United States Prevention, Pesticides EPA 739-R-08-002
Environmental Protection and Toxic Substances March 2008
Agency (751 OP)
Reregistration Eligibility Decision
for Diiodomethyl p-tolyl sulfone
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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 diiodomethyl p-tolyl
sulfone. The enclosed Reregi strati on Eligibility Decision (RED) document was approved on
March 31,2008.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone are available
to the public in EPA's Pesticide Docket EPA-HQ-OPP-2007-1151 at: www.regulations.gov.
The diiodomethyl p-tolyl sulfone RED was developed through EPA's public participation
process, published in the Federal Register in 2008, which provides opportunities for public
involvement in the Agency's pesticide tolerance reassessment and reregi strati on programs.
Developed in partnership with USDA and with input from EPA's advisory committees and
others, 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 diiodomethyl p-tolyl sulfone 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, residential and ecological risks posed by exposure
to diiodomethyl p-tolyl sulfone alone. This document also identifies 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 diiodomethyl p-tolyl sulfone will be
eligible for reregistration provided that all the conditions identified in this document are satisfied.
Sections IV and V of this RED document describe the necessary labeling amendments for end-
use products and data requirements. Instructions for registrants on submitting the revised
labeling can be found in the set of instructions for product-specific data that will accompany this
DCI.
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 Adam Heyward at (703)-308-6422.
Sincerely,
Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Diiodomethyl p-tolyl sulfone
ListD
CASE 4009
Sanders
Director, Antimicrobials Division
March 31,2008
Attachment
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Table of Contents
Diiodomethyl p-tolyl sulfone 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 Diiodomethyl p-tolyl sulfone Risk Assessments 6
A. Human Health Risk Assessment 6
1. Toxicity of Diiodomethyl p-tolyl sulfone 6
2. FQPA Safety Factor 11
3. Population Adjusted Dose (PAD) 11
a. Acute PAD 11
b. Chronic PAD 12
4. Indirect Food Contact Dietary Exposure Assumptions 12
5. Indirect Food Contact Dietary Risk Assessment 13
a. Dietary Risk from Indirect Food Contact 13
b. Dietary Risk from Drinking Water 14
6. Residential Risk Assessment 14
a. Toxicity 15
b. Residential Handlers 17
i. Exposure Assessment 17
ii. Risk Assessment 18
c. Residential Post-Application 20
i. Exposure Assessment 20
ii. Risk Assessment 23
7. Aggregate Risk Assessment 24
8. Occupational Risk 26
a. Occupational Toxicity 27
b. Occupational Handler Exposure 27
c. Occupational Handler Risk Summary 29
d. Occupational Post-application Risk Summary 36
9. Human Incident Data 40
B. Environmental Risk Assessment 40
1. Environmental Fate and Transport 40
a. Bioaccumulation in Aquatic Organisms 41
2. Ecological Risk 41
a. Environmental Toxicity 42
b. Ecological Exposure and Risk 45
c. Risk to Listed Species 50
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 52
A. Determination of Reregistration Eligibility 52
B. Public Comments and Responses 52
C. Regulatory Rationale 53
1. Human Health Risk Management 53
a. Dietary (Food) Risk Mitigation 53
b. Drinking Water Risk Mitigation 53
c. Residential Risk Mitigation 54
i. Handler Risk Mitigation 54
ii. Post-Application Risk Mitigation 55
d. Occupational Risk Mitigation 56
i. Handler Risk Mitigation 56
ii. Post-Application Risk Mitigation 58
2. Environmental Risk Management 58
3. Other Labeling Requirements 60
4. Listed Species Considerations 60
a. The Endangered Species Act 60
b. General Risk Mitigation 61
V. What Registrants Need to Do 62
A. Manufacturing-Use Products 64
1. Additional Generic Data Requirements 64
2. Labeling for Manufacturing Use Products 66
B. End-Use Products 66
1. Additional Product-Specific Data Requirements 66
2. Labeling for Technical and End-Use Products 66
a. Label Changes Summary Table 67
VI. Appendices 70
A. Table of Use Patterns for Diiodomethyl p-tolyl sulfone 71
B. Table of Generic Data Requirements and Studies Used to Make the 77
Reregistration Decision
C. Technical Support Documents 83
D. Bibliography Citations 85
E. Generic Data Call-In 97
F. Product Specific Data Call-In 98
G. Batching of End-Use Products 99
H. List of All Registrants Sent the Data Call-In 100
I. List of Available Forms 101
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Diiodomethyl p-tolyl sulfone Reregistration Team
Health Effects Risk Assessment
Jonathan Chen
William Hazel
Cassi Walls
Najm Shamim
Ecological Risk Assessment
Siroos Mostaghimi
William Erickson
Environmental Fate Risk Assessment
James Breithaupt
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
CMB S 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
11
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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 diiodomethyl p-tolyl sulfone and is
issuing its risk management decision. The risk assessments, which are summarized
below, are based on the review of the required target database supporting the use patterns
of currently registered products and 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 diiodomethyl p-tolyl sulfone that pose risks of
concern. As a result of this review, EPA has determined that diiodomethyl p-tolyl
sulfone containing products are eligible for reregistration, 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.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregistration Eligibility Decision (RED) for diiodomethyl p-tolyl sulfone.
The diiodomethyl p-tolyl sulfone case consists of one PC Code: 101002. The first product
containing diiodomethyl p-tolyl sulfone was registered in 1980. For a list of the current
products, please see Appendix A.
Diiodomethyl p-tolyl sulfone is an algaecide, bactericide, and fungicide. Diiodomethyl p-
tolyl sulfone is used as a materials preservative in paints, air duct coatings, fire-retardant
coatings, pigment dispersions, inks, emulsions, extender slurries, adhesives, caulks, sealants,
rubbers, plastic, textiles, leather, paper production to protect pulp and slurries, paper/paperboard,
and wetlap. Diiodomethyl p-tolyl sulfone is also used as a wood preservative.
The Agency has determined that analysis of the potential need for a special hazard-based
safety factor under the FQPA is not needed at this time. The Agency does not anticipate dietary
or drinking water exposures based on the registered use patterns and there are no tolerances or
tolerance exemptions for the use of diiodomethyl p-tolyl sulfone as an active ingredient.
Therefore, an FQPA hazard analysis is not necessary at this time.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of diiodomethyl p-tolyl sulfone. 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 diiodomethyl p-tolyl sulfone in this RED. The revised
risk assessments and related addenda are not included in this document, but are available in the
Public Docket at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-1151).
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 diiodomethyl p-tolyl sulfone and its
regulatory history. Section III, Summary of diiodomethyl p-tolyl sulfone Risk Assessments,
gives an overview of the human health and environmental assessments, based on the data
available to the Agency. Section IV, Risk Management and Reregistration, presents the
reregistration eligibility and risk management decisions. Section V, What Registrants Need to
1
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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
Diiodomethyl p-tolyl sulfone was first registered as an active ingredient by the United
Sates Environmental Protection Agency (EPA) on September 17, 1980. Currently, there are
eight products containing diiodomethyl p-tolyl sulfone as an active ingredient. Diiodomethyl p-
tolyl sulfone is an algaecide, bactericide, and fungicide. Diiodomethyl p-tolyl sulfone is used as
a materials preservative in paints, air duct coatings, fire-retardant coatings, pigment dispersions,
inks, emulsions, extender slurries, adhesives, caulks, sealants, rubbers, plastic, textiles, leather,
paper production to protect pulp and slurries, paper/paperboard, and wetlap. Diiodomethyl p-
tolyl sulfone is also used as a wood preservative.
B.
Chemical Identification
Technical Diiodomethyl p-tolyl sulfone
Figure #1. Molecular Structure of Diiodomethyl p-tolyl sulfone
Common name:
Chemical name:
Chemical family:
Empirical formula:
CAS Registry No.:
Case number:
Diiodomethyl p-tolyl sulfone
Benzene, 1 -((diiodomethyl)sulfonyl)-4-methyl
Sulfone, Benzene
P TT T /~V C
Lxgrlg 12 IJ2O
20018-09-1
4009
OPP Chemical Code: 101002
Molecular weight: 42201
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Other names:
Basic manufacturer:
Chemical properties:
Amical 48™; p-Tolyl diiodomethyl sulfone; Toluene, 4-
(diiodomethylsulfonyl)-; 4-Tolyl diiodomethyl sulfone;
Benzene, l-((Diiodomethyl)sulfonyl)-4-methyl;
Diiodomethyl 4-tolyl sulfone; Sulfone, diiodomethyl p-
tolyl; p-Methylphenyl diiodomethyl sulfone; p-Tolyl
diidomethyl sulfone
The Dow Chemical Company
Diiodomethyl p-tolyl sulfone is tan and is a powder at room
temperature. Diiodomethyl p-tolyl sulfone has a melting point of
136° C/ 149-152°C; aboiling point of 394° C; is stable at room
temperature and at 54 ± 2° C for two weeks; and has a flammability
of 60° C. The vapor pressure is 1.87 x 10"6 mm Hg/ 5.3 x 10"8 mm
Hg at 25° C. Diiodomethyl p-tolyl sulfone has a Log Kow of 2.66,
a Log Koc of 2.7838 and its solubility is 10 mg/L at 25° C in
water. The Henry Law Constant is 6.03 x 10" atm-m3/mole.
Diiodomethyl p-tolyl sulfone is persistent in air for 23.4 hours and
its specific gravity is ~1 at 25° C. Diiodomethyl p-tolyl sulfone
should not be used around electric equipment and has a UV-visible
spectra at two absorptions peaks (200 and 233-234 nm; the spectra
were run from 200-800 nm range). Diiodomethyl p-tolyl sulfone is
stable for eight years at ambient temperature, stable for 36 months
at 30° C and for 6 months at 40° C.
C.
Use Profile
The following information is a description of the currently registered uses of
diiodomethyl p-tolyl sulfone products and an overview of use sites and application methods. A
detailed table of the uses of diiodomethyl p-tolyl sulfone eligible for reregi strati on is contained in
Appendix A.
Type of Pesticide: Algaecide, Bactericide and Fungicide
Summary of Use:
Wood Preservative:
As a wood preservative diiodomethyl p-tolyl sulfone is registered for
general formulation use in wood preservative coatings and stains.
Diiodomethyl p-tolyl is also registered for direct use on fresh cut wood,
lumber frames, fences, decking, siding, logs, poles and wood pressure
treatment.
Materials Preservative:
Diiodomethyl p-tolyl sulfone is used as a materials preservative in paints,
air duct coatings, fire-retardant coatings, pigment dispersions, inks,
emulsions, extender slurries, adhesives, caulks, sealants, rubbers, plastics,
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Target Pests:
textiles, leather, paper production (non-food use), paper/paperboard (non-
food use) and wetlape.
Algae; Bacteria (causing rot or decay); Decay; Deterioration/spoilage
bacteria; Fungal decay/rot; Fungal slime (of paper mills/water systems);
Fungi (coatings, leather); Mildew; Mold; Sapstain; Termites; Wood
rot/decay/fungi; Wood stain fungi
Formulation Types: Powder (Technical Grade Active Ingredient); Flowable dispersion,
Wettable powder, and Powder (End Use Products)
Method and Rates of Application:
Equipment for Use: Diiodomethyl p-tolyl sulfone end-use products are added during
the manufacturing process of treated articles and materials. Examples
specific to materials preservation include: Diiodomethyl p-tolyl sulfone is
added to pigment grinds and added via open pour for in-can paint and air
duct coatings; Added via mixing and in-can preservation for fire-retardant
coatings; Added via mixing during manufacturing for pigment dispersions,
inks, emulsions and extender slurries; Added by mixing via open pour and
in-can preservation for adhesives, caulks and sealants; Added during the
manufacturing processes for rubbers and plastics; Added via open pour for
non-clothing textiles; Added for leather tanning; Added to systems where
mixing occurs for paper production; Added to Whitewater or stock, the
applicator rolls or showers, size press or water box for mold inhibition in
paper and paperboard; Added to material to be preserved for paper plant
storage. For wood preservation, diiodomethyl p-tolyl sulfone end-use
products are applied via dip, dip roller, spray, pressure treatment, high
pressure spray, brush, or by adding it to a water based treatment.
Application Rates:
For details about specific use sites for diiodomethyl p-tolyl sulfone, refer
to Appendix A.
Materials Preservatives:
• Application rates can range from
o Paint- 0.01 Ib ai/gal -0.050 Ib ai/gal (flowable liquid)
o Adhesives and Caulks- 0.01% ai per wt- 0.29% ai per wt.
o Leather- 0.01% ai per wt.-0.026% ai per wt. (wettable powder)
Wood Preservatives:
• Application rates can range from
o 0.001 gal/ gal water - 0.5 gal/gal water
o 0.05 - 2.70 Ib pcf
o 0.10% - 1% active ingredient
o 0.30% - 2.0% active ingredient (formulate use only)
Use Classification: General use.
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III. Summary of Diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone. While the risk assessments and related
addenda are not included in this document, they are available from the OPP Public Docket EPA-
HQ-OPP-2007-1151, 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 diiodomethyl p-tolyl sulfone 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 Diiodomethyl p-tolyl sulfone
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 diiodomethyl p-tolyl
sulfone can be found in the "Diiodomethyl p-tolyl sulfone: Hazard Assessment," dated March
14, 2008; and the "Diiodomethyl p-tolyl sulfone. P.C. Code: 101002. Human Health and
Ecological Effects Risk Assessments for the Reregi strati on Eligibility Decision (RED)
Document. Case 4009," dated April 29, 2008. These documents are available on the Agency's
website in the EPA Docket at: http://www.regulations.gov (Docket ID EPA-HQ-OPP-2007-
1151).
The Agency has reviewed all toxicity studies submitted for diiodomethyl p-tolyl sulfone
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 gives a summary of the acute toxicity data and the toxicological
endpoints selected for the dietary exposure scenarios are summarized in Table 2.
Table #1. Summary of Acute Toxicity Data for Diiodomethyl p-tolyl sulfone
Guideline
No.
Study Type
MRID #(s)
Results
Toxicity
Category
Acute Toxicity
870.1100
(§81-1)
870.1200
(§81-2)
Acute Oral
Acute Dermal (Rats)
41765401
43008702
42586801
00123023
LD50 > 5000 mg/kg
( for both male and female)
LD50 (Males) > 20000 mg/kg
IV
IV
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Guideline
No.
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
Study Type
Acute Inhalation
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
MRID #(s)
43660901
00087842
41765402
43008703
47354903
41765403
00141066
00054963
Results
LC5o (combined)= 0.96 mg/L
LC50(male)= 1.1 5 mg/L
LC50 (female) = 0.77 mg/L
Severe irritant to ocular tissue of Rabbit
Minimum irritant to skin of Rabbit
Toxicity
Category
II
I
IV
Not a Dermal Sensitizer
Table #2. Dietary Toxicological Endpoints for Diiodomethyl p-tolyl sulfone
Exposure
Scenario
Acute Dietary
(all populations)
Chronic Dietary
(all populations)
Carcinogenicity
Dose Used in Risk
Assessment, UF
Target MOE,
Uncertainty
Factory (UF) for
Risk Assessment
Study and Toxicological Effects
No appropriate endpoints were identified that represent a single dose effect (aRfD).
Therefore, an acute dietary risk assessment is not required.
OralNOAEL=2
mg/kg/day
UF = 1000
[lOx for inter-
species, lOx for
intra-species, 10X
for database
uncertainty (missing
chronic/cancer
studies)]
90-day Oral (Dog)
MRIDs 42054403, 43246402
NOAEL= 2 mg/kg/day, based on decreased
body weight gain, decreased activity,
dehydration, mucoid ocular discharge,
weakened appearance, abnormal feces, and
degeneration of the thyroid.
There are no chronic and/or cancer studies available. Diiodomethyl p-tolyl sulfone has not
been formally classified for carcinogenicity.
Notes: LTF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD
= population adjusted dose (a = acute, c = chronic) RiD = reference dose.
General Toxicity Observations
Acute Toxicity
Diiodomethyl p-tolyl sulfone exhibits low acute oral and acute dermal toxicity (Toxicity
Category IV), and high acute inhalation toxicity (Toxicity Category II). Diiodomethyl p-tolyl
sulfone is classified as an eye corrosive (Toxicity Category I). For dermal irritation,
Diiodomethyl p-tolyl sulfone is a low irritant (Toxicity Category IV) and is not classified as a
dermal sensitizer.
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Developmental & Reproductive Toxicity
Four developmental and two reproductive studies are available for diiodomethyl p-tolyl
sulfone. No clear developmental and/or reproductive toxic effects are noted in the available
developmental and reproductive toxicity data. All of the effects that were noted are associated
with maternal toxicity.
For the rat developmental study the following signs were noted at a dose level associated
with significant maternal toxic effects: decreased mean litter size, increased number of
resorptions relative to the number of implantation sites, reduced mean fetal body weight,
increased incidences of umbilical hernia and incomplete ossification of the supra-occipital bones.
In the rabbit developmental study there are no developmental effects at the highest dose tested of
2 mg/kg/day. In the rat reproductive studies, effects on the offspring include post-implantation
loss and decreased gestation survival, decreased litter size, and decreased neonatal survival
and/or pup body weight at a dose level of 10 mg/kg/day or above. However, it should be noted
that offspring effects in the rat reproductive studies were noted at dosages with significant
maternal effects.
The release of iodine from diiodomethyl p-tolyl sulfone is considered to result in
dystocia, changes in the thyroid and pituitary in the parents, and decreased survival and pup
weights in the offspring. The primary organ affected by diiodomethyl p-tolyl sulfone is the
thyroid. Degeneration of the thyroid gland is noted in the 90-day dog study. Increased thyroid
gland weight is noted in the rabbit and rat developmental studies. Also, histopathological
changes (e.g., altered colloid staining, hypertrophy, hyperplasia and/or follicular dilatation) were
noted in the rat reproductive studies.
Acute & Chronic Reference Dose (RfD)
An acute reference dose (RfD) value was not assigned for diiodomethyl p-tolyl sulfone.
No appropriate endpoints were identified that represent a single dose effect for the acute dietary
risk assessment. Therefore an acute dietary assessment was not conducted.
The chronic RfD value for diiodomethyl p-tolyl sulfone is 0.002 mg/kg/day for all
populations. The chronic RfD was established by using an oral NOAEL of 2 mg/kg/day, which
is based on a 90-day oral dog study that observed decreased activity, dehydration, mucoid ocular
discharge, weakened appearance, abnormal feces, and thyroid degeneration. Although female
dogs in the 90-day dog study had decreased mean body weight-gain from days 0 to 91 of at least
20% in comparison to the control value, the differences are within an acceptable range as is
shown in historical control data.
For chronic toxicity exposure the Agency had potential concerns regarding the chronic
and/or carcinogenic effects associated with diiodomethyl p-tolyl sulfone exposure. However, the
Agency determined that iodine is a degradation moiety of the body once diiodomethyl p-tolyl
sulfone is absorbed. Some of the effects associated with diiodomethyl p-tolyl sulfone exposure
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may be associated with, but not necessarily limited to, the release of iodine in the body. For the
human health risk assessment the Agency has determined that rodents are not an appropriate
model for studying iodine associated effects. Therefore, the Agency believes that chronic rodent
and cancer studies are not required to support the use of diiodomethyl p-tolyl sulfone at this time.
To address possible chronic exposure concerns for diiodomethyl p-tolyl sulfone, an additional
uncertainty factor of lOx was applied.
For diiodomethyl p-tolyl sulfone, an uncertainty factor of 1,000 was applied (lOx for
inter-species extrapolation; lOx for intra-species variation; and lOx for database uncertainty
[missing chronic and cancer data]).
Incidental Oral Exposure
The NOAEL for the short-term incidental oral endpoint is 4 mg/kg/day. The NOAEL is
based on a 30-day oral rabbit developmental toxicity study, which observed clinical signs of
toxicity, reduced body weight gain, and reduced food consumption of maternal animals at a dose
of 15 mg/kg/day. For the short-term incidental oral exposure, the target margin of exposure
(MOE) for diiodomethyl p-tolyl sulfone is 100 (lOx inter-species extrapolation; lOx intra-species
variation).
For the intermediate-term incidental oral endpoint a NOAEL of 2 mg/kg/day was used.
The NOAEL is based on a 90-day oral dog study, which observed decreased activity,
dehydration, mucoid ocular discharge, weakened appearance, abnormal feces, and thyroid
degeneration at a dose of 10 mg/kg/day. For intermediate-term incidental oral exposure, the
target MOE for diiodomethyl p-tolyl sulfone is 100 (lOx for inter-species extrapolation; lOx for
intra-species variation).
Dermal Exposure
For the short-term (ST) dermal endpoint an oral NOAEL of 4 mg/kg/day was used. The
NOAEL is based on an oral rabbit developmental toxicity study, which observed clinical signs of
toxicity, reduced body weight-gain, and reduced food consumption at a dose of 15 mg/kg/day.
The target MOE for ST dermal exposure is 100 (lOx inter-species extrapolation; lOx intra-
species variation).
For the intermediate-term (IT) and long-term (LT) dermal endpoints an oral NOAEL of 2
mg/kg/day was used. The oral NOAEL is based on a 90-day oral dog study, which observed
decreased activity, dehydration, mucoid ocular discharge, weakened appearance, abnormal feces,
and thyroid degeneration at a dose of 10 mg/kg/day. The target MOE for IT dermal exposure is
100 (lOx for inter-species extrapolation; lOx for intra-species variation). The target MOE for LT
dermal exposure is 1,000 (lOx for inter-species extrapolation; lOx for intra-species variation; lOx
for database uncertainty factor). However, because the technical registrant is cancelling the use
of diiodomethyl p-tolyl sulfone for metalworking fluid use, there are no longer any applicable
long-term dermal exposure use scenarios for diiodomethyl p-tolyl sulfone.
-------
Because an oral dosing toxicity study was used for the dermal risk assessment, a dermal
adsorption factor was calculated to be 10% based on a rat pharmacokinetic and metabolism study
(MRID 47076601).
Inhalation Exposure
For the short-, intermediate-, and long-term (ST, IT, LT) inhalation exposures the
endpoint was based on an oral NOAEL of 2 mg/kg/day. The NOAEL is based on a 90-day oral
dog study, which observed decreased activity, dehydration, mucoid ocular discharge, weakened
appearance, abnormal feces, and thyroid degeneration at a dose of 10 mg/kg/day. The target
MOE for identifying inhalation risks of concern is 100 (lOx for intra-species variation; lOx for
inter-species variation) and the target MOE for identifying the need for confirmatory inhalation
toxicity data is 1,000 (lOx for inter-species extrapolation; lOx for intra-species variation; lOx for
route-to-route extrapolation). An inhalation absorption factor of 100% was used (equivalency to
oral absorption was assumed) for all inhalation exposure durations since the MOE calculations
are based on an oral endpoint. In cases where inhalation endpoints are set using oral toxicity
data, as was done for diiodomethyl p-tolyl sulfone, the Agency will consider requiring an
inhalation toxicity study to confirm that the use of route-to-route extrapolation does not
underestimate risk. The Agency determines the need for confirmatory inhalation data by
evaluating the inhalation MOEs. For diiodomethyl p-tolyl sulfone, if MOEs are greater then 100
but less then 1,000 confirmatory inhalation toxicity data are required to account for the use of
route-to-route extrapolation. Since several inhalation MOEs are below 1,000 for diiodomethyl p-
tolyl sulfone, confirmatory inhalation data are required.
Carcinogenicity
There are no chronic and or cancer studies for diiodomethyl p-tolyl sulfone. For chronic
toxicity exposure the Agency had potential concerns regarding the chronic and/or carcinogenic
effects associated with diiodomethyl p-tolyl sulfone exposure. However, the Agency determined
that iodine is a degradation moiety of the body once diiodomethyl p-tolyl sulfone is absorbed.
Some of the effects associated with diiodomethyl p-tolyl sulfone exposure may be associated
with, but not necessarily limited to, the release of iodine in the body. For the human health risk
assessment the Agency has determined that rodents are not an appropriate model for studying
iodine associated effects. To address possible chronic exposure concerns for diiodomethyl p-
tolyl sulfone an additional uncertainty factor of lOx was applied.
