Document ID: EPA-HQ-OPP-2006-0156-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-22T04:00Z

SEQ CHAPTER \h \r 1 							

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: July 19, 2006

MEMORANDUM

SUBJECT:	Alkylbenzene Sulfonates (ABS) Risk Assessment for the
Reregistration Eligibility Decision  (RED) Document.  PC Codes: 079010,
190116 and 098002.(active); 790102, 790116, 790101 (inert) Case No.
4006.  DP Barcode: D330338

		Regulatory Action:  Reregistration Eligibility Decision (RED) (Phase
I)

		Risk Assessment Type:  Single Chemical Aggregate

FROM:	Deborah Smegal, MPH, Toxicologist/Risk Assessor

		Ayaad Assaad, PhD.  Toxicologist

		William Dykstra, PhD., Toxicologist

		Health Effects Division (HED) (7509C)

		And

		Talia Milano, Chemist 

		Robert Quick, Chemist

		Richard Petrie, Agronomist

		Cassi Walls, PhD, Chemist

		Najm Shamim, Ph.D. Chemist

		Antimicrobials Division (AD) (7510C)

		And

		Kerry Leifer, Chemist

		Registration Division (RD)

THRU:		Michael S. Metzger, Branch Chief

		Whang Phang, Senior Scientist

		Reregistration Branch I

		Health Effects Division (HED), (7509C) 

TO:		Heather Garvie, Chemical Review Manager, Reregistration Team 36

		Regulatory Management Branch II

		Antimicrobials Division (7510C)     

        

Attached is the Risk Assessment for the Alkylbenzene Sulfonates (ABS)
for the purpose of issuing a Reregistration Eligibility Decision (RED). 
This document has been revised to address public comments.  The
disciplinary science chapters and other supporting documents for the
Alkylbenzene Sulfonates RED are also included as attachments as follows:
 

Occupational and Residential Exposure Assessment for Alkylbenzene
Sulfonates for the Reregistration Eligibility Decision Document (RED)
(Active Uses).   T. Milano.  July 6, 2006.  D330329 

Residential Exposure Inert Assessment of Alkylbenzene Sulfonates for the
Reregistration Eligibility Decision Document (RED).   T. Milano/C.
Walls,  July 6, 2006.  D330330 

Environmental Fate Assessment of Alkylbenzene Sulfonates for the
Reregistration Eligibility Document (RED).   T. Milano.July 6, 2006. 
D323968  

Product Chemistry Science Chapter for Benzene Sulfonic Acid, C10-C16
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.

Dietary Exposure Assessments for the Reregistration Eligibility
Decision.  R. Quick.  March 23, 	2006.  D327731.  

Toxicology Disciplinary Chapter for the Reregistration Eligibility
Decision (RED) Document, A.Assaad/W.Dyksra/L.Scarano,  July 6, 2006,
D330328 

Inert Ingredient Dietary Risk Assessment for Linear Alkyl
Benzenesulfonate.  K. Leifer. 

            March 23, 2006.  	   TOC \o "1-3" \h \z \u  

  HYPERLINK \l "_Toc141690976"  1.0 	EXECUTIVE SUMMARY	  PAGEREF
_Toc141690976 \h  4  

  HYPERLINK \l "_Toc141690977"  2.0	PHYSICAL AND CHEMICAL PROPERTIES	 
PAGEREF _Toc141690977 \h  11  

  HYPERLINK \l "_Toc141690978"  3.0.	ENVIRONMENTAL FATE	  PAGEREF
_Toc141690978 \h  12  

  HYPERLINK \l "_Toc141690979"  4.0	HAZARD CHARACTERIZATION	  PAGEREF
_Toc141690979 \h  13  

  HYPERLINK \l "_Toc141690980"  4.1 Hazard Profile	  PAGEREF
_Toc141690980 \h  13  

  HYPERLINK \l "_Toc141690981"  4.2   FQPA Considerations	  PAGEREF
_Toc141690981 \h  15  

  HYPERLINK \l "_Toc141690982"  4.3 Dose-Response Assessment	  PAGEREF
_Toc141690982 \h  16  

  HYPERLINK \l "_Toc141690983"  4.4	Endocrine Disruption	  PAGEREF
_Toc141690983 \h  18  

  HYPERLINK \l "_Toc141690984"  5.0	PUBLIC HEALTH DATA	  PAGEREF
_Toc141690984 \h  19  

  HYPERLINK \l "_Toc141690985"  6.0	EXPOSURE ASSESSMENT AND
CHARACTERIZATION	  PAGEREF _Toc141690985 \h  20  

  HYPERLINK \l "_Toc141690986"  6.1 Summary of Registered Uses	  PAGEREF
_Toc141690986 \h  20  

  HYPERLINK \l "_Toc141690987"  6.2 	Dietary Exposure and Risk	  PAGEREF
_Toc141690987 \h  21  

  HYPERLINK \l "_Toc141690988"  6.2.1	Dietary Exposure for Active
Ingredient Uses	  PAGEREF _Toc141690988 \h  21  

  HYPERLINK \l "_Toc141690989"  6.2.2	Dietary Exposure for Inert
Ingredient Uses	  PAGEREF _Toc141690989 \h  24  

  HYPERLINK \l "_Toc141690990"  6.3   Drinking Water Exposure and Risk
for Inert Ingredient Uses	  PAGEREF _Toc141690990 \h  25  

  HYPERLINK \l "_Toc141690991"  6.4 	Residential Exposure and Risks from
Inert Ingredient Use	  PAGEREF _Toc141690991 \h  27  

  HYPERLINK \l "_Toc141690992"  7.0 	AGGREGATE RISK ASSESSMENTS AND RISK
CHARACTERIZATION	  PAGEREF _Toc141690992 \h  30  

  HYPERLINK \l "_Toc141690993"  8.0	CUMULATIVE EXPOSURE AND RISK	 
PAGEREF _Toc141690993 \h  33  

  HYPERLINK \l "_Toc141690994"  9.0	OCCUPATIONAL EXPOSURE AND RISK	 
PAGEREF _Toc141690994 \h  33  

  HYPERLINK \l "_Toc141690995"  10.0 	ENVIRONMENTAL RISK	  PAGEREF
_Toc141690995 \h  37  

  HYPERLINK \l "_Toc141690996"  10.1	Active Ingredient Uses	  PAGEREF
_Toc141690996 \h  37  

  HYPERLINK \l "_Toc141690997"  10.2	Inert Ingredient Use	  PAGEREF
_Toc141690997 \h  42  

  HYPERLINK \l "_Toc141690998"  11.0	DEFICIENCIES/DATA NEEDS	  PAGEREF
_Toc141690998 \h  42  

  HYPERLINK \l "_Toc141690999"  12.0	REFERENCES	  PAGEREF _Toc141690999
\h  43  

 

	

1.0 	EXECUTIVE SUMMARY  tc "1.0 	EXECUTIVE SUMMARY" 

The alkylbenzene sulfonates evaluated in this risk assessment are: (1)
sodium dodecylbenzene sulfonate (CAS # 25155-30-0), (2) dodecylbenzene
sulfonic acid (CAS # 27176-87-0), and (3) benzenesulfonic acid, C10-C16
alkyl derivatives (CAS # 68584-22-5).  These compounds are collectively
called DDBSA by the DDBSA Joint Venture Task Force.  Dodecylbenzene
sulfonic acid is not considered to be a pure compound, and is included
in the mixture of benzenesulfonic acid, C10-16 alkyl derivatives.  

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

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

Approximately 300,000 pounds of alkylbenzene sulfonates are used in EPA
registered antimicrobial products, which is a small fraction of the
approximately 860 million pounds produced each year.  The majority of
uses of alkylbenzene sulfonates are as household laundry and dish
detergents.  The alkylbenzene sulfonates   SEQ CHAPTER \h \r 1 are
listed on the EPA High Production Volume (HPV) Challenge Program.  HPV
chemicals are those that are manufactured or imported into the U.S. in
production volumes greater than one million pounds per year.  The
alkylbenzene sulfonates are sponsored by the Linear Alkylbenzene (LAB)
Sulfonic Acids Coalition, which has generated data for these chemicals. 
 

	

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

	

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

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

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

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

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

	Inhalation Exposure:  For the short-, intermediate- and long-term
inhalation exposure a NOAEL of 1 mg/m3 was selected (equivalent to 0.14
mg/kg/day) from a subchronic inhalation monkey study that noted weight
loss and decreased weight gain at 10 mg/m3 (1.4 mg/kg/day) following
exposure to a detergent dust containing 13% active ingredient of
alkylbenzene sulfonates.   In the absence of data, it was conservatively
assumed that inhalation absorption is 100% to convert the air
concentration into a dose equivalent.  The target MOE is 100 for both
residential and occupational exposures (10X for interspecies
extrapolation, 10X for intraspecies variability, includes 1X FQPA factor
discussed below).    

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

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

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

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

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

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

 [Dietary Exposure Evaluation Model (DEEM™)] that assumed 100% of all
commodities, and 100% of all crops were treated with the alkylbenzene
sulfonates, with no limitation on the fraction of inert ingredient.  The
highest dietary risk estimate is 84% of the cPAD for children 1-2 years
of age, which is below the Agency’s level of concern.  The
conservative screening-level drinking water assessment predicted chronic
Estimated Drinking Water Concentrations (EDWC) of 6.6 ppb using the FQPA
Index Reservoir Screening Tool (FIRST), which represents <0.1% of the
cPAD.  The Agency concludes there is no concern for aggregate food and
drinking water exposures to the alkylbenzene sulfonates resulting from
their use as pesticide inert ingredients. 

	Residential (Non-Occupational) Exposure and Risk:  There are no
residential use sites for the alkylbenzene sulfonates as active
ingredients.  However, alkylbenzene sulfonates are formulated as inert
ingredients in approximately 350 registered end-use products, many of
which are used in residential settings.   Some examples of the specified
use sites on the products consist of indoor hard non-porous surfaces
(e.g. floors, walls etc.), carpets, food contact surfaces (glasses,
dishes, silverware, countertops, etc.), agricultural tools and crops,
lawns and turfs, fruits and vegetables (post-harvest), wood
preservatives, materials preservatives, metalworking fluids, and pet
products.  In this screening level assessment, the Agency selected
representative scenarios for the vast majority of products, based on
end-use product application methods and use amounts.  The Agency
evaluated the following high end exposure scenarios: (1) outdoor
residential turf treatment (ready to use liquid); (2) indoor hard
surface cleaner (ready to use liquid; and (3) pet flea and tick products
(aerosol can spray).  For each of the use sites, the Agency assessed
residential handler (applicator) inhalation exposure and post
application incidental ingestion by toddlers.  

	For most scenarios, the Agency utilized EPA’s Pesticide Inert Risk
Assessment Tool (PiRat) to estimate residential applicator and
post-application exposures from the use of alkylbenzene sulfonates as
inert ingredients in residential products.  For the pet product scenario
and the hard surface cleaner post application exposure assessment, the
Agency used assumptions based on the Residential Exposure Assessment
Standard Operating Procedures (SOPs).  Because there are a large number
of products that contain alkylbenzene sulfonates as an inert ingredient,
and to be conservative the Agency assessed a representative high end
formulation product.  A  SEQ CHAPTER \h \r 1  dermal assessment was not
conducted because a dermal endpoint was not selected.   An inhalation
post-application assessment was not conducted because the vapor pressure
of the sulfonates is extremely low.  The duration of exposure was
assumed to be short-term (1-30 days) for all residential scenarios
assessed.  

s as inert ingredients, the short-term inhalation MOEs were above the
target MOEs (i.e., >100) and thus, do not exceed the Agency’s level
of concern, with the exception of the flea and tick product where the
MOE was 87 for the high-end formulation containing 24% alkylbenzene
sulfonates.  However, this scenario is conservative because it assumes a
person treats his/her pet with 0.5 cans of flea product that contains
24% alkylbenzene sulfonates every day for a month.  

	Residential Postapplication Risk Estimates.  	There are no residential
postapplication risk concerns for the household products that contain
alkylbenzene sulfonates as an inert ingredient.  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 alkylbenzene sulfonates caused dermal irritation following repeated
dermal exposure, generally to concentrations greater than 20%.  Thus,
dermal exposure would be self-limiting to preclude dermal irritation. 
The majority of residential products contain less than 5% alkylbenzene
sulfonates.  The Agency intends to consider the potential for irritation
in recommended labeling language of pesticide products containing the
alkylbenzene sulfonates, and consider available dermal toxicity data on
a diluted end-use formulation.  

	Aggregate Exposure and Risk: In order for a pesticide registration to
continue, it must be shown that the use does not result in
“unreasonable adverse effects on the environment”.  Section 2 (bb)
of FIFRA defines this term to include “a human dietary risk from
residues that result from a use of a pesticide in or on any food
inconsistent with standard under section 408...” of FFDCA.  As
mandated by the FQPA amendments to FIFRA and the Federal Food, Drug and
Cosmetic Act (FFDCA), the Agency must consider total aggregate exposure
from food, drinking water and residential sources of exposure to
alkylbenzene sulfonates.  

	An acute aggregate assessment was not conducted because there are no
adverse effects attributable to acute exposure.  An intermediate-term
aggregate assessment was not conducted because there are no residential
exposures of this duration.  In addition, because there are no long-term
residential exposures, the chronic aggregate assessment only considered
food and drinking water exposures from the inert uses that were
previously determined to not be of risk concern.  Thus, only short-term
and chronic aggregate assessments were conducted.  Oral and inhalation
exposure and risk estimates were conservatively combined for the
aggregate risk assessment because these endpoints both identify adverse
effects on body weight.  Dermal exposures were not considered in the
risk assessment because a toxicological endpoint was not established.  

