Document ID: EPA-HQ-OPP-2005-0487-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-01-25T05:00Z

Page
1
of
10
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
sorbitol.
There
are
many
existing
uses
of
sorbitol
in
our
food
production
processes.
There
are
no
reported
effects
in
humans,
except
for
cases
where
large
amounts
(
more
than
50
grams
per
day
which
can
cause
a
laxative
effect)
are
ingested.
Based
on
its
long
history
of
use
as
a
food
additive,
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
sorbitol
from
its
uses
as
an
inert
ingredient
in
pesticide
products.
The
sorbitol
exemptions
from
the
requirement
of
a
tolerance
as
established
in
40
CFR
180.1001
(
c)
and
(
e)
are
reassessed.
Based
on
its
low
toxicity,
the
classification
of
sorbitol
as
List
4A
is
confirmed.
Page
2
of
10
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
22,
2003
Memorandum
Subject:
Sorbitol
Science
Assessment
Document
for
Tolerance
Reassessment.

CAS
No.:
50­
70­
4
Chemical
Class:
polyhydric
alcohol
40
CFR:
180.1001
(
c),
(
e)

From:
Bentley
C.
Gregg,
Risk
Assessor
Product
Reregistration
Branch
Special
Review
and
Reregistration
Division
(
7508C)

Through:
Linda
Propst,
Branch
Chief
Mark
Perry,
Team
Leader
Product
Reregistration
Branch
Special
Review
and
Reregistration
Division
(
7508C)

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
sorbitol.
This
assessment
summarizes
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
exposure
profile,
and
environmental
fate
and
ecotoxicity
of
this
substance.
In
performing
this
assessment,
EPA
has
relied
on
peer­
reviewed
evaluations
performed
by
the
Food
and
Drug
Administration
(
FDA),
and
the
Food
and
Agriculture
Organization
of
the
World
Health
Organization
(
FAO/
WHO).
Page
3
of
10
I.
Executive
Summary:

Sorbitol
is
a
polyhydric
alcohol.
It
is
considered
by
the
U.
S.
FDA
to
be
Generally
Recognized
As
Safe
(
GRAS)
for
its
use
as
a
direct
food
substance.
Among
its
GRAS
approvals,
it
is
used
in
candy
manufacturing
(
at
levels
up
to
99%)
and
as
a
sugar
substitute
for
diabetics.
It
also
occurs
naturally
in
a
number
of
fruits.
Exposure
to
other
types
of
sorbitol­
containing
products
may
come
from
a
wide
variety
of
sources,
since
it
is
used
for
manufacturing
purposes,
and
as
a
humectant
(
moisture
conditioner)
and
in
pharmaceuticals.

Open
literature
studies
and
information
from
various
internet
websites
show
that
there
are
limited
toxicological
effects
from
exposure
to
sorbitol,
with
the
acute
oral
toxicity
being
greater
than
15
grams
per
kilogram
to
rats
and
mice.
In
repeated
dosing
tests,
essentially
no
adverse
effects
were
observed,
at
dosing
levels
of
up
to
10%
of
the
diet.
Sorbitol
was
negative
in
various
mutagenicity
tests.
There
are
no
reported
effects
in
humans,
except
for
cases
where
large
amounts
(
more
than
50
grams
per
day)
are
ingested.
FDA
has
indicated
that
labeling
is
required
on
some
products
to
indicate
"
Excess
consumption
may
have
a
laxative
effect."

Pesticidal
use
of
sorbitol
as
an
inert
ingredient
is
as
an
antidusting
agent.
There
is
an
active
ingredient
Chemical
Code
number,
but
there
are
no
registered
uses
of
this
substance
as
an
active
ingredient
in
pesticide
formulations.

The
information
and
estimations
concerning
the
environmental
fate
of
sorbitol
indicate
that
it
will
be
very
mobile
in
soil
and
water,
will
not
partition
to
the
atmosphere,
and
will
be
readily
degraded
by
biological
degradation
processes.

