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United States Chemical Safety December 2010

Environmental Protection and Pollution Prevention

Agency (7510P)

Dimethoxane

Summary Document

Registration Review: Initial Docket

December 2010
Docket Number: EPA-HQ-OPP-2010-0686 

\VWW.regulations.gov 

Dimethoxane 

Summary Document 

Registration Review: Initial Docket 

December 2010 

Case # 3064 

Approved By: 

Date: 

, r 7 

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TABLE OF CONTENTS

Dimethoxane Registration Review Team............................................................................4

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet ......................................................................................................................12

III. Summary of Data Gaps................................................................................................15

IV. Appendix A..................................................................................................................16

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents:

1. Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the 

Dimethoxane Registration Review Decision Document. October 12, 2010

2. Summary of Human Health Effects Data for Dimethoxane Registration Review. October 

15, 2010

Additional supporting documents for dimethoxane may be found in the registration review docket

EPA-HQ-OPP-2010-0686 located on the internet at www.regulations.gov. 
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Dimethoxane Registration Review Team

Tim Dole

Human Health & Environmental Effects

Srinivas Gowda

Monisha Harris

Risk Management

Lance Wormell

Philip Ross

Office of General Counsel
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I. Preliminary Work Plan -- Dimethoxane

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency), based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the dimethoxane case.

The first product containing dimethoxane (PC Code 001001) , as an active ingredient was 

registered in the United States in 1962. Currently there is one registered product containing 

dimethoxane. Dimethoxane is a bacteriostat/fungistat registered for use for the preservation of 

materials such as industrial adhesives (tape joint compounds, silicone based adhesives, starch 

based adhesives, and other adhesives), paints, emulsions (latex, polyvinyl alcohol, silicone, oil, 

acrylic, polyethylene, polyvinyl chloride), coatings, specialty industrial products (pigment 

slurries, dyestuffs, inks, thickeners, gums, lingosulfonates), textile chemicals and finishes (dye 

levelers, textile auxiliaries, softeners, lubricants, antistats, sizings, print pastes), leather 

processing liquors (dyes, wet processing leather finishes), and distillation fuels against microbial 

degradation during manufacture, storage, and service life. EPA completed a Reregistration 

Eligibility Decision (RED) for dimethoxane in 1996.

Documents associated with the registration review of dimethoxane can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2010-0686. Below is a summary of the issues 

relevant to the registration review case.
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Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct an environmental fate risk assessment. The Agency 

anticipates the need to conduct a human health risk assessment. The Agency anticipates needing 

additional data to conduct the registration review of dimethoxane. 

Ecological Risk:

• No ecological risk assessment has been performed for dimethoxane. An ecological risk 

assessment was not performed at the time of the RED because the use patterns were 

expected to result in minimal exposure to the environment and because dimethoxane is 

not more than slightly toxic to fish and aquatic invertebrates, and slightly toxic to 

practically nontoxic to birds.

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether dimethoxane’s use has “no effect or “may 

affect” federally listed threatened or endangered species (listed species) or their designed 

critical habitats. When an assessment concludes that a pesticide’s use “may affect” a 

listed species or its designated critical habitat, the Agency will consult with the U.S. Fish 

and Wildlife Service and/or National Marine Fisheries Services (the Services), as 

appropriate. 

• The Agency does not anticipate the need to require additional ecological data at this time.

• The Agency anticipates the need to require the following additional environmental fate 

data to conduct the registration review of dimethoxane.

835.1110 -- Activated Sludge Sorption Isotherm

835.3110 -- Ready Biodegradability

• Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity 

Data for the Dimethoxane Registration Review Decision Document located in the docket, 

for a detailed discussion of these anticipated risk assessment and data needs.

Human Health Risk: 

• The most recent human health risk assessment for dimethoxane was completed in 2009, 

in support of a new use in household, industrial, and institutional water based products. 

The application for the new use was withdrawn in 2010. 

• A human health risk assessment was not conducted to support the 1996 RED because, at 

that time, occupational and residential exposure were expected to be minimal and 

potential resulting toxic effects were expected to be negligible. Because of an incorrect 

assumption that dimethoxane had a low vapor pressure, these determinations will be 

reevaluated during registration review and the Agency anticipates conducting complete 

occupational and residential exposure risk assessments.
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• There is a potential for drinking water exposure from the material preservative use of 

dimethoxane. The Agency intends to determine the need for a drinking water assessment 

upon the submission and review of the environmental fate data anticipated to be needed 

for this registration review. The need for an aggregate risk assessment will also be 

determined by the outcome of the anticipated environmental fate data.

• There are no tolerances or exemptions from tolerances for dimethoxane.

• The Agency anticipates the need to require the following data to conduct human health 

risk assessments for dimethoxane.

