DRAFT Alkyl Dimethyl Benzyl Ammonium Chloride ( ADBAC)

Occupational and Residential Exposure Assessment Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1801 South Bell St. Arlington, VA 22202 Date: April 11, 2006 Page 2 of 107 TABLE OF CONTENTS EXECUTIVE SUMMARY............................................................................................................................................ 3 1.0 INTRODUCTION........................................................................................................................................ 10 1.1 Purpose...................................................................................................................................................... 10 1.2 Criteria for Conducting Exposure Assessments ....................................................................................... 10 1.3 Chemical Identification ............................................................................................................................. 12 1.4 Physical/ Chemical Properties ................................................................................................................... 14 2.0 USE INFORMATION.................................................................................................................................. 15 2.1 Formulation Types and Percent Active Ingredient .................................................................................. 15 2.2 Summary of Use Pattern and Formulations ............................................................................................. 15 3.0 SUMMARY OF TOXICITY DATA............................................................................................................ 15 3.1 Acute Toxicity........................................................................................................................................... 15 3.2 Summary of Toxicity Endpoints................................................................................................................ 16 3.3 FQPA Considerations ............................................................................................................................... 17 4.0 RESIDENTIAL EXPOSURE ASSESSMENT ............................................................................................ 18 4.1 Summary of Registered Uses .................................................................................................................... 18 4.2 Residential Exposure................................................................................................................................. 18 4.2.1 Residential Handler Exposures ....................................................................................................... 19 4.2.2 Residential Post application Exposures.......................................................................................... 22 <IP_ADDRESS> Hard Surface Floor and Carpets                   ..  23 <IP_ADDRESS> Textiles                               26 <IP_ADDRESS> Treated Lumber                          ... 29 <IP_ADDRESS> Air Deodorizers                         ...  32 <IP_ADDRESS> Swimming Pools & Spas                      .  34 <IP_ADDRESS> Humidifiers                            . 36 <IP_ADDRESS> Instrument Mouth Piece/ Reed                     . 38 4.2.3 Data Limitations/ Uncertainties                        .. 38 5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION .......................... 39 6.0 OCCUPATIONAL EXPOSURE ASSESSMENT....................................................................................... 39 6.1 Occupational Handler Exposures ............................................................................................................. 43 6.2 Occupational Post application Exposures ................................................................................................ 48 6.2.1 Hand Sanitizing ............................................................................................................................... 49 6.2.2 Fogging ( Food Processing Plant and Hatchery) ............................................................................. 50 6.3 Wood Preservation.................................................................................................................................... 52 6.3.1 Non Pressure Treatment Scenarios ( Handler and Post application) ............................................. 52 <IP_ADDRESS> Scenarios Assessed by Worker Function                 . 54 <IP_ADDRESS> Scenarios Assessed for Exposure from Applications to Existing Homes ( Handler)... 59 6.3.2 Pressure Treatment Scenarios ( Handler and Post Application)..................................................... 58 6.4 Data Limitations/ Uncertainties ................................................................................................................. 60 7.0 REFERENCES .............................................................................................................................................. 63 APPENDIX A: Master ADBAC Label ........................................................................................................................ 65 APPENDIX B: Summary of CMA and PHED Data.................................................................................................... 78 APPENDIX C: Input/ Output from Residential MCCEM Modeling............................................................................ 81 APPENDIX D: Input/ Output from Occupational MCCEM Modeling........................................................................ 98 APPENDIX E: Calculation of DDAC Unit Exposure Values .................................................................................. 105 Page 3 of 107 EXECUTIVE SUMMARY This document is the Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision ( RED) document for the Group II Quat Cluster. It addresses the potential risks to humans that result from the use of chemicals in this group in occupational and residential settings. The Group II Quat Cluster group consists of structurally similar quaternary ammonium compounds (" quats") that are characterized by having positively charged nitrogen covalently bonded to three alkyl group substituents and a benzyl substituent. In finished form, these quats are salts with the positively charged nitrogen ( cation) balanced by a negatively charged molecule ( anion). The most common anion for the quats in this cluster is chloride. However, other anions, such as saccharinate and bromide are also used. The group will be referred to as ADBAC ( alkyl dimethyl benzyl ammonium chloride) in this document.

ADBAC is the active ingredient in numerous types of products. The products are mainly disinfectants and deodorants that are used in agricultural, food handling, commercial/ institutional/ industrial, residential and public access, and medical settings ( Use Site Categories I, II, III, IV, and V respectively). Examples of registered uses for ADBAC in these settings include application to indoor and outdoor hard surfaces ( e. g., walls, floors, tables, toilets, and fixtures), eating utensils, laundry, carpets, agricultural tools and vehicles, egg shells, hands and gloves, shoes, milking equipment and udders, humidifiers, RV tanks, medical instruments, human remains, ultrasonic tanks, reverse osmosis units, and water storage tanks. There are also ADBAC containing products that are used in residential and commercial swimming pools ( Use Site Category XI), in aquatic areas ( Use Site Category XII) such as decorative ponds, decorative fountains, and agricultural watering lines, and in industrial process and water systems ( Use Site Category VIII) such as once through and re circulating cooling waters systems, cooling towers, evaporative condensers, pasteurizers, drilling muds and packer fluids, oil well injection and wastewater systems, and in pulp and paper products, water, and chemicals. Additionally, ADBAC containing products are used for wood preservation ( Use Site Category X) through non pressure and pressure treatment method. There are registered uses for fogging and/ or air deodorization in both occupational and residential settings. Products containing ADBAC are formulated as liquid ready to use, soluble concentrate, pressurized liquid, and water soluble packaging. The percentage of ADBAC in the various end use products ranges from 0.06% to 80%. Residential products such as EPA Reg. No. 10324 45 range up to 50% ADBAC for swimming pools and spas.

The durations and routes of exposure evaluated in this assessment include short term ( ST), intermediate term ( IT), and in some instances long term ( LT) inhalation exposures, ST dermal exposures, and ST oral exposures. The inhalation endpoint ( all durations) is based on an oral NOAEL of 3 mg/ kg/ day from a developmental toxicity study in rats. The adverse effect for this endpoint is based on clinical signs of toxicity in maternal rabbits. For the oral exposure scenarios, the ST endpoint ( 10 mg/ kg/ day) is based on adverse effects of decreased bodyweight and food consumption in a developmental toxicity study in rats. No short term dermal endpoint for systemic effects was selected for ADBAC, since no systemic effects were identified. However, short and intermediate term dermal irritation endpoints were identified. The short term endpoint was determined from a 21 day dermal toxicity in guinea pigs where a denuded non vascularized epidermal layer was observed at 40 mg ai/ kg/ day. The NOAEL from this study is 20 mg ai/ kg/ day which is equivalent to 333 µ g ai/ cm2. The Page 4 of 107 intermediate term dermal was determined from 90 day dermal toxicity in rats. The NOAEL from this study is 20 mg ai/ kg/ day which is equivalent to 80 µ g ai/ cm2. The endpoint is the highest dose tested before irritation became significant ( effect first observed at day 43). Because the effect is to the skin, a skin concentration ( µ g/ cm2), rather then a dose ( mg/ kg/ day) was used to assess the dermal risk concerns. No body weight is needed for the dermal irritation endpoint, since no systemic dose is calculated. Note: Although the dose of 20 mg/ kg/ day is the same for both dermal studies, the concentration of the skin of the animal was different in each study because of the difference in the size of the skin area dosed and the total amount of chemical applied ( i. e., body weights differed). Because the toxicological endpoint for inhalation is female specific, a body weight of 60 kilograms is used in the assessment. Antimicrobial Division's ( AD) level of concern ( LOC) for occupational and residential ADBAC dermal, inhalation and oral exposures is 100 ( i. e., a margin of exposure ( MOE) less than 100 exceeds the level of concern). The level of concern is based on 10x for interspecies extrapolation and 10x for intraspecies extrapolation.

This occupational and residential assessment was based on examination of product labels describing uses for the product. There are many end use products that contain ADBAC; therefore, only labels on the Master Label developed by AD and the registrants were reviewed. It has been determined that exposure to handlers can occur in a variety of occupational and residential environments. Additionally, post application exposures are likely to occur in these settings. The representative scenarios selected by the Antimicrobials Division ( AD) for assessment were evaluated using maximum application rates as stated on the product labels. The representative scenarios are believed to represent high end uses resulting in dermal, inhalation, and incidental oral exposure.

To assess most handler risks, AD used surrogate unit exposure data from the Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED). Post application/ bystander exposures were assessed using EPA's Health Effects Division's ( HED) Standard Operating Procedures ( SOPs) for Residential Exposure Assessment, MCCEM ( Multi Chamber Concentration and Exposure Model), and Swim Model. Additionally, handler and post application exposures resulting from wood preservation activities were assessed using surrogate data from the studies Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride ( DDAC) Used in the Protection of Cut Lumber ( Phase III) ( Bestari et al., 1999, MRID 455243 04) and " Assessment of Potential Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Arsenical Wood Products" ( ACC, 2002a).

Residential Handler Risk Summary Dermal For the residential handler dermal exposure and risk assessment, dermal risks were calculated by comparing residues on the surface of the skin to the short term dermal irritation endpoint. Residues on the surface of the skin ( dermal irritation exposure) were determined using hand unit exposures from CMA/ PHED adjusted for the surface area of the hand ( mg/ lb ai/ cm2), application rates, and use amounts. The dermal MOEs were above the target MOE of 100 for all scenarios except for the wiping and low pressure spray on carpets ( MOEs = 76 and 72, respectively). Therefore, the risks for these two scenarios exceed AD's level of concern. Page 5 of 107 Inhalation For the residential handler inhalation assessment, the inhalation risks were calculated by comparing the daily doses to the short term inhalation endpoint. The inhalation MOEs were above the target MOE of 100 for all scenarios.

Residential Post Application/ Bystander Risk Summary Dermal The residential post application dermal risks were assessed by comparing the surface residue on the skin ( dermal irritation exposure) to the short term dermal endpoint. It was assumed that during the exposure period the skin repeatedly contacts the treated surface until a steady state concentration of residues is achieved on the skin. The short term endpoint was used because it was assumed that exposure to the residues is not a daily occurrence. For all of the residential scenarios, the post application dermal MOEs were above the target MOE of 100; therefore, the risks do not exceed the level of concern.

Inhalation For the residential post application exposure and risk assessment, the MOEs were below the target MOE of 100 for the following scenario:

  Humidifier: ST/ IT 8 hr MOE = 71 for adults and 11 for children; ST/ IT 24 hr MOE = 10 for adults and 4 for children Incidental Oral For the residential post application incidental oral assessment, the MOEs were above the target MOE of 100 for all scenarios; therefore, the risks do not exceed AD's level of concern.

Occupational Handler Risk Summary Dermal ADBAC dermal irritation exposures and risks were not estimated for occupational handler exposures. Instead, dermal irritation exposures and risks will be mitigated using default personal protective equipment requirements based on the toxicity of the end use product. To minimize dermal exposures, the minimum PPE required for mixers, loaders, and others exposed to end use products containing concentrations of ADBAC that result in classification of category I, II, or III for skin irritation potential will be long sleeve shirt, long pants, shoes, socks, chemical resistant gloves, and chemical resistant apron. Once diluted, if the concentration of ADBAC in the diluted solution would result in classification of toxicity category IV for skin irritation potential, then the chemical resistant gloves and chemicalresistant apron can be eliminated for applicators and others exposed to the dilute. Note that chemical resistant eyewear will be required if the end use product is classified as category I or II for eye irritation potential.

Inhalation Page 6 of 107 For the occupational handler inhalation exposure and risk assessment, the MOEs were above the target MOE of 100 for all scenarios except for the following scenarios listed below.

  Agricultural fogging ( mixing and loading): ST/ IT Inhalation MOE = 26   Medical premises, mopping: ST/ IT Inhalation MOE = 95   Pulp and paper, liquid pump: ST/ IT Inhalation MOE = 33   Once through cooling water, metering pump: Using the average flow rate for high flow streams ( 153 MGD) the ST Inhalation MOE = 50 for initial applications and the IT MOE = 95 for maintenance applications; however, using the average flow rate for low flow streams ( 5.9 MGD) the ST Inhalation MOE = 1,300 for initial applications and the IT MOE = 2,500 for maintenance applications.   Small process water systems, liquid pour: ST/ IT Inhalation MOE = 6   Wood Preservation ( non pressure treatment), blender/ sprayer operator: ST/ IT/ LT Inhalation MOE = 84   Wood Preservation ( existing homes), airless sprayer: ST/ IT/ LT Inhalation MOE = 17 A confirmatory inhalation toxicity study may be warranted because inhalation MOEs were below 1,000 ( additional 10x uncertainty factor is considered because of the lack of an inhalation route specific toxicological endpoint) for the following scenarios:

  Agricultural  hard surfaces, wiping: ST/ IT Inhalation MOE = 590, and for low pressure hand wand MOE = 380.   Food handling  hard surfaces, wiping: ST/ IT Inhalation MOE = 580   Commercial/ Institutional premises   hard surfaces, wiping: ST/ IT Inhalation MOE = 360 Occupational Post Application/ Bystander Risk Summary Dermal Dermal irritation exposures are assumed to be negligible for all post application occupational scenarios, except those associated with wood preservation and hand sanitization. As with occupational handlers, dermal irritation exposures and risks from post application activities in a wood preservation treatment facility will be mitigated using default personal protective equipment requirements based on the toxicity of the end use product. For the hand sanitization and construction worker scenarios the calculated MOEs are above the target MOE of 100.

Inhalation For the inhalation post application exposure and risk assessment, the MOEs were above the target MOE of 100 for all scenarios except for the following scenarios listed below.

