Reregistration
Eligibility
Decision
Exposure
and
Risk
Assessment
on
Lower
Risk
Pesticide
Chemicals
CASE:
Aliphatic
Solvents
(
3004)

Active
Ingredients:
Mineral
Oils
(
063502)
&
Aliphatic
Petroleum
Hydrocarbons
(
063503)

Special
Review
and
Reregistration
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
One
Potomac
Yard,
2777
Crystal
Drive
Arlington,
VA
22202
2
Interim
Reregistration
Eligibility
Decision
(
IRED)
Document
for
Aliphatic
Solvents
(
Mineral
Oil
and
Aliphatic
Petroleum
Hydrocarbons)

Approved
by:
____________________
Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Date:
____________________
3
Table
of
Contents
Background:
         ..    ...   ..    .  .   ..
4
I.
Executive
Summary:
      .       ..   .   .   
4
II.
Use
Information:
               ..   . .  ... ..
7
III.
Physical/
Chemical
Properties:
           .. .  ...  .
12
IV.
Hazard
Assessment:
        .. ..  ..  ..    .  ...
14
V.
Exposure
Assessment:
                   . . 
17
VI.
Dietary
(
Food)
Exposure:
         .. ..      . . .
18
VII.
Drinking
Water
Exposure:
           .  ..  ... . .
18
VII.
Aggregate
Exposure
Assessment:
         ..      ...
19
IX.
Cumulative
Exposure:
          ..       .. . ...
20
X.
Environmental
Fate/
Ecotoxicity/
Environmental
Risk
Assessment:
 ......
20
X.
I.
Environmental
Fate
and
Transport:
      .. .... .. ..
20
X.
II.
Ecological
Effects
Toxicity
Data:
        .. ....... .
20
X.
III.
Estimated
Environmental
Concentrations:
       . 
24
X.
IV.
Ecological
Risk
Assessment:
        ..   ...  
27
XI.
Mosquito
Larvicide/
Pupacide
Uses:
       ......    ............
30
XII.
Labeling
for
Aliphatic
Solvents
Products:
          .  ..
32
XIII.
Tolerance
Reassessment:
               .. ...  
32
XIV.
References:
                 ..    . ..  
33
Appendix
A.
SLUA
        ..           ..  . ...
36
Appendix
B.
Health
Effects
      ..           .. . ..
40
Appendix
C.
Detailed
Information
on
Use
Rates
for
Aliphatic
Solvents
  .....
53
4
Background:

This
document
represents
the
Reregistration
Eligibility
Decision
(
RED)
document
for
aliphatic
solvents.
The
Aliphatic
Solvents
Case
(
3004)
includes
two
closely
related
chemicals,
the
mineral
oils
and
aliphatic
petroleum
hydrocarbons,
which
are
products
of
various
types
of
petroleum
distillation
processes,
and
thus,
represented
by
several
different
CAS
Numbers.
This
assessment
summarizes
available
information
on
the
uses,
physical
and
chemical
properties,
toxicological
effects,
dietary
assessment,
and
the
environmental
fate
and
ecotoxicity
of
these
aliphatic
solvents.
These
chemicals
have
insecticide
and/
or
larvicide
uses
as
spray
oils
on
agricultural
crops
and
by
residential
homeowners,
as
well
as
occupational
and
residential
uses
as
acaricides,
fungicides,
herbicides,
and
virucides,
in
addition
to
aquatic
uses
as
mosquito
larvicides/
pupacides.
There
are
also
inert
ingredient
uses
for
many
of
these
same
CAS
Number
chemicals;
the
exemption
from
the
requirement
for
a
tolerance
for
the
inert
ingredient
uses
of
Mineral
Oil
has
already
been
reassessed
during
2005,
and
the
exemptions
from
the
requirement
for
tolerances
for
the
inert
ingredient
uses
of
most
of
the
other
chemicals
in
this
RED
are
being
reassessed
in
a
separate
document.

I.
Executive
Summary:

The
Aliphatic
Solvents
(
Case
3004)
includes
both
mineral
oil
(
OPP
Chemical
Code
063502)
and
aliphatic
petroleum
hydrocarbons
(
063503).
Twelve
chemicals
(
individual
CAS
Numbers)
are
covered
in
this
group.

These
aliphatic
solvents
are
the
product
of
petroleum
distillations
processes,
and
thus,
they
are
complex
mixtures
of
long­
chain
aliphatic
(
paraffinic)
compounds.
They
are
formulated
as
liquid
concentrates
for
use
as
insecticides
and/
or
larvicides
on
crops,
animal
premises,
commercial/
industrial
premises,
medical
premises,
aquatic
areas,
and
residential
premises,
as
well
as
occupational
and
residential
uses
as
acaricides,
fungicides,
herbicides,
and
virucides
(
for
plant
pathogens).
The
aquatic
area
applications
are
for
usage
as
a
mosquito
larvicide/
pupacide.
Application
equipment
includes
the
following:
for
agricultural
crops,
by
airplane,
groundboom
sprayer,
airblast
sprayer,
handgun
sprayer,
low­
pressure
handwand
sprayer,
and/
or
high­
pressure
handwand
sprayer;
for
use
at
commercial/
industrial
sites,
by
low­
pressure
handwand
sprayer,
handgun
sprayer,
airplane,
truck­
mounted
ULV
sprayer,
airblast
sprayer,
rights­
of­
way
sprayer,
and/
or
high
pressure
handwand
sprayer;
and
for
residential
settings,
by
hose­
end
sprayer,
low
pressure
handwand
sprayer,
and
trigger­
pump
sprayer.
For
the
aliphatic
petroleum
hydrocarbons,
several
end­
use
products
allow
for
application
to
agricultural
crops
via
chemigation,
and
some
products
can
be
applied
via
dip
to
ornamental
nursery
stock,
pineapples,
and
citrus.

These
chemicals
have
a
low
degree
of
acute
toxicity.
For
example,
there
was
no
mortality
in
rats
at
acute
oral
doses
of
28,000
mg/
kg
body
weight,
and
only
slight
eye
irritation
in
rats
and
rabbits.
Based
on
subchronic
and
chronic
toxicity,
these
chemicals
are
virtually
non­
toxic
by
the
oral
or
dermal
route,
and
they
have
limited
toxicity
via
the
inhalation
route,
caused
by
their
physical
properties
(
i.
e.,
the
observed
effects
are
not
due
5
to
chemical
toxicity,
but
due
to
irritating
effects,
such
as
interstitial
inflammation
and
alveolar
histiocytosis,
related
to
the
body's
defense
mechanism
against
the
exposure
to
a
foreign
material,
when
the
aliphatic
oils
enter
the
lungs).

There
is
a
short­
term
dermal
NOAEL
of
2000
mg/
kg/
day,
from
a
28­
day
dermal
toxicity
study.
However,
this
is
a
very
conservative
estimate
of
dermal
exposures,
because
it
is
based
on
a
study
in
which
no
effects
were
seen
even
at
the
highest
test
concentration
(
2000
mg/
kg/
day).
The
actual
NOAEL
could
potentially
be
much
higher,
with
possibly
virtually
no
adverse
effects
at
any
dose
at
which
these
oils
might
be
applied
to
the
skin.

There
is
a
short­
term
inhalation
LOAEL
of
146.64
mg/
kg/
day,
based
on
a
28­
day
inhalation
study,
in
which
effects
were
observed,
even
at
the
lowest
inhalation
dose
tested,
0.52
mg/
L,
including
the
following:
(
1)
various
effects
in
the
lungs,
(
2)
increased
white
blood
cell
counts
in
males,
(
3)
increased
absolute
liver
weight,
(
4)
accessory
spleens
and/
or
abnormally
colored
spleens,
and
(
5)
additional
microscopic
findings.
There
is
also
an
intermediate­
term
inhalation
NOAEL
of
26.1
mg/
kg/
day,
derived
from
a
90­
day
inhalation
study,
based
on
effects
observed
at
0.9
mg/
L,
with
no
adverse
effects
observed
at
0.1
mg/
L.

An
HED
memo
by
OREB
(
USEPA
1995a)
determined
that
"
because
toxicity
is
very
low
(
the
FDA
has
recommended
mineral
oil
for
GRAS
status),
dermal
exposure
does
not
warrant
an
exposure
study
at
this
time
for
reregistration."
In
the
same
memo,
it
also
was
stated
that
"
OREB
does
not
require
an
inhalation
exposure
study
for
reregistration
at
this
time,"
and
the
"
OREB
does
not
require
a
mixer/
loader/
applicator
exposure
study
for
reregistration."
Consequently,
this
RED
does
not
present
any
assessment
for
the
potential
occupational
or
residential
handler
dermal
or
inhalation
exposures,
nor
any
assessment
for
any
occupational
or
residential
postapplication
exposures.
Instead
the
Agency
has
qualitatively
assessed
these
exposures,
and
has
determined
that
risks
are
not
of
concern.

The
overall
dietary
exposure,
and
the
drinking
water
(
only)
dietary
exposure,
have
also
each
been
qualitatively
assessed,
based
on
the
absence
of
acute
and
chronic
oral
effects
from
exposures
to
mineral
oils
and
aliphatic
petroleum
hydrocarbons.
These
dietary
exposures
are
not
of
concern
to
the
Agency,
nor
does
the
Agency
have
concerns
for
the
aggregate
exposures
to
these
chemicals.

The
environmental
fate
assessment
of
these
chemicals
indicates
they
have
low
to
very
low
vapor
pressures,
very
low
solubility
in
water,
high
octanol­
water
partition
coefficients,
and
high
sorption
to
organic
matter.
Thus,
these
chemicals
will
exhibit
very
poor
migration,
due
to
their
high
sorption,
and
low
solubility
in
water,
as
well
as
low
potential
for
volatility.
Fugacity
modeling
suggests
they
would
remain
partitioned
to
the
terrestrial
phase,
remaining
sorbed
to
soil
or
the
foliar
surfaces
to
which
they
are
applied.

The
ecological
toxicity
assessment
of
these
chemicals
indicates
they
have
virtually
no
toxic
effects
to
mammals
or
birds
(
however,
there
is
potential
for
impairing
the
hatching
of
bird
eggs,
if
the
spray
oils
are
applied
directly
to
the
eggs
in
the
nests).
These
chemicals
are
also
virtually
non­
toxic
to
honey
bees,
based
on
the
results
from
contact
6
toxicity
testing.
Testing
of
phytotoxic
effects
have
not
been
submitted
to
the
Agency,
but
very
high
levels
of
materials
are
applied
to
many
different
types
of
plants,
without
effects
reported
by
applicators
or
growers,
so
the
Agency
does
not
have
concerns
for
phytotoxicity,
other
than
warnings
which
appear
on
a
few
of
the
labels
among
the
many
currently
formulated
products.
(
Evidence
is
available
that
most
registrants
have
been
moving
to
cleaner
technical
grade
formulations,
with
lower
amounts
of
polynuclear
aromatic
hydrocarbons
(
PAHs),
those
components
of
the
spray
oils
which
had
historically
been
thought
to
contribute
to
phytotoxicity).
The
results
of
toxicity
testing
with
fish,
both
estuarine/
marine
and
freshwater
species,
have
shown
virtually
no
toxic
effects,
and
there
were
no
toxic
effects
in
testing
with
estuarine/
marine
mysid
shrimp.
There
is
a
study
showing
adverse
effects
on
oyster
shell
deposition
(
EC50
=
6
mg/
L),
but
this
might
be
due
to
the
mineral
oils
coating
the
surfaces
of
the
food
sources
for
the
oysters,
impairing
their
ability
to
digest
their
food.
Studies
with
daphnia
have
shown
effects,
even
at
very
low
exposure
concentrations,
but
many
of
the
studies
submitted
to
the
Agency
had
been
conducted
with
products
no
longer
produced
as
registered
products.
In
the
most
recently
submitted
study
with
daphnia,
the
effects
observed
included
immobilization
in
the
water
column
and/
or
floating
on
the
surface,
but
visual
observations
with
a
microscope
revealed
the
daphnia
hearts
were
still
beating.
Thus,
while
immobilization
and
floating
effects
were
observed
even
at
the
lowest
test
concentration
(
EC50
=
<
0.9
mg/
L),
the
study
reported
that
"
the
test
compound,
VHVI­
4,
was
not
lethal
to
Daphnia
magna
at
the
highest
test
concentration
(
14
mg/
L)
after
48
hours
exposure."

