Document ID: EPA-HQ-OPP-2006-0156-0019
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-22T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES

 

						

July 6, 2006

MEMORANDUM

SUBJECT:	Occupational and Residential Exposure Assessment of
Alkylbenzene Sulfonates for the Reregistration Eligibility Decision
Document (RED).

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

		Regulatory Management Branch II

Antimicrobials Division (7510C)

		

		And

Deborah Smegal, Risk Assessor

Reregistration Branch I

Health Effects Division (7509C)

FROM:	Talia Milano, Chemist, Team II

		Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510C)

THRU:	Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510C)

DP Barcode: 330329

Case No.: 4006

	Chemical Name (s) 								CAS #1				PC CODE1

	

Sodium dodecylbenzene sulfonate				 25155-30-0		079010

Benzenesulfonic acid, C10-16-alkyl derivatives 		68584-22-5		190116

Dodecylbenzene sulfonic acid 				27176-87-0		098002

1: The CAS # and PC Codes listed reflect the current numbering system.
However, Dodecylbenzene sulfonic acid is not a pure chemical, and is
considered part of the mixture of Benzenesulfonic acid.  A discussion of
this discrepancy can be found in the text of the chapter along in the
Preliminary Risk Assessment.



OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT OF

ALKYLBENZENE SULFONATES IN SUPPORT OF THE REREGISTRATION ELIGIBILITY
DECISION DOCUMENT (RED)

REREGISTRATION CASE 4006

7/6/06

 

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

TABLE OF CONTENTS:

EXECUTIVE
SUMMARY.................................................................
...............................4

INTRODUCTION............................................................
...........................................7

Purpose.................................................................
.............................................7

Criteria for Conducting Exposure
Assessments................................................7

	Chemical
Identification..........................................................
............................7

Physical/Chemical
Properties..............................................................
..............8

2.0   USE
INFORMATION.............................................................
...................................8

		2.1 Formulation Types and Percent Active
Ingredient..............................................8

 		2.2	 Summary of Use Pattern and
Formulations........................................................8

3.0   SUMMARY OF TOXICITY
DATA....................................................................
......10

		3.1 Acute
Toxicity................................................................
.....................................10

		3.2 Summary of Toxicity
Endpoints...............................................................
...........11

		3.3 FQPA
Considerations..........................................................
................................14

4.0   RESIDENTIAL EXPOSURE
ASSESSMENT..........................................................14

	4.1	 tc \l2 "4.1	Summary of Registered Uses Residential
Exposure................................................................
......................14

5.0	OCCUPATIONAL EXPOSURE
ASSESSMENT.................................................16

	5.1 	Occupational Handler
Exposures...............................................................
.....22

	5.2  	Occupational Post-application
Exposures.......................................................29

	5.3	Data
Limitations/Uncertainties...............................................
.........................29

6.0   
REFERENCES..............................................................
...............................................30 

APPENDIX A
........................................................................
................................................ tc \l2 "6.3	Data
Limitations/Uncertainties 31

APPENDIX B
........................................................................
................................................ tc \l2 "6.3	Data
Limitations/Uncertainties 33

 tc \l1 "6.0	OCCUPATIONAL EXPOSURE AND RISK 

 tc \l2 "4.4	Residential Exposure/Risk Pathway 



EXECUTIVE SUMMARY 

This document is the Occupational and Residential Exposure Assessment
for the Reregistration Eligibility Decision Document (RED) for
alkylbenzene sulfonates.  The currently listed active ingredients that
are included under this decision are sodium dodecylbenzene sulfonate
(CAS # 25155-30-0), dodecylbenzene sulfonic acid (CAS # 27176-87-0), and
benzenesulfonic acid, C10-C16 alkyl derivatives (CAS # 68584-22-5).  To
date, dodecylbenzene sulfonic acid has been listed separately from
benzenesulfonic acid, C10-C16 alkyl derivatives, and identified by the
CAS #27176-87-0 on numerous labels and in different databases. 
Dodecylbenzene sulfonic acid is not considered to be a pure compound,
and is included in the mixture of benzenesulfonic acid, C10-16 alkyl
derivatives.  For future references of this chapter, any conclusions
that are made specifically about benzenesulfonic acid, C10-C16 alkyl
derivatives will be representative of dodecylbenzene sulfonic acid.  For
this specific chapter, the chemicals are referred to as they are
identified in current databases.  

At this time alkylbenzene sulfonates are active ingredients in
twenty-three registered end-use products such as cleaners and sanitizers
that are designated for used in agricultural, food handling and
commercial/institutional/industrial settings (Use Site Categories I, II,
and III respectively). These products have not been identified to have
any residential use sites, and therefore a residential assessment was
not conducted at this time.  In addition, a majority of the currently
registered labels require the use of gloves, protective clothing,
goggles, and a face shield.   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).  This
assessment contains the non-dietary occupational exposure assessment for
alkylbenzene sulfonates when they are listed as active ingredients.  The
dietary assessment as well as an inert assessment for the uses of the
sulfonates will be assessed separately in supporting documents of this
RED.  The percentage of alkylbenzene sulfonates in various products can
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 durations and routes of exposure that was evaluated in this
assessment include short-term (ST) and intermediate-term (IT) inhalation
exposures.   Both of these durations have the same toxicological
endpoint, so the risks calculated are representative for both ST and IT
durations of exposures.  There is no evidence of systemic toxicity via
the dermal route, and this is why a dermal endpoint was not provided,
and thus, no dermal assessment has been conducted at this time. 
Alkylbenzene sulfonates are considered to be dermal irritants in
formulations that have listed amounts of active ingredient generally
greater than 20%.  The following excerpt is reiterated from the
toxicological endpoint Table 4.

		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.  

For the dose calculations, the default inhalation absorption factor was
100%.  In addition, the toxicological report is important to review for
a more detailed explanation of the endpoints that were calculated.  

The use sites and application rates were examined for all of the labels
that included the one of the three sulfonates as the active ingredient. 
From this examination, the representative scenarios were chosen. 
However, even though the toxicological endpoints selected for all of the
chemicals represented by this case number are the same, the labels that
listed sodium dodecylbenzene sulfonate still had be assessed
individually if they were not selected as the representative label.  The
reason for this is because for each label that lists sodium
dodecylbenzene sulfonate as the active ingredient; there was direction
for a handler to use the same product for both the cleaning and
sanitizing steps via various methods.  There is an expected risk to the
handler that performs both cleansing and sanitizing in the same time
frame, and this risk was evaluated by calculating the total MOE.

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

For the occupational handler inhalation risk assessment, the MOEs were
greater than or equal to the target MOE of 100 for all scenarios except
the following:

Handler Risk Summary for alkylbenzene sulfonates:

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

Total Exposure Summary for sodium dodecylbenzene sulfonate (results from
cleaning and sanitizing with the same product in the same time frame)

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.

Data Limitations and Uncertainties:

There are a number of uncertainties associated with this assessment and
these have been reiterated from Section 6.3.

Surrogate inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix A for summaries of
these data sources). Most of the CMA data are of poor quality;
therefore, AD requests that confirmatory monitoring data be generated to
support the values used in these assessments.  

The quantity handled/treated were estimated based on information from
various sources, and in certain cases, no standard values were available
for some scenarios.  Assumptions and groupings for these scenarios were
based on Agency estimates and could be further refined with input from
registrants.

