United States Prevention, Pesticides EPA 739-R-06-006
Environmental Protection and Toxic Substances July 2006
A ^^%Ji A9encY (751 OP)
Reregistration Eligibility Decision
for Alkylbenzene Sulfonates
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial alkylbenzene sulfonates
(ABS). The enclosed Reregi strati on Eligibility Decision (RED) document was approved on July
27, 2006.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for alkylbenzene sulfonates and its associated human health and
environmental risks. A Notice of Availability will be published in the Federal Register
announcing the publication of the RED.
The RED and supporting risk assessments for alkylbenzene sulfonates are available to the
public on the U.S. Federal Government website www.regulations.gov. The docket is EPA-HQ-
OPP-2006-0156.
The alkylbenzene sulfonates RED was developed through EPA's public participation
process, published in the Federal Register on September 10, 2004, which provides opportunities
for public involvement in the Agency's pesticide tolerance reassessment and reregi strati on
programs. Developed in partnership with USDA and with input from EPA's advisory
committees and others, the public participation process encourages robust public involvement
starting early and continuing throughout the pesticide risk assessment and risk mitigation
decision making process. The public participation process encompasses full, modified, and
streamlined versions that enable the Agency to tailor the level of review to the level of
refinement of the risk assessments, as well as to the amount of use, risk, public concern, and
complexity associated with each pesticide. Using the public participation process, EPA is
attaining its strong commitment to both involve the public and meet statutory deadlines.
Please note that the alkylbenzene sulfonates risk assessment and the attached RED
document concern only this particular pesticide. This RED presents the Agency's conclusions
on the dietary, drinking water, occupational, residential and ecological risks posed by exposure
to alkylbenzene sulfonates alone. This document also identifies both generic and product-
specific data that the Agency intends to require in Data Call-Ins (DCIs). Note that DCIs, with all
pertinent instructions, will be sent to registrants at a later date. Additionally, for product-specific
DCIs, the first set of required responses will be due 90 days from the receipt of the DCI letter.
The second set of required responses will be due eight months from the receipt of the DCI letter.
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As part of the RED, the Agency has determined that alkylbenzene sulfonates will be
eligible for reregi strati on provided that all the conditions identified in this document are satisfied.
Sections IV and V of this RED document describe the necessary labeling amendments for end-
use products and data requirements. Instructions for registrants on submitting the revised
labeling can be found in the set of instructions for product-specific data that will accompany this
DCI.
If you have questions on this document or the label changes relevant to this reregi strati on
decision, please contact the Chemical Review Manager, Heather Garvie, at (703) 308-0034. For
questions about product reregi strati on and/or the Product DCI that will follow this document,
please contact Adam Heyward at (703) 308-6422.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Alkylbenzene Sulfonates
ListD
CASE 4006
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
July 27, 2006
Attachment
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Table of Contents
Alkylbenzene Sulfonates Reregistration Team i
Glossary of Terms and Abbreviations ii
Executive Summary iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 4
1. Sodium Dodecylbenzene Sulfonate 4
a. Chemical Overview 4
b. Use Profile 4
2. Dodecylbenzene Sulfonic Acid 5
a. Chemical Overview 5
b. Use Profile 6
3. Benzenesulfonic acid, C10-16-alkyl derivatives 7
a. Chemical Overview 7
b. Use Profile 7
III. Summary of Alkylbenzene Sulfonates Risk Assessments 9
A. Human Health Risk Assessment 9
1. Toxicity of Alkylbenzene Sulfonates 9
2. FQPA Safety Factor 13
3. Population Adjusted Dose (PAD) 13
a. Acute PAD 14
b. Chronic PAD 14
4. Dietary Exposure Assumptions 14
5. Dietary (Food) Risk Assessment 15
a. Acute and Chronic Dietary Risk 15
b. Dietary Exposure for Inert Ingredient Uses 17
c. Dietary Risk from Drinking Water 18
6. Residential Risk Assessment 19
a. Toxicity 19
b. Residential Handler 21
i. Exposure Scenarios, Data and Assumptions 21
ii. Residential Handler Risk Estimates 22
c. Residential Post-Application 24
7. Aggregate Risk 24
a. Short-Term Aggregate Risk 25
b. Chronic Aggregate Risk 26
8. Occupational Exposure and Risk 27
a. Occupational Toxicity 28
b. Occupational Handler Exposure 28
c. Occupational Handler Risk Summary 28
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d. Occupational Post-Application Exposure 32
B. Environmental Risk Assessment 32
1. Environmental Fate and Transport 32
2. Ecological Risk 33
3. Risk to Listed Species 34
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 36
A. Determination of Reregistration Eligibility 36
B. Public Comments and Responses 36
C. Regulatory Position 37
1. Food Quality Protection Act Findings 37
a. "Risk Cup" Determination 37
b. Determination of Safety to U.S. Population 37
c. Determination of Safety to Infants and Children 38
d. Endocrine Disrupter Effects 38
e. Cumulative Risks 39
2. Tolerance Summary 39
D. Regulatory Rationale 41
1. Human Health Risk Management 41
a. Dietary (Food) Risk Mitigation 41
b. Drinking Water Risk Mitigation 41
c. Residential Risk Mitigation 41
d. Occupational Risk Mitigation 42
i. Handler Risk Mitigation 42
ii. Post-Application Risk Mitigation 42
2. Environmental Risk Management 42
3. Listed Species Considerations 42
a. The Endangered Species Act 42
b. General Risk Mitigation 43
V. What Registrants Need to Do 44
A. Manufacturing-Use Products 46
1. Additional Generic Data Requirements 46
2. Labeling for Technical and Manufacturing-Use Products 46
B. End-Use Products 46
1. Additional Product-Specific Data Requirements 46
2. Labeling for End-Use Products that Contain Alkylbenzene
Sulfonates as an Inert Ingredient 48
VI. Appendices 49
A. Table of Use Patterns for Alkylbenzene Sulfonates 50
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 57
C. Technical Support Documents 63
D. Bibliography Citations 65
E. Generic Data Call-In 69
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F. Product Specific Data Call-In 70
G. Batching of End-Use Products 71
H. List of All Registrants Sent the Data Call-In 72
I. List of Available Forms 73
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Alkylbenzene Sulfonates Reregistration Team
Health Effects Risk Assessment
Deborah Smegal
Ayaad Assaad
Talia Milano
Cassi Walls
Kerry Leifer
Najm Shamim
Robert Quick
Ecological Risk Assessment
Rick Petrie
Environmental Fate Risk Assessment
Talia Milano
Registration Support
Adam Heyward
Risk Management
Heather Garvie
Jennifer Slotnick
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
ii
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MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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EXECUTIVE SUMMARY
The Environmental Protection Agency (hereafter referred to as EPA or the Agency) has
completed preliminary risk assessments and its review of error correction and public comments
on the human health and environmental risk assessments for alkylbenzene sulfonates and is
issuing its risk management decision. The Agency will accept public comments on this decision
and supporting documents for 60 days following publication. The Agency has decided
alkylbenzene sulfonates are eligible for reregi strati on provided all measures outlined in this
document are implemented. If during the comment period the Agency receives new or
additional information that substantially changes the risk assessment findings or the risk
management decision, the Agency will issue an amendment to this document.
Alkylbenzene sulfonates are used largely as food-contact sanitizers in food processing
plants and eating establishments. They are also used as disinfectants and sanitizers for
agricultural, commercial, institutional, industrial, and public access uses. Approximately
300,000 pounds of alkylbenzene sulfonates are used in EPA registered antimicrobial products.
However, the largest overall use of alkylbenzene sulfonates is in household laundry and dish
detergents. The alkylbenzene sulfonates are listed on the EPA High Production Volume (HPV)
Challenge Program. HPV chemicals are those that are manufactured or imported into the U.S. in
production volumes greater than one million pounds per year.
Overall Risk Summary
An acute dietary assessment was not conducted because there are no adverse effects
attributable to a single dose seen in animal studies. Chronic dietary risk estimates were provided
for the general U.S. population and all population subgroups. All chronic dietary risk estimates
are below the Agency's level of concern.
Because there are no adverse effects attributable to acute exposure, an acute aggregate
assessment was not conducted. An intermediate-term aggregate assessment was not conducted
because there are no residential exposures of this duration. Therefore, only short-term and
chronic aggregate assessments were conducted. In addition, because there are no long-term
residential exposures, the chronic aggregate assessment only considered food and drinking water
exposures. The short-term aggregate assessment considers both the active and inert uses of the
alkylbenzene sulfonates. The chronic aggregate assessment considers average dietary exposure
(food and drinking water) from both the active food contact sanitizer uses and the inert uses on
agricultural commodities. The dietary exposures from the fruit and vegetable wash were not
considered because it would be overly conservative to assume simultaneous exposure to
alkylbenzene sulfonates from three different use patterns. The short-term aggregate oral and
inhalation risks are not of concern for adults or children. In addition, the chronic aggregate
assessment found no risk of concern for children or adults.
The Agency's human heath risk assessment indicates that there are four occupational
handler inhalation scenarios with MOEs less than the target of 100. These four scenarios have
MOEs between 90 and 93. Although these MOEs are below the Agency target of 100, the
iv
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Agency is not requiring mitigation since the risk assessment is based on conservative
assumptions and the MOEs are very close to the target so that the Agency does not have risk
concerns.
Dermal exposures were not considered in the risk assessment because a toxicological
endpoint was not established for this route of exposure.
An environmental risk assessment was also conducted for alkylbenzene sulfonates. Due
to limited potential for environmental exposure, environmental risks are below the Agency's
level of concern.
Dietary Risk
The Agency conducted three chronic dietary exposure and risk assessments for
alkylbenzene sulfonates: (1) as an active ingredient in food contact sanitizing solutions; (2) as an
active ingredient in a fruit and vegetable wash; and (3) as an inert ingredient in pesticide
formulations that may be applied to growing agricultural crops, raw agricultural commodities
after harvest, and to animals. An acute dietary assessment was not conducted because there are
no adverse effects attributable to a single dose in animal studies.
The dietary risk estimates for the active ingredient, total food contact sanitizing uses are
below the Agency's level of concern for the general U.S. population for all age groups (less than
11% of the cPAD). The dietary risk estimates for the fruit and vegetable wash are also below the
Agency's level of concern for all age groups (less than 71.2% of the cPAD).
The dietary risk estimates for the inert ingredient uses are below the Agency's level of
concern for the general U.S. population (24% of the cPAD) and all population subgroups (84%
of the cPAD for children 1-2 years of age). There is no concern for aggregate food and drinking
water exposures to the alkylbenzene sulfonates resulting from their use as inert ingredients in
pesticide products.
The chronic dietary risk assessment concludes that risk estimates are below the Agency's
level of concern for the general U.S. population and all subpopulations. Therefore, no mitigation
measures are necessary.
Drinking Water Risk
There are no currently registered outdoor uses of alkylbenzene sulfonates as active
ingredients. However, the potential exists for transport into drinking water resulting from the
pesticidal inert ingredient uses of alkylbenzene sulfonates. Therefore, the Agency estimated
drinking water concentrations resulting from the inert ingredient uses of these substances. The
Agency did not estimate acute drinking water risks for the inert ingredient use because an acute
dietary endpoint (i.e., aPAD) was not selected as there were no effects attributable to a single
dose exposure in animal studies. The Agency concluded that there are no risk concerns for the
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general U.S. population and all population subgroups for drinking water exposures to the
alkylbenzene sulfonates as pesticide inert ingredients.
Residential Risk
Residential handler and post-application exposure scenarios were assessed using high end
exposure scenarios, end-use product application methods and use rates for inert uses. For each
of the use scenarios, the Agency assessed residential handler (applicator) inhalation exposure and
post application incidental ingestion by toddlers. All margins of exposure (MOEs) for short-term
inhalation exposure for residential handlers are above the target MOE of 100 and, therefore, not
of concern, with the exception of the flea and tick product where the MOE was 87. However,
this screening level assessment was conducted using conservative assumptions because it
assumes a person treats his/her pet with 0.5 cans of flea product that contains 24% alkylbenzene
sulfonates every day for a month. All MOEs for residential post-application exposure are above
the target of MOE of 100 and, therefore, are not of concern. Therefore the Agency does not have
risk concerns.
Aggregate Risk
The chronic aggregate assessment considers average dietary exposure (food and drinking
water) from both the active food contact sanitizer uses and the inert uses on agricultural
commodities. The dietary exposures from the fruit and vegetable wash were not considered
because it would be overly conservative to assume simultaneous exposure to alkylbenzene
sulfonates from three different use patterns. Oral and inhalation exposure and risk estimates
were conservatively combined for the aggregate risk assessment. Both short-term and chronic
aggregate assessments were conducted. The short-term aggregate oral and inhalation risks are
not of concern for adults, as the total aggregate MOE is 340 which is greater than the target of
100. For children, the aggregate risk estimate is very close to the target MOE of 100 (MOE=99).
Because of the conservative nature of the assessment, the Agency does not have any risks of
concern for children. The chronic aggregate assessment found no risk of concern for children or
adults.
Occupational Risk
The Agency's human heath risk assessment indicates that there are four occupational
handler inhalation scenarios with MOEs less than the target of 100. These four scenarios have
MOEs between 90 and 93. The Agency is not requiring mitigation because the conservative
assumptions used in the risk assessment, combined with the nearness of the MOE to the target,
do not suggest concerns.
For most of the occupational scenarios, postapplication dermal exposure is not expected
to occur or is expected to be negligible based on the application rates and chemical properties of
alkylbenzene sulfonates.
VI
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Alkylbenzene sulfonates are dermal irritants at concentrations greater than 20%. Almost
all of the labels require the use of gloves by workers.
Ecological Risk
Minimal or no environmental exposure to terrestrial or aquatic organisms is expected to
occur from the majority of alkylbenzene sulfonate antimicrobial indoor pesticide uses given that
only a very small number of total alkylbenzene sulfonates pounds are used for these purposes.
Available data suggest that the alkylbenzene sulfonates may be more toxic to aquatic organisms
as the number of carbons in the chain increase. Available data also indicate that the
alkylbenzene sulfonates are slightly toxic to green algae.
The inert agricultural uses of alkylbenzene sulfonates are not expected to adversely affect
avian or mammalian species on an acute or chronic basis. Aquatic organisms are also not
expected to be adversely affected by inert alkylbenzene sulfonates use acutely or chronically due
to the low estimated level of alkylbenzene sulfonates in water.
Use of alkylbenzene sulfonates in agricultural pesticide formulations is not expected to
result in significant environmental exposure, therefore, no adverse effects (NE) to listed species
are anticipated.
Regulatory Decision
The Agency has completed its review and has determined that the data are sufficient to
support reregi strati on of all supported products containing alkylbenzene sulfonates. The Agency
is issuing this RED for alkylbenzene sulfonates, as announced in a Notice of Availability
published in the Federal Register. The RED and supporting risk assessment documents for
alkylbenzene sulfonates are available to the public on the U.S. Federal Government website
www.regulations.gov. The docket is EPA-HQ-OPP-2006-0156.
