United States Chemical Safety September 2011

Environmental Protection and Pollution Prevention

Agency (7510P)

1H-Pyrazole-1-Methanol, 3,5-Dimethyl-

(DMHMP)

Summary Document:

Registration Review: Initial Docket

September 2011

Docket Number: EPA-HQ-OPP-2011-0619

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TABLE OF CONTENTS

1H-Pyrazole-1-Methanol, 3,5-Dimethyl- Registration Review Team.................................4

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

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

III. Summary of Anticipated Data Requirements..............................................................16

IV. Appendix A..................................................................................................................17

________________________________________

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 1HPyrazole-1-methanol, 3,5-dimethyl- Registration Review Decision Document. August 11, 

2011

2. Summary of Human Health Effects Data for the 1H-Pyrazole-1-methanol, 3,5-dimethyl 

(DMHMP) Registration Review Decision Document. August 29, 2011

Additional supporting documents for the 1H-Pyrazole-1-Methanol, 3,5-Dimethyl- Case may be 

found in the registration review docket EPA-HQ-OPP-2011-0619 located on the internet at

www.regulations.gov.
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1H-Pyrazole-1-Methanol, 3,5-Dimethyl- Registration Review Team

Human Health & Environmental Effects

Nathan Mottl

Srinivas Gowda

Risk Management

Eliza Blair

Lance Wormell

Office of General Counsel

Philip Ross
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I. Preliminary Work Plan -- 1H-Pyrazole-1-Methanol, 3,5-DimethylIntroduction:

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 1H-Pyrazole-1-Methanol, 3,5-Dimethyl- case.

The first product containing 1H-Pyrazole-1-methanol, 3,5-dimethyl-

(dimethyl1hydroxymethylpyrazole or DMHMP) (PC Code 129074) as an active ingredient was 

registered in the United States in 1996. Currently, there is only one product registered with EPA.

The product containing DMHMP is registered for use as a material preservative in emulsion 

paints, adhesives, latex emulsions, liquid polishes and waxes, detergents, paper making 

chemicals and coatings. There are no pesticide tolerances or exemptions from the requirement of 

tolerance for DMHMP. A Reregistration Eligibility Decision (RED) has not been issued by EPA 

for DMHMP because the initial registration date was after November 1, 1984.

Documents associated with the registration review of 1H-Pyrazole-1-methanol, 3,5-dimethylcan be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0619. Below is a summary 

of the issues relevant to this registration review case.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of DMHMP. The Agency 

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

additional data for use in conducting the registration review for DMHMP.
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Ecological Risk:

• No recent ecological risk assessment has been performed for DMHMP. 

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

species determination for DMHMP. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether DMHMP’s use has 'no 

effect' or 'may affect' federally listed threatened or endangered species (listed species) or 

their designated 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 anticipates the need to require the following additional ecological data for 

use in the registration review of DMHMP.

o (GLN 850.5400) Algal toxicity (Tier II) using freshwater green alga, Selenastrum 

capricornutum.

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

data for use in the registration review of DMHMP.

o (GLN 850.6800) Modified Activated Sludge Respiration Inhibition

o (GLN 835.3110) Ready biodegradability

o (GLN 835.3220) Porous Pot Test

o (GLN 835.3240) Simulation Test – Aerobic Sewage Treatment: A. Activated 

Sludge Units

o (GLN 835.3280) Simulation Tests to Assess the Biodegradability of Chemicals 

Discharged to Wastewater1

.

• For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the 1H-Pyrazole-1-methanol, 3,5-dimethyl- Registration 

Review Decision Document, located in the docket.

Human Health Risk:

• No recent human health risk assessment has been performed for DMHMP.

