1
of
10
MEMORANDUM
Date:
3/
23/
2006
SUBJECT:
Dietary
Risk
Assessment
for
Alkylbenzene
Sulfonates
REVIEWER:
Robert
Quick,
Chemist
Risk
Assessment
&
Science
Support
Branch
Antimicrobials
Division
(
7510C)

THROUGH:
Norm
Cook,
Chief
Risk
Assessment
&
Science
Support
Branch
Antimicrobials
Division
(
7510C)

TO:
Heather
Garvie,
Chemical
Review
Manager
Regulatory
Management
Branch
Antimicrobials
Division
(
7510C)

PC
CODES:
079010
Sodium
dodecylbenzene
sulfonic
acid
098002
Dodecylbenzene
sulfonic
acid
190116
C10­
16­
Alkylbenzene
sulfonic
acid
DP
BARCODES:
D327731
DECISION
#:
362580
2
of
10
Alkylbenzene
Sulfonate
Dietary
Exposure
The
Registration
Elgibility
Document
(
RED)
covers
the
potential
dietary
exposure
to
the
active
ingredient(
s)
sodium
dodecylbenzene
sulfonate,
dodecylbenzene
sulfonate
and
benzene
sulfonic
acid.
This
RED
does
not
address
the
dietary
exposure
that
will
result
from
the
use
of
products
containing
these
chemicals
as
inert
ingredients.
Chemicals
classed
as
any
of
these
chemicals
are
being
considered
together
because
chemicals
named
dodecylbenzene
sulfonate
actually
contain
alkylbenzene
sulfonates
in
addition
to
dodecylbenzene
sulfonate.
Labeling
modifications
will
be
made
to
these
chemicals
as
a
result
of
the
reregistration
process.

The
uses
for
these
chemicals
include:
(
1),
food
handling/
storage
establishments,
premises
and
equipment;
(
2)
agricultural
premises
and
equipment;
and
(
3)
fruit
and
vegetable
rinses.

The
21
CFR
178.1010
Regulation
for
sanitizing
solutions
read:

Dodecylbenzene
sulfonate:
178.1010(
b)(
7)
and
178.1010(
c)(
5).
The
site
reads:
"
In
addition
to
use
on
food­
processing
equipment
and
utensils,
this
solution
may
be
used
on
glass
bottles
and
other
glass
containers
intended
for
holding
milk".
The
use
limitation
for
the
chemical
is
400
ppm.

Dodecylbenzene
sulfonic
acid:
178.1010
(
b)(
10)
and
178.1010
(
c)(
7).
The
site
reads:
"
In
addition
to
use
on
food­
processing
equipment
and
utensils,
this
solution
may
be
used
on
beverage
containers
except
milk
containers
or
equipment".
The
use
limitation
is
400
ppm.

Sodium
dodecylbenzenesulfonate:
178.1010(
b)(
21)
and
178.1010(
c)(
16).
The
site
reads,
"
In
addition
to
use
on
food
processing
equipment
and
utensils
this
solution
can
be
used
on
glass
bottles
and
other
glass
containers
intended
for
holding
milk".
The
use
limitation
is
430
ppm
equivalent
to
~
400ppm
of
the
free
acid.

Dodecylbenzene
sulfonic
acid;
178.1010(
b)(
40)
and
178.1010(
c)(
35).
The
site
reads:
"
In
addition
to
use
on
food­
processing
equipment
and
utensils,
this
solution
may
be
used
on
dairy
processing
equipment".
The
use
limitation
is
5.5
ppm.

It
appears
that
dodecylbenzenesulfonic
acid
solutions
containing
up
to
400
ppm
can
be
used
on
glass
bottles
and
containers
containing
milk
but
cannot
be
used
on
dairy
processing
equipment
at
this
level.
The
registrant
and
user
may
have
difficulty
in
distinguishing
between
glass­
lined
equipment
and
glass
containers.
3
of
10
These
21
CFR
citations
do
not
specifically
state
that
the
solutions
may
be
used
on
food
contact
articles
including
dishes,
pots
and
pans,
glasses
etc.
However,
there
are
many
labels
registered
for
use
on
these
sites.