Special Study -- Skin (dermal) sensitization

870.3465 -- 90-day inhalation toxicity (rat)

875.1200 -- Dermal indoor exposure

875.1400 -- Inhalation indoor exposure

875.1600 -- Application exposure data reporting and calculations

875.1700 -- Product use information

Special Study -- Leaching study on textiles

Special Study -- Leaching study on leather

• Please refer to Summary of Human Health Effects Data for Dimethoxane Registration 

Review, located in the docket, for a detailed discussion of the anticipated human health 

risk assessment and data needs for dimethoxane. 

Product Chemistry:

• The Agency does not anticipate the need to require additional product chemistry data at 

this time.

• Dimethoxane is believed to react with water to form acetic acid and a transient 

intermediate, dioxinol, which then breaks down into acetaldehyde and aldol (3-

hydroxybutanal).

• Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity 

Data for the Dimethoxane Registration Review Decision Document, located in the 

docket, for a detailed discussion of the anticipated risk assessments and data needs. 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

Endocrine Disruptor Screening Program
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systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Dimethoxane was not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for all 

Registration Review cases, including those for which EPA has already opened a Registration 

Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

EPA has created the following estimated timeline for the completion of the Dimethoxane

registration review:

Timeline

Registration Review for Dimethoxane – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and Public Comment Period December 2010

Close Public Comment Period February 2011

Case Development

Final Work Plan May 2011

Issue DCI May 2012

Data Submission May 2014

Open Public Comment Period for Draft Risk Assessments September 2015

Close Public Comment Period December 2015

Registration Review Decision

Open Public Comment Period for Proposed Registration Review 

Decision 

March 2016

Close Public Comment Period June 2016

Registration Review Decision and Begin Post-Decision Follow-up 2016

Total (years) 6
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The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the dimethoxane registration review case.

Guidance for Commenters:

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

Dimethoxane is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Dimethoxane, 

based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES.

More information on impaired water bodies and TMDLs can be found at 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to dimethoxane compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 
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the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, 

OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this 

time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

dimethoxane case, then the Agency invites submission of this information. The submitter would 

be expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining the risk assessments. The Agency is interested in receiving the following 

information:

1. Confirmation on the following label information:

a. Sites of application
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b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, application intervals and maximum number of 

applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes in February 2011, the Agency will review and 

respond to any comments received in a timely manner, and then issue a Final Work Plan for the 

dimethoxane case. 
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II. Fact Sheet

Background Information:

• Active Ingredient: Dimethoxane

• Chemical Name: 2,6-Dimethyl-m-dioxan-4-ol acetate

• Registration review case number: 3064

• PC Code: 001001

• CAS#: 828-00-2

• Technical registrants: Dow Chemical Company

• First approved for use in a registered product: 1962

• There are no tolerances or exemptions from tolerances for dimethoxane.

• Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen, 

vondem-hagen.rebecca@epa.gov

• Antimicrobials Division Product Manager (PM): Marshall Swindell, 

swindell.marshall@epa.gov

• Dimethoxane is registered for use as a bacteriostat/fungistat

Use & Usage Information:

•

o Preservation of materials such as industrial adhesives (tape joint compounds, 

silicone based adhesives, starch based adhesives, and other adhesives), paints, 

emulsions (latex, polyvinyl alcohol, silicone, oil, acrylic, polyethylene, polyvinyl 

chloride), coatings, specialty industrial products (pigment slurries, dyestuffs, inks, 

thickeners, gums, lingosulfonates), textile chemicals and finishes (dye levelers, 

textile auxiliaries, softeners, lubricants, antistats, sizings, print pastes), leather 

processing liquors (dyes, wet processing leather finishes), and distillation fuels 

against microbial degradation during manufacture, storage, and service life

Antimicrobial Use Sites:

Recent/Pending Regulatory Actions:

• The most recent human health risk assessment for dimethoxane was completed in 2009 in 

support of a new use in household, industrial, and institutional water based products. The 

application for the new use was withdrawn in 2010. 

• There are no other recent or pending regulatory actions involving dimethoxane.

The Agency has not conducted an ecological risk assessment for dimethoxane. An ecological 

risk assessment was not performed at the time of the RED because the use patterns were 

expected to result in minimal exposure to the environment and because dimethoxane is not more 

than slightly toxic to fish and aquatic invertebrates, and slightly toxic to practically nontoxic to 

birds. Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data 

Ecological Risk Assessment Status:
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for the Dimethoxane Registration Review Decision Document, located in the docket, for a 

detailed discussion of the anticipated environmental fate risk assessment.

The following are key findings of the recent human health risk assessments for dimethoxane. 

Please refer to Summary of Human Health Effects Data for Dimethoxane Registration Review,

located in the docket, for a detailed discussion of the human health risk assessment.

Human Health Risk Assessment Status:

Hazard Characterization:

• Dimethoxane is a strong sensitizer and of low to moderate acute toxicity by all routes of 

exposure.

• A complete database of acute toxicity data was available to the Agency at the time the 

RED was written. 

