Page 1 of 62 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: March 23, 2006 MEMORANDUM SUBJECT: Alkylbenzene Sulfonates ( ABS) Preliminary Risk Assessment for the Reregistration Eligibility Decision ( RED) Document. PC Code: 079010, 190116 and 098002. Case No. 4006. DP Barcode: D323972 Regulatory Action: Reregistration Eligibility Decision ( RED) ( Phase I) Risk Assessment Type: Single Chemical Aggregate FROM: Deborah Smegal, MPH, Toxicologist/ Risk Assessor Ayaad Assaad, PhD. Toxicologist William Dykstra, PhD., Toxicologist Health Effects Division ( HED) ( 7509C)

And Talia Milano, Chemist Robert Quick, Chemist Richard Petrie, Agronomist Cassi Walls, PhD, Chemist Najm Shamim, Ph. D. Chemist Antimicrobials Division ( AD) ( 7510C)

And Kerry Leifer, Chemist Registration Division ( RD)

THRU: Phang Whang, Branch Senior Scientist Reregistration Branch I Health Effects Division ( HED), ( 7509C)

TO: Heather Garvie, Chemical Review Manager, Reregistration Team 36 Regulatory Management Branch II Antimicrobials Division ( 7510C) Page 2 of 62 Attached is the Preliminary Risk Assessment for the Alkylbenzene Sulfonates ( ABS) for the purpose of issuing a Reregistration Eligibility Decision ( RED). The disciplinary science chapters and other supporting documents for the Alkylbenzene Sulfonates RED are also included as attachments as follows:

Occupational and Residential Exposure Assessment for Alkylbenzene Sulfonates for the Reregistration Eligibility Decision Document ( RED) ( Active Uses). T. Milano. March 23. D327732 Residential Exposure Inert Assessment of Alkylbenzene Sulfonates for the Reregistration Eligibility Decision Document ( RED). T. Milano/ C. Walls, March 23, 2006. D327733 Environmental Fate Assessment of Alkylbenzene Sulfonates for the Reregistration Eligibility Document ( RED). T. Milano. March 23, 2006. D323968 Product Chemistry Science Chapter for Benzene Sulfonic Acid, C10 C16 Derivatives and Sodium Salt. A. N. Shamim. March 2006. D323976. Ecological Hazard and Environmental Risk Assessment of Alkylbenzene Sulfonates for the Registration Eligibility Document ( RED). R. Petrie. January 2006. D323970. Dietary Exposure Assessments for the Reregistration Eligibility Decision. R. Quick. March 23, 2006. D327731. Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision ( RED) Document, A. Assaad/ W. Dyksra/ L. Scarano, March 23, 2006. D327886. Inert Ingredient Dietary Risk Assessment for Linear Alkyl Benzenesulfonate. K. Leifer. March 23, 2006. Page 3 of 62 1.0 EXECUTIVE SUMMARY...................................................................................................................... 4 2.0 PHYSICAL AND CHEMICAL PROPERTIES...................................................................................... 12 3.0. ENVIRONMENTAL FATE .................................................................................................................. 13 4.0 HAZARD CHARACTERIZATION....................................................................................................... 14 4.1 Hazard Profile ......................................................................................................................... 14 4.2 FQPA Considerations.............................................................................................................. 16 4.3 Dose Response Assessment ..................................................................................................... 17 4.4 Endocrine Disruption............................................................................................................. 19 5.0 PUBLIC HEALTH DATA..................................................................................................................... 20 6.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION................................................................. 21 6.1 Summary of Registered Uses ............................................................................................. 21 6.2 Dietary Exposure and Risk................................................................................................ 22 6.2.1 Dietary Exposure for Active Ingredient Uses ..................................................................... 22 6.2.2 Dietary Exposure for Inert Ingredient Uses........................................................................ 25 6.3 Drinking Water Exposure and Risk for Inert Ingredient Uses .............................................. 26 6.4 Residential Exposure and Risks from Inert Ingredient Use................................................. 28 7.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION........................................ 31 8.0 CUMULATIVE EXPOSURE AND RISK ............................................................................................. 34 9.0 OCCUPATIONAL EXPOSURE AND RISK......................................................................................... 35 10.0 ENVIRONMENTAL RISK ................................................................................................................... 39 10.1 Active Ingredient Uses...................................................................................................... 39 10.2 Inert Ingredient Use .......................................................................................................... 43 11.0 DEFICIENCIES/ DATA NEEDS............................................................................................................ 43 12.0 REFERENCES...................................................................................................................................... 44 Page 4 of 62 1.0 EXECUTIVE SUMMARY The alkylbenzene sulfonates evaluated in this risk assessment are: ( 1) sodium dodecylbenzene sulfonate ( CAS # 25155 30 0), ( 2) dodecylbenzene sulfonic acid ( CAS # 27176 87 0), and ( 3) benzenesulfonic acid, C10 C16 alkyl derivatives ( CAS # 68584 22 5). These compounds are collectively called DDBSA by the DDBSA Joint Venture Task Force. Dodecylbenzene sulfonic acid is not considered to be a pure compound, and is included in the mixture of benzenesulfonic acid, C10 16 alkyl derivatives.

The alkylbenzene sulfonates are both active and inert ingredients in pesticide products. As active ingredients, there are currently twenty three registered end use products used as a disinfectant, food contact sanitizer, bacteriocide/ bacteriostat, microbiocide/ microbiostat, fungicide/ fungistat, and virucide. Alkylbenzene sulfonates are in cleaners and sanitizers that are designated for use in agricultural, food handling and commercial/ institutional/ industrial settings. Examples of registered uses for alkylbenzene sulfonates include, but are not limited to: application to indoor hard surfaces ( e. g. urinals, shower stalls, toilet bowls, etc.), food dispensing equipment ( e. g. pre mix and post mix vending machines), food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools, and fruits and vegetables ( post harvest). As active ingredients, there are no residential or outdoor uses currently registered. Concentrations of alkylbenzene sulfonates as an active ingredient in products range from 0.036% to 25.6%. Products containing alkylbenzene sulfonates are formulated as soluble concentrates, flowable concentrates, ready to use solutions, or water soluble packaging.

As inert ingredients, there are approximately 350 registered end use products containing these chemicals. Many of these products are used in residential settings, and outdoors in agricultural settings. The percent formulations for most of the products that contain alkylbenzene sulfonates as an inert ingredient range from 0.01% to 5%. However, the majority of the labels in this range contain 2% alkylbenzene sulfonates. It should be noted that a few sanitizing products have inert levels as high as 30% and the highest concentration of alkylbenzene sulfonates are found in wood preservative products up to 65 %.

Of the approximate 30 million pounds of alkylbenzene sulfonates produced per year, 0.1% or 300,000 pounds are used in EPA registered antimicrobial products. The rest is primarily used in household laundry and dish detergents annually. The alkylbenzene sulfonates are listed on the EPA High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the U. S. in production volumes greater than one million pounds per year. The alkylbenzene sulfonates are sponsored by the Linear Alkylbenzene ( LAB) Sulfonic Acids Coalition, which has generated data for these chemicals.

Hazard: The toxicology database for the alkylbenzene sulfonates consists almost entirely of published literature, and is essentially complete and of acceptable quality to assess the potential hazard to humans. The alkylbenzene sulfonates are readily absorbed following oral ingestion, but not following dermal exposure. Following oral exposure, they are readily metabolized, excreted fairly rapidly, and do not accumulate in any tissues. Available acute toxicity data show that alkylbenzene sulfonates are not highly acutely toxic ( Categories III IV), are irritating to the eye and skin ( categories I and II, respectively), and they are weak moderate skin sensitizers. Page 5 of 62 Subchronic and chronic exposures show that the liver, kidney and intestinal tract ( following oral exposures) are the major target organs of toxicity. Both in vitro and in vivo genotoxicity data show that alkylbenzene sulfonates are not genotoxic. The alkylbenzene sulfonates did not cause reproductive or developmental toxicity in acceptable studies. Early ( pre GLP) carcinogenicity studies indicate that alkylbenzene sulfonates do not cause an increase in tumor incidence.

Toxicity Endpoints: The toxicity endpoints used in this document to assess potential risks include chronic dietary, short term incidental oral, and short, intermediate and/ or long term inhalation exposure scenarios. The Health Effects Division's Toxicity Advisory Clinic ( TAC) was consulted and agreed with the choice of toxicity endpoints of concern selected for the aforementioned exposure scenarios in December 2005 for the alkylbenzene sulfonates as a group.

Acute and Chronic Reference Dose ( RfDs): No acute dietary endpoint was selected because there were no effects attributable to a single dose exposure.

The chronic RfD is 0.5 mg/ kg/ day for all populations, using a no observable adverse effect level ( NOAEL) of 50 mg/ kg/ day based on a weight of evidence from three toxicological studies that observed decreased pup body weight at 250 mg/ kg/ day and increased caecum weight and slight kidney damage at 114 mg/ kg/ day. An uncertainty factor of 100 ( 10X for interspecies extrapolation, 10X for intraspecies variability) was applied to the NOAEL to obtain the chronic RfD.

Incidental oral Exposure: For the short term incidental oral exposure, a NOAEL of 50 mg/ kg/ day was selected based on a weight of evidence from three toxicological studies that observed decreased pup body weight at 250 mg/ kg/ day and increased caecum weight and slight kidney damage at 114 mg/ kg/ day. The target margin of exposure ( MOE) is 100 ( 10X for interspecies extrapolation, 10X for intraspecies variability, and 1X FQPA factor discussed below).

Dermal Exposure: The Agency determined that quantitation of dermal risk is not required because: ( 1) the alkylbenzene sulfonates are surfactants that are dermal irritants at concentrations generally greater than 20% solution ( WHO 1996). Thus, dermal exposure would be self limiting to preclude dermal irritation. Most pesticide formulations have less than 5% alkylbenzene sulfonates as an inert ingredient, with the vast majority of household products containing approximately 2%. Additionally, the requirement of the dermal toxicity studies with the end use product will determine whether personal protective clothing would be necessary to protect against irritation during product use; ( 2) no systemic toxicity was seen following repeated dermal applications to rabbits at 200 mg/ kg/ day ( with an end use product); ( 3) no developmental toxicity concerns were seen following repeated dermal applications to pregnant mice, rats or rabbits ( developmental effects were seen either in the presence of maternal toxicity or at doses higher than those that caused maternal toxicity); and ( 4) there is no residential exposure to alkylbenzene sulfonates as an active ingredient, however, residential exposure from its use as an inert ingredient in pesticide formulations is expected to be of an intermittent nature ( i. e, no continuous, constant contact, multi day exposure) from household products. Page 6 of 62 Inhalation Exposure: For the short, intermediate and long term inhalation exposure a NOAEL of 1 mg/ m3 was selected ( equivalent to 0.14 mg/ kg/ day) from a subchronic inhalation monkey study that noted weight loss and decreased weight gain at 10 mg/ m3 ( 1.4 mg/ kg/ day) following exposure to a detergent dust containing 13% active ingredient of alkylbenzene sulfonates. In the absence of data, it was conservatively assumed that inhalation absorption is 100% to convert the air concentration into a dose equivalent. The target MOE is 100 for both residential and occupational exposures ( 10X for interspecies extrapolation, 10X for intraspecies variability, includes 1X FQPA factor discussed below).

FQPA Safety Factor. The TAC agreed that the FQPA safety factor should be removed ( 1X). A number of developmental studies via the oral route have been performed with alkylbenzene sulfonates in rats, mice and rabbits. The available information in these studies does not suggest any qualitative or quantitative evidence for susceptibility between the fetuses and maternal animals. The alkylbenzene sulfonates were tested in several multigeneration studies in rats, and there were no effects on offspring toxicity in any of these tests at doses up to 250 mg/ kg/ day.

Based on OPP policy, the cRfD modified by a FQPA safety factor is a population adjusted dose ( PAD) 1. OPP calculated a chronic PAD and used this value to estimate chronic dietary risk.

Dietary ( Food/ Drinking Water) Exposure and Risk: The Agency has conducted three chronic dietary exposure and risk assessments for the alkylbenzene sulfonates: ( 1) as active ingredients in food contact sanitizing solutions; ( 2) as active ingredients in a fruit and vegetable wash; and ( 3) as inert ingredients in pesticide formulations that may be applied to growing agricultural crops, raw agricultural commodities after harvest, and to animals. An acute dietary assessment was not conducted because there are no adverse effects attributable to a single dose.

In assessing the food contact sanitizing uses, the Agency believes that a counter top, utensils or glassware that are treated with these products may come into contact with food, which in turn may be ingested. This is considered to be an indirect food use. Dodecylbenzene sulfonic acid ( 27176 87 0) and sodium dodecylbenzene sulfonate ( 25155 30 0) have tolerance exemptions as specified in 40 CFR 180.940 ( b) and ( c). Both dodecylbenzene sulfonic acid and sodium dodecylbenzene sulfonate have limitations for the ready to use end use concentration not to exceed 400 ppm and 430 ppm, respectively for food processing equipment and utensils. However, dodecylbenzene sulfonic acid has a much lower limitation of 5.5 ppm for use on dairy processing equipment.

When assessing chronic ( non cancer) dietary risk, the Agency considered potential dietary exposure to the U. S. population including infants and children, as well as to females of childbearing age ( 13 50 years). EPA expresses dietary risk estimates as a percentage of the chronic PAD. Dietary exposures that are less than 100% of the cPAD are below the Agency's level of concern.