Based
on
available
information
on
sorbitol,
its
expected
use
patterns,
safe
history
of
use
as
a
food
additive,
and
extensive
use
in
commercially­
available
foods,
OPP
has
determined
that
a
screening­
level
quantitative
risk
assessment
is
not
required
for
sorbitol.

II.
Use
Information:

The
pesticidal
and
non­
pesticidal
uses
of
sorbitol
are
summarized
briefly
below.

Use
Pattern
(
pesticidal
­
inert
ingredient)

Chemical
Name
(
common)
Inert
PC
Code
40
CFR
180.1001
Inert
Use
Pattern
(
Pesticidal)
Current
Inert
List
sorbitol
900008
(
c)
antidusting
agent
4A
(
e)
antidusting
agent
Sorbitol
also
has
an
active
ingredient
PC
Code,
000008,
but
there
are
apparently
no
active
or
pending
registrations
for
the
active
ingredient
at
this
time.
Page
4
of
10
Use
Pattern
(
non­
pesticidal):

Sorbitol
is
Generally
Recognized
As
Safe
(
GRAS)
by
the
U.
S.
FDA
when
used
as
a
direct
food
ingredient
(
21
CFR
184.1835),
and
also
generally
recognized
as
safe
when
migrating
to
food
from
paper
and
paperboard
products
used
in
food
packaging
(
21
CFR
182.90),
as
well
as
a
nutrient
and/
or
dietary
supplement
in
animal
drugs,
feeds,
and
related
products,
when
used
in
accordance
with
good
manufacturing
or
feeding
practice
(
21
CFR
582.5835).

In
the
U.
S.
FDA
listing
of
sorbitol
as
GRAS
for
use
as
a
direct
food
ingredient
(
21
CFR
582.1835),
Paragraph
(
c)
indicates
that
sorbitol
may
be
used
in
food
for
the
following
purposes:
anticaking
agent
and
free­
flow
agent;
curing
and
pickling
agent;
drying
agent;
emulsifier
and
emulsifier
salt;
firming
agent;
flavoring
agent
and
adjuvant;
formulation
aid;
lubricant
and
release
agent;
nutritive
sweetener;
sequestrant;
stabilizer
and
thickener;
surface­
finishing
agent;
and
texturizer.
Paragraph
(
d)
indicates
that
sorbitol
may
be
used
at
up
to
99%
in
hard
candy
and
cough
drops,
and
up
to
98%
in
soft
candy,
as
well
as
somewhat
lower
levels
as
a
sweetener
in
other
foods.

In
the
monograph
prepared
for
the
U.
S.
FDA
to
evaluate
the
health
aspects
of
sorbitol
as
a
food
ingredient
(
FDA
1972),
at
that
time,
sorbitol
was
present
in
foods
in
amounts
ranging
from
93.5
to
0.001
percent.
The
monograph
reported
that
sorbitol
was
used
in
the
food
industry
to
promote
retention
of
original
food
quality
during
storage
and
shipment
or
to
endow
foods
with
improved
quality
or
texture,
because
of
its
capacity
to
function
as
a
crystallization
modifier,
humectant,
softening
or
plasticizing
agent,
sweetness
or
viscosity
controller,
or
rehydration
agent.

Sorbitol
also
has
the
following
uses:
in
the
manufacture
of
ascorbic
acid,
sorbose,
propylene
glycol,
synthetic
plasticizers
and
resins;
as
a
humectant
(
moisture
conditioner)
on
printing
rolls
and
in
toothpaste;
in
candy
manufacturing;
in
leather;
in
writing
inks;
in
antifreeze
mixtures;
as
a
pharmaceutical
aid
(
sweetening
agent
and
table
excipient);
as
a
sugar
substitute
for
diabetics;
and
in
veterinary
medicines
for
ruminant
ketosis,
as
an
osmotic
diuretic,
and
a
laxative.

Sorbitol
is
the
most
widely
distributed
polyol
(
polyhydric
alcohol)
in
nature.
It
is
found
mainly
in
fruits
of
Rosacea,
including
the
following:
apples,
plums,
pears,
cherries,
dates,
peaches,
and
apricots,
as
well
as
other
fruits.