1.0	 INTRODUCTION tc \l1 "1.0	 INTRODUCTION 

	1.1	Purpose  tc \l2 "1.1	Purpose  

	In this document, the Agency presents the results of its review of the
potential effects of occupational exposure to the alkylbenzene
sulfonates when they are listed as active ingredients in registered
products. This information is for use in EPA's development of the
alkylbenzene sulfonates Reregistration Eligibility Decision Document
(RED). 

	1.2	Criteria for Conducting Exposure Assessments tc \l2 "1.2	Criteria
for Conducting Exposure Assessments 

	An occupational exposure assessment is required for an active
ingredient if (1) certain toxicological criteria are triggered and (2)
there is potential exposure to handlers (mixers, loaders, applicators,
etc.) during use or to persons entering treated sites after application
is complete.  For alkylbenzene sulfonates, both criteria are met.

	Using surrogate unit exposure data, maximum application rates from
labels, and EPA estimates of daily amount handled, exposures and risks
to handlers were calculated and assessed.  Appendix A includes all of
the equations utilized and is supplemented with some definitions. Also,
in lieu of registrant submitted data, the proprietary unit exposure data
that was used for this assessment are discussed in Appendix B.

	In addition to the target MOEs from Section 3.2 that were used for the
analysis, a series of assumptions and exposure factors served as the
basis for completing the handler risk assessment. Each general
assumption and factor for the occupational assessment is detailed below.
 Assumptions specific to the use site category are listed in each
separate section of this document.  The general assumptions and factors
include:

The Agency has patterned this risk assessment on a series of likely
representative scenarios for each use site that are believed by the
Agency to represent the vast majority of alkylbenzene sulfonate uses.

Based on the adverse effects for the endpoints, the average body weight
of an adult handler of 70 kg was used to complete the non-cancer risk
assessment.  

Exposure factors used to calculate daily exposures to handlers were
based on applicable data, if available.  When appropriate data were
lacking, values from a scenario deemed similar were used. 

The maximum application rates allowed by labels were assumed. 	

	1.3	Chemical Identification tc \l2 "1.3	Chemical Identification 

Three chemical names are considered in this document: 1) sodium
dodecylbenzene sulfonate, 2) dodecylbenzene sulfonic acid, and 3)
benzenesulfonic acid, C10-C16 alkyl derivatives. Dodecylbenzene sulfonic
acid is not a pure compound, and for future references will be addressed
jointly with benzenesulfonic acid, C10-C16 alkyl derivatives.  However,
as previously stated, this document follows the current nomenclature
that is found in databases, in which dodecylbenzene sulfonic acid is
listed and identified separately.   These chemical properties have been
extracted from the “Product Chemistry Science Chapter” of this RED. 

Table 1  Chemical Identification Information for Alkylbenzene Sulfonates

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

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

Molecular Formula	C18H29O3S Na	C16H26O3S	C18H30O3S

	1.4	 Physical/Chemical Properties tc \l2 "1.4	Physical/Chemical
Properties 

	Table 2 displays the physical/chemical characteristics that have been
reported for the alkylbenzene sulfonates.  As previously stated, the
product chemistry chapter provides a comprehensive list of the different
physical/chemical properties. 

Table 2  Physical/Chemical Properties of Alkylbenzene Sulfonates

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

Molecular Weight	348.48 g/mol	326.5 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

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)

2.0	 USE INFORMATION tc \l1 "2.0	 USE INFORMATION 

	2.1	 Formulation Types and Percent Active Ingredient tc \l2 "2.1	
Formulation Types and Percent Active Ingredient 

	The twenty-three EPA registered products that contain alkylbenzene
sulfonates as the active ingredients (a.i.) are formulated as soluble
concentrates, flowable concentrates, ready-to-use solutions, and water
soluble packaging.  Concentrations of alkylbenzene sulfonates in these
products range from 0.036% to 25.6%. 

		

	2.2	 Summary of Use Pattern and Formulations tc \l2 "2.2	 Summary of
Use Pattern and Formulations 

Alkylbenzene sulfonates are active ingredients in numerous sanitizing
and cleaning products. The Agency recognizes that the alkylbenzene
sulfonates are also used extensively as inerts in several products such
as formulated detergents, cleaners, and other consumer products.  The
inert uses will be assessed under a separate review document as a part
of the RED process.  The Agency determines potential exposures to
handlers of the product by identifying exposure scenarios from the
various application methods that are plausible, given the label uses.
These scenarios are identified in Table 3, and are listed separately by
each active ingredient that is currently listed on the labels and in
databases.  Based on a review of labels, products containing
alkylbenzene sulfonates are intended for use in agricultural, food
handling and commercial/institutional/industrial settings (Use Site
Categories I, II, and III respectively).  Examples of registered uses
for alkylbenzene sulfonates include application to indoor hard surfaces
(e.g. urinals, shower stalls, toilet bowls, equipment, 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
previously stated, the dietary assessment will also be conducted in a
separate review document as a part of the RED process.

Table 3 Potential Use Scenarios Based on Product Labels for Alkylbenzene
Sulfonates

Use Site Category	Example Use Sites	Scenarios

Sodium dodecylbenzene sulfonate (CAS No. 25155-30-0)

Use Site Category 

II  

Food Handling/Storage Establishments Premises and Equipment	Dairy and
food processing plants; meat and poultry plants; and other eating
establishments	Application to hard surfaces and equipment through brush,
low pressure spray, high pressure spray, mopping, wiping, foam,
flooding, immersion, CIP.

Application to dishes and silverware by brush, foam, wiping, low
pressure spray, and immersion.

Application to fruits and vegetables by immersion and spray.

	

Application to food dispensing equipment through circulation.

Dodecylbenzene Sulfonic Acid (CAS No. 68584-22-5)

Use Site Category I

Agricultural Premises and Equipment	Dairy Farms

General Farm Use	Application to hard surfaces and equipment through
brush, low pressure spray, high pressure spray, foam, flooding,
immersion, CIP.

Use Site Category 

II 

Food Handling/Storage Establishments Premises and Equipment	Dairy and
food processing plants; food service industry; carbonated beverage
industry; meat and poultry plants; food service areas of public eating
places, schools, and bars	Application to hard surfaces and equipment
through brush, low pressure spray, high pressure sprayer, foam, pump or
trigger sprayer, flooding, immersion, mopping, wiping, CIP.

Application to glasses, dishes, stoves, countertops, and silverware by
brush, foam, wiping, low pressure spray, trigger sprayer, and immersion.

Application to fruits and vegetables by immersion.				

Application to food dispensing equipment through circulation cleaning
system.

Use Site Category III Commercial/Institutional and Industrial Premises
and Equipment	Toilet bowls, urinals, shower stalls; institutional
premises1,2

	Application to hard surfaces through cloth, sponge, bowl mop, or
immersion.

Benzenesulfonic Acid, C10-C16 alkyl derivatives (CAS No. 68584-22-5)

Use Site Category I

Agricultural Premises and Equipment	Dairy farms	Application to hard
surfaces through foam, brush, immersion, low pressure spray.  	

Use Site Category 

II 

Food Handling/Storage Establishments Premises and Equipment	Dairy and
food processing plants; restaurants; beverage plants; meat and poultry
plants	Application to hard surfaces and equipment through brush,
immersion, low pressure spray, foam, and CIP.