 1 Based on the results of any required Activated Sludge Respiration Inhibition Test (ASRI), registrants 

may be able to request that EPA waive the requirements for additional biodegradation tests. If the ASRI 

test EC50 is less than or equal to 20 mg/L, registrants would need to perform one of 835.3220, 835.3240, 

or 835.3280. If the ASRI test EC50 is greater than 20 mg/L, registrants would need to perform either (i) 

835.3110 or (ii) one of 835.3220, 835.3240, or 835.3280. If the antimicrobial reaches pass levels for 

835.3110 (i.e., 70% removal of dissolved organic carbon (DOC) and 60% removal of theoretical oxygen 

demand (ThOD) or theoretical carbon dioxide (ThCO2) production for respirometric methods) in a 10-day 

window within the 28-day period of the test, registrants would be able to request that EPA waive the 

requirements for additional biodegradation tests. If the antimicrobial does not pass 835.3110, the 

registrants would need to perform one of 835.3220, 835.3240, or 835.3280.
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• The Agency anticipates the need to require the following additional human health data 

for use in the registration review of DMHMP.

o (GLN 870.3465) 90-Day Inhalation Toxicity

o (GLN 870.3250) 90-Day Dermal Toxicity

o (GLN 875.1200) Dermal Exposure (Indoor)

o (GLN 875.1400) Inhalation Exposure (Indoor)

o (GLN 875.1600) Application exposure data reporting and calculations

o (GLN 875.1700) Product Use Information

o (GLN 875.2400) Postapplication Exposure (Dermal)

o (GLN 875.2500) Postapplication Exposure (Inhalation)

o (GLN 875.2700) Product Use Information

o (GLN 875.2900) Data Reporting and Calculations

• For more information, please refer to Summary of Human Health Effects Data for the 1HPyrazole-1-methanol, 3,5-dimethyl (DMHMP) Registration Review Decision Document,

located in the docket.

Product Chemistry:

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

this registration review at this time.

• For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the 1H-Pyrazole-1-methanol, 3,5-dimethyl- Registration 

Review Decision Document, located in the docket.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for DMHMP, EPA reviewed 

these data and selected the most sensitive endpoints for relevant risk assessment scenarios from 

the existing hazard database. However, as required by FFDCA section 408(p), DMHMP is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

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

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 dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 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. DMHMP is not among the 

group of 58 pesticide active ingredients on the initial list to be screened under the EDSP.

Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, 

requiring the submission of EDSP screening assays for DMHMP. For further information on the 

status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timeline for the completion of the DMHMP registration 

review:

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket September 2011

Close Public Comment Period for Docket November 2011

Phase 2: Case Development

Develop Final Work Plan (FWP) March 2012

Issue DCI March 2013

Data Submission March 2014

Open Public Comment Period for Preliminary Risk Assessments September 2015

Close Public Comment Period for Preliminary Risk Assessments November 2015

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision March 2016

Close Public Comment Period for Proposed Reg. Review Decision April 2016

Final Decision and Begin Post-Decision Follow-up 2016

Total (years) 5

Guidance for Commenters:

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 DMHMP registration review case.
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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:

DMHMP 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 DMHMP, 

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 DMHMP 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 

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. 
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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 

DMHMP 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 its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information:

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

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

applications
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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

Next Steps:

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

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

case. 
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II. Fact Sheet

Background Information:

• Active Ingredient: 1H-Pyrazole-1-methanol, 3,5-dimethyl- (DMHMP)

• Case number: 5035

• PC Code: 129074

• CAS number: 85264-33-1

• Technical registrants: Buckman Laboratories

• First approved for use in a registered product: 1996

• There are no pesticide tolerances or exemptions from the requirement of tolerance for 

DMHMP.

• Antimicrobials Division Chemical Review Manager (CRM): Eliza Blair, 

blair.eliza@epa.gov

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

swindell.marshall@epa.gov

• Chemical Structure:

Use & Usage Information:

• DMHMP is registered for use as a material preservative emulsion paints, adhesives, latex 

emulsions, liquid polishes and waxes, detergents, paper making chemicals and coatings.

Recent/Pending Regulatory Actions:

• No recent or pending regulatory actions exist for DMHMP.

Ecological Risk Assessment Status:

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

the 1H-Pyrazole-1-methanol, 3,5-dimethyl- Registration Review Decision Document, located in 

the docket, for a detailed discussion of the ecological risk assessments.

