Document ID: EPA-HQ-OPPT-2004-0071-0033
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-11-09T05:00Z

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t
h
ro
u
g
h
La
w
a
n
d
S
c
i
e
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November
18,
2004
Via
E­
mail
at
(
sharkey.
susan@
epa.
gov)

Susan
Sharkey
7406M
USEPA
Headquarters
Ariel
Rios
Building
1200
Pennsylvania
Avenue,
N.
W.
Washington,
DC
20460
Re:
Supplemental
Submission
on
Canola
Oil,
Xylitol,
Soybean
Meal
and
Fats
and
Glyceridic
Oils,
Vegetable
Dear
Ms.
Sharkey:

The
following
information
is
submitted
by
the
Coalition
consisting
of
the
Corn
Refiners
Association,
the
National
Oilseed
Processors
Association,
the
Institute
of
Shortening
and
Edible
Oils,
the
National
Cotton
Council
of
America,
and
the
Soy
Protein
Council
as
a
supplement
to
its
Petition
dated
December
30,
2003,
to
partially
exempt
certain
food­
related
chemical
substances
from
TSCA
Inventory
Update
Reporting
requirements,
in
2006.
This
Supplemental
Submission
responds
to
a
voicemail
inquiry
by
you,
in
mid­
October
2004,
seeking
additional
information
on
Canola
Oil,
Xylitol,
Soybean
Meal,
and
Fats
and
Glyceridic
Oils,
Vegetable.

I.
Summary
A.
Toxicity
1.
Canola
Oil.
According
to
EPA's
Office
of
Pesticide
Programs
canola
oil
"
has
low
chronic
toxicities".
In
addition,
FDA
has
granted
"
generally
recognized
as
safe"
(
GRAS)
status
to
low
erucic
acid
rapeseed
oil
for
use
as
an
edible
fat
or
oil
in
human
food.
(
It
should
be
noted
that
canola
and
low
erusic
acid
rapeseed
oil
(<
2.0%
erusic
acid)
are
essentially
the
same.
The
FDA
issued
a
final
rule
in
the
Federal
Register
of
December
29,
1998
(
Vol.
53,
No.
250,
P.
52682)
revising
its
regulations
{
21CFR184.1555(
c)]
to
include
"
canola
oil"
as
the
alternate
common
and
usual
name
for
low
erusic
rapeseed
oil.)
Canola
oil
is
an
edible
substance
that
is
readily
metabolized
by
humans.
There
is
adequate
information
available
from
literature
sources
to
characterize
the
toxicity
of
canola
oil.

2.
Xylitol.
Acute
toxicity
end­
points
for
xylitol
are
all
greater
than
8
gm/
kg
 
i.
e.,
virtually
non­
toxic.
Inhalation
of
aerosolized
iso­
osmotic
xylitol
was
well­
tolerated
by
naive
and
atopic
mice,
and
by
healthy
human
volunteers.
Xylitol
may
be
safely
used
in
foods
for
special
Herb
Estre
i
c
he
r
(
2
0
2
)
4
3
4
­
4
3
3
4
e
s
t
r
e
i
c
h
er@
k
hl
aw.
com
Susan
Sharkey
November
9,
2005
Page
2
KELLER
AND
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O
This
document
was
delivered
electronically.
dietary
uses,
provided
the
amount
used
is
not
greater
than
that
required
to
produce
its
intended
effect.
The
only
citation
found
that
indicated
any
toxicity
was
to
an
existing
E.
coli
C
mutant
strain.

3.
Soybean
meal.
Soybean
meal
is
considered
safe
as
an
animal
feed.
Although
there
are
some
reports
in
the
literature
that
raw
soybean
meal
may
cause
some
enlargement
of
the
pancreas
of
growing
chicks
and
rats,
soybean
meal
is
heat
treated
before
use
to
remove
the
constituents
that
may
cause
these
effects.

4.
Fats
and
Glyceridic
Oils.
The
acute
toxicity
endpoint
for
an
intravenous
study
on
rabbits
exposed
to
fats
and
glycederic
oils
was
840
mg/
kg.
Studies
on
exposure
to
vegetable
oil
mist
in
manufacturing
settings
have
shown
that
"
vegetable
oil
mists
seem
to
have
little
adverse
effect
on
the
lungs
and
do
not
produce
significant
organic
disease
or
toxic
effects
when
exposures
are
kept
under
reasonable
control."
The
Occupational
Safety
and
Health
Administration
(
OSHA)
Permissible
Exposure
Limit
is
15
mg/
m3
for
total
exposure
and
5
mg/
m3
for
the
respirable
fraction.

