Document ID: EPA-HQ-OPP-2005-0487-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-25T05:00Z

Page
1
of
22
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
27,
2003
MEMORANDUM
FROM:
Kathryn
Boyle,
Chair
Lower
Toxicity
Pesticide
Chemical
Focus
Group
Registration
Division
TO:
Susan
Lewis,
Acting
Chief
Minor
Use,
Inerts,
and
Emergency
Response
Branch
Registration
Division
SUBJECT:
Recommendation
for
Tolerance
Reassessment
The
attached
science
assessment
discusses
the
toxicity
of
various
salts
of
various
fatty
acids.
In
the
human
body,
these
salts
tend
to
dissociate
and
thus
tend
to
react
in
the
body
as
the
anion
(
the
fatty
acid)
and
the
cation
(
sodium,
potassium,
magnesium,
calcium,
or
aluminum.)
Based
on
the
available
information
on
fatty
acids
(
including
the
previous
Agency­
performed
assessments);
the
required
roles
of
sodium,
potassium,
magnesium,
and
calcium
in
the
proper
functioning
of
the
human
body;
and
an
understanding
of
the
body's
metabolism
of
aluminum
salts,
a
qualitative
assessment
was
performed.

Based
on
its
review
and
evaluation
of
the
available
information,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
residues
of
the
various
salts
of
various
fatty
acids
from
their
uses
as
inert
ingredients
in
pesticide
products.
The
following
exemptions
from
the
requirement
of
a
tolerance
as
established
in
40
CFR
180.1001
(
c)
are
reassessed:
Salts
of
fatty
acids,
(
conforming
to
21
CFR
172.863),
Soap
(
sodium
or
potassium
salts
of
fatty
acids),
and
Aluminum
stearate.

Based
on
the
body's
ready
ability
to
metabolize
the
sodium,
potassium,
magnesium,
and
calcium
salts
of
the
C
8
to
C
18
fatty
acids,
the
following
chemical
substances
are
classified
as
List
4A:
Page
2
of
22
sodium,
potassium,
magnesium,
and
calcium
salts
of
n­
octanoic
acid
(
C8
with
no
branching:
caprylic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
decanoic
acid
(
C10:
capric
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
dodecanoic
acid
(
C12,
saturated:
lauric
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
tetradecanoic
acid
(
C14,
saturated:
myristic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
hexadecanoic
acid
(
C16,
saturated:
palmitic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
(
Z)­
9­
hexadecenoic
acid
(
C16,
unsaturated:
palmitoleic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
1­
octadecanoic
acid
(
C18,
saturated:
stearic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
cis­
9­
octadecenoic
acid
(
C18,
unsaturated:
oleic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
9,12­
Octadecadienoic
acid
(
9Z,
12Z)­
(
C18,
unsaturated:
linoleic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
9,12,15­
Octa­
decatrienoic
acid,
(
9Z,
12Z,
15Z)­
(
C18,
unsaturated:
linolenic
acid)

sodium,
potassium,
magnesium,
and
calcium
salts
of
9­
Octadecenoic
acid,
12­
hydroxy­,
(
R­(
Z))­
(
C18,
unsaturated:
ricinoleic
acid)

Based
on
aquatic
toxicity
concerns,
the
following
chemical
substances
are
classified
as
List
4B:

n­
octanoic
acid,
aluminum
salt
decanoic
acid,
aluminum
salt
dodecanoic
acid,
aluminum
salt
tetradecanoic
acid,
aluminum
salt
hexadecanoic
acid,
aluminum
salt
(
Z)­
9­
hexadecenoic
acid,
aluminum
salt
1­
octadecanoic
acid,
aluminum
salt
cis­
9­
octadecenoic
acid,
aluminum
salt
9,12­
Octadecadienoic
acid
(
9Z,
12Z)­,
aluminum
salt
Page
3
of
22
9,12,15­
Octa­
decatrienoic
acid,
(
9Z,
12Z,
15Z)­,
aluminum
salt
9­
Octadecenoic
acid,
12­
hydroxy­,
(
R­(
Z))­,
aluminum
salt
Page
4
of
22
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
25,
2003
Memorandum
Subject:
Salts
of
Fatty
Acids:
Antimicrobials
Division
Science
Assessment
Document
for
Tolerance
Reassessment.

From:
Deborah
Smegal,
Risk
Assessor
Risk
Assessment
and
Science
Support
Branch
(
RASSB)
Antimicrobials
Division
(
7510C)

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

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

Background:

Attached
is
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group's
science
assessment
for
salts
of
fatty
acids.
The
purpose
of
this
review
is
a
reassessment
of
the
exemption
from
the
requirement
of
a
tolerance.
This
assessment
summarizes
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
exposure
profile,
and
environmental
fate
and
ecotoxicity
of
these
fatty
acid
salts.
In
performing
this
assessment,
EPA
has
utilized
reviews
previously
performed
by
EPA
and
relied
on
peer­
reviewed
evaluations
performed
by
the
Food
and
Drug
Administration
(
FDA),
Food
and
Agriculture
Organization
of
the
World
Health
Organization
(
FAO/
WHO),
and
the
Cosmetic
Ingredient
Review
(
CIR)
expert
panel.

This
assessment
builds
on
the
previous
tolerance
reassessments
described
in
the
following
documents:

a)
The
tolerance
exemptions
for
calcium
stearate
(
40
CFR
180.1001
(
c)
(
e))
and
magnesium
Page
5
of
22
stearate
(
40
CFR
180.1001
(
c))
were
reassessed
in
the
IIFG
Decision
Document
"
Various
Salts
of
Stearic
Acid",
dated
July
31,
2002.
They
are
classified
as
List
4B.

(
b)
The
tolerance
exemptions
for
fatty
acids
(
40
CFR
180.1001
(
c))
were
reassessed
in
the
IIFG
Decision
Document
"
Fatty
Acids",
dated
July
31,
2002.

I.
Executive
Summary:

The
salts
of
fatty
acids
evaluated
in
this
report
include
the
aluminum,
calcium,
magnesium,
potassium,
and
sodium
salts
of
caprylic,
capric,
lauric,
myristic,
palmitic,
oleic
and
stearic
acids
which
contain
between
eight
and
18
carbons
(
C
8
­
C
18
).
Exposure
to
fatty
acid
salts
may
come
from
a
wide
variety
of
sources,
including
(
but
not
limited
to)
FDA­
approved
uses
as
food
additives,
in
food
packaging
products,
or
through
its
use
in
soaps,
household
cleaning
products,
and
other
cosmetic
products.
Fatty
acids
are
present
in
common
fats
and
oils,
which
are
a
major
source
of
calories
in
the
human
diet,
accounting
for
between
30
and
40%
of
dietary
intake
in
the
U.
S.
The
fatty
acids
normally
are
metabolized,
forming
simple
compounds
that
serve
as
energy
sources
and
structural
components
used
in
all
living
cells.
The
Joint
FAO/
WHO
Expert
Committee
on
food
additives
has
evaluated
most
of
these
fatty
acid
salts
and
assigned
a
"
not
limited"
acceptable
daily
intake
(
ADI)
for
many
of
these
compounds
when
used
as
food
additives.