Application to glasses, stoves, countertops, dishes and silverware by
brush, foam, wiping, low pressure spray, trigger sprayer, and immersion.

Application to food dispensing equipment through circulation of the
cleaning solution.

Use Site Category III Commercial/Institutional and Industrial Premises
and Equipment	Institutional establishments2	Application to hard surfaces
and equipment through brush, immersion, low pressure spray, and foam.

1:  These bathroom sites, on label Reg. # 3635-279, are assumed to be in
industrial, institutional, and commercial premises, not residential.  A
complete discussion of the label terminology leading to the Agency’s
decision not to assess residential exposure is included in Section 4.1,
Residential Exposure.

2:  Institutional premises can include daycare centers in which there is
potential exposure to children.  However, hard surfaces that are treated
with this product do not include floors.  For example, Reg. # 74210-1
lists, “plates, utensils, cups, [and] glasses,” as the use sites for
institutional premises.  As mentioned in footnote number 1, a more
elaborate discussion on label terminology leading to the conclusion that
a residential exposure assessment is not warranted (handler or post
application) is included in Section 4.1.

From Table 3, the Agency selected representative exposure scenarios to
assess for the occupational inhalation exposure assessment.  The
selections were based on the product usage patterns and are believed to
provide high-end degrees of dermal, inhalation, or incidental ingestion
exposure.  The representative scenarios assessed in this document are
shown in Table 6.

3.0	SUMMARY OF TOXICITY DATA tc \l1 "3.0	SUMMARY OF TOXICITY CONCERNS
RELATING TO EXPOSURE 

Acute Toxicity

The acute toxicity is also presented in the toxicological chapter of
this RED.  The data base for acute toxicity is considered complete.  No
additional studies are required at this time.  The acute toxicity data
on the linear alkylbenzene sulfonate (LAS) technical is summarized below
in Table 4.

Table 4. Acute Toxicity Data on Linear alkylbenzene Sulfonate (LAS):

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	003442*	LC50 = 200 mg/L	IV

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

	* Tox record No.

	3.2	Summary of Toxicity Endpoints

	

	Table 5 indicates the toxicological endpoints that were developed for
the assessment of the alkylbenzene sulfonates.  The complete discussion
is included in the toxicological chapter of the alkylbenzene sulfonate
RED.  



Table 5. 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 LOAEL = 250 mg/kg/day based on
decreased Day 21 female pup body weight (Buehler, E. et al. 1971. Tox.
Appl. Pharmacol. 18:83-91) 

plus 

LOAEL= 145 mg/kg/day from 9 month drinking water rat study based on
decreased body weight 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 

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

plus 

LOAEL= 145 mg/kg/day from 9 month drinking water rat study based on
decreased body weight 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 

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

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

(a) Equation used to convert inhalation air concentration to a dose=
mg/L* absorption*respiratory volume (L/hr)*duration (hrs) * activity
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).

	 tc \l2 "3.2	Summary of Toxicity Concerns Relating to Exposures 3.3
FQPA Considerations 

These considerations are also presented in the toxicological chapter for
this RED.  

Special Sensitivity to Infants and Children

Based on the available hazard data, it doesn’t appear that LAS
exposure in laboratory animal studies results in any special sensitivity
to the young.  Therefore, the FQPA factor may be reduced to 1X.

Several reproduction and many developmental studies have been performed
with LAS 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 parental or
offspring in the other two reproductive toxicity studies (see Toxicity
Profile Table) – high doses of 70 or 170 mg/kg/d.

There’s no evidence in the literature to indicate any neurotoxic
effects of LAS in humans or laboratory animal.

There is no need for a special FQPA factor because the mid-dose level of
50 mg/kg/d (NOAEL for offspring effects) in the Buehler study is the
basis for the chronic RfD of 50 mg/kg/d.  Thus, the chronic hazard value
is based on slight pup effects and is protective of laboratory animals
of all ages in this hazard assessment.

  TC \l2 "6.1	Special Sensitivity to Infants and Children 

Recommendation for a Developmental Neurotoxicity Study

  TC \l2 "6.2	Recommendation for a Developmental Neurotoxicity Study 

	A DNT is not required because there is no evidence of either
neurotoxicity or susceptibility to the young following LAS exposure to
laboratory animals.

4.0	RESIDENTIAL EXPOSURE ASSESSMENT  tc \l1 "4.0	RESIDENTIAL EXPOSURE
ASSESSMENT 

	4.1	 tc \l2 "4.1	Summary of Registered Uses Residential Exposure tc \l2
"4.4	Residential Exposure/Risk Pathway 

Based on the Agency’s professional judgment, there is no residential
exposure to assess at this time for products that contain the
alkylbenzene sulfonates as the active ingredient.  The Agency
acknowledges that there are labels with language which initially appear
to warrant a residential assessment, and these specific labels are
discussed below along with justification for not conducting the
residential risk assessment.  Again, to reiterate, there is a separate
dietary chapter that will be provided for the dietary risks that stem
from the use of products containing alkylbenzene sulfonates.  There will
also be a separate inert chapter to assess the exposure to products that
contain alkylbenzene sulfonates as the inert ingredient. 

Reg. #71094-1 (PRO-SAN), and #71094-2 (PRO-SAN L) direct use on but not
limited to the following food preparation areas: countertops, cutting
boards, dishes and utensils that are found in kitchens, restaurants, and
other eating establishments along with dairies and food processing
plants. The method of application for these surfaces includes brush,
wiping, foam, sponge, or low-pressure spray.  These labels also include
directions for fruit and vegetable washing via immersion, spraying,
scrubbing (with a mesh pad, brush, or by mechanical agitation).  There
is also a use for circulation cleaning and sanitizing of equipment (such
as soft ice cream, juice, and vending machines).   

Based on the titles of these products indicating “professional
sanitation” along with the use patterns and use rates on these labels,
it is assumed that these products are distributed to commercial or
industrial users, and not to residential handlers.  There is no
indication that excludes residential use sites, and it is suggested that
language is included on these labels to restrict the use sites so that
there is no risk of these products ending up in the hands of residential
homeowners.

Several of the labels also restrict label use to industry only but there
are some exceptions in which a label was not exclusive to industrial
applications.  In these cases, label language and use sites were used to
justify that a residential risk assessment is not warranted at this
time.

Some of the labels that did not restrict product usage to industrial
applications.  These labels include but are not limited to the following
use sites: food-processing equipment in dairies, beverage, and food
processing plants (Reg. Numbers associated with this statement include:
#1670-150, #1270-254, #4959-29, #9152-18, #150-61, and #2686-10).  Due
to the use sites that were directed on these labels, there appears to be
no residential risk.

This group of labels does not restrict product use to industrial
applications and there is the use site category of, “institutional
premises.”  The Agency includes daycares as a potential facility
included in the institutional category.  Based on the language of these
labels, there appears to be no risk to children in daycares (post
application exposure to treated floors) because of the specific surfaces
that the products are applied to.  These surfaces include but are not
limited to food serving equipment, dishes, utensils, pots, and pans
(Reg. Numbers associated with this statement include: #74210-1, #875-85,
#875-185, #1677-56, #5389-12, #5174-11, #65001-1).

