UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: February 1, 2006 Subj: Propiconazole: Revised Occupational and Residential Exposure Assessment of the Antimicrobial Uses to Support the Reregistration Eligibility Decision ( RED) Document. PC Code: 122101. Reregistration Case No. 3125. DP Barcode 324052.

From: Tim Leighton, Environmental Scientist Antimicrobials Division/ Regulatory Management Branch 2 ( 7510C)

Through: Mark Hartman, Branch Chief Antimicrobials Division/ Regulatory Management Branch 2 ( 7510C)

To: Stacey Grigsby, Chemical Review Manager Antimicrobials Division/ Regulatory Management Branch 2 ( 7510C)

And,

Yan Donovan, Risk Assessor Health Effects Division/ Registration Action Branch 4 ( 7509C)

The attached assessment is the revised draft occupational and non occupational ( residential) exposure and risk estimates for the antimicrobial uses of propiconazole to support HED's Reregistration Eligibility Decision ( RED) document. The revisions are based on the " erroronly comments submitted by Janssen Pharmaceutica Inc. 1 TABLE OF CONTENTS EXECUTIVE SUMMARY................................................................................................... 2 1.0 INTRODUCTION.................................................................................................... 6 1.1 Purpose ................................................................................................................. 6 1.2 Criteria for Conducting Exposure Assessments ...................................................... 6 1.3 Chemical Identification .......................................................................................... 7 1.4 Physical/ Chemical Properties.................................................................................. 8 2.0 USE INFORMATION.............................................................................................. 8 2.1 Formulation Types and Percent Active Ingredient ................................................. 8 2.2 Summary of Use Pattern and Formulations............................................................ 8 3.0 SUMMARY OF TOXICITY DATA ........................................................................ 10 3.1 Acute Toxicity...................................................................................................... 10 3.2 Summary of Toxicity Endpoints ............................................................................ 10 3.3 FQPA Considerations ........................................................................................... 12 4.0 RESIDENTIAL EXPOSURE ASSESSMENT......................................................... 12 4.1 Summary of Registered Uses ................................................................................ 12 4.2 Residential Exposure............................................................................................. 12 4.2.1 Residential Handler Exposures ...................................................................... 13 4.2.2 Residential Post application Exposures.......................................................... 14 4.2.3 Data Limitations/ Uncertainties ...................................................................... 15 5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION.......................................................................................... 15 6.0 OCCUPATIONAL EXPOSURE ASSESSMENT .................................................... 15 6.1 Occupational Handler Exposures .......................................................................... 18 6.2 Occupational Post application Exposures.............................................................. 23 6.3 Metalworking Fluids: Machinist ........................................................................... 23 6.4 Wood Preservation ............................................................................................... 25 6.4.1 Non Pressure Treatment Scenarios ( Handler and Post application)................ 25 <IP_ADDRESS> Scenarios Assessed by Worker Function................................................... 25 <IP_ADDRESS> Scenarios Assessed for High Pressure/ High Volume Spray Application Methods.................................................................................................... 31 6.4.2 Pressure Treatment Scenarios ( Handler and Post Application)....................... 34 6.5 Data Limitations/ Uncertainties .............................................................................. 36 7.0 REFERENCES......................................................................................................... 38 APPENDIX A ( Summary of CMA and PHED Data) :.......................................................... 40 APPENDIX B ( Calculation of DDAC Unit Exposure Values) .............................................. 43 2 EXECUTIVE SUMMARY This document is the Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision Document ( RED) for propiconazole. It addresses the potential risks to humans that result from the use of this chemical in occupational and residential settings.

At this time, propiconazole is the active ingredient in material preservative products ( Use Site Category VII) and in wood preservation products ( Use Site Category X). As a materials preservative, the products are used in items such as metalworking fluids, adhesives, caulks, coatings, stains, paints, inks, paper, textiles1, canvas, cordage, leather, and leather finishing pastes, fat liquors, or finishes. As a wood preservative, the products can be used on green or fresh cut lumber, poles, posts, and timbers; manufactured wood products such as logs ( including for log home construction), wood chips/ sawdust, plywood veneer, and particle board; dry lumber; and finished wood products such as millwork, shingles, shakes, siding, plywood, and structural lumber and composites. The majority of the products are intended for use at wood treatment facilities; however, propiconazole is also formulated for use in mushroom houses to protect timber trays and benches and for use on cooling tower wood. The wood and wood products can be treated through non pressure treatment methods and pressure treatment methods. The percentage of propiconazole in various products can range from 0.1% to 50%. Products containing propiconazole are formulated as liquid ready to use, soluble concentrates, emulsifiable concentrates, and flowable concentrates.

The durations and routes of exposure evaluated in this assessment include short term ( ST), intermediate term ( IT), and in some instances long term ( LT) dermal and inhalation exposures as well as ST incidental oral exposures. Short term dermal, inhalation, and incidental oral endpoints are based on an acute neurotoxicity ( oral) study in rats. The shortterm endpoint ( NOAEL) is 30 mg/ kg/ day for dermal, inhalation, and incidental oral exposures. The adverse effects for these endpoints are based on observations of clinical signs consisting piloerection, diarrhea, and tip toe. The intermediate and long term dermal, inhalation, and incidental oral toxicological endpoints are the same at 10 mg/ kg/ day. These endpoints are based on a 24 month oncogenicity ( oral) study in mice where adverse effects included increased liver weight and liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly) in males. A dermal absorption factor of 40% was used based the results of a dermal absorption study. For inhalation assessments, an absorption factor of 100% was used.

The Agency's level of concern for non cancer risks ( i. e., target level for MOEs or Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a 10X factor to account for inter species extrapolation and a 10X factor to account for intra species variation. The total uncertainty factors that have been applied to non cancer risk assessments are 100 for occupational and residential short and intermediateterm scenarios. Propiconazole is listed as a Group C, Possible Human Carcinogen. A cancer slope factor was not identified for propiconazole, therefore a quantitative cancer risk assessment is not provided at this time. Since the toxicity effects were the same for dermal, inhalation and incidental oral exposures, these exposures were combined for a total MOE for 1 It should be noted that Syngenta and Janssen agree to withdraw the use of propiconazole for the treating of carpet fibers, apparel, and furnishings. The primary textile use includes " canvas" ( i. e., awnings, boat covers, carpet backing, cordage, tents, tarpaulins, and wall coverings). 3 both occupational and residential assessments.

Based on examination of product labels describing uses for the product, it has been determined that exposure to handlers can occur in a variety of occupational and residential environments. Additionally, postapplication exposures are likely to occur only in the occupational setting. The representative scenarios selected by the Antimicrobials Division ( AD) for assessment were evaluated using maximum application rates as stated on the product labels.

To assess the handler risks, AD used surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers Association ( CMA) antimicrobial exposure study, the Pesticide Handlers Exposure Database ( PHED), 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 which is a Sapstain Industry Task Force Study, # 73154), and " Assessment of Potential Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Arsenical Wood Products" ( ACC, 2002). Additionally, EPA's Health Effects Division's ( HED) Standard Operating Procedures ( SOPs) for Residential Exposure Assessments was used to estimate postapplication/ bystander exposures.

Residential Handler Risk Summary For the residential handler dermal and inhalation risk assessment, all dermal, inhalation and total MOEs were above the target MOE of 100.

Occupational Handler Risk Summary For the occupational handler dermal and inhalation risk assessment, the MOEs were above the target MOE of 100 at either baseline PPE/ open pouring or through the use of mitigation ( e. g., metering pumps) for all scenarios except for the following scenarios listed below. The reader is referred to Tables 6.2 through 6.10 to review the various needs for PPE and/ or metering pumps to mitigate risks for each scenario. It should be noted that the baseline ( ungloved) dermal MOEs for material preservation of paints, textiles, adhesives, and metalworking fluid were calculated using unit exposure values from the cooling tower CMA data set because baseline dermal unit exposures are not available for preservative or metal fluid categories.

Wood Preservation:   Wood Preservation, spray in wood treatment facility: IT/ LT dermal MOE ( gloves) at 50 gallons = 96, IT/ LT total MOE at 50 gallons = 86   Wood Preservation, spray in mushroom house: IT dermal MOE ( gloves) at 1,000 gallons = 56, IT total MOE at 1,000 gallons = 50.   Wood Preservation, treatment operator ( pressure treatment): IT dermal MOE = 86 and IT total MOE = 86 Material Preservation: 4   Painting, airless sprayer: IT baseline dermal MOE = 26 and IT gloved dermal MOE = 71. IT baseline total MOE = 25 and IT gloved total MOE = 62.

Occupational Post application/ Bystander Risk Summary For the occupational postapplication risk assessment, the MOEs were above target MOE of 100, and therefore not of concern for all scenarios except the following:

Wood Preservation:   Wood Preservation, clean up worker ( non pressure treatment): IT/ LT dermal MOE = 51 and IT/ LT total MOE = 49.

Data Limitations and Uncertainties:

There are a number of uncertainties associated with this assessment and these have been reiterated from Sections 4.4.3 ( residential) and 6.5 ( occupational) respectively.

The data limitations and uncertainties associated with the residential handler and postapplication exposure assessments include the following:

  Surrogate dermal and inhalation unit exposure values were taken from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summary of this database).   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 AD standard assumptions. 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.   Propiconazole is used on many different types of wood. AD needs additional information on the " dry lumber" uses. The other wood treatments would result in minimal dermal and/ or incidental oral exposure. Inhalation exposure ( e. g., in log homes treated with propiconazole) is also expected to be negligible based on the low vapor pressure. The " dry lumber" uses need to be defined by the registrant to determine if propiconazole treated lumber is used to build residential decks and/ or play sets. There is the potential for dermal exposure to treated lumber for uses in decks and or play sets. To complete an assessment, dislodgeable residues from treated wood need to be generated ( i. e., wipe studies).

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 A 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. 5   The baseline ( ungloved) dermal exposures and risks for material preservation of paints, textiles, adhesives, and metalworking fluid were calculated using unit exposure values from the cooling tower CMA data set because baseline dermal unit exposures are not available for preservative or metal fluid CMA unit exposure categories.   For the wood preservative pressure treatment scenarios, proprietary CCA exposure data were used for lack of propiconazole specific exposure data and for the wood preservative non pressure treatment scenarios, proprietary DDAC exposure data were used for the lack of propiconazole 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 propiconazole, and therefore the exposures could be used as surrogate data for workers that treat wood with propiconazole. o For environmental modeling, it was assumed that the leaching process from the propiconazole treated wood would be similar to that of CCA and DDAC. However, due to the lack of real data for propiconazole  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 AD standard assumptions. 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. In particular, the quantities handled/ treated for the application of propiconazole to wood in mushroom houses through high pressure/ high volume spray methods could be further refined. 6 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 propiconazole. This information is for use in EPA's development of the propiconazole Reregistration Eligibility Decision Document ( RED).

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 propiconazole, both criteria are met.

In this document, 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 dermal or inhalation handler exposures are estimated for each applicable handler task with the application rate, quantity treated/ handled in a day, and the applicable dermal or inhalation unit exposure using the following formula:

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

Where: E = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount 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; 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). 7 Daily Dose: The daily dermal or 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 40% was used for dermal exposures and an absorption factor of 100% was used for inhalation exposures since the endpoint was based on an oral study. 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) deposited on the surface of the skin that is available for dermal absorption or amount 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 and dermal risks for each applicable handler scenario are calculated using a Margin of Exposure ( MOE), which is a ratio of the daily dose to the toxicological endpoint of concern.

