Document ID: EPA-HQ-OPP-2004-0302-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-10T04:00Z

PINE
OIL
Risk
Assessment
Office
of
Pesticide
Programs
Antimicrobials
Division
U.
S.
Environmental
Protection
Agency
1801
South
Bell
Street
Arlington,
VA
22202
September
8,
2004
1.0
EXECUTIVE
SUMMARY
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3
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
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2.1
Chemical
Identification
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9
2.2
Physical/
Chemical
Properties
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9
3.0
HAZARD
CHARACTERIZATION
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10
3.1
Hazard
Profile
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10
3.2
FQPA
Considerations
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12
3.3
Dose­
Response
Assessment
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13
3.4
Endocrine
Disruption
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14
4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
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15
4.1
Summary
of
Registered
Uses
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15
4.2
Dietary
Exposure/
Risk
Pathway
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15
4.3
Drinking
Water
Exposure/
Risk
Pathway
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17
4.4
Residential
Exposure/
Risk
Pathway
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17
4.4.1
Residential
Handler
Scenarios
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17
4.4.1.1General
Purpose
Cleaner
Scenario
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18
4.4.1.2Dog
Bath
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20
4.4.2
Residential
Postapplication
Exposure
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20
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
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24
5.1
Acute
and
Chronic
Dietary
Aggregate
Risk.
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24
5.2
Short­,
Intermediate­,
and
Long­
Term
Aggregate
Risk.
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5.3
Dermal
Aggregate
Risk.
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27
6.0
OCCUPATIONAL
EXPOSURE
AND
RISK
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28
6.1
Occupational
Handlers
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28
6.2
Occupational
Postapplication
Exposure
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30
7.0
INCIDENTS
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30
8.0
ENVIRONMENTAL
FATE
ASSESSMENT
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30
9.0
ECOTOXICOLOGY
ASSESSMENT
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32
10.0
REFERENCES
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34
Page
3
of
34
Page
4
of
34
1.0
EXECUTIVE
SUMMARY
Pine
Oil
is
a
complex
combination
of
terpenes
produced
by
high
temperature
distillation
of
oil
of
turpentine
or
by
catalytic
hydration
of
terpenes.
Pine
oil
contains
a
minimum
of
60%
isomeric
secondary
and
tertiary
cyclic
terpene
alcohols
and
a
maximum
of
40%
non­
terpene
alcohol
components
consisting
of
terpene
hydrocarbons,
terpene
ether,
and
ketones.

Pine
Oil
is
registered
for
use
as
a
disinfectant,
sanitizer,
microbiocide/
microbiostat,
virucide,
and
insecticide
for
indoor
food
use,
indoor
non­
food
use,
indoor
residential
use,
indoor
medical
use,
and
aquatic
non­
food
industrial
use.
Some
of
these
formulations
are
allowed
for
use
as
hard
surface
disinfectants
in
eating
establishments
where
there
may
be
the
potential
for
indirect
transfer
to
food.

Hazard:
The
acute
toxicity
of
pine
oil
is
relatively
low
by
the
oral
route
(
Toxicity
Category
III),
dermal
route
(
Toxicity
category
III),
and
inhalation
route
(
Toxicity
category
IV).
Pine
oil
is
a
moderate
skin
irritant
(
Toxicity
category
III),
but
shows
a
stronger
response
as
an
eye
irritant
(
Toxicity
category
II).

Subchronic
toxicity
testing
of
pine
oil
in
rats
showed
no
systemic
toxicity
by
the
dermal
route
(
90­
day
dermal
toxicity
study).
No
studies
are
available
regarding
subchronic
toxicity
by
the
oral
route.
The
Agency
recommends
that
a
subchronic
oral
toxicity
study
with
neurotoxicity
evaluation
be
performed
for
adequate
evaluation
of
the
hazard
from
repeated
oral
exposure.

In
a
developmental
toxicity
study
in
rats,
maternal
toxicity
was
observed
at
doses
of
600
and
1,200
mg/
kg/
day.
Maternal
deaths
at
the
dose
level
of
1,200
mg/
kg/
day
indicated
a
potential
neurotoxic
effect.
In
fetuses,
increased
fetal
and
litter
incidence
of
depressed
eye
bulge
were
observed
at
the
1,200
mg/
kg/
day
dose.
Dilation
of
the
lateral
ventricles
was
present
at
1,200
mg/
kg/
day,
and
increased
incidence
of
micropthalmia
was
also
noted.
Increased
fetal
and
litter
incidence
of
non­
ossified
or
incompletely
ossified
skull,
vertebrae,
manubrium,
sternebrae,
and
pelvis
were
also
reported
in
the
study.
The
maternal
and
developmental
toxicity
NOAEL
for
this
study
is
50
mg/
kg/
day.
This
value
is
considered
somewhat
conservative
based
on
the
lack
of
any
other
studies
available
for
non­
acute
toxicity
of
pine
oil.

Toxicity
Endpoints:
The
toxicity
endpoints
used
in
this
document
to
assess
potential
risks
include
acute
and
chronic
dietary
reference
doses
(
RfDs),
short­
and
intermediate­
term
incidental
oral
dose,
intermediate­
and
long­
term
dermal
dose
and
short­,
intermediate­,
and
longterm
inhalation
dose.
These
endpoints
were
selected
in
2004
by
the
Antimicrobials
Division's
Toxicology
Endpoint
Selection
Committee
(
ADTC)
for
use
as
appropriate
in
occupational/
residential
exposure
assessments.

Acute
and
Chronic
RfDs:
The
aRfD
for
females
of
child
bearing
age
(
13­
50
years)
and
the
general
population
is
0.05
mg/
kg/
day.
The
female
(
13­
50
year)
aRfD
is
based
on
adverse
developmental
effects
(
decreased
fetal
weight,
fetal
malformations,
retardation
of
ossification)
at
Page
5
of
34
600
mg/
kg/
day
in
the
rat
developmental
study,
while
the
aRfD
for
the
general
population
is
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
in
maternal
rats
at
600
mg/
kg/
day
in
the
same
study.
Uncertainty
factors
were
included
for
interspecies
extrapolation
(
10x),
intra­
species
variation
(
10x),
and
lack
of
an
adequate
hazard
database
(
10x).

The
chronic
RfD
is
0.016
mg/
kg/
day
based
on
adverse
maternal
effects
at
600
mg/
kg/
day
in
the
rat
developmental
study.
Uncertainty
factors
were
included
for
inter­
species
extrapolation
(
10x),
intra­
species
variation
(
10x),
lack
of
an
adequate
hazard
database
(
10x),
and
lack
of
a
long­
term
study
(
3x).

Incidental
oral
endpoints:
The
short­
term,
and
intermediate­
term
incidental
oral
endpoint
of
50
mg/
kg/
day
is
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
and
food
consumption
at
600
mg/
kg/
day
in
maternal
animals
in
the
rat
developmental
study.
Uncertainty
factors
were
included
for
inter­
species
extrapolation
(
10x),
intra­
species
variation
(
10x),
lack
of
an
adequate
hazard
database
(
10x),
and
lack
of
a
long­
term
study
(
3x;
intermediate­
term
endpoint
only).
Thus,
the
target
margin
of
exposure
(
MOE)
is
1,000
for
shortterm
exposures
and
3,000
for
intermediate­
term
exposures.

Dermal
endpoints:
A
short­
term
dermal
endpoint
was
not
needed
for
pine
oil.
This
conclusion
was
based
on
the
results
of
a
14­
day
dermal
toxicity
study
(
submitted
with
the
90­
day
dermal
toxicity
study)
in
which
no
adverse
dermal
effects
were
observed
at
a
dose
near
a
limit
dose
(
940
mg/
kg/
day).
For
intermediate­
and
long­
term
dermal
exposure,
the
highest
dose
tested
in
the
90­
day
dermal
toxicity
study
was
selected
as
the
endpoint
(
NOAEL
of
226
mg/
kg/
day).
Uncertainty
factors
were
used
for
inter­
species
extrapolation
(
10x)
and
intra­
species
variation
(
10x).
The
target
MOE
is
100.
Although
this
study
is
not
acceptable
by
OPP's
published
guidelines,
extra
uncertainty
factors
were
not
applied
to
the
endpoint
based
on
the
conservative
nature
of
the
dose
level
(
i.
e.
226
mg/
kg/
day
vs.
940
mg/
kg/
day
in
the
14
day
dermal
study)
and
the
observation
that
higher
dose
levels
could
not
be
tested
dermally
Inhalation
endpoints:
The
inhalation
endpoint
for
all
exposure
durations
is
50
mg/
kg/
day
and
is
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
and
food
consumption
at
600
mg/
kg/
day
in
maternal
animals
in
the
rat
developmental
study.
Uncertainty
factors
were
included
for
inter­
species
extrapolation
(
10x),
intra­
species
variation
(
10x),
and
lack
of
an
adequate
hazard
database
including
a
route­
specific
inhalation
study
(
10x)
for
the
short­
term
inhalation
endpoint.
For
the
intermediate
and
long­
term
endpoint,
an
additional
uncertainty
of
3x
was
applied
for
the
lack
of
a
long­
term
study
from
which
to
determine
a
long­
term
exposure
endpoint.
Thus,
the
MOE
is
1,000
for
short­
and
intermediate­
term
exposures
and
3,000
for
longterm
exposures.

FQPA
Safety
Factor:
On
February
24,
2004
,
the
ADTC
reviewed
the
available
toxicology
data
for
pine
oil
and
recommended
that
the
hazard­
based
special
FQPA
safety
factor
be
reduced
(
1X)
when
assessing
dietary
risks
resulting
from
the
uses
of
pine
oil.
The
ADTC
also
concluded
that
there
is
no
evidence
for
susceptibility
to
exposure
to
pine
oil
from
the
limited
data
available.
Page
6
of
34
1
PAD
=
Population
Adjusted
Dose
=
Acute
or
Chronic
RfD
FQPA
Safety
Factor
Based
on
Agency
policy,
a
RfD
modified
by
a
FQPA
safety
factor
is
a
population
adjusted
dose
(
PAD)
1.
The
Agency
calculated
an
acute
PAD
and
a
chronic
PAD,
and
uses
this
value
to
estimate
acute
and
chronic
dietary
risk.
The
acute
PAD
is
the
acute
RfD
divided
by
the
FQPA
safety
factor.
The
chronic
PAD
is
the
chronic
RfD
divided
by
the
FQPA
safety
factor.

Dietary
Exposure
and
Risk:
AD
considered
potential
dietary
exposure
to
pine
oil
residues
in
food.
When
assessing
acute
and
chronic
(
non­
cancer)
dietary
risk,
AD
considered
potential
dietary
exposure
to
the
U.
S.
population
including
infants
and
children
as
well
as
to
females
13­
50
years,
based
on
the
developmental
toxicity
potential
of
this
active
ingredient.
AD
expresses
dietary
risk
estimates
as
a
percentage
of
the
aPAD
or
chronic
PAD.
Dietary
exposures
that
are
less
than
100%
of
the
aPAD
or
cPAD
are
below
the
Agency's
level
of
concern.

Several
registered
product
labels
exist
in
which
pine
oil
is
used
as
a
disinfectant
in
restaurants,
kitchens,
cafeteria,
food
storage
areas,
counter
tops,
stove
tops,
drain
boards,
microwaves,
food
processing
plants,
and
picnic
tables.
The
Agency
did
not
request
nor
was
any
data
received
on
the
residue
chemistry
of
pine
oil.
Therefore,
the
Agency
has
relied
upon
the
models
developed
by
the
Food
and
Drug
Administration
(
FDA)
to
estimate
dietary
exposure
through
the
indirect
food
contact
uses
of
pine
oil.
The
results
of
the
dietary
exposure
and
risk
analysis
indicated
that
of
the
five
product
formulations
registered
for
indirect
food
uses,
two
formulations
indicated
risks
of
concern
for
adults
and
children
where
dietary
exposure
exceeded
100%
of
the
aPAD
and
cPAD.
The
acute
dietary
risk
estimates
ranged
from
7
to
400%
of
the
aPAD,
while
the
chronic
dietary
risk
estimates
ranged
from
21
to
1,250%
of
the
cPAD.
The
highest
dietary
risk
estimates
are
for
children.