Label Reg. # 3635-279 includes the cleaning of toilets and shower
stalls, but the label restricts the use of the product to industrial,
institutional, and commercial premises. In addition, the surfaces to be
cleaned are restricted to toilets and shower stalls so that there is no
expected post application exposure risk for children’s exposure to
treated floors in daycares.

Label Reg. # 7546-4 has language that specifies that institutional and
commercial premises are the use sites, but does restrict use of the
product to: food service areas of public eating places, healthcare
facilities, schools, and bars for the purpose of sanitizing glassware
and other utensils.  Again, it is assumed that there is no post
application exposure risk for children on treated floors in daycares.

5.0	OCCUPATIONAL EXPOSURE ASSESSMENT tc \l1 "6.0	OCCUPATIONAL EXPOSURE
AND RISK 

	The exposure scenarios that are assessed in this document for the
representative uses for sodium dodecylbenzene sulfonate, dodecylbenzene
sulfonic acid, and benzenesulfonic acid, C10-C16 alkyl derivatives are
shown in Table 6.  The table shows the maximum application rate
associated with the representative use and the appropriate EPA
Registration number for the product label. Potential occupational
handler exposure can occur in various use sites, which include;
agricultural premises, food handling premises, and
commercial/institutional/industrial premises. It should be noted that
for the calculation of application rates in which 8.34 lb a.i./gal is
noted, the product is assumed to have the density of water because it is
diluted with water.  

	However, it will be apparent that throughout Table 6, that some of the
application methods are repeated. This is because when the labels that
contain sodium dodecylbenzene sulfonate as the active ingredient were
not chosen to be the representative label for all of the sulfonates
(e.g. highest application rate); they still had to be included so that
the total MOE assessment could be conducted.  This was necessary because
all of the products that contain sodium dodecylbenzene sulfonate as the
active ingredient have label direction for the product to be used to
clean the specified surface, and then immediately follow with sanitation
of the surface with the same product.  For this reason, the risks
resulting from the use of the products that contain sodium
dodecylbenzene sulfonate were assessed individually and presented in
Table 6.  Subsequently, these handful of labels were then assessed
jointly to generate a total exposure assessment (combined scenarios are
identified in Table 7). 

	



Table 6:  Representative Exposure Scenarios Associated with
Occupational Exposures to Alkylbenzene Sulfonates

Representative Use	Method of Application	Exposure Scenario	Registration
#	Application Rate1

Agricultural Premises and Equipment (Use Site Category I)

Indoor Hard Surfaces (includes stainless steel bulk tanks, pails, tiles,
milk machines, etc.)	Brush 

Mechanical Foam	ST and IT Handler: inhalation	74210-12	0.0667 lb ai/gal

(25.6% ai x 4 oz product/gal water x 1 gal/128 oz x 8.34 lb/gal)

	Flooding	ST and IT Handler: inhalation

	875-185	0.00183 lb ai/gal

(4.5% ai x 2.5 oz product/4 gal water x 1 gal/128 oz x 8.34 lb/gal)

	CIP3	ST and IT Handler: inhalation	4959-29	0.00195 lb ai/gal

(15% ai x 1 oz product/5 gal water x 1 gal/128 oz x 8.34 lb/gal)

	High pressure spray4	ST and IT Handler: inhalation

	875-85	0.00326 lb ai/gal

(5% ai x 2 oz product/2 gal water x 1 gal/128 oz x 8.34 lb/gal)

	Immersion

Low pressure spray

Trigger pump spray	ST and IT Handler: inhalation

	74210-12	0.00334 lb ai/gal

(25.6% ai x 2 oz product/10 gal water x 1 gal/128 oz x 8.34 lb/gal)

Food Handling (Use Site Category II)

Indoor Hard Surfaces (includes dishes and silverware, food processing
equipment, refrigerated storage areas, etc.)	Brush5

Mechanical foam6	ST and IT Handler: inhalation

	74210-12	0.0667 lb ai/gal

(25.6% ai x 4 oz product/gal water x 1 gal/128 oz x 8.34 lb/gal)

	Brush  (sanitize)	ST and IT Handler: inhalation	1020-132,7	0.0115 lb
ai/gal

(2.75% ai x 5% solution x 8.34 lb/gal)

	Brush (cleaning)	ST and IT Handler: inhalation

0.0018 lb ai/gal

(2.75% ai x 1oz. product/ gal water x 1 gal/128 oz x 8.34 lb/gal)

	Brush (cleaning)	ST and IT Handler: inhalation	71094-12,8

(WSP)9	0.00603 lb ai/gal

(3.6% ai x 0.67 lb product/4 gal water)

	Brush (cleaning)	ST and IT Handler: inhalation	71094-22,10

(RTU) 9	0.00300 lb ai/gal

(0.036% ai x 8.34 lb/gal)

	Foaming (cleaning)	ST and IT Handler: inhalation	71094-12,8

(WSP)9	0.00603 lb ai/gal

(3.6% ai x 0.67 lb product/4 gal water)

	Immersion

Trigger pump sprayer	ST and IT Handler: inhalation	74210-12	0.00334 lb
ai/gal

(25.6% ai x 2 oz product/10 gal water x 1 gal/128 oz x 8.34 lb/gal)

	Low pressure spray (cleaning)	ST and IT Handler: inhalation	71094-12,8

(WSP)9	0.00603 lb ai/gal

(3.6% ai x 0.67 lb product/4 gal water)

	Low pressure spray (sanitizing)

	0.00302 lb ai/gal

(3.6% ai x 0.67 lb product/8 gal water)

	Low Pressure Spray (cleaning) 	ST and IT Handler: inhalation
71094-22,10

(RTU) 9	0.00300 lb ai/gal

(0.036% ai x 8.34 lb/gal)

	Trigger pump  (sanitize)

High pressure spray (sanitize)11	ST and IT Handler: inhalation
1020-132,7	0.0115 lb ai/gal

(2.75% ai x 5% solution x 8.34 lb/gal)

	High pressure spray (cleaning)

	0.0018 lb ai/gal

(2.75% ai x 1oz. product/ gal water x 1 gal/128 oz x 8.34 lb/gal)

	Immersion (sanitizing)

Flooding (sanitizing)	ST and IT Handler: inhalation	71094-12,8

(WSP)9	0.00302 lb ai/gal

(3.6% ai x 0.67 lb product/8 gal water)

	Immersion (sanitizing) 

Flooding (sanitizing) 

	ST and IT Handler: inhalation	71094-22,10

(RTU) 9	0.00300 lb ai/gal

(0.036% ai x 8.34 lb/gal)

	Mop	ST and IT Handler: inhalation

	65001-112

	0.00244 lb ai/gal (15% ai x 1 oz/4 gal water x 1 gal/128 oz x 8.34
lb/gal)

	Wiping surfaces (cleaning)	ST and IT Handler: inhalation	71094-12,8

(WSP)9	0.00603 lb ai/gal

(3.6% ai x 0.67 lb product/4 gal water)

	Sponge/Mesh/Wiping (cleaning)	ST and IT Handler: inhalation	71094-22,10

(RTU) 9	0.00300 lb ai/gal

(0.036% ai x 8.34 lb/gal)

	CIP (cleaning and sanitizing)3	ST and IT Handler: inhalation	1020-13
0.00358 lb ai/gal