The
physical,
chemical
and
environmental
behavior
of
fatty
acid
salts
are
dominated
by
the
fatty
acid
groups.
These
compounds
are
insoluble
in
water,
and
exist
primarily
as
dimers
and
complex
arrays.
In
the
human
body,
these
salts
tend
to
dissociate
and
thus,
for
the
most
part,
react
in
the
body
as
the
anion
and
the
cation.
The
human
body
can
effectively
metabolize
the
fatty
acids
and
cations.
Even
if
these
fatty
acid
salts
do
not
dissociate,
it
is
likely
they
will
be
metabolized
within
the
human
body.

The
available
ecotoxicity
data
for
fatty
acid
salts
indicate
that
these
compounds
are
very
highly
toxic
to
fish
and
other
aquatic
organisms,
but
are
relatively
non­
toxic
to
birds.
However,
these
compounds
are
immobile,
bind
tightly
to
sediment
and
soils
and
undergo
rapid
microbial
degradation,
which
is
expected
to
mitigate
any
potential
for
risk.
Fatty
acids
are
also
a
significant
part
of
the
normal
daily
diet
of
mammals,
birds,
and
invertebrates.
EPA
believes
that
the
fatty
acid
salts
will
not
cause
unreasonable
adverse
effects
on
the
environment.

Based
on
available
information
on
the
salts
of
fatty
acids,
their
expected
use
patterns,
their
safe
history
of
use
as
food
additives,
their
dissociation
to
fatty
acids
and
cations
that
the
body
can
effectively
metabolize,
extensive
use
in
commercially­
available
cosmetics
and
soaps,
and
their
low
toxicity,
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
has
determined
that
a
quantitative
risk
assessment
is
not
required
for
these
compounds.

II.
Use
Information:

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.
Page
6
of
22
Table
1
Tolerance
Exemptions
Being
Reassessed
in
this
Document
Tolerance
Exemption
Expression
40
CFR
Use
Pattern
(
Pesticidal)

salts
of
fatty
acids,
(
conforming
to
21
CFR
172.863)
180.1001
(
c)
binder,
emulsifier,
anticaking
agent
soap
(
sodium
or
potassium
salts
of
fatty
acids)
180.1001
(
c)
surfactant,
emulsifier,
wetting
agent
aluminum
stearate
180.1001
(
c)
surfactant
C12­
C18
fatty
potassium
salts
180.1068
insecticide,
acaricide,
herbicide,
algaecide
Soaps
are
mineral
salts
of
naturally
occurring
fatty
acids.
Thus,
this
tolerance
exemption
covers
the
various
sodium
and
potassium
salts
of
the
fatty
acids.
Most
fatty
acid
salts
are
not
a
pure,
single
fatty
acid
with
only
one
chain
length
(
i.
e.,
a
C
10
fatty
acid,
decanoic
acid,
also
called
capric
acid);
rather,
these
substances
typically
consist
of
a
mixture
of
salts
of
various
fatty
acids.
The
salts
of
fatty
acids
(
conforming
to
21
CFR
172.863)
is
defined
as
one
or
any
mixture
of
two
or
more
of
the
aluminum,
calcium,
magnesium,
potassium
and
sodium
salts
of
caprylic,
capric,
lauric,
myristic,
palmitic,
oleic,
and
stearic
acids.

The
following
Table
describes
the
fatty
acid
salts
(
conforming
to
21
CFR
172.863)
evaluated
in
this
document:

Table
2
Salts
of
fatty
acids
(
conforming
to
21
CFR
172.863)
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
(
a)
PC
Code
List
Classification
aluminum
caprylate
n­
Octanoic
acid,
aluminum
salt
6028­
57­
5
900214
3
aluminum
caprate
Decanoic
acid,
aluminum
salt
22620­
93­
5
 
 

aluminum
laurate
Dodecanoic
acid,
aluminum
salt
7230­
93­
5
 
 

aluminum
myristate
Tetradecanoic
acid,
aluminum
salt
4040­
50­
0
 
 

aluminum
palmitate
Hexadecanoic
acid,
aluminum
salt
555­
35­
1
 
 

aluminum
oleate
9­
Octadecenoic
acid
(
Z)­,
aluminum
salt
688­
37­
9
 
­­

aluminum
stearate
Octadecanoic
acid,
aluminum
salt
637­
12­
7
800147
4B
Table
2
Salts
of
fatty
acids
(
conforming
to
21
CFR
172.863)
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
(
a)
PC
Code
List
Classification
Page
7
of
22
calcium
caprylate
n­
Octanoic
acid,
calcium
salt
6107­
56­
8
900671
calcium
octanoate
4B
calcium
caprate
Decanoic
acid,
calcium
salt
13747­
30­
3
­­
­­

calcium
laurate
Dodecanoic
acid,
calcium
salt
4696­
56­
4
­­
­­

calcium
myristate
Tetradecanoic
acid,
calcium
salt
15284­
51­
2
­­
­­

calcium
palmitate
Hexadecanoic
acid,
calcium
salt
542­
42­
7
­­
­­

calcium
oleate
9­
Octadecenoic
acid
(
Z)­,
calcium
salt
142­
17­
6
­­
­­

calcium
stearate
previously
reassessed
magnesium
caprylate
n­
Octanoic
acid,
magnesium
salt
3386­
57­
0
­­
­­

magnesium
caprate
Decanoic
acid,
magnesium
salt
42966­
30­
3
­­
­­

magnesium
laurate
Dodecanoic
acid,
magnesium
salt
4040­
48­
6
­­
­­

magnesium
myristate
Tetradecanoic
acid,
magnesium
salt
4086­
70­
8
­­
­­

magnesium
palmitate
Hexadecanoic
acid,
magnesium
salt
2601­
98­
1
­­
­­

magnesium
oleate
9­
Octadecenoic
acid
(
Z)­,
magnesium
salt
1555­
53­
9
­­
­­

magnesium
stearate
previously
reassessed
potassium
caprylate
n­
Octanoic
acid,
potassium
salt
764­
71­
6
900851
3
["
potassium
octoate"]

potassium
caprate
Decanoic
acid,
potassium
salt
13040­
18­
1
­­
­­

potassium
laurate
Dodecanoic
acid,
potassium
salt
67701­
09­
1;
4040­
48­
6;
10124­
65­
9
079021
­­

potassium
myristate
Tetradecanoic
acid,
potassium
salt
13429­
27­
1
779022
3
potassium
palmitate
Hexadecanoic
acid,
potassium
salt
2624­
31­
9
­­
­­

potassium
oleate
9­
Octadecenoic
acid
(
Z)­,
potassium
salt
143­
18­
0
079095
4B
potassium
stearate
Octadecanoic
acid,
potassium
salt
593­
29­
3
900073
4B
sodium
caprylate
n­
Octanoic
acid,
sodium
salt
1984­
06­
1
ai:
079063
inert:
900463
3
Table
2
Salts
of
fatty
acids
(
conforming
to
21
CFR
172.863)
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
(
a)
PC
Code
List
Classification
Page
8
of
22
sodium
caprate
Decanoic
acid,
sodium
salt
1002­
62­
6
­­
­­

sodium
laurate
Dodecanoic
acid,
sodium
salt
629­
25­
4
079026
­­

sodium
myristate
Tetradecanoic
acid,
sodium
salt
822­
12­
8
­­
­­

sodium
palmitate
Hexadecanoic
acid,
sodium
salt
408­
35­
5
­­
­­

sodium
oleate
9­
Octadecenoic
acid
(
Z)­,
sodium
salt
143­
19­
1
ai:
031704
inert:
800007
4B
sodium
stearate
Octadecanoic
acid,
sodium
salt
822­
16­
2
ai:
079070
inert:
800176
4B
(
a)
Source:
ChemIDplus,
part
of
TOXNET,
and
OPPIN,
where
available.