This RED document includes guidance and time frames for making any necessary label
changes for products containing alkylbenzene sulfonates.
Summary of Mitigation Measures
Since no risks of concern were identified, no specific mitigation measures are needed for
alkylbenzene sulfonates.
Data Requirements
Additional confirmatory data is required to complete the reregi strati on of alkylbenzene
sulfonates. A complete list of data gaps is presented Section V and Appendix B (Table of
Generic Data Requirements). In addition, product-specific data is required for all products
containing alkylbenzene sulfonates as described in Section V of this document.
vn
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregi strati on of products with active ingredients registered prior
to November 1, 1984 and amended again by the Pesticide Registration Improvement Act
of 2003 to set time frames for the issuance of Reregi strati on Eligibility Decisions. The
amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (EPA or the Agency). Reregi strati on involves a
thorough review of the scientific database underlying a pesticide's registration. The
purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed
into law. This Act amends FIFRA to require tolerance reassessment. The Agency has
decided that, for those chemicals that have tolerances and are undergoing reregi strati on,
the tolerance reassessment will be initiated through this reregi strati on process. The Act
also requires that by 2006, EPA must review all tolerances in effect on the day before the
date of the enactment of the FQPA. FQPA also amends the Federal Food, Drug, and
Cosmetic Act (FFDCA) to require a safety finding in tolerance reassessment based on
factors including consideration of cumulative effects of chemicals with a common
mechanism of toxicity. This document presents the Agency's revised human health and
ecological risk assessments and the Reregi strati on Eligibility Decision (RED) for
alkylbenzene sulfonates (ABS).
The alkylbenzene sulfonates case is comprised of three active ingredients: sodium
dodecylbenzene sulfonate, dodecylbenzene sulfonic acid and alklybenzene sulfonic acid.
Sodium dodecylbenzene sulfonate and dodecylbenzene sulfonic acid (DDESA) were first
registered with the EPA on September 25, 1968 and February 24, 1969. C10-16
alkylbenzene sulfonic acid was registered on September 20, 1988.
As the case currently stands, sodium dodecylbenzene sulfonate (PC Code 079010)
has three active products. Dodecylbenzene sulfonic acid (PC Code 098002) has 18 active
products. C10-16-alkylbenzene sulfonic acid (PC Code 190116) has one active product.
For a list of all the current products, please see Appendix A. In addition, these chemicals
are also used as inert ingredients in other pesticide products.
Alkylbenzene sulfonates are antimicrobial pesticides that are used largely as food-
contact sanitizers in food processing plants and eating establishments. They are also used
as disinfectants and sanitizers for agricultural, commercial, institutional, industrial, and
public access uses.
Tolerance exemptions for the active food-contact sanitizer uses of these
ingredients have been established and can be found at 40 CFR 180.940(b) and (c).
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The Agency has concluded that the FQPA Safety Factor for alkylbenzene
sulfonates should be removed (equivalent to IX), based on the available data and the risk
assessment that does not underestimate risks for infants and children. A number of
developmental studies via the oral route have been performed with alkylbenzene
sulfonates in rats, mice and rabbits. The available information in these studies does not
suggest any qualitative or quantitative evidence for susceptibility between the fetuses and
maternal animals. The alkylbenzene sulfonates were tested in several multigeneration
studies in rats, and there were no effects on offspring in any of these tests at doses up to
250 mg/kg/day.
The Food Quality Protection Act (FQPA) requires that the Agency consider
available information concerning the cumulative effects of a particular pesticide's
residues and other substances that have a common mechanism of toxicity. The reason for
consideration of other substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a common toxic
mechanism could lead to the same adverse health effect that would occur at a higher level
of exposure to any of the substances individually. 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 for alkylbenzene sulfonates and
any other substances. Alkylbenzene sulfonates do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this action, therefore, EPA
has not assumed that alkylbenzene sulfonates have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregi strati on
eligibility of the registered uses of alkylbenzene sulfonates. In an effort to simplify the
RED, the information presented herein is summarized from more detailed information
which can be found in the technical supporting documents for alkylbenzene sulfonates
referenced in this RED. The revised risk assessments and related addenda are not
included in this document, but are available in the Public Docket at www.regulations.gov.
This document consists of six sections. Section I is the Introduction. Section II,
Chemical Overview, provides regulatory history, a profile of the use and usage of
alkylbenzene sulfonates and a basic overview of the chemical. Section III, Summary of
Alkylbenzene Sulfonates Risk Assessments, gives an overview of the human health and
environmental assessments, based on the data available to the Agency. Section IV, Risk
Management, Reregi strati on, and Tolerance Reassessment Decision, presents the
reregi strati on eligibility and risk management decisions. Section V, What Registrants
Need to Do, summarizes the necessary label changes based on the risk mitigation
measures, if any, outlined in Section IV. Finally, the Appendices list all use patterns
eligible for reregi strati on, bibliographic information, related documents and how to
access them, and Data Call-In (DCI) information.
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II. Chemical Overview
A. Regulatory History
The alkylbenzene sulfonates case is comprised of three active ingredients.
Sodium dodecylbenzene sulfonate (PC Code 079010) and dodecylbenzene sulfonic acid
or DDES A (PC Code 098002) were first registered with the EPA on September 25, 1968
and February 24, 1969, respectively. C10-16-alkylbenzene sulfonic acid (PC Code
190116) was not registered until 1988. According to the unregistered technical
manufacturers, at least some of the technical material contains a carbon mixture (CIO-16)
in the alkyl string and not pure C12 (as the name dodecyl- implies). As the case currently
stands, sodium dodecylbenzene sulfonate has three active products. Dodecylbenzene
sulfonic acid has 18 active products. C10-16-alkylbenzene sulfonic acid has one active
product.
These chemicals are antimicrobials used largely as food-contact sanitizers in food
processing plants and eating establishments. They are also used as disinfectants and
sanitizers for agricultural, commercial, institutional, industrial, and public access uses. In
addition to the pesticidal uses, the linear alkylbenzene sulfonate (LAS) surfactants are
used in laundry and dish detergents as well as many other common uses. As inert
ingredients in pesticide products, the chemicals are used in residential and outdoor
agricultural settings.
The DDES A Steering Committee/Joint Venture ("Joint Venture") formed on
January 23, 1992 in response to EPA's October 23, 1989 notice initiating reregi strati on
under FIFRA § 4 for List D of active pesticide ingredients. Current Joint Venture
Members include: Acuity Specialty Products/Zep; Alex C. Fergusson, Inc.; Anderson
Chemical Co.; DeVere Chemical Co., Inc.; Ecolab, Inc.; Hydrite Chemical Co.;
JohnsonDiversey, Inc.; Morgan-Gallacher, Inc.; Oakite Products, Inc.; Quadra
Chemical, Inc.; Thatcher Company; and West Agro, Inc.
Exemptions from the requirement of a tolerance for the active food-contact
sanitizer uses of these ingredients have been established in the 40 CFR 180.940(b) and
(c).
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B. Chemical Identification
CH3(CH£>5CH{CH2)J!1CH.3
SO,- Na*
Figure 1: Sodium Dodecylbenzene Sulfonate (also named as dodecylbenzene sulfonic acid, sodium salt)
1. Sodium Dodecylbenzene Sulfonate (079010)
a. Chemical Overview
Common Name:
Chemical Name:
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Empirical Formula:
Molecular Weight:
Highest Percentage of Active:
End-Use Product Distributors:
Sodium dodecylbenzene sulfonate
Alkyl(C12) benzenesulfonic acid, sodium
salt
Benzenesulfonic acid, dodecyl-, sodium salt
Dodecylbenzene sodium sulfonate
Dodecylbenzenesulfonic acid, sodium salt
Sodium laurylbenzenesulfonate
079010
25155-30-0
4006
Ci8H29Na03S / Ci2H25C6H4S03Na
348.5
3.6%
Oakite Products Inc.
Microcide Inc.
b. Use Profile
Type of pesticide:
Disinfectant
Microbiocide
Bacteriocide
Sanitizer
Microbiostat
Bacteriostat
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Use Sites:
FOOD HANDLING/STORAGE ESTABLISHMENT PREMISES AND
EQUIPMENT
Fruit and Vegetable Wash Water
Food Processing, Handling, and Storage Plant Surfaces, Equipment, and Premises
Milk and Dairy Processing Plant Surfaces, Equipment, and Premises
Meat and Poultry Processing Plant Surfaces, Equipment, and Premises
Eating Establishment Food Contact Surfaces, Equipment and Utensils
Food Dispensing Equipment
Vending Machines
Soft Custard Equipment
COMMERCIAL. INSTITUTIONAL. INDUSTRIAL PREMISES AND
EQUIPMENT
Mine Acid Control
2. Dodecylbenzene Sulfonic Acid (098002)
a. Chemical Overview
Common Name:
Chemical Name:
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Empirical Formula:
Molecular Weight:
Highest Percentage of Active:
End-Use Product Distributors:
Dodecylbenzene sulfonic acid
Dodecylbenzene sulfonic acid
098002
27176-87-0
4006
326.5
15.67%
Anderson Chemical Co.
ZEP Manufacturing Co.
Hydrite Chemical Co.
Devere Company Inc.
Morgan-Gallacher Inc.
FiveStar Affiliates Inc
Alex C. Fergusson, Inc.
International Chemical Corp.
Chemical Systems of Florida Inc
Diverseylever
Ecolab, Inc.
West Argo Inc.
US Chemical Corp.
Drexel Chemical Co.
-------
b. Use Profile:
Type of Pesticide: Sanitizer Disinfectant
Virucide Bacteriocide
Bacteriostat
Use Sites:
AGRICULTURAL PREMISES AND EQUIPMENT
Dairy Farms (enclosed premise treatment)
Milking Equipment
Teat Liner
FOOD HANDLING/STORAGE ESTABLISHMENTS PREMISES AND
EQUIPMENT
Dairy Equipment, Premises, and Utensils
Milk Storage (bulk)
Fruit and Vegetable Wash Water
Food/Milk Transportation Vehicles
Food Processing Plant Equipment, Premises, and Surfaces
Bakery Processing Equipment
Brewery Process Plant Equipment and Surfaces
Cannery Processing Equipment
Milk and Dairy Processing Plant Equipment, Premises, and Surfaces
Potato Washing Machines
Fruit and Vegetable Processing Equipment
Meat and Poultry Processing Plant Equipment, Premises, and Surfaces
Winery Processing Equipment
Egg Processing Equipment
Beverage Processing Equipment and Surfaces
Fish Processing Equipment
Eating Establishment Equipment, Glassware, Utensils, Surfaces
Food Vending Machines
Food Dispensing Equipment
Food Store/Market/Supermarket Premises
Seed Houses/Stores/Storage Areas/Warehouses
COMMERCIAL. INSTITUTIONAL. INDUSTRIAL PREMISES AND
EQUIPMENT
Research Animal Facilities (enclosed premise treatment)
Zoo Premises (enclosed premise treatment)
Airports
Campgrounds
Commercial Transportation Facilities
Aircraft (non feed/food)
Buses (non feed/food)
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Ships
Railroad Trains
Commercial Premises and Equipment
Shower Stalls
Urinals
Toilet Bowls
RESIDENTIAL AND PUBLIC ACCESS PREMISES
Boat Premises
Automobiles
MEDICAL PREMISES AND EQUIPMENT
Sickroom Premises
3. Benzenesulfonic acid, C10-16-alkyl derivatives (190116)
a. Chemical Overview
Common Name:
Chemical Name:
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Empirical Formula:
Molecular Weight:
Highest Percentage of Active:
End-Use Product Distributors:
b. Use Profile:
Type of Pesticide:
Benzenesulfonic acid, C10-16-alkyl derivs.
C10-16-Alkylbenzene sulfonic acid
190116
68584-22-5
4006
324
25.6%
Kay Chemical Co.
Quadra Chemicals, Inc.
Sanitizer
Bacteriostat
B acted ocide
Use Sites:
AGRICULTURAL PREMISES AND EQUIPMENT
Dairy/Milking Equipment and Utensils
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FOOD HANDLING/STORAGE ESTABLISHMENTS PREMISES AND
EQUIPMENT
Milk Storage (bulk)
Food Processing Plant Equipment and Surfaces
Meat and Poultry Processing Plant Equipment and Premises
Milk and Dairy Processing Plant Equipment and Premises
Beverage Processing Plant Equipment, Premises, and Surfaces
Eating Establishment Equipment, Utensils, and Surfaces
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III. Summary of Alkylbenzene Sulfonates Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features
and findings of these risk assessments and to help the reader better understand the
conclusions reached in the assessments. The human health and ecological risk
assessment documents and supporting information listed in Appendix C were used to
formulate the safety finding and regulatory decision for alkylbenzene sulfonates. While
the risk assessments and related addenda are not included in this document, they are
available from the U.S. Federal Government Public Docket at www.regulations.gov. The
docket identification number is EPA-HQ-OPP-2006-0156. Hard copies of these
documents may be found in the OPP public docket which is located in Room S-4400,
One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is open Monday
through Friday, excluding Federal holidays, from 8:30 a.m.to 4:00 p.m.
A. Human Health Risk Assessment
The Agency's use of human studies in the alkylbenzene sulfonates risk
assessment is in accordance with the Agency's Final Rule promulgated on January 26,
2006, related to Protections for Subjects in Human Research, which is codified in 40 CFR
Part 26.
1. Toxicity of Alkylbenzene Sulfonates
A brief overview of the toxicity studies used for determining endpoints in the risk
assessments are outlined below in Table 1. Further details on the toxicity of
alkylbenzene sulfonates can be found in the "Alkylbenzene Sulfonates (ABS) Toxicology
Chapter for the Reregi strati on Eligibility Decision (RED) Document," dated July 06 ,
2006; and "Sulfonates (ABS) Revised Risk Assessment for the Reregi strati on Eligibility
Decision (RED) Document," dated July 19, 2006. These documents are available on the
U.S. Federal Government Public Docket website at www.regulations.gov.
The Agency has reviewed all toxicity studies submitted for alkylbenzene
sulfonates and has determined that the toxicological database is sufficient for
reregi strati on. The studies have been submitted to support guideline requirements.
Major features of the toxicology profile are presented in Table 1.
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Table 1. Acute Toxicity Studies for Alkylbenzene Sulfonates
Guideline No./ Study Type
870. 1 100 Acute oral toxicity
870.1200 Acute dermal toxicity
870.1300 Acute inhalation toxicity
870.2400 Acute eye irritation
870.2500 Acute dermal irritation
870.2600 Skin sensitization
MRID No.
43498402
43498408
43498430
94032006
Open
Literature
43498405
40359306
Open
Literature
Results
LD50 = range from 404 to over 5000
mg/kg
LD50 = 1200 mg/kg
LC50 = 0.31mg/L
Cornea! opacity not reversed at 72
hours.