Margins of Exposure: MOE = NOAEL or LOAEL ( Eq. 3) 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 = Dose level in a toxicity study, where no observed adverse effects ( NOAEL) or where the lowest observed adverse effects ( LOAEL) occurred in the study ( mg/ kg/ day); and ADD = Average daily dose or the absorbed dose received from exposure to a chemical in a given scenario ( mg ai/ kg body weight/ day).

In addition to the target MOEs from 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:

  Propiconazole 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 propiconazole uses.   The average body weight of an adult handler of 70 kg was used to complete the noncancer 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 8 Propiconazole is identified as follows:

  Common/ Chemical Name: Propiconazole   PC Code: 122101   CAS Number: 60207 90 1 1.4 Physical/ Chemical Properties Table 1.1 shows physical/ chemical characteristics that have been reported for propiconazole.

Table 1.2. Physical/ Chemical Properties of Propiconazole Parameter Propiconazole Molecular Weight 342.23 Density 1.27 g/ cm3 Boiling Point 180 C at 0.1 mmHg Water Solubility 110 ppm at 20 C Vapor Pressure 1.0 x 10  6 mmHg at 20 C 2.0 USE INFORMATION 2.1 Formulation Types and Percent Active Ingredient The products containing propiconazole as the active ingredient ( a. i) are formulated as liquid ready to use, soluble concentrates, emulsifiable concentrates, and flowable concentrates. Concentrations of propiconazole in these products range from 0.1% to 50%.

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 Table 2.1. Based on a review of product labels, propiconazole is the active ingredient in material preservation products ( Use Site Category VII) and in wood preservation products ( Use Site Category X). As a materials preservative, the products are used in items such as metalworking fluids, adhesives, caulks, coatings, stains, paints, inks, paper, textiles2, canvas, cordage, leather, and leather finishing pastes, fat liquors, or finishes. As wood preservative, the products can be used on green or fresh cut lumber, poles, posts, and timbers; manufactured wood products such as logs ( including for log home construction), wood chips/ sawdust, plywood veneer, and particle board; dry lumber; and 2 It should be noted that Syngenta and Janssen agree to withdraw the use of propiconazole for the treating of carpet fibers, apparel, and furnishings. The primary textile use includes " canvas" ( i. e., awnings, boat covers, carpet backing, cordage, tents, tarpaulins, and wall coverings). 9 finished wood products such as millwork, shingles, shakes, siding, plywood, and structural lumber and composites. The majority of the products are intended for use at wood treatment facilities, however, propiconazole is also formulated for use in mushroom houses to protect timber trays and benches and for use on cooling tower wood. The wood and wood products can be treated through non pressure treatment methods and pressure treatment methods.

From Table 2.1, AD selected representative exposure scenarios to assess the labeled uses of propiconazole 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 or inhalation, exposure. The representative scenarios assessed in this document are shown in Table 4.1 ( residential) and Table 6.1 ( occupational).

Table 2.1. Potential Use Scenarios Based on Product Labels for Propiconazole Registration Numbers Example Use Sites Scenarios Use Site Category VII  Material Preservatives 5383 114, 1448 394, 3813 19, 43813 37, 43813 16, 70227 6, 71406 1 Used in the production of various household, institutional and industrial items   Adhesives   Caulks   Coatings ( including paper, roof and stucco and EIFS coatings)   Inks   Joint cements   Leather   Leather finishing pastes, fatliquors, or finishes   Metalworking fluids   Paints   Sealants   Stains   Canvas, and cordage ( through dye incorporation, pad, exhaust, or spray application) Use Site Category X  Wood Preservatives 1022 585, 1448 394, 1448 414, 5383 114a, 43813 15, 43813 16b, 43813 19, 43813 37c, 57227 3, 57227 6, 60061 102d, 60061 107, 60061 109, 60061 112, 60061 114, 60061 115, 62190 12, 62190 17, 70227 4, 70227 6, 71406 1, 72616 1, 74405 1, 75101 1   Fresh lumber, poles, posts, timbers   Dry lumber   Wood products such as logs ( including log home construction, poles, timbers), particle board, wafer board, wood chips, saw dust, and plywood   Wood in cooling towers   Wood in mushroom houses   Non pressure treatment of wood and wood products through methods such as dipping, conventional spray system, spray box, low pressure spray, high pressure spray, low volume spray machine, immersion, brush, roller coater, and flood.

  Pressure treatment of wood and wood products through methods such as vacuum, full cell, and modified fullcell

  Spray and paint cooling tower wood   Pouring of product into cooling tower water for protection of wood   Spray ( large droplet sprayer) or dip wood trays and boards in mushroom house a. Label 5383 114 does not provide an application method. b. Label 43813 16 does not specifically indicate if the cooling tower wood is treated before or after manufacture 10 of the cooling tower. c. Label 43813 37 indicates a maximum of 1% ai solution for non pressure treatment methods such as immersion, roller coater, flood, spray, and brush d. Label 60061 102 indicates that the product ( Kop Coat Woodtreat 10) is to be used only in combination with Kop Coats sapstain control products.

3.0 SUMMARY OF TOXICITY DATA 3.1 Acute Toxicity The acute toxicity data for propiconazole are summarized below in Table 3.1 ( USEPA, 2003).

Table 3.1. Acute Toxicity Profile for Propiconazole Guideline No. Study Type MRID # Results Toxicity Category 81 1 Acute Oral  rat 00058591 LD50 = 1517 mg/ kg III 81 2 Acute Dermal rabbit 00058596 LD50 = > 4000 mg/ kg III 81 3 Acute Inhalation  rat 41594801 LC50 = > 50.84 mg/ L IV 81 4 Primary Eye Irritation 00058597 Corneal opacity reversed in 72 hours III 81 5 Primary Skin Irritation 00058598 No irritation IV 81 6 Dermal Sensitization 00058600 Non sensitizer

3.2 Summary of Toxicity Endpoints Table 3.2 summarizes the toxicological endpoints for propiconazole ( USEPA, 2003).

Table 3.2 Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13 50) Dev. NOAEL = 30 mg ai/ kg/ day UF = 100 Acute RfD = 0.3 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.3 mg/ kg/ day Developmental Toxicity Study  Rats. Increased incidence of rudimentary ribs, cleft palate malformations ( 0.3%) unossified sternebrae, as well as increased incidence of shortened and absent renal papillae.

Acute Dietary ( General Population including infants and children) NOAEL = 30 mg ai/ kg UF = 100 Acute RfD = 0.3 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.3 mg/ kg/ day Acute Neurotoxicity Study  Rats. Clinical toxicity: piloerection, diarrhea, tip toe at 100 mg/ kg 11 Table 3.2 Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Chronic Dietary ( All populations) NOAEL = 10 mg ai/ kg/ day UF = 100 Chronic RfD = 0.1 mg/ kg/ day 1X cPAD = chronic RfD FQPA SF = 0.1 mg/ kg/ day 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Short Term ( 1 30 days) Incidental Oral NOAEL= 30 mg ai/ kg Residential MOE = 100 Occupational = NA Acute Neurotoxicity Study  Rats. Clinical toxicity: piloerection, diarrhea, tip toe at 100 mg/ kg Intermediate Term ( 1  6 months) Incidental Oral NOAEL= 10 mg ai/ kg/ day Residential MOE = 100 Occupational = NA 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Short Term ( 1  30 days) Dermal ( General Pop. including infants and children) Oral NOAEL= 30 mg ai/ kg ( Dermal absorption rate = 40%) Residential MOE = 100 Occupational MOE = 100 Acute Neurotoxicity Study  Rats. Clinical toxicity: piloerection, diarrhea, tip toe at 100 mg/ kg Intermediate Term ( 1  6 months) and Long Term Dermal (> 6 months) Oral NOAEL= 10 mg ai/ kg/ day ( Dermal absorption rate = 40%) Residential MOE = 100 Occupational MOE = 100 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Short Term ( 1  30 days) Inhalation Oral NOAEL= 30 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 100 Occupational MOE = 100 Acute Neurotoxicity Study  Rats. Clinical toxicity: piloerection, diarrhea, tip toe at 100 mg/ kg Intermediate Term ( 1  6 months) and Long Term Inhalation (> 6 months) Oral NOAEL= 10 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 100 Occupational MOE = 100 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Cancer ( Oral, dermal, inhalation) Group C, possible human carcinogen UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic), RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable. 12 It should be noted that although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL.

3.3 FQPA Considerations It has been determined by the HED Hazard Identification Assessment Review Committee ( HIARC) that no special FQPA safety factor is required for propiconazole because there are no residual uncertainties for pre and/ or post natal toxicity. For a more thorough review of the FQPA safety factor the reader is referred to the HIARC report ( USEPA 2003a).

4.0 RESIDENTIAL EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Some products containing propiconazole can be used as a material preservative in a variety of products, such as textiles and paints, which can result in exposure to residential users handling the treated products. Table 2.1 presents a summary of all exposure scenarios, including those scenarios which may occur in residential settings. Table 4.1 identifies the representative exposure scenarios assessed in this document. It should be noted that Syngenta and Janssen agree to withdraw the use of propiconazole for the treating of carpet fibers, apparel, and furnishings. The primary textile use includes " canvas" ( i. e., awnings, boat covers, carpet backing, cordage, tents, tarpaulins, and wall coverings).

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. Handler exposures were assessed for the application of propiconazole used as a material preservative in paint ( paint brush/ roller and airless sprayer). Based on the low vapor pressure of propiconazole, no post application inhalation exposure is anticipated to occur. Furthermore, based on the new use patterns ( i. e., no treated fibers/ textiles) in the residential setting, no post application exposures are expected to occur. 13 Table 4.1. Representative Uses Associated with Residential Exposure to Propiconazole Representative Use Exposure Scenario Application Method Registration # Application Rate Using treated paint ST Handler: Adult dermal and inhalation ( aerosols) Paint brush/ rollers, airless sprayer 5383 114 0.35% a. i. by weight of material to be preserved ( 5% product by weight of material treated x 7% a. i. in the product)

ST = Short term exposure 4.2.1 Residential Handler Exposures The residential handler scenarios described in Table 4.1 were assessed to determine dermal and inhalation exposures. The scenarios were assessed using PHED data and Equations 1 3 in Section 1.2, " Criteria for Conducting Risk Assessment." A summary of the PHED data set is presented in Appendix A.

Unit Exposure Values: Unit exposure values were taken from the PHED data presented in HED's Residential SOPs ( USEPA, 1997).

  For the airless sprayer scenario, PHED dermal and inhalation unit exposure values for a residential handler applying a pesticide using an airless sprayer were used. These unit ungloved exposure values ( 79 mg/ lb a. i. for dermal and 0.83 mg/ lb a. i. for inhalation) represent a handler wearing short pants and a short sleeve shirt, with no gloves.   For the brush/ roller scenario, PHED dermal and inhalation unit exposure values for a residential handler applying a pesticide in paint using a paint brush to paint a bathroom were used. These unit exposure values ( 230 mg/ lb a. i. for dermal and 0.284 mg/ lb a. i. for inhalation) represent a handler wearing short pants and a short sleeve shirt, with no gloves.

Quantity handled/ treated: The quantities handled/ treated were estimated based on information from various sources, including AD's standard assumptions.

