### Page 2 of 63 Alkylbenzene Sulfonates Registration Review Team

Human Health & Environmental Effects
Nate Mottl Zoë Layton
Srinivas Gowda Najm Shamim Pat Jennings
Steve Malish

Risk Management Jacqueline Hardy
Wanda Henson

Office of General Counsel Philip Ross

### Page 3 of 63 

### Table of Contents

1 Introduction

................................ ................................ ................................ ............................. 5
1.1 Statutory and Regulatory Authority

................................ ................................ ................. 5
1.2 Updates to the Work Plan

................................ ................................ ................................ . 6
1.3 Case Overview

................................ ................................ ................................ ................. 7
1.4 Chemical Ide ntification and Properties

................................ ................................ ............ 7
1.5 Use/Usage Description

................................ ................................ ................................ ..... 9
1.5.1 Registrations

................................ ................................ ................................ ............. 9
1.5.2 Summary of Registered Uses

................................ ................................ .................... 9
1.5.3 Usage Information

................................ ................................ ................................ .. 11
1.6 Regulatory History

................................ ................................ ................................ ......... 11
1.6.1 Recent/Pending Regulatory Actions

................................ ................................ ....... 11
1.6.2 Tolerance Information

................................ ................................ ............................ 11
1.7 Incidents

................................ ................................ ................................ ......................... 12
1.7.1 Human Health

................................ ................................ ................................ ......... 12
1.7.2 Ecological

................................ ................................ ................................ ............... 12
2 Anticipated Da ta Needs

................................ ................................ ................................ ...... 12
3 Human Health Risk Assessment

................................ ................................ ........................... 14
3. 1 Existing Toxicological Endpoints

................................ ................................ .................. 14
3.2 Dietary Exposure

................................ ................................ ................................ ............ 16
3.2.1 Food

................................ ................................ ................................ ........................ 16
3.2.2 Drinking Water

................................ ................................ ................................ ....... 19
3.3 Occupati onal and Residential Exposures

................................ ................................ ....... 19
3.3.1 Occupational Handler Exposure

................................ ................................ ............. 19
3.3.2 Residential Exposures

................................ ................................ ............................. 21
3.4 Aggregate and Cumulative Exposure

................................ ................................ ............. 21
3.4.1 Aggregate Exposures

................................ ................................ .............................. 21
3.4.2 Cumulative Exposures

................................ ................................ ............................ 21
4 Envi ronmental Risk Assessment

................................ ................................ ........................... 21
4.1 Environmental Fate and Transport

................................ ................................ ................. 21
4.2 Environmental Conceptual Model Exposure Pathways

................................ ................. 23
4.2.1 Mechanism of Action

................................ ................................ .............................. 25
4.2.2 Measures of Effect (Ecotoxicology Endpoints)

................................ ...................... 25
4.3 Exposure Analysis Plan

................................ ................................ ................................ .. 27
4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

................................ ............ 27
4.3.2 Human Health Drinking Water Exposure Estimates

................................ .............. 28
4.4 Effects Analysis Plan

................................ ................................ ................................ ..... 28
4.5 Endangered Species Determination

................................ ................................ ............... 28
5 Endocrine Disruptor Screening Program (EDSP)

................................ ................................ . 29

6 Optional Label Changes

................................ ................................ ................................ ........ 29

7 Next Steps

................................ ................................ ................................ ............................. 30
8 References

................................ ................................ ................................ ............................. 31

Appendix A T oxicology Profile

................................ ................................ ............................... 33 Appendix B Dietary Profile

................................ ................................ ................................ ..... 52 Appendix C Environmental Fate

................................ ................................ ............................. 53

### Page 4 of 63 Appendix D Ecotoxicology Profile

................................ ................................ .......................... 59 Appendix E Comments Received Concerning the Preliminary Work Plan

............................ 63

List of Tables
Table 1

– Summary of Anticipated Risk Assessments and Data Needs: ABS

............................... 5
Table 2

– Anticipated Registration Review Schedule for ABS

................................ ...................... 6
Table 3

– Chemical Identification of Alkylbenzene Sulfonates

................................ ..................... 7
Table 4

– Physical

- Chemical and Fate Prope rties for Alkylbenzene Sulfonates

............................ 8
Table 5

– Distribution of Products by Specific Alkylbenzene Sulfonate

................................ ....... 9
Table 6

– Summary of ABS Registered Uses

................................ ................................ ................. 9
Table 7

– Existing Regulations for dodecylbenzene sulfonic acid (PC Code 098002)

................ 11
Table 8

– Existing Regulations for s odium dodecylbenzene sulfonate (PC Code 079010)

......... 12
Table 9

– Studies Anticipated as Needed for the Registration Review of ABS

........................... 13
Table 10

– Existing Toxicological Endpoints

................................ ................................ ............... 14
Table 11

- Alkylbenzene Sulfonate Labels with Fruit and Vegetable Wash Uses

....................... 18
Table 12

– Occupational Handler Exposure Scenarios for ABS

................................ .................. 20
Table 13

– Existing Effects Endpoints for Risk Assessment of ABS

................................ ........... 26
Table 14

– Acute Toxicity Studies for ABS

................................ ................................ ................. 33
Table 15

– Subchronic/Chronic and Other Toxicity Studies

................................ ........................ 42
Table 16

– Endpoints to be Ree valuated Using the Most Current Acceptable Data

.................... 48
Table 17

- Abiotic Degradation of ABS

................................ ................................ ....................... 54
Table 18

- Biotic Degradation of ABS

................................ ................................ ......................... 55
Table 19

— Estimated Physical Properties

................................ ................................ ..................... 55
Table 20

– Available Endpoints from Avian Ecotoxicity Studies for Sodium Dodecylbenzene
Sulfonate

................................ ................................ ................................ ................................ ....... 59
Table 21

– Available Endpoints from Freshwater Fish Ecotoxicity Studies for LAS

.................. 60
Table 22

– Available Endpoints from Freshwater Invertebrate Ecotoxicity Studies for LAS

..... 61
Table 23

– Available Endpoints from Freshwater Aquatic Plants

................................ ................ 61

List of Figures Figure 1

– Conceptual Model for Ecological Exposure and Effects of Dodecylbenzene Sulfonic Acid and its Reaction Products/Degradates from Indoor Food and Non

- food Use Sanitizers Ecological Ef fects Assessment

................................ ................................ ................................ ..... 24 Figure 2

– Conceptual Model for Ecological Exposure and Effects of Sodium Dodecyl Sulfonate
and its Reaction Pro ducts/Degradates from Antimicrobial Fruit and Vegetable Washes and Food
Contact Sanitizer

................................ ................................ ................................ ........................... 25

### Page 5 of 63 

# 1 Introduction

This document is the Environmental Protection Agency’s (EPA or “the agency”) Final Work Plan ( F WP) for Alkylbenzene Sulfonates (ABS). The FWP document explains what EPA's Office of Pesticide Programs knows about ABS , highlighting anticipated data and asses sment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing their review. This work plan also addresses public comments received concerning t he Preliminary Work Plan (PWP), which was posted in the Alkylbenzene Sulfonates registration review docket (EPA

- HQ

OPP

- 201 3

- 00 97 ). Further, this document makes final the work plan for the Alkylbenzene
Sulfonates registration review process.



## 1.1 Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will

occu r over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CF R 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses
and data or information it believes a re needed to make a registration review decision. The PWP published on March 2 7 , 2013 and the comment period ended May 2 7 , 2013.

Documents associated with this registration review can be viewed at http://www.regulations.gov
in docket EPA

- HQ

- OPP

- 20 13

- 0097 . Below is a summary of the issues relevant to this registration review case.

T able 1

– Summary of Anticipated Risk Assessments and Data Needs : ABS

Risk Assessment Assessment Necessary to Support Registration Review Date of Most

R ecent
Assessment Type of Assessment Required (New/Updated) Data Anticipated as
Needed (See Table 9
for details )

Dietary (food) Yes 2006 Updated Residue Chemistry

Dietary (drinking water) No (see See 3.2.2 ) None None None

Occupational Handler (Inhalation/Exposure) Yes 2006 Updated Inhalation Exposure

### Page 6 of 63 Risk Assessment Assessment Necessary to Support Registration Review Date of Most

R ecent
Assessment Type of Assessment Required (New/Updated) Data Anticipated as
Needed (See Table 9
for details )

Residential Handler No (see Section 3.3.2 ) None None None

Aggregate Yes None New Residue Chemistry Inhalation Exposure

Cumulative No (see Section 3.4.2 ) None None None

Tolerance Review No (see Section 1.6.2 ) None None None

Ecological No 1 (see Section 4 ) None None None

1 A hazard assessment for discharge to wastewater treatment plants will be conducted but given the extensive literature open literature available on LAS no additional data is anticipated to be required to perform this

assessment.



### Table 2

– Anticipated Registration Review Schedule for ABS

Anticipated Activity Target Date * Completion Date Phase 1: Opening the Docket Open Docket and 60

- Day Comment Period for Preli minary Work Plan 2013

- 03 2013

- 03

- 2 7

Close Public Comment Period 2013

- 05 2013

- 05

- 27 Phase 2: Case Development

Issue Final Work Plan 2013

- 09

Issue Data Call

- In (DCI) 2014

- 09

Receive Data to be Considered in Risk Assessment 2016

- 09 Open 30

- Day Public Comment Period for Preliminary Risk Assessment(s) 2018

- 03

Close Public Comment Period 2018

- 04 Phase 3: Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Pro posed Decision 2018

- 09

Close Public Comment Period 2018

- 11

Issue Final Decision 2019

- 03 Begin Post

- Decision Followup 2019 Total (years) 6

* The anticipated schedule will be revised as necessary ( e.g. , need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).


## 1.2 Updates to the Work Plan

Since the publication of the PWP, the agency has made the following updates:

• Added Updates to the Work Plan section.

• Updated the dates in Table 2

.

• Removed the Guidance for Commenter s Section

• Added Appendix E “Comments Received Concerning the Preliminary Work Plan.”

• Updated the application rates under Table. These updates were made in response to comments received during the public comment period (see Appendix E).

The Agency received one comment on the initial docket. The comment received did not affect
the data needs of the work plan and timeline described in the PWP. A summary of the comment received and the Agency’s responses are presented in Appendix E.

### Page 7 of 63 

## 1.3 Case Overview

The docket for the Alkylbenzene Sulfonates Case (Case 4006) has been established at http://www.regulations.gov in docket number EPA

- HQ

- OPP

- 2013

- 0097. Except where otherwise noted, the active ingredients in this case will be referred to collectively as “alkylbenzene sulfonates” or “ABS”.

The alkylbenzene sulfonates are registered for use as food

- contact sanitizers in food processing plants and eating establishments. They are also registered for use as disinfectants and sanitizers for agricultural, commercial, institutional, industrial, and public access uses. However, the largest overall use of alkylbenzene sulfonat es is as surfactants in household laundry and dish detergents , which do not make pesticidal claims and are not part of this assessment

. In examining aggregate exposure, EPA takes into account the available and reliable information concerning

exposures to p esticide residues in food and drinking water, and non

- occupational pesticide exposures. The aggregate exposure does not take into consideration non

- pesticidal uses.

The Alkylbenzene Sulfonates (ABS) Case originally include d three antimicrobial compounds as
follows:

• Sodium dodecylbenzene sulfonate (PC Code : 079010 );

• Dodecylbeneze sulfonic acid (PC Code: 098002) and;

• C10

- 16 alkylbenzene sulfonic acid (PC Code: 190116).

All registrations containing C10

- 16

- alkylbenzene sulfonic acid (PC Code: 190116) have be en voluntarily cancelled as of February 6, 2013. Therefore, C10

- 16

- alkylbenzene sulfonic acid will no longer be assessed under this registration review case.



## 1.4 Chemical Identification and Properties

Table 3 p resents the two active ingredients to be assessed in Case 4006: Sodium dodecylbenzene sulfonate (PC Code: 079010) and Dodecylben z e n e sulfonic acid (PC Code: 098002). The major
difference bet ween these actives are the ions on the sulfonate groups which are sodium versus hydrogen respectively, both ionize. ABS product chemistry information relevant to risk
assessment is summarized in Table 4

.
Table 3

– Chemical Identification of Alkylbenzene Sulfonates

Chemical Name Sodium dodecylbenzenesulfonate Dodecylbenzenesulfonic acid

Classification Linear alkylbenzene sulfonates (LAS) Linear alkylbenzene (LAB) Sulfonic Acid

PC Code 079010 098002

CAS No. 25155

- 30

- 0 27176

- 87

- 0

Molecular Formula C 18 H 29 NaO 3 S C 18 H 30 O 3 S Molecular Weight 348.48 g/mol 326.49 g/mol

Molecular Structure

### Page 8 of 63 Table 4

– Physical

- Chemical and Fate Properties for Alkylbe nzene Sulfonates

OPPTS
Guideline
No. Physical and
Chemical Properties Sodium dodecylbenzenesulfonate Dodecylbenzenesulfonic acid

830.1550 Product identity and composition Refer to Table 3

. Refer to Table 3

.

830.1650 Description of
Formulation

Process Confidential Business Information (CBI) CBI

830.6302 Color White to light yellow flakes, granules, or powder. Colorless liquid / Light yellow to brown

830.6303 Physical State Crystalline powder Colorless liquid.

830.6304 Odor No discernible odor No discernible odor

830.6313 Stability to sunlight, normal
and elevated
temperature, metals/metal ions Stable under normal temperature. Stable under normal temperature.

830.7000 pH 7.5

– 10.5 1% aqueous solution at 25 ° C. <1

830.7050 UV/Visible Absorption Highly susceptible to photodegradation. Stability to Sunlight: 80% photodegrade at
223 nm within 10 hours. 215 nm. Highly susceptible to photodegradation.

830.7100 Viscosity Not applicable for solids. 890 cP at 25°C
Viscous Liquid

830.7200 Melting point 287.63°C Not applicable. It is a liquid

830.7220 Boiling point Not applicable. It is a solid. 205°C

830.7300 Density 1.0 at 20°C for 60% slurry. 1.06 (kg/l) (relative) 1.06 g/mL at 20 °C

830.7370 Dissociation
Constant In aqueous solution at neutral pH solutions of LAS, where the sodium ion will disassociate to form the LAS anion (linear alkyl benzene

- SO3  ̄ ). pKa: 4.19 (25 o C) : 4.12 (20 o C) The LAB sulfonic acids are strong acids (pKa <1) that are completely ionized in

aqueous so lutions. The chemical species present in aqueous solutions is the LAS ion (linear alkyl benzene

- SO 3 - ).

830.7550 Partition coefficient ( n

octanol/water) 1.96 1.96

830.7840 Solubility in water LA S is made up of a polar (hydrophillic)

group,

- SO 3 - and a nonpola r (hydrop ho bic) long

- chain aliphatic group. It disperses in
water to form micelles rather than dissolving. The dispersion saturation point
at 25 o C is 30

- 35 g/mL. This ai is made up of a polar (hydrophillic) group,

- SO 3 - and a nonpola r (hydrop ho bic) long

- chain aliphatic group. It disperses in water to form micelles rather than dissolving.

830.7950 Vapor pressure 2.29 x10 - 15 mm Hg at 25 °C (Source: EPI Suite) 7.93 x 10 - 11 mm Hg at 25° C (Source: EPI Suite)
Source: MRIDs, 00161996, 00161997, 00162297, 41221301, 42439801, 43377801, 43656401, 43656402, 43656403, and 43787401, HPV, and EPI Suite v4.1

### Page 9 of 63 

## 1.5 Use/Usage Description

1.5.1 Registrations

There are 12 registered products that contain alkylbenzene sulfonates. The distribution of products by specific alkylbenzene sulfonates is presented in Table 5 . Most o f the products are formulated as flakes, granules, powder and liquids.

Table 5

– Distribution of Products by Specific Alkylbenzene Sulfonate

Chemical Name PC
Code % ai Formulations Registered Products

Sodium dodecylbenzene
sulfonate 079010 0.036

- 3.6% Soluble Concentrate; Ready to Use 1677

- 234

, 71094

- 1

, 71094

- 2

Dodecylbeneze
sulfonic acid 098002 2.93

- 17.46% Soluble Concentrate 1677

- 56

, 19713

- 299

, 4959

- 29

, 63838

- 14

, 65001

- 1

, 875

- 184

, 875

- 185

, 875

- 85

, 71695

- 1



### Three registered products contain the active ingredient sodium dodecylbenzene sulfonate (PC Code: 079010). All three of these products are registered as antimicrobial fruit and vegetable

treatments for use to reduce pathogens and control spoilage and decay caused by
micro organisms. The fruit and vegetable washes are used in food retail eating establishments such as restaurants, cafeterias, food service operations, commissaries, and kitchens. Additionally, two of the three products containing sodium dodecylbenzene sulfonate (Reg #s 71094

- 1 and
71094

- 2) are registered for use as food

- contact sanitizers to control bacteria on sinks, drain and cutting boards, counter tops, forks, knives, dishes, utensils, and salad preparation surfaces in kitchens, restaurants, other eating est ablishments, dairies, and food processing plants.

Nine registered products contain the active ingredient dodecylbenzene sulfonic acid (PC Code: 098002). The products are registered for use as indoor food and non

- food use sanitizers for various sites including dairy farm milking machines and milk handling equipment and facilities, dairy and cheese processing plant equipment, ice cream processing plant equipment, egg processing and packaging e quipment and surfaces, eating establishments (including equipment, glassware and utensils), food processing equipment and surfaces, meat and poultry processing plants, carbonated beverage and brewery processing equipment and surfaces, winery and brewery pr ocessing equipment and surfaces, and seafood processing plants.