Water
Exposure
and
Risk:
Pine
Oil
is
registered
for
indoor
uses
only
and
it
is
not
likely
to
contaminate
surface
or
ground
water.
In
an
event,
however,
if
Pine
oil
is
released
to
a
waste
stream,
the
three
major
constituents
namely:
alpha­
pinene,
beta
pinene
and
alpha
terpineol
volatilize
rapidly
from
surface
water,
are
highly
biodegradable,
they
have
short
half
lives
in
water,
and
have
low
mobility
in
soils.
Hence
there
is
low
probability
of
surface
and
ground
water
contamination.

Residential
(
Non­
Occupational)
Exposure
and
Risk:
Pine
oil,
found
in
many
residential­
use
products,
is
used
as
a
cleaner,
disinfectant,
sanitizer,
fungicide,
mildewstat,
and
deodorizer.
The
handler
scenarios
used
in
the
residential
exposure
assessment
were
developed
to
encompass
multiple
uses
but
still
represent
a
high
end
exposure
scenario
for
all
uses
represented.
The
residential
handler
scenarios
considered
in
this
assessment
include
handling
of
liquid
general
purpose
cleaner
and
dog
bathing.
These
scenarios
were
selected
because
they
are
believed
to
yield
the
greatest
amount
of
handler
exposure
to
pine
oil.
Page
7
of
34
For
the
general
purpose
cleaner
scenario,
the
calculated
dermal
MOEs
are
not
of
concern
for
any
of
the
scenarios
(
MOE
=
530
and
2,800,
for
wiping
and
mopping,
respectively).
The
calculated
inhalation
aerosol
MOE
for
the
wiping
is
of
concern
because
the
estimated
MOE
of
500
is
below
the
target
MOE
for
1,000.
The
inhalation
aerosol
MOE
for
mopping
is
not
of
concern
(
MOE
=
19,000).
Refinements
to
the
amount
of
wipes
handled
on
a
daily
basis
should
be
submitted
by
the
registrant.
In
addition,
inhalation
MOEs
from
the
vapor
of
pine
oil
are
not
of
concern
(
MOE­
1,300).

Residential
exposure
to
pine
oil
products
used
for
washing
dogs
(
i.
e.,
specified
on
label
as
a
"
dog
bath")
was
also
evaluated.
This
scenario
is
believed
to
be
best
represented
by
the
shortterm
exposure
duration.
Because
there
is
no
short­
term
dermal
endpoint,
dermal
risks
were
not
evaluated.
However,
a
short­
term
inhalation
exposure
and
risks
to
pine
oil
vapors
were
estimated
using
the
methodology
outlined
in
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
U.
S.
EPA
2000)
for
calculating
handler
inhalation
doses
from
treating
pets
with
shampoo
is
based
on
a
percentage
of
the
application
rate.
Because
pine
oils
have
a
relatively
high
vapor
pressure,
the
model
EFAST
was
used.
However,
EFAST
does
not
contain
an
exposure
scenario
for
bathing
a
dog.
Therefore,
to
determine
the
potential
inhalation
exposure
to
pine
oil
when
used
to
bath
a
dog,
the
air
concentration
estimate
for
general
purpose
cleaners
was
used
as
a
screening­
level
assessment.
The
application
rate
for
a
dog
bath
(
EPA
Reg.
No.
62644­
1)
is
3
teaspoons
of
a
19.9
%
ai
formulation
per
gallon
of
water.
Therefore,
the
weight
fraction
is
determined
to
be
0.00078
(
i.
e.,
3
tsp/
768
tsp
per
gallon
x
8
lb/
gal
x
0.199
=
0.0062
lb
ai
per
gallon
of
dog
bath.
Weight
fraction
is
0.0062
lb
ai
per
gallon
/
8
lb
per
gallon
wash
solution
density
=
0.00078).
The
weight
fraction
used
for
the
general
purpose
cleaner
assessment
above
was
higher
 
0.01.
Therefore,
the
estimated
inhalation
risk
for
the
dog
bath
is
less
than
that
posed
by
the
cleaner
use
(
i.
e.,
higher
MOE
than
the
1,300
estimated
above
for
vapor
exposures)
and
not
of
concern.

The
residential
post­
application
scenario
considered
in
this
assessment
is
exposure
to
residue
from
hard
surfaces
(
i.
e.,
floors)
that
have
been
mopped
with
a
product
containing
pine
oil.
At
this
time
the
Antimicrobials
Division
has
not
developed
a
methodology
to
assess
exposure
to
pets
after
treatment.
This
is
considered
a
data
gap
that
needs
to
be
addressed
by
the
registrant.

Dermal
and
incidental
oral
exposures
of
toddlers
crawling
on
floors
treated
with
pine
oil
products
were
assessed
as
part
of
the
post­
application
exposure
and
risk
assessment.
The
dermal
MOE
from
this
scenario
(
530)
does
not
indicate
a
risk
of
concern
for
toddlers
(
target
MOE

100).
However,
the
short­
and
intermediate­
term
incidental
oral
MOEs
for
toddlers
are
1,000
and
2,000,
respectively
(
target
MOE

1000
for
short­
term
and
3000
for
intermediate
term).
Therefore,
only
the
intermediate­
term
incidental
oral
MOE
is
of
concern
(
i.
e.,
less
than
the
target
MOE
of
3000).

In
addition,
short­
term
postapplication
inhalation
exposures
to
vapors
are
not
of
concern
for
adults
for
cleaning
products
(
MOE=
1,300
versus
target
MOE

1000),
but
are
of
concern
for
children
(
MOE
=
260)
for
the
80%
ai
cleaning
products.
However,
the
postapplication
inhalation
(
vapor)
MOE
for
the
dog
bathing
scenario
is
below
the
Agency's
level
of
concern
(
MOE=
7,400
Page
8
of
34
versus
target
MOE
of

1000).

Aggregate
Exposure
and
Risk:
For
the
short­
term
aggregate
assessment,
adult
exposures
from
dietary
exposure
and
cleaning
could
be
aggregated.
In
the
case
of
pine
oil,
the
dietary
exposure
is
aggregated
with
the
inhalation
exposures
from
cleaning.
The
dermal
exposure
is
not
included
as
the
study
and
endpoint
defining
the
toxicity
by
the
dermal
route
differ
from
the
oral
and
inhalation
route.

For
toddlers,
only
the
short­
term
incidental
oral
exposure
from
the
floor
cleaning
(
postapplication)
are
aggregated
with
dietary
exposure.
Dermal
exposures
are
not
aggregated
for
the
same
reason
as
stated
for
adults.
In
addition,
there
are
no
aggregate
intermediate­
term
scenarios
for
toddlers,
although
there
are
intermediate­
term
exposure
scenarios.

The
Aggregate
Risk
Index
(
ARI)
method
is
used
to
aggregate
the
above
scenarios,
as
the
uncertainty
factor
from
chronic
dietary
exposure
(
3000)
is
dissimilar
to
the
uncertainty
factors
for
the
short­
and
intermediate­
term
inhalation
exposure
(
1000).
Based
on
this
approach,
the
ARI
for
adult
males
ranged
from
0.21­
0.45,
for
adult
females
0.19­
0.44,
and
for
children
0.06­
0.2,
which
are
below
the
target
ARI
of

1,
and
thus,
exceed
the
Agency's
level
of
concern.

Occupational
Exposure
and
Risk:
Worker
exposure
to
pine
oil
is
expected
to
occur
through
the
use
of
pine
oil­
containing
products
in
commercial/
institutional
settings
(
e.
g.,
janitors).
Dermal
and
inhalation
exposures
from
contact
with
pine
oil
were
assessed
for
handling
pine
oilcontaining
cleaning
products
through
low
pressure
spray,
wipe,
and
mopping
application
methods.
While
pine
oil
products
have
other
listed
uses,
these
additional
exposure
scenarios
are
not
expected
to
result
in
higher
exposures
than
the
selected
scenario.
Therefore,
exposures
to
pine
oil
from
cleaning
was
considered
representative
of
a
high
end
exposure.

Occupational
handler
exposures
were
assessed
for
low
pressure
spray,
wipe,
and
mopping
application
methods
using
surrogate
data
obtained
from
the
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
study
(
U.
S.
EPA,
1999).
In
addition,
product
label
maximum
application
rates,
related
use
information,
and
Agency
standard
values
were
used
to
evaluate
occupational
handler
exposures.
The
dermal
and
inhalation
risk
estimates
for
all
3
scenarios
are
not
of
concern
(
dermal
MOEs
range
from
270
to
2,900
and
the
inhalation
MOEs
range
from
2,500
to
32,000,
with
target
MOEs
of
100
and
1,000,
respectively).

Occupational
postapplication
dermal
and
aerosol­
and
vapor­
generated
inhalation
exposures
to
pine
oil
are
likely
to
be
minimal
compared
to
handler
exposure
because
of
dilution
with
water.
(
Note:
postapplication
exposure
from
cleaning
products
are
assessed
for
residents
in
the
residential
section.)
Therefore,
a
separate
screening­
level
assessment
was
not
conducted
for
occupational
postapplication
scenarios.

Environmental
Fate:
No
data
are
available
regarding
the
fate
characteristics
of
pine
oil,
which
is
a
complex
mixture
of
terpenes.
The
fate
properties
of
the
major
components
of
pine
oil,
namely
alpha­
terpineol
and
alpha­
and
beta­
pinene,
were
used
instead
to
assess
the
environmental
fate
of
this
complex
blend.
Based
on
alpha­
and
beta­
pinene's
bioconcentration
factors
of
2,800
Page
9
of
34
and
440,
respectively,
and
high
log
K
ow
values,
bioaccumulation
or
bioconcentration
in
aquatic
organisms
is
possible.
Likewise,
alpha­
terpineol's
bioconcentration
factor
of
110
suggests
that
the
potential
for
bioconcentration
is
high
while
a
log
K
ow
of
2.98
indicates
potential
to
moderately
bioaccumulate.
However,
alpha­
and
beta­
pinene
are
expected
to
undergo
rapid
biodegradation
and
volatilization
in
water.
Alpha­
terpineol,
on
the
other
hand,
does
not
seem
to
biodegrade
and
volatilize
as
rapidly
as
alpha­
and
beta­
pinene.

Alpha­
/
beta­
pinene
and
alpha­
terpineol
have
been
shown
to
be
readily
biodegradable
in
soil
by
microorganisms.
In
addition,
the
Henry's
Law
Constants
for
these
chemicals
indicate
that
they
will
volatilize
from
most
moist
soils.
However,
they
are
expected
to
absorb
with
a
high
degree
to
suspended
particles
and
sediments
in
the
water
column
based
on
estimated
K
oc
values
(
1,000
for
alpha­
pinene
and
alpha­
terpineol
and
1,200
for
beta­
pinene).

In
general,
the
rapid
volatilization
and
biodegradation
and
low
half­
lives
in
water
of
alpha­
/
beta­
pinene
and
alpha­
terpineol
indicate
a
low
probability
for
contamination
of
water
systems.
Due
to
their
volatilization,
biodegradation
and
low
mobility
in
soils,
contamination
of
ground
or
surface
water
systems
is
not
likely.

Ecotoxicology:
Ecological
effects
data
indicate
that
pine
oil
is
practically
non­
toxic
to
avian
species
and
only
slightly
toxic
to
freshwater
fish
and
invertebrates
on
an
acute
basis.
Chronic
toxicity
testing
for
freshwater
organisms
is
not
required
for
pine
oil
and
no
information
is
currently
available.
Likewise,
plant
toxicity
information
on
pine
oil
is
not
available;
however,
terrestrial
and
aquatic
plant
testing
is
not
required
to
support
the
indoor
uses
of
pine
oil.