  For the airless sprayer in paint applications, it is assumed that 15 gallons ( or 150 lb/ day, assuming paint has a density of 10 lb/ gal) of treated paint will be used per day ( USEPA, 2005b).   For the brush/ roller in paint applications, it is assumed that 2 gallons ( or 20 lb/ day, assuming paint has a density of 10 lb/ gal) of treated paint will be used per day ( USEPA, 2005b).

Duration of Exposure: The duration of exposure for most homeowner applications of paint 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 postapplication scenarios are assumed to be episodic, not daily. In addition, homeowners are assumed to use different products with varying actives, not exclusively propiconazole treated products. 14 Results The resulting short term exposures and MOEs for the representative residential handler scenarios are presented in Table 4.2. The calculated dermal and total MOEs were above the target MOE of 100 for both scenarios ( 330 for brush/ roller and 130 for airless spray). The inhalation MOEs were also well above the target MOE of 100.

Although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL. All short term inhalation MOEs exceeded 1,000 therefore, a confirmatory inhalation toxicity study is not warranted based on the results of these exposure scenarios.

Table 4.2 Short Term Residential Handlers Exposures and MOEs Unit Exposure ( mg/ lb a. i.) Absorbed Daily Dose ( mg/ kg/ day) e MOE f Exposure Scenario  Application Method Application Ratea Quantity Handled/ Treated per dayb Dermalc Inhalationd Dermal Inhalation Dermal ( Target = 100) Inhalation ( Target = 100) TOTAL MOE g ( Target = 100)

Painting  Brush/ Roller 0.35% a. i. by weight 20 lbs 230 0.284 0.092 0.0003 330 110,000 330 Painting  Airless Sprayer 0.35% a. i. by weight 150 lbs 79 0.83 0.24 0.0062 130 4,800 120 a Application rates are the maximum application rates determined from EPA registered labels for propiconazole. b Amount handled per day values are estimates based on AD's standard assumptions. c All dermal unit exposures represent ungloved, short sleeve shirt, and short pants replicates. d Baseline = No respirator e Absorbed Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb a. i.) * application rate (% a. i. weight) * quantity treated ( lb/ day) * absorption factor ( 0.4 for dermal; 1.0 for inhalation)]/ Body weight ( 70 kg). f MOE = NOAEL / Absorbed Daily Dose. [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation]. Target MOE is 100. g Total MOE = 1/(( 1/ Dermal ST MOE) + ( 1/ Inhalation ST MOE)). The target MOE is 100.

4.2.2 Residential Post application Exposures As previously stated, post application residential scenarios were not necessary to assess because of propiconazole's low vapor pressure ( therefore, no inhalation exposure) and the registrants' deletion of the only other residential use ( i. e., materials preservative in fabrics, textiles, are carpet fibers).

Additionally, propiconazole is used to treat various types of wood. Propiconazole is used on many different types of wood including 1) green or fresh cut lumber, poles, posts, and timbers; 2) manufactured wood products such as logs ( including for log home construction), wood chips/ sawdust, plywood veneer, and particle board; 3) dry lumber; and 4) finished wood products such as millwork, shingles, shakes, siding, plywood, and structural lumber and composites. From these 4 groupings, AD needs additional information on the " dry lumber" uses. The other 3 groupings would result in minimal dermal and/ or incidental oral exposure. Inhalation exposure ( e. g., in log homes treated with propiconazole) is also expected to be 15 negligible based on the low vapor pressure. The " dry lumber" uses need to be defined by the registrant to determine if propiconazole treated lumber is used to build residential decks and/ or play sets. There is the potential for dermal and incidental oral exposures to treated lumber for uses in decks and or play sets. To complete an assessment, dislodgeable wood residues would need to be generated ( i. e., wipe studies).

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

  Surrogate dermal and inhalation unit exposure values were taken from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources).   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.

5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION The aggregate risk assessment for propiconazole will be conducted by the Health Effects Division ( HED). However, there are no antimicrobial residential uses that are likely to co occur.

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 a. i./ gal is noted, the product is assumed to have the density of water because no product specific density is available.

Occupational handler exposure can occur during the preservation of materials that are used for household, institutional, and industrial uses ( metalworking fluid, paint, canvas, etc), along with the preservation of wood. Additionally, occupational post application exposures can occur through the use of the treated products through job functions such as a painter and machinist. The " preservation of materials" refers to the scenario of a worker adding the preservative to the material being treated through either liquid pour or liquid pump methods. Liquid pour refers to transferring the antimicrobial product from a small container to an open vat. Liquid pump refers to transferring the preservative by connecting/ disconnecting a chemical metering pump from a tote or by gravity flow. 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 in a separate section, 6.4. 16 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to Propiconazole Representative Use Method of Application Exposure Scenario Registration # Application Rate Material Preservation ( Use Site Category VII)

Paint Preservation of paint   Liquid pour   Liquid pump Professional painter   Brush/ Roller   Airless sprayer IT and ST Handler: Dermal and inhalation ST Prof Painter: Dermal and inhalation 5383 114 0.35% a. i. by weight of material to be preserved ( 5% product by weight of material treated x 7% a. i. in the product)

Textiles/ Canvas   Liquid pour   Liquid pump IT and ST Handler: Dermal and inhalation 5383 114 0.28% a. i. by weight of material to be preserved ( 4% product by weight of material treated x 7% a. i. in the product)

Adhesives, coatings, caulks, sealants, and inks   Liquid pour   Liquid pump IT and ST Handler: Dermal and inhalation 43813 19 1.213% a. i. by weight of material to be preserved ( 12.5% based on total weight of formulation x 9.7% a. i. in product)

Metalworking fluid ( worker pouring preservative into fluid being treated)   Liquid pour   Liquid pump IT/ LT and ST Handler: Dermal and inhalation ST and IT/ LT Machinist: dermal and inhalation 43813 16 0.07% a. i. by weight of fluid ( 700 ppm a. i. in diluted fluid x 1%/ 10,000 ppm) 17 Wood Preservation ( Use Site Category X)

Handler Worker Functions   Diptank Operators   Blender/ spray operators   Chemical operators Post Application Worker Functions   Graders   Trim saw operators   Clean up crews   Construction Workers IT/ LT and ST Handler and Post application: Dermal and inhalation 43813 19 or 43813 37a Diptank operators and blender/ spray operators:

1% ai solution for sapstain ( 43813 19)

and 0.5% ai solution for decay control All other worker functions:

50% ai in product ( 43813 37) Non pressure treatment of wood and wood products in wood treatment facilities   High pressure/ high volume spray IT and ST Handler: Dermal and inhalation 60061 112 0.1460 lb ai gal ( 1 gal product/ 2 gal water * density 8.34 lb/ gal * 3.5% ai)

Mushroom house ( Nonpressure treatment)   High pressure/ high volume spray IT and ST Handler: Dermal and inhalation 43813 15 0.0125 lb ai/ gal ( 19.5 oz/ 25gal water* 1gal/ 128 oz * 2.05 lb ai/ gal)

** 1 gal solution/ 200 ft2 wood Cooling towers ( Non pressure treatment)   High pressure/ high volume spray IT and ST Handler: Dermal and inhalation 43813 16 0.0216 lb ai/ gal ( 1.1% product solution * 23.6% ai * 8.34 lb/ gal)

** 1 gal solution/ 47 ft2 wood 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 IT/ LT and ST Handler and Post application: Dermal and inhalation Provided by Registrant b 1% ai solution ST= short term ( 1 to 30 days), IT= intermediate term ( 1 to 6 months), LT = long term ( greater than 6 months) a. Diptank operators and blender/ spray operators are assessed using the maximum percent ai in solution. The maximum application for non pressure treatment methods such as immersion, roller coater, flood, spray, and brush is 1% ai solution ( 43813 19). These methods are for finished wood products. Label 43813 37 also indicates a maximum of 1% ai solution for these application methods; however, the dilution rate on the label ( gallons product to gallons water) does not coincide with % ai in solution. The Registrant indicated that for dip tank, conventional spray, and electrostatic spray methods, the maximum application rate is 0.5% ai solution from Propiconazole Use Closure Memo Amendment dated April 22, 2005 ( USEPA, 2005a). Therefore, the assessment for diptank operators and blender/ spray operators was conducted using both application rates. It should be noted, however, that the maximum application rates according to the labels are 0.65% ai solution ( 60061 115) for an open dip tank, 0.8% ai solution ( 1448 394) for conventional spray, and 50% ai ( 43813 37) for electrostatic spray. For the remaining worker functions, the exposures are assessed using the % active ingredient in the product. The product with the highest 18 percent active ingredient is 43813 37 ( 50% ai).

b. Not all of the labels provided the application rate in terms of % ai solution, therefore, pressure treatment was assessed using the maximum application rate of 1 % which was provided by the Registrant and reported in the Propiconazole Use Closure Memo Amendment dated April 22, 2005 ( USEPA, 2005a). The application rate is needed in terms of % ai solution in order to use the surrogate unit exposure data.

6.1 Occupational Handler Exposures The occupational handler scenarios included in Table 6.1 were assessed to determine dermal and inhalation exposures. The general assumptions and equations that were used to calculate occupational handler 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.

Unit Exposure Values ( UE): Dermal 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).

  For the liquid pour scenarios for materials preservatives, 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 Metalworking fluid: CMA metal fluid gloved data. The dermal UE is 0.184 mg/ lb a. i. and the inhalation UE is 0.00854 mg/ lb a. i.. The values are based on 8 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. Since no baseline dermal ( ungloved) unit exposure data are available for metalworking fluid, the baseline dermal exposures were evaluated using the cooling tower CMA data ( 50.3 mg/ lb ai). o Adhesives, Paint and Textiles: CMA preservative gloved data. The dermal UE is 0.135 mg/ lb a. i. and the inhalation UE is 0.00346 mg/ lb a. i.. The values are based on 2 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. Since no baseline dermal ( ungloved) unit exposure data are available for preservative uses in adhesives, paint, or textiles, the baseline dermal exposures were evaluated using the cooling tower CMA data ( 50.3 mg/ lb ai).   For the liquid 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 Metalworking fluid: CMA metal fluid gloved data. The dermal UE is 0.312 mg/ lb a. i. and the inhalation UE is 0.00348 mg/ lb a. i. The values are based on 2 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. Since no baseline dermal ( ungloved) unit exposure data are available for metalworking fluid, the baseline dermal exposures were evaluated using the cooling tower CMA data ( 0.454 mg/ lb ai). o Adhesives, Paint and Textiles: CMA preservative gloved data. The dermal UE is 0.00629 mg/ lb a. i. and the inhalation UE is 0.000403 mg/ lb a. i. The values are based on two replicates where the test subjects were wearing a single layer of 19 clothing and chemical resistant gloves. Since no baseline dermal ( ungloved) unit exposure data are available for preservative uses in adhesives, paint, or textiles, the baseline dermal exposures were evaluated using the cooling tower CMA data ( 0.454 mg/ lb ai).   For roller/ brush scenarios, the occupational PHED dermal and inhalation unit exposure values for paintbrush applications ( PHED scenario 22) were used ( single layer of clothing). The inhalation exposure value is 0.28 mg/ lb a. i. The dermal unit exposures are 180 mg/ lb a. i. for ungloved replicates and 24 mg/ lb a. i. for gloved replicates.   For airless sprayer scenarios, the occupational PHED dermal and inhalation unit exposure values for airless sprayer application ( PHED scenario 23) were used ( single layer of clothing). The inhalation exposure value is 0.83 mg/ lb a. i. The dermal unit exposures are 38 mg/ lb a. i. for ungloved replicates and 14 mg/ lb a. i. for gloved replicates.

