Document ID: EPA-HQ-OPP-2004-0302-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-10T04:00Z

DRAFT
1
Ecological
Hazard
and
Environmental
Risk
Assessment
­
Pine
Oil
Pine
oil
is
actually
a
blend
of
compounds
used
as
disinfectants,
sanitizers,
microbiocide/
microbiostats,
virucides,
and
insecticides.
All
current
products
are
for
indoor
uses;
there
is
an
aquatic
non­
food
industrial
use
pattern
(
drainage
systems)
listed
in
the
Agency
reference
system,
but
there
are
currently
no
active
products
labeled
for
that
use.
The
following
ecological
hazard
and
environmental
risk
assessment
is
therefore
based
only
on
indoor
uses
for
pine
oil.

1.
Ecological
Toxicity
Data
A.
Toxicity
to
Terrestrial
Animals
(
i).
Birds,
Acute
and
Subacute
In
order
to
establish
the
toxicity
of
an
indoor
use
pesticide
to
birds,
the
Agency
requires
an
acute
oral
toxicity
study
using
the
technical
grade
of
the
active
ingredient
(
TGAI).
The
preferred
test
species
is
either
mallard
duck
(
a
waterfowl)
or
northern
bobwhite
quail
(
an
upland
game
bird).
The
results
of
one
toxicity
study
are
provided
in
the
following
table
(
Table
1).

Table
1.
Acute
Oral
Toxicity
of
Pine
Oil
to
Birds
Species
%
Active
Ingredient
(
ai)
Endpoint
(
mg
ai/
kg)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Bobwhite
quail
(
Colinus
virginianus)
100%
LD50
>
2,250
NOEL
=
486
Practically
non­
toxic
Yes
­
core
study
­
age
8
months
­
14­
day
test
duration
Campbell
and
Beavers,
1994
(
MRID
433752­
01)

The
results
in
Table
1
indicate
that
pine
oil
is
practically
non­
toxic
to
avian
species
on
an
acute
oral
basis.
The
study
is
acceptable
and
fulfills
the
guideline
requirements
(
71­
1/
OPPTS
850.2100)
(
MRID
433752­
01).

Notably,
a
similar
acute
oral
toxicity
study
was
conducted
using
the
mallard
(
Anas
platyrhynchos)
(
MRID
433752­
02).
However,
due
to
regurgitation
observed
in
the
test
organisms
during
the
study,
this
study
was
considered
invalid
and
does
not
fulfill
the
guideline
requirements
for
an
avian
acute
oral
study.

A
subacute
dietary
study
using
the
TGAI
may
be
required
on
a
case­
by­
case
basis
DRAFT
2
depending
on
the
results
of
the
lower
tier
ecological
studies
and
pertinent
environmental
characteristics
to
establish
the
toxicity
of
pine
oil
to
avian
species.
The
preferred
test
species
are
mallard
duck
or
northern
bobwhite
quail.
This
testing
was
not
required
for
pine
oil;
however,
one
avian
dietary
study
was
submitted
to
the
Agency.
The
results
of
this
study
are
provided
in
the
following
table
(
Table
2).

Table
2.
Subacute
Dietary
Toxicity
of
Pine
Oil
to
Birds
Species
%
Active
Ingredient
(
ai)
Endpoint
(
ppm)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Mallard
(
Anas
platyrhynchos)
100%
LC50
>
5,620
Practically
non­
toxic
Yes
­
core
study
­
5
days
exposure
Campbell
and
Beavers,
1994
(
MRID
433752­
04)

The
results
of
the
study
indicate
that
pine
oil
is
practically
non­
toxic
to
avian
species
on
a
subacute
dietary
basis.
The
study
is
acceptable
and
fulfills
the
guideline
requirements
(
71­
2/
OPPTS
850.2200)
(
MRID
433752­
04).

ii.
Toxicity
to
Mammals
Wild
mammal
testing
was
not
required
for
pine
oil.
In
most
cases,
rat
toxicity
values
obtained
from
studies
conducted
to
support
data
requirements
for
human
health
risk
assessment
substitute
for
wild
mammal
testing.
These
toxicity
values
are
reported
below
(
Table
3).