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

	The aggregate oral and inhalation risks are not of concern for adults,
as the total aggregate MOE is 340 which is greater than the target of
100.  For children, the aggregate risk estimate is very close to the
target MOE of 100 (MOE=99).  As noted previously, several conservative
assumptions were used in this assessment.  

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

	It should also be recognized that the majority of the uses of
alkylbenzene sulfonates are not in pesticide products, but rather are
used in household laundry and dish detergents.  Over 800 millions pounds
of these compounds are produced each year, while only 300,000 pounds are
used in EPA registered antimicrobial products.  The Agency did not
consider potential exposure and risks from the numerous other
residential exposures to alkylbenzene sulfonates because the Agency
lacks reliable information at this time to assess the consumer product
uses of these chemicals. 

	Occupational Exposure and Risk.  	  SEQ CHAPTER \h \r 1 Based on
examination of product labels describing uses for the product, it has
been determined that exposure to handlers can occur in a variety of
occupational environments.  The representative scenarios selected by the
Agency for assessment were evaluated using maximum application rates as
recommended on the product labels for the three alkylbenzene sulfonate
active ingredients assessed in this report.   

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

ST and IT inhalation exposure from cleaning hard surfaces via wiping in
the food handling category, inhalation MOE = 93.

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

ST and IT inhalation exposure from cleaning indoor hard surfaces via
wiping and then following with sanitizing via immersion/flooding in the
food handling premises category, inhalation MOE = 93.

ST and IT inhalation exposure from cleaning indoor hard surfaces via
wiping and then following with sanitizing via low pressure spray in the
food handling premises category, inhalation MOE  = 90.

ST and IT inhalation exposure from cleaning indoor hard surfaces via
sponge/mesh/wiping and then sanitizing via immersion/flooding in the
food handling premises category, inhalation MOE = 90.

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

	As noted previously, the alkylbenzene sulfonates are dermal irritants
at concentrations greater than 20%.  Thus, dermal exposure would be
self-limiting to preclude dermal irritation.  The Agency intends to
consider the potential for irritation in recommended labeling language
of pesticide products containing the alkylbenzene sulfonates, and
consider available dermal toxicity data on a diluted end-use
formulation.  The Agency should confirm that all products with greater
than 20% require the use of gloves.   

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

Environmental Hazard and Risk.	The alkylbenzene sulfonates are slightly
toxic to the Northern bobwhite quail, and moderately toxic to freshwater
fish and freshwater invertebrates following acute exposure. The
available data indicate that the alkylbenzene sulfonates are slightly
toxic to green algae.  

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

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

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

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

2.0	PHYSICAL AND CHEMICAL PROPERTIES

	 

	The physical and chemical properties for the three alkylbenzene
sulfonates  assessed in this document: (1) sodium dodecylbenzene
sulfonate, (2) benzene sulfonic acid, C10-16-alkyl derivatives, and (3)
dodecylbenzene sulfonic acid are provided in Table 1.  The product
chemistry chapter (memo from N. Shamim, July 2006, D330332) provides a
comprehensive list of the different physical/chemical properties.  Below
is the chemical structure for a representative  C12-linear alkylbenzene
sulfonate (LAS).  

                  

Figure 1: Sodium Dodecylbenzene Sulfonate (also named as dodecylbenzene
sulfonic acid, sodium  salt)                       

	

Table 1  Physical/Chemical Properties of Linear Alkylbenzene Sulfonates 

Parameter	Sodium Dodecylbenzene Sulfonate	Benzene Sulfonic Acid,
C10-16-alkyl derivatives	Dodecylbenzene Sulfonic Acid (DDBSA)

PC Chemical Code	079010 (active)

790102 (inert)	190116 (active)

790116 (inert)	098002 (active)

790101 (inert)

Cas Number	25155-30-0	68584-22-5	27176-87-0

Molecular Formula	C18H29O3S Na	C18H20O3S

	C18H30O3S

Synonyms	Alkyl(C12)benzenesulfonic acid, sodium salt

Benzenesulfonic acid, dodecyl-, sodium salt

Dodecylbenzene sodium sulfonate

Dodecylbenzenesulfonic acid, sodium salt

Sodium laurylbenzenesulfonate

Benzenesulfonic acid, dodecyl

Molecular Weight	348.48 g/mol	326.6 g/mol	326.50 g/mol

Henry Law Constant	6.02 x 10-17  atm.-m3/mol	2.8 x 10-11 atm- m3/mol	4.8
x 10-11 atm- m3/mol

Melting Point	287.6OC	167.7 OC	178 OC

Boiling Point	660OC	437 OC	460 OC

Water Solubility	800 mg/L	400 g/L (25 O C)	400 g/L (25 O C) 

log Kow	1.96	3.80	4.78

Vapor Pressure	6.02 x 10-15 mm Hg	5.1 x 10-10 mm Hg (25o C)	7.9 x 10-11
mm Hg (25o C)

Half-life in air	0.66 days = 7.9 hours 	0.79 days = 9.48 hours 	0.654
days = 7.85 hours

	

3.0.	ENVIRONMENTAL FATE

Detailed information on environmental fate is presented in the attached
memo from T. Milano (July 6, 2006, D323968).  A brief summary is
provided below.  

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

The environmental fate assessment for DDBSA is based on US EPA(s
Estimation Programs Interface (EPI) Suite.  EPI Suite provides
estimations of physical/chemical properties and environmental fate
properties.

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

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

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

	

4.0	HAZARD CHARACTERIZATION tc "

3.0	HAZARD CHARACTERIZATION" 

   4.1 Hazard Profile  tc "3.1 Hazard Profile " \l 2 

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

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

Acute Toxicity. Alkylbenzene sulfonates exhibit a wide range of acute
toxicity via the oral route in rats (LD50s of 404 – 1980 mg/kg), with
a narrower range in mice (LD50s of 1259-2300 mg/kg).  This spans the
acute oral toxicity categories of III-IV.  Alkylbenzene sulfonates are
classified as acute toxicity category II for the dermal 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).

 

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, the animal data suggest that the liver, kidney and caecum
(for oral studies) are the major target organs for toxicity.  The liver
and kidney effects were dose and duration related in that mild effects
(organ weight changes and serum enzyme/clinical chemistry changes
indicative of mild organ effects) were seen at lower doses, but
increased in severity with both dose and time.

For the purposes of this hazard assessment, several studies were
considered collectively to determine a NOAEL of 50 mg/kg/day for the
chronic dietary endpoint.  The NOAELs in the three studies used to
develop the chronic endpoint are 40, 50 and 85 mg/kg/day, as shown on
Table 3.  The chronic endpoint is based on:  increased caecum weight and
slight kidney damage (at a LOAEL of 114 mg/kg/day in the six month rat
study); reduced body weight in 21-day old pups (at a LOAEL of 250
mg/kg/day in a reproductive toxicity rat study); and significant
decreases in renal biochemical parameters (at a LOAEL of 145 mg/kg/day
in a nine month drinking water study in rats).

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

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

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

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

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

Table 2  Acute Toxicity Studies for Alkylbenzene Sulfonates

Guideline No./ Study Type	

MRID No.	

Results	

Toxicity Category

870.1100 Acute oral toxicity	Multiple	LD50 = range from 404 to over 5000
mg/kg 	III-IV

870.1200 Acute dermal toxicity	94032006	LD50 = 1200 mg/kg	II

870.1300 Acute inhalation toxicity	Literature (HERA 2004) 	LC50 = 310
mg/m3	II

870.2400 Acute eye irritation	0033443*	Corneal opacity not reversed at
72 hours.	I

870.2500 Acute dermal irritation	003444*	Severe irritation at 72 hours
II

870.2600 Skin sensitization	Open Literature

	Non-Sensitizer 

* Toxicity record No.

4.2   FQPA Considerations  tc "3.2   FQPA Considerations " \l 2  

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

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

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

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

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

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

4.3 Dose-Response Assessment  tc "3.3 Dose-Response Assessment " \l 2  

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

Table 3. Summary of Toxicological Dose and Endpoints for Alkylbenzene
Sulfonates

Exposure

Scenario	Dose Used in Risk Assessment, UF 	Special FQPA SF*, endpoint
and Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(All populations)	No endpoint was selected.  No effects are attributable
to a single dose.

Chronic Dietary

(All populations)	Systemic/

Reproductive NOAEL= 50  mg/kg/day

UF = 100 

Chronic RfD = 

 0.5 mg/kg/day

	FQPA SF = 1X

cPAD = 

chronic RfD

 FQPA SF

= 0.5 mg/kg/day	Systemic/Reproductive 

NOAEL= 50 mg/kg/day; LOAEL = 250 mg/kg/day based on decreased Day 21
female pup body weight (Buehler, E. et al. 1971. Tox. Appl. Pharmacol.
18:83-91) 

plus 

NOAEL = 85 mg/kg/day; LOAEL= 145 mg/kg/day from 9 month drinking water
rat study based on decreased body weight gain, and serum/ biochemical
and enzymatic changes in the liver and kidney  (Yoneyama et al. 1976
Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2):105-112)

 plus 

NOAEL= 40 mg/kg/day (0.07%)

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

Short-Term Incidental Oral (1-30 days) 

	Oral NOAEL= 50 mg/kg/day	Residential LOC for MOE < 100 
Systemic/Reproductive 

NOAEL= 50 mg/kg/day; LOAEL = 250 mg/kg/day based on decreased Day 21
female pup body weight (Buehler, E. et al. 1971. Tox. Appl. Pharmacol.
18:83-91) 

plus 

NOAEL = 85 mg/kg/day; LOAEL= 145 mg/kg/day from 9 month drinking water
rat study based on decreased body weight gain, and serum/ biochemical
and enzymatic changes in the liver and kidney  (Yoneyama et al. 1976
Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2):105-112)

 plus 

NOAEL= 40 mg/kg/day (0.07%);

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

Short-, intermediate- and Long-Term Inhalation (1 to 30 days, 1-6
months, >6 months)

	Inhalation study NOAEL= 1mg/m3 detergent dust combined with up to 0.1
mg/m3 enzyme dust

Equivalent to approximately 0.14 mg/kg/day (a)

(inhalation absorption rate = 100%)

purity= 13% active ingredient	Residential LOC for MOE < 100 

Occupational LOC for MOE < 100 	Subchronic Inhalation Monkey Study

LOAEL = 10 mg/m3 detergent combined with 0.1 mg/m3 enzyme dust based on
weight loss and decreased weight gain (W. Coates, et al  1978. Tox.
Appl. Pharmacol. 45: 477-496)  This air concentration is equivalent to
approximately 1.4 mg/kg/day (a)  

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

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

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL =
no observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, NA =
Not Applicable

 (a) Equation used to convert inhalation air concentration to a dose=
mg/L* absorption*respiratory volume (L/hr)*duration (hrs) * activity
factor / body weight.  Thus, 0.001 mg/L * 1*67.94 L/hr (based on default
respiratory volumes for a New Zealand Rabbit which is used as a
surrogate for a cynomolgus monkey) * 6 hrs * 1 / 2.98 kg (body weight
for New Zealand Rabbit used as a surrogate for cynomolgus monkey, study
reports monkey body weight ranges from 1.6 to 3.7 kg).

4.4	Endocrine Disruption  tc "3.4	Endocrine Disruption " \l 2 

	  SEQ CHAPTER \h \r 1 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 such endocrine effects as the
Administrator may designate.”  Following recommendations of its
Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA
determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to
the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation
that the Program include evaluations of potential effects in wildlife. 
For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an
effect in humans, FFDCA authority to require the wildlife evaluations. 
As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disruptor Screening
Program (EDSP).

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

5.0	PUBLIC HEALTH DATA

	Incident Reports.   tc "8.0	INCIDENTS" There are no human incident
reports associated with alkylbenzene sulfonates.    SEQ CHAPTER \h \r 1
The Agency consulted the following databases for poisoning incident data
for alkylbenzene sulfonates:

OPP Incident Data System (IDS) - The Incident Data System of The Office
of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA)
contains reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies
and individual consumers, submitted to OPP since 1992.  Reports
submitted to the Incident Data System represent anecdotal reports or
allegations only, unless otherwise stated.  Typically no conclusions can
be drawn implicating the pesticide as a cause of any of the reported
health effects.  Nevertheless, sometimes with enough cases and/or enough
documentation risk mitigation measures may be suggested. 

  SEQ CHAPTER \h \r 1 Poison Control Centers (1993-2003) - as the result
of a data purchase by EPA, OPP received Poison Control Center data
covering the years 1993 through 2003 for all pesticides.  Most of the
national Poison Control Centers (PCCs) participate in a national data
collection system, the Toxic Exposure Surveillance System, which obtains
data from about 65-70 centers at hospitals and universities.  PCCs
provide telephone consultation for individuals and health care providers
on suspected poisonings, involving drugs, household products,
pesticides, etc. 

  SEQ CHAPTER \h \r 1 California Department of Pesticide Regulation
(1982-2004) - California has collected uniform data on suspected
pesticide poisonings since 1982.  Physicians are required, by statute,
to report to their local health officer all occurrences of illness
suspected of being related to exposure to pesticides.  The majority of
the incidents involve workers.  Information on exposure (worker
activity), type of illness (systemic, eye, skin, eye/skin and
respiratory), likelihood of a causal relationship, and number of days
off work and in the hospital are provided.

  SEQ CHAPTER \h \r 1 National Pesticide Telecommunications Network
(NPTN) - NPTN is a toll-free information service supported by OPP.  A
ranking of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991, inclusive, has been prepared. 
The total number of calls was tabulated for the categories human
incidents, animal incidents, calls for information, and others.