The
40
CFR
180
Regulation
reads:

Tolerance
Exemption
Expression/
Chemical
Name
CAS
No.
PC
Code
40
CFR
180.
Use
Pattern
(
Pesticidal)
Active
Products
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
Benzenesulfon
ic
acid,
dodecyl­
27176­
87­
0
098002
940
(
c)
food
contact
sanitizing
solutions
for
food
processing
equipment
and
utensils;
end
use
concentration
not
to
exceed
400
ppm
18
Benzenesulfon
ic
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
3
The
RMB
II
Chemical
Review
Manager
should
ascertain
the
correct
use
sites
and
limitations
for
these
chemicals.

Many
of
the
labels
include
uses
for
the
sanitization
of
food
serving
equipment,
glasses,
dishes,
utensils
and
pots
and
pans.
These
surfaces
that
have
been
treated
with
the
dodecylbenzene
sulfonate
products
may
bear
small
residues
of
the
dodecylbenzene
sulfonate
Residues
from
treated
surfaces
can
migrate
to
food
coming
into
contact
with
the
treated
surfaces
and
can
be
ingested
by
humans.

The
maximum
label
rates
for
the
dodecylbenzene
sulfonates
are
400
ppm
for
use
in
antimicrobial
formulations
(
Food
contact
surface
sanitizing
solutions).

The
maximum
rate
for
dodecylbenzene
sulfonates
in
sanitizer
end­
use
solutions
is
400
ppm
except
for
dairy
processing
equipment.
Uses
on
food
processing
equipment
are
discussed
below
under
"
Food
Processing
Industry".
4
of
10
FOOD
CONTACT
SURFACES
IN
THE
FOOD
SERVICE
INDUSTRY
AD
will
use
the
400
ppm
level
permitted
in
an
end
use
solution
in
our
calculations.

In
the
absence
of
residue
data
for
residues
of
dodecylbenzene
sulfonate
on
treated
food
contact
surfaces
reflecting
the
registered
use
patterns,
the
Agency
can
calculate
residue
levels
that
may
occur
in
food
from
the
application
rates
on
food
contact
surfaces.

To
estimate
the
Estimated
Daily
Intake
(
EDI),
the
Agency
has
used
the
following
model
calculation.
This
model
is
taken
from
FDA
Guidelines.

The
maximum
ingredient
percentage
for
dodecylbenzene
sulfonates
registered
for
use
in
food
handling
establishments
in
kitchens,
cafeterias,
supermarkets
and
meat
and
poultry
plants
is
400
ppm).

EDI
=
(
1
mg/
cm2)
x
wt.
fraction
of
wash
solution
(
AR)
x
SA
x
FMF/
BW
Where:
AR
=
Application
rate
SA
=
surface
to
which
food
is
exposed,
assume
4000
cm2
FMF
=
Fraction
of
pesticide
migrating
to
food,
assume
100%*
BW
=
70
for
male
adults,
60
kg
for
female
adults
and
15
kg
for
children
EDI
from
the
FDA
model
=
400
µ
g/
1000
mg
(
ppm)
x
1.0
mg/
cm2
x
4000
cm2
/
person/
day
=
1600
µ
g
dodecylbenzene
sulfonate/
person/
day
Assuming
that
an
average
adult
consumes
3000
gm
of
food
per
day,

Then
1600
µ
g
a.
i./
3000
gm
food
=
0.
53
µ
g
a.
i./
gm
(
ppm)
of
food
This
calculation
reduces
the
dietary
consumption
to
µ
g
of
a.
i.
per
gm
of
food.