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 Metalworking fluid: 2,502 lbs ( approximately 300 gallons, based on the density of of water, 8.34 lb a. i./ gal) ( Dang, 1997) o Paint: 2,000 lbs ( approximately 200 gallons, weight based on a density 10 lb a. i./ gal) ( standard AD assumption). o Adhesives and Textiles: 10,000 lbs ( standard AD assumption).   For the liquid 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 Metalworking fluid: 2,502 lbs ( approximately 300 gallons, based on the density of of water, 8.34 lb a. i./ gal) ( Dang, 1997) o Paint: 10,000 lbs ( approximately 1,000 gallons, weight based on a density of 10 lb a. i./ gal) ( standard AD assumption). o Adhesives and Textiles: 10,000 lbs ( standard AD assumption).   For the roller/ brush painting scenario, it was assumed that 50 lbs ( approximately 5 gallons of paint with a density of 10 lb/ gal) of treated paint are used ( standard AD assumption).   For the airless sprayer in the painting scenario, it was assumed that 500 lbs ( approximately 50 gallons of paint with a density of 10 lb/ gal) of treated paint are used. ( standard AD assumption).

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 exposures and MOEs for the representative occupational handler scenarios are presented in Table 6.2 ( short term) and in Table 6.3 ( intermediate term). The calculated MOEs were above the target MOE of 100 for all scenarios, except those listed below. It should be noted that the baseline ( ungloved) dermal MOEs for the material preservation of paints, textiles, adhesives, and metalworking fluid were calculated using unit exposure values from the cooling tower CMA data set because baseline dermal unit exposures are not available for preservative or metal fluid categories. 20   Adhesives, liquid pour: IT baseline dermal MOE and IT baseline total MOE = < 1. ST baseline dermal MOE and ST baseline total MOE = < 1.   Adhesives, liquid pump: ST baseline dermal MOE and ST baseline total MOE = 95. IT baseline dermal MOE and IT baseline total MOE = 32.   Metalworking fluid, liquid pour: ST baseline dermal MOE and ST baseline total MOE = 60. IT/ LT baseline dermal MOE and IT/ LT baseline total MOE = 20.   Paint, liquid pour: ST baseline dermal MOE and ST baseline total MOE = 15. IT baseline dermal MOE and IT baseline total MOE = 5.   Textiles, liquid pour: ST baseline dermal MOE and ST baseline total MOE = 4. IT baseline dermal MOE and IT baseline total MOE = 1.   Painting ( professional), brush/ roller: IT baseline dermal MOE = 56 and IT baseline total MOE = 55.   Painting ( professional), airless sprayer: IT baseline dermal MOE = 26 and IT gloved dermal MOE = 71. IT baseline total MOE = 25 and IT gloved total MOE = 62. ST baseline dermal MOE = 79 and ST baseline total MOE = 75.

It should be noted that although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL. All of the occupational inhalation MOEs were above 1,000, except for the following scenarios:

  Painting ( professional), airless sprayer: IT inhalation MOE = 480. 21 Table 6.2 Short Term Risks Associated with Occupational Handlers Unit Exposure ( mg/ lb a. i.) Absorbed Daily Dose ( mg/ kg/ day) c MOEd Baseline Dermal ( Target MOE =

100) a PPE Gloves Dermal ( Target MOE =

100) b Inhalation ( Target MOE =

100) Total ST MOEe ( Target MOE = 100)

Exposure Scenario Method of Application Baseline Dermala PPEGloves Dermalb Inhalation Application Rate (% a. i.

by weight) Quantity Handled/

Treated per day Baseline Dermala PPEGloves Dermalb Inhalation ST ST ST Baseline PPE Material Preservatives ( Use Site Category VII)

Liquid Pour 50.3 0.135 0.00346 1.213 10,000 lbs 35 0.094 0.006 < 1 320 4,300 < 1 300 Preservation of Adhesives Liquid Pump 0.454 0.00629 0.000403 1.213 10,000 lbs 0.31 0.0044 0.0007 95 6,900 37,000 95 5,900 Liquid Pour 50.3 0.184 ( f) 0.00854 0.07 2,502 lbs 0.50 0.0018 0.00021 60 16,000 ( f) 120,000 60 15,000 ( f)

Preservation of Metalworking Fluid Liquid Pump 0.454 0.312 ( f) 0.00348 0.07 2,502 lbs 0.0045 0.0031 0.000087 6,600 9,600 ( f) 3,00,000 6,500 9,300 ( f)

Liquid Pour 50.3 0.135 0.00346 0.35 2,000 lbs 2.0 0.0054 0.00035 15 5,600 74,000 15 5,200 Preservation of Paint Liquid Pump 0.454 0.00629 0.000403 0.35 10,000 lbs 0.091 0.0013 0.00020 330 24,000 130,000 330 21,000 Liquid Pour 50.3 0.135 0.00346 0.28 10,000 lbs 8.0 0.022 0.0014 4 1,400 19,000 4 1,300 Preservation of Textiles Liquid Pump 0.454 0.00629 0.000403 0.28 10,000 lbs 0.073 0.0010 0.00016 410 30,000 160,000 410 26,000 Brush/ Roller 180 24 0.28 0.35 50 lbs 0.18 0.024 0.0007 170 1,300 37,000 170 1,200 Application of Paint by professionals Airless Sprayer 38 14 0.83 0.35 500 lbs 0.38 0.14 0.021 79 210 1,200 75 190 ST = short term, N/ A= No data available a Baseline Dermal: Long sleeve shirt, long pants, no gloves. It should be noted that the baseline dermal unit exposures for the preservation of adhesives, metalworking fluid, paint, and textiles were from the cooling tower CMA data set because baseline ( ungloved) dermal unit exposures are not available for the preservation CMA data set.

b PPE Dermal with gloves: baseline dermal plus chemical resistant gloves.

c Absorbed Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb a. i.) * absorption factor ( 0.4 for dermal; 1.0 for inhalation) * application rate * quantity treated / Body weight ( 70 kg).

d MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation].

e Total ST MOE = 1/(( 1/ Dermal ST MOE) + ( 1/ Inhalation ST MOE))

f The dermal exposures for the MWF use for liquid pour vs. pump appear to be illogical/ inconsistent with the protection afforded by closed systems. The liquid pour value is based on 8 replicates while the pump is based on 2 replicates. 22 Table 6.3 Intermediate Term Risks Associated with Occupational Handlers Unit Exposure ( mg/ lb a. i.) Absorbed Daily Dose ( mg/ kg/ day) c MOEd Baseline Dermal ( Target MOE =

100) a PPE Gloves Dermal ( Target MOE =

100) b Inhalation ( Target MOE =

100) Total IT MOEe ( Target MOE = 100)

Exposure Scenario Method of Application Baseline Dermala PPEGloves Dermalb Inhalation Application Rate (% a. i.

by weight) Quantity Handled/

Treated per day Baseline Dermala PPEGloves Dermalb Inhalation IT IT IT Baseline PPE Material Preservatives ( Use Site Category VII)

Liquid Pour 50.3 0.135 0.00346 1.213 10,000 lbs 35 0.094 0.006 < 1 110 1,700 < 1 100 Preservation of Adhesives Liquid Pump 0.454 0.00629 0.000403 1.213 10,000 lbs 0.31 0.0044 0.0007 32 2,200 14,000 32 2,000 Liquid Pour 50.3 0.184 0.00854 0.07 2,502 lbs 0.50 0.0018 0.00021 20 5,400 47,000 20 4,900 Preservation of Metalworking Fluid Liquid Pump 0.454 0.312 0.00348 0.07 2,502 lbs 0.0045 0.0031 0.000087 2,200 3,200 110,000 2,200 3,100 Liquid Pour 50.3 0.135 0.00346 0.35 2,000 lbs 2.0 0.0054 0.00035 5 1,900 29,000 5 1,700 Preservation of Paint Liquid Pump 0.454 0.00629 0.000403 0.35 10,000 lbs 0.091 0.0013 0.00020 110 7,900 50,000 110 6,900 Liquid Pour 50.3 0.135 0.00346 0.28 10,000 lbs 8.0 0.022 0.0014 1 460 7,200 1 440 Preservation of Textiles Liquid Pump 0.454 0.00629 0.000403 0.28 10,000 lbs 0.073 0.0010 0.00016 140 9,900 62,000 140 8,600 Brush/ Roller 180 24 0.28 0.35 50 lbs 0.18 0.024 0.0007 56 420 14,000 55 400 Application of Paint by professionals Airless Sprayer 38 14 0.83 0.35 500 lbs 0.38 0.14 0.021 26 71 480 25 62 IT = intermediate term, N/ A= No data available a Baseline Dermal: Long sleeve shirt, long pants, no gloves. It should be noted that the baseline dermal unit exposures for the preservation of adhesives, metalworking fluid, paint, and textiles were from the cooling tower CMA data set because baseline ( ungloved) dermal unit exposures are not available for the preservation CMA data set.

b PPE Dermal with gloves: baseline dermal plus chemical resistant gloves.

c Absorbed Daily dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb a. i.) * absorption factor ( 0.4 for dermal; 1.0 for inhalation) * application rate * quantity treated / Body weight ( 70 kg).

d MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose [ Where intermediate and long term NOAEL = 10 mg/ kg/ day for dermal and inhalation]. Note MWF is considered to be long term.

e Total IT MOE = 1/(( 1/ Dermal IT MOE) + ( 1/ Inhalation IT MOE)) 23 6.2 Occupational Post application Exposures Except for the post application scenarios assessed for wood preservatives in Section 6.4, occupational post application exposures are assumed to be negligible.

6.3 Metalworking Fluids: Machinist There is a potential for dermal and inhalation exposure when a worker handles treated metalworking fluids. This route of exposure occurs after the chemical has been incorporated into the metalworking fluid and a machinist is using/ handling this treated endproduct

Dermal Exposures Exposure Calculations A short term and an intermediate and long term exposure estimate were derived using the 2 hand immersion model from ChemSTEER. The model is available at www. epa. gov/ opptintr/ exposure/ docs/ chemsteer. htm. The 2 hand immersion equation is as follows:

PDR = SA x % a. i. x FT x FQ BW where:

PDR = Potential dose rate ( mg/ kg/ day); SA = Surface area of both hands ( cm2); % a. i. = Fraction active ingredient in treated metalworking fluid ( unitless) FT = Film thickness of metal fluid on hands ( mg/ cm2) FQ = Frequency of events ( event/ day); BW = Body weight ( kg)

Assumptions   The surface of area of both hands is 840 cm2 ( USEPA 1997)   The body weight of an adult is 70 kg ( USEPA 1997)   The percent active ingredient in treated metalworking fluid is 0.07 % ( EPA Registration No. 43813 16).   For short, intermediate and long term durations, the film thickness on the hands is 1.75 mg/ cm2, which was extracted from the document entitled, " A Laboratory Method to Determine the Retention of Liquids on the Surface of Hands" ( Cinalli, 1992). The film thickness is based on a machinist immersing both hands in metalworking fluid and then partially cleaning hands with a rag. The film thickness was chosen because the dermal endpoint for short, intermediate and long term durations is based on systemic effects. 24 Inhalation Exposures Exposure Calculations A screening level intermediate and long term inhalation exposure estimate for treated metalworking fluids has been developed using the OSHA PEL for oil mist. The equation used for calculating the inhalation dose is:

PDR = PEL x IR x % a. i. x ED BW where: PDR = Potential dose rate ( mg/ kg/ day); PEL = OSHA PEL ( mg/ m3); IR = Inhalation rate ( m3 / hr) % a. i. = Fraction active ingredient in treated metalworking fluid ( unitless) ED = Exposure duration ( hrs/ day); BW = Body weight ( kg)

Assumptions   The high end oil mist concentration is based on OSHA's Permissible Exposure Limit ( PEL) of 5 mg/ m3 ( NIOSH, 1998).   The percent active ingredient in treated metalworking fluid is 0.07 % ( EPA Registration No. 43813 16).   The inhalation rate for a machinist is 1.0 m3 / hr.   A machinist is exposed to the metalworking fluid 8 hours a day, for 5 days a week.   The body weight of an adult is 70 kg ( USEPA 1997).