Table
3.
Acute
Toxicity
of
Pine
Oil
to
Mammals
Species
Test
Type
LD50
(
mg/
kg)
(
a)
NOEL
(
mg/
kg/
day)
LOEL
(
mg/
kg/
day)
Reference
(
MRID)

Rat
Acute
oral
2.7
g/
kg
(
combined)
­­
­­
40253502
Rat
Acute
dermal
>
2000
­­
­­
40253503
Rat
Developmental
­­­­­.
50
­
maternal
and
developmental
600
­
maternal
and
developmental
40515201
DRAFT
3
B.
Toxicity
to
Aquatic
Animals
i.
Freshwater
Fish,
Acute
In
order
to
establish
the
acute
toxicity
of
indoor
use
pesticides
to
freshwater
fish,
the
Agency
requires
a
freshwater
fish
toxicity
study
using
the
TGAI.
Data
are
generally
required
for
only
one
species.
The
preferred
test
species
are
rainbow
trout
(
a
coldwater
fish)
or
bluegill
sunfish
(
a
warmwater
fish),
although
other
test
species
identified
in
the
Guideline
(
i.
e.,
OPPTS
850.1075
(
e)(
4)(
i)(
A))
may
also
be
used.
Two
freshwater
fish
toxicity
studies
were
submitted
to
the
Agency
for
pine
oil,
and
the
results
of
these
studies
are
presented
in
Table
3.

Table
3.
Acute
Toxicity
of
Pine
Oil
to
Freshwater
Fish
Species
%
Active
Ingredient
(
ai)
Endpoints
(
ppm
ai)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Rainbow
trout
(
Oncorhynchus
mykiss)
100%
LC50
=
18.4
NOEC
=
10
slightly
toxic
Yes
­
core
study
­
96h
test
duration;
­
flow­
through
system
Graves
and
Swigert,
1994
(
MRID
433752­
06)

Bluegill
(
Lepomis
macrochirus)
100%
LC50
=
54.8
NOEC
=
36
slightly
toxic
Yes
­
core
study
­
96h
test
duration;
­
flow­
through
system
Graves
and
Swigert,
1994
(
MRID
433752­
05)

The
results
indicate
that
pine
oil
is
slightly
toxic
to
freshwater
fish
on
an
acute
basis.
The
studies
are
acceptable
and
fulfill
guideline
requirements
(
72­
1/
OPPTS
850.1075)
(
MRIDs
433752­
06,
433752­
05).

ii.
Freshwater
Invertebrates,
Acute
The
Agency
requires
a
freshwater
aquatic
invertebrate
study
using
the
TGAI
to
establish
the
acute
toxicity
of
an
indoor
use
pesticide
to
freshwater
invertebrates.
The
preferred
test
species
is
Daphnia
magna
or
Daphnia
pulex.
Results
of
one
toxicity
study
are
provided
in
the
following
table
(
Table
4).

Table
4.
Acute
Toxicity
of
Pine
Oil
to
Freshwater
Invertebrates
DRAFT
4
Species
%
Active
Ingredient
(
ai)
Endpoints
(
ppm
ai)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Water
flea
(
Daphnia
magna)
100%
EC50
=
24.5
NOEC
=
11
slightly
toxic
Yes
­
core
study
­
48h
test
duration;
­
flow­
through
system
­
endpoint
immobilization
Graves
and
Swigert,
1994
(
MRID#
433752­
07)

The
results
indicate
that
pine
oil
is
slightly
toxic
to
aquatic
invertebrates
on
an
acute
basis.
The
study
is
acceptable
and
fulfills
guideline
requirements
(
72­
2/
OPPTS
850.1010)
(
MRID
433752­
07).

iii.
Freshwater
Organisms,
Chronic
Chronic
toxicity
testing
for
freshwater
organisms
is
not
required
for
indoor
use
pesticides.
The
ECOTOX
database
(
EPA,
2002)
was
searched
for
any
appropriate
chronic
testing
with
fish
and
invertebrates,
but
no
such
data
were
located.

iv.
Estuarine
and
Marine
Organisms
Acute
toxicity
testing
with
estuarine
and
marine
organisms
using
the
TGAI
is
not
required
for
indoor
use
pesticides.