B.
Ecotoxicity
and
Environmental
Fate
According
to
USDA,
"
Vegetable
oils
have
superb
environmental
credentials,
such
as
being
inherently
biodegradable,
having
low
eco­
toxicity
and
low
toxicity
towards
humans,"
EPA
notes
that
"
Although
the
Agency
does
not
have
toxicity
test
results
for
nontarget
insects,
fish,
and
other
wildlife
directly
exposed
to
canola
oil,
numerous
metabolic
studies
on
the
dietary
effects
and
metabolism
of
canola
in
birds,
mammals,
and
fish
are
reported
in
the
literature.
Ecological
effects
data
for
terrestrial
and
aquatic
animals,
and
nontarget
plants
for
canola
were
waived
for
the
same
reasons
given
above;
principally,
the
low
toxicity
of
the
product,
and
its
rapid
degradation
in
the
environment."
Two
studies
looking
at
exposures
of
tropical
fish
and
coral
to
vegetable­
derived
lubricants
(
VDL)
and
mineral­
derived
lubricants
(
MDL)
showed
that
VDL
was
less
toxic.
Studies
with
sunflower
oil
and
linseed
oil
resulted
in
longer
degradation
time
for
sunflower
oil,
but
a
study
with
VDL
and
MDL
indicated
significantly
faster
degradation
of
VDL.

C.
Physical
Properties
Physical
properties
data
are
limited.
Data
for
canola
oil
are
included
below
and
information
for
xylitol
and
vegetable
oil
are
included
in
the
MSDS
information
attached
at
the
end
of
this
paper.
Susan
Sharkey
November
9,
2005
Page
3
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This
document
was
delivered
electronically.
II.
Substance­
specific
Information
A.
Canola
Oil
http://
www.
epa.
gov/
pesticides/
biopesticides/
ingredients/
tech_
docs/
tech_
011332.
htm,
Canola
EPA
Technical
data
sheet
1.
Toxicity
Much
of
what
is
known
about
the
toxicology
and
environmental
effects
and
fate
of
Canola
Oil
is
summarized
in
the
above
referenced
EPA
Technical
data
sheet
supporting
the
registration
of
canola­
based
products
as
biopesticides
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
("
FIFRA").
The
Office
of
Pesticide
Programs
(
OPP)
has
waived
the
generic
data
requirements
for
canola
oil,
except
for
certain
technical
chemistry
information,
in
light
of
its
low
toxicity.
Available
literature
indicates
that
this
substance
has
low
chronic
toxicities.
In
addition,
FDA
has
granted
GRAS
status
to
low
erucic
acid
rapeseed
oil
for
use
as
an
edible
fat
or
oil
in
human
food.
Canola
oil
is
an
edible
substance
that
is
readily
metabolized
by
humans.

There
is
adequate
information
available
from
literature
sources
to
characterize
the
toxicity
of
canola
oil.
These
studies
indicate
that
canola
oil's
nutritional
and
toxicological
profiles
are
similar
to
those
of
other
vegetable
oils
(
50FR
3745,
3752)
(
Kramer
et.
al.,
1983).
Moreover,
the
available
literature
indicates
that
the
use
of
this
substance
as
a
component
of
food
is
safe.
Data
available
on
soybean
oil,
discussed
in
Reregistration
Eligibility
Decision
(
RED):
Flower
and
Vegetable
Oils
EPA
738­
R­
93­
031
December,
1993
also
support
the
low
toxicity
of
canola
oil.
There
are
no
incident
reports
on
file
for
low
erucic
acid
canola
oil.
Canola
oil
has
a
non­
toxic
mode
of
action
for
the
target
pests.

