Page
1
of
23
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
18,
2004
MEMORANDUM
SUBJECT:
Tolerance
Reassessment
Decisions
Completed
by
the
Lower
Risk
Pesticide
Chemical
Focus
Group
FROM:
Betty
Shackleford,
Associate
Director
Registration
Division
TO:
Peter
Caulkins,
Associate
Director
Special
Review
and
Reregistration
Division
Please
find
attached
the
Focus
Group
Decision
Documents
for
glycerol
and
the
glycerol
esters
of
fatty
acids.
The
three
tolerance
exemptions
in
40
CFR
180.910
[
formerly
40
CFR180.1001(
c)]
and
the
two
tolerance
exemptions
in
40
CFR
180.930
[
formerly
40
CFR180.1001(
e)]
for
these
chemicals
are
reassessed.

If
you
have
any
comments
or
questions,
please
contact
Kathryn
Boyle
at
703­
305­
6304.

Attachment
Page
2
of
23
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
18,
2004
MEMORANDUM
FROM:
Kathryn
Boyle,
Co­
Chair
and
Kerry
Leifer,
Co­
Chair
Lower
Risk
Pesticide
Chemical
Focus
Group
Registration
Division
TO:
Betty
Shackleford,
Associate
Director
Registration
Division
SUBJECT:
Recommendation
for
Tolerance
Reassessment
The
attached
science
assessment
discusses
the
toxicity
of
glycerol,
also
known
as
glycerin,
and
various
glycerol
esters
of
various
fatty
acids.
In
the
human
body,
these
esters
are
hydrolyzed
to
the
fatty
acid
and
glycerol.
Based
on
the
available
information
on
fatty
acids
(
including
the
previous
Agency­
performed
assessments)
and
on
glycerol
(
including
reviews
by
FDA),
and
an
understanding
of
the
body's
metabolism
of
the
various
glycerol
esters
of
various
fatty
acids,
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
glycerol
and
the
various
glycerol
esters
of
various
fatty
acids
from
their
uses
as
inert
ingredients
in
pesticide
products.
The
following
five
exemptions
from
the
requirement
of
a
tolerance
as
established
in
40
CFR
180
are
reassessed:

glycerol
40
CFR180.910
[
formerly
40
CFR180.1001(
c)]

glycerol
(
glycerin)
40
CFR180.930
[
formerly
40
CFR180.1001(
e)]

glycerol
monooleate
40
CFR180.930
[
formerly
40
CFR180.1001(
e)]

mono­
and
diglycerides
of
C
8
­
C
18
fatty
acids
40
CFR180.910
[
formerly
40
CFR180.1001(
c)]
Page
3
of
23
polyglycerol
esters
of
fatty
acids
(
conforming
to
21
CFR
172.854)
40
CFR180.910
[
formerly
40
CFR180.1001(
c)]

The
classification
of
glycerol
is
confirmed
as
List
4A.
Based
on
the
body's
ready
ability
to
metabolize
the
various
glycerol
esters
of
the
C
8
to
C
18
fatty
acids,
the
following
23
chemical
substances
are
classified
as
List
4A:

Octadecanoic
acid,
monoester
with
1,2,3­
propanetriol
31566­
31­
1
Octadecanoic
acid,
ester
with
1,2,3­
propanetriol
11099­
07­
3
9­
Octadecenoic
acid
(
9Z)­,
monoester
with
1,2,3­
propanetriol
25496­
72­
4
9­
Octadecenoic
acid
(
9Z)­,
2,3­
dihydroxypropyl
ester
111­
03­
5
Hexadecanoic
acid,
monoester
with
1,2,3­
propanetriol
26657­
96­
5
Tetradecanoic
acid,
2,3­
dihydroxypropyl
ester
589­
68­
4
Tetradecanoic
acid,
monoester
with
1,2,3­
propanetriol
27214­
38­
6
Dodecanoic
acid,
2,3­
dihydroxypropyl
ester
142­
18­
7
Dodecanoic
acid,
monoester
with
1,2,3­
propanetriol
27215­
38­
9
Decanoic
acid,
monoester
with
1,2,3­
propanetriol
26402­
22­
2
Octanoic
acid,
monoester
with
1,2,3­
propanetriol
26402­
26­
6
9­
Octadecanoic
acid,
monoester
with
oxybis
(
propanediol)
12694­
22­
3
9­
Octadecenoic
acid,
ester
with
1,2,3­
propanetriol
49553­
76­
6
Octadecanoic
acid,
diester
with
1,2,3­
propanetriol
1323­
83­
7
9­
Octadecenoic
acid
(
9Z)­,
diester
with
1,2,3­
propanetriol
25637­
84­
7
Hexadecanoic
acid,
diester
with
1,2,3­
propanetriol
26657­
95­
4
Tetradecanoic
acid,
diester
with
1,2,3­
propanetriol
53563­
63­
6
Dodecanoic
acid,
diester
with
1,2,3­
propanetriol
27638­
00­
2
Decanoic
acid,
diester
with
1,2,3­
propanetriol
53988­
07­
1
Octanoic
acid,
diester
with
1,2,3­
propanetriol
36354­
80­
0
1,2,3­
propanetriol,
homopolymer
(
9Z)­
9­
octadecenoate
9007­
48­
1
9­
Octadecenoic
acid,
monoester
with
tetraglycerol
71012­
10­
7
1,2,3­
propanetriol,
homopolymer,
octadecanoate
9009­
32­
9
Page
4
of
23
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
12,
2004
Memorandum
Subject:
Glycerol,
and
Glycerol
Esters
of
Fatty
Acids:
Antimicrobials
Division
Science
Assessment
Document
for
Tolerance
Reassessment.

From:
Deborah
Smegal,
Toxicologist/
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
Risk
Pesticide
Chemical
Focus
Group
Kathryn
Boyle,
Co­
Chair
Kerry
Leifer,
Co­
Chair
Registration
Division
(
7505C)

Background:

Attached
is
the
Lower
Risk
Pesticide
Chemical
Focus
Group's
science
assessment
for
glycerol
and
glycerol
esters
of
fatty
acids,
which
include:
glycerol,
glycerol
monooleate,
monoand
diglycerides
of
C
8
­
C
18
fatty
acids
and
polyglycerol
esters
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
compounds.
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),
the
Cosmetic
Ingredient
Review
(
CIR)
expert
panel,
and
the
Organization
for
Economic
Cooperation
and
Development­
Screening
1
Calculated
as
total
polyglycerol
ester
of
palmitic
acid.

Page
5
of
23
Information
Data
Set
(
OECD­
SIDS)
evaluation.

This
assessment
builds
on
the
previous
tolerance
reassessment
described
in
the
following
document:

a)
The
tolerance
exemption
for
glycerol
monostearate
(
40
CFR
180.1001
(
c)
(
e))
was
reassessed
in
the
IIFG
Decision
Document
"
Butyl
Stearate
and
Glycerol
Monostearate",
dated
July
31,
2002.

I.
Executive
Summary:

The
glycerol
fatty
acids
evaluated
in
this
report
include:
glycerol,
glycerol
monooleate,
mono­
and
diglycerides
of
C
8
­
C
18
fatty
acids
and
polyglycerol
esters
of
fatty
acids.
Exposure
to
glycerol
and
glycerol
esters
of
fatty
acids
may
come
from
a
wide
variety
of
sources,
including
(
but
not
limited
to)
FDA­
approved
uses
as
food
additives,
in
pharmaceuticals,
or
through
its
use
in
soaps,
shampoos,
toothpastes,
baby
lotions,
and
other
cosmetic
products.
Glycerol,
and
monodi
and
triglycerides
of
fatty
acids
are
present
in
common
consumed
fats
and
oils.
Such
fats
and
oils
are
a
major
source
of
calories
in
the
human
diet,
accounting
for
between
30
and
40%
of
dietary
intake
in
the
U.
S.
Fatty
acids
normally
are
metabolized,
forming
simple
compounds
that
serve
as
energy
sources
and
structural
components
used
in
all
living
cells.
The
FDA
has
affirmed
glycerol
(
glycerin)
and
several
glycerol
esters
of
fatty
acids
as
generally
recognized
as
safe
(
GRAS).
The
Joint
FAO/
WHO
Expert
Committee
on
food
additives
(
1974)
has
evaluated
the
polyglycerol
esters
of
fatty
acids
and
assigned
an
acceptable
daily
intake
(
ADI)
of
0.25
mg/
kg/
day.
1
This
value
is
based
on
a
no­
adverse
effect
level
for
rats
of
2500
mg/
kg/
day
(
50,000
ppm
or
5%)
in
the
diet.