  Fogging in a hatchery: The 8 hr MOE from 0 to 8 hours ( immediately after fogging) = 0.5; however, the 8 hr MOE from 2 to 10 hours ( 2 hour re entry interval) = 1,500.   Fogging in a food processing plant: The 8 hr MOE from 2 to 10 hours ( 2 hour reentry interval) = 1. The difference in the MOEs for hatcheries versus food processing plants is the assumed ventilation rate ( hatcheries assigned a higher rate). Page 7 of 107 A confirmatory inhalation toxicity study may be warranted because the inhalation MOE was below 1,000 ( additional 10x uncertainty factor is considered because of the lack of an inhalation route specific toxicological endpoint) for the following scenario:

  Non pressure treatment wood preservation, clean up worker: ST/ IT/ LT Inhalation MOE = 480 Data Limitations and Uncertainties:

There are a number of uncertainties associated with this assessment and these have been reiterated from Sections 4.2.3 ( residential) and 6.4 ( occupational). The data limitations and uncertainties associated with the residential handler and post application exposure assessments include the following:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix B for summaries of these data sources). Most of the CMA data are of poor quality therefore, AD requests that confirmatory monitoring data be generated to support the values used in these assessments.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, and 2001). In certain cases, no standard values were available for some scenarios. Assumptions for these scenarios were based on AD estimates and could be further refined from input from registrants.   Some labels for products which can be used by homeowners in residential settings, as well as by workers in occupational settings, indicate that low pressure sprayers can be used for application of the disinfectant to hard, non porous surfaces such as floors and walls. A low pressure spray scenario was not assessed for the residential scenario because it is not a typical cleaning method for homeowners.   At this time, the Agency does not have exposure data to assess oral exposures to children and adults from using treated mouthpieces and reeds; therefore, the Agency is requesting residue data from treated mouthpieces and reeds.   In this assessment, incidental ingestion and dermal exposures to treated wood were estimated for ADBAC using surrogate DDAC data. The degree of uncertainty ( under or overestimation) associated with using the surrogate DDAC hand residue data for ADBAC dermal and oral exposure from contacting treated lumber are unknown. The amount of residue measured on the test subjects hands is variable and are influenced by the duration of exposure, how often wood is contacted, and the degree of contact ( i. e., do the hand residues from the DDAC study mimic a child's play activity on decks and play sets?). A confirmatory wipe study with ADBAC and/ or DDAC treated wood will need to be determined during the risk mitigation phase of the RED process.   Available data to assess the levels of ADBAC in soil contaminated with ADBAC treated wood do not exist at this time. In addition, leaching data were also not available. Because of this data gap, EPA was not able to accurately predict dermal and incidental ingestion residential post application exposures to soil contaminated with ADBAC treated wood. Page 8 of 107 The data limitations and uncertainties associated with the occupational handler and postapplication exposure assessments include:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix B for summaries of these data sources). Since the CMA data are of poor quality, the Agency requests that confirmatory data be submitted to support the occupational scenarios assessed in this document.   Unit exposures are not available for some of the specific scenarios that are prescribed for ADBAC. These scenarios include the following: open loading into oil well/ field environments and metering into once through cooling water systems at power plants.

o The CMA data used for oil well uses are based on open pouring of a material preservative. Although these data are only represented by 2 replicates each, the exposure values are similar to open loading of pesticides in PHED. Furthermore, there are no representative unit exposure data for chemical metering into secondary recovery oil operations. Since the volume of water being treated in secondary recovery operations is so large, the available CMA data can not be reliably extrapolated because they are based on activities that handle much lower volumes and possibly different techniques. Therefore, it was assumed that if the open pour handling activities for the other oil well operations resulted in MOEs that are not of concern, then the MOEs for the closed system chemical metering into secondary recovery operations would also be not of concern. AD requests that confirmatory data be conducted to show that this is accurate. o The CMA data used for once through cooling water systems at power plants are based on closed metering for pulp and paper. The pulp and paper unit exposures were deemed more appropriate than the cooling water tower data because of the large volume of water treated in once through cooling water systems at power plants. However, the CMA data for pulp and paper does not reliably represent the volume of water treated and the possibly different techniques used to treat the water.   For the wood preservative pressure treatment scenarios, CCA exposure data were used for lack of ADBAC specific exposure data and for the wood preservative non pressure treatment scenarios, DDAC exposure data were used for the lack of ADBAC specific exposure data. Limitations and uncertainties associated with the use of these data include: o The assumption was made that exposure patterns for workers at treatment facilities using CCA and DDAC would be similar to exposure patterns for workers at treatment facilities using ADBAC, and therefore the exposures could be used as surrogate data for workers that treat wood with ADBAC. o For environmental modeling, it was assumed that the leaching process from the ADBAC treated wood would be similar to that of CCA and DDAC. However, due to the lack of real data for ADBAC  treated wood, it is not possible to verify this assumption.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, and 2001) and personal communication with Page 9 of 107 experts. In particular, the use information for the pulp and paper processing, oil well uses, and small process water system uses are based on personal communication with biocide manufacturers for these types of uses. The individuals contacted have experience in these operations and their estimates are believed to be the best available without undertaking a statistical survey of the uses. In certain cases, no standard values were available for some scenarios. Assumptions for these scenarios were based on AD estimates and could be further refined from input from registrants. For example, the quantities handled/ treated for the application of ADBAC to the surface of metal/ wood cooling towers could be refined.   The type of spray equipment to be used was not specifically mentioned on the labels for some scenarios, such as for surface sprays to metal and wood cooling water towers. Therefore, these scenarios were assessed using the PHED airless spray unit exposures, which represents high end exposure. In these cases, the appropriate application equipment could be further refined.   The percent active ingredient in solution for the pressure treatment of lumber needs to be refined by the registrants. The labels only provided a retention rate. For this assessment, the application rate on the master label was used, which is the same as the application rate for non pressure treatment of lumber. Page 10 of 107 1.0 INTRODUCTION 1.1 Purpose In this document, the Antimicrobials Division ( AD) presents the results of its review of the potential human health effects of occupational and residential exposure to ADBAC. This information is for use in EPA's development of the ADBAC Reregistration Eligibility Decision ( RED) document.

1.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For ADBAC, both criteria are met. Toxicological endpoints were selected for short and intermediate term dermal, inhalation, and incidental oral exposures to ADBAC. There is a significant potential for exposure in a variety of occupational and residential settings. Therefore, risk assessments are required for occupational and residential handlers as well as for occupational and residential post application exposures that can occur as a result of ADBAC use.

In this document, handler scenarios were assessed by using unit exposure data to estimate occupational and residential handlers' exposures. Unit exposures are estimates of the amount of exposure to an active ingredient a handler receives while performing various handler tasks and are expressed in terms of micrograms or milligrams ( 1 mg = 1,000 µ g) of active ingredient per pounds of active ingredient handled. A series of unit exposures have been developed that are unique for each scenario typically considered in assessments ( i. e., there are different unit exposures for different types of application equipment, job functions, and levels of protection). The unit exposure concept has been established in the scientific literature and also through various exposure monitoring guidelines published by the USEPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development).

Using surrogate unit exposure data, maximum application rates from labels, and EPA estimates of daily amount handled, exposures and risks to handlers were assessed. The exposure/ risks were calculated using the following equations:

Daily Exposure: Daily skin concentration and inhalation handler exposures are estimated for each applicable handler task with the application rate, quantity treated/ handled in a day, and the applicable inhalation unit exposure using the following formula:

Daily Inhalation Exposure: E = UE x AR x AT ( Eq. 1a)

Where: E = Amount ( mg ai/ day) inhaled that is available for inhalation absorption; UE = Unit exposure value ( mg ai/ lb ai) derived from August 1998 PHED data or from 1992 CMA data; Page 11 of 107 AR = Maximum application rate based on a logical unit treatment, such as acres ( A), square feet ( sq. ft.), gallons ( gal), or cubic feet ( cu. ft). Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and AT = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dermal Skin Irritation Exposure: E = UEhand/ SAhand x AR x AT ( Eq. 1b)

Where: E = Amount ( mg ai/ cm2) deposited on the surface of the skin; UEhand = Unit exposure value ( mg ai/ lb ai) derived from August 1998 PHED data or from 1992 CMA data; SAhand = Surface area of two hands ( 820 cm2); AR = Maximum application rate based on a logical unit treatment, such as acres ( A), square feet ( sq. ft.), gallons ( gal), or cubic feet ( cu. ft). Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and AT = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dose: The inhalation dose is calculated by normalizing the daily exposure by body weight and adjusting, if necessary, with an appropriate absorption factor. An absorption factor of 100% was used for inhalation exposures. A daily dose is not calculated for dermal exposures, because the dermal endpoint selected is based on irritation effects, not systemic effects. Daily dose was calculated using the following formula:

Daily Dose: ADD = E x ABS ( Eq. 2) BW Where: ADD = Average daily dose or the absorbed dose received from exposure to a chemical in a given scenario ( mg active ingredient/ kg body weight/ day); E = Amount ( mg ai/ day) inhaled that is available for inhalation absorption; ABS = A measure of the amount of chemical that crosses a biological boundary such as lungs (% of the total available absorbed); and BW = Body weight determined to represent the population of interest in a risk assessment ( kg).

Margins of Exposure: Non cancer inhalation risks for each applicable handler scenario are calculated using a Margin of Exposure ( MOE). This is the ratio of the daily inhalation dose or dermal exposure to the toxicological endpoint of concern.

Margins of Exposure ( inhalation): MOE = NOAEL or LOAEL ( Eq. 3a) ADD Where: MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); NOAEL or LOAEL = Systemic toxicity level where no observed adverse effects ( NOAEL) or where the lowest observed adverse effects ( LOAEL) occurred in the study ( mg ai/ kg body weight/ day); and ADD = Average daily inhalation dose in a given scenario ( mg ai/ kg body weight/ day).

Margins of Exposure ( dermal): MOE = NOAEL or LOAEL ( Eq. 3b) E Page 12 of 107 Where: MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); NOAEL or LOAEL = Irritation level where no observed adverse effects ( NOAEL) or where the lowest observed adverse effects ( LOAEL) occurred in the study (: g/ cm2); and E = Dermal skin irritation exposure in a given scenario (: g/ cm2).

In addition to the target MOEs presented in Table 3.2 that were used for the analysis, a series of assumptions and exposure factors served as the basis for completing the handler risk assessment. Each general assumption and factor for both residential and occupational assessments is detailed below. Assumptions specific to the use site category are listed in each separate section of this document. The general assumptions and factors include:

  ADBAC products are widely used and have a large number of use patterns that are difficult to completely capture in this document. As such, AD has patterned this risk assessment on a series of likely representative scenarios for each use site that are believed by AD to represent the vast majority of ADBAC uses.   Based on the adverse effects for the endpoints, the average body weight of a female adult handler ( 60 kg) was used for the inhalation risk assessment.   Exposure factors used to calculate daily exposures to handlers were based on applicable data, if available. When appropriate data were lacking, values from a scenario deemed similar were used.   The maximum application rates allowed by labels were assumed.

1.3 Chemical Identification The Group II Quat Cluster ( ADBAC), is comprised of a group of structurally similar quaternary ammonium compounds (" quats") that are characterized by having a positively charged nitrogen covalently bonded to three alkyl group substituents and a benzyl substituent. In finished form, these quats are salts with the positively charged nitrogen ( cation) balanced by a negatively charged molecule ( anion). The most common anion for the quats in this cluster is chloride. However, other anions, such as saccharinate and bromide are also used.

Currently, there are 21 active ingredients included in the group. Table 1.1 below provides the common chemical name, active ingredient code, CAS number, chemical structure and number of registered product for each compound.

Table 1.1. Active Ingredients in the Group II Quat Cluster Identified by the AIJV Product Code CAS RN Name Structure Chain Lengths 69104 53516 76 0 ADBAC N+

CH3 CH3 R Cl R = C12 ( 5%) C14 ( 60%) C16 ( 30%) C 18 ( 5%)

69105 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 40%) C14 ( 50%) C16 ( 10%) Page 13 of 107 Table 1.1. Active Ingredients in the Group II Quat Cluster Identified by the AIJV Product Code CAS RN Name Structure Chain Lengths 69106 8001 54 5 ADBAC N+

CH3 CH3 R Cl R = C12 ( 50%) C14 ( 30%) C16 ( 17%) C18 ( 3%)

69107 139 08 2 ADBAC N+

CH3 CH3 R Cl R = C12 ( 1%) C14 ( 98%) C16 ( 1%)

69119 73049 75 9 Dialkyl Methyl BAC N+

R CH3 R Cl R = C12 ( 5%) C14 ( 60%) C16 ( 30%) C18 ( 5%)

69137 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 25%) C14 ( 60%) C16 ( 15%)

69140 61789 71 7 ADBAC N+

CH3 CH3 R Cl R = C8 10 ( 2.5%) C14 ( 61%) C16 ( 23%) C18 ( 2.5%)

69141 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 14%) C14 ( 58%) C16 ( 28%)

69157 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 65%) C14 ( 25%) C16 ( 10%)

69175 68391 01 5 ADBAC N+

CH3 CH3 R Cl R = C12 ( 67%) C14 ( 25%) C16 ( 7%) C18 ( 1%)

69189 68391 01 5 ADBAC N+

CH3 CH3 R Cl R = C12 ( 61%) C14 ( 23%) C16 ( 11%) C18 ( 5%)

69184 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 3%) C14 ( 95%) C16 ( 2%)

69192 85409 22 9 ADBAC N+

CH3 CH3 R Cl

R = C12 ( 70%) C14 ( 30%)

69194 68424 85 1 ADBAC N+

CH3 CH3 R Cl R = C12 ( 5%) C14 ( 90%) C16 ( 5%)

128928 63449 41 2 ADBAC N+

CH3 CH3 R Cl R = C8   Not specified C10   Not specified C12 ( 67%) C14 ( 25%) C16 ( 7%) C18   Not specified 69171 68989 01 5 ADBA Saccharinate N +

R CH3 R O  N S O O R = C12 ( 40%) C14 ( 50%) C16 ( 10%)

69154 85409 23 0 ADEBAC N+

CH3 CH3 R Cl H3C R = C12 ( 68%) C14 ( 32%) Page 14 of 107 Table 1.1. Active Ingredients in the Group II Quat Cluster Identified by the AIJV Product Code CAS RN Name Structure Chain Lengths 69111 8045 21 4 ADEBAC N+

CH3 CH3 R Cl H3C R = C12 ( 50%) C14 ( 30%) C16 ( 17%) C18 ( 3%)

69122 121 54 0 Diisobutylphenoxyethyoxyethyl dimethyl benzyl ammonium chloride [ Benzethonium Chloride] CH3 H3C O O N+

H3C CH3 CH3 H3C CH3 Cl

69129 1399 80 0 Methyl dodecyl benzyl tri methyl ammonium chloride  80%

Methyl dodecyl xylene bis tri methyl ammonium chloride   20%

69134 25155 18 4 Diisobutyl cresoxyethoxyethyl dimethyl benzyl ammonium chloride monohydrate 1.4 Physical/ Chemical Properties Table 1.2 shows physical/ chemical characteristics that have been reported for ADBAC.

Table 1.2. Physical/ Chemical Properties of ADBAC Parameter ADBAC Molecular Weight 377.83 Density 0.9429 g/ cm3 at 25 C Boiling Point Could not be established Water Solubility Completely soluble Vapor Pressure 3.53E 12 mmHg Page 15 of 107 2.0 USE INFORMATION 2.1 Formulation Types and Percent Active Ingredient The products containing ADBAC as the active ingredient ( a. i) are formulated as liquid ready to use, soluble concentrate, pressurized liquid, and water soluble packaging. Concentrations of ADBAC in these products range from 0.06% to 80% as reported on the Master Label spreadsheet ( Appendix A).