Severe irritation at 72 hours
Toxicity
Category
III-IV
II
II
I
II
Non-Sensitizer
The doses and toxicological endpoints selected by the Agency for the various
exposure scenarios are summarized below in Table 2.
Table 2. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates
Exposure
Scenario
Acute Dietary
(All populations)
Dose Used in
Risk
Assessment,
UF
Special FQPA
SF*, endpoint
and Level of
Concern for
Risk Assessment
Study and Toxicological Effects
No endpoint was selected. No effects are attributable to a single dose in animal studies.
10
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Table 2. Summary of Toxicological Dose and Endpoints for Alkylbenzene Sulfonates
Exposure
Scenario
Dose Used in
Risk
Assessment,
UF
Special FQPA
SF*, endpoint
and Level of
Concern for
Risk Assessment
Study and Toxicological Effects
Chronic Dietary
(All populations)
Systemic/
Reproductive
NOAEL= 50
mg/kg/day
UF = 100
Chronic RfD =
0.5 mg/kg/day
FQPA SF = IX
cPAD =
chronic RfD
FQPA SF
= 0.5 mg/kg/day
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)
plus
Systemic/Reproductive NOAEL = 50
mg/kg/day and LOAEL = 250 mg/kg/day
based on decreased Day 21 female pup body
weight (Buehler, E. etal. 1971. Tox. Appl.
Pharmacol. 18:83-91)
plus
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): 105-112)
General Toxicity Observations
Acute Toxicity. Alkylbenzene sulfonates exhibit a wide range of acute toxicity via
the oral route in rats (LDsoS of 404 - 1980 mg/kg), with a narrower range in mice (LDsoS
of 1259-2300 mg/kg). This spans the acute oral toxicity categories of III-IV.
Alkylbenzene sulfonates are classified as acute toxicity category II for the dermal and
inhalation routes of exposure. They are irritants to the eye (category I) and skin (category
II), and are not skin sensitizers.
Absorption, Distribution, Metabolism, Excretion. In animal tests (oral -
monkeys, pigs, rats), alkylbenzene sulfonates are readily absorbed from the
gastrointestinal tract, are distributed throughout the body, and are extensively
metabolized. Excretion is via both the urine and feces. Available dermal absorption data
(rats and guinea pigs) indicate that alkylbenzene sulfonates are poorly absorbed from the
skin, although prolonged contact may lead to irritation and thus compromise the skin to
permit more absorption (WHO, 1996 and HERA, 2004).
11
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Repeated Dose Toxicity (Subchronic and Chronic). There have been many oral
repeated dose studies performed with alkylbenzene sulfonates ranging from a 28-day
study in monkeys to nine month studies conducted with rats and mice. There have also
been repeated dose dermal (guinea pigs, rabbits, and rats) and inhalation studies (dogs
and monkeys). Collectively, animal data suggests that the liver, kidney and caecum (for
oral studies) are the major target organs for toxicity. The liver and kidney effects were
dose and duration related in that mild effects (organ weight changes and serum
enzyme/clinical chemistry changes indicative of mild organ effects) were seen at lower
doses, but increased in severity with both dose and time.
For the purposes of this hazard assessment, several studies were considered
collectively to determine a no-observable adverse effect level (NOAEL) of 50 mg/kg/day
for the chronic dietary endpoint. This is based on: increased caecum weight and slight
kidney damage (at a NOAEL of 40 mg/kg/day and at a LOAEL of 114 mg/kg/day in the
six month rat study); reduced body weight in 21-day old pups (at a NOAEL of 50
mg/kg/day and a LOAEL of 250 mg/kg/day in a reproductive toxicity rat study); and
significant decreases in renal biochemical parameters (at a NOAEL of 85 mg/kg/day and
a LOAEL of 145 mg/kg/day in a nine month drinking water study in rats).
Developmental Toxicity. A number of developmental studies via the oral and
dermal routes have been performed with alkylbenzene sulfonates in rats, mice and
rabbits; there were also several subcutaneous injection developmental studies reported in
mice (WHO, 1996). In these developmental studies, there is varying quality in the more
than 20 studies submitted. However, it is concluded that some developmental effects
(including some terata) were observed at high doses at which maternal toxicity was
observed and the available information does not suggest any qualitative or quantitative
susceptibility differences between fetuses and maternal animals.
Reproductive Toxicity. Alkylbenzene sulfonates were tested in several
multigeneration studies in rats. There were no effects on reproductive parameters in any
of these tests at doses up to 250 mg/kg/day.
Carcinogenicity. The available long-term studies that assessed carcinogenicity
were older studies (pre-1970) that would not be acceptable under current standards due to
low number of animals used, insufficient number of doses and duration of dosing, and
limited histopathological examinations. However, the limited studies provide no
evidence of carcinogenicity in animals given alkylbenzene sulfonates orally.
Genotoxicity. The toxicological data show that alkylbenzene sulfonates were not
genotoxic in vitro or in vivo.
Neurotoxicity. There is no evidence in the available toxicity studies or scientific
literature to indicate neurotoxic effects of the alkylbenzene sulfonates in humans or
laboratory animals.
12
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Endocrine Disruption Potential. EPA is required under the Federal Food Drug
and Cosmetic Act (FFDCA), as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate." Following recommendations of its Endocrine Disrupter and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for
including, as part of the program, the androgen and thyroid hormone systems, in addition
to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. For pesticide chemicals,
EPA will use FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow, screening of
additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP). When the appropriate screening and/or testing protocols being considered under
the Agency's Endocrine Disrupting Screening Program (EDSP) have been developed,
alkylbenzene sulfonates may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safely Factor (as required by the Food Quality Protection Act of 1996)
is intended to provide an additional 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, or to compensate for an incomplete database. The FQPA Safety
Factor has been removed (i.e., reduced to IX) for alkylbenzene sulfonates based on: (1) a
lack of evidence that alkylbenzene sulfonates will induce neurotoxic effects, (2) no
quantitative or qualitative evidence of increased susceptibility to the fetus following in
utero exposure in the prenatal developmental toxicity studies, and (3) no quantitative or
qualitative evidence of increased susceptibility to the offspring when adults are exposed
in the two-generation reproductive study. The FQPA Safety Factor assumes that the
exposure databases (food, drinking water, and residential) are complete and that the risk
assessment does not underestimate the potential risk for infants and children. These
criteria have been met for alkylbenzene sulfonates. Based on the analysis of submitted
developmental toxicity studies, the Agency determined that no special FQPA Safety
Factor was needed since there were no residual uncertainties for pre- and/or postnatal
toxicity.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD),
which reflects the reference dose (RfD), either acute or chronic, that has been adjusted to
account for the FQPA Safety Factor (SF). This calculation is performed for each
population subgroup. A risk estimate that is less than 100% of the acute or chronic PAD
is not of concern.
13
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a. Acute PAD
Acute dietary risk is assessed by comparing acute dietary exposure estimates (in
mg/kg/day) to the acute Population Adjusted Dose (aPAD). Acute dietary risk is
expressed as a percent of the aPAD. 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.
b. Chronic PAD
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 percent 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 a NOAEL of 50 mg/kg/day based on a
weight of evidence from three toxicological studies that observed decreased pup body
weight at 250 mg/kg/day and increased caecum weight, slight kidney damage at 114
mg/kg/day and significant decreases in 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 as shown in Table 2. An uncertainty factor of 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 the FQPA safety factor (IX) for
the overall U.S. population or any population subgroups.
4. Dietary Exposure Assumptions
Chronic dietary exposure assessments for alkylbenzene sulfonates were conducted
for the following uses: (1) as active ingredients in food contact sanitizing solutions; (2) as
active ingredients in a fruit and vegetable wash; and (3) as inert ingredients in pesticide
formulations that may be applied to growing agricultural crops, raw agricultural
commodities after harvest, and to animals (pet product).
In the absence of residue data for residues of alkylbenzene sulfonates on treated
food contact surfaces, the Agency estimated residue levels that may occur in food from
the application rates on food contact surfaces. As mentioned previously, to determine the
Estimated Daily Intake (EDI), the Agency has used an FDA model. The maximum
percentage of active ingredient for dodecylbenzene sulfonates in food handling
establishments from the various labels is 400 ppm. The Agency estimates that use of
this product results in food residues of 530 ppb (jig/kg). The Agency assumed that food
can contact 4000 cm2 of treated surfaces, utensils, glassware, or pots and pans and that
100% of the pesticide migrates to food based on the standard assumptions used in the
FDA Sanitizing Solution Guidelines. It was assumed that an adult and child consume
3000 and 1500 grams of food per day, respectively that will contact the treated surfaces.
14
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The Agency used the FDA milk truck model to estimate residues in milk that
could result from the use of alkylbenzene sulfonates in the food processing equipment, as
representative of the potential uses in the food processing industry. As a conservative
measure, the Agency assessed the maximum application rate of 400 ppm for
dodecylbenzene sulfonates, as listed on the labels, although the current tolerance
exemption has a limitation of 5.5 ppm for dairy processing equipment. The Agency
estimates that use of this product results in maximum milk residues of 10 ppb (|ig/kg).
The Agency will be proposing a change to the 40 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 also estimated dietary exposure from the fruit and vegetable wash of
the alkylbenzene sulfonates. This use is regulated by the FDA in 21 CFR 173.315, which
permits the wash solution to contain dodecylbenzene sulfonic acid up to a maximum
application rate of 0.2% (2000 ppm), without a potable rinse. The Agency assumed this
maximum application rate of 2000 ppm in wash solution, along with assumptions for
Thompson Seedless grapes as a surrogate to represent residues on all treated fruits and
vegetables. The model estimates dodecylbenzene sulfonic acid residues of 9.25 ppm.
Most of the pesticide labels are in compliance with this limitation. One label however,
allows a vegetable wash solution containing 0.31% (3100 ppm) dodecylbenzene sulfonic
acid, but requires a potable rinse following washing. The Agency plans to establish 0.2%
as the maximum application rate that can be used without a potable rinse.
As inert ingredients in pesticide formulations, a conservative screening level
dietary exposure model, Exposure Evaluation Model (DEEM™), was used that assumed
100% of all commodities, and 100% of all crops were treated with the alkylbenzene
sulfonates, with no limitation on the fraction of inert ingredient. A complete explanation
of the assumptions used in the generic screening model for estimating inert ingredient
dietary exposure is given in Appendix A of the Inert Ingredient Dietary Risk Assessment
for Linear Alkyl Benzenesulfonate.
5. Dietary (Food) Risk Assessment
a. Acute and Chronic Dietary Risk
Generally, a dietary risk estimate that is less than 100% of the acute or chronic
PAD does not exceed the Agency's risk concerns. A summary of chronic risk estimates
for active uses is shown in Table 3. A summary of chronic risk estimates for inert uses is
shown in Table 4. Based on the pesticide labels, the Agency assessed dietary exposure
that could result from the use of alkylbenzene sulfonates in the food service industry
(treated surfaces, dishes, utensils, glassware, pots and pans), in the food processing
industry (food processing equipment such as breweries and beverage plants, meat and
poultry processing plants, milk and dairy products/packing plants etc), and as a fruit and
vegetable wash. For additional information, please see the Dietary Exposure
Assessments for the Reregi strati on Eligibility Decision and the Inert Ingredient Dietary
Risk Assessment for Linear Alkyl Benzenesulfonate documents.
15
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The daily estimates for food handling establishments, food processing equipment
and the fruit and vegetable wash were conservatively used to assess chronic dietary risks,
which are shown below in Table 3. As noted previously, an acute dietary assessment was
not conducted because there were no adverse effects attributable to a single dose
exposure in animal studies.
The dietary risk estimates for the total food contact sanitizing uses are below the
Agency's level of concern for all age groups (less than 11% of the cPAD). In addition,
the dietary risk estimates for the fruit and vegetable wash for adults and young children
are below the Agency's level of concern for all age groups (less than 71.2% of the
cPAD). These risk estimates are based on a number of conservative assumptions, and
thus may overestimate the actual risks.
Table 3. Summary of Dietary Exposure and Risk for Alkylbenzene Sulfonates
Pesticidal Active Uses
Use
Food Service Industry (treated
surfaces, utensils, glassware,
etc)
Food Processing Industry
(Food Processing Equipment)
Total Food Contact Surface
Sanitizing Uses
Fruit and Vegetable Wash
Population
Subgroup
adult male
females (13-50 years)
infants/children
adult male
females (13-50 years)
infants/children
adult male
females (13-50 years)
infants/children
U.S population
children l-2yrs
children 3 -5 yrs
Chronic Dietary
Dietary Exposure
(mg/kg/day) a
0.023
0.027
0.053
0.00043
0.0005
0.001
0.023
0.027
0.054
0.0979
0.3558
0.2573
% cPAD b
4.6
5.4
10.6
0.086
0.1
0.2
4.6
5.4
10.8
19.6
71.2
51.5
NA=not applicable
a~ chronic exposure analysis based on body weights of 70 kg, 60 kg, and 15 kg for adult males,
females and children, respectively.
b~ %PAD = dietary exposure (mg/kg/day) / cPAD, where cPAD=0.5 mg/kg/day for all populations.
16
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b. Dietary Exposure for Inert Ingredient Uses
Included in this RED is the reassessment of alkylbenzene sulfonates when used
as an inert ingredient in pesticide products. Alkylbenzene sulfonates are used as
solvents, surfactants, dispersants, detergents, or wetting agents. Some of these
products are designed for use in agricultural settings (pre- and post-harvest and when
applied to animals), where there is a potential for dietary exposure.
Inert Dietary Exposure Assumptions
A dietary exposure analysis for the inert ingredient use of the alkylbenzene
sulfonates was conducted using a screening model for estimating inert ingredient dietary
exposure. The dietary assessment is unrefined and extremely conservative in nature
because the screening model assumes that the inert ingredient is used on all commodities,
and that 100 percent of crops are treated with the inert ingredient. Further, the model
assumes residues will be present for every consumed commodity (including meat, milk,
poultry and eggs) that is included in the Dietary Exposure Evaluation Model (DEEM™).
The conservative nature of this assessment is believed to capture all potential dietary
exposures, including those from direct application to animals.
The alkylbenzene sulfonates assessed in this document are constituents of a larger
group of compounds that have a tolerance exemption as an inert ingredient in 40 CFR
180.910 and 180.930. The tolerance exemption is listed as Alkyl (C8-C24)
benzenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium and
zinc salts.
Inert Dietary Risk from Food
Table 4 provides a summary of the results of the chronic dietary risk estimates
for alkylbenzene sulfonates as an inert ingredient.
Based on the use of the screening level inert ingredient dietary exposure model,
there are no risk concerns associated with dietary exposures as the estimated dietary
exposures for the U.S. population and all population subgroups are below 100% of the
cPAD. As noted, a number of conservative assumptions were used in this screening level
dietary risk assessment of inert uses.