The
physical,
chemical
and
environmental
behavior
of
glycerol
fatty
acids
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,
glycerol
fatty
acids
are
metabolized
to
free
fatty
acids
and
glycerol,
both
of
which
are
available
for
resynthesis
of
triglycerides.
These
breakdown
products
are
indistinguishable
from
the
natural
background
of
these
same
compounds
in
living
systems.

The
available
ecotoxicity
data
for
glycerol
indicates
that
it
is
of
low
toxicity
to
fish
and
other
aquatic
organisms.
Based
on
its
low
Log
K
ow
,
glycerol
has
a
low
potential
for
sorption
to
soil
and
is
not
expected
to
bioaccumulate.
Glycerol
fatty
acid
esters
are
immobile,
bind
tightly
to
sediment
and
soils
and
undergo
rapid
microbial
degradation.
Glycerol
fatty
acid
esters
are
also
a
significant
part
of
the
normal
daily
diet
of
mammals,
birds,
and
invertebrates.
EPA
believes
that
glycerol
and
the
glycerol
fatty
acid
esters
will
not
cause
unreasonable
adverse
effects
on
the
environment.

Based
on
available
information
on
glycerol
and
glycerol
fatty
acid
esters,
their
presence
in
common
dietary
fats
and
oils,
their
expected
use
patterns,
their
safe
history
of
use
as
food
additives,
their
known
metabolism,
extensive
use
in
commercially­
available
cosmetics,
2A
final
rule
was
published
in
the
Federal
Register
on
January
3,
1974,
in
which
some
some
revisions
and
additions
to
40
CFR
180.1001(
c),
(
d)
and
(
e)
were
made.
Included
in
the
additions
in
that
final
rule
was
the
Page
6
of
23
toothpastes,
soaps,
and
baby
lotions,
and
their
low
toxicity,
the
Lower
Risk
Pesticide
Chemical
Focus
Group
has
determined
that
a
quantitative
risk
assessment
is
not
required
for
these
compounds.

II.
Use
Information:

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

Table
1
Tolerance
Exemptions
Being
Reassessed
in
this
Document
Tolerance
Exemption
Expression
Cas
No.
PC
Code
40
CFR

180.
Use
Pattern
(
Pesticidal)
List
Classification
glycerol
(
glycerin)
56­
81­
5
063507
844502
910
and
930
thickener,
solvent
4A
glycerol
monooleate
25496­
72­
4;
111­
03­
5
079096
900066
930
surfactant,
related
adjuvants
of
surfactants
4B
mono­
and
diglycerides
of
C8­
C18
fatty
acids
(
various,
see
Table
2)
910
surfactants,
related
adjuvants
of
surfactants
See
Table
2
polyglycerol
esters
of
fatty
acids
(
conforming
to
21
CFR
172.854)
(
a)
(
various)
910
surfactants,
related
adjuvants
of
surfactants
See
Table
3
polyethylene
esters
of
fatty
acids
(
conforming
to
21
CFR
172.854)
(
b)
(
various)
910
surfactants,
related
adjuvants
of
surfactants
See
Table
3

Residues
listed
in
40
CFR
180.910
[
formerly
40
CFR180.1001
(
c)]
are
exempted
from
the
requirement
of
a
tolerance
when
used
as
inert
ingredients
in
pesticide
formulations
when
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest.
Residues
listed
in
40
CFR
180.930
[
formerly
180.1001(
e)]
are
exempted
from
the
requirement
of
a
tolerance
when
used
as
inert
ingredients
in
pesticide
formulations
applied
to
animals.
(
a)
Based
on
21
CFR
172.854,
polyglycerol
esters
of
fatty
acids,
up
to
and
including
the
decaglycerol
esters,
may
be
safely
used
in
food
in
accordance
with
the
following
prescribed
conditions:
(
a)
They
are
prepared
from
corn
oil,
cottonseed
oil,
lard,
palm
oil
from
fruit,
peanut
oil,
safflower
oil,
sesame
oil,
soybean
oil,
and
tallow
and
the
fatty
acids
derived
from
these
substances
(
hydrogenated
and
nonhydrogenated)
meeting
the
requirements
of
Sec.
172.860(
b)
and/
or
oleic
acid
derived
from
tall
oil
fatty
acids
meeting
the
requirements
of
Sec.
172.862.
(
b)
There
is
a
typographical
error
in
40
CFR
180.930
[
formerly
180.1001
(
e)].
This
listing
should
read
"
polyglycerol
esters
of
fatty
acids
(
conforming
to
21
CFR
172.854)"
2
establishment
of
a
tolerance
exemption
for
"
Polyglycerol
esters
of
fatty
acids
conforming
to
Title
21,
[
section]
121.1120"
under
40
CFR
180.1001(
c)
and
"
Polyglycerol
esters
of
fatty
acids,
conforming
to
Title
21
[
section]
121.1120"
under
40
CFR
180.1001(
e).
These
listings
were
subsequently
codified
into
the
Code
of
Federal
Regulations
and
appeared
that
way
through
the
1977
revision
of
the
CFR
(
40
CFR
Parts
100
to
399,
Revised
as
of
July
1,
1977).
However,
in
the
1978
revision
of
the
Code
of
Federal
Regulations
(
40
CFR
Parts
100
to
399,
Revised
as
of
July
1,
1978),
the
listing
under
40
CFR
180.1001(
c)
remained
the
same
but
the
listing
under
40
CFR
180.1001(
e)
read
"
Polyethylene
esters
of
fatty
acids,
conforming
to
Title
21
[
section]
121.1120."
All
subsequent
versions
of
40
CFR
from
1979
to
2003
also
then
contained
that
same
"
polyethylene
esters..."
listing
under
40
CFR
180.1001(
e)
[
Note:
The
21
CFR
121.1120
reference
was
later
recodified
as
21
CFR
172.854]

Changes
to
a
volume
of
CFR
which
were
made
by
documents
published
in
the
Federal
Register
are
enumerated
in
an
index
that
is
found
in
the
individual
volumes
of
the
CFR
entitled
"
List
of
CFR
Sections
Affected."
The
1978
revision
to
40
CFR
Parts
100
to
399
lists
only
two
Federal
Register
documents
that
revised
or
amended
40
CFR
180.1001(
e)
for
that
revision
year
(
42
FR
40909;
August
12,
1977,
and
42
FR
63783;
December
20,
1977).
Neither
of
those
two
Final
Rules
revised
or
amended
the
40
CFR
180.1001(
e)
entry
of
"
Polyglycerol
esters
of
fatty
acids,
conforming
to
Title
21
[
section]
121.1120."
Based
on
this
information,
it
can
be
concluded
that
the
current
listing
of
"
Polyethylene
esters
of
fatty
acids
conforming
to
21
CFR
172.854"
listed
under
40
CFR
180.930
[
formerly
180.1001(
e)]
is
in
fact
a
typographical
error
in
the
Code
of
Federal
Regulations
that
correctly
should
read
exactly
as
the
corresponding
entry
in
40
CFR
180.910
[
formerly
180.1001(
c)],
namely
as
"
Polyglycerol
esters
of
fatty
acids
conforming
to
21
CFR
172.854."

Page
7
of
23
There
are
two
types
of
glycerol
(
or
glycerin):
natural
glycerol
derived
from
oils
and
fats
from
such
sources
as
coconuts,
and
synthetic
glycerol
derived
from
petroleum.
Glycerol
is
present
in
the
form
of
its
esters
(
mono­,
di­
and
triglycerides)
in
all
animal
and
vegetable
fats
and
oils.
Dietary
intake
of
glycerol
comes
mainly
from
these
molecules
in
animal
and
plant
products.
(
http://
www.
pdrhealth.
com/
drug_
info/
nmdrugprofiles/
nutsupdrugs/
gly_
0304.
shtml,
February
5,
2004).