	  SEQ CHAPTER \h \r 1 

6.0	EXPOSURE ASSESSMENT AND CHARACTERIZATION tc "4.0	EXPOSURE ASSESSMENT
AND CHARACTERIZATION" 

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

Approximately 300,000 pounds of alkylbenzene sulfonates are used in EPA
registered antimicrobial products, which is a small fraction of the
approximately 860 million pounds produced each year.  The majority of
uses of alkylbenzene sulfonates are as household laundry and dish
detergents.  The alkylbenzene sulfonates   SEQ CHAPTER \h \r 1 are
listed on the EPA HPV Challenge Program.  HPV chemicals are those that
are manufactured or imported into the U.S. in production volumes greater
than one million pounds per year.  The HPV Challenge Program is a
voluntary partnership between industry, environmental groups, and the
EPA which invites chemical manufacturers and importers to provide basic
hazard data on the HPV chemicals they produce/import.  The goal of this
program is to facilitate the Public’s right-to-know about the
potential hazards of chemicals found in their environment, their homes,
their workplace, and in consumer products.  The alkylbenzene sulfonates
are sponsored by the Linear Alkylbenzene (LAB) Sulfonic Acids Coalition,
which has generated data for these chemicals.   

6.1 Summary of Registered Uses  tc "4.1 Summary of Registered Uses " \l
2 

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

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

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

6.2 	Dietary Exposure and Risk  tc "4.2 	Dietary Exposure and Risk " \l
2  

6.2.1	Dietary Exposure for Active Ingredient Uses

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

Table 4.  Tolerance Exemptions for Food Contact Sanitizer Uses (Active
Uses)

Tolerance Exemption Expression/

Chemical Name	

CAS No.	

PC Code	

40 CFR ( 180.	

Use Pattern (Pesticidal)

Benzenesulfonic acid, dodecyl-	

27176-87-0	

098002

	

940 (b)	

food contact sanitizing solutions for dairy processing equipment, and
food processing equipment and utensils; end use concentration not to
exceed 5.5 ppm

	

940 (c)	

food contact sanitizing solutions for food processing equipment and
utensils; end use concentration not to exceed 400 ppm

 Benzenesulfonic acid dodecyl-, sodium salt	

25155-30-0

	

079010 	

940 (c)	

food contact sanitizing solutions for food processing equipment and
utensils; end use concentration not to exceed 430 ppm

	Based on the pesticide labels, the Agency assessed dietary exposure
that could result from the use of alkylbenzene sulfonates in the food
service industry (treated surfaces, dishes, utensils, glassware, pots
and pans), in the food processing industry (food processing equipment
such as breweries and beverage plants, meat and poultry processing
plants, milk and dairy products/packing plants etc), and as a fruit and
vegetable wash.  

Food Handling Establishments.  In the absence of residue data for
residues of alkylbenzene sulfonates on treated food contact surfaces,
the Agency estimated residue levels that may occur in food from the
application rates on food contact surfaces.  To determine the Estimated
Daily Intake (EDI), the Agency has used an FDA model.  The maximum
ingredient percentage for dodecylbenzene sulfonates in food handling
establishments from the various labels is 400 ppm.   The Agency
estimates that use of this product results in food residues of 530  SEQ
CHAPTER \h \r 1  ppb (µg/kg).  The Agency assumed that food can contact
4000 cm2 of treated surfaces, utensils, glassware, or pots and pans and
that 100% of the pesticide migrates to food based on the standard
assumptions used in the FDA Sanitizing Solution Guidelines.  It was
assumed that an adult and child consume 3000 and 1500 grams of food per
day, respectively that will contact the treated surfaces.  

Food Processing Equipment.  The Agency used the FDA milk truck model to
estimate residues in milk that could result from the use of alkylbenzene
sulfonates in the food processing equipment, as representative of the
potential uses in the food processing industry.  As a conservative
measure, the Agency assessed the maximum application rate of 400 ppm for
dodecylbenzene sulfonates, as listed on the labels, although the current
tolerance exemption has a limitation of 5.5 ppm for dairy processing
equipment.  The Agency estimates that use of this product results in
maximum milk residues of 10  SEQ CHAPTER \h \r 1  ppb (µg/kg).  

Fruit and Vegetable Wash.  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 0.2% (2000 ppm),
without a potable rinse.  Most of the pesticide labels are in compliance
with this limitation.  One label however, allows a vegetable wash
solution containing 0.31% (3100 ppm) dodecylbenzene sulfonic acid, but
requires a potable rinse following washing.  

™), Version 2.03 which uses food consumption data from the USDA’s
Continuing Surveys of Food Intake by Individuals (CSFII) from 1994-1996
and 1998.  This assessment is Tier 1, conservative (assumes 100% of
fruits and vegetables are washed) and uses the deterministic approach.  

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

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

Table 5.  Summary of Dietary Exposure and Risk for Alkylbenzene
Sulfonates

Pesticidal Active Uses

Use	Population Subgroup	Chronic Dietary

Dietary Exposure

(mg/kg/day) a	% cPAD b

Food Service Industry (treated surfaces, utensils, glassware, etc)	adult
male	0.023  	4.6

	females (13-50 years)	0.027	5.4

	infants/children	 0.053	10.6

Food Processing Industry (Food Processing Equipment) 	adult male	0.00043
0.086

	females (13-50 years)	0.0005	0.1

	infants/children	0.001	0.2

Total Food Contact Surface Sanitizing Uses	adult male	0.023	4.6

	females (13-50 years)	0.027	5.4

	infants/children	0.054	10.8   

Fruit and Vegetable Wash	U.S population	  0.0979	19.6

	children 1-2 yrs	0.3558	71.2

	children 3-5 yrs	0.2573	51.5

NA=not applicable

a-- 	chronic exposure analysis based on body weights of 70 kg, 60 kg,
and 15 kg for adult males, females and children, respectively.

b--	%PAD = dietary exposure (mg/kg/day) /  cPAD, where cPAD=0.5
mg/kg/day for all populations.

6.2.2	Dietary Exposure for Inert Ingredient Uses 

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

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

Table 6.  Tolerance Exemptions for Inert Use

Tolerance Exemption Expression	

40 CFR ( 180. (a)	

Use Pattern 

Alkyl (C8-C24) benzenesulfonic acid and its ammonium, calcium,
magnesium, potassium , sodium and zinc salts	

910	

Surfactants, related adjuvants of surfactants

	930	Surfactants, emulsifier, related adjuvants of surfactants

  (a) Residues listed in 40 CFR §180.910 are exempted from the
requirement of a tolerance when used as inert ingredients in pesticide
formulations when applied to growing crops or to raw agricultural
commodities after harvest (i.e., pre- and post-harvest).  Residues
listed in 40 CFR §180.930 are exempted from the requirement of a
tolerance when used as inert ingredients in pesticide formulations when
applied to animals only.

Inert Dietary Exposure Assumptions and Risk Estimates	

Evaluation Model (DEEM™).  The conservative nature of this assessment
is believed to capture all potential dietary exposures, including those
from direct application to animals.

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

Table 7.  Summary of Dietary Exposure and Risk for Alkylbenzene
Sulfonates as Inert Ingredients

Population Subgroup	Chronic Dietary

	Dietary Exposure

(mg/kg/day) 	% cPAD a

U.S. population	0.12  	24

females (13-50 years)	0.087	17

children 1-2 yrs	 0.422	84

children 3-5 yrs	0.31	62

a--	%PAD = dietary exposure (mg/kg/day) /  cPAD, where cPAD=0.5
mg/kg/day for all populations.

6.3   Drinking Water Exposure and Risk for Inert Ingredient Uses  tc "

4.3   Drinking Water Exposure and Risk " \l 2 

There are no currently registered outdoor uses of the alkylbenzene
sulfonates as active ingredients that are being supported by the
registrant.  However, these compounds are inert ingredients in many
residential and agricultural products that are used outdoors.  The
majority of these products contain alkylbenzene sulfonates at low
concentrations that are generally less than 5%.  Based on the
“Environmental Fate Assessment of Alkylbenzene Sulfonates for the
Registration Eligibility Document (RED)” (T. Milano, March 2006),
linear alkyl benzenesulfonates are water soluble, nonvolatile and
mobile, but also readily biodegradable.  There are no readily available
data on the occurrence of linear alkyl benzenesulfonates in ambient or
treated drinking water.  No ambient water quality criteria, drinking
water maximum contaminant levels or health advisory levels have been
established for these compounds by EPA’s Office of Water.  The
potential for transport into drinking water resulting from pesticide
inert ingredient uses of these substances do exist, therefore the Agency
estimated drinking water concentrations resulting from the inert
ingredient uses of these substances.  Details of this analysis are
presented in the Inert Ingredient Dietary Risk Assessment memorandum
from K. Leifer, March 23, 2006.    

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

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

Table 8.  Chronic Drinking Water Exposure Estimates for 

Inert Ingredient Uses of Alkylbenzene Sulfonates

Population Subgroup	EDWC1

(µg/L)	%cPAD2	DWLOC3 (µg/L)

U.S. Population (total)	6.6	<0.1%	38 -1,500

Children (1-2 years)	6.6	<0.1%	8 - 500

1 Estimated Drinking Water Concentration (EDWC) for chronic drinking
water exposure as determined by the use of FIRST modeling analysis
described above for inert ingredient use.  [The EDWC for linear alkyl
benzenesulfonates is the value reported as the “Adjusted Annual
Average (Chronic) Untreated Water Concentration”  ]

2  %cPAD = drinking water exposure (mg/kg/day) /  cPAD, where cPAD=0.5
mg/kg/day for all populations.  It was assumed that a 15 kg child
ingests 1 L water per day and that a 70 kg adult ingests 2L water per
day.

3 Drinking Water Level of Comparison (DWLOC) is the maximum contribution
from water allowed in the diet based on food and drinking water from
inert use only.  In this case, since the allowable risk contribution
from food is based on a screening level model, the use of a single,
deterministic value for the DWLOC is not appropriate.  Rather a DWLOC
range is given, with the values in the range corresponding to an upper
value of range of drinking water concentrations ranging from 100% of the
cPAD (i.e., assuming no food exposure) to a lower value that considers
food exposures to be at the dietary screening level value.

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

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

6.4 	Residential Exposure and Risks from Inert Ingredient Use  tc "4.4 
Residential Exposure/Risk Pathway " \l 2 

Exposure Scenarios

	As noted previously, there are no residential use sites for the
alkylbenzene sulfonates as active ingredients.  However, alkylbenzene
sulfonates are formulated as inert ingredients in approximately 350
registered end-use products, many of which are used in residential
settings.   Some examples of the specified use sites on the products
consist of indoor hard non-porous surfaces (e.g. floors, walls etc.),
carpets, food contact surfaces (glasses, dishes, silverware,
countertops, etc.), agricultural tools and crops, lawns and turfs,
fruits and vegetables (post-harvest), wood preservatives, materials
preservatives, metalworking fluids, and pet products.  

Details of the residential inert exposure assessment can be found within
the companion memorandum (memorandum from T. Milano/C. Walls,  July
2006, D330330).  A summary of the residential assessment is presented
below.

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

	1)	outdoor residential turf treatment (ready to use liquid), 

	2)	indoor hard surface cleaner (ready to use liquid), and

	3)	pet flea and tick products (aerosol can spray).  

	For each of the use sites, the Agency assessed residential handler
(applicator) inhalation exposure and post application incidental
ingestion by toddlers.  Residential postapplication exposures result
when bystanders, such as children come in contact with alkylbenzene
sulfonates in areas where end-use products have recently been applied
(e.g., treated hard surfaces/floors), or when children incidentally
ingest the residues through mouthing the treated end products/treated
articles (i.e., hand-to-mouth or object-to-mouth contact).   Although
the alkylbenzene sulfonates are also present in carpet cleaners as an
inert ingredient, the Agency believes that the risk associated with a
toddler contacting treated hard surfaces are representative of risks
associated with a toddler contacting a treated carpet.    SEQ CHAPTER \h
\r 1 As previously mentioned, there is no dermal endpoint, and
therefore, there were no dermal assessments conducted (handler or post
application). 

Exposure Data and Assumptions

For most residential scenarios, the Agency used EPA’s Pesticide Inert
Risk Assessment Tool (PiRat) to estimate residential applicator and
post-application exposures and risks from the use of alkylbenzene
sulfonates as an inert ingredient in representative residential
products.  Background information and the downloadable executable file
for PiRat can be found at
http://www.epa.gov/opptintr/exposure/docs/pirat.htm.  The Agency
utilized all of PiRat’s default values, along with high-end percent
formulations based on the review of the Confidential Statements of
Formula (CSFs) for the various residential products that contain the
alkylbenzene sulfonates as inert ingredients.  For the assessment of the
pet products 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).

	

	Because there are a large number of products that contain alkylbenzene
sulfonates as an inert ingredient, the Agency assessed a representative
high-end formulation product to be conservative.  

	An inhalation post-application assessment was not conducted because the
vapor pressure of the alkylbenzene sulfonates is extremely low
(5.1x10-10 to 6x10-15 mmHg).  In addition, a dermal assessment was not
conducted because of the lack of a dermal toxicological endpoint.  

Risk Characterization

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

	There are no residential postapplication risk concerns for the
household products that contain alkylbenzene sulfonates as an inert
ingredient as shown on Table 10.   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.  

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

Table 9. 

