TXR
NO.
0050634
April
3,
2002
MEMORANDUM
SUBJECT:
CARBARYL
­
3
rd
Reassessment
Report
of
the
FQPA
Safety
Factor
Committee.

NOTE:
THIS
REPORT
REPLACES
THE
PREVIOUS
REPORT
OF
THE
FQPA
SAFETY
FACTOR
COMMITTEE
DATED
APRIL
30,
2001
(HED
DOC.
NO.
014553).

FROM:
Carol
Christensen,
Acting
Executive
Secretary
And
Brenda
Tarplee,
Executive
Secretary
FQPA
Safety
Factor
Committee
Health
Effects
Division
(7509C)

THROUGH:
Ed
Zager,
Chairman
FQPA
Safety
Factor
Committee
Health
Effects
Division
(7509C)

TO:
Virginia
Dobozy,
Risk
Assessor
Reregistration
Branch
1
Health
Effects
Division
(7509C)

PC
Code:
056801
The
Health
Effects
Division
(HED)
FQPA
Safety
Factor
Committee
(SFC)
met
on
January
14,
2002
and
February
25,
2002
to
re­
evaluate
the
hazard
and
exposure
data
for
Carbaryl
with
regard
to
making
a
decision
on
the
additional
safety
factor
for
the
protection
of
infants
and
children.
The
SFC
determined
that
reliable
data
demonstrate
that
the
safety
of
infants
and
children
will
be
protected
by
use
of
an
additional
safety
factor
of
3X.
This
report
replaces
the
previous
report
of
the
FQPA
Safety
Factor
Committee
dated
April
30,
2001
(HED
Doc.
No.
014553
).
2
I.
HAZARD
ASSESSMENT
(Correspondence:
V.
Dobozy
to
C.
Christensen
dated
February
25,
2002)

Since
the
last
FQPA
SFC
meeting
(April
30,
2001),
the
toxicology
data
base
for
Carbaryl
was
reevaluated
by
the
HED
Hazard
Identification
Assessment
Review
Committee
(HIARC)
on
December
18,
2001
and
February
19,
2002.

1.
Adequacy
of
the
Toxicology
Database
The
toxicology
data
base
for
Carbaryl
is
complete
for
FQPA
assessment.
There
are
acceptable
guideline
developmental
studies
in
the
rat
and
rabbit
and
a
2­
generation
reproduction
study
in
rats.
The
toxicology
data
base
was
reviewed
by
the
Hazard
Science
Assessment
Review
Committee
(HIARC)
on
July
7,
1998,
April
7,
1999,
November
2,
1999,
March
1,
2001,
December
18,
2001
and
February
19,
2002.

2.
Determination
of
Susceptibility
There
was
no
evidence
of
quantitative
or
qualitative
susceptibility
following
in
utero
exposures
in
developmental
studies
in
the
rat
and
rabbit.

In
the
reproduction
study,
there
was
evidence
of
quantitative
susceptibility
of
the
offspring.
The
LOAEL
for
parental
systemic
toxicity
was
based
on
decreased
body
weight,
weight
gain,
and
food
consumption;
the
NOAEL
was
27
mg/
kg/
day
in
males
and
30
mg/
kg/
day
in
females.
In
the
offspring
the
LOAEL
was
based
on
increased
numbers
of
F2
pups
with
no
milk
in
the
stomach
and
decreased
pup
survival;
the
NOAEL
was
5
mg/
kg/
day
in
males
and
6
mg/
kg/
day
in
females.
No
adverse
effects
were
observed
in
the
reproductive
parameters;
the
NOAEL
was
the
highest
dose
tested.

In
the
developmental
neurotoxicity
study,
there
was
evidence
of
qualitative
susceptibility.
For
maternal
toxicity,
the
LOAEL
was
based
on
decreased
body
weight
gain,
alterations
in
Functional
Observational
Battery
measurements
and
inhibition
of
plasma,
whole
blood
and
brain
cholinesterase
activity;
the
NOAEL
was
1
mg/
kg/
day.
For
developmental
neurotoxicity,
the
LOAEL
was
based
on
the
morphometric
changes
seen
in
the
brain
of
the
offsprings;
the
NOAEL
was
1
mg/
kg/
day.