Glyceryl
monoesters
are
not
pure
monoesters,
but
are
mostly
mixtures
with
mono­,
diand
triesters
(
CIR
2001).
The
following
Table
describes
the
mono­
and
diglycerides
of
C
8
­
C
18
(
caprylic
to
stearate)
fatty
acids
evaluated
in
this
document:

Table
2
Mono­
and
Diglycerides
of
C8­
C18
fatty
acids
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
PC
Code
List
Classification
glyceryl
monostearate
Note:
previously
assessed
in
2002
Octadecanoic
acid,
monoester
with
1,2,3­
propanetriol
(
9CI)

Octadecanoic
acid,
ester
with
1,2,3­
propanetriol
(
9CI)
31566­
31­
1
11099­
07­
3
900085
(
inert)
4A
Table
2
Mono­
and
Diglycerides
of
C8­
C18
fatty
acids
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
PC
Code
List
Classification
Page
8
of
23
glyceryl
monooleate
9­
Octadecenoic
acid
(
9Z)­
,
monoester
with
1,2,3­
propanetriol
9­
Octadecenoic
acid
(
9Z)­,
2,3­
dihydroxypropyl
ester
(
9CI)
25496­
72­
4;

111­
03­
5
079096
(
active)

900066
(
inert)
4B
4B
glyceryl
monopalmitate
Hexadecanoic
acid,
monoester
with
1,2,3­
propanetriol
26657­
96­
5
­­­

glyceryl
myristate
Tetradecanoic
acid,
2,3­
dihydroxypropyl
ester
Tetradecanoic
acid,
monoester
with
1,2,3­
propanetriol
(
9CI)
589­
68­
4
27214­
38­
6
­­­

glyceryl
monolaurate
Dodecanoic
acid,
2,3­
dihydroxypropyl
ester
Dodecanoic
acid,
monoester
with
1,2,3­
propanetriol
(
9CI)
142­
18­
7
27215­
38­
9
 

011290
(
active)

glyceryl
monocaprate
Decanoic
acid,
monoester
with
1,2,3­
propanetriol
26402­
22­
2
011291(
active)
­­­(
inert)

glyceryl
monocaprylate
Octanoic
acid,
monoester
with
1,2,3­
propanetriol
26402­
26­
6
011292
(
active)
911292
(
inert)
3
diglyceryl
stearate
9­
Octadecanoic
acid,
monoester
with
oxybis
(
propanediol)
12694­
22­
3
­­­
­­­

diglyceryl
monooleate
9­
Octadecenoic
acid,
ester
with
1,2,3­
propanetriol
49553­
76­
6
­­­
­­­

glyceryl
distearate
Octadecanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
1323­
83­
7
911619
(
inert)
3
glyceryl
dioleate
9­
Octadecenoic
acid
(
9Z)­,
diester
with
1,2,3­
propanetriol
(
9CI)
25637­
84­
7
911285
(
inert)
3
glyceryl
dipalmitate
Hexadecanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
26657­
95­
4
­­­
­­­

glyceryl
dimyristate
Tetradecanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
53563­
63­
6
­­­
­­­

glyceryl
dilaurate
Dodecanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
27638­
00­
2
­­­
­­­
Table
2
Mono­
and
Diglycerides
of
C8­
C18
fatty
acids
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
PC
Code
List
Classification
Page
9
of
23
glyceryl
dicaprate
Decanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
53988­
07­
1
­­­
­­­

glyceryl
dicaprylate
Octanoic
acid,
diester
with
1,2,3­
propanetriol
(
9CI)
36354­
80­
0
­­­
­­­

(
a)
Source:
ChemIDplus,
part
of
TOXNET,
and
OPPIN,
where
available.

Polyglycerol
esters
of
fatty
acids
are
mixtures
of
the
esters
of
these
fatty
acids
with
the
polyglycerol
mixture.
They
include
a
large
group
of
closely
related
compounds
of
complex
composition.
For
tolerance
reassessment
purposes,
this
includes
the
identity
of
polyglycerol
esters
of
fatty
acids
with
the
polyglycerol
moiety
range
from
diglycerol
to
the
decaglycerol
with
not
less
than
70%
being
di­,
tri­
and
tetraglycerols
and
not
more
than
10%
being
the
hepta­,
octa­,
nona­,
and
decaglycerol
ester.
Individual
components
of
these
fatty
acid
mixtures
are
found
as
normal
constituents
of
the
human
diet,
i.
e.,
glycerol,
glycerol
mono­,
di­
and
tri­
fatty
acid
esters
and
individual
fatty
acids,
with
the
exceptions
of
the
artificially
produced
polymers
of
glycerol,
polymers
of
certain
fatty
acids
and
the
actual
separate
esters
between
these
polymers.
These
latter
compounds
represent
the
toxicologically
important
constituents
(
WHO
1974).
The
following
Table
describes
those
polyglycerol
esters
of
fatty
acids
that
are
found
in
EPA's
listing
of
inert
ingredients.

Table
3
Polyglycerol
esters
of
Fatty
Acids
(
a)

Chemical
Substance
(
Common
Name)
Nomenclature
(
9th
CI
name)
CAS
Reg.
No.
PC
Code
List
Classification
decaglyceryl
monooleate
(
polyglycerol
ester
of
oleic
acid)
1,2,3­
propanetriol,
homopolymer
(
9Z)­
9­
octadecenoate
9007­
48­
1
900483
4B
tetraglyceryl
monooleate
9­
Octadecenoic
acid,
monoester
with
tetraglycerol
71012­
10­
7
900068
4B
polyglyceryl
stearate
1,2,3­
propanetriol,
homopolymer,
octadecanoate
9009­
32­
9
800438
3
(
a)
Source:
ChemIDplus,
part
of
TOXNET,
and
OPPIN,
where
available.

Agricultural
Uses
of
Glycerol
Fatty
Acid
Monoesters:

Glycerol
monocaprylate,
glycerol
monocaprate
and
glycerol
monolaurate
have
agricultural
uses
as
described
in
Table
3.
They
are
pesticidal
active
ingredients
recently
registered
by
EPA
in
2003
that
act
against
bacteria,
viruses,
fungi
and
lipid
coated
yeasts
to
control
spoilage
of
food
and
feed
crops
after
harvest.
They
are
generally
applied
at
levels
between
0.1%
and
1%
in
the
diluted
formulation
at
a
rate
sufficient
to
wet
thoroughly
the
commodity
being
treated.
The
end
Page
10
of
23
use
products
are
not
intended
for
outdoor
use
(
EPA
2003).

Table
4
Use
Pattern
(
pesticidal
­
active
ingredient)

Tolerance
Exemption
Expression
Active
PC
Code
Active
Use
Pattern
(
Pesticidal)
Use
Sites
glycerol
monocaprylate
011292
bacteria,
viruses,
fungi,
and
lipid
coated
yeasts
Post
harvest
fruits
and
vegetables
glycerol
monocaprate
011291
glycerol
monolaurate
011290
FDA
Uses:

Glycerol
(
glycerin)
is
classified
by
FDA
as
a
direct
food
additive
affirmed
as
generally
recognized
as
safe
(
GRAS)
(
21
CFR
182.1320).
It
also
has
diverse
uses
in
medicine.
It
has
moisturizing
and
lubricating
properties
that
can
increase
serum
osmolality.
It
is
given
to
reduce
intraocular
pressure
and
vitreous
volume
in
eye
surgery
and
is
used
as
an
adjunct
in
the
management
of
acute
glaucoma.
Glycerol
may
also
be
used
to
reduce
corneal
edema
during
eye
exams,
as
a
laxative
in
suppositories,
and
in
cough
preparations.
Glycerol
is
used
by
some
athletes
to
improve
thermoregulation
and
endurance
during
exercise
or
exposure
to
hot
environments.
(
http://
www.
pdrhealth.
com/
drug_
info/
nmdrugprofiles/
nutsupdrugs/
gly_
0304.
shtml,
February
5,
2004).

Mono­
and
diglycerides
consisting
of
a
mixture
of
glyceryl
mono­
and
diesters,
and
minor
amounts
of
triesters,
that
are
prepared
from
fats
or
oils
or
fat­
forming
acids
derived
from
edible
sources
are
affirmed
as
generally
recognized
as
safe
(
GRAS)
substances
(
21
CFR
182.1505)
and
indirect
food
additives
(
21
CFR
175.105,
176.210)
for
human
consumption
without
restriction
on
their
concentration
(
at
concentrations
not
to
exceed
good
manufacturing
practice,
GMP).

Glycerol
monostearate
and
glycerol
monooleate
are
classified
by
FDA
as
direct
food
substances
affirmed
as
GRAS
with
no
limitation
other
than
under
current
good
manufacturing
practices
(
21
CFR
184.1324
and
184.1323,
respectively).
Glycerol
monooleate
is
a
priorsanctioned
food
ingredient
(
21
CFR
181.27)
and
is
an
indirect
food
additive
(
21
CFR
175.300,
175.320).
Glycerol
monooleate
is
a
synthetic
flavor,
and
is
also
used
in
pharmaceuticals
(
HSDB
2003).