Estimates of  Inhalation Exposures and Risks to Residential Handlers of

Alkylbenzene Sulfonates as Inert Ingredients

(Short-Term Duration)

Product Use	

Application Method	

Area Treated/Quantity Handleda	Inhalation Exposure (mg/kg/day)
Inhalation MOEsc  

(Target MOE ≥ 100)

Outdoor Products

Ready to Use Liquid Turf spot/gardensb	

Low pressure handwand; MLAP	1000 ft2/day (spot)	7.07x10-6	20,000 

	

Hose end sprayer; MLAP	2x104 ft2/day

 (full broadcast)	4.48x10-5	3,100 

	

Backpack; MLAP	1000 ft2/day (spot)	7.07x10-6	20,000

	Sprinkling can; MLAP

2.24x10-6	63,000 

Indoor Products

Ready to Use Liquid (hard surface cleaner)d,e	Low pressure handwand;
MLAP	0.5 gallons/day	1.37x10-4	1.000 

Pet Flea and Tick  Productf	Aerosol Can Spray	0.5 6 oz can	1.61x10-3	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 lb
product/ft2 was assumed for all scenarios and the body weight = 70kg.

c:  MOEs = NOAEL / exposure where inhalation NOAEL = 0.14 mg/kg/day and
the target MOE ≥ 100 

d: % formulation used =  8%

e: An application rate of 8 lb/gallon, which is the density of water,
was assumed for all scenarios and the body weight =70kg.

f= % formulation = 24%.

Table 10. Summary of Short-Term 

Residential Postapplication Exposure and Risk Estimates 

from Alkylbenzene Sulfonates as Inert Ingredientsa

Product Use	

Route of Exposure	

Exposure

mg/kg/dayb	

MOEsc 

(Target MOE ≥ 100

Ready to Use Liquid Turf spot/gardensd	Incidental ingestion: hand to
mouth	1.08x10-2	4,600 

Ready to Use Liquid 

(hard surface cleaner)a, e

0.0068	7,400

Pet Flea and Tick  Productf	Incidental ingestion: hand to mouth	0.4739
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%

7.0 	AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION tc "5.0 
AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION" 

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

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

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

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

	Individual scenarios that had risks of concern were not included in the
aggregate assessment.  These include exposure to some of the high-end
formulation products such as the residential handler of pet flea and
tick products (inhalation MOE is 87 compared to target MOE>100).  As
noted previously, a number of very conservative assumptions were used to
derive these risk estimates.   

	Aggregate risks were calculated using the total MOE approach outlined
in OPP guidance for aggregate risk assessment (August 1, 1999, Updated
“Interim Guidance for Incorporating Drinking Water Exposure into
Aggregate Risk Assessments”).  The assumptions and equations are
presented in the footnotes on Table 11. 

	Table 11 presents a summary of the short-term aggregate risk MOEs.  The
aggregate oral and inhalation risks are not of concern for adults, as
the total aggregate MOE is 340 which is greater than the target of 100. 
For children, the aggregate risk estimate is very close to the target
MOE of 100 (MOE=99.  As noted previously, several conservative
assumptions were used in this assessment.  For example, dietary exposure
from both the active sanitizer use and the inert uses were considered
together to estimate an upper-bound exposure estimate, since these use
patterns are very different and thus could co-occur.  To compensate for
this conservative assumption, the Agency only included one
representative residential use scenario in the aggregate assessment even
though these compounds are used extensively as inert ingredients in
approximately 350 pesticide products.  

	It should also be recognized that the majority of the uses of
alkylbenzene sulfonates are not in pesticide products, but rather are
used in household laundry and dish detergents.  Over 800 millions pounds
of these compounds are produced each year, while only 300,000 pounds are
used in EPA registered antimicrobial products.  The Agency did not
consider potential exposure and risks from the numerous other
residential exposures to alkylbenzene sulfonates because the Agency
lacks reliable information at this time. 

Table 11

Summary of Short-Term Aggregate Risk Estimates

Exposure Scenario	Dose a

(mg/kg/day)	Total MOEb

(Target MOE≥100)

	Child 

(15 kg)	Adult 

	Child

(15 kg)	Adult

Oral Exposure

Dietary Exposure

     Food Contact Sanitizer         	0.054	0.027	926

(10.8% of  cPAD)	1,850

(5.4% of cPAD)

     Inert Ingredient Uses (Food)	0.422	0.12	118 

(84% of cPAD)	417

(24% of the cPAD)

Drinking Water Exposure  (Inert) c	0.00044 	0.000189 	114,000 

(<1% of cPAD	227,000

(<1% of cPAD)

Hard Surface Cleaner 	0.0068	NA	7,400	NA

Inhalation Exposure

Handler of hard surface cleaning products 	NA	0.000137	NA	1,000

Total Aggregate Dose and MOE	0.5	0.147	99 	340

NA= Not applicable

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.    

rget MOE ≥ 100.

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.   

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

Table 12

Summary of Chronic Aggregate Risk Estimates

Exposure Scenario	Dose a

(mg/kg/day)	%cPADb

	Child 

(15 kg)	Adult 

	Child

(15 kg)	Adult

Oral Exposure

Dietary Exposure

     Food Contact Sanitizer         	0.054	0.027	10.8%	5.4% 

     Inert Ingredient Uses (Food)	0.422	0.12	84% 	24% 

Drinking Water Exposure  (Inert) c	0.00044 	0.000189 	<1% 	<1%

Total Aggregate Dose and Risk	0.476	0.147	95% 	29% 

NA= Not applicable

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.    

%cPAD = dietary exposure (  SEQ CHAPTER \h \r 1 mg/kg/day) / cPAD, where
cPAD -= 0.5 mg/kg/day for all populations.   

Exposure estimates assume a 15 kg child ingests 1L water/day and that a
60 kg adult female ingests 2L water per day containing 6.6 ppb
alkylbenzene sulfonates.  The 6.6 ppb estimate is based on the chronic
estimated drinking water concentration (EDWC)) resulting from
agricultural use of products that contain the alkylbenzene sulfonates as
an inert ingredient.     

8.0	CUMULATIVE EXPOSURE AND RISK tc "6.0	CUMULATIVE EXPOSURE AND RISK" 

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

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

9.0	OCCUPATIONAL EXPOSURE AND RISK tc "7.0	OCCUPATIONAL EXPOSURE AND
RISK"  

		The Agency has assessed the exposures and risks to occupational
workers that handle alkylbenzene sulfonates (memorandum from T. Milano,
July 6, 2006, D330329  SEQ CHAPTER \h \r 1 ).  This section summarizes
the results of the occupational exposure assessment. 

	Based on examination of product labels describing uses for the product,
it has been determined that exposure to handlers can occur in a variety
of occupational settings.  Additionally, postapplication exposures are
likely to occur in these settings.  The representative scenarios
selected by the Agency for assessment were evaluated using maximum
application rates as recommended on the product labels for alkylbenzene
sulfonates. 

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

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

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

						

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

ST and IT inhalation exposure from cleaning hard surfaces via wiping in
the food handling category, inhalation MOE = 93.

	

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

ST and IT inhalation exposure from cleaning indoor hard surfaces via
wiping and then following with sanitizing via immersion/flooding in the
food handling premises category, inhalation MOE = 93.

ST and IT inhalation exposure from cleaning indoor hard surfaces via
wiping and then following with sanitizing via low pressure spray in the
food handling premises category, inhalation MOE  = 90.

ST and IT inhalation exposure from cleaning indoor hard surfaces via
sponge/mesh/wiping and then sanitizing via immersion/flooding in the
food handling premises category, inhalation MOE = 90.

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

 

Table 13

Short-, and Intermediate-Term Inhalation Risks for Occupational Handlers

(Representative Scenarios)

Exposure Scenario	Method of Application	Application Rate  (lb ai/
gallon)	Quantity Handled/

Treated per day (gallons)	Baseline

Inhalation MOE (a)

(Target MOE≥100)

Agricultural Premises and Equipment

Application to hard surfaces 

	Brush	0.0667	0.26	2,000

	Mechanical Foam	0.0667	0.26	430

	Flooding	0.00183	10	280

	Cleaning in place (CIP) 	

0.00195

	10,000	1,200

	High Pressure spray	0.00326	40	630

	Immersion	0.00334	10	160

	Low pressure spray	0.00334	10	430

	Trigger Pump Spray	0.00334	0.26	8,700

Food  Handling 

Application to indoor hard surfaces 	Brush	0.0667	

0.26	

2,000

	Mechanical Foam	0.0667	0.26	430

	Immersion	0.00334	10	160

	Trigger Pump Spray	0.00334	0.26	8,700

	Low pressure handwand

(clean) 	0.00603	2	1,200

	High pressure spray (sanitize)	0.0115	40	

180

	Immersion, flooding for RTU (sanitize)	0.003	10	170

	Mopping	0.00244	2	840

	Wiping (clean) 	0.00603	0.26	93

	Sponge/mesh wipe (clean) 	0.003	0.26	190

	Cleaning in Place (CIP) (clean and sanitize) 	

0.00358

	10,000	680

Food dispensing equipment	Cleaning in Place (CIP) (clean)	

0.00603	10,000	400

	Cleaning in Place (CIP) (sanitize)	

0.00302	10,000	810

Fruits and vegetables	Immersion	0.00455	10	110

	Trigger pump spray	0.003	0.26	9,700

Commercial/Institutional Premises 

Application to indoor hard surfaces (includes utensils and silverware)
Brush	0.0667	0.26	2,000

	Mechanical Foam	0.0667	0.26	430

	Immersion	0.00334	10	160

	Low Pressure Handwand	0.00334	2	2,200

	Trigger Pump Spray	0.00334	0.26	8,700

Shower stalls and toilets	Mopping	0.0177	2	120

	Swabbing after a liquid pour	0.0177	0.26	1,100 

 (a)	MOE = NOAEL  (mg/kg/day) / Daily Dose [Where short-and
intermediate-term 

≥ 100.  

	

Table 14  Short, and Intermediate Term Inhalation Risks to Occupational
Handlers 

Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene
Sulfonate

Representative Use	Registration #	Method of CLEANING Application 

(Baseline MOE)	Method of SANITIZING Application

(Baseline MOE)	Total  Inhalation MOE (Baseline) (Target MOE≥100)

Food Handling/Storage Establishments Premises and Equipment 

Indoor Hard Surfaces (includes dishes and silverware)	1020-13	High
pressure spray (1,100)	High pressure spray (180)	150

	Brush (12,000)	1,000

Brush

(75,000)	High pressure spray (180)	180

	Brush (12,000)	10,000

	71094-1

	Low pressure spray (1,200)	Immersion/Flooding (1.4X106)	1,200

	Low pressure spray (2,400)	800

Wiping (93)	Immersion/Flooding (1.4X106)	93

	Low pressure spray (2,400)	90

Foam (4,800) 	Immersion/Flooding (1.4X106)	4,800 

	Low pressure spray (2,400)	1,600

Brush (22,000)	Immersion/Flooding (1.4X106)	22,000

	Low pressure spray (2,400)	2,000

	71094-2	Sponge/Mesh/Wiping (190)	Immersion/Flooding (170)	90

	Trigger Pump (9,700)	190

Low Pressure Spray (2,400)	Immersion/Flooding (170)	160

	Trigger Pump (9,700)	1,900

Brush (45,000)	Immersion/Flooding (170)	170

	Trigger Pump (9,700)	8,000

	1020-13	CIP (680)	CIP (680)	340

Food dispensing equipment	71094-1	CIP (400)	CIP (810)	270

	Postapplication Exposure and Risk.  For most of the occupational
scenarios, postapplication dermal exposure is not expected to occur or
is expected to be negligible based on the application rates and chemical
properties of these chemicals. The alkylbenzene sulfonates have a low
vapor pressure (5.1x10-10 to 6.02x10-15  mmHg), so that any standing
solutions that may result in post application exposure were deemed
negligible.  

 

10.0 	ENVIRONMENTAL RISK

 tc "9.0	ENVIRONMENTAL RISK" 

	10.1	Active Ingredient Uses

  		A detailed ecological hazard and environmental risk assessment for
the alkylbenzene sulfonates is presented in the attached memorandum for
the active ingredient pesticidal uses (memo from R. Petrie, July 12,
2006).  A brief summary is presented below.  

	

Ecological Toxicity Data.  

	Acute toxicity to terrestrial organisms:  As shown in the acute
toxicity summary Table 15, alkylbenzene sulfonates are slightly toxic to
the Northern bobwhite quail on an acute oral basis. The avian acute oral
LD50 is > 500 ppm, therefore, an avian environmental hazard statement
for birds is not required on manufacturing use product labels.  No
evidence of endocrine disrupting effects was observed in mammalian
toxicity studies.  No data are available or required for terrestrial
plants.

	Acute toxicity to aquatic organisms:  As shown in Table 15,
supplemental acute studies indicate that alkylbenzene sulfonates are
moderately toxic to freshwater fish and freshwater aquatic
invertebrates.  In addition, 11 acute freshwater fish studies using
commercially relevant LAS and LAB formulations indicate the LC50 values
range from 1.67 to 7.7 mg/L [LAS SIDS Initial Assessment Report,
(SIAR)].  Data using LAB sulfonic acids in the LAS SIAR report range in
toxicity from 3.0 to 10.0 mg/L.  Research by Fairchild et al. (1993)
indicates that “Degradation processes rapidly reduce chain lengths of
LAS in the environment to averages lower than C12.  Thus, hazard
assessments of LAS to aquatic organisms should focus on environmentally
relevant mixtures of average chain lengths of C12 or less.”  Based on
study results above (MRIDs 44260002, 44260009) and studies presented in
LAS SIAR, an environmental hazard statement for fish is not required on
manufacturing use products under consideration in this RED.