• DMHMP is slightly toxic to avian species on an acute oral basis and practically nontoxic 

to avian species on subacute dietary basis; practically non-toxic to mammals on an acute 

oral basis; practically nontoxic to slightly toxic to freshwater fish; and slightly toxic to 

aquatic invertebrates. For the ecological risk assessment, including an endangered 

species assessment for all uses, the Agency anticipates requiring the algal toxicity data.

• The Agency has not conducted an ecological and environmental fate assessment for 

DMHMP. The Agency needs to conduct environmental fate and ecological risk 

assessments for DMHMP’s use as a materials preservative. For use in the planned 
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ecological risk assessment, including an endangered species assessment, the Agency 

anticipates needing ecological effects data to characterize DMHMP’s material 

preservative uses that potentially pass through waste water treatment plants (WWTPs) 

and may be discharged into terrestrial and aquatic environments. 

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

endangered species effects determination. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether DMHMP use has “no 

effect” or “may affect” federally listed threatened or endangered species (listed species) 

or their designated 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.

Human Health Risk Assessment Status:

Please refer to Summary of Human Health Effects Data for the 1H-Pyrazole-1-methanol, 3,5-

dimethyl (DMHMP) Registration Review Decision Document, located in the docket, for a 

detailed discussion of the human health risk assessment.

Hazard Characterization:

• At the time of DMHMP’s initial registration, the Agency did not select any dermal, 

inhalation or oral toxicological endpoints for short-term, intermediate-term occupational, 

residential and dietary exposures as indicated in the 1995 Toxicology Selection Endpoint 

Document (U.S. EPA, 1995b). However, for registration review, the Agency believes 

that additional studies and toxicological endpoints will be needed. If relevant 

toxicological endpoints are available for dermal and inhalation, EPA anticipates that new 

occupational and residential risk assessments will be needed. 

Dietary (Food and Water):

• Although likely to be infrequent, dietary exposures via drinking water may occur in the 

event of a down-the-drain discharge. The contaminated water could pass through 

wastewater treatment facilities into the drinking water or may be discharged directly to 

surface water which is later treated. However, at this time there are no environmental fate 

data to determine whether DMHMP can pass through wastewater treatment facilities into 

drinking water or migrate into residential groundwater wells as a result of its current use 

patterns. Since the product is used as an industrial preservative in slurries, the Agency 

anticipates that the effluent wastewater could discharge directly to surface water and 

exposures could occur. The Agency will use environmental fate data submitted in 

response to any DCI issued for this registration review in its evaluation of any need for a 

drinking water assessment.

• According to the label (EPA Reg# 1448-351), DMHMP “may NOT be used for the 

preservation of materials which may contact food” for adhesives and papermaking uses. 

Therefore, EPA anticipates that an indirect dietary assessment will not be needed. 
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Occupational and Residential Exposure:

• There are potential short- and intermediate-term exposures for occupational and 

residential uses. There are potential dermal and inhalation occupational handler exposure 

scenarios identified by the Agency after review of the labels. The potential occupational 

handler scenarios (both short-term (1-30 days) and intermediate-term (>30 days) include: 

o Mixing/loading solid granulars for paints; 

o Mixing/loading solid granulars for slurries (e.g., adhesives, polishes/waxes, 

construction materials, detergents, inks, papermaking chemicals/coatings, textile 

emulsions);

o Applying detergents (trigger sprays, mopping and wiping); and,

o Applying paints (airless sprayer, paint brush, and aerosol can)

• The potential postapplication scenarios (both short-term (1-30 days) and intermediateterm (>30 days) include: 

o Inhalation exposure to paints (e.g. bystander exposure indoors); and

o Dermal postapplication exposures to treated clothing made from impregnated textiles 

with DMHMP.

Aggregate:

• The Agency has not conducted an aggregate risk assessment for DMHMP. 

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

information concerning exposures to residues in food and drinking water, and nonoccupational pesticide exposures. EPA will evaluate the need for an aggregate assessment 

for residential and drinking water using any submitted environmental fate data that are 

expected to be required through registration review. 

