United States Chemical Safety September 2011 Environmental Protection and Pollution Prevention Agency (7510P) 

# Amines, C 10

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# a lkyldimethyl, N

- o xides Summary Document: Registration Review : Initial Docket September 2011Docket Number: EPA

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## Amines, C lO - 1 6 

## alkyldimethyl, N-oxides Summary Document Registrat i o n Review: Initial Docket S e ptember 2011 Case 

## # 5003

n Harrigan-Farrel y irector, Antimicrobials Division
Date :

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### TABLE OF CONTENTS Amines, C 10

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- o xides Registration Review Team
................................ ... 4 I. Preliminary Work Plan
................................ ................................ ................................ ..... 5 II. Fact Sheet
................................ ................................ ................................ ...................... 1 2 III. Summary of Anticipated Data Requirements
................................ .............................. 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. Amines, C 10

- 16 alkyldimethyl, N

- oxides. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document for Registration Review
. September 7 , 2011 2. Summary of Human Health Effects Data for the Alkyl (C10

- C16) Dimethyl Amine Oxide (ADAO) Registration Review Decision Document
. August 24, 2011 Addition al supporting documents for the Amines, C 10

- 16 a lkyldimethyl, N

- o xides Case may be found in the registration review docket EPA

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.Docket Number: EPA

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4 of 16 Amines, C 10 - 16 a lkyldimethyl, N - o xides Registration Review Team
Nathan Mottl Human Health & Environmental Effects Srinivas Gowda
Seiichi Murasaki Risk Management Lance Wormell Philip Ross Office of General CounselDocket Number: EPA

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5 of 16 I. Preliminary Work Plan -- Amines, C 10 - 16 a lkyldimethyl, N - o xides
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 (US EPA, 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 abilit y 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 pra ctices 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 Introduction:

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
. Afte r 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 Amines, C 10

- 16 - Alkyldimethyl,N

- Oxides c ase. The first product containing amines, C 10

- 16 alkyldimethyl, N

- oxides (known chemically as alkyl dimethylamine oxides or ADAO) (PC Code 000439 ) as an active ingredient was registered in the United States in 1999
. Currently, only one product containing this active ingredient is registe red with EPA. The only registered antimicrobial use of ADAO is as a n antibacterial dishwashing detergent in residential premises. ADAO currently has an inert tolerance exemption under 40 CFR 180.910 for use as a surfactant in pesticide formulations. EPA d oes not maintain a tolerance or exemption from the requirement of a tolerance for residues for the ADAO active ingredient. During registration review, the Agency will determine if any tolerances or exemptions from the requirement of a tolerance are needed for antimicrobial uses. ADAO was not subject to reregistration because the first pesticide product containing it was registered after November 1, 1984. Documents associated with the registration review of ADAO 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 review case.
The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of ADAO
. The Agency anticipates Anticipated Risk Assessment and Data Needs:Docket Number: EPA

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6 of 16 the need to conduct a human health risk assessment. The Agency anticipates needing additional data for use in conducting the registration review for ADAO
. Ecological Risk:

**•** The Agency has not conducted a risk assessment that supports a complete endangered species determination for ADAO
. The ecological risk assessment planned duri ng registration review will allow the Agency to determine whether ADAO ’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 pesti cide’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 requir e the following additional ecological data for use in the registration review of ADAO
. 850.2100

-- Avian acute oral toxicity test 850.5400

-- Algal Toxicity Tier I and Tier II

**•** The Agency anticipates the need to require the following additional environmental fate data for use in the registration review of ADAO
. 835.1110

-- Activated Sludge Sorption Isotherm 835.2120

-- Hydrolysis 835.2240

-- Photodegradation in water 835.3110

-- Ready Biodegradability 835.3220

-- Porous Pot Test 835.32 4 0

-- Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units 835.3280

-- Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 850.6800

-- Modified act ivated slud ge, respiration inhibition test 1

**•** F or more information , please refer to Amines, C 10

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- oxides. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document for Registration Review , located in the docket
. Human Health Risk:

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, 835.3240, or 835.3280. If the ASRI test EC 50 is greater th an 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 oxy gen 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 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.Docket Number: EPA

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7 of 16 **•** The most recent human health risk assessments for ADAO were completed in 1999 , in support of initial registration.