Assume
that
an
adult
consumes
3000
gm
of
food
/
day
1600
µ
g
a.
i./
70
kg
BW
=
22.9
µ
g
dodecylbenzene
sulfonate/
kg/
day
for
a
male
adult
1600
µ
g
a.
i./
60
kg
BW
=
26.7
µ
g
dodecylbenzene
sulfonate/
kg/
day
for
a
female
adult
Assuming
that
a
child
consumes
1500
gm
of
food
per
day,
Then:
0.
53
µ
g
a.
i./
gm
(
ppm)
of
food
x
1500
=
795
µ
g
a.
i./
day
800
µ
g
a.
i./
15
kg
BW
=
53
µ
g
dodecylbenzene
sulfonate/
kg/
day
for
child
5
of
10
FOOD
CONTACT
SURFACES
IN
THE
FOOD
PROCESSING
INDUSTRY
The
21
CFR
178.1010
Regulations
and
the
40
CFR
940
Regulations
do
not
specifically
permit
the
use
on
milk
processing
equipment
at
a
level
of
400
ppm.

However,
the
labels
include
uses
for
the
sanitization
of
food
processing
equipment
such
as
tanks,
pipelines,
evaporators,
filters,
pasteurizers,
aseptic
equipment
including
dairies,
wineries,
breweries
and
beverage
plants,
meat
and
poultry
processing/
packing
plants,
milk
and
dairy
products
/
packing
plants,
seafood
and
vegetable
processing/
packing
plants,
food
processing/
packing
plants
and
egg
processing/
packing
equipment
surfaces.
These
uses
would
permit
the
sanitization
of
the
interior
of
food
processing
and
storage
equipment.

This
use
could
be
additive
to
the
treatment
of
food
contact
surfaces
such
as
glasses,
dishes,
utensils
and
pots
and
pans.

AD
will
use
an
FDA
model
to
estimate
residues
that
could
transfer
from
treated
surfaces
to
food
from
this
type
of
use.

According
to
the
FDA,
the
exposure
estimates
for
this
type
of
use
can
be
calculated
using
the
milk
truck
model
that
is
described
in
the
FDA
document,
"
Sanitizing
Solutions:
Chemistry
Guidelines
For
Food
Additive
Petitions",
pages
9­
10.

This
guidance
states
on
page
9,
"
For
applications
limited
to
use
of
the
food
sanitizer
on
food
processing
equipment
and
utensils,
the
Agency
has
determined
that
estimates
of
sanitary
exposure
from
use
in
dairy
processing
plants
significantly
exceed
estimates
based
on
other
uses
with
food
processing
equipment
and
utensils.
Depending
on
the
available
safety
data,
the
petitioner
may
either
submit
a
petition
for
the
broader
use
of
its
sanitizer
on
"
food
processing
equipment
and
utensils
including
dairy
processing
plants"
or
for
the
more
limited
use
on
"
food
processing
equipment
and
utensils
excepting
use
in
dairy
processing
plants."

The
next
paragraph
of
the
document
states,
"
The
following
simplified
example
will
illustrate
the
calculation
of
the
EDI
of
residual
sanitizer
solution
in
milk
from
sanitizer
use
in
a
dairy
processing
plant.
Although
in
practice
consideration
of
all
of
the
components
of
a
milk
handling
system
must
be
included
as
sources
of
sanitizer
residue
in
milk,
for
this
example
the
only
source
is
assumed
to
be
a
sanitized
tank
truck
to
transport
the
milk.
It
is
further
assumed
that
the
milk
undergoes
no
additional
dilution
prior
to
reaching
the
consumer.
Assuming
a
cylindrical
model
for
the
tank
truck
(
4000
gallon
capacity)
with
a
length
of
19.9
feet
and
cross­
sectional
diameter
of
6
feet,
and
an
internal
surface
area
of
413
sq
ft
is
calculated
for
the
tank.
Assuming
that
the
sanitizer
treatment
leaves
a
residue
of
1
mg/
sq
cm
and
the
`
at
use'
concentration
of
component
X
is
200
ppm,
the
concentration
of
X
in
the
milk
residing
in
the
tank
would
equal:
6
of
10
413
sq
ft/
1
truck
x
1truck/
4000gal
x
1
mg/
sq
cm
x
200
µ
g/
1000
mg
x
929
sq
cm/
1
sq
ft
x
0.264
gal/
1L
=
5.1
µ
g
x/
L
milk
~
5.1
ppb".