17
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Table 4. Summary of Dietary Exposure and Risk for Alkylbenzene Sulfonates as Inert
Ingredients
Population Subgroup
U.S. population
females (13-50 years)
children l-2yrs
children 3 -5 yrs
Chronic Dietary
Dietary Exposure
(mg/kg/day)
0.12
0.087
0.422
0.31
% cPAD a
24
17
84
62
a~ %PAD = dietary exposure (mg/kg/day) / cPAD, where cPAD=0.5 mg/kg/day for all population
c. Dietary Risk from Drinking Water
The drinking water exposure analysis is based on a derivation of estimated upper
bound drinking water concentrations from these substances' use as pesticidal inert
ingredient from the FQPA Index Reservoir Screening Tool (FIRST). The results of the
FIRST modeling analysis and the conservative assumptions utilized as inputs into the
inert ingredient drinking water exposure assessment model are provided in Appendix B
of the Inert Ingredient Dietary Risk Assessment for Linear Alkyl Benzenesulfonate.
For chronic drinking water exposures to linear alkylbenzene sulfonates as inert
ingredients, the Drinking Water Level of Comparison (DWLOC) range for chronic
exposure is 38-1500 |ig/L for the general U.S. population and 8-500 |ig/L for children 1-2
years old. The Estimated Drinking Water Concentration (EDWC) used to assess chronic
(non-cancer) dietary risk from drinking water is 6.6 |ig/L. The chronic estimated
concentration is below the DWLOCs for the general U.S. population and all population
subgroups. Drinking water risks, therefore, are not of concern.
The Agency did not estimate acute drinking water risks for the inert ingredient
use because an acute dietary endpoint (i.e., aPAD) was not selected as there were no
effects attributable to a single dose exposure.
The estimated chronic drinking water concentration and drinking water level of
concern for chronic exposure to linear alkyl benzenesulfonates is given in Table 5.
18
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Table 5. Chronic Drinking Water Exposure Estimates for
Inert Ingredient Uses of Alkylbenzene Sulfonates
Population Subgroup
U.S. Population (total)
Children (1-2 years)
EDWC1
(HS/L)
6.6
6.6
%cPAD2
0.1%
0.1%
DWLOC3
(HS/L)
38-1,500
8-500
1 Estimated Drinking Water Concentration (EDWC) for chronic drinking water exposure as determined by
the use of FIRST modeling analysis described above for inert ingredient use. [The EDWC for linear alkyl
benzenesulfonates is the value reported as the "Adjusted Annual Average (Chronic) Untreated Water
Concentration"]
2 %cPAD = drinking water exposure (mg/kg/day) / cPAD, where cPAD=0.5 mg/kg/day for all
populations. It was assumed that a 15 kg child ingests 1 L water per day and that a 70 kg adult ingests 2L
water per day.
3 Drinking Water Level of Comparison (DWLOC) is the maximum contribution from water allowed in the
diet based on food and drinking water from inert use only. In this case, since the allowable risk
contribution from food is based on a screening level model, the use of a single, deterministic value for the
DWLOC is not appropriate. Rather a DWLOC range is given, with the values in the range corresponding
to an upper value of range of drinking water concentrations ranging from 100% of the cPAD (i.e., assuming
no food exposure) to a lower value that considers food exposures to be at the dietary screening level value.
6. Residential Risk Assessment
Residential exposure assessment considers all potential pesticide exposure, other
than exposure due to residues in food or in drinking water. Exposure may occur during
treatment of outdoor residential turf, while cleaning indoor hard surfaces, or while using
pet flea and tick products. Each route of exposure (oral, dermal, inhalation) is assessed,
where appropriate, and risk is expressed as a Margin of Exposure (MOE), which is the
ratio of estimated exposure to an appropriate NOAEL. Based on its use patterns,
alkylbenzene sulfonates has been assessed for the residential mixing/loading/applicator
(or "handler") exposure for applications by homeowners using an aerosol spray or by
using a ready-to-use liquid with a low pressure hand wand, a hose or a sprinkling can. An
inhalation post-application assessment was not conducted because the vapor pressure of
the alkylbenzene sulfonates is extremely low (S.lxlO"10 to 6xlO"15 mmHg). In addition, a
dermal assessment was not conducted because of the lack of a dermal toxicological
endpoint. Post application incidental ingestion by toddlers that may contact turf, hard
surfaces or a pet treated with pesticide products containing alkylbenzene sulfonates is
expected to be minimal, and all the scenarios evaluated have MOEs above 100.
a. Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing
the non-dietary risks for alkylbenzene sulfonates are listed in Table 6.
A MOE greater than or equal to 100 is considered adequately protective for the
residential exposure assessment for the incidental oral and inhalation routes of
exposure. The MOE of 100 includes 10X for interspecies extrapolation and 10X for
intraspecies variation.
19
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Table 6. Summary of Toxicological Dose and Endpoints for Assessing Occupational and
Residential Risk for Alkylbenzene Sulfonates
Exposure
Scenario
Dose Used in
Risk
Assessment,
UF
Special FQPA
SF*, endpoint
and Level of
Concern for
Risk Assessment
Study and Toxicological Effects
Short-Term
Incidental Oral (1-
30 days)
Oral NOAEL= 50
mg/kg/day
UF = 100
Residential LOC for
MOE < 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)
plus
Systemic/Reproductive NOAEL = 50
mg/kg/day and LOAEL = 250 mg/kg/day
based on decreased Day 21 female pup body
weight (Buehler, E. etal. 1971. Tox. Appl.
Pharmacol. 18:83-91)
plus
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): 105-112)
Short-,
Intermediate- and
Long-Term
Inhalation (1 to 30
days, 1-6 months,
>6 months)
Inhalation study
NOAEL= lmg/m3
detergent dust
combined with up
to 0.1 mg/m3
enzyme dust
Equivalent to
approximately 0.14
mg/kg/day (a)
(inhalation
absorption rate =
100%)
purity = 13% active
ingredient
UF = 100
Residential LOC for
MOE < 100
Occupational LOC
for MOE < 100
Subchronic Inhalation Monkey Study
LOAEL =10 mg/m3 detergent combined with
0.1 mg/m3 enzyme dust. Toxicological effect
is weight loss and decreased weight gain (W.
Coates, et al 1978. Tox. Appl. Pharmacol. 45:
477-496) This air concentration is equivalent
to approximately 1.4 mg/kg/day (a)
20
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Table 6. Summary of Toxicological Dose and Endpoints for Assessing Occupational and
Residential Risk for Alkylbenzene Sulfonates
Exposure
Scenario
Dermal Endpoint
Cancer (oral,
dermal, inhalation)
Dose Used in
Risk
Assessment,
UF
Special FQPA
SF*, endpoint
and Level of
Concern for
Risk Assessment
Study and Toxicological Effects
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.
The requirement of the dermal toxicity studies with the end-use products will determine
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 developmental toxicity concerns were
seen following repeated dermal applications to pregnant mice, rats or rabbits
(developmental effects were seen either in the presence of maternal toxicity or at doses
higher than those that caused maternal toxicity).
No evidence of carcinogenicity in reported studies in rats
(a) Equation used to convert inhalation air concentration to a dose= mg/L* absorption*respiratory volume
(L/hr)*duration (hrs) * activity factor/body weight. Thus, 0.001 mg/L * 1*67.94 L/hr (based on
default respiratory volumes for a New Zealand Rabbit which is used as a surrogate for a cynomolgus
monkey) * 6 hrs * 1 / 2.98 kg (body weight for New Zealand Rabbit used as a surrogate for
cynomolgus monkey, study reports monkey body weight ranges from 1.6 to 3.7 kg).
b. Residential Handler
i. Exposure Scenarios, Data and Assumptions
Residential exposure may occur for alkylbenzene sulfonates during applications
of turf treatment, hard surface cleaners and pet flea and tick products. A number of
assumptions, or estimates, such as adult body weight and area treated per application, are
made by the Agency for residential risk assessment. Also, note that residential handlers
are sometimes addressed somewhat differently than occupational handlers in that
homeowners are assumed to complete all elements of an application (mix/load/apply)
without the use of personal protective equipment.
The quantitative exposure/risk assessment developed for residential handlers is based
on these scenarios:
1) outdoor residential turf treatment (ready to use liquid),
2) indoor hard surface cleaner (ready to use liquid), and
3) pet flea and tick products (aerosol can spray).
For the purposes of this screening level assessment, the Agency selected
representative scenarios for the vast majority of products, based on end-use product
application methods and use amounts. The above scenarios reflect high-end exposure
and risk estimates for all products represented in a residential setting.
21
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For most residential scenarios, the Agency used EPA's Pesticide Inert Risk
Assessment Tool (PiRat) to estimate residential applicator and post-application exposures
and risks from the use of alkylbenzene sulfonates as an inert ingredient in representative
residential products. For the assessment of the pet products and hard surface cleaners, the
Agency used assumptions in the Residential Standard Operating Procedures (SOPs).
Typically, most products used in a residential setting result in exposures occurring over a
short-term duration. Thus, the residential handler and postapplication scenarios are
assumed to be of short- term duration (1-30 days).
An inhalation post-application assessment was not conducted because the vapor
pressure of the alkylbenzene sulfonates is extremely low (S.lxlO"10 to 6xlO"15 mmHg)
and not expected to result in inhalation exposure. In addition, a dermal assessment was
not conducted because of the lack of a dermal toxicological endpoint was not identified in
animal studies.
ii. Residential Handler Risk Estimates
Based on toxicological criteria and potential for exposure, the Agency has
conducted incidental oral and inhalation exposure assessments. As noted previously,
MOEs greater than or equal to 100 for the inhalation route of exposure and 100 for
incidental oral exposure are considered adequately protective for the residential exposure
assessment.
A summary of the residential handler exposures and risk are presented in Table 7.
For residential handlers that handle products containing alkylbenzene sulfonates as inert
ingredients, the short-term inhalation MOEs were above the target MOE of 100, and thus,
do not exceed the Agency's level of concern, with the exception of the flea and tick
product where the MOE was 87 for the high-end formulation containing 24%
alkylbenzene sulfonates. This scenario is conservative because it assumes a person treats
their pet with 0.5 cans of flea product that contains 24% alkylbenzene sulfonates every
day for a month. It is unlikely that a person would treat his/her pet every day for one
month. Therefore, the Agency is not requiring risk mitigation. In addition, there are no
risk concerns for the majority of pet products containing 2% alkylbenzene sulfonates.
22
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Table 7. Estimates of Inhalation Exposures and Risks to Residential Handlers of
Alkylbenzene Sulfonates as Inert Ingredients
(Short-Term Duration)
Product Use
Application
Method
T , „,„ .. „ Inhalation
Area Inhalation
Treated/Quantity Exposure .Mrnr
Handled3 (mg/kg/day) V***?™™
Outdoor Products
Ready to Use Liquid
Turf spot/gardens'3
Low pressure
handwand;
MLAP
Hose end
sprayer; MLAP
Backpack;
MLAP
Sprinkling can;
MLAP
1000 ft2/day (spot)
2xl04 ft2/day
(full broadcast)
1000 ft2/day (spot)
7.07xlO"6
4.48xlO'5
7.07xlO"6
2.24X10'6
20,000
3,100
20,000
63,000
Indoor Products
Ready to Use Liquid
(hard surface
cleaner)d'e
Pet Flea and Tick
Productf
Low pressure
handwand;
MLAP
Aerosol Can
Spray
0.5 gallons/day
0.5 6 oz can
1.37xlO"4
1.61xlO"3
1.000
87
a: Standard PiRat model input parameters, except for pet products and hard surface cleaner, which are
based on an AD assumption.
b: percent formulation used = 11%; an application rate of 0.00015 Ib product/ft2 was assumed for all
scenarios and the body weight = 70kg.
c: MOEs = NOAEL / exposure where inhalation NOAEL = 0.14 mg/kg/day and the target MOE > 100
d: % formulation used = 8%
e: An application rate of 8 Ib/gallon, which is the density of water, was assumed for all scenarios and the
body weight =70kg.
f= % formulation = 24%.
23
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c. Residential Post-Application
Residential post application exposures occur when bystanders contact areas in
which the antimicrobial end use product has recently been applied. For alkylbenzene
sulfonates there are no residential postapplication risk concerns for the household
products that contain alkylbenzene sulfonates as an inert ingredient as shown on Table 8.
All of the scenarios evaluated have short-term MOEs above 100, and thus are not of
concern including postapplication incidental oral risks to children that may contact turf,
hard surfaces or a pet treated with pesticide products containing alkylbenzene sulfonates
as an inert ingredient. The postapplication MOEs range from 106 to 7,400.-
Table 8. Summary of Short-Term
Residential Postapplication Exposure and Risk Estimates
from Alkylbenzene Sulfonates as Inert Ingredientsa
Product Use
Ready to Use Liquid Turf
spot/gardens'1
Ready to Use Liquid
(hard surface cleaner)3' e
Pet Flea and Tick Productf
Route of
Exposure
Incidental ingestion:
hand to mouth
Incidental ingestion:
hand to mouth
Exposure
mg/kg/dayb
l.OSxlO"2
0.0068
0.4739
MOEsc
(Target MOE >
100
4,600
7,400
106
a: The representative use sites assessed through using PiRAT for incidental oral post application exposures
to toddlers are turf products. Exposure from hard surface cleaner and pet products was based on AD
assumptions.
b: The body weight used in this calculation was 15kg, which is assumed to be the body weight of a toddler.
c: MOEs = NOAEL / exposure where incidental oral NOAEL = 50 mg/kg/day. Target MOE > 100.
d: % formulation used = 11%
e: % formulation used = 8%
f: % formulation used = 24%
7. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and
Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable
certainty that no harm will result from aggregate exposure to pesticide chemical residue,
including all anticipated dietary exposures and other exposures for which there are
reliable information." Aggregate exposure will typically include exposures from food,
drinking water, residential uses of a pesticide, and other non-occupational sources of
exposure. Aggregate exposure is the total exposure to a single chemical (or its residues)
that may occur from dietary (i.e., food and drinking water), residential, and other non-
occupational sources, and from plausible exposure routes (oral, dermal, and inhalation).
In performing aggregate exposure and risk assessments, the Office of Pesticide
Programs has published guidance outlining the necessary steps to perform such
24
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assessments (General Principles for Performing Aggregate Exposure and Risk
Assessments, November 28, 2001; available at:
http://www.epa.gov/pesticides/trac/science/aggregate.pdf. Steps for deciding whether to
perform aggregate exposure and risk assessments are listed and include: identification of
toxicological endpoints for each exposure route and duration; identification of potential
exposures for each pathway (food, water, and/or residential); reconciliation of durations
and pathways of exposure with durations and pathways of health effects; determination of
which possible residential exposure scenarios are likely to occur together within a given
time frame; determination of magnitude and duration of exposure for all exposure
combinations; determination of the appropriate technique (deterministic or probabilistic)
for exposure assessment; and determination of the appropriate risk metric to estimate
aggregate risk.