(2.75% ai x 2 oz product/gal water x 1 gal/128 oz x 8.34 lb/gal)

Food dispensing equipment (i.e. soft icecream machines, juice machines,
etc.)	CIP(cleaning)	ST and IT Handler: inhalation

	71094-1	0.00603 lb ai/gal

(3.6% ai x 0.67 lb product/4 gal water)

	CIP(sanitize)

	0.00302 lb ai/gal

(3.6% ai x 0.67 lb product/8 gal water)

Fruit and Vegetable washing	Immersion 	ST and IT Handler: inhalation
71695-1	0.00455 lb a.i./gal

(17.46 % a.i. x 2 oz/5 gal water x 1 gal/128 oz x 8.34 lb/gal)

	Trigger pump spray	ST and IT Handler: inhalation	71094-2	0.00300 lb
ai/gal

(0.036% ai x 8.34 lb/gal)

Commercial/Institutional and Industrial Premises and Equipment  (Use
Site Category III)

Indoor Hard Surfaces (includes walls, dishes and silverware, etc.)	Brush

Mechanical foam5	ST and IT Handler: inhalation	74210-12	0.0667 lb ai/gal

(25.6% ai x 4 oz product/gal water x 1 gal/128 oz x 8.34 lb/gal)

	Immersion

Low pressure sprayer

Trigger pump sprayer	ST and IT Handler: inhalation	74210-12	0.00334 lb
ai/gal

(25.6% ai x 2 oz product/10 gal water x 1 gal/128 oz x 8.34 lb/gal)

Shower Stalls/toilets	Mopping

Liquid\

pour/wiping 13	ST and IT Handler: inhalation	3635-279	0.0177 lb ai/gal

(15.52% ai x 1.75 oz/gal water x 1 gal/128 oz x 8.34 lb/gal)

All application rates for the soluble concentrate and ready-to-use
liquid products were calculated assuming the product has the same
density as water (8.34 lb/gal). 

This product can be used on food contact surfaces in industrial
premises.  

CIP treatment involves circulation/recirculation or flushing of the
treatment solution through a metered closed system.  

High pressure spray is assumed to be representative of a “coarse
droplet spray” per label # 833-75 and #875-184 which both state
“high pressure spray cleaning using a coarse droplet”.

Label Reg. # 74210-1 has language that states for manual cleaning (brush
or scrub), 1-2 ounces of product should be diluted with a gallon of
water. The label also has a general direction that the product is to be
used on all hard nonporous surfaces in industrial use sites.  The label
also has the direction for mechanical foam application listed as 4
ounces product/gallon of water is to be applied, “to surfaces by
manual procedures or by mechanical foam.”  It is assumed that
“manual procedures” is indicative of brush applications. 

Mechanical foam is listed for mineral film removal and regular foaming
is listed as a general cleaning instruction.  These methods are listed
on the same label with application specific use rates, which is why they
are both listed in the table.  However, for assessment purposes,
mechanical foam and regular foaming share the same unit exposure values.
 Also, the application rate for mechanical foam is higher than that for
regular foaming, so the mechanical foaming application is assumed
representative for the foaming application.

Label Reg. #1020-13 states that there is a cleaning step and a
sanitizing step, and there are different application rates for each of
these steps.  The label does not specify which method of application for
cleaning and sanitizing should follow each other (i.e. coarse spray
sanitizing followed by either coarse spray rinse or brush rinse). 
Because the cleaning and sanitizing step occur in the same time frame, a
total exposure effect will result.

Label Reg. #71094-1 states that there is a cleaning step and a
sanitizing step.  According to label #71094-1, the cleaning step
involves application of the product through brush, foam, wipe or low
pressure spray and the sanitizing step involves application of the
product through immersion, flooding, or spraying.  The label does not
specify which methods of cleaning and sanitizing steps should be used
jointly. Because the cleaning and sanitizing step occur in the same time
frame, a total exposure effect will result.  

Exposure to both the water soluble packing and ready-to-use formulation
were assessed.  Even though the water soluble packaging (0.67 lbs) has a
higher application rate, the unit exposure values for ready-to-use
products (liquid pour data) are higher.

Label Reg. #71094-2 states that there is a cleaning step and a
sanitizing step.  According to label #71094-2, the cleaning step
involves application of the product through sponge, brush, mesh, wipe or
low pressure spray and the sanitizing step involves application of the
product through immersion, flooding, or spraying. The label does not
specify which methods of cleaning and sanitizing steps should be used
jointly. Because the cleaning and sanitizing step occur in the same time
frame, a total exposure effect will result.

Coarse spraying, as directed on label #1020-13 is assumed to be
analogous with “coarse droplet spray” per labels # 833-75 and#
875-184 which states “high pressure spray cleaning using a coarse
droplet”.  As a result, unit exposures for this scenario use those
developed for high pressure spray.

The label Reg. # 65001-1 lists 1 ounce per 4 gallons of water for the
directed dilution.  This is equivalent to 200ppm.  The label states the
ppm concentration that can be allowed for the product to be 300 ppm. 
This value is equivalent to 1 ounce of product per 4 gallons of water
dilution, and this is the value that was used in the assessment.

The application listed on this label, Reg. #3635-279 involves squirting
approximately 1 ounce of the concentrate into the toilet bowl.  This
direct pour application was not assessed, because the majority of
handler inhalation exposure will be as a result of swabbing the toilet
bowl with the diluted mixture of the concentrate and toilet bowl water. 
Any inhalation exposure to the undiluted concentrate as a result of
directly squirting it into the toilet bowl water is assumed negligible. 



Table 7  Representative Exposure Scenarios Assessed for the Products
that Contain Sodium Dodecylbenzene Sulfonate as the Active Ingredient 

Representative Use	Registration #	Method of CLEANING Application	Method
of SANITIZING Application	Groups assessed 1

Food Handling/Storage Establishments Premises and Equipment (Use Site
Category II)

Indoor Hard Surfaces (includes dishes and silverware)	

1020-13	

High Pressure spray

Brush	

High Pressure spray

Brush	

High pressure spray with high pressure spray or brush

Brush with high pressure spray or brush

	

71094-1

	

 Low pressure spray 

Wiping  

Foam 

Brush	

Immersion 

Flooding 

Low pressure spray 	

Low pressure spray with immersion/flooding, or low pressure spray

Wiping with immersion/flooding, or low pressure spray

Foam with immersion/flooding, or low pressure spray

Brush with immersion/flooding, or low pressure spray

	

71094-2

	

Sponge/Mesh/Wiping 

Low Pressure Spray 

Brush	

Immersion 

Flooding 

Trigger Pump	

Sponge with immersion/flooding, or spraying

Low pressure spray with immersion/flooding, or spraying

Brush with immersion/flooding, or spraying

	1020-13	CIP 	CIP	Cleaning and sanitizing of food processing equipment.

Food dispensing equipment	71094-1	CIP	CIP	Involves automated circulation
of a solution in food dispensing equipment/vending machines, cleaning
and sanitizing steps

Fruit and Vegetable Washing	There are no separate steps for cleaning and
sanitizing for this use site, it only involves cleaning.

1: The groups that are listed are the different combinations of cleaning
and sanitizing methodologies that can subsequently occur.  These are the
combinations that are assessed in Table 9.