3.
Degree
of
Concern
and
Residual
Uncertainties
Since
there
is
evidence
of
increased
susceptibility
of
the
young
following
exposure
to
Carbaryl
in
the
2­
generation
reproduction
study
and
in
the
developmental
neurotoxicity
study,
HIARC
performed
a
Degree
of
Concern
Analysis
to:
1)
determine
the
level
of
concern
for
the
effects
observed
when
considered
in
the
context
of
all
available
toxicity
data;
and
2)
identify
any
residual
concerns
after
establishing
toxicity
endpoints
and
traditional
uncertainty
factors
to
be
used
in
the
risk
assessment
of
this
chemical.
If
residual
concerns
are
identified,
HIARC
examines
whether
these
residual
concerns
can
3
be
addressed
by
a
special
FQPA
safety
factor
and,
if
so,
the
size
of
the
factor
needed.
The
results
of
the
HIARC
Degree
of
Concern
analyses
for
Carbaryl
follow.

A.
2­
Generation
Reproduction
Study
The
HIARC
concluded
that
there
are
no
residual
concerns
related
to
the
2­
generation
reproduction
study
because
the
dose­
response
for
the
offspring
effects
is
wellcharacterized
and
these
effects
occurred
at
a
dose
level
which
is
above
that
used
for
establishing
the
Chronic
Reference
Dose
(cRfD)
for
chronic
dietary
risk
assessment.

The
HIARC
established
the
Chronic
RfD
using
the
LOAEL
of
3.1
mg/
kg/
day
in
the
chronic
toxicity
study
in
dogs.
Since
a
NOAEL
was
not
established
in
this
study,
an
additional
uncertainty
factor
of
3X
was
applied
to
the
LOAEL
(i.
e,
UFL).
The
HIARC
determined
that
3X
is
adequate
to
account
for
the
lack
of
a
NOAEL
in
this
case
because:
1)
the
study
was
well­
conducted
and
there
are
sufficient
data
from
subchronic
and
other
chronic
studies
in
other
species
that
support
cholinesterase
inhibition
as
the
critical
effect
for
Carbaryl;
2.)
the
data
indicate
that
the
dog
is
more
sensitive
to
the
cholinergic
effects
of
Carbaryl
and
using
this
species
to
establish
the
RfD
provides
additional
protection
for
the
effects
seen
in
the
rat
(including
the
reproduction
and
developmental
neurotoxicity
studies);
3.)
the
magnitude
of
inhibition
of
plasma
cholinesterase
inhibition
(12­
23%
decrease)
seen
in
this
study
was
comparable
to
the
magnitude
of
inhibition
(22%)
seen
in
the
5­
week
study
in
dogs
­
indicating
no
cumulative
effect
following
long­
term
exposure;
4.)
The
cholinesterase
inhibition
seen
in
females
at
the
LOAEL
in
this
study
was
not
accompanied
by
clinical
signs
(response
was
not
judged
to
be
severe);
and
5.)
no
inhibition
was
seen
for
any
cholinesterase
compartment
in
males
at
this
dose
(response
was
seen
in
only
one
sex).

The
HIARC
concluded
that
the
extrapolated
NOAEL
of
1
mg/
kg/
day
used
to
establish
the
Chronic
RfD
for
Carbaryl
is
below
the
NOAEL
for
offspring
toxicity
(5
mg/
kg/
day)
in
the
2­
generation
reproduction
study
and
is
protective
of
chronic
dietary
exposures
to
infants
and
children.

B.
Developmental
Neurotoxicity
Study
The
HIARC
concluded
that
there
was
a
low
level
of
concern
for
the
developmental
effects
seen
in
the
developmental
neurotoxicity
study
and
no
residual
uncertainties
with
respect
to
this
study
based
on
the
following
evidence:

°
Any
concern
for
the
lack
of
brain
morphometric
measurements
in
the
offspring
at
the
mid­
dose
(1
mg/
kg/
day)
was
negated
since
even
at
the
high
dose
of
10
mg/
kg/
day,
the
morphometric
changes
were
minimal
and
therefore,
it
is
unlikely
that
adverse
effects
would
be
seen
at
the
mid­
dose
level
(1
mg/
kg/
day
­
10%
of
the
LOAEL).