Typically, aggregate risk assessments are conducted for acute (1 day), short-term
(1-30 days), intermediate-term (1-6 months) and chronic (6 months to lifetime)
exposures. However, an acute aggregate assessment was not conducted because there are
no adverse effects attributable to acute exposure. An intermediate-term aggregate
assessment was not conducted because there are no residential exposures of this duration.
In addition, because there are no long-term residential exposures, the chronic aggregate
assessment only considered food and drinking water. Thus, only short-term and chronic
aggregate assessments were conducted. Oral and inhalation exposure and risk estimates
were conservatively combined for the aggregate risk assessment because these endpoints
both identify adverse effects on body weight. Dermal exposures were not considered in
the risk assessment because a toxicological endpoint was not established.
a. Short- Term Aggregate Risk
This assessment considers both the active and inert uses of the alkylbenzene
sulfonates. For children, the short-term aggregate assessment includes average dietary
exposure (food and drinking water) from both the active food contact sanitizer uses and
the inert uses on agricultural commodities, in addition to estimated incidental oral
exposures to children from residential uses such as hard surface cleaning products as an
inert ingredient. For adults, the aggregate assessment includes dietary (food and drinking
water) from both active and inert uses and residential inhalation exposures from wiping a
hard surface cleaning products since this scenario represents the highest exposure from
the inert use. The residential handler scenario for pet flea and tick products (inhalation
MOE of 87) was not included in the aggregate assessment. The pet flea and tick product
assumes a person treats his/her pet with 0.5 cans of flea product that contains 24%
alkylbenzene sulfonates every day for a month. The Agency does not have any risks of
concern for this scenario because it is very conservative in nature.
The aggregate oral and inhalation risks are not of concern for adults, as the total
aggregate MOE is 340 which is greater than the target of 100. For children, the aggregate
risk estimate is very close to the target MOE of 100 (MOE = 99). As noted previously,
several conservative assumptions were used in this assessment, and thus the Agency does
25
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not have any risk concerns. The assumptions and equations are presented in the footnotes
on Table 9.
Table 9 presents a summary of the short-term aggregate risk MOEs.
Table 9. Summary of Short-Term Aggregate Risk Estimates
Exposure Scenario
Dosea
(mg/kg/day)
Child
Adult
Total MOEb
(Target MOE>100)
Child
Adult
Oral Exposure
Dietary Exposure
Food Contact Sanitizer
Inert Ingredient Uses (Food)
Drinking Water Exposure
(Inert) c
Hard Surface Cleaner (2%
Inert)
0.054
0.422
0.00044
0.0068
0.027
0.12
0.000189
NA
926
(10.8% of cPAD)
118
(84% of cP AD)
114,000
( 100.
(c) Exposure estimates assume a 15 kg child ingests 1L water/day and that a 60 kg adult female ingests
2L water per day of 6.6 ppb (the chronic estimated drinking water concentration (EDWC) based on
the inert ingredient use.
b. Chronic Aggregate Risk
The chronic aggregate assessment considers average dietary exposure (food and
drinking water) from both the active food contact sanitizer uses and the inert uses on
agricultural commodities. The dietary exposures from the fruit and vegetable wash were
not considered because it would be overly conservative to assume simultaneous exposure
to alkylbenzene sulfonates from three different use patterns. As shown on Table 10, the
dietary aggregate risk is 95% of the cPAD for children, while for adults it is 29% of the
cPAD.
It should also be recognized that the majority of the uses of alkylbenzene
sulfonates are not in pesticide products, but rather are used in household laundry and dish
detergents. Over 800 million pounds of these compounds are produced each year, while
only 300,000 pounds are used in EPA registered antimicrobial products. The Agency did
26
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not consider potential exposure and risks from the numerous other residential exposures
to alkylbenzene sulfonates because the Agency lacks reliable information at this time.
Table 10 presents a summary of the chronic aggregate risk estimates.
Table 10.
Summary of Chronic Aggregate Risk Estimates
Exposure Scenario
Dosea
(mg/kg/day)
Child
(15 kg)
Adult
%cPADb
Child
(15 kg)
Adult
Oral Exposure
Dietary Exposure
Food Contact Sanitizer
Inert Ingredient Uses (Food)
Drinking Water Exposure
(Inert) c
Total Aggregate Dose and Risk
0.054
0.422
0.00044
0.476
0.027
0.12
0.000189
0.147
10.8%
84%
<1%
95%
5.4%
24%
<1%
29%
NA= Not applicable
(a) Chronic dietary exposure for females 13-50 years for sanitizer use. The total general population
dietary exposure was used to assess inerts, since this population has higher exposure than females 13-
50 years.
(b) %cPAD = dietary exposure (mg/kg/day) / cPAD, where cPAD -= 0.5 mg/kg/day for all populations.
(c) Exposure estimates assume a 15 kg child ingests 1L water/day and that a 60 kg adult female ingests
2L water per day containing 6.6 ppb alkylbenzene sulfonates. The 6.6 ppb estimate is based on the
chronic estimated drinking water concentration (EDWC)) resulting from agricultural use of products
that contain the alkylbenzene sulfonates as an inert ingredient.
8. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational handlers of alkylbenzene sulfonates
include workers in a variety of occupational settings. Additionally, postapplication
exposures are likely to occur in these settings. The representative scenarios selected for
assessment were evaluated using maximum application rates as recommended on the
product labels for alkylbenzene sulfonates.
Occupational risk is assessed for exposure at the time of application (termed
"handler" exposure) and is assessed for exposure following application, or post-
application exposure. Application parameters are generally defined by the physical nature
of the formulation (e.g., formula and packaging), by the equipment required to deliver the
chemical to the use site, and by the application rate.
Occupational risk for all of these potentially exposed populations is measured by
a Margin of Exposure (MOE) which determines how close the occupational exposure
comes to a No Observed Adverse Effect Level (NOAEL) from toxicological studies. In
the case for alkylbenzene sulfonates, MOEs greater than 100 for inhalation exposures
27
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are not of concern to the Agency for short- and intermediate-term exposures. For
workers entering a treated site, MOEs are calculated for each day after application to
determine the minimum length of time required before workers can safely re-enter.
a. Occupational Toxicity
Table 6 provides a listing of the toxicological endpoints used in the
occupational risk assessment for alkylbenzene sulfonates.
b. Occupational Handler Exposure
The Agency has determined that there is potential for dermal and inhalation
worker exposure to alkylbenzene sulfonates at various use sites when used at various use
sites including agricultural premises, food handling, and
commercial/institutional/industrial premises. Representative scenarios were selected for
evaluation based on the use sites and maximum application rates for all three of the active
ingredients in this assessment. As noted previously, the Agency did not select a dermal
endpoint, and thus only inhalation exposure and risk estimates are presented.
To assess the handler risks, the Agency used surrogate unit exposure data from
both the proprietary Chemical Manufacturers Association (CMA) antimicrobial exposure
study and the Pesticide Handlers Exposure Database (PHED). Short-, and intermediate-
term inhalation risks to occupational handlers for sanitizing scenarios, and estimated risks
are presented in Table 11.
The Agency also calculated a total MOE for one of the active ingredients, sodium
dodecylbenzene sulfonate based on the label use directions, which recommend the same
product be used for both cleaning and sanitizing. Short-, and intermediate-term
inhalation risks to occupational handlers cleaning and sanitizing with products that
contain sodium dodecylbenzene sulfonate are shown in Table 12.
c. Occupational Handler Risk Summary
The occupational handler risk assessment included only inhalation exposures
because the Agency did not select a dermal endpoint. For the occupational handler
inhalation risk assessment, the short- and intermediate- term risks calculated at baseline
exposure (no respirators) were above target MOEs for all scenarios (i.e., inhalation
MOEs were >100), except:
• Short-Term and Intermediate-Term inhalation exposure from cleaning hard
surfaces via wiping in the food handling category, inhalation MOE = 93.
Due to the conservative nature of the assessment, the Agency does not have a risk
concern for this scenario.
The Agency also calculated a total MOE for one of the active ingredients, sodium
28
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dodecylbenzene sulfonate based on the label use directions, which recommend the same
product be used for both cleaning and sanitizing. As shown on Table 12, all total
inhalation MOEs for cleaning and sanitizing (baseline) were above the target MOE of
100 for all scenarios, except the following:
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via wiping and then following with sanitizing via immersion/flooding in
the food handling premises category, inhalation MOE = 93.
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via wiping and then following with sanitizing via low pressure spray in
the food handling premises category, inhalation MOE = 90.
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via sponge/mesh/wiping and then sanitizing via immersion/flooding in
the food handling premises category, inhalation MOE = 90.
Again, due to the conservative nature of the assessment, risk estimates making a
lot of assumptions, and the MOEs being so close to the target, the Agency does not have
a risk concern for these scenarios.
Table 11. Short-, and Intermediate-Term Inhalation Risks for Occupational Handlers
for Sanitizing
(Representative Scenarios)
Exposure
Scenario
Method of
Application
Applicati
on Rate
(Ib ai/
gallon)
Quantity
Handled/
Treated
per day
(gallons)
Baseline
Inhalation MOE (a)
(Target MOE>100)
Agricultural Premises and Equipment
Application to
hard surfaces
Brush
Mechanical Foam
Flooding
Cleaning in place (CIP)
High Pressure spray
Immersion
Low pressure spray
Trigger Pump Spray
0.0667
0.0667
0.00183
0.00195
0.00326
0.00334
0.00334
0.00334
0.26
0.26
10
10,000
40
10
10
0.26
2,000
430
280
1,200
630
160
430
8,700
Food Handling
Application to
indoor hard
surfaces
Brush
Mechanical Foam
Immersion
Trigger Pump Spray
Low pressure handwand
(clean)
0.0667
0.0667
0.00334
0.00334
0.00603
0.26
0.26
10
0.26
2
2,000
430
160
8,700
1,200
29
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Table 11. Short-, and Intermediate-Term Inhalation Risks for Occupational Handlers
for Sanitizing
(Representative Scenarios)
Exposure
Scenario
Food
dispensing
equipment
Fruits and
vegetables
Method of
Application
High pressure spray
(sanitize)
Immersion, flooding for
RTU (sanitize)
Mopping
Wiping (clean)
Sponge/mesh wipe (clean)
Cleaning in Place (CIP)
(clean and sanitize)
Cleaning in Place (CIP)
(clean)
Cleaning in Place (CIP)
(sanitize)
Immersion
Trigger pump spray
Applicati
on Rate
(Ib ai/
gallon)
0.0115
0.003
0.00244
0.00603
0.003
0.00358
0.00603
0.00302
0.00455
0.003
Quantity
Handled/
Treated
per day
(gallons)
40
10
2
0.26
0.26
10,000
10,000
10,000
10
0.26
Baseline
Inhalation MOE (a)
(Target MOE>100)
180
170
840
93
190
680
400
810
110
9,700
Commercial/Institutional Premises
Application to
indoor hard
surfaces
(includes
utensils and
silverware)
Shower stalls
and toilets
Brush
Mechanical Foam
Immersion
Low Pressure Handwand
Trigger Pump Spray
Mopping
Swabbing after a liquid
pour
0.0667
0.0667
0.00334
0.00334
0.00334
0.0177
0.0177
0.26
0.26
10
2
0.26
2
0.26
2,000
430
160
2,200
8,700
120
1,100
(a) MOE = NOAEL (mg/kg/day) / Daily Dose [Where short-and intermediate-term
NOAEL = 0.14 mg/kg/day for inhalation exposure] Target MOE is > 100.
30
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Table 12. Short, and Intermediate Term Inhalation Risks to Occupational Handlers
Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene Sulfonate
Representative Use
Method of
CLEANING
Application
(Baseline MOE)
Method of
SANITIZING
Application
(Baseline MOE)
Total
Inhalation
MOE
(Baseline)
(Target
MOE>100)
Food Handling/Storage Establishments Premises and Equipment
Indoor Hard Surfaces
(includes dishes and
silverware)
Food dispensing equipment
High pressure spray
(1,100)
Brush
(75,000)
Low pressure spray
(1,200)
Wiping (93)
Foam (4,000)
Brush (22,000)
Sponge/Mesh/Wiping
(190)
Low Pressure Spray
(2,400)
Brush (45,000)
CIP (680)
CIP(400)
High pressure spray (180)
Brush (12,000)
High pressure spray (180)
Brush (12,000)
Immersion/Flooding
(1.4X106)
Low pressure spray (2,400)
Immersion/Flooding
(1.4X106)
Low pressure spray (2,400)
Immersion/Flooding
(1.4X106)
Low pressure spray (2,400)
Immersion/Flooding
(1.4X106)
Low pressure spray (2,400)
Immersion/Flooding (170)
Trigger Pump (9,700)
Immersion/Flooding (170)
Trigger Pump (9,700)
Immersion/Flooding (170)
Trigger Pump (9,700)
CIP (680)
CIP (810)
150
1,000
180
10,000
1,200
800
93
90
4,800
1,600
22,000
2,000
90
190
160
1,900
170
8,000
340
270
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d. Occupational Post-Application Exposure
For most of the occupational scenarios, postapplication dermal exposure is not
expected to occur or is expected to be negligible based on the application rates and
chemical properties of these chemicals. The alkylbenzene sulfonates have a low vapor
pressure (S.lxlO"10 to 6.02xlO"15 mmHg), so that any standing solutions that may result in
post application exposure were deemed negligible. For additional information, please see
the Occupational and Residential Exposure Assessment for Alkylbenzene Sulfonates for
the Reregi strati on Eligibility Decision document, dated July 6, 2006.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented
below. The following risk characterization is intended to describe the magnitude of
the estimated environmental risks for alkylbenzene sulfonates use sites and any
associated uncertainties.
For detailed discussions of all aspects of the environmental risk assessment, see
the Environmental Fate Assessment of Alkylbenzene Sulfonates for the Reregi strati on
Eligibility Decision and the Ecological Hazard and Environmental Risk Assessment of
Alkylbenzene Sulfonates for the Reregi strati on Eligibility Decision document, dated July
12, 2006.
1. Environmental Fate and Transport
No fate studies for alkylbenzene sulfonates are available in US EPA's files. Thus,
the Agency has relied on scientific literature and the Agency's EPI Suite model to obtain
different environmental properties for the alkylbenzene sulfonates. The EPI Suite model
predicts that alkylbenzene sulfonates are not likely to persist in water or microbial soils
and sediments. The Agency also conducted a literature search to further support the
output parameters that were provided by the EPI Suite model. Extensive literature are
available that describe the fate and significance of alkylbenzene sulfonates in the
environment from a long history of detergent use.
Environmental exposure modeling was not conducted for alkylbenzene sulfonic
acids and sulfonates because the currently registered uses are indoor spray applications.