1 PAD = Population Adjusted Dose = Chronic RfD FQPA Safety Factor Page 7 of 62 Active Ingredient Dietary Risk Estimates. There are no currently registered outdoor uses of alkylbenzene sulfonates that are being supported by the registrant as an active ingredient. Thus, the dietary assessment for active uses was limited to potential food exposures. The risk analysis assumes daily exposure from the hard surface sanitation of counter tops, utensils, glassware and food processing equipment ( i. e., beverage plants, meat and poultry processing plants, milk and dairy plants). The dietary risk estimates for the fruit and vegetable wash were considered separately, because this use is regulated by the Food and Drug Administration ( FDA). The dietary risk estimates for the total food contact sanitizing uses are below the Agency's level of concern for all age groups ( less than 11% of the cPAD). In addition, the dietary risk estimates for the fruit and vegetable wash are below the Agency's level of concern for all age groups ( less than 71.2% of the cPAD). These risk estimates are based on a number of conservative assumptions, and thus may overestimate the actual risks.

Inert Ingredient Dietary Risk Estimates. The alkylbenzene sulfonates have some uses as inert ingredients in food use pesticide products that are used outdoors on agricultural crops. Thus, the inert assessment considered both food and drinking water exposures. The Agency utilized a conservative screening level dietary exposure model [ Dietary Exposure Evaluation Model ( DEEM   ) ] that assumed 100% of all commodities, and 100% of all crops were treated with the alkylbenzene sulfonates, with no limitation on the fraction of inert ingredient. The highest dietary risk estimate is 84% of the cPAD for children 1 2 years of age, which is below the Agency's level of concern. The conservative screening level drinking water assessment predicted chronic Estimated Drinking Water Concentrations ( EDWC) of 6.6 ppb using the FQPA Index Reservoir Screening Tool ( FIRST), which represents < 0.1% of the cPAD. The Agency concludes there is no concern for aggregate food and drinking water exposures to the alkylbenzene sulfonates resulting from their use as pesticide inert ingredients.

Residential ( Non Occupational) Exposure and Risk: There are no residential use sites for the alkylbenzene sulfonates as active ingredients. However, alkylbenzene sulfonates are formulated as inert ingredients in approximately 350 registered end use products, many of which are used in residential settings. Some examples of the specified use sites on the products consist of indoor hard non porous surfaces ( e. g. floors, walls etc.), carpets, food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools and crops, lawns and turfs, fruits and vegetables ( post harvest), wood preservatives, materials preservatives, metalworking fluids, and pet products. In this screening level assessment, the Agency selected representative scenarios for the vast majority of products, based on end use product application methods and use amounts. The Agency evaluated the following high end exposure scenarios: ( 1) outdoor residential turf treatment ( ready to use liquid); ( 2) indoor hard surface cleaner ( ready to use liquid); ( 3) indoor carpet cleaner ( ready to use liquid); and ( 4) pet flea and tick products ( aerosol can spray). For each of the use sites, the Agency assessed residential handler ( applicator) inhalation exposure and post application incidental ingestion by toddlers. Page 8 of 62 For most scenarios, the Agency utilized EPA's Pesticide Inert Risk Assessment Tool ( PiRat) to estimate residential applicator and post application exposures from the use of alkylbenzene sulfonates as inert ingredients in residential products. For the pet product scenario, the Agency used assumptions based on the Residential Exposure Assessment Standard Operating Procedures ( SOPs). Because there are a large number of products that contain alkylbenzene sulfonates as an inert ingredient, the Agency assessed both a high end formulation in addition to a 2% formulation product. The 2% value was selected because the majority of the labels contain 2% alkylbenzene sulfonates as an inert ingredient. A dermal assessment was not conducted because a dermal endpoint was not selected. An inhalation post application assessment was not conducted because the vapor pressure of the sulfonates is extremely low. The duration of exposure was assumed to be short term ( 1 30 days) for all residential scenarios assessed.

Residential Handler Risk Estimates. For residential handlers that handle products containing alkylbenzene sulfonates as inert ingredients, the short term inhalation MOEs were above the target MOEs ( i. e.,   > 100) and thus, do not exceed the Agency's level of concern, with the exception of the flea and tick product where the MOE was 87 for the high end formulation containing 24% alkylbenzene sulfonates. T. However, this scenario is conservative because it assumes a person treats his/ her pet with 0.5 cans of flea product that contains 24% alkylbenzene sulfonates every day for a month. However, there are no risk concerns for the majority of pet products containing 2% alkylbenzene sulfonates.

Residential Postapplication Risk Estimates. There are no residential postapplication risk concerns for the majority of household products that contain 2% alkylbenzene sulfonates as an inert ingredient. However, there are potential postapplication incidental oral risks to young children resulting from indoor use of products that may contain alkylbenzene sulfonates. The MOEs are 30 and 40 for hard surface and carpet cleaners, respectively, which are less than the Agency's target MOE of 100. However, these risk estimates are considered to be conservative screening level values, based on products that contain between 6 8% alkylbenzene sulfonates. The majority of products contain concentrations below 5%. The postapplication incidental oral risks to children that may contact a treated pet are not of concern as the range of MOEs ( 106 1,300) is above the target MOE of 100.

The alkylbenzene sulfonates caused dermal irritation following repeated dermal exposure, generally to concentrations greater than 20%. Thus, dermal exposure would be self limiting to preclude dermal irritation. The majority of residential products contain less than 5% akylbenzene sulfonates. The Agency intends to consider the potential for irritation in recommended labeling language of pesticide products containing the alkylbenzene sulfonates, and consider available dermal toxicity data on a diluted end use formulation.

Aggregate Exposure and Risk: In order for a pesticide registration to continue, it must be shown that the use does not result in " unreasonable adverse effects on the environment". Section 2 ( bb) of FIFRA defines this term to include " a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with standard under section 408..." of FFDCA. As mandated by the FQPA amendments to FIFRA and the Federal Food, Drug and Cosmetic Act ( FFDCA), the Agency must consider total aggregate exposure from food, drinking water and residential sources of exposure to alkylbenzene sulfonates. Page 9 of 62 An acute aggregate assessment was not conducted because there are no adverse effects attributable to acute exposure. An intermediate term aggregate assessment was not conducted because there are no residential exposures of this duration. In addition, because there are no long term residential exposures, the chronic aggregate assessment only considered food and drinking water exposures from the inert uses that were previously determined to not be of risk concern. Thus, only short term and chronic aggregate assessments were conducted. Oral and inhalation exposure and risk estimates were conservatively combined for the aggregate risk assessment because these endpoints both identify adverse effects on body weight. Dermal exposures were not considered in the risk assessment because a toxicological endpoint was not established.

Short Term. This assessment considers both the active and inert uses of the alkylbenzene sulfonates. For children, the short term aggregate assessment includes average dietary exposure ( food and drinking water) from both the active food contact sanitizer uses and the inert uses on agricultural commodities, in addition to estimated incidental oral exposures to children from residential uses such as hard surface cleaning products as an inert ingredient. For adults, the aggregate assessment includes dietary ( food and drinking water) from both active and inert uses and residential inhalation exposures from wiping a hard surface cleaning products since this scenario represents the highest exposure from the inert use. Individual scenarios that had risks of concern were not included in the aggregate assessment.

The aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is 340 which is greater than the target of 100. For children, the aggregate risk estimates are less than the target MOE of 100 ( MOE= 54) and are of risk concern. The aggregate child risks are of concern because both the dietary and residential scenarios alone are very close to the target MOEs or 100% of the cPAD ( i. e., food and drinking water accounts for approximately 95% of the cPAD), while the incidental oral exposure from a hard surface cleaner MOE is 120 ( for a 2% product). As noted previously, several conservative assumptions were used in this assessment.

Chronic Aggregate. The chronic aggregate assessment considers average dietary exposure ( food and drinking water) from both the active food contact sanitizer uses and the inert uses on agricultural commodities. The dietary exposures from the fruit and vegetable wash were not considered because they already exceed the Agency's level of concern. For children, the dietary aggregate risk is 95% of the cPAD, while for adults it is 29% of the cPAD.

It should also be recognized that the majority of the uses of alkylbenzene sulfonates are not in pesticide products, but rather are used in household laundry and dish detergents. Over 30 millions pounds of these compounds are produced each year, while only 300,000 pounds are used in EPA registered antimicrobial products. The Agency did not consider potential exposure and risks from the numerous other residential exposures to alkylbenzene sulfonates because the Agency lacks reliable information at this time to assess the consumer product uses of these chemicals.

Occupational Exposure and Risk. 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 Page 10 of 62 occupational environments. The representative scenarios selected by the Agency for assessment were evaluated using maximum application rates as recommended on the product labels for the three alkylbenzene sulfonate active ingredients assessed in this report.

To assess the handler risks, the Agency used surrogate unit exposure data from both the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED). Only inhalation risks were evaluated because a dermal toxicity endpoint was not selected. For the occupational handler inhalation risk assessment, the short and intermediate term risks calculated at baseline exposure ( no respirators) were above target MOEs for all scenarios ( i. e., inhalation MOEs were > 100) for all scenarios except the following:

  ST and IT inhalation exposure from cleaning hard surfaces via circulation/ flow/ flushing in the agricultural premises and equipment category, inhalation MOE < 1.   ST and IT inhalation exposure from application to hard surfaces via ( 1) circulation systems/ flow method, or ( 2) Cleaning in Place ( CIP) in the food handling category, inhalation MOE < 1.   ST and IT inhalation exposure from cleaning hard surfaces via wiping in the food handling category, inhalation MOE = 93.   ST and IT inhalation exposure from cleaning food dispensing equipment via circulation systems/ flow method in the food handling category, inhalation MOE < 1.   ST and IT Inhalation exposure from cleaning shower stalls and toilets via ( 1) a liquid pour application or ( 2) wiping in the commercial/ institutional premises, inhalation MOE = 13 and MOE < 1, respectively.

Many product labels have use directions that recommend both cleaning and sanitizing with the same product. Thus, the Agency estimated total risks resulting from use of these specific products. The following scenarios had risks of concern ( i. e., MOE < 100).

  ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 93.   ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via low pressure spray in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning indoor hard surfaces via sponge/ mesh/ wiping and then sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning and sanitizing steps to be conducted through CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE < 1.

Although all the inhalation risks of concern are for baseline exposures, the Agency does not believe it is practicable to require the use of respiratory protection on cleaning products used in janitorial situations. In addition, engineering controls are not feasible for the current use patterns on the labels. Page 11 of 62 As noted previously, the alkylbenzene sulfonates are dermal irritants at concentrations greater than 20%. Thus, dermal exposure would be self limiting to preclude dermal irritation. The Agency intends to consider the potential for irritation in recommended labeling language of pesticide products containing the alkylbenzene sulfonates, and consider available dermal toxicity data on a diluted end use formulation. The Agency should confirm that all products with greater than 20% require the use of gloves.

For most of the occupational scenarios, postapplication dermal exposure is not expected to occur or is expected to be negligible based on the application rates and chemical properties of the chemical. The alkylbenzene sulfonates have a low vapor pressure ( less than 10 9 mmHg), so that any standing solutions that may result in post application exposure were deemed negligible.

Environmental Hazard and Risk. The alkylbenzene sulfonates are slightly toxic to the Northern bobwhite quail, and moderately toxic to freshwater fish following acute exposure. Available data suggest that the alkylbenzene sulfonates may be more toxic to aquatic organisms as the number of carbons in the chain increase. No acute fish toxicity data are available for carbon chains above 12, and thus a fish environmental hazard label statement is required on manufacturing use product labels at this time. The acute toxicity to the freshwater invertebrate, Daphnia magna is variable, dependent on the length of the carbon chain, and ranges from slightly to highly toxic to freshwater invertebrates. Based on the available information, an environmental hazard statement for aquatic invertebrates is required on manufacturing use products because the EC50 is < 1.0 ppm ( C14, C16). The available data indicate that the alkylbenzene sulfonates are slightly toxic to green algae.

The guideline requirement for a freshwater fish acute test ( 850.1075), and acute freshwater invertebrate study ( 850.1010) are outstanding. These studies are required to support the current indoor uses and to document potential acute toxicity to these organisms in the unlikely event that exposure to alkylbenzene sulfonates does occur.

Available literature for linear alkylbenzene sulfonate ( LAS) detergent use indicates that the alkylbenzene sulfonates are not expected to bioaccumulate in the environment or aquatic organisms ( i. e. fish) and are expected to be soluble in water such that they will exhibit mobility through the soil. The model calculated linear and non linear biodegradation probabilities suggest that these chemicals will most likely biodegrade rapidly. The short half life indicates that if these chemicals are present in the soil, they are not likely to be volatile and are expected to degrade rapidly in the environment.

Minimal or no environmental exposure is expected to occur from the majority of alkylbenzene sulfonate antimicrobial pesticide uses because a very small number of pounds of this chemical are sold for antimicrobial use per data provided by the manufacturers.

The inert agricultural uses of alkylbenzene sulfonates are not expected to adversely affect avian or mammalian species on an acute or chronic basis. Aquatic organisms are also not expected to be adversely affected by inert alkylbenzene sulfonates use acutely or chronically due to the low predicted level of alkylbenzene sulfonates in water. A chronic freshwater fish toxicity test Page 12 of 62 NOAEC of 400 ug/ L alkylbenzene sulfonates is considered protective of ecosystem structure and function in experimental streams. Therefore, the predicted concentration of 6.6 ppb in water is well below the Agency's chronic Level of Concern ( LOC).