Glyceryl
tristearate
is
approved
by
the
FDA
as
a
direct
food
additive
for
human
consumption
when
used
as
a
crystallization
accelerator
in
cocoa
products,
imitation
chocolate,
and
in
compound
coatings
(
not
to
exceed
1%
of
combined
weight
of
formulation),
as
a
formulation
aid,
lubricant
and
release
agent,
and
surface­
finishing
agent
(
not
to
exceed
0.5%),
as
a
formulation
aid
in
confections
(
not
to
exceed
3%
of
the
combined
weight
of
the
formulation),
as
a
formulation
aid
in
fats
and
oils
(
not
to
exceed
1%
of
the
combined
weight
of
the
formulation),
and
Page
11
of
23
as
a
winterization
and
fractionation
aid
in
fat
and
oil
processing
(
not
to
exceed
0.5%
by
weight
of
the
processed
fat
or
oil)
(
21
CFR
172.811).

Polyglycerol
esters
of
fatty
acids,
up
to
and
including
decaglycerol
esters
are
approved
for
use
in
food
by
the
FDA
(
21
CFR
172.854).
They
are
prepared
from
corn
oil,
cottonseed
oil,
lard,
palm
oil
from
fruit,
peanut
oil,
safflower
oil,
sesame
oil,
soybean
oil,
and
tallow
and
the
fatty
acids
derived
from
these
substances.
They
are
used
as
emulsifiers
in
food,
in
amounts
not
greater
than
that
required
to
produce
the
intended
physical
or
technical
effects.
Polyglycerol
esters
of
a
mixture
of
stearic,
oleic,
and
coconut
fatty
acids
are
used
as
a
cloud
inhibitor
in
vegetable
and
salad
oils.
Polyglycerol
esters
of
butter
oil
fatty
acids
are
used
as
emulsifiers
(
21
CFR
172.854).

Table
5:
Use
Pattern
(
FDA
GRAS)

Chemical
GRAS
Citation
GRAS
Uses
glycerin
21
CFR
182.1320
Multiple
purpose
GRAS
food
substance
when
used
in
accordance
with
good
manufacturing
practice.

glyceryl
monooleate
21
CFR
184.1323
flavoring
agent,
adjuvant,
solvent,
vehicle
glyceryl
monostearate
21
CFR
184.1324
emulsifier
in
baked
goods
and
ice
cream,
food
additive
Mono­
and
diglycerides
21
CFR
184.1505
dough
strengthener,
emulsifier
and
emulsifier
salt,
flavoring
agent
and
adjuvant,
formulation
aid,
lubricant,
solvent
and
vehicle,
stabilizer
and
thickener,
surface­
active
agent,
texturizer
Other
Uses
Glycerol
is
widely
used
as
a
solvent,
as
a
sweetener
in
candy,
syrup,
liquor
and
some
foods,
in
the
manufacture
of
dynamite,
cosmetics,
liquid
soaps,
inks,
and
lubricants;
to
keep
fabrics
pliable;
as
a
component
of
antifreeze
mixtures;
as
a
source
of
nutrients
for
fermentation
cultures
in
the
production
of
antibiotics
and
in
medicine
(
www.
factmonster.
com/
ce6/
sci,
August
22,
2003).
Glycerol
is
used
in
over
200
household
products,
including
cosmetics,
soaps,
toothpaste,
shampoos,
baby
lotions,
and
diaper
rash
cream.
Concentrations
generally
range
from
1
to
10%
(
Household
Products
Database,
http://
hpd.
nlm.
nih.
gov/
cgi­
din/
household/,
February
11,
2004).

Glycerol
monooleate
is
an
ingredient
in
over
700
cosmetic
formulations,
at
concentrations
ranging
from
#
0.1
to
5%
in
formulations
that
were
predominantly
lipsticks,
eye
shadows,
makeup
bases
and
skin
care
preparations
(
CIR
1986).
Caprylic/
capric
triglyceride
is
derived
from
coconut
oil,
and
is
also
used
extensively
in
cosmetics,
foods
and
pharmaceuticals.
It
is
present
in
over
500
cosmetic
formulations
at
concentrations
ranging
from
>
0.1
to
>
50%
in
bath
oils,
hair
sprays
and
lipsticks
(
CIR
1980).

The
Agency
notes
that
glycerol
is
included
on
the
Agency's
list
of
chemicals
included
in
Page
12
of
23
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.
Glycerol
is
sponsored
by
the
ICCA­
APAG
Glycerol
Group.
In
addition,
a
SIDS
assessment
is
available
for
glycerol.

III.
Physical/
Chemical
Properties:

Glycerol
is
a
liquid
with
a
calculated
vapor
pressure
of
0.000106
hPa
(
at
25oC),
is
fully
miscible
in
water
and
has
a
log
K
ow
of
­
1.76
(
measured).
It
has
a
calculated
half­
life
for
photooxidation
of
about
7
hours
and
is
not
susceptible
to
hydrolysis
(
OECD
SIDS
2002).

Glyceryl
monoesters
of
fatty
acids
are
primarily
white
to
yellow
oils
or
oily
waxes
with
faint
fatty
odors.
These
substances
are
not
pure
substances,
but
are
mixtures
with
mono­,
di­
and
tri­
ester
contents
approximately
4:
4:
2.
Glyceryl
laurate
and
glyceryl
caprylate
are
practically
insoluble
in
water.
Glyceryl
monoesters
have
calculated
Log
K
ow
s
in
the
range
of
2.06
to
7
for
glyceryl
caprylate
and
glyceryl
oleate,
respectively
(
CIR
2001).

The
physical,
chemical
and
environmental
behavior
of
glyceryl
fatty
acid
esters
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).

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,
OECD
SIDS
assessments,
and
Food
and
Agriculture
Organization
of
the
World
Health
Organization
(
FAO/
WHO)
evaluations.

Glycerol
and
glyceryl
fatty
acid
esters
are
natural
constituents
of
dietary
fats
and
oils
(
e.
g.,
coconut
and
palm
oils)
and
natural
breakdown
products
from
fat
metabolism
in
living
organisms
(
EPA
2003).
Animal
and
vegetable
fats
contain
about
10
percent
by
weight
of
glycerol
(
FDA
1975).
In
vertebrate
organisms
(
e.
g.,
humans),
glyceryl
fatty
acid
esters
are
formed
as
part
of
the
metabolism
of
triglycerides.
Glyceryl
fatty
acid
esters
are
metabolized
to
free
fatty
acids
and
glycerol,
both
of
which
are
available
for
the
resynthesis
of
triglycerides
(
CIR
2001).
The
EPA
concluded
that
the
breakdown
products
are
indistinguishable
from
the
natural
background
of
these
same
compounds
in
living
systems
(
EPA
2003).

In
general,
fatty
acids
are
a
group
of
naturally
occurring,
monocarboxylic
acids
which
are
Page
13
of
23
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.
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.

In
the
sections
below,
are
the
available
toxicological
data
for
glycerol,
and
the
glyceryl
esters
of
fatty
acids
via
the
oral,
dermal
and/
or
inhalation
routes
of
exposure.

A.
Toxicological
data
Glycerol:

Glycerol
is
one
of
the
most
common
alcohols
found
in
human
metabolism.
Following
ingestion,
glycerol
is
efficiently
absorbed
and
rapidly
metabolized.
It
is
eliminated
in
the
kidney
by
filtration.
The
elimination
half­
life
of
glycerol
is
from
30
to
40
minutes.
(
http://
www.
pdrhealth.
com/
drug_
info/
nmdrugprofiles/
nutsupdrugs/
gly_
0304.
shtml,
February
5,
2004).

Glycerol
is
of
low
toxicity
when
ingested,
inhaled
or
in
contact
with
the
skin
(
OECD
SIDS
2002).
The
acute
oral
LD
50
is
32
g/
kg
in
mice
and
27
g/
kg
in
rats.
(
http://
www.
sykogyo
co.
jp/
english/
sei/
1_
gly.
html,
August
20,
2003).
At
very
high
dose
levels,
the
signs
of
toxicity
include
tremor,
hyperaemia
of
the
gastrointestinal
tract,
nausea,
headache,
and
diarrhea.
Skin
and
eye
irritation
studies
indicate
that
glycerol
has
low
potential
to
irritate
the
skin
and
eyes.
The
available
human
and
animal
data,
together
with
the
widespread
potential
for
exposure
and
the
absence
of
case
reports
of
sensitization,
indicate
that
glycerol
is
not
a
skin
sensitizer
(
OECD
SIDS
2002).
Due
to
its
low
vapor
pressure,
inhalation
of
vapors
at
room
temperature
is
unlikely.
Inhalation
of
mist
may
cause
irritation
of
the
respiratory
tract.
Persons
with
pre­
existing
skin
disorders
or
eye
problems
or
impaired
liver
or
kidney
function
may
be
more
susceptible
to
the
effects
of
glycerol.
(
http://
www.
jtbaker.
com/
msds/
englishhtml.
g4774.
htm,
February
5,
2004).

