Docket Number; EPA–HQ–OPP–2009–0727 www.regulations.gov

United States Chemi cal Safety June 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# Lauryl Sulfate Salts Final Work Plan & Proposed Registration Review Final Decision

Case 4061Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

3 

### TABLE OF CONTENTS

Lauryl Sulfate Salts Regi stration Review Team......................................................................... 4

I. INTRODUCTION ................................................................................................................ ..... 5

II. SCIENTIFIC ASSESSMENT ................................................................................................. 6

III. REGISTRATION REVIEW PROPOSED FINAL DECISION....................................... 12

IV. NEXT STEPS AND TIMELINE ......................................................................................... 12

V. GLOSSARY of TERMS & ABBREVIATIONS.................................................................. 14Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

4 Lauryl Sulfate Salts Registration Review Team

Human Health & Environmental Effects

William J. Hazel Najm Shamim

Risk Management
Monisha Harris

Lance Wormell

Office of General Counsel Philip RossDocket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

5 I. INTRODUCTION

This document is EPA’s Final Work Pl an and Proposed Registration Review Final Decision for lauryl sulf ate salts and is being issued pursuant to 40 CFR Sections 155.57 and 155.58. A registration review deci sion is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Additional information and documents on lauryl sulfate salts can be found in EPA’s public docket (EPA-HQ-OPP2009-0167) at www.regulations.gov

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FIFRA, as amended by the Food Qual ity Protection Act (FQPA) of 1996, mandated the continuous review of existing pestic ides. All pesticides distributed or sold in the United States must generally be registered by EPA, 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 asse ss 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 us e practices will occur over time. Through the registration review program, the Agency periodically reev aluates 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/oppsrr d1/registration_review/

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In 2006, the Agency implemented the Registration Review program pursuant to FIFRA Section 3(g) and will review each regist ered pesticide every 15 years to determine

whether it continues to meet the FIFR A standard for registration.

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review for lauryl sulfate salts with the following timeline:

• December 2009 : Publication of a Preliminary Work Plan (PWP) in the docket for lauryl sulfate salts (EPA-HQ-OPP-2 009-0727). The Agency received no comments during the 90 day public comment period which closed on March 16,

2010.

• June 2010: Issuance of a Final Work Plan and Proposed Registration Review Final Decision for lauryl sulf ate salts. This document states that the most recent exposure and risk assessments for lauryl sulfate salts continue to support the registration of pesticide pr oducts containing lauryl su lfate salts and meet the requirements of registration review under 40 CFR Sec.155.50. This document will be issued for a 60-day public comment period.

No comments were received on the laur yl sulfate salts Preliminary Work Plan (PWP) issued in December 2009. Given the lack of comments, the low hazard and exposure of lauryl sulfate salts and that no ri sk assessments were required, the Agency is combining the Final Work Plan and the Pr oposed Registration Review Final Decision into a single document for this case. The data and information evaluated to support laurylDocket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

6 sulfate salts, as published in the December 2009 PWP, continue to support this pesticide registration as summarized herei n. The status of these and ot her registration review cases

is available at: http//www.epa.gov/oppsrrd1/registration review/ review

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Sodium lauryl sulfate is the only active ingredient in case 4061 and there is only one registered product that cont ains sodium lauryl sulfate as an active ingredient. Products containing sodium lauryl sulfate as an active ingredient were first registered in 1948. It is widely used as an intentionally -added inert ingredient in pesticide products and is one of two active ingredients incl uded as an antiviral compound in Kleenex® Brand Antiviral Tissues; the PC Code is 079011. The antiviral tissues contain 2.02% sodium lauryl sulfate and are registered by Kimberly-Clark Global Sales, LLC (EPA Reg. No. 9402-10). The tissues also contain citric acid as an active ingredient at 7.51%. A manufacturing-use product containing sodium lauryl sulfate has not been registered.

Sodium lauryl sulfate is widely used as a surfactant adde d to lower the surface

tension of other substances and is also used as an emulsifier, whi pping agent, or wetting

agent. However, it is by far much more widely -used for industrial purposes because of these surface-active properties.

