Document ID: EPA-HQ-OPP-2005-0261-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
30,
2005
Memorandum
Subject:
Oleic
Acid
Sulfonates
and
Related
Compounds:
Antimicrobials
Division
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
and
for
Tolerance
Reassessment
Barcode:
323799
From:
Deborah
Smegal,
Risk
Assessor
Risk
Assessment
and
Science
Support
Branch
(
RASSB)
Antimicrobials
Division
(
7510C)

Najm
Shamim,
Ph.
D.
Chemist
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

Through:
Norm
Cook,
Branch
Chief
Risk
Assessment
and
Science
Support
Branch
(
RASSB)
Antimicrobials
Division
(
7510C)

To:
Lower
Risk
Pesticide
Chemical
Focus
Group
Kathryn
Boyle,
Chair
Registration
Division
(
7505C)

Background:

This
document
represents
the
Antimicrobials
Division=
s
risk
assessment
to
support
the
Reregistration
Eligibility
Decision
(
RED)
on
oleic
acid,
sulfonated,
sodium
salt
(
CAS
Reg.
Nos.
68443­
05­
0
and
67998­
94­
1),
which
is
used
as
an
active
ingredient
in
food­
contact
sanitizing
solutions.
In
addition,
this
document
evaluates
sulfonated
oleic
acid,
which
is
used
as
an
inert
2
ingredient
in
food­
contact
sanitizing
solutions
(
68988­
76­
1).
This
assessment
summarizes
the
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
exposure
profiles,
and
environmental
fate
and
ecotoxicity
for
these
chemicals.
This
assessment
relies
primarily
on
a
Structure
Activity
Relationship
(
SAR)
assessments
conducted
by
the
Agency,
in
addition
to
some
limited
information
submitted
by
the
registrant
of
the
active
ingredient
oleic
acid,
sulfonated,
sodium
salt.

The
purpose
of
this
document
is
to
reassess
the
oleic
acid
sulfonate,
sodium
salt
and
oleic
acid,
sulfonated
tolerance
exemptions
when
used
as
active
and/
or
inert
ingredients
in
food
contact
surface
sanitizing
pesticide
formulations.
In
addition,
the
two
tolerance
exemptions
need
to
be
reassessed
to
meet
the
Food
Quality
Protection
Act
(
FQPA)
standard.
The
Agency
has
considered
any
new
data
generated
after
the
tolerance
exemption
was
issued,
new
Agency
guidance
or
other
federal
regulations,
as
well
as
previously
available
information
in
this
assessment.

1.0
EXECUTIVE
SUMMARY
This
document
addresses
the
exposures
and
risks
from
use
of
oleic
acid,
sulfonated,
sodium
salt,
an
active
ingredient
(
food­
contact
sanitizer),
and
oleic
acid
sulfonate,
which
is
an
inert
ingredient
in
food­
contact
sanitizing
solutions.
Potential
residential
exposures
and
risks
are
also
addressed
pursuant
to
the
language
and
intent
of
the
Food
Quality
Protection
Act
(
FQPA).

The
Agency
believes
these
compounds
are
generally
of
low
toxicity
for
human
health
concerns,
based
primarily
on
the
SAR
assessments
conducted
by
the
Agency.
In
this
process,
the
chemical=
s
structural
similarity
to
other
chemicals
(
for
which
data
are
available)
is
used
to
determine
toxicity.
For
human
health,
this
process
can
be
used
to
assess
absorption
and
metabolism,
mutagenicity,
carcinogenicity,
developmental
and
reproductive
effects,
neurotoxicity,
systemic
effects,
immunotoxicity,
and
sensitization
and
irritation.
This
is
a
qualitative
assessment
using
terms
such
as
good,
not
likely,
poor,
moderate,
or
high.
SAR
assessments
have
been
performed
by
OPPT
for
over
25
years.
It
is
an
expert
judgment
by
a
group
of
Agency
scientists
who
evaluate
the
toxicity
of
the
chemical
in
a
systematic,
efficient,
and
effective
hazard/
toxicity
review
process
that
is
predicative
in
nature.
Based
on
the
SAR
for
these
compounds,
there
are
concerns
for
surfactant
effects
on
the
lung
and
concern
for
irritation
effects.
However,
the
use
pattern
as
food­
contact
sanitizers
are
unlikely
to
result
in
significant
inhalation
exposures,
based
on
their
low
vapor
pressure
(<
1x10­
6
mmHg),
and
because
the
application
method
to
food
processing
equipment
and
utensils
is
unlikely
to
generate
aerosol
particles
that
will
be
respirable.
In
addition,
there
are
limitations
on
the
end­
use
concentrations
of
oleic
acid,
sulfonated,
sodium
salt,
and
oleic
acid
sulfonate
(
not
to
exceed
200
and
312
ppm,
respectively),
which
will
further
limit
the
potential
for
exposure.
Furthermore,
these
concerns
would
be
handled
at
the
time
of
product
reregistration
via
the
label
review
process.

Although
the
Agency
believes
it
can
make
a
safety
finding
at
this
time,
the
Agency
still
requests
some
confirmatory
data
for
oleic
acid,
sulfonated,
sodium
salt,
because
the
active
3
ingredient
food­
contact
sanitizer
use
is
considered
to
be
an
indirect
food
additive
use.
The
Agency
requests
a
90­
day
oral
toxicity
study
and
a
developmental
study
to
confirm
the
conclusions
of
the
SAR.
It
is
noted
that
the
registrant
has
proposed
to
bridge
toxicity
data
from
other
anionic
surfactants,
such
as
alkylbenzene
sulfonates
and
alcohol
sulfates,
to
satisfy
the
data
requirements
for
the
sulfonated
oleic
acid,
sodium
salt.
The
Agency
believes
there
may
be
some
merit
in
this
approach,
but
would
still
require
a
minimum
toxicity
data
set
to
confirm
that
this
bridging
argument
is
appropriate.

Given
the
available
toxicological
information
and
emphasizing
the
predictive
nature
of
the
SARs=
judgment
of
low
to
moderate
toxicity,
a
qualitative
assessment
of
the
risk
of
these
two
chemicals
is
appropriate.
Adequate
review
of
labeling
considering
the
results
of
the
end­
product
acute
toxicity
testing
should
address
all
concerns.

Although
these
chemicals
show
moderate
to
strong
tendency
to
bind
with
soils
and
sediments,
and
show
a
tendency
to
be
immobile,
the
dissipation
pathway,
estimated
by
various
degradation
models,
for
these
chemicals
appear
to
be
through
biodegradation
in
soils
and
sediments
within
a
couple
of
weeks
maximum.
Hence,
the
possibility
of
surface
and
ground
water
contamination
is
low.

The
SAR
predicted
low
to
moderate
toxicity
concern
for
ecological
effects
for
these
three
chemicals
(
68443­
05­
0,
67998­
94­
1
and
68988­
76­
1).
However,
these
compounds
are
immobile,
bind
tightly
to
sediment
and
soils,
and
undergo
fairly
rapid
microbial
degradation,
which
is
expected
to
mitigate
any
potential
for
risk.
EPA
believes
that
these
compounds
will
not
cause
unreasonable
adverse
effects
on
the
environment.
However,
the
Agency
is
requesting
confirmatory
ecotoxicity
data
to
support
the
registered
use
of
oleic
acid,
sulfonated,
sodium
salt.
These
studies
include
an
acute
oral
bird
study,
an
acute
fish
study
and
an
acute
invertebrate
study.
These
studies
are
necessary
for
product
labeling
in
case
of
an
accidental
spill
during
transport.

Based
on
its
review
and
evaluation
of
all
available
information,
AD
concludes
that
there
is
a
reasonable
certainty
of
no
harm
resulting
from
exposure
to
oleic
acid,
sulfonated
sodium
salt
as
an
active
(
sanitizer)
ingredient,
or
oleic
acid,
sulfonated
as
an
inert
ingredient
(
sanitizer)
to
the
general
population
and
to
infants
and
children
in
particular.
As
a
result,
AD
has
determined
that
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
the
oleic
acid
sulfonates
is
appropriate.

