Document ID: EPA-HQ-OPP-2004-0302-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-10T04:00Z

Pine
Oil
Occupational/
Residential
Exposure
Assessment
Office
of
Pesticide
Programs
Antimicrobials
Division
U.
S.
Environmental
Protection
Agency
1801
South
Bell
Street
Arlington,
VA
22202
September
9,
2004
Page
2
of
17
EXPOSURE/
RISK
ASSESSMENT
AND
CHARACTERIZATION
EXECUTIVE
SUMMARY
This
document
contains
the
occupational
and
residential
exposure
assessment
for
industrial,
commercial,
and
residential
uses
of
pine
oil
marketed
under
a
variety
of
product
names.
Pine
oil­
containing
products
include
many
use
sites,
such
as
eating
establishments,
food
processing
plants,
commercial/
institutional/
industrial
premises
and
equipment,
household
or
domestic
dwellings
and
contents,
and
medical
sites
and
items.
Pine
oil
is
used
as
a
disinfectant,
sanitizer,
microbicide/
microbistat,
virucide,
and
insecticide.
Products
can
contain
a
maximum
of
80%
pine
oil,
and
are
generally
intended
to
be
diluted
with
water.
Several
ready­
to­
use
products
are
available
for
household
use
in
spray
bottles,
but
these
products
contain
<
1%
of
the
active
ingredient,
pine
oil.
Products
containing
99
to
100%
pine
oil
are
available
for
the
manufacturing
of
germicides
and
disinfectants.
Based
on
examination
of
the
labels,
all
formulations
are
liquid
formulations.
The
application
rates
used
in
the
assessment
are
based
on
the
maximum
stated
application
rates
on
labels.

The
endpoints
used
in
this
document
to
assess
pine
oil
risks
are
the
intermediate­
and
long­
term
dermal
and
short­,
intermediate­,
and
long­
term
inhalation
endpoints.
The
intermediate­
and
longterm
dermal
LOAEL
is
226
mg/
kg/
day.
The
dermal
NOAEL
is
based
on
a
90­
day
dermal
toxicity
test
performed
on
rats.
The
inhalation
NOAEL
of
50
mg/
kg/
d
is
based
on
developmental
toxicity
in
rats.

The
scenarios
considered
in
the
risk
assessment
are
shown
in
Table
1.
These
scenarios
were
selected
based
on
examination
of
product
labels
describing
uses
for
the
product.

Several
different
sources
of
handler
and
postapplication
exposure
data
were
used
to
assess
occupational
and
residential
pine
oil
risks.
Data
from
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
and
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study
were
used
to
assess
exposure.
In
addition,
the
model
EFAST
(
Exposure
and
Fate
Assessment
Screening
Tool)
was
used
to
estimate
the
inhalation
exposure
to
the
vapor
phase
of
pine
oils.

In
summary,
the
occupational
dermal
exposure
was
not
of
concern
for
any
scenarios
(
i.
e.,
MOE
greater
than
the
target
MOE
of
100).
For
the
inhalation
exposures,
the
MOEs
for
all
scenarios
were
higher
than
the
target
MOE
of
1000
for
short­
and
intermediate­
term.
For
the
residential
uses
of
pine
oil,
the
handler
risks
are
not
of
concern
except
for
the
short­
term
inhalation
MOE
for
wiping
(
inhalation
MOE
is
500,
target
MOE
is
1000).
Refinements
to
the
amount
of
chemical
used
for
wiping
should
be
submitted
by
the
registrant.
In
addition,
the
risks
are
of
concern
for
the
postapplication
intermediate­
term
incidental
oral
for
children
crawling
on
treated
floors
at
day
care
facilities.
The
estimate
intermediate­
term
MOE
for
hand­
to­
mouth
activities
is
2,000
(
target
intermediate­
term
MOE
=
3,000).
Page
3
of
17
There
are
a
number
of
uncertainties
associated
with
this
assessment
(
See
Section
4.0).
In
general,
conservative
values
were
used
in
cases
where
data
were
lacking
and
data
should
be
submitted
by
the
registrant
to
refine
the
input
parameters.

Table
1.
Pine
Oil
Exposure
Scenarios
Use
Site
Category
Scenario
Commercial/
Institutional
Premises
and
Industrial
Areas/
Premises
General
purpose
cleaner
Residential
and
Public
Access
Premises
(
Residential)
General
purpose
cleaner
Washing
a
pet
dog
with
pine
oil­
containing
product
1.0
BACKGROUND
Purpose
In
this
document,
which
is
for
use
in
EPA's
development
of
the
Pine
Oil
Reregistration
Eligibility
Decision
Document
(
RED),
EPA
presents
the
results
of
its
review
of
the
potential
human
health
effects
of
occupational
and
residential
exposure
to
pine
oil.