5.1	  Occupational Handler Exposures

	The occupational handler scenarios included in Tables 6 and 7 were
assessed to determine baseline inhalation exposures. The general
assumptions and equations that were used to calculate occupational
handler risks are provided in Appendix A.  The majority of the scenarios
were assessed using CMA data and Equations 1-3 in Appendix A. However,
for the occupational scenarios in which CMA data were insufficient,
other data and methods were applied.  The majority of the labels
assessed for this chapter indicate that PPE (gloves, protective
clothing, and goggles/face shield) are to be used.  At this time, there
is no dermal endpoint that has been calculated for this chemical. 
Because of this, there was no dermal assessment conducted.  

	There are also total MOEs that are presented in Table 8, which were
calculated because of the use direction found on the labels that contain
sodium dodecylbenzene sulfonate as the active ingredient. The scenarios
that are assessed in this table were extracted from Table 7.  The total
MOE was calculated using the following equation:

		Total MOE = 1 / ((1/MOEsanitizing) + (1/MOEcleaning))

	

Unit Exposure Values (UE): Inhalation unit exposure values were taken
from the proprietary Chemical Manufacturers Association (CMA)
antimicrobial exposure study (USEPA, 1999: DP Barcode D247642) or from
the Pesticide Handler Exposure Database (USEPA, 1998).  

For the low pressure handwand scenarios, the CMA inhalation unit
exposure value for the use of a low pressure spray was used, 0.681 mg/lb
a.i.  This value is based on data collected from eight replicates in
which the applicator hand sprayed carpet using 200 psi, then used a push
broom rake to raise the carpet nap.

For the high-pressure spray scenario, the occupational PHED inhalation
unit exposure value for liquid/open pour/high pressure spray were used.
The inhalation unit exposure value is 0.12 mg/lb a.i.

For the mopping scenarios, the CMA inhalation unit exposure value for
mopping was used, 2.38 mg/lb a.i.  This value is based on data collected
from six replicates in which the applicator mopped the floor and
received exposure via contact with the mop or with the bucket.

For the wiping scenario, the CMA inhalation unit exposure value for
wiping was used, 67.3 mg/lb a.i.  This value is based on data collected
from six replicates (dental technicians) who used a finger pump sprayer
to apply the product and then wiped the surfaces with a paper towel.

For the brush scenario, the occupational PHED inhalation unit exposure
value for paintbrush applications was used.  The inhalation exposure
value is 0.28 mg/lb a.i. 

For the trigger pump spray, foam, and mechanical foam scenarios, the
PHED inhalation unit exposure value for aerosol applications (PHED
scenario 10) was used.  The inhalation unit exposure is 1.3 mg/lb a.i.

For immersion, and flooding for the label that indicates that the
product is a water soluble packaging (Reg. # 71094-1), the PHED data for
use of a wettable powder/water soluble bag was used, and the value is,
0.00024 mg/lb a.i.

For immersion and flooding, in which soluble concentrate formulations
were used to prepare the solutions for these application methods, the
CMA  disinfectant liquid pour for disinfectants inhalation unit exposure
value was used.  The inhalation unit exposure value is 1.89 mg/lb a.i.
This value is based on data collected from two replicates pouring a
disinfectant product from a jug into sterilization trays designed for
dental instruments, adding water and instruments to the tray, removing
the instruments, and discarding the old solution.

For CIP (Cleaning in Place) for food processing equipment and food
dispensing equipment, CMA preservative gloved data for metered pumping
were used, and the inhalation UE is 0.000403 mg/lb a.i.  This value is
based on two replicates where the test subjects were wearing a single
layer of clothing and chemical resistant gloves.  This unit exposure
value was selected to be the most representative of CIP systems since
they are commonly found in large industrial manufacturing facilities,
and involves an automated cleaning and sanitizing processes.  The
directions associated with this use require the user to fill the system
with solution (the water-diluted concentrate) and then turn it on to
allow all surfaces to come into contact with the treatment solution.  

Quantity handled/treated: The quantity handled/treated values were
estimated based on information from various sources as well as label
language and input from the registrants.  The following assumptions were
made:

For the low-pressure handwand scenario, 10 gallons of solution are used
for agricultural uses (Exposure Policy #009) and AD’s standard
assumption is that 2 gallons are used in all other applications.	

For the high-pressure spray scenario, it was assumed that 40 gallons of
solution are used (Exposure Policy #009). 

For the mopping scenario, AD’s standard assumption is that 2 gallons
of solution are used in the food handling and
commercial/institutional/industrial setting.

For the wiping, brush, trigger pump spray, liquid pour, foam and
mechanical foam scenarios AD’s standard assumption is that 1 L (0.26
gallons) is used.

For the immersion and flooding scenarios, the quantities listed on the
label range from 1 gallon (i.e. label Reg. # 5389-12) up to 10 gallons
and appear to be either for fruit or vegetable cleaning/sanitizing 
These application methods are used interchangeably, such as on Reg. #
875-185, “To sanitize [e.g.: utensils]...by immersion, flooding, or
spraying...” AD’s standard assumption is that 10 gallons is the
amount used, and assumes that the quantities handled for immersion and
flooding are the same.  The way that the term “flooding” is used on
labels does not appear to indicate the flooding of large hard surfaces
in industrial plants.

For the CIP systems, it was assumed that the capacity of a CIP system is
10,000 gallons and is based on standard AD assumptions.

Duration of Exposure: Potential doses were calculated for the short- and
intermediate-term durations for occupational handlers.  The alkylbenzene
sulfonates have a low vapor pressure as indicated in Table 2,
Physical/Chemical Properties of Alkylbenzene Sulfonates (less than
10-9), so that any standing solutions that may result in post
application exposure were deemed negligible.  

Exposure Calculations and Results 			

	The calculated baseline inhalation doses and baseline MOEs for the
alkylbenzene sulfonates are shown in Table 8, and the total MOE
calculations for the labels that contain sodium dodecylbenzene sulfonate
are listed in Table 9.  The reason that a baseline inhalation assessment
was conducted was because of the use sites of the labels.  The Agency
believes it is not practicable, based on the product usage, that a
respirator can be required on the handler (e.g. janitorial services). 
In addition, engineering controls are not feasible for the current use
patterns on the labels.  All of MOEs in the occupational setting were
above the target MOE of 100 for inhalation and total exposures, except
for the following scenarios:

Handler Risk Summary for alkylbenzene sulfonates:

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

Total Exposure Summary for sodium dodecylbenzene sulfonate (results from
cleaning and sanitizing with the same product in the same time frame)

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.