2.0
USE
INFORMATION
Sulfonated
oleic
acid,
sodium
salt
is
registered
as
an
active
ingredient
as
a
no­
rinse
sanitizer
for
food
processing
facilities.
The
active
ingredient
consists
of
two
chemical
constituents,
one
as
the
primary
ingredient
(
9­
octadecenoic
acid,
sulfonated,
sodium
salt,
CAS
Reg.
No.
68443­
05­
0)
and
the
other
as
a
by­
product
(
octadecanoic
acid,
sulfo,
sodium
salt,
67998­
94­
1).
The
registrant
supports
the
following
use
sites:
non­
porous
dairy,
beverage,
brewery
and
food
processing
equipment.
There
is
currently
one
registered
product
containing
4
2.66%
sulfonated
oleic
acid,
sodium
salt
(
approximately
200
ppm)
as
an
active
pesticide
ingredient
(
PER­
VAD7
Low
Foam
Anionic
Acid
Sanitizer,
EPA
875­
90).

The
tolerance
exemptions
being
reassessed
in
this
document,
the
40
CFR
location
of
the
established
tolerance
exemption,
and
the
use
pattern
as
an
inert
or
active
ingredient
are
listed
in
Table
1.

Table
1
Exemptions
from
the
Requirement
of
a
Tolerance
Being
Reassessed
in
this
Document
Nomenclature
or
Synonyms
Tolerance
Exemption
Expression/
Chemical
Name
CAS
No.
PC
Code
40
CFR

180.
Use
Pattern
(
Pesticidal)
List
Classification
Active
Products
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
68443­
05­
0
079064
(
active)

(
inert)
940
(
c)
food
contact
sanitizing
solutions
for
food
processing
equipment
and
utensils;
end
use
concentration
not
to
exceed
200
ppm
3
1
Product
(
PC
079064)
oleic
acid,
sulfonated,
sodium
salt
octadecanoic
acid,
sulfo,
sodium
salt
67998­
94­
1
079064
(
active)
no
tolerance
exemption
­­­
­­­
­­­

sulfonated
oleic
acid
9­
octadecenoic
acid
(
9Z­),
sulfonated
68988­
76­
1
(
inert)
940
(
c)
food
contact
sanitizing
solutions
for
food
processing
equipment
and
utensils;
end
use
concentration
not
to
exceed
312
ppm
3
1
Product
C
=
Not
relevant
5
Use
in
Food
Contact
Surface
Sanitizing
Solutions
Oleic
acid
sulfonates
have
uses
in
food
contact
surface
sanitizing
solutions
as
specified
under
40
CFR
180.940
(
c).
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
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
(
CAS
Reg.
No.
68443­
05­
0)
and
9­
octadecenoic
acid
(
9Z­),
sulfonated
(
68988­
76­
1)
have
limitations
for
the
ready­
to­
use
end­
use
concentration
not
to
exceed
200
ppm
and
312
ppm,
respectively
Other
Uses
The
Agency
notes
that
9­
octadecanoic
acid
(
9Z­),
sulfonated,
sodium
salt
(
one
of
the
active
ingredients
assessed
in
this
document,
CAS
No.
67998­
94­
1)
is
included
on
the
Agency=
s
list
of
chemicals
included
in
the
High
Production
Volume
(
HPV)
Challenge
Program.
HPV
chemicals
are
those
that
are
manufactured
or
imported
into
the
United
States
in
volumes
greater
than
one
million
pounds
per
year.
There
are
approximately
3,000
HPV
chemicals
that
are
produced
or
imported
into
the
United
States.
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.
This
chemical
is
not
sponsored
by
any
industry
groups
for
data
development.

3.0
PHYSICAL/
CHEMICAL
PROPERTIES
The
physical
and
chemical
characteristics
of
the
oleic
acid
sulfonates
have
been
extracted
from
two
major
sources
for
this
document:
1)
EPISuite,
developed
by
EPA=
s
OPPT
Program;
2)
Structure
Activity
Relationship
Assessments,
also
performed
by
the
Agency=
s
OPPT
Program.
Both
compounds
are
fatty
acid
derivatives.
Fatty
acids
are
carboxylic
acids
containing
long,
aliphatic
carbon
chains.
It
is
the
structural
features
of
fatty
acids
that
define
the
physical
and
chemical
behavior
of
these
compounds.
The
long
carbon
chain
provides
a
hydrophobic
(
lipophilic)
end,
generally
referred
as
the
Ahydrophobic
tail,@
whereas
the
carboxylic
acid
constitutes
the
polar,
hydrophilic
(
lipophobic)
headgroup.
The
hydrophobic
end
interacts
with
hydrophobic
substances
while
the
hydrophilic
group
interacts
with
hydrophilic
substances,
in
a
Alike­
dissolves­
like@
manner
(
USEPA
2002,
EFED
memo).
Table
3
lists
the
physical
and
chemical
characteristics
of
the
three
chemicals
evaluated
in
this
document.
Some
of
these
characteristics
are
estimated
and
some
may
be
actual
measured
values.
6
Table
3.
Physical
and
Chemical
Properties
of
Oleic
Acid
Sulfonates
Physical
and
Chemical
Property
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
68443­
05­
0
Oleic
acid,
sulfonated,
sodium
salt
(
octadecanoic
acid,
sulfo,
sodium
salt)
67998­
94­
1
9­
Octadecenoic
acid
(
9Z­),
sulfonated
(
sulfonated
oleic
acid)
68988­
76­
1
Molecular
Formula
C18H33NaO5S
C18H35NaO5S
C18H34O5S
Molecular
Weight
384.51
386.52
363
Water
Solubility,
mg/
L
(
dispersible)
608
2
Vapor
Pressure,
mmHg
<
1
x
10­
6
2.29
x
10­
20,
estimated
<
1
x
10­
6
Henry
=

s
Law
Constant,
atmm3
mole
<
1
x
10­
8
8.75
x
10­
12
<
1
x
10­
8
Log
Kow
2.29
2.51,
estimated
4.44
Log
Koc
2.92
2.92
2.92
Log
BCF
1.85,
estimated
1.85,
estimated
1.85,
estimated
Melting
point,
0C
312
311.7
219
Boiling
point,
0C
>
400
712
>
400
Structure
O
O
S
O
O­
Na+

Sulfonated
Oleic
acid,
sodium
salt
O
O
O
S
O
O
O
Na
O
O
S
O
O
O
7
4.0
HAZARD
CHARACTERIZATION
4.1
Hazard
Profile
Very
limited
toxicological
data
are
available
for
the
three
compounds
assessed
in
this
document.
A
few
acute
toxicity
studies
are
available
for
sulfonated
oleic
acid,
sodium
salt,
which
were
submitted
by
the
Registrant.
In
addition,
the
Agency
conducted
an
extensive
literature
search
including
TOXNET
databases
(
HSDB,
IRIS,
CCRIS,
GENE­
TOX,
TOXLINE,
and
DART/
ETIC)
and
searched
the
internet
(
using
the
Google
search
engine).
Given
the
limited
toxicity
data
available
in
the
literature,
the
Agency
conducted
Structure
Activity
Relationship
(
SAR)
assessments
for
these
compounds
assessed
in
this
document.
In
addition,
the
Agency
has
considered
the
toxicity
data
for
other
anionic
surfactants
(
such
as
linear
alkyl
benzene
sulfonate
and
alcohol
sulfates),
which
the
Registrant
believes
are
toxicologically
similar
to
sulfonated
oleic
acid,
sodium
salt.

The
oleic
acid
sulfonates
are
considered
to
be
fatty
acid
derivatives.
Fatty
acids
are
a
group
of
compounds
which
are
monocarboxylic
acids
attached
to
aliphatic
carbon
chains.
Oleic
acid
(
unsaturated
C18)
is
one
of
the
most
common
naturally
occurring
fatty
acids.
Fatty
acids
are
present
in
common
fats
and
oils
(
such
as
corn
oil,
peanut
oil,
and
butter)
as
triglycerides.
A
triglyceride
is
composed
of
three
fatty
acid
molecules
and
a
single
molecule
of
glycerol.
For
example,
oleic
acid
is
a
natural
constituent
of
common
oils
such
as
soybean
oil
(
19­
30%),
corn
oil
(
19­
50%),
cottonseed
oil
(
13­
44%),
sunflower
seed
oil
(
14­
65%),
peanut
oil
(
35­
72%),
olive
oil
(
56­
83%),
rapeseed
(
canola)
oil
(
8­
45%),
palm
kernel
oil
(
0.7­
54%),
coconut
oil
(
0.9­
3.7%),
butter
(
27%),
lard
(
pork)
(
44.4%)
and
beef
tallow
(
47.5%).