°
Any
concern
for
the
lack
of
comparative
data
in
adults
and
offspring
for
cholinesterase
inhibition
was
negated
since
no
FOB
alterations
were
seen
in
pups.
4
Other
studies
in
the
data
base
show
that
when
cholinesterase
inhibition
was
seen
in
adult
animals,
it
usually
was
accompanied
by
FOB
alterations.
Additionally,
the
results
of
the
National
Institute
for
Environmental
Health
Sciences
study
(discussed
below)
indicate
that
there
is
no
difference
in
cholinesterase
inhibition
in
pups
and
adults.
The
dose­
related
decrease
in
cholinesterase
activity
in
the
brain
and
blood
of
dams
at
gestation
day
19
was
very
similar
to
the
fetal
brain
cholinesterase
levels
taken
at
the
same
time.

The
HIARC
established
the
Acute
RfD
for
Carbaryl
using
the
NOAEL
of
1
mg/
kg/
day
in
the
developmental
neurotoxicity
study
in
rats
which
is
protective
of
single
dose
exposures
to
infants
and
children.

4.
Summary
of
Open
Literature
Findings
In
the
scientific
literature,
there
are
two
relatively
recent
studies
which
demonstrated
effects
on
sperm
at
high
doses
(50
and
100
mg/
kg/
day)
of
Carbaryl.
The
results
of
these
two
studies
indicated
that
Carbaryl
caused
weight
reductions
in
the
testes,
epididymides,
seminal
vesicles,
prostate
and
coagulating
glands
of
young
rats;
changes
in
testicular
enzymes;
decreased
sperm
counts
and
sperm
motility;
increased
sperm
morphological
abnormalities;
and
moderate
atrophy
of
seminiferous
tubules
of
the
testes.

In
a
published
developmental
study
in
Fisher
344
rats
conducted
by
EPA's
Health
Effects
Research
Laboratory,
Carbaryl
was
administered
from
gestation
day
6
through
19
at
doses
of
78
or
104
mg/
kg/
day.
Clinical
signs
related
to
cholinesterase
inhibition
(tremor,
motor
depression,
jaw
clonus
and
lacrimation)
were
observed
in
dams
but
it
is
unclear
if
they
occurred
at
both
dose
levels.
There
was
also
increased
prenatal
mortality
at
the
high
dose
(104
mg/
kg/
day)
and
decreased
pup
weights
at
the
low
(78
mg/
kg/
day)
doses.

In
an
unpublished
developmental
neurotoxicity
study
in
SD
rats
from
the
National
Health
and
Ecological
Effects
Research
Laboratories
at
EPA
and
the
National
Institute
for
Environmental
Health
Sciences/
National
Toxicology
Program
Carbaryl
was
administered
by
gavage
at
doses
of
0,
6,
12
or
25
mg/
kg/
day.
The
chemical
or
its
metabolite
1­
naphthol
was
not
present
in
pups'
plasma
above
the
limit
of
detection
at
any
exposure
concentration
(0,
6,
12
or
25
mg/
kg/
day).
There
was
a
dose­
related
decrease
in
ChE
activity
in
the
brain
and
blood
of
dams
at
GD
19,
and
fetuses
taken
at
that
time
also
showed
a
very
similar
level
of
inhibition
in
fetal
brain
cholinesterase.
There
was
a
decrease
in
the
number
of
live
pups/
litter
at
the
high
dose.
There
were
no
changes
in
cognitive
function.
Equivocal
changes
in
Functional
Observational
Battery
parameters
were
observed
in
male
and
female
offspring.

II.
EXPOSURE
ASSESSMENT
1.
Dietary
(Food)
Exposure
Considerations
(Correspondence:
V.
Dobozy
to
C.
Christensen
dated
January
7,
2002)
5
Carbaryl
is
used
late
in
the
season
at
maximum
seasonal
rates
of
6
­12
lb
of
active
ingredient
(a.
i.)
per
acre.
Pre­
harvest
intervals
(PHIs)
range
from
1­
29
days,
but
most
PHIs
are
one
week
or
less.
Single
application
rates
are
1­
5
lb
ai/
A
with
repeated
applications
on
a
weekly
basis.
U.
S.
tolerances
range
from
10­
100
ppm.
Codex
MRLs
have
been
established
for
numerous
commodities,
including
fruits,
grains,
forage/
fodder,
and
livestock
commodities.
The
limits
range
from
0.1/
0.5
for
livestock
commodities
to
100
ppm
for
forage/
hay.
Most
fruit
and
vegetable
limits
range
from
1
to
10
ppm.