In aquatic invertebrates, LAS toxicity is variable, depending on the
length of the carbon chain.  LAS/SIAR (page 37) summarizes 11 Daphnia
magna studies on commercially relevant LAS that range in EC50 values
from 1.62 to 9.3 mg/L.  Data on the LAB sulfonic acids give EC50 values
for Daphnia magna ranging from 2.9 to 12 mg/L.  Formulations tested
included the C10-C16 benzene sulfonic acid and the dodecylbenzene
sulfonic acid.  Even though the higher carbon chains are more toxic, the
CLER (Council for LAB/LAS Environmental Research) ensures that the
typical LAS or LAB formulations contain less than 1 - 10% carbon chains
C14 or greater.  The LAS SIAR report cites 11 Daphnia magna studies on
commercial LAS formulations with EC50 values ranging from 1.62 to 9.3
mg/L.  LAB formulations ranged in toxicity from 2.9 to 12 mg/L. 
Research by Fairchild et al. (1993) states: “Degradation processes
rapidly reduce chain lengths of LAS in the environment to averages lower
than C12.  Thus, hazard assessments of LAS to aquatic organisms should
focus on environmentally relevant mixtures of average chain lengths of
C12 or less.”  Based on study results above (MRID 47025025) and
studies presented in LAS SAIR, an environmental hazard statement for
aquatic invertebrates is not required on manufacturing use products
under consideration in this RED.  

	Chronic toxicity to aquatic organisms:  Chronic toxicity testing (Fish
early life stage, 850.1300/72-4a and aquatic invertebrate life cycle,
850.1400/72-4b) is required for pesticides when certain conditions of
use and environmental fate apply.  Chronic aquatic organism tests are
not required for alkylbenzene sulfonates because the currently
registered uses are indoor applications.  A 28 day chronic freshwater
fish toxicity test was found in the literature.  The NOAEC was 0.7 mg/L
for a carbon chain C11.7 (Fairchild et al, 1993).  Scientists studying
alkylbenzene sulfonates have concluded that a laboratory derived NOAEC
of 0.4 mg/L alkylbenzene sulfonates is protective of ecosystem structure
and function in experimental streams.  Alkylbenzene sulfonates
literature indicates slight toxicity to green algae. 

Table 15.  Acute Toxicity of Alkylbenzene Sulfonates

Species	Chemical, % active ingredient (ai)	Endpoint 	Toxicity Category
(TGAI)	Satisfies Guidelines/Comments	Reference

Birds

Northern bobwhite

(Colinus virginianus)	87.6%Carbon chain not identified. (Nacconal 90G
used)	

LD50 >  1382 mg/kg

NOEL = 279 mg/kg	

Slightly toxic	

Yes.  Acceptable.

14 day test	

MRID: 

41143901

Freshwater Fish

Fathead Minnow (Pimephales promelas)	

14.0% (Carbon chain not identified.)	

96hr LC50 = 

3.4 mg/L	

Moderately toxic	

Yes. Supplemental study.  	

44260002

Rainbow trout

 Oncorhynchus

     mykiss)	 

65.0%

C11, C12	

96 hr LC50 =

1.68 mg/L	

Moderately toxic	

Yes. Supplemental 

study.  	

44260009

Freshwater Invertebrates

Waterflea

(Daphnia magna)	

Not reported.	

48-hr. EC50 = LAS-C10 = 29.5 mg/L, LAS-C12 = 6.84 mg/L, LAS-C14 = 0.80
mg/L, LAS-C16 = 0.20 mg/L.	

C-12 = Moderately toxic 

	

Yes. Supplemental study.	

47025025

Green Algae

Selenastrum

capricornutum	Not

Reported.  (Carbon chain not identified.)	96 hr. EC50 = 

     70.27 ppm	Slightly

toxic	No.  Supplemental.	42439803

	Data Requirements:  	There are no outstanding ecological data
requirements.   The guideline requirements for a freshwater fish acute
test (Guideline 850.1075), and freshwater invertebrate (Guideline
850.1010) have been fulfilled.  Acute estuarine/marine tests, chronic
toxicity testing (Fish early life stage, 850.1300/72-4a and aquatic
invertebrate life cycle, 850.1400/72-4b) and non-target plant
phytotoxicity tests are not required for indoor uses.  

Environmental Fate and Exposure Assessment.  

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

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

Ecological Risk Characterization.  

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

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

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

Endangered Species Considerations

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

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

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81).  Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered to fall under a
“no effects” determination.  The active ingredient uses of
alkylbenzene sulfonic acids and sulfonates fall into this category for
the following reasons:

The amount that will actually reach the environment is very small based
on usage data for down-the-drain uses. 

Use for toilets and urinals is limited (no home-owner or residential
uses are registered).

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. 

10.2	Inert Ingredient Use

	The alkylbenzene sulfonates are used as "inert" ingredients in
agricultural herbicide formulations.  Preplant incorporated and
preemergence herbicide treatments are typically applied once per year to
the tilled, minimally tilled or no-tilled field before planting or
before crop emergence in the spring.  Spray applications are primarily
via ground spray boom and occasionally by aircraft if a wet spring. 
Movement of the alkylbenzene sulfonates from the treated field to the
aquatic environment can occur at the time of application due to spray
drift, or following application via surface water/soil flow or by
percolation to groundwater.  The FIRST model has predicted a maximum
potential concentration of 6.6 ppb alkylbenzene sulfonates in drinking
water from inert agricultural uses (memo from K. Leifer, 2006). 
Available modeling and literature suggest that these chemicals will most
likely biodegrade rapidly in soil due to microbial degradation.  

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

11.0	DEFICIENCIES/DATA NEEDS

	Hazard Data Gaps.    The toxicology database for the alkylbenzene
sulfonates consists almost entirely of published literature, is
essentially complete and of acceptable quality to assess the potential
hazard to humans.  Due to limitations with the monkey inhalation study,
which used 13% LAS, in addition to the presence of enzyme, the Agency
requests a 90-day nose only rat inhalation study using DDBSA.  

Ecological Data Gaps.  There are no outstanding ecological data
requirements

Label Hazard Statements for Terrestrial and Aquatic Organisms

Manufacturing and end-use products must state:  

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

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

	

12.0	REFERENCES tc "11.0		REFERENCES" 

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

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

 

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

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

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

Fairchild, J. F., F. J. Dwyer, T. W. La Point, S. A. Burch, and C. G.
Ingersoll.  1993.  Evaluation of a Laboratory-Generated NOEC For Linear
Alkylbenzene Sulfonate In Outdoor Experimental Streams.  Environmental
Toxicology and Chemistry. Vol. 12(10):  1763-1775.  Symposium on
Surfactants and Their Environmental Safety, 11th Annual Meeting, Society
of Environmental Toxicology and Chemistry, Arlington, VA, Nov. 11-15,
1990.

Human and Environmental Risk Assessment (HERA).  2004.  LAS – Linear
Alkylbenzene Sulphonates (CAS No. 68411-30-3)

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

OECD SIDS Initial Assessment Report (SIAR).  2005.  April.  Linear
Alkylbenzene Sulfonate (LAS).  

World Health Organization (WHO).  1996. Environmental Health Criteria
Document for Linear Alkylbenzene Sulfonates and Related Compounds. (EHC
169, available at   HYPERLINK
"http://www.inchem.org/documents/ehc/ehc/ehc169.htm" 
http://www.inchem.org/documents/ehc/ehc/ehc169.htm  )



Appendix A

Toxicity Profile for Alkylbenzene Sulfonates



Table A-1

Toxicity Profile of Alkylbenzene Sulfonates

Guideline No./

Study Type	MRID No./

Reference Information/

Study Classification	Dosing and Animal Information	Results

Subchronic Toxicity

870.3100

Oral Subchronic (rodent)	Bornmann et al (1963) Study of a Detergent
Based on Dodecylbenzene Sulfonate. Fette Seifen Anstrichm, 65 (10):
818-824.  (EHC 169)

Open Literature	0.01% of a preparation containing 51% LAS was
administered in the drinking water for 100 weeks

Rats (60/sex)

Purity: Not Reported	No detrimental effects on body weight and no
pathological effects, including tumors, were reported

870.3100

Oral Subchronic

(rodent)	Ikawa et al., (1980)/

Ann. Rep. Tokyo Metrop. Res. Lab. Public Health.  29(2):  51-54(Z). 
1978 (in Japanese, see WHO, 1996 and HERA, 2004).

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

Male rats (five/group)

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

870.3100

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

Open Literature

	Administration by oral gavage at doses of 0, 155, 310, or 620 mg/kg/day
(LAS-Mg) and 125, 250, and 500 mg/kg/day (LAS-Na) for one month  

Sprague-Dawley Rats (12/sex/group)

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

870.3100

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

Acceptable

Guideline	SDDBS administered in the diet at dietary levels of 0, 200,
1000, and 5000 ppm for 90 days

Weanling Sprague-Dawley Rat (10/sex/dose)

Purity: 87.9% a.i.

	NOEL: 5000 ppm (HDT)

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

870.3100

Oral Subchronic (rodent)	MRID No. 43511401 Mathur et al. (1986)
Toxicological Evaluation of a Synthetic Detergent after Repeated Oral
Ingestion in Rats. Industrial Toxicology Research Centre, Mahatma Ganghi
Marg, Lucknow Study No. DDBSA JV-RP-013.

Acceptable	LAS was administered as a commercial synthetic detergent
solution at doses of 0, 50, 100, or 250 mg/kg/day in the feed for 10
weeks

F Albino Rat (9/group)

Purity: Not Reported	NOEL: < 50 mg/kg/d

LOEL: 50 mg/kg/d based on alterations of several enzymes indicative of
liver and kidney damage

870.3100

Oral Subchronic (rodent)	MRID No. 43498402 Oser et al. (1965)
Toxicologic Studies with Branched and Linear Alkyl Benzene Sulfonates in
the Rat.  Toxicol. Appl. Pharmacol. 7: 819-825.  (HERA)

Acceptable

Guideline	LAS and ABS were administered at dietary levels of 0, 50, or
250 mg/kg/day, adjusted for bw and fc, for 90 days

FDRL Strain (Wistar-derived) Rat (15/sex/dose)

Purity: Not Reported

	NOEL: 50 mg/kg/d 

LEL: 250 mg/kg/d for increased absolute and 

relative liver weight in both sexes (21%) and increased relative cecal
weight (21%) in males

870.3100

Oral Subchronic (rodent)	Watari et al. (1977) Ultrastructural
Observations of the Protective Effect of Glycyrrhizin for Mouse Liver
Injury Caused by Oral Administration of Detergent Ingredients (LAS), J.
Clin. Electron. Microscopy (Nihon Rinsho Denshikenbikyo Kaishi) 10
(1-2): 121-139.

Open Literature	Benzenesulfonic acid, C10-13- alkyl derivatives, sodium
salt was administered in the drinking water for 6 months at 0 and 100
ppm with 2 months recovery (M: 0 and 17 mg/kg bw, F: 0 and 20 mg/kg bw) 

M/F ddy Mouse

Purity: Not Reported

	Liver effects were observed at the only dose tested (17-20 mg/kg/d),
but they disappeared following the 2-month recovery period.

870.3100

Oral Subchronic (rodent)	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)

Open Literature	LAS was administered in the diet at concentrations of
180, 360, or 540 mg/kg bw/d for two and four weeks

M Wistar Rat (5/group)

Purity: 60% a.i.	Body weight gain was suppressed in the group receiving
540 mg/kg bw/d at four weeks, and the relative liver weight was
increased at two weeks and thereafter in the groups receiving 360 mg/kg
bw/d  and 540 mg/kg bw/d.  The levels of triglyceride and total lipids
in the serum had decreased markedly at two weeks in all the experimental
groups, and the levels of phospholipids and cholesterol in the serum had
decreased significantly at two weeks in the groups given 360 and 540
mg/kg bw/d.  These changes were less apparent at four weeks, but
triglyceride, phospholipid, and cholesterol levels in serum were
significantly decreased in the group given 540 mg/kg bw.   Significant
increases in triglyceride levels were seen in the liver after two weeks
in the groups receiving 180 and 540 mg/kg bw/d, and in cholesterol 

levels in the group given 180 mg/kg bw.

870.3100

Oral Subchronic (rodent)	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.

Open Literature	LAS was administered at a concentration of 200 mg/kg
bw/d in the diet or in drinking water (560 mg/kg bw/d) for two weeks to
determine the effect on the synthesis of lipids in the liver

M Wistar Rat (5/group)

Purity: Not Reported	Uptake of acetate-1-14C by lipids in the liver was
increased in both groups; uptake of phospholipids and triglycerides
tended to increase, and that of phospholipids increased significantly in
rats given LAS in the diet.

870.3100

Oral Subchronic (rodent)	MRID No. 43498413 Heywood et al. (1978)
Toxicology Studies of Linear Alkyl Sulphonate (LAS) in Rhesus Monkeys I.
Simultaneous Oral and Subcutaneous Administration for 28 Days. Toxicol.
Appl. Pharmacol. 11: 245-250.  (HERA)

Acceptable

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

subcutaneously (sc). Control groups were used.

Rhesus Monkey (3/sex/dose), 18-36 months old

Purity: Not Reported

	At 300 (po) and 1.0 (sc) mg/kg bw/day, the monkeys

vomited frequently and usually within 3 hours of administration. An
increased frequency of loose or liquid faeces was recorded for animals
receiving 150 (po) and 0.5 (sc) mg/kg bw/day. These effects

are probably related to the inherent irritative effects of LAS rather
than to its systemic toxicity.

Fibrosis of the injection sites was found among the entire test group,
the incidence and severity being

dose related. Ophthalmoscopy, laboratory examination of blood and urine,
organ weight analysis and

histopathological investigation did not detect any further
treatment-related responses.

The LOAEL is 150 mg/kg bw/day (po) + 0.5 mg/kg bw/day (sc) based on an
increase in liquid feces and the NOAEL is 30 mg/kg/d

870.3200

21-Day Dermal	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)

Open Literature	A solution of LAS in distilled water equivalent to 60
mg/kg bw was applied to a 4-cm2 area of clipped dorsal skin daily for 30
days

12 Guinea Pigs

Purity: Not Reported	The activities of B-glucuronidase, gamma- glutamyl
transpeptidase, 5-nucleotidase, and sorbitol dehydrogenase were
increased in liver and kidney.  Lipid peroxidation was increased in the
kidney but not in liver, and the glutathione content was unchanged in
both organs.  Extensive fatty changes were found in hepatic lobules,
with dilation of sinusoids; tubular lesions were found in the kidney,
predominantly in the proximal and distal portions.