Acute
toxicity
data
were
submitted
to
OPP
in
support
of
the
end­
use
product
registrations
for
NEU1161,
which
contains
the
active
ingredients:
89.5%
canola
oil
and
0.5%
pyrethrins.
NEU1161
is
classified
as
toxicity
category
IV
(
virtually
non­
toxic)
for
acute
inhalation
and
primary
eye
toxicity.
These
data
are
considered
adequate
to
support
all
three
canola
formulations
that
are
registered
with
EPA:
NEU1160
Vegetable
Oil
Spray,
NEU1161,
and
NEU1161
RTU.
It
should
be
noted,
however,
that
the
NEU1160
and
NEU1161
RTU
products
contain
either
no
or
substantially
less
pyrethrin,
respectively,
and
are
thus
likely
to
have
a
lower
acute
toxicity
than
the
NEU1161
product.

2.
Ecological
Toxicity:
Numerous
metabolic
studies
on
the
dietary
effects
and
metabolism
of
canola
oil
in
birds,
mammals,
and
fish
are
reported
in
the
literature.
Susan
Sharkey
November
9,
2005
Page
4
KELLER
AND
HECKMAN
LLP
L
AW
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WAS
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O
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D
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C.
BR
US
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LS
SA
N
F
RA
NC
I
S
C
O
This
document
was
delivered
electronically.
Ecological
effects
data
for
terrestrial
and
aquatic
animals,
and
nontarget
plants
(?)
for
canola
were
waived
by
the
Office
of
Pesticide
Programs
principally
because
of
the
low
toxicity
of
the
product,
and
its
rapid
degradation
in
the
environment.

3.
Physical
Properties
for
Canola
Oil
Material
Safety
Data
Sheet
PHYSICAL
STATE
Liquid
COLOR
Yellow
ODOR
Slight
SPECIFIC
GRAVITY
@
25
°
C
0.91­
0.92
VAPOR
DENSITY
N/
A
FLASH
POINT
(
Cleveland
closed
cup)
>
329
°
C
VAPOR
PRESSURE
N/
A
SOLUBILITY
IN
H2O
Insoluble
pH
N/
A
VOLATILES
(%)
<
0.1
Canola
Oil
 
Exemption
from
Requirements
of
a
Tolerance
Under
Section
408
of
the
FFDCA
(
63
FR
18326­
29
(
April
15,
1998))

In
connection
with
the
grant
of
an
exemption
from
tolerance
for
the
use
of
canola
oil
on/
in
food
under
408(
b)(
2)(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
EPA
reviewed
the
scientific
data
and
other
relevant
information
on
the
dietary
risk
associated
with
consumption
of
canola
oil
food
residues.
EPA
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children,
to
canola
oil.
Data
waivers
were
granted
for
acute
oral,
dermal,
inhalation,
and
eye
toxicity,
dermal
sensitization,
genotoxicity,
reproductive
and
developmental
toxicity,
subchronic
(
90­
day)
oral
and
inhalation
toxicity,
and
teratogenicity.
The
waivers
were
granted
based
on
the
long
history
of
use
of
canola
as
an
edible
fat
and
oil
in
food
without
any
indication
of
deleterious
effects;
its
low
toxicity;
its
natural
occurrence
as
an
oil
extracted
from
plants;
its
low
erucic
acid
(
less
than
2%)
content;
its
conformity
with
21
CFR
184.1555(
c);
and,
its
classification
by
FDA
as
"
generally
recognized
as
safe"
(
GRAS)
for
use
as
an
edible
fat
or
oil
in
human
food.
Available
toxicity
data
on
vegetable
oils
from
the
open
literature
and
the
Reregistration
Eligibility
Decision
document
for
Flower
and
Vegetable
Oils
(
EPA
738­
R­
93­
031)
supported
this
finding.
Susan
Sharkey
November
9,
2005
Page
5
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This
document
was
delivered
electronically.
4.
Other
Literature
Findings:
http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstr
act&
list_
uids=
12909273
Twenty
Wistar
male
rats,
with
ages
varying
from
21
days
to
12
months,
were
fed
with
diets
supplemented
by
soybean
oil
(
S
group),
canola
oil
(
CA
group),
lard
and
egg
yolk
(
LE
group),
and
canola
plus
lard
and
egg
yolk
(
CA+
LE
group).
The
LE
group
presented
the
highest
heart
mass/
body
mass
ratio
and
the
highest
blood
pressure
as
well.
The
aortic
structure
suffered
a
number
of
alterations,
from
CA
rats
group
(
minor
alterations)
to
LE
and
CA+
LE
rats
group
(
major
alterations).
The
CA
group
showed
the
smallest
aorta
thickness.
No
significant
differences
among
groups
were
found
concerning
the
number
of
aortic
lamellae
and
the
density
of
tunica
media
smooth
muscle
nuclei.
Surface
density
of
the
aortic
lamellae
was
greater
in
the
CA
group
and
smaller
in
the
LE
group.
These
results
suggest
that
the
dietary
intake
of
canola
oil
could
attenuate
the
aorta
structure
aging
process
with
a
favorable
BP
maintenance.
Susan
Sharkey
November
9,
2005
Page
6
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C
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This
document
was
delivered
electronically.
B.
Xylitol
1.
Toxicity
Xylitol
is
listed
in
Section
172.395
of
the
FDA
regulations
as
a
direct
food
additive.
Section
172.395
states
that
"
Xylitol
may
be
safely
used
in
foods
for
special
dietary
uses,
provided
the
amount
used
is
not
greater
than
that
required
to
produce
its
intended
effect."