Dietary (Food and Water):

• Dimethoxane is not registered for any direct or indirect food uses, nor does it have any 

FDA approvals for such uses. Product labeling does not permit use in the manufacture of 

coatings that may come in contact with food. 

• The Agency did not complete a dietary risk assessment for the RED.

Residential:

• The Agency has not conducted a residential risk assessment for dimethoxane.

Aggregate:

• In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, as 

well as non-occupational pesticide exposures. An aggregate risk assessment has not been 

conducted for dimethoxane.

Occupational:

• The Agency has not conducted an occupational risk assessment for dimethoxane. 

Cumulative:

• EPA does not have, at this time, available data to determine whether dimethoxane has a 

common mechanism of toxicity with other substances or how to include this pesticide in 

a cumulative risk assessment. For the purposes of this Registration Review, EPA has 

assumed that dimethoxane does not have a common mechanism of toxicity with other 

substances when used as an antimicrobial as registered. The Agency did not conduct a 

cumulative risk assessment for the 1996 RED.
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• The Agency has reviewed the OPP Incident Data Systems (IDS) and no incidents have 

been reported for dimethoxane. 

Incidents:

Tolerances and International Harmonization:

• There are no tolerances or exemptions from tolerances for dimethoxane.

• As a result of the 1995 RED, a product specific data call-in (PDCI) was issued in 1996. 

The most recent generic data call-in (GDCI) was issued in 1992. The data required by 

the previous data call-ins have been satisfied. The Agency anticipates issuing a generic 

data call-in (GDCI) for the registration review of dimethoxane.

Data Call-In Status:

Labels:

Registered active products, including EPA registration numbers are provided in Table 1 below. 

For future reference, during registration review a list of product registration numbers will be 

included in the docket. Product registration labels may be obtained from the Pesticide Product 

Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home.

Table 1. Registered Active Products – Dimethoxane

Registration # Registration Name Company Name Formulation Type % A.I.

464-682 Bioban DXN The Dow Chemical Company Soluble Concentrate 87
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III. Summary of Anticipated Data Requirements – Dimethoxane

The table below summarizes anticipated data needs for dimethoxane listed in Section I of this 

document (Preliminary Work Plan), Summary of Product Chemistry, Environmental Fate, and 

Ecotoxicity Data for the Dimethoxane Registration Review Decision Document, and Summary of 

Human Health Effects Data for Dimethoxane Registration Review.

Table 2. Summary of Anticipated Data Requirements – Dimethoxane

Guideline 

Number

Anticipated Data Requirement Test Material Estimated 

Timeframe

(months) 

(Measured 

from DCI 

Receipt)

835.1110 Activated Sludge Sorption Isotherm TGAI 12

835.2120 Hydrolysis TGAI 12

835.3110 Ready Biodegradability TGAI 12

870.2600 Skin (dermal) sensitization TGAI 24

870.3465 90-day inhalation toxicity (rat) TGAI 24

875.1200 Dermal indoor exposure TGAI 24

875.1400 Inhalation indoor exposure TGAI 24

875.1600 Application exposure data reporting and calculations TGAI 24

875.1700 Product use information TGAI 12

Special Study Leaching Study on Textiles TGAI 24

Special Study Leaching Study on Leather TGAI 24
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IV. Appendix A: Use Patterns – Dimethoxane

EPA 

Reg. #

Formulation % Active 

Ingredient 

in End Use 

Formulation

Use 

Category

Use Site Treatment 

Site/Surfaces

Method of 

Application

Max 

Application/Use 

Rate

Use 

Limitations

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Adhesives, 

Industrial 

(Nonfood 

Contact)

Tape joint 

compounds, 

silicone based 

adhesives, starch 

based adhesives, 

other adhesives

Not 

provided

.0125 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives Paints Paints Not 

provided

0.04 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Specialty 

products

Emulsions: such as 

latex, PVA, silicone, 

oil acrylic, 

polyethylene, PVC

Not 

provided

0.0 15 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Coatings, 

Industrial Coatings Not 

provided

0.06 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Specialty 

products

Specialty industrial 

products: such as 

pigment slurries, 

dyestuffs, inks, 

thickeners, gums, 

lingosulfonates 

Not 

provided

0.015 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Textiles / 

Corgage 

Products

Textile chemicals 

and finishes such 

as dye levelers, 

textile auxiliaries, 

softeners, 

lubricants, antistats, 

sizings and print 

pastes 

Not 

provided

0.05 - 0.2% by 

weight

464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Hides / Leather 

/ Leather 

Products 

(Surfaces)

Leather processing 

liquors such as 

dyes, wet 

processing leather 

finishes 

Not 

provided

add 0.05% -

0.2% by weight
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464-682 Soluble 

concentrate 87.00% Materials 

Preservatives

Specialty 

products Distillation fuels Not 

provided

0.025 - 0.2% by 

weight