EPA has established exemptions from th e requirements of a tolerance for residues of sodium lauryl sulfate in foods [40 CF R 180.940(a), -(b), and -(c)] due to the low toxicity. The Food and Drug Administration (F DA) has classified sodium lauryl sulfate

as both a direct and indirect food additive. It is Generally Recognized as Safe (GRAS) when directly-added to eggs, marshmallows , beverages, and oils (21 CFR 172.822) at up to 125 ppm as an emulsifier, whipping agent, surfactant, or wetting agent. Other FDAregulated uses include: a citrus coating (21 CFR 172.210); a component of food contact paper and paperboard [21 CFR 176.170(a)(5)] ; a defoaming agent component of food contact paper and paperboard [21 CFR 176.210(d)(3)]; and an em ulsifier or other surface active agent during manufactur e of articles intended for food contact [21 CFR 178.3400(c)].

A Reregistration Eligibility Decision (RED) for lauryl su lfate salts was issued in September 1993.

II. SCIENTIFIC ASSESSMENT

A. Chemical Identification

Table 1 provides information on the chemical identity of lauryl sulfate salts

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Table 1: Chemical Identity

Common Name Lauryl sulfate salts

Chemical Name Sodium lauryl sulfate

PC Code 079011 CAS Registry Number 151-21-3Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

7 Molecular Structure

B. Product Chemistry

Table 2 provides information on the physical and chemical properties of lauryl sulfate salts. All product chemistry data re quirements have been fulfilled for the active ingredient lauryl sulfate salts . Therefore, no additional produ ct chemistry data for lauryl

sulfate salts are needed at this time. Further product chemistry information is available in the document titled, “Summary of Produc t Chemistry, Environmental Fate, and Ecotoxicity Data for the Laur yl Sulfate Salts Registration Review Decision Document,” dated October 15, 2009.

Table 2: Physical and Chemical Pr operties of Lauryl Sulfate Salts

Guideline No./

Study Type Results MRID No./

Reference

Information

830.6302

Color The TGAI is white in color. The product is clear watery

solution. 44805201

830.6303 Physical state The TGAI is solid at room temperature. The product is a liquid at room temperature. 44805201

830.6304

Odor The TGAI and product are odorless. 44805201

830.6313 Stability to normal and elevated temperatures, metals, and metal ions Sodium lauryl sulfate is stable 44805201

830.6314

Oxidation/reduction This product does not contain an oxidizing or reducing

agent. 44805201

830.6315 Flammability This product does not contain combustible liquids 44805201

830.6316 Explodability This product is not potentially explosive. 44805201

830.6317 Storage stability The product is stable beyond one year. 44805201

830.6319 Miscibility This product is not an emulsifiable liquid. 44805201

830.6320

Corrosion characteristics The corrosion character istics have not been determined/not applicable 44805201

830.6321

Dielectric breakdown This product is not intended for use in or around electrical equipment 44805201Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

8 Guideline No./

Study Type Results MRID No./

Reference

Information
voltage

830.7000 pH 8.5 to 9.0 (product) 44805201

830.7100 Viscosity The viscosity of this product has not been determined.> 97% aqueous solution; likely to have the viscosity close

to water. 44805201

830.7200 Melting point 205.5 o C RD Memo

830.7220 Boiling point Not applicable for TGAI 44805201

830.7300 Density The density of this product is not determined OECD/SIDS: 0.6 g/cc OECD SIDS

Document

830.7370

Dissociation constant This is not determined; not applicable 44805201

830.7550 Partition coefficient (K OW) Highly water soluble. log K OW = 1.6. RD Memo

830.7860 Solubility TGAI: 150 g/L 44805201

830.7950 Vapor pressure 1..1 x10 -12 mm Hg at 25 °C RD Memo

C. Human Health Risk Assessment Status

A Reregistration Eligibility Decision (RED) for lauryl su lfate salts was issued in September 1993. This document can be located at: http://www.epa.gov/pesticides /reregistration/status.htm