Upon
consumption
of
fats
and
oils,
the
triglycerides
(
which
typically
comprise
greater
than
98%
of
fats
and
refined
oils)
are
rapidly
hydrolyzed
in
the
human
body,
forming
glycerol
and
free
fatty
acids.
Free
fatty
acids
are
then
degraded
to
produce
acetyl
CoA
(
one
acetyl
CoA
for
each
2
carbons
in
the
chain)
which
is
used
in
the
Citric
Acid
Cycle
or
for
ketone
body
synthesis.
Fats
and
oils
account
for
30­
40%
(
average)
of
dietary
intake
in
the
U.
S.
During
the
1990s,
average
per
capita
fat
consumption
in
the
U.
S.
ranged
from
60
to
about
100
grams/
day.

SAR
Assessments
Performed
by
USEPA
(
2004)

The
Agency
conducted
Structure
Activity
Relationship
(
SAR)
assessments
for
these
three
chemicals
because
limited
toxicological
information
were
found
in
the
literature.
In
this
process,
the
chemical
=

s
structural
similarity
to
other
chemicals
(
for
which
data
are
available)
is
used
to
determine
toxicity.
For
human
health,
this
process,
can
be
used
to
assess
absorption
and
metabolism,
mutagenicity,
carcinogenicity,
developmental
and
reproductive
effects,
neurotoxicity,
systemic
effects,
immunotoxicity,
and
sensitization
and
irritation.
This
is
a
qualitative
assessment
using
terms
such
as
good,
not
likely,
poor,
moderate,
or
high.

SAR
assessments
were
performed
in
June
2004
by
the
Office
of
Pollution
Prevention
and
8
Toxics
(
OPPT)
(
USEPA
2004).
For
these
chemicals,
absorption
is
expected
to
be
poor
from
the
skin,
moderate
from
the
gastrointestinal
tract
and
good
from
the
lung.
There
is
concern
for
surfactant
effects
on
the
lung;
irritation
to
the
eye,
skin
(
chronic),
mucous
membranes
and
lung
based
on
surfactant
properties
of
the
compounds.
These
three
compounds
were
judged
to
be
of
low
to
moderate
toxicity
concern.
There
are
no
concerns
for
mutagenicity,
carcinogenicity,
developmental
or
reproductive
effects.

A.
Toxicological
Data
Available
for
Oleic
Acid
Sulfonates
The
Agency
has
some
limited
information
on
acute
toxicity
of
sulfonated
oleic
acid,
sodium
salt
that
indicate
a
low
toxicity
concern
for
the
active
ingredient
(
AI)
pesticide
and
the
one
actively
registered
end­
use
pesticide
product.

The
acute
toxicity
of
sulfonated
oleic
acid,
sodium
salt
is
low
for
oral
and
inhalation
toxicity
(
Toxicity
Category
IV),
and
moderate
for
dermal
toxicity
(
Toxicity
Category
III).
It
is
a
minimal
primary
skin
irritant
(
Toxicity
Category
IV),
but
is
a
moderate
to
severe
eye
irritant
(
Toxicity
Category
II).
It
is
noted
that
the
acute
inhalation
toxicity
value
could
be
higher,
but
this
study
did
not
satisfy
the
guideline
requirements
because
the
exposure
duration
was
only
one
hour
(
when
a
4­
hour
exposure
is
required).
Table
4
presents
the
acute
toxicity
data
for
sulfonated
oleic
acid,
sodium
salt.

Table
4.
Summary
of
Acute
Toxicity
Data
for
Sulfonated
Oleic
Acid,
Sodium
Salt
Test
Species
Results
Reference
>
5000
mg/
kg
(
Toxicity
Category
IV)
MRID
41861503
Slover
1991
Oral
LD50
Rat
>
5000
mg/
kg
(
a)

(
Toxicity
Category
IV)
MRID
43423804
Christopher
1994
Dermal
LD50
Rabbit
>
2000
mg/
kg
(
Toxicity
Category
III)
MRID
41861503
Slover
1991
>
207
mg/
L
(
1­
Hour)
(
Toxicity
Category
IV)
MRID
41861503
Slover
1991
Inhalation
LC50
Rat
>
2.02
mg/
L
(
4­
Hour)(
a)

(
Toxicity
Category
IV)
MRID
44008401
Douds,
1996
Dermal
Irritation
Rabbit
Slight
Erythema
and
Edema
(
Toxicity
Category
IV)

Eye
Irritation
Rabbit
24­
Hr:
19.3;
48­
Hr:
12.3;
72­
Hr:
13.3;
7­
Day:
1
(
Toxicity
Category
II)
MRID
41861503
Slover
1991
(
a)
Contains
2.6%
sodium
sulfonated
oleic
acid
9
B.
Consideration
of
Toxicity
Data
for
Anionic
Surfactants:
Linear
Alkylbenzene
Sulfonates
and
Alcohol
Sulfates
Recently,
a
submission
was
made
by
one
of
the
registrants
supporting
sulfonated
oleic
acid
(
Johnson
Diversey
2004),
in
which
it
was
stated
that
A
the
acute
and
chronic
toxicity
of
[
sulfonated
oleic
acid]
is
expected
to
be
similar
to
that
of
other
anionic
surfactants.
As
a
class,
these
materials
are
irritants.@
Specifically,
the
registrant
stated
that
the
A
acute
toxicology
data
on
[
sulfonated
oleic
acid,
sodium
salt]
are
consistent
with
what
is
known
about
other
anionic
surfactants
that
contain
fatty
alkyl
chains
@

(
such
as
alcohol
sulfates
and
linear
alkylbenzene
sulfonates).
The
Registrant
believes
that
A
on
an
acute
basis,
the
data
reported
for
sulfonated
oleic
acid,
sodium
salt
are
very
similar
to
those
available
from
HERA
on
the
longer
chain
alcohol
sulfates
and
linear
alkylbenzene
sulfonate.@

A
Both
the
alcohol
sulfates
and
linear
alkylbenzene
sulfonate
have
been
extensively
studied;
no
evidence
of
any
significant
acute
or
chronic
effects
has
been
reported.
These
surfactant
types
are
not
considered
to
be
mutagenic,
carcinogenic
or
reproductive/
developmentally
toxic.
All
have
enjoyed
a
long
history
of
safe
use
in
conventional
cleaning
products
in
both
the
consumer
and
institutional
markets.
Some
members
of
these
categories
are
also
approved
for
use
in
food
contact
applications.@
(
JohnsonDiversey
2004).

In
conclusion,
the
Registrant
states
that
A
We
believe
that
the
overall
toxicity
of
[
sulfonated
oleic
acid,
sodium
salt]
will
be
similar
to
that
of
both
the
alcohol
sulfates
and
linear
alkyl
benzene.
[
Sulfonated
oleic
acid,
sodium
salt]
is
structurally
similar
to
both
the
alcohol
sulfates
and
linear
alkyl
benzene
and
is
likely
metabolized
and
excreted
by
similar
mechanisms.
Additional
testing
to
further
characterize
the
toxicity
of
oleic
acid
sulfonate
is
not
necessary.@

The
Agency
has
considered
the
Registrant
=

s
submission
on
this
toxicity
bridging
argument
in
a
memorandum
from
T.
McMahon
to
D.
Smegal,
dated
September
23,
2004
(
D308387)
(
Attachment
1).
The
Agency
believes
the
information
provided
on
alcohol
sulfates
may
be
more
closely
similar
to
oleic
acid
sulfonates
than
the
linear
alkylbenzene
sulfonates,
which
contain
a
benzene
ring.
The
Agency
was
not
able
to
obtain
and
independently
review
the
primary
literature
summarized
in
the
HERA
documents,
because
these
are
unpublished
studies,
many
of
which
were
conducted
in
the
early
1970s.
The
following
information
is
a
summary
from
the
EPA
memo.

Alcohol
Sulfates
Based
on
toxicity
data
in
the
HERA
(
2002)
assessment,
a
low
order
of
acute
toxicity
is
observed
for
the
alcohol
sulfates.
Oral
LD50
values
are
reported
as
ranging
from
1.4
to
>
8
g/
kg.
Acute
dermal
LD50
values
were
not
available,
but
testing
up
to
500
mg/
kg
did
not
cause
mortality
in
rabbits.
Skin
and
eye
irritation
are
observed
with
the
alcohol
sulfates
at
concentrations
of
5­
10%
and
above.
No
dermal
sensitization
is
reported
for
this
class
of
chemicals.