Criteria
for
Conducting
Exposure
Assessments
An
occupational
exposure
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
pine
oil,
both
criterion
are
met.

1.1
Summary
of
Toxicity
Concerns
Relating
to
Exposures
Endpoints
of
Concern
Toxicological
endpoints
of
concern
for
pine
oil
and
associated
uncertainty
factors
used
in
assessing
the
risks
for
pine
oil
are
presented
in
Table
2.
Page
4
of
17
Table
2.
Pine
Oil
Hazard
Endpoints
and
Uncertainty
Factors
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Dietary
Risk
Assessment
Acute
Dietary
(
general
population)
NOAEL
=
50
UF
=
100
Acute
RfD
=
0.05
mg/
kg/
d
Maternal
LOAEL
of
600
mg/
kg/
d
based
on
observed
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
developmental
toxicity
­
rats
Acute
Dietary
(
females
13+)
NOAEL
=
50
UF
=
1000
Developmental
toxicity
LOAEL
of
600
mg/
kg/
d
based
on
decreased
fetal
weight,
fetal
malformations,
retardation
of
ossification
developmental
toxicity
­
rats
Chronic
Dietary
NOAEL
=
50
UF
=
3000
Chronic
RfD
=
0.016
mg/
kg/
d
Maternal
LOAEL
of
600
mg/
kg/
d
based
on
observed
toxicity,
decreased
body
weight,
weight
gain,
food
consumption
developmental
toxicity
­
rats
Incidental
Oral
Short­
Term
(
1­
30
days)
NOAEL
=
50
UF
=
1000
developmental
toxicity
­
rats
Incidental
Oral
Intermediate­
Term
(
1­
6
months)
NOAEL
=
50
UF
=
3000
developmental
toxicity
­
rats
Non­
Dietary
Risk
Assessment
Dermal
Short­
term
Endpoint
not
required
Dermal
Intermediate­
and
Long­
Term
NOAEL
=
226
UF
=
100
subchronic
dermal
toxicity
­
rats
Inhalation
All
durations
NOAEL
=
50
UF
=
1000
(
ST,
IT)
UF
=
3000
(
LT)
developmental
toxicity
­
rats
Notes:
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
RfD
=
reference
dose,
MOE
=
margin
of
exposure
Page
5
of
17
1.2
Summary
of
Use
Pattern
and
Formulations
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
include:
bathrooms,
toilet
bowls,
kitchens,
non­
porous
surfaces,
garbage
cans,
household
items,
laundry,
and
pets.
A
detailed
listing
of
use
sites
for
pine
oil
is
presented
in
Appendix
A.

Formulation
Types
and
Percent
Active
Ingredient
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
after
use
immediately.

The
Agency
determines
potential
exposures
to
handlers
of
the
product
by
identifying
exposure
scenarios
from
the
various
application
methods
that
are
plausible,
given
the
label
uses.
Based
on
reviewing
product
labels,
the
following
use
patterns
specific
to
pine
oil
are
representative
of
the
maximum
potential
exposures
to
pine
oil:

Commercial
Uses:

1.
General
cleansing
of
premises/
areas.

Residential
Uses:

2.
Cleansing
bathroom/
kitchen
areas,
and
3.
Washing
a
dog.

Pine
oil
is
also
available
in
a
technical
grade
for
reformulation
and
repackaging
use.
Products
containing
99
to
100%
pine
oil
are
available
to
manufacturers
for
germicide
and
disinfectant
production.
Page
6
of
17
Daily
Inhal
Exposure
mg
AI
day
Inhal
Unit
Exposure
mg
AI
lb
AI
Max
Appl
Rate
lb
AI
Gal
Max
Volume
Treated
Gallons
Day
.
.
..
.






=








 






 






2.0
COMMERCIAL/
INSTITUTIONAL
PREMISES
(
HANDLER
AND
POSTAPPLICATION)

2.1
Occupational
Handlers
2.1.1
Handler
Exposures
Scenarios
Inhalation
and
dermal
handler
exposures
were
addressed
for
occupational
populations
using
surrogate
data
from
the
Chemical
Manufacturers
Association
(
CMA,
1992).
Using
surrogate
unit
exposure
data,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
and
risks
to
handlers
were
assessed.
The
following
handler
exposure
scenario
has
been
identified:

°
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
are
considered
representative
of
a
high
end
exposure.