Three
of
the
products
are
also
registered
solely
as
mosquito
larvicides/
pupacides,
acting
as
surface
film
agents.
Information
has
been
received
from
the
US
Centers
for
Disease
Control
and
Prevention
(
CDC)
that
these
products
have
important
public
health
benefits,
compared
with
the
various
other
mosquito
larvicides,
because
these
products
are
among
the
only
pupacides,
and
"
surface
films
provide
a
valuable
option
to
an
integrated
mosquito
control
program."
In
addition,
information
was
presented
by
CDC
that
"
surface
film
larvicides
generally
have
a
shorter
environmental
persistence
(
approx.
2­
3
days)
than
most
chemical
larvicide
alternatives."
The
transient
nature
of
these
surface
films
may
have
a
mitigating
effect
on
the
potential
adverse
impacts
upon
daphnia
observed
above.

The
overall
Ecological
Risk
Assessment
for
these
mineral
oils
and
aliphatic
petroleum
hydrocarbons
indicates
essentially
no
concerns
for
terrestrial
effects
(
other
than
the
potential
for
adverse
effects
on
bird
egg­
hatching,
if
spray
oils
are
applied
directly
to
the
nests).
In
addition,
there
were
no
effects
on
most
aquatic
organisms,
including
fish
(
both
freshwater
and
marine)
and
water­
column
marine/
estuarine
invertebrates
(
mysid
shrimp);
however,
some
impacts
were
noted
in
an
oyster
shell
deposition
study,
and
there
is
a
potential
for
adverse
effects
in
daphnids,
including
immobilization
and
floating
of
the
daphnia,
in
the
transient
surface
films
which
might
result
from
the
applications
of
these
end­
use
products,
including
off­
site
drift
from
airblast
applications
to
orchards
(
the
EFED
Memo
stated
that
"
9.7%
of
the
total
amount
of
a
product
applied"
is
assumed
to
drift
offsite
The
Agency
is
proposing
to
mitigate
these
potential
adverse
impacts
on
aquatic
invertebrates,
effects
which
might
be
caused
by
off­
site
spray
drift,
by
placing
spray
drift
language
on
the
revised
labels
to
be
submitted
as
part
of
the
reregistration
process.
7
II.
Use
Information:

The
Aliphatic
Solvents
(
Case
3004)
include
both
"
Mineral
Oil
 
includes
paraffin
oil
from
063503"
(
OPP
Chemical
Code
063502)
and
"
Aliphatic
Petroleum
Hydrocarbons"
(
OPP
Chemical
Code
063503).
In
addition,
according
to
the
"
Status
of
Pesticides
in
Registration,
Reregistration,
and
Special
Review"
(
Spring
1998),
commonly
called
the
Rainbow
Report,
the
Case
also
includes
Kerosene
(
063501),
Mineral
Spirits
(
063506),
and
Isoparaffinic
Hydrocarbons
(
505200),
although
each
of
which
are
each
listed
in
the
Rainbow
Report
as
"
cancelled."

Note,
however,
that
OPPIN
Query
does
list
some
products
in
the
Kerosene
OPP
Chemical
Code;
however,
some
of
these
products
contain
kerosene
only
as
an
inert
ingredient,
according
to
their
Confidential
Statements
of
Formula
(
CSFs).
Based
on
their
respective
CSFs,
each
of
the
other
products
in
OPPIN
Query
within
the
Kerosene
Chemical
Code
are
end­
use
products
which
are
be
formulated
with
various
Technical
Grade
Active
Ingredients
(
TGAIs)
from
each
of
the
other
two
supported
OPP
Chemical
Codes,
063502
and
063503,
but
none
of
these
end­
use
products
actually
contains
Kerosene
as
the
active
ingredient.
Thus,
while
these
products
are
clearly
misclassified
within
OPPIN
Query
as
"
Kerosene",
this
information
also
suggests
that
the
various
TGAIs
within
each
of
these
supported
OPP
Chemical
Codes
have
very
similar
chemical
characteristics,
especially
considering
that
these
end­
use
product
registrants
are
able
to
utilize
these
"
Mineral
Oil"
and
"
Aliphatic
Petroleum
Hydrocarbon"
TGAIs
interchangeably
on
their
respective
CSFs.

There
are
currently
about
165
products
listed
in
OPPIN
within
OPP
Chemical
Codes
covered
in
this
Case
(
063501,
063502
[
and
063503]).
Based
on
a
thorough
search
of
the
CSFs
for
the
165
products
(
a
total
of
about
225
CSFs,
accounting
for
both
Basic
and
Alternate
formulations),
there
are
twelve
different
CAS
Numbers
included
in
this
Case
(
Table
1).
Each
of
these
CAS
Numbers
is
listed
on
one
or
more
of
the
CSFs
for
one
or
more
of
the
TGAIs
within
this
Case.
Some
of
these
CAS
Numbers
have
very
similar
components,
because
different
CAS
Numbers
may
represent
petroleum
distillates
which
are
very
closely
related
to
each
other,
since
the
assigning
of
CAS
Numbers
for
petroleum
distillation
products
(
by
the
Chemical
Abstract
Service
(
CAS)
of
the
American
Chemical
Society)
is
based
on
the
last
step
in
the
refining
process.
Thus,
virtually
identical
distillation
products,
produced
via
alternative
refining
pathways,
will
have
different
CAS
Numbers,
although
being
essentially
identical
"
oils."
The
materials
represented
by
these
CAS
Numbers
also
have
other
uses,
in
addition
being
pesticide
active
ingredients
and
as
pesticidal
inert
ingredients,
including
as
various
other
types
of
oil­
based
products;
for
example,
all
these
CAS
Numbers
(
except
for
the
mineral
oils)
are
in
the
High
Production
Volume
(
HPV)
data
set
submitted
under
the
name
Lubricating
Oil
Basestocks
Category).

Table
1.
Description
of
Chemicals
included
in
the
Aliphatic
Solvents
Case
Chemical
Name
CAS
number
Description
Mineral
oil;
Oil
mist
(
mineral)
8012­
95­
1
Liquid
hydrocarbons
from
petroleum.
8
Table
1.
Description
of
Chemicals
included
in
the
Aliphatic
Solvents
Case
Chemical
Name
CAS
number
Description
Mineral
oil;
Hydrocarbon
oils;
paraffin
liquid
8020­
83­
5
A
mixture
of
liquid
hydrocarbons
obtained
from
petroleum.

White
mineral
oil,
petroleum
8042­
47­
5
A
highly
refined
petroleum
mineral
oil
consisting
of
a
complex
combination
of
hydrocarbons
obtained
from
the
intensive
treatment
of
a
petroleum
fraction
with
sulphuric
acid
and
oleum,
or
by
hydrogenation,
or
by
a
combination
of
hydrogenation
and
acid
treatment.
Additional
washing
and
treating
steps
may
be
included
in
the
processing
operation.
It
consists
of
saturated
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C50.

Lubricating
oils,
petroleum
C15­
30,
hydrotreated
neutral
oil
based,
containing.
solvent
deasphalted
residual
oil
72623­
84­
8
A
complex
combination
of
hydrocarbons
obtained
by
treating
light
vacuum
gas
oil,
heavy
vacuum
gas
oil,
and
solvent
deasphalted
residual
oil
with
hydrogen
in
the
presence
of
a
catalyst
in
a
two
stage
process
with
dewaxing
being
carried
out
between
the
two
stages.
It
consists
predominantly
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C30
and
produces
a
finished
oil
having
a
viscosity
of
approximately
10cSt
at
40.
degree.
C
(
104.
degree.
F).
It
contains
a
relatively
large
proportion
of
saturated
hydrocarbons.

Lubricating
oils,
petroleum,
C15­
30,
hydrotreated
neutral
oilbased
72623­
86­
0
A
complex
combination
of
hydrocarbons
obtained
by
treating
light
vacuum
gas
oil
and
heavy
vacuum
gas
oil
with
hydrogen
in
the
presence
of
a
catalyst
in
a
two
stage
process
and
dewaxing
being
carried
out
between
the
two
stages.
It
consists
predominantly
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C30
and
produces
a
finished
oil
having
a
viscosity
of
approximately
15cSt
at
40
°
C.
It
contains
a
relatively
large
proportion
of
saturated
hydrocarbons.

Lubricating
oils,
petroleum,
C20­
50,
hydrotreated
neutral
oilbased
72623­
87­
1
A
complex
combination
of
hydrocarbons
obtained
by
treating
light
vacuum
gas
oil,
heavy
vacuum
gas
oil
and
solvent
deasphalted
residual
oil
with
hydrogen
in
the
presence
of
a
catalyst
in
a
two
stage
process
with
dewaxing
being
carried
out
between
the
two
stages.
It
consists
predominantly
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C20
through
C50
and
produces
a
finished
oil
with
a
viscosity
of
approximately
32cSt
at
40
°
C.
It
contains
a
relatively
large
proportion
of
saturated
hydrocarbons.

Distillates,
petroleum,
solvent­
refined
heavy
paraffinic
64741­
88­
4
A
complex
combination
of
hydrocarbons
obtained
as
the
raffinate
from
a
solvent
extraction
process.
It
consists
predominantly
of
saturated
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C20
through
C50
and
produces
a
finished
oil
with
a
viscosity
of
at
least
100
SUS
at
100
°
F
(
19cSt
at
40
°
C).

Distillates,
petroleum,
solvent­
refined
light
paraffinic
64741­
89­
5
A
complex
combination
of
hydrocarbons
obtained
as
the
raffinate
from
a
solvent
extraction
process.
It
consists
predominantly
of
saturated
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C30
and
produces
a
finished
oil
with
a
viscosity
of
less
than
100
SUS
at
100
°
F
(
19cSt
at
40
°
C).

Distillates,
petroleum,
hydrotreated
heavy
paraffinic
64742­
54­
7
A
complex
combination
of
hydrocarbons
obtained
by
treating
a
petroleum
fraction
with
hydrogen
in
the
presence
of
a
catalyst.
It
consists
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C20
through
C50
and
produces
a
finished
oil
of
at
least
100
SUS
at
100
°
F
(
19cSt
at
40
°
C).
It
contains
a
relatively
large
proportion
of
saturated
hydrocarbons.

Distillates,
petroleum,
hydrotreated
light
paraffinic
64742­
55­
8
A
complex
combination
of
hydrocarbons
obtained
by
treating
a
petroleum
fraction
with
hydrogen
in
the
presence
of
a
catalyst.
It
consists
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C30
and
produces
a
finished
oil
with
a
viscosity
of
less
than
100
SUS
at
100
°
F
(
19cSt
at
40
°
C).
It
contains
a
relatively
large
proportion
of
saturated
hydrocarbons.

Distillates,
petroleum,
solvent­
dewaxed
light
paraffinic
64742­
56­
9
A
complex
combination
of
hydrocarbons
obtained
by
removal
of
normal
paraffins
from
a
petroleum
fraction
by
solvent
crystallization.
It
consists
predominantly
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C15
through
C30
and
produces
a
finished
oil
with
a
viscosity
of
less
than
100
SUS
at
100
°
F
(
19cSt
at
40
°
C).

Distillates,
petroleum,
solvent­
dewaxed
heavy
paraffinic
64742­
65­
0
A
complex
combination
of
hydrocarbons
obtained
by
removal
of
normal
paraffins
from
a
petroleum
fraction
by
solvent
crystallization.
It
consists
predominantly
of
hydrocarbons
having
carbon
numbers
predominantly
in
the
range
of
C20
through
C50
and
produces
a
finished
oil
with
a
viscosity
not
less
than
100
SUS
at
100.
degree.
F
(
19cSt
at
40.
degree.
C).
9
Based
on
this
review
of
the
approximately
225
CSFs,
it
was
observed
that
most
of
these
CSFs
have
been
recently
submitted
(
within
the
last
10
years
or
so),
even
for
products
with
a
long
history
of
registration.
Discussions
at
the
SMART
Meeting
indicated
that
many
registrants
have
been
converting
their
processes
to
produce
TGAIs
and
to
formulate
end­
use
products
which
have
lower
amounts
of
undesirable
components
(
i.
e.,
with
lower
amounts
of
sulfur­
and
nitrogen­
containing
groups,
and
with
fewer
side­
chains
containing
polynuclear
aromatic
hydrocarbons).
These
polyaromatic
hydrocarbons
have
been
found
to
be
the
source
of
some
phytotoxicity,
formerly
causing
concerns
among
growers
using
these
spray
oil
products.
(
Some
of
the
newer
CSFs
continue
to
show
aliphatic
petroleum
distillates
with
some
side­
chains
containing
naphtha­
groups
[
cyclic
saturated
rings,
as
opposed
to
unsaturated
aromatic
rings],
because
it
has
been
reported
by
some
registrants
that
small
amounts
of
naphtha­
containing
side­
chains
are
necessary
for
pourability;
thus,
with
no
naphtha­
containing
groups
within
these
aliphatic
materials,
the
petroleum
distillates
would
have
poor
pourability,
and
would
be
classified
as
"
waxes".)