Carbaryl
is
registered
for
use
on
almost
all
crop
groups
and
miscellaneous
commodities
including
pome
fruit,
stone
fruit,
legumes,
cereal
grains
and
fruiting
vegetables.
Residues
are
expected
in
meat
and
milk.
The
qualitative
nature
of
the
residue
of
Carbaryl
in
plants
and
animals
is
adequately
understood.
Based
on
the
results
of
plant
and
animal
metabolism
studies,
the
HED
Metabolism
Committee
concluded
that
the
Carbaryl
residue
to
be
regulated
in
plants
is
Carbaryl
per
se
(DP
Barcode
D221979,
S.
Hummel,
2/
8/
96).
The
Metabolism
Committee
also
concluded
that
the
residues
of
concern
in
meat
and
milk
are
the
free
and
conjugated
forms
of
Carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
and
5­
methoxy­
6­
hydroxy
carbaryl
(C.
Olinger,
D255855,
6/
21/
99).
Residues
are
primarily
surface
residues.

DEEM
analyses
are
being
conducted
at
the
highest
level
of
refinement
available
(Tier
IV).
Adequate
PDP
and
FDA
monitoring
data
are
available
for
the
vast
majority
(>
80%)
of
the
commodities.
These
commodities
include
those
which
are
considered
to
be
significant
in
the
diets
of
children
such
as
apples,
potatoes,
carrots,
succulent
beans,
soybean,
orange,
orange
juice,
apple,
apple
juice,
pear,
peach,
wheat,
banana,
grape,
grape
juice
and
milk.
For
those
commodities
not
monitored
by
FDA
and
PDP,
field
trial
data
will
be
used.
These
include
garden
beets,
turnips,
mustards,
dried
beans,
almonds,
pecans,
walnuts,
field
corn
grain,
rice,
flax
seed,
okra,
olive,
peanuts,
pistachio,
and
sunflower.
Carbaryl
residues
from
field
trials
were
<LOQ
in/
on
sweet
potato,
sugar
beets,
corn
grain,
flax
seed,
and
peanuts.
Quantifiable
residues
were
detected
in
all
other
raw
agricultural
commodities
(RACs).
For
a
given
crop,
residue
levels
were
quite
variable
overall,
probably
owing
to
climactic
variations,
but
were
generally
consistent
within
any
specific
field
trial
location.
Percent
of
crop
treated
will
also
be
incorporated.
Crops
with
the
highest
percent
of
the
crop
treated
include
apples,
(30%),
avocados
(85%),
blueberries(
45%),
cherries
(36%),
asparagus
(87%),
among
others.
Carbamate
market
basket
data
are
also
available
for
the
commodities,
orange,
apple,
peach,
broccoli,
lettuce,
tomato,
bananas,
and
grapes.

Additional
data
were
required
for
the
dermal
use
of
Carbaryl
on
poultry
and
its
use
in
poultry
houses;
however,
the
registrant
has
stated
that
they
are
no
longer
supporting
these
uses.
In
the
previously
conducted
dietary
assessment,
the
current
tolerance
for
poultry
was
used,
and
as
a
result,
poultry
was
determined
to
be
a
significant
contributor
to
the
risk
estimate.
When
poultry
is
not
included
in
the
diet,
the
results
of
the
Critical
6
Exposure
Contribution
analysis
showed
no
specific
commodity
comprised
a
large
percentage
of
the
residues
found
in
the
tail
end
of
acute
exposure.

2.
Dietary
(Drinking
Water)
Exposure
Considerations
(Correspondence:
V.
Dobozy
to
C.
Christensen
dated
January
7,
2002)

The
environmental
fate
data
base
for
Carbaryl
is
adequate
for
the
characterization
of
drinking
water
exposure.
Fate
data
indicate
that
parent
Carbaryl
and
its
degradate
1­
naphthol
are
fairly
mobile
and
slightly
persistent.
In
general
they
are
not
likely
to
persist
or
accumulate
in
the
environment,
however,
under
acidic
conditions
with
limited
microbial
activity
they
may
persist.

