Page
1
of
40
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
June
8,
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
and
Jack
Housenger,
Associate
Director
Antimicrobial
Division
Please
find
attached
the
Focus
Group
Decision
Document
for
isopropanol
also
known
as
isopropyl
alcohol
or
2­
propanol.
The
tolerance
exemptions
in
40
CFR
180.910
[
formerly
40
CFR180.1001(
c)],
40
CFR
180.930
[
formerly
40
CFR180.1001(
e)],
and
40
CFR
180.940
are
reassessed.

If
you
have
any
comments
or
questions,
please
contact
Kathryn
Boyle
at
703­
305­
6304.
Page
2
of
40
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
June
8,
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
isopropanol
(
CAS
Reg.
No.
67­
63­
0).
Three
reliable
sources
of
information
are
used
to
reassess
the
existing
tolerance
exemptions
for
isopropanol:
(
1)
a
1990
World
Health
Organization
(
WHO)
report,
(
2)
the
1995
ReRegistration
Eligibility
Decision
Document
(
RED)
prepared
by
the
Office
of
Pesticide
Programs
(
OPP),
and
(
3)
the
1997
OECD­
SIDS
(
Organization
for
Economic
Cooperation
and
Development
­
Screening
Information
Data
Set)
evaluation.

Isopropanol
is
a
very
widely­
used
chemical.
It
has
been
marketed
for
many
years
to
the
public
and
is
routinely
sold
in
grocery
and
drug
stores.
No
adverse
effects
from
such
uses
have
been
identified.
The
Agency
is
performing
a
qualitative
assessment.
However,
considering
that
isopropanol
is
very
widely­
used,
screening­
level
exposure
assessments
are
used
to
bracket
the
potential
exposures
to
isopropanol.
There
are
no
concerns
for
exposure
to
isopropanol
in
a
pesticide
product.

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
Page
3
of
40
children
from
aggregate
exposure
to
residues
of
isopropanol.
The
tolerance
exemptions
in
40
CFR
180.910
[
formerly
40
CFR180.1001(
c)],
40
CFR
180.930
[
formerly
40
CFR180.1001(
e)],
and
40
CFR
180.940
are
reassessed.

Given
the
available
toxicity
information
for
isopropanol
and
its
long
history
of
safe
use,
classification
as
List
4A
is
appropriate.
Page
4
of
40
Lower
Risk
Pesticide
Chemical
Focus
Group
Science
Assessment
for
Isopropanol
1.
Purpose
of
Assessment
This
review
is
conducted
to
reassess
the
existing
tolerance
exemptions
for
isopropanol
(
2­
propanol
or
isopropyl
alcohol,
IPA)
(
CAS
Reg.
No.
67­
63­
0).

Table
1:
Tolerance
Exemptions
Being
Reassessed
in
this
Document
Tolerances
Exemption
Expression
40
CFR

Uses
Isopropyl
alcohol
910
[
formerly
180.1001
(
c)]
solvent,
cosolvent,
stabilizer,
inhibitor
Isopropyl
alcohol
930
[
formerly
180.1001
(
e)]
solvent,
cosolvent
2­
Propanol
940
(
a)
940
(
b)
940
(
c)
­­­­­­


Residues
listed
in
40
CFR
180.910
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
are
exempted
from
the
requirement
of
a
tolerance
when
used
as
inert
ingredients
in
pesticide
formulations
applied
to
animals.
Residues
listed
in
40
CFR
180.940
are
exempted
from
the
requirement
of
a
tolerance
when
used
as
either
active
or
inert
ingredients
in
antimicrobial
formulations
(
food­
contact
surface
sanitizing
solutions).

2.
Executive
Summary
Three
reliable
sources
of
information
are
used
to
reassess
the
existing
tolerance
exemptions
for
isopropanol:
(
1)
a
1990
World
Health
Organization
(
WHO)
report,
(
2)
the
1995
ReRegistration
Eligibility
Decision
Document
(
RED)
prepared
by
the
Office
of
Pesticide
Programs
(
OPP),
and
(
3)
the
1997
OECD­
SIDS
(
Organization
for
Economic
Cooperation
and
Development
­
Screening
Information
Data
Set)
evaluation.
These
three
assessments
thus
represent
a
time­
period
of
approximately
10
years
in
which
the
available
toxicity
information
for
isopropanol
was
reviewed
and
analyzed.
During
that
time
period
the
scientific
techniques
changed,
thus
accounting
for
differences
in
interpretation.
Page
5
of
40
The
Agency
is
performing
a
qualitative
assessment;
however,
considering
that
isopropanol
is
very
widely­
used,
screening­
level
exposure
assessments
are
used
to
bracket
the
potential
exposures
to
isopropanol.
There
are
no
concerns
for
exposure
to
isopropanol
in
a
pesticide
product.

3.
Background
Isopropanol
is
a
very
widely­
used
chemical.
It
has
been
marketed
for
many
years
to
the
public
and
is
routinely
sold
in
grocery
and
drug
stores.
It
is
sometimes
referred
to
as
"
rubbing
alcohol,"
which
is
70%
isopropanol
by
volume,
and
in
this
context
has
been
used
in
alcohol
baths
that
have
even
been
given
to
children,
including
infants.
No
adverse
effects
from
such
uses
have
been
identified.

Isopropanol
is
included
in
hundreds
of
pesticide
products
as
an
inert
ingredient.
It
is
also
an
active
ingredient,
and
under
40
CFR
180.940
can
be
used
in
food
contact
surface
sanitizing
solutions.
Isopropanol
is
contained
in
many
products
used
in
and
around
the
home.
A
search
of
Toxnet's
(
http://
www.
toxnet.
nlm.
nih.
gov/)
Household
Products
Database
using
the
search
term
isopropyl
alcohol
retrieved
a
listing
(
approximately
six
pages
long)
of
autocare,
hobby/
craft,
home
care
(
inside),
home
maintenance,
and
personal
care
products
containing
isopropanol.

Isopropanol
is
sponsored
under
the
High
Production
Volume
(
HPV)
Challenge
Program.
This
is
indicative
of
yearly
production
greater
than
1,000,000
pounds.

4.
Toxicity
Reviews
and
Evaluation
by
WHO
In
1990,
WHO
reviewed
and
evaluated
through
its
Environmental
Health
Criteria
Report
(
EHC
103)
the
available
information
on
isopropanol.
This
review
and
evaluation
of
isopropanol
was
performed
by
a
Task
Group
of
international
scientists
which
included
participation
by
the
United
States
Environmental
Protection
Agency
(
EPA)
and
the
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH).
The
following
Summary
of
Evaluation
(
section
1.9)
was
extracted
directly
from
that
report:

"
Exposure
of
human
beings
to
2­
propanol
may
occur
through
inhalation
during
manufacture,
processing,
and
both
occupational
and
household
use.
Exposure
to
a
potentially
lethal
level
in
the
general
population
may
result
from
accidental
or
intentional
ingestion
and
children
may
be
exposed
when
sponged
with
2­
propanol
preparations
(
rubbing
alcohol).

2­
Propanol
is
rapidly
absorbed
and
distributed
throughout
the
body,
partly
as
acetone.
Exposure­
effect
data
on
human
beings
under
conditions
of
acute
overexposure
are
scarce
and
show
great
variation.
The
major
effects
are
gastritis,
depression
of
the
central
nervous
system
with
hypothermia
and
respiratory
depression,
and
hypotension.
The
acute
mortality
data
on
experimental
animals
indicate
that
the
toxicity
of
2­
propanol
is
low,
the
oral
LD
50
values
in
various
Page
6
of
40
species
ranging
between
4475
and
7990
mg/
kg,
and
the
inhalation
LC
50
values
for
rats
being
around
50,000
mg/
m3.
In
rabbits
2­
propanol
did
not
irritate
the
skin,
but
the
application
of
0.1
ml
undiluted
2­
propanol
irritated
the
eyes.

In
man,
the
most
likely
acute
effects
of
exposure
to
high
levels
of
2­
propanol
through
ingestion
or
inhalation
are
alcoholic
intoxication
and
narcosis.
No
adequate
animal
studies
are
available
from
which
an
evaluation
can
be
made
of
the
human
health
risks
associated
with
repeated
exposure
to
2­
propanol.
However,
the
results
of
two
short­
term
studies
on
rats,
including
inhalation
exposure
(
500
mg/
m3
for
4
h/
day,
5
days
per
week,
for
4
months)
and
oral
exposure
(
600
­
3900
mg/
kg
in
the
drinking­
water),
suggest
that
exposure
to
2­
propanol
at
some
of
the
very
high
occupational
exposure
levels
reported
should
be
avoided.

Inhalation
exposure
of
pregnant
rats
to
2­
propanol
provided
a
lowest­
observed­
effect
level
(
LOEL)
of
18,327
mg/
m3
(
7450
ppm)
and
a
no­
observed­
effect
level
(
NOEL)
of
9001
mg/
m3
(
3659
ppm)
for
maternal
toxicity.
In
the
same
study,
9001
mg/
m3
(
3659
ppm)
was
a
LOEL
for
developmental
toxicity,
with
no
demonstration
of
a
NOEL.
These
concentrations
are
higher
than
those
likely
to
be
encountered
under
conditions
of
human
exposure.

2­
Propanol
was
negative
in
genotoxicity
tests
but
induced
mitotic
aberrations
in
the
bone
marrow
of
rats.
Although
these
findings
suggest
that
the
substance
does
not
have
any
genotoxic
potential,
no
adequate
assessment
of
mutagenicity
can
be
made
on
the
basis
of
the
limited
data.