Table
3
Use
Pattern
(
pesticidal
­
active
ingredient)

Tolerance
Exemption
Expression
Active
PC
Code
Active
Use
Pattern
(
Pesticidal)

Food
Contact
Surface
Sanitizer
Solutions
Fatty
acids,
coco,
potassium
salts
079021
food
contact
sanitizing
solutions
Agricultural
Uses
C12­
C18
fatty
acid
potassium
salts
079021
insecticide,
acaricide,
herbicide,
and
algaecide
Use
in
Food
Contact
Surface
Sanitizing
Solutions
Salts
of
fatty
acids
(
i.
e.,
fatty
acids,
coco,
potassium
salts)
have
uses
in
food
contact
surface
sanitizing
solutions
as
specified
under
21
CFR
178.1010.
At
this
time,
there
is
a
proposed
rule
to
shift
these
substances
to
40
CFR.
The
predominant
fatty
acid
in
coconut
oil
is
lauric
acid,
with
minor
amounts
of
myristic,
caprylic,
capric,
palmitic,
stearic
and
oleic
acid.
Therefore,
the
potassium
salts
of
fatty
acids
derived
from
coconut
oil
would
be
potassium
laurate,
myristate,
caprylate,
caprate,
palmitate,
stearate,
and
oleate.
Information
for
these
fatty
acid
salts
was
previously
presented
on
Table
2.
Page
9
of
22
Agricultural
Uses
of
Fatty
Acids
Salts
C
12
­
C
18
fatty
acid
potassium
salts
(
including
potassium
laurate,
potassium
myristate,
potassium
oleate
and
potassium
ricinoleate).
These
salts
include
potassium
salts
of
the
following
fatty
acids:
lauric
(
C
12
,
saturated),
myristic
(
C
14
,
saturated),
palmitoleic
(
C
16
,
unsaturated),
palmitic
(
C
16
,
saturated),
linoleic
(
C
18
,
unsaturated),
oleic
(
C
18
,
unsaturated),
stearic
(
C
18
,
saturated),
and
linolenic
(
C
18
unsaturated)
acids.
Many
of
these
fatty
acid
salts
were
previously
presented
in
Table
2;
the
remaining
compounds
are
shown
in
Table
4.

Certain
potassium
salts
(
C
12
­
C
18
)
have
agricultural
uses
as
described
previously
in
Table
1.
Potassium
salts
of
fatty
acids
are
used
as
insecticides,
acaricides,
herbicides,
and
algaecides.
They
are
used
to
control
a
variety
of
insects
and
mosses,
algae,
lichens,
liverworts,
and
other
weeds,
in
or
on
many
food
and
feed
crops,
ornamental
flower
beds,
house
plants,
trees,
shrubs,
walks,
and
driveways,
and
on
dogs,
puppies,
and
cats
(
EPA
1992).

Table
4
Potassium
Fatty
Acid
Salts
Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
PC
Code
List
Classification
potassium
ricinoleate
9­
Octadecenoic
acid,
12­
hydroxy­,
monopotassium
salt,
(
R­(
Z))­
7492­
30­
0
ai:
079023
inert:
879023
3
potassium
linoleate
9,12­
Octadecadienoic
acid
(
9Z,
12Z)­,
potassium
salt
3414­
89­
9
­­
 

potassium
linolenate
9,12,15­
Octadecatrienoic
acid,
(
9Z,
12Z,
15Z)­,
potassium
salt
38660­
45­
6
­­
 

FDA
Uses
As
a
group,
the
fatty
acid
salts
are
approved
by
the
FDA
as
direct
food
additives
for
human
consumption
when
used
as
binders,
emulsifiers
and
anticaking
or
defoaming
agents
(
21
CFR
172.615,
21
CFR
172.863,
173.340,
CIR
1982,
FDA
1977).
Calcium
oleate,
potassium
oleate
and
stearate,
aluminum
mono­,
di
and
tristearate,
and
sodium
stearate
are
FDA­
approved
food
additives
that
act
as
a
stabilizer
when
migrating
from
food
packaging
material
(
21
CFR
181.29).
In
addition,
the
aluminum,
calcium,
magnesium,
potassium,
and
sodium
salts
of
fatty
acids
are
approved
for
use
as
indirect
food
additives
for
use
as
a
component
of
adhesives
(
21
CFR
175.105).
Additional
uses
for
specific
fatty
acids
and
salts
are
discussed
below.

Aluminum
salts:
Aluminum
oleate
and
palmitate
are
generally
recognized
as
safe
(
GRAS)
by
the
U.
S.
FDA
when
used
in
food
packaging,
as
substances
migrating
to
foods
from
paper
and
paperboard
products
(
21
CFR
182.90).

Sodium
salts:
Sodium
oleate
and
sodium
palmitate
are
generally
recognized
as
safe
(
GRAS)
by
the
U.
S.
FDA
when
used
as
substances
migrating
to
foods
from
paper
and
paperboard
Page
10
of
22
products
used
in
food
packaging
(
21
CFR
186.1770,
186.1771,
FDA
1977).

Fatty
Acids:
As
a
group,
caprylic,
capric,
lauric,
myristic,
palmitic,
stearic,
and
oleic
acids
are
classified
by
FDA
as
food
additives
permitted
for
direct
addition
to
food
for
human
consumption
when
used
as
lubricants,
binders
or
defoaming
agents
(
21
CFR
172.860).
Caprylic
acid
is
classified
as
a
direct
food
substance
affirmed
as
GRAS
when
used
as
a
flavoring
agent
and
adjuvant
under
good
manufacturing
practices
(
21
CFR
184.1025).
Oleic
acid
is
specified
as
GRAS
substance
when
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
(
21
CFR
182.90).
Stearic
acid
is
classified
as
a
direct
food
substance
affirmed
as
GRAS
when
used
as
a
flavoring
agent
and
adjuvant
under
good
manufacturing
practices
(
21
CFR
184.1090).

Table
5:
Use
Pattern
(
FDA
GRAS)

Chemical
GRAS
Citation
GRAS
Uses
aluminum
oleate
21
CFR
182.90
Stabilizer.
Substances
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
aluminum
palmitate
21
CFR
182.90
Substances
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
sodium
oleate
21
CFR
186.1771
Substances
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
sodium
palmitate
21
CFR
186.1771
Substances
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
Other
Uses
Aluminum
salts:
Aluminum
palmitate
is
used
in
waterproofing
leather,
paper,
textiles,
thickening
for
lubricating
oils,
and
as
a
gelling
agent
(
Sax
1987
as
cited
in
TOXNET
2003).
Aluminum
stearate,
distearate,
and
tristearate
are
used
in
cosmetics
for
increasing
the
viscosity
of
oils,
as
emulsifiers,
in
hair
grooming
products
to
impart
a
gel
structure,
as
water
repellents,
paint
and
varnish
driers,
and
as
waterproofing
agents
in
fabrics
and
ropes
(
CIR
1982).