Dermal and Inhalation Results Table 6.4 shows the calculation of the absorbed daily dose and MOE for a machinist working with metalworking fluids. The dermal and inhalation MOE values are above the target MOE of 100 for all durations. Total MOEs are also above the target MOE of 100 for short and intermediate/ long term exposures ( ST Total MOE = 4,800 and IT/ LT Total MOE = 1,600).

Although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL. Since the inhalation MOEs are above 1,000, a confirmatory inhalation toxicity study is not warranted based on the results of this scenario. 25 Table 6.4. Short, Intermediate, and Long Term Risks Associated with Postapplication Exposure to Metalworking Fluids treated with Propiconazole ( Machinist)

Dermal Inputs Inhalation Inputs Absorbed Daily Dose ( mg/ kg/ day) MOE Dermal MOE ( Target MOE = 100) c Inhalation MOE ( Target MOE = 100) d Total MOE ( Target MOE = 100) e % a. i. Hand Surface Area ( cm2) Film thickness ( mg/ cm2) Frequency ( event/ day) OSHA PEL ( mg/ m3) Inhal. rate ( m3/ hr) Exposure Duration ( hrs/ day) Dermal a Inhal. b ST IT/ LT ST IT/ LT ST IT/ LT 0.07 840 1.75 1 5 1.0 8 0.0059 0.00040 5,10 0 1,700 75,00 0 25,000 4,80 0 1,600 a Absorbed Dermal Daily Dose ( mg/ kg/ day) = [(% active ingredient * hand surface area* dermal absorption factor ( 40% for all durations)* film thickness ( mg/ cm2)* Frequency ( event/ day)] / Body weight ( 60 kg). b Absorbed Inhalation Daily Dose ( mg/ kg/ day) = % active ingredient * OSHA PEL ( mg/ m3) * Inhalation rate ( m3/ hr) * exposure duration ( hr/ day) * inhalation absorption factor ( 100% for all durations)/ body weight ( 70 kg) c Dermal MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose ( mg/ kg/ day) [ Where: short term NOAEL = 30 mg/ kg/ day and intermediate   and long term NOAEL = 10 mg/ kg/ day for dermal exposures, Table 3.2 ]. d Inhalation MOE = NOAEL ( mg/ kg/ day) / Absorbed Daily Dose ( mg/ kg/ day) [ Where: short term NOAEL = 30 mg/ kg/ day and intermediate and long term NOAEL = 10 mg/ kg/ day for inhalation exposures, Table 3.2]. e Total MOE = 1/(( 1/ Dermal MOE) + ( 1/ Inhalation MOE))

6.4 Wood Preservation Propiconazole is used in products that are intended to preserve wood through both non pressure treatment methods and pressure treatment methods. The products can be used on many different types of wood including 1) green or fresh cut lumber, poles, posts, and timbers; 2) manufactured wood products such as logs ( including for log home construction), wood chips/ sawdust, plywood veneer, and particle board; 3) dry lumber; and 4) finished wood products such as millwork, shingles, shakes, siding, plywood, and structural lumber and composites. The majority of the products are intended for use at wood treatment facilities, however, propiconazole is also formulated for use in mushroom houses to protect timber trays and benches. Propiconazole is also formulated for use on cooling tower wood, however, the label does not specifically indicate if the wood is treated prior to or after manufacture of the cooling tower.

The exposure scenarios assessed in this document for the representative wood preservation uses selected by AD are shown in Table 6.1. Section 6.4.1 presents the exposure analysis for the handler and post application scenarios for non pressure treatment scenarios and Section 6.4.2 presents the exposure analysis for the handler and post application scenarios for pressure treatment scenarios.

6.4.1 Non Pressure Treatment Scenarios ( Handler and Post application)

<IP_ADDRESS> Scenarios Assessed by Worker Function 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 which is a Sapstain Industry Task Force Study, # 73154) identified various worker functions/ positions for individuals that 26 handle DDAC containing wood preservatives for non pressure treatment application methods and for individuals that could then come into contact with the preserved wood. The worker functions/ positions identified in the DDAC study are presented below. It was assumed that similar tasks are performed when handling propiconazole products and propiconazole treatedwood therefore, these same functions were assessed for propiconazole.

Handler:   Blender/ spray operators are workers that add the wood preservative into a blender/ sprayer system for composite wood via closed liquid pumping.   Diptank Operators can be in reference to wood being lowered into the treating solution through an automated process ( i. e., elevator diptank, forklift diptank). This scenario can also occur in a smaller scale treatment facility in which the worker can manually dip the wood into the treatment solution.   Chemical operators for a spray box system consist of chemical operators, chemical assistants, chemical supervisors, and chemical captains. These individuals maintain a chemical supply balance along with flushing and cleaning spray nozzles.

Post application:   Graders, positioned right after the spray box, grade dry lumber by hand ( i. e. detect faults). In the DDAC study, graders graded wet lumber; therefore, the exposures to graders using propiconazole are worst case scenarios.   Millwrights repair all conveyer chains and general up keep of the mill.   Clean up crews perform general cleaning duties at the mill.   Trim saw operators operate the hula trim saw and consist of operators and strappers. In the DDAC study, hula trim saw operators handled dry lumber.   Construction workers install treated plywood, oriented strand board, medium density fiberboard, and others.

As very little chemical specific data were available regarding typical exposures to propiconazole as a wood preservative, surrogate data were used to estimate exposure risks. The blender/ spray operator position was assessed using CMA unit exposure data and the remaining handler and post application positions were assessed using data from the DDAC study ( Bestari et al., 1999, Task Force # 73154). This study is proprietary; therefore, data compensation needs to be addressed for use of these data in this exposure assessment.

Blender/ Spray Operators Exposures and risks to the composite wood blender/ spray operators were assessed using Equations 1 through 3 in Section 1.2. The surrogate unit exposures were taken from the CMA study ( USEPA 1999). Specifically, the liquid pump preservative unit exposures for gloved workers were used in this assessment. The dermal unit exposure was 0.00629 mg/ lb ai and the inhalation unit exposure was 0.000403 mg/ lb ai. These values are based on two replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. The quantity of the wood being treated was derived from other wood preservative estimates ( USEPA, 2004) for the amount of wood slurry treated because no chemical specific data were available for propiconazole. It was assumed that batches of wood slurry are treated in 10,000 gallon tanks, and that eight batches of wood slurry are treated per day ( one per hour for an 8 hr work shift). Additionally, it was assumed that each batch requires 3,000 gallons of 27 preservatives and the remainder volume of the tank consists of wood slurry ( 7,000 gallons of wood slurry per batch). Wood chips have a density of approximately 380 kg/ m3 ( SIMetric, 2005), therefore, the total amount of wood slurry treated per day would be 178,000 lbs ( 8 batches/ day * 7,000 gallons/ batch * 0.003785 m3/ gallon * 380 kg/ m3 * 2.2 lb/ kg). The assumptions used for batch sizes and the quantity of preservative needed are consistent with an assessment performed previously by the EPA. The propiconazole assessment was conducted for both the 1% ai solution and 0.5% ai solution application rates. The higher maximum application rate represents the labels which indicate the product can be used on finished wood products through immersion, roller coater, flood, spray, and brush application methods. The lower application rate used in this assessment represents the maximum application rate presented by the registrant in the Propiconazole Use Closure Memo Amendment dated April 22, 2005 ( USEPA, 2005a) for dip tank, conventional spray, and electrostatic spray methods on seasoned and unseasoned forest products. It should be noted, however, that the maximum application rates according to the label review are 0.65% ai solution ( 60061 115) for an open dip tank, 0.8% ai solution ( 1448 394) for conventional spray, and 50% ai solution ( 43813 37) for electrostatic spray.

Table 6.5 provides the short and intermediate term doses and MOEs for the workers adding the preservative to the wood slurry. All MOEs are above the target MOE of 100 for short, intermediate, and long term dermal, inhalation, and total exposures.

It should be noted that although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL. All of the occupational inhalation MOEs were above 1,000, except for the following scenarios:

$ Blender/ spray operator: IT/ LT inhalation MOE at the 1% application rate = 980.

Table 6.5. Short, Intermediate, and Long term Exposures and MOEs for Wood Preservative Blender/ Spray Operators Absorbed Daily Dosee ( mg/ kg/ day) MOEsf Dermal Inhalation Totalg Exposure Scenario Dermal Unit Exposurea ( mg/ lb ai) Inhalation Unit Exposureb ( mg/ lb ai) Application Ratec (% ai in solution/

day) Wood Slurry Treatedd ( lb/ day) Dermal Inhalation ST IT/ LT ST IT/ LT ST IT/ L T Occupational Handler CMA Liquid Pump 0.00629 0.000403 0.50 178,000 0.032 0.051 940 310 5,900 2,000 810 270 CMA Liquid Pump 0.00629 0.000403 1.0 178,000 0.064 0.010 470 160 2,900 980 400 130 ST = Short term duration; IT = Intermediate term duration; and LT = long term. a. Dermal unit exposure: Single layer clothing with chemical resistant gloves. b. Inhalation unit exposure: Baseline. c. The assessment was conducted using both the 0.5% and 1% ai solution application rates where 0.5% is for sapstain treatment and 1% is for decay control. d. Wood slurry treated = ( 8 batches/ day * 7,000 gallons/ batch * 0.003785 m3/ gallon * 380 kg/ m3 * 2.2 lb/ kg) e. Absorbed Daily Dose = unit exposure ( mg/ lb ai) x App Rate (% ai/ day) x Quantity treated ( lb/ day) x absorption factor ( 40% dermal and 100% for inhalation) / BW ( 70 kg) f. MOE = NOAEL ( mg/ kg/ day)/ Daily dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation and IT/ LT NOAEL = 10 mg/ kg/ day for dermal and inhalation]. Target MOE is 100 for dermal and inhalation exposures. g. Total MOE = 1/ (( 1/ MOEdermal) + ( 1/ MOEinhalation)). Target MOE is 100. 28 Chemical Operators, Graders, Millwrights, Clean up Crews, and Trim Saw Operators Exposures to chemical operators, graders, millwrights, trim saw operators, and cleanup crews were assessed using surrogate data from the DDAC study ( Bestari et al., 1999, Task Force # 73154). The DDAC study examined individuals= exposure to DDAC while working with antisapstains and performing routine tasks at 11 sawmills/ planar mills in Canada. Dermal and inhalation exposure monitoring data were gathered for each job function of interest using dosimeters and personal sampling tubes. Dosimeters and personal air sampling tubes were analyzed for DDAC. Exposure data for individuals performing the same job functions were averaged together to determine job specific averages. Monitoring was conducted using 2 trim saw workers, 13 grader workers, 11 chemical operators, 3 millwrights, and 6 clean up staff.