Repeated
oral
exposure
to
glycerol
does
not
induce
adverse
effects
other
than
local
irritation
of
the
gastrointestinal
tract.
In
a
two
year
rat
study,
no
adverse
systemic
or
local
effects
were
observed
at
dietary
concentrations
up
to
10,000
mg/
kg/
day.
For
inhalation
exposure
to
aerosols,
the
no­
observed­
adverse
effect
concentration
is
165
mg/
m3
for
local
irritant
effects
of
the
upper
respiratory
tract,
and
662
mg/
m3
for
systemic
effects
(
OECD
SIDS
2002).
In
another
chronic
rat
study,
no
adverse
effects
were
noted
in
rats
fed
up
to
20%
of
the
diet
for
one
year
or
5
to
10%
glycerin
for
2
years
(
approximately
5
and
10
g/
kg/
day,
respectively)
(
FDA
1975).
Dogs
fed
balanced
diets
containing
5,
10
or
20%
glycerin
(
approximately
1.25,
2.5
and
5
g/
kg/
day,
respectively)
did
not
experience
adverse
effects
(
FDA
1975).
Page
14
of
23
Glycerol
does
not
have
structural
alerts,
which
raise
concern
for
mutagenicity.
It
is
negative
for
gene
mutations
in
bacterial
strains,
chromosomal
effects
in
mammalian
cells
and
primary
DNA
damage
in
vitro.
In
vivo
tests
with
glycerol
also
did
not
result
in
significant
effects,
although
study
limitations
prevent
definitive
conclusions.
Overall,
glycerol
is
not
considered
to
possess
genotoxic
potential
(
OECD
SIDS
2002).

Data
from
studies
designed
to
investigate
tumor
promotion
activity
in
male
mice
suggest
that
oral
administration
of
glycerol
up
to
20
weeks
had
a
weak
promotion
effects
on
the
incidence
of
tumor
formation.
However,
there
was
no
evidence
of
carcinogenicity
in
a
2­
year
rat
study
(
OECD
SIDS
2002).

No
effects
on
fertility,
reproductive
performance,
growth
or
offspring
development
were
observed
in
a
two
generation
rat
study
with
glycerol
administered
by
gavage
(
NOAEL
2000
mg/
kg)
(
OECD
SIDS
2002,
FDA
1975).
No
maternal
toxicity
or
teratogenic
effects
were
seen
in
the
rat,
mouse,
or
rabbit
at
the
highest
dose
levels
tested
in
a
guideline
comparable
teratogenicity
study
(
NOAEL
1180
mg/
kg/
day)
(
OECD
SIDS
2002).
Developmental
studies
with
mice
and
rats
at
doses
up
to
1.28
g/
kg/
day
and
1.31
g/
kg/
day,
respectively
during
gestational
days
6­
15
showed
no
clearly
discernable
effects
on
implantation,
maternal
or
fetal
survival
or
fetal
development
(
FDA
1975).

In
humans,
there
are
rare
reports
of
cardiac
dysrhythmias
occurring
with
oral
glycerol
use
and
one
report
of
hypertension
occurring.
Other
adverse
reactions
include
headaches,
dizziness,
confusion
and
amnesia
(
in
elderly
subjects)
and
hyperglycemia.
Hyperosmolarity,
which
occurs
with
oral
glycerol,
is
usually
clinically
significant
only
in
those
with
type
2
diabetes.
The
most
frequent
adverse
reactions
are
gastrointestinal
and
include
nausea
and
vomiting,
bloating
and
diarrhea.
(
http://
www.
pdrhealth.
com/
drug_
info/
nmdrugprofiles/
nutsupdrugs/
gly_
0304.
shtml,
February
5,
2004).

Typical
doses
for
exercise
performance
enhancement
are
2
to
4
tablespoons
(
approximately
60
mL
or
75
grams)
of
glycerol
in
water,
or
other
liquid.
The
ratio
of
fluids
to
glycerol
is
about
20
to
1
(
http://
www.
pdrhealth.
com/
drug_
info/
nmdrugprofiles/
nutsupdrugs/
gly_
0304.
shtml,
February
5,
2004)
.

For
glycerin
mist
occupational
exposures,
the
OSHA
Permissible
Exposure
Limit
(
PEL)
is
15
mg/
m3
(
TWA)
for
total
dust,
and
5
mg/
m3
(
TWA)
for
respirable
fraction.
The
ACGIH
Threshold
Limit
Value
(
TLV)
is
10
mg/
m3.
(
http://
www.
jtbaker.
com/
msds/
englishhtml.
g4774.
htm,
February
5,
2004).

Mono­,
Di­
and
Triglycerides
of
Fatty
Acids:

In
1960,
the
Food
Protection
Committee
of
the
National
Academy
of
Sciences­
National
Research
Council
Food
and
Nutrition
Board
(
National
Academy
of
Sciences
as
cited
in
CIR
2001)
concluded
that
there
appears
to
be
no
reason
to
question
the
safety
of
mono­,
di­,
and
Page
15
of
23
triglycerides
of
lauric
acid
(
i.
e.,
Glyceryl
Laurate,
Glyceryl
Dilaurate,
or
Glyceryl
Trilaurate)
as
food
additives.
This
conclusion
was
based
on
the
following:
(
1)
Lauric
acid
glycerides
are
used
in
important
foods,
such
as
human
and
cow's
milk
at
concentrations
of
3­
6%
and
large
quantities
are
present
in
coconut
oil.
The
use
of
these
foods
has
not
been
accompanied
by
recognized
toxic
effects.
(
2)
Lauric
acid
glycerides
undergo
the
usual
metabolic
changes
of
the
higher
fatty
acids.
(
3)
When
lauric
acid
glycerides
are
fed
in
diets
containing
a
variety
of
glycerides,
there
is
no
evidence
of
a
specific
toxic
or
harmful
effect
(
CIR
2001).

In
1975,
the
FDA
reviewed
the
available
toxicological
data
for
the
mono­
and
diglycerides
of
edible
fat­
forming
fatty
acids
and
concluded
"
there
is
no
evidence
in
the
available
information
on
mono­
and
diglycerides
of
fat
forming
fatty
acids
that
demonstrates
or
suggests
reasonable
grounds
to
suspect
a
hazard
to
the
public
when
they
are
used
at
levels
that
are
now
current
or
that
might
reasonably
be
expected
in
the
future"
(
FDA
1975).

EPA
(
2003)
recently
reviewed
the
C
8
,
C
10
and
C
12
straight
chain
fatty
acid
monoesters
of
glycerol:
glycerol
monocaprylate,
glycerol
monocaprate
and
glycerol
monolaurate,
and
registered
these
compounds
as
new
pesticidally
active
ingredients
acting
against
bacteria,
viruses,
fungi
and
lipid­
coated
yeasts.
The
Agency
concluded
that
these
compounds
are
non­
toxic
on
an
acute
basis
(
except
for
eye
irritation)
and
are
rapidly
metabolized
in
vertebrate
systems
to
polyols
and
free
fatty
acids.
These
compounds
are
not
known
to
be
genotoxic,
developmental/
reproductive
toxicants,
nor
compounds
that
induce
immune
response.
Breakdown
products
are
indistinguishable
from
the
natural
background
of
these
same
compounds
in
living
systems.

Acute
toxicity
data
for
glycerol
monolaurate
(
a
C
8
monoester)
indicate
low
acute
toxicity
via
the
oral
(
LD
50
>
5000
mg/
kg),
and
dermal
(
LD
50
>
5000
mg/
kg/
day)
routes
of
exposure
(
MRIDs
45405505,
45428503).
Acute
inhalation
data
are
not
available
because
all
glycerol
fatty
acid
monoesters
are
waxy
solids
at
room
temperature,
which
makes
it
impossible
to
generate
respirable
particles.
In
the
rabbit
primary
eye
irritation
study,
glycerol
monolaurate
caused
slight
conjunctivitis
at
72­
96
hours,
which
cleared
by
day
7
(
MRID
45405509).
It
also
caused
mild
to
slight
erythema
in
the
primary
rabbit
dermal
irritation
study
(
MRID
45405511),
and
was
not
a
dermal
sensitizer
(
MRID
45428504).
The
Agency
granted
requests
for
waivers
from
the
data
requirements
for
genotoxicity
studies,
teratogenicity
studies
and
immune
response
studies
based
on
studies/
data/
information
submitted
by
the
registrant
(
EPA
2003).