The
maximum
application
rate
for
the
dodecylbenzene
sulfonate
chemicals
in
food
processing
equipment
is
400
ppm.

Then
using
the
FDA
model,
residues
resulting
in
milk
from
the
use
would
be
calculated
as:

413
sq
ft/
1
truck
x
1truck/
4000gal
x
1
mg/
sq
cm
x
400
µ
g/
1000
mg
x
929
sq
cm/
1
sq
ft
x
0.264
gal/
1L
=
5.1
µ
g
x/
L
milk
~
10.1
ppb.

If
an
adult
were
to
consume
3000
gm
of
food
per
day
containing
10.1
µ
g/
L
or
10.1
µ
g/
kg
(
1000
gm),
then
the
person
would
ingest
30.4
µ
g
of
dodecylbenzene
sulfonate
per
day.

A
child
consuming
1500
gm
of
food
per
day
would
consume
would
ingest
15.2
µ
g
of
dodecylbenzene
sulfonate
per
day.

DIETARY
EXPOSURE
ASSESSMENT
FOR
THE
FOOD
SERVICE
AND
FOOD
PROCESSING
INDUSTRIES
TABLE
1
Cumulative
Estimated
Dietary
Intake
of
LAS
Use
Dietary
Conc.
(
ppb)
Estimated
Daily
Intake
(
µ
g/
person/
day)
Daily
Dietary
Dose
(
mg/
kg
bw/
day)
Food
Service
Industry
0.53
ppb
1600
(
adult
M)
1600
(
adult
F)
800
(
child)
0.023
(
adult
M)
0.027
(
adult
F)
0.053
(
child)
Food
Processing
Industry
10.1
ppb
30.3
(
adult
M)
30.3
(
adult
F)
15.1
(
child)
0.00043
(
adult
M)
0.00050
(
adult
F)
0.001
(
child)
Cumulative
12.6
ppb
1630.3
(
adult
M)
1630.3
(
adult
F)
815.1
(
child)
0.023
(
adult
M)
0.027
(
adult
F)
0.054(
child)

There
were
no
effects
attributable
to
a
single
dose
for
the
acute
dietary
risk
(
Deborah
Smegal
memo.

Utilizing
the
chronic
RfD
or
cPAD
of
0.5
mg/
kg/
day
taken
from
the
Deborah
Smegal
memo,
the
dietary
risks
were
estimated
in
Table
2
below.

%
PAD
=
exposure/
PAD
x
100
7
of
10
TABLE
2
Dietary
Risks
of
LAS
USE
DAILY
DIETARY
DOSE
(
mg/
kg
bw/
day)
%
aPAD
%
cPAD
Food
Service
Industry
0.023
(
adult
M)
0.027
(
adult
F)
0.053
(
child)
No
effects
No
effects
No
effects
4.6%
5.4%
10.6%
Food
Processing
Industry
0.00043(
adult
M)
0.00050
(
adult
F)
0.001
(
child)
No
effects
No
effects
No
effects
0.086%
0.1%
0.2%
Cumulative
0.0234(
adult
M)
0.0275(
adult
F)
0.054(
child)
No
effects
No
effects
No
effects
4.69%
5.5%
10.8%

The
food
service
and
food
processing
industry
uses
do
not
result
in
dietary
risks
of
concern.

FRUIT
AND
VEGETABLE
WASH
The
label,
CS­
100
Acid
Anionic
Sanitizer,
EPA
Reg.
#
71695­
1,
bears
a
use
for
washing
fruits
and
vegetables.