The
exposure/
risks
were
calculated
using
the
following
equations.

The
daily
dermal
exposures
are
calculated
using
the
following
formula:

Daily
Dermal
Exposure
mg
AI
day
Dermal
Unit
Exposure
mg
AI
lb
AI
Max
Appl
Rate
lb
AI
Gal
Max
Volume
Treated
Gallons
Day






=








 






 






.
.
.

Potential
daily
inhalation
exposures
are
calculated
using
the
following
formula:

These
calculations
of
potential
daily
exposure
to
pine
oil
by
handlers
are
used
to
calculate
the
potential
doses
and
total
risk
to
those
handlers.

Daily
intermediate­
and
long­
term
Dermal
Dose
(
mg/
kg/
day)
is
calculated
as:

Daily
Dermal
Exposure
mg
day
dermal
absorption
dermal
tox
study
Body
Weight
kg
(
/
)
(
)

(
)
 
  
1
Page
7
of
17
Daily
Inhalation
Exposure
mg
day
inhalation
absorption
inhalation
tox
study
Body
Weight
kg
(
/
)
(
)

(
)
 
  
1
Short
and
Intermediate
Duration
Exposure
MOE
NOAEL
mg
kg
day
DailyDose
mg
kg
day
=
(
/
/
)

(
/
/
)
Daily
Inhalation
Dose
(
mg/
kg/
day)
is
calculated
as:

Margin
of
Exposure
(
MOE)
is
calculated
by
dividing
the
NOAEL
or
LOAEL
by
the
daily
dose.

The
assumptions
used
in
calculating
the
exposures/
risks
are
summarized
in
Table
3.

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.
Specifically,
it
was
assumed
that
occupational
handlers
will
use
1.5
ounces
of
liquid
pine
oil­
containing
product
(
EPA
Reg.
No.
4313­
9,
80%
ai)
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.

Using
the
assumptions
discussed
above,
the
calculated
short­
and
intermediate­
term
aerosol­
generated
inhalation
and
dermal
MOEs,
respectively,
are
32,000
and
520
for
the
low
pressure
spray
scenario,
2,500
and
270
for
the
wiping
scenario,
and
9,200
and
1,400
for
the
mopping
scenario.
The
calculated
MOEs
indicate
that
the
inhalation
risks
are
not
of
concern
for
short­
and
intermediate­
term
durations
for
all
uses.
For
dermal
exposure,
the
calculated
short­
and
intermediate­
term
MOEs
indicate
that
the
risks
are
not
of
concern
for
all
uses.

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
presented
in
the
residential
section
below.
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).
Page
8
of
17
Table
3.
Intermediate­
and
Long­
term
Risks
Associated
with
Commercial/
Institutional
Uses
of
Pine
Oila
Exposure
Scenario
Dermal
Unit
Exposure
(
mg/
lb
ai)
b
Inhalation
Unit
Exposure
(
mg/
lb
ai)
c
Appl.
Rate
d
(
lb
a.
i./
gal)
Amount
of
Product
Handled
Dermal
Dose
(
mg/
kg/
day)
e
Dermal
MOE
f
Inhalation
Dose
(
mg/
kg/
day)
g
Inhalation
MOE
h
Commercial/
Institutional
Premises
Cleaning
products
­
Low
pressure
sprayer
191
0.681
0.08
2
gallons
0.44
520
0.0016
32,000
Cleaning
products
­
Wiping
2870
67.3
0.08
1
liter
0.85
270
0.020
2,500
Cleaning
products
­
Mopping
71.6
2.38
0.08
2
gallons
0.16
1,400
0.0054
9,200
a
Handler
is
assumed
to
be
wearing
long
pants,
and
long­
sleeved
shirt.
b
Dermal
unit
exposures
are
from
CMA
study.
c
Inhalation
unit
exposures
are
from
CMA
study.
d
Application
rates
are
based
on
the
pine
oil
labels.
e
Dermal
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
ai)
*
Appl.
rate
(
lb
ai/
gallon)
*
gallons
handled
/
Body
weight
(
71.8
kg)].
f
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
Where
intermediate­
and
long­
term
dermal
NOAEL
=
226
mg/
kg/
day].
Target
MOE
is
100.
g
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).
h
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
Where
short­,
intermediate­,
and
long­
term
inhalation
NOAEL
=
50
mg/
kg/
day].
Target
MOE
is
1000
for
short­
and
intermediate­
term
exposure
and
3000
for
long­
term
exposure.