The individual dermal and inhalation exposures from the DDAC study are presented in Table B 1 in Appendix B. To determine propiconazole exposures, the average DDAC exposures measured on individuals ( in terms of total mg DDAC) were multiplied by a modification factor of 0.625 to account for the difference in percent active ingredient between propiconazole and DDAC ( 50% propiconizole in the wood preservative product versus 80% DDAC in the comparative wood preservative product). The lb ai handled by each person or the % ai in the treatment solution were not provided for these worker functions.

The following equation was used to calculate daily dose for propiconazole:

Daily Dose = DDAC UE x CR x AB BW Where DDAC UE = DDAC dermal or inhalation unit exposure ( mg/ day); CR = Conversion ratio ( 50% propiconazole / 80% DDAC) ; AB = Absorption factor ( 40% for dermal, 100% for inhalation); and BW = Body weight ( 70 kg).

In using this methodology, the following assumptions were made:

  DDAC and propiconazole end use products will be used in similar quantities.

  The procedures for applying both chemicals are similar.

  The limits of detections ( LOD) for inhalation residues from chemical operators, graders, mill wrights, and clean up staff replicates were not provided in the DDAC report. For lack of better data, it was assumed that the inhalation LODs for these worker positions are equal to the LOD of the diptank operator replicates ( 5.6 Fg). For all measurements below the air concentration associated with this detection limit, half the detection limit was used. The dermal LOD for all operators is also 5.6 Fg.

  In the DDAC study, dermal exposures to hands were measured separately from the rest of the body. For each replicate, the body dose measurements and hand dose measurements were summed for a total dermal dose. 29   Air concentrations were reported in the DDAC study. To convert air concentrations ( Fg/ m3) into terms of inhalation unit exposure ( mg/ day), the air concentrations were multiplied by an inhalation rate of 1.0 m3/ hr for light activity ( EPA 1997), an exposure duration of 8 hrs/ day, and a conversion factor of 1 mg/ 1000 mg. Table B 1 in Appendix B presents the inhalation and dermal DDAC exposures.

  Average DDAC dermal and inhalation exposures were multiplied by a conversion ratio of 0.625 to account for the differences in propiconazole and DDAC concentrations [( 50% propiconazole / 80% DDAC)].

Table 6.6 provides the short, intermediate, and long term doses and MOEs for chemical operators, graders, millwrights, clean up crews, and trim saw operators. For all worker functions, the inhalation MOEs are above the target MOE of 100 for ST/ IT/ LT durations, and therefore are not of concern. For all worker functions, except the clean up worker, the dermal and total MOEs are above the target MOE of 100 for ST/ IT/ LT durations. For the clean up worker, the intermediate and long term dermal and total MOEs are below the target MOE of 100 ( MOE of 51 and 49, respectively).

All inhalation MOEs exceeded 1,000, therefore, a confirmatory inhalation toxicity study is not warranted based on the results of these exposure scenarios.

Table 6.6. Short, Intermediate and Long Term Exposures and MOEs for Wood Preservative Chemical Operators, Graders, Trim Saw Operators, and Clean Up Crews Absorbed Daily Dosesd ( mg/ kg/ day) MOEse Dermal Inhalation Totalf Exposure Scenarioa ( number of volunteers) Dermal UEb ( mg/ day) Inhalation UEb ( mg/ day) Conversion Ratioc Dermal Inhalation ST IT/ LT ST IT/ LT ST IT/ LT Occupational Handler Chemical Operator ( n= 11) 9.81 0.0281 0.625 0.035 0.00025 860 290 120,000 40,000 850 280 Occupational Post application Grader ( n= 13) 3.13 0.0295 0.625 0.011 0.00026 2,700 890 110,000 38,000 2,600 870 Trim Saw ( n= 2) 1.38 0.061 0.625 0.0049 0.00054 6,100 2,000 56,000 19,000 5,500 1,800 Millwright ( n= 3) 12.81 0.057 0.625 0.046 0.00051 660 220 59,000 20,000 650 220 Clean Up ( n= 6) 55.3 0.60 0.625 0.20 0.0054 150 51 5,600 1,900 150 49 ST = Short term duration; IT = Intermediate term duration; and LT = long term a. The exposure scenario represents a worker wearing short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill. b. Dermal and inhalation unit exposures are from Bestari et al ( 1999, Task Force # 73154). Refer to Table B 1 in Appendix B for the calculation of the dermal and inhalation exposures. Inhalation exposure ( mg/ day) was calculated 30 using the following equation: air concentration ( Fg/ m3) x inhalation rate ( 1.0 m3/ hr) x sample duration ( 8 hr/ day) x unit conversion ( 1 mg/ 1000 Fg). The inhalation rate is from USEPA, 1997. c. Conversion Ratio = 50% propiconazole / 80% DDAC d. Absorbed Daily dose ( mg/ kg/ day) = exposure ( mg/ day) * conversion ratio ( 0.625) * absorption factor ( 40% for dermal and 100% for inhalation)/ body weight ( 70 kg). e. MOE = NOAEL ( mg/ kg/ day)/ Daily dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation and intermediate and long term NOAEL = 10 mg/ kg/ day for dermal and inhalation]. Target MOE is 100 for dermal and inhalation exposures. f. Total MOE = 1/ (( 1/ MOEdermal) + ( 1/ MOEinhalation)). Target MOE is 100.

Diptank Operators Exposures to diptank operators were also assessed using surrogate data from the DDAC study ( Bestari et al., 1999). The diptank scenario assessment was conducted differently than for the other job functions because the concentration of DDAC in the diptank solution was provided. The exposure data for diptank operators wearing gloves were converted into A unit exposures @

in terms of mg a. i. for each 1% of concentration of the product. The calculation of the dermal and inhalation unit exposures ( 2.99 and 0.046 mg/ 1% solution, respectively) is presented in Table B 2 in Appendix B. The air concentrations presented in the DDAC study were converted to unit exposures using an inhalation rate of 1.0 m3/ hr ( light activity) and sample duration of 8 hrs/ day.

The following equations are used to estimate dermal and inhalation handler exposure:

Daily Dose = DDAC UE x AI x AB BW Where DDAC UE = DDAC dermal unit exposure ( mg/ 1% in solution); AI = AI ( 1% ai and 0.5% ai in solution/ day); AB = Absorption factor ( 40% for dermal, 100% for inhalation); and BW = Body weight ( 70 kg).

Table 6.7 provides the short term and the intermediate and long term doses and MOEs for diptank operators. All MOEs were above the target MOE of 100 for dermal, inhalation, and total exposures and therefore, are not of concern.

All inhalation MOEs exceeded 1,000, therefore, a confirmatory inhalation toxicity study is not warranted based on the results of these exposure scenarios. 31 Table 6.7. Short, Intermediate, and Long Term Exposures and MOEs for Diptank Operator Absorbed Daily Dosesc ( mg/ kg/ day) MOEsd Dermal Inhalation Totalf Exposure Scenarioa ( number of replicates) Dermal Unit Exposureb ( mg DDAC/ 1% solution) Inhalation Unit Exposureb ( mg DDAC/ 1% solution) App Rate (% a. i. in solution/ day) c Dermal Inhalation ST IT/ LT ST IT/ LT ST IT/ LT Occupational Handler Dipping, with gloves ( n= 7) 2.99 0.046 0.50 0.0085 0.00033 3,500 1,200 91,000 30,000 3,400 1100 Dipping, with gloves ( n= 7) 2.99 0.046 1.0 0.017 0.00066 1,800 580 46,000 15,000 1,700 560 ST = Short term duration; IT = Intermediate term duration; and LT = long term. a. The exposure scenario represents a worker wearing long sleeved shirts, cotton work trousers, and gloves. Gloves were worn only when near chemical, not when operating diptank b. Dermal and inhalation unit exposures are from DDAC study ( MRID 455243 04, Task Force # 73154). Refer to Table B 2 in Appendix B for the dermal and inhalation unit exposure calculations. Inhalation exposure ( mg) was calculated using the following equation: Air concentration ( mg/ m3) x Inhalation rate ( 1.0 m3/ hr) x Sample Duration ( 8 hr). The inhalation rate is from USEPA, 1997. c. The assessment was conducted using both the 0.5% and 1% ai solution application rates where 0.5% is used for sapstain treatments and 1% is used for decay control. d. Absorbed Daily dose ( mg/ kg/ day) = unit exposure ( mg/ 1% ai solution) * percent active ingredient in solution * absorption factor ( 40% for dermal and 100% for inhalation) / body weight ( 70 kg). e. MOE = NOAEL ( mg/ kg/ day) / Daily dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation and intermediateand long term NOAEL = 10 mg/ kg/ day for dermal and inhalation]. Target MOE is 100 for dermal and inhalation exposures. f. Total MOE = 1/ (( 1/ MOEdermal) + ( 1/ MOEinhalation)). Target MOE is 100.

Construction workers Not enough data exists to estimate the amount of exposure associated with construction workers who install treated wood. In particular, values for the transfer coefficient associated with a construction worker handling the wood could not be determined. However, it is believed that the construction worker using a trim saw will have larger dermal and inhalation exposures than the installer, due to the amount of sawdust generated and the greater amount of hand contact that would be necessary to handle the wood when using a saw compared to installing the wood.

<IP_ADDRESS> Scenarios Assessed for High Pressure/ High Volume Spray Application Methods Handler exposures from operating high pressure/ high volume spray equipment were assessed using Equations 1 through 3 in Section 1.2 for applications to wood in wood treatment facilities, wood in mushroom houses, and cooling tower wood. Dermal and inhalation unit exposure values were taken from PHED ( liquid/ open pour/ high pressure spray). These unit exposure data were monitored in greenhouses where the applications were made to floors, benches, and overhead plants. The dermal and inhalation unit exposure values are 2.5 mg/ lb a. i. and 0.12 mg/ lb a. i., respectively ( single layer of clothing and gloves) ( USEPA 1998). Only a gloved scenario was assessed because ungloved data are not available. 32 Due to the uncertainty in the quantity of solution used for these scenarios, the scenarios were assessed using a range of 25 to 1,000 gallons. For wood treatment facility non pressure spray applications, large applications are assumed to be performed by mechanical dip operations while smaller treatments may be performed by reel type handwand methods where the quantity handled ranges from 25 to 50 gallons. During the error comment period Janssen provide additional information on the quantities applied to cooling tower wood. An applicator of cooling tower wood preservatives using a high pressure/ high volume spray method could apply a maximum of 200 gallons of diluted solution per day assuming a complete 8 hr work shift is dedicated to the application of the preservative. Typical quantities handled are less than 100 gallons per day because service crews handle many other unrelated maintenance tasks at the facility. The values could be further refined from additional input from registrants.

The calculated dermal, inhalation, and total MOEs are shown in Table 6.8 for short, intermediate, and long term durations of exposure. All MOEs for high pressure/ high volume wood preservative uses were above the target MOE of 100 for all scenarios except for the following:

  Wood Preservation, high pressure/ high volume spray in wood treatment facility: IT/ LT dermal MOE ( gloves) at 50 gallons = 96, IT/ LT total MOE at 50 gallons = 86.

  Wood Preservation, high pressure/ high volume spray in mushroom house: IT dermal MOE ( gloves) at 1,000 gallons = 56, IT total MOE at 1,000 gallons = 50.