The
available
data
are
inadequate
to
assess
the
carcinogenicity
of
2­
propanol
in
experimental
animals.
There
are
no
data
to
assess
the
carcinogenicity
of
2­
propanol
in
human
beings."

The
assessment
by
WHO
concluded
by
stating
that
it
was
"
unlikely
that
2­
propanol
will
pose
a
serious
health
risk
for
the
general
population
under
exposure
conditions
likely
to
be
normally
encountered."

5.
Toxicity
Reviews
and
Evaluation
by
OPP
The
Office
of
Pesticide
Programs
published
its
Aliphatic
Alcohols
RED
which
included
isopropanol
in
1995.
At
that
time
OPP
evaluated
the
re­
registration
eligibility
of
the
active
ingredient
uses
of
isopropanol.
The
inert
ingredient
uses
were
not
considered.
Selected
reviews
have
been
abstracted
from
that
document.
OPP's
review
of
the
acute
toxicity
studies
indicated
the
following:
acute
oral
(
Toxicity
Category
III),
acute
dermal
(
Toxicity
Category
IV),
acute
inhalation
(
Toxicity
Category
IV),
primary
eye
irritation
(
Toxicity
Categories
III
and
IV),
and
primary
dermal
irritation
(
Toxicity
Category
IV).
(
Note
that
Toxicity
Category
IV
is
the
category
of
lowest
concern.)
There
was
also
a
review
of
an
acute
neurotoxicity
study:
Page
7
of
40
"
In
an
acute
neurotoxicity
study,
Fischer
344
rats
were
exposed
for
six
hours
in
a
whole
body
chamber
to
air
only
(
control)
or
to
isopropanol
vapors
at
concentrations
of
500,
1500,
5000,
or
10,000
ppm.
Motor
activity
and
Functional
Observational
Battery
(
FOB)
were
evaluated.
No
deaths
occurred
during
the
study.
Motor
activity
was
decreased
in
a
dose­
dependent
manner
in
1500,
5000
and
10,000
ppm
males
and
in
5000
and
10000
ppm
females,
with
severe
effects
at
10,000
ppm.
FOB
findings
included
narcosis
at
10,000
ppm
and
central
nervous
system
sedation
at
5000
ppm.
FOB
findings
at
10,000
ppm
included
prostration,
decreased
arousal
and
muscle
tone,
hypothermia,
abnormal
respiration
and
loss
of
righting
reflex.
At
24
hours,
hind
leg
splay
and
hypothermia
were
still
observed,
otherwise
recovery
was
essentially
complete.
Based
on
the
results
of
this
study,
the
NOEL
for
neurobehavioral
effects
was
at
500
ppm
in
males
and
1500
ppm
in
females.
The
LOEL
was
1500
ppm
in
males
(
decreased
motor
activity)
and
5000
ppm
in
females
(
decreased
motor
activity
and
FOB
changes)."

6.
Toxicity
Reviews
and
Evaluation
by
OECD­
SIDS
Most
recently
(
March
1997),
isopropanol
was
sponsored
as
part
of
the
OECD­
SIDS
(
Organization
for
Economic
Cooperation
and
Development
­
Screening
Information
Data
Set)
Program
on
the
Investigation
of
Existing
Chemicals.
(
see
http://
cs3­
hq.
oecd.
org/
scripts/
hpv/).
Isopropanol
was
sponsored
by
the
United
States.
Sponsorship
indicates
that
the
US
(
EPA/
Office
of
Pollution
Prevention
and
Toxics
(
OPPT))
took
a
lead
role
in
the
information
gathering
and
evaluation
process.
OPPT's
evaluations
represent
the
Agency's
most
recent
evaluation
of
isopropanol.

After
review
and
evaluation
of
the
member
countries,
the
SIAR
(
Screening
Information
Assessment
Report)
was
published
by
the
United
Nations
Environment
Programme
(
UNEP).
This
evaluation
contained
very
detailed
evaluations
of
the
reproductive
and
developmental
toxicity
studies
and
carcinogenicity
studies
that
were
not
available
at
the
time
of
EHC
103.
The
Summary
of
Health
Effects
(
sections
3.3,
3.4,
and
3.6)
conclusions
of
the
SIAR
for
reproductive
and
developmental
toxicity
and
carcinogenicity
are
extracted
directly
from
that
report:

"
A
recent
two­
generation
reproductive
study
characterized
the
reproductive
hazard
for
isopropanol
associated
with
oral
gavage
exposure.
This
study
found
that
the
only
reproductive
parameter
apparently
affected
by
isopropanol
exposure
was
a
statistically
significant
decrease
in
male
mating
index
of
the
F1
males.
It
is
possible
that
the
change
in
this
reproductive
parameter
was
treatment
related
and
significant,
although
the
mechanism
of
this
effect
could
not
be
discerned
from
the
results
of
the
study.
However,
the
lack
of
a
significant
effect
of
the
female
mating
index
in
either
generation,
the
absence
of
any
adverse
effect
on
litter
size,
and
the
lack
of
histopathological
findings
of
the
testes
of
the
high­
dose
males
suggest
that
the
observed
reduction
in
male
mating
index
may
not
be
biologically
meaningful.
Additional
support
for
this
conclusion
is
provided
by
the
fact
that
most
of
the
females
became
pregnant.
Furthermore,
male
and
female
fertility,
and
female
Page
8
of
40
fecundity
indices
of
rats
dosed
with
isopropanol
were
not
different
from
those
of
controls
by
statistical
analysis
and
were
within,
or
relatively
close
to,
historical
control
values.
No
reproductive
effects
were
noted
in
other
studies
in
which
rats
were
dosed
up
to
2%
in
the
drinking
water.
Exposure
to
1000
mg/
kg/
day
and
to
a
lesser
extent
500
mg/
kg/
day
did
result
in
a
reduction
in
postnatal
survival
in
both
F1
and
F2
litters.
Derivation
of
an
appropriate
NOAEL
for
offspring
effects
was
made
difficult
because
of
conflicting
interpretations
of
the
reductions
in
postnatal
survival
for
the
500
mg/
kg/
day
treatment
group.
[
Two
reviewers]
concluded
the
reductions
were
treatment­
and
dose­
related,
a
conservative
interpretation
that
supports
a
NOAEL
of
100
mg/
kg/
day.
Alternatively,
[
two
different
reviewers]
deemed
the
observations
not
to
be
biologically
significant
and
concluded
the
NOAEL
to
be
500
mg/
kg/
day.
In
order
to
clarify
this
issue
a
benchmark
dose
(
BMD)
assessment
was
conducted
for
the
study's
developmental
and
reproductive
findings
....
For
the
offspring
developmental
effects,
BMD
dosages
(
BMDL5)
of
449
and
418
mg/
kg/
day
were
estimated
for
the
F1
and
F2
generations,
respectively.
Based
upon
the
decrease
in
male
mating
index
observations
in
the
P2
males,
a
BMDL10
of
407
mg/
kg/
day
was
estimated
for
reproductive
effects.

The
developmental
toxicity
of
isopropanol
has
been
characterized
in
rat
and
rabbit
developmental
toxicity
studies
and
in
a
rat
developmental
neurotoxicity
study.
The
rats
were
dosed
by
oral
gavage
at
400,
800
or
1200
mg/
kg
from
gestational
days
6
through
15.
The
rabbits
were
dosed
by
oral
gavage
at
120,
240
or
480
mg/
kg
from
gestational
days
6
through
18.
These
studies
indicate
that
isopropanol
is
not
a
selective
developmental
hazard.
Isopropanol
produced
developmental
toxicity
in
rats,
but
not
in
rabbits.
In
the
rat,
the
developmental
toxicity
occurred
only
at
maternally
toxic
doses
and
consisted
of
decreased
fetal
body
weights,
but
no
teratogenicity.
These
data
suggest
the
developmental
NOAEL
is
400
mg/
kg/
day
for
rats
and
480
mg/
kg/
day
for
rabbits.

Isopropanol
has
also
been
tested
for
developmental
toxicity
in
rats
via
oral
gavage.
The
rats
were
dosed
at
200,
700
and
1200
mg/
kg
from
gestational
days
6
through
21.
No
exposure­
related
effects
were
noted
on
motor
activity,
weights
of
the
four
regions
of
the
brain,
developmental
landmarks,
or
morphological
changes
to
the
tissues
of
the
central
nervous
tissue.
These
data
suggest
the
developmental
neurotoxicity
NOAEL
for
rats
is
1200
mg/
kg.

Two
recent
chronic
exposure,
rodent
inhalation
studies
were
conduct[
ed]
to
evaluate
isopropanol
for
cancer
potential.
One
study
was
performed
exposing
Fischer
344
rats
to
500,
2500
and
5000
ppm
of
IPA
for
6
hours/
day,
5
days/
week
for
24
months.
The
only
tumor
rate
increase
seen
was
for
interstitial
(
Leydig)
cell
tumors
in
the
male
rats.
Interstitial
cell
tumors
of
the
testis
is
typically
the
most
frequently
observed
spontaneous
tumor
in
aged
male
Fischer
344
rats
.....
Nearly
all
male
Fischer
rats
will
develop
these
proliferative
tumors
if
they
are
allowed
to
complete
their
lifespan
.....
A
mouse
inhalation
study
was
performed
exposing
CD
Page
9
of
40
1
mice
to
500,
2500
and
5000
ppm
of
IPA
for
6
hours/
day,
5
days/
week
for
18
months.
There
was
no
increased
frequency
of
neoplastic
lesions
in
any
of
the
treated
groups.
These
studies
demonstrate
that
isopropanol
does
not
exhibit
carcinogenic
potential
relevant
to
humans.
Furthermore,
there
was
no
evidence
from
this
study
to
indicate
the
development
of
carcinomas
of
the
testes
in
the
male
rat,
nor
has
isopropanol
been
found
to
be
genotoxic.
Thus,
the
testicular
tumors
seen
in
the
isopropanol
exposed
male
rats
are
considered
of
no
significance
in
terms
of
human
cancer
risk
assessment."