Use of alkylbenzene sulfonates in agricultural pesticide formulations is not expected to result in significant environmental exposure. Therefore, no adverse effects ( NE) to listed species are anticipated.

2.0 PHYSICAL AND CHEMICAL PROPERTIES The physical and chemical properties for the three alkylbenzene sulfonates assessed in this document: ( 1) sodium dodecylbenzene sulfonate, ( 2) benzene sulfonic acid, C10 16 alkyl derivatives, and ( 3) dodecylbenzene sulfonic acid are provided in Table 1. The product chemistry chapter ( memo from N. Shamim, March 2006, D323976) provides a comprehensive list of the different physical/ chemical properties. Below are the chemical structures.

Figure 1: Sodium Dodecylbenzene Sulfonate Figure 2: Dodecylbenzene Sulfonic Acid ( DDBSA) also ( also named as dodecylbenzene sulfonic representative of Benzene Sulfonic Acid, C10 acid, sodium salt) 16 alkyl derivatives Table 1 Physical/ Chemical Properties of Linear Alkylbenzene Sulfonates Parameter Sodium Dodecylbenzene Sulfonate Benzene Sulfonic Acid, C10 16 alkyl derivatives Dodecylbenzene Sulfonic Acid ( DDBSA)

PC Chemical Code 079010 190116 098002 Cas Number 25155 30 0 68584 22 5 27176 87 0 Molecular Formula C18H29O3S Na C16H26O3S C18H30O3S Page 13 of 62 Table 1 Physical/ Chemical Properties of Linear Alkylbenzene Sulfonates Synonyms Alkyl( C12) benzenesulfonic acid, sodium salt Benzenesulfonic acid, dodecyl, sodium salt Dodecylbenzene sodium sulfonate Dodecylbenzenesulfonic acid, sodium salt Sodium laurylbenzenesulfonate Benzenesulfonic acid, dodecyl Molecular Weight 348.48 g/ mol 298.44 g/ mol 326.50 g/ mol Henry Law Constant 6.02 x 10 17 atm. m3/ mol 2.8 x 10 11 atm m3/ mol 4.8 x 10 11 atm m3/ mol Melting Point 287.6OC 167.7 OC 178 OC Boiling Point 660OC 437 OC 460 OC Water Solubility Highly water soluble 400 g/ L ( 25 O C) 0.7 mg/ L log Kow 1.96 3.80 4.78 Vapor Pressure 6.02 x 10 15 mm Hg 5.1 x 10 10 mm Hg ( 25o C) 7.9 x 10 11 mm Hg ( 25o C)

Half life in air 0.66 days = 7.9 hours 0.79 days = 9.48 hours 0.654 days = 7.85 hours 3.0. ENVIRONMENTAL FATE Detailed information on environmental fate is presented in the attached memo from T. Milano ( March 23, 2006, D323968). A brief summary is provided below.

The environmental fate properties of dodecylbenzene sulfonic acid are assumed to be represented by the conclusions made pertaining to benzenesulfonic acid, C10 C16 alkyl derivatives. This is because dodecylbenzene sulfonic acid ( DDBSA) is not considered to be a pure compound, and is actually included in the mixture of benzenesulfonic acid, C10 16 alkyl derivatives. These compounds will be addressed as a group, DDBSA.

The environmental fate assessment for DDBSA is based on US EPA =

s Estimation Programs Interface ( EPI) Suite. EPI Suite provides estimations of physical/ chemical properties and environmental fate properties.

Based on the output of the model, sodium dodecylbenzene sulfonate is highly unlikely to bioaccumulate in the environment or aquatic organisms ( i. e. fish) because the low value for the log Kow ( 1.96). This also supports that the chemical is soluble in water such that it will exhibit mobility through the soil. In addition, the low log Koc ( 4.22) further supports the expected soil mobility. The model calculated linear and non linear biodegradation probabilities suggest that the linear carbon chain will biodegrade rapidly, whereas the benzene ring is not expected to biodegrade as rapidly. The extremely low vapor pressure along with the short half life of approximately 7.9 hours indicates that if this chemical is present in the soil, it is not likely to be volatile and is expected to degrade rapidly. Page 14 of 62 Based on the output of the model, DDBSA is expected to behave very similarly as what is projected for sodium dodecylbenzene sulfonate. Based on the low Kow value ( 3.8), DDBSA is highly unlikely to bioaccumulate in the environment or aquatic organisms ( i. e. fish). The chemical is also expected to be soluble in water such that it will exhibit mobility through the soil. In addition, the log Koc ( 3.69) is low, and this further supports the expected soil mobility. The model calculated linear and non linear biodegradation probabilities suggest that the chemical will most likely biodegrade rapidly. The extremely low vapor pressure along with the short half life of approximately 9.48 hours indicates that this chemical is not likely to be volatile and is expected to degrade rapidly.

The output parameters from the EPI Suite model support that any potential impacts of these chemicals are expected to be very short lived. This is because they are not likely to persist in water or microbial soils and sediments. As a result, the environmental fate of alkylbenzene sulfonate is not likely to be of concern.

4.0 HAZARD CHARACTERIZATION 4.1 Hazard Profile The toxicology database for the alkylbenzene sulfonates consists almost entirely of published literature, is essentially complete and of acceptable quality to assess the potential hazard to humans.

A detailed Toxicology Assessment for the linear alkylbenzene sulfonates is presented in the attached memorandum ( memo from A. Assaad/ W. Dykstra/ L. Scarano, March 2006). Table 2 highlights the acute toxicity studies for the alkylbenzene sulfonates. A detailed summary of the key toxicological studies is presented in Appendix A because of the large number of available toxicological information on these compounds. A brief hazard assessment is presented below.

Acute Toxicity. Alkylbenzene sulfonates exhibit a wide range of acute toxicity via the oral route in rats ( LD50s of 404   1980 mg/ kg), with a narrower range in mice ( LD50s of 1259 2300 mg/ kg). This spans the acute oral toxicity categories of III IV. Alkylbenzene sulfonates are classified as acute toxicity category II for the dermal route and category IV ( least toxic) via the inhalation route. They are irritants to the eye ( category I), skin ( category II), and are weak moderate skin sensitizers ( category III).

Absorption, Distribution, Metabolism, Excretion. In animal tests ( oral   monkeys, pigs, rats), alkylbenzene sulfonates are readily absorbed from the gastrointestinal tract, are distributed throughout the body, and are extensively metabolized. Excretion is via both the urine and feces. Available dermal absorption data ( rats and guinea pigs) indicate that alkylbenzene sulfonates are poorly absorbed from the skin, although prolonged contact may lead to irritation and thus compromise the skin to permit more absorption ( WHO, 1996 and HERA, 2004).

Repeated Dose Toxicity ( Subchronic and Chronic). There have been many oral repeated dose studies performed with alkylbenzene sulfonates ranging from a 28 day study in monkeys to nine month studies conducted with rats and mice. There have also been repeated dose dermal Page 15 of 62 ( guinea pigs, rabbits, and rats) and inhalation studies ( dogs and monkeys). Collectively, the animal data suggest that the liver, kidney and caecum ( for oral studies) are the major target organs for toxicity. The liver and kidney effects were dose and duration related in that mild effects ( organ weight changes and serum enzyme/ clinical chemistry changes indicative of mild organ effects) were seen at lower doses, but increased in severity with both dose and time.

For the purposes of this hazard assessment, several studies were considered collectively to determine a NOAEL of 50 mg/ kg/ day for the chronic dietary endpoint. This is based on: increased caecum weight and slight kidney damage ( at a LOAEL of 114 mg/ kg/ d in the six month rat study); reduced body weight in 21 day old pups ( at a LOAEL of 250 mg/ kg/ day in a reproductive toxicity rat study); and significant decreases in renal biochemical parameters ( at a LOAEL of 145 mg/ kg/ day in a nine month drinking water study in rats).

Developmental Toxicity. A number of developmental studies via the oral and dermal routes have been performed with alkylbenzene sulfonates in rats, mice and rabbits; there were also several subcutaneous injection developmental studies reported in mice ( WHO, 1996). There is a spectrum of quality in the 20+ studies in terms of dosing ( some had only one or two doses), purity of alkylbenzene sulfonates used ( some used formulated products that ranged from 1 45% alkylbenzene sulfonates content), and overt toxicity to the pregnant females in the dermal studies due to severe irritating effects. It is concluded that some developmental effects ( including some terata) were observed at high doses at which maternal toxicity was observed and the available information does not suggest any qualitative or quantitative susceptibility differences between fetuses and maternal animals.

Reproductive Toxicity. Alkylbenzene sulfonates were tested in several multigeneration studies in rats. There were no effects on reproductive parameters in any of these tests at doses up to 250 mg/ kg/ day.

Carcinogenicity. The available long term studies that assessed carcinogenicity were older studies ( pre 1970) that would not be acceptable under current standards ( due to low number of animals used, insufficient number of doses and duration of dosing, and limited histopathological examinations. However, the limited studies provide no evidence of carcinogenicity in animals given alkylbenzene sulfonates orally.

Genotoxicity. The toxicological data show that alkylbenzene sulfonates were not genotoxic in vitro or in vivo.

Neurotoxicity. There is no evidence in the available toxicity studies or scientific literate to indicate neurotoxic effects of the alkylbenzene sulfonates in humans or laboratory animals.

Table 2 Acute Toxicity Studies for Alkylbenzene Sulfonates Guideline No./ Study Type MRID No. Results Toxicity Category Page 16 of 62 Table 2 Acute Toxicity Studies for Alkylbenzene Sulfonates Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity Multiple LD50 = range from 404 to over 5000 mg/ kg III IV 870.1200 Acute dermal toxicity 94032006 LD50 = 1200 mg/ kg II 870.1300 Acute inhalation toxicity 003442* LC50 = 200 mg/ L IV 870.2400 Acute eye irritation 0033443* Corneal opacity not reversed at 72 hours. I 870.2500 Acute dermal irritation 003444* Severe irritation at 72 hours II 870.2600 Skin sensitization Open Literature { Nusair TL, PJ Danneman, J Stotte, PHS Bay ( 1988) Consumer Products: Risk Assessment Process for Contact Sensitization, Toxicologist 8: 258. ( HERA)} Weak to moderate sensitization * Toxicity record No.

4.2 FQPA Considerations Under the Food Quality Protection Act ( FQPA), P. L. 104 170, which was promulgated in 1996 as an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug and Cosmetic Act ( FFDCA), the Agency was directed to " ensure that there is a reasonable certainty that no harm will result to infants and children" from aggregate exposure to a pesticide chemical residue. The law further states that in the case of threshold effects, for purposes of providing this reasonable certainty of no harm, " an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre and post natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide residue only if, on the basis of reliable data, such margin will be safe for infants and children."

The toxicology database is complete with respect to assessing the increased susceptibility to infants and children as required by FQPA for alkylbenzene sulfonates. The prenatal developmental and reproduction studies showed no qualitative or quantitative evidence of increased susceptibility ( i. e., developmental NOAELs/ LOAELs were the higher than those for maternal effects). Therefore, the FQPA factor was reduced to 1X.

Several reproduction and many developmental studies have been performed with alkylbenzene sulfonate in a number of animal species. In the developmental studies, whenever Page 17 of 62 toxicity was observed in adults, it was generally for mild effects ( slight body weight changes, intestinal disturbances) except for severe dermal irritation effects in dermal developmental studies. Any developmental toxicity observed in these same studies included minor increases in visceral/ skeletal anomalies and some fetal losses; but only at maternally toxic doses.

In one reproduction study ( Buehler et al., 1971), there were slight changes in hematology and histopathology ( both within historical control ranges) and slight decreases in body weight in the offspring at the highest dose of 250 mg/ kg/ d ( at which there were no effects on the parental generation). There were no effects in either the parents or offspring in the other two reproductive toxicity studies ( see Toxicity Profile Table)   high doses of 70 or 170 mg/ kg/ day.

There is no evidence in the available toxicity studies or scientific literature to indicate neurotoxic effects of the alkylbenzene sulfonates in humans or laboratory animals.

Based on hazard data, the Agency recommended the special FQPA SF be reduced to 1X because there are no concerns and no residual uncertainties with regard to pre and/ or postnatal toxicity. The risk assessment team evaluated the quality of the exposure data; and based on these data the team also recommended that the special FQPA SF be reduced to 1X. There is no need for a special FQPA factor because the mid dose level of 50 mg/ kg/ day ( NOAEL for offspring effects) in a reproduction study ( Buehler et al. 1971) is the basis for the chronic RfD of 0.5 mg/ kg/ day. Thus, the chronic hazard value is based on slight pup effects and is protective of laboratory animals of all ages in this hazard assessment.

4.3 Dose Response Assessment The Health Effects Division's Toxicity Advisory Clinic ( TAC) was consulted and agreed with the choice of toxicity endpoints of concern in December 2005 for the alkylbenzene sulfonates as a group.