2.2 Summary of Use Pattern and Formulations The Agency determines potential exposures to handlers of the product by identifying exposure scenarios from the various application methods that are plausible, given the label uses. These scenarios are identified in Appendix A. Based on a review of product labels, ADBAC is the active ingredient in products used in the following use site categories: I ( Agricultural premises and equipment), II ( Food handling/ storage establishments premises and equipment), III ( Commercial, institutional and industrial premises and equipment), IV ( Residential and public access premises), V ( Medical premises and equipment), VIII ( Industrial processes and water systems), X ( Wood preservatives), XI ( Swimming pools), and XII ( Aquatic areas).

From the scenarios in Appendix A, AD selected representative exposure scenarios to assess the labeled uses of ADBAC in this document. These scenarios were selected to be representative of the vast majority of uses and are believed to provide high end degrees of dermal, inhalation, or incidental ingestion exposure. The representative scenarios assessed in this document are shown in Table 4.1 ( residential) and Table 6.1 ( occupational).

3.0 SUMMARY OF TOXICITY DATA 3.1 Acute Toxicity The acute toxicity data for ADBAC are summarized below in Table 3.1 ( USEPA, 2006).

Table 3.1. Acute Toxicity of ADBAC.

Guideline Number Test Substance MRID Results Toxicity Category 870.1100 Acute oral, rat BQ451 8 Biocide ( Purity 82.26%) 45109204 LD50 = 304.5 mg/ kg ( combined)

LD50 = 510.9 mg/ kg ( males) LD50 = 280.8 mg/ kg ( females) II 870.1200 Acute dermal, rat BQ451 8 Biocide ( Purity 82.26%) 45109202 LD50 = 930 mg/ kg ( combined)

LD50 = 1100 mg/ kg ( males) LD50 = 704 mg/ kg ( females) II 870.1300 Acute inhalation, rat 44885201 0.054 < LC50 < 0.51 mg/ L II Page 16 of 107 ( Purity 82.26%)

870.2400 Primary Eye Irritation Waived N/ A I 870.2500 Primary Dermal Irritation, , rabbit BQ451 8 Biocide ( Purity 82.26%) 45109201 Corrosive I 870.2600 Dermal sensitization, guinea pigs BQ451 8 Biocide ( Purity 82.26%) 45109201 Not a dermal sensitizer N/ A 3.2 Summary of Toxicity Endpoints Table 3.2 summarizes the toxicological endpoints for ADBAC ( USEPA, 2006).

Table 3.2 Summary of Toxicological Endpoints for ADBAC Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE or UF, Special FQPA SF for Risk Assessment Study and Toxicological Effects Acute Dietary ( general population; females 13+) An acute dietary endpoint was not identified in the data base. This risk assessment is not required FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Chronic toxicity/ carcinogenicity   rat MRID 41947501 LOAEL = 88 mg/ kg/ day, based on decreased body weight and weight gain Chronic Dietary NOAEL = 44 mg/ kg/ day Chronic RfD = 0.44 mg/ kg/ day Incidental Oral ( short term) NOAEL = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Developmental Toxicity   Rat, MRID 42351501 LOAEL = 30 mg/ kg/ day, based on decreased body weight and food consumption Incidental Oral ( intermediate term) NOAEL = 10 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Developmental Toxicity   Rat, MRID 42351501 LOAEL = 30 mg/ kg/ day, based on decreased body weight and food consumption Short Term Dermal [ formulated product ( 4% ai)] NOAEL= 20 mg ai/ kg/ day ( 333 µ g ai/ cm2) FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) 21 day dermal toxicity guinea pigs MRID 41105801 LOAEL = 40 mg ai/ kg/ day, based on denuded non vascularized epidermal layer Page 17 of 107 Table 3.2 Summary of Toxicological Endpoints for ADBAC Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE or UF, Special FQPA SF for Risk Assessment Study and Toxicological Effects Intermediate Term Dermal [ technical grade a. i. ( 80% ai)] NOAEL = 20 mg ai/ kg/ day ( 80 µ g ai/ cm2) UF = 100 ( 10x inter species extrapolation, 10x intra species variation) 90 day dermal toxicity in rats MRID 41499601 20 mg ai/ kg/ day is the highest dose tested before irritation became significant at day 43 Short Term Dermal ( technical grade a. i.) No appropriate endpoint identified from the available data on dermal irritation. Dermal irritation in the 90 day dermal toxicity study was not evident until day 43 ( MRID 41499601).

Long Term Dermal ( TGAI) No appropriate endpoint identified. No systemic effects observed up to 20 mg/ kg/ day, highest dose of technical grade that could be tested without irritation effects.

Inhalationc ( Any time point) NOAEL= 3 mg/ kg/ day MOE = 100c UF = 100 ( 10x inter species extrapolation, 10x intra species variation)

Note: an additional 10x is used for route extrapolation to determine if a confirmatory study is needed Developmental Toxicity   rabbit, MRID 42392801 LOAEL = 9 mg/ kg/ day, based on clinical signs of toxicity in maternal rabbits UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable. a Formulated based dermal endpoint = ( 20 mg ai/ kg guinea pig x 0.43 kg guinea pig x 1000 ug/ mg) / 25.8 cm2 area of guinea pig dosed = 333 µ g ai/ cm2 . b TGAI based dermal endpoint = ( 20 mg ai/ kg rat x 0.2 kg rat x 1000 ug/ mg) / 50 cm2 area of rat dosed = 80 µ g ai/ cm2 cAn additional uncertainty factor of 10x is applied for use of an oral endpoint for route to route extrapolation to determine if a confirmatory inhalation toxicity study is warranted.

3.3 FQPA Considerations The ADTC ( USEPA, 2006) recommended that the FQPA safety factor be removed for ADBAC, based upon the existence of a complete developmental and reproductive toxicity database and the lack of evidence for increased susceptibility in these data. Page 18 of 107 4.0 RESIDENTIAL EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Products containing ADBAC can be used as general cleaners, disinfectants, and deodorizers. These products are primarily for use on indoor surfaces such as hard floors, carpets, walls, bathroom fixtures, trash cans, toilet bowls, and household contents. Additionally, other uses in the home include aerosol air deodorizing products, liquid laundry deodorizers that are added to the final rinse of the wash cycle, algaecide/ bactericides that are added to portable humidifiers and RV holding tanks, disinfectants for musical instrument mouthpieces and reeds, swimming pools, and decorative ponds and fountains. Residents may also be exposed to items that have been treated with ADBAC in occupational settings, such as dimensional lumber for decks and play sets. Appendix A presents a summary of all exposure scenarios that may occur in residential settings based on examination of product labels. Table 4.1 identifies the representative exposure scenarios assessed in this document.

4.2 Residential Exposure The exposure scenarios assessed in this document for the representative uses selected by AD are shown in Table 4.1. The table also shows the maximum application rate associated with the representative use and the EPA Registration number for the corresponding product label. It should be noted that for the calculation of application rates in which 8.34 lb/ gal is noted, the product is assumed to have the density of water because no product specific density is available. Handler exposures were assessed for the application of ADBAC to indoor hard surfaces, carpets, RV holding tanks, and swimming pools. Post application exposures were assessed for dermal and/ or oral contact with treated surfaces including hard floors, carpets, textiles, lumber, and pool water. Post application/ bystander inhalation exposures were assessed for air deodorizer and humidifier. ADBAC has a low vapor pressure, and therefore, inhalation exposure is to the aerosol generation.

Table 4.1. Representative Uses Associated with Residential Exposure Representative Use Application Method Exposure Scenario Registration # Application Rate Indoor Hard Surfaces   Mopping   Wiping   Trigger pump spray ST Handler: adult dermal and inhalation ST Post app: child incidental ingestion and dermal 6836 193 (# 10% ai) and 10324 118 (> 10% ai) a Products with # 10% ai 0.025 lb ai/ gal ( 0.3% ai x 8.34 lb/ gal)

Products with > 10% ai 0.0070 lb ai/ gal for mop and wipe ( 21.7% ai x 8.34 lb/ gal x 0.5 oz/ gal x 1 gal/ 128 oz) and 0.014 lb ai/ gal for trigger pump sprayer ( 21.7% ai x 8.34 lb/ gal x 1 oz/ gal x 1 gal/ 128 oz) Page 19 of 107 Table 4.1. Representative Uses Associated with Residential Exposure Representative Use Application Method Exposure Scenario Registration # Application Rate Indoor Hard Surfaces/ Air Deodorization   Aerosol spray ST Handler: adult dermal and inhalation ST Post app: child and adult inhalation 1839 85 0.2% a. i. by weight Carpets   Low pressure spray ST Handler: adult dermal and inhalation ST Post app: child incidental ingestion and dermal 1839 86 0.014 lb ai/ gal ( 10% ai x 8.34 lb/ gal x 2.2 oz/ gal x 1 gal/ 128 oz)

Swimming pool   Liquid pour ST Handler: adult dermal and inhalation ST Post app: ingestion ( child and adult) 1839 141 Dermal and Inhalation Handler: 0.000052 lb ai/ gal ( 50.0% x 16 oz/ 10000 gal x 8.34 lb/ gal x 1 gal/ 128 oz)

Post application: 5 ppm RV holding tank   Liquid Pour ST Handler: Adult dermal and inhalation 10324 111 0.834 lb ai/ gal ( 10% ai x 8.34 lb/ gal)

Contacting Preserved Wood   NAb ST Post app: child incidental ingestion and dermal 1839 184 3% ai solution Wearing clothing and diapers treated during final rinse cycle of wash   NAc ST Post app: adult dermal; child incidental ingestion and dermal 1839 110 0.10 lb ai/ 100 lbs dry laundry ( 8 oz product/ 100 lbs dry laundry x 20% ai x 1 lb/ 16 oz)

Using treated musical instrument mouthpieces and reeds   NAc ST Post app: adult and child incidental ingestion 32977 1 0.0050 lb a. i./ gal ( 0.06% a. i. x 8.34 lb/ gal)

Humidifier   NAc ST Post app: child and adult inhalation 1839 120 0.00049 lb ai/ gal ( 4.5% ai x 8.34 lb/ gal x 0.167 oz / gal x 1 gal/ 128 oz) a All products, regardless of the percent active ingredient, were assessed using the short term dermal endpoint. b The handlers scenarios were not assessed because the products can only be applied occupationally. c Handler exposures for application to laundry, humidifiers, and musical instruments are represented by the application to RV holding tank scenario because it is based on a larger volume handled to represent the high end exposure potential.

4.2.1 Residential Handler Exposures The residential handler scenarios described in Table 4.1 were assessed to determine Page 20 of 107 dermal and inhalation exposures. The scenarios were assessed using PHED and CMA data and the equations in Section 1.2, " Criteria for Conducting Risk Assessment." A summary of the PHED and CMA data sets are presented in Appendix B.

Unit Exposure Values: Unit exposure values were taken from the PHED data presented in HED's Residential SOPs ( USEPA, 1997) and from the CMA data from the EPA memorandum Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study ( USEPA, 1999).

$ For the mopping scenario, the CMA dermal ( hand) and inhalation unit exposure values for ungloved mopping were used ( 52 mg/ lb a. i. and 2.38 mg/ lb a. i., respectively). After normalization for the surface area of the hand ( 820 cm2), the dermal unit exposure value is 0.063 mg/ lb a. i/ cm2. These values are based on data collected from six replicates mopping floors and receiving exposure via contact with the mop or with the bucket.

$ For the wiping scenario, the CMA dermal ( hand) and inhalation unit exposure values for ungloved wiping were used ( 1,100 mg/ lb a. i. and 67.3 mg/ lb a. i., respectively). After normalization for the surface area of the hand ( 820 cm2), the dermal unit exposure value is 1.34 mg/ lb a. i/ cm2. These values are based on data collected from six replicates ( dental technicians) who used a finger pump sprayer to apply the product and then wiped the surfaces with a paper towel.

$ For aerosol spray and trigger pump scenarios, the PHED dermal ( hand) and inhalation unit exposure values are 106 mg/ lb a. i. and 2.4 mg/ lb a. i., respectively. After normalization for the surface area of the hand ( 820 cm2), the dermal unit exposure value is 0.129 mg/ lb a. i/ cm2. The values are based on homeowners applying an aerosol insecticide to baseboards in kitchens and are representative of a handler wearing short pants and a short sleeve shirt, with no gloves.

$ For low pressure hand wand, the CMA dermal ( hand) and inhalation unit exposure values for ungloved use of a low pressure spray are 132 and 0.681 mg/ lb a. i., respectively. After normalization for the surface area of the hand ( 820 cm2), the dermal unit exposure value is 0.161 mg/ lb a. i/ cm2. The values are based on data collected from eight replicates who hand sprayed carpet using 200 psi, then used a push broom rake to raise the carpet nap.

$ For liquid pour in swimming pool and RV holding tank scenarios, the cooling tower CMA data for liquid pour was used for dermal exposures. This set of data was used because no other CMA data sets represent ungloved replicates pouring liquid. The dermal hand unit exposure value is 0.196 mg/ lb a. i. After normalization for the surface area of the hand ( 820 cm2), the dermal unit exposure value is 0.000239 mg/ lb a. i/ cm2. For inhalation exposures, the CMA preservative data were used for swimming pool exposures. The inhalation unit exposure is 0.00346 mg/ lb a. i. and is based on 2 replicates. Although this unit exposure is based on minimal replicates, the exposure value is similar to the one found in PHED for a similar scenarios. For the RV holding tank scenario, CMA data for liquid pour of disinfectants were used. The inhalation unit exposure value is 1.89 mg/ lb a. i. The value is based on data collected from two gloved replicates involving pouring a disinfectant product from a jug into sterilization trays designed for dental instruments, adding water and instruments to the tray, removing the instruments, and discarding the old solution. Page 21 of 107 Quantity handled/ treated: The quantities handled/ treated were estimated based on information from various sources, including Antimicrobial Division estimates.

$ For mopping scenarios, it is assumed that 1 gallon of diluted solution is used.

$ For wiping and trigger pump spray scenarios, it is assumed that 0.5 liter ( 0.13 gal) of diluted solution is used.

$ For aerosol sprays, it is assumed that one can is used. The net weight of the can was not provided on the label; therefore, it was assumed that the can contained 16 oz of product.

$ For low pressure hand wand, it was assumed that 2 gallons are used in all indoor applications.