DATA
GAPS
/
REQUIREMENTS
For
the
uses
of
Pine
Oil
in
the
RED,
data
gaps
exist
for
a
two­
generation
reproduction
toxicity
test,
a
90­
day
oral
toxicity
test
with
neurotoxic
endpoint
evaluation,
and
a
90­
day
oral
dog
study
because
of
the
indirect
food
uses
for
phenol.
These
aspects
of
Pine
oil
toxicity
are
not
adequately
addressed
by
the
current
toxicology
database,
and
uncertainty
factors
have
been
used
in
the
absence
of
these
data.

In
addition,
the
dermal
sensitization
assay
and
the
in
vitro
mammalian
cells
in
culture
assay
must
be
repeated.
The
sensitization
assay
used
an
inadequate
number
of
animals
to
make
a
determination
of
sensitization,
and
the
CHO
assay
had
significant
problems
with
the
integrity
of
the
cell
cultures
that
compromised
the
results
of
the
study.

The
residential
post­
application
scenario
considered
in
this
assessment
is
exposure
to
residue
from
hard
surfaces
(
i.
e.,
floors)
that
have
been
mopped
with
a
product
containing
pine
oil.
At
this
time
the
Antimicrobials
Division
has
not
developed
a
methodology
to
assess
exposure
to
pets
after
treatment.
This
is
considered
a
data
gap
that
needs
to
be
addressed
by
the
registrant
Page
10
of
34
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
2.1
Chemical
Identification
Chemical
identification
parameters,
including
chemical
and
common/
trade
names,
chemical
family,
CAS
Number,
and
molecular
formula
are
provided
in
Table
1.

Table
1.
Chemical
Identification
Chemical
Name
1­
Methyl­
4­
isopropyl­
1­
cyclo­
hexen­
8­
ol
Common/
Trade
Names
Pine
Oil
80
Chemical
Family
alpha­
Terpineol
and
Terpinolene
(
Terpene
alcohol)

CAS
Number
8002­
09­
3
Molecular
Formula
C10H18O
2.2
Physical/
Chemical
Properties
The
physical
and
chemical
properties
of
Pine
oil
are
shown
in
Table
2.

Table
2.
Physical/
Chemical
Properties
Parameter
Value
Molecular
Weight
154.0
Color
Colorless
to
pale
yellow
Physical
State
Liquid
Specific
gravity
0.952
at
20
oC
Boiling
Point
~
210
o
C
at
750
mm
Hg
Dissociation
Constant
NA
(
insoluble
in
water)

pH
NA
(
insoluble
in
water)

Stability
30­
day
accelerated
storage
study
showed
the
substance
is
stable
Melting
point
N/
A
Water
Solubility
Insoluble
in
water
(
immiscible)

Solubility
in
organic
solvents
Isopropyl
alcohol
>
90%
Toluene
>
90%

Octanol­
water
Partition
Coefficient
Can
not
be
determined
(
insoluble
in
water)

Vapor
Pressure
0.2
mm
Hg
at
20

C
Page
11
of
34
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
A
detailed
hazard
assessment
for
pine
oil
is
presented
in
the
attached
appendix
(
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
May
2004).

Acute
Toxicity.
In
acute
toxicity
studies,
pine
oil
has
been
shown
to
have
low
toxicity
by
the
oral
route
(
Toxicity
Category
III),
inhalation
route
(
Toxicity
Category
IV)
and
dermal
route
(
Toxicity
Category
III).
Pine
oil
is
a
moderate
skin
irritant
(
Toxicity
Category
III),
but
shows
a
stronger
response
as
an
eye
irritant
(
category
II).
No
dermal
sensitization
has
been
observed
with
pine
oil;
however,
the
available
dermal
sensitization
assay
is
considered
unacceptable
because
an
inadequate
number
of
animals
was
used
to
make
the
determination
of
sensitization.
Table
3
presents
the
acute
toxicity
data
for
pine
oil.
Table
4
highlights
results
of
key
toxicological
studies
with
pine
oil.

Subchronic
Toxicity.
The
database
for
subchronic
toxicity
of
pine
oil
consists
of
one
14­
day
dermal
toxicity
test
and
one
90­
day
dermal
toxicity
test
in
rats.
In
the
14­
day
dermal
toxicity
test
no
significant
adverse
effects
were
observed
up
to
a
dose
of
940
mg/
kg/
day.
In
the
90­
day
dermal
toxicity
study,
no
significant
adverse
dermal
or
systemic
effects
were
observed
due
to
treatment.
The
systemic
no­
observed­
adverse
effect
level
(
NOAEL)
was

226
mg/
kg/
day
(
the
highest
dose
tested);
a
lowest­
observable­
adverse
effect
level
(
LOAEL)
could
not
be
determined
due
to
a
lack
of
treatment­
related
effects.

Developmental
Toxicity.
In
a
prenatal
developmental
toxicity
study
in
rats,
maternal
toxicity
in
the
form
of
excess
salivation,
alopecia,
and
ungroomed
coat
was
observed
at
doses
of
600
and
1,200
mg/
kg/
day.
In
addition,
adrenal
gland
weight
was
significantly
increased
in
maternal
animals
at
the
1,200
mg/
kg/
day
dose
level.
Maternal
deaths
were
also
increased
at
the
1,200
mg/
kg/
day;
animals
exhibited
ataxia,
decreased
motor
activity,
and
impaired
righting
reflex
prior
to
death,
raising
the
possibility
of
a
neurotoxic
effect.
External
examination
of
fetuses
showed
an
increased
fetal
and
litter
incidence
of
depressed
eye
bulge
at
the
1,200
mg/
kg/
day
dose.
Visceral
examination
showed
dilation
of
the
lateral
ventricles
at
1,200
mg/
kg/
day,
and
increased
incidence
of
micropthalmia.
Skeletal
examination
showed
increased
fetal
and
litter
incidence
of
non­
ossified
or
incompletely
ossified
skull,
vertebrae,
manubrium,
sternebrae,
and
pelvis.
The
maternal
and
developmental
toxicity
NOAEL
for
this
study
is
50
mg/
kg/
day.
This
value
is
considered
somewhat
conservative
based
on
the
lack
of
any
other
available
studies
for
non­
acute
toxicity
of
pine
oil.

Reproductive
Toxicity.
Studies
with
pine
oil
were
not
available
to
satisfy
the
data
requirements
for
reproductive
toxicity
for
this
chemical.
As
there
are
indirect
food
uses
for
this
chemical,
and
in
accordance
with
the
interim
working
policy
of
AD
regarding
indirect
food
use
data
requirements,
a
reproductive
toxicity
study
is
required
in
order
to
properly
characterize
these
risks.
Page
12
of
34
Carcinogenicity.
Pine
oil
has
not
been
classified
as
to
its
carcinogenicity.
However,
carcinogenicity
data
are
not
required
at
this
time.

Mutagenicity.
Acceptable
mutagenicity
studies
including
Ames
Salmonella
assay
and
micronucleus
assay
were
conducted
with
pine
oil.
No
mutagenic
response
was
observed
in
these
studies.
In
an
unacceptable
in
vitro
cytogenetics
assay,
a
negative
mutagenic
response
was
also
observed
for
this
chemical.
This
study
was
deemed
unacceptable
due
to
problems
with
the
integrity
of
the
cell
cultures.

Neurotoxicity.
Studies
with
pine
oil
were
not
available
to
satisfy
the
data
requirements
for
neurotoxicity
for
this
chemical.
The
Agency
recommends
that
a
subchronic
oral
toxicity
study
with
neurotoxicity
evaluation
be
perform
to
address
the
neurotoxicty
of
pine
oil.

Metabolism.
Metabolism
data
are
not
required
at
this
time.

Table
3.
Acute
Toxicity
of
Pine
Oil
Guideline
No./
Study
Type
MRID
No.
Results
Toxicity
Category
870.1100
Acute
oral
toxicity­
Rat
40253502
LD50(
combined)
=
2.7
g/
kg
III
870.1200
Acute
Dermal
toxicity­
Rat
40253503
LD50
>
2000
mg/
kg
III
870.1300
Acute
inhalation
toxicity­
Rat
43375208
LC50
>
3.67
mg/
L
IV
870.2500
Dermal
irritation­
Rabbit
43375210
Erythema/
edema
up
to
7
days
post
dose
III
870.2400
Primary
Eye
Irritation
43375209
Irritation
lasting
up
to
16
days
II
870.2600
Skin
sensitization­
Guinea
pig
Not
a
sensitizer.
Study
unacceptable
Table
4.
Toxicity
Profile
of
Pine
Oil
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification/
Doses
Results
870.3250
90­
day
Dermal
Toxicity
in
Rats
40515401
(
1988)/
Unacceptable/
Doses:
0,
50,
113,
226
mg/
kg/
day
to
shaved
skin,
6
hrs/
day,
5days/
wk,
13
weeks
Systemic
Toxicity
NOAEL
=
>
226
mg/
kg/
day
Systemic
Toxicity
LOAEL
=
>
226
mg/
kg/
day
NOAEL
can
be
estimated
from
a
14­
day
range­
finding
study
that
showed
a
dermal
NOAEL
of
940
mg/
kg/
day.
Page
13
of
34
Table
4.
Toxicity
Profile
of
Pine
Oil
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification/
Doses
Results
870.3700
Developmental
Toxicity
in
Rats
40515201
(
1988)/
Acceptable­
guideline/
Doses:
0,
50,
600,
1200
mg/
kg/
day
Maternal/
Developmental
Toxicity
NOAEL
=
50
mg/
kg/
day
Maternal/
Developmental
Toxicity
LOAEL
=
600
mg/
kg/
day
The
dose
spacing
in
this
study
(
i.
e.
50,
600,
1,200
mg/
kg/
day)
along
with
the
appearance
of
effects
mainly
at
1200
but
also
at
600
mg/
kg/
day
suggests
that
effects
could
have
arisen
at
doses
lower
than
1,200
mg/
kg/
day
but
greater
than
600
mg/
kg/
day.
This
leads
to
a
conservative
assumption
of
50
mg/
kg/
day
as
the
NOAEL
for
maternal
and
developmental
toxicity.

Mutagenicity
Gene
Mutation
870.5100
Ames
Salmonella
Assay
43375212
(
1994)/
Acceptable/
concentrations
of
0.1,
1.0,
10,
100,
1,000,
10,000

g/
plate
No
evidence
of
an
increase
in
induced
mutant
colonies
over
background
in
the
absence
or
presence
of
metabolic
activation.

In
vitro
Cytogenetics
870.5300
40341403
(
1987)/
Unacceptable/
100,
130,
170,
200,
250
ng/
mL
(­
S9);
50,
100,
200,
300,
400
nL/
mL
(+
S9)
No
evidence
of
induction
of
mutant
colonies
over
background.
Study
not
acceptable
and
must
be
repeated.
Cells
not
checked
for
mycoplasma
contamination,
and
several
cultures
were
lost
to
contamination
during
conduct
of
the
assay.

870.5395
Micronucleus
Assay
40341403
(
1987)/
Acceptable/
i.
p.
doses
of
0,
116,
578,
1155
mg/
kg
No
significant
increase
in
frequency
of
micronucleated
polychromatic
erythrocytes
in
bone
marrow
at
any
test
concentration
or
harvest
time.

Neurotoxicity
870.6300
Developmental
neurotoxicity
Not
required
3.2
FQPA
Considerations
Under
the
Food
Quality
Protection
Act
(
FQPA),
P.
L.
104­
170,
which
was
promulgated
in
1996
as
an
amendment
to
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
the
Agency
was
directed
to
"
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children"
from
aggregate
exposure
to
a
pesticide
chemical
residue.
The
law
further
states
that
in
the
case
of
threshold
effects,
for
purposes
of
providing
this
reasonable
certainty
of
no
harm,
"
an
additional
tenfold
Page
14
of
34
margin
of
safety
for
the
pesticide
chemical
residue
and
other
sources
of
exposure
shall
be
applied
for
infants
and
children
to
take
into
account
potential
pre­
and
post­
natal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
Notwithstanding
such
requirement
for
an
additional
margin
of
safety,
the
Administrator
may
use
a
different
margin
of
safety
for
the
pesticide
residue
only
if,
on
the
basis
of
reliable
data,
such
margin
will
be
safe
for
infants
and
children."