870.3200

21-Day Dermal	Tox Record No. 003441 Subchronic (28-day) Percutaneous
Toxicity (Rabbit) of Compound: B0002.01, (Bio/dynamics Inc., Project No.
4717-77, March 17, 1978, submitted by Procter and Gambel Company, May
10, 1978).

Unacceptable

Core-Minimum Data	SDDBS (end use product Comet Cleanser) was applied to
the skin of rabbits for 28 days at 200 mg/kg/d.  The hair of each rabbit
was clipped from its trunk, so as to expose approximately 25% of the
total body surface area and the skin was abraded daily just prior to
treatment. 

20 M/F Albino New Zealand White Rabbits (5/sex/group)

Purity: 10% 	NOEL: > 200 mg/kg/d

870.3465

90-Day Inhalation	MRID No. 43498403 Coate et al. (1978) Respiratory
Toxicity of Enzyme Detergent Dust.  Toxicol. Appl. Pharmacol., 45:
477-496.

Acceptable

Guideline	SDDBS was administered a SDDBS mixture at levels of 0,
100(detergent), and [ .001, .01, 0.1 and 1 (enzyme)] together with [+0,
1, 10, and 100 (detergent)] mg/m3 for 6 hours daily, 5 days a week, for
6 months 

12 groups of 5 M/4 F Cynomolgus Monkeys

Purity: 13%	NOEL: 1 mg/m3 detergent dust combined with

up to 0.1 mg/m3 enzyme dust.

The detergent dust alone at 100 mg/m3 caused gross signs of respiratory
distress, pulmonary histopathological effects, and pulmonary function
impairment indicative of constricted bronchioles. Exposure to 10 or 100
mg/m3 together with 0.01 and 0.1 mg/m3 enzyme dust produced the same
effects along with weight loss and decreased weight gain.

Developmental Toxicity

870.3700a

Developmental Toxicity (rodent)	Daly et al. (1980) A Teratology Study of
Topically Applied LAS in Rats, Fd. Cosmet. Toxicol. 18: 55-58.  (HERA)

Open Literature	LAS was applied to the skin on days 0 through 21 of
gestation at doses of 20, 100, and 400 mg/kg bw/d 

Rat

Purity: Not Reported	NOAEL (maternal): 20 mg/kg bw/d

NOAEL (fetuses): 400 mg/kg bw/d

Maternal toxicity: the dams treated with 400 mg/kg bw/day and 100 mg/kg
bw/day showed inhibition

of body weight gain and llocal skin effects that compromised the
integrity of the skin and caused

overt toxicity, like inhibition of the body weight gain.

Teratogenicity: there were no findings indicative of effects of LAS on
the foetal parameters evaluated.

There were no indications of teratogenic or embryotoxic effects.

870.3700a

Developmental Toxicity (rodent)	Endo et al. (1980) Studies of the
Chronic Toxicity and Teratogenicity of Synthetic Surfactants, Ann. Rep.
Tokyo Metrop. Res. Inst. Environ. Prot. (Tokyo Kogai Kenkyujo Nempo),
236-246.  (HERA)

Open Literature	LAS was administered in the drinking water at 0.1%,
corresponding to 383 mg/kg bw/d for rats and up to 3030 mg/kg bw/d for
rabits from day 6 to 15 (rats) and day 6 to 18 (rabbits) of pregnancy.  

F Rat and Rabbit

Purity: Not Reported	NOAEL (maternal): 383 mg/kg bw/d (rat)

LOAEL (maternal): 3030 mg/kg bw/d (rabbit)

NOAEL (fetuses): 383 mg/kg bw/d (rat)

LOAEL (fetuses): 3030 mg/kg bw/d (rabbit)

The effect on the dams was a slight inhibition of body weight gain in
the rabbits. The litter parameters of both species did not show any
significant differences from those of the controls. Delayed ossification
was observed in rabbits, but there was no increase in malformations in
either the rabbits or the rats.

870.3700a

Developmental Toxicity (rodent)	Imahori et al. (1976) Effects of LAS
Applied Dermally to Pregnant Mice on the Pregnant Mice and their
Fetuses, J. Jpn. J. Public Health (Nihon Koshueisei Zasshi) 23(2):
68-72.  (HERA)

Open Literature	LAS was applied daily at dermal doses of 15, 150, and
1500 mg/kg bw/d on days 6 through day 15 of pregnancy  

F Mouse

Purity: Not Reported	NOAEL (maternal): 150 mg/kg bw/d

NOAEL (fetuses): 1500 mg/kg bw/d

The 1500 mg/kg bw/day group showed a clear decrease in the pregnancy
rate (67.9%) when

compared with a rate of 96.3% in the controls. However, there were no
decreases in the litter size, and

no changes in the litter parameters with the exception of a slight
decrease in foetal body weight. There

were no significant increases in the incidence of malformations in the
foetuses.

870.3700a

Developmental Toxicity (rodent)	MRID No. 43498423

Masuda et al. (1974) Effects of LAS Applied Dermally to Pregnant Mice on
the Development of their Fetuses.  15: 349-355.

Acceptable

Guideline	LAS was applied dermally at a level of 0.5 ml.  The ICR-JCL
strain received doses of 0, 0.85, 1.7, 2.55, and 3.4% solutions daily
from days 1 to 13 of gestation and the ddY strain received doses of 0,
0.017, 0.17, and 1.7% solutions daily from days 2 to 14 of gestation.

Mouse (ICR-JCL strain and ddY strain)

Purity: Not Reported	NOEL (maternal and developmental toxicity - ddY):
1.7% (HDT)

NOEL (maternal toxicity - ICR-JCL): 2.55%

NOEL (developmental toxicity - ICR-JCL): 1.7%

At 3.4% LAS, maternal body weight and the absolute weight of liver,
kidney, spleen were significantly increased over control.. Pregnancy
rates were significantly less (33.35) compared to controls (69%).

The number of implantations, live fetuses, sex ratio, dead or resorbed
fetuses, placenta weight and external malformations  were comparable
with control. Fetal body weights of 2.55% and 3.4% LAS-treated groups
were significantly less than controls. 

870.3700a

Developmental Toxicity (rodent)	MRID 43498424 and 43498425

Nomura, T et al. (1980) The Synthetic Surfactants AS and LAS Interrupt
Pregnancy in Mice.  Life Sciences, 26: 49-54.  (HERA)

Nomura, T. et al. (1987) Killing of Preimplantation Mouse Embryos by AS
and LAS. Mutation Research 190: 25-29.  (HERA)

Acceptable

Guideline	LAS (0.1 ml ) was applied at a concentration of 20% to the
dorsal skin of pregnant mice during the pre-implantation period  twice a
day from day 0 to day 3 of pregnancy

Female  ICR/Jcl Mouse, 

9-10 weeks old

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

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

870.3700a

Developmental Toxicity (rodent)	MRID 43498426

Palmer et al. (1975) Assessment of the Teratogenic Potential of
Surfactants, (Part I), Toxicology 3: 91-106.

Acceptable

Guideline	LAS was administered by gavage on days 6-15 of pregnancy in
rats and mice and days 6-18 of pregnancy in rabbits at doses of 0.2, 2,
300, and 600 mg/kg bw/d 

20 CD Rats, 20 CD-1 Mice, and 13 New Zealand White Rabbits  

Purity: 17%	NOAEL (rat - maternal): 300 mg/kg bw/d

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

NOAEL (rabbit - maternal): 2.0 mg/kg b/d (However, the study does not
allow determination of reliable NOAELs, given the large difference
between the maternal no-effects doses of 2 mg/kg bw/d and the maternal
LOAEL dose (300 mg/kg bw/d) that is also the dose for which effects on
litters could not be determined due to the high mortality rate in parent
animals) 

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

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

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

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

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

NOAEL (rabbit - fetal): could not be determined

870.3700a

Developmental Toxicity (rodent)	MRID 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. DDBSA
JV-RP4-029.  Toxicology 4: 171-181.

Acceptable

Guideline	LAS was administered percutaneously to shaved skin at
solutions of 0.03%, 0.3%, and 3% during pregnancy on days 2-13 in mice,
2-15 in rats, and 1-16 in rabbits.  Dosages employed were 0.5 ml/rat or
mouse/day and 10 ml/rabbit/day 

CD-1 Mice (20/group), CD Rats (20/group), N2W Rabbits (13/group)

Purity: 0.03%, 0.3%, and 3%	LOEL (maternal toxicity, mice): 0.3% (50
mg/kg/d) 

LOEL (maternal toxicity, rats): 3.0% (60 mg/kg/d)

LOEL (maternal toxicity, rabbits): 0.3% (9.0 mg/kg/d)

NOEL (maternal toxicity, mice): 0.03% (5.0 mg/kg/d)

NOEL (maternal toxicity, rats):  0.3% (6.0 mg/kg/d)

NOEL (maternal toxicity, rabbits): 0.03% ((0.9 mg/kg/d)

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

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

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

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

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

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

Marked local skin reaction, irritability, weight loss and failure to
maintain or establish pregnancy was evident in mice treated with LAS 3%
soap, 3 or 30%: marked local reaction and weight loss also occurred in
rabbits receiving LAS 3%.

Moderate maternal toxicity was observed among mice treated with LAS,
0.3% and mild maternal toxicity in rats receiving LAS 3% or soap 30% and
rabbits receiving LAS 0.3%.

Effects on litter parameters were dose-dependent,  causing marked
maternal toxicity in mice, the principal  higher fetal loss,  reduction
in viable litter size. 

LAS at 3% showed marked maternal toxicity in the rabbit

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

870.3700a

Developmental Toxicity (rodent)	Sato et al. (1972) Studies on the
Toxicity of Synthetic Detergents: (III), Examination of Teratogenic
Effects of Alkylbenzene Sulfonates Spread on the Skin of Mice. Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health 24: 441-448.  (HERA)

Open Literature	LAS was applied to the skin of female mice daily on days
0 through 13 of pregnancy with a single LAS dose of 110 mg/kg bw/d. 
Control group not specified.

F Mouse

Purity: Not Reported	NOAEL (maternal): 110 mg/kg bw/d

No abnormalities were seen in the dam or foetuses.

870.3700a

Developmental Toxicity (rodent)	Shiobara S., Imahori A. (1976) Effects
of LAS Orally Administered to Pregnant Mice on the Pregnant Mice and
their Fetuses.  J.Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku Zasshi) 17(4):
295-301.

Open Literature	LAS was administered by gavage at doses of 10, 100, and
300 mg/kg bw/d at day 6 through 15 of gestation

ICR-SLC Mouse (25-33/dose)

Purity: Not Reported	LOAEL (maternal): 10 mg/kg bw/d

NOAEL (fetuses): 300 mg/kg bw/d

1.  Marked maternal and embryonic toxicities, such as maternal death,
premature delivery, total litter loss and high fetal death rate, were
observed at 300 mg/kg group.

2.  Slight suppression of maternal body weight gain and slight body
weight suppression of live fetuses were observed in each treated group.

3.  External malformations such as cleft palate and exencephaly were
observed sporadically both in the control and the treated groups. 
However, the incidence of these malformations was not significant, and
considered to be within the spontaneous incidence of ICR mice.

870.3700a

Developmental Toxicity (rodent)	Takahashi et al. (1975) Teratogenicity
of Some Synthetic Detergent and LAS. Ann. Rep. Tokyo Metrop. Res. Lab.
Public Health 26(2): 67-78.  (HERA)

Open Literature	LAS doses of 40, and 400 mg/kg bw/d were administered
daily from day 0 to day 6 of pregnancy or from day 7 to 13 of pregnancy
by gavage

Mouse (13-14/group) 

Purity: not reported	NOAEL (maternal): 40 mg/kg bw/d

NOAEL (fetuses): 400 mg/kg bw/d

At 400 mg/kg bw/day, the pregnancy rate was 46.2% compared to 92.9% in
the controls. There was no

increase in malformations. Although no information on maternal toxicity
is available, it appears

likely that maternal toxicity was present at the high dose group.

870.3700a

Developmental Toxicity (rodent)	Tiba et al. (1976) Effects of LAS on
Dam, Fetus, and Newborn Rat. J. Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku
Zassh) 17(1): 66-71.  (HERA)

Open Literature	LAS was administered in the diet at doses of 80 and 780
mg/kg bw/d from day 0 to 20 of gestation 

F Rat (16/dose) 

Purity: Not Reported	NOAEL (maternal): 780 mg/kg bw/d

NOAEL (fetuses): 780 mg/kg bw/d

At 780 mg/kg bw/day there were no abnormalities in the body weight gains
of the dams, or in the occurrence and maintenance of pregnancy. The
values of the litter parameters did not differ from those of the
controls and there was no evidence of teratogenicity. The number of
offsprings was rather low in the highest dose group, and the weaning
rate of 78.3% was lower than the 100% rate observed in the controls.
However, there

were no abnormalities in body weight gain, organ weights or functions in
the offsprings.

Reproduction Toxicity

870.3800

Reproduction

	MRID 43498416

Buehler, E., Newmann, E., and King, W.  (1971) Two Year Feeding and
Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS).
Tox. Appl. Pharm. 18: 83-91.  (HERA)

Acceptable

Guideline	LAS was administered in the diet at doses of 0, 0.02, 0.1, and
0.5% , equivalent to (0, 10, 50, 250 mg/kg bw/day) for 84 days.

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

Purity: 98.1%	NOAEL Parental: 250 mg/kg bw/day

NOAEL Offspring: 50 mg/kg/d.