Cumulative:

• Unlike other pesticides for which EPA has followed a cumulative risk approach based on 

a common mechanism of toxicity, EPA has not made a common mechanism of toxicity 

finding as to DMHMP and any other substances and DMHMP does not appear to produce 

a toxic metabolite produced by other substances. For the purposes of this registration 

review action, therefore, EPA has not assumed that DMHMP has a common mechanism 

of toxicity with other substances. For information regarding EPA’s efforts to determine 

which chemicals have a common mechanism of toxicity and to evaluate the cumulative 

effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide 

Programs concerning common mechanism determinations and procedures for cumulating 

effects from substances found to have a common mechanism on EPA’s website at 

http://www.epa.gov/pesticides/cumulative/.

Incidents:
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Ecological:

• There are no reported incidents in the Agency's Ecological Incident Information System 

(EIIS) regarding DMHMP. 

Human Health:

• There have been no human incidents in the OPP Incident Data System (IDS) that are 

associated with exposure to DMHMP.

Tolerances and International Harmonization:

• There are no pesticide tolerances or exemptions from the requirement of tolerance for 

DMHMP.

Data Call-In Status:

• No recent data call-in has been issued for DMHMP.

Labels:

Registered 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 Products – DMHMP

Registration

No.

Registration

Name

Company

Name

Formulation

Type

% of Active

Ingredient

1448-351 BUSAN 1104 Buckman 

Laboratories Inc. Ready-to-Use Solution 93
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III. Summary of Anticipated Data Requirements – 1H-Pyrazole-1-Methanol, 3,5-DimethylThe table below summarizes anticipated data needs for the 1H-Pyrazole-1-Methanol, 3,5-

Dimethyl- Case in Section I of this document (Preliminary Work Plan), Summary of Product 

Chemistry, Environmental Fate, and Ecotoxicity Data for the 1H-Pyrazole-1-methanol, 3,5-

dimethyl- Registration Review Decision Document, and Summary of Human Health Effects Data 

for the 1H-Pyrazole-1-methanol, 3,5-dimethyl (DMHMP) Registration Review Decision 

Document.

Table 2. Summary of Anticipated Data Requirements – DMHMP

Guideline

Number Anticipated Data Requirement Test Material

Estimated Timeframe 

(Measured in months from 

DCI Receipt)

835.3110 Ready Biodegradability TGAI 12

835.3220 Porous Pot Test TGAI 12

835.3240 Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge Units TGAI 12

835.3280

Simulation Tests to Assess the 

Biodegradability of Chemicals 

Discharged to Wastewater

TGAI 12

850.5400 Algal toxicity (Tier II) using freshwater 

green alga, Selenastrum capricornutum TGAI 12

870.3250 90-Day Dermal Toxicity TGAI 24

870.3465 90-Day Inhalation Toxicity TGAI 24

875.1200 Dermal Exposure (Indoor) TGAI 24

875.1400 Inhalation Exposure (Indoor) TGAI 24

875.1600 Application Exposure Data Reporting and 

Calculations TGAI 24

875.1700 Product Use Information TGAI 24

875.2400 Postapplication Exposure (Dermal) TGAI 24

875.2500 Postapplication Exposure (Inhalation) TGAI 24

875.2700 Product Use Information TGAI 24

875.2900 Data Reporting and Calculations TGAI 24
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IV. Appendix A: Use Patterns – 1H-Pyrazole-1-methanol, 3,5-dimethylUse Site Formulation/

EPA Reg. 

no.

Method of 

Application

Application Rate/ 

No. of applications

Use Limitations

Materials Preservative

emulsion paints, adhesives, 

latex emulsions, caulks,

liquid polishes and waxes, 

detergents, paper making 

chemicals and coatings

1448-351 Add 0.02 to 0.4% 

Busan 1104 based 

on total weight of 

the formulation

“Busan 1104 may 

NOT be used for the 

preservation of 

materials which may 

contact food.”

Textiles 1448-351 Add 0.05 to 0.3% 

Busan 1104 by 

weight