The
Agency
notes
that
aluminum
stearate
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.
Page
11
of
22
Potassium
salts:
Potassium
stearate,
commonly
known
as
soap,
is
used
in
a
wide
range
of
household
and
industrial
cleaning
products.
It
is
also
used
as
a
component
of
chewing
gum
and
textile
softeners,
and
is
used
as
an
emulsifier
in
hand
creams
(
CIR
1982).
The
Agency
notes
that
potassium
oleate
is
included
on
the
HPV
Challenge
Program.

Sodium
salts:
Sodium
stearate,
classified
as
soap,
is
used
in
a
variety
of
household
and
cleaning
products,
and
as
a
waterproofing
and
gelling
agent,
a
stabilizer
in
plastics,
and
as
an
emulsifying
and
stiffening
agent
in
pharmaceuticals.
It
is
also
used
in
solid
fragrances
as
a
solidifying
agent,
in
hand
creams,
and
in
shampoos
as
a
soluble
soap
that
provides
both
thickness
and
opacity
(
CIR
1982).
Sodium
caprylate
and
sodium
stearate,
are
also
included
on
the
HPV
Challenge
Program.

III.
Physical/
Chemical
Properties:

The
physical,
chemical
and
environmental
behavior
of
fatty
acid
salts
are
dominated
by
the
fatty
acid
groups
(
EPA
2002,
EFED
memo
from
S.
Termes
to
M.
Perry).
As
a
group
the
solubilities,
vapor
pressures,
and
Henry's
Law
Constants
decrease
with
increasing
chain
length,
but
the
n­
octanol­
water
partition
coefficients
and
strength
of
binding
to
soils
increase
with
increasing
chain
length
(
EPA
2002,
EFED
memo).

Aluminum
stearate
compounds
are
insoluble
in
water,
immobile
and
bind
tightly
to
sediment.
Their
biodegradation
is
expected
to
be
similar
to
other
fatty
acids
(
approximately
3.5
days)
(
EPA
2002,
EFED
memo
from
S.
Termes
to
M.
Perry).
Other
fatty
acid
salts,
such
as
aluminum
oleate
is
also
insoluble
in
water
(
Sax
and
Lewis
1987
as
cited
in
TOXNET
2003).
However,
the
sodium
and
potassium
fatty
acid
salts
(
of
myristic,
palmitic
and
stearic
acids)
are
soluble
in
water
(
FDA
1974).

IV.
Hazard
Assessment:

The
key
toxicological
data
in
the
following
sections
were
obtained
from
ToxNet
(
www.
toxnet.
nlm.
nih.
gov)
and
other
websites,
such
as
FirstGov
(
www.
firstgov.
gov),
as
well
as
from
the
Cosmetic
Ingredient
Review
(
CIR)
safety
assessment,
FDA
GRAS
assessments,
Food
and
Agriculture
Organization
of
the
World
Health
Organization
(
FAO/
WHO)
evaluations,
and
Structure
Activity
Relationship
(
SAR)
Assessments.

In
the
human
body,
fatty
acid
salts
tend
to
dissociate
in
the
gastrointestinal
tract
and
thus,
for
the
most
part,
react
in
the
body
as
the
negatively
charged
anion
and
the
positively
charged
cation
(
i.
e.,
aluminum,
calcium,
magnesium,
potassium,
and
sodium).
The
human
body
can
effectively
metabolize
the
free
fatty
acids
and
cations.
The
FDA
concluded
that
the
sodium
salts
of
fatty
acids
are
toxicologically
indistinguishable
from
the
free
fatty
acids
when
consumed
in
small
amounts
(
FDA
1977).

In
the
sections
below,
the
available
toxicological
data
for
specific
fatty
acid
salts
via
the
oral,
dermal
and/
or
inhalation
routes
of
exposure
are
summarized
first,
followed
by
a
discussion
of
the
toxicity
of
fatty
acids
and
cations.
1
Aluminum,
calcium,
potassium,
magnesium
and
sodium
salts
of
capric,
caprylic,
lauric
acids,
and
aluminum
and
magnesium
salts
of
oleic
acids
were
evaluated
in
1985;
the
calcium,
magnesium,
potassium
and
sodium
salts
of
myristic,
palmitic
and
stearate
acids
were
evaluated
in
1974.

2calcium,
magnesium,
sodium
and
potassium
salts
of
myristic,
palmitic,
and
stearic
acids.

Page
12
of
22
A.
Toxicological
data
available
for
the
salts
of
fatty
acids:

The
Joint
FAO/
WHO
Expert
Committee
on
food
additives
(
1974,
1985)
has
evaluated
most
of
these
fatty
acid
salts,
1
and
assigned
a
"
not
limited"
acceptable
daily
intake
(
ADI)
for
many
of
these
compounds
as
food
additives.
In
addition,
the
Committee
noted
that
many
of
the
fatty
acid
salts
2
are
normal
products
of
metabolism
of
fats
and
their
metabolic
fate
is
well
established
(
WHO
1974).
OPP
has
previously
evaluated
the
ammonium,
calcium,
magnesium,
and
zinc
salts
of
stearic
acid
(
EPA
2002,
memo
dated
7/
31/
02).
These
salts
have
a
history
of
safe
use
as
either
direct
or
indirect
food
additives,
or
as
cosmetic
ingredients,
and
are
processed
by
known
metabolic
pathways
within
the
body.
Adequate
data
are
available
to
determine
that
the
use
of
these
materials
in
pesticide
products
is
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup
from
consumption
of
residues
of
salts
of
stearic
acid.
No
additional
information
is
needed
to
assess
their
safety.

Aluminum
fatty
acid
salts.
Aluminum
salts
may
cause
irritation
of
eyes,
and
mucous
membranes,
conjunctivitis,
dermatoses,
and
eczema.
Aluminum
salts
are
absorbed
in
small
amounts
from
digestive
tract
(
ToxNet
2003).
Aluminum
stearate
taken
orally
were
practically
nontoxic
to
rats
(
LD
50
>
5
g/
kg);
demonstrated
low
potential
for
acute
dermal
toxicity
when
applied
to
guinea
pigs
(
LD
50
>
3
g/
kg),
and
showed
minimal
irritation
to
eyes
and
skin
(
CIR
1982).

A
safety
assessment
of
aluminum
stearate,
distearate
and
tristearate
(
Journal
of
the
American
College
of
Toxicology,
1[
2])
by
an
expert
panel
of
the
CIR
was
performed
in
1982.
Acute
oral,
dermal,
skin
irritation
studies
were
available.
This
evaluation
concluded
that
these
materials
are
"
safe
as
cosmetic
ingredients
in
the
present
practices
of
use
and
concentration."
The
use
concentration
of
the
aluminum
stearate
in
cosmetic
products
varies
from
0.1
to
25
percent.

Calcium
fatty
acid
salts.
A
structure
activity
relationship
(
SAR)
for
calcium
octanoate
indicates
low
concern
for
human
health
hazard
and
predicted
poor
absorption
through
the
skin
and
good
absorption
via
the
gastrointestinal
tract
and
lungs
(
EPA
1995).