On
February
24,
2004
,
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
reviewed
the
available
toxicology
data
for
pine
oil
and
recommended
that
the
hazard­
based
special
FQPA
safety
factor
be
removed
(
1x)
when
assessing
dietary
risks
resulting
from
the
uses
of
pine
oil.
This
conclusion
is
based
on
the
use
of
conservative
NOAEL
values
from
the
developmental
toxicity
study
for
calculation
of
dietary
and
non­
dietary
endpoints.
The
ADTC
also
concluded
that
there
is
no
evidence
for
susceptibility
to
exposure
to
pine
oil
from
the
limited
data
available.

3.3
Dose­
Response
Assessment
The
doses
and
toxicological
endpoints
selected
for
various
exposure
scenarios
are
summarized
in
Table
5.

Table
5.
Toxicological
Endpoints
Exposure
Scenario
Dose
used
in
risk
assessment
UF
/
MOE
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Dietary
Risk
Assessments
Acute
Dietary
(
gen
pop)
NOAEL
of
50
mg/
kg/
day
UF=
100
DB=
10X
Acute
RfD
=
0.05
mg/
kg/
day
FQPA
SF
=
1x
aPAD=
acute
RfD
FQPA
=
0.05
mg/
kg/
day
Developmental
toxicity
study
in
rats
Maternal
LOAEL
of
600
mg/
kg/
day
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
Acute
Dietary
(
females
13+)
NOAEL
of
50
mg/
kg/
day
UF=
100
DB=
10X
Acute
RfD
=
0.05
mg/
kg/
day
FQPA
SF
=
1x
aPAD=
acute
RfD
FQPA
=
0.05
mg/
kg/
day
Developmental
toxicity
study
in
rats
Developmental
toxicity
LOAEL
of
600
mg/
kg/
day
based
on
decreased
fetal
weight,
fetal
malformations,
retardation
of
ossification.
Page
15
of
34
Table
5.
Toxicological
Endpoints
Exposure
Scenario
Dose
used
in
risk
assessment
UF
/
MOE
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Chronic
Dietary
NOAEL=
50
UF=
300
DB=
10X
Chronic
RfD
=
0.016
mg/
kg/
day
FQPA
SF
=
1x
cPAD=
chronicRfD
FQPA
=
0.016
mg/
kg/
day
Developmental
toxicity
study
in
rats
Maternal
LOAEL
of
600
mg/
kg/
day
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
Non­
Dietary
Risk
Assessments
Incidental
Oral
Short
 
and
Intermediate­
Term
(
1
­
30
Days,
and
1­
6
months)
Maternal
NOAEL=
50
mg/
kg/
day
Target
MOE=
1,000
(
short­
term)
3,000
(
intermediateterm
Developmental
toxicity
study
in
rats
Maternal
LOAEL
of
600
mg/
kg/
day
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
Dermal
Short
­
term
Endpoint
not
required
Dermal
intermediate
and
long­
term
Dermal
NOAEL
>
226
mg/
kg/
day
Target
MOE=
100
(
residential
and
occupational)
90­
day
dermal
toxicity
study
in
rats
Dermal
NOAEL
of
>
226
mg/
kg/
day
(
highest
dose
tested)

Inhalation
All
durations
NOAEL
=
50
mg/
kg/
day
(
assume
inhalation
and
oral
absorption
are
equivalent,
i.
e.,
100%)
Target
MOE
=
1,000
(
ST,
IT)

=
3,000
(
LT)

(
residential
and
occupational
Developmental
toxicity
in
rats
Maternal
LOAEL
of
600
mg/
kg/
day
based
on
clinical
observations
of
toxicity,
decreased
body
weight,
weight
gain,
food
consumption.

Notes:
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
RfD
=
reference
dose,
MOE
=
margin
of
exposure
A
short­
term
dermal
endpoint
was
not
needed
for
pine
oil.
This
conclusion
was
based
on
the
results
of
a
14­
day
dermal
toxicity
study
(
submitted
with
the
90­
day
dermal
toxicity
study)
in
which
no
adverse
dermal
effects
were
observed
at
a
dose
near
a
limit
dose
(
940
mg/
kg/
day).

Database
Uncertainty
Factor.
Based
on
the
lack
of
specific
neurotoxicity
endpoints
and
a
reproductive
toxicity
study,
a
database
uncertainty
factor
of
10x
applies
to
pine
oil
for
residents
and
workers
for
oral
and
inhalation
exposures.
Page
16
of
34
3.4
Endocrine
Disruption
The
Agency
is
required
under
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
4.1
Summary
of
Registered
Uses
Pine
oil
is
the
active
ingredient
in
numerous
formulations
and
is
used
as
a
disinfectant,
sanitizer,
microbicide/
microbistat,
virucide,
and
insecticide.
Products
containing
pine
oil
are
designated
for
occupational
and
residential
use.
The
occupational
use
sites
include:
eating
establishments
(
surfaces,
equipment,
and
utensils),
food
processing
plants/
areas,
commercial/
institutional/
industrial
premises
and
equipment,
commercial
transportation
facilities,
refuse
and
soil
waste
transportation
and
handling
equipment,
barber
and
beauty
shop
equipment
and
instruments,
laundry,
and
hospitals
and
related
institutions.
The
residential
uses
locations
include:
bathrooms,
toilet
bowls,
kitchens,
non­
porous
surfaces,
garbage
cans,
household
items,
laundry,
and
pets.

Concentrations
of
pine
oil
in
products
range
from
80%
to
<
10%,
with
several
ready­
to­
use
products
containing
<
1%
of
the
active
ingredient.
All
formulations
are
in
liquid
form,
and
are
generally
intended
to
be
diluted
with
water
prior
to
use.
Label
instructions
also
indicate
that
products
may
be
used
full
strength
for
heavy­
duty
cleaning
jobs
or
tough
stains,
but
areas/
items
should
be
rinsed
with
water
immediately.

4.2
Dietary
Exposure/
Risk
Pathway
Several
registered
product
labels
exist
in
which
pine
oil
is
used
as
a
disinfectant
in
restaurants,
kitchens,
cafeteria,
food
storage
areas,
counter
tops,
stove
tops,
drain
boards,
microwaves,
food
processing
plants,
and
picnic
tables.
The
Agency
did
not
request
nor
was
any
data
received
on
the
Page
17
of
34
residue
chemistry
of
pine
oil.
Therefore,
the
Agency
has
relied
upon
the
models
developed
by
the
Food
and
Drug
Administration
(
FDA)
to
estimate
dietary
exposure
through
the
indirect
food
contact
uses
of
pine
oil.
In
estimating
the
dietary
exposure
from
the
disinfectant
use
of
pine
oil,
the
Agency
has
made
the
following
assumptions:

1.
Residual
solution
of
the
formulation
on
Surface:
1
mg/
cm2
(
FDA's
worst
Case
scenario
and
EPA
also
has
used
this
assumption)

2.
Area
of
treated
surface:
2000
cm2
(
50%
of
the
FDA
worst
case
assumption,
and
EPA
also
has
used
this
assumption)

3.
EPA
is
making
the
assumption
that
in
all
scenarios
listed
for
the
product
labels,
the
maximum
exposure
of
food
(
indirect
contact)
is
2000
cm2,
including
drain
boards.

4.
The
Agency
recognizes
that
as
a
disinfectant
use,
there
will
be
a
potable
water
rinse
following
application
of
the
disinfectant.
Although
there
are
quantitative
approaches
to
measuring
the
reduction
in
residue,
the
Agency
has
assumed
a
90%
reduction
in
residue
level
as
reasonable.
Hence
the
dietary
exposure
risk
assessment
is
carried
out
based
on
the
90%
reduction
scenario.

Estimation
of
dietary
exposure
for
the
registered
pine
oil
formulation
taking
into
account
the
above
assumptions
yielded
exposure
estimates
from
0.0034­
0.0448
mg/
kg/
day
for
adult
males,
0.0039­
0.0523
mg/
kg/
day
for
adult
females,
and
0.0158­
0.2
mg/
kg/
day
for
children
(
15kg).
The
exposure
estimates
and
resulting
dietary
risk
are
summarized
in
the
following
table:

Dietary
Exposure
and
Risk
Formulation
Exposure
(
mg/
kg/
day)
(
males)
%
aPAD
%
cPAD
Lonza
P­
13
0.007
14
44
Lonza
P­
6
0.0035
7.0
22
Lonza
P­
39
0.0034
7.0
21
El­
Pinol
60
0.0448
90
280
El­
Pinol
19.9
0.0175
35
109
Formulation
Exposure
(
mg/
kg/
day)
(
females)
%
aPAD
%
cPAD
Lonza
P­
13
0.0081
16
50
Lonza
P­
6
0.0041
8.2
25
Lonza
P­
39
0.0039
8.0
24
Page
18
of
34
El­
Pinol
60
0.0523
104
326
El­
Pinol
19.9
0.0205
41
128
Page
19
of
34
Formulation
Exposure
(
mg/
kg/
day)
(
child)
%
aPAD
%
cPAD
Lonza
P­
13
0.032
64
200
Lonza
P­
6
0.0164
33
102
Lonza
P­
39
0.0158
32
99
El­
Pinol
60
0.2
400
1250
El­
Pinol
19.9
0.082
164
512
As
is
observed
from
the
above
calculations,
three
of
the
formulas
do
not
present
any
dietary
risk
to
adults
or
children,
but
two
of
the
formulations
(
El­
Pinol
60
and
El­
Pinol
19.9)
present
a
risk
of
concern
to
all
populations
studied.
The
acute
dietary
risk
estimates
ranged
from
7
to
400%
of
the
aPAD,
while
the
chronic
dietary
risk
estimates
ranged
from
21
to
1,250%
of
the
cPAD.
The
highest
dietary
risk
estimates
are
for
children.

4.3
Drinking
Water
Exposure/
Risk
Pathway
Pine
Oil
is
registered
for
indoor
uses
only
and
it
is
not
likely
to
contaminate
surface
or
ground
water.
In
an
event,
however,
if
Pine
oil
is
released
to
a
waste
stream,
the
three
major
constituents
namely:
alpha­
pinene,
beta
pinene
and
alpha
terpineol
volatilize
rapidly
from
surface
water,
are
highly
biodegradable,
they
have
short
half
lives
in
water,
and
have
low
mobility
in
soils.
Hence
there
is
low
probability
of
surface
and
ground
water
contamination.

4.4
Residential
Exposure/
Risk
Pathway
A
detailed
residential
and
occupational
risk
assessment
for
pine
oils
is
provided
in
the
attached
Appendix.
A
summary
of
the
exposures
and
risks
to
residential
handlers
is
provided
below.

4.4.1
Residential
Handler
Scenarios
Pine
oil,
found
in
many
residential­
use
products,
is
used
as
a
cleaner,
disinfectant,
sanitizer,
fungicide,
mildewstat,
and
deodorizer.
The
handler
scenarios
used
in
the
residential
exposure
assessment
were
developed
to
encompass
multiple
uses
but
still
represent
a
high
end
exposure
scenario
for
all
uses
represented.
The
residential
handler
scenarios
considered
in
this
assessment
include
handling
of
liquid
general
purpose
cleaner
and
dog
washing.
These
scenarios
were
selected
because
they
are
believed
to
yield
the
greatest
amount
of
handler
exposure
to
pine
oil.
Page
20
of
34
4.4.1.1
General
Purpose
Cleaner
Scenario
The
following
two
scenarios
were
considered
for
residential
handlers
of
pine
oil­
containing
cleaning
products:

°
Use
of
cleaner/
disinfectant/
deodorizing
wipe
on
hard
non­
porous
surfaces,
and
°
Use
of
cleaner/
disinfectant/
deodorizing
mopping
on
hard
non­
porous
surfaces.