Table 3. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF*, endpoint and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( All populations) No endpoint was selected. No effects are attributable to a single dose. Page 18 of 62 Table 3. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF*, endpoint and Level of Concern for Risk Assessment Study and Toxicological Effects Chronic Dietary ( All populations) Systemic/ Reproductive NOAEL= 50 mg/ kg/ day UF = 100 Chronic RfD = 0.5 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD FQPA SF = 0.5 mg/ kg/ day Systemic/ Reproductive LOAEL = 250 mg/ kg/ day based on decreased Day 21 female pup body weight ( Buehler, E. et al. 1971. Tox. Appl. Pharmacol. 18: 83 91)

plus LOAEL= 145 mg/ kg/ day from 9 month drinking water rat study based on decreased body weight gain, and serum/ biochemical and enzymatic changes in the liver and kidney ( Yoneyama et al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27( 2): 105 112)

plus LOAEL= 114 mg/ kg/ day ( 0.2%) based on increased caecum weight and slight kidney damage in a 6 month rat dietary study ( Yoneyama et al 1972 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 24: 409 440)

Short Term Incidental Oral ( 1 30 days) Oral NOAEL= 50 mg/ kg/ day Residential LOC for MOE < 100 Systemic/ Reproductive LOAEL = 250 mg/ kg/ day based on decreased Day 21 female pup body weight ( Buehler, E. et al. 1971. Tox. Appl. Pharmacol. 18: 83 91)

plus LOAEL= 145 mg/ kg/ day from 9 month drinking water rat study based on decreased body weight gain, and serum/ biochemical and enzymatic changes in the liver and kidney ( Yoneyama et al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27( 2): 105 112)

plus LOAEL= 114 mg/ kg/ day ( 0.2%) based on increased caecum weight and slight kidney damage in a 6 month rat dietary study ( Yoneyama et al 1972 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 24: 409 440) Page 19 of 62 Table 3. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF*, endpoint and Level of Concern for Risk Assessment Study and Toxicological Effects Short, intermediateand Long Term Inhalation ( 1 to 30 days, 1 6 months, > 6 months) Inhalation study NOAEL= 1mg/ m3 detergent dust combined with up to 0.1 mg/ m3 enzyme dust Equivalent to approximately 0.14 mg/ kg/ day ( a) ( inhalation absorption rate = 100%) purity= 13% active ingredient Residential LOC for MOE < 100 Occupational LOC for MOE < 100 Subchronic Inhalation Monkey Study LOAEL = 10 mg/ m3 detergent combined with 0.1 mg/ m3 enzyme dust based on weight loss and decreased weight gain ( W. Coates, et al 1978. Tox. Appl. Pharmacol. 45: 477 496) This air concentration is equivalent to approximately 1.4 mg/ kg/ day ( a)

Dermal Endpoint Quantification of dermal risk is not required since: 1) the alkylbenzene sulfonates are surfactants that are dermal irritants at concentrations generally greater than 20% solution ( WHO 1996). Thus, dermal exposure would be self limiting to preclude dermal irritation. Most pesticide formulations have less than 5% alkylbenzene sulfonates as an inert ingredient, with the vast majority of household products containing approximately 2%. Additionally, the requirement of the dermal toxicity studies with the end use product will determine whether personal protective clothing would be necessary to protect against irritation during product use; 2) no systemic toxicity was seen following repeated dermal applications to rabbits at 200 mg/ kg/ day ( with an end use product); 3) no developmental toxicity concerns were seen following repeated dermal applications to pregnant mice, rats or rabbits ( developmental effects were seen either in the presence of maternal toxicity or at doses higher than those that caused maternal toxicity); and 4) there is no residential exposure to alkylbenzene sulfonates as an active ingredient, however, residential exposure from its use as an inert ingredient in pesticide formulations is expected to be of an intermittent nature ( i. e, no continuous, constant contact, multi day exposure) from household products.

Cancer ( oral, dermal, inhalation) No evidence of carcinogenicity in reported studies in rats done before 1980 GLPs 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 ( a) Equation used to convert inhalation air concentration to a dose= mg/ L* absorption* respiratory volume ( L/ hr)* duration ( hrs) * activity factor / body weight. Thus, 0.001 mg/ L * 1* 67.94 L/ hr ( based on default respiratory volumes for a New Zealand Rabbit which is used as a surrogate for a cynomolgus monkey) * 6 hrs * 1 / 2.98 kg ( body weight for New Zealand Rabbit used as a surrogate for cynomolgus monkey, study reports monkey body weight ranges from 1.6 to 3.7 kg).

4.4 Endocrine Disruption EPA is required under the FFDCA, as amended by FQPA, to develop a screening program Page 20 of 62 to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor and Testing Advisory Committee ( EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

In the available toxicity studies on the alkylbenzene sulfonates, there was no estrogen, androgen, and/ or thyroid mediated toxicity. When additional appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, alkylbenzene sulfonates may be subjected to further screening and/ or testing to better characterize effects related to endocrine disruption.

5.0 PUBLIC HEALTH DATA Incident Reports. There are no human incident reports associated with alkylbenzene sulfonates. The Agency consulted the following databases for poisoning incident data for alkylbenzene sulfonates:

( 1) OPP Incident Data System ( IDS)  The Incident Data System of The Office of Pesticide Programs ( OPP) of the Environmental Protection Agency ( EPA) contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, sometimes with enough cases and/ or enough documentation risk mitigation measures may be suggested. ( 2) Poison Control Centers ( 1993 2003)  as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 2003 for all pesticides. Most of the national Poison Control Centers ( PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc. ( 3) California Department of Pesticide Regulation ( 1982 2004)  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure ( worker activity), type of illness ( systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of Page 21 of 62 days off work and in the hospital are provided. ( 4) National Pesticide Telecommunications Network ( NPTN)  NPTN is a toll free information service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984 1991, inclusive, has been prepared. The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others.

6.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION Dietary exposure to alkylbenzene sulfonates can occur from its use in food contact sanitizing solutions as an active ingredient, and as an inert ingredient in food use pesticide products applied to agricultural crops, and animals. There are no currently registered products used in residential settings where alkylbenzene sulfonates are considered to be an active ingredient. However, alkylbenzene sulfonates are used as an inert ingredient in pesticide products used in residential settings, including hard surface and carpet cleaners, lawn products, and pet products. Postapplication residential exposure can occur in children from hand to mouth incidental oral exposure from treated surfaces, and contacting pets treated with flea and tick products. Occupational exposure to alkylbenzene sulfonates can occur from mixing/ loading/ application activities in various use sites, including agricultural food handling, and commercial/ institutional/ industrial premises.

Of the approximate 30 million pounds of alkylbenzene sulfonates produced per year, 0.1% or 300,000 pounds are used in EPA registered antimicrobial products. The rest is primarily used in household laundry and dish detergents annually. The alkylbenzene sulfonates are listed on the EPA HPV Challenge Program. HPV chemicals are those that are manufactured or imported into the U. S. in production volumes greater than one million pounds per year. The HPV Challenge Program is a voluntary partnership between industry, environmental groups, and the EPA which invites chemical manufacturers and importers to provide basic hazard data on the HPV chemicals they produce/ import. The goal of this program is to facilitate the Public's right to know about the potential hazards of chemicals found in their environment, their homes, their workplace, and in consumer products. The alkylbenzene sulfonates are sponsored by the Linear Alkylbenzene ( LAB) Sulfonic Acids Coalition, which has generated data for these chemicals.

6.1 Summary of Registered Uses The alkylbenzene sulfonates are both active and inert ingredients in pesticide products. As active ingredients, they are currently in twenty three registered end use products as a disinfectant, food contact sanitizer, bacteriocide/ bacteriostat, microbiocide/ microbiostat, fungicide/ fungistat, and virucide. Alkylbenzene sulfonates are in cleaners and sanitizers that are designated for use in agricultural, food handling and commercial/ institutional/ industrial settings. Examples of registered uses for alkylbenzene sulfonates include, but are not limited to: application to indoor hard surfaces ( e. g. urinals, shower stalls, toilet bowls, etc.), food dispensing equipment ( e. g. pre mix and post mix vending machines), food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools, and fruits and vegetables ( post harvest). As active Page 22 of 62 ingredients, there are no residential or outdoor uses currently registered. As active ingredients, concentrations of alkylbenzene sulfonates in products range from 0.036% to 25.6%. Products containing alkylbenzene sulfonates are formulated as soluble concentrates, flowable concentrates, ready to use solutions, or water soluble packaging. The application rates used in this assessment were the maximum application rates as recommended on the product labels.

As inert ingredients, there are approximately 350 registered end use products containing these chemicals. Some of the inert functions of alkylbenzene sulfonates in the registered products are listed as solvent, surfactant, dispersant, detergent, and wetting agent. Products that contain alkylbenzene sulfonates as an inert are designated for use in agricultural settings, food handling premises, medical premises, commercial/ institutional/ industrial settings, and residential settings. Some examples of the specified use sites of the products consist of indoor hard non porous surfaces ( e. g. floors, walls etc.), carpets, food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools and crops, lawns and turfs, fruits and vegetables ( post harvest), wood preservatives, materials preservatives, metalworking fluids, and pet products. Many of these products are formulated as soluble concentrates, flowable concentrates, ready to use solutions, or water soluble packaging.

As inert ingredients, the percent formulations for most of the products that contain alkylbenzene sulfonates as an inert ingredient range from 0.01% to 5%. However, the majority of the labels in this range contain 2% alkylbenzene sulfonates. Therefore, the risks were assessed at 2% formulation, which represents the formulation that is most likely to be used, and at an appropriate high end formulation, which is dependent upon the product type. It should be noted that a few sanitizing products have inert levels as high as 30% and the highest concentration of alkylbenzene sulfonates are found in wood preservative products up to 65 %.

6.2 Dietary Exposure and Risk 6.2.1 Dietary Exposure for Active Ingredient Uses Estimates of dietary risk from the use of alkylbenzene sulfonates as active ingredients in pesticide products are based upon the detailed analysis in the Dietary Exposure Assessment memorandum ( memo from R. Quick, March 2006, D327731) and are summarized here for completeness. Dodecylbenzenesulfonic acid ( 27176 87 0) and sodium dodecylbenzene sulfonate ( 25155 30 0) have uses in food contact surface sanitizing solutions with tolerance exemptions as specified in 40 CFR 180.940 ( b) and ( c), and summarized in the Table below. Residues for these compounds are exempt from the requirement of a tolerance when used in accordance with good manufacturing practice as ingredients in an antimicrobial pesticide formulation, provided that the substance is applied on a semi permanent or permanent food contact surface ( other than being applied on food packaging) with adequate draining before contact with food. Both dodecylbenzene sulfonic acid, and sodium dodecylbenzene sulfonate have limitations for the ready to use end use concentration not to exceed 400 ppm and 430 ppm, respectively for food processing equipment and utensils. However, dodecylbenzene sulfonic acid has a much lower limitation of 5.5 ppm for use on dairy processing equipment. The Agency estimates that the 430 ppm limitation for the sodium salt is equivalent to approximately 400 ppm of the free acid form. Page 23 of 62 Table 4. Tolerance Exemptions for Food Contact Sanitizer Uses ( Active Uses)

Tolerance Exemption Expression/ Chemical Name CAS No. PC Code 40 CFR

180. Use Pattern ( Pesticidal)

940 ( b) food contact sanitizing solutions for dairy processing equipment, and food processing equipment and utensils; end use concentration not to exceed 5.5 ppm Benzenesulfonic acid, dodecyl 27176 87 0 098002 940 ( c) food contact sanitizing solutions for food processing equipment and utensils; end use concentration not to exceed 400 ppm Benzenesulfonic acid dodecyl, sodium salt 25155 30 0 079010 940 ( c) food contact sanitizing solutions for food processing equipment and utensils; end use concentration not to exceed 430 ppm Based on the pesticide labels, the Agency assessed dietary exposure that could result from the use of alkylbenzene sulfonates in the food service industry ( treated surfaces, dishes, utensils, glassware, pots and pans), in the food processing industry ( food processing equipment such as breweries and beverage plants, meat and poultry processing plants, milk and dairy products/ packing plants etc), and as a fruit and vegetable wash.

Food Handling Establishments. In the absence of residue data for residues of alkylbenzene sulfonates on treated food contact surfaces, the Agency estimated residue levels that may occur in food from the application rates on food contact surfaces. To determine the Estimated Daily Intake ( EDI), the Agency has used an FDA model. The maximum ingredient percentage for dodecylbenzene sulfonates in food handling establishments from the various labels is 400 ppm. The Agency estimates that use of this product results in food residues of 530 ppb ( µ g/ kg). The Agency assumed that food can contact 4000 cm2 of treated surfaces, utensils, glassware, or pots and pans and that 100% of the pesticide migrates to food based on the standard assumptions used in the FDA Sanitizing Solution Guidelines. It was assumed that an adult and child consume 3000 and 1500 grams of food per day, respectively that will contact the treated surfaces.

Food Processing Equipment. The Agency used the FDA milk truck model to estimate residues in milk that could result from the use of alkylbenzene sulfonates in the food processing equipment, as representative of the potential uses in the food processing industry. As a conservative measure, the Agency assessed the maximum application rate of 400 ppm for dodecylbenzene sulfonates, as listed on the labels, although the current tolerance exemption has a limitation of 5.5 ppm for dairy processing equipment. The Agency estimates that use of this product results in maximum milk residues of 10 ppb ( µ g/ kg).

Fruit and Vegetable Wash. The Agency also estimated dietary exposure from the fruit and Page 24 of 62 vegetable wash of the alkylbenzene sulfonates. This use is regulated by the FDA in 21 CFR 173.315, which permits the wash solution to contain dodecylbenzene sulfonic acid up to 0.2% ( 2000 ppm), without a potable rinse. Most of the pesticide labels are in compliance with this limitation. One label however, allows a vegetable wash solution containing 0.31% ( 3100 ppm) dodecylbenzene sulfonic acid, but requires a potable rinse following washing.