Mutagenicity Potential
The mutagenicity studies for diiodomethyl p-tolyl sulfone are negative and, therefore,
diiodomethyl p-tolyl sulfone is not mutagenic.
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
10
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(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), 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 the Program
include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA
and, to the extent that effects in wildlife may help determine whether a substance may have an
effect in humans, FFDCA 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, diiodomethyl p-tolyl sulfone may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The Agency has determined that analysis of the potential need for a special hazard-based
safety factor under the FQPA is not needed at this time. The Agency does not anticipate dietary
or drinking water exposures based on the registered use patterns and there are no tolerances or
tolerance exemptions for the use of diiodomethyl p-tolyl sulfone as an active ingredient.
Therefore, an FQPA hazard analysis is not necessary at this time.
3. Population Adjusted Does (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic. This calculation is performed for each
population subgroup. A risk estimate that is less than 100% of the acute or chronic PAD is not
of concern. The Agency has conducted an indirect food contact dietary exposure and risk
assessment for the use of diiodomethyl p-tolyl sulfone as a materials preservative in adhesives,
can-end and side-seam cements, and sealants and caulking materials for repeat use food contact
surfaces.
a. Acute PAD
Acute indirect food contact dietary risk is assessed by comparing acute dietary exposure
estimates (in mg/kg/day) to the acute Population Adjusted Dose (aPAD). Acute dietary risk is
expressed as a percent of the aPAD. An acute indirect food contact dietary assessment was not
conducted for diiodomethyl p-tolyl sulfone because the use patterns are not expected to result in
acute indirect food contact dietary exposure. Furthermore, no endpoints appropriate for an
indirect food contact dietary risk assessment were identified in the toxicity database. Therefore,
diiodomethyl p-tolyl sulfone does not pose as an indirect food contact acute dietary risk and an
indirect food contact acute dietary risk assessment was not required.
11
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b. Chronic PAD
The indirect food contact chronic dietary risk for diiodomethyl p-tolyl sulfone is assessed
by comparing indirect food chronic dietary exposure estimates (in mg/kg/day) to the chronic
Population Adjusted Dose (cPAD). Chronic indirect food dietary risk is expressed as a percent
of the cPAD. The cPAD is the chronic reference dose (0.002 mg/kg/day). For the adhesives
preservative use, the cPAD is 14% for adults and 33% for children; for the repeat-use rubber
sealants and caulking materials uses, the cPAD is 2% for adults and 5% for children; and for the
can side-seam cements preservatives use, the cPAD is 6% for adults and 14% for children. The
combined cPAD is 22% for adults and 52% for children. Therefore, there are no indirect food
contact chronic dietary risks of concern as a result of these uses because the cPAD does not
exceed the Agency's level of concern for chronic exposure durations to diiodomethyl p-tolyl
sulfone.
4. Indirect Food Contact Dietary Exposure Assumptions
The Agency assessed the potential indirect food dietary and drinking water exposures and
risks to diiodomethyl p-tolyl sulfone from its use as an indirect food additive. The potential
indirect food dietary exposures for diiodomethyl p-tolyl sulfone are as follows: indirect food
additive from paper products when used as a preservative in adhesives, can end and side-seam
cements, and sealants and caulking materials for repeat use food contact surfaces.
The United States Food and Drug Administration (US FDA) has granted diiodomethyl p-
tolyl sulfone indirect food clearances for the following uses:
• 175.105- Substances for use only as components of adhesives;
• 175.300- Substances for use as components of coatings- resinous and
polymeric coatings (can end and side seam cements) with a limitation to not
exceed 0.3% by wt in can-sealing cements;
• 176.300- Substances for use as basic components of paper and paperboard
components- slimicides with a limitation to not exceed 0.2 pounds per ton of
dry weight of fiber; and
• 177.2600- Substances for use as basic components of repeated use food
contact surfaces- rubber articles intended for repeated use with a limitation to
not exceed 0.3% by wt of sealants and caulking materials.
It should be noted that in 21CFR 176.300, US FDA has cleared the use of diiodomethyl p-tolyl
sulfone as an indirect food additive for its use as a pulp and paper slimicide at a maximum level
of 0.20 pound per ton of dry weight fiber. However, this use was not assessed for the
reregi strati on eligibility decision (RED) because all of the current diiodomethyl p-tolyl sulfone
labels for the pulp and paper slimicide use state for non-food contact paper only. Although the
EPA accepts this language on the labels, examples of non-food contact paper (e.g., newsprint,
12
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Kraft paper, brown paper mills, sheets for corrugated board, etc.) must also be listed on the
appropriate labels. Most of the diiodomethyl p-tolyl sulfone labels will need to be updated to
include non-food contact paper examples.
No residue data have been submitted in support of the diiodomethyl p-tolyl sulfone
antimicrobial dietary uses. Therefore, a screening-level assessment has been conducted using the
US FDA's Center for Food Safety & Applied Nutrition's (CFSAN) approach as presented in
"Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact
Substances: Chemistry Recommendations," dated December 2007; and, memos obtained from
FDA granting the diiodomethyl p-tolyl sulfone clearances. Using the maximum application rates
and the US FDA's default assumptions, "worst-case" dietary concentration values were
calculated by the Agency. Additional information can be found in the "Revised Dietary and
Drinking Water Exposure Chapter for diiodomethyl p-tolyl sulfone for the Reregi strati on
Eligibility Decision (RED) Document (Case 4009)," dated January 2, 2008; and the
"Diiodomethyl p-tolyl sulfone. P.C. Code: 1001002. Human Health and Ecological Effects Risk
Assessments for the Reregi strati on Eligibility Decision (RED) Document (Case 4009)," dated
April 29, 2008.
5. Indirect Food Contact Dietary Risk Assessment
The Agency conducted an indirect food contact dietary exposure and risk assessment for
the use of diiodomethyl p-tolyl sulfone as an indirect food additive in adhesives, repeat-use
rubber sealants and caulking material, and can side-seam cements. Generally, a dietary risk
estimate that is less than 100% of the acute or chronic PAD (aPAD or cPAD) does not exceed
the Agency's risk concerns. A summary of the chronic risk estimates is shown in Table 3.
a. Dietary Risk from Indirect Food Contact
Diiodomethyl p-tolyl sulfone is used as a materials preservative, indirect food additive in
adhesives, repeat-use rubber sealants and caulking material, and can side-seam cements. An
acute dietary assessment was not conducted for diiodomethyl p-tolyl sulfone because the use
patterns are not expected to result in acute dietary exposure and toxicity endpoints were not
identified. Therefore, diiodomethyl p-tolyl sulfone does not pose as an acute dietary risk.
Utilizing the chronic PAD of 0.002 mg/kg/day, dietary risks were estimated and are
summarized in Table 3 below. None of the uses exceed the Agency's level of concern for the
chronic exposure durations. Therefore, there are no chronic dietary risks of concern for treated
adhesives, repeat-use rubber sealants and caulking material, and can side-seam cements.
13
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Table #3. Dietary Risks of Diiodomethyl p-tolyl sulfone Indirect Food Uses
FDA
Clearance
(21 CFR §)
175.105
177.2600
175.300
Use
Preservative in Adhesives
Preservative in Repeat-use Rubber Sealants and Caulking Materials
Preservative in Can Side-Seam Cements
Combined
Dose
(mg/kg/day)
Adult
0.00029
0.000043
0.00012
0.0004
Child
0.00067
0.00010
0.00027
0.0010
% cPAD
Adult
14%
2%
6%
22%
Child
33%
5%
14%
52%
% cPAD = exposure/ cPAD x 100
b. Dietary Risk from Drinking Water
Diiodomethyl p-tolyl sulfone is not used for water treatment and the active ingredient is
not expected to contact fresh water environments. Also, the wood preservation use of
diiodomethyl p-tolyl is for terrestrial use only, and is not expected to contact aquatic
environments provided that the appropriate label language and mitigation measures outlined in
chapters IV and V of this document are implemented. Based on the use patterns, the potential
for diiodomethyl p-tolyl sulfone to impact drinking water sources is negligible. Therefore, a
drinking water assessment was not conducted.
6.
Residential Risk Assessment
Based on registered use patterns from product labels, it has been determined that
exposure to residential handlers or applicators can occur in a variety of residential environments.
Additionally, post-application exposures are likely to occur in these settings. The representative
scenarios selected by the Agency for assessment were evaluated using maximum application
rates as stated on the product labels. The residential exposure assessment considers all potential
pesticide exposure, other than exposure due to residues in food and drinking water. Exposure
may occur during application for several use patterns including painting/applying wood
preservative via brush/roller and airless sprayer. In addition, toddlers may be exposed to
diiodomethyl p-tolyl sulfone when using finger paints preserved with this active ingredient.
Post-application exposure may occur from dermal and incidental oral contact with treated lumber
(playground equipment or decking) or through incidental oral contact with finger-paint. Each
route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed
as a Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate No
Observed Effect Level (NOAEL) dose. Additional information can be found in the
14
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"Occupational and Residential Exposure Chapter for Diiodomethyl p-tolyl sulfone," dated March
27, 2008; and the "Diiodomethyl p-tolyl sulfone. PC Code: 101002. Human Health and
Ecological Effects Risk Assessments for the Reregi strati on Eligibility Decision (RED)
Document. Case 4009," dated April 29, 2008.
a. Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential and occupational risks for diiodomethyl p-tolyl sulfone are listed in Table 4.
For the residential handler assessment, a Margin of Exposure (MOE) greater than or
equal to 100 is considered adequately protective for short-term (ST) and intermediate-term (IT)
dermal exposures. The MOE of 100 includes an uncertainty factor (UF) of lOx for inter-species
extrapolation and lOx for intra-species variation.
For inhalation exposure the target MOE for identifying inhalation risks of concern is 100
and the target MOE for identifying the need for confirmatory inhalation toxicity data is 1,000.
An UF of lOx for inter-species extrapolation, lOx for intra-species variation and lOx for route-to-
route extrapolation was applied. However, if an inhalation MOE of 1,000 is not achieved a
route-specific inhalation toxicity study is needed to confirm that the use of route-to-route
extrapolation does not underestimate risk.
For the ST and IT incidental oral exposure an MOE greater then or equal tolOO is
considered adequately protective. An UF of lOx for inter-species extrapolation and lOx for
intra-species variation was applied.
Table #4. Residential and Occupational Toxicological Doses and Endpoints for
Diiodomethyl p-tolyl sulfone
Exposure
Scenario
Incidental Oral
Short-Term
(1-30 days)
Incidental Oral
Intermediate-Term
(1-6 months)
Dermal Absorption
Factor
Dose Used in Risk
Assessment
Oral Maternal
NOAEL =4 mg/kg/day
Oral NOAEL =2
mg/kg/day
Target MOE/ UF,
for Risk
Assessment
UF = 100
(1 Ox for inter-
species, lOx for
intra-species)
MOE = 100
(1 Ox for inter-
species, lOx for
intra-species)
Study and Toxicological Effects
Rabbit Developmental Toxicity
(MRID 42243801 and 43246404)
Based on clinical signs, reduced body
weight gain and food consumption.
90-day Oral (Dog)
MRID 42054403 and 43246402
Based on decreased body weight gain,
decreased activity, dehydration, mucoid
ocular discharge, weakened
appearance, abnormal feces, and
degeneration of the thyroid.
10% Based on the Rat Pharmacokinetics and Metabolism data (MRID 47076641).
15
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Exposure
Scenario
T)prm ill
A/C1 111 ill
System, Short-Term
(1-30 days)
Dermal
Intermediate-Term
(1-6 months)
Dermal1
Long-Term
(>6 months)
Inhalation2
All Exposure Terms
Cancer
(oral, dermal,
inhalation)
Dose Used in Risk
Assessment
Oral Maternal
NOAEL =4 mg/kg/day
Oral
NOAEL = 2 mg/kg/day
Oral NOAEL =2
mg/kg/day
Oral NOAEL =2
mg/kg/day
Target MOE/UF,
for Risk
Assessment
MOE = 100
(1 Ox for inter-
species, lOx for
intra-species)
MOE = 100
(1 Ox for inter-
species, lOx for
intra-species)
MOE = 1,000
(1 Ox for inter-
species, lOx for
intra-species, lOx
for database
uncertainty [missing
chronic/cancer and
reproductive
studies])
MOE = 1,000
(1 Ox for inter-
species, lOx for
intra-species, lOx
for route-to-route
extrapolation)
Study and Toxicological Effects
Rabbit Developmental Toxicity
(MRID 42243801 and 43246404)
Based on clinical signs, reduced body
weight gain and food consumption.
90-day Oral (Dog)
MRIDs 42054403 and 43246402
Based on decreased body weight gain,
decreased activity, dehydration, mucoid
ocular discharge, weakened
appearance, abnormal feces, and
degeneration of the thyroid.
90-day Oral (Dog)
MRID 42054403 and 43246402
Based on decreased body weight gain,
decreased activity, dehydration, mucoid
ocular discharge, weakened
appearance, abnormal feces, and
degeneration of the thyroid. Based on
lymphocytic infiltration in females and
erosion of gastric mucosa and
prominence of limiting ridge of the
stomach in males.
90-day Oral (Dog)
MRID 42054403 and 43246402
Based on decreased body weight gain,
decreased activity, dehydration, mucoid
ocular discharge, weakened
appearance, abnormal feces, and
degeneration of the thyroid.
Lymphocytic infiltration in females and
erosion of gastric mucosa and
prominence of limiting ridge of the
stomach in males.
No cancer data are available
1 The registrant has requested voluntary cancellation of the metalworking fluid uses. There are no long-term dermal
exposure scenarios as a result of this use cancellation.
2 The inhalation absorption factor of 100% (default value, assuming oral and inhalation absorption are equivalent)
should be used since an oral endpoint was selected for the inhalation exposure scenarios. If results are below an
MOE of 1,000, confirmatory inhalation toxicity data are warranted.
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UF = Uncertainty Factor, NOAEL = No Observed Adverse Effect Level, LOAEL = Lowest Observed Adverse Effect Level,
PAD = Population Adjusted Dose (a = acute, c = chronic) RiD = Reference Dose, MOE = Margin Of Exposure, LOG = Level Of
Concern, NA = Not Applicable
b.
Residential Handlers
i. Exposure Assessment
Residential handler exposure to diiodomethyl p-tolyl sulfone can occur through the
application of treated paints via brush, roller, and airless sprayer; and the application of wood
preservatives to treat wood surfaces via brush, roller and airless sprayer. In addition, toddlers
may be exposed to diiodomethyl p-tolyl sulfone when using finger paints preserved with this
active ingredient. The residential exposure scenarios assessed for diiodomethyl p-tolyl sulfone
represent worst case exposure scenarios. The EPA selected high-end representative use
scenarios based on maximum application rates as stated on the product labels. The residential
handler exposure use scenarios assessed are shown in Table 5. This table also shows the
maximum application rates associated with the representative uses and the EPA Registration
numbers for the corresponding product labels.
Table #5. Representative Uses Associated with Residential Handler Exposure
Representative Use
Applying Wood
Preservatives on Decks
Applying Treated Paints
(in-can preservative)
Two Hand Immersion
(Toddler Finger-
Painting)
Exposure Scenario
ST Handler: Adult
Dermal and
Inhalation
ST Handler: Adult
Dermal and
Inhalation
ST Handler: Child
Dermal
Application
Method
Paint brush,
Roller,
Airless-
sprayer
Paint brush,
Roller,
Airless-
sprayer
Finger-
Painting
EPA Reg. No.
60061-9
464-672
NA
Maximum Application
Rate
0.0002 llbai/sq ft
(8.34 Ib/galx 0.38% aix
1 gal 7150 sq. ft)
0.050 Ib ai/gal
(10.2 lb/100 gal x 48.45%)
NA
Note: Only EPA registered products with specified use directions/use applications are included in this table.
Products listed were selected based on maximum use rates by application method.
ST = Short-term exposure
*Handler dermal and inhalation exposure were assessed using PHED unit exposures.
Dermal and inhalation exposures were assessed for these scenarios using the Pesticide
Handler Exposure Database (PHED, Version 1.1) and values were found in the EPA's Standard
Operating Procedures (SOP) for Residential Exposure Assessments (U.S. EPA, 1997a, 2001).
The dermal and inhalation exposures from these techniques have been normalized by the amount
of active ingredient handled and are reported as unit exposures (UE), which are expressed as
mg/lb of active ingredient handled.
Surrogate unit exposure data, maximum application rates from labels, and EPA estimates
17
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of daily amounts handled were used to assess residential handler exposures and risks. The
residential handler scenarios were assumed to be of short-term duration (1-30 days).
11.
Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation risk assessments for residential handler exposure. An MOE greater than
or equal to 100 is considered adequately protective for the dermal route of exposure.
For inhalation exposure the target MOE for identifying risks of concern is 100 and the
target MOE for identifying the need for confirmatory inhalation toxicity data is 1,000. An
inhalation MOE greater than or equal to 100 is considered adequately protective. However, if
the inhalation MOE is greater then 100 but less then 1,000, inhalation toxicity data are needed
to confirm that the use of route-to-route extrapolation does not underestimate inhalation
exposure risk. For diiodomethyl p-tolyl sulfone the inhalation endpoint was set using oral
toxicity data. When oral toxicity data are used to select an inhalation endpoint, as was done for
diiodomethyl p-tolyl sulfone, the Agency considers requiring inhalation toxicity data to confirm
that the use of route-to-route extrapolation does not underestimate potential risk.
For the residential handler risk assessment the calculated dermal and inhalation MOEs
are all above their respective target MOEs of 100, except for the following use scenario. The
following residential exposure scenario indicates risks of concern:
• Painting: Airless Sprayer
(ST Dermal MOE = 48)
An inhalation toxicity study is needed to confirm that there are no inhalation risks of
concern because the inhalation MOE for painting via airless sprayer (MOE = 230) is below the
high-end target of 1,000. A summary of the residential handler exposures and risks are presented
in Table 6.
Table #6. Short-Term Residential Handler Exposures and MOEs
Wood
Preservative
Painting
Method of
Application
Brush/roller
Airless
sprayer
Brush/roller
Unit Exposure
(mg/lb ai)
Dermal3
230
79
230
Inhalation
0.284
0.83
0.284
Application
Rate
0.00021 Ib
ai/sq ft
0.00021 Ib
ai/sq ft
0.05 Ib
ai/gal
Quantity
Handled/
Treated
per day
300 sq ft
300 sq ft
2 gal
Absorbed Daily Dose
(mg/kg/day)
Dermal"
2.52E-2
8.6E-3
3.9E-2
Inhalation0
2.6E-4
7.5E-4
4.0E-4
MOE
Dermal
ST
(Target=100)
192
559
123
Inhalation
(Target =
100)e
7800
2700
5000
18
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Airless
sprayer
79
0.83
0.05 Ib
ai/gal
15 gal
l.OE-1
8.8E-3
48
230
All dermal unit exposures represent ungloved replicates. The brush/roller, and airless sprayer unit exposures represent short sleeve and
short pant replicates.
b Dermal Daily Dose (mg/kg/day) = [dermal unit exposure (mg/lb ai) * application rate * quantity handled * ABS (0.12) / body weight
(70 kg).
c Inhalation Daily Dose (mg/kg/day) = [inhalation unit exposure (mg/lb ai) * application rate * quantity handled / body weight (70 kg).
d Dermal MOE = NOAEL (mg/kg/day) / Daily Dose. Target dermal MOE is 100 for ST and 300 for IT (ST NOAEL 4 mg/kg/day and
IT LOAEL 2 mg/kg/day.
e Inhalation MOE = LOAEL (2 mg/kg/day) / Daily Dose. Target inhalation MOE is 300.
In addition to painting activities, children may have dermal exposure as a result of
handling treated finger-paint. Therefore, a short-term dermal exposure assessment was
conducted to assess potential dermal risks to children from finger-painting. For this exposure
scenario, it was assumed that the amount of treated paint present on the painter's skin could be
represented by an estimate of the paint remaining on hands (i.e., wet film thickness) following
complete immersion into the paint with some wiping since the toxicological endpoint is a
systemic effect. For short-term durations, the film thickness of the paint on the hands was based
on a study in which both hands were dipped in mineral oil and then partially cleaned with a rag
(US EPA 1992). The film thickness value of 1.75 mg/cm2 (partial wipe) was chosen because the
dermal endpoint for short-term durations is based on systemic effects and represents an estimate
in the absence of more specific data. However, the density of the finger-paint was assumed to be
somewhat higher then oil/water. Therefore, to bracket the risk, a worst-case estimate for film
thickness residue data (10.3 mg/cm2) for the amount remaining after immersion of hands in
mineral oil was assumed. The calculated short-term dermal MOEs are above the target MOE of
100 and, therefore, are not of concern. A summary of the short-term dermal exposures and
MOEs for toddlers' finger painting can be found in table 7.
Table #7. Short-term Dermal Exposures and MOEs for Toddlers Finger-Painting
Exposure
Scenario
Painter -
two hand
immersion
%ai
0.06
Film
thickness
(mg/cm2)
10.3
1.75
Frequency
(events/day)
1
1
Hand Surface
Area
(cm2)
350
350
PDRa (mg/mg/kg/day)
0.0034
0.0057
ST MOEb
(Target MOE=100)
118
695
a PDR= (% ai x FT x FQx SA x ABS)/BW. Dermal absorption or ABS is 12%.
b MOE = NOAEL (mg/kg/day) / Potential dose rate (mg/kg/day [Where: ST NOAEL = 4 mg/kg/day, Table 3.2].
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c. Residential Post-application
i. Exposure Assessment
Residential post-application exposures result when adults and children come in contact
with diiodomethyl p-tolyl sulfone in areas where pesticide end-use products have recently been
applied (e.g., treated wood), or when children incidentally ingest the pesticide residues through
mouthing the treated end-products/treated articles (i.e., hand-to-mouth or object-to-mouth
contact).
Post-application scenarios have been developed to encompass potential high-end
exposures from various wood and materials preservative products. Representative post-
application scenarios assessed include children contacting treated wood (dermal and incidental
oral exposure). Post-application residential inhalation exposure risks of concern were not
assessed because diiodomethyl p-tolyl sulfone has a relativity low vapor pressure (less than 1E-6
mm Hg) and, therefore, post-application inhalation exposure is expected to be negligible.
It should be noted that the registrant has indicated that they do not intend to support the
use of treated polymers/plastics for the use as toy products. The Agency requires the following
label langue for treated polymer/plastics labels to ensure that these products are not used to
manufacture toys, "Treated plastics can not be used to manufacture children's toys." If labels are
not amended to include this language, a risk assessment will be required for the use of
diiodomethyl p-tolyl sulfone in plastic/polymer toys.
At this time, the Agency does not have residue dissipation data or reliable use pattern
data, including the frequency and duration of use of antimicrobial products in the residential
setting. Therefore, to assess residential handler and post-application risks, the Agency used
surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers
Association (CMA) antimicrobial exposure study; the Pesticide Handlers Exposure Database
(PHED); Stochastic Human Exposure and Dose Simulation (SHEDS) model (USEPA 2005a);
and the proprietary sapstain study (task force # 73154), Measurement and Assessment of Dermal
and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the
Protection of Cut Lumber (Phase III) (Bestari et al., 1999, MRID 455243-04). Additionally, the
EPA's Health Effects Division's (HED) Standard Operating Procedures (SOPs) for Residential
Exposure Assessments, was used when estimating post-application/ bystander exposures.
Treated Carpet
The technical registrant for diiodomethyl p-tolyl sulfone has indicated that diiodomethyl
p-tolyl sulfone is intended to treat carpet-backing only, not carpet fiber. The use of diiodomethyl
p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone in carpets, to
carpet-backing only, by adding limitation language to the labels. As a result of the cancellation
of the use of diiodomethyl p-tolyl sulfone to treat carpet fibers, and label language limiting the
use of diiodomethyl p-tolyl sulfone to treat carpet-backing only, the Agency has determined that
20
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a post-application residential risk assessment is not needed to assess risks from treated carpet-
backing. 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 diiodomethyl p-tolyl sulfone 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. However, if the carpet fiber use is not cancelled and labels are not amended to restrict
the use of diiodomethyl p-tolyl sulfone to carpet-backing only, the Agency will have to assess
possible exposure resulting from the use of diiodomethyl p-tolyl sulfone in carpet fiber.