An
expert
panel
of
the
Cosmetic
Ingredient
Review
(
CIR)
conducted
a
safety
assessment
for
43
glyceryl
monoesters
in
2000,
including
glyceryl
oleate,
glyceryl
palmitate,
glyceryl
myristate
glyceryl
laurate,
glyceryl
caprate,
and
glyceryl
caprylate
(
CIR
2001).
This
assessment
considered
numerous
toxicological
studies,
including
various
acute,
subchronic,
and
chronic/
carcinogenicity
toxicity,
and
mutagenicity
studies.
This
report
also
details
extensive
use
of
this
glyceryl
monoesters
in
numerous
cosmetic
products
at
concentrations
ranging
from
0.1­
7
percent.
Based
on
the
available
information,
the
panel
concluded
that
"
glyceryl
monoesters
are
safe
as
cosmetic
ingredients
in
the
present
practices
of
use
and
concentration"
(
CIR
2001).

Glyceryl
monoesters
have
little
acute
or
short­
term
toxicity
in
animals,
and
no
toxicity
was
noted
following
chronic
administration
of
a
mixture
consisting
of
mostly
glyceryl
di­
and
mono
3
Irritation
was
noted
in
the
following
tests:
acute
test
with
undiluted
or
50%
glyceryl
oleate
in
corn
oil;
acute
test
with
0.5
mL
of
a
5%
glyceryl
oleate
formulation,
20
applications
of
2
ml/
kg
of
a
25%
corn
oil
solution;
4
week
test
with
5%
glyceryl
oleate
formulation.

4
No
irritation
was
noted
in
the
following
tests:
single
insult
15%
and
30%
concentrations
of
aqueous
glycerol
oleate;
single
insult
fragrance
preparation
containing
19%
glyceryl
oleate;
cumulative
patch
test
with
5%
glyceryl
oleate
sunscreen
formulations;
repeated
insult
patch
test
with
15%
aqueous
glyceryl
oleate
preparations
or
5%
sunscreen
formulation.

Page
16
of
23
esters.
Undiluted
monoesters
may
produce
minor
skin
irritation,
especially
in
abraded
skin,
but
in
general
these
ingredients
are
not
irritating
at
concentrations
used
in
cosmetics.
Glyceryl
monoesters
are
not
sensitizers,
or
photosensitizers
(
CIR
2001).

Glyceryl
Laurate:
The
acute
oral
LD
50
for
glyceryl
laurate
is
>
20,000
mg/
kg
in
rats
(
CIR
2001).
Glyceryl
laurate
is
a
mild
irritant
following
inhalation
exposure
to
an
aerosol
containing
10%
glyceryl
laurate
in
animals.
It
also
had
strong
hemolytic
activity
in
an
in
vitro
assay
using
sheep
erythrocytes.
However,
it
was
not
an
eye
irritant
in
rabbits,
nor
a
dermal
sensitizer
in
guinea
pigs
(
CIR
2001).
No
adverse
effects
were
reported
for
rats
exposed
to
14,
one­
hour
inhalation
exposures
at
concentrations
of
280
mg/
m3
(
Unichema
International
1997b
as
cited
in
CIR
2001).
Glyceryl
citrate/
lactate/
linoleate/
oleate
was
not
mutagenic
in
the
Ames
test
system.
glyceryl
laurate
exhibited
antitumor
activity
and
glyceryl
stearate
was
negative
in
a
tumor
promotion
assay.
In
a
2­
year
study,
rats
fed
a
mixture
of
Trilaurin
(
2%),
glyceryl
dilaurate
(
11%)
and
glyceryl
laurate
(
10
to
11%)
had
no
significant
differences
from
basal
diet
controls,
except
for
slight
microscopic
fatty
liver
changes.
These
effects
were
also
in
the
control
group
fed
hydrogenated
cottonseed
oil
(
Fithugh
et
al.
1960
as
cited
in
CIR
2001).
At
high
concentrations,
glyceryl
laurate
caused
moderate
erythema
in
human
clinical
studies,
but
the
other
glyceryl
monoesters
did
not
produce
any
adverse
reactions
(
CIR
2001).

Glyceryl
Oleate:
A
1986
safety
assessment
of
glyceryl
oleate
(
Journal
of
the
American
College
of
Toxicology,
5[
5])
was
performed
by
an
expert
panel
of
the
Cosmetic
Ingredient
Review
(
CIR
1986).
This
assessment
considered
numerous
toxicological
studies,
including
various
acute,
subchronic,
and
chronic/
carcinogenicity
toxicity
studies.
This
report
also
details
extensive
use
of
this
glyceryl
fatty
acid
monester
in
numerous
cosmetic
products
at
concentrations
ranging
from
#
0.1­
5
percent.
Based
on
the
available
information,
the
panel
concluded
that
"
glyceryl
oleate
is
safe
as
a
cosmetic
ingredient
in
the
present
practices
of
use
and
concentration"
(
CIR
1986).

Glyceryl
oleate
has
low
acute
toxicity.
No
signs
of
toxicity
were
noted
in
rats
given
a
single
13
ml/
kg
oral
dose
of
a
sunscreen
formulation
containing
5%
glyceryl
oleate.
Minimal
to
moderate
eye
irritation
was
produced
by
undiluted
glyceryl
oleate,
50%
glyceryl
oleate
in
corn
oil,
and
a
fragrance
preparation
containing
19%
glyceryl
oleate
when
administered
to
rabbits.
In
animals,
dermal
irritation
was
reported
in
acute
and
repeated
dermal
studies
with
glyceryl
oleate3.
However,
in
clinical
human
tests,
no
dermal
irritation
or
sensitization
was
noted
for
glyceryl
oleate
preparations4
in
single
insult
or
cumulative
occlusive
patch
tests.
A
few
subjects
exhibited
5
Calculated
as
total
polyglycerol
ester
of
palmitic
acid.

Page
17
of
23
slight,
transient
erythematous
responses
in
the
photoallergy
and
phototoxicity
tests
(
CIR
1986).

In
a
two
generation
mouse
study,
a
few
brain
tumors
(
3
tumors
in
63
mice)
were
noted
in
mice
fed
50­
100
mg/
mouse
glyceryl
oleate.
However,
in
the
same
study,
mice
fed
4­
5
mg
cholesterol
developed
a
higher
incidence
of
brain
tumors
(
20
tumors
in
80
mice).
Digestive
tract
tumors
were
found
in
mice
fed
200
mg/
mouse
per
day
glyceryl
oleate
(
feed
supplement)
for
fourseven
generations
and
were
considered
due
to
free
fatty
acid
impurities.
The
CIR
Expert
Panel
found
the
results
of
these
studies
equivocal
(
CIR
1986).

Caprylic/
Capric
Triglyceride:
An
expert
panel
of
CIR
conducted
a
safety
assessment
for
caprylic/
capric
triglyceride
(
CIR
1980)
and
concluded
that
it
has
very
low
toxicity
to
humans
and
animals
based
on
acute,
subchronic
and
chronic
oral
studies,
dermal,
skin
sensitization,
intraperitoneal,
and
intramuscular
injection
toxicity
tests,
skin
and
eye
irritation
tests,
and
a
twogeneration
reproductive
study.
The
rat
oral
LD
50
is
>
5
g/
kg
(
CIR
1980).
The
expert
panel
concluded
that
the
cosmetic
product,
Caprylic/
capric
triglyceride
is
"
safe
when
incorporated
in
amounts
similar
to
those
present
on
the
market."

Polyglycerol
esters
of
fatty
acids
The
Joint
FAO/
WHO
Expert
Committee
on
food
additives
(
1974)
has
evaluated
the
polyglycerol
esters
of
fatty
acids
and
assigned
an
acceptable
daily
intake
(
ADI)
of
0.25
mg/
kg/
day.
5
This
value
is
based
on
a
no­
adverse
effect
level
for
rats
of
2500
mg/
kg/
day
(
50,000
ppm
or
5%)
in
the
diet.

Acute
toxicity
data
show
no
adverse
effects
in
rats
given
a
single
oral
dose
up
to
29
g/
kg
polyglycerol
ester,
a
single
intraperitoneal
(
i.
p.)
dose
of
up
to
7
g/
kg
or
5­
daily
oral
doses
of
10
g/
kg.
A
single
i.
p.
dose
of
10
g/
kg
to
rats
caused
some
peritoneal
reaction
but
no
deaths
(
WHO
1974).
Rabbits
dosed
orally
with
10­
29
g/
kg
showed
no
toxic
effects.

The
metabolic
studies
show
hydrolysis
of
polyglycerol
esters
in
the
gastrointestinal
tract
and
the
utilization
and
digestibility
studies
justify
the
assumption
that
the
fatty
acid
moiety
is
metabolized
in
the
normal
manner
(
WHO
1974).
There
is
no
evidence
of
cumulation
of
the
polyglycerol
moiety
in
the
body
tissues.
Human
studies
showed
no
adverse
effects.
A
study
in
rats
showed
the
percentage
of
dietary
fatty
acids
absorbed,
as
measured
by
fecal
fatty
acids,
decreased
as
the
level
of
polyglycerol
ester
increased
in
the
diet
(
WHO
1974).