These
aliphatic
solvents
are
formulated
as
liquid
concentrates,
with
each
TGAI
being
listed
on
the
respective
CSF
as
100%
active
ingredient,
with
no
impurities
(
Table
2).
These
TGAIs
are
then
formulated
into
end­
use
products
(
often
only
with
an
emulsifier),
usually
with
the
active
ingredient
at
97%
or
greater,
for
use
as
insecticides
and/
or
larvicides
on
crops,
animal
premises,
commercial/
industrial
premises,
medical
premises,
aquatic
areas,
and
residential
premises.
In
addition,
there
are
three
products
specifically
registered
as
mosquito
larvicides/
pupacides,
thus
there
is
direct
application
to
water
bodies.
For
the
various
OPP
Chemical
Codes,
the
number
of
total
products
(
TGAIs,
Manufacturing
Use
Products
(
MUPs),
and
end­
use
products)
are
as
follows:
Chemical
Code
063502
(
Mineral
Oil),
130
total
products;
Chemical
Code
063503
(
Aliphatic
Petroleum
Hydrocarbon),
30
total
products;
and
as
indicated
above,
5
total
products
in
Chemical
Code
063501
(
Kerosene).

Table
2.
Information
on
TGAIs
Within
Each
OPP
Chemical
Code
Chem
Code
Number
Name
Number
of
TGAIs
CAS
Numbers
Represented
on
the
Various
CSFs
within
each
Chemical
Code
063501
Kerosene
None
(
See
text
for
explanation
of
this
Chemical
Code.)
063502
Mineral
Oil
10
(
including
1
MUP)
64742­
55­
8
64742­
56­
9
64742­
65­
0
72623­
84­
8
72623­
86­
0
72623­
87­
1
8012­
95­
1
8042­
47­
5
063503
Aliphatic
Petroleum
Hydrocarbon
16
(
including
4
MUPs)
64741­
88­
4
64741­
89­
5
64742­
54­
7
64742­
55­
8
72623­
84­
81
8002­
05­
9
8020­
83­
5
1
When
revised
CSFs
are
submitted
during
reregistration,
it
is
likely
that
CAS
Numbers
72623­
86­
0
and
72623­
87­
1
will
also
be
included,
because
these
newer
CAS
Nos.
are
not
currently
listed
on
the
older
CSFs
from
one
registrant,
but
those
CAS
Nos.
are
listed
on
the
CSFs
for
the
TGAIs
from
which
these
products
are
formulated.
10
Based
on
the
information
in
Table
2,
many
of
the
CAS
Numbers
are
listed
on
the
CSFs
for
the
various
TGAIs
within
both
of
the
two
different
Chemical
Codes;
thus,
there
is
overlap.
In
fact,
one
company
has
four
TGAIs,
all
within
063502,
while
all
five
of
their
end­
use
products
(
formulated
from
only
those
four
TGAIs)
are
within
the
other
Chemical
Code,
063503.
Plus,
as
described
in
the
section
above,
the
end­
use
products
within
063501
(
Kerosene)
do
not
contain
kerosene
as
an
active
ingredient,
but
each
product
is
formulated
with
TGAIs
from
both
of
the
other
two
OPP
Chemical
Codes.
Consequently,
as
part
of
this
Reregistration
Eligibility
Decision,
the
Agency
is
planning
to
place
all
these
products
within
the
"
Aliphatic
Solvents"
Case
into
a
single
OPP
Chemical
Code
(
possibly
in
a
new
Chemical
Code,
063500,
currently
an
unused,
unassigned
number
designation
for
an
OPP
Chemical
Code,
and
actually
the
number
at
the
lower
end
of
the
series
for
most
of
these
"
aliphatic
solvents"
products).

These
aliphatic
solvents
containing
products
are
formulated
as
liquid
concentrates.
The
application
equipment
includes
airplane,
groundboom
sprayer,
airblast
sprayer,
handgun
sprayer,
low­
pressure
handwand
sprayer,
and/
or
high­
pressure
handwand
sprayer
for
applications
to
agricultural
crops;
for
commercial/
industrial
sites,
application
equipment
includes
low­
pressure
handwand
sprayer,
handgun
sprayer,
airplane,
truck­
mounted
ULV
sprayer,
airblast
sprayer,
rights­
of­
way
sprayer,
and/
or
high
pressure
handwand
sprayer.
In
residential
settings,
typical
application
equipment
includes
hose­
end
sprayer,
low
pressure
handwand
sprayer,
and
trigger­
pump
sprayer.
For
petroleum
hydrocarbons,
several
products
have
product
labels
which
allow
for
application
to
agricultural
crops
via
chemigation.
In
addition,
some
products
can
be
applied
via
dip
to
ornamental
nursery
stock,
pineapples,
and
citrus.
The
three
currently
registered
mosquito
larvicide/
pupacide
products
are
applied
by
ground
equipment,
with
one
product
also
having
a
label
listing
aerial
applications.

Appendix
C
contains
more
detailed
information
on
the
crops/
use
sites,
application
equipment,
timing
of
application,
maximum
application
rate,
and
re­
entry
interval
(
if
applicable).
These
data
were
derived
by
the
Biological
and
Economic
Assessment
Division
(
BEAD)
in
the
EFED
spreadsheets
(
for
the
Environmental
Fate
and
Effects
Division).
In
some
cases,
the
entries
in
the
EFED
table
did
not
provide
pounds
active
ingredient
per
gallon
for
the
mineral
oils
or
the
aliphatic
petroleum
hydrocarbons.
A
review
of
the
physical/
chemical
characteristics
obtained
through
a
literature
search
provided
a
range
of
densities
for
both
chemicals.
As
a
default,
the
highest
density
found
for
each
chemical
(
7.7
lb
ai/
gal
for
mineral
oil,
and
8.0
lb
ai/
gal
for
aliphatic
petroleum
hydrocarbons,
respectively)
was
used
as
an
estimate
for
adjusting
the
application
rates
for
the
respective
active
ingredient,
when
necessary.

The
information
presented
in
Appendix
C
indicates
many
different
types
of
application
methods
and
many
different
use
sites
for
these
Mineral
Oil
and
Aliphatic
Petroleum
Hydrocarbon
products.
According
to
the
BEAD
Screening
Level
Usage
Assessment
(
SLUA),
there
may
be
as
much
as
75
million
pounds
of
these
products
used
in
the
United
States
annually.
(
See
Appendix
A
for
additional
details
concerning
the
BEAD
SLUA.)
11
Mineral
oil
(
8012­
95­
1)
has
recently
been
designated
by
the
US
Food
and
Drug
Administration
(
U.
S.
FDA)
as
Generally
Recognized
as
Safe
(
GRAS);
the
specific
usage
which
is
GRAS
is
as
a
release
agent
sprayed
on
potato
processing
equipment,
resulting
in
a
presence
on
food
of
no
more
than
5
ppm
(
GRAS
Notice
No.
GRN
00071;
April
21,
2001).
In
addition,
there
are
many
other
uses
for
Mineral
Oil
listed
in
USFDA
website,
Everything
Added
to
Food
in
the
United
States
(
EAFUS),
under
their
FDA
regulations
pertaining
to
food
additives,
especially
21CFR
172.878,
specifically
describing
the
uses
of
"
White
Mineral
Oil",
but
there
are
many
other
listings
identified
in
EAFUS,
including
listings
as
food
additives
for
direct
addition
(
172.842),
as
well
as
for
secondary
additives
(
173.340),
various
indirect
additives
(
175.105,
175.210,
175.230,
175.300,
176.170,
177.1200,
177.2260,
177.2600,
177.2800,
178.2010,
178.3570,
178.3620,
178.3740,
178.3910),
and
food
additives
permitted
in
feed
and
drinking
water
of
animals
(
573.680).
The
citations
in
EAFUS
specifically
refer
to
"
Mineral
oil,
white"
CAS
No.
8012­
95­
1,
and
not
any
of
the
other
mineral
oil
CAS
Numbers;
in
addition,
a
search
by
CAS
Number
of
EAFUS
indicates
there
are
no
listings
for
any
of
the
other
chemicals
in
this
RED,
the
aliphatic
petroleum
hydrocarbons.

The
tolerance
exemptions
being
reassessed
in
this
RED,
with
the
respective
citation
in
the
Code
of
Federal
Regulations
(
CFR)
and
use
pattern
as
an
active
ingredient,
are
listed
in
Table
3.
Table
3
also
includes
the
inert
ingredient
uses
of
these
chemicals.
The
exemptions
from
the
requirement
of
a
tolerance
for
the
inert
ingredient
uses
of
Mineral
Oils
(
180.910
and
180.930)
have
already
previously
been
reassessed,
in
a
document
dated
December
30,
2005,
while
the
other
petroleum
hydrocarbon
exemptions
as
inert
ingredients
are
currently
undergoing
reassessment,
within
the
Registration
Division,
with
a
completion
date
on
or
before
August
3,
2006.

Table
3.
Tolerances
and
Exemptions
Being
Reassessed
for
the
Aliphatic
Solvents
Tolerance
Expression;
and
Specific
Tolerance
40
CFR
PC
Code
Use
Pattern
Active
Ingredient
"
Corn,
grain,
post­
harvest":
200
ppm
Mineral
oil
"
Sorghum,
grain,
grain,
postharvest":
200
ppm
180.149
063502
Insecticide
Petroleum
oils
Exempt
from
the
requirement
for
a
tolerance
180.905
063502
/
063503
Pesticide
"
Inert
(
or
occasionally
active)
Ingredient"

"
Mineral
oil,
U.
S.
P.,
or
conforming
to
21
CFR
172.878
or
178.3620(
a)
(
CAS
Reg.
No.
8012­
95­
1)"
180.910
063502
Diluent,
carrier
and
solvent
"
Petroleum
hydrocarbons,
light
odorless
conforming
to
21
CFR
172.884"
180.910
063503
Solvent,
diluent
"
Petroleum
hydrocarbons,
synthetic
isoparaffinic,
conforming
to
21
CFR
172.882"
180.910
063503
Solvent,
diluent
"
Mineral
oil,
U.
S.
P.,
or
conforming
to
21
CFR
172.878
or
178.3620(
a)
(
b)"
180.930
063502
Solvent,
diluent
"
Petroleum
hydrocarbons,
light
odorless
conforming
to
21
CFR
172.884
or
178.3650"
180.930
063503
Solvent,
diluent
"
Petroleum
hydrocarbons,
synthetic
isoparaffinic,
conforming
to
21
CFR
172.882
or
178.3530"
180.930
063503
Solvent,
diluent
12
The
active
ingredient
use
listed
in
Table
3
for
180.149
predates
the
establishment
of
the
Environmental
Protection
Agency.
Spray
Oils
(
petroleum
oils)
have
been
utilized
for
insect
control
on
crops
and
trees
for
over
130
years,
while
the
post­
harvest
uses
on
corn
and
sorghum
to
combat
storage
insect
infestation
were
in
a
Tolerance
Petition
in
the
1950s.
BEAD
and
SRRD
conducted
a
review
of
the
EFED
spreadsheets
(
data
complied
based
on
the
existing
labels),
and
this
search
did
not
detect
any
Mineral
Oils
products
with
a
current
label
for
this
grain
storage
use,
as
listed
at
40
CFR
180.149;
thus,
as
part
of
the
RED
process,
SRRD
will
publish
a
notification
in
the
Federal
Register
proposing
to
cancel
this
use,
and
to
revoke
this
tolerance
at
40
CFR
180.149.

Some
of
the
maximum
application
rates
on
some
of
the
labels
are
very
high.
For
example,
for
one
suite
of
pests
on
citrus,
in
Florida,
Texas,
and
California,
various
labels
indicate
that
applications
may
be
made
at
up
to
4500
gallons
of
spray
mix
(
prepared
as
a
thorough
coverage
spray
mix
of
up
to
1.5
gallons
of
end­
use
product
in
100
gallons
of
water).
These
registrants
have
voluntarily
agreed
to
reduce
this
maximum
amount
applied
to
only
1500
gallons
in
Florida
and
Texas,
and
to
1800
gallons
in
California.
This
higher
rate
in
California
was
proposed
by
researchers
at
the
University
of
California,
Kearney
Ag
Center,
due
to
a
unique
citrus
pest
found
in
California;
this
feedback
resulted
from
the
Agency
requesting
that
USDA
seek
guidance
from
researchers,
growers,
and
other
stakeholders.

There
currently
are
few
labels
with
application
restrictions
on
the
number
of
applications
per
year,
or
the
timing
between
applications,
although
there
are
some
residential
products
for
homeowner
use
that
do
include
such
reapplication
restrictions.