2.
Other
Information
on
Xylitol:
http://
www.
cdc.
gov/
niosh/
rtecs/
zfc3500.
html
1.
ACUTE
TOXICITY
DATA
AND
REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT
REFERENCE
intramuscular
mouse
lethal
dose
(
50
percent
kill):
10,200
mg/
kg
N/
R
NIIRDN
­
,297,1990
intramuscular
rat
lethal
dose
(
50
percent
kill):
15
gm/
kg
N/
R
NIIRDN
­
,297,1990
intraperitoneal
mouse
lowest
published
lethal
dose:
22,100
mg/
kg
N/
R
RPTOAN
34,124,1971
intravenous
mouse
lethal
dose
(
50
percent
kill):
8,500
mg/
kg
N/
R
NIIRDN
­
,352,1995
intravenous
rat
lethal
dose
(
50
percent
kill):
10,800
mg/
kg
N/
R
NIIRDN
­
,297,1990
intravenous
rabbit
lethal
dose
(
50
percent
kill):
4
gm/
kg
Biochemical:
Metabolism
(
intermediary):
Other
FEPRA7
31,726,1972
oral
mouse
lethal
dose
(
50
percent
kill):
12,500
mg/
kg
Behavioral:
General
anesthetic
Gastrointestinal:
Ulceration
or
bleeding
from
stomach
Liver:
Other
changes
GISAAA
36(
2),
25,1971
oral
rat
lethal
dose
(
50
percent
kill):
16,500
mg/
kg
N/
R
NIIRDN
­
,297,1990
oral
rabbit
lethal
dose
(
50
percent
kill):
25
gm/
kg
Behavioral:
General
anesthetic
GISAAA
36(
2),
25,1971
Susan
Sharkey
November
9,
2005
Page
7
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BR
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S
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SA
N
F
RA
NC
I
S
C
O
This
document
was
delivered
electronically.
Gastrointestinal:
Ulceration
or
bleeding
from
stomach
Liver:
Other
changes
subcutaneous
mouse
lethal
dose
(
50
percent
kill):
18,300
mg/
kg
N/
R
NIIRDN
­
,297,1990
subcutaneous
rat
lethal
dose
(
50
percent
kill):
>
25
gm/
kg
N/
R
NIIRDN
­
,297,1990
3.
Other
Literature
Findings:
http://
www.
pubmedcentral.
nih.
gov/
articlerender.
fcgi?
artid=
221841
D­
Arabitol
was
observed
to
be
toxic
to
many
laboratory
strains
of
Escherichia
coli
K­
12,
but
xylitol
was
found
to
be
toxic
to
only
one
existing
E.
coli
C
mutant
strain.
Xylitol
toxicity
is
prevented
by
fructose
in
both
wild­
type
and
mutant
strains.
http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
15377394.

Safety
assessment
of
inhaled
xylitol
in
mice
and
healthy
volunteers:
http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
15377394.
CONCLUSIONS:
Inhalation
of
aerosolized
iso­
osmotic
xylitol
was
welltolerated
by
naive
and
atopic
mice,
and
by
healthy
human
volunteers.