**•** The Agency anticipates the need to require the following additional human health data for use in the registration review of ADAO
. 875.1200

-- Dermal indoor exposure 875.1600

-- Application exposure data reporting and calculations 875.1700

-- Product use information 875.2800

-- Description of human activity

**•** F or more information , please refer to Summary of Human Health Effects Da ta for the Alkyl (C10

- C16) Dimethyl Amine Oxide (ADAO) 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 case a t this time.

**•** F or more information , please refer to Amines, C10

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- oxides. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document for Registration Review , located in the docket
. 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, neurotoxici ty, 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 maturati on, 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 pa rt of its most recent registration decision , 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), ADAO is subject to the en docrine screening part of the Endocrine Disruptor Screening Program (EDSP). Endocrine Disruptor Screening Program

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 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 system s will proceed to the next stage of the EDSP where EPADocket Number: EPA

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8 of 16 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 es tablish 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. ADAO 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 i ssue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for ADAO
. 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 sc reening battery, please visit our website: http://www.epa.gov/endo/
. EPA has created the following estimated timeline for the completion of the Amines, C10

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- oxides registration review: Timeline

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 201 4 Open Public Comment Period for Preliminary Risk Assessments September 201 5 Close Public Comment Period for Preliminary Risk Assessments October 201 5 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision March 201 6 Close Public Comment Period for Proposed Reg. Review Decision May 201 6 Final Decision and Begin Post

- Decision Follow

- up 201 6 Total (years) 5

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 Amines, C10

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- alkyldimethyl,N

- oxides registration review case. Guidance for Commenters:

Trade Irritants:Docket Number: EPA

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9 of 16 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
. Grow ers 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.

ADAO 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 ADAO , 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. Water Quality:

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 e xtent 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.
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, unusua lly high exposure to ADAO compare d 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. E nvironmental Justice:

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 con ducted 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 wel l as the dose and endpoints at which an adverse effect can occur in various animal species. Structure Activity Relationships:

Today, there is significant interest in alternative techniques, i.e., techniques other than data generation that could significantly inform the Agency’s decision

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10 of 16 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

- the

evidence 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 biolog ical 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 lo wer 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 d ata needs for the Amines, C10

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- Oxides c ase, 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 scientifi c 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.

Stakeholders are also s pecifically 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: Additional Information:

1. Con firmation 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 f. Geographic limitations on use 2. Use or potential use distribution 3. Use historyDocket Number: EPA

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11 of 16 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 Amines, C 10

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12 of 16 II. Fact Sheet

**•** Active Ingredient: alkyl dimethylamine oxides (amines, C 10

- 16 alkyldimethyl, N

- oxides) Background Information:

**•** C ase number: 5003 **•** PC Code: 000439 **•** CAS number : 70592

- 80

- 2 **•** Technical registrants: Proctor & Gamble **•** First approved for use in a registered product: 1999 **•** ADAO currently has an inert tolerance exemption under 40 CFR 180. 910 for use as a surfactant in pesticide formulations. EPA does not maintain a tolerance or exemption from the requirement of a tolerance for residues for the ADAO active ingredient. During registration review, the Agency will determine if any tolerances or exemptions from the requirement of a tolerance are needed for antimicrobial uses. **•** Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki , murasaki.seiichi@epa.gov **•** Antimicrobials Division Product Manager (PM): Velma Noble , noble.velma@ep a.gov **•** Chemical Structure:

( ADAO

– shortest and longest chains illustrated)

**•** The only registered antimicrobial use of ADAO is as a n antibacterial dishwashing detergent in residential premises. Use & Usage Information:

Please refer to Amines, C10

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- oxides. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document for Registration Review , located in the docket, for a detailed discussion of the ecological risk assessments. Ecological Risk Assessment Status:

**•** The Agency has not conducted a risk assessment that supports a complete endangered species determination for ADAO
.
**•** ADAO is practically non

- toxic to mammals on an acute oral basis; and moderately toxic to freshwater fish and invertebrate. For use in conducting an ec ological risk assessment, including an endangered species assessment for all uses, the Agency anticipates requiring acute avian oral toxicity data and algal toxicity data. Human Health Risk Assessment Status:Docket Number: EPA

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13 of 16 The following are key findings of the recent hu man health risk assessments for Amines, C10