### 1.5.2 Summary of Registered Uses

Table 6 presents a summary of the registered uses of Alkylbenzene Sulfona tes that will be assessed in this registration review

. Alkylbenzene Sulfonates can be applied by the following application methods:

Table 6

– Summary of ABS Registered Uses

Site Category Registration # Application Method Application
Rate

Fruit & Vegetable Wash 71094

- 1 Brush, flood treatment, foam application, Immersion, Spray, Wipe 1 oz/8 gal or 2oz/4gal

71094

- 2 Agitation, Drip, Scrub, Spay 1 unspecified

1677

- 234 Agitation 1 oz /1 gal Commercial Transportation Facilities 875

- 85 Spray 2 oz /2 gal

### Page 10 of 63 Site Category Registration # Application Method Application
Rate
Commercial/Industrial/Institutional Premises and Equipment 1677

- 234 Agitation 1 oz

Dairy Farm Milk Handling Facilities and Equipment 1677

- 56 Immersion, ( Spray ) 1 oz / 2 gal or (1oz/1 gal)

19713

- 299 Spray 1 oz /5 gal

4959

- 29 Flush, Spray 1 oz /5 gal

63838

- 14 Brush, Dip, Spray 1 oz /5 gal

65001

- 1 Immersion, Mop, Spray, Sponge 1 oz /5 gal

875

- 184 Circulation, Flush, Immersion, Spray 1oz /6 gal

875

- 185 Flood, Foam, Immersion, Spray 2.5 oz /4 gal

875

- 85 Circulation, , Immersion, ( Spray ) , Mop Wipe on,

, Flood, Foam, Brush 1 oz/2 gal or ( 2

oz /2 gal)

Eating Establishments 65001

- 1 Immersion, Mop, Spray, Sponge 1 oz /5 gal

875

- 184 Spray, Circulation, Immersion, Flush 1oz /6 gal

875

- 185 Spray, Foam, Flood, Immersion, 2.5 oz /4 gal

875

- 85 Spray, Circulation, Immersion, Mop, Wipe, Foam, Flood, Brush, 1

- oz / 2 gal

Egg Handling Facilities and Equipment 875

- 184 Flush, Spray , Circulation,
Immersion 1 oz /6 gal

875

- 185 Foam, Flood, Immersion, Spray 2.5 oz /4 gal

Food Processing Plant Premises/Equipment 19713

- 299 Spray 1 oz /5 gal

4959

- 29 Brush, Soak, Spray 1 oz /5 gal

63838

- 14 Brush, Dip, Spray 1 oz /5 gal

65001

- 1 Immersion, Mop, Spray, Sponge 1 oz /5 gal

875

- 184 Spray, Circulation

, Immersion, Flush 1 oz /6 gal

875

- 185 Spray, , Flood, Foam Immersion, 2.5 oz /4 gal

875

- 85 Brush, Circulation, Flood, Immersion, , ( Spray ) Mop, Wipe, Foam 1 oz /2 gal (2 oz/2 gal

1677

- 56 Spray 1 oz /1 gal

Food/Grocery Marketing/Storage/Distribution Facility
Premise 19713

- 299 Spray 1 oz /5 gal

875

- 184 Spray , Circulation, Immersion, Flush 1 oz /6al

875

- 185 Spray , Foam, Flood ,
Immersion 2.5 oz /4 gal

875

- 85 Circulation, Immersion, (Spray), Mop, Wipe, Flood, Foam, Brushing 1 oz /2 gal or (2oz/2 gal)

Tanks, Tank Trucks, Silos, Vats, Pails, Pipelines and Closed Systems 19713

- 299 Spray 1 oz /5 gal

Bathroom Premises/Hard Surfaces 65001

- 1 Sponge, Wipe, Spray 1 oz /5 gal

### Page 11 of 63 

### 1.5.3 Usage Information

The alkylbenzene sulfonates are registered for use as disinfectants and both food and non

- food
sanitizers as summarized in Table 6

. The alkylbenzene sulfonates are listed on the Office of Pollution Prevention and Toxics (OPPT)’s High Production Volume (HPV) Challenge Program 1 

### . HPV chemicals are those that are manufactured or imported into the U.S. in production volumes greater than one million pounds per year. Approximately 10 million pounds of alkylbenzene sulfonates are used in EPA registered antimicr obial products according to the Section Seven Tracking System for the years
2001

- 2010.



## 1.6 Regulatory History

The first product containing Sodium dodecylbenzene sulfonate (PC Code 079010) as an active ingredient was registered in the United States in 1968. The first product containing dodecylbenzene sulfonic acid (PC Code 098002) as an active ingredient was registered in the
United States in 196 9

. The Agency completed a Reregistration Eligibility Decision (RED) for
ABS in 2006.



### 1.6.1 Recent/Pending Regulatory Actions

There are currently no pending registrations for the alkylbenzene sulfonates case.



### 1.6.2 Tolerance Information

Dodecylbenzenesulfonic acid (098002) and sodium dodecylbenzene sulfonate (079010) have
uses in food

- contact surface sanitizing solutions with toleranc e exemptions specifi ed in 40 CFR 180.940(b) and (c) respectively, and food additive regulations established by FDA under FFDCA Sec. 409, which are summarized in Table 7 and Table 8 . R esidues for these compounds from the
food

- contact surface sanitizing solution are exemp t from the requirements of a tolerance when used in accordance with good manufacturing practices as ingredients in 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 dodecylbenzenesulfonic acid (098002) and sodium dodecylbenzene sulfonate (079010) 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 2006 RED states that, “the agency will be proposing a change to the 4 0 CFR 180.940(b) to have the end

- use concentration not to exceed 400 ppm, rather than the current limitation of 5.5 ppm”, the agency anticipates making this change to 40 CFR 180.940(b).

Table 7

– Existing Regulations for dodecylben zene sulfonic acid (PC Code 098002)

Regulation Allowed Use Site Limit 21 CFR 178.1010(b)(7) and 178.1010(c)(5) food

- processing equipment and utensils, glass bottles and other glass containers intended for holding milk 400

ppm 21 CFR 178.1010 (b)(10) and food

- processing equipment and utensils and other food

- contact 400

1 EPA (U.S. Environmental Protection Agency). 2006. Assessment Plan for the Linear Alkylbenzene (LAB) Sulfonic Acids Category in Accordance with the USEPA High Production Volume Chemical Challenge Program.
EPA 201

- 14485A. Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Washington,
DC. May 20, 2003.

### Page 12 of 63 Regulation Allowed Use Site Limit 178.1010 (c)(7) articles, beverage containers except milk containers or equipment ppm 21 CFR 178.1010(b)(40) and 178.1010(c)(35) dairy processing equipment 5.5

ppm

40 CFR 180.940 (c) food

- processing equipment and utensils 400

ppm

40 CFR 180.940 (b) dairy processing equipment, and food

- processing equipment and
utensils 5.5

ppm



### Table 8

– Existing Regulations for sodium dodecylbenzene sulfonate (PC Code 079010)

Regulation Allowed Use Sites Limit
21 CFR 178.1010(b)(21) and 178.1010(c)(16) food

- processing equipment and utensils, glass bottles and other glass containers intended for holding milk 430 ppm

40 CFR 180.940 (c) food

- processing equipment and utensils 430 ppm

21 CFR 173.315 to wash or to assist in the peeling of fruits and vegetables (no potable water rinse required) 0.2% in wash

water



## 1.7 Incidents

1.7.1 Human Health

From 1999 to 2006 there were twelve human exposure incidents that were recorded in the OPP Incident Data System (IDS) which could be attributed to alkylbenzene sulfonates products.
Irritation concerns were the primary effect, but may be due to other more i rritating chemicals that were also included in the products such as acids and quaternary ammonium compounds. Therefore, the agency cannot attribute the incidents to alkylbenzene sulfonates.



### 1.7.2 Ecological

No reported incidents from registered use in the agency's Ecological Incident Information System ( EllS ).



# 2 Anticipated Data Needs

Table 9 presents a summary of the data anticipated as being needed to support this registration
review.

### Page 13 of 63 Table 9

– Studies Anticipated as Needed for the Registration Review of ABS

GLN Study Name Test
Substance Time Frame (Months) (Measured in months

from DCI Receipt) Risk Assessment(s)

Data Will Support Use Site(s) Triggering Anticipated
Data Requirement Applicable Exposure
Scenarios

Studies Anticipated to be Required through the Registration Review DCI

875.1700 Product Use
Information TEP 12 All All All
Scenarios

860.1500 Residue in Crops 2 TEP 24 Dietary Fruit and Vegetable
Wash Chronic dietary

Studies Expected to be Required through the Anticipated Post

- RED DCI

870.3465 90

- day
Inhalation Toxicity TGAI 24 Occupational Hard Surface Disinfection, Restaurants,
and Food Processing Equipment Trigger Spray,

Low
Pressure Spray, and Mopping

875.1400 Inhalation Exposure

Indoor 3 TEP 24 Occupational Hard Surface Disinfection, Restaurants,
and Food Processing Equipment Trigger Spray,

Low

Pressure Spray, and Mopping

875.1600 Application Exposure Monitoring Data Reporting TEP 24 Occupational Hard Surface Disinfection, Restaurants,
and Food Processing Equipment Trigger Spray,

Low

Pressure Spray, and Mopping

875.2800 Description of

Human Activity TEP 12 Occupational Hard Surface Disinfection, Restaurants,
and Food Processing Equipment Mopping

2 Residue trails (860.1500) are expected to be necessary for the following representative fruits and vegetables: Artichoke, Brocc oli, Cantaloupe, Sweet Pepper, Loose

- head Lettuce, Mushrooms, Blackberry, and Apricot to determine dietary exposure to ABS following fruit and vegetable washing.

3 Indoor exposure data are expected to be needed for the following occupational handler scenar ios: 1

- Open pour liquids and powder, mop, wipe, low pressure spray and trigger spray for hard surface disinfection and food processing equipment 2

- Open pour, wiping and brushing for restaurant equipment dishes, glasses, utensils and other food handling e quipment 3

- Immersion of hands for fruit and vegetable wash or sanitizing pots, pans, etc. , 4

- Open pour for circulate in place for food processing plants. The label uses are for commercial and institutional uses only
and there are no residential uses. The refore, no residential handler or post

- application assessments are expected to be
needed.

### Page 14 of 63 

# 3 Human Health Risk Assessment

The Agency anticipates the need to conduct a human health risk assessment for ABS. The Agency expects to require additional data for use in conducting the registration review.



## 3.1 Existing Toxicological Endpoints

The toxicological points of departure (PODs) for the alkylbenzene sulfonates are included in
Table 10 and were established by the RED in 2006 based on the toxicity database. These PODs have not been updated. It should be noted that the there are no toxicological endpoints f or dermal exposure and a dermal risk assessment will not be conducted in registration review.

Table 10

– Existing Toxicological Endpoints

Exposure
Scenario Dose Used in Risk Assessment, UF

(mg/kg/day) Special FQPA SF*, endpoint and Level of
Concern for Risk Assessment Study and Toxicological
Effect Acute Dietary (females 13+) No endpoint was selected. No effects are attributable to a single dose in animal studies.

Chronic Dietary

(All Populations) Systemic/Reproductive
Oral NOAEL= 50 mg/kg/day

UF

- 100 NOAEL= 40 mg/kg/day (0.07%) and 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 )

Systemic/Reproductive NOAEL= 50 mg/kg/day and LOAEL = 250 mg/kg/day based on decreased Day 21 female pup body weight (Bueler, E. et al . 1971. Tox Appl. Pharmacol. 18:83

- 91)

NOAEL=85 mg/kg/day and LOAEL = 145 mg/kg/day from 9 month drinking water rat st udy 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. 6

- month Oral Toxicity

– Rat

Developmental Toxicity

- Rat

9

- month Drinking Water Study

Incidental Oral, Short

Term Oral NOAEL= 50 mg/kg/day

UF

- 100 NOAEL= 40 mg/kg/day (0.07%) and 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)

Systemic/Reproductive NOAEL= 50 mg/kg/day and LOAEL = 250 mg/kg/day based on decreased Day 21 female pup body weight (Bueler, E. et al . 1971. Tox Appl. Pharmacol. 18:83

- 91)

NOAEL=85 mg/kg/day and 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): 1 05

- 112. 6

- month Oral Toxicity

– Rat

Developmental Toxicity

- Rat

9

- month Drinking Water Study

### Page 15 of 63 Exposure
Scenario Dose Used in Risk Assessment, UF

(mg/kg/day) Special FQPA SF*, endpoint and Level of
Concern for Risk Assessment Study and Toxicological
Effect

Short

- and
Intermediate

Term (Dermal) Not Required 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. Thus, dermal exposure
would be self

- limiting to preclude dermal irritation. Additionally, the anticipated requirement of the dermal toxicity studies with the end

- use product will
d etermine and be used for the personal protective clothing 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), and 3) no
d evelopmental 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). De velopmental Toxicity

– Rat

Inhalation (Any time

point) Inhalation study NOAEL= 1mg/m 3 detergent dust combined with up to 0.1 mg/m 3 enzyme dust Equivalent to approximately 0.14 mg/kg/day (a) (inhalation absorption rate = 100%) purity= 13% active ingredient

UF

- 100 Subchronic Inhalation Monkey Study LOAEL = 10 mg/m 3 detergent combined with 0.1 mg/m 3 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 appr oximately 1.4 mg/kg/day (a) Inhalation Toxicity

– Rat

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, L OC = level of concern, NA = Not Applicable

NOTE: No Special FQPA Safety Factor recommended because the exposure databases (dietary food, drinking water, and residential) are complete and the risk assessment for each potential exposure scenario includes all metabolites and/or degradates of concern and does not underestimate the potential risk for infants and children.

(a) Equation used to convert inhalation air concentration to a dose= mg/L* absorption*respiratory volume (L/hr)*duration (hrs) * activity fact or / 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 cynomol gus monkey, study reports monkey body weight ranges from 1.6 to 3.7 kg).

### Page 16 of 63 

## 3.2 Dietary Exposure

3.2.1 Food

3.2.1.1 Food Use Patterns

Although antimicrobial products are not meant to be ingested, the use patterns summarized in
table Table 6 may result in residues that remain on the surfaces of utensils, dishware, food processing equipment, and/or the food products themselves. Subsequent residues may be ingested in small amounts by consumers and therefore it is necessary to assess the risk of dietary consumption of alkylbenzene sulfonates.

Food uses for alkylbenzene sulfonates can be categorized into two general use patterns: food contact surface sanitizers and fruit and vegetable washes.

3.2.1.1.1 Food

- Contact Surface Sanitizers


### Alkylbenzene sulfonates are used as sanitizers in various phases of food production including agriculture, food

- processing, transportation, and eating areas. Agricultural areas include milking facilities and equipment, and egg packing equipment. In the food

- processing phase, alk ylbenzene sulfonates are used to sanitize facilities that process meat, poultry, seafood, eggs, beverages, wine, ice cream, cheese, and other dairy products. Sanitization of these facilities includes equipment such as conveyor bel ts, utensils, glassware, f ood handling/storage areas, premises, and transportation areas. Finally, alkylbenzene sulfonates are used to sanitize public eating places, including countertops, utensils, glassware, a nd food preparation equipment (a detailed list
of uses for each chemica l can be found in Table 6

.

3.2.1.1.2 Fruit and Vegetable Wash


### Human dietary exposure to alkylbenzene sulfonates residues may occur as a result of their use in fruit and vegetable rinses, both processed and raw agricultural commodities (RACs).

3.2.1.2 Dietary Risk Characterization

Dietary risk is characterized in terms of the Population Adjusted Dose (PAD). The PAD is a function of the Reference Dose (RfD) adjusted t o account for the FQPA Safety Factor (SF). A Reference Dose is an estimate of a daily oral exposure to the human population that is likely to be without an appreciable risk of deleterious effects during a lifetime. The FQPA SF is intended to provide an add itional 10

- fold safety factor (10x) to protect for special sensitivity in infants and children to specific pesticide residues in food, drinking water, or residential exposures. A risk
estimate that is less than 100% of the acute or chronic PAD is not of co ncern.
An acute dietary assessment for alkylbenzene sulfonates was not conducted because there are no adverse effects attributable to a single dose exposure in animal studies.

A chronic dietary assessment for alkylbenzene sulfonates was conducted in the 2 006 RED. Chronic dietary risk for alkylbenzene sulfonates is assessed by comparing chronic dietary exposure estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk is expressed as a percentage of the cPAD. The cPAD is the chronic reference dose (0.5 mg/kg/day) modified by the FQPA safety factor. The chronic RfD is 0.5 mg/kg/day for all populations, using the NOAEL of 50 mg/kg/day based on the weight of evidence from three toxicological studies ( Tab le 15 ) that observed decreased pup body weight at 250 mg/kg/day and increased caecum weight, slight kidney damage at 114 mg/kg/day and significant decreases in

### Page 17 of 63 renal biochemical parameters at 145 mg/kg/day. The NOAELs in the three studies used to develop the chronic endpoint are 40, 50 and 85 mg/kg/day and are shown in ( Table 15 )

. An uncertainty factor o f 100 (10X for interspecies extrapolation, 10X for intraspecies variability) was applied to the NOAEL to obtain the chronic RfD. The alkylbenzene sulfonates cPAD is 0.5 mg/kg/day based on a reference dose of 0.5 mg/kg/day, which includes the incorporation of the FQPA safety factor (reduced to 1X) for the overall U.S. population and all population subgroups.