C.
SOYBEAN
MEAL
1.
Toxicity
http://
www.
asa­
europe.
org/
pdf/
evaluation.
pdf
There
are
a
number
of
reports
in
the
public
literature
indicating
that
raw
soybean
meal
may
negatively
impact
the
growth
of
rats,
but
this
potential
effect
is
eliminated
when
the
raw
soybean
meal
is
cooked
or
otherwise
heat
processed,
as
is
commonly
done
to
improve
the
nutritional
value
and
digestibility
of
soybean
meal.
See
http://
www.
fao.
org/
docrep/
X5738E/
x5738e0l.
htm
Initial
studies
on
the
nutritive
value
of
soybeans
were
done
on
rats.
Osborne
and
Mendel
(
1917)
and
Hayward
et
al.
(
1936)
observed
that
full­
fat
or
fat­
extracted
raw
soybean
meal
inhibited
growth
of
rats,
and
growth
inhibition
was
overcome
in
cooked
or
heat­
processed
soybeans.
Pigs
also
grew
better
on
diets
containing
heat­
processed
soybeans
rather
than
raw
soybeans
(
Robison,
1930;
Vestal
and
Shrewsbury,
1932;
Hayward
et
al.,
1935).
Similar
results
Susan
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November
9,
2005
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was
delivered
electronically.
were
reported
for
growing
chickens
(
Wilgus
et
al.,
1936;
Hayward
et
al.,
1937).
Deleterious
substances
which
were
inactivated
by
heat
treatment
were
not
characterized
for
many
years,
and
serious
attempts
were
only
made
to
incorporate
soybean
meal
in
animal
feeds
from
World
War
II
onwards.

Soybeans
also
are
reported
to
contain
several
protease
inhibitors,
generally
called
trypsin
inhibitors
(
Read
and
Haas,
1938;
Ham
and
Sandstedt,
1944;
Bowman,
1944;
Ham
et
al.,
1945;
Kunitz,
1945;
Borcher
et
al.,
1947,
1948;
Almquist
and
Merrit,
1952;
Birk
and
Gertler,
1961;
Birk
et
al.,
1963;
Liener
and
Kakade,
1980),
hemagglutinin
or
lectins
(
Liener,
1951;
Pallansch
and
Liener,
1953;
Jaffe,
1980)
and
estrogens
(
Carter
et
al.,
1955;
Booth
et
al.,
1960;
Naim
et
al.,
1974;
Wada
and
Yuhara,
1964).
Saponins
(
Wolf,
1966;
Gestetner
et
al.,
1966;
Fenwick
and
Oakenfull,
1981),
and
urease
(
Caskey
and
Knapp,
1944)
are
also
present
in
raw
soybeans,
but
it
is
doubtful
that
any
of
these
substances
are
deleterious
to
monogastric
animals,
such
as
humans.

Raw
soybean
meal
has
also
been
reported
to
cause
enlargement
of
the
pancreas
of
growing
chicks
(
Chernick
et
al.,
1948;
Applegarth
et
al.,
1964)
and
rats
(
Rackis,
1965;
Khayambashi
and
Lyman,
1966).
The
causative
agents
are
inactivated
by
heat
treatment
(
Brambila
et
al.,
1961;
Saxena
et
al.,
1963;
Garlich
and
Nesheim,
1966;
Gertler
et
al.,
1967).

Liener
(
1951)
observed
toxicity
of
hemagglutinin,
or
lectin,
when
injected
intraperitoneally
into
rats
and
chicks,
and
there
are
suggestions
that
the
destruction
of
lectins
by
heat
may
explain
the
effect
of
heat
treatment
on
inactivating
any
potential
growth
inhibition
associated
with
raw
soybean
meal
ingestion.
Hemagglutinin
is
a
multicomponent
entity
that
is
also
inactivated
by
heat
treatment
of
soybeans.