These
potential
exposures
from
a
general
purpose
cleaner
are
expected
to
be
best
represented
by
the
short­
term
duration.
However,
because
no
dermal
endpoint
has
been
identified
for
the
pine
oil
short­
term
duration
(
i.
e.,
short­
term
dermal
risks
are
not
of
concern)
the
risks
for
the
intermediate­
term
duration
have
been
presented
to
bracket
the
potential
risks
for
the
regulatory
managers.
The
dermal
portion
of
the
risks
presented
(
as
opposed
to
short­
term
inhalation)
should
not
be
included
into
the
aggregate
risk
because
they
are
not
believed
to
be
representative
of
the
pine
oil
use
pattern.

An
application
rate
of
1.5
ounces
of
liquid
pine
oil­
containing
product
diluted
in
1
gallon
of
water
has
been
identified
for
wiping,
and
mopping
application
methods
(
EPA
Reg.
No.
4313­
9).
The
80%
ai
product
is
the
highest
percent
ai
formulation
found,
there
are,
however,
many
other
labels
with
lower
ai
percentages.
The
dilution
rate
for
the
application
of
treated
cleaning
products
is
~
0.08
lb
ai/
gallon
for
the
wiping
and
mopping
application
methods.
CMA
data
were
used
to
determine
the
unit
dermal
and
inhalation
exposures.
The
inhalation
portion
of
the
exposure
from
CMA
is
not
the
vapor
phase
but
rather
resulting
from
aerosols/
splashing
of
liquid.
The
no
gloved
CMA
unit
exposure
data
for
wiping
and
mopping
were
used
to
determine
the
dermal
and
inhalation
exposure.
It
was
assumed
that
0.5
liter
is
used
for
wiping
and
1
gallon
for
mopping.
The
0.5
liter
assumption
for
the
wipes
is
a
screening­
level
estimate
and
should
be
refined
by
the
registrant.

Because
pine
oil
has
a
relatively
high
vapor
pressure
(
0.2
mmHg
@
20
C),
there
is
also
the
concern
for
potential
vapor
inhalation
exposure.
To
determine
the
potential
inhalation
exposure
resulting
from
the
vapor
of
pine
oil,
the
model
EFAST
(
Exposure
and
Fate
Assessment
Screening
Tool)
was
used
to
estimate
the
air
concentration.
OPPT/
EETD
has
developed
the
model,
EFAST,
to
estimate
air
concentrations.
More
information
and
access
to
the
EFAST
model
is
available
at
http://
www.
epa.
gov/
opptintr/
exposure/.
In
summary,
EFAST
Version
1.0
bases
its
air
concentration
estimates
on
physical/
chemical
properties.
The
air
concentration
estimates
for
the
pine
oils
are
based
on
the
model's
standard
input
parameters.
EFAST
presents
a
peak
air
concentration
as
well
as
a
daily
air
concentration.
The
peak
air
concentration
estimate
"...
is
the
highest
instantaneous
air
concentration
that
is
modeled
during
the
exposure
event."
This
peak
air
concentration
is
not
expected
for
any
appreciable
length
of
time.

EFAST
was
used
to
model
the
air
concentration
from
general
purpose
cleaners
using
a
weight
fraction
of
0.01
for
the
pine
oil
cleaning
solution/
water
(
i.
e.,
1
percent).
EFAST
indicates
a
peak
concentration
of
4.38
mg/
m3
from
this
activity.
Because
the
peak
concentration
does
not
represent
a
daily
inhalation
exposure,
the
daily
dose
rather
than
the
peak
estimate
from
EFAST
is
used
to
compare
to
the
short­
term
inhalation
toxicological
endpoint.
If
a
short­
term
toxicological
Page
21
of
34
endpoint
of
less
than
one
day
were
to
be
generated
it
should
be
compared
to
the
peak
air
concentration
estimate.
However,
because
the
toxicological
endpoint
of
concern
is
based
on
greater
than
one
day
of
exposure,
the
daily
dose
rate
of
0.040
mg/
kg/
day
from
EFAST
is
used
in
this
assessment.
The
daily
dose
rate
is
based
on
the
average
daily
concentration
of
0.22
mg/
m3.

The
results
of
the
MOE
analysis
for
these
scenarios
are
presented
in
Table
6.
The
calculated
dermal
MOEs
(
intermediate­
term)
are
not
of
concern
for
any
of
the
scenarios
(
MOE
=
530
and
2,800,
for
wiping
and
mopping,
respectively).
The
intermediate­
term
dermal
risks
are
presented
to
bracket
the
potential
risks
as
there
are
no
short­
term
dermal
toxicological
concerns.
The
calculated
short­
term
inhalation
MOEs
from
the
CMA
data
for
the
wiping
is
of
concern
because
the
estimated
MOE
of
500
is
below
the
target
MOE
for
1,000.
This
estimate
is
based
on
the
80
percent
active
ingredient.
The
risks
for
the
lower
percent
active
ingredient
formulations
of
pine
oil
will
be
proportional
to
the
percent
active
ingredient.
The
inhalation
MOE
from
the
CMA
data
for
mopping
is
not
of
concern
(
MOE
=
19,000).
The
results
of
the
EFAST
model
exposure
of
0.040
mg/
kg/
day
indicate
an
inhalation
MOE
(
all
exposure
durations)
from
the
vapor
of
pine
oil
to
be
1,300.
Therefore,
the
vapor
inhalation
portion
of
pine
oil
is
not
of
concern
(
i.
e.,
above
the
target
MOE
of
1,000).

Table
6.
Calculation
of
Dermal
and
Inhalation
MOEs
based
on
CMA
Data
for
Residential
Handlers
a
Exposure
Scenario
Method
of
Applicati
on
Dermal
Unit
Exposure
(
mg/
lb
ai)
b
Inhalation
Unit
Exposure
(
mg/
lb
ai)
c
Appl.
Rate
d
(
lb
a.
i./
gal)
Amount
Treated
Absorbed
Dermal
Dose
(
mg/
kg/
day)
f
Dermal
MOE
g
Inhalation
Dose
(
aerosol)
(
mg/
kg/
day)
(
h
Inhalatio
n
(
aerosol)
MOE
i
Hard
Surface
Disinfection
Wipes
2870
(
CMA
no
glove)
67.3
(
CMA)
0.08
0.5
liter
of
product
(
0.13
gal)
0.43
530
0.10
500
Mopping
71.6
2.38
0.08
1
gallon
0.08
2,800
0.0027
19,000
a
MOEs
rounded
to
2
significant
figures.
b
Dermal
unit
exposures
are
from
CMA.
c
Inhalation
unit
exposures
are
from
CMA.
d
Application
rates
are
based
on
the
pine
oil
labels.
f
Dermal
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
ai)
*
Appl.
rate
(
lb
ai/
gallon)
*
gallons
handled
/
Body
weight
(
70
kg).
g
Intermediate­
term
Dermal
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
Where
intermediate­
term
dermal
NOAEL
=
226
mg/
kg/
day].
Target
MOE
is
100.
Note:
Short­
term
not
of
concern.
h
Inhalation
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
ai)
*
max
appl
rate
(
lb
ai/
gal)
*
gallons
handled
*
1
inhalation
absorption]
/
Body
weight
(
70
kg).
i
Inhalation
MOE
=
LOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
LOAEL
for
all
durations
=
50
mg/
kg/
day].
Target
MOE
is
1000
for
short­
and
intermediate­
term.
Page
22
of
34
4.4.1.2
Dog
Bath
Residential
exposure
to
pine
oil
products
used
for
washing
dogs
(
i.
e.,
specified
on
label
as
a
"
dog
bath")
is
believed
to
be
best
represented
by
the
short­
term
exposure
duration.
Therefore,
because
a
short­
term
dermal
endpoint
was
not
identified
(
i.
e.,
determined
not
to
be
of
concern)
no
estimates
are
presented
for
the
dermal
exposure
to
homeowners
bathing
a
dog
(
dog
shampoo
exposure
estimates
are
very
crude
and
therefore
not
presented
to
bracket
the
risks
for
the
intermediate­
term
duration).
However,
a
short­
term
inhalation
endpoint
has
been
identified
for
pine
oil.
The
methodology
outlined
in
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
U.
S.
EPA
2000)
for
calculating
handler
inhalation
doses
from
treating
pets
with
shampoo
is
based
on
a
percentage
of
the
application
rate.
Because
pine
oils
have
a
relatively
high
vapor
pressure,
the
model
EFAST
was
used.
However,
EFAST
does
not
contain
an
exposure
scenario
for
bathing
a
dog.
Therefore,
to
determine
the
potential
inhalation
exposure
to
pine
oil
when
used
to
bath
a
dog,
the
air
concentration
estimate
for
general
purpose
cleaners
was
used
as
a
screening­
level
assessment.
The
application
rate
for
a
dog
bath
(
EPA
Reg.
No.
62644­
1)
is
3
teaspoons
of
a
19.9
%
ai
formulation
per
gallon
of
water.
Therefore,
the
weight
fraction
is
determined
to
be
0.00078
(
i.
e.,
3
tsp/
768
tsp
per
gallon
x
8
lb/
gal
x
0.199
=
0.0062
lb
ai
per
gallon
of
dog
bath.
Weight
fraction
is
0.0062
lb
ai
per
gallon
/
8
lb
per
gallon
wash
solution
density
=
0.00078).
The
weight
fraction
used
for
the
general
purpose
cleaner
assessment
above
was
higher
 
0.01.
Therefore,
the
estimated
inhalation
risk
for
the
dog
bath
is
less
than
that
posed
by
the
cleaner
use
(
i.
e.,
higher
MOE
than
the
1,300
estimated
above)
and
not
of
concern.

4.4.2
Residential
Postapplication
Exposure
Post­
application
exposures
can
occur
to
toddlers
from
the
dermal,
oral
(
incidental)
and
inhalation
routes
from
floors
that
have
been
mopped
with
a
product
containing
pine
oil.
Additionally,
adults
may
be
exposed
to
inhalation
exposures
after
this
use
Although
residential
floors
are
believed
to
be
washed/
moped
on
an
intermittent
basis
(
perhaps
weekly),
facilities
such
as
day
care
centers
may
clean
the
floors
more
often.
Therefore,
the
intermediate­
term
dermal
risks
have
been
presented
(
no
short­
term
dermal
endpoints
of
concern).
In
addition,
both
the
short­
and
intermediate­
term
incidental
oral
endpoints
are
provided
to
assess
the
potential
risks.
The
shortand
intermediate­
term
inhalation
exposure
to
vapors
of
pine
oil
after
treatment
are
also
of
potential
concern.
Finally,
there
is
also
the
potential
exposure
to
toddlers
playing/
sleeping
with
treated
dogs.
The
duration
of
exposure
is
expected
to
be
short­
term
because
of
the
intermittent
bathing
of
dogs
and
the
relatively
high
vapor
pressure
of
pine
oil.
Although
there
is
no
dermal
endpoint
of
concern
for
the
short­
term
duration,
inhalation
exposure
and
risks
are
presented.

Dermal
Exposure
There
is
the
potential
for
intermediate­
term
dermal
exposure
to
toddlers
crawling
on
the
floors
where
cleaning
occurs
more
often
than
in
a
residence,
such
as
at
day
care
facilities.
To
determine
toddler
exposure
to
residues
on
treated
floor,
the
following
equation
was
used:
Page
23
of
34
PDD
FR
x
SA
BW
=

where
PDD
=
Potential
daily
dose
FR
=
Flux
rate
of
chemical
from
material
(
mg/
m2/
day)
SA
=
Surface
area
of
the
body
which
is
in
contact
with
floor
(
m2)
BW
=
Body
weight
(
kg)

The
following
conservative
assumptions
were
made
in
calculating
the
exposures/
risks
due
to
limited
data:

$
Toddlers
(
3
years
old)
are
used
to
represent
the
1
to
6
year
old
age
group
and
are
assumed
to
weigh
15
kg,
the
median
for
male
and
female
toddlers
(
USEPA,
2000b).
A
body
surface
area
of
0.657
m2
has
been
assumed,
which
is
the
median
value.