3.2.1.3 Anticipated Dietary Risk Assessments

Both exposure amounts and toxicity endpoints are necessary to assess the risk of alkylbenzene
sulfonates. Risk mus t be assessed for both food

- contact surface sanitizers as well as fruit and vegetable wash. The use patterns for alkylbenzene sulfonates with food

- contact uses ( Table 6 ) can be broadly categorized for risk assessment purposes:

• Food contact sanitizing solutions

• Fruit and vegetable wash

3.2.1.3.1 Food Contact Sanitizing Solutions


### Currently, the agency does not have data for residues of alkylbenzene sulfonates on treated food

cont act surfaces. In the absence of raw data, the agency has the ability to calculate residue levels that may occur in food from the application rates on food contact surfaces. In order to estimate the Estimated Daily Intake (EDI), the agency used a model calc ulation from FDA Guidelines (1993) 4



### . Due to the availability of this model, the agency does not anticipate requiring data for food contact sanitizing solutions

. Variables necessary for the calculation include application rate,
surface area to which food is exposed, fraction of pesticide migrating to food, and body weight. Per the tolerance exemption for dodecylbenzene sulfonates, the maximum ingredient percentage (application rate) registered for use in food handling establishments in kitchens, cafeterias, supermarkets and meat and poultry plants is 400 ppm. The surface area to which food is exposed
is assumed to be 4000 cm 2 

### which is the summation of the surface area of utensils, china, and glass used by a person who regularly eats three meals a day. Pestici de migration to food is
assumed to be 100%. Finally, based on the FDA’s accumulation of experimental residue data for sanitizers, a “worst case” assumption for residues is one milligram of sanitizer solution per square centimeter of treated surface. Using this assumption the following EDI values were
calculated in the 2006 RED:

• Adult Male: 22.9 μg dodecylbenzene sulfonate/kg/day

• Adult Female: 26.7 μg dodecylbenzene sulfonate/kg/day

• Child: 53 μg dodecylbenzene sulfonate/kg/day

The calculations presented in the 2006 RED assumed body weights of 15 kg for a 3 year old, 70 kg for an adult male, and 60 kg for an adult female. These body weights have been replaced with 11 kg for a 1

- 2 year old, 80 kg for an adult male, and 69 kg for an adult female (Exposure

Facto rs Handbook. Vol 2, 2012)

. The new values will be used in the updated risk assessment. A detailed example of the calculations in the RED can be found on regulations.gov under docket

EPA

- HQ

- OPP

- 2006

- 0156, memo entitled Dietary Risk Assessment for Alkylbenze ne Sulfonates

. If the registrant disagrees with the approximation and/or assumptions, they may elect to provide

4 Ibid.

### Page 18 of 63 their own experimental data. The agency does not anticipate calling in residue data for food contact sanitizing solutions.

In the 2006 RED, the agency used a model calculation from FDA Guidelines (1993) 5 

### to estimate residues in milk that would result from the use of alkylbenzene sulfonates in food processing equipment as representative of the potential uses in the food processing industry. As a

c onservative 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 estimat ed that use of this product results in maximum milk residues of 10 ppb ( μg/kg).

3.2.1.3.2 Fruit and Vegetable Wash



### As listed in Table 11 , several alkylbenzene sulfonate labels include a use for washing fruit and vegetables.

Table 11

- Alkylbenzene Sulfonate Labels with Fruit and Vegetable Wash Uses

Registration
Number Product Name PC
Code Application Instructions Potable
Water
Rinse

71094

- 1 PRO

- SAN ® 079010 solution containing 1% (one pouch/8 gallons) or 2% (1 pouch/4 gallons) of PRO

- SAN ® powder to potable (drinking) water Yes

71094

- 2 PRO

- SAN L ® 079010 thoroughly wet the surface of fruits and vegetables by dipping in or spraying with PRO

- SAN L ®
solution Yes

1677

- 234 Antimicrobial Fruit & Vegetable

Treatment 079010 dilute Antimicrobial Fruit & Vegetable Treatment into the processing vessel by adding 0.75

- 1.00 ounces of concentrate to a gallon of water No

71695

- 1 CS

- 100 Anionic
Sanitizer 098002 1 ounce of the product to 5 gallons of water (15.6 mL to 10 L); at no time should the concentration of
CS

- 100 Acid Anionic Sanitizer in the wash water exceed 2 ounces to 5 gallons (31.2 mL to 10L Yes



### FDA ’s r egulation at 21 CFR 173.315 permits this use pro vided that the wash solution does not contain dodecylbenzene sulfonic acid at a level greater than 0.2% (2,000 ppm), without a potable
water rinse. It is presumed that the use limitation is for the parent chemical because the regulation makes no mention of formulations.

EPA Reg. Nos. 71094

- 1, 71094

- 2, and 71695

- 1 bear instructions that include a potable water rinse. However, there are no data showing that the level of residues on fruits and vegetables
would be reduced to the level that would have occurred from 0.2% wash. The a gency intends during registration review to work with registrants to update the labels for all four EPA registrations for fruit and vegetable washes to reflect application rates (ppm on an active ingredient basis). Application rates ar e necessary in order to conduct a dietary assessment of the fruit and vegetable wash use pattern.

In 2006, a dietary assessment was conducted for fruit and vegetable washes based on EPA Reg.
No. 71695

- 1. The assessment was not based on residue data but on an assumption that the solution film thickness on a rinsed grape would be the same as that adhering to dishware surfaces rinsed after washing with a dishwashing product. As these uses are likely to result in measurable

5 Ibid.

### Page 19 of 63 residues on raw agricultural commodi ties (RACs) and processed fruits and vegetables, EPA anticipates that residue trials treating RACs and processed fruits and vegetables will need to be conducted for risk assessment purposes. Residue tr ia ls (860.1500) are anticipated to be necessary for the following representative fruits and vegetables:

• Artichoke

• Broccoli

• Cantaloupe

• Sweet Pepper

• Loose

- head Lettuce

• Mushrooms

• Blackberry

• Apricot



### 3.2.2 Drinking Water

It was determined in the 2006 RED that minimal or no drinking water risk is expected to occur due to the fact that the use patterns were considered indoors. has since been recognized that
such use patterns may have an additional down

- the

- drain component resulting in potential
releases to wastewater treatment plants (WWTPs) and subsequently the environment. Such
releases for the linear 12 carbon chain ABS (C12

- ABS) actives in this case are considered highly unlikely to be discharged from WWTPs due to sorption and rapid biodegradation as discussed in Section 4.1. Therefore no quantitative drinking water assessment is planned for
ABS.



## 3.3 Occupational and Residential Exposures

T he Agency anticipates the need to revise the occupational assessments conducted in support of the 2006 RED since Margins of Exposure (MOE)s were calculated using assumptions that possibly underestimates exposure and will need to be reassessed using updated values. Uses of ABS that may result in occupational handler exposure are presented in Table 12

. 

### 3.3.1 Occupational Handler Exposure

Occupational and Residen tial Exposures were assessed in the July 2006 RED and were assessed
in a separate occupational risk assessment ( D 327732 )

. At that time in 2006, alkylbenzene sulfonates active ingredients were used in twenty

- three registered end

- use products

. Alkylbenzene s ulfonates are registered for use as sanitizers that are designated for use in agricultural, food handling and commercial/institutional/industrial settings (Use Site Categor ies I, II, and III respectively). ABSs are also an ingredient in certain cleaning pr oducts. However, alkylbenzene sulfonates are now in twelve registered pesticide products. The current use patterns are similar, and the application rates are either the same or lower than those presented in the

RED. No r esidential use sites were identified for the active ingredient ; therefore, a residential
assessment will not be conducted.

A dermal toxicological endpoint was not required in the RED and the agency does not anticipate a dermal toxicological endpoint for registration review. Thus, an occupat ional dermal assessment
will not be conducted. According to the RED, ABS did not exhibit systemic or developmental toxicity in several dermal toxicity studies. The agency stated that workers will likely be protected from irritation effects based on the per sonal protective equipment specified on the labels.

### Page 20 of 63 Although the agency conducted an occupational inhalation risk assessment in the RED, the agency anticipates the need to conduct an updated occupational inhalation risk assessment for registration review. Based on the need to assess current application rates, reevaluation of toxicity data and the expected inhalation toxicity that will be received from the RED DCI, the agency anticipates that a new inhalation toxicological endpoint will likely be developed.

Workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide

. Occupational inhalation post

- application exposures are presumed to be negligible because of the low vapor pressure of ABS. This is consistent with the earlier ris k assessment for the RED which stated that “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 (EPA, 2006).”

Occupational han dlers of alkylbenzene sulfonates include workers in a variety of occupational settings including food processing facilities and at agricultural premises. Examples of registered uses found on labels and outlined in the RED for ABS include application to ind oor non

- food hard surfaces (e.g. floors, walls, tables, chairs, and benches), food dispensing equipment (e.g.

pre

- mix and post

- mix vending machines, conveyor belts, slicers, peelers, tanks), indoor food contact hard surfaces (glasses, dishes, silverware, c ountertops, etc.), agricultural tools, and fruits and vegetables (post

- harvest).

EPA, 2006. Alkylbenzene Sulfonates (ABS) Preliminary Risk Assessment for the Reregistration Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002. Case No. 4 006. D. Smegal/ A.Assaad/W.Dyksra. DP Barcode: D323972.

The representative scenarios selected for assessment w ill be evaluated using maximum application rates as recommended on the product labels for ABS.

Table 12

– Occupational Handler Exposure Scenarios for ABS

Scenario Exposure Route(s) Duration

Occupational Exposures Agricultural Premises and Equipment (Use Category I)

Dairy Farm Milking Equipment Open pour for circulate

- in

place (CIP) cleaning

Inhalation Short and
Intermediate Term Wipe Trigger Spray Low Pressure Spray Food Handling/Storage Establishments Premises and Equipment (Use Site Category II) b

Hard surface sanitizers on countertops and
floors a Open pour liquids and powders

Inhalation Short and
Intermediate Term Wipe Trigger Spray Low Pressure Spray Mopping

Restaurants/Eating Establishments b Immersion

Inhalation Short and
Intermediate Term Wipe Low Pressure Spray

Food processing equipment c (tanks, conveyor belts, spray systems) Open pour liquids and powders for CIP Inhalation Short and
Intermediate Term Wipe Trigger Spray

### Page 21 of 63 Low Pressure Spray a Hard surfaces are treated in restaurants and food processing plants
b Restaurant uses of sanitizers include washing dishes, glasses, utensils, pots and pans

c Representative exposure scenarios that examine possible exposures when cleaning equipment found in food processing plants, beverage processing plants, dairy farm plan ts, dairy farm cheese plants, meat processing plants, poultry processing plants, and bottling plants.



### 3.3.2 Residential Exposures

Since there are no residential uses for the currently registered products, a residential assessment
will not be conducted.



## 3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures

EPA anticipates the need to revise the aggregate assessment conducted in support of the 200 6
RED. Upon a reevaluation and selection of toxicological endpoints, combined with the human health exposure assessments expected as a part of this registration review case, aggregate exposures will need to be assessed. This assessment will include dietary exposu res.



### 3.4.2 Cumulative Exposures

With respect to cumulative exposure, 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 ABS and an y other substances and ABS do es not appear to produce a toxic metabolite produced by other substances. For the purposes of this registration review, therefore, EPA has not assumed that ABS has a common mechanism of toxicity with other substances. For infor mation regarding EPA’s efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs at http://www.epa.gov/pesticides/cumulative/

. 

# 4 Environmental Risk Assessment

An ecological risk assessment was not conducted previously on the use patterns for ABS

. It was
determined in the 2006 RED that minimal or no environmen tal exposure to terrestrial or aquatic organisms is expected to occur due to the fact that the use patterns were considered indoor s

. I t has since been recognized that such use pattern s may have an additional down

- the

- drain component resulting in potential release s to wastewater treatment plants (WWTPs) and subsequently the environment

. S uch releases for the linear 12 carbon chain ABS (C 12 

### - ABS )
actives in this case are considered highly unlikely to be discharged from WWTPs due to sorption
and rapid biodegradation as discussed in Section 4.1

. Therefore except for evaluating the potential hazard to WWTPs , no quantitative environmental risk assessment is planned for ABS

. 

## 4.1 Environmental Fate and Transport

R egistrants have submitted studies primarily from the open literature to support uses of ABS

. The agency has also identified additional open literature studies which address fate of linear C 12 

### - ABS or used EPI Suite version 4.1 to estimate physical parameters for the actives in this case

. The actives considered in this case are a subset of the linear alkylbenzene sulfonate (LAS) group
and contain a C 12 

### alkyl chain length and a sulfate group in the para or 4 position on the ring

. In

### Page 22 of 63 the open literature

, unless otherwise noted, the term linear alkylbenzene sulfonate (LAS) refers to a mixture of homologues of different alkyl chain lengths (C 10

- 16 

### ) and isomers differing in the phenyl ring positions (2 to 5 phenyl)

. Additi onally the term ABS in the open literature may include branch chain alkyl groups

. Fate can be affected by the chain length , branching, and phenyl isomer configuration, so fate in formation specifically for the linear C 12 

### - ABS considered
in this case is used when available rather than general information on LAS or ABS

. Studies that were conducted by registrants include a hydrolysis study ( MRID 40548801 and 40970701 ) and a soil leaching/adsorption/ desorption study ( MRID 40655201 and 94032011 )

. The following

su mmary is based on a more detailed summary and review of the fate data provided in Appendix
C.

Based on available fate data t he major environmental dissipation for LAS, including linear C 12 

### - ABS, is aerobic biodegradation (Fairchild, 1993; Larson and Payne, 1981; Temmink and Klapwijk, 2004 ). In an activated sludge pilot

- scale municipal waste plant monitoring study >99% of the LAS (C 12 

### - homologue) load was removed by aerobic biodegradation (Temmink and Klapwijk, 2004)

. Fairchild (1993) reporte d rapid environmental degradation of LAS homologs in aquatic systems with measured half

- lives of <2 days

. Early work by Larson and Payne (1981) o n linear ABS using water samples collected from a bove and below a municipal WWTP discharge
also showed r apid de gradation with a half life of 0.23 days (5.52 hours) for the alkyl chain , while the same study showed that the benzene ring mineralized with a half life of 0.73 days (17.52 hours) as indicated by the amount of radiolab eled carbon dioxide collected

.
The ot her major determinate of fate from the available studies is adsorption to sludge, and
soil/sediment. In the Temmink and Klapwijk (2004) pilot

- plant study 92

- 98% of the LAS

- C12 adsorbed to sludge. Jacobsen (2004) discussed the mechanistic basis for sorption of LAS to
soils. The sorption of LAS to soil was identified as attributable to a combination of several mechanisms and sorption to both the organic and inorganic fraction of the soil has been demonstrated. The linear alkyl group of LAS is hydrophobic and s orbs to the non

- polar fractions of the soil, such as the organic matter. However, the sulfonate group of LAS is negatively charged and hydrophilic and therefore interacts with positively charged soil components or polar groups, such as hydroxyl

- groups, min erals, or oxides.

Based on the following the antimicrobial uses of linear C 12 

### - ABS are not expected to exceed levels of concern in the environment for federally listed endangered and threatened species ( i.e

., listed species) or non

- listed species and their critical habitat:

• R apid aquatic biodegradation and mineralization of alkyl groups (half

- life ) of 5.52 hours and the benzene ring (half

- life 17.52 hours) ( Larson and Payne, 1981 

### );

• R apid sorption to sludge (5

- 10 min equilibrium with >99% sorption) (T emmink and Klapwijk, 2004 ) ;

• Rapid biodegradation in activated sludge (half

- life <2 days) ((Fairchild, 1993; Larson and Payne, 1981; Temmink and Klapwijk, 2004 ) ;

### Page 23 of 63 • Disposal down drains would be expected to be below levels of concern given the production volume for antimicrobial use is on only on the order of 300,000 lbs annually, and use would be widely dispersed across the nation and its territories 6



### . 

## 4.2 Environmental Conceptual Model Exposure Pathways

Figure 1 presents the conceptual model diagram for ecological exposure and effects of dodecylbenzene sulfonic acids and its reaction/products/degradates from indoor food and non

food use sanitizers. Although there is potential for t his chemical and its reaction products/degradates to be released to wastewater treatment plants as a result of its use as indoor
food and non

- food use sanitizers, persistence in surface water of any residual amounts of this
chemical and its reaction products/degradates that may be discharged from wastewater treatment plant effluents is not expec ted due to rapid biodegradation and sorption to sludge

. Figure 2 presents the conceptual model diagram for ecological exposure and effects of sodium dodecyl sulfonate and its reaction products/degradates from antimicrobial fruit and vegetable
washes and fo od contact sanitizer. Although there is potential for these chemicals and their reaction products/degradates to be released to wastewater treatment plants as a result of their use fruit/vegetable washes and food contact sanitizers, persistence in surface w ater of any residual amounts of these chemicals and their reaction products/degradates that may be discharged from wastewater treatment plant effluents is not expected due to rapid biodegradation

.

6 For example a conservative estimate (300000 pounds annually/356 days) (453.592E3 mg/pound) ÷ (42,225E6 gallons/day)(3.78541 liters/gallon) = 0.002 m g/L where the wastewater treatment volume of 42,225E6 is from the 1996 U.S. Census ( http://www.allcountries.org/uscensus/391_wastewater_treatment_facilities.html ).