Table 8: Short and Intermediate Term Risks Associated with Occupational
Handlers Using Products Containing Alkylbenzene Sulfonates

Exposure Scenario	Method of Application	Unit Exposure (mg/lb a.i.)	App.
Rate (lb ai/gal)	Quantity Handled/ Treated per day (gal)	

Daily Dose (mg/kg/day)a	Baseline MOEb

Inhalation

	Inhalation	Inhalation

(Target MOE = 100)

Agricultural Premises and Equipment (Use Site Category I)

Application to hard surfaces	Brush	0.28	0.0667	0.26	6.9x10-5	2,000

	Mechanical Foamc	1.3	0.0667	0.26	0.00032	430

	Flooding	1.89	0.00183	10	0.00049	280

	CIP	0.000403	0.00195	10,000	0.00011	1,200

	High Pressure spray	0.12	0.00326	40	0.00022	630

	Immersion	1.89	0.00334	10	0.0009	160

	Low pressure spray	0.681	0.00334	10	0.00032	430

	Trigger Pump Spray	1.3	0.00334	0.26	1.6x10-5	8,700

Food Handling (Use Site Category II)

Application to hard surfaces	Brush	0.28	0.0667	0.26	6.9x10-5	2,000

	Mechanical Foamc	1.3	0.0667	0.26	0.00032	430

	Brush (sanitize) d	0.28	0.0115	0.26	1.2x10-5	12,000

	Brush (Clean) d	0.28	0.0018	0.26	1.8x10-6	75,000

	Brush (clean) e	0.28	0.00603	0.26	6.3x10-6	22,000

	Brush (clean) f	0.28	0.003	0.26	3.1x10-6	45,000

	Foam (clean) e	1.3	0.00603	0.26	2.9x10-5	4,800

	Immersion	1.89	0.00334	10	0.0009	160

	Trigger Pump Spray	1.3	0.00334	0.26	1.6x10-5	8,700

	Low pressure spray (clean) e	0.681	0.00603	2	0.00012	1,200

	Low pressure spray (sanitize) e	0.681	0.00302	2	5.9x10-5	2,400

	Low pressure spray (clean) f	0.681	0.003	2	5.8x10-5	2,400

	Trigger pump (sanitize) f	1.3	0.003	0.26	1.4x10-5	9,700

	High pressure spray (sanitize) d	0.12	0.0115	40	0.00079	180

	High pressure spray (Clean) d	0.12	0.0018	40	0.00012	1,100

	Immersion, flooding for WSP (sanitize) e,g	0.00024	0.00302	10	1.0x10-7
1.4x106

	Immersion, flooding for RTU (sanitize) f,g	1.89	0.0030	10	0.00081	170

	Mopping	2.38	0.00244	2	0.00017	840

	Wiping (clean) e	67.3	0.00603	0.26	0.0015	93

	Sponge/mesh wipe (clean) f	67.3	0.003	0.26	0.00075	190

	CIP (clean and sanitize) d, h	0.000403	0.00358	10,000	0.00021	680

Food dispensing equipment	CIP (clean) e	0.000403	0.00603	10,000	0.00035
400

	CIP (sanitize) e	0.000403	0.00302	10,000	0.00017	810

Fruits and vegetables	Immersion	1.89	0.00455	10	0.0012	110

	Trigger pump spray 	1.3	0.003	0.26	1.4x10-5	9,700

Commercial/Institutional Premises (Use Site Category III )

Application to hard surfaces (includes utensils and silverware)	Brush
0.28	0.0667	0.26	6.9x10-5	2,000

	Mechanical Foamc	1.3	0.0667	0.26	0.00032	430

	Immersion	1.89	0.00334	10	0.0009	160

	Low Pressure spray	0.681	0.00334	2	6.5x10-5	2,200

	Trigger Pump Spray	1.3	0.00334	0.26	1.6x10-5	8,700

Shower stalls and toilets	Mopping	2.38	0.0177	2	0.0012	120

	Swabbing after a liquid pouri	1.89	0.0177	0.26	0.00012	1,100

	ST = short-term, IT = intermediate-term

	a	Daily dose (mg/kg/day) = [unit exposure (mg/lb ai) * absorption (1.0
for ST/IT inhalation) * application rate (lb ai/gal) * quantity treated
(gal) / Body weight (70 kg).

	b	MOE = NOAEL  (mg/kg/day) / Daily Dose, where NOAEL = 0.14 mg/kg/day.

	c	Represents foam and mechanical foam because it has the highest
application rate of the two.  Foam and mechanical foaming are assumed to
share the same unit exposure values.

	d	These uses are assessed based on the rates found on label Reg. #
1020-13, and the active ingredient is sodium

		dodecylbenzene sulfonate.

	e	These uses are assessed based on the rates found on label Reg. #
71094-1 (WSP), and the active ingredient is 

		sodium dodecylbenzene sulfonate.

	f	These uses are assessed based on the rates found on label Reg. #
71094-2 and the active ingredient is sodium dodecylbenzene sulfonate.

	g	Exposure to both the water soluble packing (WSP) and ready-to-use
(RTU) formulation were assessed.  Even though the water soluble
packaging has a higher 	application 	rate, the unit exposure values for
ready-to-use, which is represented by liquid pour, are higher.

	h	CIP is carried out two times in the same time frame, and the first
step is considered a cleaning, in which drainage occurs, and then the
second step is for sanitation.

	i. 	Although the liquid pour involves a squirt of an ounce of
concentrated product into a toilet bowl it is assumed that the dilution
that results form mixing the ounce of product

	with a toilet bowl full of water will result in exposure to the diluted
mixture of water and sulfonate product.  The exposure to the concentrate
is assumed to be negligible

	because of the extremely small time duration that squirting one ounce
can occur for.Table 9 (derived from the combinations of cleaning and
sanitizing steps outlined in Table 7) presents the total baseline MOE
calculations, which presents the risk to occupational handlers that use
products that contain sodium dodecylbenzene sulfonate as the active
ingredient.  These handful of labels that contain this active ingredient
are unique to this RED because they direct the user to both clean and
sanitize in the same time frame with the same product.  The
parenthetical numbers are a reiteration of the MOEs calculated and then
presented in Table 8, and then the total MOE was calculated using the
following equation:

Total MOE = 1 / ((1/MOEsanitizing) + (1/MOEcleaning))

Table 9  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	Method
of SANITIZING Application	Total Baseline Inhalation MOE (Target MOE =
100)

Food Handling/Storage Establishments Premises and Equipment (Use Site
Category II)

Indoor Hard Surfaces (includes dishes and silverware, food processing
equipment, etc.)	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)	2,200

	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

 

	5.2  	Occupational Post-application Exposures

Occupational inhalation post-application exposures are presumed to be
negligible because of the low vapor pressure of the alkylbenzene
sulfonates.

	5.3	Data Limitations/Uncertainties tc \l2 "6.3	Data
Limitations/Uncertainties 

	There are several data limitations and uncertainties associated with
the occupational handler exposure assessment.  These include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix A for summaries of
these data sources).   Since the CMA data are of poor quality, the
Agency requests that confirmatory data be submitted to support the
occupational scenarios assessed in this document.

The quantities handled/treated were estimated based on information from
various sources, including HED’s Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA 2000, and 2001) and the AD
Draft SOP use table.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined with input from
registrants. 

The aerosol can unit exposure data from PHED were used to assess
application to hard surfaces by foam.  The aerosol can scenario may not
be representative of foam application, however, for lack of better data,
these values were used.

6.0	REFERENCES tc \l1 "7.0	REFERENCES 

USEPA.  1997.  Standard Operating Procedures (SOPs) for Residential
Exposure Assessments.  EPA Office of Pesticide Programs(Human Health
Effects Division (HED). Dated December 18, 1997.

USEPA.  1997a.  Exposure Factors Handbook. Volume I-II.  Office of
Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1.   Washington,
DC:  U.S. Environmental Protection Agency.