$ For liquid pour in swimming pool scenario, it was assumed that a residential pool contains 20,000 gallons of water.

$ For liquid pour in RV holding tank scenario, it was assumed that one tank would be treated. The product label states a maximum application rate of 4 oz ( 0.031 gallons) product per tank.

Duration of Exposure: The duration of exposure for most homeowner exposures is believed to be best represented by the short term duration ( 1 to 30 days). The reason that short term duration was chosen to be assessed is because the different handler and post application scenarios are assumed to be episodic, not daily. In addition, homeowners are assumed to use different products with varying activities, not exclusively ADBAC treated products.

Results The resulting short term exposures and MOEs for the representative residential handler scenarios are presented in Tables 4.2 ( inhalation) and 4.3 ( dermal). The calculated inhalation MOEs are above the target MOE of 100 for all scenarios. The dermal MOEs were above the target MOE of 100 for all scenarios except for the wiping and low pressure spray on carpets ( MOEs = 76 and 72, respectively). Therefore, the risks for these two scenarios exceed AD's level of concern.

A confirmatory inhalation toxicity study may be warranted because inhalation MOE was below 1,000 for the wiping scenario ( MOE = 820).

Table 4.2 Short Term Residential Handler Inhalation Exposures and MOEs Exposure Scenario Application Method Application Method Application Ratea Quantity Handled/ Treated per dayb Unit Exposure ( mg/ lb a. i.) Absorbed Daily Dose ( mg/ kg/ day) c MOE d ( Target MOE = 100)

Mopping 0.025 lb ai/ gal 1 gallon 2.38 0.00099 3,000 Wiping 0.025 lb ai/ gal 0.13 gallon 67.3 0.0036 820 Application to indoor hard surfaces Trigger Spray 0.025 lb ai/ gal 0.13 gallon 2.4 0.00013 23,000 Air deodorization Aerosol Spray 0.2% ai by weight 1 can ( 1 lb) 2.4 0.00008 38,000 Application to Carpets Low Pressure Spray 0.014 lb ai/ gal 2 gallons 0.681 0.00033 9,200 Application to Swimming Pools Liquid Pour 0.000052 lb ai/ gal 20,000 gallons 0.00346 0.00006 50,000 Page 22 of 107 Application to RV holding tanks Liquid Pour 0.834 lb ai/ gal 0.031 gal ( 1 tank at 4 oz product/ tank) 1.89 0.00082 3,700 a Application rates are the maximum application rates determined from EPA registered labels for ADBAC. b Amount handled per day values are estimates or label instructions. c Absorbed Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb a. i.) x application rate (% a. i. weight or lb ai/ gal) x quantity treated ( lb/ day or gal/ day) x absorption factor ( 1.0 for inhalation)]/ Body weight ( 60 kg for inhalation). d MOE = NOAEL / Absorbed Daily Dose. [ Where short term NOAEL = 3 mg/ kg/ day for inhalation]. Target MOE = 100.

Table 4.3 Short Term Residential Handler Dermal Risks Exposure Scenario Application Method Application Ratea ( lb ai/ gal) Quantity Handled/ Treated per dayb Hand Unit Exposure Adjusted for Surface Area ( mg/ lb ai/ cm2) c Dermal Skin Irritation Exposure d (: g/ cm2) MOE e ( Target MOE = 100)

Products with # 10% ADBAC ( NOAEL = 333 µ g/ cm2)

Mopping 0.025 lb ai/ gal 1 gallon 0.063 1.587 210 Wiping 0.025 lb ai/ gal 0.13 gallon 1.341 4.363 76 Application to indoor hard surfaces Trigger Spray 0.025 lb ai/ gal 0.13 gallon 0.129 0.420 790 Air deodorization Aerosol Spray 0.2% ai by weight 1 can ( 1 lb) 0.129 0.259 1,300 Application to Carpets Low Pressure Spray 0.014 lb ai/ gal 2 gallons 0.161 4.615 72 Application to RV holding tanks Liquid Pour 0.834 lb ai/ gal 0.031 gal ( 1 tank at 4 oz product/ tank) 0.000239 0.0062 54,000 Products with > 10% ADBAC ( NOAEL = 333 µ g/ cm2)

Mopping 0.0070 lb ai/ gal 1 gallon 0.063 0.44 760 Wiping 0.0070 lb ai/ gal 0.13 gallon 1.341 1.22 270 Application to indoor hard surfaces Trigger Spray 0.014 lb ai/ gal 0.13 gallon 0.129 0.24 1,400 Application to swimming pools Liquid Pour 0.000052 lb ai/ gal 20,000 gallons 0.000239 0.25 1,300 a Application rates are the maximum application rates determined from EPA registered labels for ADBAC. b Amount handled per day values are estimates or label instructions. c Unit Exposure ( mg/ lb ai/ cm2) = Unit Exposure from PHED or CMA ( mg/ lb ai) / surface area of hand ( 820 cm2). d Dermal Skin Irritation Exposure (: g/ lb ai/ cm2) = Unit Exposure ( mg/ lb ai/ cm2) x Application Rate ( lb ai/ gal) x Quantity Treated ( gal/ day) x 1,000 : g/ mg e MOE = NOAEL (: g/ cm2)/ Surface Residue on Skin (: g/ cm2). [ Where short term dermal formulated based NOAEL = 333 µ g/ cm2]. Target MOE = 100.

4.2.2 Residential Post application Exposures For the purposes of this screening level assessment, post application scenarios have been developed that encompass multiple products, but still represent a high end exposure scenario for all products represented. As shown in Table 4.1, representative post application scenarios assessed include crawling on treated hard surfaces, carpets, and treated lumber such as decks/ play sets ( dermal and incidental oral exposure to children), wearing treated clothing ( dermal exposure to adults and children and incidental oral exposure to children), using air deodorizers ( adult and child inhalation exposure), using portable humidifiers ( adult and child inhalation exposure), swimming in treated pools ( adult and child incidental ingestion), and using treated instrument mouthpieces and reeds ( child and adult incidental exposure). Page 23 of 107 Since no toxicological endpoint of concern was identified for dermal systemic adverse effects, post application dermal risks were assessed using the toxicological endpoint of concern for dermal irritation. The residential post application dermal risks were assessed by comparing the surface residue on the skin ( dermal irritation exposure) to the short term dermal irritation endpoint. It was assumed that during the exposure period the skin repeatedly contacts the treated surface until a steady state concentration of residues is achieved on the skin.

<IP_ADDRESS> Hard Surface Floor and Carpets Dermal Exposure to Children from Treated Hard Floors and Carpets Exposure Calculations There is the potential for dermal exposure to toddlers crawling on hard floors and carpets after mopping or cleaning with ADBAC. Risks were calculated for children contacting treated floors in residential homes and institutions ( i. e., daycare centers). To determine toddler exposure to floor residues, the following equation was used:

E = AR x DTF x DRF x CF1 X CF2 ( Eq. 4)

Where: E = Dermal skin irritation exposure ( µ g/ cm2); AR = Application rate ( lb/ ft2); DTF = Dermal transfer factor ( fraction, unitless); DRF = Disinfectant fraction remaining on floor ( unitless); CF1 = Conversion factor ( 4.54x108 µ g/ lb); CF2 = Conversion factor ( 0.00108 ft2/ cm2);

Assumptions Due to limited data, a number of conservative assumptions have been made:

$ No transferable residue data were available that could be used to estimate the transfer of ADBAC from the floor to skin. Therefore, it is assumed that 10% of the deposition rate is available for dermal transfer from hard floors and 5% of the deposition rate is available for dermal transfer from carpets ( USEPA, 2000 and 2001).

$ No data could be found regarding the quantity of solution residue left on the floor after treatment. As a conservative measure, it has been assumed that 25% of the cleaning solution remains after the final cleaning/ mopping.

$ For mopping, the labels did not provide information on the volume of disinfectant to be used for cleaning floors. It was assumed that the diluted treatment solution was applied at a rate of 1 gallon per 1,000 sq. ft. The maximum application rate on the product labels for application to hard surfaces is 0.025 lb ai/ gal ( see Table 4.1) for a residential setting. Therefore, the application rate used in the post application hard floor scenarios was 0.000025 lb ai/ ft2. For carpets, the labels stated that 1 gallon of diluted treatment solution should be applied at a rate of 1 gallon per 300 to 500 sq. ft for rotary floor machines. Using a rate of 1 gallon solution per 300 sq. ft. and a Page 24 of 107 maximum application rate of 0.014 lb ai/ gal ( see Table 4.1) for residential and institutional settings, the application rate used in the post application carpet scenarios was 0.000047 lb ai/ ft2.

$ It was assumed that the exposed toddler plays regularly on the treated floor. In a residential home, short term exposure duration is most likely since homeowners are expected to clean the floor only intermittently.

Results The calculation of the short term dermal doses and MOEs are shown in Table 4.4. The dermal MOEs are above the target MOE of 100 ( MOE = 1,100 for hard surfaces and 1,200 for carpets).

Table 4.4. Short term Dermal Risks Associated with Post application Exposure from a Treated Hard Surface Floor and Carpet Exposure Scenario Application Rate ( lb ai/ sq ft) Product remaining after applying Percent Transfer Residue Dermal skin irritation exposure a ( µ g/ cm2) MOE Hard surface 0.000025 25% 10% 0.306 1,100 Carpet 0.000047 25% 5% 0.286 1,200 a Dermal skin irritation exposure ( µ g/ cm2) = ( Application rate, lb/ ft2) x ( conversion factor, 4.54 E8 µ g/ lb) x ( conversion factor, 0.00108 ft2 / cm2) x ( product remaining after mopping, 25%) x ( dermal transfer factor, 10% for hard surface and 5% for carpets) b. MOE = NOAEL ( µ g/ cm2) / Surface Residue on skin ( µ g/ cm2). Short term dermal NOAEL is 333 µ g/ cm2. Target MOE = 100.

Child Incidental Ingestion Exposure to Treated Hard Floors and Carpets Exposure Calculations In addition to dermal exposure, toddlers crawling on treated hard floors will also be exposed to ADBAC via incidental oral exposure through hand to mouth activity. To calculate incidental ingestion exposure to these chemicals due to hand to mouth transfer, the scenarios established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA, 2000 and 2001) were used. These scenarios use assumptions are similar to those used in calculating exposures due to dermal contact of ADBAC from toddlers crawling on treated floors. Risks were calculated for children contacting treated floors in residential homes and in commercial day care centers. Typically the day care center scenario is assessed as the intermediate term duration because the frequency of cleaning is assumed to be greater than that of the residential setting. However, for ADBAC, the short and intermediate term incidental oral endpoints are identical. The following equations were used to determine risks from hand to mouth transfer of pesticide residues to toddlers:

PDRnorm= SR x DTF x SA x FQ x ET x SE x CF1 ( Eq. 5) BW Where:

PDRnorm = Potential dose rate ( mg/ kg/ day); SR = Indoor Surface Residue ( µ g/ cm2); DTF = Dermal transfer factor ( unitless fraction); Page 25 of 107 SA = Surface area of the hands that contact both the treated area, and the individuals mouth ( cm2/ event); FQ = Frequency of hand to mouth events ( events/ hr); SE = Saliva extraction efficiency ( unitless fraction); ET = Exposure time ( hrs/ day); CF1 = Unit conversion factor ( 0.001 mg/: g); and BW = Body weight ( kg) And SR= AR x DRF x CF2 x CF3 Where:

SR = Surface residue on floor ( µ g/ cm2); AR = Application rate ( lb ai/ ft2); DRF = Disinfectant fraction remaining on floor ( 25%); CF2 = Unit conversion factor ( 4.54x108 µ g/ lb); and CF3 = Unit conversion factor ( 0.00108 ft2/ cm2)

Assumptions Due to limited data, a number of conservative assumptions have been made:

$ Toddlers ( 3 years old) were used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000 and 2001).

$ Based on the SOP, it is assumed that the surface area used for each hand to mouth event is 20 cm2, and that there are 20 events per hour for short term exposures ( 90th percentile ( USEPA, 2000 and 2001)). The short and intermediate term incidental oral endpoints are the same, therefore, intermediate term assumptions are not presented.

$ For hard floors, the exposure time is 4 hours/ day, based on the time spent in the kitchen and bathroom for adults. For carpets, the exposure time is 8 hours/ day based on the total amount of time spent indoors for young children and subtracting the amount of time spent sleeping, eating, and bathing ( USEPA, 2000 and 2001).

$ The saliva extraction efficiency is 50% ( USEPA, 2000, 2001)

$ No data could be found regarding the quantity of solution residue left on the floor after treatment. As a conservative measure, it has been assumed that 25% of the cleaning solution remains after the final mopping or cleaning.

$ No transferable residue data were available that could be used to estimate the transfer of ADBAC from the floor to skin. Therefore, it was assumed that 10% of the deposition rate is available for dermal transfer from hard floors and 5% of the deposition rate is available for dermal transfer from carpets ( USEPA, 2000 and 2001).

Results The calculation of the short term oral doses and MOEs are shown in Table 4.5. The oral MOEs are above the target MOE of 100 ( MOE = 610 for hard floors and 330 for carpets). Note: The short term duration is protective of the intermediate term exposures at a Page 26 of 107 day care facility because the toxicity data are identical.

Table 4.5. Short term Incidental Oral Risks Associated with Post application Exposure from a Treated Hard Surface Floor and Carpet Exposure Scenario Appl. Rate ( lb ai/ sq ft) Percent transferable residue Product remaining after applying Surface area mouthed ( cm2/ event) Exposure Frequency ( events/ hr) Saliva Extraction Factor Exposure Time ( hrs/ day) Surface Residue on floora ( µ g/ cm 2 ) Potential Dose Rateb ( mg/ kg / day) Incidental Oral MOEc Hard Surface 0.000025 10% 25% 20 20 50% 4 3.06 0.016 610 Carpet 0.000047 5% 25% 20 20 50% 8 5.72 0.031 330 a Surface residue on floor ( µ g/ cm2) = ( application rate, lb ai/ ft2) x ( Disinfectant fraction remaining on floor, 25%) x ( conversion factor to convert lb to µ g, 4.54E+ 08 µ g/ lb) x ( conversion factor to convert ft2 to cm2, 1.08E 03 ft2/ cm2) b Potential Dose Rate ( mg/ kg/ day) = [( Surface residue on floor, µ g/ cm2) x ( transferable residue, 0.10 for hard floors and 0.05 for carpets) x ( exposure time, 4 hrs/ day for hard floors and 8hrs/ day for carpets) x ( surface area of hands, 20 cm2/ event) x ( exposure frequency, 20 events/ hr) x ( product remaining after applying, 25%) x ( extraction by saliva, 50 %) x ( conversion factor to convert : g to mg, 0.001 mg/ µ g)]/( body weight, 15 kg) c MOE = NOAEL ( mg/ kg/ day) / potential dose rate ( mg/ kg/ day) [ Where oral NOAEL = 10 mg/ kg/ day for short term]. Target MOE = 100.