With
regard
to
developmental
and
reproductive
toxicity
of
alcohol
sulfates,
only
one
10
reproductive
toxicity
study
was
available
for
what
is
claimed
to
be
a
structurally
related
compound,
alpha
olefin
sulfonate.
The
summary
of
this
study
indicates
no
significant
treatmentrelated
effects
up
to
250
mg/
kg/
day
in
a
2­
generation
study.
One
published
developmental
toxicity
study
was
available
for
an
alcohol
sulfate
which
was
tested
up
to
600
mg/
kg/
day
by
oral
gavage
in
rats,
mice,
and
rabbits
(
Palmer
et
al.,
1975,
in
http://
www.
heraproject.
com/
RiskAssessment.
cfm)
and
which
reported
a
maternal
NOAEL
of
2
mg/
kg/
day
for
all
species
and
developmental
NOAELs
of
300
mg/
kg/
day
in
rabbits
and
mice
and
600
mg/
kg/
day
in
rats.

With
respect
to
mutagenicity,
data
on
in
vitro
and
in
vivo
mutagenicity
tests
were
summarized
in
an
Appendix
to
the
HERA
document.
As
the
data
are
extensive,
they
are
not
reproduced
here.
However,
in
summary,
it
is
noted
that
most
of
the
studies
show
negative
results.
There
are
some
data
indicating
a
positive
response,
for
example,
in
an
in
vivo
chromosome
aberration
test
in
hamsters,
a
dose
of
2.5
g/
kg
showed
marginal
but
statistically
significant
increases
in
chromatid
gaps
in
high
dose
females.
In
a
rodent
dominant
lethal
assay
at
doses
of
210/
300,
960/
980,
and
3050/
3010
mg/
kg/
day,
decreased
pregnancy
frequency
and
increased
early
embryonic
deaths
were
observed
at
week
four
of
an
8­
week
study,
although
the
dose
causing
this
effect
was
not
noted
in
the
summary.
The
nature
of
the
positive
response
may
be
based
upon
a
non­
specific
disruption
of
cell
membranes
by
a
high
concentration
of
the
surfactant
and
not
a
specific
mechanism.

USEPA
Conclusions:

The
EPA
memo
concludes
the
following:

The
data
cited
by
the
Registrant
in
support
of
characterizing
the
toxicity
of
sulfonated
oleic
acid
raises
several
issues
with
respect
to
the
risk
from
exposure
to
sulfonated
oleic
acid:

1)
The
position
by
the
Registrant
that
sulfonated
oleic
acid
is
biotransformed
(
metabolized
and
excreted)
in
a
manner
similar
to
the
alcohol
sulfates
and/
or
linear
alkylbenzene
sulfonates
is
not
supported
by
actual
data
but
only
by
modeling
results.
An
actual
metabolism
study
would
be
helpful
in
addressing
this
issue.

2)
The
observation
of
liver
and
kidney
toxicity
from
administration
of
the
alcohol
sulfates
and
the
linear
alkylbenzene
sulfonates.....
raises
questions
regarding
the
potential
for
sulfonated
oleic
acid
to
produce
similar
effects.
In
addition,
the
range
of
NOAEL
values
observed
for
both
the
results
of
testing
of
both
classes
of
chemicals
makes
it
difficult
to
compare
results
for
a
single
chemical
entity
(
i.
e.
sulfonated
oleic
acid)
with
chemical
classes
composed
of
more
than
one
component.
In
order
to
determine
whether
there
is
any
similarity,
some
side­
by­
side
toxicity
comparisons
would
need
to
be
conducted
with
sulfonated
oleic
acid
and
the
linear
alkylbenzene
sulfonates
and
alcohol
sulfates
to
conclude
with
any
certainty
that
data
can
be
bridged
from
the
alcohol
sulfates
and/
or
linear
alkylbenzene
sulfonates.
A
minimum
data
set
of
one
oral
90
day
rodent
study
and
an
oral
11
developmental
study
are
required
to
determine
if
bridging
is
feasible.

3)
As
with
the
repeated
dose
toxicity
data,
the
available
data
on
developmental
toxicity
and
reproductive
toxicity
show
NOAELs
over
a
range
of
doses
but
no
actual
data
on
sulfonated
oleic
acid
for
comparison.
Thus,
a
determination
of
an
FQPA
safety
assessment,
as
needed
for
the
indirect
food
uses
of
sulfonated
oleic
acid,
could
only
be
addressed
through
generation
of
data
relevant
for
bridging
as
noted
above,
or
generation
of
data
specific
to
sulfonated
oleic
acid
to
fulfill
data
requirements
for
the
uses
being
supported
in
the
Reregistration
Eligibility
Decision.

4.2
FQPA
Considerations
(
Special
Considerations
for
Infants
and
Children)

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."

At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children
based
on
the
SARs
for
these
three
compounds
and
the
available
data
for
other
anionic
surfactants
(
linear
alkylbenzene
sulfonates
and
alcohol
sulfates)
that
show
all
developmental
effects
occurred
at
or
above
those
dose
levels
associated
with
maternal
effects.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.
However,
the
Agency
is
requesting
a
developmental
study
for
sulfonated
oleic
acid,
sodium
salt
to
confirm
the
conclusions
of
the
SAR.

4.3
Dose­
Response
Assessment
The
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
met
in
February
2003
to
review
the
available
toxicity
data
for
sulfonated
oleic
acid
and
to
discuss
potential
endpoint
selection
for
use
in
risk
assessment.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
sulfonated
oleic
acid
was
also
evaluated
by
the
committee
in
order
to
meet
the
statutory
requirements
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
committee
considered
that
the
registered
uses
for
sulfonated
oleic
acid
may
result
in
residues
in
food.
12
The
ADTC
committee
concluded
that
no
toxicity
endpoints
of
concern
are
necessary
for
sulfonated
oleic
acid.
These
conclusions
are
based
on
the
following
information:
the
FDA
has
approved
the
indirect
food
use
of
sulfonated
oleic
acid
up
to
200
ppm
for
food
processing
equipment
and
glass
bottles
for
milk.
This
level
of
clearance
is
orders
of
magnitude
greater
than
the
Agency
=

s
level
of
concern
for
indirect
food
uses
of
antimicrobial
pesticides
(
ie.,
>
200
ppb),
so
the
ADTC
believes
that
sulfonated
oleic
acid
is
of
a
low
order
of
toxicity.
Further,
the
ADTC
recognized
that
sulfonated
oleic
acid
is
a
fatty
acid
derivative.
Fatty
acids
are
processed
by
known
metabolic
pathways
within
the
body
and
are
necessary
for
normal
cellular
functioning.
As
the
exposures
anticipated
from
the
indirect
food
uses
(
as
well
as
non­
dietary
dermal
and/
or
inhalation
exposure)
are
insignificant
in
comparison
to
levels
encountered
for
fatty
acids
in
the
normal
human
diet,
use
of
these
chemicals
in
pesticide
products
is
unlikely
to
pose
any
significant
hazard
to
the
general
population
or
to
any
subgroup,
including
infants
and
children.
Therefore,
the
Agency
=

s
ADTC
did
not
select
toxicity
endpoints
for
sulfonated
oleic
acid.

4.4
Endocrine
Disruption
FQPA
requires
that
EPA
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticides
and
inerts)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect...."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
Endocrine
Disruptor
Screening
Program
(
EDSP),
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
EDSP.

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency
=

s
EDSP
have
been
developed,
oleic
acid
sulfonates
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

5.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
The
primary
uses
of
sulfonated
oleic
acid
and
its
sodium
salt
as
antimicrobial
pesticides
are
non­
porous
dairy,
beverage,
brewery
and
food
processing
equipment
as
indirect
food­
contact
sanitizers.
In
addition,
the
Agency
notes
that
sulfonated
oleic
acid,
sodium
salt
(
67998­
94­
1)
is
on
EPA
=

s
HPV
Challenge
Program
list,
indicating
that
the
manufacture
of
importation
is
greater
than
1
million
lbs/
year,
and
thus
there
is
significant
use
by
industry
that
could
lead
to
additional
human
exposures.

Residues
from
the
pesticide
uses
of
these
three
oleic
acid
sulfonates
are
expected
to
be
13
low
because
both
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
(
CAS
Reg.
No.
68443­
05­
0)
and
9­
octadecenoic
acid
(
9Z­),
sulfonated
(
68988­
76­
1)
have
limitations
for
ready
to
use
end­
use
concentration
not
to
exceed
200
ppm
and
312
ppm,
respectively.
In
addition,
there
is
only
one
currently
registered
product
for
sulfonated
oleic
acid,
sodium
salt,
that
contains
2.66%
AI.
The
SARs
predict
low
to
moderate
toxicity
to
humans
for
both
compounds,
and
there
is
no
reason
to
expect
that
reasonable
use
will
constitute
any
significant
hazard.
In
addition,
oleic
acid
sulfonates
have
no
appreciable
vapor
pressure
at
ambient
temperatures,
and
thus
inhalation
exposure
is
expected
to
be
minimal.
Therefore,
a
quantitative
screening­
level
exposure
assessment
has
not
been
conducted.