III.
Physical/
Chemical
Properties:

Table
4
provides
physical/
chemical
properties
that
are
available
for
certain
aliphatic
solvents.
Information
was
not
found
for
all
CAS
Numbers
included
in
this
RED.

Based
on
the
data
in
Table
4,
as
well
as
various
estimates
derived
from
EPIWIN
and
other
models
for
developing
physical
and
chemical
properties
information
(
and
characterizations
for
the
CAS
Numbers
in
the
HPV
submission),
it
is
not
feasible
to
report
specific
data
for
each
property,
due
to
the
diversity
of
different
compounds
present
as
components
within
each
of
these
mineral
oils
and
aliphatic
petroleum
hydrocarbons.
However,
certain
patterns
are
evident
in
describing
these
oils.
The
melting
points
(
pour
point,
or
temperature
at
which
flow
characteristics
appear)
are
below
0
°
C.
The
actual
boiling
points
listed
are
a
reflection
that
they
are
mixtures
of
compounds,
dependent
on
the
types
and
order
of
distillation
and
refining
processes
employed,
with
constituent
hydrocarbons
of
these
oils
having
boiling
points
ranging
from
300
to
800
°
C.
Similarly,
their
vapor
pressures
exhibit
a
very
wider
range,
ranging
from
10­
4
Pa
to
10­
16
Pa
(
about
10­
3
to
10­
14
mm
Hg),
ranging
from
the
smaller
to
larger
constituents.
Their
octanolwater
partition
coefficients
are
high,
with
log
Kow
values
ranging
from
about
5
to
about
20,
from
the
smaller
chain­
length
to
the
larger
chain
length
molecules.
The
constituents
of
the
oils
are
also
very
poorly
water
soluble,
with
solubility
values
ranging
from
0.001
to
0.6
mg/
L,
being
least
soluble
for
the
larger
constituents.
13
Table
4.
Physical/
Chemical
Properties
of
the
Aliphatic
Solvents
CAS
No.
8012­
95­
1
8042­
47­
5
64742­
55­
8
64741­
97­
5
72623­
87­
1
72623­
84­
8
64742­
56­
9
64741­
88­
4
Various1
Appearance,

Physical
State,

Color
Oily,
colorless
Clear,
water
white
liquid
Bright,
clear,

straw
colored
Liquid
Clear
and
bright
neutral
Light
straw
White,
clear
liquid
Amber,
viscous
liquid
Viscous
liquid;

colourless
to
light
yellow
Odor
Odorless
Essentially
odorless
Mild
lube
oil
odor
­­
None
Hydrocarbon
odor
Hydrocarbon
Mild
or
faint;

petroleum
Odourless
or
mild
petroleum
oil
like
Solubility
in
water
Insoluble
Insoluble
Insoluble
­­
Negligible
Insoluble
Nil
Insoluble
Insoluble
Boiling
point
360oC
>
2600C
/
500oF
>
500oF
150­
600oC
600­
894
(
temperature
scale
not
provided)
0oF
560
 
760oF
150­
600oC
Not
available
Density/

Specific
Gravity
0.875­
0.905
<
1
0.86
~
0.84­
0.94
at
15oC
0.8493
0.875
0.86
~
0.84­
0.94
at
15oC
0.851
to
0.863
kg/
L
at
15oC
Vapor
density
­­
>
1
­­
­­
NA
NA
>
1
>
5
Not
available
Vapor
pressure
<
0.5
mmHg
@
20oC
­­
­­
­­
0.0225
mmHg
@

20oC
NA
<
1
mmHg
@
68oF
Negligible
at
ambient
temperature
and
pressure
1:
Various
CAS
#
s
are
listed,
as
follows:
8042­
47­
5,
64742­
46­
7,
64742­
52­
5,
64742­
54­
7,
72623­
84­
8,
72623­
85­
9,
72623­
86­
0,
72623­
87­
1,
178603­
64­
0,
178603­
65­
1,
178603­
66­
2,
445411­
73­
4
References:
8012­
95­
1:
HSDB,
2002
8042­
47­
5:
MSDS,
2002b
64742­
55­
8:
MSDS,
1994
64741­
97­
5:
ICSC,
2001a
72623­
87­
1:
MSDS,
2003a
72623­
84­
8:
MSDS,
2004
64742­
56­
9:
MSDS,
2003b
64741­
88­
4:
ICSC,
2001b;
MSDS,
2002a
14
IV.
Hazard
Assessment:

The
toxicity
data
available
for
various
chemicals
in
the
aliphatic
solvents
group
are
provided
in
Appendix
B.
These
data
were
obtained
from
the
MRIDs
submitted
by
registrants
and
EPA's
Health
Effects
Division
(
HED)
Toxicity
Data
Evaluation
Reviews
(
DERs)
of
these
MRIDs,
as
well
as
from
the
Registry
of
Toxic
Effects
of
Chemical
Substances
(
RTECS)
of
the
National
Institute
for
Occupational
Safety
and
Health,
and
from
High
Production
Volume
(
HPV)
Robust
Summaries,
various
Material
Safety
Data
Sheets
(
MSDSs),
and
the
open
literature.

Acute
toxicity
data
for
representative
chemical
constituents
are
provided
in
Table
5.
In
general,
these
mineral
oils
and
aliphatic
petroleum
hydrocarbons
exhibit
a
very
low
degree
of
acute
toxicity
in
mammalian
testing.

Table
5.
Summary
of
Representative
Acute
Toxicity
Data
for
the
Aliphatic
Solvents
(
Mineral
Oil
and
Aliphatic
Petroleum
Hydrocarbons)
(
See
Appendix
B
for
additional
data
and
further
details)

Study
Type
Species
Data
Source
(
MRID,
or
citation)
CAS
Number
Results
Toxicity
Category
Acute
oral
Rat
(
Hine
and
Zuidema
(
1970);
also
cited
in
INCHEM
(
WHO),
1982)
Various
(
lower
range
of
carbon
lengths)
LD50
>
25.0
mL/
kg
(>
28,000
mg/
kg)
no
deaths
observed
IVa
Rabbit
(
NIOSH,
1997a)
64742­
54­
7
LD50
>
5
g/
kg
IV
Acute
dermal
Rat
(
EPA,
1994a)
64742­
56­
9
LD50
>
5
g/
kg
for
males
and
females
IV
Acute
inhalation
Rat
(
NIOSH,
2000)
64742­
55­
8
LD50
=
3,900
mg/
m3
(
3.9
mg/
L)
for
4
hr
1
III
Rabbit
(
NIOSH,
2003)
8012­
95­
1
Moderate
effect
at
500
mg
III
Acute
eye
irritation
Rat
(
EPA,
1994c)
"
Mineral
Oil"
Slight
eye
irritation;
did
not
clear
at
day
14
(
last
day
of
observation)
III
Guinea
pig
(
NIOSH,
2003)
8012­
95­
1
Mild
effect
at
100
mg
for
24
hour
IV
Acute
dermal
irritation
Rabbit
(
NIOSH,
2003)
8012­
95­
1
Mild
effect
at
100
mg
for
24
hour
IV
Skin
sensitization
Guinea
pig
(
EPA,
1994a)
64742­
56­
9
Not
a
dermal
sensitizer
1.
Most
other
reports
from
inhalation
toxicity
testing
indicated
no
lethality
was
observed.

Based
on
the
subchronic
toxicity
data
in
Appendix
B,
representative
data
are
presented
in
Table
6.
For
certain
specific
aliphatic
solvents,
it
has
been
reported
that
the
effects
of
short­
term
exposure
include
mild
irritation
to
the
skin,
and
if
swallowed,
aspiration
into
the
lungs
may
result
in
chemical
pneumonitis.
The
effects
of
long­
term
exposure
include
possible
dermatitis
with
repeated
or
prolonged
contact
with
skin
(
Inchem,
2001a,
b;
MSDS,
1994,
2002).
15
Table
6.
Summary
of
Selected
Sub­
Chronic
Toxicity
Tests
for
Aliphatic
Solvents
Study
Test
material
Test
animal
Doses
Results
28­
day
dermal
MRID
413688­
22
(
EPA,
1996)
Light
neutral
oil,
Gulf
(
purity
not
provided)
C3H/
HeNCrlBR
mice
(
15/
sex/
dose)
Undiluted
test
material
or
42.5%
(
w/
v)
solution
in
heavy
mineral
oil
once
daily,
3x/
week
for
4
weeks
NOEL
>
2000
mg/
kg/
day
28­
day
inhalation
MRID
413688­
24
(
EPA,
1996)
Light
Neutral
Oil,
Gulf
(
purity
not
provided)
Fischer
344
rats
(
10/
sex/
dose)
0,
0.52,
0.76,
or
1.53
g/
m3
or
g/
mL
for
6­
hours/
day.
Five
days/
week,
for
total
of
28
days
LOEL
=
520
mg/
m3
or
mg/
mL
(
146.64
mg/
kg/
day)

90­
day
inhalation
MRID
450029­
01
(
Ulrich,
1999)
GB­
1111
Crl:
CD
®
(
SD)
IGS
BR
rats
Target
concentrations:
0.01,
0.1,
and
1.0
mg/
L
Actual
concentrations:
0.012,
0.10,
and
0.9
mg/
L
6
hr
exposure
NOEL
=
0.1
mg/
L
(
26.1
mg/
kg/
day)
a
A
short­
term
exposure
duration
dermal
NOAEL
of
2000
mg/
kg/
day
was
observed
in
a
28­
day
repeat­
dose
study,
in
which
no
adverse
effects
were
observed
at
the
highest
test
concentration
(
2000
mg/
kg/
day)
(
EPA,
1996;
MRID
413688­
22).
The
actual
NOAEL
could
potentially
be
very
much
higher,
because
it
is
quite
possible
that
there
would
be
no
adverse
effects
from
dermal
exposures,
even
at
the
highest
possible
dosage
which
could
be
applied
to
the
skin.

A
short­
term
exposure
duration
inhalation
LOAEL
of
146.64
mg/
kg/
day
was
observed
in
a
28­
day
inhalation
study.
Adverse
effects
were
reported
at
the
lowest
exposure
dosage,
0.5
mg/
L,
based
on
the
following
observations:
(
1)
multiple
lung
effects,
(
2)
increased
white
blood
cell
counts
in
males,
(
3)
increased
absolute
liver
weight,
(
4)
accessory
spleens
and/
or
abnormally
colored
spleens,
and
(
5)
additional
microscopic
findings
(
EPA,
1996;
MRID
413688­
24).
An
intermediate­
term
exposure
duration
inhalation
NOAEL
of
26.1
mg/
kg/
day
was
observed
in
a
90­
day
inhalations
study,
in
which
effects
were
observed
at
0.9
mg/
L,
but
there
were
no
adverse
effects
observed
at
0.1
mg/
L
(
EPA,
1996;
MRID
450029­
01).

Metabolism
/
absorption:
Oral
doses
of
mineral
oils
and
aliphatic
petroleum
hydrocarbons
are
poorly
absorbed
across
the
gastrointestinal
tract
lining,
and
most
are
rapidly
eliminated
unchanged
in
the
feces
(
75
to
98%,
within
8
hours
to
4
days).
In
addition,
these
materials
also
show
very
poor
permeability
across
the
dermal
barrier
(
very
little
is
absorbed
through
the
skin).
Similarly,
any
of
these
materials
which
enter
the
lungs
are
also
generally
not
absorbed,
but
there
may
be
phagocytosis
by
the
surrounding
lung
cells,
with
some
materials
then
16
being
transported
to
the
spleen
and
liver,
with
eventual
elimination
occurring,
mostly
unmetabolized,
within
the
feces.

The
April
1997
data
call­
ins
for
the
Mineral
Oils
(
GCDI­
063502­
17721)
and
for
Aliphatic
Petroleum
Hydrocarbons
(
GCDI­
063503­
17722)
did
not
require
data
for
various
types
of
repeat
dose
toxicity
studies,
including
either
reproductive/
developmental
or
carcinogenicity
toxicity
testing,
via
either
oral
or
dermal
exposure
dosing.
Thus,
these
data
have
not
been
submitted
by
registrants,
and
the
information
presented
was
derived
from
various
review
documents.
Data
were
required
for
Mutagenicity/
Genotoxicity
(
Gene
mutation
 
Ames
[
84­
2a;
870.5100])
and
for
Structural
Chromosomal
Aberration
[
84­
2b;
870.5375]);
a
number
of
studies
have
been
submitted,
and
DERs
written
for
most.