Treated Lumber
A number of diiodomethyl p-tolyl sulfone end-use products are registered for wood
preservative uses in pressure and non-pressure treatments of wood products intended for
residential applications. As a result of these uses, there is potential for post-application exposure
to individuals exposed to diiodomethyl p-tolyl sulfone treated wood in residential settings.
Typical uses for diiodomethyl p-tolyl sulfone end-use wood preservative products include
building lumber, furniture, frames, fences, decking, shingles, siding, logs and poles. Incidental
ingestion exposure for adults is expected to be negligible and dermal contact for adults is
expected to be lower than exposure for children crawling on wood decks. Because children are
more likely than adults to contact wood surfaces using playground equipment (play-sets) and
because children have a higher surface area to body weight ratio, they have been used to
represent the maximum exposed individual.
There are no available data to assess the levels of diiodomethyl p-tolyl sulfone residues in
soil contaminated from treated wood (above ground fabricated components of decks or play-
sets). Because of this data gap, the Agency was not able to estimate dermal and incidental
ingestion residential post-application exposures to soil contaminated with diiodomethyl p-tolyl
sulfone treated wood. There are also no data that can be used to estimate either exposure to
adults from inhalation of wood dust during construction of wood decks or to children exposure to
treated wood.
As previously mentioned, there are no chemical-specific surface wipe residue data
available to assess the dermal and incidental exposure for children playing on treated structures.
As a result of this lack of data, the Agency conducted a screening-level assessment of incidental
ingestion and dermal exposures to children from contact with treated wood using surrogate data.
For the reregi strati on decision, a conservative surface residue value of 1 //g/cm2 was used. The 1
//g/cm2 value accounts for the skin reduction factor, or "transfer efficiency" from a cloth wipe
(e.g., cloth wipe surface residues are higher than that available to the skin). This high-end
residue value is higher than the maximum residue seen for chromium and non chromium-based
wood preservatives. The deterministic screening-level assessment was developed by the EPA to
assess children's exposure using the 1 //g/cm2 wood residue value along with exposure
algorithms and parameters from the probabilistic Stochastic Human Exposure and Dose
Simulation (SHEDS) model (USEPA 2005a). SHEDS was developed by the EPA to assess
21
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exposure to children contacting CCA-treated structures (i.e., decks and play sets). The SHEDS
report along with the EPA's response to the Science Advisory Panel's (SAP) review comments is
located at http://www.epa.gov/heasd/sheds/cca treated.htm.
Based on the results of the CCA assessment and preliminary calculations for
diiodomethyl p-tolyl sulfone, direct contact with treated wood exhibits the highest potential for
exposure. The leaching of wood preservative into the soil and subsequent exposure is less then
that attributed to direct contact with the treated wood itself. Therefore, for screening-level
assessment purposes, only contact with treated wood is quantified. If the risks are not of concern
for contacting the treated wood directly, then the soil exposure and aggregate of the soil exposure
with the direct wood exposure is expected to be of minimal additional contribution.
Diiodomethyl p-tolyl sulfone is used to treat dimensional lumber, and potential dermal
exposure to children can result from playing on diiodomethyl p-tolyl sulfone treated structures
such as decks and/or play sets. The dermal and incidental oral toxicological endpoints of
concern for Diiodomethyl-p-tolyl sulfone are non-cancerous. Therefore, the amortization of
exposure over time that is provided in the SHEDS model for CCA is not appropriate for
diiodomethyl p-tolyl sulfone. The frequency of exposure is believed to be best represented by
the short-term (ST) duration (e.g., 1 to 30 days of continuous exposure). However, intermediate-
term (IT) durations were also calculated to provide risk estimates for that portion of the
population that plays continuously on treated structures up to 6 months at a time. A surface
residue wipe study is required to confirm the findings of the screening level assessment
conducted by the Agency.
TreatedHVACs
Post-application/ bystander inhalation exposure was not assessed for the use of
diiodomethyl p-tolyl sulfone to treat HVAC systems because bystander exposure is expected to
be negligible. Additional HVAC use information was obtained by the registrant during the
Phase III public comment period (MRID 473073-12). According to the technical registrant, the
product is robotically sprayed inside HVAC air ducts and there is no airflow in the ducts during
spraying. The product is allowed to dry for 2 hours. When HVAC systems turn on, any
diiodomethyl p-tolyl sulfone vapor in the ducts is vented into buildings and mixed with room air.
The vapor pressure is 6.9E-6 Pa at 25C (5.2E-8 mm Hg at 25C) (MRID 472340-04). Therefore,
based on the refined use pattern presented by the registrant, post-application inhalation exposures
are expected to be negligible and therefore, an assessment for this use is not needed nor included
in this document.
Hand-to-Mouth from Finger Painting
During finger painting activities, children may have incidental oral exposure via hand-to-
mouth activity. The Agency did not have estimates of exactly how much finger paint a child
would ingest per day. At the time of this assessment, the Agency did not have the exact density
of finger paint solution since it was not initially specified on any of the labels. It should be noted
22
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that the registrants did provide information to verify the concentration of active ingredient in
finger paint. Therefore, in order to see if this route of exposure could pose as a risk of concern,
the Agency back-calculated the acceptable short-term ingestion dose to estimate the amounts of
finger painting that would be acceptable given the NOAEL of 4 mg/kg/day and the target MOE
of 100. The Agency back-calculated that 960 mg (or 0.96 grams) of finger paint ingested could
trigger a potential concern for Diiodomethyl-p-tolyl sulfone. The Agency commonly assumes
for example that 1 tol.5 grams of toothpaste gel is applied to a toothbrush. Given, that finger
paint is a gel similar to toothpaste; the Agency believes that it is reasonable to assume that a
child could potentially ingest 1 to 1.5 grams of finger paint.
Table 8 presents the residential post-application scenarios evaluated by the Agency.
These scenarios are considered to be representative of all possible post-application residential
exposure scenarios.
Table #8. Representative Uses Associated with Residential Post-Ap
Representative Use
HVAC Air Duct
Coatings3
Wood Preservatives on
Decks
Textiles (i.e. carpets)
Finger-Painting
Exposure Scenario
ST Bystander:
Child Inhalation
ST/IT Post-app:
Child dermal,
incidental ingestion
ST/IT Post-app:
Child dermal,
incidental ingestion
ST Handler: Child
Oral
Application
Method
Sprayer
NA
NA
Finger-
Painting
EPA. Reg. No.
464-672
60061-9
464-670
NA
plication Exposure
Maximum Application
Rate
0.05 Ib ai/gal (10.2 Ib ai/100
gal x 48.45%)
0.0002 llbai/sq ft
(8.34 Ib/galx 0.38% aix
1 gal 7150 sq. ft)
0.00475 Ib ai/lb dry fabric (5
Ib per 1000 Ib dry fabric x
95%)
NA
11.
Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted a
residential post-application assessment for dermal and incidental oral exposure scenarios. An
MOE greater than or equal to 100 is considered adequately protective for short-term (ST) and
intermediate-term (IT) dermal and incidental oral exposures.
Post-application residential inhalation exposure risks of concern were not assessed because diiodomethyl p-tolyl sulfonee has a
relativity low vapor pressure (less than 1E-6 mm Hg) and, therefore, post-application inhalation exposure is expected to be
negligible. Post-application inhalation exposures are expected to be negligible for the use of diiodomethyl p-tolyl sulfonee to
treat HVAC systems. Therefore, an assessment for this use is not included in this document.
23
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For the residential post-application risk assessment, MOEs are above their respective
target MOEs of 100 for all but one of the exposure scenarios. Incidental oral risks of concern
were identified for post-application exposure of children to finger-paint. Using 1.5 grams of
finger paint and a NOAEL of 4 mg/kg/day, the resulting incidental oral MOE ranges from 65-
100. Therefore, there are incidental oral risks of concern for the finger-painting use scenario.
For further information regarding the post-application exposures and risk estimates for
children exposed to treated lumber and finger-paint please refer to Table 9.
Table #9. Residential Post-application Risks for Children
Child Contacting Treated Wood
Child Hand-to-Mouth Exposure
from Finger-Painting
Dermal MOE
(Target 100 ST/ IT)
ST MOE = 237 @ 1 ug/cm2
IT MOE = 119(3), lug/cm2
NA
Incidental Oral MOE
(Target 100 ST/ IT)
ST MOE = 7 10 @ lug/cm2
IT MOE = 355 @ lug/cm2
ST MOE = 65-100
7. 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.
Dietary and non-dietary aggregate assessments were conducted for diiodomethyl p-tolyl
sulfone. When selecting the exposure scenarios for the aggregate assessment, the use patterns of
diiodomethyl p-tolyl sulfone and the probability of co-occurrence were considered. The
following use scenarios were selected for the dietary and non-dietary aggregate exposure
assessment:
Aggregate Exposure Assessment- Dietary Scenarios for Children
• Chronic dietary exposure from combined indirect food uses
• Post-application incidental oral exposure to wood preservatives in residential
settings
Aggregate Exposure Assessment- Non-Dietary Scenarios for Children
• Dermal exposure to finger-paint treated with diiodomethyl p-tolyl sulfone
• Post-application dermal exposure to wood preservatives in residential settings
• Incidental oral exposure to finger-paint treated with diiodomethyl p-tolyl
sulfone
• Post-application incidental oral exposure to wood preservatives in residential
settings
24
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Table 10 summarizes the short- and intermediate-term aggregate exposure scenarios that were
assessed.
Table #10. Short-term and Intermediate-term Aggregate Exposure Use Scenarios
Short-term Aggregate
Intermediate-Term Aggregate
Children
Dermal:
Dermal:
Handler exposure to diiodomethyl-p-
tolylsulfone for finger painting
activities
Post-application exposure to
diiodomethyl-p-tolylsulfone from
wood preservatives used in decks
Post-application exposure to diiodomethyl-
p-tolylsulfone from wood preservatives used
in decks
Incidental Oral:
• Post-application hand-to-mouth
exposure to wood preservatives on
decks
• Post-application hand-to-mouth
exposure from finger-painting
Incidental Oral:
• Post-application hand-to-mouth exposure to
wood preservatives on decks
• Chronic dietary exposure from indirect food
use
Intermediate Dietary Aggregate Risk
An aggregate assessment for children was conducted for chronic dietary exposure from
the indirect dietary food uses of diiodomethyl p-tolyl sulfone and from intermediate-term post-
application incidental oral exposure to treated wood in residential settings. In order to
accommodate the dissimilar uncertainty factors between intermediate-term residential exposure
and long-term dietary exposure an aggregate risk index (ARI) approach was utilized. An ARI
less then lindicates risks of concern. For diiodomethyl p-tolyl sulfone, the ARI is 1.6 and,
therefore, there are no aggregate risks of concern for incidental oral exposure to treated wood
and chronic dietary exposure from indirect food use. Please refer to Table 11 for further
information regarding the aggregate risk assessment for incidental oral and indirect dietary
exposure of children to diiodomethyl p-tolyl sulfone.
Table #11. Aggregate Risk Assessment for Incidental Oral and Indirect Dietary Exposure
to Children
Exposure Routes
Incidental oral aggregate
- dietary
-hand-to-mouth wood
Exposure
(mg/kg/day)
0.00067
0.0056
Margin of
Exposure
2990
355
Uncertainty
Factor (UF)
1000
100
Risk
Index
(RI)
3.0
3.6
ART
1.6
a: Aggregate MOE = I/ ((1/RI incidental oral) + (1/RId products)) where MOE = NOAEL (mg/kg/day) / absorbed daily dose
(mg/kg/day) [OralNOAEL (systemic): 2 mg/kg/day].
25
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Short- and Intermediate-term Non-Dietary Aggregate Risk
A short-term (ST) aggregate assessment for adults was not performed for diiodomethyl p-
tolyl sulfone because of a low-probability for exposure and co-occurrence. When selecting the
exposure scenarios for the aggregate assessment, the use patterns of diiodomethyl p-tolyl sulfone
and the probability of co-occurrence were considered. Residential painting and wood preserving
activities are expected to occur only once or twice a year. The probability of co-occurrence and
the potential for exposure to residues from these uses with other diiodomethyl p-tolyl sulfone
products on the same day is highly unlikely. Therefore, ST adult exposure scenarios were not
aggregated for diiodomethyl p-tolyl sulfone. An IT aggregate exposure assessment was not
conducted for adults because there are no IT use scenarios for diiodomethyl p-tolyl sulfone.
An aggregate assessment was not conducted for inhalation exposure because
diiodomethyl p-tolyl sulfone has a relativity low vapor pressure and, therefore, post-application
inhalation exposure is expected to be negligible.
For toddlers, aggregation 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, it was possible to aggregate route specific exposures (e.g.,
incidental oral aggregate assessment and dermal aggregate assessment). An aggregate
assessment was conducted for ST dermal exposures of children to treated finger-paint and treated
wood decks. The total MOE for the ST dermal aggregate exposure assessment (MOE = 237) is
above the target of 100 and therefore, not of concern. An aggregate assessment was not
conducted for intermediate-term (IT) dermal exposure of children because the finger-painting
use pattern is not expected to occur on an IT basis. Results of the short-term dermal aggregate
assessment for toddlers/children are presented in Table 12.
Table #12. Short-term Dermal Aggregate Assessment for Children
Exposure Route
Dermal (Child)
MOEs
Wood
237
Finger painting
695
Aggregate
237
Target MOE
100
a: Aggregate MOE = 1/((I/MOEwood) + (1/MOEfmgerpainting)
An aggregate assessment was not conducted for short- and intermediate-term incidental
oral exposure of children because there are individual risks of concern for hand-to-mouth
exposure from treated finger-painting (MOE = 65-100). An incidental oral aggregate assessment
would only reflect the previously identified risks of concern and incorporation of this scenario
into an aggregate assessment would result in risks of concern. Therefore, an incidental oral
exposure assessment was not conducted.
8. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, applying a pesticide, or
re-entering treated sites. Diiodomethyl p-tolyl sulfone is used as a materials and wood
preservative. Potential occupational handler exposure can occur in various use sites during the
26
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preservation of materials that are used for household, institutional, and industrial uses; and the
preservation of wood.
The "preservation of materials" refers to the scenario of a worker adding the preservative
to the material being treated (paint, textiles, etc.) through either liquid pour or liquid pump
methods. For the preservation of wood at treatment plants and lumber mills, the methods for
treatment can vary (pressure/non-pressure), such that multiple worker functions were analyzed.
The representative uses assessed include the following materials preservative and wood
preservative incorporation and application methods: mixing and loading of product concentrates
for materials preservative incorporation into paint, paper (production), adhesives/caulks,
emulsion, leather, plastics/rubber, slurries, textiles, and air duct coatings (liquid pour, liquid
pump, open pour wettable powder, sprayer); application of treated paint (paint brush, roller, and
airless sprayer); and application of protective wood coatings (pressure treatment, brush, airless
sprayer, dip-non-pressure treatment).
a. Occupational Toxicity
The toxicological endpoints used in the occupational handler assessment of diiodomethyl
p-tolyl sulfone can be found in Table 4, "Residential and Occupational Toxicological Doses and
Endpoints for Diiodomethyl p-tolyl sulfone," 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.
The Agency evaluated representative scenarios using maximum application rates as
recommended on diiodomethyl p-tolyl sulfone product labels. It should be noted that for the
calculation of application rates in which 8.34 Ib active ingredient/gal is noted, the product is
assumed to have the density of water because no product-specific density is available. To assess
handler risk, the Agency used surrogate unit exposure data primarily from 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.
In lieu of chemical-specific data available regarding typical exposures to diiodomethyl p-
tolyl sulfone as a wood preservative, surrogate data were used to estimate exposure and risks.
The blender/spray operator position was assessed using CMA unit exposure data and the
27
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remaining handler and post-application positions were assessed using data from the proprietary
study, "Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase III) " (Bestari et al.,
1999, MRID 455243-04). It is assumed that the workers at facilities using diiodomethyl p-tolyl
sulfone wood preservatives and handling the treated wood are performing similar tasks as those
monitored in the DDAC study. Dermal and inhalation exposures for treated wood pressure
treatment uses were derived from information in the exposure study sponsored by the American
Chemistry Council (2002) entitled, "Assessment of Potential Inhalation and Dermal Exposure
Associated with Pressure Treatment of Wood with Arsenical Wood Products" (ACC, 2002).
The durations and routes of exposure evaluated for occupational exposure of
diiodomethyl p-tolyl sulfone include: short-term (ST) (1 to 30 days) and intermediate-term (IT-
30 days to 6 months) dermal and inhalation routes of exposure for the occupational scenarios.
For more information on the assumptions and calculations of the potential risks of
diiodomethyl p-tolyl sulfone to workers, refer to the "Diiodomethyl p-tolyl sulfone. P.C. Code:
101002. Human Health and Ecological Effects Risk Assessments for the Reregi strati on
Eligibility Decision (RED) Document. Case 4009," dated April 29, 2008 and the "Occupational
and Residential Exposure Chapter for Diiodomethyl p-tolyl sulfone," dated March 27, 2008.
Based on the representative use patterns of diiodomethyl p-tolyl sulfone, the exposure scenarios
in Table 13 were assessed:
Table #13. Representative Exposure Scenarios Associated with Occupational Exposures to
Diiodomethyl p-tolyl sulfone
Representative
Use
Method of Application
Exposure
Scenario
EPA Reg. No.
Maximum Application
Rate
Materials Preservatives
Paint
Air Duct Coatings
Paper production
Preservation of paint
Liquid pour
Liquid pump
Professional painter
Brush/Roller
Airless sprayer
Sprayer
Liquid pump
IT and ST
Handler:
dermal and
inhalation
ST Prof
Painter:
dermal and
inhalation
(aerosol and
vapor)
IT and ST
Handler:
inhalation
Bystander
inhalation
IT and ST
Handler:
dermal and
inhalation
464-672
464-673
464-672
464-672
464-673
0.049 Ib ai/gal wettable
powder (WP)
0.049 Ib ai/gal flowable
liquid (F)
0.049 Ib ai/gal
0.775 Ibai/tonWP
0.768 Ibai/tonF
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Representative
Use
Adhesives and
Caulks
Emulsions
Leather
Plastics
Rubbers
Slurries
Textiles
Method of Application
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Exposure
Scenario
IT and ST
Handler:
dermal and
inhalation
IT and ST
Handler:
dermal and
inhalation
IT and ST
Handler:
dermal and
inhalation
IT and ST
Handler:
dermal and
inhalation
IT and ST
Handler:
dermal and
inhalation
IT and ST
Handler:
dermal and
inhalation
EPA Reg. No.
464-672
464-673
464-672
464-673
464-672
464-673
464-672
464-673
464-672
464-673
464-672
464-673
Maximum Application
Rate
0.29% ai per wt. F
0.30% ai per wt. WP
0.14%aiperwt. F
0.15%aiperwt. WP
0.26% ai per wt. F
0.296% ai per wt. WP
0.026% ai per wt. F
0.278% ai per wt. WP
0. 15% ai per wt. F and
WP
0.0048 Ib ai/lb dry wt. F
0.005 Ib ai/lb dry wt. WP
Wood Preservatives
Wood Preservative
(pressure and non-
pressure treated)
Pressure Treatment
Brush
Airless Sprayer
Dip (Non-Pressure
Treatment)
IT and ST
Handler &
Post-
application:
dermal and
inhalation
464-673
(pressure
treatment)
60061-009
(brush/airless
sprayer)
0.4 Ib ai/cubic ft (pressure
treatment)
0.0002 llbai/sq ft
(brush/airless sprayer)
Note: Only EPA registered products with specified use directions/use applications are included in this table.
Products listed were selected based on maximum use rates by application method.
ST = Short-term exposure, IT = Intermediate-term exposure, LT= Long-term exposure.
c. Occupational Handler Risk Summary
The occupational handler risk assessment for diiodomethyl p-tolyl sulfone includes both
inhalation and dermal exposure scenarios. The target MOE for short- and intermediate- term
(ST/ IT) dermal exposure is 100. For inhalation exposure the target MOE for identifying risks of
concern is 100 and the target MOE for identifying the need for confirmatory inhalation toxicity
data is 1,000. An inhalation MOE greater than or equal to 100 is considered adequately
protective. However, if the inhalation MOE is greater then 100 but less then 1,000, inhalation
toxicity data are needed to confirm that the use of route-to-route extrapolation does not
underestimate inhalation exposure risk.
29
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Materials Preservation & Application- Occupational Handler Risk Summary
For occupational handlers the use of PPE is required on all product labels. Without the
use of PPE several dermal and inhalation risks of concern are identified. However, with the use
of gloves and respirators (PPE) the MOEs for most exposure scenarios are above the target
MOEs. However, it should be noted that the Agency can not require the use of gloves or
respirators (PPE) on in-can paint preservative labels.
As previously mentioned, the calculated dermal MOEs for many of the exposure
scenarios are above the ST and IT target MOEs with the use of gloves (PPE). However, the
following occupational handler exposure scenario indicates dermal risks of concern even with
the use of gloves (PPE):
• Rubber & Plastics Preservation: Open Pour Wettable Powder
(IT Dermal MOE w/ gloves = 53)
The IT dermal MOE for paint preservation via open pour wettable powder is 83 with the use of
gloves. However, because the Agency uses conservative assessment methods and the MOE of
83 is very close to the target of 100, the Agency believes that there are no risks of concern of this
use pattern.
For the application of paint via airless sprayer and brush/roller two dermal exposure
scenarios indicate risks of concern. It should be noted, that the Agency can not require the use of
gloves (PPE) on in-can paint preservative labels. The following application use scenarios
indicate dermal risks of concern for occupational handlers:
• Painting: Airless Sprayer
(Dermal MOE = 29 ST)
• Painting: Brush/Roller
(Dermal MOE = 62 ST)
For inhalation exposure, the target MOE for identifying risks of concern is 100 for short-
and intermediate-term exposure durations. The target MOE for identifying the need for
confirmatory inhalation toxicity data is 1,000. An inhalation MOE greater than or equal to 100 is
considered adequately protective. However, if the inhalation MOE is greater then 100 but less
then 1,000, inhalation toxicity data are needed to confirm that the use of route-to-route
extrapolation (use of oral toxicity data to set an inhalation endpoint) does not underestimate
inhalation exposure risk.
All of the inhalation materials preservation scenarios assessed indicate no risks of
concern for occupational handlers (MOEs above 100) with the use of a respirator (PPE) and,
therefore, are not of concern.
30
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For application of in-can paint, PPE (respirator or gloves) can not be required. The
following occupational application inhalation exposure scenario has an MOE below the target of
100 and, therefore, is of concern:
• Painting: Airless Sprayer
(Inhalation MOE = 67)
Confirmatory inhalation toxicity data are needed because several of the inhalation MOEs
are below the high-end target MOE of 1,000. For further information regarding the short- and
intermediate-term risks associated with occupational handlers, refer to Table 14 below.
Table #14. Short- and Intermediate-Term Risks Associated with Occupational Handlers
Exposure
Scenario
Preservation
of Paint
Application
of Paint by
a
Professional
Painter
Preservation
of
Adhesives
and Caulks
Method of
Application
Liquid Pour
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Brush/
Roller
Airless
Sprayer
Liquid Pour
Unit Exposure (mg/lb a.i.)
Baseline
Dermal11
NA
NA
NA
NA
180
38
NA
PPE-
Gloves
Dermal"
0.135
0.17
0.00629
0.0098
24
14
0.135
Inhalation
0.00346
0.0434
0.000403
0.00024
0.28
0.83
0.00346
% ai or
Ib
ai/gal.(%
aiper
wt)
40%
0.05 Ib
ai/gal
95%
0.049 Ib
ai/gal
0.05 Ib
ai/gal
0.049 Ib
ai/gal
0.05 Ib
ai/gal
0.05 Ib
ai/gal
40%
0.29% ai
by wt.