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- alkyldimethyl,N

- oxides . Please refer to Summary of Human Health Effects Data for the Alkyl (C10

- C16) Dimethyl Amine Oxide (ADAO) Registration Review Decision Document , located in the docket, for a detailed dis cussion of the human health risk assessment. Hazard Characterization:

**•** ADAO exhibits moderate acute toxicity (toxicity category II and III) and is a severe eye and skin irritant (Category I) based on acute oral and dermal studies in animals. Dietary (Food a nd Water):

**•** Food and Drug Administration (FDA) worst case calculations described in "Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions" were used to estimate dietary exposure for a human health risk assessment in 1999. Acute and chroni c dietary risk s were assessed and found to be acceptable for all subpopulations listed. A new indirect dietary assessment is not anticipated to be required. A drinking water risk assessment was conducted for registration because, although likely to be in frequent, dietary exposures to ADAO from drinking water may occur from residues on a cup washed with ADAO. A new drinking water assessment is not anticipated to be required. Residential:

**•** Assessments of residential risk are planned for registration review b ecause potential exposure is expected through the dermal route resulting from the use of the dishwashing detergent. Aggregate:

**•** In examining aggregate exposure, EPA takes into account available and reliable information concerning exposures to residues in fo od and drinking water, non

occupational pesticide exposures, and inert uses. An aggregate risk assessment for ADAO is expected to be needed to assess aggregate exposures from dietary sources (food and water) and residential dermal exposures. Occupational:

**•** Occupational handler exposure is not expected with currently registered uses, and an occupational risk assessment will not be conducted during registration review. Cumulative:

**•** EPA does not have, at this time, available data to determine whether ADAO 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 ADAO does not have a common mechanism of toxicity with other subs tances when used as an antimicrobial as registered.Docket Number: EPA

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14 of 16 Ecological: Incidents:

**•** No ADAO ecological incidents have been reported in the Agency’s Ecological I ncident Information System (EISS)
. Human Health:

**•** No ADAO human poisoning incidents have been reported in OPP ’s Incident Data System (IDS)
. Tolerances and International Harmonization:

**•** ADAO currently has an inert tolerance exemption under 40 CFR 180.910 for use as a surfactant in pesticide formulations. EPA does not maintain a tolerance or exemption from the requirement of a tolerance for residues for the ADAO active ingredient. During registration review, the Agency will determine if any tolerances or exemptions from the requirement of a tolerance are needed for antimicrobial uses.

**•** There are no outstanding data call

- in (DCI) requirements for ADAO. Data Call - In Status:

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 in cluded 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

– ADA O Registration # Registration Name Company Name Formulation Type % A.I.
3573

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15 of 16 III. Summary of Anticipated Data Requirements

– ADAO The table below summarizes anticipated data needs for the Amines, C 10

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o xides Case in Section I of this document (Preliminary Work Plan), Amines, C10

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- oxides. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document for Registration Review , and Summ ary of Human Health Effects Data for the Alkyl (C10

- C16) Dimethyl Amine Oxide (ADAO) Registration Review Decision Document . Table 2. Summary of Anticipated Data Requirements

– ADAO Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months

from DCI Receipt) 850.21 00 Avian acute oral toxicity TGAI 12 850.54 00 Algal Toxicity Tier I and Tier II TGAI 12 835.111 0 Activated Sludge Sorption TGAI 12 835.212 0 Hydrolysis TGAI 12 835.224 0 Photodegradation in water TGAI 12 835.311 0 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 12 850.68 00 Modified activated sludge , respiration inhibition test 2 TGAI 12 875.12 00 Dermal indoor exposure TGAI 12 875.16 00 Application exposure data TGAI 12 875.17 00 Product use information TGAI 12 875.28 00 Description of human acti vity TGAI 12

2 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, 835.3240, or 835.3280. If the ASRI test EC 50 is greater than 20 mg/L, registrants w ould 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 theo retical 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 waive the requirements for additional biodegradation tests. If the antimicrobial do es 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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16 of 16 IV. Appendix A : Use Patterns

– ADAO

Use Category / Use Site / Treatment Site Formulation/ EPA Reg. no. Method of Application Application Rate/ No. of applications Residential and public access premises / Household and domestic dwellings (Indoor food handling areas) / Dishes Ready

- to
- Use Solution / 3573

- 62 Open pour Five minute contact time