$
1.5
ounces
of
liquid
pine
oil­
containing
product
diluted
in
1
gallon
of
water
is
used
for
mopping.
Additionally,
based
on
the
label
for
EPA
Registration
Nos.
4313­
9,
it
is
assumed
that
products
containing
80%
a.
i.
are
used
per
gallon
of
water.
Therefore,
the
use
amount
for
the
application
of
treated
cleaning
products
is
0.08
lb
ai/
gallon,
and
that
the
resulting
solution
is
applied
at
a
rate
of
1000
sq.
ft.
per
gallon.
°
No
data
could
be
found
regarding
the
quantity
of
solution
residue
left
on
the
floor
after
treatment.
As
a
conservative
measure,
it
has
been
assumed
that
25%
of
the
cleaner
remains
after
the
final
mopping.
°
No
transferable
residue
data
were
available
that
could
be
used
to
estimate
the
skin
transfer
of
pine
oil
from
the
floor.
Therefore,
Residential
SOPs
estimate
of
10%
of
the
amount
on
the
hard
surface
is
available
for
dermal
transfer.

The
calculation
of
the
dermal
dose
and
the
dermal
MOE
are
presented
in
Table
7.
The
dermal
MOE
is
estimated
to
be
530
which
is
above
the
target
MOE
of
100,
and
therefore
not
of
concern.

Table
7.
Intermediate­
term
Risks
Associated
with
Postapplication
Dermal
Exposure
on
Treated
Floors.

Parameter
Value
Rationale
Application
Rate
1000
ft2/
gallon
of
solution
USEPA
Assumption
Cleaning
Solution
0.08
lb
ai/
gallon
Maximum
rate
listed
on
label
(
EPA
Reg.
No.
4313­
9)

Transferable
Residues
(
TR)
9.8
mg/
m2/
day
((
0.08
lb
ai/
gal)/(
1000ft2
per
gallon))
*
(
25%
remaining)*
(
10%
transfer)
*
(
Conversion
Factors)

Surface
Area
of
Body
in
Contact
with
Carpet
0.657
m2
Median
surface
area
of
toddler
Page
24
of
34
Table
7.
Intermediate­
term
Risks
Associated
with
Postapplication
Dermal
Exposure
on
Treated
Floors.

Parameter
Value
Rationale
Body
Weight
15
kg
Median
body
weight
of
toddler
Potential
Dermal
Exposure
0.43
mg/
kg/
day
TR
*
SA/
BW
Dermal
NOAEL
226
mg/
kg/
day
Dermal
MOE
530
(
Derm.
NOAEL)
/
(
Daily
Derm.
Dose).
Target
MOE
=
100.

TR
=
[((
0.08
lb
ai/
gal
/
1000ft2)
x
(
454
gr/
lb)
x
(
1000
mg/
gr)
x
(
1
ft2
/
0.093
m2))
x
(
0.25
remaining)
x
(
0.1
transferable)]

Incidental
Ingestion
In
addition
to
dermal
exposure,
infants
crawling
on
treated
floors
will
also
be
exposed
to
pine
oils
via
incidental
oral
exposure.
To
calculate
incidental
ingestion
exposure
to
pine
oils
due
to
hand­
to­
mouth
transfer,
the
scenarios
established
in
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
were
used.
These
scenarios
use
assumptions
that
are
similar
to
those
used
in
calculating
exposures
due
to
dermal
contact
of
pine
oils
from
toddlers
crawling
on
treated
floors.
The
assumptions
above
in
the
dermal
assessment
(
Table
7)
estimates
the
transferable
residues
as
0.98
µ
g/
cm2
(
equivalent
to
9.8
mg/
m2).
The
estimated
potential
ingestion
dose
rate
immediately
after
application
would
be
calculated
as
follows:

PDR
norm=
ISR
t
x
SA
x
FQ
x
SE
x
ET
x
0.001
mg/
µ
g
BW
where:

PDR
norm
=
Potential
dose
rate
(
mg/
kg/
day);
ISR
t
=
Indoor
Surface
Residue
(
µ
g/
cm2)
at
time
0;
SA
=
Surface
area
of
the
hands
that
contact
both
the
treated
area,
and
the
individuals
mouth
(
cm2/
event);
FQ
=
Frequency
of
hand­
to­
mouth
events
(
events/
hr);
SE
=
Saliva
extraction
efficiency
of
50%;
and,
ET
=
Exposure
Time
(
4
hrs/
day)
BW
=
Body
weight
(
15
kg)

The
surface
area
used
for
each
hand­
to­
mouth
event
is
20
cm2.
It
is
assumed
that
there
are
20
hand­
to­
mouth
exposure
events
per
hour
(
90th
percentile)
for
the
short­
term
duration
and
9.5
events
per
hour
for
the
intermediate­
term
duration
(
mean).
The
short­
term
incidental
oral
NOAEL
of
50
mg/
kg/
day
(
target
MOE
=
1,000)
is
believed
to
best
represent
the
homeowner
uses
because
of
the
intermittent
nature
of
cleaning
the
floor
and
the
intermediate­
term
duration
best
represents
uses
in
day
care
centers.
The
intermediate­
term
incidental
oral
NOAEL
is
the
same
but
the
target
MOE
is
3,000.
The
potential
dose
rate
(
PDR)
using
this
equation
for
the
short­
term
exposure
is
0.05
mg/
kg/
day
and
0.025
mg/
kg/
day
for
the
intermediate­
term,
resulting
in
a
hand­
to­
mouth
short­
term
MOE
for
toddlers
of
1,000
and
2,000
for
the
intermediate­
term.
Therefore,
the
Page
25
of
34
incidental
oral
exposure
is
only
of
concern
for
the
intermediate­
term
duration
(
i.
e.,
below
the
target
MOE
of
3,000
for
intermediate­
term).

Inhalation
Exposure
Post­
application
inhalation
exposure
to
adults
and
toddlers
after
pine
oil
use
(
as
a
general
cleaner
and/
or
dog
bath)
is
of
concern
because
of
the
relatively
high
vapor
pressure
of
pine
oil
(
i.
e.,
0.2
mm
Hg
@
20C).
No
postapplication
air
concentration
data
have
been
submitted
to
determine
potential
inhalation
risk.
Therefore,
EFAST
was
used
to
present
a
screening­
level
estimate
of
the
potential
inhalation
risk.
The
inhalation
toxicological
endpoint
represents
both
the
short­
and
intermediate­
term
exposure
durations
with
the
same
target
MOE
of
1,000.
The
exposure
pattern
is
believed
to
be
of
a
short­
term
duration.
The
post­
application
estimates
are
based
on
the
EFAST
results
for
the
air
concentration
and
inhalation
dose
from
the
adult
handlers.
The
toddler
risk
estimates
are
corrected
for
the
lower
body
weight
(
i.
e.,
15
kg).

EFAST
was
used
to
model
the
air
concentration
(
vapors)
from
general
purpose
cleaners
using
a
weight
fraction
of
1
percent.
EFAST
indicates
a
peak
concentration
of
4.38
mg/
m3
from
this
activity.
Because
the
peak
concentration
does
not
represent
a
daily
inhalation
exposure,
the
daily
dose
rather
than
the
peak
estimate
from
EFAST
is
used
to
compare
to
the
short­
term
inhalation
toxicological
endpoint.
If
an
acute
(
less
than
one
day)
toxicological
endpoint
were
to
be
generated
it
should
be
compared
to
the
peak
air
concentration
estimate.
However,
because
the
toxicological
endpoint
of
concern
is
based
on
greater
than
one
day
of
exposure,
the
daily
dose
rate
of
0.040
mg/
kg/
day
from
EFAST
is
used
in
this
assessment
for
adults
and
0.19
mg/
kg/
day
for
toddlers
(
i.
e.,
0.04
mg/
kg/
day
x
71.8
kg
adult
BW
x
(
1/
15
kg
toddler
BW)).
The
daily
dose
rate
is
based
on
the
average
daily
concentration
of
0.22
mg/
m3.
The
inhalation
vapor
MOE
for
adults
is
not
of
concern
(
i.
e.,
MOE
=
NOAEL
of
50
mg/
kg/
day
/
0.04
mg/
kg/
day
=
1,300,
target
MOE
of
1,000).
However,
based
on
the
same
scenario,
the
toddler
inhalation
vapor
risk
is
of
concern
because
of
the
difference
in
body
weight
(
i.
e.,
MOE
=
NOAEL
of
50
mg/
kg/
day
/
0.19
mg/
kg/
day
=
260,
target
MOE
of
1,000).

EFAST
was
also
used
to
estimate
the
potential
inhalation
risks
resulting
from
the
treatment
of
dogs.
Although
EFAST
does
not
provide
a
scenario
for
pets,
it
does
provide
a
screening­
level
assessment
for
cleaning
products.
Based
on
the
cleaning
product
scenario
and
a
weight
fraction
of
0.00078
(
pine
oil
dog
wash
solution),
the
acute
dose
rate
is
0.0068
mg/
kg/
day.
The
short­
term
inhalation
MOE
is
7,400
which
is
not
of
concern
(
short­
term
target
MOE
is
1,000).
Page
26
of
34
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
In
order
for
a
pesticide
registration
to
continue,
it
must
be
shown
that
the
use
does
not
result
in
"
unreasonable
adverse
effects
on
the
environment".
Section
2
(
bb)
of
FIFRA
defines
this
term
to
include
"
a
human
dietary
risk
from
residues
that
result
from
a
use
of
a
pesticide
in
or
on
any
food
inconsistent
with
standard
under
section
408..."
of
FFDCA.
Consequently,
even
though
no
pesticide
tolerances
have
been
established
for
pine
oils,
the
standards
of
FQPA
must
still
be
met,
including
"
that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
is
the
total
exposure
to
a
single
chemical
(
or
its
residues)
that
may
occur
from
dietary
(
i.
e.,
food
and
drinking
water),
residential,
and
other
non­
occupational
sources,
and
from
all
known
or
plausible
exposure
routes
(
oral,
dermal,
and
inhalation).

5.1
Acute
and
Chronic
Dietary
Aggregate
Risk
Aggregate
dietary
risk
includes
exposure
from
food
and
drinking
water.
Pine
oil
is
used
as
a
hard
surface
disinfectant,
and
dietary
exposures
from
the
use
of
the
five
products
have
been
noted
above
in
the
dietary
exposure
and
risk
section.
Pine
oil
is
not
expected
to
impact
drinking
water
from
the
registered
uses
as
noted
above.
With
respect
to
the
five
pine
oil
formulations
noted
in
the
dietary
exposure
and
risk
section
of
this
chapter,
only
the
El­
Pinol
19.9
and
El­
Pinol
60
formulations
show
a
dietary
risk
of
concern
for
chronic
exposure
in
adults
and
children.
One
other
formulation
(
Lonza
P­
6)
shows
some
risk
of
concern
for
children
(
102%
of
the
cPAD)
but
this
value
is
close
to
100%
of
the
cPAD
and
thus
is
in
actuality
not
interpreted
as
a
risk
of
concern.
The
other
estimations
of
dietary
risk
are
interpreted
as
conservative
and
would
likely
be
lower
with
additional
data
on
residue
levels
after
use
of
these
formulations.

5.2
Short­,
Intermediate­,
and
Long­
Term
Aggregate
Risk
In
accordance
with
the
policy
of
the
Office
of
Pesticide
Programs,
short­,
intermediate­,
and
long­
term
risk
typically
involves
exposure
from
dietary
sources
(
food
and
water)
in
combination
with
residential
scenarios
that
have
a
reasonable
chance
of
co­
occurrence.
In
the
case
of
pine
oil,
residential
scenarios
are
not
felt
to
be
long­
term
exposures,
only
short­
term
and
sometimes
intermediate­
term.
Thus,
there
is
no
long­
term
aggregate
risk
assessment.