The LOAEL of 250 mg/kg/day in the offspring is due to slight
(non-significant) changes in hematology and histopathology and slight
decrease in day 21 body weights.

870.3800

Reproduction

	Endo et al. (1980) Studies of the Chronic Toxicity and Teratogenicity
of Synthetic Surfactants, Ann. Rep. Tokyo Metrop. Res. Inst. Environ.
Prot. (Tokyo Kogai Kenkyujo Nempo), 236-246.  (HERA)

Open Literature	LAS was administered at 70 mg/kg bw/day in the drinking
water  in a four generation rat study.

M/F Wistar Rat

Purity: Not Reported	NOAEL: > 70 mg/kg (only dose tested)

No effects of LAS administration were observed

870.3800

Reproduction

	Palmer et al. (1974)  Effect of CLD Reproductive Function of Multiple
Generations in the Rat, Report LFO10/731029, Unpublished results. 
(HERA)

Open Literature	A commercial light duty liquid detergent of LAS (17%)
and alkyl ethoxylate sulphate (7%)  was continuously administered in the
diet for three generations 60 days prior to mating at concentrations of
0, 40, 200, and 1000 mg/kg bw/d.  The corresonding administration of LAS
was of 0, 6.8, 34, and 170 mg/kg bw/d. 

Rat

Purity: 17%	NOAEL: 170 mg/kg bw/d

Among parental animals over the three

generations there were no signs of adverse effects of treatment. Food
consumption and bodyweight

changes showed no consistent relationship to dosage. Necroscopy revealed
no changes due to treatment. The mating performance, the pregnancy rate
and the duration of gestation were unaffected. 

Among litter parameters, organ weight

analysis, histopathology and skeletal staining of representative young
from the F3b generation

revealed no changes that could be conclusively related to treatment.

Chronic Toxicity

870.4100a Chronic Toxicity (rodent)	Taniguchi et al. (1978) Results of
Studies on Synthetic Detergents.  Tokyo, Science and Technology Agency,
Research and Coordination Bureau, pp. 18-54.  (WHO 1996)

Open Literature	LAS were applied to the dorsal skin of rats three times
per week at doses of 1, 5, or 25 mg/rat for 24 months.  Each application
was washed from the skin with warm water after 24 hours.

SLC-Wistar Rats

Purity: 19.7% a.i.	Treatment had no effect on organ weights or
histopathological appearance, and there was no evidence of toxicity or
carcinogenicity.

870.3100

Chronic Toxicity

(rodent)	Yoneyama et al. (1976) Subacute Toxicity of LAS, Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health27(2): 105-112, See: IPCS, 1996.
(HERA)

Open Literature	LAS was administered in the diet at concentrations of
500 and 1000 mg/kg bw/d and in drinking water at concentrations of 100,
250, 600 mg/kg bw/d for males and 100, 250, 900 mg/kg bw/d for females
for 9 months 

Mouse (8 or 9/sex/dose)

Purity: Not Reported	LOAEL: 500 mg/kg bw/d (in diet)

NOAEL: 250 mg/kg bw/d (in water)

LAS in diet: in the mice given 500 mg/kg bw/day, body weight gain was
not suppressed, but the

weight of the liver increased in male and female mice. Enzymatic
examinations revealed significant

decreases in LDH of the liver and in acid phosphatase of the kidneys in
the male mice.

LAS in drinking water: body weight was depressed at the highest dose for
male and females, increase in liver weight in females, significant
decreases in renal Na,K-ATPase.

870.3100

Chronic Toxicity

(rodent)	Yoneyama et al. (1976) Subacute Toxicity of LAS, Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health27(2): 105-112,  See: IPCS, 1996.
(HERA)

Open Literature	LAS was administered for 9 months in the drinking water
at doses of 85, 145, 430 mg/kg bw/day 

M/F Wistar Rat

Purity: Not Reported

	NOAEL: 85 mg/kg bw/d

LOAEL: 145 mg/kg bw/d

Haematological examination revealed no significant changes in any
experimental group and no organ

weight changes were observed. Body weight gain was suppressed in the
males of the highest dose

group and also serum-biochemical and enzymatic parameters of the liver
and kidney were affected. A

significant decrease in renal Na,K-ATPase was seen in the group given
145 mg/kg bw/day of LAS.

870.4100a Chronic Toxicity (rodent)	Yoneyama et al. (1972) Studies on
the Toxicity of Synthetic Detergents.  (II) Subacute Toxicity of Linear
and Branched Alkyl Benzene Sulfonates in Rats.  Ann Rep Tokyo Metrop Res
Lab Public Health, 24: 409-440.

Open Literature	Technical-grade LAS was administered in the feed for 6
months at a concentration of 0, 0.07, 0.2, 0.6, or 1.8%

Wistar SLC Strain Rat (10/sex/dose)

Purity: Not Reported	NOAEL: 0.07% (40 mg/kg bw/day)

At 1.8%, diarrhea, decrease in body weight gain and tissue damage in
caecum liver and kidney were observed.  The damage to the kidney was
especially remarkable.

At 0.6% of the LAS or ABS, the adverse effects observed were a slight
decrease of body weight, increase of ceacum weight, increased activity
of alkaline phosphatase, decrease of total protein in blood, and the
tissue damage in the kidney.

At 0.2% of the LAS or ABS, an increase of caecum weight and a slight
damage to the kidney were observed.

Carcinogenicity

870.4200a Oncogenicity (Rat)	MRID 43498416

Buehler, E., Newmann, E., and King, W.  (1971) Two Year Feeding and
Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS).
Tox. Appl. Pharm. 18: 83-91.  (HERA)

Acceptable

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

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

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

870.4200a

Oncogenicity (Rat)	Endo et al. (1980) Studies of the Chronic Toxicity
and Teratogenicity of Synthetic Surfactants, Ann. Rep. Tokyo Metrop.
Res. Inst. Environ. Prot. (Tokyo Kogai Kenkyujo Nempo), 236-246.  (HERA)

Open Literature	LAS was administered in the drinking water at the dose
of 200 mg/kg bw/d  

62 M/F Wistar Rat

Purity: 38.74% a.i.	The administration of LAS had no effect on the
intake of water, mortality, body weight gain, or general condition.  In
pathological examinations, looseness, atrophy, and fatty change of the
hepatic cells in the liver were found in the experimental control group
at 6 months, together with significant increases in GOT, GTP and
bilirubin.  In hematological examinations no effects due to LAS were
observed.

870.4200a

Oncogenicity (Rat)	Fujii et al. (1977) Pathological Examination of Rats
Fed with LAS for their Lifespan, Ann. Rep. Tokyo Metrop. Res. Lab.
Public Health 28(2): 85-108. (HERA)

Yoneyama et al. (1977) Toxicity of LAS by Dietary Administration for
Life-Span to Rats, Ann. Rep. Tokyo Metrop. Res. Lab. Public Health
28(2): 73-84.  (HERA)

Open Literature	LAS was administered in the feed at a concentration of
0.04, 0.16, and 0.60% for  24 months or lifespan

Wistar Weanling Rat (15/sex/dose) 

Purity: Not Reported	Histopathological examination revealed that there
was no evidence of a treatment-related effect on any tissue examined. 
Whereas a variety of tumors were observed in both linear alkylbenzene
sulfonate treated and control rats, none was attributed for the exposure
to linear alkylbenzene sulfonate.  There was no relationship among the
dosage groups, sex, type of tumor, or the site of occurrence.

870.4200a

Oncogenicity (Rat)	MRID 43498420

Takahasi et al. (1969) Effect of Alkylbenzenesulfonate as a Vehicle for
4-Nitroquinoline-1-Oxide on Gastric Carcinogenesis in Rats.  GANN: 8,
241-261.

Acceptable

Guideline	For 560 days; Group I (79 rats): 1 mg 4-NQO and 80 mg SDDBS
2-3x per week for 18 weeks; Group I' (17 rats): same as Group 1, but
fasted for 12 hours prior to dosing,; Group II (37 rats):  1 mg 4-NQO
only; Group III (28 rats): 80 mg SDDBS only

 97 M Wistar Rats

Purity: Not Reported	In Groups I and I', the presence of SDDBS shifts
the incidence of benign papillomas to malignant papillomas of the
forestomach and the incidence of adenocarcinoma and sarcoma of the
stomach were increased in comparison to Group II with only 4-NQO.  The
administration of SDDBS by itself has no effect on gastric tumors (Group
III).  The study authors concluded that the increased carcinogenicity
produced by SDDBS was due to the better uptake of 4-NQO via LAS's
surfactive/detersive effects on the protective mucous barrier which is
normally found in the glandular stomach and other gastric compartments
of the rat.  The effect of SDDBS was physical rather than chemical in
promoting the increased tumorigenicity.

870.4200a

Oncogenicity (Rat)	MRID 43498419

Takahasi et al. (1970) Effect of 4-Nitroquinoline-1-Oxide with
Alkylbenzenesulfonate on Gastric Carcinogenesis in Rats.  GANN: 61,
27-33.

Acceptable

Guideline	Rats were divided into three groups and gavaged with the
following regimen for 560 days: Group I (37 rats) - 1 mg 4-NQO + 80 mg
SDDBS + 20 mg ethanol in a 1 ml gavage for 18 weeks; Group II (13 rats)
- 4-NQO and ethanol for 18 weeks; Group III (13 rats) - SDDBS + ethanol
for 18 weeks 

64 M Motoyama Strain Rat

Purity: Not Reported	Survival: Mortality was 59% in Group I, 31% in
Group II, and 23% in Group III

Tumors: Group III - no gastric tumors; Group II - 9 benign papillomas of
forestomach; Group I - 8 benign papillomas of forestomach, 2 malignant
papillomas of forestomach, 1 hemangiosarcoma of forestomach.  In
glandular stomach, 2 adenocarcinomas, 1 hemangiosarcoma, 1 hemangioma, 5
squamous cell carcinomas, and 2 rats exhibited atrophic gastritis.

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

870.4200a

Oncogenicity (Rat)	MRID 43498421, -22

Takahasi et al. (1973) Carcinogenic Effect of
N-Methyl-N'-Nitro-N-Nitrosoguanidine with Various Kinds of Surfactant in
the Glandular Stomach of Rats.

Acceptable

Guideline	SDDBS was administered to 5 groups of rats: (I) 13 rats
received 0.1g of MNNG + 4000 mg Tween 60 per L of drinking water for 36
weeks; (II) 16 rats received 0.1 g MNNG + 2000 mg nonipol per L of
drinking water for 36 weeks; (III) 15 rats received 0.1 g of MNNG + 1000
mg branched ("hard") SDDBS per L of drinking water for 63 weeks; (IV) 10
rats received 0.1 g MNNG + 1000 mg of linear ("soft") SDDBS per L of
drinking water for 63 weeks; (V) 14 rats received o.1 g MNNG per L of
drinking water for 63 weeks

M Wistar Rats 

Purity: Not Reported	Survivial was 100% in Groups I, III, and IV, and
93% and 94% in Groups V and II, respectively.  

The Group I and II rats had more tumors than the controls (Group V),
whereas, the rats in Group III, ("hard" SDDBS, and particularly, Group
IV (linear "soft" SDDBS) had the fewest tumors in comparison to
controls.

870.4200a

Oncogenicity (Rat)	Tiba S (1972) Studies on the Acute and Chronic
Toxicity of LAS, J. Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku Zasshi)
13(6): 509-516.  (HERA)

Open Literature	LAS was administered in drinking water for 2 years at
doses of 20, 100, and 200 mg/kg bw/d 

M Wistar Rat (20/group)

Purity: Not Reported	There were no changes due to the administration of
LAS in regard to growth, mortality, the weight of major organs, or
histopathological findings

Mutagenicity

870.5100 Bacterial reverse mutation test	Huls, Report No. AM-93/12,
Unpublished data, 1993.  (As cited in HERA-2004)

Open Literature	LAS was tested at 8-5000 ug/plate with and without
metabolic activation. The cytotoxicity concentration was  >5000
ug/plate.  

Salmonella typhimurium, strains TA 98, TA 100, TA 1535, TA 1537, and TA
1538 

Purity: Not Reported	Negative results

870.5100 Bacterial reverse mutation test	MRID 43498429

Inoue et al. (1980)  Studies of In Vitro Cell Transformation and
Mutagenicity by Surfactants and other Compounds, Food. Cosmet. Toxicol
18: 289-296.  (HERA)

Acceptable

Guideline	SDDBS was tested at cytotoxic levels or limit concentrations
of 2,000-30,000 ug/plate for 2 days (Salmonella) or 8 days (SHE) 

Strain: Salmonella typhimurium - TA 98 and TA 100 cells and Embryonic
Syrian Golden Hamster cells (SHE) 

Purity: Not Reported	Negative (both with and without S-9 metabolic
activation)

870.5100 Bacterial reverse mutation test	Sunakawa et al. (1981) Studies
on the Mutagenicity of Surfactants Following Activation with Various
Liver Homogenates (S-9) and Mutagenicity in the Presence of Norharman,
Hyg. Chem. (Eisei Kagaku) 27(4): 204-211, See: WHO, 1996.

Open Literature	LAS was tested at up to 500 ug/plate

Salmonella typhimurium 

Purity: Not Reported	Negative Results

870.5300

In Vitro mammalian cell gene mutation test	Inoue, K. et al. (1977)
Osaka-furitsu Koshu Eisei Kenkyusho Kenkyu Hokoku, Shokuhin Eisei Hen 8:
25-8.  (HERA)

Open Literature	Sodium alkylbenzenesulfonate was added to culture at
62.5 ug/ml and 125 ug/l 

Hamster Lung Cell

Purity: Not Reported	At 62.5 ug/ml: induced cell mutation, no effect on
sister chromatid exchange

At 125 ug/ml: destroyed the cells completely

870.5300	

 In Vitro cell transformation

	MRID No. 43498427 

K. Inoue et al (1980)

Food Cosmetic Toxicol.