<IP_ADDRESS> Textiles Dermal Exposure to Laundered Clothing Adult and Child Exposure Calculations Some ADBAC fabric softener/ sanitizing products are added to the final rinse cycle water to provide self sanitizing and bacteriostatic activity against odor causing organisms. The product labels specifically indicate that they can be used on clothing and diapers. To determine dermal skin irritation exposure to treated clothing, the guidance provided in Human and Environmental Risk Assessment ( HERA) Guidance Document ( 2003, 2005) was used. The following equation, modified from the basic equation provided in HERA ( 2003), is used to calculate dermal exposure:

Dermal Skin Irritation Exposure ( µ g/ cm 2 ) = AR x F x FD x F1 x F2 x CF1 ( Eq. 6)

Where: AR = Application rate in mg a. i./ mg weight of fabric; F = Weight fraction of the chemical left on the clothing after the final spin; FD = Fabric density ( mg/ cm2); F1 = Weight fraction transferred from clothing to skin; F2 = Weight fraction remaining on skin; and CF1 = Conversion factor, 1,000 µ g/ mg.

Assumptions   The application rate is 0.001 mg a. i/ mg weight of fabric, based on product label # 1839 110.   In HERA ( 2003), it was determined that 2.5% of the chemical in the laundry detergent remains after the final rinse cycle. It is assumed that a washing machine containing laundry, detergent, and water would go through an agitation period, and then spin dry, then refill with fresh water for rinsing, agitate, and then spin dry again. Page 27 of 107 Assuming that the fraction of chemical removed during each spin dry cycle is the same, then:

Mf / Mi = Xspin 2 = 0.025 ( Eq. 7) Where:

Mf = Mass of chemical remaining on clothing after the final rinse, Mi = Mass of chemical originally added to laundry machine, and Xspin = Fraction of chemical remaining after each spin cycle.

The quantity Xspin is squared because the laundry and the detergent undergo two spin cycles. For assessment of fabric softener/ sanitizer, the fraction of chemical remaining will be equivalent to Xspin, since the fabric softener/ sanitizer, which is applied during the rinse cycle, will only undergo one spin cycle. Taking the square root of both sides of Equation 7 gives an Xspin value of 0.158, or 15.8%.

  The fabric density is 10 mg/ cm2, which is the value provided in HERA ( 2003) for mixed cotton and synthetics.

  No leaching data were available that could be used to estimate a flux rate of the chemical from clothing. Exposures were calculated using a conservative transfer factor of 100%, which assumes that all residues are transferable from clothing surfaces to the skin, and using HERA's value of 1% transfer ( HERA 2003).

  No dissipation data were available; therefore, the amount of ADBAC remaining on the skin is assumed to be 100 percent.

Results The resulting short term dermal exposures and MOEs are presented in Table 4.6. The dermal MOE was above the target MOE of 100 assuming the 1 or 100% transfer, and therefore, not of concern. A confirmatory study to determine the percent transfer is not warranted as the MOE estimated assuming 100% transfer is not of concern.

Table 4.6. Short term Dermal Post application Exposure and MOE for Contacting Laundered Clothing   Adult and Child Parameter Value Rational Application rate 0.001 mg a. i/ mg weight of fabric See Table 4.1 Weight fraction of residue remaining after final spin 15.8% Eq. 7 Fabric density 10 mg/ cm2 Mixed cotton and synthetics ( HERA 2003) Residue transfer factor from clothing to skin 1% and 100% EPA assumption and HERA 2003 Weight fraction remaining on skin 100% HERA, 2003 Dermal Exposurea 1% = 0.0158 µ g/ cm2 100% = 1.58 µ g/ cm2 Eq. 6 Dermal NOAEL 333 µ g/ cm2 Dermal endpoint selected Page 28 of 107 Table 4.6. Short term Dermal Post application Exposure and MOE for Contacting Laundered Clothing   Adult and Child Parameter Value Rational Dermal Short term MOEb 1% = 21,000 100% = 210 Eq. 3b ( Target MOE = 100)

a Dermal Exposure ( µ g/ cm2) =( Application rate, 0.001 mg a. i/ mg weight of fabric) x ( residue left after spin cycle, 15.8%) x ( fabric density, 10 mg/ cm2) x ( weight fraction transferred from clothing to skin) x ( weight fraction remaining on skin) x ( conversion factor, 1000 µ g/ mg) b MOE = NOAEL ( µ g/ cm2) / dermal exposure ( µ g/ cm2) [ Where short term dermal NOAEL = 333 µ g/ cm2]. Target MOE = 100.

Incidental Oral Exposure to Laundered Clothing Adult and Child Oral exposure associated with toddlers mouthing clothing was assessed using an equation similar to that used for assessing dermal exposure to laundered clothing:

Oral Exposure ( mg/ kg/ day) = AR x F x FD x Smouthed x SE ( Eq. 8) BW Where:

AR = Application rate in mg a. i./ mg weight of fabric; F = Weight fraction of the chemical left on the clothing after the final spin; FD = Fabric density ( mg/ cm2); Smouthed = Surface area of fabric that is mouthed ( cm2); SE = Saliva extraction factor; and BW = Body weight ( kg).

Assumptions   The surface area of fabric mouthed is 100 cm2 ( HERA, 2003).   The saliva extraction factor is 50% ( USEPA 2000a and 2001).   Assumptions regarding fabric density and weight fraction of chemical left after final spin are identical to those used for the assessment of dermal exposure to laundered clothing.

Results The resulting short and intermediate term oral exposure and MOE are presented in Table 4.7. The oral MOE was above the target MOE of 100.

Table 4.7. Short and Intermediate term Incidental Oral Post application Exposure and MOE for Contacting Laundered Clothing   Child Parameter Value Rational Application rate 0.001 mg a. i/ mg weight of fabric See Table 4.1 Weight fraction of residue remaining after final spin 15.8% HERA 2005 Fabric density 10 mg/ cm2 Mixed cotton and synthetics ( HERA 2003)

Surface area of clothing available for mouthing 100 cm2 HERA 2003 Saliva Extraction Factor 50% HERA 2003 Body weight 15 kg EPA 1997, median body weight Page 29 of 107 Table 4.7. Short and Intermediate term Incidental Oral Post application Exposure and MOE for Contacting Laundered Clothing   Child Parameter Value Rational Oral Exposurea 0.00525 mg/ kg/ day Eq. 8 Oral NOAEL 10 mg/ kg/ day Oral endpoint selected Short term MOEb 1,900 Eq. 3 a Oral Exposure ( mg/ kg/ day) = ( Application rate, 0.001 mg a. i/ mg weight of fabric) x ( residue left after spin cycle, 15.8%) x ( fabric density, 10 mg/ cm 2 ) x ( surface area mouthed, 100 cm 2 ) x ( Saliva extraction factor, 50%) / ( body weight, kg) b MOE = NOAEL ( mg/ kg/ day) / potential daily dose ( mg/ kg/ day) [ Where short term oral NOAEL = 10 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Treated Lumber Scenarios The Agency is concerned that there are potential residential post application exposure to children and adults exposed to ADBAC treated wood. The potential outdoor residential post application exposure pathways considered are outlined below:

Children ° Dermal contact with ADBAC treated wood products ( e. g., residential playground equipment, utility poles, posts, decks, shingles, fencing, lumber, piers, etc.);

° Incidental ingestion due to hand to mouth contact with ADBAC treated wood products;

° Incidental ingestion of soil contaminated with ADBAC;

° Dermal contact with soil contaminated with ADBAC ( e. g., soil contaminated by treated decks and playground equipment); and Adults ° Dermal contact with wood from construction of decks and playground equipment;

° Incidental ingestion with wood from construction of decks and playground equipment; and,

Currently, there are no study data that can be used to estimate either exposure to adults during construction of wood decks or to children exposed to treated wood. Incidental ingestion exposure for adults is expected to be negligible and dermal contact for adults is expected to be lower than children for crawling on wood decks. Because children exhibit a more intense play contact on surfaces and have a higher surface area to body weight ratio, they would generally be considered to represent the maximum exposed individual.

Available data to assess the levels of ADBAC in soil contaminated with ADBACtreated wood do not exist at this time. In addition, leaching data were also not available. Because of this data gap, EPA was not able to estimate dermal and incidental ingestion residential post application exposures to soil contaminated with ADBAC treated wood. In this assessment, incidental ingestion and dermal exposures to children from contact with Page 30 of 107 treated wood were estimated using surrogate data.

Surrogate Data No chemical specific residential post application studies conforming to Series 875 guidelines were available; however, data from the proprietary study, " Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride ( DDAC) Used in the Protection of Cut Lumber ( Phase III)" ( Bestari et al., 1999, MRID 455243 04) can be used as surrogate data to estimate screening level exposures for the following pathways: outdoor residential dermal contact with ADBAC treated wood products ( e. g., residential playground equipment, utility poles, posts, decks, shingles, fencing, lumber, piers, etc.); and outdoor residential incidental ingestion due to hand to mouth contact with pressure treated wood products. The DDAC study measured dermal and inhalation exposures for various worker functions/ positions for individuals handling DDAC containing wood preservatives for non pressure treatment application methods and for individuals that could then come into contact with the preserved wood.

Outdoor Residential Dermal Contact with ADBAC treated Wood Products Potential risks resulting from children's dermal contact with ADBAC treated wood are assessed using average and maximum worker residue data for hands available in the DDAC study. The data in Table 4.8 were used to approximate the residues transferred from treated wood to skin. No other data are available ( e. g., no wipe data). The data from the following job descriptions in the DDAC study were chosen because of the possibility of the contact with dry treated wood. The average and maximum concentrations ( 1.4 and 3.0 : g/ cm2) were assumed to be the dermal skin irritation exposure. The results indicate that the dermal MOEs are above the target MOE.

  End Stacker  Operates an automated stacking system at the end of the conveyor. Lumber stacked into loads.

  Stickman  Places sticks between stacks of wood manually. At some mills, this is done automatically by end stacker operator.

  Tallyman  Staples information sheet on to wood. May come in contact with treated lumber. ( Note: there were two reps available for tallyman)

Table 4.8. Hand Residue Data for DDAC for Handling of Dry Wood Job Description Total Hand Residue Data ( µ g/ cm2) End Stacker 1.2 Stickman 0.6 Tallyman 0.8 Tallyman 3.0 Average 1.4 Dermal Skin Irritation Exposurea ( µ g/ cm2) 1.4 and 3.0 MOEb ( Target MOE = 100) 240 ( average) and 110 ( maximum) a Dermal Skin Irritation Exposurea ( µ g/ cm2)= 1.4 and 3.0 µ g/ cm2 average and maximum hand residues b MOE = NOAEL ( µ g/ cm2) / dermal skin irritation exposure ( µ g/ cm2). Dermal short term NOAEL is 333 µ g/ cm2. Target MOE = 100. Page 31 of 107 Outdoor Residential Hand to Mouth Contact with ADBAC treated Wood Products Potential risks from a child's hand to mouth activities are also assessed using worker residue data for hands that are available in the DDAC study. The most appropriate hand values to estimate potential residues of a child playing on treated decks/ playground structures are for the " dry" strata test subjects ( as defined above). These test subjects handled the dry treated wood from the non pressure treatments. Of the 20 test subjects measured for handling " dry" wood in the DDAC study, 19 had detectable hand values ( one value non detect) ranging from 0.04 to 3.0 µ g/ cm2 ( DDAC study page 104). The highest value ( most conservative) ( 3.0 µ g/ cm2) represents the " Tallyman" that wore no gloves ( DDAC study page 189).

The daily hand to mouth dose ( mg/ kg/ day) is estimated using the following equation:

Oral Dose t= Handt x Hand SA x SEF x Frequency x CF1 x ET ( Eq. 9) BW Where:

Handt = DDAC highest hand residue detected ( i. e.," Tallyman" working with dry wood ( µ g/ cm2)), Hand SA = hand surface area ( cm2/ event), SEF = saliva extraction factor ( unitless), Frequency = frequency of exposure event ( events/ hr), ET = exposure time ( hr/ day), CF1 = conversion factor ( 0.001 mg/ µ g), and BW = body weight ( kg).

In addition to the hand residue value from the DDAC study, the following inputs are used in the hand to mouth estimate:

  The palmer surface area of 3 fingers of a toddler, 20 cm2, is used to estimate handmouthing as opposed to whole hand mouthing ( USEPA 2001).   The rate of hand to mouth activity for outdoor playing is 7 events per hour based on Freeman et. al ( 2001) at the 95th percentile.   The exposure time ( ET) is 2 hours and is consistent with the Agency's CCA assessment for time playing outdoors. Although the 2 hour duration represents " outdoor" time, it is used as a conservative estimate for playing on decks and play sets.   The saliva extraction factor ( SEF) is 0.5 and is based on the assumption of 50 percent removal efficiency of residues from hands by human saliva ( USEPA 2001).   The mean body weight of a child at age 3 is 15 kg.

The results of the hand to mouth estimates are presented in Table 4.9. The estimated short term MOE for the hand to mouth exposure is above the target MOE of 100 ( MOE = 360) and is not of concern. Because the dermal and oral endpoints represent different toxicological effects, an aggregate of the dermal ( discussed above) and oral MOEs are not appropriate. Page 32 of 107 Table 4.9: Residential Post application Incidental Oral Exposures with ADBAC treated Wood Product Hand concentration from DDAC Study ( µ g/ cm2) Finger surface area ( cm2) Exposure Frequency for outdoor playing ( events/ hr) Saliva Extraction Factor Exposure Time ( hrs/ day) Average Daily Oral Dose a ( mg/ kg/ day) Incidental Oral MOEb ( Target MOE = 100)

3.0 20 7 0.5 2 0.028 360 a Average Daily Oral Dose ( mg/ kg/ day) = [ handt ( 3 µ g/ cm2 ) x Hand SA ( 20 cm2) x SEF ( 0.5) x Frequency ( 7 events/ hr) x Exposure Time ( 2 hrs/ day) x 0.001 mg/ µ g] / BW ( 15 kg) b MOE = NOAEL ( mg/ kg/ day) / daily dose ( mg/ kg/ day). For oral, NOAEL is 10 mg/ kg/ day. Target MOE = 100.