OECD/
SIDS
concluded
that
there
is
sufficient
information
to
allow
"
the
characterization
of
toxicity
hazard
of
[
isopropanol]
for
both
human/
mammalian
and
environmental
effects."

7.
Hazard
Characterization
The
toxicity
of
isopropanol
is
defined
by
a
large
database
of
studies
which
adequately
define
its
carcinogenic,
reproductive
and
developmental
effects.
A
partial
listing
of
the
repeated
dose
studies
via
the
oral
route
were
extracted
from
the
summary
table
in
the
OECD/
SIDS
assessment:

Table
2:
Oral
NOAELs
from
Isopropanol
Repeated
Dose
Studies
Study
NOAEL
12
week
rat
(
oral)
1%
in
the
diet
(
870
mg/
kg/
day)

developmental
rat
(
oral)
MATERNAL
400
mg/
kg/
day
DEVELOPMENTAL
400
mg/
kg/
day
developmental
rabbit
(
oral)
MATERNAL
240
mg/
kg/
day
DEVELOPMENTAL
480
mg/
kg/
day
2­
generation
reproductive
rat
(
oral)
PARENTAL
is
equal
to
or
less
than
500
mg/
kg/
day
(
BMDL
10
=
407
mg/
kg/
day)
REPRODUCTIVE
EFFECTS
F1
offspring
is
equal
to
or
less
than
500
mg/
kg/
day
(
BMDL
5
=
449
mg/
kg/
day)
REPRODUCTIVE
EFFECTS
F2
offspring
is
equal
to
or
less
than
500
mg/
kg/
day
(
BMDL
5
=
418
mg/
kg/
day)

The
greatest
concern
for
isopropanol
is
not
via
the
oral
route
as
demonstrated
by
the
oral
NOAELs
in
the
above
table
which
are
all
in
the
hundreds
of
mg/
kg/
day.
The
greatest
effect
for
dermal
exposure
is
defatting
of
the
skin,
which
can
cause
cracking.
Solvents,
such
as
isopropanol,
Page
10
of
40
can
display
irritation
effects
to
mucous
membranes,
lungs
and
eyes.
The
greatest
concern
is
for
the
inhalation
route
of
exposure.

Like
any
organic
solvent,
isopropanol
can
depress
the
central
nervous
system.
The
acute
central
nervous
system
(
CNS)
effects
of
any
organic
solvent
can
include
dizziness,
drowsiness,
narcosis,
anesthesia,
central
nervous
system
depression,
respiratory
arrest,
unconsciousness,
and
death.
Exposures
generally
need
to
be
"
high"
and/
or
"
prolonged"
for
these
solvent
neurotoxicity
effects
to
occur.
Also,
for
acute
exposures
the
effects,
generally,
are
reversible.
Generally
concerns
are
for
occupational
exposures
since
the
potential
for
day
in/
day
out
exposure
can
occur
in
the
workplace.
To
minimize
irritation
and
CNS
effects,
workplaces
are
required
to
reduce
exposure
to
organic
solvents
 
at
least
to
the
concentrations
specified
in
existing
Occupational
Safety
and
Health
Administration
(
OSHA)
permissible
exposure
limits
(
PEL's).
Only
PELs
are
legally
enforceable.
Other
occupational
exposure
limits
are
the
NIOSH
recommended
exposure
limits
(
REL's)
and
the
American
Conference
of
Governmental
Industrial
Hygienist
(
ACGIH)
threshold
limit
value
(
TLVs).
Unless
otherwise
stated
all
of
these
values
are
determined
as
an
8­
hr
time­
weighted
average
(
TWA)
concentration.
For
isopropanol,
the
NIOSH
15
minute
exposure
limit
is
500
ppm.
The
ACGIH
TLV­
STEL
(
short
term
exposure
limit),
the
OSHA
PEL,
and
the
NIOSH
REL
are
all
400
ppm.
The
ACGIH
TLV­
TWA
is
200
ppm.

Table
3:
Isopropanol
Repeated
Dose
Inhalation
Studies
Study
NOAEL
Rat
and
Mouse
(
13
week)
OECD/
SIDS
500
ppm
Rat
(
24
months)
OECD/
SIDS
Does
not
exhibit
carcinogenic
potential
relevant
to
humans.
500
ppm
(
systemic)

Mouse
(
18
months)
OECD/
SIDS
Does
not
exhibit
carcinogenic
potential
relevant
to
humans.
500
ppm
(
systemic)

The
NOAELs
from
the
repeated
dose
inhalation
studies
and
the
occupational
exposure
levels
are
all
in
the
hundreds
of
ppm.

8.
Type
of
Assessment
EPA
is
conducting
a
qualitative
risk
assessment
for
isopropanol.
Given
the
oral
NOAELs
in
the
hundreds
of
mg/
kg/
day
in
several
studies,
and
the
inhalation
NOAELs
in
the
hundreds
of
ppm,
a
quantitative
approach
is
not
needed
for
this
risk
assessment.
However,
isopropanol
is
Page
11
of
40
widely­
used,
over
1
million
pounds
of
isopropanol
are
either
produced
or
imported
per
year.
Bottles
of
isopropanol
are
in
most
homes
in
the
United
States.
Therefore,
to
better
understand
the
potential
exposure
patterns,
the
Agency
will
bracket
some
of
the
potential
residential
exposures
for
isopropanol.

9.
Additional
Safety
Factor
for
the
Protection
of
Infants
and
Children
The
toxicity
database
for
isopropanol
includes
two
oral
developmental
toxicity
studies
(
rat
and
rabbit)
and
a
rat
oral
reproductive
toxicity
study
that
are
in
the
hundreds
of
mg/
kg/
day.
This
is
the
typical
amount
of
developmental
and
reproductive
toxicity
information
required
for
registration
of
an
active
pesticide
ingredient,
and
is
therefore
sufficient
information
for
the
Agency
to
judge
the
potential
for
developmental
and
reproductive
effects
of
isopropanol.
There
is
no
evidence
of
increased
susceptibility
in
these
studies.
No
additional
data
are
needed
to
assess
the
toxicity
of
isopropanol.

Isopropanol
has
been
widely­
used
for
many
years
with
no
indications
of
adverse
effects.
There
is
no
reason
to
expect
that
the
reasonably,
foreseeable
uses
of
isopropanol
will
constitute
any
significant
hazard.
EPA
has
not
used
a
safety
factor
analysis
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

10.
Screening­
level
Exposure
Assessment
Various
publicly­
available
screening­
level
models
were
used
to
estimate
some
of
the
existing
levels
of
exposure
that
could
occur
in
and
around
the
home.
To
assure
protectiveness,
these
models
create
estimates
that
are
deliberately
intended
to
over­
estimate
exposure.
See
Attachment
1
for
the
models
and
assumptions
used.

Table
4:
Screening­
Level
Exposure
Estimates
Conducted
through
Modeling
Oral
Exposures
Type
of
Exposure
Potential
Exposure
Level
Dietary
­
Food
(
as
a
result
of
application
to
crops)
acute
exposure:
less
than
1
mg/
kg/
day
at
95th
percentile
chronic
exposure:
less
than
1
mg/
kg/
day
Dietary
­
Drinking
Water
acute
exposure:
range
from
0.0024
mg/
kg/
day
to
0.036
mg/
kg/
day
for
adults
and
0.0084
mg/
kg/
day
to
0.018
mg/
kg/
day
for
children
chronic
exposure:
range
from
0.0001
mg/
kg/
day
to
0.016
mg/
kg/
day
for
adults
and
0.0004
mg/
kg/
day
to
0.056
mg/
kg/
day
for
children
Page
12
of
40
Primarily
Inhalation
Exposures
Residential
(
as
a
result
of
using
a
cleaning
product
or
rubbing
compound)
acute
exposure:
90
ppm
chronic
exposure:
3
ppm
Residential
(
aerosol
paint)
acute
exposure:
358
ppm
chronic
exposure:
much
less
than
1
ppm
Dermal
and
Inhalation
Exposures
Residential
(
use
in
cosmetics
or
personal
care
product)
much
less
than
1
mg/
kg/
day
(
only
dermal
exposure
considered)

Residential
(
use
in
perfumes)
much
less
than
1
mg/
kg/
day
(
dermal
and
inhalation
exposure)

Residential
(
use
of
an
adhesive)
acute
exposure:
approximately
2
mg/
kg/
day
with
most
of
the
exposure
via
the
dermal
pathway
chronic
exposure:
much
less
than
1
mg/
kg/
day
Food
Contact
Surface
Sanitizing
Solutions
inhalation
component
same
as
the
residential
cleaning
component
(
above)
chronic
inadvertent
ingestion
component:
0.08
mg/
kg/
day
(
50th
percentile)
0.10
mg/
kg/
day
(
90th
percentile)

All
screening­
level
oral
exposures
are
much
less
than
any
of
the
NOAELs
from
the
repeated
dose
oral
isopropanol
toxicity
studies.
All
screening­
level
primarily
inhalation
exposures
are
less
than
any
of
the
NOAELs
from
the
repeated
dose
inhalation
isopropanol
toxicity
studies.