In the absence of data for residues on fruits and vegetables, the Agency developed a model and used a number of conservative assumptions. The Agency assumed the maximum application rate of 2000 ppm in wash solution, along with assumptions for Thompson Seedless grapes as a surrogate to represent residues on all treated fruits and vegetables. The model estimates dodecylbenzene sulfonic acid residues of 9.25 ppm, which were used to estimated dietary exposure using the Dietary Exposure Evaluation Model ( DEEM FDIC   ) , Version 2.03 which uses food consumption data from the USDA's Continuing Surveys of Food Intake by Individuals ( CSFII) from 1994 1996 and 1998. This assessment is Tier 1, conservative ( assumes 100% of fruits and vegetables are washed) and uses the deterministic approach.

The daily estimates for the above three use patterns were conservatively used to assess chronic dietary risks, which are shown below in Table 5. As noted previously, an acute dietary assessment was not conducted because there are no adverse effects attributable to a single dose exposure.

The dietary risk estimates for the total food contact sanitizing uses are below the Agency's level of concern for all age groups ( less than 11% of the cPAD). In addition, the dietary risk estimates for the fruit and vegetable wash for adults and young children are below the Agency's level of concern for all age groups ( less than 71.2% of the cPAD). These risk estimates are based on a number of conservative assumptions, and thus may overestimate the actual risks.

Table 5. Summary of Dietary Exposure and Risk for Alkylbenzene Sulfonates Pesticidal Active Uses Chronic Dietary Use Population Subgroup Dietary Exposure ( mg/ kg/ day) a % cPAD b adult male 0.023 4.6 females ( 13 50 years) 0.027 5.4 Food Service Industry ( treated surfaces, utensils, glassware, etc)

infants/ children 0.053 10.6 adult male 0.00043 0.086 females ( 13 50 years) 0.0005 0.1 Food Processing Industry ( Food Processing Equipment)

infants/ children 0.001 0.2 adult male 0.023 4.6 Total Food Contact Surface females ( 13 50 years) 0.027 5.4 Page 25 of 62 Table 5. Summary of Dietary Exposure and Risk for Alkylbenzene Sulfonates Pesticidal Active Uses Chronic Dietary Use Population Subgroup Dietary Exposure ( mg/ kg/ day) a % cPAD b Sanitizing Uses infants/ children 0.054 10.8 U. S population 0.0979 19.6 children 1 2 yrs 0.3558 71.2 Fruit and Vegetable Wash children 3 5 yrs 0.2573 51.5 NA= not applicable a chronic exposure analysis based on body weights of 70 kg, 60 kg, and 15 kg for adult males, females and children, respectively. b % PAD = dietary exposure ( mg/ kg/ day) / cPAD, where cPAD= 0.5 mg/ kg/ day for all populations.

6.2.2 Dietary Exposure for Inert Ingredient Uses Included in this risk assessment is the reassessment of the alkylbenzene sulfonates when used as an inert ingredient in pesticide products. Estimates of dietary risk from the inert uses of alkylbenzene sulfonates are based upon the detailed analysis in the Inert Ingredient Dietary Risk Assessment memorandum ( memo from K. Leifer, March 2006, D327731). As noted previously, some of the inert functions of alkylbenzene sulfonates in the registered products are listed as solvent, surfactant, dispersant, detergent, and wetting agent. Some of these products are designated for use in agricultural settings ( i. e., pre and post harvest and when applied to animals), where there is a potential for dietary exposure.

The alkylbenzene sulfonates assessed in this document are constituents of a larger group of compounds that have a tolerance exemption as an inert ingredient in 40 CFR 180.910 and 180. 930. As shown in Table 6, the tolerance exemption is listed as Alkyl ( C8 C24) benzenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium and zinc salts.

Table 6. Tolerance Exemptions for Inert Use Tolerance Exemption Expression 40 CFR

180. ( a) Use Pattern 910 Surfactants, related adjuvants of surfactants Alkyl ( C8 C24) benzenesulfonic acid and its ammonium, calcium, magnesium, potassium , sodium and zinc salts 930 Surfactants, emulsifier, related adjuvants of surfactants ( a) Residues listed in 40 CFR § 180.910 are exempted from the requirement of a tolerance when used as inert ingredients in pesticide formulations when applied to growing crops or to raw agricultural commodities after harvest ( i. e., pre and post harvest). Residues listed in 40 CFR § 180.930 are exempted from the requirement of a tolerance Page 26 of 62 when used as inert ingredients in pesticide formulations when applied to animals only.

Inert Dietary Exposure Assumptions and Risk Estimates A dietary exposure analysis for the inert ingredient use of the alkylbenzene sulfonates was conducted using the generic screening model for estimating inert ingredient dietary exposure. The dietary assessment is unrefined and extremely conservative in nature because the screening model assumes that the inert ingredient is used on all commodities, and that 100 percent of crops are treated with the inert ingredient, with no limitation on the fraction of inert ingredient. Further, the model assumes residues will be present for every consumed commodity ( including meat, milk, poultry and eggs) that is included in the Dietary Exposure Evaluation Model ( DEEM   ) . The conservative nature of this assessment is believed to capture all potential dietary exposures, including those from direct application to animals.

Based on the use of the screening level inert ingredient dietary exposure model, there are no risk concerns associated with dietary exposures as the estimated dietary exposures for the U. S. population and all population subgroups are below 100% of the cPAD. As noted, a number of conservative assumptions were used in this screening level dietary risk assessment1 of inert uses.

Table 7. Summary of Dietary Exposure and Risk for Alkylbenzene Sulfonates as Inert Ingredients Chronic Dietary Population Subgroup Dietary Exposure ( mg/ kg/ day) % cPAD a U. S. population 0.12 24 females ( 13 50 years) 0.087 17 children 1 2 yrs 0.422 84 children 3 5 yrs 0.31 62 a % PAD = dietary exposure ( mg/ kg/ day) / cPAD, where cPAD= 0.5 mg/ kg/ day for all populations.

6.3 Drinking Water Exposure and Risk for Inert Ingredient Uses There are no currently registered outdoor uses of the alkylbenzene sulfonates as active ingredients that are being supported by the registrant. However, these compounds are inert ingredients in many residential and agricultural products that are used outdoors. The majority of these products contain alkylbenzene sulfonates at low concentrations that are generally less than 1 A review of those products listed as containing ingredients Benzenesulfonic acid, dodecyl ( CAS Reg. No. 27176 87 0); Sodium dodecylbenzenesulfonate ( CAS Reg. No. 25155 30 0); and Benzenesulfonic acid, C10 16 alkyl derivs ( CAS Reg. No. 68584 22 5) was conducted. The results of that review indicate that the linear alkylbenzenesulfonates are primarily used in low concentrations ( typically less than 5% w/ w) in herbicide products that typically are applied in a preemergent or early post emergent fashion. Page 27 of 62 5%. Based on the " Environmental Fate Assessment of Alkylbenzene Sulfonates for the Registration Eligibility Document ( RED)" ( T. Milano, March 2006), linear alkyl benzenesulfonates are water soluble, nonvolatile and mobile, but also readily biodegradable. There are no readily available data on the occurrence of linear alkyl benzenesulfonates in ambient or treated drinking water. No ambient water quality criteria, drinking water maximum contaminant levels or health advisory levels have been established for these compounds by EPA's Office of Water. The potential for transport into drinking water resulting from pesticide inert ingredient uses of these substances do exist, therefore the Agency estimated drinking water concentrations resulting from the inert ingredient uses of these substances. Details of this analysis are presented in the Inert Ingredient Dietary Risk Assessment memorandum from K. Leifer, March 23, 2006.

The drinking water analysis is based on a derivation of estimated upper bound Tier I drinking water concentrations from these substances' use as pesticide inert ingredients from the FQPA Index Reservoir Screening Tool ( FIRST). A number of conservative assumptions were utilized as inputs into the inert ingredient drinking water exposure assessment model. For example, it was assumed that the linear alkylbenzene sulfonates were stable, and pesticide products were applied via aerial spray. The results of the model were scaled to account for a linear alkylbenzene sulfonate weight fraction of 5% ( which is a 95th percentile value). The Estimated Drinking Water Concentration ( EDWC) for chronic drinking water exposure is 6.6 ug/ L ( ppb).

The Agency did not estimate acute drinking water risks for the inert ingredient use because an acute dietary endpoint ( i. e., aPAD) was not selected as there were no effects attributable to a single dose exposure. The estimated chronic drinking water concentration and drinking water level of concern for chronic exposure to linear alkyl benzenesulfonates is given in Table 8 below.

Table 8. Chronic Drinking Water Exposure Estimates for Inert Ingredient Uses of Alkylbenzene Sulfonates Population Subgroup EDWC1 ( µ g/ L) % cPAD2 DWLOC3 ( µ g/ L) U. S. Population ( total) 6.6 < 0.1% 38  1,500 Children ( 1 2 years) 6.6 < 0.1% 8  500 1 Estimated Drinking Water Concentration ( EDWC) for chronic drinking water exposure as determined by the use of FIRST modeling analysis described above for inert ingredient use. [ The EDWC for linear alkyl benzenesulfonates is the value reported as the " Adjusted Annual Average ( Chronic) Untreated Water Concentration" ] 2 % cPAD = drinking water exposure ( mg/ kg/ day) / cPAD, where cPAD= 0.5 mg/ kg/ day for all populations. It was assumed that a 15 kg child ingests 1 L water per day and that a 70 kg adult ingests 2L water per day. 3 Drinking Water Level of Comparison ( DWLOC) is the maximum contribution from water allowed in the diet based on food and drinking water from inert use only. In this case, since the allowable risk contribution from food is based on a screening level model, the use of a single, deterministic value for the DWLOC is not appropriate. Rather a DWLOC range is given, with the values in the range corresponding to an upper value of range of drinking water concentrations ranging from 100% of the cPAD ( i. e., assuming no food exposure) to a lower value that considers food exposures to be at the dietary screening level value.

For chronic drinking water exposures to linear alkyl benzenesulfonates as inert ingredients, the Drinking Water Level of Comparison ( DWLOC) range for chronic exposure is 38 1500 µ g/ L for the general U. S. population and 8 500 µ g/ L for children 1 2 years old. The EDWC used to Page 28 of 62 assess chronic ( non cancer) dietary risk from drinking water is 6.6 µ g/ L. The chronic estimated concentration is below the DWLOCs for the general U. S. population and all population subgroups. Drinking water risks, therefore, are not of concern.

The Agency concludes that there are no risk concerns for chronic aggregate dietary and drinking water exposures to the alkylbenzene sulfonates as pesticide inert ingredients. This is based on the conservative assumptions used in the screening level dietary exposure model, as well as the estimated upper bound drinking water concentrations from these substances' use as pesticide inert ingredients derived from FIRST.

6.4 Residential Exposure and Risks from Inert Ingredient Use Exposure Scenarios As noted previously, there are no residential use sites for the alkylbenzene sulfonates as active ingredients. However, alkylbenzene sulfonates are formulated as inert ingredients in approximately 350 registered end use products, many of which are used in residential settings. Some examples of the specified use sites on the products consist of indoor hard non porous surfaces ( e. g. floors, walls etc.), carpets, food contact surfaces ( glasses, dishes, silverware, countertops, etc.), agricultural tools and crops, lawns and turfs, fruits and vegetables ( post harvest), wood preservatives, materials preservatives, metalworking fluids, and pet products. Details of the residential inert exposure assessment can be found within the companion memorandum ( memorandum from T. Milano./ C. Walls March 23, 2006. D327733). A summary of the residential assessment is presented below.

For the purposes of this screening level assessment, the Agency selected representative scenarios for the vast majority of products, based on end use product application methods and use amounts. These scenarios reflect high end exposure and risk estimates for all products represented. The following residential use sites were assumed to be the high end representative scenarios for inert uses of alkylbenzene sulfonates. These include:

1) outdoor residential turf treatment ( ready to use liquid), 2) indoor hard surface cleaner ( ready to use liquid), 3) indoor carpet cleaner ( ready to use liquid), and 4) pet flea and tick products ( aerosol can spray).

For each of the use sites, the Agency assessed residential handler ( applicator) inhalation exposure and post application incidental ingestion by toddlers. Residential postapplication exposures result when bystanders, such as children come in contact with alkylbenzene sulfonates in areas where end use products have recently been applied ( e. g., treated hard surfaces/ floors), or when children incidentally ingest the residues through mouthing the treated end products/ treated articles ( i. e., hand to mouth or object to mouth contact). As previously mentioned, there is no dermal endpoint, and therefore, there were no dermal assessments conducted ( handler or post application). Page 29 of 62 Exposure Data and Assumptions For most residential scenarios, the Agency used EPA's Pesticide Inert Risk Assessment Tool ( PiRat) to estimate residential applicator and post application exposures and risks from the use of alkylbenzene sulfonates as an inert ingredient in representative residential products. Background information and the downloadable executable file for PiRat can be found at http:// www. epa. gov/ opptintr/ exposure/ docs/ pirat. htm. The Agency utilized all of PiRat's default values, along with high end percent formulations based on the review of the Confidential Statements of Formula ( CSFs) for the various residential products that contain the alkylbenzene sulfonates as inert ingredients. For the assessment of the pet products, the Agency used assumptions in the Residential Standard Operating Procedures ( SOPs). Typically, most products used in a residential setting result in exposures occurring over a short term duration. Thus, the residential handler and postapplication scenarios are assumed to be of short term duration ( 1 30 days).