<IP_ADDRESS> Air Deodorizers Inhalation Exposures for Areas with Treated Air Deodorizers Adult and Child Inhalation exposures to aerosols from ADBAC used in air deodorizers may also occur. To determine potential vapor inhalation risk, the Multi Chamber Concentration and Exposure Model ( MCCEM v1.2) was used to provide a screening level estimate of potential inhalation risk to adults and children. MCCEM estimates average and peak indoor air concentrations of chemicals released from products or materials in houses, apartments, townhouses, or other residences. It estimates inhalation exposures to chemicals, calculated as single day doses, chronic average daily doses, or lifetime average daily doses. All dose estimates calculated by MCCEM are potential doses; they do not account for actual absorption into the body.

Assumptions   The area being deodorized is a bedroom in a generic house ( 2 chamber model).   The activity pattern is based on a sedentary inhalation rate of 12 m3/ day for adults and 9.6 m3/ day for children over a 24 hour period ( USEPA 1997).   Deodorization occurs instantaneously, so that the entire mass of product is mixed homogeneously with the indoor air as soon the product is deployed. It was assumed that 100% of the product is available as inhalable and/ or respirable aerosols.   The labels did not provide information on the quantity of air deodorizer that should be used in a room. For lack of better information, it was assumed that 168 g of deodorizer ( 168 g x 0.2% ai = 0.336 g a. i.) could treat a volume of 6,000 ft3 ( 170 m3) for 30 days. Based on this rate, the amount used in one bedroom ( 35 m3 in the MCCEM generic house) per day is 0.0023 g ( 0.336 g a. i. x 35 m3 / 170 m3 / 30 days).   The labels state that the product can be used in both residential and institutional settings, such as daycare facilities. Short term exposure was assessed for adults and children in residential settings, assuming intermittent use. For children in daycare facilities, intermediate term exposure was assessed, since deodorizers may be used on a more routine basis at such facilities.

Results The resulting short and intermediate term inhalation exposures and MOEs for the representative post application inhalation exposures to air deodorizer treated areas are Page 33 of 107 presented in Table 4.10. The MOEs for children and adults were above the target MOE of 100.

Table 4.10. Short and Intermediate term Post application Exposures and MOEs for Adults and Children in Areas Treated with Air Deodorizersa Value Parameter Adult Child Rationale House Generic House ( 2 chambers: 35 m3 bedroom, 373 m3 other rooms) MCCEM default Activity Schedulea In bedroom at start of modeling, out after 8 hours EPA Assumption Concentration of product 0.2% ai Chemical specific product label Quantity a. i. Used per Day in bedroom 0.0023 g ai ( 168 g product) x ( 0.2%) x ( 30 m3) / ( 170 m3) / ( 30 days) Concentration in Bedroom after spraying ( Initial Concentration in Bedroom) a 6.57 x 10 5 g a. i./ m3 ( Quantity used in bedroom per day, 0.0023 g) / ( bedroom size, 35 m3)

Body Weighta 60 kg 15 kg Average body weights for adults and young children Inhalation Ratea 12 m3/ day 9.6 m3/ day Average resting rate for adults and young children ( USEPA, 1997) MCCEM Outputs Dose ( mg/ kg/ day) 0.00052301 0.0016736 MCCEM Output ( ADPR)

Inhalation NOAEL 3 mg/ kg/ day Inhalation endpoint selected Inhalation short and intermediate term MOEb 5,700 1,800 Eq. 3a a Used as MCCEM input. Default values from MCCEM were used for all inputs not listed in the table above. b MOE = NOAEL ( mg/ kg/ day) / daily dose ( mg/ kg/ day) [ Where short and intermediate term inhalation NOAEL = 3 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Swimming Pools & Spas There are post application exposures associated with use of ADBAC products in swimming pools and spas. For swimming pools, only incidental oral exposures are assessed in this document. Dermal and inhalation exposures are expected to be negligible due to the low concentration of ADBAC in pool water and the low vapor pressure of ADBAC. Because the amount of exposure will most likely be greater for swimming pools than for spas, swimming pool scenarios were evaluated to represent the high end exposures associated with use of ADBAC in pools and spas.

The SWIMODEL 3.0 was developed by EPA as a screening tool to conduct exposure Page 34 of 107 assessments of pesticides found in swimming pools and spas ( Versar, 2003). The SWIMODEL uses well accepted screening exposure assessment equations to calculate the total worst case exposure for swimmers expressed as a mass based intake value ( mg/ event). The model focuses on potential chemical intakes only and does not take into account metabolism or excretion of the chemical of concern. Detailed information and the downloadable executable file are available at http:// www. epa. gov/ oppad001/ swimodel. htm. For this assessment, the actual model was not used, however, the same equations as provided in the SWIMODEL User's Manual ( version 3.0) were used in a spreadsheet format to estimate post application incidental oral and inhalation exposures for use of ADBAC in swimming pools.

It should be noted that this exposure assessment identifies short term ( 1 30 days) and intermediate term ( 1 6 months) noncancer exposure doses based on the reported toxicology endpoints for ADBAC. Because of the shorter exposure durations of these toxicological endpoints, conservative event based exposure assumptions are used to calculate upper bound daily dose estimates. The noncancer doses are not amortized over a lifetime.

Post application Incidental Ingestion Exposure through Swimming Pool Use The following equation was used to calculate incidental ingestion doses:

PDR = Cw x IR x ET ( Eq. 10) BW Where: PDR = Potential dose rate ( mg/ kg/ day); Cw = Chemical concentration in pool water ( mg/ L); IR = Ingestion rate of pool water ( L/ hr); ET = Exposure time ( hrs/ day); and BW = Body weight ( kg).

Assumptions   For short term exposures, the application rate for heavy algae contamination ( 5.00 ppm or 5.0 mg ADBAC/ L) was used.

  The ingestion rate is based on the value used in EPA's Residential SOPs ( US EPA, 2000) and an EPA pilot study as discussed in ACC's swimmer survey ( ACC, 2002b).

  Exposure time for non competitive swimmers is based on the summary statistics from the National Human Activity Pattern Survey ( NHAPS) ( USEPA, 1996) whereas competitive swimmer exposure time data are based on the Agency's review of the American Chemistry Council ( ACC) study ( ACC, 2002b.

  The assumed body weight is 60 kg for adult females, 48 kg for children ( age 11 14 years), and 30 kg for children ( age 7 10 years). Page 35 of 107 Table 4.11. Parameters for Swimming Ingestion Exposure and Dose Estimate Population Adult Child 7 10 yrs Child 11 14 yrs Type of Swimmer Competitive Non Competitive Competitive Non Competitive Competitive Non Competitive Cw ( mg/ L)   Short term exposure 5.0 5.0 5.0 5.0 5.0 5.0 IR ( L/ hr) 0.0125 0.0125 0.05 0.05 0.025 0.05 ET( hr/ day) 3 2a 1 3a 2 2.6a BW( kg) 60 60 30 30 48 48 a 90th percentile values Short term MOE values were calculated for ingestion of swimming pool water and are presented in Table 4.12. The calculations for short term incidental ingestion of ADBAC indicate no risk concern for the non competitive or competitive swimming pool scenarios ( i. e., MOE> 100).

Table 4.12. Short Term Ingestion Dose and MOE for Residential Swimming Post Application Use Type Scenario Description Ingestion Dose ( mg/ kg/ day) Ingestion MOE a Adult, Competitive 0.0031 3,200 Adult, Non Competitive 0.0021 4,800 Child ( 7 10 yrs), Competitive 0.0083 1,200 Child ( 7 10 yrs), Non Competitive 0.025 400 Child ( 11 14 yrs), Competitive 0.0052 1,900 Swimming Pool Child ( 11 14 yrs), Non Competitive 0.0135 740 aMOE = NOAEL ( mg/ kg/ day)/ Ingestion Dose ( mg/ kg/ day). Short term Oral NOAEL = 10 mg/ kg/ day. Target MOE = 100 <IP_ADDRESS> Humidifiers Inhalation Exposures for Portable Humidifiers  Adult and Child Aerosol inhalation exposures to ADBAC used in portable humidifiers may also occur. EPA assumes inhalable particles include sizes up to 100 microns. To determine potential inhalation risk, the Multi Chamber Concentration and Exposure Model ( MCCEM v1.2) was used to provide a screening level estimate of potential inhalation risk to adults and children. A summary of MCCEM capabilities are described above in the air deodorization section.

Assumptions   The entire house is being humidified; therefore, a single chamber model was run. Page 36 of 107   A person is exposed to the release for either 8 hours a day or 24 hours a day.   The inhalation rates for the 8 hour exposure period are based on the sedentary activities ( 0.5 m3/ hr for adults and 0.4 m3/ hr for children). The inhalation rates for the 24 hour exposure period are based on the chronic inhalation rates ( 13.3 m3/ day for adults and 8.3 m3/ day for children) ( USEPA, 1997).   For the 8 hr exposure duration assessment, the MOE was calculated using concentrations from 0 to 8 hours after the humidifier was turned on. For the 24 hr exposure assessment, it was assumed that the humidifier had already been running for the previous day; therefore, the concentrations from 24 to 48 hours after the fogger was turned on were used.   Release of the product occurs at a steady state throughout the day ( constant emission rate from one source).   The label indicated that 1/ 6 oz of product should be used per gallon. The label did not provide information on the quantity of solution that is released per hour. A release rate of 11 gallons/ 1,700 ft2/ 24 hours was used in this assessment based on the Cool Mist Console Harmony Humidifier Model# HM4600 U. ( http:// www. holmesproducts. com/ estore/ product. aspx? CatalogId= 3& CategoryId= 112 0& ProductId= 582). It was assumed that 11 gallons of the dilute solution would be released into the generic MCCEM house ( approximately 1,800 ft2 assuming 8 ft ceilings) over a 24 hour period. Based on an application rate of 0.00049 lb ai/ gal, approximately 0.102 g ai/ hr would be emitted into the house.   It was assumed that 100% of the product is available as inhalable.

Results The resulting short and intermediate term inhalation exposure and MOE for the representative post application inhalation scenarios are presented in Table 4.13 and 4.14. The 8 hr and the 24 hr MOEs for children and adults are below the target MOE of 100. Refinements to this assessment would require air monitoring data.

Table 4.13. Short and Intermediate term Post application Exposures and MOEs for Adults and Children in Houses Being Humidified ( 8 hr Exposure Duration) Value Parameter Adult Child Rationale Housea Generic House ( 1 chamber) A portable humidifier humidifies the entire house Activity Schedule 8 hour Time Weight Average ( TWA) starting at time 0. EPA Assumption Air Exchange Rate 0.18/ hr MCCEM default ( 10th% tile estimate for all regions, USEPA 1997, page 17 11 and 17 12)

Application Rate 0.00049 lb ai/ gal Chemical specific product label Quantity Dilute Used 11 gallons/ 24 hours Cool Mist Console Harmony Humidifier Model# HM4600 U Page 37 of 107 Table 4.13. Short and Intermediate term Post application Exposures and MOEs for Adults and Children in Houses Being Humidified ( 8 hr Exposure Duration) Value Parameter Adult Child Rationale Emission Ratea 0.102 gram ai/ hr Application rate ( lb ai/ gal) * Use amount ( gal/ hr) * CF ( g/ lb)

Body Weighta 60 kg 15 kg Average body weights for adults and young children Inhalation Ratea 12 m3/ day ( 0.5 m3/ hr) 9.6 m3/ day ( 0.4 m3/ hr) Sedentary rate for adults and young children ( USEPA, 1997)

MCCEM Outputs Average Concentration over 8 hrs ( mg/ m3) 0.637607 0.637607 Average of MCCEM calculated air concentrations from 0 to 8 hrs Dose ( mg/ kg/ day) 0.042507 0.272046 Average Conc. * 8 hrs * Inhal. Rate / BW Inhalation short and intermediate term MOEb 71 11 NOAEL ( 3 mg/ kg/ day) / Dose a Used as MCCEM input. Default values from MCCEM were used for all inputs not listed in the table above. b MOE = NOAEL ( mg/ kg/ day) / daily dose ( mg/ kg/ day) [ Where short, intermediate term inhalation NOAEL = 3 mg/ kg/ day]. Target MOE = 100.

Table 4.14. Short and Intermediate term Post application Exposures and MOEs for Adults and Children in Houses Being Humidified ( 24 hr Exposure Duration)

Value Parameter Adult Child Rationale Housea Generic House ( 1 chamber) A portable humidifier humidifies the entire house Activity Schedule 8 hour Time Weight Average ( TWA) starting at time 0. EPA Assumption Air Exchange Rate 0.18/ hr MCCEM default ( 10th% tile estimate for all regions, USEPA 1997, page 17 11 and 17 12)

Application Rate 0.00049 lb ai/ gal Chemical specific product label Quantity Dilute Used 11 gallons/ 24 hours Cool Mist Console Harmony Humidifier Model# HM4600 U Emission Ratea 0.102 gram ai/ hr Application rate ( lb ai/ gal) * Use amount ( gal/ hr) * CF ( g/ lb)

Body Weighta 60 kg 15 kg Average body weights for adults and young children Inhalation Ratea 13.3 m3/ day 8.3 m3/ day Chronic rate for adults and young children ( USEPA, 1997)

MCCEM Outputs Page 38 of 107 Table 4.14. Short and Intermediate term Post application Exposures and MOEs for Adults and Children in Houses Being Humidified ( 24 hr Exposure Duration)

Value Parameter Adult Child Rationale Average Concentration over 24 hrs ( mg/ m3) 1.39 1.39 Average of MCCEM calculated air concentrations from 24 to 48 hrs Dose ( mg/ kg/ day) 0.307 0.767 Average Conc. * 24 hrs * Inhal. Rate / BW Inhalation short, intermediate term MOEb 10 4 NOAEL ( 3 mg/ kg/ day) / Dose a Used as MCCEM input. Default values from MCCEM were used for all inputs not listed in the table above. b MOE = NOAEL ( mg/ kg/ day) / potential daily dose ( mg/ kg/ day) [ Where short, intermediate term inhalation NOAEL = 3 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Instrument Mouthpiece/ Reed The product Sterisol Germicide ( EPA Reg. # 32977 1), a liquid ready to use formulation containing 0.06% ai ( 0.0050 lb ai/ gal), can be used in schools and studios to sanitize and disinfect mouthpieces, reeds, and pre band instruments. Sanitization involves immersion for one minute and disinfection involves immersion for 10 minutes followed by a potable water rinse. At this time, the Agency does not have exposure data to assess oral exposures to children and adults; therefore, the Agency is requesting residue data from mouthpieces and reeds.