11.
Risk
Characterization
The
Agency's
screening
level
dietary
assessment
was
performed
based
on
data
derived
from
chemicals
that
are
solids.
For
isopropanol
the
vapor
pressure
is
33
mm
Hg,
thus
indicative
of
significant
evaporation.

One
of
the
greatest
uncertainties
of
this
assessment,
is
the
potential
for
isopropanol
to
enter
the
food
supply
as
a
result
of
agricultural
applications.
Based
on
the
vapor
pressure
(
1)
it
is
unlikely
that
any
significant
amount
of
residues
of
such
a
volatile
chemical
would
remain
on
the
surface
of
the
plant
or
edible
commodity
and
(
2)
it
is
also
unlikely
that
residues
of
such
a
volatile
chemical
would
be
incorporated
into
the
raw
agricultural
commodity
that
is
eventually
harvested.
While
there
is
a
logic
to
this
rationale,
the
Agency
also
acknowledges
a
great
deal
of
uncertainty
on
this
issue.
Page
13
of
40
Generally,
the
Agency
has
advocated
a
position
that
if
a
pesticide
chemical
is
used
on
a
food
crop,
residues
of
that
chemical
substance
are
assumed
to
be
present
unless
there
is
compelling
data
to
the
contrary.
Such
data
could
be
a
radiolabelled
uptake
study
of
sufficient
sensitivity
to
ascertain
whether
or
not
the
residues
exist
in
the
edible
commodity.
The
Agency
is
unaware
of
such
data
for
any
solvent.
Therefore,
the
generic
dietary
exposure
estimates
used
in
this
assessment
are
overly
conservative
for
a
solvent
such
as
isopropanol,
and
the
orders
of
magnitude
difference
between
the
oral
NOAELs
and
the
screening­
level
dietary
exposure
estimates
could
be
even
larger.

The
Agency
has
used
various
screening­
level
models
to
estimate
some
of
the
existing
levels
of
exposure
to
isopropanol.
To
assure
protectiveness,
these
estimates
are
deliberately
intended
to
over­
estimate
exposure.
There
is
a
sufficient
order
of
magnitude
difference
between
the
inhalation
NOAELs
and
the
screening­
level
inhalation
exposure
estimates.
There
is
also
a
self­
limiting
irritation
factor
that
should
be
considered.
Like
many
solvents
isopropanol
can
display
irritation
effects
to
mucous
membranes,
lungs
and
eyes.
Especially
for
acute
exposures,
these
irritation
effects
can
cause
consumers
to
self­
limit
their
exposure.

12.
Environmental
Fate
Review
and
Evaluation
by
WHO
The
following
conclusions
were
extracted
directly
from
WHO's
1990
EHC:

"
2­
Propanol
disappears
rapidly
(
half­
life
of
2.5
days)
from
the
atmosphere
and
removal
of
2­
propanol
from
water
and
soil
occurs
rapidly
by
aerobic
and
anaerobic
biodegradation,
especially
after
adaptation
of
initially
seeded
microorganisms.
In
view
of
the
physical
properties
of
2­
propanol,
its
potential
for
bioaccumulation
is
low.
It
does
not
present
a
risk
to
naturally
occurring
organisms
at
concentrations
that
usually
occur
in
the
environment."

13.
Environmental
Fate
Review
and
Evaluation
by
OECD/
SIDS
The
following
conclusions
were
extracted
directly
from
the
OECD
evaluation
(
section
2.1
Environmental
Fate):

"
Based
on
calculated
results
from
a
leve[
l]
1
fugacity
model,
isopropanol
(
IPA)
is
expected
to
partition
primarily
to
the
aquatic
compartment
(
77.7%)
with
the
remainder
to
the
air
(
22.3%).
IPA
has
been
shown
to
biodegrade
rapidly
in
aerobic,
aqueous
biodegradation
tests
and
therefore,
would
not
be
expected
to
persist
in
aquatic
habitats.
IPA
is
also
not
expected
to
persist
in
surface
soils
due
to
rapid
evaporation
to
the
air.
In
the
air,
physical
degradation
will
occur
rapidly
due
to
hydroxy
radical
(
OH)
attack.
Overall,
IPA
presents
a
low
potential
hazard
to
aquatic
or
terrestrial
biota.

IPA
is
expected
to
volatilize
slowly
from
water
based
on
a
calculated
Henry's
Law
constant
of
7.52
x
10
­
6
atm°
m
3
/
mole.
The
calculated
half­
life
for
the
volatilization
Page
14
of
40
from
surface
water
(
1
meter
depth)
is
predicted
to
range
from
4
days
(
from
a
river)
to
31
days
(
from
a
lake).
Hydrolysis
is
not
considered
a
significant
degradation
process
for
IPA.
However,
aerobic
biodegradation
of
IPA
has
been
shown
to
occur
rapidly
under
non­
acclimated
conditions,
based
on
a
result
of
49%
biodegradation
from
a
5
day
BOD
test.
Additional
biodegradation
data
developed
using
standardized
test
methods
show
that
IPA
is
readily
biodegradable
in
both
freshwater
and
saltwater
media
(
72
to
78%
biodegradation
in
20
days).

IPA
will
evaporate
quickly
from
soil
due
to
it's
high
vapor
pressure
(
43
kPa
at
20
/

C),
and
is
not
expected
to
partition
to
the
soil
based
on
a
calculated
soil
adsorption
coefficient
(
log
Koc)
of
0.03.
IPA
has
the
potential
to
leach
through
the
soil
due
to
it's
low
soil
adsorption.
In
the
air,
isopropanol
is
subject
to
oxidation
predominantly
by
hydroxy
radical
attack.
The
room
temperature
rate
constants
determined
by
several
investigators
are
in
good
agreement
for
the
reaction
of
IPA
with
hydroxy
radicals.
The
atmospheric
half­
life
is
expected
to
be
10
to
25
hours,
based
on
measured
degradation
rates
ranging
from
5.1
to
7.1
x
10
­
12
cm3
/
molecule­
sec,
and
an
OH
concentration
of
1.5
x
106
molecule/
cm3
,
which
is
a
commonly
used
default
value
for
calculating
atmospheric
half­
lives.
Using
OH
concentrations
representative
of
polluted
(
3
x
106
)
and
pristine
(
3
x
105
)
air,
the
atmospheric
half­
life
of
IPA
would
range
from
9
to
126
hours,
respectively.
Direct
photolysis
is
not
expected
to
be
an
important
transformation
process
for
the
degradation
of
IPA."

14.
Ecotoxicity
Review
and
Evaluation
by
WHO
The
following
was
extracted
directly
from
WHO's
1990
EHC
(
section
1.6
Effects
on
Organisms
in
the
Environment).

"
The
toxicity
of
2­
propanol
for
aquatic
organisms,
insects,
and
plants
is
low.
The
inhibitory
threshold
for
cell
multiplication
of
a
sensitive
protozoan
species
ranged
from
104
to
4930
mg/
litre
under
various
experimental
conditions.
Progressing
higher
through
the
phylogenetic
chain,
various
species
of
crustacea,
including
Daphnia
magna,
showed
EC
50
s
at
levels
ranging
from
2285
to
9714
mg/
litre.
LC
50
s
(
96­
h)
for
freshwater
fish
ranged
from
4200
to
11,130
mg/
litre.
Data
obtained
for
fruit
fly
species
showed
LC
50
s
ranging
between
10
200
and
13
340
mg/
litre
of
nutrient
media.
The
LC
50
for
third
instar
mosquito
larvae
(
Aedes
aegypti)
was
25
­
120
mg/
litre
in
a
4­
h
static
test.

The
effects
on
plants
of
exposure
to
2­
propanol
at
concentrations
between
2100
mg/
litre
and
more
than
36,000
mg/
litre
ranged
from
no
effect
to
complete
inhibition
of
germination."

15.
Ecotoxicity
Review
and
Evaluation
by
OECD/
SIDS
Page
15
of
40
A
listing
of
the
ecotoxicity
studies
as
extracted
from
the
table
in
the
OECD
evaluation
follows:

Table
5:
Isopropanol
Ecotoxicity
Studies
Study
Species
Result
(
mg/
L
­
unless
otherwise
noted)

Acute/
prolonged
toxicity
to
fish
Pimephales
promelas
LC
50
(
96­
hr)
=
9640
Acute
toxicity
to
aquatic
invertebrates
Daphnia
magna
EC
50
(
24­
hr)
>
10,000
Crangon
crangon
LC
50
(
48­
hr)
=
1400
Toxicity
to
aquatic
plant
(
algae)
Scenedesmus
quadricuada
Toxicity
Threshold
=
1800
Toxicity
to
microorganisms
(
bacteria)
Pseudomonas
putida
Toxicity
Threshold
=
1050
Entosiphon
sulcatum
Toxicity
Threshold
=
4930
Microcystis
aeruginosa
Toxicity
Threshold
=
1000
Chilomonas
paramecium
(
protozoa)
Toxicity
Threshold
=
104
Chronic
toxicity
to
aquatic
invertebrates
(
Daphnia)
NOEC
(
16­
day)
=
141
(
Growth)
NOEC
(
21­
day)
=
30
Toxicity
to
other
non­
mammalian
terrestrial
species
(
including
birds)
Drosophila
LC
50
(
48­
hr)
=
10200­
13340
ppm
The
OECD/
SIDS
conclusion
is
that
isopropanol
is
considered
to
have
a
low
order
of
acute
aquatic
toxicity,
and
that
the
toxicity
of
isopropanol
to
plants
is
expected
to
be
low.