III.
Physical/
Chemical
Properties:

The
actual
chemical
name
for
the
substance
known
by
the
common
name
Sorbitol
is
1,2,3,4,5,6­
hexanehexol,
and
it
has
a
Chemical
Abstracts
Service
9th
Chemical
Index
(
CI)
name
of
D­
Glucitol.
It
is
a
hexahydric
alcohol,
differing
from
mannitol
and
the
other
hexahydric
alcohols
by
having
a
different
optical
rotation.
Sorbitol
is
produced
by
the
electrolytic
reduction,
or
the
transition
metal
catalytic
hydrogenation,
of
sugar
solutions
containing
glucose
or
fructose.
Page
5
of
10
Table
1.
Physical/
Chemical
Properties
(
from
HSDB,
unless
specified).

Molecular
formula
C
6
H
14
O
6
Molecular
weight
182.17
Melting
point
110­
112
°
C
Solubility
in
water
Freely
soluble
in
water
pH
about
7.0
Density/
Specific
Gravity
1.49
@
20
°
C
/
4
°
C
Octanol/
Water
Partition
Coefficient
log
K
ow
=
­
2.20
Physical
state
White
crystalline
powder,
granules
or
flakes
Estimated
Vapor
Pressure
4.9
x
10­
9
mm
Hg
@
25
°
C
Henry's
Law
constant
7.3
x
10­
13
atm­
m3/
mole
Soil
Sorption
Coefficient
K
oc
=
2
Bioconcentration
Factor
1.0
Environmental
Biodegradation
since
it
is
a
simple
sugar
alcohol,
sorbitol
should
be
readily
biodegraded
in
the
environment
Environmental
Abiotic
Degradation
sorbitol
is
not
expected
to
undergo
hydrolysis
in
the
environment
due
to
a
lack
of
hydrolyzable
functional
groups,
nor
to
directly
photolyze
due
to
the
lack
of
absorption
in
the
environmental
UV
spectrum
IV.
Hazard
Assessment:

Toxicological
Profile:
The
acute
oral
LD
50
values
for
sorbitol
have
been
reported
to
be
15,900
mg/
kg
in
the
rat,
and
17,800
mg/
kg
in
the
mouse.
In
a
repeated
dosing
study,
rats
were
fed
a
diet
enriched
in
sorbitol,
and
exhibited
a
readily
detectable
increase
of
liver
hexokinase,
as
well
as
an
increase
in
the
glycogen
content
in
the
liver.
In
three­
generation
feeding
study
in
the
rat,
there
were
no
abnormalities
of
the
adrenal
medulla
seen
grossly
or
microscopically
in
rats
in
any
generation,
in
either
the
high­
dose
group
(
levels
up
to
10%
in
the
diet)
or
the
control
group.
The
study
concluded
that
sorbitol
administered
in
the
diet
to
three
successive
generations
of
rats
at
levels
up
to
10%
of
the
diet
had
no
adverse
effects
on
growth
or
reproduction
in
either
sex.
Various
studies
to
evaluate
the
mutagenicity
of
sorbitol
provide
evidence
that
it
is
negative
for
mutagenicity
effects,
including
Ames
test
data
(
Ames
salmonella
typhimurium
strains
TA97A
and
TA
102,
both
with
and
without
activation),
and
assays
in
insects
(
Drosophila
melanogaster
to
test
both
sex­
linked
recessive
lethal
gene
mutation
and
chromosome
effects,
specifically,
Page
6
of
10
aneuploidy,
whole
chromosome
loss,
and
chromosome
aberrations),
and
in
mammals
(
dominant
lethal
test
in
male
rats
to
test
chromosome
effects
in
vivo
in
mammalian
germ
cells).