For
the
short­
term
aggregate
assessment,
adult
exposures
from
diet
and
cleaning
could
be
aggregated.
In
the
case
of
pine
oil,
the
dietary
exposure
is
aggregated
with
the
inhalation
exposures
from
cleaning
as
the
study
and
endpoint
describing
the
effects
from
these
two
routes
of
exposure
was
the
same.
The
dermal
exposure
is
not
included
as
the
study
and
endpoint
defining
the
toxicity
by
the
dermal
route
differ
from
the
oral
and
inhalation
route.

For
toddlers,
dietary
exposure
is
aggregated
with
the
incidental
oral
exposure
from
the
floor
cleaning.
Dermal
exposures
are
not
aggregated
for
the
same
reason
as
stated
for
adults.
In
addition,
there
are
no
aggregate
intermediate­
term
scenarios
for
toddlers,
although
there
are
intermediate­
term
exposure
scenarios.
Page
27
of
34
The
Aggregate
Risk
Index
method
is
used
to
aggregate
the
above
scenarios,
as
the
uncertainty
factor
for
the
chronic
dietary
endpoint
(
3000)
is
dissimilar
to
the
uncertainty
factor
for
the
short­
and
intermediate­
term
inhalation
exposure
(
1000).
Thus,
ratios
of
MOE/
UF
are
calculated
to
yield
a
risk
index
(
RI)
for
each
scenario
aggregated,
which
can
then
be
inserted
into
the
equation:

ARI
=
1
1
+
1
+
....
1
RI
1
RI
2
RI
n
The
result
is
compared
against
the
number
1.
ARIs
greater
than
1
indicate
no
risk
of
concern
while
values
less
than
1
indicate
the
potential
for
risk.
Using
the
results
of
the
dietary
exposure
estimations
for
the
five
pine
oil
formulations
in
combination
with
the
inhalation
exposures
as
noted
above
for
adults
and
toddlers,
the
following
results
are
obtained:

Aggregate
Short­
term
Risks
for
Adult
Males
Dietary
exposure
Diet
MOE1
Diet
MOE/
UF2
Inhalation
exposure3
(
mg/
kg/
day)
Inhalation
MOE
Inhalation
MOE/
UF
ARI
0.007
7142
2.4
0.1
500
0.5
0.41
0.0035
14285
4.7
0.45
0.0034
14705
4.9
0.45
0.0448
1116
0.37
0.21
0.0175
2857
0.95
0.33
1Diet
MOE
=
short­
term
incidental
oral
NOAEL
/
food
exposure
2MOE/
UF
=
calculated
MOE
/
chronic
dietary
UF
[
3000]
3inhalation
exposure
from
cleaning
product
(
wiping).

Aggregate
Short­
term
Risks
for
Adult
Females
Dietary
exposure
(
mg/
kg/
day)
Diet
MOE1
Diet
MOE/
UF2
Inhalation
exposure3
(
mg/
kg/
day)
Inhalation
MOE
Inhalation
MOE/
UF
ARI
0.0081
6172
2.0
0.1
500
0.5
0.40
0.0041
12195
4.0
0.44
0.0039
12820
4.3
0.44
Page
28
of
34
Aggregate
Short­
term
Risks
for
Adult
Females
Dietary
exposure
(
mg/
kg/
day)
Diet
MOE1
Diet
MOE/
UF2
Inhalation
exposure3
(
mg/
kg/
day)
Inhalation
MOE
Inhalation
MOE/
UF
ARI
0.0523
956
0.32
0.19
0.0205
2439
0.81
0.31
1Diet
MOE
=
short­
term
incidental
oral
NOAEL
/
food
exposure
2MOE/
UF
=
calculated
MOE
/
chronic
dietary
UF
[
3000]
3inhalation
exposure
from
a
cleaning
product
(
wiping)

Aggregate
Short­
term
Risks
for
Children/
toddlers
Dietary
exposure
Diet
MOE1
Diet
MOE/
UF2
Inhalation
exposure3
(
mg/
kg/
day)
(
MOE)
MOE/
UF
Incidental
Oral
exposure4
(
mg/
kg/
day)
,
(
MOE),
MOE/
UF
ARI
0.032
1562
0.52
0.19
260
0.26
0.05
1000
1.0
0.17
0.0164
3048
1.0
0.2
0.0158
3164
1.0
0.2
0.2
250
0.08
0.06
0.082
609
0.2
0.11
1Diet
MOE
=
short­
term
incidental
oral
NOAEL
/
food
exposure
2MOE/
UF
=
calculated
MOE
/
chronic
dietary
UF
[
3000]
3inhalation
post­
application
exposure
from
cleaning
product
4Incidental
oral
exposure
from
treated
floors
The
above
calculations
show
ARIs
of
less
than
1
for
adults
and
children/
toddlers.
As
shown,
the
ARI
for
adult
males
ranged
from
0.21­
0.45,
for
adult
females
0.19­
0.44,
and
for
children
0.06­
0.2,
which
are
below
the
target
ARI
of

1,
and
thus,
exceed
the
Agency's
level
of
concern.
For
adult
residential
handlers,
the
inhalation
exposures
during
cleaning
are
a
significant
contributor
to
the
aggregate
risks
of
concern.
This
is
because,
this
scenario
alone,
also
exceeds
the
Agency's
level
of
concern
(
MOE=
500,
versus
target
MOE

1000).
In
addition,
the
dietary
risk
estimates
for
two
of
the
disinfectant
products
also
contribute
significantly
to
the
aggregate
risk
estimates,
since
these
risks
are
also
of
concern
alone
(%
cPAD
109­
326%).

Children's/
toddlers
calculated
ARI
values
are
lower
than
the
adult
values.
The
postapplication
exposure
from
the
80%
ai
cleaning
product
is
a
primary
driver
for
the
risk
estimate
Page
29
of
34
derived
here,
except
when
the
dietary
estimate
from
the
El­
Pinol
formulations
contributes
significantly
to
the
ARI
value.

5.3
Dermal
Aggregate
Risk
Dermal
exposures
are
considered
short­
term
only
except
for
the
toddler
dermal
scenario
from
crawling
on
treated
floors.
For
pine
oil,
no
short­
term
dermal
endpoint
was
identified
in
the
available
toxicology
database.
As
there
is
only
one
quantified
dermal
scenario,
no
aggregation
of
dermal
exposure
is
performed
for
pine
oil.

6.0
OCCUPATIONAL
EXPOSURE
AND
RISK
A
detailed
residential
and
occupational
risk
assessment
for
pine
oils
is
provided
in
the
attached
Appendix.
A
summary
of
the
exposures
and
risks
to
occupational
handlers
is
provided
below.

6.1
Occupational
Handlers
The
handlers
were
identified
as
those
individuals
who
use
pine
oil­
containing
products
in
commercial/
institutional
setting
(
including
industrial
and
medical
uses).
The
following
short­
and
intermediate­
term
handler
exposure
scenario
was
evaluated
for
pine
oil:

°
Handling
pine
oil­
containing
cleaning
products
through
low
pressure
spray,
wipe,
and
mopping
application
methods.

While
pine
oil
products
have
other
listed
uses,
these
additional
exposure
scenarios
are
not
expected
to
result
in
higher
exposures
than
the
selected
scenario.
Therefore,
exposures
to
pine
oil
from
cleaning
would
be
considered
representative
of
a
high
end
exposure.

There
are
no
chemical­
specific
exposure
data
to
assess
cleaning
product
applications.
Therefore,
dermal
and
inhalation
exposures
were
assessed
for
low
pressure
spray,
wipe,
and
mopping
application
methods
using
surrogate
data.
Specifically,
values
from
the
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
study
(
U.
S.
EPA,
1999)
were
used.
The
dermal
and
inhalation
exposures
from
these
techniques
have
been
normalized
by
the
amount
of
active
ingredient
handled
and
reported
as
unit
exposures
(
UE)
expressed
as
mg/
lb
ai
handled.
In
addition,
product
label
maximum
application
rates,
related
use
information,
and
Agency
standard
values
were
used
to
assess
occupational
handler
exposures.
Specifically,
it
was
assumed
that
occupational
handlers
will
use
1.5
ounces
of
liquid
pine
oil­
containing
80%
product
diluted
in
1
gallon
of
water
for
low
pressure
spray,
wiping,
and
mopping
application
methods.
Therefore,
the
use
amount
for
the
application
of
treated
cleaning
products
is
0.08
lb
ai/
gallon
for
the
low
pressure
spray,
wiping,
and
mopping
application
methods.
For
spraying
and
mopping
it
is
assumed
that
2
gallons
(
each)
are
used
for
daily
cleaning
and
that
1
liter
is
used
for
wiping.

The
results
of
the
MOE
analysis
are
presented
in
Table
9.
The
calculated
MOEs
indicate
that
aerosol­
generated
inhalation
exposure
risks
are
not
of
concern
(
i.
e.,
MOEs

1,000)
for
short­
Page
30
of
34
and
intermediate­
term
exposures
under
all
scenarios
assessed.
For
dermal
exposure,
the
calculated
MOEs
indicate
that
risks
do
not
exceed
the
Agency's
level
of
concern
for
the
low
pressure
spray
and
mopping
scenarios
(
i.
e.,
MOE
>
100),
but
exceed
the
level
of
concern
for
wiping.

The
aerosol­
generated
inhalation
exposure
and
risk
estimates
from
the
CMA
data
discussed
above
do
not
account
for
the
potential
vapor
inhalation
exposure
to
pine
oil
(
pine
oil
has
a
relatively
high
vapor
pressure).
Therefore,
the
potential
vapor
inhalation
exposure
to
handlers
are
addressed
by
modeling
of
the
air
concentrations.
Because
the
occupational
handlers
use
the
same
weight
fraction
of
pine
oil
as
the
residential
handlers,
the
same
type
of
application
techniques
(
i.
e.,
wipes,
sprays,
mop),
and
will
clean
in
various
rooms
to
accommodate
the
additional
amount
handled
(
e.
g.,
moving
room­
to­
room
in
a
hotel),
the
air
concentrations
and
vapor­
generated
inhalation
risk
estimates
will
be
similar
to
those
experienced
by
the
residents.
Based
on
these
assumptions,
the
short­
and
intermediate­
term
vapor­
derived
inhalation
risks
are
not
of
concern
(
i.
e.,
MOE
of
1,300
greater
than
the
target
MOE
of
1000
for
the
average
daily
dose).

Table
9.
Estimates
of
Exposure
and
Risks
to
Primary
Occupational
Handlers
of
Pine
Oil
Exposure
Scenario
Dermal
Dose
(
mg/
kg/
day)
a
Inhalation
Dose
(
mg/
kg/
day)
b
Dermal
MOE
c
Inhalation
MOE
d
Cleaning
products
­
Low
pressure
sprayer
0.44
0.0016
520
32,000
Cleaning
products
­
Wiping
0.85
0.020
270
2,500
Cleaning
products
­
Mopping
0.16
0.0054
2,900
9,200
a
Abs.
Dermal
Dose
(
mg/
kg/
day)
=
[
Appl.
rate
(
lb
ai/
gallon)
*
Gallons
handled
*
Unit
Exposure
(
mg/
lb
ai)]
/
Body
Weight
(
70
kg)].
Clothing
attire
is
long
pants,
long
sleeved
shirts,
and
no
gloves.
b
Inhalation
Dose
(
mg/
kg/
day)
=
[
Appl.
rate
(
lb
ai/
gallon)
*
Gallons
handled
*
Unit
Exposure
(
mg/
lb
ai)
*
1
Inhalation
Absorption]
/
Body
Weight
(
70
kg).
c
Dermal
MOE=
Dermal
NOAEL
(
226
mg/
kg/
day)/
Dermal
Dose
(
mg/
kg/
day).
Target
MOE
is
100.
d
Inhalation
MOE=
Inhalation
NOAEL
(
50
mg/
kg/
day)/
Inhalation
Dose
(
mg/
kg/
day).
Target
MOE
is
1,000
for
shortand
intermediate­
term
exposure.