Drinking
Water
Considerations
The
Agency
believes
the
possibility
of
surface
and
ground
water
contamination
is
low.
This
is
because
these
chemicals
show
moderate
to
strong
tendency
to
bind
with
soils
and
sediments
and
show
a
tendency
to
be
immobile.
The
dissipation
pathway,
estimated
by
various
degradation
models,
for
these
chemicals
appear
to
be
through
biodegradation
in
soils
and
sediments
within
a
couple
of
weeks
maximum.
A
more
detailed
discussion
of
environmental
fate
and
potential
for
ground
and
surface
water
impacts
is
discussed
below
in
Section
10.

6.0
RISK
CHARACTERIZATION
The
chemistry
of
fatty
acids
is
important
in
understanding
the
human
metabolism
of
these
chemicals.
Edible
fatty
acids
are
an
important
dietary
source
of
calories
and
nutrition.
The
compounds
evaluated
are
fatty
acid
derivatives
that
contain
several
of
the
same
fatty
acids
that
are
derived
from
crops
such
as
corn,
peanut
and
sunflower
oils.

SARs
(
Structure
Activity
Relationship
assessments)
are
available
for
the
oleic
acid
sulfonates.
These
SARs
are
almost
identical
for
human
health,
as
these
three
chemicals
are
judged
to
be
low
to
moderate
concern.
Of
note,
these
chemicals
are
considered
to
have
poor
absorption
from
the
skin
and
moderate
absorption
from
the
gastrointestinal
tract.
SAR
assessments
have
been
performed
by
OPPT
for
over
25
years.
It
is
an
expert
judgment
by
a
group
of
Agency
scientists
who
evaluate
the
toxicity
of
the
chemical
in
a
systematic,
efficient,
and
effective
hazard/
toxicity
review
process
that
is
predicative
in
nature.
Based
on
the
SARs
for
these
compounds,
there
are
concerns
for
respiratory
effects
(
because
they
are
surfactants)
and
concerns
for
irritation
effects.
However,
the
use
patterns
of
sulfonated
oleic
acid
and
its
sodium
salt
as
food­
contact
sanitizers
are
unlikely
to
result
in
significant
inhalation
exposures,
based
on
their
low
vapor
pressure
(<
1x10­
6
mmHg),
and
because
the
application
method
to
food
processing
equipment
and
utensils
is
unlikely
to
generate
aerosol
particles
that
will
be
respirable.
In
addition,
there
are
limitations
on
the
end­
use
concentrations
of
oleic
acid,
sulfonated,
sodium
salt
and
oleic
acid
sulfonate
(
not
to
exceed
200
and
312
ppm,
respectively),
which
will
further
limit
the
potential
for
exposure.
Furthermore,
these
concerns
would
be
handled
at
the
time
of
product
re­
registration
via
the
label
review
process.
14
Given
the
available
toxicological
information
and
emphasizing
the
predictive
nature
of
the
SARs
=

judgment
of
low
to
moderate
toxicity,
a
qualitative
assessment
of
the
risk
of
these
three
chemicals
is
appropriate.
Adequate
review
of
labeling
considering
the
results
of
the
end­
product
acute
toxicity
testing
should
address
all
concerns.

7.0
AGGREGATE
EXPOSURE
AND
RISK
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

For
the
oleic
acid
sulfonates
assessed
in
this
document,
a
qualitative
assessment
for
all
pathways
of
human
exposure
(
food,
drinking
water,
and
residential)
is
appropriate
given
their
low
toxicity,
and
the
body
=

s
ability
to
metabolize
these
sulfonated/
sulfated
fatty
acid
compounds.
The
SAR
assessments
further
support
the
low
concern
for
human
health
hazard.

8.0
INCIDENT
REPORTS
(
HUMAN
EXPOSURE)

In
the
data
sources
available
to
the
Agency,
no
reports
of
serious
illness
have
been
associated
with
human
exposure
to
the
oleic
acid
sulfonates.
The
Agency
has
reviewed
the
databases
of
the
OPP
Incidence
Data
System
(
IDS),
the
Poison
Control
Centers
(
from
1993­
1998),
California
Department
of
Pesticide
Regulation
(
from
1982­
1996),
and
the
National
Pesticide
Telecommunications
Network
(
NPTN)
for
reported
incident
information
of
oleic
acid
sulfonates.

9.0.
CUMULATIVE
EXPOSURE
AND
RISK:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information
@

concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity.@
The
three
oleic
acid
sulfonates
are
structurally
related;
however,
all
are
low
toxicity
chemicals.
Therefore,
the
resultant
risks
separately
and/
or
combined
should
also
be
low.

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
the
oleic
acid
sulfonates
assessed
in
this
document
have
a
common
mechanism
of
toxicity
with
other
substances.
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
oleic
acid
sulfonates
and
any
other
substances
and
they
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
the
oleic
acid
sulfonates
have
a
common
mechanism
of
toxicity
with
15
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/.

10.0.
ENVIRONMENTAL
FATE
CHARACTERIZATION/
DRINKING
WATER
CONSIDERATIONS
The
fate
and
transport
processes
for
sulfonic
acid
and/
or
sodium
salts
of
sulfonic
acid
of
oleic
acid
are
presented
in
Table
5.
Although
these
chemicals
show
moderate
to
strong
tendency
to
bind
with
soils
and
sediments
and
show
a
tendency
to
be
immobile,
the
dissipation
pathway,
estimated
by
various
degradation
models,
for
these
chemicals
appear
to
be
through
biodegradation
in
soils
and
sediments
within
a
couple
of
weeks
maximum.
Hence,
the
possibility
of
surface
and
ground
water
contamination
is
low.

These
chemicals
do
not
appear
to
persist
in
air
for
a
long
period
of
time
as
half­
lives
of
these
compounds
is
about
six
hours.
No
hydrolytic
study
on
these
ionic
substances
has
been
reported.
Various
fate
models
have
indicated
that
the
half
lives
of
these
substances
in
water
will
be
similar
to
their
half
lives
in
soils
and
sediments.
Hence
aerobically
or
anaerobically,
these
chemicals
will
likely
degrade
in
aquatic
systems
as
readily
as
in
soils
and
sediments.

These
three
chemicals
have
moderate
(
log
Kow
=
2.29)
to
high
(
log
Kow
=
4.44,
CAS
No.
68988­
76­
1)
log
Kows.
These
Kows
are
estimates
based
on
modeling
programs.
Despite
these
moderate
to
high
Kows,
the
compounds
are
not
likely
to
bioaccumulate
in
aquatic
organisms
as
they
biodegrade
readily
in
soils
and
sediments.

In
general,
these
chemicals
are
not
persistent
in
air,
water
or
soils,
and
are
not
bioaccumulative
in
aquatic
organisms
and
at
this
time
the
Agency
has
no
concerns
for
fate
and
transport
processes
in
air,
soils
or
water.

Table
5
Environmental
Fate
Risk
Assessment
of
Oleic
Acid
Sulfonates
Chemical
Name
CAS
No.
Fate
Parameters
Fate/
Risk
Assessment
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
68443­
05­
0
log
Koc
=
2.92;
log
BCF
=
1.85
(
BCF
=
70.8);
POTW
removal
(%)
=
90%
via
sorption
and
biodeg;
complete
ultimate
aerobic
biodeg:
1
week;
sorption
to
soils
and
sediments
=
moderate
to
strong;
migration
to
ground
water
=
negligible
It
can
biodegradate
within
a
week
and
hence
is
not
likely
to
persist
in
soils;
it
has
been
shown
to
be
over
90%
removed
in
POTW.
Probability
of
migration
to
ground
water
is
negligible.
It
is
not
likely
to
bioaccumulate.