16.
Environmental
Exposure
and
Risk
Characterization
Based
on
data
from
the
WHO
and
OECD
evaluations,
isopropanol
is
not
likely
to
pose
a
risk
to
non­
target
organisms
when
applied
to
crops
and
other
outdoor
areas.
Applications
made
by
aerial
spray
and
air­
blast
equipment
will
likely
pose
the
least
potential
for
exposures
due
to
volatilization
and
subsequent
rapid
reaction
with
hydroxyl
radicals.
Ground
spray
applications
pose
the
greatest
potential
for
environmental
exposures
if
runoff
producing
irrigation
or
rainfall
occurs
within
one
to
two
days
following
applications.
However,
it
is
unlikely
that
concentrations
in
surface
water
will
approach
Agency
Levels
of
Concern
(
LOC)
for
any
of
the
risk
presumption
categories
(
i.
e.,
acute
risks,
restricted
use,
and
endangered
species
risks).
Conservative
Page
16
of
40
environmental
modeling
and
qualitative
descriptions
of
concentrations
detected
in
surface
water
and
drinking
water
indicates
that
concentrations
of
isopropanol
will
not
exceed
the
low
parts
per
billion
for
peak
estimates
and
up
to
one
order
of
magnitude
lower
for
longer
term
exposures.
For
modeling,
these
estimates
are
based
on
microbial
degradation
half­
lives
in
soil
and
water
considerably
longer
than
qualitative
summary
data
would
suggest,
did
not
factor
physical
removal
factors
such
as
volatilization,
and
assumed
that
87
percent
of
a
watershed
would
be
treated
on
the
same
day.
Levels
in
drinking
water
are
not
likely
to
exceed
the
low
parts
per
billion
(
see
Table
3
of
Attachment
1).
Removal
or
transformation
during
drinking
water
treatment
is
unlikely
except
for
those
utilities
using
advanced
air­
striping
technology.
Groundwater
exposure
are
predicted
to
be
lower
than
those
estimated
for
surface
water.

17.
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."

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
isopropanol
and
any
other
substances,
and
isopropanol
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
isopropanol
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/.

18.
Conclusion
Isopropanol
is
sold
for
unrestricted
use
in
grocery
and
drug
stores.
Individual
consumers
are
able
to
use
isopropanol
in
the
amounts
that
they
choose,
according
to
their
needs
and
desires.
It
is
perceived
by
many
consumers
to
be
a
very
safe
chemical.
With
the
exception
of
the
solvent
effects,
isopropanol
presents
as
a
lower
toxicity/
lower
risk
chemical.
Like
many
solvents
isopropanol
can
display
irritation
effects
to
mucous
membranes,
lungs
and
eyes.
Especially
for
acute
exposures,
these
irritation
effects
can
cause
consumers
to
self­
limit
their
exposure.

Considering
the
ready
availability
of
isopropanol
to
the
consumer
and
the
number
of
nonpesticidal
products
containing
isopropanol,
the
exposure
from
pesticidal
products
is
a
very
small
portion
of
the
existing
uses.
However,
even
considering
the
widely­
available
nature
of
isopropanol
and
the
potential
for
aggregate
exposures,
the
use
of
isopropanol
in
a
pesticide
product
should
result
in
human
exposure
far
below
any
dose
level
that
could
possibly
produce
an
adverse
effect.
Page
17
of
40
18.
References
WHO
(
World
Health
Organization)
Environmental
Health
Criteria
(
EHC
103);
2­
Propanol;
1990;
(
http://
www.
inchem.
org/
documents/
ehc/
ehc/
ehc103.
htm.
)
(
MRID
46200901)

EPA
(
Environmental
Protection
Agency)
Aliphatic
Alcohols
(
C1
to
C4)
RED
(
Re­
Registration
Eligibility
Decision
Document)
which
included
isopropanol;
April
1995;
(
http://
www.
epa.
gov/
oppsrrd1/
REDs/
4003.
pdf)

OECD­
SIDS
(
Organization
for
Economic
Cooperation
and
Development
­
Screening
Information
Data
Set)
Program
on
the
Investigation
of
Existing
Chemicals;
2­
Propanol
(
CAS
No.
67­
63­
0);
(
http://
www.
chem.
unep.
ch/
irptc/
sids/
volume6/
part2/
v62_
propanol.
pdf)
(
MRID
46200801)
Page
18
of
40
Attachment
1:
Screening­
Level
Exposure
Assessments
for
Isopropanol
(
CAS
Reg.
No.
67­
63­
0)

Dietary
(
Food)
Exposure
DEEM
Model
Assumptions
­
Actual
crop­
specific
residue
data
for
active
ingredients
can
be
utilized
as
surrogate
data
for
inert
ingredient
residue
levels
(
including
secondary
residues
in
meat,
milk,
poultry
and
eggs)
­
Inert
ingredients
are
used
on
all
crops
and
100%
of
all
crops
are
"
treated"
with
inert
ingredients
­
No
adjustment
made
for
%
of
inert
in
formulation,
application
rate,
or
multiple
applications
of
different
active
ingredient
formulations
­
Considers
only
preharvest
applications
Dietary
modeling
was
performed
utilizing
the
highest
established
tolerance
level
residue
for
each
commodity.

Table
1.
Estimated
Chronic
Dietary
Exposure1
for
a
Generic
Inert
Ingredient
Population
Subgroup2
Estimated
Exposure,
mg/
kg/
day
U.
S.
Population
(
total)
0.120
All
infants
(<
1
year)
0.245
Children
(
1­
2
years)
0.422
Children
(
3­
5
years)
0.310
Children
(
6­
12
years)
0.174
Youth
(
13­
19
years)
0.100
Adults
(
20­
49
years)
0.087
Adults
(
50+
years)
0.086
Females
(
13­
49
years)
0.087
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs.
2Only
representative
population
subgroups
are
shown.
Page
19
of
40
Table
2.
Estimated
Acute
Dietary
Exposure1
for
a
Generic
Inert
Ingredient
Population
Subgroup2
Estimated
Exposure,
mg/
kg/
day
95th
Percentile
99th
Percentile
99.9th
Percentile
U.
S.
Population
(
total)
0.336
0.643
1.164
All
infants
(<
1
year)
0.701
1.060
2.056
Children
(
1­
2
years)
0.939
1.382
2.106
Children
(
3­
5
years)
0.683
1.010
1.476
Children
(
6­
12
years)
0.395
0.563
0.827
Youth
(
13­
19
years)
0.239
0.357
0.815
Adults
(
20­
49
years)
0.199
0.295
0.468
Adults
(
50+
years)
0.191
0.263
0.357
Females
(
13­
49
years)
0.198
0.287
0.415
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs.
2Only
representative
population
subgroups
are
shown.
Page
20
of
40
Drinking
Water
Exposure
(
modeled
using
FIRST
see
http://
www.
epa.
gov/
oppefed1/
models/
water/
index.
htm)

Model
Assumptions
­
1
lb/
acre
application
rate
and
15
lb/
acre
application
rates
to
bracket
­
Koc
of
1.0
(
degradation
does
occur)

­
Half
life
of
15
days
­
Consumption
(
2L/
day
for
adults,
1L/
day
for
child)

­
Body
weights
(
70
kg
adult,
10
kg
child)

Table
3.
Drinking
Water
Estimated
Environmental
Concentrations
and
Human
Drinking
Water
Exposures
Chronic
Acute
1
lb
application
concentration
=
3.7
ppb
1
lb
application
concentration
=
84
ppb
chronic
exposure
(
adult)
=
0.0001
mg/
kg/
day
acute
exposure
(
adult)
=
0.0024
mg/
kg/
day
chronic
exposure
(
child)
=
0.0004
mg/
kg/
day
acute
exposure
(
child)
=
0.0084
mg/
kg/
day
15
lb
application
concentration
=
56
ppb
15
lb
application
concentration
=
1260
ppb
chronic
exposure
(
adult)
=
0.0016
mg/
kg/
day
acute
exposure
(
adult)
=
0.036
mg/
kg/
day
chronic
exposure
(
child)
=
0.0056
mg/
kg/
day
acute
exposure
(
child)
=
0.018
mg/
kg/
day
Page
21
of
40
FQPA
Index
Reservior
Screening
Tool
(
FIRST)

RUN
No.
1
FOR
Isopropanol
ON
Generic
*
INPUT
VALUES
*
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
%
CROPPED
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
AREA
(
IN)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1.000(
1.000)
1
1
1.0
*****
GROUND(
6.4)
87.0
0.0
FIELD
AND
RESERVOIR
HALFLIFE
VALUES
(
DAYS)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
RESERVOIR)
(
RES.­
EFF)
(
RESER.)
(
RESER.)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
15.00
2
N/
A
0.00­
.00
15.00
15.00
UNTREATED
WATER
CONC
(
MICROGRAMS/
LITER
(
PPB))
Ver
1.0
AUG
1,
2001
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
PEAK
DAY
(
ACUTE)
ANNUAL
AVERAGE
(
CHRONIC)
CONCENTRATION
CONCENTRATION
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
84.242
3.693
Page
22
of
40
inc.