Use
Informtion
50 Ib
prod. /day
(Registrant
Estimate)
2000
gallon
(250 Ib
prod/day)
50 Ib
prod/day
(Registrant
Estimate)
2000
gallon
(250 Ib
prod/day)
20000
gallon
(2,500 Ib
prod/day)
20000
gallon
(2,500 Ib
prod/day)
5 gal
50 gal
50 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(72 Ib
prod/day)
Absorbed Daily
Dose
(mg/kg/day)c
Dermal
ST/IT
NA
NA
NA
6.4E-2
0.14
NA
PPE-
Gloves
Dermal
ST/IT"
3.9E-3
1.9E-2
4.9E-3
2.4E-2
9.0E-3
1.4E-2
NA
NA
3.9E-3
5.6E-3
Inhal.
ST/IT
9.9E-
4
4.9E-
3
1.2E-
2
6.1E-
2
5.8E-
3
3.4E-
3
l.OE-
03
0.03
9.9E-
4
1.4E-
3
Base
Der
(Ta
MO
100
/IT
ST
NA
NA
NA
NA
NA
NA
62
29
NA
line
mal
rget
E =
ST
)M
IT
NA
NA
NA
NA
NA
NA
31
15
NA
PPE-C
Der
(Targe
= 1005
1001
ST
1037
207
824
167
445
289
NA
NA
1037
720
Jloves
mal
tMOE
>Tand
IT
519
104
412
83
223
145
NA
NA
519
360
InhalationfTarget
MOE = 100
ST/IT)"
Baseline
2023
405
161
33
347
590
2000
67
2023
1405
PPE
NA
NA
NA
163
1737
2951
NA
NA
NA
-------
Exposure
Scenario
Preservation
of
Adhesives
and Caulks
Preservation
of Slurries
Preservation
of
Emulsions
Method of
Application
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Liquid Pour
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Liquid Pour
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Unit Exposure (mg/lb a.i.)
Baseline
Dermal11
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
PPE-
Gloves
Dermal"
0.17
0.00629
0.0098
0.135
0.17
0.00629
0.0098
0.135
0.17
0.00629
0.0098
Inhalation
0.0434
0.000403
0.00024
0.00346
0.0434
0.000403
0.00024
0.00346
0.0434
0.000403
0.00024
% ai or
Ib
ai/gal.(%
aiper
wt)
95%
0.30% ai
per wt.
0.30% ai
per wt.
40%
0.15%
95%
0.15%ai
per wt.
0.15%ai
per wt.
0.15%ai
per wt.
40%
0. 14% ai
per wt.
95%
0.15%ai
per wt.
0.15%ai
per wt.
0.15%ai
per wt.
Use
Informtion
20 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(30 Ib
prod/day)
10000 Ib
(30 Ib
prod/day)
10000 Ib
(30 Ib
prod/day)
50 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(38
Ib
prod/day)
20 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(15
Ib
prod/day)
10000 Ib
(15
Ib
prod/day)
50 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(38
Ib
prod/day)
20 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(15 Ib
prod/day)
10000 Ib
(15 Ib
prod/day)
10000 Ib
(15 Ib
prod/day)
Absorbed Daily
Dose
(mg/kg/day)c
Dermal
ST/IT
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
PPE-
Gloves
Dermal
ST/IT"
4.6E-3
6.9E-3
2.6E-4
4E-4
3.9E-3
2.9E-3
4.6E-3
3.6E-3
1.4E-4
2.1E-4
3.9E-3
2.7E-3
4.6E-3
3.6E-3
1.3E-4
2.1E-4
Inhal.
ST/IT
1.2E-
2
1.8E-
2
1.7E-
4
9.8E-
5
9.9E-
4
7.5E-
4
1.2E-
2
9.3E-
3
8.8E-
5
5.1E-
5
9.9E-
4
7.0E-
4
1.2E-
2
9.3E-
3
8.2E-
5
5.1E-
5
Base
Der
(Ta
MO
100
/IT
ST
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
line
mal
rget
E =
ST
}M
IT
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
PPE-C
Der
(Targe
= 100S
1001
ST
867
578
15457
10025
1037
1365
867
1097
29286
19023
1037
1455
867
1097
31239
19023
Jloves
mal
tMOE
>Tand
rp-, b,d
IT
433
289
7728
5013
519
682
433
548
14643
9511
519
728
433
548
15619
9511
InhalationfTarget
MOE = 100
ST/IT)"
Baseline
170
113
12062
20468
2023
2662
170
215
22855
38838
2023
2839
170
215
24379
38838
PPE
849
566
NA
NA
NA
NA
849
1074
NA
NA
NA
849
1074
NA
32
-------
Exposure
Scenario
Preservation
of Rubber
and Plastics
Method of
Application
Liquid Pour
Open Pour
Wettable
Powder
Unit Exposure (mg/lb a.i.)
Baseline
Dermal11
NA
NA
PPE-
Gloves
Dermal"
0.135
0.17
Inhalation
0.00346
0.0434
% ai or
Ib
ai/gal.(%
aiper
wt)
15
0.264%ai
per wt.
95%
0.78% ai
per wt.
Use
Informtion
50 Ib
prod/day
(Registrant
Estimate)
2,000 gallons
or 20000 Ib
(300 Ib
prod/day)
20 Ib
prod/day
(Registrant
Estimate)
2,000 gallons
or 20,000 Ib
(320 Ib
prod/day)
Absorbed Daily
Dose
(mg/kg/day)c
Dermal
ST/IT
NA
NA
PPE-
Gloves
Dermal
ST/IT"
1 .4E-3
1E-2
3.7E-4
3.8E-2
Inhal.
ST/IT
3.7E-4
2.6E-3
9.4E-4
9.6E-2
Base
Der
(Ta
MO
100
/IT
ST
NA
NA
line
mal
rget
E =
ST
)"•"
IT
NA
NA
PPE-C
Der
(Targe
= 100S
1001
ST
2765
393
1092
106
Jloves
mal
tMOE
>Tand
rp-, b,d
IT
1383
196
546
53
Inhalation(Target
MOE = 100
ST/IT)"
Baseline
5395
766
2130
21
PPE
NA
NA
104
Exposure
Scenario
Preservation
of Rubber
and Plastics
Preservation
of Leather
(Tanning
Drum)
Preservation
of Leather
(Tanning
Drum)
Method of
Application
Liquid
Pump
Water
Soluble
Bags
Liquid Pour
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Unit Exposure (mg/lb a.i.)
Baseline
Dermal11
NA
NA
NA
NA
NA
NA
PPE-
Gloves
Dermal"
0.00629
0.0098
0.135
0.17
0.00629
0.0098
Inhalation
0.000403
0.00024
0.00346
0.0434
0.000403
0.00024
% ai or
Ib ai/gal.
0.264%ai
per wt.
0.78% ai
per wt.
40%
0.26%ai
per wt.
95%
0.296%ai
per wt.
0.26%ai
per wt.
0.296%ai
per wt
Lb
product
handled
per day
20,000
gallons or
200,000 Ib
(3,000 Ib
prod/day)
20,000
gallons or
200,000 Ib
(3,000 Ib
prod/day)
11 Ib
prod/day
(Registrant
Estimate)
10000 Ib
(172 Ib
prod/day)
61b
prod/day
(Registrant
Estimate)
10000 Ib
(78 Ib
prod/day)
10000 Ib
(172 Ib
prod/day)
10000 Ib
(78 Ib
prod/day)
Absorbed Daily Dose
(mg/kg/day)c
Dermal
ST/IT
NA
NA
NA
NA
NA
NA
NA
PPE-
Gloves
Dermal
ST/IT"
4.7E-3
2.2E-2
8.5E-4
1.3E-2
1.4E-3
1.9E-2
6.2E-4
1.1E-3
Inhal.
ST/IT
3E-3
5.3E-
3
2.2E-
4
3.4E-
3
3.5E-
3
4.8E-
2
4.0E-
4
2.6E-
04
Baseline
Dermal
(Target
MOE =
100 ST
/IT)"'"
ST
NA
NA
NA
NA
NA
NA
NA
IT
NA
NA
NA
NA
NA
NA
NA
PPE-Gloves
Dermal
(Target
MOE = 100
ST and 100
IT) "'"
ST
843
184
4714
302
2890
214
6485
3718
IT
422
92
2357
151
1445
107
3243
1859
InhalationfTarget
MOE = 100
ST/IT)"
Baseline
658
376
9196
589
566
42
5061
7591
PPE
3290
1881
NA
2947
2830
210
NA
NA
33
-------
Exposure
Scenario
Preservation
of Textiles
(Non-
Clothing)
Preservation
of Textiles
(Non-
Clothing)
Preservation
of Paper
Application
of Wood
Preservative
by
professionals
Method of
Application
Liquid Pour
Open Pour
Wettable
Powder
Liquid
Pump
Water
Soluble
Bags
Liquid
Pump
Water
Soluble
Bags
Brush/
Roller
Airless
Sprayer
Unit Exposure (mg/lb a.i.)
Baseline
Dermal"
NA
NA
NA
NA
180
38
PPE-
Gloves
Dermal"
0.135
0.17
0.00629
0.0098
0.00629
0.0098
24
14
Inhalation
0.00346
0.0434
0.000403
0.00024
0.000403
0.00024
0.28
0.83
% ai or
Ib ai/gal.
40%
0.0048 Ib
ai/lb dry
weigh
95%
0.005 Ib
ai/lb dry
weigh
0.0048 Ib
ai/lb dry
weigh
0.005 Ib
ai/lb dry
weigh
0.768 Ib
ai/ton
0.775 Ib
ai/ton
2.1E-4
Lb ai/sq
ft
Lb
product
handled
per day
50 Ib
prod/day
(Registrant
Estimate)
10000 Ib
dry wt.
50 Ib
prod/day
(Registrant
Estimate)
10000 Ib
dry wt.
10000 Ib
dry wt.
10000 Ib
dry wt.
500 tons
300sqft
Absorbed Daily Dose
(mg/kg/day)c
Dermal
ST/IT
NA
NA
NA
NA
NA
1.6E-2
3.4E-3
PPE-
Gloves
Dermal
ST/IT"
3.90E-
03
9.2E-3
1.2E-02
1.2E-02
4.3E-04
7E-04
3.5E-3
5.4E-3
2.2E-3
1.3E-3
Inhal.
ST/IT
9.9E-
04
2.3E-
03
2.9E-
02
3.1E-
02
2.7E-
04
1.7E-
04
2.2E-
3
1.3E-
3
2.5E-
4
7.5E-
4
Baseline
Dermal
(Target
MOE =
100 ST
/IT)"'"
ST
NA
NA
NA
NA
NA
245
1163
IT
NA
NA
NA
NA
NA
123
581
PPE-Gloves
Dermal
(Target
MOE = 100
ST and 100
IT) M
ST
1037
437
347
329
9372
5714
1159
737
1841
2661
IT
519
218
173
165
4686
2857
580
369
920
1578
InhalationfTarget
MOE = 100
ST/IT)"
Baseline
2023
852
68
65
7314
11667
905
1505
7888
2661
PPE
NA
4259
340
323
NA
NA
4523
NA
NA
NA
ST = short-term, IT = intermediate-term, N/A= Not applicable. For material preservative, no appropriate surrogate data was found for ungloved conditions.
a Baseline Dermal: Long-sleeve shirt, long pants, no gloves.
b PPE Dermal with gloves: baseline dermal plus chemical-resistant gloves.
c Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb ai) * absorption (1.0 for ST/IT inhalation and ST dermal, 0.10 for ST/IT dermal) * application
rate * quantity treated / Body weight (70 kg).
d MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where short-term NOAEL = 4 mg/kg/day for dermal and intermediate-term LOAEL = 2 mg/kg/day
for IT dermal and inhalation exposures].
NC = Not conducted: IT exposures were not assessed for professional painters because it was assumed that professional painters applying paint or wood
preservatives will not use Diiodomethyl-p-tolylsulfone preserved paint on a continuous basis.
Wood Preservation & Application- Handler Risk Summary
Occupational handler exposure to diiodomethyl p-tolyl sulfone may occur as a result of
wood preservation and wood preservative application. The calculated dermal exposure MOEs
for wood preservation were all above the target MOE of 100 and, therefore, are not of concern.
34
-------
For inhalation exposure the target MOE for identifying risks of concern is 100 and the
target MOE for identifying the need for inhalation toxicity data is 1,000. An inhalation MOE
greater than or equal to 100 is considered adequately protective. However if the inhalation MOE
is greater then 100 but less then 1,000, inhalation toxicity data are needed to confirm that the
use of route-to-route extrapolation (use of oral toxicity data to set an inhalation endpoint) does
not underestimate inhalation exposure risk. All of the inhalation scenarios assessed were not of
concern (MOEs greater then 100) for occupational wood preservation. However, one of the
inhalation scenarios has an MOE below 1,000 and, therefore, triggers the need for an inhalation
toxicity study to confirm that there are no inhalation risks of concern. The following use
scenario triggers the need for confirmatory inhalation toxicity data:
• Blender/ Spray Operator: CMA Liquid Pump
(Inhalation MOE = 203 @ 0.96% application rate; MOE = 403 @
0.48% application rate)
For further information regarding the short- and intermediate-term risks and MOEs for
wood preservative blender/spray operators, chemical operators, and diptank operators refer to
Tables 15, 16 and 17.
Table #15. Short- and Intermediate-term Exposures and MOEs for Wood Preservative
Blender/spray Operators
CMA
Liquid
Pump
CMA
Dermal
UE
(mg/lb
ai)
0.00629
CMA
Inhal UE
(mg/lb
ai)
0.000403
App
Rate
(% ai)
0.96%
0.48%
Quantity
Treated
(Ib/day)
178,000
Daily Dermal
Dose"
(mg/kg/day)
0.015
0.0077
Daily Inhal.
Dose"
(mg/kg/day)
0.0098
0.0050
Dermal MOE
b
ST
261
516
IT
130
258
Inhalation
MOEb
203
403
a Daily Dose = UE (mg/lb ai) x App Rate (% ai) x Quantity treated (Ib/day) x absorption factor (ST/IT dermal = 0.10, not
necessary for inhalation)/ BW (70 kg)
b MOE = NOAEL (mg/kg/day)/ Daily dose [Where short-term NOAEL = 4 mg/kg/day for dermal and the NOAEL for inhalation
exposures and intermediate-term = 2 mg/kg/day for dermal and inhalation exposures].
Table #16. Short- and Intermediate-term Exposures and MOEs for Wood Preservative
Chemical Operators
Exposure
Scenario"
(number
of
volunteers)
Chemical
Operator
Dermal
UEb
(mg/day)
9.81
Inhalation
UEb
(mg/day)
0.0281
Conversion
Ratio0
0.32
Absorbed Daily Dosesd
(mg/kg/day)
Dermal
0.0045
Inhalation
0.00013
MOE=
100
MOE=100
Dermal
ST
892
IT
446
Inhalation
ST /IT/LT
15,569
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term duration
a. The exposure scenario represents a worker wearing short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under
chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill.
35
-------
b. Dermal and inhalation unit exposures are from Bestari et al (1999). Refer to Table A-l in Appendix A for the calculation of the dermal
and inhalation exposures. Inhalation exposures (mg/day) were calculated using the following equation: air concentration (ug/m3) x
inhalation rate (1.0 m /hr) x sample duration (8 hr/day) x unit conversion (1 mg/1000 ug). The inhalation rate is from USEPA, 1997a.
c. Conversion Ratio = 0.95% ai solution/3.0% ai solution
d. Absorbed Daily Dose (mg/kg/day) = exposure (mg/day) * conversion ratio (0.6) * absorption factor (012 for ST/IT dermal and 1.0
for inhalation) / body weight (70 kg).
e.MOE = NOAEL (mg/kg/day)/ Daily Dose [Where ST NOAEL = 4 mg/kg/day for dermal exposures, and IT LOAEL = 2 mg/kg/day for
IT dermal and all durations of inhalation]. Target MOE is 100 for ST dermal and 300 for IT dermal and inhalation exposures.
Table #17. Short- and Intermediate-term Exposures and MOEs for Wood Preservative
Diptank Operators
Exposure
Scenario"
(number
of
replicates))
Chemical
Operator
Dipping
with
Gloves
Dermal
Unit
Exposure1"
(mg
DD AC/1%
solution)
2.99
Inhalation
Unit
Exposure1"
(mg
DD AC/1%
0.046
Application
Rate
(% a.i. in
solution/
day)c
0.96
Absorbed Daily Dosesd
(mg/kg/day)
Dermal
0.0041
Inhalation
0.00063
MOEse
(target
MOE =
100)
MOEse (target MOE =
300)
Dermal
ST
975
IT
488
Inhalation
ST/IT
3170
ST = Short-term duration; IT =Intermediate-term duration; and LT = long-term.
a. The exposure scenario represents a worker wearing long-sleeved shirts, cotton work trousers, and gloves. Gloves were worn
only when near chemicals, not when operating the diptank.
b. Dermal and inhalation unit exposures are from the DDAC study (MRID 455243-04). Refer to Table A-2 in Appendix A for the
dermal and inhalation unit exposure calculations. Inhalation exposure (mg) was calculated using the following equation: Air
concentration (mg/m3) x Inhalation rate (1.0 m3/hr) x Sample Duration (8 hr). The inhalation rate is from USEPA, 1997a.
c. The application rate is 0.96%a.i. in treatment solution (formulated product is applied at a rate of 48.45% of the weight of the
wood treated, and the product contains 2% a.i.)
d. Absorbed Daily Dose (mg/kg/day) = unit exposure (mg/1% ai solution) * percent active ingredient in solution absorption
factor (12% for dermal ST/IT, and 100% for all other exposures/durations) / body weight (70 kg).
e. MOE = NOAEL (mg/kg/day)/ Daily Dose [Where ST NOAEL = 4 mg/kg/day for dermal and the IT LOAEL = 2 mg/kg/day
for dermal and all inhalation durations]. Target MOE is 100 for ST dermal and 300 for IT dermal and inhalation exposures.
d. Occupational Post-application Risk Summary
Occupational handlers may have post-application exposure to diiodomethyl p-tolyl
sulfone by handling treated wood. Diiodomethyl p-tolyl sulfone products that are intended to
preserve wood (pressure and non-pressure treatment) are used for control of mildew, sapstain,
and wood rotting organisms. Diiodomethyl p-tolyl sulfone can be incorporated into appropriate
vehicles to protect wood from stain and decay (for formulating uses only). Diiodomethyl p-tolyl
sulfone can also be used for control of mildew, sapstain, and wood rotting organisms at wood
treatment facilities; or it can be incorporated into other registered wood preservatives for typical
uses such as building lumber, furniture, frames, decking, fences, shingles, and siding logs and
poles. Occupational post-application risks are assumed to be negligible for all diiodomethyl p-
tolyl sulfone use patterns with the exception of the wood preservative scenarios.
36
-------
Chemical Operators/ Graders/Millwrights/ Trim Saw Operators/ Clean-up Crews
Post-application exposures to chemical operators, graders, millwrights, trim saw
operators, and clean-up crews were assessed using surrogate data from the DDAC study (Bestari
et al., 1999). This study examined individuals' exposure to DDAC while working with anti-
sapstain chemicals and performing routine tasks at 11 sawmills/planar mills in Canada. Dermal
and inhalation exposure monitoring data were gathered for each job function of interest using
dosimeters and personal sampling tubes. These sample media were then analyzed for DDAC,
and the results were reported in terms of mg DDAC exposure per person per day. The study
reported average daily exposures for workers in various categories. Exposure data for
individuals performing the same job functions were averaged together to determine job specific
averages. Total exposures from 2 trim saw workers, 13 grader workers, 11 chemical operators, 3
millwrights, and 6 clean-up staff were used.
To determine diiodomethyl p-tolyl sulfone exposures, the average DDAC exposures
measured on individuals (in terms of total mg DDAC) were multiplied by a modification factor
of 0.32 to account for the difference in percent active ingredient between diiodomethyl p-tolyl
sulfone and DDAC (48% diiodomethyl p-tolyl sulfone in the wood preservative product versus
80% DDAC in the comparative wood preservative product). The pounds (Ib) of active ingredient
handled by each person or the percent (%) active ingredient in the treatment solution were not
provided for these worker functions.
Table 18 provides the short-, intermediate-, and long-term doses and MOEs for graders,
millwrights, clean-up crews, and trim saw operators. For all but one of the worker functions, the
post-application dermal MOEs are above the target MOE of 100 for ST/ IT durations assessed.
The following post-application worker function has an IT dermal MOE below 100 and,
therefore, is of concern:
• Clean-Up: Wood Preservation
(IT Dermal MOE = 79)
For all worker functions, the inhalation MOEs are above the target MOE of 100 and,
therefore, are not of concern. However, one of the inhalation scenarios has an MOE below the
high-end target MOE of 1,000 and, therefore, triggers the need for an inhalation toxicity study
to confirm that there are no inhalation risks of concern. The following use scenario triggers the
need for confirmatory inhalation toxicity data:
• Clean-Up: Wood Preservation
(Inhalation MOE = 729)
37
-------
Table #18. Short- and Intermediate-term Post-application Occupational Exposures and
MOEs for Wood Preservative Grader, Trim Saw, Millwright and Clean-Up Staff
Exposure
Scenario"
(number
of
volunteers)
Grader
(n=13)
Trim Saw
(n=2)
Millwright
(n=3)
Clean-Up
(n=6)
Dermal
UEb
(mg/day)
3.13
1.38
12.8
55.3
Inhalation
UEb
(mg/day)
0.0295
0.061
0.057
0.60
Conversion
Ratio0
0.32
0.32
0.32
0.32
Absorbed Daily Dosesd
(mg/kg/day)
Dermal
0.0014
0.00063
0.0059
0.026
Inhalation
0.00013
0.00027
0.00026
0.0027
MOE=
100
MOE=100
Dermal
ST
2796
6341
683
158
IT
1398
3170
342
79
Inhalation
ST /IT/LT
14,831
7,172
7,675
729
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term duration
a.The exposure scenario represents a worker wearing short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical resistant
gloves. Volunteers were grouped according to tasks they conducted at the mill.
b Dermal and inhalation unit exposures are from Bestari et al (1999). Refer to Table A-l in Appendix A for the calculation of the dermal and inhalation
exposures. Inhalation exposures (mg/day) were calculated using the following equation: air concentration (ug/m3) x inhalation rate (1.0 mVhr) x sample
duration (8 hr/day) x unit conversion (1 mg/1000 ug). The inhalation rate is from USEPA, 1997a.
c Conversion Ratio = 0.95% ai solution/3.0% ai solution
d.Absorbed Daily Dose (mg/kg/day) = exposure (mg/day) * conversion ratio (0.6) * absorption factor (012 for ST/IT dermal and 1.0 for inhalation) / body
weight (70 kg).
e. MOE = NOAEL (mg/kg/day)/ Daily Dose [Where ST NOAEL = 4 mg/kg/day for dermal exposures, and IT LOAEL = 2 mg/kg/day for IT
dermal and all durations of inhalation]. Target MOE is 100 for ST dermal and 300 for IT dermal and inhalation exposures.
Construction Workers
Not enough data exists to estimate the amount of exposure associated with construction
workers who install treated wood. In particular, values for the transfer coefficient associated
with a construction worker handling the wood could not be determined. It is believed that the
construction worker using a trim saw will have larger dermal and inhalation exposures than the
installer, due to the amount of sawdust generated and the greater amount of hand contact that
would be necessary to handle the wood when using a saw compared to installing the wood.
Because the dermal and inhalation MOEs are well above the target of 100 for trim saw operators
and handler exposure is expected to be greater for trim saw operation, risks of concern are not
anticipated for construction workers installing treated wood.