Octadecanoic
acid,
sulfo,
sodium
salt
67998­
94­
1
Prob.
of
rapid
biodegradation:
linear
model:
0.6719;
non­
linear
model:
0.9873;
expert
survey
biodegradation:
ultimate
survey
The
most
probable
route
of
degradation
of
this
chemical
is
likely
through
biodegradation
as
predicted
by
16
Table
5
Environmental
Fate
Risk
Assessment
of
Oleic
Acid
Sulfonates
Chemical
Name
CAS
No.
Fate
Parameters
Fate/
Risk
Assessment
model:
2.53
(
weeks­
months);
primary
survey
model:
3.467
(
days­
weeks);
readily
biodeg
prob
(
MITI
model):
linear
model:
0.402;
nonlinear
model:
0.208
atmospheric
oxidation:
half
life=
5.62
hours;
removal
in
wastewater
treatment:
total
removal:
1.88%;
total
biodeg:
0.09%;
total
sludge
adsorption:
1.79;
total
to
air:
0.00
Level
III
fugacity
model:
air:
11.2
hours;
water:
900
hours;
soil:
900
hours;
sediment:
900
hours
various
fate
models.
It
has
a
tendency
to
bind
strongly
with
soils,
and
hence
ground
water
contamination
is
not
likely
to
occur.
It
is
not
stable
in
air
as
its
half­
life
is
about
six
hours,
and
it
oxidizes
through
hydroxy
radical
route.
It
is
not
likely
to
bioaccumulate.
It
is
not
likely
to
contaminate
surface
water.
It
biodegrades
readily.

9­
Octadecenoic
acid
(
9Z­),
sulfonated
68988­
76­
1
POTW
removal
%:
=
90%
via
sorption
and
biodeg;
time
for
complete
ultimate
biodeg:
=
1
week;
sorption
to
soil/
sediment:
moderate
to
strong;
migration
to
ground
water
=
negligible
It
has
a
low
Koc
and
has
a
tendency
to
moderately
to
strongly
bind
with
soils
and
sediments.
It
readily
biodegrades
through
adsorption
with
in
POTW
(
90%
removal
rate),
and
the
half­
life
is
about
a
week.
Although
it
is
likely
to
bioaccumulate
(
Kow
=
4.44),
since
it
dissipates
through
microbial
degradation
in
soils
and
sediments,
it
is
not
bioaccumulative.

Source:
EPI
Suite/
OPPT
Structure
and
Activity
Team
Report
(
USEPA
2004)

11.0
ECOTOXICITY
AND
ECOLOGICAL
RISK
CHARACTERIZATION
No
ecotoxicity
data
were
located
for
the
sulfonated
oleic
acid
and
its
sodium
salt.
Thus,
the
Agency
conducted
Structure
Activity
Relationship
(
SAR)
assessments
for
these
three
compounds
(
USEPA
2004).
The
results
of
the
assessments
are
presented
on
Table
6.
All
three
chemicals
(
67998­
94­
1,
68443­
05­
0,
68988­
76­
1)
were
of
moderate
toxicity
concern.
The
greater
the
length
of
the
hydrophobe
to
the
sulfonic
acid,
the
greater
the
toxicity
and
surfactancy.
All
three
chemicals
had
a
low
potential
for
persistence,
bioaccumulation
and
toxicity.
These
compounds
are
immobile,
bind
tightly
to
sediment
and
soils,
and
undergo
fairly
rapid
microbial
degradation,
which
is
expected
to
mitigate
any
potential
for
risk.
EPA
believes
that
these
compounds
will
not
cause
unreasonable
adverse
effects
on
the
environment.
Adequate
review
of
labeling
considering
the
results
of
the
end­
product
acute
toxicity
testing
should
address
all
concerns.

The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
risk
assessments
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
17
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.

The
labeled
use
of
oleic
acid
sulfonate
and
its
sodium
salt
as
food
contact
sanitizers
is
not
expected
to
result
in
significant
environmental
exposure.
Therefore,
adverse
effects
on
endangered/
threatened
terrestrial
and
aquatic
animal
species
are
not
anticipated.
Nevertheless,
the
Agency
is
requesting
confirmatory
ecotoxicity
data
to
support
the
registered
use
as
a
pesticidal
active
ingredient,
which
is
a
data
requirement
for
labeling
in
case
there
is
an
accidental
spill
during
transport.
These
studies
include
an
acute
fish,
acute
invertebrate
and
an
acute
bird
study.

T
able
6.
Summary
of
Ecotoxicity
Data
for
Oleic
Acid
Sulfonates
Parameter
Oleic
acid,
sulfonated,
sodium
salt
(
octadecanoic
acid,
sulfo,
sodium
salt)
67998­
94­
1
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
68443­
05­
0
9­
Octadecenoic
acid
(
9Z­),
sulfonated
(
sulfonated
oleic
acid)
68988­
76­
1
Fish
96­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
50,
predicted
Daphnid
48­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
40,
predicted
Green
Algae
96­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
50,
predicted
Chronic
Fish
Value
(
mg/
L)
$
20,
predicted
$
8,
predicted
Chronic
Daphnid
Value
(
mg/
L)
$
20,
predicted
$
6,
predicted
Chronic
Algal
Value
(
mg/
L)
$
30,
predicted
>
10,
predicted
SAR
Conclusions
Moderate
concern
for
toxicity
Moderate
concern
for
toxicity
18
XI.
Conclusions
Based
on
its
review
and
evaluation
of
all
available
information,
AD
concludes
that
there
is
a
reasonable
certainty
of
no
harm
resulting
from
exposure
to
oleic
acid,
sulfonated,
sodium
salt
as
an
active
(
sanitizer)
or
oleic
acid,
sulfonated
as
an
inert
ingredient
(
sanitizer
solution),
to
the
general
population
and
to
infants
and
children
in
particular.
As
a
result,
AD
has
determined
that
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
the
oleic
acid
sulfonates
is
appropriate.

References:

Human
and
Environmental
Risk
Assessment
(
HERA).
2004.
Linear
Alkylbenzene
Sulphonate
(
CAS
No.
68411­
30­
3).
May
2004.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
Human
and
Environmental
Risk
Assessment
(
HERA).
2002.
Human
and
Environmental
Risk
Assessment
on
the
ingredients
of
European
household
cleaning
products.
Alcohol
Sulphates
Human
Health
Risk
Assessment.
Draft.
December
2002.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
JohnsonDiversey
2004.
Memorandum
from
F.
Heitfeld
to
L.
Amadio.
Toxicity
Review
of
Sulfonated
Oleic
Acid,
Sodium
Salt.
September
2,
2004.

U.
S.
Environmental
Protection
Agency
(
USEPA).
2004
Structure
Activity
Relationship
(
SAR)
for
octadecanoic
acid,
sulfo,
sodium
salt
(
67998­
94­
1),
9­
octadecen­
1­
ol,
hydrogen
sulfate,
sodium
salt,
(
Z)­
(
1847­
55­
8),
9­
Octadecenoic
acid,
12­(
sulfooxy)­,
disodium
salt,
[
R­(
Z)]
(
61702­
68­
9),
9­
Octadecenoic
acid,
12­(
sulfooxy)­,
monosodium
salt,
(
9Z,
12R)­
(
29704­
46­
9),
9­
Octadecenoic
acid,
12­(
sulfooxy)­,
sodium
salt
,
(
9Z,
12R)
(
8043­
44­
5),
octadecanoic
acid,
9(
or
10)­
sulfooxy)­
monosodium
salt
(
68964­
56­
7),
Octadecanoic
acid,
9(
or
10)­(
sulfooxy)­,
sodium
salt
(
68331­
91­
9),
octadecanoic
acid,
9­(
sulfooxy)­,
sodium
salt
(
68413­
72­
9),
Octadecanoic
acid,
9­(
sulfooxy)­,
disodium
salt
(
65151­
76­
0),
9­
Octadecenoic
acid
(
9Z)­
sulfonated,
sodium
salt
(
68443­
05­
0),
9­
Octadecenoic
acid
(
9Z)­
sulfonated
(
68988­
76­
1),
Structure
Activity
Team
Report.
OPPT.
June
8,
2004.

U.
S.
Environmental
Protection
Agency
(
EPA)
2002.
IIFG
Decision
Documents
on
Reassessment
of
Exemptions
from
the
Requirement
of
a
Tolerance
for
Fatty
Acids.
Memorandum
from
K.
Boyle
and
K.
Leifer
to
F.
Forrest.
July
21,
2002.