Potassium
fatty
acid
salts.
Potassium
salts
of
fatty
acids
(
e.
g.,
soap
salts)
are
of
low
toxicity
when
taken
orally
or
exposed
briefly
to
the
skin,
and
have
been
placed
in
Toxicity
Category
IV
for
these
acute
effects.
They
can
cause
mild
or
moderate
dermal
and
eye
irritation,
but
are
not
dermal
sensitizers.
On
human
skin,
2.5
mg
of
soap
for
24
hours
caused
moderate
irritation;
and
10
mg
of
soap
on
rabbit
skin
caused
mild
irritation.
On
human
skin,
11,800
mg
of
potassium
salt
of
palmitic
acid
was
irritating,
while
7,320
mg
of
potassium
salt
of
caprylic
acid
3
In
a
clinical
study
with
0.5%
sodium
stearate,
4/
20
subjects
demonstrated
minimal
to
moderate
skin
erythema.
In
a
21­
day
patch
test
with
10
subjects,
an
aqueous
"
bath
soap
and
detergent"
containing
0.1­
0.25%
sodium
stearate
caused
minimal
skin
irritation.
An
aqueous
solution
of
the
same
formulation
containing
0.3­
0.75%
sodium
stearate
caused
no
sensitization
in
100
subjects.

Page
13
of
22
was
irritating
(
EPA
1992,
soap
salt
RED).
In
humans,
effects
of
exposure
to
high
doses
of
sodium
and
potassium
soap
salts
may
include
nausea,
vomiting,
diarrhea,
mild
eye
irritation,
and
occupational
asthma.

Potassium
soap
salts
caused
reproductive
and
mutagenic
effects
when
administered
to
laboratory
animals
at
high
doses.
Potassium
salts
of
coconut
fatty
acids
given
to
pregnant
mice
on
days
2­
13
of
pregnancy
increased
post­
implantation
mortality
at
6
g/
kg
and
caused
musculoskeletal
system
abnormalities
at
600
mg/
kg.
Sodium
salt
of
caprylic
acid
caused
DNA
inhibition
of
guinea
pig
kidney
cells
at
600
µ
mol/
L
(
EPA
1992,
soap
salt
RED).

A
SAR
for
potassium
ricinoleate
indicates
low
concern
for
human
health
hazard
and
predicted
poor
absorption
through
the
skin
and
moderate
absorption
via
the
gastrointestinal
tract
and
lungs.
There
is
concern
for
adverse
effects
on
the
lungs
through
surfactant
activity
if
inhaled.
It
is
expected
to
be
an
irritant
to
the
mucous
membranes
(
EPA
1995).

Sodium
fatty
acid
salts:
As
noted
previously,
sodium
salts
of
oleic
and
palmitic
acids
are
classified
by
FDA
as
GRAS
substances
(
21
CFR
186.1771)
that
migrate
to
food
from
paper
and
paperboard
products
used
in
food
packaging.
A
1982
CIR
safety
assessment
of
sodium
stearate,
and
other
stearate
salts
concluded
that
these
materials
are
"
safe
as
cosmetic
ingredients
in
the
present
practices
of
use
and
concentration."
The
use
concentration
of
the
sodium
stearate
in
cosmetic
products
varies
from
0.1
to
25
percent.

Soaps,
such
as
sodium
stearate,
are
practically
non­
toxic
based
on
acute
oral
toxicity
studies
in
rats
(
LD
50
>
5
g/
kg)(
CIR
1982).
Sodium
palmitate
is
also
practically
nontoxic
to
slightly
toxic
in
acute
oral
rat
toxicity
studies
(
Gosselin
et
al.
1976
as
cited
in
Toxnet
2003).
Product
formulations
containing
sodium
stearate
have
a
low
potential
for
dermal
toxicity
(
LD
50
>
3
g/
kg);
rabbits
dermally
exposed
to
a
"
bath
soap
and
detergent"
formulation
containing
10­
25%
sodium
stearate
for
3
months
did
not
exhibit
adverse
effects
at
a
dose
of
2
g/
kg.
Sodium
stearate
is
nonirritating
to
the
skin
of
rabbits
in
pure
form,
although
one
formulation
was
moderately
irritating
to
rabbits,
and
other
formulations
were
minimally
to
moderately
irritating
to
several
human
subjects
following
both
single
and
repeated
dermal
applications.
3
Sodium
stearate
is
a
minimal
to
mild
eye
irritant.
Dermal
sensitization
was
noted
in
individuals
dermally
exposed
to
a
formulated
product
(
deodorant
stick)
containing
7%
sodium
stearate,
but
not
in
individuals
exposed
to
a
more
diluted
"
bath
soap
and
detergent"
containing
0.3­
0.75%
sodium
stearate
(
CIR
1982).

A
few
animal
studies
have
investigated
the
toxicity
of
sodium
oleate.
In
one
study,
rats
administered
dietary
concentrations
of
22,000
mg/
kg/
day
sodium
oleate
exhibited
increased
Page
14
of
22
excitability
of
the
neuromuscular
system,
shortened
nerve
chronaxia,
and
increased
muscle
chronaxia
withing
48
hours.
The
authors
ascribed
the
effect
to
a
dietary
imbalance,
which
was
neutralized
by
the
addition
of
B
vitamins
(
FDA
1974,
1977).
In
another
study,
sodium
oleate
administered
in
the
drinking
water
of
50
sex/
F344
rats
for
108
weeks
at
concentrations
of
2.5
and
5%
caused
organ
weight
changes
in
the
liver
and
thymus,
but
did
not
result
in
any
other
significant
treatment­
related
differences
in
urine
or
serum
analyses,
hematological
parameters,
or
elevated
tumor
incidence
(
Hiasa
et
al.
1985
as
cited
in
TOXNET
2003).

Rabbits
fed
20
ml
of
a
2%
sodium
oleate
solution
(
1.2
g/
dose)
3
times
a
week,
simultaneously
with
cholesterol
for
3
months
showed
intensification
of
experimental
atherosclerosis
(
deposition
of
lipids
and
cholesterol
in
the
aorta).
The
authors
suggested
this
finding
was
due
to
increased
absorption
of
exogenous
cholesterol
and
decreased
excretion
of
endogenous
cholesterol
in
the
presence
of
oleic
acid
(
FDA
1974).

B.
Fatty
Acids
In
general,
fatty
acids
are
a
group
of
naturally
occurring,
monocarboxylic
acids
which
are
present
in
common
fats
and
oils
(
such
as
corn
oil,
peanut
oil,
and
butter)
as
triglycerides.
The
most
common
are
palmitic,
stearic,
and
oleic
acids.
A
triglyceride
is
composed
of
three
fatty
acid
molecules
and
a
single
molecule
of
glycerol
and
typically
make
up
greater
than
98%
of
most
fats
and
refined
oils.
Fats
and
oils
are
a
major
source
of
calories
in
the
human
diet,
commonly
comprising
between
30
and
40%
of
dietary
intake
in
the
United
States.
During
the
1990s,
average
per
capita
fat
consumption
in
the
U.
S.
ranged
from
60
to
about
100
grams/
day.
Stearic
acid,
for
example,
is
present
in
sunflower
oil
from
2­
10%,
palm
kernel
oil
from
10­
23%,
pork
fat
at
11%,
and
in
coconut
oil
and
butter
at
up
to
12%.
Once
fats
and
oils
are
consumed,
the
triglycerides
are
rapidly
hydrolyzed
in
the
human
body
into
glycerol
and
the
free
fatty
acids
(
such
as
stearic
acid).
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.

