis. 27(5):345-6.
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Thormann, J. (1982) Contact dermatitis to a ne/w fungicide, 2-n-octyl-4-isothiazolin-3-one.
Contact Dermatitis. May; 8(3):204
Young, HS,; Ferguson, JE., Beck MH. (2004) Contact dermatitis from 2-n-octyl-4 isothiazolin-
3-one in a PhD student. Contact Dermatitis. 50(l):47-8.
3. Other Supporting Documents
Citation
AWPA. (2006) Book of Standards. American Wood Preservers' Association, Birmingham,
Alabama.
HERA. (2003) Human and Environmental Risk Assessment, Guidance Document
Methodology, April 22, 2002 (http://www.heraproiect.com/files/Guidancedocument.pdf).
Rohm& Haas Technical Reports on Environmental Fate Studies. Reports#: 23-71-4, 23-72-3,
3923-74-38, 3923-75-3, and3923-75-11
SIMetric. (2005) Mass, Weight, Density, or Specific Gravity of Bulk Materials.
http://www.simetric.co.uk/si materials.htm, last accessed January 2007.
The 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), http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm
U.S. Air Force (USAF). (2003) Department of The Air Force - Headquarters Air Force Civil
Engineer Support Agency, April 16, 2003 memo with the subject "Engineering Technical
Letter (ETL) 03-3: Air Force Carpet Standard."
U.S. Environmental Protection Agency (EPA). (1992) A Laboratory Method to Determine the
Retention of Liquids on the Surface of Hands. Prepared by C. Cinalli, C. Carter, A.
Clark, and D. Dixon, under EPA Contract No. 68-02-4254. EPA-747/R-92-003.
Exposure Evaluation Division, Office of Pollution Prevention and Toxics. September
1992.
U.S. Environmental Protection Agency (EPA). (1997a.) Standard Operating Procedures (SOPs)
for Residential Exposure Assessments. EPA Office of Pesticide ProgramsBHuman
Health Effects Division (HED). December 18, 1997.
U.S. Environmental Protection Agency (EPA). (1997b) Exposure Factors Handbook. Volume I-
II. Office of Research and Development. Washington, D.C. EPA/600/P-95/002Fa.
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U.S. Environmental Protection Agency (EPA). (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.
U.S. Environmental Protection Agency (EPA). (1999) Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study. Memorandum from Siroos
Mostaghimi, Ph.D., USEPA, to Julie Fairfax.
U.S. Environmental Protection Agency (EPA). (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.
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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 OIT
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 OIT Products for Meeting Acute Toxicity Data Requirements for
Reregistration
The Agency will complete the batching for OIT 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
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement ProgramStorage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
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
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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