U.
S.
Environmental
Protection
Agency
(
EPA).
2002.
A
Tolerance
Review
of
Compounds
Known
as
Fatty
Acids,
Fatty
Acid
Salts,
and
Fatty
Acid
Esters,
and
Fatty
Acid
Derivatives
Classified
as
Inert
Ingredients
in
Terrestrial
and/
or
Aquatic
Agricultural
and
Non­
Agricultural
Uses
@.
Memorandum
from
S.
C.
Termes/
H.
Craven,
Environmental
Fate
and
Effects
Division
(
EFED)
to
M.
Perry,
Special
Review
and
Reregistration
Division
(
SRRD).
May
15,
2002.
19
U.
S.
Environmental
Protection
Agency
(
EPA)
2003.
Salts
of
Fatty
Acids:
Antimicrobials
Division
Science
Assessment
Document
for
Tolerance
Reassessment.
Memorandum
from
D.
Smegal
to
K.
Boyle,
Chair
of
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group.
September
25,
2003.
20
ATTACHMENT
1
21
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
September
23,
2004
Subject:
Similarity
of
Linear
Alkylbenzene
Sulfonates
and
Alcohol
Sulfates
to
Sulfonated
Oleic
Acid
with
Respect
to
Toxicity
Barcode:
D308387
FROM:
Timothy
F.
McMahon,
Ph.
D.
Chair,
Antimicrobials
Division
Toxicity
Endpoint
Selection
Committee
Antimicrobials
Division,
OPP
TO:
Deborah
Smegal,
Risk
Assessor
Antimicrobials
Division,
OPP
This
memorandum
addresses
data
cited
by
the
Registrant
Johnson
Diversey
in
support
of
the
RED
for
sulfonated
oleic
acid
and
issues
raised
with
respect
to
the
bridging
of
toxicity
data
from
linear
alkylbenzene
sulfonates
and
alcohol
sulfates
to
sulfonated
oleic
acid.

In
conclusion,
the
Agency
believes
that
there
are
insufficient
information
at
this
time
to
bridge
the
toxicity
data
for
linear
alkylbenzene
sulfonates
and
alcohol
sulfates
to
the
oleic
acid
sulfonates
and
its
sodium
salt.
At
a
minimum,
a
mutagenicity
battery
(
bacterial
reverse
mutation
assay,
in
vitro
mammalian
gene
mutation,
and
in
vivo
cytogenetics
study),
a
90­
day
oral
rat
study,
and
an
oral
developmental
toxicity
study
would
be
required
for
oleic
acid,
sulfonated,
sodium
salt
to
demonstrate
that
these
chemicals
are
toxicologically
similar.
22
Background:

Oleic
acid,
sulfonated,
sodium
salt,
is
a
pesticidal
active
ingredient
currently
being
reassessed
as
part
of
reregistration.
There
are
very
few
toxicity
data
available
for
this
chemical,
which
are
limited
to
acute
toxicity
data
(
acute
oral,
dermal,
and
inhalation
studies
and
dermal
irritation,
and
eye
irritation
studies).
These
data
indicate
low
acute
toxicity
and
that
sulfonated
oleic
acid,
sodium
salt
is
a
dermal
and
eye
irritant.

On
February
25,
2003,
the
Antimicrobials
Division
=

s
Toxicity
Endpoint
Selection
Committee
(
ADTC)
met
to
discuss
toxicology
data
for
sulfonated
oleic
acid
and
discussed
endpoint
selection
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
This
meeting
was
held
as
part
of
the
development
of
the
risk
assessment
for
the
Reregistration
Eligibility
Decision
for
sulfonated
oleic
acid.

At
the
ADTC
meeting,
the
committee
concluded
that
sulfonated
oleic
acid
was
related
to
oleic
acid
itself,
a
fatty
acid
that
has
been
determined
to
be
of
low
toxicity
by
OPP
=

s
Low
Risk
Focus
Group
and
that
has
received
food
additive
clearances
by
the
Food
and
Drug
Administration
(
FDA)
without
limitation,
supporting
the
low
toxicity
of
this
chemical.
Therefore,
there
is
no
risk
of
concern
from
the
uses
of
sulfonated
oleic
acid
as
an
antimicrobial
pesticidal
active
ingredient
(
as
an
indirect
food­
contact
sanitizer
in
milking
equipment,
food
processing,
handling,
and
storage
areas,
breweries,
milk
processing
plants,
meat
processing
plants,
and
beverage
processing
plants),
and
no
toxicity
endpoints
are
needed.

Registrant
Submission:

Recently,
a
submission
was
made
by
one
of
the
registrants
supporting
sulfonated
oleic
acid
(
Johnson
Diversey
2004),
in
which
it
was
stated
that
A
the
acute
and
chronic
toxicity
of
[
sulfonated
oleic
acid]
is
expected
to
be
similar
to
that
of
other
anionic
surfactants.@
Specifically,
the
registrant
states
that
A
We
believe
that
the
overall
toxicity
of
[
sulfonated
oleic
acid]
will
be
similar
to
that
of
both
the
alcohol
sulfates
and
linear
alkyl
benzene.
[
Sulfonated
oleic
acid]
is
structurally
similar
to
both
the
alcohol
sulfates
and
linear
alkyl
benzene
and
is
likely
metabolized
and
excreted
by
similar
mechanisms.
Additional
testing
to
further
characterize
the
toxicity
of
oleic
acid
sulfonate
is
not
necessary.@

The
OPP
has
no
formal
toxicology
studies
for
sulfonated
oleic
acid
(
except
the
acute
toxicity
studies)
but
initially
relied
on
the
similarity
of
this
chemical
to
oleic
acid
itself,
which
has
shown
a
low
order
of
toxicity
from
available
data,
analysis
by
the
Low
Risk
Focus
Group
in
OPP,
and
existing
food
additive
clearances
by
the
FDA.
However,
data
are
presented
in
the
Human
and
Environmental
Risk
Assessment
(
HERA)
documents
that
the
registrant
claims
can
be
used
to
support
the
hazard
of
sulfonated
oleic
acid
(
available
at
www.
heraproject.
com).
A
summary
is
presented
for
both,
taken
from
the
HERA
assessments.
23
Linear
Alkylbenzene
Sulfonates
Acute
toxicity
data
for
the
linear
alkylbenzene
sulfonates
(
LAS)
show
a
low
order
of
toxicity
for
acute
oral
toxicity
(
LD50
values
from
1086­
1980
mg/
kg)
and
dermal
toxicity
(
LD50
of
>
2000
mg/
kg),
some
skin
irritation
potential
(
moderately
irritating
at
5%)
and
significant
eye
irritation
using
a
47%
solution,
non­
irritating
at
1%,
and
no
dermal
sensitization
potential.
Acute
inhalation
data
are
inconclusive
but
showed
no
effect
up
to
260
mg/
m3
(
HERA
2004).

Non­
acute
testing
shows
effects
on
the
liver
and
kidney,
as
summarized
from
the
report
below:

Summary
of
Repeated
Dose
Toxicity
Studies
for
Linear
Alkylbenzene
Sulfonate
Data
reproduced
from
http://
www.
heraproject.
com/
RiskAssessment.
cfm
This
table,
reproduced
from
the
risk
assessment
for
the
linear
alkyl
benzene
sulfonates,
shows
the
effect
levels
from
the
various
oral
toxicity
studies
cited
in
the
risk
assessment.
Although
not
indicated
in
this
table,
the
text
of
the
risk
assessment
indicated
effects
in
the
liver
and
kidney
from
oral
administration,
including
liver
weight
increase
at
250
mg/
kg/
day
(
Oser
et
al.,
1965),
degeneration
of
renal
tubules
at
115
mg/
kg/
day
(
Yoneyama
et
al.,
1972),
enzyme
changes
of
the
liver
and
kidneys
at
780
mg/
kg/
day
(
Yoneyama
et
al.,
1976),
increases
in
alkaline
phosphatase,
decreased
glucose­
6­
phosphatase
and
glucose­
6­
phosphate
dehydrogenase,
increased
isocitrate
dehydrogeanse
at
750
mg/
kg/
day
(
Ikawa
et
al.,
1978),
and
hepatic
damage
at
20
mg/
kg/
day
in
24
mice
(
Watari
et
al.,
1977)
(
HERA
2004).

It
should
be
noted
also
from
these
data
that
the
NOAEL
values
vary
widely,
without
an
obvious
explanation.
It
could
be
based
upon
the
use
of
compounds
of
this
class
of
varying
chain
lengths
(
as
noted
in
the
HERA
assessment,
A
commercial
LAS
consists
of
more
than
20
individual
components
@)
.

In
vitro
mutagenicity
tests
conducted
with
LAS
(
Ames
Salmonella,
recombination
assay
with
bacillus
subtilis,
reverse
mutation
with
E.
coli)
were
negative,
as
were
in
vivo
mutagenicity
assays
(
chromosomal
aberration
test,
dominant
lethal
assay,
micronucleus
assay).