Pressure Treatment Scenarios (Handler & Post-Application Exposure Scenarios)
Diiodomethyl p-tolyl sulfone wood preservatives may be used to treat wood and wood
products using pressurized application methods, specifically empty-cell vacuum pressure
techniques. Chemical-specific exposure data are not available to asses the potential pressure
treatment exposure of diiodomethyl p-tolyl sulfone. Therefore, the assessment was based on
surrogate chromated copper arsenate (CCA) data (ACC, 2002). Dermal and inhalation exposures
for pressure treatment uses are derived from information in the exposure study sponsored by the
American Chemistry Council (2002) entitled "Assessment of Potential Inhalation and Dermal
38
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Exposure Associated with Pressure Treatment of Wood with Arsenical Wood Products" (ACC,
2002). In this study, a treatment solution of CCA was approximately 0.5 percent active
ingredient. The CCA exposure monitoring study is considered a valid surrogate source of data
for pressure treatment applications and was therefore used in estimating exposure to
diiodomethyl p-tolyl sulfone.
The estimated dermal and inhalation handler and post-application exposures and risks for
the diiodomethyl p-tolyl sulfone pressure treatment uses are presented in Table 19. Risks of
concern have been identified for occupational handler treatment operators (TO) for IT dermal
exposure. The following pressure treatment occupational handler scenario is of concern:
• Pressure Treatment Operator: Wood Preservation
(IT Dermal MOE = 69)
The dermal and inhalation MOEs are all above the target of 100 for all occupational post-
application pressure treatment job functions and therefore, are not of concern.
Table #19. Short-, Intermediate-, and Long-Term Exposures and MOEs for Pressure
Treatment Handler & Post-Application Scenarios
Exposure Scenario"
Unit Exposure"
(jig As/ppm)
Dermal
Inhalation
Application
Rate
(% ai
solution)
Absorbed Daily
Dosesb
(ms/ks/dav)
Dermal
Inhalation
MOEsc
Dermal
ST/IT
Target =
100
ST
IT
Inhalation
ST/IT/LT
Target-100
Occupational Handler
Treatment Operator (TO)
Treatment Assistant (TA)
2.04
0.24
0.00257
0.000802
1
1
0.029
0.0034
3.67E-5
1.15E-5
137
1167
69
583
5.45E+4
1.75E+5
Occupational Post-application
All Job Functions
(Tram setter, stacker
operator, loader operator,
supervisor, test borer, and
tallyman)
0.74
0.00160
1
0.011
2.29E-5
378
189
8.75E+4
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term.
a. Unit exposure values are taken from CCA study as shown above and in Table 6.6.
b. Absorbed Daily Dose (mg/kg/day) = Unit Exposure (ug As/ppm) * [% Diiodomethyl-p-tolylsulfone in solution (1 ) *
10,000 (parts per million conversion)] * (0.001 mg/ng) * absorption factor (0.12 for dermal; 100% for inhalation) /
Body weight (70 kg).
c. MOE = NOAEL (mg/kg/day) / Daily dose [Where ST (systemic) NOAEL = 4 mg/kg/day for dermal and IT LOAEL =
2 mg/kg/day for inhalation]. Target ST/IT MOE is 100 for dermal exposure, and 100 for inhalation exposure.
39
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9. Human Incident Data
The Agency reviewed the following information for human poisoning incidents related to
diiodomethyl p-tolyl sulfone use and discovered that no incidents have been reported: (1) OPP
Incident Data System (IDS)- The Office of Pesticides 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 Telecommunications Network (NPTN)- NPTN 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) National Poison Control Centers
(PCC) (1993-2002)- The Agency has received PCC data covering the years 1993-2002 for all
pesticides. Most of the national PCCs participate in a national data collection system, the Toxic
Exposure Surveillance System, which obtains data from about 65-70 centers at hospitals and
universities. PCCs provide telephone consultation for individuals and health care providers on
suspected poisonings involving drugs, household products, pesticides, etc.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below.
Diiodomethyl p-tolyl sulfone is used as an above-ground wood preservative for control of
mildew, sapstain, and wood-rotting organisms at wood treatment facilities. Diiodomethyl p-tolyl
sulfone is also incorporated into other registered wood preservatives. Environmental exposure
levels from wood preservative applications may be of concern for organisms exposed to leachate
or runoff. Therefore, an ecological risk assessment was conducted for the wood preservative/
treatment uses of diiodomethyl p-tolyl sulfone. All other diiodomethyl p-tolyl sulfone uses are
considered to be indoor uses and to have minimal to no environmental exposure potential
following use. Therefore, the material preservative uses were not assessed for ecological risk.
The following risk characterization is intended to describe the magnitude of the estimated
environmental risks for diiodomethyl p-tolyl sulfone use sites and any associated uncertainties.
For a detailed discussion of all aspects of the environmental risk assessment, refer to the
"Diiodomethyl p-tolyl sulfone. P.C. Code: 101002. Human Health and Ecological Effects Risk
Assessments for the Reregi strati on Eligibility Decision (RED) Document. Case 4009," dated
April 29, 2008; the "Revised Environmental Hazards and Ecological Risk Assessment for the
Diiodomethyl p-tolyl sulfone RED," dated March 12, 2008; and the "Environmental Fate
Assessment of Diiodomethyl p-tolyl sulfone for the RED," dated March 26, 2008.
1. Environmental Fate and Transport
Diiodomethyl p-tolyl sulfone degrades by hydrolysis and metabolism to form
dehalogenated and demethylated compounds. Diiodomethyl p-tolyl sulfone is stable to
40
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hydrolysis at pH 5, but degrades at pH 7 and 9 to form MIMPTS (monoiodo-p-tolylsulfone),
which only degrades slightly. Water solubility and vapor pressure increases as degradation
continues, but volatility from water is negligible because of increasing solubility. Significant
bioconcentration is not expected from parent diiodomethyl p-tolyl sulfone or the metabolites
based on the low (<3) log Kow (Log P). Release to water from treated soil and wood are
significant routes of dissipation.
Acute exposure to parent diiodomethyl p-tolyl sulfone may occur, but chronic exposure is
not likely. Parent half-lives range from 1.5-9.6 days in hydrolysis (pH 7-9) and in metabolism
studies. Aqueous residues of parent diiodomethyl p-tolyl sulfone were higher than sediment
residues for seven days in the anaerobic aquatic metabolism study (representing bottom
sediment).
Chronic exposure to aquatic organisms is likely to occur from MIMPTS (parent minus
one iodo group) and from MPTS (parent minus both iodo groups). MIMPTS was the terminal
residue in hydrolysis and aqueous photodegradation studies. MIMPTS was stable in non-
irradiated soil but degraded with a half-life of 12.5 day in the irradiated samples. In aerobic soil
(the top layer of non-flooded soil), the half-lives of MIMPTS and MPTS were 32 and 53-173
days, respectively. In anaerobic soil (the second layer of soil), MIMPTS was a major degradate
with a half-life of 21 days and was found predominantly in water. MPTS reached 81% by the
end of the study and was primarily found in water. Anaerobic aquatic metabolism (representing
bottom sediment) degrades MIMPTS with a total system half-life of 11 days. MPTS was the
terminal metabolite and increased to 95% by 4-6 months. Aqueous residues were greater than
sediment residues for MIMPTS and MPTS for 180 and 60 days, respectively.
In addition, diiodomethyl p-tolyl sulfone degrades to residues with greater polarity and
water solubility than itself. The water solubility of the parent, MIMPTS, and MPTS from the
EPI-Suite model are 0.8, 175, and 1750 mg/1, respectively. Therefore, aqueous residues of
diiodomethyl p-tolyl sulfone metabolites will likely be present for extended periods of time from
treated wood on land.
a. Bioaccumulation in Aquatic Organisms
Significant bioconcentration is not expected from the parent diiodomethyl p-tolyl sulfone
or the metabolites based on the low (<3) log Kow (Log P). Release to water from treated soil
and wood are significant routes of dissipation. The Log Kow (Log P) of diiodomethyl p-tolyl
sulfone is 2.66. The estimated Log Kow values for MIMPTS, MPTS, and PTSA are 2.2, 1.1, and
0.56, respectively.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data. A summary of the submitted data is provided below.
41
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a. Environmental Toxicity
Terrestrial Animals
Toxicity to Birds, Acute & Dietary
Available data indicate that diiodomethyl p-tolyl sulfone is practically non-toxic to birds
when ingested on an acute oral and dietary basis. Therefore, an avian precautionary statement is
not required on product labels.
Toxicity to Mammals, Acute
Based on the results of mammalian studies conducted to meet human toxicity data
requirements, diiodomethyl p-tolyl sulfone exhibits low acute oral and acute dermal toxicity
(Toxicity Category IV), and high acute inhalation toxicity (Toxicity Category II). Diiodomethyl
p-tolyl sulfone is classified as an eye corrosive (Toxicity Category I). For dermal irritation,
diiodomethyl p-tolyl sulfone is a low irritant (Toxicity Category IV) and is not classified as a
dermal sensitizer.
Aquatic Organisms
Toxicity to Freshwater Fish; Freshwater Invertebrates; Estuarine & Marine Organisms, Acute
On an acute basis, diiodomethyl p-tolyl sulfone is highly to very highly toxic to
freshwater fish and freshwater invertebrates.
Acute toxicity testing with estuarine marine organisms using the TGAI is required when
an end-use product is intended for direct application to the marine/estuarine environment, or the
active ingredient is expected to reach this environment in significant concentrations because of
its expected use and mobility. There are currently no acceptable acute toxicity data for
estuarine/marine fish (OPPTS 850.1075), estuarine marine shrimp (OPPTS 850.1035), or
estuarine/marine mollusk (OPPTS 850.1025) for diiodomethyl p-tolyl sulfone. These data are
required to support the wood preservative uses of diiodomethyl p-tolyl sulfone. Such data will
allow the Agency to conduct and complete an ecological assessment for those species that could
not be assessed as a result of data gaps. Also, this data may remove uncertainties and may result
in more accurate exposure estimations.
Toxicity to Aquatic Organisms, Chronic
Chronic toxicity data [(OPPTS 850.1400) Fish Early Life Stage; and (OPPTS 850.1300)
Aquatic Invertebrate Life Cycle] are required for antimicrobial pesticides when certain
conditions apply. For diiodomethyl p-tolyl sulfone, these conditions include acute toxicity to
freshwater organisms and solubility and persistence of the major degradates. No chronic aquatic
organism data are available for diiodomethyl p-tolyl sulfone. Chronic testing is required for both
the freshwater fish and freshwater invertebrate. The preferred test material is the major
42
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degradate, MIMPTS (parent minus one iodo group), and the preferred freshwater test species are
the rainbow trout and Daphnia magna. Such data will allow the Agency to conduct and
complete an ecological assessment for those species that could not be assessed as a result of data
gaps. Also, this data may remove uncertainties and may result in more accurate exposure
estimations.
Toxicity to Aquatic Plants
The use of diiodomethyl p-tolyl sulfone as a wood treatment may result in chemical
leachate from treated wood into the aquatic environment. As a result, aquatic plant toxicity data
are required to assess this risk. No aquatic plant toxicity data are available for diiodomethyl p-
tolyl sulfone. Therefore, the following data are required to fulfill aquatic plant toxicity data
gaps: (1) freshwater diatom, Naviculapelliculosa (OPPTS 850.5400); (2) marine diatom,
Skeletonema costatum (OPPTS 850.5400); (3) bluegreen cyanobacteria, Anabaena flos-aquae
(OPPTS 850.5400); (4) freshwater green alga, Selenastrum capricornutum (OPPTS 850.5400);
(5) freshwater loating macrophyte duckweed, Lemna gibba (OPPTS 850.4400); (6) freshwater
rooted macrophyte rice seedling emergence, Oryza saliva (OPPTS 850.4225); (7) freshwater
rooted macrophyte rice vegetative vigor (OPPTS 850.4250). These data are conditionally
required to fulfill the aquatic plant toxicity data gaps for diiodomethyl p-tolyl sulfone, because
aquatic plants may be exposed to diiodomethyl p-tolyl sulfone as a result of the wood
preservative applications. This data may remove uncertainties and may result in more accurate
exposure estimations. However, it should be noted that these data will not be required if
appropriate label language is added to product labels that prohibits the use of pre-treated wood in
structures located is surface waters (e.g., pilings) and prohibits topical application of
diiodomethyl p-tolyl sulfone (e.g., brush on) to existing structures located or to be placed in
surface waters (e.g., docks).
A summary of the submitted acute ecological, chronic aquatic organism, and aquatic
plant toxicity data are provided in Tables 20, 21 and 22.
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Table #20. Acute Ecological Toxicity
Species
Chemical
% Active
Ingredient
(AD
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
(MRID)
Birds (Acute Oral Toxicity & Dietary Toxicity)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Diiodomethyl
p-tolyl sulfone
(Acute Oral)
Diiodomethyl
p-tolyl sulfone
(Dietary)
Diiodomethyl
p-tolyl sulfone
(Dietary)
95%
95%
95%
LD50 >2000
(mg ai/kg
bw)
LD50 = 5620
(ppm)
LD50 = 5620
(ppm)
Practically Non-
Toxic
Practically Non-
Toxic
Practically Non-
Toxic
Yes (core)
Yes (core)
Yes (core)
123643
123642
124488
Freshwater Fish (Acute Toxicity)
Rainbow trout
Oncorhynchus-
mykiss)
Bluegill
sunfish
(Lepomis
macrochirus)
Diiodomethyl
p- tolyl sulfone
Diiodomethyl
p- tolyl sulfone
Diiodomethyl
p- tolyl sulfone
97.7%
95%
95%
96-hLC50 =
66.7 (ug
ai/L)
96-hLC50 =
130(ugai/L)
96-hLC50 =
750 (ug ai/L)
Very highly
toxic
Highly toxic
Highly toxic
Supplemental
Yes (core)
Yes (core)
47234001
149730
149731
Freshwater Invertebrates (Acute Toxicity)
Waterflea
(Daphnia
magna)
Diiodomethyl
p- tolyl sulfone
Diiodomethyl
p- tolyl sulfone
Diiodomethyl
p- tolyl sulfone
97.7%
95%
95%
48-hEC50 =
279 (ug
ai/L)
48-hEC50 =
7,400 (ug
ai/L)4
48-hEC50 =
71(ugai/L)5
Highly toxic
Moderately
Toxic
Very Highly
Toxic
Yes (core)
Yes (core)
Supplemental
47234002
149729
123644
Estuarine/Marine Organisms (Acute Toxicity)
No data are currently available.
The reported LC50 of 8 ppm in the Data Evaluation Report has been readjusted to an EC50, based on immobility of test
daphnids reported at the 10 ppm test concentration.
Daphnids were entrapped at the air-water interface in all test concentrations; the presence of the toxicant at the solution surface,
and the resulting entrapment of the test organisms, likely influenced the incidence of daphnid mortality.
44
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Table #21. Chronic Aquatic Organisms Toxicity
Species
Chemical,
% Active
Ingredient
Tested
Endpoint
(mg/L)
Satisfies Guidelines/
Comments
Reference
(MRID No.)
Aquatic Organisms (Chronic)
No data are currently available.
Table #22. Aquatic Plant Toxicity
Species
Chemical,
% Active
Ingredient
Tested
Endpoint
(mg/L)
Satisfies Guidelines/
Comments
Reference
(MRID No.)
Aquatic Plants
No data are currently available.
b. Ecological Exposure and Risk
For the ecological exposure and risk assessment, the Agency has evaluated diiodomethyl
p-tolyl sulfone wood preservative use scenarios. Wood preservative uses are considered to be
"outdoor uses," which are considered during reregi strati on. As discussed earlier, all other
diiodomethyl p-tolyl sulfone uses are considered to be indoor uses and to have minimal to no
environmental exposure potential following use.
The EPA performed an environmental risk assessment using estimated environmental
concentrations (EECs) for diiodomethyl p-tolyl sulfone, which were developed from various
models. EECs were modeled for antisapstain treatment and for wood treated by pressurized
spray. Examples of treated wood products include wood houses, fences, decks, and transmission
poles. The Agency does not believe that treated wood will be placed in surface waters (e.g.,
pilings) nor will topical application (e.g., brush-on) be made to wood (e.g., docks) located in
water bodies. However, a label statement prohibiting such use needs to be added to product
labels with wood preservative uses to limit these exposures. Provided that this label change is
made, the data requirements discussed earlier will change as well.
Antisapstain Wood Preservative Use
To assess the use of diiodomethyl p-tolyl sulfone as an antisapstain treatment, storm
water runoff concentrations of diiodomethyl p-tolyl sulfone were estimated for a hypothetical
lumber yard where diiodomethyl p-tolyl sulfone is applied as an antisapstain (wood preservative)
treatment. The methodology is based on a screening-level model to determine runoff
concentrations of pesticides from antisapstain facilities in British Columbia, Canada (Krahn and
Straub 1990). The concentration of diiodomethyl p-tolyl sulfone in runoff was calculated by
dividing its concentration in leachate by a storm water dilution factor. For example, with the
45
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dilution factor of 15, diiodomethyl p-tolyl sulfone leachate entering the storm drain is assumed to
be diluted with uncontaminated runoff water at a 1:15 ratio. This dilution factor value is based
on measurements of runoff in storm drains at facilities using antisapstain chemicals in British
Columbia. The dilution factor ratios of 1:6 and 1:23 were used by Krahn and Straub (1990) to
represent a "general industry wide" range of predicted runoff concentrations. For further
information on the calculations used to derive these estimations as well as the uncertainties and
limitations of the calculations, please refer to the "Revised Environmental Hazards and
Ecological Risk Assessment for the Diiodomethyl p-tolyl sulfone RED," dated March 12, 2008.
Other Wood Preservative Uses
EECs resulting from leaching of diiodomethyl p-tolyl sulfone from treated lumber into
soil and surface waters were calculated for six uses including transmission poles, fence posts,
fences, deck posts, decks, and houses. Use scenarios were evaluated using an estimate of the
maximum cumulative aqueous release of diiodomethyl p-tolyl sulfone from a treated wood over
a 14-day period. The methodology for this analysis is based on an environmental risk
assessment previously prepared by the Rohm and Haas Company (2006) for 4,5-dichloro-2-n-
octyl-3(2H)-isothiazolone (DCOIT). In this methodology, leaching of diiodomethyl p-tolyl
sulfone from treated wood surfaces is modeled to estimate soil loadings and concentrations. Soil
concentrations and other input data were then used with EPA's Express model EXAMS-PRZM
Exposure Simulation Shell (version 1.03.02) to estimate concentrations in surface water. For
further information on the calculations used to derive these estimations as well as the
uncertainties and limitations of the calculations, please refer to the "Revised Environmental
Hazards and Ecological Risk Assessment for the Diiodomethyl p-tolyl sulfone RED," dated
March 12, 2008.
Terrestrial Risk Assessment
Risk Assessment of Birds & Mammals, Acute
Minimal acute risk to birds and mammals is presumed for all registered uses of
diiodomethyl p-tolyl sulfone because available data indicate that it is practically nontoxic to
birds and mammals. Based on available avian toxicity data for diiodomethyl p-tolyl sulfone, the
various wood treatments are not expected to be acutely toxic to avian & mammalian species.
Aquatic Risk Assessment
Risk Assessment of Freshwater Fish; Freshwater Invertebrates; Estuarine & Marine Organisms,
Acute
To develop risk quotients (RQs), the estimated environmental concentrations (EECs)
determined by modeling were compared to the most sensitive endpoint for each taxa. Acute
LOCs (0.5) were not exceeded for non-listed freshwater fish or non-listed freshwater aquatic
invertebrates for any scenario. However, freshwater fish and freshwater aquatic invertebrate
LOCs were exceeded for listed (e.g., endangered and threatened) species for all three dilution-
rate scenarios from antisapstain use.
46
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There are currently no acceptable acute toxicity data for estuarine/marine fish (OPPTS
850.1075), estuarine marine shrimp (OPPTS 850.1035), or estuarine/marine mollusk (OPPTS
850.1025) for diiodomethyl p-tolyl sulfone. Therefore, the acute aquatic estuarine/marine
species assessment is incomplete due to lack of toxicity data. These data are required to support
the wood preservative uses of diiodomethyl p-tolyl sulfone. Such data will allow the Agency to
conduct and complete an ecological assessment for those species that could not be assessed as a
result of data gaps. Also, this data may remove uncertainties and may result in more accurate
estimates. However, it should be noted that these data requirements will be waived and not
needed if the appropriate antisapstain label statement is added to the labels, and if all product
labels are updated to include the appropriate label language, which prohibits the use of pre-
treated wood in structures located in surface waters (e.g., pilings) and prohibits topical
application of diiodomethyl p-tolyl sulfone (e.g., brush on) to existing structures located or to be
placed in surface waters (e.g., docks). Such language will limit the possibility for diiodomethyl
p-tolyl sulfone to contact all aquatic organisms, mitigating possible acute and chronic risks to
aquatic organisms.
Risk Assessment of Aquatic Organisms, Chronic
The chronic aquatic toxicity assessment for estuarine/marine species could not be
assessed due to lack of data. No chronic aquatic organism data [(OPPTS 850.1400) Fish Early
Life Stage; and (OPPTS 850.1300) Aquatic Invertebrate Life Cycle] are available for
diiodomethyl p-tolyl sulfone. The need for chronic freshwater fish and invertebrate studies are
triggered based on acute toxicity. However, there are no acceptable chronic toxicity studies
available for aquatic organisms. Chronic data are required for both the freshwater fish and
freshwater invertebrate to fulfill current data guideline requirements for diiodomethyl p-tolyl
sulfone. The preferred test material is the major degradate, MIMPTS (parent minus one iodo
group), and the preferred freshwater test species are the rainbow trout and Daphnia magna.
Such data will allow the Agency to conduct and complete an ecological assessment for those
species that could not be assessed as a result of data gaps. Also, this data may remove
uncertainties and may result in more accurate estimates. However, it should be noted that these
data requirements will be waived and not needed if the appropriate antisapstain label statement is
added to the labels, and if all product labels are updated to include the appropriate label
language, which prohibits the use of pre-treated wood in structures located in surface waters
(e.g., pilings) and prohibits topical application of diiodomethyl p-tolyl sulfone (e.g., brush on) to
existing structures located or to be placed in surface waters (e.g., docks). Such language will
limit the possibility for diiodomethyl p-tolyl sulfone to contact all aquatic organisms, mitigating
possible acute and chronic risks to aquatic organisms.
Risk Assessment of Aquatic Plants
An aquatic plants toxicity assessment could not be conducted due to lack of data. The
use of diiodomethyl p-tolyl sulfone as a wood treatment may result in chemical leachate from
treated wood into the aquatic environment. As a result, aquatic plant toxicity data are required to
assess this risk. However, no aquatic plant toxicity data are available for diiodomethyl p-tolyl
47
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sulfone. Therefore, the following data are required to fulfill aquatic plant toxicity data gaps: (1)
freshwater diatom, Naviculapelliculosa (OPPTS 850.5400); (2) marine diatom, Skeletonema
costatum (OPPTS 850.5400); (3) bluegreen cyanobacteria, Anabaenaflos-aquae (OPPTS
850.5400); (4) freshwater green alga, Selenastrum capricornutum (OPPTS 850.5400); (5)
freshwater loating macrophyte duckweed, Lemna gibba (OPPTS 850.4400); (6) freshwater
rooted macrophyte rice seedling emergence, Oryza saliva (OPPTS 850.4225); (7) freshwater
rooted macrophyte rice vegetative vigor (OPPTS 850.4250). This data will allow the Agency to
conduct and complete an ecological assessment for aquatic plants, which could not be assessed
as a result of data gaps. However, it should be noted that these data requirements will be waived
and not needed if the appropriate antisapstain label statement is added to the labels, and if all
product labels are updated to include the appropriate label language, which prohibits the use of
pre-treated wood in structures located in surface waters (e.g., pilings) and prohibits topical
application of diiodomethyl p-tolyl sulfone (e.g., brush on) to existing structures located or to be
placed in surface waters (e.g., docks). Such language will limit the possibility for diiodomethyl
p-tolyl sulfone to contact all aquatic organisms, mitigating possible acute and chronic risks to
aquatic organisms.
Risk Assessment of 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
diiodomethyl p-tolyl sulfone 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.