6.2
Occupational
Postapplication
Exposure
Occupational
postapplication
dermal
and
aerosol­
generated
inhalation
exposures
to
pine
oil
are
likely
to
be
minimal
compared
to
handler
exposure
because
of
dilution
with
water.
Therefore,
a
screening
level
assessment
was
not
conducted
for
these
occupational
postapplication
scenarios.
Any
residential
postapplication
exposure
resulting
from
the
occupational/
commercial
treatments
(
e.
g.,
cleaning
of
day
care
centers)
are
assessed
in
the
residential
section
above.

There
is,
however,
the
for
potential
short­
and
intermediate­
term
postapplication
exposures
to
pine
oils
based
on
the
relatively
high
vapor
pressure.
Postapplication
inhalation
exposure
is
expected
for
bystanders
remaining
in
areas
of
treatment.
At
this
time,
air
concentration
Page
31
of
34
measurements
taken
after
pine
oil
treatments
are
not
available.
In
addition,
modeled
results
for
inhalation
exposure
are
not
specific
for
occupational
postapplication
uses.
Therefore,
the
air
concentration
for
the
80%
product
(
diluted
in
water
to
a
weight
fraction
of
0.01)
that
was
used
in
the
EFAST
model
estimate
listed
in
the
residential
handler
section
above
is
expected
to
yield
similar
results
for
bystanders.
The
average
daily
air
concentration
is
0.040
mg/
m3.
Using
an
8­
hour
workday,
the
dose
is
estimated
to
be
0.0057
mg/
kg/
day
(
i.
e.,
0.040
mg/
m3
x
1.25
m3/
hr
breathing
rate
x
8
hr/
day
x
(
1/
70
kg
BW)).
The
short­
and
intermediate­
term
inhalation
MOE
is
8,800,
and
therefore,
not
of
concern
(
i.
e.,
LOAEL
of
50
mg/
kg/
day
/
0.0057
mg/
kg/
day,
target
MOE
=
1,000).

7.0
INCIDENTS
The
main
routes
of
exposure
reported
in
incident
reports
are
oral,
dermal,
and
inhalation.
Ingestion
incidents
have
occurred
due
to:
people
have
mistaking
a
container
of
pine
oil
as
something
drinkable,
people
trying
to
commit
suicide,
or
people
using
a
product
for
its
alcohol
content.
Thirty­
one
cases
of
ingestion
were
found
in
the
databases,
7
of
which
resulted
in
death.
Dermal
exposure
causes
irritation,
rash,
and
allergic
reaction.
Inhalation
exposures
cause
respiratory
symptoms
 
shortness
of
breath,
etc.
Ocular
exposure
causes
imitation
and
blurred
vision.
There
was
nothing
in
the
databases
regarding
chronic
effects,
and
no
evidence
of
delayed
toxicity.
Only
a
small
fraction
of
the
cases
involved
something
serious
enough
to
involve
medical
attention.

8.0
ENVIRONMENTAL
FATE
ASSESSMENT
No
submitted
data
or
open
literature
are
available
regarding
the
fate
characteristics
of
pine
oil,
which
is
a
complex
mixture
of
terpenes
produced
by
high
temperature
distillation
of
oil
of
turpentine
or
by
catalytic
hydration
of
terpenes.
The
fate
properties
of
the
major
components
of
pine
oil,
namely
alpha­
terpineol
and
alpha­
and
beta­
pinene,
were
used
instead
to
assess
the
environmental
fate
of
this
complex
blend.
Environmental
fate
properties
of
these
three
components
are
shown
in
Table
9.
Alpha­
and
beta­
pinene's
bioconcentration
factors
of
2,800
and
440,
respectively,
and
high
log
K
ow
values
suggest
that
bioaccumulation
or
bioconcentration
in
aquatic
organisms
is
possible.
Likewise,
alpha­
terpineol's
bioconcentration
factor
of
110
suggests
that
the
potential
for
bioconcentration
is
high
while
a
log
K
ow
of
2.98
indicates
potential
to
moderately
bioaccumulate.
However,
a
recent
paper
by
the
National
Park
Service
of
Colorado
and
Colorado
State
University
indicates
that
turpentine
oil
(
of
which
alpha/
beta
pinenes
constitute
up
to
90%)
does
not
appear
to
bioaccumulate
possibly
due
to
the
fact
that
turpentine
oil
is
highly
biodegradable
(
Roy
Erwin,
National
Park
Service,
Water
Resource
Division,
Fort
Collins,
Colorado,
July
1997).
Both,
alpha­
and
beta­
pinene
undergo
rapid
biodegradation
in
water
as
indicated
by
aqueous
aerobic
degradation
studies.
Estimated
volatilization
half­
lives
for
alpha­
and
beta­
pinene
are
4
hours
and
1.2
hours,
respectively,
in
a
model
river.
Alpha­
terpineol,
on
the
other
hand,
does
not
seem
to
biodegrade
as
rapidly
as
alpha­/
beta­
pinene.
Estimated
half­
life
for
alphaterpineol
is
4
days
in
a
model
river.

Alpha­
/
beta­
pinene
and
alpha­
terpineol
have
been
shown
to
be
readily
biodegradable
in
soil
by
microorganisms.
In
addition,
the
Henry's
Law
Constants
for
these
chemicals
indicate
that
they
will
volatilize
from
most
moist
soils.
However,
they
are
expected
to
absorb
with
a
high
degree
to
Page
32
of
34
suspended
particles
and
sediments
in
the
water
column
based
on
estimated
K
oc
values
(
1,000
for
alpha­
pinene
and
alpha­
terpineol
and
1,200
for
beta­
pinene).

In
general,
the
rapid
volatilization
and
biodegradation
and
low
half­
lives
in
water
of
alpha­
/
beta­
pinene
and
alpha­
terpineol
indicate
a
low
probability
for
contamination
of
water
systems.
Due
to
their
volatilization,
biodegradation
and
low
mobility
in
soils,
contamination
of
ground
or
surface
water
systems
is
not
likely.

Table
10.
Environmental
Fate
Properties
of
Alpha­
and
Beta­
Pinene
and
Alpha­
Terpineol
Parameter
Alpha­
Pinene
Beta­
Pinene
Alpha­
Terpineol
Vapor
Pressure
@
25C
(
mm
Hg)
4.75
2.93
0.0423
Henry's
Law
Constant
(
air/
water
partition
coefficient)
(
atm­
cu­
m/
mole)
0.107
0.16
1.2x10­
5
KOC
(
organic
carbon
ratio
in
soil)
1000
1200
1000
Log
KOW
(
octanol/
water
partition
coefficient
4.83
4.35
2.98
BCF
2800
440
110
9.0
ECOTOXICOLOGY
ASSESSMENT
Environmental
Modeling/
Exposure
Environmental
exposure
modeling
was
not
conducted
for
the
indoor
uses
of
Pine
Oil
considered
in
this
RED.
Environmental
exposure
is
not
expected
to
result
when
registered
products
are
used
according
to
label
directions.

Ecological
Hazard
and
Risk
Results
of
an
acute
oral
toxicity
study
with
northern
bobwhite
quail
indicate
that
pine
oil
is
practically
non­
toxic
to
avian
species
on
an
acute
oral
basis.
In
an
subacute
avian
dietary
study,
pine
oil
was
also
found
to
be
practically
non­
toxic
to
avian
species.
The
acute
toxicity
of
pine
oils
to
mammals
is
defined
by
rat
toxicity
values
obtained
from
studies
conducted
to
support
data
requirements
for
human
health
risk
assessment.
Toxicity
data
for
pine
oils
are
presented
in
Tables
10­
12.
Acute
toxicity
testing
with
estuarine
and
marine
organisms
is
not
required
for
pine
oil.

Pine
oil
is
slightly
toxic
to
freshwater
fish
and
invertebrates
on
an
acute
basis.
Chronic
toxicity
testing
for
freshwater
organisms
is
not
required
for
pine
oils
and
no
information
is
currently
available.
Likewise,
plant
toxicity
information
on
pine
oil
is
not
available;
however,
terrestrial
and
aquatic
plant
testing
is
not
required
to
support
the
indoor
uses
of
pine
oil.

Table
11.
Acute
Oral
Toxicity
of
Pine
Oil
Species
Endpoint
Toxicity
Category
Bird
Page
33
of
34
Table
11.
Acute
Oral
Toxicity
of
Pine
Oil
Species
Endpoint
Toxicity
Category
Bobwhite
quail
(
Colinus
virginianus)
LD50
>
2,250
mg/
kg
NOEL
=
486
mg/
kg
Practically
non­
toxic
Mammal
Rat
LD50
=
2.7
g/
kg
(
combined)
­­­­

Table
12.
Acute
Ecotoxicity
of
Pine
Oil
Species
Endpoints
Toxicity
Category
Freshwater
Fish
Rainbow
trout
(
Oncorhynchus
mykiss)
LC50
=
18.4
ppm
NOEC
=
10
ppm
Slightly
toxic
Bluegill
(
Lepomis
macrochirus)
LC50
=
54.8
ppm
NOEC
=
36
ppm
Slightly
toxic
Freshwater
Invertebrate
Water
flea
(
Daphnia
magna)
EC50
=
24.5
ppm
NOEC
=
11
ppm
Slightly
toxic
Table
13.
Other
Toxicity
Studies
of
Pine
Oil
Species
Endpoint
Toxicity
Category
Subacute
Dietary
Toxicity
Mallard
(
Anas
platyrhynchos)
LC50
>
5,620
ppm
Practically
non­
toxic
Acute
Dermal
Toxicity
Rat
>
2,000
mg/
kg
­­­

Developmental
Toxicity
Rat
NOAEL=
50
mg/
kg/
day
(
maternal
and
developmental)

LOAEL
=
600
mg/
kg/
day
(
maternal
and
developmental)
 
The
indoor
uses
of
Pine
Oil
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur
when
it
is
used
according
to
label
directions.
The
low
toxicity
to
birds,
mammals,
and
aquatic
organisms
makes
it
even
more
unlikely
that
the
indoor
uses
of
this
chemical
pose
a
risk
to
these
species.
Risk
to
plants
cannot
be
Page
34
of
34
addressed
due
to
a
lack
of
phytotoxicity
data;
however,
exposure
to
plants
is
unlikely
from
the
indoor
uses
of
this
chemical.

Endangered
Species
Consideration
The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
risk
assessments
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.

Based
on
the
low
likelihood
of
environmental
exposure
from
the
registered
indoor
uses,
coupled
with
the
low
toxicity
of
pine
oil
to
fish,
aquatic
invertebrates,
mammals,
and
birds,
adverse
impacts
to
endangered
birds,
fish
and
aquatic
invertebrate
species
are
not
expected
from
the
registered
uses
of
pine
oil.
Risk
to
endangered
plants
cannot
be
addressed
due
to
a
lack
of
phytotoxicity
data;
however,
exposure
to
endangered
plants
is
unlikely
from
the
indoor
uses
of
this
chemical.

10.0
REFERENCES
U.
S.
EPA.
1997.
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments.
Contract
No.
68­
W6­
0030.
Prepared
by
the
Residential
Exposure
Assessment
Work
Group.
Office
of
Pesticide
Programs,
Health
Effects
Division
and
Versar.
July
1997.

USEPA.
1999.
Evaluation
of
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study.
Memorandum
from
Siroos
Mostaghimi,
Ph.
D.,
USEPA,
to
Julie
Fairfax,
USEPA.
Dated
November
4,
1999.
DP
Barcode
D247642.

USEPA,
2000.
Residential
SOPs.
EPA
Office
of
Pesticide
Programs
 
Human
Health
Division.
Dated
April
5,
2000.