A
summary
of
developmental
and
reproductive
toxicity
studies
for
LAS
was
also
presented
in
the
HERA
document
and
is
shown
below.
These
data
show
Maternal
NOAEL
values
from
oral
studies
ranging
from
10
mg/
kg/
day
in
mice
to
780
mg/
kg/
day
in
rat
oral
studies,
with
LOAELs
ranging
from
100
to
3330
mg/
kg/
day.
There
are
no
apparent
developmental
NOAELs
that
are
below
the
maternal
NOAELs,
but
only
summary
data
are
provided
in
the
HERA
assessment
(
2004).
Oral
NOAELs
for
teratogenicity
ranged
from
135
to
600
mg/
kg/
day,
with
a
LOAEL
of
600
mg/
kg/
day
identified
in
one
study.
Dermal
developmental
maternal
NOAELs
range
from
0.9
to
150
mg/
kg/
day,
while
maternal
LOAELs
range
from
9
to
1500
mg/
kg/
day,
possibly
suggesting
the
LAS
may
be
more
toxic
via
the
dermal
route
of
exposure
in
some
studies.
25
Alcohol
Sulfates
With
respect
to
the
alcohol
sulfates,
from
the
summary
of
toxicity
data
in
the
HERA
(
2002)
assessment,
a
similar
low
order
of
acute
toxicity
is
observed
as
with
the
linear
alkylbenzene
sulfonates.
Oral
LD50
values
are
reported
as
ranging
from
1.4
to
>
8
g/
kg.
Acute
dermal
LD50
values
were
not
available
but
testing
up
to
500
mg/
kg
did
not
cause
mortality
in
rabbits.
As
with
the
linear
alkylbenzene
sulfonates,
skin
and
eye
irritation
are
observed
with
the
alcohol
sulfates
at
concentrations
of
5­
10%
and
above.
No
dermal
sensitization
is
reported
for
this
class
of
chemicals.

Toxic
effects
are
observed
from
repeated
dose
administration
of
alcohol
sulfates.
These
data
are
again
reproduced
from
the
HERA
risk
assessment
below:

Data
reproduced
from
http://
www.
heraproject.
com/
RiskAssessment.
cfm
26
As
for
the
linear
alkylbenzene
sulfonates,
the
alcohol
sulfates
also
show
effects
on
the
liver
from
repeated
dose
toxicity
studies
at
doses
which
could
be
considered
for
setting
toxicity
endpoints
of
concern.
There
is
less
variation
in
NOAEL
values
compared
to
the
linear
alkylbenzene
sulfonates
but
consistent
effects
on
the
liver
are
noted.

With
regard
to
developmental
and
reproductive
toxicity
of
alcohol
sulfates,
only
one
reproductive
toxicity
study
was
available
for
what
is
claimed
to
be
a
structurally­
related
compound,
alpha
olefin
sulfonate.
The
summary
of
this
study
indicates
no
significant
treatment­
related
effects
up
to
250
mg/
kg/
day
in
a
2­
generation
study.
One
published
developmental
toxicity
study
was
available
for
alcohol
sulfate
which
was
tested
up
to
600
mg/
kg/
day
by
oral
gavage
in
rats,
mice,
and
rabbits
(
Palmer
et
al.,
1975,
in
http://
www.
heraproject.
com/
RiskAssessment.
cfm)
and
which
reported
a
maternal
NOAEL
of
2
mg/
kg/
day
for
all
species
and
developmental
NOAELs
of
300
mg/
kg/
day
in
rabbits
and
mice
and
600
mg/
kg/
day
in
rats.

With
respect
to
mutagenicity,
data
on
in
vitro
and
in
vivo
mutagenicity
tests
were
summarized
in
an
Appendix
to
the
HERA
document.
As
the
data
are
extensive,
they
are
not
reproduced
here.
However,
in
summary,
it
is
noted
that
most
of
the
studies
show
negative
results.
There
are
some
data
indicating
a
positive
response,
for
example,
in
an
in
vivo
chromosome
aberration
test
in
hamsters,
a
dose
of
2.5
g/
kg
showed
marginal
but
statistically
significant
increases
in
chromatid
gaps
in
high
dose
females.
In
a
rodent
dominant
lethal
assay
at
doses
of
210/
300,
960/
980,
and
3050/
3010
mg/
kg/
day,
decreased
pregnancy
frequency
and
increased
early
embryonic
deaths
were
observed
at
week
four
of
an
8­
week
study,
although
the
dose
causing
this
effect
was
not
noted
in
the
summary.
The
nature
of
the
positive
response
may
be
based
upon
a
non­
specific
disruption
of
cell
membranes
by
a
high
concentration
of
the
surfactant
and
not
a
specific
mechanism.

Conclusions
The
data
cited
by
the
Registrant
in
support
of
characterizing
the
toxicity
of
sulfonated
oleic
acid
raises
several
issues
with
respect
to
the
risk
from
exposure
to
sulfonated
oleic
acid:

1)
The
position
by
the
Registrant
that
sulfonated
oleic
acid
is
biotransformed
(
metabolized
and
excreted)
in
a
manner
similar
to
the
alcohol
sulfates
and/
or
linear
alkylbenzene
sulfonates
is
not
supported
by
actual
data
but
only
by
modeling
results.
An
actual
metabolism
study
would
be
helpful
in
addressing
this
issue.

2)
The
observation
of
liver
and
kidney
toxicity
from
administration
of
the
alcohol
sulfates
and
the
linear
alkylbenzene
sulfonates,
as
shown
in
the
summary
tables
included
in
this
memorandum,
raises
questions
regarding
the
potential
for
sulfonated
oleic
acid
to
produce
similar
effects.
In
addition,
the
range
of
NOAEL
values
observed
for
both
the
results
of
testing
of
both
classes
of
chemicals
makes
it
difficult
to
compare
results
for
a
single
chemical
entity
(
i.
e.
sulfonated
oleic
acid)
with
chemical
classes
composed
of
more
than
one
component.
In
order
to
determine
whether
there
is
any
similarity,
some
side­
by­
side
toxicity
comparisons
would
need
to
be
conducted
with
sulfonated
oleic
acid
and
the
linear
alkylbenzene
sulfonates
and
alcohol
sulfates
to
conclude
with
any
certainty
27
that
data
can
be
bridged
from
the
alcohol
sulfates
and/
or
linear
alkylbenzene
sulfonates.
A
minimum
data
set
of
one
oral
90­
day
rodent
study
and
an
oral
developmental
study,
in
addition
to
the
mutagenicity
battery
(
bacterial
reverse
mutation
assay,
in
vitro
mammalian
gene
mutation
assay
and
in
vivo
cytogenetics
study)
are
required
to
determine
if
bridging
is
feasible.

Alternately,
toxicology
data
on
sulfonated
oleic
acid
could
be
developed
to
meet
the
data
requirements
in
support
of
the
registered
uses
as
a
food­
contact
sanitizer.
This
would
include
(
in
addition
to
the
acute
toxicity
data
and
standard
mutagenicity
battery)
a
developmental
toxicity
study
in
the
rat,
a
2­
generation
reproduction
toxicity
study
in
the
rat,
and
subchronic
toxicity
studies
in
the
rodent
and
non­
rodent
to
support
the
indirect
food
uses
for
this
active
ingredient.

3)
As
with
the
repeated
dose
toxicity
data,
the
available
data
on
developmental
toxicity
and
reproductive
toxicity
show
NOAELs
over
a
range
of
doses
but
no
actual
data
on
sulfonated
oleic
acid
for
comparison.
Thus,
a
determination
of
an
FQPA
safety
assessment,
as
needed
for
the
indirect
food
uses
of
sulfonated
oleic
acid,
could
only
be
addressed
through
generation
of
data
relevant
for
bridging
as
noted
above
or
generation
of
data
specific
to
sulfonated
oleic
acid
to
fulfill
data
requirements
for
the
uses
being
supported
in
the
RED.

References:

Human
and
Environmental
Risk
Assessment
(
HERA).
2004.
Linear
Alkylbenzene
Sulphonate
(
CAS
No.
68411­
30­
3).
May
2004.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
Human
and
Environmental
Risk
Assessment
(
HERA).
2002.
Human
and
Environmental
Risk
Assessment
on
the
ingredients
of
European
household
cleaning
products.
Alcohol
Sulphates
Human
Health
Risk
Assessment.
Draft.
December
2002.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
JohnsonDiversey
2004.
Memorandum
from
F.
Heitfeld
to
L.
Amadio.
Toxicity
Review
of
Sulfonated
Oleic
Acid,
Sodium
Salt.
September
2,
2004.