EPA
has
recently
evaluated
the
following
free
fatty
acids:
caprylic
acid,
capric
acid,
lauric
acid,
myristic
acid,
palmitic
acid,
stearic
acid,
and
oleic
acid
(
EPA
2002,
memo
dated
7/
31/
02).
As
noted
previously,
many
of
the
fatty
acids
are
classified
by
the
FDA
as
GRAS
substances.
These
fatty
acids
have
a
history
of
safe
use
as
natural
components
of
many
foods,
as
direct
food
additives,
and
as
cosmetic
ingredients.
Furthermore,
fatty
acids
are
processed
by
known
metabolic
pathways
within
the
body
and
contribute
to
normal
body
function.
Consumption
of
saturated
fatty
acids
contributes
to
cardiovascular
disease.
However,
dietary
consumption
of
fatty
acids
is
considered
an
individual
choice
and
not
necessarily
the
only
risk
factor
associated
with
such
disease.
Adequate
data
are
available
to
determine
that
the
use
of
these
fatty
acids
in
pesticide
products
is
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup
from
consumption
of
residues
of
fatty
acids.
No
additional
information
is
needed
to
assess
their
safety.

In
1999
the
FAO/
WHO
published
the
"
Evaluation
of
Certain
Food
Additives
and
Contaminants,
WHO/
FAS
49/
TRS
884"
which
addresses
a
group
of
flavoring
agents
including
caprylic,
capric,
lauric,
myristic,
palmitic,
and
stearic
acids.
This
evaluation
considered
acute
Page
15
of
22
toxicity,
reproductive/
developmental,
and
mutagenicity/
genotoxicity
studies
for
some
of
these
fatty
acids,
and
estimated
that
exposure
to
these
fatty
acids
(
as
flavoring
agents)
ranged
from
0.05
mg
(
stearic)
to
3.8
mg
(
caprylic)
per
person
per
day.
The
committee
concluded
that
"
the
substances
in
this
group
would
not
present
safety
concerns
at
the
current
level
of
intake."
While
considering
the
possibility
of
combined
(
or
simultaneous)
intake
of
these
flavoring
agents,
the
committee
stated
that
"
all
of
the
substances
in
this
group
and
their
metabolites
are
innocuous
and
endogenous,
and
their
combined
intake
was
judged
by
the
committee
not
to
give
rise
to
perturbations
outside
the
physiological
range."

A
1987
safety
assessment
of
oleic
acid,
lauric
acid,
palmitic
acid,
myristic
acid,
and
stearic
acid
(
Journal
of
the
American
College
of
Toxicology,
6[
3])
was
performed
by
an
expert
panel
of
the
Cosmetic
Ingredient
Review
(
CIR).
This
assessment
considered
numerous
toxicological
studies,
including
various
acute,
subchronic,
and
chronic/
carcinogenicity
toxicity
studies,
and
mutagenicity
studies.
This
report
also
details
extensive
use
of
these
fatty
acids
in
numerous
cosmetic
products
at
concentrations
ranging
from
1­
25
percent.
Based
on
the
available
information,
the
panel
concluded
that
"
oleic,
lauric,
palmitic,
myristic,
and
stearic
acids
are
safe
in
present
practices
of
use
and
concentration
in
cosmetics."

The
FDA
evaluated
the
toxicological
data
for
oleic
and
linoleic
acid
(
FDA
1977)
and
concluded
"
None
of
the
available
biological
information
indicates
that
these
substances
are
hazardous
to
man
or
animals
even
when
consumed
at
levels
that
are
orders
of
magnitude
greater
than
could
result
from
their
use
for
their
use
purposes
covered
in
this
report"
(
which
is
in
paper
and
packaging
materials,
and
as
a
nutrient
or
dietary
supplement,
respectively
for
oleic
acid
and
linoleic
acid).

A
SAR
for
fatty
acids,
coco,
hydrogenated,
indicates
low
concern
for
human
health
hazard
and
predicted
no
absorption
through
the
skin
and
poor
absorption
via
the
gastrointestinal
tract
and
lungs
(
EPA
1995).

C.
Cations:
Calcium,
Magnesium,
Potassium,
Sodium
and
Aluminum,

Cations
such
as
calcium,
magnesium,
potassium,
and
sodium
are
required
for
proper
functioning
of
human
biological
systems.
For
risk
assessment
purposes
an
important
feature
of
these
cations
is
that
overall
the
body
does
have
an
effective
means
of
processing
them.
The
primary
means
of
exposure
to
these
cations
is
ingestion.
Chemically,
sodium
and
potassium
belong
to
the
same
chemical
family:
calcium
and
magnesium
belong
to
a
different
chemical
family.
Potassium
and
sodium
are
part
of
the
body's
metabolism
and
electrolyte
balance.
Aluminum
is
one
of
the
most
ubiquitous
elements
in
the
environment.
It
is
common
in
diet,
and
daily
intake
in
adults
has
been
estimated
to
be
10
mg/
day.

Calcium:
The
human
body
burden
of
calcium
is
approximately
1
kg
for
a
70
kg
adult;
thus,
1/
70th
of
our
weight
is
calcium.
The
calcium
cation
is
necessary
for
bone
and
teeth
formation.
It
is
also
important
to
the
proper
functioning
of
nerves,
enzymes,
and
muscles,
and
plays
a
role
in
blood
clotting
and
the
maintenance
of
cell
membranes.
The
recommended
daily
allowances
(
RDAs)
for
calcium
are
1000
mg/
day
for
adults
aged
19
to
50
years,
and
1200
mg/
day
for
Page
16
of
22
individuals
older
than
50
years.

Magnesium:
The
human
body
burden
of
magnesium
is
approximately
20
g
for
a
70
kg
adult.
The
magnesium
cation
is
also
used
in
building
bones.
It
plays
a
role
in
releasing
energy
from
muscles
and
regulating
body
temperature.
The
RDA
is
310
to
320
mg/
day
for
adult
females,
and
400
to
420
mg/
day
for
adult
males,
with
the
RDA
increasing
with
increasing
age.

Potassium:
The
human
body
burden
of
potassium
is
approximately
140
g
for
a
70
kg
adult.
The
potassium
cation
is
important
in
regulating
blood
pressure,
regulating
cellular
water
content,
maintaining
proper
pH
balance,
and
transmission
of
nerve
impulses.
It
helps
to
regulate
the
electrical
activity
of
the
heart
and
muscles.
The
potassium
RDA
is
900
mg/
day.

Sodium:
The
human
body
burden
of
sodium
is
approximately
20
g
for
a
70
kg
adult.
The
sodium
cation
is
necessary
for
the
nerves
and
muscles
to
function
properly.
It
is
the
principal
cation
of
extracellular
fluid,
and
helps
to
maintain
the
body's
water
balance.
These
electrolytes,
the
electrically
charged
ions
in
the
body
fluids,
consist
to
a
great
extent
of
sodium
and
potassium.
There
is
no
Recommended
Dietary
Allowance
(
RDA)
for
sodium.