18:289-296

Acceptable

Open Literature	Duplicate primary cultures of embryonic SHE and
Salmonella typhimurium strain TA 98 and TA 100 cells were exposed to
SDDBS and positive and negative controls for 8 days.	SDDBS was negative
for transformation up to cytotoxic levels and did not induce mutation in
either strains of Salmonalla when allplied up to cytotoxic levels or
limit concentration of 2000-3000 ug/plate.

SDDBS was tested negative at cytotoxic levels or limit concentrations
(both with and without S-9 metabolic activation) of 2,000-30,000
ug/plate for 2 days (Salmonella) or 8 days (SHE)

870.5385

Mammalian bone marrow chomosomal aberration test	Inoue K, et al. (1979) 
In vivo Cytogenetic Tests of Some Synthetic Detergents in Mice, Ann.
Rep. Osaka Perfect. Inst. Public Health 8: 17-24 (in Japanese), See:
IPCS, 1996.  (HERA)

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

M Mouse

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

870.5385

Mammalian bone marrow chomosomal aberration test	Inoue, K. et al. (1977)
In Vivo Cytogenetic Tests of Some Synthetic Detergents in Mice.  Ann Rep
Osaka Prefect Inst Public Health, 8: 17-24.  (HERA)

Open Literature	LAS was administered at a dose of 200, 400, and 800
mg/kg bw/d by gavage for 5 days.  One commercial preparation containing
19.0% LAS was also given, at a dose of 800, 1600, or 3200 mg/kg bw, and
another containing 17.1% LAS at a dose of 1000, 2000, or 4000 mg/kg bw
once only by gavage.

M ICR:JCL Mouse

Purity: Not Reported	There was no significant difference between any of
the groups given LAS and the negative control group in the incidence of
chromosomal aberrations

870.5385

Mammalian bone marrow chomosomal aberration test	MRID 43498428

J. Hope (1977) Absence of Chromosome Damage in the Bone Marrow of Rats
Fed Detergent Actives for 90 Days.  Mutation Research, 56: 47-50.

Acceptable

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

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

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

870.5385

Mammalian bone marrow chomosomal aberration test	Masabuchi et al. (1976)
Cytogenetic Studies and Dominant Lethal Tests with Long Term
Administration of Butylated Hydroxytoluene (BHT) and LAS in Mice and
Rats, Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2): 100-104. 
(HERA)

Open Literature	LAS was administered in the diet for 9 months at a dose
of 0.9% in rats (450 mg/kg bw/d) and in mice (1170 mg/kg bw/d) 

Male Rat and Male Mouse

Purity: Not Reported	There were no significant differences in the
incidences of chromosomal aberrations between the experimental and
control groups

870.5395

Mammalian erthrocyte micronucleus test	Kishi et al. (1984) Effects of
Surfactants on Bone Marrow Cells, Bull. Kanagawa Public Health Lab. 14:
57-58.  (HERA)

Open Literature	LAS was administered as a single intraperitoneal
injection at a dose of 100 mg/kg bw 

3 M ddY Mice

Purity: Not Reported	There were no differences in the incidences of
polychromatic erythrocytes with micronuclei in the bone marrow cells
between the treated group and the control group

870.5395

Mammalian erthrocyte micronucleus test	Koizumi et al. (1985)
Implantation Disturbance Studies with LAS in Mice, Arch. Environ.
Contam. Toxicol. 14: 73-81.  (HERA)

Open Literature	LAS were administered as a single oral dose of 2 mg to
pregnant mice on day 3 of gestation.  On day 17 of gestation, each
animal received a subcutaneous dose of 1, 2, or 10 mg and were killed 24
h later. 

Pregnant ICR Mice

Purity: Not Reported	There was no difference among treated groups in the
incidence of polychromatic erythrocytes with micronuclei in maternal
bone marrow or fetal liver or blood.  No mutagenetic effect was found in
any of the groups.

870.5450

Rodent dominant lethal assay	Masubuchi MA et al. (1976) Cytogenetic
Studies and Dominant Lethal Tests with Long Term Administration of
Butylated Hydroxytoluene (BHT) and Linear Alkylbenzene Sulfonate (LAS)
in Mice and Rats.  Ann Rep Tokyo Metrop Res Lab Public Heath, 27(2):
100-104.

(HERA)

Open Literature	A diet containing 0.6% LAS at 300 mg/kg bw/d was
administered to mice for 9 months. Each of the male mice was then mated
with two female mice that had not been given LAS, and 11 of the 14
females became pregnant.  The pregnant mice were laparotomized on day 13
of gestation

7 M ICR:JCL Mice 

Purity: Not Reported	There were no significant differences in fertility,
mortality of ova and embryos, the number of surviving fetuses, or the
index of dominant lethal induction (Roehrborn) between the experimental
and control groups.

Metabolism

870.7485 General Metabolism	MRID 43498410

Creswell et al. (1978) Toxicology Studies of Linear Alkylbenzene
Sulphonate (LAS) in Rhesus Monkeys II.  The Disposition of C14-LAS After
Oral or Subcutaneous Administration.  Toxicology, 11: 5-17.

Acceptable

Guideline	Single oral doses of C14-LAS (SDDBS; 25 ucuries) were
administered to each animal, following 2-3 weeks between dose levels, at
levels of 30, 150, and 300 mg/kg.  Following 2-3 weeks after the last
single oral dose, each monkey received 7 consecutive daily oral doses of
30 mg/kg/d of C14-LAS.    

2 M/2 F Rhesus Monkeys

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

870.7485 General Metabolism	Lay JP, et al. (1983) Toxicol. Letters 17
(1-2): 187-192

Open Literature	(14)C-labeled sodium dodecylbenzenesulfonate was
administered daily in the diet at a concentration of 1.4 mg/kg for 5
weeks

M Rat

Purity: not reported	From a total uptake of 1.213 + or - 0.08 mg/animal
of DBS, 81.8% was excreted during the dosing period: 52.4% in feces and
29.4% in urine.  Low levels of (14)C-DBS-derived residues were detected
in all tissues analyzed on day 35 of the study.  Following 1 week on a
normal diet, only 7.8% of the nominally stored amount of (14)C was found
in the excreta.

870.7485 General Metabolism	Sunakawa et al. (1979) Yakuzaigaku 39 (2):
59-68

Open Literature	Sodium-para-dodecylbenzenesulfonate 

Rat

Purity: Not Reported	Blood levels were max at 2 hr, negligible at 48 hr

Excretion rate of radioactive label was 99.4% after 48 hr

870.7485 General Metabolism	The Royal Society of Chemistry. (1981)
Foreign Compound Metabolism in Mammals. Volume 6: A Review of the
Literature Published during 1978 and 1979. London: The Royal Society of
Chemistry, p.354.

Open Literature	(35)S-labeled sodium dodecylbenzenesulfonate was
administered as a single oral dose 

Rat

Purity: Not Reported	Rats excreted 64% and 24% of the dose in urine and
feces, respectively

870.7485 General Metabolism	The Royal Society of Chemistry. (1981)
Foreign Compound Metabolism in Mammals. Volume 6: A Review of the
Literature Published during 1978 and 1979. London: The Royal Society of
Chemistry, p.354.	Repeated doses of (14)C-labeled alkylbenzenesulfonate
were orally administered 

Rhesus Monkey

Purity: Not Reported	Radioactivity did not accumulate in the tissues

870.7485 General Metabolism	MRID 43498431

W. Michael (1968) Metabolism of Linear Alkylate Sulfonate and Alkyl
Benzene Sulfonate. Toxicol. Appl. Pharmacol. 12: 473-485.

Acceptable

Guideline	LAS-S35 was administered orally to fasted rats at doses of
0.6, 1.2, 8, and 40 mg

Charles River CD M Rat

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

Similar levels of radioactivity were found in urine and feces and within
3 days, 85.2% - 96.6% of the label was recovered. 

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

Following methylation, one urinary metabolite was identified as
4-(4'-methylsulfophenyl) pentanoate.  LAS-S35 in the feces remained
unmetabolized.

Special Studies

870.3700a

Developmental Toxicity (rodent)	Koizumi et al. (1985) Implantation
Disturbance Studies with LAS in Mice, Arch. Environ. Contam. Toxicol.
14: 73-81.  (HERA)

Open Literature	LAS was administered as a single oral dose of 350 mg/kg
bw on day 3 of gestation 

Pregnant ICR Mice

Purity: Not Reported	LAS was not detected in the uterus

Other	Inoue K, T Sunakawa. (1979)  Mutagenicity Tests of Surfactants,
Jpn. Fragr. J. 38: 67-75, (in Japanese),  See: IPCS, 1996.  (HERA)

Open Literature	LAS tested in a recombination assay at concentrations up
to 50 ug/plate

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 Nagoya Med J, 28 (3-4): 211-5

Open Literature	The proliferation rate of the connective tissue was
examined by measuring the activity of proline hydroxylase.  The dorsal
neck skin of rats was coated with sodium laurylbenzenesulfonate for 4
days, and on the 5th day, the enzyme activity in the skin was measured.

Rat

Purity: Not Reported	The proline hydroxylase in the part of the skin
coated with the irritants showed clearly higher activity than normal
skin, although it was still lower than the injured skin region prepared
as a positive control.

Other	MRID 43498430 and 43498408            Kimura et al. (1982)
Mechanisms of Toxicities of Some Detergents Added to a Diet and the
Ameliorating Effects of Dietary Fiber in the Rat. J. Nutrit. Science and
 Science and Vitaminology, 28: 483-489.

Kimura et al. (1982) Toxicity for Detergent Feeding and Effect of the
Concurrent Feeding of Dietary Fiber in the Rat. Nutrition Reports
International, 26(2): 271-279.

Acceptable

Guideline	Ringer's bicarbonate (containing sodium lauryl benzene
sulfonate) at 0.5 ml/min was used to perfuse a 10 cm length of jejunal
segment for 150 minutes; equilibrated for 30 minutes and then the
perfusates were collected in 30 minute aliqouts for 120 minutes

M Wistar Rat

Purity: 0.5%	Alkaline phosphatase was released by an increase of 15-fold
in comparison to Ringer's alone (controls without added sodium lauryl
benzene sulfonate) and 3-7 times greater than other surfactants tested
in Ringer's.  The authors conclude that SDDBS has an exfoliative effect
on the intestinal brush border

Other	Oba et al. (1968) Biochemical Studies of n-alpha-olefin
sulfonates: (II) Acute Toxicity, Skin and Eye Irritation, and Some Other
Physiological Properties.  J Jpn Oil Chem Soc, 17 (11): 628-634.  (EHC
169)

Open Literature	Solutions of various concentrations of LAS were mixed
with red blood cells from rabbits at room temperature for 3 hours

Rabbit Red Blood Cell

Purity: Not Reported	The 50% haemolytic concentration of LAS was 9
mg/litre

Other	Samejima Y (1991) Effects of Synthetic Surfactants and Natural
Soap on the Development of Mouse Embryos In Vitro and the Fertilizing
Capacity of Mouse and Human Sperm.  J Osaka Univ Med Sch, 3 (12):
675-682.  (EHC 169)

Open Literature	Eggs were fertilized in vitro and incubated in culture
medium containing LAS at concentrations between 0.015 and 0.03%.  

F B6C3F1 Mouse Egg 

Purity: Not Reported	Concentrations of LAS less than 0.025%: Eggs
exposed for 1 hr, washed, and then cultured for 5 days developed
normally to the blastocyst stage

Concentrations of LAS higher than 0.03%:  The eggs did not develop
beyond the one-cell stage

With continuous exposure to LAS for five days, a concentration of 0.01%
slightly impaired development to the blastocyst stage, and 0.025%
prevented development to the one-cell stage

Other	Takahashi et al. (1974) Inhibition of Thrombin by Linear
Alkylbenzene Sulfonate (LAS).  Ann Rep Tokyo Metrop Res Lab Public
Health, 25: 637-645.  (HERA)

Open Literature	Purified LAS at various concentrations were added to 10
ul of plasma from rats and prothrombin time was determined

M Rat

Purity: Not Reported	Prothrombin time was prolonged; the 50% inhibitory
concentration was about 0.6 mmol/litre.  When LAS at various
concentrations were added to a mixture of 1% fibrinogen and thrombin,
the time of formation of a mass of fibrin was prolonged by inhibition of
thrombin activity.  The 50% inhibitory concentration was about 0.05
mmol/litre.

Other	Yanagisawa et al. (1964) Biochemical Studies of Dodecylbenzene
Sulfonates; Differences Between Soft and Hard Detergents.  Jpn. J Public
Health, 11(13): 859-864.  (EHC 169)

Open Literature	The haemolytic action of LAS was investigated by mixing
red blood cells from rabbits with solutions of LAS at concentrations of
1-1000 mg/litre at 38 C for 30 min

Rabbit Red Blood Cell

Purity: Not Reported	Haemolysis occurred at concentrations >= 5
mg/litre.

  TC \l3 "9.1.2	Subchronic, Chronic and Other Toxicity Tables 

	1 PAD = Population Adjusted Dose = Chronic RfD

						  FQPA Safety Factor

 A review of those products listed as containing ingredients
Benzenesulfonic acid, dodecyl- (CAS Reg. No. 27176-87-0); Sodium
dodecylbenzenesulfonate (CAS Reg. No. 25155-30-0); and Benzenesulfonic
acid, C10-16-alkyl derivs (CAS Reg. No.68584-22-5) was conducted.  The
results of that review indicate that the linear alkylbenzenesulfonates
are primarily used in low concentrations (typically less than 5% w/w) in
herbicide products that  typically are applied in a preemergent or early
post-emergent fashion.

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