The
FDA
Regulation,
21
CFR
173.315,
permits
this
use
provided
that
the
wash
solution
does
not
contain
dodecylbenzene
sulfonic
acid
at
a
level
greater
than
0.2%.
No
potable
water
rinse
is
required
by
the
Regulation.
We
presume
that
the
use
limitation
is
for
the
parent
chemical
because
the
Regulation
makes
no
mention
of
formulations.
The
use
limitation
states,
"
Not
to
exceed
0.2%
in
wash
water.
May
be
used
in
washing
or
to
assist
in
the
lye
peeling
of
fruits
and
vegetables".
Note:
If
the
use
limitation
were
intended
to
apply
to
a
formulation,
there
would
be
a
broad
range
of
application
rates
depending
on
the
concentration
of
the
chemical
in
the
formulation.

The
label
bears
a
use
that
provides
for
a
fruit
and
vegetable
wash
with
a
solution
containing
0.16
%
dodecylbenzene
sulfonic
acid,
without
a
potable
water
rinse.

The
label
also
bears
a
use
a
use
that
provides
for
a
fruit
and
vegetable
wash
with
a
solution
containing
0.31%
dodecylbenzene
sulfonic
acid,
with
a
potable
water
rinse.

There
are
no
data
to
show
that
the
level
of
residues
on
fruits
and
vegetables
would
be
reduced
to
the
level
that
would
have
occurred
from
a
0.2%
wash.
However,
AD
concludes
that
dodecylbenzene
sulfonic
acid
residues
would
be
significantly
reduced
by
the
potable
water
rinse
and
would
be
less
than
residues
resulting
from
the
0.2%
wash.

There
are
no
residue
data
to
show
the
level
of
dodecylbenzene
sulfonic
acid
that
will
result
on
fruits
and
vegetables
from
the
0.2%
wash
solution
with
a
potable
water
rinse.
8
of
10
Lacking
residue
data
to
show
the
level
of
residues
expected
on
fruits
and
vegetables,
we
have
calculated
the
level
of
residues
on
fruits
and
vegetables
using
the
following
model.

Dodecylbenzene
sulfonate
Fruit
and
Vegetable
Wash
Dietary
Residue
Calculations:

Calculation
for
percent
dodecylbenzene
sulfonate
in
the
wash
water:

The
maximum
use
rate
is
2000
ppm
of
dodecylbenzene
sulfonate
(
0.2%
x
10,000)
for
fruit
and
vegetables.

We
will
use
the
surface
area
and
weight
of
Thompson
Seedless
grapes
to
calculate
residues
in
fruits
and
vegetables.
This
is
a
small
grape
which
accounts
for
half
of
the
table
grapes
grown
in
California
and
is
used
to
make
over
90%
of
the
grapes
grown
in
the
United
States.

Grapes
specifications:
Diameter
of
one
grape
=
16
mm
(
Source:
University
of
California
Cooperative
Extension,
Tulare
County
http://
cetulare.
ucdavis.
edu/
pubgrape/
tb195.
htm
Mass
of
one
grape
=
4.0
gm
or
0.0040
kg
(
Source:
University
of
California
Cooperative
Extension,
Tulare
County
http://
cetulare.
ucdavis.
edu/
pubgrape/
tb195.
htm
)

Surface
area
of
one
grape
=
15.88
cm2
Based
on
surface
area
of
a
sphere
where
A
=
4 r2
(
where
r
=
8
mm)
A
=
4
x
3.14
x
(
8
mm)
2
A
=
803.8
mm2
A
=
8.04
cm2
Amount
of
Residue
on
Grapes:
Assume
the
film
thickness
of
the
solution
on
the
surface
of
the
grape
is
0.0023
g/
cm2
(
Source:
Proctor
and
Gamble
exposure
assessment
for
ingestion
of
dishwashing
product
residues
­
based
on
the
amt
of
rinse
water
in
contact
with
dishware
surfaces
http://
www.
scienceinthebox.
com/
en_
UK/
safety/
ingestionfromsurface_
en.
html)