Aluminum:
The
general
effects
of
exposure
to
aluminum
and
aluminum
compounds
(
such
as
aluminum
stearate)
include
irritation
to
the
eyes,
mucous
membranes,
and
respiratory
tract.
Aluminum
compounds
are
not
expected
to
be
absorbed
through
the
skin
in
a
significant
quantity
(
ATSDR,
1999).
Oral
ingestion
of
aluminum
compounds
may
result
in
cramping
and/
or
nausea,
and
in
more
severe
instances,
vomiting
and/
or
hemorrhagic
gastroenteritis.
Death
from
ingestion
of
30
grams
aluminum
in
adults
and
two
to
four
grams
aluminum
in
children
has
been
reported;
ATSDR
(
1999)
estimates
the
average
daily
dose
of
aluminum
in
adults
to
be
approximately
10
mg
Al/
day,
with
some
estimates
as
high
as
100
mg
AL/
day.

Long­
term
industrial
exposure
to
aluminum
may
result
in
such
severe
pulmonary
reactions
as
fibrosis,
emphysema,
and
pneumothorax;
however,
factors
that
make
one
susceptible
to
lung
damage
from
aluminum
exposure
are
not
well
characterized
(
Gosselin,
R.
E.,
et
al.,
1984;
as
cited
in
TOXNET
2003).
Reported
adverse
effects
of
aluminum
exposure
are
often
the
result
of
very
high
aluminum
concentrations,
either
ingested
or
inhaled,
that
greatly
exceed
amounts
of
aluminum
found
under
more
normal
circumstances,
such
as
those
expected
from
pesticide
formulations
(
National
Research
Council,
1981;
as
cited
in
TOXNET
2003).

ATSDR
(
1999)
notes
that
"
there
is
sufficient
evidence
from
oral
studies
in
animals
to
conclude
that
aluminum
is
potentially
developmentally
toxic
in
humans,
especially
under
conditions
in
which
aluminum
is
particularly
bioavailable
or
in
which
renal
dysfunction
facilitates
aluminum
accumulation."

Aluminum
salts
are
poorly
absorbed
through
the
gastrointestinal
(
GI)
tract,
with
estimates
of
only
0.1
­
0.3%
aluminum
absorbed
under
normal
dietary
conditions.
This
low
absorption
rate
is
a
result
of
the
transformation
of
aluminum
salts
into
insoluble
aluminum
phosphate
in
the
digestive
tract,
caused
by
changes
in
pH
and
the
presence
of
phosphate
in
the
diet.
Unabsorbed
aluminum
is
mainly
excreted
via
the
feces.
Absorbed
aluminum
is
excreted
mainly
through
urine
Page
17
of
22
and
bile
(
ATSDR,
1999).
Aluminum
is
distributed
throughout
the
body
by
binding
to
ligands
in
the
blood.
The
highest
concentrations
of
aluminum
in
the
human
body
are
found
in
bone
and
lung
tissues
(
ATSDR,
1999).
A
steady­
state
of
uptake
and
elimination
of
aluminum
appears
to
be
maintained
in
healthy
adults
(
ATSDR,
1999).
In
healthy
individuals,
aluminum
does
not
appear
to
bioaccumulate.

Standard
mutagenic
assays
show
aluminum
compounds
to
be
non­
mutagenic
(
Friberg,
L.,
et
al.,
1986;
as
cited
in
TOXNET
2003).
Aluminum
is
not
classified
for
carcinogenicity
by
the
EPA,
and
animal
tests
have
not
shown
aluminum
to
be
carcinogenic
(
ATSDR,
1999).

D.
Special
Considerations
for
Infants
and
Children
At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

V.
Exposure
Assessment:

Exposure
to
fatty
acid
salts
may
be
through
FDA­
approved
uses
as
food
additives,
in
food
packaging
products,
or
through
its
use
in
soaps,
household
cleaning
products
and
other
cosmetic
products.
Fatty
acids
are
present
in
common
fats
and
oils,
which
are
a
major
source
of
calories
in
the
human
diet,
accounting
for
between
30
and
40%
of
dietary
intake
in
the
U.
S.

Residues
from
the
pesticide
uses
of
fatty
acid
salts
are
not
likely
to
exceed
levels
of
naturally
occurring
fatty
acids
in
commonly
eaten
foods.
In
addition,
the
use
of
fatty
acid
salts
in
pesticide
products
is
expected
to
result
in
much
lower
exposure
than
the
FDA­
regulated
use
of
these
compounds,
as
well
as
lower
exposure
than
the
use
in
cosmetics.
For
example,
cosmetic
products
containing
aluminum,
sodium,
and
potassium
stearate
may
be
used
from
once
a
week
up
to
several
times
a
day,
and
may
remain
in
contact
with
body
surfaces
for
a
few
minutes
(
hair
bleachers,
cleansing
creams)
to
as
long
as
a
few
days
(
moisturizing
creams)
(
CIR
1982).
The
fatty
acid
salts
are
of
low
toxicity
to
humans,
and
there
is
no
reason
to
expect
that
reasonable
use
will
constitute
any
significant
hazard.
Therefore,
a
quantitative
screening­
level
exposure
assessment
has
not
been
conducted.

VI.
Risk
Characterization:

The
fatty
acids
are
a
significant
part
of
the
normal
daily
diet,
for
they
occur
in
dietary
lipids
which
usually
constitute
about
90
grams
in
a
day's
diet.
As
previously
discussed
in
this
document,
there
are
many
FDA
approved
uses.
Residues
from
the
pesticide
uses
of
fatty
acid
salts
are
not
likely
to
exceed
levels
of
naturally
occurring
fatty
acids
in
commonly
eaten
foods.

Taking
into
consideration
all
available
information
on
fatty
acid
salts,
including
their
low
acute
toxicity
via
oral
and
dermal
routes,
FDA's
designation
of
certain
salts
of
fatty
acids
as
GRAS,
their
presence
in
food
products,
food
additives,
cosmetics,
and
cleaning
products,
as
well
as
the
significant
contribution
of
fatty
acids
in
the
diet,
the
uses
of
fatty
acid
salts
as
inert
and
Page
18
of
22
active
ingredients
in
pesticide
products
are
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup.
Exposures
from
the
aforementioned
uses
are
expected
to
result
in
human
exposure
below
any
dose
level
that
could
possibly
produce
an
adverse
effect.
As
a
result,
OPP
is
conducting
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
salts
of
fatty
acids.

As
noted
previously,
four
the
fatty
acid
salts
assessed
in
this
document,
aluminum
stearate,
potassium
oleate,
sodium
caprylate,
and
sodium
stearate,
are
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.
Based
on
the
available
toxicity
data
for
the
fatty
acid
salts,
the
Agency
feels
confident
in
proceeding
with
this
tolerance
reassessment
decision.
Any
submission
of
data
by
sponsors
of
aluminum
stearate,
potassium
oleate,
sodium
caprylate,
and
sodium
stearate
as
part
of
the
HPV
Challenge
Program
may,
in
the
future,
be
used
by
OPP
to
revise
or
update
their
tolerance
reassessment
decision
for
these
fatty
acid
salts
as
deemed
necessary
and
appropriate.

