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 2011Docket Number: EPA

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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 1H

Pyrazole

- 1

- methanol, 3,5

- dimethyl

- Registration Review Decision Document
. August 11, 201 1 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

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- 0619 located on the internet at www.regulations.gov
.Docket Number: EPA

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4 of 17 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 RossDocket Number: EPA

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5 of 17 I. Preliminary Work Plan -- 1H - Pyrazole - 1 - Methanol, 3,5 - Dimethyl 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 show ing 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 htt p://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 t o 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 d ocket 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 receiv ed 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

- c ase . The first product containing 1H

- Pyrazole

- 1

- methanol, 3,5

- dimethyl

- ( dimethyl1hydroxymethylpyrazole or DMHMP ) (PC Code 129074 ) as an active ingredient was regis tered 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 exemptio ns 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

- dimethyl

can be viewed at www.regulations.gov in docket EPA

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. Below is a summary of the issues relevant to th is registration re view 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 u ses 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
.Docket Number: EPA

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6 of 17 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 a n 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) A lgal 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) Modif ied 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 Biodegradab ility of Chemicals Discharged to Wastewater 1

.

**•** F or 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 EC 50 is less than or equal to 20 mg/L, registrants would need to perform one of 835.3220, 8 35.3240, or 835.3280. If the ASRI test EC 50 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 dissolv ed organic carbon (DOC) and 60% removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO 2 ) 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 w aive 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.Docket Number: EPA

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7 of 17 **•** The Agency anticipates the need to require the following additional human hea lth 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

**•** F or more information , 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
. Product Chemistr y :

**•** The Agency does not anticipate the need to require addi tional product chemistry data for this registration review at this time.

**•** F or more information , please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the 1H

- Pyrazole

- 1

- methanol, 3,5

- dimethyl

- Regi stration 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, includi ng 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 st udies 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 scena rios 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 determin e 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 aDocket Number: EPA

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8 of 17 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 necess ary 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 a nd 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 order s/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 T ier 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 Nov ember 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 P reliminary W ork P lan 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.Docket Number: EPA

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9 of 17 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 a s 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: ht tp://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 treatme nt 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 compare d to the general po pulation. 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 inte rest
. 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 eff ect can occur in various animal species.Docket Number: EPA

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10 of 17 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 us e 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 u sed 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
. Quantitativ e 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 conside red 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

- the

evidence evaluation
. At this time, EPA believes that for certain endpoi nts, 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 SA R 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 c ase , then the Agency invit es 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 t he 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 Ag ency 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. App lication methods and equipment d. Maximum application rates e. Frequency of application, application intervals and maximum number of applicationsDocket Number: EPA

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11 of 17 f. Geographic limitations on use 2. Use or potential use distribution 3. Use history 4. Usage/use information for non

- agricultur al 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 c as e .Docket Number: EPA

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12 of 17 II. Fact Sheet Background Information : **•** Active Ingredient: 1H

- Pyrazole

- 1

- methanol, 3,5

- dimethyl

- ( DMHMP ) **•** C ase 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@e pa.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.

**•** D M HMP 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 t o 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 ecolo gical 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 plannedDocket Number: EPA

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13 of 17 ecological risk assessment, including an endangered speci es 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 dete rmine whether D MHMP 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 o f DMHMP’s initial registration, t he 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 Docume nt (U.S. EPA, 1995b). However, for registration review , the Agency believes that ad ditional studies and toxicological endpoints w ill be needed. If relevant toxicological endpoints are available for dermal and inhalation, EPA anticipates that new occupatio nal 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 con taminated 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 effluen t 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 evaluat ion of any need for a drinking water assessme nt.

**•** 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.Docket Number: EPA

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14 of 17 Occupational and Residential Exposure :

**•** There are potential short

- an d 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/c oatings, 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 intermediate

term (>30 da ys) 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 non

occupational 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 re gistration 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 cumul ative 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:Docket Number: EPA

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15 of 17 Ecological:

**•** There are no reported incidents in the Agency' s Ecological Incident Information System (EIIS) regarding DMHMP. Hum an 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 t he requirement of tolerance for DMHMP. Data Call - In Status :

**•** No recent data call

- in has been issued for DMHMP. Labels : Registered products, including EPA r egistration n umbers 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 93Docket Number: EPA

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16 of 17 III. Summary of Anticipated Data Requirements

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

- Registrat ion 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 Est imated 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 24Docket Number: EPA

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17 of 17 IV. Appendix A : Use Patterns

– 1H - Pyrazole - 1 - methanol, 3,5 - dimethyl Use 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 coating s 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 conta ct food.” Textiles 1448

- 351 Add 0.05 to 0.3% Busan 1104 by weight