### Page 24 of 63 Figure 1

– Conceptual Model for Ecological Exposure and Effects of Dodecylbenzene
Sulfonic Acid and its Reaction Products/Degradates from Indoor Food and Non

- food Use
Sanitizers Ecological Effects Assessment

Stressor

Source

Receptors and Exposure

Routes

Attribute Change(s) Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae Reduction in prey

Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity
Reduced cover Community change
Modification of PCEs related to
habitat Aquatic Animals

Invertebrates
Vertebrates Exposure
Media

Ingestion Ingestion Uptake/gills
or integument

Aquatic Plants

Non

- vascular
Vascular Uptake or sorption by

cells, roots, leaves,

Piscivorous*

Invertebrates
Vertebrates Phytoplanktivore/

Herbivore
Invertebrates

Vertebrates

*As used here this term refers to animals (terrestrial or aquatic) that eat not just fish but any aquatic animal ( e.g ., amphibians, mollusks, crustaceans, etc .) Ingestion Waste Water Treatment Plant (WWTP)

Key Most likely

exposure pathway contributing to risk
Low likelihood of contributing to risk Indoor food and non

- food use sanitizers

WWTP microorganisms Uptake or sorption

Population Respiration
inhibition Waste Water Disposal Down

- the

- Drain

Surface Water

Sediment

### Page 25 of 63 Figure 2

– Conceptual Model for Ecological Exposure and Effects of Sodium Dodecyl Sulfonate and its Reaction Products/Degradates from Antimicrobial Fruit and Vegetable
Washes and Food Contact Sanitizer



### 4.2.1 Mechanism of Action

ABS are surface

- active substances and interact with the lipid

- bilayer membrane of livi ng cells in the same way they facilitate phase mixing and micelle formation (Singer et al ., 1994).

For aquatic organisms the destabilization of cell membranes and resulting altered membrane permeability and lysis lead to interrupted cellular respiration an d asphxyation. In a fish early life

stage study, embryo mortality was due to rupture of the embryonic membrane (Singer et al

., 1993). The agency does not anticipate the need to conduct a quantitative ecological risk assessment for alkylbenzene sulfonates. The registered use pattern as a food and non

- food contact sanitizer and a fruit and vegetable wash is expected to result in minor or insignificant amounts reaching surface waters due to rapid biodegradation of the chemicals.



### 4.2.2 Measures of Effect (Ecotoxicolo gy Endpoints)

Current selected ecotoxicological endpoints for conducting the risk assessment are provided in
Table 13 . All available ecotoxicity endpoints from studies submitted by registrants are tabulated separately for each alkylbenzene sulfonate in Appendix D

Stressor

Source

Receptors and Exposure

Routes

Attribute Change(s) Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae Reduction in prey

Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity
Reduced cover Community change
Modification of PCEs related to
habitat Aquatic Animals

Invertebrates
Vertebrates Exposure
Media

Ingestion Ingestion Uptake/gills
or integument

Aquatic Plants

Non

- vascular
Vascular Uptake or sorption by

cells, roots, leaves,

Piscivorous*

Invertebrates
Vertebrates Phytoplanktivore/

Herbivore
Invertebrates

Vertebrates

*As used here this term refers to animals (terrestrial or aquatic) that eat not just fish but any aquatic animal ( e.g ., amphibians, mollusks, crustaceans, etc .) Ingestion Waste Water Treatment Plant (WWTP)

Key Most likely

exposure pathway contributing to risk
Low likelihood of contributing to risk Antimicrobials Fruit and Vegetable Washes and Food Contact Sanitizer

WWTP microorganisms Uptake or sorption

Population Respiration
inhibition Waste Water Disposal Down

- the

- Drain

Surface Water

Sediment

### Page 26 of 63 Table 13

– Existing Effects Endpoints for Risk Assessment of ABS

Receptor Group Test Material Surrogate Species Risk
Scenario Toxicity Endpoint Reference

Avian LAS 87.6% Northern Bobwhite ( Colinus virginianus ) Acute LC 50 > 1382 mg/L (LAS) 41143901 Supplemental

Freshwater
Fish Sodium alkylbenzene sulfonate (ABS) 70%, Sodium laurylbenzene sulfonate (LAS)
65% Rainbow Trout ( Oncorhyncus mykiss ) Acute 96

- h LC 50 = 1.68 mg/L (LAS) 44260009 Supplemental 96

- h LC 50 = 10.8 mg/L (ABS)

LAS 14% Fathead Minnow ( Oncorhynchus mykiss ) Acute 96

- h LC 50 = 3.4 mg/L 44260002 Supplemental

Benzenesulfonic acid, C10

- 13

- alkyl derivatives (85536

- 14

- 7) as a surrogate for benzene sulfonic acid, C10

- 16

- alkyl derivatives (190116) Carp ( Cyprinus carpio ) Acute 96

- h LC 50 = 5.6 mg/L HPV cited Kurtin 1997; OECD 1984 (reliability: 1

- valid without restriction) 7

n

- dodecylbenzene sulfonate as a surrogate for dodecylbenzene sulfonic acid (098002) Ide ( Leuciscus
idus ) Acute 96

- h LC 50 = 4.1 mg/L HPV cited Knie et al . 1983 (reliability:

1

– valid without restriction) 8

7 Only studies with the highest level of reliability were listed in this table. The Klimisch et al . (1997) scoring system is used to categorize the reliability of HPV studies as follows: 1 = reliable without restrictions: “studies or data...generated according to generally valid and/or internationally accepted testing guidelines (preferably perf ormed according to GLP) or in which the test parameters documented are based on a specific (national) testing guideline...or in which all parameters described are closely related/comparable to a guideline method.”
2 = reliable with restrictions: “studies or data...(mostly not performed according to GLP), in which the test parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data or in which investigations are described which cannot be subsumed un der a testing guideline, but which are nevertheless well documented and scientifically acceptable.” 3 = not reliable: “studies or data...in which there were interferences between the measuring system and the test substance or in which organisms/test syste ms were used which are not relevant in relation to the exposure ( e.g. , unphysiologic pathways of application) or which were carried out or generated according to a method which is not acceptable, the documentation of which is not sufficient for assessment and which is not convincing for an expert judgment.” 4 = not assignable: “studies or data....which do not give sufficient experimental details and which are only listed in short abstracts or secondary literature (books, reviews, etc. ).

8 Ibid.

### Page 27 of 63 Receptor Group Test Material Surrogate Species Risk
Scenario Toxicity Endpoint Reference

Freshwater
Invertebrates LAS 65.0% C11, C12 Waterflea ( Daphnia

magna ) Acute EC 50 : LAS

- C10 = 29.5 mg/L
LAS

- C12 = 6.84 mg/L
LAS

- C14 = 0.80 mg/L

LAS

- C16 = 0.20 mg/L 47025025 Supplemental

Benzenesulfonic acid, C10

- 13

- alkyl derivatives (85536

- 14

- 7) as a surrogate for benzene sulfonic acid, C10

- 16

- alkyl derivatives (190116) Waterflea ( Daphnia

magna ) Acute 48

- h EC 50 = 5.2 mg/L Kurtin 1997; OECD
1984 (reliability: 1

- valid without restriction)

Dobanic acid (linear alkyl benzenesulfonic acid, C10

- 13) as a surrogate for benzene sulfonic acid, C10

- 16

- alkyl derivatives (190116) Waterflea ( Daphnia

magna ) Acute 48

- h EC 50 = 2.9 mg/L HPV Cited Stephenson 1981 (reliability: 1

– valid without restriction)

n

- dodecylbenzene sulfonate as a surrogate for dodecylbenzene sulfonic acid (098002) Waterflea ( Daphnia

magna ) Acute 24

- h EC 50 = 12 mg/L HPV cited Knie et al . 1983 (reliability:

1

– valid without restriction)

Aquatic
Plants LAS Algae ( Selenastrum capricornutum) 96

- h EC 50 = 70.27 mg/L 42439803 Supplemental

Benzenesulfonic acid, C10

- 13

- alkyl derivatives (85536

- 14

- 7) as a surrogate for benzene sulfonic acid, C10

- 16

- alkyl derivatives (190116) Algae ( Scenedesmus subspicatus ) 72

- h EC 50 = 36 mg/L HPV cited Kurtin 1994; OECD 1984 (reliability: 1

– valid without restriction)

Dobanic acid (linear alkyl benzenesulfonic acid, C10

- 13) as a surrogate for benzene sulfonic acid, C10

- 16

- alkyl derivatives (190116) Algae ( Selenastrum capricornutum) 96

- h EC 50 = 170 mg/L HPV cited Stephenson 1981 (reliability: 1

– valid without restriction)

n

- dodecylbenzene sulfonate as a surrogate for dodecylbenzene sulfonic acid (0 98002) Algae ( Haematococcus pluvialis ) 96

- h EC 50 = 50 mg/L HPV cited Knie et al . 1983 (reliability:

1

– valid without restriction)



## 4.3 Exposure Analysis Plan

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

Although there is potential for dodecylbenzene sulfonic acids and their reaction products/degradates to be released to wastewater treatment plants as a result of their use as
indoor food and non

- food use sanitizers and for sodium dodecyl sulfonate and its reaction products/degradates to be released to wastewater treatment plants as a result of use in

### Page 28 of 63 fruit/vegetable washes and food contact sanitizers, these uses are not expected to result in
exceedance of exp osures of concern based on the following factors ;

• R apid sorption to sludge (5

- 10 min equilibrium with >99% sorption) (T emmink and Klapwijk, 2004 ) which will remove ABS from the water column;

• Rapid biodegradation in activated sludge (half

- life <2 days) ((Fairchild, 1993; Larson and Payne, 1981; Temmink and Klapwijk, 2004 );

• R apid aquatic biodegradation and mineralization of alkyl groups (half

- life ) of 5.52 hours
and the benzene ring ( half

- life 17.52 hours) ( Larson and Payne, 1981 

### ) ; and

• Down the drain loads would be expected to be below levels of concern given the production volume for a ntimicrobial use is only on the order of 300,000 lbs annually , use would be widely dispersed across the nation and its territories, and there would be dilution and time for degradation to occur before reaching any WWTP 9



### .
E xceedance of levels of concern is expected to be highly unlikely for terrestrial organisms given the following factors:

• The only potential route of exposure for terrestrial organisms is from the aquatic exposure route as uses are indoors;

• ABS from antimicrobial uses are not expected to rea ch the aquatic environment or reach it in significant quantities as discussed in the preceding paragraph ;

• Exposure via the food web is highly unlikely g iven the low bioconcentration potential (BCFs <1000 see Appendix C), and the lack of significant quantit ies reaching the aquatic
environment. .



### 4.3.2 Human Health Drinking Water Exposure Estimates

As discussed in Section 4.1 and Appendix C, b ased on environmental fate data, d rinking water concentrations are expected to be limited because of lack of persistence in environmental media and sorption to soil and sediment. Therefore additional data and a drinking water assessment are not considered to be necessary at this time.



## 4.4 Effects Analysis Plan

The re are no effects data gaps for ABS.



## 4.5 Endangered Species Determinati on

Based on the ABS use patterns, their ready biodegradability, and low toxicity, the Agency anticipates the registered uses will have “no effect” on endangered or threatened terrestrial or aquatic species, or their designated critical habitats, as listed by the USFWS and the NOAA. However, the Agency will review any comments made by the public on this document and will
conduct an environmental risk assessment if new information warrants such action. An ecological risk assessment planned during registration review allows the Agency to determine whether an antimicrobial pesticide’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical

9 For examp le a conservative estimate (300000 pounds annually/356 days) (453.592E3 mg/pound) ÷ (42,225E6 gallons/day)(3.78541 liters/gallon) = 0.002 mg/L where the wastewater treatment volume of 42,225E6 is from the 1996 U.S. Census ( http://www.allcountries.org/uscen sus/391_wastewater_treatment_facilities.html ).

### Page 29 of 63 habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.



# 5 Endocrine Disruptor Screening Program ( EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurot oxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual mat uration, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its 2006 reregistration decision for ABS

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), ABS is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and
establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. ABS is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for ABS

. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our
website: http://www.epa.go v/endo/

. 

# 6 Optional Label Changes

It is recommended that the labels for all four EPA registrations for fruit and vegetable washes be updated to reflect application rates (ppm on an active ingredient basis). This information is necessary in order to conduct a dietary assessment of the fruit and vegetable wash use pattern.

### Page 3 0 of 63 

# 7 Next Steps

A DCI will be developed regarding the data needs listed under Table 9 “ Studies Anticipated as Needed for the Registration Review of ABS ” of this document. The agency expects to issue the
DCI in September 2014.

### Page 31 of 63 

# 8 References

Barid, Coli n

. Environmental Che m istry, 2 nd Edition

. W

. H. Fr ee m an and C o m pany: New York, 2003. Cavalli, L., et. al. (1993). “LAS R e moval and Bi o degradation in a W astewater T r eat ment Plant

. ”
Environ m e n tal Toxicology and Che m istry. Vol. 12. pp 1777

- 1788. EPA (U.S. Environmental Protection Agency). 2006. Assessment Plan for the Linear Alkylbenzene (LAB) Sulfonic Acids Category in Accordance with the USEPA High Production Volume Chemical Challenge Program. EPA 201

- 14485A. Office of Pollution Prevention and Toxics, U.S. Environmental Protection agency, Washington, DC. May 20, 2003 [online]. Available: http://www.epa.gov/HPV/pubs/summaries/ linalkbz/c14485tp.pdf [accessed Nov. 20, 2012]. EPA (U.S. Environmental Protection Agency). 2006. An AD Memo from Talia Milano to Heather Garvie on “Environmental Fate Assessment of Alkylbenzene Sulfonates for the Registration Eligibility Decision (RED), July, 2006.” EPA (U.S. Environmental Protection Agency). 2006. An AD Memo from Richard Petrie to Jennifer Slotnick on “Ecological Hazard and Envi ronmental Risk Assessment of alkylbenzene sulfonates for Regitration Eligiblity Document (RED), January, 2006.” EPA (U.S. Environmental Protection Agency). 2006. AD Memo from Robert Quick to Heather Garvie on “Dietary risk assessment for alkylbenzene sulfo nates, March, 2006.” EPA (U.S. Environmental Protection Agency). 2006. Reregistration Eligibility Decision for Alkylbenzene
Sulfonates. 

### European Oilfield Speciality Chemicals Association. 2000. Summary Report Surfactant Bioaccumulation Review Project. 106 pp. http://www.eosca.eu/wp

content/uploads/Surfactants

- Report.pdf Fairchild, Ja mes F, et. al. (1993). E valuat i on of a Laboratory

- Generated OEC For L i near Alkylbenzene
Sulfonate in Outdoor Experi mental Strea m s. Environ m ental Toxicology and Ch e m istry. Vol. 12.

pp 1763

- 1776.


### Federle TW and NR Itrich (1997), Comprehensive approach for assessing the kinetics of primary and ultimate biodegradation of chemicals in activated sludge: application to LAS,
Environ. Sci. Technol. 31: 1178

- 1184. FDA (U.S. Food and Drug Administration). “Sanitizing Solutions: Ch emistry Guidelines for Food Additive Petitions”. Version 1.1; January 1993.Geneva, 1996 http://inchem.org/docu m ents/ehc/ehc/ehc169.ht m

. 

### Huddleston,RL, and Allred, RC. 1963. Microbial oxidation of sulfonated alkylbenzenes

. Dev.Ind. Microbiol., vol.4, pp24

- 38

International Progra mme on Ch e mical Safety, Environ me n tal Health C r iteria 169, Linear Alkylbenzene
Sulfonates and Related C o m pound s

. W orld Health Organization. Jacobsen, A nne Marie, Gerda Krog Mortensen, and Hans Christian Bruun Hansen. (2004). “Degradation
and Mobility of Linear Alkylbenzene Sulfonate and Nonylphenol in Sludge

- A m ended Soil.”

Jo u r nal of Environ m ental Quality. Vol 33. pp. 232

- 240. Kuhnt, Gerald. (1993). “Behavior and Fate of Surfactants in Soil.” Enviro n m ental Toxicology and
Che m istry. Vol. 12. pp 1813

- 1820. 

### Kwok, T.K. 2011. Assessing the effect of surfactants on activated sludge processes using sequencing batch reactors

. Master’s Thesis Environmental Engineering, School of Civil, Environmental and Chemical Engineering, RMIT University. 111 pp. http://researchbank.rmit.edu.au/eserv/rmit:11997/Kwok.pdf Larson, RJ, and Payne, AG. 1981. Fate of the Benzene Ring of Linear Alkylbenzene Sulfonate in
Natural Waters. Applied Environ. Microbiol ., vol. 41(3), pp 621

- 627 Painter, H. A. (1986) Testing the toxicity of chemicals by the inhibition of respiration of activated sludge. Toxicity Assessment 1:515

- 524.