Reproduction/
Developmental
Effects:
In
the
HPV
Submission
for
Lubricating
Oils
Basestocks
(
for
most
of
the
CAS
Numbers
as
in
this
RED),
various
repeat
dose
studies
were
reviewed
for
reproductive
and
developmental
toxicity
effects.
It
was
concluded
from
dermal
dosing
studies,
that
mineral
oil
had
no
effects
(
on
mortality,
clinical
signs
of
toxicity,
on
body
weight,
food
consumption,
absolute
organ
weights,
microscopic
changes
in
reproductive
organs
of
parental
animals,
number
of
corpora
lutea,
implantation
sites,
live
pups
per
litter,
no
gross
anomalies,
and
body
weights
of
pups
or
weight
gains
of
pups).
In
a
4­
week
inhalation
study,
there
were
no
treatment
related
effects
on
sperm
morphology.
In
a
one­
generation
reproduction
study,
both
males
and
females
were
dosed
by
gavage,
and
there
were
no
adverse
effects
(
no
clinical
findings,
growth
weights
and
food
consumption
was
normal,
no
effects
on
fertility
and
mating
indices
in
either
males
or
females,
and
at
necropsy,
organ
weights
and
histopathology
were
considered
normal
by
the
study
authors).
Two
other
studies
were
reported
with
white
mineral
oil,
both
via
single
daily
gavage
doses.
In
one
study,
both
sexes
were
dosed,
and
some
effects
were
observed,
which
the
study
authors
concluded
were
within
the
"
spectrum
of
malformations
[
which]
occurs
spontaneously
in
Sprague­
Dawley
rat."
In
the
companion
study
in
which
only
pregnant
females
were
dosed,
fetal
effects
were
noted,
but
"
the
study
authors
considered
these
malformations
to
be
minor
and
within
the
normal
ranges
for
the
strain
of
rat"
(
Sprague­
Dawley).
In
general,
these
studies
were
performed
at
very
high
dosages,
from
about
900
mg/
kg­
bw/
day
(
1
mL/
kg­
bw/
day)
to
about
4500
mg/
kg­
bw/
day
(
5
mL/
kg­
bw/
day).

Carcinogenicity:
The
following
information
has
been
reported
for
the
aliphatic
solvents
with
regards
to
carcinogenicity
(
IARC,
1987):

Untreated
and
mildly­
treated
oils
are
carcinogenic
to
humans
(
Group
1),
and
Highly­
refined
oils
are
not
classifiable
as
to
their
carcinogenicity
to
humans
(
Group
3).

The
chemicals
included
in
this
RED
are
categorized
as
highly
to
severely
refined
oils
and,
therefore,
are
classified
as
Group
3,
meaning
the
evidence
of
carcinogenicity
is
inadequate
in
humans
and
inadequate
or
limited
in
experimental
animals.
17
Mutagenicity/
Genotoxicity:
In
DERs
written
by
HED
(
EPA,
1994d),
the
mutagenicity
of
various
test
materials
were
all
characterized
as
being
in
general
non­
mutagenic,
but
with
problems
due
to
the
presence
of
suspended
oil
droplets,
due
to
the
poor
water
solubility
of
the
test
materials.
Results
reported
show
the
following:
no
treatment
related
increases
in
the
number
of
revertants
to
histidine
in
either
the
plate
incorporation
or
liquid
suspensions
assays
(
Ames
tests);
in
a
mouse
lymphoma
forward
mutation
assay,
there
were
no
adverse
effects
(
but
problems
were
encountered
in
removing
the
test
material
from
the
cells,
due
to
the
insolubility
with
the
aqueous
media);
the
test
material
did
not
appear
to
be
clastogenic
in
an
in
vivo
mammalian
cytogenetics
assay
with
bone
marrow,
but
the
DER
stated
evidence
must
be
submitted
to
indicate
that
the
test
material
is
absorbed
from
the
gastrointestinal
tract
and
transports
to
target
tissue
[
bone
marrow]
in
effective
concentrations.

In
the
HPV
Submission
for
Lubricating
Oils
Basestocks
(
HPV,
2004),
it
was
concluded
that
the
in
vitro
(
mutagenicity)
tests,
the
results
had
low
mutagenicity
indices,
and
that
the
in
vivo
results
would
probably
be
negative,
due
to
the
low
bioavailability
of
these
test
materials,
and
due
to
the
negative
results
observed
in
in
vitro
mutagenicity
testing
and
dermal
carcinogenicity
studies.

Special
Considerations
for
Infants
and
Children:

The
data
found
on
reproductive
or
developmental
toxicity
for
the
aliphatic
solvents
(
the
mineral
oils
and
aliphatic
petroleum
hydrocarbons)
indicate
that
for
most
CAS
Numbers,
there
are
few
effects
that
suggest
any
reproductive
impairment
or
adverse
fetal
impacts
that
occur
at
doses
not
also
having
maternal
impacts.
In
general,
most
of
the
studies
reported
in
the
HPV
submission
were
conducted
at
very
high
dosing
levels,
whether
by
the
dermal,
inhalation,
or
oral
route
of
exposure.
Overall,
therefore,
there
are
no
concerns
at
the
present
time
for
potential
sensitivity
of
infants
and
children
to
these
mineral
oils
and
aliphatic
petroleum
hydrocarbons,
because
any
reproductive
and
developmental
toxicity
effects
only
occurred
at
doses
much
greater
than
those
expected
from
use
of
these
chemicals
as
active
ingredients.

V.
Exposure
Assessment:

There
is
a
potential
for
dermal
and
inhalation
exposure
to
aliphatic
solvents
(
both
mineral
oils
and
aliphatic
petroleum
hydrocarbons)
in
occupational
scenarios
from
handling
aliphatic
solvent­
containing
products
during
the
mixing,
loading
and
application
process
(
i.
e.,
mixers/
loaders/
applicators).
Short­
term
exposures
are
likely
(
from
1
to
30
days);
however,
it
is
less
certain
that
pesticide
handlers
would
have
intermediate­
term
exposures
(
i.
e.,
continuous
exposures
of
greater
than
30
days,
that
is,
from
1
month
to
6
months).
However,
as
part
of
the
earlier
Phase
4
Reregistration
Process,
the
Occupational
and
Residential
Exposure
Branch
(
OREB)
of
HED
(
USEPA
1995b)
determined
that,
for
the
Mineral
Oils
and
Aliphatic
Petroleum
Hydrocarbons
the
"
toxicity
is
very
low
(
the
FDA
has
recommended
mineral
oil
for
GRAS
status),
dermal
exposure
does
not
warrant
an
exposure
study
at
this
time
for
reregistration."
In
addition
"
OREB
does
not
require
an
inhalation
exposure
study
for
reregistration
at
this
time,"
and
"
OREB
does
not
require
a
18
mixer/
loader/
applicator
exposure
study
for
reregistration."
Thus,
various
Guidelines
were
waived
by
OREB,
and
not
required
as
part
of
a
GDCI,
including
Guidelines
133­
4,
Inhalation
Exposure
(
new
#
875.2500),
as
well
as
the
following
applicator
exposure
monitoring:
Guideline
231,
Estimation
of
Dermal
Exposure
at
Outdoor
Sites
(
new
#
875.1100),
Guideline
232,
Estimation
of
Inhalation
Exposure
at
Outdoor
Sites
(
new
#
875.1300),
Guideline
233,
Estimation
of
Dermal
Exposure
at
Indoor
Sites
(
new
#
875.1200),
and
Guideline
234,
Estimation
of
Inhalation
Exposure
at
Indoor
Sites
(
new
#
875.1400).

Thus,
the
Agency
has
determined
that
only
a
qualitative
exposure
assessment
is
required
for
these
scenarios,
and
that
the
application
rates,
anticipated
use
patterns,
and
current
labels
for
the
aliphatic
solvents
products
are
not
of
concern
to
the
Agency.
This
qualitative
exposure/
risk
assessment
suggests
there
are
no
concerns
for
handlers,
reentry
workers,
or
residential
homeowners.

A
review
of
many
of
the
current
labels
indicates
that
about
half
of
these
labels
list
requirements
for
gloves
as
Personal
Protective
Equipment
(
PPE).
This
qualitative
assessment
of
human
exposure
risk
has
indicated
there
are
no
risk
concerns;
any
PPE
requirements
needed
for
end­
use
products
will
be
determined
based
on
the
acute
toxicity
testing
review
data
developed
during
reregistration
for
these
end­
use
products.

Cancer
risks
were
not
calculated,
since
no
toxicological
endpoint
for
cancer
was
selected,
because
these
materials
described
in
this
RED
are
not
carcinogens.

VI.
Dietary
(
Food)
Exposure:

There
has
been
a
tolerance
of
200
ppm
established
for
mineral
oil,
for
post
harvest
uses
on
corn
and
sorghum
(
40
CFR
180.149).
However,
an
HED
Memo
(
EPA,
1995a)
indicated
that
residue
data
would
not
be
required
for
Mineral
Oil,
and
specifically
that
the
following
data
requirements
were
"
not
applicable":
171­
4(
a),
Nature
of
residue
 
plants;
171­
4(
b),
Nature
of
residue
 
animals:
171­
4(
c),
Residue
analytical
method
 
plant;
171­
4(
d),
Residue
analytical
method
 
animals;
171­
4(
e),
Storage
stability;
171­
4(
f),
Magnitude
of
residue
 
potable
water;
171­
4(
g),
Magnitude
of
residue
 
fish;
171­
4(
h),
Magnitude
of
residue
 
irrigated
crop;
171­
4(
i),
Magnitude
of
residue
 
food
handling;
171­
4(
j),
Magnitude
of
residue
 
meat/
milk/
poultry/
eggs;
171­
4(
k/
l),
Crop
field
trials/
process.

The
Agency
has
no
concerns
for
food
uses
of
these
mineral
oils
and
aliphatic
petroleum
hydrocarbons,
as
a
result
of
their
use
as
an
active
ingredient.
As
described
in
previous
sections,
the
acute
and
chronic
oral
toxicity
of
these
materials
is
extremely
low,
and
thus,
no
quantitative
assessment
of
dietary
(
food
only)
risk
is
deemed
necessary.

VII.
Drinking
Water
Exposure:

The
HED
Memo
(
EPA,
1995a),
which
indicated
that
various
types
of
residue
data
would
not
be
required
for
Mineral
Oil,
specifically
indicated
that
the
data
requirement
for
19
Magnitude
of
residue
 
Potable
water
(
Old
Guideline
Number:
171­
4(
f),
New
Guideline
Number
860.1400)
was
"
not
applicable":
Thus,
residue
data
have
not
been
collected
for
drinking
water
concentrations
of
these
active
ingredients.
One
use
of
mineral
oil
has
been
granted
GRAS
status,
and
many
other
uses
of
mineral
oil
have
been
permitted
under
various
other
food
use
regulations
by
US
FDA.
Based
on
the
available
data
concerning
the
absence
of
acute
and
chronic
oral
toxicity
for
both
mineral
oil
and
aliphatic
petroleum
hydrocarbons,
these
active
ingredients
are
not
of
concern
to
the
Agency.

VIII.
Aggregate
Exposure
Assessment:

For
aggregate
exposure,
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
section
408
directs
the
Agency
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
non­
occupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).
The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
[
FFDCA,
Section
408(
b)(
2)(
A)(
ii)]
require
"
that
there
is
a
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."
In
assessing
the
aggregate
exposure
for
the
aliphatic
solvents,
the
Agency
has
determined
in
the
preceding
sections
that
risks
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure
are
minimal,
having
virtually
insignificant
impact
on
human
health.

IX.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
the
Aliphatic
Solvents
have
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
the
Aliphatic
Solvents
and
any
other
substances,
and
the
Aliphatic
Solvents
do
not
appear
to
produce
toxic
metabolites
produced
by
other
substances.

For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
Aliphatic
Solvents
have
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
the
Agency's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.
20
X.
Environmental
Fate/
Ecotoxicity/
Ecological
Risk
Assessment:

X.
I.
Environmental
Fate
and
Transport:

There
is
a
wide
range
of
components
present
in
each
of
these
various
mineral
oils
and
aliphatic
petroleum
hydrocarbons
products,
but
the
EFED
Memorandum
concluded
that
"
based
on
the
broad
descriptions
of
the
CAS
Numbers,
it
appears
that
the
composition
of
the
oils
are
similar
across
the
two
PC
Codes.
Therefore,
the
toxicological
and
fate
properties
may
be
similar."