SCREENING
LEVEL
EXPOSURE
ASSESSMENT
for
Residential
Uses
of
Isopropanol
Prepared
for
Registration
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
Prepared
by
Versar,
Inc.
6850
Versar
Center
P.
O.
Box
1549
Springfield,
VA
22151
March
17
and
April
29,
2004
Contract
Number:
68­
W­
01­
036
Work
Assignment
No.:
0082.4000.003,
Task
4­
3­
3
Note
that
EPA
has
added
several
definitions
and
web
addresses,
but
has
not
changed
any
of
the
modeling
runs.
Page
23
of
40
Screening­
Level
Exposure
Assessment
for
Residential
Uses
for
Isopropanol
(
CAS
Reg.
No.
67­
63­
0)

Isopropanol
is
a
colorless,
flammable
liquid
with
a
characteristic
alcohol
odor.
It
is
completely
miscible
with
most
solvents,
including
water,
and
is
a
suitable
solvent
for
acrylic
and
epoxy
resins,
ethyl
cellulose,
natural
resins,
gums,
polyvinyl
butyral,
alkaloids
and
some
essential
oils.
It
is
commonly
used
in
nitrocellulose
lacquers
and
thinners,
in
adhesives,
pharmaceuticals,
cosmetics
and
toiletries,
disinfectants,
rubbing
compounds,
and
lithography.
It
is
also
used
as
a
coupling
agent
in
cleaners
and
polishers,
as
a
chemical
intermediate,
and
as
a
dehydrating
agent
and
extractant.

Weight
fractions:
(
from
PIRAT
(
Pesticide
Inert
Risk
Assessment
Tool
see
http://
www.
epa.
gov/
opptintr/
exposure/
docs/
pirat.
htm
)
model,
defaults
for
Ready­
to­
Use
Liquid,
Functional
Use
Category
=
Solvent)
50th
percentile:
0.835
90th
percentile:
0.988
Molecular
Weight:
60.0956
Vapor
Pressure:
33
mmHg
[
CEM
is
the
Consumer
Exposure
Module
in
E­
Fast
(
Exposure,
Fate
Assessment
Screening
Tool
see
http://
www.
epa.
gov/
opptintr/
exposure/
docs/
efast.
htm]

Summary
of
Scenarios
Used
for
Risk
Assessments
Use
Scenario
Summary
of
methodology
and
sources
General
purpose
cleaner;
Rubbing
compound
Used
CEM
generic
scenario
for
General
Purpose
Cleaner
with
weight
fractions
chosen
by
the
Agency
based
on
information
which
included
percent
in
formulation
from
Household
Products
Database
Spray
paint
Used
CEM
generic
scenario
for
Aerosol
Paint
with
weight
fractions
chosen
by
the
Agency
based
on
information
which
included
percent
in
formulation
from
Household
Products
Database
for
inhalation
exposure.
Dermal
exposure
expected
to
be
minimal.
Summary
of
Scenarios
Used
for
Risk
Assessments
Use
Scenario
Summary
of
methodology
and
sources
Page
24
of
40
Cosmetics
and
toiletries
Used
CEM
user­
defined
scenario
(
product
directly
contacting
skin)
with
the
parameters
below
for
dermal
exposure.
Inhalation
exposure
expected
to
be
minimal.
Amount
retained
on
skin
­
1.9e­
06
g/
cm2­
event
(
bar
soap
value
from
CEM)
Years
of
Use
­
Used
50,
based
on
scientific
judgement
Frequency
of
Use
­
365
days/
year
(
upper
90th
percentile
frequency
of
use
for
foundations
­
EFH,
1999)
Surface
Area
to
Body
Weight
Ratio
­
calculated
from
values
in
EFH,
1999
­
half
of
mean
adult
female
head
surface
area
divided
by
mean
adult
female
body
weight
(
EFH,
1999)
0.5
*
0.110
m2
*
(
100
cm/
m)
2
/
65.4
kg
=
8.41
cm2/
kg
Perfume
Dermal
Exposure
­
Used
CEM
user­
defined
scenario
(
product
directly
contacting
skin)
with
the
following
parameters:
Amount
retained
on
skin
­
1.9e­
06
g/
cm2­
event
(
bar
soap
value
from
CEM)
Years
of
Use
­
40,
based
on
scientific
judgement
Frequency
of
Use
­
250
days/
year
(
5
days/
week),
based
on
scientific
judgement
Surface
Area
to
Body
Weight
Ratio
­
1.39
cm2/
kg,
based
on
scientific
judgement
­
perfume
applied
on
a
5
cm
x
5
cm
area
on
each
wrist,
and
on
2
areas
of
neck
­
cologne
application
area
assumed
to
be
similar
(
100
cm2)
divided
by
BW
of
71.8
kg
Inhalation
Exposure
­
Used
CEM
user­
defined
scenario
(
product
applied
to
surface)
with
the
following
parameters:
Inhalation
Rate
During
Use
­
0.55
m3/
hr
(
CEM
default)
Inhalation
Rate
After
Use
­
0.55
m3/
hr
(
CEM
default)
Mass
of
Product
Used
per
Event
(
median)
­
0.23
g
(
EFH,
1999)
Mass
of
Product
Used
per
Event
(
90th
percentile)
­
0.46
g,
double
of
mean,
based
on
scientific
judgement
Air
Exchanges
per
hour
­
1
Duration
of
Use
(
median)
­
0.003
hours/
event,
based
on
scientific
judgement
Duration
of
Use
(
90th
percentile)
­
0.008
hours/
event,
based
on
scientific
judgement
Note:
CEM
was
modified
as
follows
to
provide
a
reasonable
worst­
case
estimate
of
exposure:
Individual
was
assumed
to
be
in
perfume
"
room"
for
8
hours,
and
outside
for
remainder
of
the
day
of
and
the
day
after
application.
Summary
of
Scenarios
Used
for
Risk
Assessments
Use
Scenario
Summary
of
methodology
and
sources
Page
25
of
40
Food
contact
surface
sanitizing
solutions
Inhalation
and
dermal
exposure
estimates
are
the
same
as
those
for
general
purpose
cleaners.
Ingestion
exposure
calculated
based
on
the
assumption
that
food
contact
surface
sanitizing
solutions
can
include
products
such
as
dish
washing
detergents.
See
below
for
details.

Resin,
Adhesive
Dermal
Exposure
­
Used
CEM
user­
defined
scenario
(
product
applied
to
surface)
with
the
following
parameters:
Amount
retained
on
skin
­
1.73x10­
2
g/
cm2­
event
Skin
surface
area
exposed:
8
cm2
Film
thickness
on
skin:
15.88x10­
3
cm
Density
of
product:
1.09
g/
cm3
(
15.88x10­
3
cm)
x(
1.09
g/
cm3)
=
1.73x10­
2
g/
cm2
Body
Weight
=
71.8
kg
(
EFH,
1999)
Years
of
Use
­
40,
based
on
scientific
judgement
Frequency
of
Use
­
12
events/
yr
Surface
Area
to
Body
Weight
Ratio
­
0.11
cm2/
kg
(
8
cm2)/(
71.8
kg)
=
0.11
cm2/
kg
Inhalation
Exposure
­
Used
CEM
user­
defined
scenario
(
product
applied
to
surface)
with
the
following
parameters:
Mass
of
Product
Used
per
Event
(
median)
­
0.22
g
Mass
of
Product
Used
per
Event
(
90th
percentile)
­
0.44
g,
double
of
mean,
based
on
scientific
judgement
Air
Exchanges
per
hour
­
1
Inhalation
Rate
During
Use
­
1.3
m3/
hr
Inhalation
Rate
After
Use
­
0.55
m3/
hr
(
CEM
default)
Duration
of
Use
(
median)
­
0.011
hours/
event
Duration
of
Use
(
90th
percentile)
­
0.022
hours/
event,
double
of
mean,
based
on
scientific
judgement
Unless
otherwise
noted,
source
is:
Standard
Scenarios;
Volume
II;
Tables
3
and
4
(
Values
to
Estimate
Inhalation
and
Dermal
Exposures
to
Components
of
Epoxy
Adhesives.)

References:

The
Dow
Chemical
Company;
http://
www.
dow.
com/
oism/
prod/
21.
htm.

U.
S.
EPA,
1999.
Exposure
Factors
Handbook
(
EFH).
Office
of
Research
and
Development,
Washington,
D.
C.
EPA/
600/
C­
99/
001.