Concerning
the
effects
of
sorbitol
in
humans,
information
presented
in
the
FDA
Evaluation
monograph
(
FDA
1972)
indicated
that
orally
administered
sorbitol
is
absorbed
and
metabolized
rapidly
through
the
normal
glycolytic
pathways,
ultimately
to
carbon
dioxide
and
water.
After
a
35
gram
dose
(
equivalent
to
583
mg/
kg)
in
normal
and
diabetic
adults,
less
than
3%
of
the
sorbitol
was
excreted
in
the
urine
in
any
adult
case,
and
the
sorbitol
in
the
blood
was
found
to
be
immeasurably
small.
No
evidence
of
toxicity
in
humans
was
reported
in
any
of
the
studies
reviewed.
Normal
children
(
5­
6
years
old)
and
normal
infants
(
20­
35
months
old)
fed
9.3
grams
of
sorbitol
(
equivalent
to
500
or
more
mg
per
kg)
remained
unaffected,
except
for
the
appearance
of
diarrheal
stools
in
the
younger
group.

Other
studies
in
mammals
were
also
reviewed
in
the
FDA
Evaluation
(
1972).
Rhesus
monkeys
were
fed
sorbitol
at
8
g/
kg/
day
for
3
months,
and
remained
unaffected.
Rats
fed
5%
sorbitol
(
equivalent
to
5
g/
kg/
day)
through
3
generations
showed
no
adverse
effects
on
growth
rate
or
liver
glycogen
storage
capacity,
and
no
gross
or
histological
abnormalities
in
the
kidney,
liver,
spleen,
pancreas,
or
duodenum
attributable
to
sorbitol.
Another
study
reported
that
weanling
rats
were
given
sorbitol
at
10
­
15%
in
the
diet
for
17
months,
and
observed
over
4
successive
generations,
and
exhibited
no
evidence
of
deleterious
effects
on
weight
gain,
reproduction,
lacation,
or
histological
appearance
of
the
major
organs
examined.
In
another
study
in
which
rats
were
fed
16%
sorbitol
for
19
months,
there
was
a
tendency
for
the
rats
to
become
hypercalcemic
after
1
year,
with
the
appearance
in
some
rats
of
bladder
concretions
and
a
generalized
thickening
of
the
skeleton;
the
FDA
Evaluation
reported
that
the
feed
consumption
or
animal
weight
figures
were
not
presented
in
the
study,
but
that
the
sorbitol
level
was
estimated
to
be
on
the
order
of
16
g/
kg.
The
FDA
Evaluation
(
1972)
stated
that
"
no
oral
studies
of
the
carcinogenic
activity
of
sorbitol
have
been
reported."
In
a
recent
on­
line
search,
there
were
no
carcinogenicity
studies
described
in
the
HSDB
of
TOXNET
(
2003),
but
the
FDA
Evaluation
reported
that
studies
in
rats
injected
with
a
sorbitol
containing
product
(
Jectofer,
which
is
an
ironsorbitol
citric
acid
product)
produced
no
injection
site
tumors.
The
FDA
Evaluation
(
1972)
described
an
FDA
study
published
that
same
year,
in
which
sorbitol
elicited
no
teratogenic
response
in
pregnant
mice
or
rats
fed
a
daily
dose
of
1600
mg/
kg
for
10
days,
or
hamsters
fed
1200
mg/
kg/
day
for
5
days.

Recent
information
is
presented
in
the
HSDB
of
TOXNET
regarding
the
effects
of
sorbitol
in
humans,
indicating
that
sorbitol
has
the
shortest
gastrointestinal
transit
time
when
compared
with
other
osmotically
active
drugs,
and
that
it
exerts
a
hygroscopic
and/
or
local
irritant
action,
drawing
water
from
tissues
into
the
feces
and
reflectively
stimulating
evacuation.
Thus,
at
high
dose
levels,
sorbitol
acts
as
a
laxative.
When
administered
rectally,
it
is
poorly
absorbed.
When
sorbitol
is
orally
ingested,
70%
is
converted
to
carbon
dioxide
without
appearing
as
glucose
in
the
blood.