0.0023
g/
cm2
x
8.04
cm2
x
0.002
(
0.2%)
dodecylbenzene
sulfonate
=
0.0000369
gm
or
0.037
mg
dodecylbenzenesulfonate
0.037
mg
dodecylbenzene
sulfonate/
0.004
kg
grape
=
9.25
mg/
kg
or
ppm
DIETARY
EXPOSURE
ASSESSMENT
FOR
THE
FRUIT
AND
VEGETABLE
WASH
9
of
10
This
part
of
the
non­
cancer
dietary
risk
assessment
was
carried
out
by
Cassi
Walls
(
RASSB/
AD).
It
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMFDIC
 
)
,
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%
crop
treatment)
and
uses
the
deterministic
approach.
As
input
parameters
for
modeling
analyses,
the
level
of
9.25
ppm
was
used
based
on
the
modeling
discussed
above.

TABLE
3
Dietary
Risk
for
Fruit
and
Vegetable
Wash
USE
DAILY
DIETARY
DOSE
(
mg/
kg
bw/
day)
%
aPAD
%
cPAD
Fruit
and
Vegetable
Wash
0.0979
(
U.
S.
Pop.)
0.2793
(
child
1­
6)
0.3558
(
child
1­
2)
0.2573
(
child
3­
5)
No
Effects
No
Effects
No
Effects
No
Effects
19.6%
55.9%
71.2%
51.5%

Dietary
risks
were
calculated
in
the
above
table
for
the
U.
S.
general
population
and
for
those
groups
exposed
to
the
highest
risk.
The
chronic
analyses
were
below
the
Agency's
level
of
concern
for
all
of
the
Population
Subgroups
using
the
Agency
DEEM.
The
most
highly
exposed
group
was
children
1­
2
years
old
with
71.2%
of
the
cPAD).

These
residue
calculations
provide
an
acceptable
dietary
risk
of
concern
for
population
subgroups
for
this
chemical.

Issues
That
Must
Be
Resolved
I.
For
the
40
CFR
180.940
Regulations
for
sanitizing
solutions:

Many
of
the
labels
include
uses
for
the
sanitization
of
food
serving
equipment,
glasses,
dishes,
utensils
and
pots
and
pans.
These
surfaces
that
have
been
treated
with
the
dodecylbenzene
sulfonate
products
may
bear
small
residues
of
the
dodecylbenzene
sulfonate
Residues
from
treated
surfaces
can
migrate
to
food
coming
into
contact
with
the
treated
surfaces
and
can
be
ingested
by
humans.

Benzenesulfonic
acid,
dodecyl­:
40
CFR
180.940(
c)
The
site
reads:
"
Food­
processing
equipment
and
utensils".
The
use
limitation
is
400
ppm.

Benzenesulfonic
acid
dodecyl­,
sodium
salt:
40
CFR
180.940(
c)
The
site
reads,
"
Food
processing
equipment
and
utensils".
The
use
limitation
is
430
ppm
equivalent
to
~
400ppm
of
the
free
acid.
10
of
10
Benzenesulfonic
acid,
dodecyl­
:
40
CFR
180.940(
b)
The
site
reads:
"
Dairy
processing
equipment,
and
food
processing
equipment
and
utensils".
The
use
limitation
is
5.5
ppm.

It
appears
that
dodecylbenzenesulfonic
acid
solutions
containing
up
to
400
ppm
can
be
used
on
dairy
processing
equipment
and
food
processing
equipment.
The
registrant
and
user
may
have
difficulty
in
distinguishing
between
food
processing
equipment
and
dairy
processing
equipment.
Many
labels
bear
use
directions
with
a
treatment
rate
of
greater
than
5.5
ppm
for
dairy
processing
equipment.

Also,
these
40
CFR
citations
also
do
not
specifically
state
that
the
solutions
may
be
used
on
food
contact
articles
including
dishes,
pots
and
pans,
glasses
etc.
However,
there
are
many
labels
registered
for
use
on
these
sites.

The
Chemical
Review
Manager
should
ascertain
the
correct
use
sites
and
limitations
for
these
chemicals.