Versar,
Inc.,
1986,
Standard
Scenarios
for
Estimating
Exposure
to
Chemical
Substances
During
Page
26
of
40
Use
of
Consumer
Products,
Volume
II.
Page
27
of
40
Use
Scenario:
General
Purpose
Cleaner,
Rubbing
Compound
CEM
Inputs
ID
Number:
IPA­
20
Product:
Isopropanol
Chemical
Name:
Isopropanol
Scenario:
General
Purpose
Cleaner
Population:
Adult
Molecular
Weight
(
g/
mole):
60.1
Vapor
Pressure
(
torr):
33
Weight
Fraction
­
Median
(
unitless):
0.2
Weight
Fraction
­
90%
(
unitless):
0.2
Inhalation
Inputs
Frequency
of
Use
(
events/
yr):
300
Years
of
Use:
57
Mass
of
Product
Used
per
Event
­
Median
(
g):
61.5
Mass
of
Product
Used
per
Event
­
90%
(
g):
123
Inhalation
Rate
During
Use
(
m3/
hr):
0.55
Duration
of
Use
­
Median
(
hours/
event):
0.667
Inhalation
Rate
After
Use
(
m3/
hr):
0.55
Duration
of
Use
­
90%
(
hours/
event):
1.42
Zone
1
Volume
(
m3):
20
Whole
House
Volume
(
m3):
369
Air
Exchange
Rate
(
air
exchanges/
hr):
0.45
Body
Weight
(
kg):
71.8
Activity
Patterns
User:
1111111221542467422744411
Start
Time:
7
Non­
User:
Room
of
Use:
2.
Kitchen
Hour:
0
6
12
18
Dermal
Inputs
Frequency
of
Use
­
Body
(
events/
yr):
300
SA/
BW
­
Body
(
cm2/
kg):
15.6
Amount
Retained
/
Absorbed
to
Skin
(
g/
cm2­
event):
3.6e­
05
Avg.
Time,
LADDpot,
LADCpot
(
days):
2.74e+
04
Avg.
Time,
ADDpot,
ADCpot
(
days):
2.08e+
04
Avg.
Time,
ADRpot,
Cppot
(
days):
1.00e+
00
Page
28
of
40
CEM
Inhalation
Exposure
Estimates
ID
Number:
IPA­
20
Scenario:
General
Purpose
Cleaner
Population:
Adult
Inhalation
Rate
(
m3/
day):
0.55
Years
of
Use
(
years):
57
Body
Weight
(
kg):
71.8
Frequency
of
Use
(
events/
year):
300
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
9.25e­
01
2.74e+
04
LADCpot
(
mg/
m3)
5.03e+
00
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
1.22e+
00
2.08e+
04
ADCpot
(
mg/
m3)
6.62e+
00
2.08e+
04
Acute
ADRpot
(
mg/
kg­
day)
2.94e+
00
1.00e+
00
Cppot
(
mg/
m3)
2.20e+
02
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)
LADC
­
Lifetime
Average
Daily
Concentration
(
mg/
m3)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)
ADC
­
Average
Daily
Concentration
(
mug/
m3)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)
Cp
­
Peak
Concentration
(
mg/
m3)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Note:
Using
the
calculation
(
mg/
m3
)(
24.45)/(
60.1)
=
ppm,
EPA
converted
the
ADCpot
of
6.62
mg/
m3
to
3
ppm
The
Cppot
of
220
mg/
m3
was
converted
to
90
ppm.
Page
29
of
40
CEM
Dermal
Exposure
Estimates
ID
Number:
IPA­
20
Scenario:
General
Purpose
Cleaner
Population:
Adult
Years
of
Use
(
years):
57
SA/
BW
Body
(
cm2/
kg):
15.6
Frequency
of
Use
(
events/
year):
300
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
7.02e­
02
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
9.23e­
02
2.08e+
04
Acute
ADRpot
(
mg/
kg­
day)
1.12e­
01
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Page
30
of
40
Use
Scenario:
Spray
Paint
CEM
Inputs
ID
Number:
IPA­
10
Product:
Isopropanol
Chemical
Name:
Isopropanol
Scenario:
Aerosol
Paint
Population:
Adult
Molecular
Weight
(
g/
mole):
60.1
Vapor
Pressure
(
torr):
33
Weight
Fraction
­
Median
(
unitless):
0.1
Weight
Fraction
­
90%
(
unitless):
0.1
Inhalation
Inputs
Frequency
of
Use
(
events/
yr):
6
Years
of
Use:
11
Mass
of
Product
Used
per
Event
­
Median
(
g):
227
Mass
of
Product
Used
per
Event
­
90%
(
g):
738
Inhalation
Rate
During
Use
(
m3/
hr):
0.55
Duration
of
Use
­
Median
(
hours/
event):
0.333
Inhalation
Rate
After
Use
(
m3/
hr):
0.55
Duration
of
Use
­
90%
(
hours/
event):
1
Zone
1
Volume
(
m3):
20
Whole
House
Volume
(
m3):
369
Air
Exchange
Rate
(
air
exchanges/
hr):
0.45
Body
Weight
(
kg):
71.8
Portion
of
Aerosol
in
Air
(
unitless):
0.01
Activity
Patterns
User:
1
1
1
1
1
1
1
2
3
5
5
4
2
4
6
7
4
2
2
7
4
4
4
1
Start
Time:
9
Non­
User:
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Room
of
Use:
5.
Utility
Room
Hour:
0
6
12
18
Dermal
Inputs
There
are
no
Dermal
inputs
for
this
scenario.

Avg.
Time,
LADDpot,
LADCpot
(
days):
2.74e+
04
Avg.
Time,
ADDpot,
ADCpot
(
days):
4.02e+
03
Avg.
Time,
ADRpot,
Cppot
(
days):
1.00e+
00
Page
31
of
40
CEM
Inhalation
Exposure
Estimates
ID
Number:
IPA­
10
Scenario:
Aerosol
Paint
Population:
Adult
Inhalation
Rate
(
m3/
day):
0.55
Years
of
Use
(
years):
11
Body
Weight
(
kg):
71.8
Frequency
of
Use
(
events/
year):
6
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
6.49e­
03
2.74e+
04
LADCpot
(
mg/
m3)
3.53e­
02
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
4.42e­
02
4.02e+
03
ADCpot
(
mg/
m3)
2.41e­
01
4.02e+
03
Acute
ADRpot
(
mg/
kg­
day)
8.70e+
00
1.00e+
00
Cppot
(
mg/
m3)
8.79e+
02
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)
LADC
­
Lifetime
Average
Daily
Concentration
(
mg/
m3)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)
ADC
­
Average
Daily
Concentration
(
mg/
m3)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)
Cp
­
Peak
Concentration
(
mg/
m3)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Note:
Using
the
calculation
(
mg/
m3
)(
24.45)/(
60.1)
=
ppm,
EPA
converted
the
ADCpot
of
.0241
mg/
m3
to
<
1
ppm
The
Cppot
of
879
mg/
m3
was
converted
to
358
ppm.
Page
32
of
40
Use
Scenario:
Cosmetics
CEM
Inputs
ID
Number:
IPA­
2
Product:
Cosmetics
Chemical
Name:
Isopropanol
Scenario:
User
Defined
Population:
Adult
Molecular
Weight
(
g/
mole):
60.1
Weight
Fraction
­
Median
(
unitless):
0.835
Weight
Fraction
­
90%
(
unitless):
0.988
Inhalation
Inputs
There
are
no
Inhalation
inputs
for
this
scenario.

Activity
Patterns
There
are
no
Activity
Patterns
for
this
scenario.

Dermal
Inputs
Frequency
of
Use
­
Body
(
events/
yr):
365
SA/
BW
­
Body
(
cm2/
kg):
8.41
Amount
Retained/
Absorbed
to
Skin
(
g/
cm2­
event):
1.9e­
06
Avg.
Time,
LADD
(
days):
2.74e+
04
Avg.
Time,
ADD
(
days):
1.82e+
04
Avg.
Time,
ADR
(
days):
1.00e+
00
Page
33
of
40
CEM
Dermal
Exposure
Estimates
ID
Number:
IPA­
2
Scenario:
User
Defined
Population:
Adult
Years
of
Use
(
years):
50
SA/
BW
Body
(
cm2/
kg):
8.41
Frequency
of
Use
(
events/
year):
365
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
8.89e­
03
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
1.33e­
02
1.82e+
04
Acute
ADRpot
(
mg/
kg­
day)
1.58e­
02
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)

ADR
­
Acute
Potential
Dose
Rate
(
mg/
kg­
day)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Page
34
of
40
Use
Scenario:
Perfume
CEM
Inputs
ID
Number:
IPA­
4a
Product:
Perfume
Chemical
Name:
Isopropanol
Scenario:
User
Defined
Population:
Adult
Molecular
Weight
(
g/
mole):
60.1
Vapor
Pressure
(
torr):
33
Weight
Fraction
­
Median
(
unitless):
0.835
Weight
Fraction
­
90%
(
unitless):
0.988
Inhalation
Inputs
Frequency
of
Use
(
events/
yr):
250
Years
of
Use:
40
Mass
of
Product
Used
per
Event
­
Median
(
g):
0.23
Mass
of
Product
Used
per
Event
­
90%
(
g):
0.46
Inhalation
Rate
During
Use
(
m3/
hr):
0.55
Duration
of
Use
­
Median
(
hours/
event):
0.003
Inhalation
Rate
After
Use
(
m3/
hr):
0.55
Duration
of
Use
­
90%
(
hours/
event):
0.008
Zone
1
Volume
(
m3):
9
Whole
House
Volume
(
m3):
369
Air
Exchange
Rate
(
air
exchanges/
hr):
1
Body
Weight
(
kg):
71.8
Activity
Patterns
User:
1333333337777777777777777
Start
Time:
1
Non­
User:
Room
of
Use:
3.
Bathroom
Hour:
0
6
12
18
Dermal
Inputs
Frequency
of
Use
­
Body
(
events/
yr):
250
SA/
BW
­
Body
(
cm2/
kg):
1.39
Amount
Retained
/
Absorbed
to
Skin
(
g/
cm2­
event):
1.9e­
06
Avg.
Time,
LADDpot,
LADCpot
(
days):
2.74e+
04
Avg.
Time,
ADDpot,
ADCpot
(
days):
1.46e+
04
Avg.
Time,
ADRpot,
Cppot
(
days):
1.00e+
00
Page
35
of
40
CEM
Inhalation
Exposure
Estimates
ID
Number:
IPA­
4a
Scenario:
User
Defined
Population:
Adult
Inhalation
Rate
(
m3/
day):
0.55
Years
of
Use
(
years):
40
Body
Weight
(
kg):
71.8
Frequency
of
Use
(
events/
year):
250
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
4.45e­
03
2.74e+
04
LADCpot
(
mg/
m3)
2.42e­
02
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
8.34e­
03
1.46e+
04
ADCpot
(
mg/
m3)
4.53e­
02
1.46e+
04
Acute
ADRpot
(
mg/
kg­
day)
3.05e­
02
1.00e+
00
Cppot
(
mg/
m3)
2.18e+
01
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)
LADC
­
Lifetime
Average
Daily
Concentration
(
mg/
m3)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)
ADC
­
Average
Daily
Concentration
(
mug/
m3)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)
Cp
­
Peak
Concentration
(
mg/
m3)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Page
36
of
40
CEM
Dermal
Exposure
Estimates
ID
Number:
IPA­
4
Scenario:
User
Defined
Population:
Adult
Years
of
Use
(
years):
40
SA/
BW
Body
(
cm2/
kg):
1.39
Frequency
of
Use
(
events/
year):
250
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
8.06e­
04
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
1.51e­
03
1.46e+
04
Acute
ADRpot
(
mg/
kg­
day)
2.61e­
03
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)