The
information
for
most
of
the
physical
and
chemical
properties
(
Table
4)
is
based
on
various
estimates
derived
from
EPIWIN
and
other
models
for
developing
physical
and
chemical
properties
information.
Thus,
any
description
of
the
environmental
fate
and
transport
of
these
mixtures
of
components
will
require
some
degree
of
generalization
in
characterizing
the
environmental
fate.
For
example,
their
vapor
pressures
exhibit
a
very
wide
range,
from
somewhat
volatile
to
very
poorly
volatile
(
i.
e.,
10­
4
Pa
to
10­
16
Pa
[
about
10­
3
to
10­
14
mm
Hg]).
Their
octanol­
water
partition
coefficients
are,
in
general,
high,
with
log
Kow
values
ranging
from
about
5
to
about
20,
for
the
smaller
chain­
length
to
the
larger
chain
length
molecules.
Thus,
these
components
are
also
likely
to
have
high
Koc
values,
indicating
a
high
degree
of
sorption
to
the
organic
matter
in
soils,
as
well
as
to
foliar
surfaces
onto
which
they
are
sprayed.
In
addition,
their
constituent
components
are
also
very
poorly
water
soluble,
with
solubility
values
ranging
from
0.001
to
0.6
mg/
L,
being
least
soluble
for
the
larger
constituents.
Thus,
these
sorption
characteristics
and
water
solubility
data
suggest
very
poor
migration
in
dissolved
phase
of
water.
Fugacity
modeling
to
determine
the
distribution
of
these
components
in
the
environment
suggest
that
most
would
partition
to
the
terrestrial
phase,
and
remain
sorbed
to
soil
or
the
foliar
surfaces
onto
which
they
are
sprayed.

These
aliphatic
oils
do
not
contain
functional
groups
which
would
undergo
photodegradation
in
the
ultraviolet
or
visible
light
ranges,
although
if
any
have
aromatic
components,
they
can
undergo
direct
photolysis
(
however,
most
registrants
now
produce
TGAIs
with
substantially
reduced
amounts
of
aromatic
components,
compared
with
the
spray
oils
formerly
formulated).
While
many
of
the
components
are
poorly
volatile,
if
some
do
volatilize,
they
might
contain
substituent
groups
that
may
undergo
atmospheric
gas­
phase
oxidation
reactions.
While
these
components
are
poorly
soluble
in
water,
they
do
not
contain
functional
groups
that
are
susceptible
to
hydrolysis
in
aqueous
suspensions.
Due
to
the
complexity
in
size
of
the
components
of
these
oils,
they
may
slowly
undergo
some
primary
biodegradation,
but
do
not
readily
undergo
rapid
mineralization
(
i.
e.,
complete
breakdown
to
carbon
dioxide
and
water).

X.
II.
Ecological
Effects
Toxicity
Data:

Based
on
their
review
of
the
environmental
effects
data
submitted
to
the
Agency
and
on
the
literature
from
other
sources
consulted
to
augment
these
submitted
data,
the
EFED
Memorandum
Describing
the
Ecological
Risk
Assessment
on
Aliphatic
Oils
(
PC
Codes
063502
and
063503)
compiled
a
summary
table
concerning
the
toxic
effects
data
with
the
21
key
biological
components
of
the
terrestrial
and
aquatic
ecosystem
(
Table
7).

Table
7.
Summary
of
eco­
toxicity
values
used
in
the
Aliphatic
Oils
screening
level
ecological
risk
assessment.
Surrogate
Species
Toxicity
Data
Used
in
the
Ecological
Risk
Assessment
a
Comment
Data
Source
for
toxicity
value
used
in
assessment
Fish
None
used
(
Essentially
no
lethality
observed
to
any
fish
species)
No
effects
were
observed
in
fish
species
in
any
of
the
multiple
studies
conducted
at
the
limit
concentrations
for
these
types
of
studies.
Weight
of
evidence
was
used
to
estimate
potential
risks.
Daphnia
EC50
=
<
0.9
mg/
L
LC50
=
>
14.0
mg/
L
LC50s:
0.02,
0.1,
0.41,
"<
0.9",
and
2.4
mg/
L.
(
The
data
for
the
three
lowest
values
are
based
on
test
materials
no
longer
appropriate
for
risk
estimation,
and
therefore,
the
next
highest
LC50
was
utilized.)
44637337
Oysters
6
mg/
L
EC50:
6
mg/
L
44762002
Aquatic
Plants
No
data
None
N/
A
Mammals
>
28
g/
kg­
bw
(
no
deaths
occurred
at
25
mL/
kg­
bw)
Data
obtained
from
secondary
literature;
no
chronic
or
reproduction
toxicity
studies
were
submitted
to
the
Agency.
(
See
Appendix
C
of
EFED
Memorandum
for
discussion
of
various
of
these
data.)
Hine
and
Zuidema
(
1970)

Birds
LD50:
>
2250
mg/
kg­
bw
LC50:
>
5620
ppm
No
chronic
or
reproduction
toxicity
studies
were
submitted.
44608001;
41793202;
41742101;
4780903;
44780902
Terrestrial
Plants
No
data
None
N/
A
a
No
chronic
or
reproduction
studies
have
been
submitted
to
the
Agency.

In
general,
these
aliphatic
oils
(
mineral
oils
and
aliphatic
petroleum
hydrocarbons)
are
not
toxic
to
most
aquatic
and
terrestrial
organisms.
There
was
essentially
no
lethality
observed
in
any
of
the
tests
conducted
with
fish
species
(
both
with
freshwater
and
with
estuarine/
marine
species),
mammals
(
rats
and
mice),
or
birds
(
in
both
acute,
oral,
singledose
and
subchronic
dietary
feeding
tests).
Data
were
cited
in
the
EFED
Memorandum
that
in
one
fish
toxicity
test,
up
to
a
50%
mixture
(
500,000
mg/
L)
did
not
result
in
any
observed
mortality.
Data
were
also
presented
indicating
no
treatment­
related
effects
in
various
honey
bee
contact
studies.
The
EFED
memo
did
report
that
some
types
of
oils
have
been
tested
on
bird
eggs,
and
have
caused
smothering
(
lack
of
oxygen
transport,
and
impaired
hatching
ability);
however,
the
data
provided
in
that
EFED
memo
do
not
appear
to
indicate
the
likelihood
that
off­
site
drift
of
spray
applications
would
have
demonstrated
impacts
on
bird
egg
hatching.

The
EFED
memo
indicated
that
no
testing
information
had
been
submitted
on
the
effects
of
these
oils
on
plants.
However,
there
is
some
information
in
the
EFED
EIIS
(
Ecological
Incidents
Information
System)
database
concerning
reports
of
incidents
involving
plant
damage.
The
HPV
submission
did
review
data
on
toxicity
testing
with
various
freshwater
algae,
and
reported
there
were
"
no
adverse
effects"
at
the
levels
tested.
There
does
not
appear
to
be
much
information
on
actual
testing
with
terrestrial
plants,
however,
it
is
clear
that
for
some
crops,
high
amounts
of
spray
oils
are
applied
onto
the
foliar
surfaces
for
insecticidal
purposes.
Historically,
there
had
been
reports
of
phytotoxic
effects
on
plants
("
burned"
leaves,
and
some
labels
currently
list
phytotoxicity
warnings);
however,
many
of
the
newer
TGAIs
being
formulated
by
most
Technical
22
registrants
do
not
appear
to
have
these
same
adverse
effects
(
possibly
because
of
the
reductions
in
the
amounts
of
polyaromatic
hydrocarbons
(
PAHs)
present
in
newer
TGAIs,
the
PAHs
postulated
as
having
been
the
cause
of
some
of
the
phytotoxic
effects).

There
was
an
oyster
shell
deposition
study,
in
which
there
was
statistically
significant
reduction
of
shell
deposition,
with
the
96­
hr
EC50
reported
in
the
study
as
5.57
mg/
L.
This
study
was
conducted
in
1998­
99
for
Golden
Bear
Oil
Specialties,
Inc.
with
a
test
material
which
is
no
longer
formulated,
and
thus
not
applied
to
the
environment.
(
The
registrant
for
this
test
material,
GB­
1111,
is
now
Clark
Mosquito
Products.)
It
is
possible
that
one
reason
for
the
reduced
oyster
shell
deposition
could
be
due
to
the
oils
coating
onto
the
outer
surface
of
the
algal
materials
made
available
of
food
to
these
filter­
feeding
oysters,
thus,
rendering
the
oysters
less
able
to
break­
down
and
utilize
these
food
materials
for
nutrition.

There
are
also
two
toxicity
studies
available
with
mysid
shrimp
(
Mysidopsis
bahia,
an
estuarine/
marine
species
of
invertebrates).
One
study
(
MRID
446254­
01),
conducted
in
1998­
99
for
Golden
Bear
Oil
Specialties,
Inc.
(
with
the
same
no­
longer
formulated
test
material
as
described
above),
yielded
a
96­
hr
LC50
value
of
1.2
mg/
L.
Another
study
MRID
450513­
02)
was
conducted
in
1997,
for
Petro­
Canada
(
with
a
test
material
still
being
utilized
as
a
TGAI,
and
described
as
severely
hydrotreated
[
i.
e.,
more
highly
refined
that
the
Golden
Bear
product]);
for
this
test
material,
a
96­
hr
LC50
value
could
not
be
calculated,
because
the
data
reported
did
not
indicate
50%
mortality,
even
at
the
highest
test
concentration,
(
nominal)
500,000
mg/
L.
The
study
reported
that
"
most
observed
mortality
appeared
to
occur
when
organisms
swam
toward
the
top
of
the
test
container
and
became
trapped
in
the
overlying
layer."
The
nominal
concentrations,
and
mortality
data,
were
reported
as
follows:
control,
10%;
31,250
mg/
L,
20%;
62,500
mg/
L,
20%;
125,000
mg/
L,
15%;
250,000
mg/
L,
25%;
and
500,000
mg/
l,
30%
mortality.

The
organism
utilized
for
the
ecological
risk
assessment
was
the
water
flea,
Daphnia
magna.
Based
on
the
data
reported
in
the
EFED
Memorandum
(
Table
7),
a
number
of
different
studies
have
been
submitted,
describing
the
results
of
daphnia
toxicity
testing.
However,
detailed
analyses
of
some
of
the
studies
submitted
reveal
that
a
few
of
the
test
materials
utilized
in
aquatic
toxicity
testing
are
no
longer
used
in
formulating
TGAIs
or
end­
use
products
for
spray
oils.
For
example,
the
lowest
LC50
value
reported
in
Table
7
for
Daphnia,
0.02
mg/
L,
was
from
a
1990­
91
study,
conducted
for
Unocal
Corporation
/
PureGro
Company,
with
90
Neutral
Oil;
however,
according
to
the
Agency
REFS
database,
this
product
was
apparently
cancelled
in
1993.
The
next
higher
LC50
value
reported
in
Table
7,
0.1
mg/
L,
was
a
test
conducted
for
Golden
Bear
Oil
Specialties,
Inc.
(
with
a
test
material
no
longer
formulated,
and
thus
not
applied
to
the
environment).
(
Note
also
that
the
registrant
for
this
test
material,
GB­
1111,
is
now
Clark
Mosquito
Products,
and
a
review
of
the
CSF
for
their
product
indicates
their
product
is
formulated
with
an
unregistered
technical;
thus,
RD
and
SRRD
have
suggested
that
when
Clark
submits
a
revised
CSF
as
part
of
the
reregistration
process,
that
the
CSF
utilize
a
registered
TGAI.)
The
next
higher
LC50
value
for
Daphnia,
0.41
mg/
L,
is
from
a
toxicity
test
conducted
in
1983,
with
a
product
called
100
Paraffine
Oil.
This
study
was
submitted
in
support
of
four
products,
two
of
which
have
since
been
cancelled
(
Chevron
23
Ag
Base
Lite
Neutral
and
Chevron
Ag
100),
and
for
the
two
other
products,
revised
CSFs
have
been
submitted
in
the
1990s
(
Valent
Orchard
Spray,
with
a
revised
CSF
submitted
in
1992,
and
Volck
Supreme
Spray,
with
a
newer,
revised
CSF
in
1996);
therefore,
it
is
clear
that
daphnia
toxicity
testing
data
developed
with
"
100
Paraffine
Oil"
is
no
longer
still
appropriate
for
characterizing
currently
formulated
TGAIs
and
end­
use
products.