Rats
fed
9%
polyglycerol
ester
and
1%
ground
nut
oil
showed
normal
kidney
function
after
17
weeks,
and
no
effects
on
the
weight
of
the
liver,
kidney,
adrenal,
spleen
and
testes
after
22
weeks.
No
gross
or
histological
effects
were
noted
in
the
liver
(
WHO
1974).
In
another
study,
up
to
10%
polyglycerol
ester
(
deca­
glycerol
deca­
oleate)
fed
to
rats
for
90
days
had
no
Page
18
of
23
adverse
effects
on
survival,
growth,
organ
weights,
body
weight
ratios,
and
hematologic
parameters.
Urinary
nitrogen
values
for
female
rats
was
elevated
at
weeks
three
and
nine.
There
were
no
compound­
related
effects
noted
upon
autopsy
and
microscopic
evaluation
(
WHO
1974).
Another
study
reported
no
adverse
effects
in
rats
fed
a
diet
containing
15%
polyglycerol
ester
of
fatty
acids
(
WHO
1974).

In
two
long
term
studies,
mice
and
rats
were
fed
either
polyglycerol
ester
or
ground­
nut
oil
at
5%
in
their
diet
for
80
weeks,
and
two
years,
respectively.
No
adverse
effects
were
noted
on
body
weight,
food
consumption,
peripheral
blood
picture,
or
survival
rate
in
either
species.
In
rats,
the
liver
and
renal
function
tests
were
normal.
In
both
mice
and
rats,
there
were
no
polyglycerol
residues
in
the
carcass
fat,
and
levels
of
free
fatty
acids,
unsaponifiable
material,
fatty
acid
composition
of
carcass
fat
and
organ
weights
were
the
same
in
exposed
and
control
groups,
except
for
the
liver
and
kidney
weights
of
female
mice,
which
were
significantly
higher.
There
were
no
remarkable
microscopic
findings
in
any
major
organ
of
either
mice
or
rats.
In
rats,
the
tumor
incidence
and
tumor
distribution
were
similar
between
exposed
and
control
animals
(
WHO
1974).

In
another
long
term
study,
mice
were
fed
1%
polyglycerol
ester
emulsifier
for
15.5
months.
There
were
no
significant
differences
between
growth
rate
and
longevity
of
test
and
control
animals,
nor
was
there
any
indication
of
carcinogenic
activity
(
WHO
1974).

In
a
human
study,
37
volunteers
were
fed
2­
20
g/
day
polyglycerol
ester
in
the
diet
for
three
weeks.
No
abnormalities
were
detected
in
plasma
proteins,
serum
amino­
acids,
thymol
turbidity,
serum
bilirubin,
total
and
free
serum
cholesterol,
serum
alkaline
phosphatase,
SGOT,
SGPT,
cholinesterase,
cholesterol
esterase,
urine
volume,
urinary
creatinine,
urea
output,
total
and
split
fecal
fat
or
total
fecal
nitrogen
(
WHO
1974).

In
a
reproductive
study,
rats
were
fed
a
diet
of
1.5%
polyglycerol
ester
for
three
generations.
There
were
no
significant
effects
on
fertility
or
reproductive
performance
during
the
first
year.
There
were
no
consistent
compound­
related
effects
on
the
third
generation
(
WHO
1974).

B.
Special
Considerations
for
Infants
and
Children
At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
Glycerol
and
glycerol
fatty
acid
esters
are
used
in
many
consumer
products
for
children,
including
baby
lotions
and
oils,
diaper
rash
cream,
and
have
a
long
history
of
safe
use
without
incident.
In
animal
studies
with
glycerol,
no
adverse
development
effects
were
noted
at
the
highest
dose
tested
in
rats,
mice
or
rabbits.
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
glycerol,
and
glyceryl
fatty
acid
esters
may
be
through
FDA­
approved
uses
as
food
additives,
or
through
its
use
in
soaps,
baby
lotions
and
oils,
household
cleaning
products
Page
19
of
23
and
other
cosmetic
products.
Cosmetic
products
containing
glycerol
or
glyceryl
monoesters
are
applied
to
most
areas
of
the
body,
and
could
come
in
contact
with
the
ocular
and
nasal
mucosae.
These
products
could
be
used
safely
on
a
daily
basis,
and
could
be
applied
frequently
over
a
period
of
several
years
(
CIR
2001).
Glycerol
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
glycerol
and
glyceryl
esters
of
fatty
acids
are
not
likely
to
exceed
levels
of
naturally
occurring
fatty
acids
in
commonly
eaten
foods.
In
addition,
the
use
of
these
compounds
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
glyceryl
oleate
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
shampoos,
cleansing
creams)
to
as
long
as
a
few
days
(
moisturizing
creams)
(
CIR
1986).
Glycerol
and
glyceryl
esters
of
fatty
acids
are
of
low
toxicity
to
humans,
and
there
is
no
reason
to
expect
that
reasonable
use
will
constitute
any
significant
hazard.
Therefore,
a
quantitative
screeninglevel
exposure
assessment
has
not
been
conducted.

VI.
Risk
Characterization:

The
glycerol
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
glycerol
and
glycerol
fatty
acid
esters,
including
their
low
acute
toxicity
via
oral
and
dermal
routes,
FDA's
designation
of
glycerol
and
certain
salts
of
glycerol
fatty
acid
esters
as
GRAS,
their
presence
in
food
products,
food
additives,
cosmetics,
and
cleaning
products,
as
well
as
the
significant
contribution
of
glycerol
fatty
acid
esters
in
the
diet,
the
uses
of
these
compounds
as
inert
and
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
these
compounds.

As
noted
previously,
glycerol
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.
Based
on
the
available
toxicity
data
for
glycerol,
and
the
OECD
SIDS
(
2002)
assessment
that
concluded
glycerol
is
a
low
hazard
potential,
the
Agency
feels
confident
in
proceeding
with
this
tolerance
reassessment
decision.
Any
submission
of
data
by
sponsors
of
glycerol
as
part
of
the
HPV
Challenge
Program
may,
in
the
future,
be
used
by
OPP
to
revise
or
update
their
tolerance
reassessment
decision
for
this
compound
as
deemed
necessary
and
appropriate.
Page
20
of
23
VII.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

Environmental
Fate
Characterization
Glycerol
is
fully
miscible
in
water.
It
has
a
calculated
half­
life
for
photooxidation
of
about
7
hours
and
is
not
susceptible
to
hydrolysis.
The
experimental
data
indicate
that
glycerol
is
readily
biodegradable
under
aerobic
conditions.
Fugacity
modelling
(
Mackay
Level
III)
predicts
that
glycerol
will
partition
to
the
aquatic
compartment
(
100%).
Based
on
the
low
Log
Kow,
it
has
a
low
potential
for
sorption
to
soil
and
is
not
expected
to
bioaccumulate
(
OECD
SIDS
2002).
It
is
not
expected
to
evaporate
significantly
from
soil.
In
air,
glycerol
may
be
moderately
degraded
by
reaction
with
photochemically
produced
hydroxyl
radicals,
and
removed
from
the
atmosphere
to
a
moderate
extent
by
wet
deposition
(
http://
www.
jtbaker.
com/
msds/
englishhtml.
g4774.
htm,
February
5,
2004).

For
the
glycerol
fatty
acid
esters,
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,
and
to
be
biodegraded
by
microorganisms
and
be
metabolized
in
animals.
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).