ADR
­
Acute
Potential
Dose
Rate
(
mg/
kg­
day)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Page
37
of
40
Use
Scenario:
Food
contact
surface
sanitizing
solutions
The
inhalation
and
dermal
exposure
estimates
for
food
contact
surface
sanitizing
solutions
would
be
the
same
as
those
for
general
purpose
cleaners.
However,
food
contact
surface
sanitizing
solutions
also
have
the
potential
exposure
pathway
of
ingestion.
Based
on
the
assumption
that
food
contact
surface
sanitizing
solutions
can
include
products
such
as
dish
washing
detergents,
the
following
method
was
used
to
estimate
exposure:

Potential
Dose
Rate
(
PDR)
=
DD
*
SA
*
WF
*
TF,
where:
DD
=
Deposition
of
product
on
Dishes
=
0.0018
mg/
cm2
(
MRI,
1979)
SA
=
Surface
Area
of
all
silverware,
china,
and
glass
used
by
a
consumer
for
3
meals
=
4000
cm2
(
FDA,
2003)
WF
=
Weight
Fraction
of
Isopropanol
in
product
(
from
PIRAT):
50th
percentile
=
0.835
90th
percentile
=
0.988
TF
=
Transfer
Factor
=
assumed
to
be
100%
(
worst
case)

Based
on
these
inputs,
the
PDR
is:
50th
percentile
=
6.01
mg/
day
90th
percentile
=
7.11
mg/
day
Normalized
PDR
(
PDR
norm
)
=
PDR
/
BW,
where:
BW
=
Body
Weight
=
71.8
kg
(
EFH,
1999)

Based
on
this
body
weight,
the
PDR
norm
is:
50th
percentile
=
0.08
mg/
kg/
day
90th
percentile
=
0.10
mg/
kg/
day
Lifetime
Average
Daily
Dose
(
LADD)
=
PDR
norm
*
ED
*
EF
/
(
AT
*
365
days/
yr),
where:
ED
=
Exposure
Duration
=
52
years
(
EFH,
1999)
EF
=
Exposure
Frequency
=
365
events/
year
(
Versar,
1986)
AT
=
Averaging
Time
=
70
years
(
EFH,
1999)

Based
on
these
inputs,
the
LADD
is:
50th
percentile
=
6.22x10­
2
mg/
kg/
day
90th
percentile
=
7.36x10­
2
mg/
kg/
day
References:

April,
2003.
http://
www.
cfsan.
fda.
gov/~
dms/
opa­
cg3a.
html.
Last
accessed
June
9,
2003.

MRI,
1979.
Chemical
technology
and
economics
in
environmental
perspective.
Task
IV­
Potential
worker
and
consumer
exposure
to
nitrilotriacetic
acid
(
NTA)
in
detergents.
Midwest
Research
Institute.
Washington,
D.
C.:
Environmental
Protection
Agency.
PB­
297
753.

Versar,
1986.
Standard
Scenarios
for
Estimating
Exposure
to
Chemical
Substances
During
Use
of
Consumer
Products.
Volume
1.
Washington,
D.
C.:
Office
of
Pesticides
and
Toxic
Substances,
U.
S.
Environmental
Protection
Agency.
EPA
68­
02­
3968.

Note:
PDRnorm
can
also
be
referred
to
as
the
potential
Average
Daily
Dose
or
ADDpot
Page
38
of
40
Use
Scenario:
Resin,
Adhesive
CEM
Inputs
ID
Number:
IPA­
6
Product:
Resin,
Adhesive
Chemical
Name:
Isopropanol
Scenario:
User
Defined
Population:
Adult
Molecular
Weight
(
g/
mole):
60.1
Vapor
Pressure
(
torr):
33
Weight
Fraction
­
Median
(
unitless):
0.835
Weight
Fraction
­
90%
(
unitless):
0.988
Inhalation
Inputs
Frequency
of
Use
(
events/
yr):
12
Years
of
Use:
40
Mass
of
Product
Used
per
Event
­
Median
(
g):
0.22
Mass
of
Product
Used
per
Event
­
90%
(
g):
0.44
Inhalation
Rate
During
Use
(
m3/
hr):
1.3
Duration
of
Use
­
Median
(
hours/
event):
0.011
Inhalation
Rate
After
Use
(
m3/
hr):
0.55
Duration
of
Use
­
90%
(
hours/
event):
0.022
Zone
1
Volume
(
m3):
40
Whole
House
Volume
(
m3):
369
Air
Exchange
Rate
(
air
exchanges/
hr):
1
Body
Weight
(
kg):
71.8
Activity
Patterns
User:
1111111231541467422744411
Start
Time:
12
Non­
User:
Room
of
Use:
1.
Bedroom
Hour:
0
6
12
18
Dermal
Inputs
Frequency
of
Use
­
Body
(
events/
yr):
12
SA/
BW
­
Body
(
cm2/
kg):
0.11
Amount
Retained
/
Absorbed
to
Skin
(
g/
cm2­
event):
0.017
Avg.
Time,
LADDpot,
LADCpot
(
days):
2.74e+
04
Avg.
Time,
ADDpot,
ADCpot
(
days):
1.46e+
04
Avg.
Time,
ADRpot,
Cppot
(
days):
1.00e+
00
Page
39
of
40
CEM
Inhalation
Exposure
Estimates
ID
Number:
IPA­
6
Scenario:
User
Defined
Population:
Adult
Inhalation
Rate
(
m3/
day):
1.3
Years
of
Use
(
years):
40
Body
Weight
(
kg):
71.8
Frequency
of
Use
(
events/
year):
12
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
3.68e­
04
2.74e+
04
LADCpot
(
mg/
m3)
8.99e­
04
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
6.89e­
04
1.46e+
04
ADCpot
(
mg/
m3)
1.69e­
03
1.46e+
04
Acute
ADRpot
(
mg/
kg­
day)
4.98e­
02
1.00e+
00
Cppot
(
mg/
m3)
7.22e+
00
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)
LADC
­
Lifetime
Average
Daily
Concentration
(
mg/
m3)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)
ADC
­
Average
Daily
Concentration
(
mug/
m3)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)
Cp
­
Peak
Concentration
(
mg/
m3)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
Page
40
of
40
CEM
Dermal
Exposure
Estimates
ID
Number:
IPA­
6
Scenario:
User
Defined
Population:
Adult
Years
of
Use
(
years):
40
SA/
BW
Body
(
cm2/
kg):
0.11
Frequency
of
Use
(
events/
year):
12
Exposure
Units
Result
AT
(
days)

Chronic
Cancer
LADDpot
(
mg/
kg­
day)
2.74e­
02
2.74e+
04
Chronic
Non­
Cancer
ADDpot
(
mg/
kg­
day)
5.13e­
02
1.46e+
04
Acute
ADRpot
(
mg/
kg­
day)
1.85e+
00
1.00e+
00
LADD
­
Lifetime
Average
Daily
Dose
(
mg/
kg­
day)

ADD
­
Average
Daily
Dose
(
mg/
kg­
day)

ADR
­
Acute
Dose
Rate
(
mg/
kg­
day)

Note:
75
years
=
2.738e+
04
days
pot
­
potential
dose
Note:
The
general
Agency
guidance
for
assessing
short­
term,
infrequent
events
(
for
most
chemicals,
an
exposure
of
less
than
24
hours
that
occurs
no
more
frequently
than
monthly)
is
to
treat
such
events
as
independent,
acute
exposures
rather
than
as
chronic
exposure.
Thus,
estimates
of
long­
term
average
exposure
like
ADD
or
ADC
may
not
be
appropriate
for
use
in
assessing
risks
associated
with
this
type
of
exposure
pattern.
(
Methods
for
Exposure­
Response
Analysis
for
Acute
Inhalation
Exposure
to
Chemicals
(
External
Review
Draft).
EPA/
600/
R­
98/
051.
April
1998