4.2.3 Data Limitations/ Uncertainties There are several data limitations and uncertainties associated with the residential handler and post application exposure assessments. These include the following:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix B for summaries of these data sources). Most of the CMA data are of poor quality, therefore, AD requests that confirmatory monitoring data be generated to support the values used in these assessments.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA, 2000 and 2001). In certain cases, no standard values were available for some scenarios. Assumptions for these scenarios were based on AD estimates and could be further refined from input from registrants.   Some labels for products which can be used by homeowners in residential settings, as well as by workers in occupational settings, indicate that low pressure sprayers can be used for application of the disinfectant to hard, non porous surfaces such as floors and walls. A residential low pressure spray scenario was not assessed for the residential scenario because it is not a typical cleaning method for homeowners.   At this time, the Agency does not have exposure data to assess oral exposures to children and adults from using treated mouthpieces and reeds; therefore, the Agency is Page 39 of 107 requesting residue data from treated mouthpieces and reeds.   In this assessment, incidental ingestion and dermal exposures to treated wood were estimated using surrogate DDAC data. The degree of uncertainty ( under or overestimation) associated with using the DDAC hand residue data for dermal and oral exposure from contacting treated lumber are unknown. The amount of residue measured on the test subjects hands is variable and are influenced by the duration of exposure, how often wood is contacted, and the degree of contact ( i. e., do the hand residues from the DDAC study mimic a child's play activity on decks and play sets?).   Available data to assess the levels of ADBAC in soil contaminated with ADBAC treated wood do not exist at this time. In addition, leaching data were also not available. Because of this data gap, EPA was not able to estimate dermal and incidental ingestion residential post application exposures to soil contaminated with ADBAC treated wood.

5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION   To be determined and presented in the risk assessment chapter.

6.0 OCCUPATIONAL EXPOSURE ASSESSMENT The exposure scenarios assessed in this document for the representative uses selected by AD are shown in Table 6.1. The table also shows the maximum application rate associated with the representative use and the appropriate EPA Registration number for the product label. It should be noted that for the calculation of application rates in which 8.34 lb/ gal is noted, the product is assumed to have the density of water because no product specific density is available. Appendix A presents a summary of all exposure scenarios that may occur in occupational settings based on examination of product labels.

Potential occupational handler exposure can occur in various use sites, which include: agricultural premises, industrial processes and water systems, food handling premises, commercial/ institutional/ industrial premises, medical premises, swimming pools, and aquatic areas. Additionally, occupational exposure can occur during the preservation of wood. For the preservation of wood, the procedure for treatment can occur in different ways, such that multiple worker functions were analyzed. Due to the complexity of the wood preservative analysis, the results for handler and post application exposures are presented separately in Section 6.3.

Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to ADBAC Representative Use Method of Application Exposure Scenario Registration # Application Rate Agricultural Premises ( Use Category I)

General Disinfectant for Hard Surfaces, Equipment, Vehicles   Low pressure hand wand   High Pressure Spray   Wiping surface   Trigger pump spray ST/ IT Handler: Inhalation 1839 155 0.017 lb ai/ gal ( 20% a. i. x 1.335 fl. oz/ gal water x 1 gal/ 128 fl. oz x 8.34 lb/ gal) Page 40 of 107 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to ADBAC Representative Use Method of Application Exposure Scenario Registration # Application Rate   Mopping ST/ IT Handler: Inhalation 67517 15 0.012 lb a. i./ gal ( 23.6% a. i. x 0.75 fl. oz/ gal water x 1 gal/ 128 fl. oz x 8.34 lb/ gal)

Hands ( cleaning)   Immerse ST Postapplication dermal 507 3 0.0017 lb ai/ gal ( 3.8 g/ 2 gal x 0.0022046 lb/ g x 40% a. i.)

Fogger   Liquid pour ST/ IT Handler ( mix/ load only): Inhalation ST Postapplication inhalation 10324 118 0.27 lb a. i./ gal ( 21.7% a. i. x 48 fl. oz/ 2.5 gal x 1 gal/ 128 fl. oz x 8.34 lb/ gal)

Food Handling ( Use Category II)   Wipe   Mop   Low pressure sprayer ST/ IT Handler: inhalation 1203 41 0.0176 lb a. i./ gal ( 4.5% a. i. x 6 oz product/ gal water x 8.34 lb/ gal x 1gal/ 128oz)

  Trigger pump spray ST/ IT Handler: inhalation 6836 193 0.025 lb a. i./ gal ( 0.3% a. i. x 8.34 lb/ gal) Indoor Hard Surfaces ( including dishes, utensils, equipment)

  Flood   Immersion   Circulation ( Liquid pour) ST/ IT Handler: inhalation 1839 155 0.00325 lb ai/ gal ( 20% a. i. x 0.25 oz product/ gal water x 8.34 lb/ gal x 1gal/ 128oz)

Fogger   Liquid pour ST Postapplication Inhalation 10324 118 0.011 lb a. i./ gal ( 21.7% x 0.75 oz/ gal x 8.34 lb/ gal x 1 gal/ 128oz)

Commercial/ Industrial/ Institutional Premises ( Use Category III)

  Low pressure hand wand   Mop   Wipe   Trigger pump sprayer ST/ IT Handler: inhalation 10324 118 0.0283 lb a. i./ gal ( 2 oz product/ gal water x 21.7% a. i. x 8.34 lb/ gal x 1 gal/ 128 oz) Indoor Hard Surfaces   Liquid pour ST/ IT Handler: Inhalation 6836 193 0.025 lb a. i./ gal ( 0.3% a. i. x 8.34 lb/ gal)

Air Deodorization, Surface disinfection and deodorization   Aerosol spray ST/ IT Handler: inhalation 1839 85 0.2% a. i. by weight Page 41 of 107 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to ADBAC Representative Use Method of Application Exposure Scenario Registration # Application Rate Carpets   Truck mounted extraction machines ( Liquid pour) ST/ IT Handler: Inhalation 1839 81 0.141 lb ai/ gal ( 9% a. i. x 24 oz product/ gal water x 8.34 lb/ gal x 1gal/ 128oz)

Medical Premises ( Use Category V) Indoor Hard Surfaces   Mop ST/ IT Handler: inhalation 1203 41 0.0176 lb a. i./ gal ( 4.5% a. i. x 6 oz product/ gal water x 8.34 lb/ gal x 1gal/ 128oz) Instruments   Immersion ( Liquid pour) ST/ IT Handler: inhalation 7211 10 0.0209 lb ai/ gal ( 0.25% a. i. x 8.34 lb/ gal)

Industrial processes and water systems ( Use Category VIII) Oil field operations  drilling mud and packing fluidsa   Liquid Pour ST/ IT Handler: Inhalation 1839 179 1.0 lb ai/ gal product ( 12% a. i. x 8.34 lb/ gal product) Pulp and Paper   preservative in additive system   Metered pump ST/ IT Handler: Inhalation 1706 177 0.0019 lb ai/ gal ( 750 mg/ L x 3.8 L/ gal x 2.2e 6 lb/ mg x 30.62% ai)

Pulp and Paper   Metered pump ST/ IT Handler: Inhalation 6836 58 41.7 lb ai/ ton paper ( 50 gal/ ton paper x 8.34 lb / gal x 10% ai )

  Liquid Pour ST/ IT Handler: Inhalation 6836 234 6.67 lb ai/ gal product ( 80% ai x 8.34 lb/ gal) Small process water systems ( i. e., evaporative condensers, water scrubbing, wastewater treatment, pasteurizers, auxiliary service water, recirculating cooling water)   Metered pump ST/ IT Handler: Inhalation 10324 21 Initial dose: 3.34E 4 lb ai/ dilute gal ( 50% ai x 8.34 lb/ gal x 10.25 fl. oz/ 1,000 gal water x 1 gal/ 128 fl. oz) Maintenance dose: 1.25E 4 lb ai/ dilute gal ( 50% ai x 8.34 lb/ gal x 3.85 fl. oz/ 1,000 gal x 1 gal/ 128 fl. oz) Once through Cooling Water Systems ( i. e. power plants)   Metered pump ST/ IT Handler: Inhalation 6836 234 Initial dose ( ST): 8.86 E 5 lb ai/ gal ( 80% ai x 8.34 lb/ gal x 1.7 fl. oz/ 1,000 gal water x 1 gal/ 128 fl. oz) Maintenance dose ( IT): 4.69E 5 lb ai/ gal ( 80% ai x 8.34 lb/ gal x 0.9 fl. oz/ 1,000 gal water x 1 gal/ 128 fl. oz) Page 42 of 107 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to ADBAC Representative Use Method of Application Exposure Scenario Registration # Application Rate Metal or Wooden Cooling tower   High pressure sprayerb ST/ IT/ LT Handler: inhalation 507 3 0.00084 lb ai/ gal [ 40% a. i. x 100 ppm product x ( 0.0095 g/ gallon)/ ppm x 0.0022046 lb/ g )

Wood Preservation ( Use Category X) Non pressure treatment of wood and wood products in wood treatment facilities Handler Worker Functions   Diptank Operators   Blender/ spray operators   Chemical operators Post Application Worker Functions   Graders   Trim saw operators   Clean up crews   Construction Workers ST/ IT/ LT Handler: inhalation ST/ IT/ LT Postapplication dermal and inhalation 1839 184 Diptank operators and blender/ spray operators: 3% ai solution All other worker functions: 50% ai in product Non pressure treatment of wood on existing homes   Airless sprayc ST/ IT Handler: inhalation 1839 184 0.25 lb ai/ gal ( 50% ai x 8.34 lb/ gal x 7.68 fl. oz./ gal x 1 gal/ 128 fl. oz) Pressure treatment of wood and wood products in wood treatment facilities Handler Worker Functions   Treatment assistant   Treatment operator Post Application Worker Functions   Tram setter, stacker operator, loader operator, supervisor, test borer, and tallyman ST/ IT/ LT Handler: inhalation ST/ IT/ LT Postapplication dermal inhalation 1839 184 3% aid Swimming Pools ( Use Category XI) Swimming pools/ Spas   Liquid pour ST/ IT Handler: inhalation 6836 310 1839 141 Maintenance: 0.0000098 lb ai/ gal ( 50.0% x 3 oz/ 10,000 gal x 8.34 lb/ gal x 1 gal/ 128 oz)

Winterizing: 0.000052 lb ai/ gal ( 50.0% x 16 oz/ 10,000 gal x 8.34 lb/ gal x 1 gal/ 128 oz) Aquatic Areas ( Use Category XII) The decorative ponds, fountains, and agricultural watering line application rates are similar to swimming pool use and therefore, are not assessed separately ( pool volume/ amount handled represents high end exposure potential). Page 43 of 107 a For the secondary recovery application, the biocide is meter pumped into the produced water before it is reinjected into the formation or well. Since the biocide is added via metering pump ( continuous or batch) in the secondary recovery systems, the drilling rig worker handling the biocide via open pouring is expected to have a higher exposure than the secondary recovery worker. Additionally, the current CMA data are not representative of handling the large volume assumed in this scenario. b The label does not indicate the type of spray equipment that should be used for surface applications to metal/ wood cooling towers. The high pressure sprayer was assessed. c The label indicates that applications to existing homes can be made through brush or spray. The airless sprayer method was selected because it is based on applying a fungicide in a house stain to the outside shakes of a house; not an aerosolized paint sprayer. d The application rate for pressure treated wood preservation is based on the master label. The actual label only provides a retention rate.

6.1 Occupational Handler Exposures The occupational handler scenarios included in Table 6.1 were assessed to determine inhalation exposures. The general assumptions and equations that were used to calculate occupational handler inhalation risks are provided in Section 1.2, Criteria for Conducting the Risk Assessment. The majority of the scenarios were assessed using CMA data and Equations 1 3. However, for the occupational scenarios in which CMA data were insufficient, other data and methods were applied.

ADBAC dermal irritation exposures and risks were not estimated for occupational handler exposures. Instead, dermal irritation exposures and risks will be mitigated using default personal protective equipment requirements based on the toxicity of the end use product. To minimize dermal exposures, the minimum PPE required for mixers, loaders, and others exposed to end use products containing concentrations of ADBAC that result in classification of category I, II, or III for skin irritation potential will be long sleeve shirt, long pants, shoes, socks, chemical resistant gloves, and chemical resistant apron. Once diluted, if the concentration of ADBAC in the diluted solution would result in classification of toxicity category IV for skin irritation potential, then the chemical resistant gloves and chemicalresistant apron can be eliminated for applicators and others exposed to the dilute. Note that chemical resistant eyewear will be required if the end use product is classified as category I or II for eye irritation potential.

Unit Exposure Values ( UE): Inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999b: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998).

$ For the liquid pour scenarios, the unit exposure depends on the material being treated. The following CMA unit exposures were available and used for the assessment of the risk associated with the treatment of the specified materials. o Swimming pools, carpets, and oilfield operations ( drilling muds and packer fluids): CMA preservative data ( gloved). The inhalation unit exposure is 0.00346 mg/ lb a. i. and is based on 2 replicates. Although this unit exposure is based on minimal replicates, the exposure value is similar to the one found in PHED for a similar scenarios. Page 44 of 107 o Indoor hard surfaces ( immersion, flooding and circulation) and medical instruments in Use Site Categories II and V: The inhalation unit exposure value for disinfectant liquid pour ( 1.89 mg/ lb a. i.) was used. o Small process water systems: CMA cooling tower data ( gloved). The inhalation unit exposure is 0.450 mg/ lb a. i. and is based on 5 replicates.

$ For the mopping scenarios, the CMA inhalation unit exposure value for ungloved mopping was used ( 2.38 mg/ lb a. i.). This value is based on data collected from six replicates in which the applicator mopped the floor and received exposure via contact with the mop or with the bucket.

$ For the wiping scenarios, the CMA inhalation unit exposure value for ungloved wiping was used ( 67.3 mg/ lb a. i.). This value is based on data collected from six replicates ( dental technicians) who used a finger pump sprayer to apply the product and then wiped the surfaces with a paper towel $ For the low pressure hand wand scenario, the CMA inhalation unit exposure value for low pressure spray was used ( 0.681 mg/ lb a. i.). This value is based on data collected from eight replicates in which the applicator hand sprayed carpet using 200 psi, then used a push broom rake to raise the carpet nap $ For the aerosol spray and trigger pump spray scenarios, the PHED inhalation unit exposure value for aerosol applications ( PHED scenario 10) was used. The inhalation unit exposure is 1.3 mg/ lb a. i.