### Page 32 of 63 Swisher, RD, 1987. Surfactant Biodegradation, second edition, Surfactant Scienc e Series Vol.18, Marcel Dekker, Inc. New York, NY Schoerl, P, 1989. Basic Principles of LAS Biodegradation, Tenside Surfactant Detergents, 26, pp
86

- 94

. The Esti m ation Progra m s Interface (EPI) Suite. W i ndows based suite of physical/che m i cal properties and
environ m ental esti m ation m odels developed by the US EPA’s Office o f Prevention, Pesticides,
and Toxic Substances ( O PPTS) and Syracuse Re s earch Instit u te (SRC). http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm 

### Temmink, H.and B. Klapwijk. 2004. Fate of linear alkylbenzene sulfonate (LAS) in activated sludge plants. Water Research 38:903

- 912. Singer MM, George S, Jacobson S, Lee I, Tjeerdema RS, Sowby ML (19 93) Comparative toxicity of two oil dispersants to the early life stages of two marine species. Environ Toxicol Chem 12:1855

- 1863. Singer MM, George S, Jacobson S, Lee I, Tjeerdema RS, Sowby ML (1994) Comparative effects of oil dispersants to the early lif e stages of topsmelt (Atherinops affinis) and kelp (Macrocystis pyrifera). Environ Toxicol Chem 13:649

- 655

### Page 33 of 63 

# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

Table 14

– Acute Toxicity Studies for ABS

Guideline/Study Type MRID No. Results Toxicity Category
870.110 Acute oral Multiple LD 50 = range from 404 to over 5000 mg/kg III

- IV
870.1200 Acute Dermal 94032006 LC 50 = 1200 mg/kg II
870.1300 Acute Inhalation 003442* LC 50 = 200 mg/L IV 870.2400 Acute Eye 003444* I
870.2600 Dermal irritation 003444* Severe Irritation at 72 hours II
870.2600 Skin Sensitization Open literature+ Weak to moderate sensitization

---


### * Tox record No. + Nusair, T.L. (1988) Consumer Products: Risk Assessment process for Contact Sensitization, Toxicologist 8:258. (HERA) 

## Subchronic Toxicity

Adequacy of data b ase for subchronic toxicity : The data base for subchronic toxicity is considered complete. No additional studies are expected to be required at this time. The major reviews by the WHO (1996), and HERA (2004) report and/or summarize many subchronic
studies via the oral (gavage, feed, and drinking water), dermal, and inhalation routes. Only the
critical studies or ones for which OPP has developed DERs over the years are summarized here.

870.3100 90

- Day Oral Toxicity

– Rat
LAS was administered for 2, 4, and 12 weeks to male rats (5/group) at a single dose of 1.5% in the diet (750 mg/kg bw/day). LAS suppressed body weight gain, and the relative liver weight
was increased after 2 weeks of LAS administration. Serum biochemical examinations revealed significant increases in ALP and GTP at each observation period and significant decreases in cholesterol and protein in 4 weeks. Enzymatic examinations of the liver revealed decreases in
G6Pase and G6PDH and an increase in isocitrate dehydrogenase (IDH) at each observation period. Enzymatic examinations of the renal cortex revealed decreases in G6Pase and 5'

- nucleotidase at each observation period, an increase in LDH at 12 weeks, and an increase in IDH at 2 and 4 weeks. Enzymatic exami nations in the renal medulla revealed a decrease in Na, ATPase, and an increase in LDH at 12 weeks, a decrease in IDH at 2 weeks, and an increase in IDH at 12 weeks (Ikawa et al .1978; as cited in HERA, 2004).

In another study (MRID No. 43498412; Kay et al . (1965) as cited in HERA, 2004), LAS (87.9% purity) was administered in the diet at dietary levels of 0, 200, 1000, and 5000 ppm for 90 days to weanling Sprague

- Dawley Rat (10/sex/dose).

Body weight and food consumption was measured pretest and weekly on all animals and hematology and urine analysis were done on 5/sex/group at days 0, 30, 60, and 90. Clinical chemistry measurements were not performed. All animals were sacrificed by ether inhalation and subject to gross necropsy. Weights of liver, kidneys, spleen, gonads, heart and brain were taken and absolute and relative (both body and brain) organ weights were calculated. Histopathology was performed on 5/sex from control and high dose and 3/sex from low and mid dose animals

### Page 34 of 63 from 25 organs and tissues. Required tissues not examined were aorta, eyes, cecum, skin, trachea, sciatic nerve, esophagus, rectum, thymus, mammary gland, epididymis, spinal cord, and salivary glands. Two low dose males died early in the study from respiratory illness There was

no co mpound

- related effects in body weight, food consumption, hematology, urine analysis, organ weight, and histopathology.
Core Classification: ACCEPTABLE/ Guideline.

870.3150 90

- Day Oral Toxicity

– Monkey, MRID 43498413 Groups of 3 male and 3 female Rhesus mo nkeys 18

- 36 months old and weighing 2.0

- 4.4 kg, were treated simultaneously with SDDBS (LAS) in distilled water at doses of 0 (controls), 30 mg/kg (oral) + 0.3. mg/kg (subcutaneous), 150 mg/kg (oral) + 0.5 mg/kg (subcutaneous) and 300 mg/kg (oral) + 1 mg/m g (subcutaneous) for 28 days (MRID 43498413). Parameters measured were body weight, ophthalmoscopy, hematology, clinical chemistries, urinalysis, necropsy, organ weights, and histopathology. NOEL is 30 mg/kg (p0) + 0.1mg/kg (sc). Effects seen in the high d ose were emesis (vomiting) and liquid feces. Liquid feces were also seen in the mid dose. All treated animals had fibrosis at the subcutaneous injection site, but this was not included in
the determination of a NOEL. Both oral and subcutaneous administration of the chemical are used in this study.
Core Classificataion Not Acceptable/non

- guideline . Both oral and subcutaneous administration of the test substance were administered simultaneously.

870.3200 21/28

- Day Dermal Toxicity

– Rat
Mathur et al . (1992). J Toxicol Cutan Ocular Toxicol, 11(1): 3

- 13 (as cited in WHO 1996). A solution of LAS in distilled water equivalent to 60 mg/kg bw was applied to a 4

- cm 2 

### area of clipped dorsal skin daily of 12 Guinea Pigs for 30 days. The activities of β

- glucu ronidase,

gamma

- glutamyl transpeptidase, 5

- nucleotidase, and sorbitol dehydrogenase were increased in liver and kidney. Lipid peroxidation was increased in the kidney but not in liver, and the glutathione content was unchanged in both organs. Extensive fa tty changes were found in hepatic lobules, with dilation of sinusoids; tubular lesions were found in the kidney, predominantly in the proximal and distal portions.
Core Classification: ACCEPTABLE

870.3465 90 Day I nhalation Toxicity ; MRID 43498403

In a subc hronic inhalation toxicity study in monkeys (MRID 43498403), groups of 5 male and 4 female cynomolgous monkeys, 1.6 to 3.7 kg, were randomly divided into 12 nominal groups (mg/m 3 

### )

- control, detergent (D), enzyme (E), or both at levels at 0, l00(D) and 0.0 01(E), 0.01(E), 0.1(E) and 1(E)) together with [ 0, 1(D), 10(D), and 100(D)] for 6 hours daily, 5 days a week for 6 month. Particle analysis and gravimetric determinations showed particle size to have a MMD and gravimetric concentrations to be slightly hig her than nominal. The detergent formulation
contained 13% C 12 

### linear alkylbenzene sulfonate (the remaining major ingredients were sodium tripolyphosphate [39%]; sodium sulfate [40%]; and sodium silicate [7%]).
Core Classification: UNACCEPTABLE/ nonguideline

The inhalation study upon further review was found unacceptable because the formulation used
13% a lkylbenzene s ulfonate in addition to the presence of enzymes. The sponsor submitted a

### Page 35 of 63 waiver was then denied. Therefore, a 90

- day nose only rat inhalation st udy using DDBSA (Guideline 870.3465) is expected to be required (Tao, J. memo, 2/7/12).



## Developmental Toxicity

Adequacy of data base for Prenatal Developmental Toxicity : The data base for prenatal developmental toxicity is considered complete. There are many developmental studies that have
been identified and reviewed in the WHO and HERA documents. No additional studies are expected to be required at this time.

870.3700a Prenatal Developmental Toxicity Study

– Rat Teratology

- rat, mouse, rabbit, MRID 434 98426 (“Palmer Part I”). Randomized groups of 20 CD

- 1 pregnant mice, 20 CD rats, and 13 NZW rabbits were housed individually and fed appropriate diets ad libitum. Day 0 of gestation was judged by a vaginal plug in rats and mice and coitus in rabbits. Dosin g began on day 6 and continued daily up to day 15 for mice and rats and day 18 for rabbits. The test material was supplied by Lion fat and Oil Co., Led, Tokyo. Doses were 0, 0.2, 2.0, 300 and 600 mg/kg BW. Animals were observed daily and weighed regularly. At termination (Days 17, 20, and 29 for mice, rats, and rabbits), the uteri were immediately dissected and contents examined to determine implantations, viable young, embryonic deaths (abortion or resorption sites). Ovaries were examined and the number of corpora lutea counted for rats and rabbits. Fetuses were weighed and externally examined for abnormalities. With rabbits, the fetuses were immediately dissected and examined for visceral abnormalities. Sex was determined by gonadal inspection and carcasses preserved in alcohol for subsequent clearing, staining with alizarin, and skeletal examination. With mice and rats, following weighing and external examination, one third were fixed in Baum’s solution for free hand sectioning for visceral abnormalities and the remaining two

- thirds fixed in alcohol, cleared, stained with alizarin and examined skeletally.

In assessing results, group means were calculated from the individual litter data in two ways. Mean A: includes all surviving ani mals showing evidence of implantation, including those with 12 of 42 total litter loss. Mean B: includes only animals bearing viable young at termination. Mean B has more meaning when only the occasional animal shows total litter loss and Mean A provides a better index when several animals show total litter loss.

Generally, maternal toxicity ranked rabbits > mice > rats. In all species tested, toxic reactions involved a disturbance of the gastrointestinal tract. Affected rabbits showed diarrhea, anorexia, weight loss and cachexia prior to death. Total litter loss (abortion and/or total resorptions) tended to occur as a result of maternal toxicity. The NOEL for maternal effects is 2.0 mg/kg for rabbits and mice, and 300mg/kg for rats. At doses at or below th e NOEL, values for litter size and fetal loss were comparable to controls.

The NOEL for developmental toxicity is 2.0 mg/kg/day in mice, 300 mg/kg/day in rats, and 2.0mg/kg/day in rabbits. Although the identity of the malformations and anomalies was not

s pecified in the report, there was no apparent increase in numbers of malformation at any dose in mice, rats and rabbits. Additionally, mice at the maternally toxic dose of 300 mg/kg/day had increases in the percent of minor visceral and skeletal anomalies. Similarly, in rats, at the maternally toxic dose of 600 mg/kg/day, there was an increase in minor visceral anomalies.

### Page 36 of 63 Core Classification: ACCEPTABLE

Dermal Developmental Toxicity

— Rat, Rabbit, Mouse MRID: 43511403. (Palmer Part III).
The surfactant lin ear alkylbenzene Sulfonate (LAS) was examined for embryotoxic and teratogenic potential following percutaneous administration (MRID 43511403). Solutions containing, 0.03, 0.3 or 3% LAS were applied to shaved skin during pregnancy days 2

- 13 in mice, 2

- 15 in rats and 1

- 16 in rabbits. Dosages employed were 0.5 mg/rat or mouse/day and 10 mg/rabbit/day. For comparison, further groups of rats and mice were similarly treated with concentrations of 0.3, 3 and 30% of a standard soap solution.

Marked local skin reac tion, irritability, weight loss and failure to maintain or establish pregnancy was evident in mice treated with LAS 3% soap, 3 or 30%: marked local reaction and weight loss also occurred in rabbits receiving LAS 3%. Moderate maternal toxicity was observed among mice treated with LAS, 0.3% and mild maternal toxicity in rats receiving LAS 3% or soap 30% and rabbits receiving LAS 0.3%.

Effects on litter parameters were generally restricted to dosages causing marked maternal toxicity in mice, the principal ef fects being higher fetal loss (with consequent reduction in viable litter size) arising from an increased incidence of total litter losses. Although LAS at 3% was considered to show marked maternal toxicity in the rabbit, the slightly higher fetal loss and lower litter size did not differ significantly from control values.

The moderate maternal toxicity of LAS, 0.3% in the mouse correlated with a higher incidence of embryonic deaths and lower litter size but only the former differed significantly from the corresponding control value.

The incidences of major malformations, minor visceral or skeletal anomalies, and skeletal variants provided no conclusive evidence of specific teratogenicity even at maternally toxic dosages.

The LOEL for maternal toxicity was 0.3% (50.0 mg/kg/day), 3.0% (60.0 mg/kg/day) and 0.3% (9.0 mg/kg/day) LAS in mice, rats and rabbits, respectively. The NOEL for maternal toxicity was 0.03% (5.0 mg/kg/day): 0.3% (6.0 mg/kg/day) and 0.03% (0.9 mg/kg/day) LAS in mice, rats and rabbits, r espectively. The LOEL for developmental toxicity was 0.3% (50.0 mg/kg/day), 3.0% (60.0 mg/kg/day) and 3.0% (90.0 mg/kg/day), respectively. The NOEL for developmental toxicity was 0.03% (5.0 mg/kg/day), 0.3% (6.0 mg/kg/day) and 0.3% (9.0 mg/kg/day),
respect ively.
Core Classification: The study is supplementary and satisfies the guideline requirement for a
series 83

- 3 developmental (dermal) toxicity study.

Mouse

- Developmental In a mouse developmental toxicity study (MRID 43498424 & 43498425), virgin female I CR/Jc1 mice, 9

- 10 weeks old, and weighing 30

- 32 grams, were used. Mice were maintained on mouse
diet CA

- 1 and tap water ad libitum . The mice were exposed to light to induce ovulation and were mated with breeder males. The presence of a vaginal plug indicat ed day 0. On day 0, the mother’s hair was plucked from a 2 x 3 cm area of the dorso

- thoracic skin and 0.1 ml of 20%

### Page 37 of 63 aqueous LAS was applied to the skin twice a day from day 0 to day 3. The mice were sacrificed on day 3 and oviducts and uterus removed.

Em bryos were flushed from the oviducts and uterus with Whitten medium. After examination, the embryos were then. cultivated at 37 o 

### C in medium equilibrated with a 5% carbon dioxide, 5% oxygen, and 90% nitrogen gas mixture.

A 2.0% dermally applied dose of LAS retarded development and interrupted cleavage of eggs. Significantly higher numbers of embryos were found to be deformed in the LAS group in comparison to controls, and most of these embryos were in the morula stage, whereas they were mostly in the late b lastocyst stage in controls.
Core Classification: ACCEPTABLE



## Reproductive Toxicity

Adequacy of data base for Reproductive Toxicity : The data base for reproductive toxicity is considered complete. No additional studies are expected to be required at this time.

870.3800 Reproduction and Fertility Effects

– Rat; MRID 43498416

In a reproduction study with rats (MRID 43498416), randomized groups of 20/sex/dose weanling Charles River CD rats (the P 0 

### parental animals) were fed test diets containing 0, 0.02, 0. 1, and 0.5% LAS (equivalent to 0, 10, 50, and 250 mg/kg/day) for 84 days (at which time they were 107

- 112 days old). Rats from each dose group were mated (1:1), litters allowed to be delivered, pups counted (F 1a 

### ), and examined, culled to 8/litter on day 4, and sacrificed at day 21 of lactation. Pups of the F 1a 

### and F 2a 

### litters were both sacrificed after day 21 of lactation. Ten days later, the rats were again mated to produce the F 1b 

### litters. 20/sex/dose of F 1b 

### weanlings were selected to generate the P 1 

### an d P 2 

### parental animals for generating the F 2a 

### , F 2b, 

### F 3a 

### and F 3b 

### litters.

Food consumption, body weight, and food efficiency were recorded weekly for the first 8 weeks.
Five male and 5 female rats from the F 1b 

### and F 2b 

### parental groups and F 3b 

### pups were selec ted for necropsy. Body weight, organ weights, hematology, and histology were performed. General reproduction including fertility, gestation, parturition, neonatal viability, lactation, and
post

- weanling growth were comparable for control and test groups a nd no gross abnormalities were found. There were comparable results in body weight, food consumption, hematology and organ weight findings between control and treated animals. The only significant finding in hematology, was in the 0.5% F 2b 

### females, whose R BCs count was depressed significantly (15.4%) but was within the range of historical control data. The only histologic lesion of possible significance, for which the data were not presented, was a pancreatic lesion seen in F 2b 

### males. This lesion usually co nsisted of acinar atrophy and degeneration accompanied by a fibrous tissue replacement. There were also indications of mild islet cell hyperplasia. There appeared to be an increased incidence of the general lesion in animals fed 0.5% LAS.

The NOEL is 0.1% or 1000 ppm for reproductive toxicity and 5000 ppm (HDT) for systemic toxicity. Based on the reported findings, the LEL is considered to be 0.5%. due to

### Page 38 of 63 histopathology, hematology, and the occasional slightly decreased day 21 body weights in female pups.
Core Classification: ACCEPTABLE



## Chronic Toxicity

Adequacy of data base for chronic toxicity : The data base for chronic toxicity is considered complete. No additional studies are expected to be required at this time.

ABS was administered to male/female rats for 9 months in drinking water, at doses of 0.07%, 0.2% and 0.6% (85, 145, 430 mg/kg bw/day) (Yoneyama et al .,1976 as cited in HERA, 2004).

Control groups were used. Hematological examination revealed no significant ch anges in any experimental group and no organ weight changes were observed. Body weight gain was suppressed in the males of the highest dose group and also serum

- biochemical and enzymatic parameters of the liver and kidney were affected. A significant decre ase in renal Na, K

- ATPase was seen in the group given 145 mg/kg bw/day of LAS. The NOAEL is 85 mg/kg bw/day and the LOAEL is 145 mg/kg bw/day.

Groups of 8 or 9 male/females mice were given diets containing LAS at concentrations of 0.6 and 1.8% (correspond ing to 500 and 1000 mg/kg bw/day) or drinking water containing LAS at concentrations of 0.07%, 0.2% and 0.6% for 9 months (corresponding to 100, 250, 600 mg/kg bw/day for males and to 100, 250, 900 mg/kg bw/day for females) (Yoneyama et al ., 1976 as
cited in HERA, 2004). Control groups were used.