Additional information regarding the diiodomethyl p-tolyl sulfone ecological assessment
can be found in the "Diiodomethyl p-tolyl sulfone. P.C. Code: 101002. Human Health and
Ecological Effects Risk Assessments for the Reregi strati on Eligibility Decision (RED)
Document. Case 4009," dated April 29, 2008; and the "Revised Environmental Hazards and
Ecological Risk Assessment for the Diiodomethyl p-tolyl sulfone RED," dated March 12, 2008.
Please refer to Tables 23 and 24 for a comprehensive list of the identified ecological risk
quotients for the antisapstain treatment and pressurized-spray treatment uses of diiodomethyl p-
tolyl sulfone.
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Table #23. Acute Risk Quotients and Risk Presumptions for Freshwater Fish
Use
EEC
Qig ai/L)
Toxicity
Oig ai/L)
Acute RQ
Acute LOCs
Exceeded
Antisapstain treatment:
Low dilution
(1:6)
Typical dilution
(1:15)
High dilution
(1:23)
33
13
9
66.7
66.7
66.7
0.49
0.19
0.13
listed species
listed species
listed species
Pressurized-spray treatment:
House
Deck
Transmission pole
Fence
Deck Post
Fence Post
0.127
0.024
0.007
0.002
0.001
O.001
66.7
66.7
66.7
66.7
66.7
66.7
0.002
O.001
0.001
O.001
0.001
O.001
none
none
none
none
none
none
Table #24. Acute Risk Quotients and Risk Presumptions for Freshwater Invertebrates
Use
EEC
(M£ ai/L)
Toxicity
<)ig ai/L)
Acute RQ
Acute LOCs
exceeded
Antisapstain treatment:
Low dilution
(1:6)
Typical dilution
(1:15)
High dilution
(1:23)
33
13
9
71
71
71
0.46
0.18
0.12
listed species
listed species
listed species
Pressurized-spray treatment:
House
Deck
Transmission pole
0.127
0.024
0.007
71
71
71
0.002
O.001
0.001
none
none
none
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Use
Fence
Deck Post
Fence Post
EEC
(M£ ai/L)
0.002
0.001
O.001
Toxicity
(M£ ai/L)
71
71
71
Acute RQ
O.001
0.001
O.001
Acute LOCs
exceeded
none
none
none
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
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 material preservative
uses for diiodomethyl p-tolyl sulfone fall into this category.
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The preliminary analysis for wood treatment uses indicates that there is a potential for
diiodomethyl p-tolyl sulfone exposure of listed freshwater and aquatic invertebrate species.
Since the models used to conduct the ecological risk assessment are only intended as
screening-level models, and, as such, have inherent uncertainties and limitations, which may
result in inaccurate exposure estimations, further refinement of the models and risk
assessment are necessary before any regulatory action is taken regarding the wood treatment
uses of diiodomethyl p-tolyl sulfone. A more refined assessment is warranted to include
direct, indirect and habitat effects. Also, clear delineation of the action area associated with
the proposed uses of diiodomethyl p-tolyl sulfone, and the best available information on the
temporal and spatial co-location of listed species with respect to the action area should be
included in a more refined assessment. Due to these circumstances, the Agency defers
making an endangered species effect determination for the wood treatment uses of
diiodomethyl p-tolyl sulfone until additional data and modeling refinements are available. At
that time, the environmental exposure assessment for the wood treatment uses of
diiodomethyl p-tolyl sulfone will be revised, and the risks to Listed Species will be
considered. Registrants are responsible for amending all diiodomethyl p-tolyl sulfone
antisapstain wood preservative product labels to incorporate the required antisapstain use
label language. The antisapstain label statement is expected to decrease possible leaching
risks associated with antisapstain use products.
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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 diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone.
The Agency has completed its assessment of the residential, occupational and ecological
risks associated with the use of pesticide products containing the active ingredient diiodomethyl
p-tolyl sulfone. The Agency has determined that all diiodomethyl p-tolyl sulfone containing
products are eligible for reregi strati on provided that: 1) all risk mitigation measures are
implemented; 2) current data gaps and confirmatory data needs are addressed; and 3) label
amendments are made as described in Section V. Appendix A summarizes the uses of
diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone, the Agency has determined that
diiodomethyl p-tolyl sulfone 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, submit confirmatory data as well as make the label changes
identified in this document, the Agency may take regulatory action to address the risk concerns
from the use of diiodomethyl p-tolyl sulfone. If all changes outlined in this document are fully
complied with, then no risks of concern exist for the registered uses of diiodomethyl p-tolyl
sulfone and 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 diiodomethyl p-tolyl sulfone. The EPA
released its preliminary risk assessment for diiodomethyl p-tolyl sulfone for public comment on
January 16, 2008. The Agency received comments from the technical registrant, Dow Chemical
Company, in response to the EPA's draft diiodomethyl p-tolyl sulfone risk assessment (RA) and
supporting science documents. The comments included suggestions to refine the hazard
assessment and endpoint selection, and comments and suggestions regarding the exposure
modeling scenarios used to conduct the ORE assessment. The technical registrant also provided
the Agency with use information that was utilized to refine the human health risk assessment.
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Other comments included suggestions for additional personal protection equipments (PPE) to
reduce possible exposure risk to occupational workers. The Agency's response to these
comments has been incorporated, as necessary, into the revised diiodomethyl p-tolyl sulfone risk
assessment and revised supporting science chapters. These revised documents are available on
the U.S. Federal Government's web docket at: http://www.reguations.gov (Docket ID EPA-HQ-
OPP-2007-1151). A Response to Comments document will be made available on the public
docket in the future. In addition, comments received by the registrant during the Phase I, Error
Only Comment Period of the RED process are available on the docket. The Agency is providing
a 60-day public comment period for this RED document.
C. Regulatory Rationale
The Agency has determined that diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone. Where labeling revisions are warranted, specific language is set
forth in the summary tables of Section V of this document.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
The indirect food contact chronic dietary risks from diiodomethyl p-tolyl sulfone residues
are below the Agency's level of concern for the treated adhesives, repeat-use rubber sealants,
caulking material, and can side-seam cements. Therefore, no mitigation measures are necessary
at this time.
b. Drinking Water Risk Mitigation
Diiodomethyl p-tolyl sulfone is not expected to come into contact with or be exposed to
drinking water and, therefore, the Agency did not conduct a drinking water exposure assessment.
Diiodomethyl p-tolyl sulfone is not used for potable water treatment and effluents containing this
chemical are not expected to contact fresh water environments. Therefore, no mitigation
measures are necessary at this time.
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c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler dermal and inhalation risks were assessed for the application of
Diiodomethyl p-tolyl sulfone treated paints via brush, roller, and airless sprayer; and the
application of wood preservatives via brush, roller, and airless sprayer to treat wood surfaces.
Short-term dermal risks of concern were identified for residential paint application via
airless sprayer (MOE = 48). To mitigate these risks of concern the registrant has agreed to lower
the maximum application rate by 50% to 0.025 Ib active ingredient (ai) for all paint application
methods, excluding the roll-coat method. By lowering the maximum paint application rate by
50% the residential handler MOE for painting via airless sprayer is raised to 96 and, therefore, is
no longer of concern. 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 with the lower
maximum application rate. All product labels must be amended to incorporate the 50% decrease
in application rates for paint use to mitigate residential paint application risks of concern.
For the paint roll-coat application method the Agency believes that there will be
negligible exposure to residential and occupational handlers, and therefore, there are no risks of
concern for this use. The roll-coater system is a surface coating application method in which the
active ingredient is applied to oriented strand board (OSB) during the manufacturing processes.
This surface coating is factory applied under controlled conditions only. Also, this coating is not
available to residential or occupational painters. The Agency recognizes that the assumptions
used in this risk assessment are conservative and believe that actual exposures may be less than
those generated by the models in this particular case. Also, the Agency recognizes that this use
pattern is limited to factory application only and believes that residential and occupational
handler exposure as a result of this application method is negligible. Therefore, the application
rate may remain at its current labeled maximum application rate of 0.05 Ib ai for paint roll-coat
use only. Restrictive language must be added to all paint labels indicating that diiodomethyl p-
tolyl sulfone can be used at its current labeled rate for roll-coat application methods only and that
the 50% lower application rates must be used for all other paint application methods.
For inhalation exposure, the target MOE for identifying risks of concern is 100 for short-
and intermediate-term exposure durations. The target MOE for identifying the need for
confirmatory inhalation toxicity data is 1,000. An inhalation MOE greater than or equal to 100 is
considered adequately protective. However, if the inhalation MOE is greater then 100 but less
then 1,000, inhalation toxicity data are needed to confirm that the use of route-to-route
extrapolation (use of oral toxicity data to set an inhalation endpoint), as was done for
diiodomethyl p-tolyl sulfone, does not underestimate inhalation exposure risk. The MOE for
residential paint application via airless sprayer (MOE of 230 @ 0.05 Ib ai; MOE = 460 @ 0.025
Ib ai) is below the high-end target inhalation MOE of 1,000 even at the lower application rate.
Because the inhalation MOE is below 1,000 for the airless sprayer use scenario, a confirmatory
inhalation toxicity study is needed to further refine the inhalation risk assessment for the
54
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residential handler in-can paint preservative airless sprayer use to confirm that the use of route-
to-route extrapolations does not underestimate inhalation exposure risk.
ii. Post-Application Risk Mitigation
For the residential post-application assessment, representative scenarios were assed for
contact with surface residues from wood treated with diiodomethyl p-tolyl sulfone (dermal and
incidental oral exposure to children); and for finger-painting activities (incidental oral exposure
to children).
Incidental oral risks of concern were identified for finger-painting activities (MOE = 65-
100). To mitigate the incidental oral finger-painting risks of concern, the registrant has agreed to
lower the concentration of the active ingredient in finger-paint to 500 ppm active ingredient. By
lowering the concentration, the MOE range is raised to 80-125. Given the uncertainties that exist
with the predicted finger-painting exposure scenario and conservative Agency assumptions, the
Agency believes that the predicted high-end range MOE of 125 is the most reasonable estimate
of actual exposure. The MOE of 125 is above the target dermal MOE of 100 and, therefore, the
Agency believes that there are no risks of concern for finger-painting if the maximum
concentration rate is lowered to 500 ppm. All product labels must be amended to incorporate the
lower concentration rate of 500 ppm to mitigate risks of concern for finger-painting. Originally,
the Agency did not conduct an aggregate assessment for incidental oral exposure to children
because individual risks of concern were identified for finger-painting. Because the Agency was
able to mitigate the incidental-oral risks of concern for finger-painting by lowering the
concentration rate to 500 ppm, an aggregate assessment for short-term incidental oral exposure to
treated wood and finger-paint was conducted, using the updated MOE of 125. The aggregated
total MOE for incidental oral exposure to treated wood and finger-paint is 102, and therefore not
of concern because it is below the target MOE of 100.
It should be noted that the registrant has indicated that they do not intend to support the
use of treated polymers/plastics for the use as toy products. The Agency requires the following
label langue for treated polymer/plastics labels to ensure that these products are not used to
manufacture toys, "Treated plastics can not be used to manufacture children's toys." If labels are
not amended to include this language, a risk assessment will be required for the use of
diiodomethyl p-tolyl sulfone in plastic/polymer toys.
The technical registrant for diiodomethyl p-tolyl sulfone has also indicated that
diiodomethyl p-tolyl sulfone is intended to treat carpet-backing only, not carpet fiber. The use of
diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone
in carpets, to carpet-backing only, by adding limitation language to the labels. As a result of the
cancellation of the use of diiodomethyl p-tolyl sulfone to treat carpet fibers, and label language
limiting the use of diiodomethyl p-tolyl sulfone to treat carpet-backing only, the Agency has
determined that a post-application residential risk assessment is not needed to assess risks from
treated carpet-backing. The rational for this decision is that the Agency does not conduct
exposure assessments for treated carpet-backing use scenarios because exposures are unlikely.
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Therefore, by limiting the use of diiodomethyl p-tolyl sulfone 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. However, if the carpet fiber use is not cancelled and labels are not
amended to restrict the use of diiodomethyl p-tolyl sulfone to carpet-backing only, the Agency
will have to assess possible exposure resulting from the use of diiodomethyl p-tolyl sulfone in
carpet fiber.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
For occupational handlers the use of gloves, or personal protective equipment (PPE), is
required on all product labels. Without the use of PPE several dermal risks of concern are
identified. However, with the use of gloves (PPE) the MOEs for most exposure scenarios are
above the target dermal MOEs. All occupational end-use labels must be amended to include
language stating that gloves (PPE) must be used by workers. However, it should be noted that
the Agency can not require the use of gloves (PPE) on in-can paint preservative labels.
Risks of concern have been identified for the application of paint via airless sprayer
(Inhalation MOE = 67 ST; Dermal MOE = 29 ST). Short-term dermal risks of concern have also
been identified for the application of paint via brush/roller (MOE = 62 ST). To mitigate these
risks of concern the registrant has agreed to lower the application rate of treated paint by 50% to
0.025 Ib active ingredient (ai) for all paint application methods, excluding the roll-coat method.
By lowering the application rate by 50% the MOEs for painting via airless sprayer and
brush/roller are raised above the target MOE of 100 (Painting via airless sprayer inhalation MOE
= 135; Painting via brush/roller dermal MOE = 124 ST). The dermal exposure MOE for painting
via airless sprayer is raised to 59, when the lower application rate is applied. The Agency
recognizes that the assumptions used in this risk assessment are conservative (e.g., dermal and
inhalation MOEs based on an oral endpoint) and believes that actual exposures may be less than
those generated by the models in this particular case. Although the MOE of 59 is below the
target MOE of 100, the Agency believes the risk assessment can be refined. Based on the
reduced rate and the likelihood that exposure is overestimated, the Agency considers the
identified risks to be adequately mitigated and do not pose a risk of concern. A 21-day dermal
toxicity study is needed to confirm this determination and to better refine the exposure
assessment. All product labels must be amended to incorporate the 50% decrease in the
maximum application rate for paint use to mitigate occupational paint application risks of
concern.
For the paint roll-coat application method, which is a factory applied surface coating, the
Agency believes that there will be negligible exposure to residential and occupational handlers at
its current maximum application rate of 0.05 Ib active ingredient, and therefore, there are no risks
of concern for this use. Therefore, the application rate may remain at its current labeled
maximum application rate for paint roll-coat use only. Restrictive language must be added to all
paint labels indicating that diiodomethyl p-tolyl sulfone can be used at its current labeled rate for
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roll-coat application methods only, and that the 50% lower application rates must be used for all
other paint application methods.
The preservation of paint via open pour wettable powder (WP) has a dermal exposure
MOE of 83 with the use of gloves. Although the MOE of 83 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 (e.g., dermal MOE based on an oral endpoint)
and the MOE is very close to the target of 100, the Agency believes that there are no dermal risks
of concern resulting from this use. Therefore, mitigation is not needed for preservation of paint
via open pour wettable powder.
The preservation of rubbers/plastics for open pour wettable powder formulations has a
dermal MOE of 53 with the use of gloves. To mitigate risks of concern, the technical registrant
has requested to voluntarily cancel preservation of rubbers/plastics for wettable powder
formulation. All wettable powder formulation product labels must be amended to indicate that
the wettable powder formulations can be used only for leather tanning, paper production, mold
inhibition in paper and paperboard, and preservation in paper plant storage. The use of
diiodomethyl p-tolyl sulfone for preservation of rubbers/plastics must be deleted from all
wettable powder formulation labels. The technical registrant has also requested to voluntarily
cancel the use of diiodomethyl p-tolyl sulfone for preservation of textiles/non-woven's and wood
preservation for wettable powder formulations only. It should be noted that the requested
rubber/plastics, textiles/non-woven's and wood preservation voluntary use cancellations are for
wettable powder formulations only. These uses will remain active for all other formulation
methods that are currently registered.
Occupational dermal risks of concern were also identified for treatment operator
pressurized wood preservation (MOE = 69 IT). To mitigate treatment operator risks of concern
the registrant has agreed to lower the dose rate from 1.0% to 0.7% Ib active ingredient for
pressure treatment wood preservation. By lowering the application rates the MOE for treatment
operators is raised to 86. Although the MOE of 86 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 (e.g., dermal MOE based on an oral endpoint) and
the MOE is very close to the target of 100, with the lower application rates. All product labels
must be amended to incorporate the lower application rate of 0.8% w/w active ingredient for
sapstain wood preservation and 0.7% Ib active ingredient for pressure treatment wood
preservation to mitigate occupational treatment operator risks of concern.
The use of respirators (PPE) is required on all wettable powder (WP) formulation product
labels. Several occupational use scenarios have inhalation risks of concern for the wettable
powder formulation uses without the use of a respirator. However, with a respirator there are no
risks of concern for these uses. All wettable powder end-use labels must be amended to include
language stating that respirators (PPE) must be worn by workers. However, it should be noted
that the Agency can not require the use of respirators (PPE) on in-can paint preservative labels.
When oral toxicity data are used to select an inhalation endpoint, as was done for diiodomethyl
p-tolyl sulfone, it is Agency policy to consider requiring inhalation toxicity data to confirm that
the use of route-to-route extrapolation does not underestimate potential risk. A high-end target
57
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inhalation MOE of 1,000 was selected for diiodomethyl p-tolyl sulfone because the inhalation
endpoint was based on an oral NOAEL. Several of the occupational handler exposures scenarios
yielded MOEs below the high-end target of 1,000. For paint application, the MOE remains
below the high-end target of 1,000 even with a 50% lower application rate. The following use
scenarios trigger the need for confirmatory inhalation toxicity data because they have MOEs
below 1,000: Paint application via airless sprayer (MOE = 135 @ 0.025 Ib active ingredient);
Paint preservation open pour wettable powder (MOE =163 with respirator); Preservation of
leather tanning drums open pour wettable powder (MOE = 210 with respirator); Blender spray
operator for wood preservation (MOE = 203). Because the inhalation MOEs are below 1,000 for
these use scenarios, a confirmatory inhalation toxicity study is needed to further refine the
inhalation risk assessment for these occupational handler uses.
The technical registrant for diiodomethyl p-tolyl sulfone has indicated that for leather
treatment, diiodomethyl p-tolyl sulfone is intended for leather tanning drum use only. Use of
diiodomethyl p-tolyl sulfone for all other leather treatment applications must be deleted from all
diiodomethyl p-tolyl sulfone labels. Also, all product labels must be amended to limit the use of
diiodomethyl p-tolyl sulfone for leather tanning drum use only.
ii. Post-Application Risk Mitigation
Post-application occupational dermal risks of concern were identified for clean-up
activities at a lumber mill (wood preservation) (MOE = 79 IT). To mitigate these risks of
concern the registrant has agreed to lower the dose rate from 1.0% to 0.8% w/w active ingredient
for sapstain wood preservation. By lowering the application rates the MOE for clean-up
activities at a lumber mill is raised to 100, and therefore does not pose as a risk of concern. All
product labels must be amended to incorporate the lower application rate of 0.8% w/w active
ingredient for sapstain wood preservation mitigate post- application occupational dermal risks of
concern for clean-up activities at lumber a mill.
For all post-application worker functions, the inhalation MOEs are above the target
MOE of 100 and, therefore, are not of concern. A confirmatory inhalation toxicity study is no
longer triggered by the clean-up crew scenario at the new application rate of 0.8% w/w active
ingredient because the MOE is very close to the high-end target MOE of 1,000 at the new
application rate (MOE = 920).
2. Environmental Risk Management
The EPA performed an environmental risk assessment using estimated environmental
concentrations (EECs) for diiodomethyl p-tolyl sulfone, which were developed using various
models. Toxicity values were also used to develop risk quotients (RQs) for comparison of levels
of concern (LOCs). The models used in the ecological assessment are a conservative
representation of all diiodomethyl p-tolyl sulfone wood preservative use scenarios.
Acute levels of concern (LOG) were not exceeded for non-listed freshwater fish or non-
listed freshwater aquatic invertebrates for any scenario. However, freshwater fish and freshwater
aquatic invertebrate LOCs were exceeded for listed (e.g., endangered and threatened) species for
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all three dilution-rate scenarios from antisapstain use.
Several ecological species risk assessments for diiodomethyl p-tolyl sulfone are
incomplete and/or could not be conducted due to data gaps or outstanding data. Therefore, to
mitigate possible aquatic risks of concern, all wood preservative product labels must be updated
to include the appropriate antisapstain label statement; and restrictive label langue must be added
that prohibits the use of pre-treated wood in structures located in surface waters (e.g., pilings)
and prohibits topical application of diiodomethyl p-tolyl sulfone (e.g., brush on) to existing
structures located or to be placed in surface waters (e.g., docks). If these label statements are not
incorporated onto the wood preservative product labels or if the current uses for diiodomethyl p-
tolyl sulfone are expanded, the ecological data described in section IV of this document will be
needed to remove uncertainties and to conduct and complete an ecological assessment for those
species that could not be assessed as a result of data gaps. The following label language is
needed to mitigate possible aquatic risks of concern:
Do not apply this product to any structure, or use any wood treated with this
product in or above water or within 100 feet of any surface water or wetland area.
For the antisapstain use of diiodomethyl p-tolyl sulfone, the Agency used a Tier I
screening model to estimate exposures that could result from this use. It should be noted that this
model has inherent assumptions and uncertainties that may result in over or under estimation of
exposure levels. Therefore, the registrant is responsible for amending all diiodomethyl p-tolyl
sulfone 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:
"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."
The following statement must be added to all product labels because the acute toxicity to
fish and aquatic invertebrates are less then 1.0 mg/L:
This product is toxic to fish and aquatic invertebrates. 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
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treatment plant authority. For guidance contact your State Water Board or
Regional Office of the EPA.
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 diiodomethyl p-tolyl sulfone 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 diiodomethyl p-tolyl sulfone. 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
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
60
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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 antisapstain wood preservation uses, fall into this
category.
The screening level assessment conducted for the antisapstain wood treatment uses of
diiodomethyl p-tolyl sulfone indicates that there is a potential for use of this chemical to overlap
with listed species and that a more refined assessment is warranted to include indirect, direct, and
habitat effects. The refined assessment should involve clear delineation of the action area
associated with proposed use of diiodomethyl p-tolyl sulfone and best available information on
the temporal and spatial co-location of listed species with respect to the action area. This
analysis has not been conducted for this assessment. Due to these circumstances, the Agency
defers from making an endangered species effect determination at this time. The label statement
required for wood preservative products is expected to provide some mitigation until a full
endangered species assessment is conducted. The revised labeling that is required in order for
products to be considered eligible for reregi strati on is expected to provide some level of
mitigation until such time as a full endangered species assessment is possible.
b. General Risk Mitigation
Diiodomethyl p-tolyl sulfone end-use products (EPs) may also contain other registered
pesticides. Although the Agency is not proposing any mitigation measures for products
containing diiodomethyl p-tolyl sulfone specific to federally listed species, the Agency needs to
address potential risks from other end-use products. 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.
61
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V. What Registrants Need to Do
The Agency has determined that diiodomethyl p-tolyl sulfone 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 26). The additional data requirements that the
Agency intends to obtain will include, among other things, submission of the following:
For diiodomethyl p-tolyl sulfone 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
62
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For end-use products containing the active ingredient diiodomethyl p-tolyl sulfone, 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 26
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 Adam Heyward at (703) 308-6422 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
Adam Heyward Adam Heyward
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
63
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of diiodomethyl p-tolyl sulfone 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
An inhalation toxicity study (OPPTS GL 870.3465) is needed as confirmatory data to
refine the residential and occupational handler inhalation risk assessments for the following
exposure scenarios: Residential handler paint application via airless sprayer (MOE = 460 @
0.025 Ib active ingredient); Occupational handler paint application via airless sprayer (MOE =
135 @ 0.025 Ib active ingredient); Paint preservation open pour wettable powder (MOE = 163
with respirator); Preservation of leather tanning drums open pour wettable powder (MOE = 210
with respirator); Blender spray operator for wood preservation (MOE = 203). When oral toxicity
data are used to select an inhalation endpoint, as was done for diiodomethyl p-tolyl sulfone, it is
Agency policy to consider requiring inhalation toxicity data to confirm that the use of route-to-
route extrapolation does not underestimate potential risk. A high-end target inhalation MOE of
1,000 was selected for diiodomethyl p-tolyl sulfone because the inhalation endpoint was based
on an oral NOAEL. For inhalation MOEs below the target of 1,000, it is Agency policy to
request confirmatory inhalation toxicity data to refine potential risks.
