Docket Number; EPA–HQ–OPP–2009–0727 

www.regulations.gov 

 

United States Chemical Safety June 2010 

Environmental Protection and Pollution Prevention 

Agency (7510P)

Lauryl Sulfate Salts Final Work Plan & 

Proposed Registration Review Final Decision 

Case 4061 

Docket Number; EPA-HQ-OPP-2009-0727 

www.regulations.gov 

3

TABLE OF CONTENTS

Lauryl Sulfate Salts Registration 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.................................................................. 14
Docket 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 Ross 
Docket Number; EPA-HQ-OPP-2009-0727 

www.regulations.gov 

5

I. INTRODUCTION

This document is EPA’s Final Work Plan and Proposed Registration Review 

Final Decision for lauryl sulfate salts and is being issued pursuant to 40 CFR Sections 

155.57 and 155.58. A registration review decision 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. 

 FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, 

mandated the continuous review of existing pesticides. 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 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 occur 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/. 

 In 2006, the Agency implemented the Registration Review program pursuant to 

FIFRA Section 3(g) and will review each registered pesticide every 15 years to determine 

whether it continues to meet the FIFRA 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-2009-0727). 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 sulfate salts. This document states that the most recent 

exposure and risk assessments for lauryl sulfate salts continue to support the 

registration of pesticide products containing lauryl sulfate 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 lauryl 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 risk assessments were required, the Agency is 

combining the Final Work Plan and the Proposed Registration Review Final Decision 

into a single document for this case. The data and information evaluated to support lauryl 
Docket 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 herein. The status of these and other registration review cases 

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

Sodium lauryl sulfate is the only active ingredient in case 4061 and there is only 

one registered product that contains 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 included 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 added to lower the surface 

tension of other substances and is also used as an emulsifier, whipping 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 the requirements of a tolerance for residues 

of sodium lauryl sulfate in foods [40 CFR 180.940(a), -(b), and -(c)] due to the low 

toxicity. The Food and Drug Administration (FDA) 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 emulsifier or other surface 

active agent during manufacture of articles intended for food contact [21 CFR 

178.3400(c)]. 

A Reregistration Eligibility Decision (RED) for lauryl sulfate salts was issued in 

September 1993. 

II. SCIENTIFIC ASSESSMENT

A. Chemical Identification 

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

Table 1: Chemical Identity 

Common Name Lauryl sulfate salts 

Chemical Name Sodium lauryl sulfate 

PC Code 079011 

CAS Registry Number 151-21-3 
Docket 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 requirements have been fulfilled for the active 

ingredient lauryl sulfate salts. Therefore, no additional product chemistry data for lauryl 

sulfate salts are needed at this time. Further product chemistry information is available in 

the document titled, “Summary of Product Chemistry, Environmental Fate, and 

Ecotoxicity Data for the Lauryl Sulfate Salts Registration Review Decision Document,” 

dated October 15, 2009.

Table 2: Physical and Chemical Properties 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 characteristics have not been 

determined/not applicable 

44805201 

830.6321 

Dielectric breakdown 

This product is not intended for use in or around 

electrical equipment 

44805201 
Docket 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 (KOW) 

Highly water soluble. 

 log KOW = 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 sulfate 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 information 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, occupational and residential exposure assessments are not needed to 

ensure that the lauryl sulfate salts registration review case meets the safety standards 

established by FIFRA and FFDCA, as amended by FQPA. For a detailed discussion of 

the human health exposure and risk assessment status, please refer to the document titled, 

“Lauryl Sulfate Salts. Human Health Effects 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 pesticide 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 sensitizer. Sodium lauryl sulfate was negative 

in tests for genotoxicity. The repeated dose toxicity data on alkyl sulfates including 

sodium lauryl sulfate demonstrate effects consistent with the irritation caused by other 
Docket 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, and 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 were 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 studies, no treatment-related 

effects were observed at doses up to approximately 100 mg/kg/day. From two 

carcinogenicity studies (summaries only available), testing closely-related alkyl (C12-C15) 

sulfonates; there is no evidence that sodium lauryl sulfate would exhibit carcinogenic 

potential when dosed at up to 1.5% of the diet. 