C.
Toxicity
to
Plants
Terrestrial
and
aquatic
plant
testing
is
not
required
to
support
the
indoor
uses
of
pine
oil.
No
studies
on
plant
toxicity
have
been
submitted
to
the
Agency.
The
ECOTOX
database
(
EPA,
2002)
was
searched
for
any
plant
toxicity
information
on
pine
oil.
No
appropriate
endpoints
(
e.
g.,
three
or
five
day
growth
or
biomass
EC50
values)
were
found.

2.
Environmental
Risk
Characterization
A.
Environmental
Fate
Assessment
(
excerpted
from
the
Environmental
Fate
Science
Chapter
of
this
RED)

Pine
oil,
as
registered
with
the
Agency,
has
a
complex
mixture
of
naturally­
occurring
constituents,
with
the
major
constituents
being
alpha­
terpineol
and
alpha­
and
peta­
pinene.
The
registrants
have
submitted
data
on
Pine
Oil
Blend
110990,
which
is
a
composite
blend
of
100%
pine
oil
manufacturing
use
products
containing
a
maximum
alpha­
terpineol
content
of
80%.
Since
the
DRAFT
5
registered
product
is
a
mixture
and
no
submitted
data
or
open
literature
are
available
on
fate
characteristics
of
this
product,
the
Agency
decided
to
make
a
comparison
of
fate
properties
of
alpha/
beta
pinenes,
and
alpha
terpineol
and
extrapolate
these
to
the
composite
110990
under
consideration
for
reregistration
where
possible.

Alpha­
and
beta­
pinene's
bioconcentration
factors
of
2800
and
440,
respectively,
and
high
log
K
ow
values
may
result
in
bioaccumulation
or
bioconcentration
in
aquatic
organisms.
However,
a
recent
paper
by
the
National
Park
Service
of
Colorado
and
Colorado
State
University
on
Turpentine
Oil
(
of
which
alpha/
beta
pinenes
constitute
up
to
90%)
does
not
indicate
bioaccumulation.
Alphaand
beta­
pinene
have
also
been
shown
to
be
readily
biodegradable
in
the
soil
by
microorganisms,
although
both
alpha­
and
beta­
pinene
absorb
with
a
high
degree
to
suspended
particles
and
sediments
in
the
water
column
having
an
estimated
K
oc
(
1000
and
1200,
respectively).

Alpha­
terpineol
volatilizes
in
both
soil
and
surface
water.
Along
with
volatilization,
it
is
highly
bio­
biodegradable
and
with
low
mobility
in
soil
it
is
not
likely
to
contaminate
ground
and
surface
water.
Alpha­
terpineol's
bioconcentration
factor
110
and
a
log
K
ow
value
may
possibly
result
in
moderate
bioaccumulation
and
bioconcentration
in
aquatic
organisms.
However,
no
data
on
bioconcentration
in
aquatic
organisms
are
available.
Alpha­
terpineol
also
readily
degrades
in
the
soil
by
microorganisms.
Alpha­
terpineol
has
a
high
absorptitivty
to
suspended
particles
and
sediments
in
the
water
column
as
its
estimated
K
oc
(
1000).

Alpha­
pinene
may
be
released
into
surface
water
via
effluents.
The
rapid
volatilization
and
biodegradation
and
low
half­
lives
in
water
provide
low
probability
for
contamination
of
water
systems.
Due
to
the
volatilization
and
low
mobility
in
soils
it
is
not
likely
to
contaminate
ground
or
surface
water
systems.