The
daphnia
toxicity
study
(
MRID
446373­
37)
with
the
next
higher
toxicity
results
was
conducted
for
Petro­
Canada,
in
1997,
with
a
product
designated
in
the
report
as
VHVI­
4,
referred
to
as
"
N100DW
basestock
which
is
one
of
the
raw
materials
used
to
make
the
final
Spray
Oil
10,
13,
15,
22
products."
These
products
are
still
being
formulated
by
Petro­
Canada,
with
their
most
recent
CSFs
dating
from
1995
and
1997,
so
clearly
this
test
material
is
representative
of
Petro­
Canada's
currently
formulated
TGAIs
and
end­
use
products,
as
well
as
the
TGAIs
and
end­
use­
products
for
some
other
registrants
who
also
purchase
their
TGAIs
from
Petro­
Canada.
The
static
testing
(
i.
e.,
not
with
continuous
flow
conditions)
was
conducted
for
48
hours,
and
samples
were
collected
for
"
later
verification
of
the
test
concentrations
if
required",
but
test
concentrations
were
not
clearly
reported,
so
the
reported
levels
will
be
considered
to
be
only
nominal
(
i.
e.,
unmeasured,
or
estimated).
The
highest
concentration
tested,
14
mg/
L,
was
reported
to
be
"
the
maximum
solubility
of
VHVI­
4
in
water;"
however,
the
text
reported
that
the
"
test
solutions
had
a
thin
film
of
oil
on
the
surface
prior
to
addition
of
test
organisms."
In
describing
the
test
results,
the
report
stated
"
there
was
no
mortality
in
any
of
the
test
treatments.
This
was
confirmed
by
examination
under
a
microscope
for
the
presence
of
a
heartbeat.
Several
neonates
in
all
test
concentrations
were
floating
on
the
surface
of
the
test
solutions
in
all
VHVI­
4
concentrations,
at
24
hours
and
48
hours."
The
actual
data
results
reported
in
Appendix
C
of
MRID
446373­
37
also
list
a
number
of
daphnia
being
counted
as
I
for
"
immobilized,"
or
F
for
"
floating",
with
20
of
20
test
organisms
floating
in
both
14
mg/
L
and
7
mg/
L,
19
floating
and
1
immobilized
at
3.5
mg/
L,
10
floating
and
10
immobilized
at
1.8
mg/
L,
17
floating
and
3
immobilized
at
0.9
mg/
L
(
the
lowest
nominal
test
concentration),
and
all
20
normal
in
the
control.
Based
on
these
data,
it
is
clear
that
there
are
some
effects
on
the
daphnia,
although
apparently
not
lethality,
even
at
the
lowest
test
concentration,
so
the
EC50
is
<
0.9
mg/
L.
It
is
also
possible
that
these
effects
may
be
transient,
and
might
be
reversible,
with
the
daphnia
becoming
free
of
their
"
immobilized"
conditions
when
the
surface
films
break
up.
Thus,
in
light
of
the
absence
of
any
significant
mortality,
even
at
the
highest
concentration
tested,
it
might
also
be
inferred
that
the
LC50
could
be
reported
as
">
14
mg/
L."
(
The
EFED
Memorandum
had
indicated
that
the
LC50
was
"<
0.9
mg/
L
(
100%
mortality
occurred
at
all
concentrations)",
but
that
is
not
in
agreement
with
the
actual
text
reported
in
the
body
of
MRID,
or
with
the
data,
as
report
in
the
body
and
appendix
of
the
MRID.)

The
EFED
Memorandum
did
conclude
that
there
was
uncertainty
whether
the
effects
observed
in
the
daphnid
toxicity
studies
were
caused
by
the
physical
effects
resulting
from
the
oils
coating
the
organism
or
from
a
different
mode
of
action
(
such
as
the
organisms
becoming
entrapped
in
the
oils
floating
on
the
surface),
although
some
studies
did
report
that
daphnids
were
also
immobile
in
the
bottom
or
in
the
middle
of
the
test
containers.
The
EFED
memo
concluded
that
entrapment
in
surface
oil
slicks
would
be
less
likely
to
occur
in
streams
and
rivers
(
moving
water
bodies),
and
oil
slicks
would
be
a
24
higher
concern
in
quiescent
waters,
such
as
wetlands
and
stagnant
lakes.

It
is
not
surprising
that
there
would
be
some
disparity
among
the
various
MRIDs
reporting
the
results
of
toxicity
tests
with
daphnia.
These
mineral
oils
and
aliphatic
petroleum
hydrocarbons
have
very
low
water
solubility,
based
on
information
available,
including
for
10
of
these
same
CAS
Numbers
reported
in
the
Lubricating
Oils
Basestocks
Category
for
the
HVP
submissions.
In
fact,
the
HPV
submission
dataset
provides
data
indicating
that
these
CAS
Numbers
are
essentially
non­
toxic
to
daphnid
invertebrates,
with
the
following
reported
data
in
the
Test
Plan
and
Robust
Summaries:
no
mortality,
based
on
Water
Accommodated
Fractions
(
WAFs),
for
48­
hr
at
1000
mg/
L
exposures
to
Daphnia
magna
and
96­
hr
at
10,000
mg/
L
exposures
to
Gammarus
pulex;
and
for
various
CAS
Numbers,
there
were
no
effects
on
mortality
or
reproduction
after
21
days
exposure
at
1000
mg/
L
for
Daphnia
magna
in
static
renewal
tests
(
with
the
following
CAS
Nos.:
64741­
88­
4;
64741­
89­
5,
64742­
55­
8,
and
64742­
65­
0).
The
differences
observed
in
the
toxicity
between
the
registrant­
submitted
MRIDs
and
the
HVP
data
may
be
partly
due
to
the
methods
of
attempting
to
get
these
poorly
soluble
oils
into
the
water
column
into
a
solution/
suspension.

X.
III.
Estimated
Environmental
Concentrations:

Terrestrial
Concentration
Estimates
The
EFED
Memorandum
described
the
procedure
utilized
to
develop
estimated
environmental
concentrations
(
EECs)
on
terrestrial
systems
by
using
the
Tier
I
exposure
model,
T­
REX
(
Version
1.2.3.).
This
procedure
was
utilized
to
estimate
the
potential
dietary
exposures
for
terrestrial
organisms,
as
a
result
of
applications
of
mineral
oils
and
aliphatic
petroleum
hydrocarbons
(
aliphatic
spray
oils)
at
various
applications
rates,
10,
50,
150,
and
477
lbs/
acre
(
single
application)
(
Table
8).

Table
8.
EECs
for
Selected
Terrestrial
Animal
Food
Items
After
Applications
of
Oils
.

EEC
(
ppm),
as
predicted,
resulting
from
application
rates
of
10
to
477
lbs
a.
i./
Acre
Food
Item
10
lbs
a.
i./
Acre
50
lbs
a.
i./
Acre
150
lbs
a.
i./
Acre
477
lbs
a.
i./
Acre
Short
grass
2400
12,000
36,000
114,000
Tall
grass
1100
5500
17,000
52,000
Broadleaf
forage,
small
insects
1350
6800
20,000
64,000
Fruits,
seeds,
pods,
large
insects
150
750
2300
7200
This
estimation
procedure
analysis
indicates
that
the
aliphatic
spray
oils
may
be
found
on
animal
feed
items
at
extremely
high
concentrations
(
up
to
114,000
ppm).
These
concentrations
were
then
converted
to
doses
(
mg/
kg­
bw)
for
15­,
35­,
and
1000­
gram
mammals,
and
20­,
100­,
and
1000­
gram
birds.
(
See
Appendix
B
of
the
EFED
Memorandum
for
details
concerning
these
calculations,
including
the
body
weight
adjusted
EECs
for
10,
150,
and
477
lbs/
acre
applications
for
both
the
birds
and
mammals.)
25
Aquatic
Concentration
Estimates
The
EFED
Memorandum
also
described
the
procedure
utilized
to
develop
EECs
in
aquatic
systems.
EFED
performed
separate
modeling
efforts
for
spray
drift
alone,
and
for
off­
site
runoff.
For
the
off­
site
spray
drift
alone,
the
modeling
to
develop
EECs
was
performed
for
airblast
applications,
known
to
have
the
highest
off­
site
drift
for
the
various
ground
application
procedures
(
Table
9).
EFED
assumed
that
"
9.7%
of
the
mass
applied
to
a
10
hectare
field
would
drift
off­
site
into
an
adjacent
20,000,000
L
water
body
(
standard
drift
assumption
in
GENEEC2
for
orchard
airblast
applications,
and
EFED's
standard
ecological
water
body
volume)."
The
EECs
in
Table
9
assume
no
runoff,
but
do
assume
an
off­
site
drift
of
9.7%
of
the
total
amount
of
a
product
applied,
and
also
assume
no
degradation,
partitioning,
or
differential
distribution
of
the
various
components
within
the
spray
oil
end­
use
product.
It
is
known
that
some
components
of
these
spray
oils
(
the
lower
molecular
weight
fractions)
may
be
more
volatile
than
others,
but
this
model
also
does
not
take
into
consideration
any
volatilization
of
components
during
off­
site
drift.

Table
9.
Preliminary
Aquatic
EECs
from
Spray
Drift
Into
a
Standard
Ecological
Pond
Application
Rate
EEC:
Resulting
Only
from
Off­
Site
Spray
Drift
(
9.7%
of
Amount
Applied)

477
lbs
a.
i./
Acre
2.6
mg/
L
150
lbs
a.
i./
Acre
0.82
mg/
L
50
lbs
a.
i./
Acre
0.27
mg/
L
10
lbs
a.
i./
Acre
0.05
mg/
L
The
EFED
Memorandum
reported
that
the
simple
screening
level
analysis,
GENEEC,
was
the
procedure
used
to
qualitatively
evaluate
the
contribution
of
off­
site
runoff
to
the
overall
aquatic
EECs.
GENEEC
was
run
assuming
that
these
aliphatic
spray
oils
were
being
applied
by
granular
application
(
not
a
labeled
use),
explaining
that
this
procedure
was
a
convenience
to
minimize
spray
drift
in
the
model
run
to
zero.
In
the
absence
of
environmental
fate
data
for
these
complex
mixtures,
EFED
assumed
that
the
relevant
processes
(
aerobic
soil
and
aquatic
metabolism,
hydrolysis,
and
photolysis)
were
all
stable.
GENEEC
was
run
across
a
very
wide
potential
range
of
Koc
values
that
might
be
expected
for
the
various
constituents
within
the
aliphatic
spray
oils
(
Table
10).

Table
10.
EECs
Predicted
Using
GENEEC,
Assuming
Only
Off­
Site
Runoff
1
Koc
Application
Rate
(
lbs
a.
i./
Acre)
EEC
(
ppm)

477
26.79
0.001
150
8.44
26
Table
10.
EECs
Predicted
Using
GENEEC,
Assuming
Only
Off­
Site
Runoff
1
Koc
Application
Rate
(
lbs
a.
i./
Acre)
EEC
(
ppm)

50
2.82
477
26.79
150
8.44
0.01
50
2.82
477
26.79
150
8.44
0.1
50
2.82
477
26.76
150
8.43
1
50
2.81
477
26.35
150
8.30
10
50
2.77
477
22.79
150
7.18
100
50
2.39
477
10.04
150
3.16
1000
50
1.05
477
2.51
150
0.79
10,000
50
0.26
477
1.41
150
0.44
100,000
50
0.15
1.
GENEEC
Model
with
No
Spray
Drift,
and
with
a
"
Complete
Stability"
Assumption
for
All
Dissipation
Processes
The
GENEEC
modeling
analysis
(
Table
10)
suggests
that
even
with
the
wide
range
of
Koc
values
used,
the
predicted
EECs
vary
by
only
a
factor
of
20
(
from
26.79
ppm
to
1.41
ppm,
at
the
current
maximum
application
rate,
477
lbs
a.
i./
Acre).
This
analysis
also
indicates
that
from
a
Koc
of
0.001
and
100,
there
is
very
little
difference
in
resulting
EECs,
but
as
Koc
increases
from
100
to
1000,
there
is
a
dramatic
drop
in
EEC.
This
pattern
is
significant,
because
most
of
the
components
which
make
up
the
spray
oils
will
27
be
in
the
higher
Koc
range.
The
EFED
Memorandum
presented
estimates
from
the
Horticultural
Oil
Spray
Task
Force
(
HSOTF),
that
the
typical
Koc
would
be
47,860.
The
EFED
Memorandum
also
presented
data
from
a
study
(
Nudelman
et
al.,
2002,
as
cited
by
HSOTF)
which
reported
that
for
many
aliphatic
spray
oils,
the
Koc
values
range
from
900
to
6600.
The
EFED
Memorandum
concluded,
based
on
the
weight
of
evidence
for
the
aliphatic
spray
oils,
that
a
reasonable
estimate
of
Koc
for
these
complex
mixtures
would
be
between
1000
and
100,000,
with
a
GENEEC
estimate
based
on
a
Koc
of
10,000
being
a
reasonable
assumption
of
exposure
due
to
runoff.
Thus,
at
the
current
highest
single
application
of
477
lbs
a.
i./
Acre,
the
contribution
to
the
EEC
from
runoff
would
not
be
expected
to
exceed
2.5
ppm
(
mg/
L),
at
150
lbs
a.
i./
Acre
predicted
to
be
0.97
ppm,
and
for
the
more
typical
average
application
rate,
50
lbs
a.
i./
Acre,
the
EEC
would
be
0.26
ppm
(
Table
10).