VII.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

Environmental
Fate
Characterization
Microbial
degradation
is
the
major
route
of
transformation
in
the
environment.
Adsorption
onto
soil
and
sediment
particulates
is
strong
and,
therefore,
there
is
limited
potential
to
reach
surface
water
by
dissolved
runoff
and/
or
leach
to
ground
water.
Volatilization
from
soils
and
water
is
not
likely
to
be
a
transport
process
in
the
environment.
Although
the
potential
to
bioaccumulate
is
high,
bioavailability
is
offset
by
the
tendency
to
adsorb
strongly
to
soil
and
sediment
particulates.
However,
concentration
at
the
water­
air
interface
is
likely
to
be
higher
than
in
the
water
column,
which
results
in
lowering
the
surface
tension
of
the
aqueous
system.
The
lowering
of
the
surface
tension
and
the
hydrophobic
layer
at
the
water­
air
interface
has
the
potential
to
alter
the
physical
and
chemical
characteristics
of
the
aquatic
environment.
As
a
group,
these
compounds
show
the
following
trends
with
increasing
chain
length:
decreasing
water
solubility,
decreasing
potential
for
volatilization,
greater
likelihood
to
partition
and
bind
to
soil
and
or
sediment
(
EPA
2002,
EFED
memo).

The
half­
life
of
potassium
fatty
acid
salts
is
estimated
to
be
less
than
one
day.
These
compounds
are
rapidly
degraded
in
soil
by
microbial
organisms,
and
do
not
persist
in
the
environment.
Soap
salts
cannot
dissipate
totally
in
soil,
however,
because
soil
has
a
natural
content
of
fatty
acids
resulting
from
plant
metabolism
and
microbial
action
(
EPA
1992,
soap
salt
RED).
Page
19
of
22
Ecotoxicity
and
Ecological
Risk
Characterization
The
only
ecotoxicity
data
for
fatty
acid
salts
are
limited
to
aluminum
stearate,
potassium
laurate,
and
potassium
fatty
acid
salts.
Based
on
this
limited
data
set,
these
compounds
appear
to
be
very
highly
toxic
to
fish
and
other
aquatic
organisms,
but
relatively
non­
toxic
to
birds.
However,
these
differences
in
toxicity
may
be
attributed
to
differences
in
routes
of
exposure,
where
the
gills
of
fish
are
exposed,
whereas
mammals
are
exposed
through
the
gastrointestinal
tract.
Aluminum
stearate
and
tristearate
exhibit
very
high
aquatic
ecotoxicity
for
fish,
Daphnia
magna,
green
algae,
and
estuarine
invertebrates
(
mysid
shrimp).
However,
immobility,
high
binding
and
rapid
microbial
degradation
of
the
fatty
acid
salts
will
likely
mitigate
any
potential
for
risk.
In
comparison,
potassium
laurate
is
practically
non
toxic
to
fish,
based
on
a
14­
day
LC
50
of
1625
ppm.
Based
solely
on
a
single
acute
oral
LD
50
to
bobwhite
quail
with
a
14
%
formulation
of
ammonium
stearate
(
2,150
mg/
kg),
these
compounds
may
be
practically
non
toxic
to
terrestrial
vertebrates
(
EPA
2002,
EFED
memo).
A
SAR
for
calcium
octanoate
indicates
this
compound
is
much
less
toxic
than
aluminum
stearate.
The
SAR
predicted
a
96­
hour
LC
50
of
310
ppm,
a
48­
hour
Daphnia
magna
LC
50
of
240
ppm,
a
96­
hour
EC
50
of
10
ppm
and
a
chronic
fish
value
of
40
ppm.

Pesticides
containing
potassium
salts
of
fatty
acids
are
used
on
a
wide
array
of
outdoor
sites.
Once
applied,
however,
the
soap
salts
are
degraded
quickly
in
soil
by
microbes.
Fatty
acids
are
a
significant
part
of
the
normal
daily
diet
of
mammals,
birds,
and
invertebrates.
Acute
and
subacute
toxicity
studies
using
potassium
salts
of
fatty
acids
indicate
that
soap
salts
are
relatively
non­
toxic
to
birds.
They
are
slightly
toxic
to
both
coldwater
and
warmwater
fish
species.
The
potassium
salts
are
highly
toxic
to
aquatic
invertebrates.
However,
since
soap
salts
are
not
applied
directly
to
water,
their
current
uses
should
not
seriously
impact
aquatic
invertebrates.
The
soap
salts
should
pose
minimal
effects
to
endangered
species.
In
summary,
based
on
the
data
reviewed,
EPA
finds
that
the
soap
salts
will
not
cause
unreasonable
adverse
effects
on
the
environment
(
EPA
1992,
soap
salt
RED).

Drinking
Water
Considerations:

There
are
no
federal
drinking
water
standards
for
the
fatty
acid
salts.
Federal
guidelines
are
available,
however
for
aluminum.

Federal
Drinking
Water
Standards
and
Guidelines:

°
A
maximum
concentration
of
0.05
to
0.2
mg
Al/
L
has
been
specified
as
a
National
Secondary
Drinking
Water
Standard.
These
non­
enforceable
standards
are
designed
for
cosmetic
and
aesthetic
purposes
(
Source:
USEPA/
Office
of
Water;
National
Secondary
Drinking
Water
Regulations.
2002).

°
Aluminum
has
a
criteria
maximum
concentration
(
CMC)
of
750
µ
g/
L,
and
a
criteria
continuous
concentration
(
CCC)
of
87
µ
g/
L.
The
CMC
is
the
highest
concentration
of
a
pollutant
to
which
aquatic
life
can
be
exposed
for
a
short
period
of
time
(
one
hour
average).
The
CCC
is
the
highest
concentration
of
a
pollutant
to
which
aquatic
life
can
be
Page
20
of
22
exposed
for
an
extended
period
of
time
(
four
days)
without
deleterious
effects
(
chronic)
(
Source:
USEPA/
Office
of
Water;
National
Recommended
Water
Quality
Criteria
for
Non­
Priority
Pollutants.
1999).

VIII.
Aggregate
Exposures
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
fatty
acid
salts
assessed
in
this
document,
a
qualitative
assessment
for
all
pathways
of
human
exposure
(
food,
drinking
water,
and
residential)
is
appropriate
given
the
their
low
toxicity
and
the
body's
ability
to
metabolize
the
fatty
acid
salts
and
their
metabolites.
As
noted
previously,
a
number
of
scientific
bodies,
in
addition
to
EPA
have
concluded
these
compounds
are
of
low
concern,
including
the
FDA,
FAO/
WHO,
and
CIR.
Many
of
the
fatty
acids
and
their
salts
are
classified
as
GRAS
substances.
SAR
assessments
further
support
the
low
concern
for
human
health
hazard.

IX.
Cumulative
Exposure:

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
fatty
acid
salts
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
fatty
acid
salts
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
fatty
acid
salts
and
any
other
substances
and
the
fatty
acid
salts
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
fatty
acid
salts
have
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

References:

(
Note
to
the
Reader:
MRID
(
Master
Record
Identification)
Numbers
were
added
to
the
references
on
October
17,
2003.
These
numbers
were
not
available
at
the
time
of
document
signature.
No
other
changes
were
made
to
the
document.)
Page
21
of
22
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