Beta­
pinene
may
be
released
into
surface
water
via
various
waste
streams.
The
rapid
volatilization
and
biodegradation
and
low
half­
lives
in
water
provide
low
probability
for
contamination
of
water
systems.
Due
to
the
volatilization
and
low
mobility
in
soils
it
is
not
likely
to
contaminate
ground
or
surface
water
systems.

The
registered
product
of
pine
oil
appears
to
have
some
differences
in
physical
properties,
such
as
low
water
solubility;
hence,
no
Kow
can
be
estimated
and
is
not
known.
Similarly,
its
vapor
pressure
is
different
(
0.20
mm
Hg
at
20
o
C)
from
alpha/
beta
pinenes
or
alpha
terpineol,
(
4.93
and
2.98
for
alpha/
beta
pinenes
vs
4.2
x
10­
2
mm
Hg
for
alpha
terpineol).
Alpha/
beta
pinenes
and
alpha
terpineol
as
separate
entities
do
not
show
any
major
environmental
concerns,
and
the
Agency
at
this
time
has
determined
that
pine
oil
is
not
likely
to
have
any
major
environmental
concerns.

B.
Environmental
Exposure
Assessment
DRAFT
6
Environmental
exposure
modeling
was
not
conducted
for
the
indoor
uses
of
pine
oil
considered
in
this
RED.
Environmental
exposure
is
not
expected
to
occur
when
registered
products
are
used
according
to
label
directions.

C.
Environmental
Risk
Assessment
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
addressed
due
to
a
lack
of
phytotoxicity
data;
however,
exposure
to
plants
is
unlikely
from
the
indoor
uses
of
this
chemical.

D.
Endangered
Species
Considerations
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,
mammlas,
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.
DRAFT
7
REFERENCES
Campbell,
S.
M.
and
J.
B.
Beavers.
1994.
Pine
oil:
Acute
oral
toxicity
study
with
the
Northern
Bobwhite.
August
31,
1994.
Wildlife
International
Ltd.,
Laboratory
Report
ID:
274­
104.
MRID
No.
433752­
01.

Campbell,
S.
M.
and
J.
B.
Beavers.
1994.
Pine
oil:
Acute
oral
toxicity
with
the
Mallard.
August
31,
1994.
Wildlife
International
Ltd.,
Laboratory
Report
ID:
274­
105.
MRID
No.
433752­
02.

Campbell,
S.
M.
and
J.
B.
Beavers.
1994.
Pine
oil:
Dietary
LC50
study
with
the
Mallard.
August
31,
1994.
Wildlife
International
Ltd.,
Laboratory
Report
ID:
274­
103.
MRID
No.
433752­
04.

Graves,
W.
C.
and
J.
P.
Swigert.
1994.
Pine
oil:
Ninety­
six
hour
flow­
through
acute
toxicity
test
with
the
Bluegill
(
Lepomis
macrochirus).
August
19,
1994.
Wildlife
International
Ltd.,
Laboratory
Report
ID:
274A­
101.
MRID
No.
433752­
05.

Graves,
W.
C.
and
J.
P.
Swigert.
1994.
Pine
oil:
Ninety­
six
hour
flow­
through
acute
toxicity
test
with
the
Rainbow
Trout
(
Oncorhynchus
mykiss).
August
19,
1994.
Wildlife
International,
Laboratory
Report
ID:
274A­
102.
MRID
No.
433752­
06.

Graves,
W.
C.
and
J.
P.
Swigert.
1994.
Pine
oil:
Forty­
eight
(
48)
hour
flow­
through
acute
toxicity
test
with
the
Cladoceran
(
Daphnia
magna).
August
19,
1994.
Wildlife
International,
Laboratory
Report
ID:
274A­
103.
MRID
No.
433752­
07.

U.
S.
Environmental
Protection
Agency
(
EPA).
2002.
ECOTOX
User
Guide:
ECOTOXicology
Database
System.
Version
3.0.
Available:
http://
www.
epa.
gov/
ecotox/