The Agency reviewed all available in formation and data, including the hazard and exposure databases for lauryl sulfate salts. Based on the low toxicity and exposure of lauryl sulfate salts, no additional toxicity and exposure data are needed for registration review. In addition, occupati onal and residential exposure as sessments are not needed to ensure that the lauryl sulfate salts regist ration review case meets the safety standards established by FIFRA and FFDCA, as amended by FQPA. For a deta iled discussion of the human health exposure and risk assessmen t status, please refer to the document titled, “Lauryl Sulfate Salts. Human Health Eff ects Scoping Document for the Registration Review Decision,” dated December 07, 2009.

Toxicity

The toxicology database for sodium lauryl sulfate is adequate to support its use as an active or inert ingredient in pesticid e formulations and to support the tolerance exemption for use as a component of food contact surface sanitizers. Sodium lauryl sulfate has low acute oral and dermal toxicity but is irritating to the skin and eyes at high doses. Sodium lauryl sulfate is not a skin se nsitizer. Sodium lauryl sulfate was negative in tests for genotoxicity. The repeated dos e toxicity data on alkyl sulfates including sodium lauryl sulfate demonstrate effects c onsistent with the ir ritation caused by otherDocket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

9 surfactants. The common target organs of toxicity following repeated-dose oral exposure were the forestomach in gavage studies, a nd the liver and kidneys in dietary studies.

A no-observed adverse effect level ( NOAEL) of 100 mg/kg/day was selected from a 28-day oral (gavage) study in rats in which decreased food consumption and decreased body-weight gain we re observed at the lowest observed adverse effect level (LOAEL) of 200 mg/kg/day. Other subchronic studies showed similar results. No evidence of neurotoxicity was observed in any of the studies. Chronic toxicity data on sodium lauryl sulfate are limited but in two 2-yr rat feeding studi es, no treatment-related

effects were observed at doses up to approximately 100 mg/kg/day. From two carcinogenicity studies (summaries only available), te sting closely-related alkyl (C 12 -C 15 ) sulfonates; there is no eviden ce that sodium lauryl sulfat e would exhibit carcinogenic potential when dosed at up to 1.5% of the diet.

No evidence of increased susceptibilit y was observed in the offspring of rats, rabbits, and mice following prenatal or postnatal exposure to sodi um lauryl sulfate. In a developmental toxicity study with sodium la uryl sulfate in rats, rabbits, and mice, maternal toxicity and developmental toxicity were seen only at the highest dose tested of 600 mg/kg/day. The NOAEL for maternal and developmental effects in that study was 300 mg/kg/day. There was no evidence of neur otoxicity in the a dult animals. A 2- generation reproductive t oxicity study conducted w ith a related chemical, α -alkyl (C 12 ) olefin sulfonate, showed no treatment-related adverse reproductive effects and no systemic adverse effects on organs at dose levels up to 285 mg/kg/day (high dose therapy).

Dietary and Drinking Water Assessment

Dietary Food Exposure

Human dietary (food) exposure is not expect ed to occur from the use of antiviral tissues, the only registered use of sodium la uryl sulfate as an active ingredient.

FDA classifies sodium lauryl sulfate as being GRAS when used as a direct food additive (for nonpesticidal purpos es) at concentrations as hi gh as 125 ppm when ready to consume, e.g., as an emulsifier in frozen or liquid egg whites. EPA has established exemptions from the requirements of a tolera nce for residues of sodium lauryl sulfate in foods [40 CFR 180.940(a), -(b), and -(c )] due to the low toxicity.