Because there are a large number of products that contain alkylbenzene sulfonates as an inert ingredient, the Agency assessed both a high end formulation in addition to a 2% formulation product. The 2% value was selected because the majority of the labels contain 2% alkylbenzene sulfonates as an inert ingredient An inhalation post application assessment was not conducted because the vapor pressure of the alkylbenzene sulfonates is extremely low ( 5.1x10 10 to 6x10 15 mmHg). In addition, a dermal assessment was not conducted because of the lack of a dermal toxicological endpoint.

Risk Characterization A summary of the residential handler exposure and risk estimates are presented on Table 9, while the postapplication incidental oral exposure and risk estimates are presented in Table 10. The non cancer risk estimates are expressed in terms of the MOE. For residential handlers that handle products containing alkylbenzene sulfonates as inert ingredients, the short term inhalation MOEs were above the target MOEs ( i. e.,   > 100) and thus, do not exceed the Agency's level of concern, with the exception of the flea and tick product where the MOE was 87 for the high end formulation containing 24% alkylbenzene sulfonates. This scenario is conservative because it assumes a person treats their pet with 0.5 cans of flea product that contains 24% alkylbenzene sulfonates every day for a month. However, there are no risk concerns for the majority of pet products containing 2% alkylbenzene sulfonates.

There are no residential postapplication risk concerns for the majority of household products that contain 2% alkylbenzene sulfonates as an inert ingredient. However, there are potential postapplication incidental oral risks to young children resulting from indoor use of products that may contain high end formulations that contain between 6 and 8% alkylbenzene sulfonates. The MOEs are 30 and 40 for hard surface and carpet cleaners, respectively, which are less than the Agency's target MOE of 100 ( Table 10). However, these risk estimates are considered to be conservative screening level values, based on products that contain between 6 8% alkylbenzene sulfonates. The vast majority of products contain concentrations 2%. The postapplication incidental oral risks to children that may contact a treated pet are not of concern as Page 30 of 62 the range of MOEs ( 106 to 1,300) is above the target MOE of 100.

Alkylbenzene sulfonates are considered to be dermal irritants in formulations that have listed amounts generally greater than 20%. Thus, dermal exposure would be self limiting due to dermal irritation. The vast majority of residential products contain less than 5% alkylbenzene sulfonates. The Agency intends to consider the potential for irritation in recommended labeling language of pesticide products containing the alkylbenzene sulfonates, and consider available dermal toxicity data on a diluted end use formulation. The Agency should confirm that all products with greater than 20% require the use of gloves.

Table 9. Estimates of Inhalation Exposures and Risks to Residential Handlers of Alkylbenzene Sulfonates as Inert Ingredients ( Short Term Duration)

Product Use Application Method Area Treated/ Quantity Handleda Inhalation Exposure ( mg/ kg/ day) Range of Inhalation MOEsc ( Target MOE   100)

Outdoor Products Low pressure handwand; MLAP 1000 ft2/ day ( spot) 7.07x10 6 20,000  110,000 Hose end sprayer; MLAP 2x104 ft2/ day ( full broadcast) 4.48x10 5 3,100  17,000 Backpack; MLAP 7.07x10 6 20,00 0 110,000 Ready to Use Liquid Turf spot/ gardensb Sprinkling can; MLAP 1000 ft2/ day ( spot)

2.24x10 6 63,000   340,000 Indoor Products Ready to Use Liquid ( hard surface cleaner) d, e, g 1.37x10 4 1,000   4,100 Ready to Use Liquid ( carpet cleaner) d, f, g Low pressure handwand; MLAP 0.5 gallons/ day 1.03x10 4 1,400   4,100 Pet Flea and Tick Producth Aerosol Can Spray 0.5 6 oz can 1.61x10 3 87   1,000 a: Standard PiRat model input parameters, except for pet products, which are based on an AD assumption. b: percent formulation used = 2%  11%; an application rate of 0.00015 lb product/ ft2 was assumed for all scenarios and the body weight = 70kg. c: MOEs = NOAEL / exposure where inhalation NOAEL = 0.14 mg/ kg/ day and the target MOE   100 d: Crack and crevice was used as the representative input parameter for the assessment of alkylbenzene sulfonates as Page 31 of 62 an inert in products that are used for hard surface cleaners or carpet cleaners. e: % formulation used = 2% to 8% f: % formulation used = 2% to 6% g: An application rate of 8 lb/ gallon, which is the density of water, was assumed for all scenarios and the body weight = 70kg. h= % formulation = 2%  24%.

Table 10. Summary of Short Term Residential Postapplication Exposure and Risk Estimates from Alkylbenzene Sulfonates as Inert Ingredientsa Product Use Route of Exposure Exposure mg/ kg/ dayb Range of MOEsc ( Target MOE   100 Ready to Use Liquid Turf spot/ gardensd 1.08x10 2 4,600   25,000 Ready to Use Liquid ( hard surface cleaner) a, e 1.67 30  120 Ready to Use Liquid ( carpet cleaner) a, f Incidental ingestion: hand to mouth 1.26 40  120 Pet Flea and Tick Productg Incidental ingestion: hand to mouth 0.4739 106   1,300 a: The representative use sites assessed through using PiRAT, for incidental oral post application exposures to toddlers are turf products, hard surface cleaners, and carpet cleaners. b: The body weight used in this calculation was 15kg, which is assumed to be the body weight of a toddler. c: MOEs = NOAEL / exposure where incidental oral NOAEL = 50 mg/ kg/ day. Target MOE   100. d: % formulation used = 2%  11% e: % formulation used = 2%  8% f: % formulation used = 2%  6% g: % formulation used = 2%  24%

7.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION In order for a pesticide registration to continue, it must be shown that the use does not result in " unreasonable adverse effects on the environment". Section 2 ( bb) of FIFRA defines this term to include " a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with standard under section 408..." of FFDCA. As mandated by the FQPA amendments to FIFRA and the Federal Food, Drug and Cosmetic Act ( FFDCA), the Agency must consider total aggregate exposure from food, drinking water and residential sources of exposure to alkylbenzene sulfonates. Aggregate exposure is the total exposure to a single chemical ( or its residues) that may occur from dietary ( i. e., food and drinking water), residential, and other non occupational sources, and from plausible exposure routes ( oral, dermal, and inhalation).

Typically, aggregate risk assessments are conducted for acute ( 1 day), short term ( 1 30 days), intermediate term ( 1 6 months) and chronic ( 6 months to lifetime) exposures. However, an acute aggregate assessment was not conducted because there are no adverse effects attributable to Page 32 of 62 acute exposure. An intermediate term aggregate assessment was not conducted because there are no residential exposures of this duration. In addition, because there are no long term residential exposures, the chronic aggregate assessment only considered food and drinking water. Thus, only short term and chronic aggregate assessments were conducted. Oral and inhalation exposure and risk estimates were conservatively combined for the aggregate risk assessment because these endpoints both identify adverse effects on body weight. Dermal exposures were not considered in the risk assessment because a toxicological endpoint was not established.

In performing aggregate exposure and risk assessments, the Office of Pesticide Programs has published guidance outlining the necessary steps to perform such assessments ( General Principles for Performing Aggregate Exposure and Risk Assessments, November 28, 2001; available at http:// www. epa. gov/ pesticides/ trac/ science/ aggregate. pdf ). Steps for deciding whether to perform aggregate exposure and risk assessments are listed, which include: identification of toxicological endpoints for each exposure route and duration; identification of potential exposures for each pathway ( food, water, and/ or residential); reconciliation of durations and pathways of exposure with durations and pathways of health effects; determination of which possible residential exposure scenarios are likely to occur together within a given time frame; determination of magnitude and duration of exposure for all exposure combinations; determination of the appropriate technique ( deterministic or probabilistic) for exposure assessment; and determination of the appropriate risk metric to estimate aggregate risk.

Short Term Aggregate Risk. Aggregate short term risk assessments are designed to provide estimates of risk likely to result from exposures to the pesticide or pesticide residues in food, water, and from residential ( or other non occupational) pesticide uses. This assessment considers both the active and inert uses of the alkylbenzene sulfonates. For children, the short term aggregate assessment includes average dietary exposure ( food and drinking water) from both the active food contact sanitizer uses and the inert uses on agricultural commodities, in addition to estimated incidental oral exposures to children from residential uses such as flea and tick products as an inert ingredient. For adults, the aggregate assessment includes dietary ( food and drinking water) from both active and inert uses and residential inhalation exposures from wiping a hard surface cleaning products since this scenario represents the highest exposure from the inert use.

Individual scenarios that had risks of concern were not included in the aggregate assessment. These include exposure to some of the high end formulation products such as the residential handler of pet flea and tick products ( inhalation MOE is 87 compared to target MOE> 100), postapplication incidental oral exposure to residues on floors from hard surface cleaners or carpet cleaners ( oral MOEs are 30 and 40, respectively compared to target MOE> 100). As noted previously, a number of very conservative assumptions were used to derive these risk estimates. However, as shown on Table 11, the aggregate assessment included exposure to household products that contain 2% alkylbenzene sulfonates as an inert ingredient.

Aggregate risks were calculated using the total MOE approach outlined in OPP guidance for aggregate risk assessment ( August 1, 1999, Updated " Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments"). The assumptions and equations are presented in the footnotes on Table 11. Page 33 of 62 Table 11 presents a summary of the short term aggregate risk MOEs. The aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is 340 which is greater than the target of 100. For children, the aggregate risk estimates are less than the target MOE of 100 ( MOE= 54) and are of risk concern. The aggregate child risks are of concern because both the dietary and residential scenarios alone are very close to the target MOEs or 100% of the cPAD ( i. e., food and drinking water accounts for approximately 95% of the cPAD), while the hard surface cleaner postapplication MOE is 120. As noted previously, several conservative assumptions were used in this assessment. For example, dietary exposure from both the active sanitizer use and the inert uses were considered together to estimate an upper bound exposure estimate, since these use patterns are very different and thus could co occur. To compensate for this conservative assumption, the Agency only included one representative residential use scenario in the aggregate assessment even though these compounds are used extensively as inert ingredients in approximately 350 pesticide products.

It should also be recognized that the majority of the uses of alkylbenzene sulfonates are not in pesticide products, but rather are used in household laundry and dish detergents. Over 30 millions pounds of these compounds are produced each year, while only 300,000 pounds are used in EPA registered antimicrobial products. The Agency did not consider potential exposure and risks from the numerous other residential exposures to alkylbenzene sulfonates because the Agency lacks reliable information at this time.

Table 11 Summary of Short Term Aggregate Risk Estimates Dose a ( mg/ kg/ day) Total MOEb ( Target MOE  100) Exposure Scenario Child ( 15 kg) Adult Child ( 15 kg) Adult Oral Exposure Dietary Exposure Food Contact Sanitizer 0.054 0.027 926 ( 10.8% of cPAD) 1,850 ( 5.4% of cPAD) Inert Ingredient Uses ( Food) 0.422 0.12 118 ( 84% of cPAD) 417 ( 24% of the cPAD) Drinking Water Exposure ( Inert) c 0.00044 0.000189 114,000 (< 1% of cPAD 227,000 (< 1% of cPAD) Hard Surface Cleaner ( 2% Inert) 0.42 NA 120 NA Inhalation Exposure Handler of hard surface cleaning products ( 2% Inert) NA 0.000137 NA 1,000 Total Aggregate Dose and MOE 0.916 0.147 54 340 NA= Not applicable ( a) Chronic dietary exposure for females 13 50 years for sanitizer use. The total general population dietary exposure was used to assess inerts, since this population has higher exposure than females 13 50 years. ( b) MOE = NOAEL ( mg/ kg/ day) / potential dose rate ( mg/ kg/ day) [ Where short term oral NOAEL = 50 mg/ kg/ day]. Target MOE   100. ( c) Exposure estimates assume a 15 kg child ingests 1L water/ day and that a 60 kg adult female ingests 2L water per Page 34 of 62 day of 6.6 ppb ( the chronic estimated drinking water concentration ( EDWC) based on the inert ingredient use.

Chronic Aggregate Risk. The chronic aggregate assessment considers average dietary exposure ( food and drinking water) from both the active food contact sanitizer uses and the inert uses on agricultural commodities. The dietary exposures from the fruit and vegetable wash were not considered because it would be overly conservative to assume simultaneous exposure to alkylbenzene sulfonates from three different use patterns. As shown on Table 12, the dietary aggregate risk is 95% of the cPAD for children, while for adults it is 29% of the cPAD.

Table 12 Summary of Chronic Aggregate Risk Estimates Dose a ( mg/ kg/ day) % cPADb Exposure Scenario Child ( 15 kg) Adult Child ( 15 kg) Adult Oral Exposure Dietary Exposure Food Contact Sanitizer 0.054 0.027 10.8% 5.4% Inert Ingredient Uses ( Food) 0.422 0.12 84% 24% Drinking Water Exposure ( Inert) c 0.00044 0.000189 < 1% < 1%

Total Aggregate Dose and Risk 0.476 0.147 95% 29%

NA= Not applicable ( a) Chronic dietary exposure for females 13 50 years for sanitizer use. The total general population dietary exposure was used to assess inerts, since this population has higher exposure than females 13 50 years. ( b) % cPAD = dietary exposure ( mg/ kg/ day) / cPAD, where cPAD = 0.5 mg/ kg/ day for all populations. ( c) Exposure estimates assume a 15 kg child ingests 1L water/ day and that a 60 kg adult female ingests 2L water per day containing 6.6 ppb alkylbenzene sulfonates. The 6.6 ppb estimate is based on the chronic estimated drinking water concentration ( EDWC)) resulting from agricultural use of products that contain the alkylbenzene sulfonates as an inert ingredient.