2.2
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
screeninglevel
assessment
was
only
conducted
for
the
vapor
inhalation
exposure.
The
for
potential
short­
and
intermediate­
term
postapplication
exposures
to
pine
oil
is
based
on
the
relatively
high
vapor
pressure.
Postapplication
inhalation
exposure
is
expected
for
bystanders
remaining
in
areas
of
treatment.
At
this
time,
air
concentration
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
below
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.,
NOAEL
of
50
mg/
kg/
day
/
0.0057
mg/
kg/
day,
target
MOE
=
1,000).
Page
9
of
17
3.0
RESIDENTIAL
AND
PUBLIC
ACCESS
PREMISES
(
HANDLER
AND
POSTAPPLICATION)

3.1
Residential
Handlers
Pine
oil,
found
in
many
residential­
use
products,
is
used
as
a
cleaner,
disinfectant,
sanitizer,
fungicide,
mildewstat,
and
deodorizer.

For
the
purposes
of
this
screening
level
assessment,
handler
scenarios
have
been
developed
that
encompass
multiple
uses
but
still
represent
the
high
end
scenario
for
all
uses
represented.
Table
4
presents
the
residential
handler
scenarios
considered
in
this
assessment.
Of
the
products
containing
pine
oil,
household
cleaning
products,
which
should
yield
the
greatest
amount
of
handler
exposure
to
the
chemical,
was
selected
for
analysis.
Also,
dog
washing
would
be
expected
to
be
another
use
that
may
result
in
a
high
handler
exposure.

Table
4.
Residential
Handler
Scenarios
Handler
Scenario
Products
Represented
Handling
of
liquid
general
purpose
cleaner
Household
cleaning
products
Dog
washing
Household
cleaning
products
with
dog
bathing
applications
3.1.1
General
Purpose
Cleaner
Scenario
The
following
scenarios
were
considered
for
residential
handlers
of
pine
oil­
containing
products:

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

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
shortterm
duration
(
i.
e.,
not
of
concern)
the
risks
for
the
intermediate­
term
duration
have
been
presented
to
bracket
the
potential
risks.
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.

Inhalation
and
dermal
exposures
were
addressed
for
residential
handlers
using
surrogate
data
from
the
Chemical
Manufacturers
Association
(
CMA,
1992).
Using
surrogate
unit
exposure
data,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
and
risks
to
residential
handlers
were
assessed.
In
addition,
pine
oil
has
a
relatively
high
vapor
pressure
(
0.2
mmHg
@
20
C),
and
therefore,
also
presents
a
concern
for
potential
vapor
inhalation
exposure.
To
determine
the
Page
10
of
17
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.
The
following
information
is
presented
in
the
EFAST
model:

"....
it
is
assumed
to
contact
the
target
surface,
and
to
subsequently
volatilize
at
a
rate
that
depends
upon
the
chemical's
molecular
weight
and
vapor
pressure."

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.

As
previously
discussed,
1.5
ounces
of
liquid
pine
oil­
containing
product
(
80%
ai
EPA
Reg.
No.
4313­
9)
diluted
in
1
gallon
of
water
has
been
identified
for
wiping,
and
mopping
application
methods.
Therefore,
the
use
amount
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
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.

The
results
of
the
MOE
analysis
from
the
CMA
data
for
these
scenarios
are
presented
in
Table
5.
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
inhalation
MOEs
(
all
durations)
for
the
wiping
is
of
concern
using
the
CMA
data
because
the
estimated
MOE
of
500
is
below
the
target
MOE
for
1,000.
The
inhalation
MOE
(
all
durations)
for
mopping
from
the
CMA
data
is
not
of
concern
(
MOE
=
19,000).
Refinements
to
the
amount
of
wipes
handled
on
a
daily
basis
should
be
submitted
by
the
registrant.
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
inhalation
toxicological
endpoint,
representing
all
durations.
If
a
short­
term
toxicological
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
EFAST
model
indicate
a
short­
term
inhalation
MOE
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).
Page
11
of
17
Table
5.
Calculation
of
Dermal
and
Inhalation
MOE
for
Residential
Handlers
a
Exposure
Scenario
Method
of
Applicatio
n
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
(
mg/
kg/
day)
h
Inhalatio
n
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
gallons
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
Dermal
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
Where
intermediate­
term
dermal
NOAEL
=
226
mg/
kg/
day].
Target
MOE
is
100.
Note:
No
short­
term
toxicological
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
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
NOAEL
for
all
durations
=
50
mg/
kg/
day].
Target
MOE
is
1000
for
short­
and
intermediate­
term.