D.
Fats
and
Glycederic
Oils,
Vegetable
http://
www.
osha.
gov/
SLTC/
healthguidelines/
vegetableoilmist/
recognition.
html
1.
Toxicology
a.
Effects
on
Animals:
The
mists
of
vegetable
oils
are
considered
biologically
inert.
High
oral
doses
of
vegetable
oils
have
a
laxative
effect
[
ACGIH
1991].
Sunflower
oil
was
lethal
in
rats
when
added
to
the
animal's
diet
in
an
amount
corresponding
to
45
percent
of
total
diet
calories
for
a
period
of
4.5
months
[
NLM
1995].
Direct
instillation
of
vegetable
oil
into
rabbit
lungs
is
expected
to
induce
acute
bronchitis
[
ACGIH
1991].

b.
Effects
on
Humans:
Most
vegetable
oil
mists
are
biologically
inert
and
are,
therefore,
considered
to
be
nuisance
particulates.
Vegetable
oil
mists
seem
to
have
little
adverse
effect
on
the
lungs
and
do
not
produce
significant
organic
disease
or
toxic
effects
when
exposures
are
kept
under
reasonable
control
[
ACGIH
1991].
Oils
from
certain
plants
such
as
castor
bean,
sesame,
acacia,
and
cashew
nut
have
caused
occupational
dermatitis
and
respiratory
irritation.
Exposure
to
acacia
gum
oil
has
been
associated
with
occupational
asthma
and
dermatitis
[
ACGIH
1991].
Susan
Sharkey
November
9,
2005
Page
9
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Ingestion
of
cottonseed
oil
that
also
contained
some
camphorated
oils
has
caused
clinical
toxicity,
coma,
and
death
[
ACGIH
1991].

http://
www.
ars.
usda.
gov/
research/
publications/
Publications.
htm?
seq_
no_
115=
145286
Vegetable
oils
have
superb
environmental
credentials,
such
as
being
inherently
biodegradable,
having
low
eco­
toxicity
and
low
toxicity
towards
humans,
being
derived
from
renewable
resources
and
contributing
no
volatile
organic
compounds
(
VOC).

http://
www.
cdc.
gov/
niosh/
rtecs/
yx1c3a90.
html
2.
ACUTE
TOXICITY
DATA
AND
REFERENCES:

ROUTE/
ORGANISM
DOSE
EFFECT
REFERENCE
intravenous
rabbit
lethal
dose
(
50
percent
kill):
840
mg/
kg
N/
R
APTOA6
45,352,1979
3.
REVIEWS:

ORGANIZATION
STANDARD
REFERENCE
American
Conference
of
Governmental
Industrial
Hygienists
(
ACGIH)
Threshold
Limit
Value
time­
weighted
average
10
mg/
m3
DTLVS*
TLV/
BEI,
2002
a)

4.
STANDARDS
AND
REGULATIONS:

ORGANIZATION
STANDARD
REFERENCE
Occupational
Safety
and
Health
Administration
(
OSHA)
Permissible
Exposure
Limit
(
General
Industry)
8
hour
time­
weighted
average
15
mg/
m3,
total
dust
CFRGBR
29,1910.1000,1994
Occupational
Safety
and
Health
8
hour
time­
weighted
CFRGBR
Susan
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November
9,
2005
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US
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This
document
was
delivered
electronically.
Administration
(
OSHA)
Permissible
Exposure
Limit
(
General
Industry)
average
5
mg/
m3,
respirable
fraction
29,1910.1000,1994
5.
NIOSH
DOCUMENTATION
AND
SURVEILLANCE:

ORGANIZATION
STANDARD
or
SURVEY
REFERENCE
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH)
Recommended
Exposure
Level
TO
VEGETABLE
OIL
MIST,
respirable
fraction­
air
time­
weighted
average
5
mg/
m3
NIOSH*
DHHS
#
92­
100,1992
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH)
Recommended
Exposure
Level
TO
VEGETABLE
OIL
MIST,
total
dust­
air
10
hour
time­
weighted
average
10
mg/
m3
NIOSH*
DHHS
#
92­
100,1992
2.
Environmental
Fate
http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
12738220
The
effects
of
a
simulated
spill
of
sunflower
oil
in
salt
marsh
sediments
were
compared
in
an
experiment
with
linseed
oil.
Sunflower
and
linseed
oil
penetrated
the
sediments
at
the
same
rates,
but
different
adsorption
of
the
oils
onto
sediment
particles
resulted
in
the
establishment
of
anaerobic
conditions
at
shallower
depths
in
sediments
contaminated
with
linseed
oil
than
with
sunflower
oil.
The
total
lipid
content
of
sunflower
oil­
contaminated
sediments
remained
almost
stable
for
six
months,
while
only
40%
of
linseed
oil
remained
in
the
sediment
after
two
months.
Numbers
of
culturable
heterotrophic
bacteria
and
aerobic
oil
degrading
bacteria
in
muddy
sediment
increased
rapidly
in
response
to
the
presence
of
the
oils,
but
bacterial
numbers
in
sandy
sediments
increased
more
slowly
for
sunflower
oil.
Changes
in
fatty
acid
composition
indicate
similar
degradation
pathways
for
both
oils,
however,
sunflower
oil
degraded
more
slowly
than
linseed
oil
and,
thus,
has
the
potential
for
longer
lasting
effects
in
marine
environments.