Uses such as urinals and toilet bowls could result in minimal exposure to the environment
when flushed, however, significant environmental exposure is not expected for the
following reasons: total alkylbenzene sulfonate usage for these industrial applications is
very minor - a very small percentage of the total pounds is used in antimicrobials;
commercial only use precludes broad environmental exposures that might occur with
residential use; applications are mostly sprayed on and allowed to air dry; alkylbenzene
sulfonate breakdown and degrade rapidly in the environment; alkylbenzene sulfonates
are significantly reduced by sewage treatment; and industrial water treatment requires a
NPDES permit in order to discharge effluents.
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2. Ecological Risk
The ecological risk assessment integrates the results of the exposure and
ecotoxicity data to evaluate the likelihood of adverse ecological effects.
Alkylbenzene sulfonates demonstrate low acute toxicity to birds, moderate acute
toxicity to freshwater fish, and low to high acute toxicity to freshwater aquatic
invertebrates depending on the length of the carbon chain. Supplemental acute studies
indicate that alkylbenzene sulfonates are moderately toxic to freshwater fish and slightly
to highly toxic to freshwater aquatic invertebrates depending on the length of the carbon
chain. A summary of submitted data is provided in Table 13.
Table 13. Acute Toxicity of Alkylbenzene Sulfonates
Species
Chemical, %
active ingredient
(ai)
Endpoint
Toxicity
Category
(TGAI)
Satisfies
Guidelines/
Comments
MRID
Birds
Northern
bobwhite
(Colinus
virginianus)
87.6%Caibon chain
not identified.
(Nacconal 90G used)
LD50> 1382
mg/kg
NOEL = 279
mg/kg
Slightly toxic
Yes.
Acceptable.
14 day test
41143901
Freshwater Fish
Fathead
Minnow
(Pimephales
promelas)
Rainbow trout
Oncorhynchus
mykiss)
14.0% (Carbon chain
not identified.)
65.0%
C11,C12
96hrLC50 =
3.4mg/L
96 hr LC50 =
1.68 mg/L
Moderately toxic
Moderately toxic
Yes.
Supplemental
study.
Yes.
Supplemental
study.
44260002
44260009
Freshwater Invertebrates
Waterflea
(Daphnia
magna)
Not reported.
48-hr. EC50 =
LAS-C10 = 29.5
mg/L, LAS-C12
= 6.84 mg/L,
LAS-C14 = 0.80
mg/L, LAS-C16
= 0.20 mg/L.
C-10 = Slightly
toxic, C14 =
highly toxic.
Yes.
Supplemental
study.
47025025
Green Algae
Selenastrum
capricornutum
Not
Reported. (Carbon
chain not identified.)
96 hr. EC50 =
70.27 ppm
Slightly
toxic
Supplemental
study.
42439803
The alkylbenzene sulfonates are used as inert ingredients in agricultural herbicide
formulations. Preplant incorporated and preemergence herbicide treatments are typically
33
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applied once per year to the tilled, minimally tilled or no-tilled field before planting or
before crop emergence in the spring. Spray applications are primarily via ground boom
spray and occasionally by aircraft. Movement of the alkylbenzene sulfonates from the
treated field to the aquatic environment can occur at the time of application due to spray
drift, or following application via surface water/soil flow or by percolation to
groundwater. The FIRST model has predicted a maximum potential concentration of 6.6
ppb alkylbenzene sulfonates in drinking water from inert agricultural uses. Available
modeling and literature suggest that these chemicals will most likely biodegrade rapidly
in soil due to microbial degradation. In addition, aquatic organisms are also not expected
to be adversely affected by inert alkylbenzene sulfonates use acutely or chronically due to
the low estimated level of alkylbenzene sulfonates in water.
3. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires
all federal agencies to consult with the National Marine Fisheries Service (NMFS) for
marine and anadromous listed species, or the United States Fish and Wildlife Services
(FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that
may affect listed species or their designated habitat. Each federal agency is required
under the Act to insure that any action they authorize, fund, or carry out is not likely to
jeopardize the continued existence of a listed species or result in the destruction or
adverse modification of designated critical habitat. To jeopardize the continued existence
of a listed species means "to engage in an action that reasonably would be expected,
directly or indirectly, to reduce appreciably the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or
distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act
subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly reduce appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or distribution of any listed
species (U.S. EPA 2004). After the Agency's screening-level risk assessment is
performed, if any of the Agency's Listed Species LOG Criteria are exceeded for either
direct or indirect effects, a determination is made to identify if any listed or candidate
species may co-occur in the area of the proposed pesticide use. If determined that listed
or candidate species may be present in the proposed use areas, further biological
assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package
as required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required (Overview of
the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S.
Environmental Protection Agency Endangered and Threatened Species Effects
Determinations, 1/23/04, Appendix A, Section IIB, pg.81). Chemicals in these categories
34
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therefore do not undergo a full screening-level risk assessment, and are considered to fall
under a "No Effect" determination. The active ingredient uses of alkylbenzene sulfonic
acids and sulfonates fall into this category for the following reasons:
1. The amount that will actually reach the environment is very small based on
usage data for down-the-drain uses.
2. Use for toilets and urinals is limited (no home-owner or residential uses are
registered).
3. Breakdown of alkylbenzene sulfonate in the environment and via sewage
treatment is rapid and well documented in the literature.
The labeled antimicrobial uses of alkylbenzene sulfonic acids and sulfonates are
not expected to result in significant environmental exposure. Therefore, no adverse
effects (NE) to listed species are anticipated. Use of alkylbenzene sulfonates as inert
ingredients in agricultural pesticide formulations is not expected to result in significant
environmental exposure. Therefore, no adverse effects (NE) to listed species are
anticipated.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing alkylbenzene sulfonates as an active ingredient. The Agency has
completed its review of these generic data and has determined that the data are sufficient to
support reregi strati on of all supported products containing alkylbenzene sulfonates.
The Agency has completed its assessment of the dietary, residential, occupational,
drinking water, and ecological risks associated with the use of pesticide products containing the
active ingredient alkylbenzene sulfonates. Based on a review of these data and on public
comments on the Agency's assessments for the active ingredient alkylbenzene sulfonates, the
Agency has sufficient information on the human health and ecological effects of alkylbenzene
sulfonates to make decisions as part of the tolerance reassessment process under FFDCA and
reregi strati on process under FIFRA, as amended by FQPA. The Agency has determined that
alkylbenzene sulfonates-containing products are eligible for reregi strati on provided that current
data gaps and confirmatory data needs are addressed. Appendix A summarizes the uses of
alkylbenzene sulfonates that are eligible for reregistration. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of alkylbenzene sulfonates and lists the submitted studies that the Agency found
acceptable. Data gaps are identified as generic data requirements that have not been satisfied
with acceptable data.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decision for alkylbenzene sulfonates. During the public
comment period on the risk assessments, which closed on June 19, 2006, the Agency received
numerous comments from The DDES A Steering Committee/Joint Venture (JV) and The Council
for LAB/LAS Environmental Research (CLER) and the European Centre on Studies on
LAB/LAS (ECOSOL) in response to EPA's draft risk assessment (RA) for alkylbenzene
sulfonates. The comments submitted include areas of toxicology, chemical structure, risks,
production volumes, and exposure. The Agency's responses to these comments are incorporated
into the risk assessment and revised chapters, which are available on the U.S. Federal
Government website at: www.regulations.gov (EPA-HO-OPP-2006-0156). A Response to
Comment document will be made available on the public docket in the future. In addition,
comments received by the registrants during Phase I of the RED process, are available on the
docket.
The Agency is providing a 60-day public comment period on this RED.
36
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C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with alkylbenzene sulfonates. The Agency has concluded that the tolerance exemptions for the
use of alkylbenzene sulfonates as an active and as an inert ingredient meet the FQPA safety
standards and that the risk from dietary exposure (food sources only) is within the "risk cup."
An acute aggregate assessment was not conducted because there are no adverse effects
attributable to acute exposure. An intermediate-term aggregate assessment was not conducted
because there are no residential exposures of this duration. In addition, because there are no
long-term residential exposures, the chronic aggregate assessment only considered food and
drinking water. Thus, only short-term and chronic aggregate assessments were conducted.
The Agency has determined that the human health risks from these combined exposures
are within acceptable levels. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as aggregate exposure from
food, drinking water and residential uses.
b. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with alkylbenzene sulfonates. The Agency has determined that the established tolerance
exemptions for alkylbenzene sulfonates meet the safety standards under the FQPA amendments
to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainly no harm will
result to the general population or any subgroup from it's use. In reaching this conclusion, the
Agency has considered all available information on alkylbenzene sulfonates.
Typically, aggregate risk assessments are conducted for acute (1 day), short-term (1-30
days), intermediate-term (1-6 months) and chronic (6 months to lifetime) exposures. However,
an acute aggregate assessment was not conducted because there are no adverse effects
attributable to acute exposure of alkylbenzene sulfonates. An intermediate-term aggregate
assessment was not conducted because there are no residential exposures of this duration. In
addition, because there are no long-term residential exposures, the chronic aggregate assessment
only considered food and drinking water. Thus, only short-term and chronic aggregate
assessments were conducted. The short-term and chronic aggregate risk estimates associated
with alkylbenzene sulfonates are well below the Agency's level of concern. Oral and inhalation
exposure and risk estimates were conservatively combined for the aggregate risk assessment
because these endpoints both identify adverse effects on body weight. The aggregate oral and
inhalation risks are not of concern for adults or children. Dermal exposures were not considered
in the risk assessment because a toxicological endpoint was not established.
37
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c. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of alkylbenzene sulfonates, with
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants
and children. The safety determination for infants and children considers factors of the toxicity,
use practices, and environmental behavior noted above for the general population, but also takes
into account the possibility of increased susceptibility to the toxic effects of alkylbenzene
sulfonates residues in this population subgroup.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from alkylbenzene sulfonates residues, the Agency considered the completeness of the database
for developmental and reproductive effects, the nature of the effects observed, and other
information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for alkylbenzene
sulfonates based on: (1) there is no concern for developmental neurotoxicity resulting from
exposure to alkylbenzene sulfonates because there is no evidence alkylbenzene sulfonates will
induce neurotoxic effects; (2) there is no quantitative or qualitative evidence of increased
susceptibility to the fetus following in utero exposure in the prenatal developmental toxicity
studies or to the offspring when adults are exposed in the two-generation reproductive study; and
(3) the risk assessment does not underestimate the potential exposure for infants and children.
d. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, alkylbenzene sulfonates may be subject to additional screening
and/or testing to better characterize effects related to endocrine disruption.
38
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e. Cumulative Risks
Risks summarized in this document are those that result only from the use of
alkylbenzene sulfonates. The Food Quality Protection Act (FQPA) requires that the Agency
consider "available information" concerning the cumulative effects of a particular pesticide's
residues and "other substances that have a common mechanism of toxicity." The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect as would a higher level of exposure to any of the substances
individually. 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 for alkylbenzene sulfonates. For information 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
concerning common mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
Active Ingredient Uses
Exemptions from the requirement of a tolerance for the active food-contact sanitizer uses
of these ingredients have been established in the 40 CFR 180.940(b) and (c).
Table 14. Tolerance Exemptions for Food Contact Sanitizer Uses (Active Uses)
Tolerance
Exemption
Expression/
Chemical Name
Benzenesulfonic
acid, dodecyl-
Benzenesulfonic
acid dodecyl-,
sodium salt
CAS No.
27176-87-0
25155-30-0
PC
Code
098002
079010
40 CFR
Citation
180.940 (b)
180.940 (c)
180.940 (c)
Use Pattern (Pesticidal)
food contact sanitizing solutions for dairy processing
equipment, and food processing equipment and
utensils; end use concentration not to exceed 5.5 ppm
NOTE: The Agency will be proposing a change to 40
CFR 180.940(b) to make the end use concentration
not to exceed 400 ppm.
food contact sanitizing solutions for food processing
equipment and utensils; end use concentration not to
exceed 400 ppm
food contact sanitizing solutions for food processing
equipment and utensils; end use concentration not to
exceed 430 ppm
39
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Dodecylbenzenesulfonic acid (27176-87-0) and sodium dodecylbenzene sulfonate
(25155-30-0) have uses in food-contact surface sanitizing solutions with tolerance exemptions as
specified in 40 CFR 180.940 (b) and (c), and summarized in Table 14. Residues for these
compounds are exempt from the requirement of a tolerance when used in accordance with good
manufacturing practice as ingredients in an antimicrobial pesticide formulation, provided that the
substance is applied on a semi-permanent or permanent food-contact surface (other than being
applied on food packaging) with adequate draining before contact with food. Both
dodecylbenzene sulfonic acid, and sodium dodecylbenzene sulfonate have limitations for the
ready-to-use end-use concentration not to exceed 400 ppm and 430 ppm, respectively for food
processing equipment and utensils. However, dodecylbenzene sulfonic acid has a much lower
limitation of 5.5 ppm for use on dairy processing equipment. The Agency estimates that the 430
ppm limitation for the sodium salt is equivalent to approximately 400 ppm of the free acid form.
The Agency will be proposing a change to the 40 CFR 180.940(b) to establish a maximum of
400 ppm for the end-use concentration of dodecylbenzenesulfonic acid, rather than the current
limitation of 5.5 ppm. As previously stated, the Agency used the FDA milk truck model to
estimate residues in milk that could result from the use of alkylbenzene sulfonates in the food
processing equipment. 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. This assessment indicated that risks are
not of concern for all subpopulations.
Inert Ingredient Uses
Included in this document is the reassessment of the alkylbenzene sulfonates when used
as an inert ingredient in pesticidal products. As noted previously, some of the inert functions of
alkylbenzene sulfonates in the registered products are listed as solvent, surfactant, dispersant,
detergent, or wetting agent. Some of these products are designated for use in agricultural
settings (i.e., pre- and post-harvest and when applied to animals), where there is a potential for
dietary exposure. The alkylbenzene sulfonates assessed in this document are constituents of a
larger group of compounds that have a tolerance exemption as an inert ingredient in 40 CFR
180.910 and 180.930. As shown in Table 15, the tolerance exemption is listed as Alkyl (C8-
C24) benzenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium and zinc
salts.
40
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Table 15. Tolerance Exemptions for Inert Use
Tolerance Exemption
Expression
Alkyl (C8-C24) benzenesulfonic
acid and its ammonium, calcium,
magnesium, potassium , sodium
and zinc salts
40CFR
Citation
180.910 (a)
180.930 (a)
Use Pattern
Surfactants, related adjuvants of surfactants
Surfactants, emulsifier, related adjuvants of
surfactants
(a) Residues listed in 40 CFR § 180.910 are exempted from the requirement of a tolerance when used as inert
ingredients in pesticidal formulations when applied to growing crops or to raw agricultural commodities
after harvest (i.e., pre- and post-harvest). Residues listed in 40 CFR §180.930 are exempted from the
requirement of a tolerance when used as inert ingredients in pesticidal formulations when applied to
animals only.