8.0 CUMULATIVE EXPOSURE AND RISK Another standard of section 408 of the FFDCA which must be considered in making an unreasonable adverse effect determination is that the Agency considers " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity."

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to the alkylbenzene sulfonates and any other substances and the alkylbenzene sulfonates do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that alkylbenzene sulfonates have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative Page 35 of 62 effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

9.0 OCCUPATIONAL EXPOSURE AND RISK The Agency has assessed the exposures and risks to occupational workers that handle alkylbenzene sulfonates ( memorandum from T. Milano, January 2006). This section summarizes the results of the occupational exposure assessment.

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 settings. Additionally, postapplication exposures are likely to occur in these settings. The representative scenarios selected by the Agency for assessment were evaluated using maximum application rates as recommended on the product labels for alkylbenzene sulfonates.

Occupational Handlers. The Agency has determined that there is potential for dermal and inhalation worker exposure to alkylbenzene sulfonates at various use sites including agricultural premises, food handling, and commercial/ institutional/ industrial premises. Representative scenarios were selected for evaluation based on the use sites and maximum application rates for all three of the active ingredients in this assessment.

As noted previously, the Agency did not select a dermal endpoint, and thus only inhalation exposure and risk estimates are presented. The alkylbenzene sulfonates are dermal irritants, and all of the labels require the use of gloves by workers, except for Reg. # 71094 2 ( 0.036% ai, ready to use product). The occupational exposure scenarios, and estimated risks are presented in Table 13.

To assess the handler risks, AD used surrogate unit exposure data from both the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED).

For the occupational handler inhalation risk assessment, the short and intermediate term risks calculated at baseline exposure ( no respirators) were above target MOEs for all scenarios ( i. e., inhalation MOEs were > 100), except the following:

  ST and IT inhalation exposure from cleaning hard surfaces via circulation/ flow/ flushing in the agricultural premises and equipment category, inhalation MOE < 1.   ST and IT inhalation exposure from application to hard surfaces via ( 1) circulation systems/ flow method, or ( 2) Cleaning in Place ( CIP) in the food handling category, inhalation MOE < 1.   ST and IT inhalation exposure from cleaning hard surfaces via wiping in the food handling category, inhalation MOE = 93. Page 36 of 62   ST and IT inhalation exposure from cleaning food dispensing equipment via circulation systems/ flow method in the food handling category, inhalation MOE < 1.   ST and IT Inhalation exposure from cleaning shower stalls and toilets via ( 1) a liquid pour application or ( 2) wiping in the commercial/ institutional premises, inhalation MOE = 13 and MOE < 1, respectively.

The Agency also calculated a total MOE for one of the active ingredients, sodium dodecylbenzene sulfonate ( 25155 30 0) based on the label use directions, which recommend the same product be used for both cleaning and sanitizing. As shown on Table 14, all total inhalation MOEs for cleaning and sanitizing ( baseline) were above the target MOEs for all scenarios ( i. e., inhalation MOEs were > 100), except the following:

  ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 93.   ST and IT inhalation exposure from cleaning indoor hard surfaces via wiping and then following with sanitizing via low pressure spray in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning indoor hard surfaces via sponge/ mesh/ wiping and then sanitizing via immersion/ flooding in the food handling premises category, inhalation MOE = 90.   ST and IT inhalation exposure from cleaning and sanitizing steps to be conducted through CIP ( Cleaning in Place) in the food handling premises category, inhalation MOE = < 1.

Although all the inhalation risks of concern are for baseline exposures, the Agency does not believe it is practicable to require the use of respiratory protection on cleaning products used in janitorial situations. In addition, engineering controls are not feasible for the current use patterns on the labels.

Table 13 Short, and Intermediate Term Inhalation Risks for Occupational Handlers ( Representative Scenarios) Exposure Scenario Method of Application Application Rate ( lb ai/ gallon) Quantity Handled/ Treated per day ( gallons) Baseline Inhalation MOE ( a) ( Target MOE  100)

Agricultural Premises and Equipment Brush 0.0667 0.26 2,000 Mechanical Foam 0.0667 0.26 430 Flooding 0.00183 10 280 Circulation, flow, flushing 0.00195 10,000 < 1 High Pressure spray 0.00326 40 630 Immersion 0.00334 10 160 Application to hard surfaces Fogger Low pressure spray 0.00334 10 430 Page 37 of 62 Table 13 Short, and Intermediate Term Inhalation Risks for Occupational Handlers ( Representative Scenarios) Exposure Scenario Method of Application Application Rate ( lb ai/ gallon) Quantity Handled/ Treated per day ( gallons) Baseline Inhalation MOE ( a) ( Target MOE  100)

Trigger Pump Spray 0.00334 0.26 8,700 Food Handling Brush 0.0667 0.26 2,000 Mechanical Foam 0.0667 0.26 430 circulation, flushing, flow method 0.00334 10,000 < 1 Immersion 0.00334 10 160 Trigger Pump Spray 0.00334 0.26 8,700 Low pressure handwand ( clean) 0.00603 2 1,200 High pressure spray ( sanitize) 0.0115 40 180 Immersion, flooding for RTU ( sanitize) 0.003 10 170 Mopping 0.00244 2 840 Wiping ( clean) 0.00603 0.26 93 Sponge/ mesh wipe ( clean) 0.003 0.26 190 Application to indoor hard surfaces Cleaning in Place ( CIP) ( clean and sanitize) 0.00358 10,000 < 1 Circulation systems, Flow method 0.00334 10,000 < 1 Food dispensing equipment Circulation system 0.00603 10,000 680 Immersion 0.00455 10 110 Fruits and vegetables Trigger pump spray 0.003 0.26 9,700 Commercial/ Institutional Premises Brush 0.0667 0.26 2,000 Mechanical Foam 0.0667 0.26 430 Immersion 0.00334 10 160 Low Pressure Handwand 0.00334 2 2,200 Application to indoor hard surfaces ( includes utensils and silverware) Trigger Pump Spray 0.00334 0.26 8,700 Mopping 0.0177 2 120 Liquid pour 1.49 0.26 13 Shower stalls and toilets Wiping 1.49 0.26 < 1 ( a) MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term NOAEL = 0.14 mg/ kg/ day for inhalation exposure] Target MOE is   100. Page 38 of 62 Table 14 Short, and Intermediate Term Inhalation Risks to Occupational Handlers Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene Sulfonate Representative Use Registration # Method of CLEANING Application ( Baseline MOE) Method of SANITIZING Application ( Baseline MOE) Total Inhalation MOE ( Baseline) ( Target MOE  100)

Food Handling/ Storage Establishments Premises and Equipment High pressure spray ( 180) 150 High pressure spray ( 1,100) Brush ( 12,000) 1,000 High pressure spray ( 180) 180 1020 13 Brush ( 75,000) Brush ( 12,000) 10,000 Immersion/ Flooding ( 1.4X106) 1,200 Low pressure spray ( 1,200)

Low pressure spray ( 2,400) 800 Immersion/ Flooding ( 1.4X106) 93 Wiping ( 93)

Low pressure spray ( 2,400) 90 Immersion/ Flooding ( 1.4X106) 4,800 Foam ( 4,000)

Low pressure spray ( 2,400) 1,600 Immersion/ Flooding ( 1.4X106) 22,000 71094 1 Brush ( 22,000)

Low pressure spray ( 2,400) 2,000 Immersion/ Flooding ( 170) 90 Sponge/ Mesh/ Wiping ( 190) Trigger Pump ( 9,700) 190 Immersion/ Flooding ( 170) 160 Low Pressure Spray ( 2,400) Trigger Pump ( 9,700) 1,900 Immersion/ Flooding ( 170) 170 71094 2 Brush ( 45,000)

Trigger Pump ( 9,700) 8,000 Indoor Hard Surfaces ( includes dishes and silverware)

1020 13 CIP (< 1) CIP (< 1) < 1 Food dispensing equipment 71094 1 Circulation system ( 680) Circulation system ( 1,400) 450 Postapplication Exposure and Risk. For most of the occupational scenarios, postapplication dermal exposure is not expected to occur or is expected to be negligible based on Page 39 of 62 the application rates and chemical properties of these chemicals. The alkylbenzene sulfonates have a low vapor pressure ( 5.1x10 10 to 6.02x10 15 mmHg), so that any standing solutions that may result in post application exposure were deemed negligible.

10.0 ENVIRONMENTAL RISK 10.1 Active Ingredient Uses A detailed ecological hazard and environmental risk assessment for the alkylbenzene sulfonates is presented in the attached memorandum for the active ingredient pesticidal uses ( memo from R. Petrie, January 2006). A brief summary is presented below.

Ecological Toxicity Data.

Acute toxicity to terrestrial organisms: As shown in the acute toxicity summary Table 10, alkylbenzene sulfonates are slightly toxic to the Northern bobwhite quail on an acute oral basis. The avian acute oral LD50 is > 500 ppm, therefore, an avian environmental hazard statement for birds is not required on manufacturing use product labels. No evidence of endocrine disrupting effects was observed in mammalian toxicity studies. No data are available or required for terrestrial plants.

Acute toxicity to aquatic organisms: As shown in Table 15, supplemental acute studies indicate that alkylbenzene sulfonates are moderately toxic to freshwater fish and slightly to highly toxic to freshwater aquatic invertebrates depending on the length of the carbon chain. Literature for aquatic species indicates that alkylbenzene sulfonate formulations are more toxic the higher the number of carbon chains. Alkylbenzene sulfonate antimicrobial formulations are comprised primarily of C10 to C14 chains ( DDBSA Task Force). No acute fish toxicity data are available for carbon chains above 12. Therefore, a fish environmental hazard label statement is required on manufacturing use product labels. Based on study MRID 47025025, an environmental hazard statement for aquatic invertebrates is required on manufacturing use products because the EC50 is < 1.0 ppm ( C14, C16).

Chronic toxicity to aquatic organisms: A 28 day chronic freshwater fish toxicity test was found in the literature. The NOAEC was 0.7 mg/ L for a carbon chain C11.7 ( Fairchild et al, 1993). Scientists studying alkylbenzene sulfonates have concluded that a laboratory derived NOAEC of 0.4 mg/ L alkylbenzene sulfonates is protective of ecosystem structure and function in experimental streams. Alkylbenzene sulfonates literature indicates slight toxicity to green algae.

Table 15. Acute Toxicity of Alkylbenzene Sulfonates Species Chemical, % active ingredient ( ai) Endpoint Toxicity Category ( TGAI) Satisfies Guidelines/ Co mments Reference Birds Northern bobwhite 87.6% Carbon chain not identified. LD50 > 1382 mg/ kg Slightly toxic Yes. Acceptable. MRID:

41143901 Page 40 of 62 Table 15. Acute Toxicity of Alkylbenzene Sulfonates Species Chemical, % active ingredient ( ai) Endpoint Toxicity Category ( TGAI) Satisfies Guidelines/ Co mments Reference ( Colinus virginianus) ( Nacconal 90G used) NOEL = 279 mg/ kg 14 day test Freshwater Fish Fathead Minnow ( Pimephales promelas) 14.0% ( Carbon chain not identified.) 96hr LC50 =

3.4 mg/ L Moderately toxic No. Supplemental study. 44260002 Rainbow trout Oncorhynchus mykiss) 65.0% C11, C12 96 hr LC50 = 1.68 mg/ L Moderately toxic No. Supplemental study. 44260009 Freshwater Invertebrates Waterflea ( Daphnia magna) Not reported. 48 hr. EC50 = LAS C10 = 29.5 mg/ L, LAS C12 = 6.84 mg/ L, LAS C14 = 0.80 mg/ L, LAS C16 = 0.20 mg/ L. C 10 = Slightly toxic, C14 = highly toxic. No. Supplemental study. 47025025 Green Algae Selenastrum capricornutum Not Reported. ( Carbon chain not identified.) 96 hr. EC50 = 70.27 ppm Slightly toxic No. Supplemental. 42439803 Data Requirements: The guideline requirements for a freshwater fish acute test ( Guideline 850.1075), and freshwater invertebrate ( Guideline 850.1010) have not been fulfilled, and are required to support the current indoor uses. Acute estuarine/ marine tests, chronic toxicity testing ( Fish early life stage, 850.1300/ 72 4a and aquatic invertebrate life cycle, 850.1400/ 72 4b) and non target plant phytotoxicity tests are not required for indoor uses.

Environmental Fate and Exposure Assessment.

No fate studies for alkylbenzene sulfonates are available in US EPA's files. Thus, the Agency has relied on scientific literature and the Agency's EPI Suite model to obtain different environmental properties for the alkylbenzene sulfonates. The EPI Suite model predicts that alkylbenzene sulfonates are not likely to persist in water or microbial soils and sediments. The Agency also conducted a literature search to further support the output parameters that were provided by the EPI Suite model. Extensive literature are available that describe the fate and significance of alkylbenzene sulfonates in the environment from a long history of detergent use.