In the mice given 500 mg/kg bw/day via the food, body weight gain was not suppressed, but the weight of the liver increased in male and female mice. Enzymatic examinations revealed significant decreases in LDH of the liver and in acid phosphatase of the kidneys in the male mice. Thus, there was no NOAEL in this study since these effects were seen at the lowest dose of 500 mg/kg/day.

In the drinking water study, body weight was depressed at the highest dose for ma le and females, increase in liver weight in females and significant decreases in renal Na, K

- ATPase resulted in a LOAEL of 600 mg/kg/d (males) and 900 mg/kg/d (females) with a NOAEL of 250 mg/kg bw/day.

In a third study by the same authors (Yoneyama et al ., 1972 as cited in HERA, 2004), 10 rats/sex/dose were given the following doses of LAS in feed: 0, 0.07%, 0.2%, 0.6%, and 1.8% (equivalent to 0, 40, 115, 340, and 1030 mg/kg/d). The following effects were observed: diarrhea (high dose group only), suppres sed growth (340 and 1030 mg/kg/d dose groups), increases cecum weight (all dose groups above 40 mg/kg/d), and renal tubular degeneration (all dose groups above 40 mg/kg/d). Thus, the NOAEL is 40 mg/kg/d with a LOAEL of 115 mg/kg/d for increased cecum weigh t and slight degeneration of renal tubules.

### Page 39 of 63 

## Carcinogenicity

Adequacy of data base for Carcinogenicity : The data base for carcinogenicity is considered complete. No additional studies are expected to be required at this time.

870.4200a Carcinogenicity Study

– rat ; MRID s: 43498420 and 43498419

Takahasi (MRID 43498420) performed an experiment to assess the ability of SDDBS to affect the induction of gastric tumors by 4

- NQO ( 4

- Nitroquinoline

- 1

- Oxide ) in male Wistar rats. Sixty

four male rats of the Motoyan ia strain and 97 male Wistar rats were used in the study under the following regimen:

Group I (79 rats): 1 mg 4

- NQO and 80 mg SDDBS (sodium dodecylbenzene sulfonate) 2

- 3 times per week for 18 weeks

Group 1’ (17 rats): same as Group I, but fasted 12 hours prior to dosing

Group II (37 rats): 4

- NQO only as per Group ‘ 1

Group III (28 rats): SDDBS only as per Group I

The experiment lasted 560 days and all rats dying on study or terminally sacrificed, were necropsied and examined histologically for gastrointest inal tumors. In Groups I and I‘, the presence of SDDBS

- shifts the incidence of benign papillomas to malignant papillomas of the
forestomach and the incidence of adenocarcinoma and sarcoma of the stomach were increased in comparison to Group II with only 4

- NQO. The administration of SDDBS by itself has no effect. on gastric tumors (Group III). The study authors concluded .that the increased carcinogenicity produced by SDDBS was due to the better uptake of 4

- NQO via LAS’S surfactive/detersive
effects on the protective mucous barrier which is normally found in the glandular stomach and other gastric compartments of the rat. The effect of SDDBS was physical rather than chemical in promoting the increased tumorigenicity.

In a similar study by the same investiga tors, (Takahasi, MRID 43498419) Motoyama male rats were divided into three groups and gavaged with the following regimen;

Group I (37 rats): 1 mg 4

- NQO + 80 mg SDDBS + 20 mg ethanol in a 1 ml gavage for 18 weeks.

Group II (13 rats): 4

- NQO and ethanol for 1 8 weeks.

Group III (13 rats): SDDBS + ethanol for 18 weeks.

Again, the experiment lasted 560 days and all rats, dying on study or terminally sacrificed, were necropsied and examined histologically for gastrointestinal tumors.

Survival : Mortality was 59% i n Group I, 31% in Group II and 23% in Group III.

Tumors :
Group III

- no gastric tumors

Group II

- 9 benign papillomas of forestomach

Group 1

- 8 benign papillomas of forestomach, 2 malignant papillomas of forestomach, 1 hemangiosarcoma of forestomach. In glandular stomach, 2 adenocarcinomas, 1

### Page 40 of 63 hemangiosarcoma, 1 hemangioma, 5 squamous cell carcinomas and 2 rats exhibited atrophic gastritis.

The increased toxicity in Group I produced increased mortality and increased numbers of malignant tumors. The role of SDDBS in the tumorigenesis of 4 NQO was to promote increased absorption o 4 NQO through the forestomach and glandular stomach.

Core Classification : ACCEPTABLE /Non

- guideline

Carcinogenicity Study

– rat ; MRID No. 43498416

Randomized groups of 50/sex/group weanling Charles River CD rats were fed diets for 24 months containing 0, 0.02, 0.1 and 0.5% LAS (200, 1000, and 5000 ppm, estimated to be 10, 50, and 250 mg/kg/day). Animals were housed individually and observed daily. Body

- weight and food consumption wa s measured weekly for 12 weeks then

- monthly. Interim sacrifices were performed on 5/sex/group at B and 15 months. Hematology was performed (RBCs, differential, WBC, hematocrit). Tail blood was collected from 5/sex/group for hematology at 4, 11, 15, and
21 months. All animals killed at interim sacrifice, died on study, or terminally sacrificed were necropsied and representative tissues were fixed in 10% Bouin and processed for H & E. The following tissues were examined: liver, kidney, thyroid, trachea, esop hagus, lungs, heart, spleen, pancreas, adrenal, stomach, small

- intestine, urinary bladder, gonads, mesenteric lymph nodes, and gross lesions. Liver and kidneys

- were weighed and relative organ weights calculated. The carcinogenic aspects of the study are co nsidered negative at 5000 ppm (HDT), which is less than the MTD since no toxicity was observed. However, it should be considered that the HDT is
about 25% of the LD 50 

### dose for SDDBS.

According to the report, overall survival exceeded 56% with the highest r ate (68%) occurring in animals on 0.5% test diet as compared with 53% in controls. There were no treatment related findings in hematology, histopathology or tumor results. Chronic interstitial nephritis and adrenal telangiectasis were the most commonly observed degenerative conditions. The majority of tumors were subcutaneous fibroadenomas. No data were presented to substantiate these

statements.

Core Classification: ACCEPTABLE /guideline 

## Mutagenicity

Adequacy of data base for Mutagenicity : The data base for Mutagenicity is considered adequate.
No additional studies are expected to be required at this time.

Gene Mutation

Guideline 870.5100 , S tudy type: Gene Mutation

- bacterial
MRID No. 43498429 Classification: Literature, acc eptable

Negative at cytotoxic levels or limit concentrations (both with and without S

- 9 metabolic activation) when tested with Salmonella typhimurium

- TA 98 and TA 100 strains.

Cytogenetics

### Page 41 of 63 Guideline 870.5385 , S tudy type: Structural Chromosomal Aberrat ions
MRID No. 43498428 Classification: Literature, acceptable

LAS were administered to rats in the diet for 90

- days at doses of 0, 280, or 565 mg/kg/d. All test preparations were negative for increased chromosomal damage over controls.

Other Genotoxicity

Guideline 870.5300 , S tudy type: In Vitro cell transformation
MRID No. 43498429 Classification,: Literature, acceptable

LAS tested negative in Syrian Hamster Ovary (SHE) cells at up to 50 micrograms/plate.

4.8 Neurotoxicity

In the available literature there was no toxicological information to indicate that this chemical
had a neurotoxic effect.

4.9 Metabolism

Adequacy of data base for M etabolism : The database for metabolism is considered to be complete. No additional studies are expected to be require d at this time.

870.7485 Metabolism

– Rat; MRID 43498431

In a rat metabolism study (MRID 43498431), groups of Charles

- River CD male rats, 150

- 200 g BW, were used in the study. LAS

- 35 

### S was given orally to fasted rats at doses of 0.6, 1.2, 8, and 40 mg. Urine and feces were collected and analyzed for radioactivity. Tissues were taken for assay at the end of the study. For metabolism studies, urine, bile, or feces were pooled. The rate and distribution of the excreted dose was independent of concentration. Similar levels of radioactivity were found in urine and feces and within 3 days, 85.2%

- 96.6% of the label was recovered in the high dose rats, no detectable radioactivity was found in the carcasses after 3 days. The limit of sensitivity was 0.1% of the dose. Urinary 35 

### S was not in inorganic form and no
intact LAS

- 35 

### S was detected. Following methylation, one urinary metabolite was identified as 4

- (4’

- methylsulfophenyl) pentanoate. LAS

35 

### S in the feces remained un

- metabolized. The absorption in rats with a ligated bile duct by a single gavage dose of 1.2 mg LAS

35 

### S demonstrated that gastrointestinal absorption did not require enterohepatic circulation, since
most of the oral dose was found i n the urine (74%) and only 9% was found in feces. Recovery
was 83%.

Enterohepatic recirculation was found to be not an important factor in LAS

- 35 

### S excretion by studies in rats with cannulated bile ducts given 1.2 mg/kg of LAS

35 

### S orally. The percent of radioactivity in bile was similar to that in feces and most label was in the urine.
Core Classification: ACCEPTABLE

### Page 42 of 63 Metabolism

– Monkey; MRID No 43498410 In a monkey metabolism study (MRID No 43498410), two groups of 2 male and 2 female Rhesus monkeys, 5 kg BW, were used for the oral and subcutaneous metabolism studies (one group for each route of exposure). For the oral studies, each animal, following 2

- 3 weeks between dose levels, received single oral doses of 14 

### C (SDDBS; 25 microcuries) at levels of 30, 150, and 300 mg/kg. Blood, urine, faces and cage washing samples were taken for mass balance, metabolite identification and plasma kinetics. Following 2

- 3 weeks after the last single oral dose, each monkey received 7 consecutive daily oral doses of 30 mg/ kg/day of 14 

### C LAS . Animals were sacrificed after the last dose and tissue samples taken for direct combustion.

For the subcutaneous studies, each animal, following 2

- 3 weeks between dose levels, received single subcutaneous doses of 14 

### C LAS (SDDBS; 25 microcuries) at levels of 0.1, 0.5 and 1.0 mg/kg. Blood, urine, feces and cage washing samples were taken for mass balance, metabolite identification and plasma kinetics. Following 2

- 3 weeks after the last, single subcutaneous dose, each monkey received 7 consecutive daily subcutaneous doses of 1.0 mg/kg/day of 14 

### C LAS. Animals were sacrificed after the last dose and tissue. samples taken for direct combustion. After single 30 mg/kg doses the radioactivity was rapidly excreted, mostly during the first 24 h ours. Feces and urine contained 23.1% and 71.2%, respectively, in the first 5 days after oral dosing. After subcutaneous injection, 10.9% and 64.1% were found in the urine and feces, respectively, after the same period.

Plasma concentrations were comparab le after single oral doses of 30, 150, and 300 mg/kg at 4 hours and averaged 34, 41, and 36 μ/ml, respectively. Peak plasma concentrations increased proportional to dose after single subcutaneous injections of 0.1, 0.5, and 1 mg/kg and were 0.16, 0.72, and 1.13 μ/ml, respectively.

During the 7 day dosing period, either by oral or subcutaneous injection, there was no accumulation of radioactivity in plasma, since peak concentrations and half

- lives were similar
after the first and seventh dose. Animals sacri ficed after the seventh dose showed no localization in any of the examined tissues. In urine samples analyzed for metabolites, there was no unchanged SDDBS and the 5 metabolites detected were polar, but were not sulphate or glucuronide conjugates.
Core Cla ssification: ACCEPTABLE

870.7600 Dermal Absorption

– Rat Studies (Howes, 1975) with isolated human skin preparations as well as in vivo investigations of percutaneous administration of LAS to rats have demonstrated that penetration through skin and subseq uent systemic absorption of this surfactant does not occur to any significant extent at 24 to
48 hours. 14 

### C

- LAS was applied on the clipped dorsal skin of the rats, which was washed after 15 min. No radioactivity was detected in urine or feces.

Table 15

– Subchronic/Chronic and O ther Toxicity Studies

Guide No/Study Type MRID No./Referrence Information/study
Classification Dosing and Animal
Information Results

### Page 43 of 63 Subchronic Toxicity

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/gr oup)

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 G 6Pase, 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) 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

- D awley 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 histop athology.

870.3100
Oral Subchronic (monkeys) MRID No. 43498413 Heywood et al . (1978) Toxicology Studies of Linear Alkyl Sulfonate (LAS) in Rhesus Monkeys I.
Simultaneous Oral and
Subcutaneous Administration for 28 Days. Toxicol. Appl.
Pharmacol. 11: 245

- 250. (HERA)

Acceptable
Guideline LAS was given to four groups of three males and
three females at doses of 30, 150, 300 mg/kg bw/day per gavage (po) and simultaneously with 0.1, 0.5, or 1.0 mg/kg bw/day subcutaneously (sc). Control groups were used.

Rhesus Monkey (3/sex/dose), 18

- 36 months
old

Purity: Not Reported At 300 (po) and 1.0 (sc) mg/kg bw/day, the monkeys vomited frequently and usually
within 3 hours of administration. An increased frequency of loose or liquid faeces was recorded for
animals receiving 150 (po) and 0.5 (sc) mg/kg bw/day. These
effects are probably related to the
inherent irritative effects of LAS rather than to its systemic toxicity. Fibrosis of the injection sites was found among the entire test group, the incidence and severity being dose related. Ophthalmoscopy, laboratory examination of blood and urine, organ weight analysis
and histopathological investigation did not detect any further

treatment

- related responses. The LOAEL is 150 mg/kg bw/day (po) + 0.5 mg/kg bw/day (sc) based on an increase in

### Page 44 of 63 liquid feces and the NOAEL is 30 mg/kg/d Developmental Toxicity

870.3700a Developmental Toxicity (rodent) MRID 43498424 and
43498425 Nomura, T et al . (1980) The Synthetic Surfactants AS and LAS Interrupt Pregnancy in
Mice. Life Sciences, 26: 49

- 54. (HERA)

Nomura, T. et al . (1987) Killing of Preimplantation Mouse Embryos by AS and
LAS. Mutation Research 190:
25

- 29. (HERA)

Acceptable
Guideline LAS (0.1 ml ) was applied
at a concentration of 20%
to the dorsal skin of
pregnant mice during the

pre

- implantation period twice a day from day 0 to day 3 of pregnancy

Female ICR/Jcl Mouse,
9

- 10 weeks old

Purity: 20% Development was retarded and cleavage of eggs was interrupted. Significantly higher numbers of embryos were found to b e deformed in the LAS group in comparison to controls, and most of these embryos were in the morula stage, whereas they were mostly in the last blastocyst stage in controls.

Some dead, deformed, and growth

- retarded embryos were observed in the treated gro up. Although the authors stated that
these effects were not due to maternal toxicity since no maternal organs were affected, this statement is probably not correct in view of the high
concentration of LAS and its
irritation effects. A secondary
effect due to maternal toxicity appears much more likely.

870.3700a Developmental Toxicity (rodent) MRID 43498426
Palmer et al . (1975) Assessment of the Teratogenic Potential of Surfactants, (Part I), Toxicology 3: 91

- 106.

Acceptable
Guideline LAS was administered by gavage on days 6

- 15 of pregnancy in rats and mice and days 6

- 18 of pregnancy in rabbits at doses of 0.2, 2, 300, and 600 mg/kg bw/d

20 CD Rats, 20 CD

- 1 Mice, and 13 New Zealand
White Rabbits

Purity: 17% NOAEL (rat

- maternal): 3 00 mg/kg bw/d NOAEL (mouse

- maternal): 2.0 mg/kg bw/d (However, there is a large difference between this dose and the next highest dose of 300 mg/kg bw/d, this study does
not allow determination of a
reliable maternal NOAEL for mice)

NOAEL (rabbit

- maternal): 2.0 mg/kg b/d (However, the study
does not allow determination of reliable NOAELs, given the large difference between the
maternal no

- effects doses of 2 mg/kg bw/d and the maternal LOAEL dose (300 mg/kg bw/d)
that is also the dos e for which
effects on litters could not be determined due to the high mortality rate in parent animals)

NOAEL (rat

- developmental): 300 mg/kg bw/d NOAEL (mouse

- developmental): 2.0 mg/kg bw/d NOAEL (rabbit

-

### Page 45 of 63 developmental): 2.0 mg/kg bw/d

NOAEL (rat

- fetal): 600 mg/kg
bw/d NOAEL (mouse

- fetal): 300 mg/kg bw/d (Due to a high mortality rate of parent animals, no assessment was possible at 600 mg/kg bw/d) NOAEL (rabbit

- fetal): could
not be determined

870.3700a Developmental Toxicity (rodent) MRID 4 3511403 Palmer, et al . (1975) Assessment of the Teratogenic Potential of Surfactants, (Part III)

- Dermal Application of LAS and Soap. Huntingdon Research Centre, Huntingdon,
Great Britain. Study No.
DDBSA JV

- RP4

- 029. Toxicology 4: 171

- 181.