D. Regulatory Rationale
The Agency has determined that alkylbenzene sulfonates are eligible for reregi strati on
provided that additional required data confirm this decision.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
The chronic dietary exposure estimates for both the active and inert ingredient uses are
below the Agency's level of concern for all age groups. Therefore, no mitigation measures are
necessary at this time.
b. Drinking Water Risk Mitigation
The chronic drinking water exposure estimates for the inert ingredient uses are below the
Agency's level of concern. Significant drinking water exposure is not expected to result from
the active ingredient uses of alkylbenzene sulfonates. Therefore, no mitigation measures are
necessary at this time.
c. Residential Risk Mitigation
Residential risk estimates for the uses of alkylbenzene sulfonates as inert ingredients are
below the Agency's level of concern. Therefore, no mitigation measures are needed at this time
for these uses, as none present a risk of concern.
41
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d. Occupational Risk Mitigation
i. Handler Risk Mitigation
The calculated short and intermediate-term inhalation MOEs are greater than 100, and
therefore, are not of concern with the exception of the following scenarios:
• Short-Term and Intermediate-Term inhalation exposure from cleaning hard surfaces via
wiping in the food handling category, inhalation MOE = 93.
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via wiping and then following with sanitizing via immersion/flooding in the food
handling premises category, inhalation MOE = 93.
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via wiping and then following with sanitizing via low pressure spray in the food
handling premises category, inhalation MOE = 90.
• Short-Term and Intermediate-Term inhalation exposure from cleaning indoor hard
surfaces via sponge/mesh/wiping and then sanitizing via immersion/flooding in the food
handling premises category, inhalation MOE = 90.
Due to the conservative nature of the assessment, risk estimates making a lot of
assumptions, and the MOEs being so close to the target, the Agency does not have a risk concern
for these scenarios.
ii. Post-Application Risk Mitigation
At this time, EPA does not foresee post-application exposures for the occupational uses
of alkylbenzene sulfonates; therefore, no mitigation measures are necessary.
2. Environmental Risk Management
The Agency considers the uses of alkylbenzene sulfonates assessed in this RED to be
unlikely to result in any appreciable exposure to terrestrial or aquatic organisms. Therefore, no
risk mitigation measures are required.
3. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
42
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To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a "no effect" determination. Due to the low
likelihood of exposure and low toxicity of alkylbenzene sulfonates, the Agency expects no
effects to listed species or critical habitat and therefore makes a "No Effect" determination for
this chemical.
b. General Risk Mitigation
Alkylbenzene sulfonates end-use products (EPs) may also contain other registered
pesticides. Although the Agency is not proposing any mitigation measures for products
containing alkylbenzene sulfonates specific to federally listed species, the Agency needs to
address potential risks from other end-use products. Therefore, users should adopt all listed
species risk mitigation measures for all active ingredients in the product. If a product contains
multiple active ingredients with conflicting listed species risk mitigation measures, the more
stringent measure(s) should be adopted.
43
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V. What Registrants Need to Do
The Agency has determined that alkylbenzene sulfonates are eligible for reregi strati on
provided that additional data that the Agency intends to require confirm this decision. The
additional data requirements that the Agency intends to obtain will include, among other things,
submission of the following:
For end-use products containing the active ingredient alkylbenzene sulfonates, the registrants
need to submit the following items as there are no registered technical manufacturers:
Within 90 days from receipt of the generic data call-in (DCI):
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact Adam Heyward at (703) 308-6422 with questions regarding generic reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Adam Heyward Adam Heyward
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
44
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For end-use products containing the active ingredient alkylbenzene sulfonates, the registrants
need to submit the following items for each product:
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. five copies of the draft label incorporating all label amendments outlined in Table 13
of this document;
4. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. the product-specific data responding to the PDCI.
Please contact Adam Heyward at (703) 308-6422 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk
Adam Heyward
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Adam Heyward
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
45
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A. Manufacturing Use Products
There are no currently registered alkylbenzene sulfonates manufacturing-use products.
However, additional generic data requirements have been identified.
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of alkylbenzene sulfonates has been
reviewed and determined to be substantially complete. However, the following additional data
requirements have been identified by the Agency as confirmatory data requirements. A generic
data call-will be issued at a later date.
The risk assessment noted deficiencies in the surrogate inhalation exposure data available
from the Chemical Manufacturers Association (CMA) data base. Therefore, the Agency is
requiring confirmatory data to support the uses assessed with the CMA exposure data within this
risk assessment. The risk assessment also noted that many of the use parameters (e.g., amount
handled and duration of use) were based on professional judgments. Therefore, descriptions of
human activities associated with the uses assessed are required as confirmatory. A 90-day nose-
only rat inhalation study using DDBSA (Guideline 870.3465) is required due to limitations with
the monkey inhalation study, which used 13% LAS, in addition to the presence of enzyme.
Table 16. Confirmatory Data Requirements for Reregistration
Guideline Study Name
90-Day Inhalation - Rat
Indoor Inhalation Exposure and Applicator
Exposure Monitoring Data Reporting
Descriptions of Human Activity
Product Use Information
New OPPTS
Guideline No.
870.3465
875. 1400 and
875.1600
875.2800
875.1700/2700
Old Guideline No.
82-4
234 and 236
133-1
N/A
2. Labeling for Technical and Manufacturing Use Products
There are no registered technical or manufacturing use products.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
46
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instructions in the Requirement Status and Registrants Response Form provided for each
product.
A product-specific data call-in, outlining data requirements, will be sent to registrants at a
later date. Possible efficacy studies that the Agency may call-in are listed in Table 17 below.
The PDCI will be based upon current efficacy-related requirements for antimicrobial pesticide
products, claims, or patterns of use. A summary of these requirements can be found on the
Agency's Antimicrobials Science Policy website at
http://www.epa.gov/oppad001/sciencepolicy.htm.
Table 17. Efficacy Data Requirements for Product Reregistration
Claim
Sanitizer
Sanitizer
Disinfectant
Virucidal
Claim in
Conjunction
with
Disinfectant
Claim
Fungicidal
Claim
Use Pattern
(non-food contact
surfaces - non-
residual)
previously cleaned
food-contact
surfaces (non
residual)
Toilet bowl, urinal
surfaces
Any
site/application
Any
site/application
Guideline Study Name
Sanitizer Test for Hard Inanimate
Non — food contact surfaces
AOAC Germicidal and Detergent
Sanitizers Method
AOAC Use Dilution Test (hard
water and organic soil)
Or
AOAC Germicidal Spray Test
Or
AOAC Hard Surface Carrier Test
(distilled water only)
Virucidal Activity Method used in
conjunction with modifications of:
AOAC Hard Surface Carrier Test
(distilled water only)
Or
AOAC Germicidal Spray Test
AOAC Fungicidal Test or
AOAC Hard Surface Carrier Test
(distilled water only)
Or
AOAC Germicidal Spray Products
Test
New OPPTS
Guideline
No.
810.2100(1)
810.2100
(m)(2)
91-7 (a) (1)
810.2100(g)
810.2 100(f)
Old Guideline No.
91-20)
91-2 (1)(2)
810.2600 (b) (1)
91-2(f)
91-2(e)
47
-------
2. Labeling for End-Use Products that Contain Alkylbenzene Sulfonates as an Inert
Ingredient
All products that contain alkylbenzene sulfonates as an inert ingredient and make a
sanitization claim must contain an active ingredient that is a sanitizer. If a product containing
alkylbenzene sulfonates as an inert ingredient makes a sanitization claim and does not contain an
active ingredient that is a sanitizer, the sanitization claim will have to be removed from the label.
If the registrant wishes to keep the sanitization claim, alkylbenzene sulfonates will need to be
listed as an active ingredient rather than an inert ingredient. All relevant data will need to be
submitted and reviewed in order to make this change.
48
-------
VI. APPENDICES
49
-------
Appendix A. Table of Use Patterns for Alkylbenzene Sulfonates
PC Code 079010
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications1
Use Limitations
Food handling/ storage establishments premises and equipment
Eating Establishments &
Equipment (utensils,
cutting boards, counter
tops, sinks, etc.), Food
handling areas
Dairy and Food
Processing Plants &
Equipment, Food Contact
Fruit and Vegetable
Rinses
Soft Ice Cream, Juice and
Vending Machines
Soluble
Concentrate
1020-13
Soluble
Concentrate
71094-1
Ready to Use
71094-2
Soluble
Concentrate
1020-13
Soluble
Concentrate
71094-1
Ready to Use
71094-2
Soluble
Concentrate
71094-1
Ready to Use
71094-2
Soluble
Concentrate
71094-1
Brush or
Spray
Immersion,
flooding or
spraying
Brush or
Spray
Immersion,
flooding or
spraying
Immersion,
gentle hand
scrub
Circulate in
system
2 oz / gallon of water
l%(one pouch/ 8 gallons)
to 2%(one pouch/ 4
gallons)
One minute contact time
2 oz / gallon of water
l%(one pouch/ 8 gallons)
to 2%(one pouch/ 4
gallons)
One minute contact time
l%(one pouch/ 8 gallons)
to 2%(one pouch/ 4
gallons)
2 to 5 minute wash
5 to 10 minute circulation
to clean
2 to 5 minute circulation
Prepare fresh solutions daily
None Stated
Prepare fresh solutions daily
None Stated
Prepare cleaning solution with potable
water
Maintain sanitizer solution pH of 2.2-2.8;
discard sanitizer if it becomes visibly dirty
or its pH increases/ solution may not be
50
-------
Use Site
Formulation/ EPA
Reg No.
Ready to Use
71094-2
Method of
Application
Application Rate/ No. of
applications1
to sanitize
Use Limitations
reused for sanitizing
1 Application rate is given in terms of end-use product, not active ingredient.
Appendix A. Table of Use Patterns for Alkylbenzene Sulfonates
PC Codes 098002 and 190116
Use Site
Formulation/
EPA Reg No.
Method of
Application
Application Rate/ No. of
applications2
Use Limitations
Agricultural premises and equipment
Dairy Farm milking
machines, milk handling
equipment and facilities
Soluble
Concentrate
833-75
875-85
875-184
1270-254
4959-29
9152-18
64328-1
74210-1
Soluble
Concentrate
875-185
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
To sanitize: 1 :200 dilution,
ten minute contact time
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
51
-------
Use Site
Formulation/
EPA Reg No.
Method of
Application
Application Rate/ No. of
applications2
Use Limitations
Food handling/storage establishments premises and equipment
Diary/Cheese processing
plant equipment
Diary/Cheese processing
plant equipment
Ice Cream processing
plant equipment
Soluble
Concentrate
150-61
833-75
875-85
875-184
1270-254
1677-169
2686-10
9152-18
19713-299
64328-1
65001-1
71695-1
74210-1
Soluble
Concentrate
875-185
Soluble
Concentrate
9152-18
Soluble
Concentrate
74210-1
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
To sanitize: 1 :200 dilution,
ten minute contact time
To sanitize: 1 oz. to two
gallons of water, five
minute contact time.
To sanitize: 1 - 2 oz per
10 gallons of water, two
minute contact time.
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
52
-------
Use Site
Formulation/
EPA Reg No.
Method of
Application
Application Rate/ No. of
applications2
Use Limitations
circulation
Egg processing and
packing equipment and
surfaces
Soluble
Concentrate
1270-254
Circulation,
flushing
To sanitize: 1 oz. to 6
gallons of water, one
minute contact time.
Soluble
Concentrate
74210-1
Immersion,
brush, spray,
flushing or
circulation
To sanitize: 1 - 2 oz per
10 gallons of water, two
minute contact time.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
NOTE: EPA Reg. No. 74210-1 has shell egg
grading and egg products on its label but no
specific directions for how to use the product
on the site.
Eating establishments
equipment, glassware and
utensils
Soluble
Concentrate
833-75
875-184
1270-254
4959-29
64328-1
Immersion,
brush, spray,
flushing or
circulation
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
Soluble
Concentrate
875-185
Immersion,
brush, spray,
flushing or
circulation
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
To sanitize: 1:200 dilution,
ten minute contact time
Food processing
equipment and surfaces
Food processing
equipment and surfaces
Soluble
Concentrate
150-61
833-75
875-85
Soluble
Concentrate
875-184
1270-254
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
53
-------
Use Site
Meat and poultry
processing plants
Formulation/
EPA Reg No.
1677-169
2686-10
4959-29
7546-4
9152-18
19713-299
64328-1
65001-1
71695-1
Soluble
Concentrate
875-185
Soluble
Concentrate
833-75
875-184
1270-254
4959-29
64328-1
74210-1
Soluble
Concentrate
875-185
Method of
Application
circulation
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Application Rate/ No. of
applications2
gallons of water. 1-5
minute contact time. (200-
400ppm)
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
To sanitize: 1 :200 dilution,
ten minute contact time
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
Use Limitations
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
54
-------
Use Site
Carbonated beverage and
brewery processing
equipment and surfaces
Wineries, carbonated
beverage and brewery
processing equipment and
surfaces
Formulation/
EPA Reg No.
Soluble
Concentrate
150-61
833-75
875-184
9152-18
19713-299
64328-1
65001-1
71695-1
74210-1
Soluble
Concentrate
875-185
Soluble
Concentrate
1270-254
Method of
Application
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Immersion,
brush, spray,
flushing or
circulation
Application Rate/ No. of
applications2
To sanitize: 1 :200 dilution,
ten minute contact time
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
1:30 to 1:40 dilution for
foam cleaning and de-
scaling
To sanitize: 1 :200 dilution,
ten minute contact time
To clean: 1 oz. to 1.5-5
gallons of water
To sanitize: 1 oz. to 1-6
gallons of water. 1-5
minute contact time. (200-
400ppm)
Use Limitations
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use
Pre-clean and pre-soak prior to use.
For cleaning follow with a potable water
rinse.
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use
55
-------
Use Site
Seafood processing plants
Fruit and vegetable rinses
Formulation/
EPA Reg No.
Soluble
Concentrate
1270-254
Soluble
Concentrate
71695-1
Method of
Application
Immersion,
brush, spray,
flushing or
circulation
Application Rate/ No. of
applications2
To sanitize: 1 oz. to 6
gallons of water, one
minute contact time.
1 oz. per 5 gallons of
water. Rinse with potable
water after the wash cycle.
Use Limitations
For sanitization, wash pre-cleaned surfaces
with approved alkaline cleaner and potable
water rinse before use.
Use a test kit to assure proper concentration
of product in the wash water. At no time
should the concentration of product exceed 2
oz. per 5 gallons of water.
Residential and public access premises
Toilets, Porcelain Urinals
and Shower Stalls
Soluble
Concentrate/
Ready to Use
3625-279
Soluble
Concentrate
65001-1
Mop, brush or
sponge
Mop, brush or
sponge
Ready to Use: Add 1 oz. to
toilet bowl, ten minute
contact time.
Concentrate: 1 oz. per
gallon of water, ten minute
contact time.
1 oz. per 5 gallons of water
Application rate is given in terms of end-use product, not active ingredient.