Because
of
the
relatively
limited
persistence
of
the
compound
in
the
environment
it
is
unlikely
that
non­
targeted
monitoring
studies
will
detect
the
maximum
concentrations
that
occur.
Some
non­
targeted
monitoring
data
are
available
but
are
of
limited
utility
in
developing
EECs
for
ecological
and
human
health
risk
assessment.
Therefore
modeling
was
used
to
estimate
surface
water
and
groundwater
concentrations
that
could
be
expected
from
normal
agricultural
use.
The
results
of
the
modeling
are
supported
by
the
available
monitoring
data.

For
developing
surface
water,
EECs
computer
modeling
with
the
EPA
PRZM3.12
and
EXAMS
2.97.7
programs
were
used
to
estimate
the
concentration
of
Carbaryl
in
surface
water.
Index
reservoir
scenarios
corrected
for
Percent
Cropped
Area
(PCA)
for
representative
crops
were
used.
SCI­
GROW
was
used
to
calculate
a
groundwater
screening
exposure
value
to
be
used
in
determining
the
potential
risk
to
human
health.

3.
Residential
Exposure
Considerations
(Correspondence:
V.
Dobozy
to
C.
Christensen
dated
January
7,
2002)

Carbaryl
is
currently
registered
for
many
residential
uses.
Homeowner
handler
exposure
scenarios
exist
for
a
variety
of
use
patterns
including
applications
of
dusts
to
vegetables,
ornamentals,
and
pets
(dogs
&
cats);
applications
of
ready­
to­
use
products
for
nuisance
insect
control;
applications
of
liquid
sprays
with
a
variety
of
hand
equipment
to
gardens,
trees,
vegetables,
and
turf;
and
applications
of
granular
formulations
to
turf.
Carbaryl
can
be
used
in
outdoor
residential
areas
and
to
treat
pets.
Therefore,
a
number
of
residential
post­
application
exposure
scenarios
exist
for
toddlers
and
children.

Several
chemical­
and
scenario­
specific
studies
designed
to
quantify
exposures
to
homeowner
applicators
are
available.
There
are
a
number
of
dislodgeable
foliar
residue
studies
for
Carbaryl
that
have
been
used
for
home
gardening
activities.
Also,
there
are
TTR
data
from
3
sites
(CA,
PA,
GA)
that
have
been
used
for
the
dermal
risk
assessments
(i.
e.,
transferability
is
>1%).
Mouthing
behaviors
have
been
addressed
using
the
new
5%
factor
for
wet
hands
and
not
the
TTRs
as
stipulated
in
the
latest
updates
to
the
Residential
SOPs.
These
data
will
be
used,
where
appropriate,
to
calculate
residue
concentrations
7
and
exposures
over
time
instead
of
using
the
Agency
default
assumptions.
In
addition,
the
latest
Outdoor
Residential
Exposure
Task
Force
(ORETF)
data
for
homeowner
applications
to
turf
have
been
used
which
are
also
the
same
values
that
have
been
incorporated
in
the
Residential
SOPs.
For
any
other
remaining
scenarios
not
addressed
by
the
Aventis
or
ORETF
data,
PHED
or
the
Residential
SOPs
were
used.

III.
SAFETY
FACTOR
RECOMMENDATION
AND
RATIONALE
1.
FQPA
Safety
Factor
Recommendations
The
FQPA
SFC
recommends
that
OPP
depart
from
the
default
10X
additional
safety
factor
and
instead
use
a
different
additional
safety
factor
of
3X.
This
recommendation
is
based
on
reliable
data
supporting
the
findings
set
forth
below.

A.
Traditional
Additional
Safety
Factor
(Addressing
Data
Deficiencies)

The
FQPA
SFC
concurs
with
the
HIARC
recommendation
for
the
use
of
a
3X
additional
safety
factor
to
address
the
use
of
a
LOAEL
in
establishing
the
Acute
and
Chronic
RfDs,
and
the
toxicity
endpoints
selected
to
assess
short­
and
long­
term
residential
exposure
scenarios
(oral,
dermal,
and
inhalation).
The
rationale
as
to
why
reliable
data
support
the
safety
of
using
a
3X
to
address
this
data
deficiency
is
discussed
above
in
Section
I.
3.