It should be noted that although the target inhalation MOE is 100, if the MOE is below 1,000 the Agency may request a confirmatory inhalation toxicity study because the current inhalation endpoint is based on an oral NOAEL. All of the occupational inhalation MOEs are above 1,000, except for the following scenarios:

  Wood Preservation, high pressure/ high volume spray in wood treatment facility: IT/ LT inhalation MOE at 50 gallons = 800   Wood Preservation, high pressure/ high volume spray in mushroom house: IT inhalation MOE at 1,000 gallons = 470. 33 Table 6.8. Short and Intermediate Term Exposures and MOEs for High Pressure/ High Volume Spray Scenarios ( Wood Treatment Facility, Mushroom House, and Cooling Tower Wood)

Absorbed Daily Dosesc ( mg/ kg/ day) MOEsd Baseline Inhalation Dermal ( gloves) Totale Exposure Site Surrogate Exposure Data App.

Rate ( lb ai/ dilute gallon) Quantity Handled/

Treated per daya ( gallons) Baseline Inhalation Unit Exposure ( mg/ lb ai) Dermal ( gloves)

Unit Exposureb ( mg/ lb ai) Baseline Inhalation Dermal ( gloves) ST IT ST IT ST IT 25 0.12 2.5 0.0063 0.052 4,800 1600 580 190 510 170 Wood Treatment Facility 0.146 50 0.12 2.5 0.013 0.10 2,400 800 290 96 260 86 100 0.12 2.5 0.0021 0.018 14,000 4,700 1,700 560 1,500 500 Mushroom House 0.0125 1,000 0.12 2.5 0.021 0.18 1,400 470 170 56 150 50 100 0.12 2.5 0.0037 0.031 8,100 2,700 970 520 870 290 Cooling Tower PHED M/ L/ A high pressure spray 0.0216 200 0.12 2.5 0.0074 0.062 4,100 1,400 490 160 430 140 a. Due to the uncertainty of the use amounts, the scenarios were assessed for both 100 and 1,000 gallons.

b. No ungloved data available such that only a gloved scenario was assessed.

c. Absorbed Daily dose ( mg/ kg/ day) = unit exposure ( mg/ 1% ai solution) * percent active ingredient in solution * absorption factor ( 40% for dermal and 100% for inhalation) / body weight ( 70 kg).

d. MOE = NOAEL ( mg/ kg/ day) / Daily dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation and intermediate term NOAEL = 10 mg/ kg/ day for dermal and inhalation].

Target MOE is 100 for dermal and inhalation exposures. The mushroom house applications are expected to be an intermittent exposure, at most once a week, and therefore the mushroom house duration is believed to be short term only.

e. Total MOE = 1/ (( 1/ MOEdermal) + ( 1/ MOEinhalation)). Target MOE is 100. 34 6.4.2 Pressure Treatment Scenarios ( Handler and Post Application)

Propiconazole may be used to treat wood and wood products using pressurized application methods such as vacuum, double vacuum, full cell, and modified full cell. The maximum rate of application used in this assessment is 1% ai solution for decay control ( USEPA, 2005a). Propiconazole specific exposure data are not available for assessment of pressure treatment exposure. Therefore, the assessment relies on surrogate chromated copper arsenate ( CCA) data ( ACC, 2002) and was based on the approach used in a previous exposure assessment ( USEPA, 2003).

Surrogate Unit Exposure Data Dermal and inhalation exposures for pressure treatment uses are derived from information in the exposure study by the American Chemistry Council ( 2002) entitled " Assessment of Potential Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Arsenical Wood Products" ( ACC, 2002). In this study, a treatment solution of CCA was approximately 0.5 percent. The CCA study is the best pressure treatment data available for a water based solution to estimate exposure to propiconazole.

The CCA study measured both handlers and post application activities. Although there is overlap in job functions, the handlers are defined as being either treating operators ( TOs) or treating assistants ( TAs). The TOs were monitored at three sites ( A, B, and C) using 5 replicates at each site. The TAs were monitored at two sites ( Sites A and C) using 5 replicates at each site. The post application activities included: tram setter ( TS) at Site A ( n= 5); stacker operator ( SO) at Site A ( n= 4); loader operator ( LO) at Sites A, B, C ( n= 15); supervisor ( S) at Site B ( n= 5); test borer ( TB) at Site C ( n= 5); and the tallyman ( TM) at Site C ( n= 5). According to the CCA study, workers wore cotton long sleeved shirts and cotton trousers ( or one piece cotton coveralls) over the whole body dosimeters (" plus additional shirts or jackets per typical practice at Site B") and chemical resistant or work gloves, when appropriate. Therefore, the CCA study provides exposure data associated with maximum PPE ( excluding respirators). In using the CCA study for this propiconazole assessment, the TO and TA handlers are assessed separately. The post application job functions, however, have been combined into one data set to represent post application activities because for most activities the sample size is small ( 5   n   15).

The measured CCA dermal and inhalation exposure values were normalized by the treatment solution concentration used at each of the 3 facilities ( i. e., unit exposure reported as µ g arsenic/ ppm treatment solution). The normalization by treatment solution concentration was performed to extrapolate the measured exposures in the CCA study ( monitored at ~ 0.5% ai solution) to the maximum propiconazole treatment solution concentration ( 1% ai solution). Table 6.9 presents the dermal and inhalation unit exposure values normalized to the treatment solution concentration in ppm for ( 1) all sites, ( 2) treatment operator ( TA handler), ( 3) treatment assistant ( TA handler), and ( 4) all post application job functions ( TS, SO, LO, S, TB, TM).

Note: The U. S. and Canadian sites indicate a 7x difference in the mean dermal exposures ( US site mean is 0.40 µ g As/ ppm compared to the Canadian site mean of 2.84 µ g As/ ppm). It is recommended that additional analysis be performed to determine if the 35 increased exposure levels at the Canadian site can be attributed to differences in site specific engineering controls or facility design.

Exposure Calculations The following equation was used to estimate dermal and inhalation handler exposure:

Daily Dose = UE x AI x AB BW Where UE = Unit exposure ( mg As/ ppm); AI = AI ( 1% ai and 0.5% ai in solution); AB = Absorption factor ( 40% for dermal, 100% for inhalation); and BW = Body weight ( 70 kg).

Results The estimated dermal and inhalation exposures and risks for propiconazole are presented in Table 6.10. The calculated dermal, inhalation, and total MOEs for short, intermediate, and long term durations are above the target MOE of 100 for all scenarios except for the intermediate and long term dermal and total MOE for the treatment operator ( both MOEs are 86).

All inhalation MOEs exceeded 1,000, therefore, a confirmatory inhalation toxicity study is not warranted based on the results of these exposure scenarios.

Table 6.9. Dermal and Inhalation Exposure Values from a CCA Pressure Treatment Study ( Exposure Data used as Surrogate Unit Exposures for Propiconazole Assessment)

Treatment Solution Site % ppma Statistic Dermal Unit Exposure ( Fg As/ ppm) Air Concentrationb ( Fg As/ m3/ ppm) Inhalation Unit Exposurec ( Fg As/ ppm)

Average ± std 0.97 ± Unknown 0.00013 ± 0.00023 0.00104 Median 0.36 0.00013 0.00104 90th percentile 2.07 0.00077 0.00617 All sites  All Data ( n = 64) 0.438 to 0.595 4,380 to 5,950 Maximum 7.74 0.0011 0.00882 Average ± std 2.04 ± 2.68 0.00032 ± 0.00038 0.00257 Median 0.37 0.00013 0.00104 90th percentile 5.39 0.00092 0.00737 All sites  Handler Treatment Operator ( n = 15) 0.438 to 0.595 4,380 to 5,950 Maximum 7.74 0.0011 0.00882 Average ± std 0.24 ± 0.14 0.0001 ± 0.00004 0.000802 Median 0.23 0.00013 0.00104 90th percentile 0.40 0.00013 0.00104 All sites  Handler Treatment Assistant ( n = 10) 0.438 to 0.595 4,380 to 5,950 Maximum 0.52 0.00014 0.00112 Average ± std 0.74 ± 0.73 0.00020 ± 0.00025 0.00160 All sites   Postapplication All job functions

Median 0.42 0.00013 0.00104 36 Table 6.9. Dermal and Inhalation Exposure Values from a CCA Pressure Treatment Study ( Exposure Data used as Surrogate Unit Exposures for Propiconazole Assessment)

Treatment Solution Site % ppma Statistic Dermal Unit Exposure ( Fg As/ ppm) Air Concentrationb ( Fg As/ m3/ ppm) Inhalation Unit Exposurec ( Fg As/ ppm)

90th percentile 1.81 0.00050 0.00401 ( TS, SO, LO, S, TB, TM) ( n = 39) Maximum 3.11 0.0011 0.00882 a. ppm = (% treatment solution) * ( 10,000). b. Air concentration was calculated as Fg collected per sample per ppm / ( 480 min per day x 2 L/ min). c. Inhalation unit exposure = air concentration ( Fg As/ m3/ ppm) * breathing rate for light activities ( 0.0167 m3/ min) * sample duration ( 480 min).

Table 6.10. Short, Intermediate, and Long Term Exposures and MOEs for Pressure Treatment Handler and Post application Scenarios Unit Exposurea ( Fg As/ ppm) Absorbed Daily Dosesb ( mg/ kg/ day) MOEsc Dermal Inhalation Totald Exposure Scenarioa Dermal Inhalation Application Rate (% ai solution) Dermal Inhalation ST IT/ L T ST IT/ LT ST IT/ LT Occupational Handler Treatment Operator ( TO) 2.04 0.00257 1 0.12 0.00037 260 86 82,000 27,000 260 86 Treatment Assistant ( TA) 0.24 0.000802 1 0.014 0.00012 2,200 730 260,000 87,000 2,200 730 Occupational Post application All ( Tram setter, stacker operator, loader operator, supervisor, test borer, and tallyman) 0.74 0.00160 1 0.042 0.00023 710 240 130,000 44,000 710 240 ST = Short term duration; IT = Intermediate term duration; and LT = long term. a. Unit exposure values taken from CCA study and are shown in Table 6.10. b. Absorbed Daily Dose ( mg/ kg/ day) = Unit Exposure ( µ g As/ ppm) * [% propiconazole in solution ( 1) * 10,000 ( parts per million conversion)] * ( 0.001 mg/ µ g) * absorption factor ( 40% for dermal and 100% for inhalation) / Body weight ( 70 kg). c. MOE = NOAEL ( mg/ kg/ day) / Daily dose [ Where short term NOAEL = 30 mg/ kg/ day for dermal and inhalation and intermediate term NOAEL = 10 mg/ kg/ day for dermal and inhalation]. Target MOE is 100 for dermal and inhalation exposures. d. Total MOE = 1/ (( 1/ MOEdermal) + ( 1/ MOEinhalation)). Target MOE is 100.

6.5 Data Limitations/ Uncertainties 37 There are several data limitations and uncertainties associated with the occupational handler and postapplication exposure assessments. These 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 A 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.   The baseline ( ungloved) dermal exposures and risks for material preservation of paints, textiles, adhesives, and metalworking fluid were calculated using unit exposure values from the cooling tower CMA data set because baseline dermal unit exposures are not available for preservative or metal fluid CMA unit exposure categories.   For the wood preservative pressure treatment scenarios, CCA exposure data were used for lack of propiconazole specific exposure data and for the wood preservative non pressure treatment scenarios, DDAC exposure data were used for the lack of propiconazolespecific 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 propiconazole, and therefore the exposures could be used as surrogate data for workers that treat wood with propiconazole. o For environmental modeling, it was assumed that the leaching process from the propiconazole treated wood would be similar to that of CCA and DDAC. However, due to the lack of real data for propiconazole  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 AD's standard assumptions. 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. In particular, the quantities handled/ treated for the application of propiconazole to wood in mushroom houses through high pressure/ high volume spray methods could be refined.   Inhalation exposures are expected to occur to bystanders as a result of material preservative applications in industrial settings. Currently, no data are available to assess these bystander exposures and therefore, monitoring data are needed. 38 7.0 REFERENCES American Chemistry Council ( ACC). 2002. Assessment of Potential Inhalation and Dermal Exposure Associated With Pressure Treatment of Wood with Arsenical Wood Products. MRID 4550211 01.