3.1.2
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.
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
in
the
general
purpose
cleaner
assessment
above
was
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.
Page
12
of
17
3.2
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
shortterm
dermal
endpoints
of
concern).
In
addition,
both
the
short­
and
intermediate­
term
incidental
oral
endpoints
are
provided
to
assess
the
potential
risks.
The
short­
and
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
dermal
exposure
to
toddlers
crawling
on
the
floor.
To
determine
toddler
exposure
to
residues
on
treated
floor,
the
following
equation
was
used:

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.
Page
13
of
17
°
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
Dermal
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
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:
Page
14
of
17
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
handto
mouth
exposure
events
per
hour
(
90th
percentile)
for
short­
term
duration
and
9.5
events
per
hour
for
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
short­
term
exposure
is
0.05
mg/
kg/
day
and
0.025
mg/
kg/
day
for
intermediate­
term
exposure,
resulting
in
a
hand­
to­
mouth
short­
term
MOE
for
toddlers
of
1,000
and
an
intermediate­
term
MOE
of
2000.
Therefore,
the
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
Postapplication
inhalation
exposure
to
adults
and
toddlers
after
pine
oil
use
(
as
a
general
cleaner
and/
or
dog
bath)
is
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.
The
postapplication
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
from
general
purpose
cleaners
using
a
weight
fraction
of
0.01
(
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
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
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
short­
term
inhalation
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).
The
risks
for
the
toddlers
were
scaled
by
body
weight
but
not
breathing
rate.
The
breathing
rate
of
a
toddler
is
lower
than
that
of
an
adult,
and
therefore,
the
MOEs
would
be
slightly
higher,
but
not
above
Page
15
of
17
the
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
concentration),
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).

4.0
LIMITATIONS
AND
UNCERTAINTIES
There
are
a
number
of
uncertainties
associated
with
this
assessment.
In
general,
extremely
conservative
values
were
used
in
cases
where
data
were
lacking.
Assessments
for
these
scenarios
should
be
considered
as
screening
assessments,
and
not
indicative
of
the
true
risk
associated
with
these
scenarios.

°
Surrogate
dermal
and
inhalation
data
from
the
limited
data
available
in
the
Chemical
Manufacturers
Association
(
CMA)
database
were
used
to
assess
handler
exposure.

°
Very
little
data
could
be
found
regarding
typical
amounts
handled
by
workers
in
commercial/
institutional
premises
or
by
residential
applicators.
Refinements
to
the
amount
handled
should
be
submitted
by
the
registrant.
Page
16
of
17
5.0
REFERENCES
USEPA.
1997.
Exposure
Factors
Handbook.
Volume
I­
II.
Office
of
Research
and
Development.
Washington,
D.
C.
EPA/
600/
P­
95/
002Fa.

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.
Page
17
of
17
APPENDIX:
Use
Sites
for
Pine
Oil
in
Product
Indoor
Food
Eating
Establishments
(
Food
Contact)
Eating
Establishments
Equipment
and
Utensils
(
Food
Contact)
Food
Processing,
Handling
and
Storage
Plants/
Areas
Meat
Processing
Plants
Poultry
Meat
Processing
Plants
Indoor
Non­
Food
Eating
Establishments
(
Non­
Food
Contact)
Commercial,
Institutional
and
Industrial
Areas/
Premises
Commercial,
Institutional
and
Industrial
Equipment
Commercial
Transportation
Facilities
(
Non­
Food
Contact)
Laundry
Equipment
Diapers
(
Commercial
Laundry)
Refuse
and
Solid
Waste
Transportation
and
Handling
Equipment
Hard
Non­
Porous
Surface
Treatments
Farm
Animals
(
All
or
Unspecified)
Automobiles
and
Ships
Indoor
Residential
Household
or
Domestic
Dwellings
Household
or
Domestic
Dwelling
Contents
Bathroom
Premises
Human
Bedding
Human
Grooming
Instruments
Laundry
(
Household/
Coin­
Operated)
Refuse
and
Solid
Waste
Containers
(
Garbage
Cans)
Refuse
and
Solid
Waste
Sites
Refuse
and
Solid
Waste
Transportation
and
Handling
Equipment
Hard
Non­
Porous
Surface
Treatments
Toilet
Bowls
and
Urinals
Pets
(
All
or
Unspecified)