Dietary Drinking Water Exposure

Dietary exposure to sodium lauryl sulfat e via drinking water is not likely to occur based on its only registered use as an active i ngredient in antiviral tissues. Even if the

antiviral tissues or their leach ate were to reach the outdoor environment, the intact parent compound would be metabolized rapidly by aquatic and soil microbes and is not expected to persist to the point it could be consumed in drinking water. Metabolites of sodium lauryl sulfate (sulfate and acetat e anions) are not of toxicological concern.Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

10 Tolerances

Sodium lauryl sulfate serves as an in tentionally-added inert in gredient in over 370 pesticide products although few of these ar e antimicrobial products. Sodium lauryl sulfate is exempt from the requirement of a to lerance when used as an inert ingredient in food contact sanitizer products provided that the final treatment solution used in public eating places contains ≤ 3 ppm; on dairy processing equipment contains ≤ 350 ppm; and on food processing equipment and utensils has no limit [40 CFR 180.940(a), -(b), and - (c), respectively]. Residues of alkyl (C 8 -C 18 ) sulfates, including s odium lauryl sulfate, are exempt from the requirement of a to lerance when used as inert ingredients (surfactants) in pesticide form ulations applied to growing crops or to raw agricultural commodities (RACs) after ha rvest (40 CFR 180.910) or to animals (40 CFR 180.930).

Aggregate and Cumulative Exposure

In examining aggregate exposure, EPA takes into account available and reliable information concerning exposures to pesticid e residues in food and drinking water, as well as non-occupational pesticide exposures . The conservative assessment of all pesticidal inert uses conducted by K. Leifer (RD) on 8/5/09 to suppor t increasing the final use concentration at 40 CFR 180.940(a) to 350 ppm demonstrated no aggregate risks of concern to the Agency. The contribution of pe sticidal sources of s odium lauryl sulfate are expected to be minimal compared to the combined industrial, culinary, pharmaceutical, cosmetic, and other personal care product sources. For these reasons, and due to its rapid rate of metabolism, s odium lauryl sulfate aggregate risks are not considered of Agency concern.

Occupational and Resi dential Assessment

A quantitative risk assessment is not required because, based on the use pattern (antiviral tissues) and low toxi city of sodium lauryl sulfat e, adverse systemic effects on

humans attributable to the dermal and inha lation routes of exposur e to sodium lauryl sulfate are not expected.

D. Environmental Fate and Ecological Effects Risk Assessment Status

1. Environmental Fate and Ecological Effects

Based on the low hazard of lauryl sulfate salts and the low exposure from the only use pattern as an antiviral tissue, environmen tal fate and ecological risk assessments are not needed for the lauryl su lfate salts registra tion review. Further information on the environmental fate and ecological risk assessment is available in the document titled, “Summary of Product Chemistry, Environmen tal Fate, and Ecotoxicity Data for the Lauryl Sulfate Salts Registration Review Decision Document,” dated October 15, 2009.Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

11 2. Endangered Species

EPA has made a “No Effect” determina tion for endangered species for lauryl

sulfate salts and further environmental ri sk assessments will not be conducted unless public comments provide new information or data that warrant such assessment. Based on the low hazard of lauryl sulfate sa lts and the low exposure from the only use pattern as an antiviral tissue, the Agency has de termined that the registered uses of lauryl sulfate salts will have “no effect” (NE) on enda ngered or threatened terrestrial or aquatic species, or their designated critical habitats , as listed by the U. S. Fish and Wildlife Service (USFWS) and the National Marine Fi sheries Service (NMFS). As a result, no further risk assessment is anticipated unle ss new information warrants such action.

E. Incidents

Since its registration in 1948, one human incident associated with human exposure to sodium lauryl sulfate has been reported. The symptoms included blisters on the face

and nose that remained for 3.5 weeks after e xposure. There are 76 incidents associated with lauryl sulfate involving domestic animal s which most commonly manifested in hair loss, difficulty breathing, and rashes.

F. Public Comments

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review for lauryl sulfate salts on December 16, 2009 with the opening of a docket and the issuance of a PWP for public comment. The Agency received no comments concerning the Preliminary Work Plan for lauryl sulf ate salts during the 90-day public comment period. The public will be invited to comment on this combined Final Work Plan and Proposed Registration Review Fi nal Decision for 60 days following the issuance of this

document.