The
World
Health
Organization
(
WHO)
Joint
Expert
Committee
on
Food
Additives
(
1967)
reviewed
the
uses
and
data
available
for
sorbitol,
and
concluded
that
"
considering
the
Page
7
of
10
biological
data
set
out
...
and
the
known
facts
about
the
nutritional
properties
of
sorbitol(,)
there
appears
to
be
no
need
for
the
limitation
of
sorbitol
in
the
human
diet
on
toxicological
grounds."
In
a
subsequent
review,
the
WHO
JECFA
panel
(
1973)
compiled
an
extensive
updating
of
toxicological
data,
and
again
concluded
that
"
considering
the
biochemical
and
toxicological
data
obtained
on
animals
and
man
and
the
known
facts
about
the
nutritional
properties
of
sorbitol,
there
appears
to
be
no
need
for
the
limitation
of
sorbitol
in
the
human
diet
on
toxicological
grounds."
This
WHO
JECFA
monograph
(
1973)
presented
an
Evaluation
that
the
Estimate
of
acceptable
daily
intake
for
man
was
"
Not
limited."
Later,
the
WHO
JECFA
panel
(
1978)
reviewed
additional,
then­
recent
toxicological
studies,
specifically
long­
term
studies
in
the
rat
and
dog,
reproduction
studies
in
the
rat,
and
teratology
studies
in
the
rat
and
rabbit,
and
did
not
revise
their
previous
conclusions
or
Evaluation
that
sorbitol
is
safe.

The
Commission
of
the
European
Communities
has
compiled
a
series
of
reports
of
the
Scientific
Committee
for
Food,
and
in
1985,
compiled
a
report
on
sweeteners,
in
which
data
were
reviewed
for
sorbitol.
The
report
stated
that
the
Committee
had
reviewed
numerous
studies
available
at
that
time,
including
metabolic,
acute,
subchronic,
two
chronic
toxicity
studies
in
rats
and
one
in
dogs,
and
a
three
generation
reproduction
and
teratogenicity
study.
The
Committee
also
had
reviewed
several
mutagenicity
studies.
No
adverse
effects
were
described
by
the
Committee
from
any
of
these
studies.
The
report
stated
that
extensive
human
data
exist
on
the
use
of
sorbitol
in
foods
for
special
nutritional
purposes
for
diabetics,
and
on
human
toleration
studies.
Laxative
effects
were
noted
at
intake
levels
of
sorbitol
above
50
grams
per
day.
At
these
high
levels,
there
may
be
dietary
imbalance
effects,
including
associated
physiological
and
metabolic
disturbances,
including
effects
on
calcium
uptake
and
excretion.
In
a
Summary
of
their
evaluation
of
sweeteners,
the
Committee
produced
a
table
which
indicated
that
ingestion
of
sorbitol
was
acceptable
and
no
ADI
was
listed,
but
a
footnote
indicated
that
laxation
may
be
observed
at
high
intakes,
but
that
consumption
of
the
order
of
20
grams
per
day
is
unlikely
to
cause
undesirable
laxative
symptoms.
The
report
of
the
Committee
concluded
that
the
Committee
did
not
consider
it
appropriate
to
establish
an
ADI
for
sorbitol,
but
had
no
objection
to
the
continued
use
of
this
sweetener,
provided
the
limitations
due
to
its
laxative
action
were
kept
in
mind.

In
21
CFR
582.1835,
paragraph
(
d)
indicates
that
sorbitol
may
be
used
in
food
at
levels
not
to
exceed
good
manufacturing
practice,
and
then
lists
the
following
current
good
manufacturing
practice
maximum
levels:
99%
in
hard
candy
and
cough
drops;
75%
in
chewing
gum;
98%
in
soft
candy;
30%
in
nonstandardized
jams
and
jellies,
commercial;
30%
in
baked
goods
and
baking
mixes;
17%
in
frozen
dairy
desserts
and
mixes;
and
12%
in
all
other
foods.
Thus,
the
FDA
acknowledges
that
sorbitol
may
be
used
in
certain
foods
at
substantially
high
levels.
However,
21
CFR
582.1835,
paragraph
(
e)
states
that
"
the
label
and
labeling
of
food
whose
reasonably
foreseeable
consumption
may
result
in
a
daily
ingestion
of
50
grams
of
sorbitol
shall
bear
the
statement:
"
Excess
consumption
may
have
a
laxative
effect.""