 No evidence of increased susceptibility was observed in the offspring of rats, 

rabbits, and mice following prenatal or postnatal exposure to sodium lauryl sulfate. In a 

developmental toxicity study with sodium lauryl 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 neurotoxicity in the adult animals. A 2-

generation reproductive toxicity study conducted with a related chemical, α-alkyl (C12) 

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 expected to occur from the use of antiviral 

tissues, the only registered use of sodium lauryl sulfate as an active ingredient. 

FDA classifies sodium lauryl sulfate as being GRAS when used as a direct food 

additive (for nonpesticidal purposes) at concentrations as high 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 tolerance 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 sulfate via drinking water is not likely to occur 

based on its only registered use as an active ingredient in antiviral tissues. Even if the 

antiviral tissues or their leachate 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 acetate anions) are not of toxicological concern. 
Docket Number; EPA-HQ-OPP-2009-0727 

www.regulations.gov 

10

Tolerances

 Sodium lauryl sulfate serves as an intentionally-added inert ingredient in over 370 

pesticide products although few of these are antimicrobial products. Sodium lauryl 

sulfate is exempt from the requirement of a tolerance 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 (C8-C18) sulfates, including sodium lauryl sulfate, 

are exempt from the requirement of a tolerance when used as inert ingredients 

(surfactants) in pesticide formulations applied to growing crops or to raw agricultural 

commodities (RACs) after harvest (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 pesticide 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 support 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 pesticidal sources of sodium 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, sodium lauryl sulfate aggregate risks are not 

considered of Agency concern. 

Occupational and Residential Assessment

 A quantitative risk assessment is not required because, based on the use pattern 

(antiviral tissues) and low toxicity of sodium lauryl sulfate, adverse systemic effects on 

humans attributable to the dermal and inhalation routes of exposure 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, environmental fate and ecological risk assessments are 

not needed for the lauryl sulfate salts registration review. Further information on the 

environmental fate and ecological risk assessment is available in the document titled, 

“Summary of Product Chemistry, Environmental 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” determination for endangered species for lauryl 

sulfate salts and further environmental risk 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 salts and the low exposure from the only use 

pattern as an antiviral tissue, the Agency has determined that the registered uses of lauryl 

sulfate salts will have “no effect” (NE) on endangered 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 Fisheries Service (NMFS). As a result, no 

further risk assessment is anticipated unless 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 exposure. There are 76 incidents associated 

with lauryl sulfate involving domestic animals 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 sulfate 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 Final Decision for 60 days following the issuance of this 

document. 

G. Environmental Justice 

 EPA seeks to achieve environmental justice - the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income - in the 

development, implementation, and enforcement 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 disproportionate 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 environmental justice issues, please visit 

EPA’s website at: http://www.epa.gov/compliance/environmentaljustice/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 section 303(d) of the Clean Water Act, based on information 

provided at: http://oaspub.epa.gov/tmdl/waters_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 comment. 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 facilitating irritant resolution. 

Growers and other stakeholders were asked to comment on any trade irritant issues 

resulting from lack of Maximum Residue Levels (MRLs) or disparities in key export 

markets, providing as much specificity as possible 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 additional data are required at this time to 

support the registration of lauryl sulfate salts. The Agency has considered lauryl sulfate 

salts in light of the standard for registration and safety factors in FIFRA and FFDCA as 

amended by FQPA. EPA has found that there are not likely to be any unreasonable 

adverse effects to the U.S. population 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 followed. 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 assessment 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 for Registration Review have been met and that 

the registration of the aforesaid lauryl sulfate 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 and placing it in the lauryl sulfate salts 

docket (EPA-HQ-OPP-2009-0727). The Final Work Plan is also included in this 

document. A Federal Register Notice will announce the availability of this combined 

Final Work Plan and Proposed Registration 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 proposed 
Docket 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 

LC50 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. 

LD50 Median Lethal Dose. A statistically derived 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 Identification (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 Dose 
Docket 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 

Q1* 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 (Registrations 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