B.
Special
FQPA
Safety
Factors
Taking
into
account
the
HIARC
recommendation
regarding
the
data
deficiency,
the
FQPA
SFC
recommends
that
no
Special
FQPA
Safety
Factor
is
necessary
to
protect
the
safety
of
infants
and
children
in
assessing
Carbaryl
exposure
and
risks.

2.
Rationale
and
Findings
Regarding
Recommendation
on
Special
FQPA
Safety
Factor
The
Committee
concluded
that
no
Special
FQPA
safety
factor
was
needed
because:

The
toxicology
database
is
complete
and
there
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
in
rat
or
rabbit
fetuses
following
in
utero
in
the
standard
developmental
studies.
Although
there
is
evidence
of
qualitative
susceptibility
developmental
neurotoxicity
study,
HIARC
concluded
there
is
a
low
level
of
concern
for
the
effects
in
the
developmental
neurotoxicity
study,
as
discussed
in
Section
I.
3.
The
RfDs
established
would
account
for
any
uncertainties
and
are
protective
of
prepre
postnatal
toxicity
following
acute
and
chronic
exposures.
Similarly,
although
there
is
evidence
of
increased
susceptibility
in
the
offspring
in
the
2­
generation
reproduction
study,
there
are
no
residual
uncertainties
(Refer
to
Section
I.
3.).
The
chronic
RfD
would
be
protective
of
the
pre­
pre/
post
natal
toxicity
following
chronic
dietary
exposures.
The
8
doses/
endpoints
selected
for
residential
exposures,
are
also
protective
of
any
pre­
pre/
post
natal
toxicity
resulting
from
non­
dietary
exposures.

There
are
no
residual
uncertainties
identified
in
the
exposure
databases.
The
dietary
food
exposure
assessment
utilizes
estimates
derived
from
monitoring
data
(PDP,
FDA),
the
carbamate
market
basket
survey,
percent
crop
treated
information
(as
applicable),
and
processing
data.
The
dietary
drinking
water
assessment
includes
a
complete
environmental
fate
database
for
both
the
parent
and
the
major
metabolite
(1­
napthol)
and
uses
modeling
results
based
on
detailed
chemical­
specific
data.
The
modeling
results
are
supported
by
drinking
water
monitoring
data
and
do
not
underestimate
the
exposure
and
risks
posed
by
Carbaryl.
The
residential
exposure
assessment
includes
chemical­
specific
dislodgeable
foliar
residue
studies
(DFRs),
ORETF
data,
a
registrant
submitted
use
and
usage
study,
and
chemical­
specific
total
transferable
residue
(TTR)
studies
for
the
handler
and
post­
application
scenarios.
In
addition,
there
are
human
biomonitoring
data
to
support
the
results
of
the
residential
exposure
estimate.

3.
Application
of
the
FQPA
Safety
Factors
(Population
Subgroups
/
Risk
Assessment
Scenarios)

The
FQPA
safety
factor
recommendation
is
for
a
3X
traditional
safety
factor
to
address
data
deficiencies
and
no
additional
Special
FQPA
safety
factor.
The
3X
traditional
safety
factor
should
be
applied
to
the
Chronic
RfD
and
to
long­
term
residential
exposure
scenarios
(dermal,
and
inhalation).
No
other
FQPA
safety
factor
would
be
appropriate
for
Carbaryl.
9
4.
Summary
of
FQPA
Safety
Factors
Summary
of
FQPA
Safety
Factors
for
Carbaryl
LOAEL
to
NOAEL
(UFL)
Subchronic
to
Chronic
(UFS)
Incomplete
Database
(UFDB)
Special
FQPA
Safety
Factor
(Hazard
and
Exposure)

Magnitude
of
Factor
3X
1X
1X
1X
Rationale
for
the
Factor
Use
of
a
LOAEL
to
establish
toxicity
endpoint
(i.
e,
a
NOAEL
was
not
identified
in
the
critical
study).
Refer
to
Section
I.
3.
No
subchronic
to
Chronic
extrapolations
performed
Toxicity
Database
is
complete
No
residual
concerns
regarding
pre
or
post­
natal
toxicity
or
completeness
of
the
toxicity
or
exposure
databases
Endpoints
to
which
the
Factor
is
Applied
Chronic
dietary
and
Long­
term
residential
exposures
(Dermal
and
Inhalation)
Not
Applicable
Not
Applicable
Not
Applicable