Risk
Characterization:
Taking
into
consideration
all
available
information
on
sorbitol,
including
the
U.
S.
FDA
designation
of
it
as
GRAS,
the
FDA
Evaluation
document,
and
the
Commission
of
the
European
Communities
report,
as
well
as
its
presence
in
food
products,
food
Page
8
of
10
additives,
and
over­
the­
counter
medicines,
the
use
of
sorbitol
as
an
inert
ingredient
in
pesticide
products
is
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup.
As
a
result,
the
Lower
Toxicity
Pesticide
Chemical
Focus
Group
is
recommending
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
sorbitol.

Special
Considerations
for
Infants
and
Children:
At
this
time,
there
is
no
concern
for
sorbitol
to
have
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
sorbitol
may
occur
from
its
GRAS
use
as
a
direct
food
ingredient,
and
may
also
occur
through
its
FDA­
approved
GRAS
use
in
food
packaging
products
comprised
of
paper
and
paperboard
products.
However,
sorbitol
is
expected
to
be
readily
absorbed
through
the
gastrointestinal
tract
and
to
be
rapidly
metabolized,
with
laxation
risks
being
the
only
effects
of
concern,
and
those
only
when
high
levels
of
ingestion
occur.
Based
on
the
existing
extensive
uses
of
sorbitol
in
many
types
of
foods,
the
exposure
that
occurs
as
a
result
of
use
in
pesticide
products
is
significantly
less
than
the
FDA­
regulated
uses.
Therefore,
a
quantitative
screening­
level
exposure
assessment
has
not
been
conducted.

Taking
into
consideration
all
available
information
on
sorbitol,
including
its
low
toxicity
via
the
oral
route,
its
designation
by
FDA
as
GRAS,
and
its
presence
as
an
ingredient
and
additive
in
food
products,
the
uses
of
sorbitol
as
an
inert
and
active
ingredient
in
pesticide
products
are
unlikely
to
pose
a
significant
hazard
to
the
general
public
or
any
population
subgroup.
Exposures
from
these
uses
are
expected
to
result
in
human
exposure
below
any
dose
level
that
could
possibly
produce
an
adverse
effect.
As
a
result,
the
Focus
Group
is
conducting
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
sorbitol.

VI.
Environmental
Fate/
Ecotoxicity/
Drinking
Water
Considerations:

HSDB
in
TOXNET
discusses
the
environmental
fate
of
Sorbitol.
Based
on
its
low
K
oc
and
low
K
ow
values,
sorbitol
is
classified
as
highly
mobile
in
soil
(
McCall
et
al.
[
undated]).
Volatilization
from
moist
soil
surfaces
would
not
be
expected
to
be
an
important
fate
process,
based
on
its
low
Henry's
Law
constant,
and
it
would
not
be
expected
to
volatilize
from
dry
soil
surfaces,
based
on
its
low
vapor
pressure.
As
a
simple
sugar
alcohol,
sorbitol
is
expected
to
be
readily
biodegraded
in
the
environment,
based
on
the
readily
biodegradability
model
(
Meylan
and
Howard,
2000),
with
primary
degradation
occurring
in
hours
to
days,
and
ultimate
(
mineralization)
degradation
in
days.
Due
to
the
lack
of
hydrolyzable
functional
groups
and
lack
of
absorption
in
the
environmental
UV
spectrum,
abiotic
degradation
of
sorbitol
would
not
be
expected
to
be
an
important
fate
process.

Sorbitol
is
highly
soluble
in
water,
but
based
on
its
K
oc
and
K
ow
values,
it
would
not
be
Page
9
of
10
expected
to
adsorb
to
suspended
solids
or
sediments
in
water.
Volatilization
from
water
would
not
be
expected
to
be
an
important
fate
process.
Based
on
its
low
K
ow
and
low
estimated
Bioconcentration
Factor
values,
there
is
a
low
potential
for
bioconcentration
in
aquatic
animals.