Acceptable
Guideline LAS was administered percutaneously to shaved skin at solutions of 0.03%, 0.3%, and 3% during pregnancy on days 2

- 13 in mice, 2

- 15 in rats, and 1

- 16 in rabbits. Dosages employed were 0.5 ml/rat or mouse/day and 10 ml/rabbit/day
CD

- 1 Mice (20/gro up), CD Rats (20/group), N2W Rabbits (13/group) Purity: 0.03%, 0.3%, and
3% LOEL (maternal toxicity, mice): 0.3% (50 mg/kg/d) LOEL (maternal toxicity, rats): 3.0% (60 mg/kg/d) LOEL (maternal toxicity, rabbits): 0.3% (9.0 mg/kg/d)

NOEL (maternal toxicity, mice): 0.03% (5.0 mg/kg/d) NOEL (maternal toxicity, rats): 0.3% (6.0 mg/kg/d) NOEL (maternal toxicity, rabbits): 0.03% ((0.9 mg/kg/d)

LOEL (developmental toxicity): 0.3% (50 mg/kg/d) LOEL (developmental toxicity): 3.0% (60 mg/kg/d) LOEL (developmental toxicity): 3.0% (90 mg/kg/d)

NOEL (developmental toxicity): 0.03% (5.0 mg/kg/d) NOEL (developmental toxicity): 0.3% (6.0 mg/kg/d) NOEL (developmental toxicity): 0.3% (9.0 mg/kg/d)

Marked local skin reaction, irritability, weight loss and
failure to maint ain or establish pregnancy was evident in mice treated with LAS 3% soap, 3 or
30%: marked local reaction and weight loss also occurred in rabbits receiving LAS 3%. Moderate maternal toxicity was observed among mice treated with LAS, 0.3% and mild
maternal toxicity in rats receiving LAS 3% or soap 30% and rabbits receiving LAS 0.3%. Effects on litter parameters were
dose

- dependent, causing marked maternal toxicity in mice, the

### Page 46 of 63 principal higher fetal loss,
reduction in viable litter size.
LAS at 3% showed marked maternal toxicity in the rabbit The moderate maternal toxicity of LAS, 0.3% in the mouse correlated with a higher incidence of embryonic deaths and lower litter size but only the former differed significantly from the corresponding control
value.

Reproduction Toxicity

870.3800 Reproduction MRID 43498416 Buehler, E., Newmann, E., and King, W. (1971) Two Year Feeding and Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS). Tox. Appl. Pharm. 18:
83

- 91. (HERA)

Acceptable
Guideline LAS was administered in the diet at doses of 0, 0.02, 0.1, and 0.5% , equivalent

to (0, 10, 50, 250 mg/kg bw/day) for 84 days.

Weanling Charles River CD Rat (20/sex/dose)

Purity: 98.1% NOAEL Parental: 250 mg/kg bw/day NOAEL Offspring: 50 mg/kg/d.

The LOAEL of 250 mg/kg/day in the offspring is due to slight (non

- significant) changes in hematology and histopathology and slight decrease in day 21 body weights.

Chronic Toxicity

870.3100
Chronic Toxicity (rodent) Yoneyama et al . (1976) Subacute Toxicity of LAS, Ann. Rep. Tokyo Metrop. Res. Lab. Public Health27(2): 105

- 112, See: IPCS, 1996. (HERA) Open Literature LAS was administered for 9 months in the drinking water at doses of 85, 145, 430 mg/kg bw/day

M/F Wistar Rat

Purity : Not Reported NOAEL: 85 mg/kg bw/d LOAEL: 145 mg/kg bw/d Haematological examination revealed no significant changes in any experimental group and

no organ weight changes were observed. Body weight gain was suppressed in the males of the highest dose group and also serum

biochemical and enzymatic parameters of the liver and kidney were affected. A significant decrease in renal Na,K

- ATPase was seen in the group given 145 mg/kg bw/day
of LAS. Carcinogenicity

870.4200a Oncogenicity (Rat) MRID 43498416 Buehler, E., Newmann, E., and King, W. (1971) Two Year Feeding and Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS). Tox. Appl. Pharm. 18:
83

- 91. (HERA)

Acceptable
Guideline LAS was administered in the diet at doses of 10, 50,
and 250 m g/kg/day for 2

years

Weanling Charles River CD Rats (50/sex/group)

Purity: Not Reported Negative at 250 mg/kg/day (HDT)

### Page 47 of 63 870.4200a Oncogenicity (Rat) MRID 43498420
Takahasi et al . (1969) Effect of Alkylbenzenesulfonate as a
Vehicle for 4

- Nitroquinoline

1

- Oxide on Gastric Carcinogenesis in Rats. GANN: 8, 241

- 261.

Acceptable
Guideline For 560 days; Group I (79 rats): 1 mg 4

- NQO and 80 mg SDDBS 2

- 3x per week for 18 weeks; Group I' (17 rats): same as Group 1, but fasted for 12 hours prior t o dosing,; Group II (37 rats): 1 mg 4

- NQO only; Group III (28 rats): 80 mg SDDBS only

97 M Wistar Rats

Purity: Not Reported In Groups I and I', the presence
of SDDBS shifts the incidence of benign papillomas to malignant papillomas of the forestomach
and the incidence of
adenocarcinoma and sarcoma of
the stomach were increased in comparison to Group II with only 4

- NQO. The administration of SDDBS by itself has no effect on gastric tumors (Group III). The study authors concluded that
the increased carc inogenicity produced by SDDBS was due to the better uptake of 4

- NQO via
LAS's surfactive/detersive effects on the protective mucous barrier which is normally found in the glandular stomach and other gastric compartments of
the rat. The effect of SDDBS

was physical rather than chemical in promoting the increased tumorigenicity. Mutagenicity

870.5385
Mammalian
bone marrow
chomosomal
aberration test MRID 43498428 J. Hope (1977) Absence of Chromosome Damage in the
Bone Marrow of Rats Fed Detergent Actives for 90 Days. Mutation Research, 56: 47

- 50.

Acceptable
Guideline SDDBS was administered in the diet for 90 days at 0, 280, and 565 mg/kg bw/d

Colworth/Wistar Weanling Rat (6/sex/dose)

Purity: Not Reported All test preparations were negative for increased chromosomal damage over
controls.

870.5100
Bacterial

reverse mutation test MRID 43498429

Inoue et al . (1980) Studies of
In Vitro Cell Transformation and Mutagenicity by
Surfactants and other Compounds, Food. Cosmet.
Toxicol 18: 289

- 296. (HERA)

Acceptable
Guideline SDDBS was tested at cytotoxic levels or limit
concentrations of 2,000

- 30,000 ug/plate for 2 days (Salmonella) or 8 days

Strain: Salmonella typhimurium

- TA 98 and
TA 100 cells and Embryonic Syrian Golden Hamster cells (SHE)

Purity: Not Repor ted Negative (both with and without
S

- 9 metabolic activation)

870.5385
Mammalian
bone marrow
chomosomal
aberration test Inoue K, et al . (1979) In vivo Cytogenetic Tests of Some Synthetic Detergents in Mice, Ann. Rep. Osaka Perfect. Inst.
Public Health 8: 17

- 24 (in Japanese), See: IPCS, 1996. (HERA)

Open Literature LAS was administered at doses of 200, 400, and 800 mg/kg bw/d by gavage for 1 and 5 days

M Mouse

Purity: Not Reported There was no significant
difference in the incidence of
chromosomal aberrations between any of the groups

### Page 48 of 63 Metabolism

870.7485
General
Metabolism MRID 43498410
Creswell et al . (1978) Toxicology Studies of Linear Alkylbenzene Sulfonate (LAS) in Rhesus Monkeys II. The Disposition of 14 C

- LAS After
Oral or Subcutaneous
Administration. Toxicology,
11: 5

- 17. Unacceptable
Not Guideline Single oral doses of 14 C

LAS (SDDBS; 25 μcuries)
were administered to each animal, following 2

- 3
weeks between dose levels, at levels of 30, 150, and 300 mg/kg. Following

2

- 3 weeks after the last single oral dose, each monkey received 7 consecutive daily oral doses of 30 mg/kg/d of

14 C

- LAS.

2 M/2 F Rhesus Monkeys

Purity: Not Reported After single 30 mg/kg doses the radioactivity was rapidly excreted, mostly during the first
24 hours. Feces and urine contained 23.1% and 71.2%, respectively, in the first 5 days after oral dosing. Plasma concentrations were comparable after the oral doses and averaged 34, 41, and 36 u/ml, respectively. Peak plasma concentrations increased proportional to the
do se and were 0.16, 0.72, 1.13 u/ml, respectively. In urine samples analyzed for metabolites, there was no unchanged SDDBS and the 5 metabolites detected were polar, but were not sulphate or glucuronide conjugates.

870.7485
General
Metabolism MRID 43498431 W. Michael (1968) Metabolism of Linear Alkylate Sulfonate and Alkyl Benzene Sulfonate. Toxicol. Appl.
Pharmacol. 12: 473

- 485.

Acceptable
Not Guideline LAS

35 S was administered orally to fasted rats at doses of 0.6, 1.2, 8, and 40

mg

Charles River CD M Ra t

Purity: Not Reported The rate and distribution of the excreted dose was independent
of concentration.

Similar levels of radioactivity
were found in urine and feces and within 3 days, 85.2%

- 96.6% of the label was
recovered.

In the high dose rats, no detectable radioactivity was
found in the carcasses after 3 days.

Following methylation, one urinary metabolite was identified
as 4

- (4'

- methylsulfophenyl)
pentanoate. 35 LAS

- S in the feces
remained unmetabolized.



### Summary of Previously Selected Toxcological Dose and Endpoints for Linear Alkytlbenzene Sulfonates

Table 16

– Endpoints to be Reevaluated Using the Most Current Acceptable Data

Summary of Toxicological Dose and Endpoints for ABS

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 No endpoint was selected. No effects are attributable to a single dose

### Page 49 of 63 (all populations)

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 gains, 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 cacum weight and slight kidney damage in a 6 month rat dietary study (Yoneyama et al 1972 Ann. Rep. Tokyo Metrop. Res.
Lab Public H ealth 24:409

- 440)

Short

- Term

Incidental Oral (1

- 30 days) Oral NOAEL = 50 mg/kg/day Residential
LOC for
MOC = 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 gains, 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)

### Page 50 of 63 plus

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

- 440)

Short, intermediate and Long

- Term Inhalation (1

- 30 days, 1

- 6 months, >6 months) Inhalation study NOAEL = 1 mg/m 3 detergent dust combined with up to 0.1 mg/m 3 enzyme dust equivalent to app. 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/m 3 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). Thi s air concentration is equivalent to approximately 1.4 mg/kg/day (a)

Cancer (oral, dermal, inhalation) No evidence of carcinogenicity in reported studies in rats done before 1980 GLPs

Dermal Endpoint Qualification 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 5 % alkylbenzene sulfonates as an inert ingredient, with the vast majority containing app 2%.

(2) no systemic toxicity was seen following repeated dermal application of 200 mg/kg/day (with an end use product)

3) no developmental toxicity concerns were seen following repeated dermal application to pregnant

mice, rats or rabbits (development effects were seen either in the presence of maternal toxicity or

at doses higher than those that caused maternal toxicity);

4. There is no residential exposure to

### Page 51 of 63 alkylbenzene sulfonates as an active ingredient, however, residential exposure from its use as an
inert ingredient in pesticide formulation is expected to be an intermediate nature ( i.e. no continuous, constant cont act, multi

- day exposure) from household products.



### Additional References

Assaad, A. Dykstra, Alkylbenzene Sulfonates (ABS) Toxicology Chapter for the Reregistration Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002.
Case No. 4006

. DP Barcode: D 327886., Doc. # EPA

- HQ

- OPP

- 2006

- 0156

- 0003.

Registration Eligibility Decision for Alkylbenzene Sulfonates , United states Environmental Protection agency, Prevention, pesticides and Toxic Substances, EPA 739

- R

- 06

- 006, July 2006.

Tao, J. Response to Waiver Request Submitted for the Alkylbenzene Sulfonates RED DCI, Feb.

### Page 52 of 63 

# Appendix B Dietary Profile

Indoor Food Use Patterns

Dodecylbenzenesulfonic acid (098002):

• 

### Beverage Processing Plant Premises

• 

### Commercial Transportation Facilities

- Feed/Food

- Empty

• 

### Dai ries/cheese processing plant equipment

• 

### Dairy farm milk handling facilities/equipment

• 

### Dairy farm milking equipment

• 

### Eating establishment

• 

### Eating establishment equipment/utensils

• 

### Egg handling rooms

• 

### Egg packing plants

• 

### Food dispensing equipment/vending machines

• 

### Food processing plant equipment

• 

### Meat processing plant equipment

• 

### Poultry processing plant equipment

• 

### Beverage Processing Plant Premises

Dodecylbenzenesulfonic acid, Sodium Salt (079010):

• 

### Commercial/institutional/industrial premises/equipment

• 

### Food processing water systems

• 

### Fruit and vegetable wash used in or on:

o 

### Artichoke

o 

### Beets

o 

### Brassica (head and stem)

o 

### Bulb vegetables

o 

### Citrus

o 

### Watercress

o 

### Cucurbit vegetables

o 

### Flavoring/spice crops

o 

### Fruiting vegetables

o 

### Grapes

o 

### Leafy vegetables

o 

### Legume vegetables

o 

### Mushrooms

o 

### Pome Fruits

o 

### Root and tuber vegetables

o 

### Small fruits

o 

### Stone fruits

o 

### Subtropical/tropical fruit

o 

### Turnips (greens)

o 

### Other miscellaneous vegetables

### Page 53 of 63 

# Appendix C Environmental Fate

Environmental Fate Properties

Except for a couple of studies, registrants have submitted studies primarily from the open literature to support uses of ABS rather than conducting their own studies. Not all open literature studies submitted have been reviewed because at the time of registration a limited data set was required. Studies that were conducted and submitted by registrants include a hydrolysis study ( MRID 40548801 and 40970701 ) and a soil leaching/adsorption/desorption study ( MRID
40655201 and 94032011 ), which have been reviewed and were found acceptable for conducting
a risk assessment. Additional o pen literature studies have been obtained by the agency. Where literature studies have not been reviewed, interim modeled values using EPI Suite version 4.1
were used. The major difference between the two actives considered in this case are the ions on
the sulfonate groups which are sodi um versus hydrogen respectively, both ionize. A summary of
the abiotic and biotic fate studies which have been submitted are summarized in Table 17 and
Table 18 , respectively. Estimated parameters using EPISuite v4.1 are provided in Table 19

.

Abiotic Parameters

Hydrolysis

A hydrolysis study ( 40548801, 40970701 and 40970701 ) was conducted with sodium dodecylbenzene sulfonate at pH 5, 7, and 9 demonstrating that it is stable.

Photodegradation in Air

The predicted extremely low vapor pressure for these actives ( Table 19 ) indicates that it is unlikely that any significant amounts of ABS will be in the atmosphere for photodegrada tion to
be of concern. Additionally, the short atmospheric half life of approximately 8 hours indicates that any atmospheric ABS would degrade rapidly by reaction with photochemically produced hydroxyl radicals in air.

Photodegradation in Water

One open li terature study was submitted for photodegradation in water (MRID 163341, Hidaka
et al . 1985)

. A half

- life of <1

- 2 days for the benzene ring and a slower rate for the alkyl chain was reported. The study has not been reviewed, and given that biodegradation i s the major dissipation pathway this was not considered a critical data requirement.

Soil Leaching/Adsorption/Desorption

One study was submitted ( MRID 40655201 and 94032011) and found to be acceptable ( Table
17 ). The results of the adsorption/desorption study indicate medium mobility of sodium dodecylbenzene sulfonate on sandy loam soil, low mobility on silty loam soil, and slight mobility
on the ot her soils. Jacobsen (2004) identified that the sorption of LAS to soil is a combination of several mechanisms and sorption to both the organic and inorganic fraction of the soil has been
demonstrated. The linear alkyl group of LAS is hydrophobic and sorbs to the non

- polar fractions

### Page 54 of 63 of the soil, such as the organic matter. However, the sulfonate group of LAS is negatively charged and hydrophilic and therefore interacts with positively charged soil components or polar groups, such as hydroxyl

- groups, minerals , or oxides

.

Table 17

- Abiotic Degradation of ABS

Parameter Test Substance Half

- lives Source/ Study Classification/
Comments Hydrolysis Sodium dodecylbenzene (LAS) [Ring

- U

- 14 C]benzene
sulfonate Stable at pH 5, 7, 9 buffers (monobasic/dibasic potassium phosphate buffers) at 25 o C MRID 40548801, 40970701
and 40970701 Korsch 1988a; Korsch 1988b, Keene, 1990, respectively Acceptable Photodegradation in

water Sodium dodecylbenzene
sulfonate Half life <1

- 2 hours for aromatic ring
Half life for the akyl group MRID 163341, Hidaka et al

. 1985/
Not reviewed Soil Leaching/ Adsorption/Desorption Sodium dodecylbenzene
sulfonate Silt Clay Loam Soil

K F 20.3 1/N (slope) 0.8560

K

oc 1400 MRID 40655201 and 94032011; Korsch and Kapostasy, 1988 and Keene,
1990/ Acceptable Silty Loam Soil

K F 13.3 1/N (slope): 0.8893

K

oc 2280 Sandy Loam Soil

K F 6.9 1/N (slope): 1.002

K

oc 390 Sandy Soil

K F 3.6 1/N (slope): 1.095

K

oc 2680 Activated sludge sorption isotherm LAS (C 12 - homologue) Batch experiments

K p = 3.21 g - 1 VSS Equilibrium achieved within 5

- 10 minutes

Pilot

- plant monitoring data Kp = 3.71 g - 1 VSS Temmink and Klapwijk,
2004 ’
Not reviewed

### Page 55 of 63 Table 18

- B iotic Degradation of ABS

Parameter Test Substance Half

- lives Source/ Study Classification/
Comments Aerobic aquatic
metabolism
162

- 4 Commercial LAS
mixture with a C 12 LAS homologue
labeled with 14 C in the benzene ring
added Half life alkyl group 0.23 days (5.52 hours)

Half life benzene ring 0.73 days (17.5 hours) Larson and Payne, 1981/ Supplemental/
Tested at 0.05 and 0.5 mg/L LAS

Biodegradation in Activated Sludge LAS (C 12 - homologue) Pilot

- scale municipal waste plant study: >99% LAS load removed by biodegradation

92

- 98% of remaining LAS
load adsorbed to sludge

Ready Biodegradation Study (OECD 301F) >60%
mineralization was achieved within 28 days and this level
was reached within a time window of 10 days Temmink and Klapwijk,
2004 /
Not reviewed

t 0.5 = 0.6

- 0.7 hours (primary)

t 0.5 = 1.3

– 1.4 hours (ultimate) Federle et al ., 1997



### Table 19

— Estimated Physical Properties

Property Structure Estimation Program LAS (CAS #25155

- 30

- 0) LAS acid (CAS #27176

- 87

- 0)

Koc (L/kg) KOCWIN v2.00 MCI method 1.238E+004 (log Koc = 4.093) 1.238E+004 (log Koc = 4.093) Melting Point MPBPVP v1.63 144.5 o C 1 177.76 o C Boiling Point MPBPVP v1.63 Note decomposition onset at

444 o C experimental data 459.93 o C

Vapor Pressure MPBPVP v1.63 2.29E

- 015 mm Hg 7.93E

- 011 mm Hg Henry’s Law
Constant HENRYWIN v3.20 6.29E

- 008 atm

- m 3 /mole 6.27E

- 008 atm

- m 3 /mole

Atmospheric
Oxidation AopWin v1.92 Hydroxyl
Radicals Reaction Half life 7.9 hrs Half life 7.846 hrs

1 

### http://www.sciencelab.com/msds.php?msdsId=9923880

2 

### http://www.sciencelab.com/msds.php?msdsId=9923881

### Page 56 of 63 Activated Sewage Sludge Sorption

An open literature study is available on sorption of LAS with activated sludge (Temmink and Klapwick, 2004). The Kd values for C 12 

### LAS was 3210 L/kg with sorption and desorption equilibria being achieved within 5

- 10 minutes. This study will be reviewed prior to the Final Work Plan to determine if this open literature study can be used to fulfill this data requirement. There is information that supports that sorption affinity decreases with increasing LAS concentration (Tolls and Sijm, 2000).