USEPA.  1999.  Evaluation of Chemical Manufacturers Association
Antimicrobial Exposure Assessment Study.  Memorandum from Siroos
Mostaghimi, Ph.D., USEPA, to Julie Fairfax, 

USEPA.  2000.  Residential SOPs.  EPA Office of Pesticide Programs(Human
Health Effects Division. Dated April 5, 2000.

USEPA.  2001.  HED Science Advisory Council for Exposure. Policy Update,
November 12.  Recommended Revisions to the Standard Operating Procedures
(SOPs) for Residential Exposure Assessment, February 22, 2001. 

	

APPENDIX A: EQUATIONS AND DEFNITIONS FOR CALCULATING MOES

Daily Exposure: Daily dermal or inhalation handler exposures are
estimated for each applicable handler task with the application rate,
quantity treated/handled in a day, and the applicable dermal or
inhalation unit exposure using the following formula:

Daily Exposure:	E = UE x AR x AT						(Eq. 1)

Where:  

E	=	Amount (mg ai/day) deposited on the surface of the skin that is
available for dermal absorption or amount inhaled that is available for
inhalation absorption;

UE	=	Unit exposure value (mg ai/lb ai) derived from August 1998 PHED
data or from 1992 CMA data;

AR	=	Maximum application rate based on a logical unit treatment, such as
acres (A), square feet (sq. ft.), gallons (gal), or cubic feet (cu. ft).
Maximum values are generally used (lb ai/A, lb ai/sq ft, lb ai/gal, lb
ai/cu ft); and

AT 	=	Normalized application area based on a logical unit treatment such
as acres (A/day), square feet  (sq ft/day), gallons (gal/day), or cubic
feet (cu ft/day).

Daily Dose: The daily dermal or inhalation dose is calculated by
normalizing the daily exposure by body weight and adjusting, if
necessary, with an appropriate absorption factor.  An absorption factor
of 100% was used for both dermal and inhalation exposures.  Daily dose
was calculated using the following formula:

Daily Dose:	ADD = E x ABS							(Eq. 2)

			   BW						

Where:

ADD 		= 	Absorbed dose received from exposure to a chemical in a given
scenario (mg active ingredient/kg body weight/day);

E 		=	Amount (mg ai/day) deposited on the surface of the skin that is
available for dermal absorption or amount inhaled that is available for
inhalation absorption;

ABS 		= 	A measure of the amount of chemical that crosses a biological
boundary such as lungs (% of the total available absorbed); and

BW		= 	Body weight determined to represent the population of interest in
a risk assessment (kg).

Margins of Exposure:  Non-cancer inhalation and dermal risks for each
applicable handler scenario are calculated using a Margin of Exposure
(MOE), which is a ratio of the daily dose to the toxicological endpoint
of concern.

Margins of Exposure:	MOE = NOAEL or LOAEL					(Eq. 3)

					ADD

Where:

MOE 			= 	Margin of exposure, value used to represent risk or how close
a chemical exposure is to being a concern (unitless);

NOAEL or LOAEL	= 	Dose level in a toxicity study, where no observed
adverse effects (NOAEL) or where the lowest observed adverse effects
(LOAEL) occurred in the study; and

ADD 			= 	Average daily dose or the absorbed dose received from exposure
to a chemical in a given scenario (mg ai/kg body weight/day).

APPENDIX B: Summary of CMA and PHED Data tc \l1 "APPENDIX A: Summary of
CMA data and PHED 

The scenarios were assessed by using unit exposure data to estimate
occupational handlers’ exposures. Unit exposures are estimates of the
amount of exposure to an active ingredient a handler receives while
performing various handler tasks and are expressed in terms of
micrograms or milligrams (1mg = 1,000 µg) of active ingredient per
pounds of active ingredient handled.  A series of unit exposures have
been developed that are unique for each scenario typically considered in
assessments (i.e., there are different unit exposures for different
types of application equipment, job functions, and levels of
protection).  The unit exposure concept has been established in the
scientific literature and also through various exposure monitoring
guidelines published by the USEPA and international organizations such
as Health Canada and OECD (Organization for Economic Cooperation and
Development).

Chemical Manufacturers Association (CMA) Data:

In response to an EPA Data Call-In Notice, a study was undertaken by the
Institute of Agricultural Medicine and Occupational Health of The
University of Iowa under contract to the Chemical Manufacturers
Association.  In order to meet the requirements of Subdivision U of the
Pesticide Assessment Guidelines (superseded by  Series 875.1000-875.1600
of the Pesticide Assessment Guidelines), handler exposure data are
required from the chemical manufacturer specifically registering the
antimicrobial pesticide.   The applicator exposure study must comply
with the assessment guidelines for (Applicator Exposure Monitoring( in
Subdivision U and the (Occupational and Residential Exposure Test
Guidelines( in Series 875.  For this purpose, CMA submitted a study on
28 February, 1990, entitled "Antimicrobial Exposure Assessment Study
(amended on December 8, 1992)" which was conducted by William Popendorf,
et al.  It was evaluated and accepted by Occupational and Residential
Exposure Branch (OREB) of Health Effect Division (HED), Office of
Pesticides Program (OPP) of EPA in 1990.  The purpose of this CMA study
was to characterize exposure to antimicrobial chemicals in order to
support pesticide reregistrations (CMA, 1992).  The unit exposures
presented in the most recent EPA evaluation of the CMA database (USEPA,
1999) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic
requirements of Subdivision U - Applicator Exposure Monitoring.  The
advantages of CMA data over other (surrogate data sets( is that the
chemicals and the job functions of mixer/loader/applicator were defined
based on common application methods used for antimicrobial pesticides. 
A few of the deficiencies in the CMA data are noted below:

The inhalation concentrations were typically below the detection limits,
so the unit exposures for the inhalation exposure route could not be
accurately calculated. 

QA/QC problems including lack of either/or field fortification,
laboratory recoveries, and storage stability information.

Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database (PHED):

The Pesticide Handlers Exposure Database (PHED) has been developed by a
Task Force consisting of representatives from Health Canada, the U.S.
Environmental Protection Agency (EPA), and the American Crop Protection
Association (ACPA).  PHED provides generic pesticide worker (i.e.,
mixer/loader and applicator) exposure estimates.  The dermal and
inhalation exposure estimates generated by PHED are based on actual
field monitoring data, which are reported generically (i.e., chemical
specific names not reported) in PHED.  It has been the Agency’s policy
to use surrogate or generic exposure data for pesticide applicators in
certain circumstances because it is believed that the physical
parameters (e.g., packaging type) or application technique (e.g.,
aerosol can), not the chemical properties of the pesticide, attribute to
exposure levels. [Note: Vapor pressures for the chemicals in PHED are in
the range of E-5 to E-7 mm Hg.]  Chemical specific properties are
accounted for by correcting the exposure data for study specific field
and laboratory recovery values as specified by the PHED grading
criteria.

PHED handler exposure data are generally provided on a normalized basis
for use in exposure assessments.  The most common method for normalizing
exposure is by pounds of active ingredient (ai) handled per replicate
(i.e., exposure in mg per replicate is divided by the amount of ai
handled in that particular replicate).  These unit exposures are
expressed as mg/lb ai handled.  This normalization method presumes that
dermal and inhalation exposures are linear based on the amount of active
ingredient handled.	

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