G. Environmental Justice

EPA seeks to achieve environmental just ice - the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income - in the development, implementation, and enforcemen t of environmental laws, regulations, and policies. At this time EPA does not believe that use of pesticide products containing lauryl sulfate salts will cause harm or a di sproportionate impact on at-risk communities. In the December 2009 Preliminary Work Plan, the Agency sought comment on environmental justice issues regarding lauryl sulfate salts. As previously mentioned, no

comments were received.

For additional information regarding envi ronmental justice issues, please visit

EPA’s website at: http://www.epa.gov/compliance/en vironmentaljustice/index.html

.Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

12 H. Water Quality

Lauryl sulfate salts is not identified as a cause of impairment for any water-bodies listed as impaired under sect ion 303(d) of the Clean Water Act, based on information provided at: http://oaspub.epa.gov/tmdl/w aters_list.impairments?p_impid=3

. The Agency sought submission of water quality data for lauryl sulfate salts when the Preliminary Work Plan was issued for co mment. The Agency did not receive any comments on water quality issues.

I. Trade Irritants

Through the registration review process, the Agency solicited information on trade irritants and, to the extent feasible, took steps toward faci litating irritant resolution.

Growers and other stakeholders were asked to comment on any trade irritant issues resulting from lack of Maximum Residue Le vels (MRLs) or disparities in key export markets, providing as much specificity as pos sible regarding the nature of the concern. The Agency did not receive any comments on trade irritant issues.

III. REGISTRATION REVIEW PROPOSED FINAL DECISION

The Agency has determined that no additi onal data are required at this time to support the registration of lauryl sulfate salts. The Agency ha s considered lauryl sulfate salts in light of the standard for registrati on and safety factors in FIFRA and FFDCA as amended by FQPA. EPA has found that ther e are not likely to be any unreasonable adverse effects to the U.S. popul ation in general, and to infants and children in particular, or to non-target organisms, from the use of products containing lauryl sulfate salts when currently required label instructions are follo wed. Further, the Agency has determined that the currently registered uses of lauryl sulfate salts will have “no effect” on any federally listed threatened or endangered species nor will such use destroy or adversely modify any designated critical habitat of such species. The Agency has found that it is not necessary to conduct a new risk assessmen t for this case and is therefore issuing a proposed final decision pursuant to 40 CFR 155.53 (c)(2) and 40 CFR 155.58.

As per 40 CFR Sections 155.57 and 155.58, the Agency’s proposed registration

review final decision is that the standards fo r Registration Review have been met and that the registration of the aforesaid lauryl su lfate salts product may be maintained.

IV. NEXT STEPS AND TIMELINE

Pursuant to 40 CFR Section 155.58, the Agency is issuing this proposed Registration Review Final Decision document a nd placing it in the la uryl sulfate salts docket (EPA-HQ-OPP-2009-0727). The Final Work Plan is also included in this document. A Federal Register Notice will a nnounce the availability of this combined Final Work Plan and Proposed Registrati on Review Final Decision and allow a 60 day comment period. If there are no significant comments or additional information submitted to the docket during that period that lead the Agency to change its proposedDocket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

13 decision, EPA will issue a final decision for lauryl sulfate salts case 4061. The Agency anticipates the final decision will be issued in Fiscal Year (FY) 2011.Docket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

14 V. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association

CBI Confidential Business Information CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration

EP End use Product EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically deri ved single dose that can be expected to

cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure

MRID Master Record Identifi cation (number). EPA's system of recording and tracking

submitted studies. MUP Manufacturing-Use Product NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment NPDES National Pollutant Discharge Elimination System NR Not Required

NOAEL No Observed Adverse Effect Level OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted DoseDocket Number; EPA-HQ-OPP-2009-0727 www.regulations.gov

15 PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval phr Pounds Per Hundred ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer

Risk Model RAC Raw Agriculture Commodity RED Reregistration Eligibility Decision REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient RTU Ready to Use SCI-GROW Tier I Ground Water Computer Model SAP Science Advisory Panel SF Safety Factor SLN Special Local Need (Registrati ons Under Section 24©) of FIFRA) TGAI Technical Grade Active Ingredient TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection Standard