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USEPA. 2003a. Propiconazole   3rd Report of the Hazard Identification Assessment Review Committee. Dated December 17, 2003. TXR No. 0052277.

USEPA. 2003b. Assessment of the Proposed Bardac Wood Preservative Pressure Treatment Use. Memorandum from Tim Leighton and Siroos Mostaghimi. February 11, 2003.

USEPA. 2004. Occupational and Residential Exposure Assessment for Carboquat WP 50. Memorandum from Siroos Mostaghimi, USEPA to Welma Noble, USEPA. Dated November 4, 2004. DP Barcodes D303714 and D303938. 39 USEPA 2005a. Propiconazole Use Closure Memo Amendment. Memorandom from Jaqueline Guerry, USEPA to Propiconazole RED Team Member, USEPA. Dated April 22, 2005. 40 APPENDIX A: Summary of CMA and PHED Data 41 Chemical Manufacturers Association ( CMA) Data: In response to an EPA Data Call In Notice, a study was undertaken by the Institute of Agricultural Medicine and Occupational Health of The University of Iowa under contract to the Chemical Manufacturers Association. In order to meet the requirements of Subdivision U of the Pesticide Assessment Guidelines ( superseded by Series 875.1000 875.1600 of the Pesticide Assessment Guidelines), handler exposure data are required from the chemical manufacturer specifically registering the antimicrobial pesticide. The applicator exposure study must comply with the assessment guidelines for AApplicator Exposure Monitoring@ in Subdivision U and the AOccupational and Residential Exposure Test Guidelines@ in Series 875. For this purpose, CMA submitted a study on 28 February, 1990, entitled " Antimicrobial Exposure Assessment Study ( amended on December 8, 1992)" which was conducted by William Popendorf, et al. It was evaluated and accepted by Occupational and Residential Exposure Branch ( OREB) of Health Effect Division ( HED), Office of Pesticides Program ( OPP) of EPA in 1990. The purpose of this CMA study was to characterize exposure to antimicrobial chemicals in order to support pesticide reregistrations ( CMA, 1992). The unit exposures presented in the most recent EPA evaluation of the CMA database ( USEPA, 1999) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic requirements of Subdivision U  Applicator Exposure Monitoring. The advantages of CMA data over other Asurrogate data sets@ is that the chemicals and the job functions of mixer/ loader/ applicator were defined based on common application methods used for antimicrobial pesticides. A few of the deficiencies in the CMA data are noted below:

  The inhalation concentrations were typically below the detection limits, so the unit exposures for the inhalation exposure route could not be accurately calculated.   QA/ QC problems including lack of either/ or field fortification, laboratory recoveries, and storage stability information.   Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database ( PHED): The Pesticide Handlers Exposure Database ( PHED) has been developed by a Task Force consisting of representatives from Health Canada, the U. S. Environmental Protection Agency ( EPA), and the American Crop Protection Association ( ACPA). PHED provides generic pesticide worker ( i. e., mixer/ loader and applicator) exposure estimates. The dermal and inhalation exposure estimates generated by PHED are based on actual field monitoring data, which are reported generically ( i. e., chemical specific names not reported) in PHED. It has been the Agency= s policy to use Asurrogate@ or Ageneric@ exposure data for pesticide applicators in certain circumstances because it is believed that the physical parameters ( e. g., packaging type) or application technique ( e. g., aerosol can), not the chemical properties of the pesticide, attribute to exposure levels. [ Note: Vapor pressures for the chemicals in PHED are in the range of E 5 to E 7 mm Hg.] Chemical specific properties are accounted for by correcting the exposure data for study specific field and laboratory recovery values as specified by the PHED grading criteria.

PHED handler exposure data are generally provided on a normalized basis for use in exposure assessments. The most common method for normalizing exposure is by pounds of active 42 ingredient ( ai) handled per replicate ( i. e., exposure in mg per replicate is divided by the amount of ai handled in that particular replicate). These unit exposures are expressed as mg/ lb ai handled. This normalization method presumes that dermal and inhalation exposures are linear based on the amount of active ingredient handled. 43 APPENDIX B:

Calculation of DDAC Unit Exposure Values ( MRID 455243 04) 44 Table B 1: DDAC Dermal and Inhalation Exposure Values for Chemical Operators, Graders, Millwrights, Clean up Crews, and Trim Saw Operatorsa Chemical Operator Grader Trim Saw Operator Millwright Cleanup Crew Dermal Inhalation Dermal Inhalation Dermal Inhalation Dermal Inhalation Dermal Inhalation Replicate Number Potential exposure ( mg) Air Concentrationb,

c (: g/ m 3 ) Potential exposured ( mg) Potential exposure ( mg) Air Concentration b, c (: g/ m 3 ) Potential exposure d ( mg) Potential exposure ( mg) Air Concentration b, c (: g/ m 3 ) Potential exposure d ( mg) Potential exposure ( mg) Air Concentration b, c (: g/ m 3 ) Potential exposure d ( mg) Potential exposure ( mg) Air Concentration b, c (: g/ m 3 ) Potential exposure d ( mg)

1 3.5 10.1 0.0808 3.05 2.90 0.0232 0.78 2.83 0.0227 1.31 2.92 0.0233 68.3 2.99145 0.0239 2 6.11 2.80 0.0224 7.47 2.93 0.0234 1.98 12.3 0.0984 29.08 2.83 0.0226 0.720 2.78840 0.0223 3 6.07 2.79 0.0223 1.09 2.91 0.0233 8.03 15.6 0.1248 166 30.3 0.2424 4 46.37 2.82 0.0226 10.51 3.00 0.0240 95.2 412 3.2960 5 0.94 2.93 0.0235 0.61 2.82 0.0226 1.20 2.83585 0.0227 6 22.15 2.83 0.0227 0.98 2.85 0.0228 0.260 2.80989 0.0225 7 21.45 2.77 0.0222 2.63 2.91 0.0233 8 0.22 2.73 0.0218 5.23 2.85 0.0228 9 0.44 2.77 0.0222 0.19 13.20 0.1056 10 0.33 3.14 0.0251 1.47 2.89 0.0231 11 0.29 2.88 0.0230 2.38 2.85 0.0228 12 4.09 2.81 0.0225 13 1.03 2.94 0.0235 Arithmetic Mean 9.81 3.51 0.0281 3.13 3.68 0.0295 1.38 7.57 0.061 12.8 7.12 0.057 55.3 75.6 0.60 Minimum 0.22 2.73 0.0218 0.19 2.81 0.0225 0.78 2.83 0.0227 1.31 2.83 0.0226 0.260 2.79 0.0223 Maximum 46.4 10.1 0.081 10.51 13.2 0.106 1.98 12.3 0.098 29.1 15.6 0.125 166 412 3.30 a. " Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride ( DDAC) Used in the Protection of Cut Lumber ( Phase III)" is the study that values were obtained from for this table ( Bestari et al., 1999, MRID 455243 04).

b. The inhalation LOD was not provided for chemical operators, graders, trim saw operators, millwrights, or the clean up crew. Therefore, the LOD provided for the diptank operator ( 5.6 : g)

was used for these positions. Residues less than the LOD were adjusted to 1/ 2 LOD.

c. The inhalation limit of detection was converted to : g/ m3 using the following equation: air concentration (: g/ m3) = 5.6 : g/ [ average flow rate ( L/ min) * sampling duration ( 480 min) * 1000 L/ m3. Data was obtained from Bestari et al ( 1999).

d. DDAC air concentrations were converted to inhalation exposure using the following equation: Air concentration (: g/ m3) x inhalation rate ( 1.0 m3/ hr) x Conversion factor ( 1 mg/ 1000 : g) x sample duration ( 8 hours/ day 45 Table B 2: Normalization of DDAC Dermal and Inhalation Exposure Values for Diptank Operatorsa Worker ID Mill number Sample Time ( min) DDAC Conc. in Diptank (%) Gloves Dermal Body Exposureb ( mg) Hand Exposureb ( mg) Total Dermal Exposure ( mg) Normalized Total Dermal Unit Exposurec ( mg/ 1 % solution) Air Conc. d ( mg/ m3) Inhalation Exposuree ( mg) Normalized Inhalation Unit Exposurec ( mg / 1% solution)

M7P1A 7 480 0.64 Rubber 0.5 3.44 3.94 6.16 0.003 0.024 0.0375 M7P1B 7 480 0.64 Rubber 0.32 2.02 2.34 3.66 0.003 0.024 0.0375 M8P4A 8 408 0.42 Rubber 0.04 f 1.34 1.38 3.29 0.003 0.024 0.057 M8P4B 8 480 0.42 Rubber 0.04f 0.5 0.54 1.29 0.003 0.024 0.057 M8P7 8 480 0.42 Cotton 0.03 0.04 0.07 0.17 0.003 0.024 0.057 M11P9A 11 395 0.63 Leather 0.15 3.33 3.48 5.52 0.003 0.024 0.0381 M11P9B 11 480 0.63 Leather 0.1 0.45 0.55 0.87 0.003 0.024 0.0381 Arithmetic Mean 0.17 1.59 1.76 2.99 0.0030 0.0240 0.046 Standard Deviation 0.18 1.39 1.53 2.32 0.0000 0.0000 0.0103 Median 0.10 1.34 1.38 3.29 0.0030 0.0240 0.0381 Geometric Mean 0.10 0.83 0.99 1.86 0.0030 0.0240 0.045 90% tile 0.39 3.37 3.66 5.78 0.0030 0.0240 0.057 Maximum 0.50 3.44 3.94 6.16 0.0030 0.0240 0.057 a. " Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride ( DDAC) Used in the Protection of Cut Lumber ( Phase III)" is the study that values were obtained from for this table ( Bestari et al., 1999, MRID 455243 04, Task Force # 73154).

b. DDAC concentration that was detected in the monitoring study ( MRID # 455243 04).

c. Normalization of DDAC data for percent ai treatment. Normalized Unit Exposure ( mg/ 1% ai solution) = Exposure ( mg DDAC) / concentration in diptank solution (% DDAC)

d. All inhalation residues were < LOD ( 5.6 Fg or 0.0056 mg/ m3). 1/ 2 LOD was used in all calculations ( 0.003 mg/ m3). Air Concentration ( mg/ m3) = 5.6 Fg / (~ 2 L/ min flow rate x ~ 480 min)

x 1000 L/ m3 conversion x 0.001 Fg/ mg = 0.003 mg/ m3 e. Inhalation exposure ( mg) = air concentration ( mg/ m3) x inhalation rate ( 1.0 m3/ hr) x sample duration ( 8 hours/ day).

f. Residues were < LOD for dermal samples M8P4A, M8P4B. Sample size of ~ 11,231 cm2 x < 0.007 ug/ cm2 = LOD of 0.079 mg. 1/ 2 LOD reported ( i. e., 0.04 mg)