Ecotoxicity
and
Ecological
Risk
Characterization
Glycerol:
The
weight
of
the
evidence
indicates
that
glycerol
is
of
low
toxicity
to
aquatic
organisms
and
this
conclusion
is
supported
by
QSAR
predictions.
The
lowest
LC
50
for
fish
is
a
24­
hr
LC
50
of
>
5000
mg/
L
for
Carassium
auratus
(
goldfish)
and
for
aquatic
invertebrates,
a
24­
hr
EC
50
of
>
10000
mg/
L
for
Daphnia
magna
is
the
lowest
EC
50
.
Several
tests
on
algae
are
available,
which
suggest
very
low
toxicity
to
a
range
of
species,
however
their
validity
is
uncertain.
A
QSAR
prediction
for
the
96
hr
EC
50
to
algae
was
78000
mg/
L.
No
toxicity
towards
the
microorganism
Pseudomonas
putida
was
observed
at
10000
mg/
L
after
exposure
for
16
hours.
No
long­
term
aquatic
toxicity
data
are
available.
Screening
studies
are
available
on
frog
and
carp
embryos
which
indicate
some
effects
on
growth
and
hatching
rates,
respectively,
at
very
high
concentrations
of
glycerol
>
7000
mg/
L.
However,
their
ecological
relevance
is
not
clear
(
OECD
SIDS
2002).
OECD­
SIDS
(
2002)
estimated
a
tentative
PNEC
of
780
mg/
L
for
aquatic
organisms
using
QSAR.
There
are
no
sediment
or
terrestrial
effect
data
for
glycerol,
but
partitioning
to
both
soil
and
sediment
is
expected
to
be
very
low
based
on
the
low
Log
Kow
of
glycerol.
OECD­
SIDS
(
2002)
estimated
tentative
PNECs
of
479
mg/
kg
wwt
and
92
mg/
kg
wwt
for
soil
and
sediment,
respectively.
Page
21
of
23
Glycerol
Fatty
Acid
Esters:
EPA
(
2003)
recently
reviewed
the
C8,
C10
and
C12
straight
chain
fatty
acid
monoesters
of
glycerol:
glycerol
monocaprylate,
glycerol
monocaprate
and
glycerol
monolaurate,
and
registered
these
compounds
as
new
pesticidal
active
ingredients
acting
against
bacteria,
viruses,
fungi
and
lipid­
coated
yeasts.
The
Agency
concluded
that
these
compounds
are
non­
toxic
on
an
acute
basis
(
except
for
eye
irritation)
and
are
rapidly
metabolized
in
vertebrate
systems
to
polyols
and
free
fatty
acids.
Breakdown
products
are
indistinguishable
from
the
natural
background
of
these
same
compounds
in
living
systems.
The
Agency
granted
requests
for
waivers
from
the
data
requirements
for
avian
acute
oral
toxicity
studies,
avian
dietary
studies,
and
freshwater
fish
studies.
Based
on
the
label
use
pattern
anticipated
for
the
end­
use
product(
s),
there
is
little
likelihood
of
exposure
to
non­
target
birds,
aquatic
organisms
or
insects
(
EPA
2003).

The
ecotoxicity
data
for
glyceryl
monostearate
indicate
the
reduced
bioavailability
and
fairly
rapid
microbial
degradation 
approximately
4
days
for
primary
degradation 
these
materials
are
not
likely
to
result
in
a
significant
risk.
Similarly
these
compounds
are
not
expected
to
pose
a
risk
to
terrestrial
vertebrates.

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
compounds
(
glycerol
and
glycerol
fatty
acid
esters)
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
these
compounds
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,
OECD­
SIDS
and
CIR.
Glycerol
and
many
of
the
glycerol
fatty
acid
esters
are
classified
as
GRAS
substances.

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
glycerol
fatty
acid
esters
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
glycerol
and
glycerol
fatty
acid
esters
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
glycerol
and
glycerol
fatty
acid
esters
and
any
other
substances
and
these
compounds
do
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
Page
22
of
23
tolerance
action,
therefore,
EPA
has
not
assumed
that
glycerol
and
glycerol
fatty
acid
esters
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:

Cosmetic
Ingredient
Review
(
CIR).
1980.
Final
Report
of
the
Safety
Assessment
for
Caprylic/
Capric
Triglyceride.
Journal
of
Environmental
Pathology
and
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4(
4):
105­
120.
MRID
46200501.

Cosmetic
Ingredient
Review
(
CIR).
1986.
Final
Report
of
the
Safety
Assessment
of
Glyceryl
Oleate.
Journal
of
the
American
College
of
Toxicology
5(
5):
391­
413.
MRID
46201401.

Cosmetic
Ingredient
Review
(
CIR).
2001.
Safety
Assessment
of
Glyceryl
Laurate,
Glyceryl
Laurate
SE,
Glyceryl
Laurate/
Oleate,
Glyceryl
Adipate,
Glyceryl
Alginate,
Glyceryl
Arachidate,
Glyceryl
Arachidonate,
Glyceryl
Behenate,
Glyceryl
Caprate,
Glyceryl
Caprylate,
Glyceryl
Caprylate/
Caprate,
Glyceryl
Citrate/
Lactate/
Linoleate/
Oleate,
Glyceryl
Cocoate,
Glyceryl
Collagenate,
Glyceryl
Erucate,
Glyceryl
Hydrogenated
Rosinate,
Glyceryl
Hydrogenated
Soyate,
Glyceryl
Hydroxystearate,
Glyceryl
Isopalmitate,
Glyceryl
Isostearate,
Glyceryl
Isostearate//
Myristate,
Glyceryl
Isostearates,
Glyceryl
Lanolate,
Glyceryl
Linoleate,
Glyceryl
Linolenate,
Glyceryl
Montanate,
Glyceryl
Myristate,
Glyceryl
Isotridecanoate/
Stearate/
Adipate,
Glyceryl
Oleate
SE,
Glyceryl
Oleate/
Elaidate,
Glyceryl
Palmitate,
....
Amended
Final
Report.
February
13,
2001.

Food
and
Drug
Administration
(
FDA).
1975.
Evaluation
of
the
Health
Aspects
of
Glycerin
and
Glycerides
as
Food
Ingredients.
Prepared
for
FDA
by
the
The
Life
Sciences
Research
Office.
Federation
of
American
Societies
for
Experimental
Biology
under
Contract
No.
FDA
223­
75­
2004.
SCOGS­
30.
Bethesda,
MD.

FAO/
WHO
(
Food
and
Agriculture
Organization
of
the
United
Nations/
World
Health
Organization).
Joint
FAO/
WHO
Expert
Committee
on
food
additives.
Summary
and
Conclusions.
17th
Report,
June
25­
July
4,
1974.
Geneva.
(
http://
www.
inchem.
org/
documents/
jecfa/
jecmono/
v05je45.
htm)(
May
5,
2003)

OECD
(
Organization
for
Economic
Cooperation
and
Development)
Screening
Information
Data
Sets
(
SIDS).
Processed
by
United
Nations
Environment
Programme
(
UNEP)
Chemicals
as
a
contribution
to
the
Inter­
Organization
Programme
for
the
Sound
Management
for
Chemicals
(
IOMC).
(
http://
www.
inchem.
org/
documents/
sids/
sids/
sids5b01.
htm.
and
http://
www.
inchem.
org/
documents/
sids/
sids/
sids5b06.
htm.
)
(
March
2002)

TOXNET
2003.
Hazardous
Substance
Data
Bank
(
HSDB).
On­
line
Scientific
Search
Engine,
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23
of
23
National
Library
of
Medicine,
National
Institute
of
Health.
Http://
www.
toxnet.
nlm.
nih.
gov.
Search
terms:
glycerol
monooleate
(
May
14,
2003).

U.
S.
Environmental
Protection
Agency
(
EPA)
2002.
IIFG
Decision
Documents
on
Reassessment
of
Exemptions
from
the
Requirement
of
a
Tolerance
for
Butyl
Stearate
and
Glyceryl
Monostearate.
Memorandum
from
K.
Boyle
and
K.
Leifer
to
R.
Forrest.
July
31,
2002.

U.
S.
Environmental
Protection
Agency
(
EPA).
2002.
"
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.

U.
S.
Environmental
Protection
Agency
(
EPA)
2003.
Science
Review
in
Support
of
the
Registration
of
the
Technical
Grade
Active
Ingredient
(
TGAI)
Product,
VMX­
42
Technology
Propylene
Glycol
Monocaprylate
(
EPA
File
Symbol
No.
10350­
AN),
Containing
Two
New
Active
Ingredients,
68.12%
Propylene
Glycol
Monocaprylate
(
Chemical
No.
082704)
and
0.15%
Propylene
Glycol
Monocaprate
(
Chemical
No.
011289);
and
Science
Review
of
Studies/
Data/
information
to
be
used
in
Support
of
VMX
Technology
Chemicals,
Consisting
of
Three
Closely­
Related
Propylene
Glycol
Monoesters
[
Propylene
Glycol
Monocaprylate
(
Chemical
No.
082704);
Propylene
Glycol
Monocaprate
(
Chemical
No.
011289);
and
Propylene
Glycol
Monolaurate
(
Chemical
No.
011288)];
and
Three
Closely­
Related
Glycerol
Monesters
[
Glycerol
Monocaprylate
(
Chemical
No.
011292);
Glycerol
Monocaprate
(
Chemical
No.
011297);
and
Glycerol
Monolaurate
(
Chemical
No.
011290)].
Memo
from
R.
Jones
to
C.
Frazer,
Biopesticide
&
Pollution
Prevention
Division.
April.