Estimated
toxicity
to
aquatic
and
terrestrial
organisms
is
expected
to
be
low,
with
predicted
acute
and
chronic
LC
50
concentrations
ranging
from
grams
per
liter
to
kilograms
per
liter
(
Meylan
and
Howard,
1998).
The
most
sensitive
organisms
appear
to
be
aquatic
and
terrestrial
invertebrates,
based
on
surrogate
species.

VII.
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."

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
sorbitol
has
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
sorbitol
and
any
other
substances,
and
sorbitol
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
sorbitol
has
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.)

Commission
of
the
European
Communities,
Directorate­
General
Internal
Market
and
Industrial
Affairs,
Food­
Science
and
Techniques.
1985.
Reports
of
the
Scientific
Committee
for
Food
Concerning
Sweeteners,
Sixteenth
Series.
EUR
10210
EN,
21
pp.

Food
and
Drug
Administration
(
FDA).
1972.
Evaluation
of
the
Health
Aspects
of
Sorbitol
As
A
Food
Ingredient.
Bureau
of
Foods,
U.
S.
FDA,
Department
of
Health,
Education
and
Welfare.
Washington,
D.
C.
Prepared
by
Life
Sciences
Research
Office,
Federation
of
American
Societies
Page
10
of
10
for
Experimental
Biology.
Bethesda
MD.
Report
No.
FDABF­
GRAS­
119.
Performing
Organization
Report
No.
SCOGS­
9.
10
pp.
(
MRID
No.
46068401)

McCall,
P.
J.,
D.
A.
Laskowski,
R.
L.
Swann,
and
H.
J.
Dishburger.
Undated.
"
Measurements
of
Sorption
Coefficients
of
Organic
Chemicals
on
their
use
in
Environmental
Fate
Analysis."
Agricultural
Products
Department,
Dow
AgroChemicals
USA,
Midland,
MI.
P104
(
89­
109).

Meylan,
W.
and
P.
Howard.
1998.
ECOSAR
Class
Program,
Version
0.99d.
Syracuse
Research
Corporation,
Syracuse,
N.
Y.
For:
U.
S.
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics,
Washington,
D.
C.

Meylan,
W.
and
P.
Howard.
2000.
Estimation
Program
Interface,
Version
3.10.
Syracuse
Research
Corporation,
Syracuse,
N.
Y.
For:
U.
S.
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics,
Washington,
D.
C.

TOXNET.
Department
of
Health
and
Human
Services,
National
Institutes
of
Health,
U.
S.
National
Library
of
Medicine,
Specialized
Information
Services.
Databases:
Hazardous
Substances
Data
Bank
and
Genetic
Toxicology
(
Mutagenicity).
Sorbitol;
CAS
Registry
Number
50­
70­
4.
Available
at
http://
www.
toxnet.
nlm.
nih.
gov.

World
Health
Organization
(
WHO).
1967.
Toxicological
Evaluation
of
Some
Antimicrobials,
Antioxidants,
Emulsifiers,
Stabilizers,
Flour­
Treatment
Agents,
Acids
and
Bases.
091.
Sorbitol.
International
Programme
on
Chemical
Safety,
Food
and
Agriculture
Organization,
Nutrition
Meetings
Report
Series
No.
40A,
B,
C.
2
pp.

World
Health
Organization
(
WHO).
1973.
Toxicological
Evaluation
of
Some
Food
Additives
Including
Anticaking
Agents,
Antimicrobials,
Antioxidants,
Emulsifiers,
Stabilizers,
and
Thickening
Agents.
349.
Sorbitol.
International
Programme
on
Chemical
Safety,
Food
and
Agriculture
Organization
(
FAO)
and
WHO.
WHO
Food
Additives
Series
No.
5.
6
pp.

World
Health
Organization
(
WHO).
1978.
Summary
of
Toxicological
Data
of
Certain
Food
Additives
and
Contaminants.
458.
Sorbitol.
International
Programme
on
Chemical
Safety,
Food
and
Agriculture
Organization
(
FAO)
and
WHO.
WHO
Food
Additives
Series
No.
13.
4
pp.