A 21/28-day dermal toxicity study (OPPTS GL 870.3200) is needed to confirm that there
are no occupational risks of concern for handlers painting via airless sprayer (MOE = 59 @
0.025 Ib active ingredient). As previously noted the Agency recognizes that the assumptions
used in this risk assessment are conservative (e.g., the dermal MOE is based on an oral endpoint)
and believes that actual exposures may be less than those generated by the models in this
particular case. Although the MOE of 59 is below the target MOE of 100, the Agency believes
that this use does not pose as a risk of concern. However, a 21-day dermal toxicity study is
needed to confirm this determination and to better refine the exposure assessment.
Surrogate data 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
(OPPTS GL 875.1200 & 875.1100, respectively), and inhalation exposure-indoor & outdoor data
(OPPTS GL 875.1400 & 875.1300, respectively). Product use information (OPPTS GL
875.1700/ 875.2700) and description of human activity data (OPPTS GL 875.2800) are also
needed to further define the exposure scenarios being supported and to further refine the
assessments.
64
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Residential Post-application Handler Confirmatory Data
A dislodgeable residue (surface wipe sampling) (GL 875.2300) study is needed as
confirmatory data. Currently there are no data that can be used to estimate exposure to adults
from inhalation from wood dust during construction of wood decks or to children exposed to
treated wood. In the absence of data, the Agency conducted a screening-level assessment using a
conservative surface residue value of lmg/cm2. Therefore, a wipe study is needed to confirm the
screening level assessment.
Ecological Confirmatory Data
Several ecological species risk assessments for diiodomethyl p-tolyl sulfone are
incomplete and/or could not be conducted due to data gaps or outstanding data. The registrant
has agreed to amend all wood preservative product labels to include the appropriate antisapstain
label statement; and restrictive label language that prohibits the use of pre-treated wood in
structures located in surface waters (e.g., pilings) and prohibits topical application of
diiodomethyl p-tolyl sulfone (e.g., brush on) to existing structures located or to be placed in
surface waters (e.g., docks). These labels statements mitigate possible aquatic risks of concern.
However, if these label statements are not incorporated onto the wood preservative product
labels or if the current uses for diiodomethyl p-tolyl sulfone are expanded, the ecological data
described in section IV of this document will be needed to remove uncertainties and to conduct
and complete an ecological assessment for those species that could not be assessed as a result of
data gaps.
Table 25 provides an outline of the requested confirmatory data for diiodomethyl p-tolyl
sulfone.
Table #25. Confirmatory and Conditional Data for Diiodomethyl p-tolyl sulfone
Guideline Study Name
New OPPTS Guideline Number
Human Health Confirmatory Data
21/28-Day Dermal Toxicity
90-Day Inhalation Toxicity Data
Dermal exposure-indoor & outdoor data
Inhalation exposure-indoor & outdoor data
Product Use Information
Surface Residue Dissipation Study6
Description of Human Activity Data
870.3200
870.3465
875. 1200 & 875. 1100
875. 1400 & 875. 1300
875. 1700 & 875.2700
875.2300
875.2800
Environmental Fate & Ecological Exposure Confirmatory Data
6 To fulfill the dislodgeable residue surface wipe sampling study confirmatory data need, Guideline 875.2300 is
needed. However, for the purpose of this assessment this study should not be conducted indoors.
65
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Residues in honej^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)
Combination of Guideline 860.1500 and
850.3030
2. Labeling for 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
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 Technical and 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 26 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 diiodomethyl p-tolyl
sulfone RED. The following table describes how language on the labels should be amended.
66
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Table #26 Labeling Changes Summary Table
Description
Amended Labeling Language
Placement on Label
All End Use Products
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"This product is toxic to fish and aquatic invertebrates. 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."
Precautionary
Statements
End Use Products Intended for Occupational Use
PPE Requirements for All End-
Use product Intended for
Occupational Use
"Occupational handlers must wear chemical resistant gloves while handling diiodomethyl p-
tolyl sulfone."
Immediately
following^elow
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
PPE Requirements for Wettable
Powder Formulations
"When handling wettable powder formulations of diiodomethyl p-tolyl sulfone, mixer loaders
must wear NIOSH approved filtering face piece respirators."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
67
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Directions For Use
For all Antisapstain End-use
Products
End-use Products Intended for
Wood Preservation/ Wood
Treatment.
End Use Products Intended for
Plastic Preservation (or treated
plastic products)
End Use Products Intended for
Carpet-backing Treatment
End Use Products Intended for
Leather Tanning Drum
Treatment
For all Wettable Powder
Formulations
End-Use Products Intended for
Paint-Preservation
End-Use Products Intended for
Antisapstain Wood Preservation
"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 runoffm^0 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."
"Do not apply this product to any structure, or use any wood treated with this product in or
above water or within 100 feet of any surface water or wetland area."
"Treated plastics can not be used tom anufacture children's toys"
"Use only to treat carpet-backing. Not for use in carpet fibers."
"For use in leather tanning drum use only."
"Wettable powder formulations can be used only for leather tanning, paper production, mold
inhibition in paper and paperboard, and preservation in paper plant storage."
All paint preservation product labels must be amended to indicate that a maximum application
rate of 0.05 Ib active ingredient is for roll-coat paint application only. The maximum
application rate for all other paint application exposure scenarios/methods, including airless
sprayer and brush/roller application, is 0.025 Ib active ingredient.
All antisapstain wood preservation product labels must be amended to state that the maximum
application rate is 0.8% w/w active ingredient for sapstain wood preservation.
This language is to be
included in the
Environmental Hazards
section of the label
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
68
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End-Use Products Intended for
Pressure Treatment Wood
Preservation.
All pressure treatment wood preservation product labels must be amended to state that the
maximum application rate is 0.7 Ib active ingredient for pressure treatment wood preservation.
Directions for Use
69
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VI. APPENDICES
70
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Appendix A. Table of Use Patterns for Diiodomethyl p-tolyl sulfone
Paint
Air Duct
Coatings
Fire-Retardant
Coatings
Product
Name
AMICAL 48
AMICAL WP
AMICAL
Flowable
Ultra-Fresh 15
Intace
Fungicide B-
6773
AMICAL 48
AMICAL WP
AMICAL
Flowable
AMICAL 48
AMICAL WP
AMICAL
Flowable
EPA Registration
Number
464-670
464-672
464-673
10466-37
74075-1
464-670
464-672
464-673
464-670
464-672
464-673
Application Method
Add to pigment grind
Add to pigment grind
Add
Add
Add
Add to pigment grind
Add to pigment grind
Add
Add with mixing
Add with mixing
Add
Intended Uses
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Algicide
Dry Film
Mildewicide
Dry Film
Mildewicide
Dry Film
Mildewicide
Lower App
Limit
1
o
5
2.5
Upper
App Limit
5
10.2
12.5
0.37
10.7
2
1
3
2.5
0.0015%
0.02%
0.00375%
26.7
20.0
5
10.2
12.5
0.3%
0.61%
0.75%
Units
lb/100 gal
lb/100 gal
lb/100 gal
fl oz / gal
lb/100 gal
lb/1000
gal
lb/100 gal
lb/100 gal
lb/100 gal
w/w
w/w
w/w
Use
Limitations
Non-Food
Contact
71
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Pigment
Dispersions, Inks,
Emulsions,
Extender Slurries
Adhesives,
Caulks, and
Sealants
Wood
Preservation
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
Intace
Fungicide B-
6773
AMICAL 48
AMICALWP
AMICAL
Flowable
464-670
464-672
464-673
10466-37
464-670
464-672
464-673
10466-37
74075-1
464-670
464-672
464-673
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Add with mixing
Formulate
Formulate
Add to water-based
treatment
Fungal Preservative
Fungal Preservative
Fungal Preservative
Fungal Preservative
Dry Film Mildew
Control / Fungal
Preservative
Dry Film Mildew
Control / Fungal
Preservative
Dry Film Mildew
Control / Fungal
Preservative
Dry Film Mildew
Control / Fungal
Preservative
Dry Film Mildew
Control / Fungal
Preservative
Formulations for
mildew, sapstain,
and rot control
Formulations for
mildew, sapstain,
and rot control
Mildew, sapstain, rot
control
0.02%
0.10%
0.05%
0.13%
0.01%
0.04%
0.025%
0.044
0.067%
2
0.30%
0.61%
0.30%
0.15%
0.31%
0.38%
1%
0.30%
0.61%
0.72%
0.176
1.90%
20
1.0%
2.0%
1.00%
w/w
w/w
w/w
w/w
w/w
w/w
w/w
fl oz/gal
w/w
gal/1000
gal
w/w
w/w
w/w
ACTIVE
Non-food
contact
Non-food
contact
Use to
formulate
only
Use to
formulate
only
Above
Ground Use
Only
72
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Metalworking
Fluids
Rubber and
Plastics
Ultra-Fresh 15
Wolman Clear
Wood
Preservative
Bazooka
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICALWP
10466-37
60061-9
60061-112
464-670
464-672
464-673
10466-37
464-670
464-672
Spray treat
Dip
Pressure Treat
Add to water-based
treatment
Spray treat
Pressure Treat
Brush, Dip Roller, or
Spray
High-pressure spray
Dip Application
Add to diluted fluid
Add to diluted fluid
Add to diluted fluid
Add to diluted fluid
Add
Add
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Mold, mildew,
bacteria, decay,
algae, and termite
protection
Mildew, sapstain, rot
control
Mildew, sapstain, rot
control
Fungal control
Fungal control
Fungal control
Fungal control
Dry-film fungal
protection
Dry-film fungal
protection
0.50%
1 minute
0.05
0.10%
0.50%
0.13
150
0.002
0.001
100
204
240
600
0.1%
0.20%
1.00
1.00%
2.70
300
0.5
0.05
3000
6122
7200
1900
0.8%
1.6%
w/w
ACTIVE
Ibpcf
w/w
ACTIVE
w/w
ACTIVE
Ibpcf
sq ft/gal
gal/gal
water
gal/gal
water
ppm
ppm
ppm
ppm
w/w
w/w
Above
Ground Use
Only
Above
Ground Use
Only
Above
Ground Use
Only
Above
Ground Use
Only
Above
Ground Use
Only
Above
Ground Use
Only
Above
Ground Use
Only
73
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Textiles and Non-
Wovens (non-
clothing)
Leather Tanning
Paper Production
Ultra-Fresh 15
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICALWP
10466-37
464-670
464-672
464-673
10466-37
464-670
464-672
464-673
10466-37
464-670
464-672
Add
Add
Add
Add
Add
Detailed on Label
Detailed on Label
Detailed on Label
Detailed on Label
Add to system where
mixing occurs
Add to system where
mixing occurs
Dry -film fungal
protection
Dry-film fungal
protection
Dry-film fungal
protection
Dry-film fungal
protection
Dry-film fungal
protection
In-process mold and
mildew protection
In-process mold and
mildew protection
In-process mold and
mildew protection
In-process mold and
mildew protection
Protection of water
system, pulp,
additives, and
slurries
Protection of water
system, pulp,
additives, and
slurries
0.50%
0.5
1
1.25
3.3
0.01%
0.02%
0.02%
0.053%
0.0008
0.004
0.0016
0.008
1.50%
5
10
12.5
33.4
0.30%
0.61%
0.66%
1.2%
0.8
3.32
1.6
6.78
w/w
lb/1000 Ib
fabric
lb/1000 Ib
dry fabric
lb/1000 Ib
dry fabric
lb/1000 Ib
dry fabric
w/w
w/w
w/w
w/w
Ib/ton
paper
lb/1000
gal
Ib/ton
paper
lb/1000
gal
Non-clothing
Non-clothing
Non-clothing
Non-clothing
Not for food
contact
Not for food
contact
74
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Mold Inhibition
in Paper and
Paperboard
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICAL WP
AMICAL
Flowable
Ultra-Fresh 15
464-673
10466-37
464-670
464-672
464-673
10466-37
Add to system where
mixing occurs
Add to system where
mixing occurs
Add to Whitewater or
stock
Applicator rolls or
shower
Size press or water box
Add to Whitewater or
stock
Applicator rolls or
shower
Size press or water box
Add to Whitewater or
stock
Applicator rolls or
shower
Size press or water box
Add to Whitewater or
stock
Applicator rolls or
shower
Size press or water box
Protection of water
system, pulp,
additives, and
slurries
Protection of water
system, pulp,
additives, and
slurries
Dry-film fungal
protection
Dry -film fungal
protection
Dry -film fungal
protection
Dry -film fungal
protection
0.0019
0.0096
0.0051
0.026
0.02
0.02
80
0.04
0.04
163
0.54
0.048
200
0.13
0.13
540
1.92
7.97
5.13
21.3
3.4
3.4
8000
6.9
6.9
16300
8.21
8.16
20000
21.8
21.8
54000
Ib/ton
paper
lb/1000
gal
Ib/ton
paper
lb/1000
gal
Ib/ton
paper
Ib/ton
paper
ppm
Ib/ton
paper
Ib/ton
paper
ppm
Ib/ton
paper
Ib/ton
paper
ppm
Ib/ton
paper
Ib/ton
paper
ppm
Not for food
contact
Not for food
contact
75
-------
Paper Plant
Storage
Nitrocellulose
Drain, Grease
Trap and Septic
System
Intace
Fungicide B-
6773
AMICAL 48
AMICALWP
AMICAL
Flowable
Ultra-Fresh 15
AMICAL 48
AMICAL
Flowable
74075-1
464-670
464-672
464-673
10466-37
464-670
464-673
Add
Add to material to be
preserved
Add to material to be
preserved
Add to material to be
preserved
Add to material to be
preserved
Add to material
Add
Dry -film fungal
protection
Fungal Preservative
Fungal Preservative
Fungal Preservative
Fungal Preservative
Fungal Preservative
Fungal Control
350
0.2
0.4
0.2
0.2
0.05%
125
2500
400
816
400
400
0.30%
1000
ppm
ppm
ppm
ppm
active
ppm
active
w/w
ppm
76
-------
APPENDIX B: Diiodomethyl p-tolyl sulfone (Case 4009)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of diiodomethyl p-tolyl
sulfone. These requirements apply to diiodomethyl p-tolyl sulfone in all products, including datarequirem ents 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). j^e data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobialpjivision use pa tterns categories for which the generic (not
product specific) data requirements apply. The number designations are used in Appendixg
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments' premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and publicacces s premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
(12) will identity each study by a "Master Record Identification (MRID) number. The listed studies are considered "valid" and acceptable for
satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study.
77
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7300
830.7840
830.7860
830.7550
830.7560
830.7570
830.7000
830.6313
830.6315
61-1
61-2a
61-3
62-2
62-3
63-0
63-2
63-3
63-4
none
63-5
63-7
63-8
63-11
63-12
63-13
63-15
Product Identity and Composition
Starting Materials and Manufacturing Process
Discussion of Formation of Impurities
Certification of Limits
Analytical Method
Reports of Multiple phys/chem Characteristics
Color
Physical State
Odor
UV/Visible absorption
Melting Point
Density
Solubility
Partition Coefficient (Octanol/Water)
PH
Stability
Flammability
4590901
42054401
4590901
4590901
4590901
45757402
42054401
42054401
42054401
472340-03
42054401
42054401
42054401
421772-02
42054401
In Review
Required
78
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
ECOLOGICAL EFFECTS
850.1010
850.1075
850.2100
72-2
72-1
71-1
Acute Aquatic Invertebrate Toxicity
Fish Acute Toxicity - Freshwater (Rainbow Trout)
Avian Acute Oral Toxicity Test (Quail/Duck)
149729, 149729
149730
123642, 123643
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3150
870.3100
870.3100
870.3150
870.3200
870.3465
870-3700
870.3700
870.3700
870.3700
81-1
81-2
81-3
81-4
81-5
81-6
82-1
82-1
82-1
82-1
82-2
82-4
83-3
83-3
83-3
83-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day Study -Dog
Subchronic Oral Toxicity: 90-Day Study- Rat
90-Day Feeding-Rodent
90-day feeding-nonrodent
21/28-Day Dermal Toxicity - Rat
90-Day Inhalation Toxicity - Rat
Teratogenicity ~ 2 Species
Prenatal developmental toxicity study
Developmental Study - Rat
Developmental Study - Rabbit
42586801, 43008702, 41765401
00123023, 00141066
43660901, 00087842
41765402, 43008703
41765403, 43008704, 00141066
00230726, 00141067, 00054963
43246402, 42054403, 43246402
43246401, 42054402
42054402, 43246401
43246402
Data Gap
Data Gap
42054404, 42054405, 42243801,
43246403, 43246404, 41161801
47242202
42054404, 42054405
42243801,47242202
79
-------
DATA REQUIREMENT
New Guideline
Number
870.3800
870.5100
870.5265
870.5300
870.5375
870.5395
870.5550
870.7485
Old Guideline
Number
83-4
84-2
84-2
84-2
84-4
84-2
84-2
84-2b
152-19
Study Title
Reproduction and fertility effects
Bacteria reverse Mutation Study
Bacterial Reverse Mutation Assay
Detection of gene mutations in somatic cells
Other genotoxic effects
Mammalian Mutagenicity Tests
Interaction with Gonadal DNA
Metabolism and pharmacokinetics
Struct, chrom. aberration
Mammalian Mutagenicity Tests
Use Pattern
CITATION(S)
MRID Number
46913302,46913301
00054961, 00054962
00054962
00160070, 00054961
160072
43120601
00160072, 00160070
00054962,00160071
47076601, 47078801
43120601
43120601
ENVIRONMENTAL FATE
835.2120
835.4100
835.4200
835.4400
835.1230
835.1240
161-1
162-1
162-2
162-3
163-1
Hydrolysis of parent and degradates as a function of pH at 24 C
Aerobic soil metabolism
Anaerobic soil metabolism
Anaerobic aquatic metab.
Leach/adsorp/desorption
43008701
41765405
41765406
42177201
41765407, 43997001
80
-------
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
850.1010
850.1400
71-1
71-2
72-1
72-2
72-4
Avian Single Dose Oral Toxicity
Avian Dietary Toxicity
Acute Toxicity to Freshwater Fish
Acute Toxicity to Freshwater Invertebrates
Fish Early Life Stage/ Aquatic Invertebrate Life Cycle Study
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
123643, 94039001
123642, 124488,
94039002, 94039003
94039004, 94039005,
149730, 149731
94039006, 149729,
123644
55326
CITATION(S)
MRID Number
ORE
875.1100
875.1200
875.1300
875.1400
875. 1700 & 875.2700
875.2300
Dermal exposure- Outdoor
Dermal Exposure- Indoor
Inhalation Exposure- Outdoor
Inhalation Exposure- Indoor
Product Use Information
Surface Residue Dissipation Study
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
81
-------
875.2400
875.2500
875.2800
133-3
133-4
Dermal passive dosimetry expo
Inhal. passive dosimetry expo
Description of Human Activity
455243-04
455243-04
Data Gap
82
-------
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 June 28, 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:
• Reregi strati on Eligibility Decision for diiodomethyl p-tolyl sulfone, 03/31/2008
Revised Risk Assessment and Supporting Science Documents:
• Diiodomethyl p-tolyl sulfone. P.C. Code: 101002. Human Health and Ecological
Effects Risk Assessments for the Reregi strati on Eligibility Decision (RED)
Document. Case 4009, 4/29/2008
• Diiodomethyl p-tolyl sulfone: Hazard Assessment, 3/14/2008
• Amended Product Chemistry of Benzene, l-((diiodomethyl)sulfonyl)-4-methyl or
Diiodomethyl p-tolyl sulfone for the Reregi strati on Eligibility Decision (RED),
2/28/2008
• Revised Occupational and Residential Exposure Chapter for Diiodomethyl-p-
tolylsulfone, 3/27/2008
• Revised Environmental Hazards and Ecological Risk Assessment for the
Diiodomethyl p-tolyl sulfone RED, 3/12/2008
• Environmental Fate Assessment of Di-iodomethyl p-tolyl sulfone for RED,
3/26/2008
Preliminary Risk Assessment and Supporting Science Documents:
• Diiodomethyl p-tolyl sulfone. P.C. Code: 101002 Human Health and Ecological
Effects Risk Assessments for the Reregi strati on Eligibility Decision (RED)
Document. Case 4009, 1/10/2008
• Diiodomethyl p-tolyl sulfone: Hazard Assessment, 1/9/2008
• Diiodomethyl p-tolyl sulfone- Incident Report, 1/9/2008
• Amended Product Chemistry for Benzene, l-(diiodomethyl)sulfonyl)-4-methyl or
Diiodomethy p-tolyl sulfone for the Reregi strati on Eligibility Decision (RED),
83
-------
1/9/2008
Revised Dietary and Drinking Water Exposure Chapter for Diidomethyl p-tolyl
sulfone for the Reregi strati on Eligibility Decision (RED) Document (Case 4009),
1/2/2008
Occupational and Residential Exposure Chapter for Diiodomethyl-p-tolylsulfone,
1/9/2008
Revised Environmental Hazards and Ecological Risk Assessment for the
Diiodomethyl p-tolyl sulfone RED, 1/8/2008
Environmental Fate Assessment of Diiodomethyl p-tolyl sulfone for RED,
1/9/2008
84
-------
Appendix D. Citations Part of the Data Base Supporting the Reregistration Decision
(Bibliography)
1. MRID Studies
MRID#
00054962
00054961
4590901
42177202
46913302
47214601
47242202
Citation
Brusick, DJ. (1977) Mutagenicity Evaluation of A-47685
50/50 Mixture with Dipropylene glycol: LBI Project No.
2683. Final rept, rev. lip. Unpublished.
Brusick, DJ. (1977) Mutagenicity Evaluation of A-47685:
LBI Project No. 2683. Final rept, rev. (Unpublished study
received Jun 15, 1977 under 275-33; prepared by Litton
Bionetics, Inc., MRID 00054961 submitted by Abbott
Laboratories, North Chicago, 111.; CDL: 230726-E).
Gonsior, S et al., 2002: Estimating Soil Adsorption
Coefficient Loc for Series of Biocides by HPLC Using
OECD Method 121: Submitted by Dow Chemical
Company.
Laster, Willard. (1991) Octanol/Water Partition Coefficient
of Amical ™48; Performing Lab: ABC Laboratories, Inc.,
MO: 65205.
Carney, E. W., Zablotny, C. L., and Johnson, K. A. (2006)
Amical 48: one-generation dietary reproduction toxicity
study in CD rats. Toxicology & Environmental Research
and Consulting, The Dow Chemical Company, Midland,
MI. Laboratory Project Study ID.: 031007, April 28, 2006.
MRID 46913302. Unpublished.
Carney, E., Zablotny, C., Card, T. et al. (2007) Amical 48
Antimicrobial Agent: Oral Gavage Developmental
Toxicity Probe Study in New Zealand White Rabbits. The
Dow Chemical Company. 149 p. MRID 47214601.
Unpublished.
Carney, E., K. Brooks, R. Rasoulpour, et al. (2007)
AMICAL™ 48, antifungal agent: oral gavage
developmental toxicity study in New Zealand white rabbits.
The Dow Chemical Company. Laboratory Project Study ID
061146, August 29, 2007. MRID 47242202. Unpublished.
85
-------
47234003
47234004
47307307
47323601
47338201
46913301
00160072
00160070
42054403
43246402
Lopez, A. (2007) Determination of UV-Visible Absorption
Characteristics of Amical 48 Antifungal Agent; Performing
Labs: PTRL West, Inc. Hercules, CA: 94547; Data were
generated by OECD guidelines 101 Lab Study ID#: PTRL
1654W.
Sudworth, J. (2007) Physical Chemical Determination for
BPD Dossier on Amical 48, Intertek ASG; Submitted by
The Dow Chemical Company.
Littel, K. (2007) Amical™ 48: Summary of Storage
Stability Studies; Submitted by The Dow Chemical
Company.