http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
14987803
Susan
Sharkey
November
9,
2005
Page
11
KELLER
AND
HECKMAN
LLP
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N
F
RA
NC
I
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C
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This
document
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delivered
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3.
Ecotoxicity
a.
Testing
the
ecotoxicology
of
vegetable
versus
mineral
based
lubricating
oils:
Degradation
rates
using
tropical
marine
microbes.

Degradation
of
some
VDL
[
vegetable­
derived
lubricant]
was
observed
by
day
7,
with
the
2­
stroke
VDL
markedly
consumed
by
mangrove
microorganisms
and
the
hydraulic
VDL
degraded
by
both
microorganism
communities
after
this
short
period.
All
of
the
VDL
groups
were
significantly
more
degraded
than
the
comparable
MDLs
mineral
oil
lubricants
over
14
days
in
the
presence
of
either
mangrove
or
coral
reef
microbial
communities.

http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
14987804
b.
Testing
the
ecotoxicology
of
vegetable
versus
mineral
based
lubricating
oils:
Induction
of
mixed
function
oxidase
enzymes
in
barramundi,
Lates
calcarifer,
a
tropical
fish
species.

This
study
is
the
first
investigation
into
the
use
of
this
key
commercial
species
in
tropical
North
Queensland,
Australia
in
stress
assessment
of
potential
hydrocarbon
pollution
using
ethoxyresorufin
O­
deethylase
(
EROD)
induction.
Our
results
indicated
that
barramundi
provide
a
wide
range
of
inducible
rates
of
EROD
activity
in
response
to
relevant
organic
stressors.
The
vegetable­
and
mineral­
based
lubricants
induced
significant
EROD
activity
at
1.0
mg
kg(­
1)
and
there
was
no
significant
difference
between
the
two
oil
treatments
at
that
concentration.
At
increasing
concentrations
of
2
and
3
mg
kg(­
1),
the
mineral­
based
lubricant
resulted
in
slightly
higher
EROD
activity
than
the
vegetable­
based
lubricant.
The
EROD
activity
of
control
and
treated
barramundi
are
found
to
be
within
ranges
for
other
species
from
temperate
and
tropical
environments.
These
results
indicate
that
vegetable­
based
lubricants
may
be
less
stressful
to
barramundi
than
their
mineral
counterparts
at
concentrations
of
lubricant
>
or
=
2
mg
kg(­
1).

http://
www.
ncbi.
nlm.
nih.
gov/
entrez/
query.
fcgi?
cmd=
Retrieve&
db=
pubmed&
dopt=
Abstract&
list
_
uids=
14987805
c.
The
ecotoxicology
of
vegetable
versus
mineral
based
lubricating
oils:
Coral
fertilization
and
adult
corals
The
coumarin­
free
[
vegetable­
derived
lubricants]
VDL­
2
exhibited
significantly
less
toxicity
towards
the
adult
corals
than
all
of
the
other
oil
types
tested,
with
the
only
measurable
effect
being
a
slight
but
significant
drop
in
photosynthetic
efficiency
at
280
microg
l(­
1).
Susan
Sharkey
November
9,
2005
Page
12
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D
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C.
BR
US
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N
F
RA
NC
I
S
C
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click
on
icon
to
open
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msds.
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veg
oil
msds.
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xylitol
msds.
pdf"

*
*
*

We
trust
this
Supplemental
Submission
serves
your
needs
by
demonstrating
the
low
potential
for
toxicity
of
the
above­
referenced
compounds.
If
you
have
any
questions,
do
not
hesitate
to
contact
us.

Sincerely,

Original
Signed
By
Herbert
Estreicher