56
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregi strati on for active ingredients within case #4006
(alkylbenzene sulfonates) covered by this RED. It contains generic data requirements that apply to alkylbenzene sulfonates in all
products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR part 158.
The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which are
available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The following
letter designations are used for the given use patterns.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishment premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify number
of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number if no MRID number
57
-------
has been assigned. Refer to the Bibliography appendix for a complete citation of the study.
58
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
42439801
42439801
42439801
42439801
43729701; 43741101; 43752001;
43750401; 43748801; 43761801
42439802
00161997
43656401
43656401
00161997
Not required
43656401
00161997
Waived
00161997; 00161996
59
-------
DATA REQUIREMENT
New
Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
830.6321
Old
Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Study Title
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Use
Pattern
1,2,3
1,2,3
1,2,3
CITATION(S)
MRID Number
Waived
00161997
43656402; 43656403; 43656401;
43787401
Not required
Not required
Not required
41221301
Not required
Not required
Not required
Not required
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
71-1
71-2
72-1
Avian Acute Oral Toxicity Test
Avian Dietary Toxicity
Acute Freshwater Fish (rainbow trout or bluegill
sunfish)
1,2,3
1,2,3
41143901
Not required
44260002, 44260009
60
-------
DATA REQUIREMENT
New
Guideline
Number
850.1010
Old
Guideline
Number
72-2
Study Title
Acute Freshwater Invertebrate (daphnia magna)
Use
Pattern
1,2,3
CITATION(S)
MRID Number
47025025
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3200
870.3250
870.3465
870.3700a
870.3700
81-1
81-2
81-3
81-4
81-5
81-6
82-la
82-lb
82-2
82-3
82-4
83-3b
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
90-Day Feeding-Non-Rodent
21/28-Day Dermal Toxicity - Rat
90-day Dermal Toxicity - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - rodent
Teratogenicity - Rabbit
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
43498402; 43498408; 43498430
94032006
Open literature
43498405
40359306
Open literature
43498412; 43498402; 43498409;
43498413 & 4351 1401; open
literature
Not required
43498411; Open literature
Not required; Reserved
Data gap
Open literature; 43498423;
43498424; 43498425; 43498426;
43511403
43498426
61
-------
DATA REQUIREMENT
New
Guideline
Number
870.3800
870.4100
870.4200
870.4300
870.5100
870.5300
870.5265
870.5385
870.5395
870.5450
870.7485
870.7600
Old
Guideline
Number
83-4
83-la
83-lb
83-2a
83 -2b
83-5
84-2a
84-2b
84-4
85-1
85-2
Study Title
Reproduction and Fertility Effects - 2 Generation
Repro
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent (dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Combined Chronic Toxicity/Carcinogenicity
Bacterial reverse mutation test
In Vitro mammalian cell gene mutation test
Gene Mutation - ames
Structural Chromosome Aberration
Mammalian erythrocyte micronucleus test
Rodent dominant lethal assay
Other genotoxic effects
General Metabolism
Dermal Absorption
Use
Pattern
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
1,2,3
CITATION(S)
MRID Number
43498416; Open literature
43498416; Open literature
Not required
43498421; 43498422; 43498419;
43498420; 43498416; Open
literature
Waived
Not required
Open literature; 43498429
Open literature; 43498427
43498428
43498429; 43498428; Open
literature
Open literature
Open literature
43498429
43498431; 43498410; Open
literature
42565201; 43498407
62
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
MRID Number
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2800
875.1200
875.1600
875.1400
875.1600
875.1700
875.2700
133-1
233
234
Description of Human Activity
Dermal Indoor Exposure
Inhalation Indoor Exposure
Product Use Information
1,2,3
1,2,3
1,2,3
1,2,3
Data gap
Waived
Data gap
Data gap
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis
1,2,3
Open literature
63
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The docket initially contained the April 19, 2006 preliminary risk assessment and the
related supporting science documents. EPA then considered comments on the risk assessment
and revised the risk assessment and supporting chapters as necessary. The revised risk
assessment will be posted in the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov
These documents include:
• Alkylbenzene Sulfonates Preliminary Risk Assessment; Notice of Availability, 4/19/06.
Preliminary Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
• Alkylbenzene Sulfonates (ABS) Preliminary Risk Assessment for the Reregi strati on
Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002. Case No.
4006. DP Barcode: D323972
• Occupational and Residential Exposure Assessment for Alkylbenzene Sulfonates for the
Reregi strati on Eligibility Decision Document (RED) (Active Uses). T. Milano. March
23. D327732
• Residential Exposure Inert Assessment of Alkylbenzene Sulfonates for the Reregi strati on
Eligibility Decision Document (RED). T. Milano/C. Walls, March 23, 2006. D327733
• Environmental Fate Assessment of Alkylbenzene Sulfonates for the Reregi strati on
Eligibility Document (RED). T. Milano. March 23, 2006. D323968
• Product Chemistry Science Chapter for Benzene Sulfonic Acid, Cio-Cie Derivatives and
Sodium Salt. A. N. Shamim. March 2006. D323976.
• Ecological Hazard and Environmental Risk Assessment of Alkylbenzene Sulfonates for
the Registration Eligibility Document (RED). R. Petrie. January 2006. D323970.
• Dietary Exposure Assessments for the Reregi strati on Eligibility Decision. R. Quick.
March 23, 2006. D327731.
• Toxicology Disciplinary Chapter for the Reregi strati on Eligibility Decision (RED)
Document, A.Assaad/W.Dyksra/L.Scarano, March 23, 2006. D327886.
• Inert Ingredient Dietary Risk Assessment for Linear Alkyl Benzenesulfonate. K. Leifer.
March 23, 2006. D324036
64
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Revised Risk Assessment and Revised Supporting Science Documents (RED Supporting
Documents):
• Alkylbenzene Sulfonates (ABS) Revised Risk Assessment for the Reregi strati on
Eligibility Decision (RED) Document. PC Code: 079010, 190116 and 098002. Case No.
4006. DP Barcode:D330338
• Occupational and Residential Exposure Assessment for Alkylbenzene Sulfonates for the
Reregi strati on Eligibility Decision Document (RED) (Active Uses). T. Milano. July 6,
2006. D330329
• Residential Exposure Inert Assessment of Alkylbenzene Sulfonates for the Reregi strati on
Eligibility Decision Document (RED). T. Milano/C. Walls, July 6, 2006. D330330
• Product Chemistry Science Chapter for Benzene Sulfonic Acid, Cio-Cie Derivatives and
Sodium Salt. A. N. Shamim. July 11, 2006. D330332.
• Ecological Hazard and Environmental Risk Assessment of Alkylbenzene Sulfonates for
the Registration Eligibility Document (RED). R. Petrie. July 12, 2006. D330326.
• Toxicology Disciplinary Chapter for the Reregi strati on Eligibility Decision (RED)
Document, A.Assaad/W.Dyksra/L.Scarano, July 6, 2006. D330328.
• Environmental Fate Assessment of Alkylbenzene Sulfonates for the Registration
Eligibility Document (RED). T. Milano. July 6, 2006. D323968.
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
MRID Studies
MRID 41143901 - Lloyd, D.; Grimes, 1; Jaber, M. (1989) Nacconol 90G: An Acute Oral
Toxicity Study with the Bobwhite: Final Report: Wildlife International Ltd. Project No. 257-
101. Unpublished study prepared by Wildlife International Ltd. 26p.
MRID 42439803 - Bollman, M.A. et. al. (1990) Report on the Algal Toxicity Tests of Selected
Office of Toxic Substances (OTS) Chemicals. US EPA Environmental Research Laboratory.
179p.
MRID 43377801 - Physical/Chemical Properties Data on DDES A and its Salts by John
Todhunter, 1995. SRS International Corp., Study ID#: DDBS/63-13/Supplemental
MRID 43498403 Coate et al. (1978) Respiratory Toxicity of Enzyme Detergent Dust. Toxicol.
Appl. Pharmacol., 45: 477-496.
MRID 43498410 Creswell et al. (1978) Toxicology Studies of Linear Alkylbenzene Sulfonate
(LAS) in Rhesus Monkeys II. The Disposition of C14-LAS After Oral or Subcutaneous
Administration. Toxicology, 11: 5-17.
MRID 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)
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)
MRID 43498419 Takahasi et al. (1970) Effect of 4-Nitroquinoline-l-Oxide with
Alkylbenzenesulfonate on Gastric Carcinogenesis in Rats. GANN: 61, 27-33.
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.
MRID 43498424 Nomura, T et al. (1980) The Synthetic Surfactants AS and LAS Interrupt
Pregnancy in Mice. Life Sciences, 26: 49-54. (HERA)
MRID 43498425 Nomura, T. et al. (1987) Killing of Preimplantation Mouse Embryos by AS
and LAS. Mutation Research 190: 25-29. (HERA)
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MRID 43498426 Palmer et al. (1975) Assessment of the Teratogenic Potential of Surfactants,
(Part I), Toxicology 3: 91-106.
MRID 43498427 K. Inoue et al (1980) Food Cosmetic Toxicol. 18:289-296
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.
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)
MRID 43498431 W. Michael (1968) Metabolism of Linear Alkylate Sulfonate and Alkyl
Benzene Sulfonate. Toxicol. Appl. Pharmacol. 12: 473-485.
MRID 43511403 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. DDESA JV-RP4-029. Toxicology 4: 171-181.
MRID 436564001 - Product Chemistry Data in support of Registration of Sodium
Dodecylbenzenesulfonic Acid by John Todhunter and Kelly White, 1995: SRS International
Corp. Lab ID# DD13SA JV/g63.13
MRID 44260002 - McKim, J. M.; Arthur, J.W.; Thorslund, T.W. (1975) Toxicity of Linear
Alkylate Sulfonate Detergent to Larvae of Four Species of Freshwater Fish. USEPA, Nat. Water
Qual. Lab., Duluth, MN. Bulletin of Environmental Contamination and Toxicology. Vol 14 (1)
pg. 1-7.
MRID 44260009 - Calamari, D.; Marchetti, R. (1973) The Toxicity of Mixtures of Metals and
Surfactants to Rainbow Trout (Salmo gairdneri rich.) Water Research. Vol. 7(10) pg. 1453-
1464.
MRID 47025025 - Maki, A.W.; Bishop, W.E. (1979) Acute Toxicity Studies of Surfactants to
Daphnia magna and Daphniapulex. Archives of Environmental Contamination and Toxicology.
Vol. 8, p. 599-612. Sponsored by The Proctor and Gamble Company USA, Ivorydale Technical
Ctr., Cincinnati, OH.
Open Literature
Barid, Colin. Environmental Chemistry, 2~ Edition. W.H. Freeman and Company: New York,
2003.
Cavalli, L., et. al. (1993). "LAS Removal and Biodegradation in a Wastewater Treatment Plant."
Environmental Toxicology and Chemistry. Vol. 12. pp 1777-1788.
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Fairchild, J. F., F. J. Dwyer, T. W. La Point, S. A. Burch, and C. G. Ingersoll. 1993. Evaluation
of a Laboratory-Generated NOEC For Linear Alkylbenzene Sulfonate In Outdoor Experimental
Streams. Environmental Toxicology and Chemistry. Vol. 12(10): 1763-1775. Symposium on
Surfactants and Their Environmental Safety, llth Annual Meeting, Society of Environmental
Toxicology and Chemistry, Arlington, VA, Nov. 11-15, 1990.
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).
Ito, et al. (1978) Acute, Subacute, and Chronic Toxicity of Magnesium LAS (LAS-Mg). J. Med.
Soc. TohoUniv. 25: 850-875.
Jacobsen, Anne Marie, Gerda Krog Mortensen, and Hans Christian Bruun Hansen. (2004).
"Degradation and Mobility of Linear Alkylbenzene Sulfonate and Nonylphenol in Sludge-
Amended Soil." Journal of Environmental Quality. Vol 33. pp. 232-240.
Kuhnt, Gerald. (1993). "Behavior and Fate of Surfactants in Soil." Environmental Toxicology
and Chemistry. Vol. 12. pp 1813-1820.
Lewis, M.A., C.A. Pittinger, D.H. Davidson and C.J. Ritchie. 1993. In Situ Response of Natural
Periphyton To An Anionic Surfactant And An Environmental Risk Assessment For Phytotoxic
Effects. Environmental Toxicology and Chemistry. Vol. 12(10): 1803-1812. Symposium on
Surfactants and Their Environmental Safety, llth Annual Meeting, Society of Environmental
Toxicology and Chemistry, Arlington, VA, Nov. 11-15, 1990.
Mathur et al. (1992) Effect of Dermal Exposure to LAS Detergent and HCH Pesticide in Guinea
Pigs: Biochemical and Histopathologic Changes in Liver and Kidney. J Toxicol Cutan Ocular
Toxicol, 11(1): 3-13. (WHO 1996)
Yoneyama & Hiraga (1977) Effect of Linear Alkylbenzene Sulfonate on Serum Lipid in Rats, J
Ann Rep Tokyo Metrop Res Lab, Public Health 28(2): 109-111. (HERA)
Yoneyama et al. (1978) Effects of LAS on Incorporation of Acetate-1-14C in Liver Lipids in
Rats. J Ann Rep Tokyo Metrop Res Lab Public Health, 29 (2): 55-57.
Websites:
http://chem.sis.nlm.nih.gov/chemidplus/isp/ChemFull
"International Programme on Chemical Safely, Environmental Health Criteria 169, Linear
Alkylbenzene Sulfonates and Related Compounds." World Health Organization. Geneva, 1996
http: //inchem. org/documents/ehc/ehc/ehc 169. htm.
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World Health Organization (WHO). 1996. Environmental Health Criteria Document for Linear
Alkylbenzene Sulfonates and Related Compounds. (EHC 169, available at
http://www. inchem. org/documents/ehc/ehc/ehc 169. htm )
Models and Internal Documents:
DEEM-FCID™ Program and Consumption Information - Version 2.1, Exponent, Inc.,
Washington, DC
The Estimation Programs Interface (EPI) Suite. Windows based suite of physical/chemical
properties and environmental estimation models developed by the US EPA's Office of
Prevention, Pesticides, and Toxic Substances (OPPTS) and Syracuse Research Institute (SRC).
http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm
Linear Alkyl Benzenesulfonate Modeling Input Parameters for FIRST and GENEEC
PiRat: http://www.epa.qov/opptintr/exposure/docs/pirat.htm
Human and Environmental Risk Assessment (HERA). 2004. LAS - Linear Alkylbenzene
Sulphonates (CAS No. 68411-30-3)
USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the
Pesticide Handler Exposure Database Version 1.1. Washington, DC: U.S. Environmental
Protection Agency.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
Assessment Study (CMA). Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie
Fairfax.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the
Alkylbenzene Sulfonates RED for a list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G. Batching of Alkylbenzene Sulfonates Products for Meeting Acute Toxicity
Data Requirements for Reregistration
The Agency will complete the batching at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
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8570-36
8570-37
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
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b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
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3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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