Environmental exposure modeling was not conducted for alkylbenzene sulfonic acids and Page 41 of 62 sulfonates because the currently registered uses are indoor spray applications. Uses such as urinals and toilet bowls could result in minimal exposure to the environment when flushed, however, significant environmental exposure is not expected for the following reasons: total alkylbenzene sulfonate usage for these industrial applications is very minor  a very small percentage of the total pounds used in antimicrobials; commercial only use precludes broad environmental exposures that might occur with residential use; applications are mostly sprayed on and allowed to air dry; alkylbenzene sulfonate breakdown and degrade rapidly in the environment; alkylbenzene sulfonates are significantly reduced by sewage treatment; and industrial water treatment requires a NPDES permit in order to discharge effluents.

Ecological Risk Characterization.

Sodium dodecylbenzene sulfonate, and DDBSA are unlikely to bioaccumulate in the environment or aquatic animals and are expected to be soluble in water such that they will exhibit mobility through the soil. Available modeling and literature suggest that these chemicals will most likely biodegrade rapidly in soil due to microbial degradation. Minimal or no environmental exposure to terrestrial or aquatic organisms is expected to occur from the majority of alkylbenzene sulfonate antimicrobial indoor pesticide uses given that only a very small number of total DDBSA pounds are used for these purposes.

Linear alkyl benzene sulfonates ( LAS) have been the principal ingredient in laundry detergent for 30+ years. Volume 12 ( 10) of the 1993 issue of Environmental Toxicology and Chemistry featured a series of papers on environmental impacts of LAS in a special symposium: Surfactants and Their Environmental Safety  convened by R. A. Kimerle, N. T. De Oude and T. W. La Point. Two papers provide excellent summaries of ecotoxicity endpoints from literature, and feature laboratory vs field analysis of detergent generated LAS impacts on aquatic organisms. An assessment of short and long term impacts of LAS detergents on the environment was conducted. Increases and decreases in natural periphyton community abundance were observed, but determined to be insignificant for the three major species evaluated: Amphora perpusilla, Navicula minima, and Schizothrix calcicola ( Lewis et al, 1993). Monitoring indicates that concentrations of 0.230 mg/ L ( continuous criterion concentration) and 0.625 mg/ L ( criterion maximum concentration) are rarely exceeded in aquatic systems protected by activated sludge treatment systems. Ecotoxicity studies indicate that a laboratory derived NOAEC value of 0.40 mg/ L for LAS is protective of structure and function of experimental streams ( Fairchild et al, 1993).

No environmental exposure is expected to occur from the majority of linear alkylbenzene sulfonate uses and it is unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur from limited commercial down the drain use because of the very small number of pounds sold for these uses plus rapid degradation in the environment.

Endangered Species Considerations Section 7 of the Endangered Species Act, 16 U. S. C. Section 1536( a)( 2), requires all federal agencies to consult with the National Marine Fisheries Service ( NMFS) for marine and Page 42 of 62 andronomus listed species, or the United States Fish and Wildlife Services ( FWS) for listed wildlife and freshwater organisms, if they are proposing an " action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means " to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C. F. R. ' 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection ( a)( 2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species ( U. S. EPA 2004). After the Agency= s screening level risk assessment is performed, if any of the Agency= s Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co occur in the area of the proposed pesticide use. If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken. The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required ( Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, 1/ 23/ 04, Appendix A, Section IIB, pg. 81). Chemicals in these categories therefore do not undergo a full screening level risk assessment, and are considered to fall under a Ano effect@ determination. The active ingredient uses of alkylbenzene sulfonic acids and sulfonates fall into this category for the following reasons:

1. The amount that will actually reach the environment is very small based on usage data for down the drain uses. 2. Use for toilets and urinals is limited ( no home owner or residential uses are registered). 3. Breakdown of alkylbenzene sulfonate in the environment and via sewage treatment is rapid and well documented in the literature.

The labeled antimicrobial uses of alkylbenzene sulfonic acids and sulfonates are not expected to result in significant environmental exposure. Therefore, no adverse effects ( NE) to listed species are anticipated. Use of alkylbenzene sulfonates as inert ingredients in agricultural pesticide formulations is not expected to result in significant environmental exposure. Therefore, no adverse effects ( NE) to listed species are anticipated. Page 43 of 62 10.2 Inert Ingredient Use The alkylbenzene sulfonates are used as " inert" ingredients in agricultural herbicide formulations. Preplant incorporated and preemergence herbicide treatments are typically applied once per year to the tilled, minimally tilled or no tilled field before planting or before crop emergence in the spring. Spray applications are primarily via ground spray boom and occasionally by aircraft if a wet spring. Movement of the alkylbenzene sulfonates from the treated field to the aquatic environment can occur at the time of application due to spray drift, or following application via surface water/ soil flow or by percolation to groundwater. The FIRST model has predicted a maximum potential concentration of 6.6 ppb alkylbenzene sulfonates in drinking water from inert agricultural uses ( memo from K. Leifer, 2006). Available modeling and literature suggest that these chemicals will most likely biodegrade rapidly in soil due to microbial degradation.

The inert agricultural uses of alkylbenzene sulfonates are not expected to adversely affect avian or mammalian species on an acute or chronic basis. Aquatic organisms are also not expected to be adversely affected by inert alkylbenzene sulfonates use acutely or chronically due to the low predicted level of alkylbenzene sulfonates in water by FIRST. A chronic freshwater fish toxicity test NOAEC of 400 ug/ L alkylbenzene sulfonates is considered protective of ecosystem structure and function in experimental streams. Therefore, the predicted concentration of 6.6 ug/ L in water is well below our chronic Level of Concern ( LOC).

11.0 DEFICIENCIES/ DATA NEEDS Hazard Data Gaps. The toxicology database for the alkylbenzene sulfonates consists almost entirely of published literature, is essentially complete and of acceptable quality to assess the potential hazard to humans.

Ecological Data Gaps. Valid acute aquatic toxicity studies for fish and invertebrates must be submitted to support indoor use patterns. These studies are:

850.1075  Acute Freshwater Fish using TGAI DDBSA on Rainbow trout or Bluegill sunfish 850.1010  Acute Freshwater Invertebrate using TGAI DDBSA on Daphnia magna Based on DDBSA task force data provided, DDBSA typically contains a range of carbon chain lengths from 10 to 16. Study MRID 47025025 indicates that the greater the number of carbons, the greater the toxicity to Daphnia magna. For example, C10 was slightly toxic and C14 was highly toxic. DDBSA TGAI with the highest carbon length must be used in aquatic toxicity tests.

Label Hazard Statements for Terrestrial and Aquatic Organisms Manufacturing use products must state: Page 44 of 62 " This pesticide is toxic to fish and aquatic invertebrates".

" Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System ( NPDES) permit and the permitting authorities are notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA."

Residential/ Occupational Data Gaps. Confirmatory worker exposure data are necessary, due to the significant limitations of the existing exposure data used in this assessment. The Agency is requesting worker exposure studies that evaluate inhalation ( Guideline 875.1400) exposure for indoor uses.

12.0 REFERENCES MRID 41143901  Lloyd, D.; Grimes, J.; Jaber, M. ( 1989) Nacconol 90G: An Acute Oral Toxicity Study with the Bobwhite: Final Report: Wildlife International Ltd. Project No. 257 101. Unpublished study prepared by Wildlife International Ltd. 26p.

MRID 42439803  Bollman, M. A. et. al. ( 1990) Report on the Algal Toxicity Tests of Selected Office of Toxic Substances ( OTS) Chemicals. US EPA Environmental Research Laboratory. 179p.

MRID 44260002  McKim, J. M.; Arthur, J. W.; Thorslund, T. W. ( 1975) Toxicity of Linear Alkylate Sulfonate Detergent to Larvae of Four Species of Freshwater Fish. USEPA, Nat. Water Qual. Lab., Duluth, MN. Bulletin of Environmental Contamination and Toxicology. Vol 14 ( 1) pg. 1 7.

MRID 44260009  Calamari, D.; Marchetti, R. ( 1973) The Toxicity of Mixtures of Metals and Surfactants to Rainbow Trout ( Salmo gairdneri rich.) Water Research. Vol. 7( 10) pg. 1453 1464.

MRID 47025025  Maki, A. W.; Bishop, W. E. ( 1979) Acute Toxicity Studies of Surfactants to Daphnia magna and Daphnia pulex. Archives of Environmental Contamination and Toxicology. Vol. 8, p. 599 612. Sponsored by The Proctor and Gamble Company USA, Ivorydale Technical Ctr., Cincinnati, OH.

Fairchild, J. F., F. J. Dwyer, T. W. La Point, S. A. Burch, and C. G. Ingersoll. 1993. Evaluation of a Laboratory Generated NOEC For Linear Alkylbenzene Sulfonate In Outdoor Experimental Streams. Environmental Toxicology and Chemistry. Vol. 12( 10): 1763 1775. Symposium on Surfactants and Their Environmental Safety, 11th Annual Meeting, Society of Environmental Toxicology and Chemistry, Arlington, VA, Nov. 11 15, 1990. Page 45 of 62 Human and Environmental Risk Assessment ( HERA). 2004. LAS   Linear Alkylbenzene Sulphonates ( CAS No. 68411 30 3)

Lewis, M. A., C. A. Pittinger, D. H. Davidson and C. J. Ritchie. 1993. In Situ Response of Natural Periphyton To An Anionic Surfactant And An Environmental Risk Assessment For Phytotoxic Effects. Environmental Toxicology and Chemistry. Vol. 12( 10): 1803 1812. Symposium on Surfactants and Their Environmental Safety, 11th Annual Meeting, Society of Environmental Toxicology and Chemistry, Arlington, VA, Nov. 11 15, 1990.

World Health Organization ( WHO). 1996. Environmental Health Criteria Document for Linear Alkylbenzene Sulfonates and Related Compounds. ( EHC 169, available at http:// www. inchem. org/ documents/ ehc/ ehc/ ehc169. htm ) Page 46 of 62 Appendix A Toxicity Profile for Alkylbenzene Sulfonates Page 47 of 62 Table A 1 Toxicity Profile of Alkylbenzene Sulfonates Guideline No./ Study Type MRID No./ Reference Information/ Study Classification Dosing and Animal Information Results Subchronic Toxicity 870.3100 Oral Subchronic ( rodent) Bornmann et al ( 1963) Study of a Detergent Based on Dodecylbenzene Sulfonate. Fette Seifen Anstrichm, 65 ( 10): 818 824. ( EHC 169)

Open Literature 0.01% of a preparation containing 51% LAS was administered in the drinking water for 100 weeks Rats ( 60/ sex)

Purity: Not Reported No detrimental effects on body weight and no pathological effects, including tumors, were reported 870.3100 Oral Subchronic ( rodent) Ikawa et al., ( 1980)/ Ann. Rep. Tokyo Metrop. Res. Lab. Public Health. 29( 2): 51 54( Z). 1978 ( in Japanese, see WHO, 1996 and HERA, 2004).

Open Literature LAS was administered for 2, 4, or 12 weeks at a single dose of 1.5% in the diet ( 750 mg/ kg/ d).

Male rats ( five/ group)

Purity not reported. LAS suppressed body weight gain and the relative liver weight was increased after two weeks. Serum biochemical alterations included: significant increases in ALP, GTP ( at 2, 4, 12 weeks); significant decreases in cholesterol and protein ( 4 weeks); decreases in liver enzymes G6Pase and G6PDH and increases in isocitrate DH ( all at 2, 4, 12 weeks). The following enzymes associated with kidney function were also altered: decreases in G6Pase, 5' nucleotidase ( at 2, 4, 12 weeks) and Na, K ATPase ( 12 wks); increase in LDH ( 12 wks) and IDH ( 2,4 wks).

870.3100 Oral Subchronic ( rodent) Ito, et al. ( 1978) Acute, Subacute, and Chronic Toxicity of Magnesium LAS ( LAS Mg). J. Med. Soc. Toho Univ. 25: 850 875.

Open Literature Administration by oral gavage at doses of 0, 155, 310, or 620 mg/ kg/ day ( LAS Mg) and 125, 250, and 500 mg/ kg/ day ( LAS Na) for one month Sprague Dawley Rats ( 12/ sex/ group)

Purity: 99.5% LAS Na: Body weight increase was suppressed; feed efficacy was decreased, and liver weight increased at 500 mg/ kg/ day. NOAEL: 125 mg/ kg bw/ d.

870.3100 Oral Subchronic ( rodent) MRID No. 43498412 Kay et al. ( 1965) Subacute Oral Toxicity of a Biodegradable, Linear Alkylbenzene Sulfonate. Toxicol Appl. Pharmacol. 7: 812 818 ( HERA)

Acceptable Guideline SDDBS administered in the diet at dietary levels of 0, 200, 1000, and 5000 ppm for 90 days Weanling Sprague Dawley Rat ( 10/ sex/ dose)

Purity: 87.9% a. i. NOEL: 5000 ppm ( HDT)

Two low dose males died early in the study from respiratory illness There was no compound related effects in body weight, food consumption, hematology, urine analysis, organ weight, and histopathology.

870.3100 Oral Subchronic ( rodent) MRID No. 43511401 Mathur et al. ( 1986) Toxicological Evaluation of a Synthetic Detergent after Repeated Oral Ingestion in Rats. Industrial Toxicology Research Centre, Mahatma Ganghi Marg, Lucknow Study No. DDBSA JV RP 013. Acceptable LAS was administered as a commercial synthetic detergent solution at doses of 0, 50, 100, or 250 mg/ kg/ day in the feed for 10 weeks F Albino Rat ( 9/ group)