Bioconcentration

As a surface

- active substance typical models for estimating bioconcentration factors (BCFs) are not applicable. T here are techniques which can be used for such chemicals but such studies are not being required at this time because of the availability of actual bioconcentration studies in the open literature. Two studies from the open literature on the bioconcentratio n of LAS were submitted to support registration of LAS (MRID 44260006 and 44260013; Kimerle at al . 1981

and Kikuchi et al . 1978, respectively). Additional studies are available in the open literature on linear ABS. BCFs using individual linear alkyl chains from C 10



### – C 13 

### range from 1.7 to 1325 for fish, 99.1 to 4,100 for daphnia (Bishop and Maki, 1980; Tolls et al . 1994; Comotto et al ., 1979;

Kimerle et al ., 1981; Gledhill et al ., 1981) where BCF increases with increasing alkyl chain length. A BCF of 211.5 was reported for the estuarine/marine mussel, Mytilus edulis (Ekelund et
al ., 1990). These studies will be reviewed for the Final Work Plan.

B iotic Parameters

Activated Sludge Respiration Inhibition

Kwok (2011) conducted a respiration inhibition test using sodium dodecylbenzene sulfonate following ISO 8192 (1986) procedure. The IC 50 

### was reported to be greater than 20 mg/L. An earlier work by Painter (1986) with sodium dodecylbenzene sulfonate using an OECD metho d reported an activated sludge inhibition of 100 mg/L.

Aerobic Aquatic Biodegradation

Several open literature studies have been submitted by registrants to address aerobic aquatic biodegradation; in addition the Agency is aware of additional studies from the open literature. While not all the data has been reviewed by the Agency at this time to derive a final biodegradation rate for use in a risk assessment, these studies provide weight of evidence as to
the fate of C 12 

### - ABS. The biodegradation reaction for LAS starts at the terminal carbon farthest from the position of attachment of the aromatic ring to the carbon chain and proceeds to the aromatic ring, cleaving two carbons at a time. The benzene ring is not degraded until degradation of the linear alkyl s egment is completed. After the linear alkyl group is degraded the major biodegradation intermediates are sulfophenyl carboxylates (Swisher, 1987; Schoerl, 1989; Huddleston and Allred, 1963). These intermediates also degrade and mineralize into carbon
dioxi de, water and sulfate ions.

### Page 57 of 63 Based on the available open literature the linear C 12 

### - ABS are expected to readily biodegrade as summarized in the following discussion. An early work by Larson and Payne (1981), on linear ABS using water samples collected from a bove and below a municipal WWTP discharge
showed r apid degradation by the alkyl groups with a half life of 0.23 days (5.52 hours), while the same study showed that the benzene ring mineralized with a half life of 0.73 days (17.52 hours)

as indicated by the amount of radiolab eled carbon dioxide collected.

Activated Sludge Biodegradation

In an activated sludge pilot

- scale municipal waste plant monitoring study >99% of the LAS (C 12 

### - homologue) load was removed by aerobic biodegradation (Temmink and Klapwijk, 20 04). Ready Biodegradation Stud ies (OECD 301F) were also conducted and found >60% mineralization was achieved within 28 days and that this level was reached within a time window of 10 days from initiation of mineralization (Temmink and Klapwijk, 2004). This study is under review for fulfilling this data requirement, and should be complete by the Final Work
Plan.

Fate
References in
this
Section 163341 Hidaka, H.; Kubota, H.; Graetzel, M.; et al. (1985) Photodegrada tion of surfactants I; Degradation of sodium dodecylbenzene sul

- fonate in aqueous semiconductor dispersions. Nouveau Journal de Chimie 9(2):67

- 69.

40548801 Korsch , B. (1988) A Hydrolysis Study with Sodium Dodecylbenzene Sulfonate: Project
ID: 87

- 0098. Unpublished study prepared by Ricerca, Inc. 84 p.

40655201 Korsch, B.; Kapostasy, W. (1988) Asorption and Desorption of Sodium Dodecylbenzene
Sulfonate to Soils: Pro ject ID: 87

- 0115: Document No. 1710

- 87

- 0115

- EF

- 001. Unpublished study prepared by Ricerca, Inc. 76 p.

40970701 Korsch , B. (1988) Supplement To: A Hydrolysis Study with Sodium Dodecylbenzene
Sulfonate ...: Document No. 1675

- 87

- 0098

- EF

- 001

- 002: Project ID: 87

- 0098. Unpublished study prepared by Ricerca, Inc. 31 p.

41069601 Sobek, A. (1989) Supplement to: A Hydrolysis Stu dy with Sodium Dodecylbenzene Sulfonate: Literature Review of Reactivity of Sodium Dodecylbenzene Sulfonate in

Non

- Sterile Media: Report Supplement Number Three: Document No. 89003

- PS. Unpublished study prepared by BFGoodrich Co. 202 p.

94032010 Keene, E. (1990) The BF Goodrich Company/Promac Systems Phase 3 Summary of MRID 40548801. A Hydrolysis Study with Sodium Dodecylbenzene Sulfonate. Prepared by Ricerca, Inc. 37 p.

94032011 Keene, E. (1990) The BF Goodrich Company/Promac Systems Phase 3 Summary of MRID 40655201. Adsorption and Desorption of Sodium Dodecylbenzene Sulfonate to Soils. Prepared by Ricerca, Inc. 25 p.

### Page 58 of 63 European Oilfield Speciality Chemicals Association. 2000. Summary Report Surfactant
Bioaccumulation Review P roject. 106 pp. http://www.eosca.eu/wp

content/uploads/Surfactants

- Report.pdf

Fairchild, James F, et. al. (1993). “Evaluation of a Laboratory

- Generated OEC For Linear Alkylbenzene Sulfonate in Outdoor Experimental Streams.” Environmental Toxicology and Chemistry. Vol. 12. pp 1763

- 1776.

Federle TW and NR Itrich (1997), Comprehensive approach for assessing the kinetics of primary and ultimate biodegradation of chemicals in activated sludge: application to LAS,
Environ. Sci. Technol. 31: 1178

- 1184.

Huddleston,RL, and Allred, RC. 1963. Microbial oxidation of sulfonated alkylbenzenes

. Dev.Ind. Microbiol., vol.4, pp24

- 38

Jacobsen, Anne Marie, Gerda Krog Mortensen, and Hans Christian Bruun Hansen. (2004). Degradation and Mobility of Linear Alkylbenzene Sulfonate and Nony lphenol in Sludge

Amended Soil. Journal of Environmental Quality. Vol 33. pp. 232

- 240.

Kwok, T.K. 2011. Assessing the effect of surfactants on activated sludge processes usi ng sequencing batch reactors

. Master’s Thesis Environmental Engineering, School of Civil, Environmental and Chemical Engineering, RMIT University. 111 pp. http://researchbank.rmit.edu.au/eserv/rmit:11997/Kwok.pdf

Larson, RJ, and Payne, AG. 1981. Fate of the Benzene Ring of Linear Alkylbenzene Sulfonate in
Natural Waters. Applied Environ. Microbiol ., vol. 41(3), pp 621

- 627

Painter, H. A. (1986) Testing the toxicity of chemicals by the inhibition of respiration of activated sludge. Toxicity Assessme nt 1:515

- 524.

Swisher, RD, 1987. Surfactant Biodegradation, second edition, Surfactant Science Series Vol.18, Marcel Dekker, Inc. New York, NY

Schoerl, P, 1989. Basic Principles of LAS Biodegradation, Tenside Surfactant Detergents, 26, pp
86

- 94

.

Temmink, H.and B. Klapwijk. 2004. Fate of linear alkylbenzene sulfonate (LAS) in activated sludge plants. Water Research 38:903

- 912.

Tolls and Sijm. 2000.

### Page 59 of 63 

# Appendix D Ecotoxicology Profile

Terrestrial Organisms

Birds

An acute oral toxicity study using the technical gra de of the active ingredient ( parent compounds, i.e. TGAI) is expected to be required to establish the toxicity of ABS to birds. One avian acute test species is expected to be required for indoor uses for label hazard purposes. The preferred test species is either a waterfowl, the mallard duck ( Anas platyrhynchos )

, or an upland game bird, the Northern bobwhite quail ( Colinus virginianus ). Data for the Northern b obwhite
have been submitted for LAS ( Table 20 ). This study indicates that LAS is slightly toxic to the Northern bobwhite quail on an acute

- oral basis (LD 50 

### > 500 ppm ). The sodium dodecylbenzene sulfonate study (MRID 4113901) fulfills the guideline requirement (850. 2100).

A sub

- acute dietary study (850.2200) using TGAI may be required on a case

- by

- case basis depending on the results of lower

- tier ecological studies and pertinent environmental fate characteristics, however, this testing is not expected to be required unless outdoor uses are added to alkylbenzene sulfonate labels.

Chronic data (850.2300) are not required.

Table 20

– Available Endpoints from Avian Ecotoxicity Studies for Sodium Dodecylbenzene Sulfonate

Study Type Species Test
material (% ai) Toxicity 1 Toxicity
Classification MRID &
Status

Acute

– Avian
Oral ( 850.2100 ) Northern

B obwhite 87.6 LD 50 : > 1382 ppm Slightly toxic 41143901 Acceptable


### Mammals

In most cases, rat toxicity studies for human health risk assessments are used as surrogates for wild mammal testing. Wild mammal tests are not expected to be required for ABS at this time because the currently registered uses are indoor spray applications. Refer to the toxicology section for mammalian toxicity data.

Nontarget I nsects

It was determined in the 2006 RED that minimal or no environmental exposure to terrestrial or aquatic organisms is expected to occur due to the fact that the use patterns were considered
indoors. It has since been recognized that such use patterns m ay have an additional down

- the

drain component resulting in potential release s to wastewater treatment plants (WWTPs) and subsequently the environment. Such releases for the linear 12 carbon chain ABS (C 12 

### - ABS) actives in this case are considered highly un likely to be discharged from WWTPs due to sorption

### Page 60 of 63 and rapid biodegradation as discussed in Section 4.1

. Therefore, no data are required because nontarget insects are highly unlikely to be exposed

. 

## Aquatic Organisms

Freshwater Fish

In order to establish the acute toxicity of pesticides to freshwater fish for environmental hazard labeling, the agency expects to require a TGAI study for indoor uses having no environmental exposure of concern. The preferred test species is either a cold

- water fish, Rainbow Trout ( Oncorhynchus mykiss ), or a warm

- water fish, Bluegill Sunfish ( Lepomis macrochirus ). Two supplemental studies a re listed in

which indicate that LAS is moderately toxic to freshwater fish. The guideline requirement for a freshwater fish acute study has not bee n fulfilled and this data gap (850.1075) was identified in
the 2006 RED. As a result of the 2006 RED one acute freshwater fish toxicity test using technical grade dodecylbenzene sulfonic acid (098002) should have been called in to the agency
in order to su pport existing indoor uses, but was not. Because the only studies measuring the toxicity of LAS to freshwater fish were determined to be supplemental, HPV Challenge Program data were used in order to create a more comprehensive toxicity profile. The agency expects to obtain and review the specific data from the HPV Challenge Program in order to satisfy this data requirement ( Table 13 ).

Table 21

– Available Endpoints from Freshwater Fish Ecotoxicity Studies for LAS

Study Type Species Test
material (% ai) Toxicity 1 Toxicity
Classification MRID &
Status

Acute

– Freshwater Fish Toxicity (840.1075) Fathead
Minnow 14.0* L C 50 : 3.4 mg/L Moderately toxic 44260002 Supplemental

Acute

– Freshwater Fish Toxicity (840.1075) Rainbow

Trout 65.0% L C 50 : 1.68 mg/L Moderately toxic 44260009 Supplemental

1 Toxicity values based on parent compound (TGAI)
* Carbon chain not identified



### Freshwater Invertebrates

In order to establish the acute toxicity of pesticides to freshwater aquatic invertebrates for environmental hazard labeling, the agency expects to require a TGAI study for indoor uses having no environmental exposure of concern. The preferre d test species is Daphnia magna or Daphnia pulex

. One supplemental study is listed in Table 22

. The results of this study indicate that the toxicity of LAS to freshwater invertebrates is variable, depending on the length of the
carbon chain. The guideline requirement for a freshwater invertebrate acute study has not been fulfilled and this data gap (850.1010) was identified in the 2006 RED. As a result of the 20 06 RED one acute freshwater invertebrate toxicity test using technical grade dodecylbenzene sulfonic acid (098002) should have been called in to the agency in order to support existing
indoor uses , but was not. Because the only study measuring the toxicity of LAS to freshwater invertebrates was determined to be supplemental, HPV Challenge Program data were used in

### Page 61 of 63 order to create a more comprehensive toxicity profile. The agency expects to obtain and review the specific data from the HPV Challenge Program i n order to satisfy this data requirement ( Table 13 ).

.

Table 22

– Available Endpoints from Freshwater Invertebrate Ecotoxicity Studies for LAS

Study Type Species Test
material (% ai) Toxicity 1 Toxicity
Classification MRID & Status

Acute

– Freshwater Invertebrate Toxicity ( 850.1010 ) Waterflea ( Daphnia magna) Not reported EC 50 : LAS

- C10 = 29.5 mg/L
LAS

- C12 = 6.84 mg/L
LAS

- C14 = 0.80 mg/L
LAS

- C16 = 0.20 mg/L Slightly to highly
toxic 47025025 Supplemental



### Estuarine and Marine Fish and Invertebrate Toxicity

Acute toxicity testing with estuarine and marine organisms using the TGAI is required when the
end

- use product is intended for direct application to the marine/estuarine environment or effluent containing the active ingredient is expected to reach this environment. Acute estuarine/marine

tests are not expected to be required for ABS because the currently registered uses are primarily indoor applications and are not expected to reach estuarine/marine environments.

Aquatic Plants

Table 23

– Available Endpoints from Freshwater Aquatic Plants

Study Type Species T est material (% ai) Toxicity 1 Toxicity
Classification MRID &
Status Aquatic Plant Growth (Algal) Tier II (Dose Response) ( 850.5400 ) Freshwater Alga ( Selenastrum capricornutum ) Sodium dodecylbenzene
sulfonate 079010 96

- hr EC 50 : 70.27 mg/L Slightly to highly toxic 42439803 Supplemental

OPP received one toxicity study conducted on alga using sodium dodecylbenzene sulfonate (MRID 42439803). The 1990 study was conducted according to the standard procedure from the Federal Register at the time (Vol. 50, Section 797.1050, Algal Acute Toxicity Test). A protocol, which provided limited information on the test system used, was provided in the Study Report. The Study Report did not include, however, the experimental observations ( i.e. , pH, temperature, dissolved oxygen), the raw data (i.e, cell counts, mean cell volume), or the dose responses in a tabular format ( i.e. , cell density, growth rate,
biom ass). This study was reviewed using EPA OPPTS Guideline 850.5400, but the review was hindered
due to the lack of the above mentioned information.

### Page 62 of 63 • Because the only study measuring the toxicity of sodium dodecylbenzene sulfonate to alga was determined to be supplemental, HPV data were used in order to create a more comprehensive toxicity profile.

### Page 63 of 63 

# Appendix E Comments Received Concerning the Preliminary Work Plan

The Agency received one comment on the initial docket, described below. In the PWP, the Agency solicited comments on specific topics: environmental justice, water body impairment, trade irritants, and structure activity relationships. No comments or information were received during the public comment period concerning these issues.

Comment: Diversey, Inc. rev iewed the ABS PWP and requested corrections to Table 6

– Summary of Registered Uses. The changes are based on the use sites, application methods and application rates.

Response: The agency has made all the applicable changes to all of the products identifi ed in

Table 6

- Summary of Registered Uses.