$ For the liquid/ metering pump scenarios, the unit exposure depends on the material being treated. The following CMA unit exposures were available and used for the assessment of the risk associated with the treatment of the specified materials. o Pulp and paper, Papermaking chemicals, and Once through cooling water systems: CMA pulp and paper gloved data were used. The inhalation unit exposure is 0.000265 mg/ lb a. i. The value is based on 7 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. This unit exposure was used for the once through cooling water system because no representative data exists for the volume of water treated in power plant facilities. o Small process water systems: CMA cooling tower data. The inhalation unit exposure is 0.00432 mg/ lb a. i. and is based on 4 replicates.

$ For the high pressure/ high volume spray and medium pressure spray scenarios, the PHED inhalation unit exposure value for liquid/ open pour/ high pressure spray ( PHED scenario 35) was used ( 0.12 mg/ lb a. i.).

$ For airless sprayer scenarios, the occupational PHED inhalation unit exposure value for airless sprayer application ( PHED scenario 23) was used. The inhalation exposure value is 0.83 mg/ lb a. i.

$ For the fogging, ULV/ mist sprayer and automated system scenarios, it was assumed that most of the exposure to the handler will be due to preparing the fogger, and that the handler leaves the room immediately after fogging commences. Therefore, the available CMA disinfectant liquid pour inhalation unit exposure value was used. The inhalation unit exposure value is 1.89 mg/ lb a. i., respectively. This value is based on data collected from two gloved replicates involving pouring a disinfectant product from a jug into sterilization trays designed for dental instruments, adding water and instruments to the tray, removing the instruments, and discarding the old solution. Page 45 of 107 Quantity handled/ treated: The quantity handled/ treated values were estimated based on information from various sources. The following assumptions were made:

  For the liquid pour scenarios, the quantity of the chemical that is handled depends on the material that is being treated. The following values were used for the different materials: o Swimming pools: 200,000 gallons. o Indoor hard surfaces ( immersion, flooding and circulation) and medical instruments: 2 gallons. o Carpets: 32 gallons, based on label 1839 81 ( solution is metered at 4 gallons per hour, assuming an 8 hour shift). o Oil field operations ( drilling muds and packer fluids): The following use information was used to estimate the amount of ai handled per day during oilwell activities. Biocide is typically added directly to drilling rig mud tanks via open pouring. Over a 3 to 6 week period, while a 13,000 ft well is being drilled, 1 to 2 drums ( 1 drum = 42 gallons) of biocide may be used if microbiological problems are encountered. Therefore, the short term exposure assessment used 5.6 gallons for the amount of biocide handled per day by the drilling rig worker [ i. e., ( 2 drums x 42 gal/ drum) / ( 5 days/ week x 3 weeks) = 5.6 gal/ day]. The intermediate term exposure assessment used 2.8 gallons for the amount of biocide handled per day by the drilling rig worker [ i. e., ( 2 drums x 42 gal/ drum) / ( 5 days/ week x 6 weeks) = 2.8 gal/ day]. Although crew changes may occur in drilling rig operations, typically a designated customer representative is responsible for the biocide feeding. Therefore, one person would be involved with the biocide application activities on a daily basis. o Small process water systems: The daily amount of biocide handled that was used in this assessment was based on the following information provided by Dick Youmans of Buckman Labs ( personal communication on 6/ 30/ 04 and 10/ 27/ 04). Workers in small systems could manually pour 5 to 10 gallons of biocide into the system, but larger systems would utilize chemical pumps in order to save time and labor expense. Therefore, AD assumed that workers handle 10 gallons of biocide per day when making open pour applications.

$ For the liquid/ metering pump scenarios the quantity that is handled depends on the material that is being treated. The following values were used for the different materials: o Pulp and Paper: 500 tons/ day. o Pulp and Paper Making Chemicals: It was conservatively assumed that 1,000 gallons of paper making chemicals could be preserved each day. o Small process water systems: AD has assumed that 20,000 gallons of water are treated daily when chemical pump applications are made. o Once through cooling water systems: AD has assumed that between 5,900,000 and 153,000,000 gallons of water are treated per day. This range is based on the average of 7Q10 values from 12 low flow streams ( 100 MGD) and 6 high flow streams ( 1,000 MGD). The streams chosen for the averages were used in the ADBAC Ecological Risk Assessment ( Versar, 2005). The 7Q10 flow rate is a flow rate that, once every ten years, a stream is expected to be below for seven consecutive days. It was assumed to be the normal cooling water flow rate. This value was chosen because it is assumed that electric plants would need to have a steady supply of cooling water, and the 7Q10 flow reflects a Page 46 of 107 rate that could be maintained continuously by the power plant. This is not a conservative assumption, since electric plants may use more cooling water under normal conditions, though at a greater risk of running out of usable water. For lack of better data, however, these values were used.   For the mopping scenarios, it was assumed that two gallons of solution are used in the agricultural, food handling, and commercial/ institutional/ industrial settings and 45 gallons are used in the medical setting. The medical setting use amount is based on a janitor cleans approximately 28 hospital rooms a day and changing the cleaning water every three rooms ( Helwig 2003).   For the wiping and trigger pump spray scenarios, it was assumed that 1 liter or 0.26 gallons were used.   For the air deodorization, surface disinfection and deodorization scenario, it was assumed that 3 cans of product are used. The product label did not provide the net weight of the can; therefore, it was also assumed that a can contains 16 oz of the product ( 3 x 16 oz = 48 oz, or 48 oz. x 1 lb/ 16oz. = 3.0 lbs product).   For the fogging scenario in the agricultural use site category, it was assumed that 150,000 ft3 is treated, based on the estimated dimensions of a poultry barn ( 300 ft x 50 ft x 10 ft). As the label directions only state to fog for one minute on maximum output per 4,000 ft3 and does not provide the amount of treatment solution to use per cubic foot, AD assumed that the maximum fogger output is 0.42 gallons/ min ( 25 gal/ hr). This value is the maximum output for the Mistermax fogger which is used to dispense fungicides, insecticides, germicides and disinfectants as wettable powders, emulsifiable concentrates, flowables or liquids in a variety of applications such as greenhouses, warehouses, food processing plants, and swine/ poultry houses ( http:// bugsource. com/ mistermax. html).   For the low pressure hand wand scenario, it was assumed that 40 gallons of solution are used in agricultural scenarios ( Exposure Policy # 009) and 2 gallons are used in all other applications.   For the high pressure spray scenario, it was assumed that 40 gallons of solution are used for application to agricultural vehicles/ equipment and for the cooling towers scenario, a range of 100 to 1,000 gallons treatment solution was used due to the uncertainty in the quantity of solution used for this scenarios. The values could be further refined from input from registrants.

Duration of Exposure: The MOEs were calculated for the short and intermediate term durations for occupational handlers using the appropriate endpoints in Table 3.2.

Exposure Calculations and Results The resulting inhalation exposures and MOEs for the representative occupational handler scenarios are presented in Table 6.2. The calculated MOEs were above the target MOE of 100 for all scenarios, except those listed below.

  Agricultural fogging ( mixing and loading): ST/ IT Inhalation MOE = 26   Medical premises, mopping: ST/ IT Inhalation MOE = 95   Pulp and paper, liquid pump: ST/ IT Inhalation MOE = 33   Once through cooling water, metering pump: Using the average flow rate for high flow streams ( 153 MGD) the ST Inhalation MOE = 50 for initial applications and the IT MOE = 95 for maintenance applications; however, using the average flow rate for Page 47 of 107 low flow streams ( 5.9 MGD) the ST Inhalation MOE = 1,300 for initial applications and the IT MOE = 2,500 for maintenance applications.   Small process water systems, liquid pour: ST/ IT Inhalation MOE = 6.

A confirmatory inhalation toxicity study may be warranted because inhalation MOEs were below 1,000 for the following scenarios ( in addition to those listed above):   Agricultural  hard surfaces, wiping: ST/ IT Inhalation MOE = 590; low pressure hand wand MOE = 380   Food handling  hard surfaces, wiping: ST/ IT Inhalation MOE = 580   Commercial/ Institutional premises   hard surfaces, wiping: ST/ IT Inhalation MOE = 360 Table 6.2 Short , Intermediate and Long Term Inhalation Risks Associated with Occupational Handlers Exposure Scenario Method of Application Inhalation Unit Exposure ( mg/ lb a. i.) Application Rate Quantity Handled/ Treated per day Inhalation Absorbed Daily Dose ( mg/ kg/ day) a Inhalation MOEb, c ( Target MOE = 100)

Agricultural Premises and Equipment ( Use Site Category I)

Mop 2.38 0.012 lb ai/ gal 2 gallons 0.00091 3,300 High pressure/ high volume spray 0.12 0.017 lb ai/ gal 40 gallons 0.0014 2,200 Low pressure hand wand 0.681 0.017 lb ai/ gal 40 gallons 0.0079 380 Trigger pump sprayer 1.3 0.017 lb ai/ gal 0.26 gallons 0.000098 31,000 Application to hard surfaces, equipment, and vehicles Wipe 67.3 0.017 lb ai/ gal 0.26 gallons 0.0051 590 Fogging ( mix/ load only) Liquid pour 1.89 2.46E 05 lb/ ft3 150,000 ft3 0.12 26 Food Handling/ Storage Establishments Premises And Equipment ( Use Site Category II)

Low pressure hand wand 0.681 0.0176 lb ai/ gal 2 gallons 0.0004 7,500 Mop 2.38 0.0176 lb ai/ gal 2 gallons 0.0014 2,100 Wipe 67.3 0.0176 lb ai/ gal 0.26 gallons 0.0051 580 Trigger pump sprayer 1.3 0.025 lb ai/ gal 0.26 gallons 0.00014 21,000 Application to indoor hard surfaces ( including dishes, utensils, equipment)

Immersion, Flooding, Circulation 1.89 0.00325 lb ai/ gal 2 gallons 0.0002 15,000 Commercial, Institutional and Industrial Premises and Equipment ( Use Site Category III )

Low pressure hand wand 0.681 0.0283 lb ai/ gal 2 gallons 0.00064 4,700 Mop 2.38 0.0283 lb ai/ gal 2 gallons 0.0022 1,300 Wipe 67.3 0.0283 lb ai/ gal 0.26 gallons 0.0083 360 Trigger pump sprayer 1.3 0.0283 lb ai/ gal 0.26 gallons 0.00016 19,000 Application to indoor hard surfaces Immersion 1.89 0.025 lb ai/ gal 2 gallons 0.0016 1,900 Air deodorization, surface disinfection and deodorization Aerosol spray 1.3 0.20% a. i. by weight 3.0 lbs 0.00013 23,000 Application to carpets Liquid pour 0.00346 0.141 lb ai/ gal 32 gallons 0.00026 12,000 Medical Premises and Equipment ( Use Site Category V)

Application to hard surfaces Mop 2.38 0.0176 lb ai/ gal 45 gallons 0.031 95 Application to dental instruments Immersion ( Liquid pour) 1.89 0.0209 lb ai/ gal 2 gallons 0.0013 2,300 Page 48 of 107 Table 6.2 Short , Intermediate and Long Term Inhalation Risks Associated with Occupational Handlers Exposure Scenario Method of Application Inhalation Unit Exposure ( mg/ lb a. i.) Application Rate Quantity Handled/ Treated per day Inhalation Absorbed Daily Dose ( mg/ kg/ day) a Inhalation MOEb, c ( Target MOE = 100)

Industrial Processes and Water Systems ( Use Site Category VIII)

Pulp and Paper Metering pump 0.000265 41.7 lb ai/ ton paper 500 tons 0.092 33 Papermaking Chemicals Metering pump 0.000265 0.0019 lb ai/ gal additive 1,000 gallons 8.5E 6 350,000 Initial Dose ( ST): 8.86E 5 lb ai/ gal water 5,900,000 gallons 0.0023 ST= 1300 Maintenance Dose ( IT): 4.69E 5 lb ai/ gal 5,900,000 gallons 0.0012 IT= 2,500 Initial Dose ( ST): 8.86E 5 lb ai/ gal water 153,000,000 gallons 0.06 ST = 50 Once through Cooling Water System  Power plant Metering pump 0.000265 Maintenance Dose ( IT): 4.69E 5 lb ai/ gal 153,000,000 gallons 0.032 IT= 95 Liquid pour 0.45 6.67 lb ai/ gal product 10 gallons 0.5 6 Initial Dose ( ST): 3.34E 4 lb ai/ gal water 20,000 gallons 0.00048 ST= 6,200 Small process water systems: Recirculating cooling tower/ evaporative condenser/ pasteurizers Metering pump 0.00432 Maintenance Dose ( IT): 1.25E 4 lb ai/ gal water 20,000 gallons 0.00018 IT= 17,000 5.6 gallons ST = 0.00032 ST = 9,300 Oil field operations  drilling mud and packing fluids Liquid pour 0.00346 1.00 lb ai/ gal product 2.8 gallons IT = 0.00016 IT = 19,000 100 gallons 0.00017 18,000 Metal/ wood cooling tower surface spray High pressure spray 0.12 0.00084 lb ai/ gal water 1,000 gallons 0.0017 1,800 Swimming Pools ( Use Site Category X)

Winterizing Dose ( ST):

0.000052 lb ai/ gal 200,000 gallons 0.0006 ST = 5,000 Application to swimming pools Liquid pour 0.00346 Maintenance Dose ( IT/ LT):

0.0000098 lb ai/ gal 200,000 gallons 0.00011 IT/ LT = 27,000 ST = short term, IT = intermediate term, LT = long term, N/ A= No data available a Absorbed Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb a. i.) x absorption factor ( 1.0 for inhalation) x application rate x quantity treated / Body weight ( 60 kg for inhalation). b MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose [ Where NOAEL = 3 mg/ kg/ day for all inhalation exposure durations]. Target MOE = 100. c The MOEs refer to short term and intermediate term duration unless indicated otherwise.

6.2 Occupational Post application Exposures Page 49 of 107 Except for the post application scenarios assessed for hand washes in Section 6.2.1, fogging in Section 6.2.2, and wood preservatives in Section 6.3, occupational post application dermal and inhalation exposures are assumed to be negligible.

6.2.1 Hand Sanitizing ADBAC containing products can be used as a hand sanitizer in occupational settings. In this scenario, a worker washes and rinses their hands and then applies the ADBACcontaining solution ( water based) to the hands. The hands are not rinsed after contact with the solution.

Dermal Exposures Exposure Calculations A short term exposure estimate was derived using the following equation:

E = % ai x FT x CF1 ( Eq. 11)

Where:

E = Dermal Skin Irritation Exposure ( µ g/ cm2); % ai = Fraction of active ingredient in treated solution ( unitless); FT = Film thickness of bath oil on hands ( mg/ cm2); and CF1 = Conversion factor ( 1,000 µ g/ mg).