Madsen, S. and Williams, M.D. (1991). Determination of
the Photolysis Rate of C-Amical 48 on Surface of Soil.
ABS Laboratories Final Report No. 38727.
Carney, E.W. (2003) Amical™ 48: 13 Weej Dietary
Reproduction Probe Study in CD Rats; Toxicology &
Environmental Research and Consulting; The Dow
Chemical Compnay; 200 pages. MRID 47338201.
Unpublished.
Carney, E.W., C.L. Zablotny, J.F. Quast, andK.A. Johnson
(2006) Amical 48: two-generation dietary reproductive
toxicity study in CD rats. Toxicology & Environmental
Research and Consulting, The Dow Chemical Company,
Midland, MI. Laboratory Project Study ID.: 031007, May
15,2006. MRID 46913301. Unpublished.
Cifone, M. (1985) Evaluation of A-9248 in the Rat Primary
Hepatocyte Unscheduled DNA Synthesis Assay: LBI
Project No. 20991: Final Report. MRID 00160072.
Cifone, M. (1985) Mutagenicity of A-9248 in a Mouse
Lymphoma Mutation Assay: LBI Project No. 20989: Final
Report. MRID 00160070 Unpublished study prepared by
Litton Bionetics, Inc. 17 p.
Creighton, J. (1986) Three-Month Toxicity Study of Amical
48 Administered Orally to Dogs: Lab Project Number:
TB85-158. Abbot labs. MRID 42054403. Unpublished.
Creighton, J.; Bollmeier, A. (1986) Three-Month Toxicity
Study of AMICAL 48 Administered Orally to Dogs:
86
-------
47076601
010504
42586801
00160071
00123023
00123023
43008702
41765401
Supplemental Data: Lab Project Number: TB85/158.
Abbott Labs. 22 p. MRID 43246402. Unpublished.
Davis, J. and Erhardt, S. (2005) Amical 48 antifungal
agent: Pharmacokinetics and metabolism in Fisher 344
rats. The Dow Chemical Company, Midland, Michigan.
Laboratory report number not reported, January 18, 2007.
MRID 47076601. Unpublished.
Dudley, R. (1986) Three-Month Toxicity Study of Amical
48 Administered Via the Diet to Rats: Lab Project Number:
TA85-096. Abbot Laboratories. MRID010504.
Unpublished.
FitzGerald, G. (1992) Acute Oral Limit Study: Amical WP:
Lab Project Number: 92G-1490. Toxikon Corp. MRID
42586801. Unpublished.
Ivett, J. (1986) Clastogenic Evaluation of A-9248...in the in
vivo Mouse Micronucleus Assay: HB Project No. 20996:
Final Report. MRID 00160071 Unpublished study prepared
by Hazleton Biotechnologies. 20 p.
Kesterson, J.; Majors, K.; Moore, L.; et al. (1976) Acute
Dermal Toxicity of Amical 48 (Dry Powder) and an
Amical 48 Dispersion in Rabbits: Study Nos. 76-245 and
76-246. (Unpublished study received Jun 16, 1976 under
275-30; submitted by Abbott Labora- tories, North
Chicago, IL; CDL:225439-A. MRID 00123023.
Unpublished.
Kesterson, J.; Majors, K.; Moore, L.; et al. (1976) Acute
Dermal Toxicity of Amical 48 (Dry Powder) and an Amical
48 Dispersion in Rabbits: Study Nos. 76-245 and 76-246.
submitted by Abbott Laboratories, North Chicago, IL;
CDL:225439-A. MRID 00123023. Unpublished.
Kreuzmann, J. (1990) Acute Oral Toxicity in Rats—Limit
Test of AMICAL 48: Supplemental Information: Lab
Project Number: 90/4015/21/A. Hill Top Biolabs, Inc.
MRID 43008702. Unpublished.
Kreuzmann, J. (1990) Acute Oral Toxicity in Rats-Limit
Test: Amical 48: Lab Project Number: 90-4015-21 Hill Top
Biolabs, Inc. MRID 41765401 Unpublished.
87
-------
42054401
42054404
42054405
42054404
42243801
42054405
43246404
43120601
Quinn, L, 1991: AMICAL 48, Product Chemistry.
Originally submitted by Angus Chemicals.
Lehrer, SB (1985). Evaluation of the Effects of Orally
Administered AMICAL® 48 on the Embryonic and Fetal
Development of the Rat - Segment II, TFR Abbott
Laboratories, North Chicago, IL MRID 42054404.
Unpublished.
Lehrer , SB (1986). Evaluation of the Effects of Orally
Administered AMICAL® 48 on the Embryonic and Fetal
Development of the Rat - Segment II, TFR Supplement to
Study TA85-022. Abbott Laboratories, North Chicago, IL
MRID 42054405. Unpublished.
Lehrer, S. (1985) Evaluation of the Effects of Orally
Administered Amical 48 on the Embryonic and Fetal
Development of the Rat: Segment II, TFR: Lab Project
Number: TE85-022. MRID 42054404 Unpublished study
prepared by Abbott Labs. 56 p.
Lehrer, S. (1985) Evaluation of the Effects of Orally
Administered AMICAL 48 on the Embryonic and Fetal
Development of the Rabbit-Segment II, TFR: Lab Project
Number: TE85-054. MRID 42243801 Unpublished study
prepared by Abbott Labs. 64 p.
Lehrer, S. (1986) Evaluation of the Effects of Orally
Administered Amical 48 on the Embryonic and Fetal
Development of the Rat: Segment II, TFR: Supplement to
Study TA85-022: Lab Project Numb- er TE85-230. MRID
42054405.Unpublished.
Lehrer, S.; Bollmeier, A. (1985) Evaluation of the Effects
of Orally Administered AMICAL 48 on the Embryonic and
Fetal Development of the Rabbit-Segment II, TFR:
Supplement: Lab Project Number: TE85/054. Abbott Labs.
179 p. MRID 43246404 Unpublished.
Putman, D.; Curry, P.; Schadly, E. (1994) Chromosome
Aberrations in Chinese Hamster Ovary (CHO) Cells
(Amical 48 Preservative): Final Report: Lab Project
Number: TD585/337. MRID 43120601. Unpublished study
prepared by Microbiological Associates, Inc. 30 p.
88
-------
47076601
47307312
47348601
47354903
455021101
45524304
41765404
43008701
41765405
Saghir, S., Brzak, K., Clark, A., et al. (2007) Amical 48
antifungal agent: Pharmacokinetics and metabolism in
Fisher 344 rats. The Dow Chemical Company, Midland,
Michigan. Laboratory report number not reported, January
18, 2007. MRID 47076601. Unpublished.
McCready, D. (2007). Screening Hazard Assessment:
Potential Exposure to Amical™ Preservatives after
Treatment of HVAC System; The Dow Chemical
Company, 8 pages. MRID 47307312.
McCready, D. (2008). Revised Screening Hazard
Assessment: Potential Exposure to Amical™ after
Treatment of an HVAC System; The Dow Chemical
Company, 8 pages. MRID 47348601.
Durando, J. (2008) Primary Eye Irritation Study in the
Rabbit; Product Safety Laboratories, Study Number 23375.
The Dow Chemical Company. MIRD 47354903.
Unpublished.
American Chemistry Council (ACC). 2002. Assessment of
Potential Inhalation and Dermal Exposure Associated With
Pressure Treatment of Wood with Arsenical Wood
Products. MRID 455021101.
Bestari et al. 1999. Measurement and Assessment of
Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of
Cut Lumber (Phase III). (MRID 45524304, Task Force
#73154).
Carpenter, M. (1988) Hydrolysis as a Function of pH at
25(degrees)C of ?carbon 14|-Amical: Lab Project Number:
36019. Unpublished study prepared by Analytical Bio-
Chemistry Labs., Inc. 756 p. MRID 41765404.
Williams, M.; Heim, L. (1993) Hydrolysis of AMICAL as
a Function of pH at 25 (degrees) C: Lab Project Number:
40886. Unpublished study prepared by ABC Laboratories,
Inc. 63 p. MRID 43008701. Conducted by Springborn
Laboratories for Rohm and Haas Company.
Cranor, W. (1990) Aerobic Soil Metabolism of ?carbon
14|-Abbott- 9248 (Amical 48): Lab Project Number: 36608.
89
-------
41765406
42177201
41765407
43997001
47292704
94039006
94039004
94039005
123643
Unpublished study prepared by Analytical Bio-Chemistry
Labs., Inc. 955 p. MRID 41765405.
Madsen, S.; Williams, M. (1990) Anaerobic Soil
Metabolism of ?carbon 14|-Amical 48: Lab Project Number:
38730. Unpublished study prepared by Analytical Bio-
Chemistry Labs., Inc. 461 p. MRID 41765406.
Madsen, S.; Williams, M. (1991) Anaerobic Aquatic
Metabolism of ?carbon 14| Amical 48: Final Report: Lab
Project Number: 38729. Unpublished study prepared by
ABC Labs, Inc. 532 p. MRID 42177201.
Daly, D.; Cranor, W. (1987) Leaching Characteristics in
Soil with ?carbon 14|-Amical-48 (Abbott-9248): Lab
Project Number: 36021. Unpublished study prepared by
Analytical Bio-Chemistry Labs., Inc. 277 p. 41765407.
Williams, M.; Bradley, A. (1996) Aqueous Availability of
AMICAL 48: Final Report: Lab Project Number: 42782:
ABC 42782. Unpublished study prepared by ABC
Laboratories Europe, Ltd. 78 p. MRID 43997001.
Kanno, J. et al. (1994) Effects of Six-Week Exposure to
Excess Iodide on Thyroid Glands of Growing and Non-
growing Male Fischer-344 Rats; Toxicologic Pathology,
ISSN: 012-6233. The Dow Chemical Company, 9 pages.
Bollmeier, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00149729. Acute Toxicity of AMICAL
to Daphnia magna: Static Acute Toxicity: Report No.
31947. Prepared by ABC Labs., Inc. 1 p. MRID 94039006.
Bollmeier, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00149731. Acute Toxicity of AMICAL
to Bluegill Sunfish: Static Acute Toxicity: Report No.
31945. Prepared by ABC Labs. Inc. 10 p. MRID
94039004.
Bollmeier, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00149730. Acute Toxicity of AMICAL
to Rainbow Trout: Static Acute Toxicity: Report No.
31946. Prepared by ABC Labs., Inc. 1 p. MRID 94039005.
Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Acute Oral
LD50- Bobwhite Quail: A-9248: Project No. 161-104.
90
-------
Final rept. (Unpublished study received Sep 7, 1979 under
275-21; prepared by Wildlife International Ltd. and
Washington College, submitted by Abbott Laboratories,
North Chicago, IL; CDL:240936-C) MRID 123643.
123642 Fink, R.; Beavers, I; Joiner, G.; et al. (1978) Eight-day
Dietary LC50»Bobwhite Quail: A-9248: Project No. 161-
105. Final rept. (Unpublished study received Sep 7, 1979
under 275-21; prepared by Wildlife International Ltd. and
Washington College, submitted by Abbott Laboratories,
North Chicago, IL; CDL:240936-B) MRID 123642.
124488 Fink, R.; Beavers, I; Grimes, J.; et al. (1978) Eight-day
Dietary LC50-Mallard Duck: A-9248: Project No. 161-
106. Final rept. (Unpublished study received Sep 7, 1979
under 275-21; prepared by Wildlife International Ltd. and
Washington College, submitted by Abbott Laboratories,
North Chicago, IL; CDL:240936-A) MRID 124488.
149729 Forbis, A.; Burgess, D.; Georgie, L. (1984) Acute Toxicity
of Amical to Daphnia magna: Static Acute Toxicity Report
# 31947. Unpublished study prepared by Analytical
Biochemistry Laborato- lies, Inc. 38 p. MRID 149729.
149730 Forbis, A.; Georgie, L.; Burgess, D. (1984) Acute Toxicity
of Amical 48 to Rainbow Trout (Salmo gairdneri): Static
Acute Toxicity Report #31946. Unpublished study
prepared by Analytical Bio- chemistry Laboratories, Inc. 60
p. MRID 149730.
149731 Forbis, A.; Georgie, L.; Burgess, D. (1984) Acute Toxicity
of Amical 48 to Bluegill Sunfish (Lepomis macrochirus):
Static Acute Toxicity Report #31945. Unpublished study
prepared by Analyti- cal Biochemistry Laboratories, Inc. 63
p. MRID 149731.
55326 Hamlin, J. (1972) Report to: Abbott Laboratories, Chemical
Division: Four-Day Static Fish Toxicity Studies with
Amical and Amical 77 in Rainbow Trout and Bluegills:
IBT No. A1244. (Unpublished study received Mar 9, 1972
under 275-22; prepared by Industrial Bio-Test.
Laboratories, Inc., submitted by Abbott Laboratories, North
Chicago, 111.; CDL:002251-H) MRID 55326.
123644 Suprenant, D.; Ziencina, M. (1978) Acute Toxicity of A-
9248 to the Water Flea (Daphnia magna): Report #BW-78-
91
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94039001
94039002
94039003
43935701
Not Assigned
Not Assigned
Not Assigned
Not Assigned
9-308. (Unpublished study received Sep 7, 1979 under 275-
21; prepared by EG & G, Bionomics, submitted by Abbott
Laboratories, North Chicago, IL; CDL:240936-D) MRID
123644.
Trueblood, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00123643. Acute Oral Toxicity Study
of AMICAL in Bob white Quail: Project #161-104.
Prepared by Wildlife International, Ltd. 13 p. MRID
94039001.
Trueblood, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00123642. Eight-Day Dietary Toxicity
Study of AMICAL in Bobwhite Quail: Project #161-105.
Prepared by Wildlife International Ltd. 12 p. MRID
94039002.
Trueblood, A. (1990) Angus Chemical Company Phase 3
Summary of MRID 00124488. Eight-Day Dietary Toxicity
Study of AMICAL in the Mallard Duck; Project No. 161-
106. Prepared by Wildlife International, Ltd. 12 p. MRID
94039003.
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.
Williams, M. (1991). Determination of the Photolysis Rate
of C-Amical 48 in pH 5 Buffered Solution at 25C;
Guideline 161-2; ABC Laboratories; Angus Chemical
Company.
Jensen, C. (2006) Amended Report for Human
Percutaneous Absorption and Coetaneous Disposition of
[14C]-Amical 48 Invitro. In Vitro Technologies, Inc. The
Dow Chemical Company; 43 pages.
Little, K. (2008). DMTS Consumption by Application and
Handling Process. The Dow Chemical Company, 11 pages.
Little, K. (2007) AMICAL™ 48: Summary of Storage
Stabilities; submitted by: The Dow Chemical Companies.
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Not Assigned Little, K. (2007) Summary of Pressure Treatment
Biological Efficacy Studies: Significance to Amical™ 48
Leaching from Pressure Treated Wood; submitted by The
Dow Chemical Company; 25 pages.
2. Open Literature
Citation
Aschacher, G. and Gruendlinger, R. (2000). Methods to evaluate the ecotoxicological
risks of anti-sapstain preservatives. Holzforschung, Austria Research and
Development. www.holzforschung.at/english/img_eng/ascha200.pdf
Cinalli, Christina, et al. A Laboratory Method to Determine the Retention of Liquids on
the Surface of Hands. Exposure Evaluation Division. September 1992.
Ema M.; Itami T.; Kawasaki H. (1992).Teratological assessment of diiodomethyl p-tolyl
sulfone in rats. Toxicol Lett. 62(l):45-52
EPA, 2006. "User Manual for EXPRESS, the EXAMS-PRZM Exposure Simulation
Shell, Version 1.03.02." Prepared by Lawrence A. Burns, National Exposure
Research Laboratory, U.S. Environmental Protection Agency, Athens, GA.
EPA/600/R-06/095. September 2006.
EPA, 2004. Wood Leaching Model: Chemical Concentration Screening Tool, vl.O.
USEPA/OPPT/AD.
Gonsior, S.J., M.A. Rivard, andM.K. Stock. (August 12, 2002) Activated Sludge
Respiration Inhibition Test (OECD 209) for Amical 48 Preservative.
Unpublished study submitted by The Dow Chemical Company. No MRID.
Krahn, P.; Strub R. (1990) Standard Leaching Test for Antisapstain Chemicals: Regional
Program Report 90-10. Environment Canada, Conservation and Protection,
Pacific and Yukon Region North Vancouver, BC
Kreuzmann, J. (1990) Acute Oral Toxicity in Rats-Limit Test: Amical 48: Lab Project
Number: 90-4015-21 Hill Top Biolabs, Inc. MRID 41765401 Unpublished.
Landenberg, B, 2007. "Screening Risk Assessment. Potential Exposure to AMICAL™
From the use of Finger-Paints." The Dow Chemical Company.
Landenberg, B, (2007) "Screening Risk Assessment. Potential Exposure to AMICAL™
From the use of Finger-Paints." The Dow Chemical Company.
Lee, R. (2004) WLM recommendation regarding chemical generalization.
Memorandum to Siroos Mostaghimi, USEPA. December 15, 2004.
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Madsen, S. and M.D. Williams. (1991) Determination of the Photolysis Rate of 14C-
Amical on the Surface of Soil. ABC Laboratories Final Report No. 38727. No
MRID.
Marino, T. A. (2007) AMICAL: An Acute Toxicity Study with the Rainbow Trout; The
Dow Chemical Company; Guideline 72-1; 42 pages.
Marino, T. A. (2007) AMICAL: An Acute Toxicity Study with the Daphnid, Daphnia
magna; The Dow Chemical Company; Guideline 72-2; 42 pages.
Rohm and Haas, 2006. Environmental Risk Assessment of DCOIT for Wood
Preservative Applications. Prepared by John P. Carbone and Andrew H.
Jacobson, Rohm and Haas Company, Spring House, PA. Company Report 06R-
1006. February 9, 2006.
Sinning, D, 2003: Physical Chemical Characteristics of AMICAL 48: Melting Point,
Boiling Point, Water, Solubility and Vapor Pressure. Sponsor Labs: Case Labs;
Submitted by the Dow Chemical Company.
Stenzel, J. et al. (2008) AMICAL™ 48: Soil Microorganisms- Nitrogen and Carbon
Transformation Test; OECD Test Guidelines 216 &217; Prepared by Wildlife
International, LTD. Project No. 103E-105; Submitted by The Dow Chemical
Company; 48 pages.
Williams, M. and Bradley, A., 1996. Aqueous Availability of AMICAL 48: Final Report:
Lab Project Number: 42782: ABC 42782. Unpublished study prepared by ABC
Laboratories Europe, Ltd. 78 p. MRID 43997001.
3. Other Supporting Documents
Citation
National Institute for Occupational Safety and Health (NIOSH): Criteria for a
Recommended Standard-Occupational Exposure to Metalworking Fluids.
Department of Health and Human Services (DHHS) NIOSH Publication #98-102
(1998).
SEVIetric, 2005. Mass, Weight, Density, or Specific Gravity of Bulk Materials.
http://www.simetric.co.ulf/si_materials.htm, last accessed June 2005.
USEPA, 2007. Breithaupt, James. (October 4, 2007) Amical 48 Environmental Fate Data
Power Point Presentation, U.S. Environmental Protection Agency.
USEPA, 2007. Exposure Assessment for the use of AMICAL ((Benzene, 1-
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(diiodomethyl)sulfonyl)-4-methyl ) on Heating, Ventilation, and Air
Conditioning Systems" Memorandum from Siroos Mostaghimi to Norm Cook,
October 22, 2007.
USEPA. 1997. Standard Operating Procedures (SOPs) for Residential Exposure
Assessments. EPA Office of Pesticide Programs Human Health Effects Division
(HED). Dated December 18, 1997.
USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa.
USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from
the Pesticide Handler Exposure Database Version 1.1. Washington, DC: U.S.
Environmental Protection Agency.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial
Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D.,
USEPA, to Julie Fairfax,
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs Human Health
Effects Division. Dated April 5, 2000.
USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November
12. Recommended Revisions to the Standard Operating Procedures (SOPs) for
Residential Exposure Assessment, February 22, 2001.
USEPA. 2003. Assessment of the Proposed Bardac Wood Preservative Pressure
Treatment Use. Memorandum from Tim Leighton and Siroos Mostaghimi.
February 11,2003.
USEPA. 2004. Occupational and Residential Exposure Assessment for Carboquat WP-
50. Memorandum from Siroos Mostaghimi, USEPA to Velma Noble, USEPA.
Dated November 4, 2004. DP Barcodes D303714 and D303938.
USEPA. 2005. Antimicrobials Division's Draft Standard Operating Procedures for
Occupational and Residential Exposure Assessments. July, 2005. (Unpublished
Internal Guidance).
USEPA. 2005. A Probabilistic Exposure Assessment for Children Who Contact CCA-
Treated Playsets and Decks. Final Report, February, 2005. US EPA Office of
Research and Development, National Exposure Research Laboratory.
Whatman, 2005. Whatman Absorbent Sinks.
http://www.whatman.com/products/7pageJXN7.32.42, Accessed March 2005.
95
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USEPA. March 14, 2008. Diiodomethyl p-tolyl sulfone: Hazard Assessment.
Memorandum from Jonathan Chen, USEPA to Kathryn Avivah Jakob, USEPA.
DP Barcode D344852.
US Food and Drug Administration (US FDA) Center for Food Safety & Applied
Nutrition's (CFSAN). 2007. "Preparation of Food Contact Notifications and
Food Additive Petitions for Food Contact Substances: Chemistry
Recommendations." http://www.cfsan.fda.gov/~dms/opa3pmnc.html. December.
US Food and Drug Administration (US FDA) Center for Food Safety & Applied
Nutrition's (CFSAN). 2002. "Preparation of Food Contact Notifications and
Food Additive Petitions for Food Contact Substances: Chemistry
Recommendations." http://www.cfsan.fda.gov/~dms/opa2pmnc.html. April.
US Food and Drug Administration (US FDA) 1999. Memorandum from the Division of
Product Manufacture and Use, Chemistry Review Team HFS-246. to the
Division of Petition Control, FIFS-215 Attn: M. Hepp, Ph.D. "FAP 9B4668
(MATS #1055 M2.0 and 2.1): Angus Chemical Co,; submission of 5/5/99. 4-
(Diiodomethylsulfonyl) toluene as a slimicide in the manufacture of paper and
paperboard." August 12.
US Food and Drug Administration (US FDA) 1987. Memorandum from the Regulatory
Food Chemistry Branch, FIFF-458. to the Indirect Additives Branch, HFF-335
Attn: M. Stephens. "FAP 6B3961-Abbott Laboratories. Submission dated
11/4/86. 4-(Diiodomethylsulfonyl) toluene (DIMST) for use as a component of
side seam cements." February 9.
US Food and Drug Administration (US FDA) 1986. Memorandum from the Regulatory
Food Chemistry Branch, FIFF-458. to the Indirect Additives Branch, HFF-335.
"FAP 6B3961-Abbott Laboratories. 4-(Diiodomethylsulfonyl) toluene (DIMST)
for use as a component of side seam cements. Submission dated 8/8/86."
October 10.
Versar, 2005. "ADBAC Antisapstain Modeling (TAP 1-4-10, CM-43)," memorandum to
Najim Shamim, U.S. EPA, from Ron Lee and Jignasha Patel, Versar, Inc.,
Decembers, 2005.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In (DCI) at a later date. See Chapter V
of the diiodomethyl p-tolyl sulfone 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 (DCI) at a later date.
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Appendix G. Batching of Diiodomethyl p-tolyl sulfone Products for Meeting Acute
Toxicity Data Requirements for Reregistration
The Agency will complete the batching for diiodomethyl p-tolyl sulfone at a later date.
99
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in (DCI) 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 Program—Storage and Disposal
Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with
Attachments (This document is in PDF format and requires the
Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in
PDF format and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of
Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format
and will require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and
Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF
format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data
(November 27, 1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is
currently in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office of
Pesticide Programs. We anticipate that this publication will become available during the
Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: ace.orst.edu/info/nptn.
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The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed postcard.
The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for the
new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or tolerance
petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which identify
the chemical (including "blind" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a CAS number if one has been
assigned.
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