The
registrants
with
the
highest
maximum
application
rates
have
voluntarily
agreed
to
lower
these
rates
by
about
a
third.
Thus,
their
maximum
rates
are
now
more
in
line
with
the
150
lbs
a.
i./
Acre
estimates
included
in
Tables
9
and
10,
with
off­
site
spray
drift
and
off­
site
runoff
EECs
of
0.82
ppm
and
0.79
ppm,
respectively,
and
a
combined
estimate
of
off­
site
EEC
of
1.6
ppm,
resulting
from
a
single
application
with
150
lbs
a.
i./
Acre.

X.
IV.
Ecological
Risk
Assessment:

Terrestrial
Organisms
The
EFED
Memorandum
compiled
a
summary
of
terrestrial
risk
estimates
(
Table
11),
based
on
the
toxic
effects
data
for
terrestrial
animals
(
Table
7)
and
the
EECs
of
aliphatic
spray
oils
which
would
occur
on
animal
food
items
(
Table
8).
Table
11
shows
the
application
rate
associated
with
the
following
key
toxicity
endpoints,
respectively:
for
birds,
a
behavioral
endpoint
(
specifically
a
"
slightly
reduced
reaction
to
external
stimuli
(
sound
and
movement)"),
and
data
from
an
acute
gavage
test
and
from
a
dietary
feeding
test,
and
for
mammals,
data
from
an
acute
gavage
test.

Table
11.
Application
Rates
Associated
with
Key
Toxicity
Endpoints
in
Terrestrial
Organisms
Application
Rate
Toxicity
Endpoint
Comment
Birds
4
lbs
a.
i./
Acre
Application
rate
associated
with
lowest
dietary
concentration
that
produced
a
toxic
effect
in
birds
(
NOAEC
1000
ppm,
and
LOAEC
1780
ppm;
MRID
417421­
01).
Toxic
effects
in
bobwhite
quail
included
a
slight
reduced
reaction
to
external
stimuli.
(
However,
no
mortality
occurred
at
the
highest
dose
tested,
5620
ppm.)

6
lbs
a.
i./
Acre
Application
rate
associated
with
highest
body
weight
adjusted
dose
tested
in
available
acute
oral
gavage
bird
studies
(
1620
mg/
kg­
bw;
adjusted
from
2250
mg/
kg­
bw
for
a
20­
gram
bird).
No
mortality
occurred
at
this
dose.

23
lbs
a.
i./
Acre
Application
rate
associated
with
highest
dietary
concentration
tested
in
available
bird
studies
(
5620
ppm).
No
mortality
occurred
at
this
concentration.

Mammals
28
12.7
lbs
a.
i./
Acre
Application
rate
associated
with
EECs
on
short
grass
that
is
1/
10th
of
the
limit
dose
tested
in
mammals,
28,000
mg/
kg­
bw.
No
mortality
occurred
at
this
concentration.
(
Hine
and
Zuidema,
1970)

The
EFED
Memorandum
stated
that
the
toxic
effects
data
available
for
acute
risk
to
terrestrial
organisms
are
difficult
to
use,
because
no
mortality
was
observed
at
the
limit
dose
in
acute
and
subacute
bird
studies,
even
though
the
levels
tested
in
the
various
studies
were
not
as
high
as
the
potential
exposures
from
the
high
application
rates.
However,
it
could
be
interpreted
that
because
there
was
no
mortality
observed
in
any
of
the
studies,
these
test
materials
are
innocuous
(
virtually
without
any
toxic
effects,
even
at
very
elevated
doses,
except
for
the
self­
limiting
aspects
of
producing
diarrhea
or
vomiting).
In
addition,
utilizing
a
startle
reflex
in
birds
or
even
assessing
the
potential
risk
based
on
limit
doses,
at
which
no
mortality
was
observed,
would
result
in
an
overestimate
of
the
potential
for
terrestrial
risks
of
these
potentially
innocuous
test
materials.

The
EFED
Memorandum
concluded
that
there
was
much
uncertainty
in
the
ecological
risk
assessment,
due
to
the
absence
of
mortality.
However,
the
information
presented
also
did
postulate
that
there
might
be
a
potential
for
risks
to
the
eggs
of
egg­
laying
animals,
in
or
adjacent
to
the
treated
field,
although
the
Agency
does
not
generally
regulate
based
on
egg­
smothering
within
application
sites.
Further,
there
was
limited
information
on
which
to
predict
the
off­
site
drift
estimates
of
the
amount
of
the
test
material
which
would
impair
egg­
hatching
in
off­
site
nests.
In
addition,
it
is
stated
that
the
high
application
rates
(
especially
the
477
lbs
a.
i./
Acre
currently
on
some
labels,
but
even
some
lower
rates)
"
do
not
allow
for
a
definitive
conclusion
with
respect
to
potential
risks
to
terrestrial
animals,"
because
the
concentrations
estimated
(
by
modeling)
to
be
on
food
items
could
actually
be
higher
than
levels
tested
in
submitted
studies
in
birds
and
mammals.
(
However,
as
stated
above,
these
test
materials
may
be
"
innocuous,"
at
virtually
any
dose
administered,
because
none
of
the
testing
data
have
revealed
any
mortality
in
birds
or
mammals.)
In
addition,
the
EFED
Memorandum
pointed
out
that
no
chronic
or
reproduction
toxicity
data
in
terrestrial
animals
have
been
submitted
to
the
Agency
under
FIFRA
(
although
apparently
none
have
ever
been
required
under
a
GDCI),
and
that
no
plant
toxicity
data
have
been
submitted;
therefore,
the
EFED
Memorandum
continued,
"
definitive
risk
conclusions
cannot
be
made
at
this
time
with
respect
to
these
surrogate
species."

In
conclusion,
the
following
factors
characterize
the
terrestrial
risk
assessment
for
the
spray
oils:
1)
a
lack
of
mortality
data
observed
in
any
testing
with
mammalian
and
avian
species;
2)
the
absence
of
current
reports
of
phytotoxicity
data
in
these
important
agricultural
crops,
even
at
high
application
rates;
and
3)
the
reductions
which
have
been
voluntarily
proposed
by
registrants
for
the
very
high,
maximum
application
rates.
Based
on
this
weight
of
evidence,
the
Agency
has
concluded
that
it
does
not
have
any
concerns
regarding
the
reregistration
of
these
mineral
oil
and
aliphatic
petroleum
hydrocarbon
products,
due
solely
to
terrestrial
risk
assessment.

Aquatic
Organisms
The
EFED
Memorandum
presented
preliminary
aquatic
risk
estimations.
The
available
29
data
from
various
toxicity
studies
had
revealed
no
mortality,
including
for
various
fish
species
and
for
estuarine/
marine
invertebrates,
mysid
shrimp.
The
aquatic
risk
assessment
information
presented
in
the
EFED
Memorandum
was
preliminary
risk
quotients
(
RQs)
based
on
the
reported
toxicity
data
for
aquatic
invertebrates.
These
RQ
values
were
based
on
EECs
developed
on
only
the
off­
site
spray
drift
and
on
the
direct
application
to
water.
The
EFED
Memorandum
pointed
out
that
the
contribution
of
runoff
to
the
EEC
is
only
discussed
qualitatively,
because
the
composition
of
the
runoff
component
might
not
be
toxicologically
similar
to
the
composition
of
oils
that
enters
water
via
spraydrift
or
those
which
were
used
in
the
available
toxicity
studies.
The
EFED
Memorandum
also
acknowledged
by
that
during
runoff,
there
may
be
a
differential
separation
of
the
components,
due
to
differences
in
solubility,
or
some
components
becoming
very
highly
sorbed
to
soil
and/
or
foliar
surfaces,
or
that
some
components
might
degrade,
or
others
become
volatilized,
and
enter
the
atmosphere.

Table
12.
Preliminary
Aquatic
EECs
from
Drift
Into
a
Standard
Ecological
Pond
Compared
with
Aquatic
Invertebrate
Toxicity
Data
Daphnid
RQs,
based
on:
Application
Rate
EEC
from
9.7%
Drift
Only
into
a
20,000,000
L
ecological
pond
EC50
=
0.02
mg/
L
EC50:
<
0.9
mg/
L
LC50:
>
14
mg/
L
Oyster
RQ,
based
on
EC50
of
6
mg/
L
477
lbs
a.
i./
Acre
2.6
mg/
L
130
2.9
0.19
0.43
150
lbs
a.
i./
Acre
0.82
mg/
L
41
0.91
0.059
0.14
50
lbs
a.
i./
Acre
0.27
mg/
L
14
0.31
0.02
0.045
10
lbs
a.
i./
Acre
0.05
mg/
L
2.5
0.056
0.0036
<
0.01
Direct
Application
EEC
2.1
mg/
L
105
2.3
0.15
0.35
For
their
daphnia
RQs,
the
EFED
Memorandum
relied
only
on
the
toxicity
data
reported
for
90
Neutral
Oil
(
MRID
419028­
03;
EC50
=
0.02
mg/
L);
however,
Table
12
lists
additional
RQ
estimates
from
a
study
with
a
different
test
material,
VHVI­
4.
These
estimates
are
included
because,
as
explained
in
the
section
above
describing
the
Ecological
Effects
Toxicity
Data,
many
of
the
available
daphnia
toxicity
studies,
previously
submitted
to
the
Agency,
had
been
conducted
with
materials
which
are
no
longer
appropriate
for
risk
assessment
purposes
(
the
products
tested
are
no
longer
registered,
or
registrants
have
agreed
to
submit
revised
CSFs
with
different
TGAIs).
Thus,
a
range
of
RQs
are
presented
in
Table
12,
with
the
data
for
the
EC50
=
0.02
mg/
L
retained
for
comparative
purposes
(
although
that
product
was
cancelled
in
1993,
thus,
these
values
are
no
longer
appropriate
and
are
overly
restrictive).

There
should
be
some
clarification
presented
on
the
other
two
data
columns.
In
the
study
with
VHVI­
4
(
MRID
446373­
37),
almost
all
the
daphnia
were
either
immobilized
or
floating,
so
the
EC50
is
less
than
0.9
mg/
l,
the
lowest
nominal
test
concentration;
however,
the
RQs
reported
in
Table
12
are
based
on
the
actual
0.9
mg/
L
value,
the
lowest
nominal
concentration
tested.
The
actual
situation
is
that
immobilization/
floating
may
actually
occur
at
even
lower
concentrations,
so
based
on
the
"
immobilization/
floating"
30
endpoint,
the
true
RQs
might
be
higher
than
in
that
data
column.
It
is
not
known
from
the
study
report
how
long
the
daphnia
would
remain
immobilized,
or
how
long
the
surface
film
would
remain
in
place,
which
is
contributing
to
their
entrapment.
However,
the
CDC
stated
in
a
letter,
dated
June
13,
2006,
that
"
surface
film
larvicides
generally
have
a
shorter
environmental
persistence
(
approx.
2­
3
days)
than
most
chemical
larvicide
alternatives."
Thus,
the
surface
film
should
break
up
within
a
few
days.
In
addition,
that
study
did
report
microscope
observations
of
the
daphnia,
revealing
that
their
hearts
were
still
beating,
thus
that
they
were
not
dead
at
the
conclusion
of
the
2­
day
test
period.
Therefore,
the
actual
LC50
value
would
be
greater
than
the
highest
dose
tested,
14
mg/
L,
also
reported
to
be
the
"
the
maximum
solubility
of
VHVI­
4
in
water."
If
the
daphnia
survive
their
immobilization,
and
are
able
to
break­
free
from
the
oils,
then
the
RQs
presented
in
that
data
column
in
Table
12
may
actually
be
overestimates
of
the
true
RQs,
and
even
for
daphnia,
the
Agency
would
not
have
any
concerns
regarding
the
reregistration
of
these
mineral
oil
and
aliphatic
petroleum
hydrocarbon
products,
based
on
the
aquatic
risk
assessments.

XI.
Mosquito
Larvicide/
Pupacide
Uses:
There
are
three
end­
use
products
with
labels
solely
for
mosquito
larvicide/
pupacide
applications:
 
Bonide
Mosquito
Larvicide,
EPA
Reg.
No.
4­
195;
 
Clarke
Mosquito
Control
Products,
Mosquito
Larvicide
GB­
1111,
EPA
Reg.
No.
8329­
72;
and
 
BVA
2
Mosquito
Larvicide
Oil,
EPA
Reg.
No.
70589­
1.

These
registered
products
(
at
least
one
is
each
of
the
OPP
Chemical
Codes,
in
Mineral
Oils
and
in
Aliphatic
Petroleum
Hydrocarbons)
have
labeled
uses
for
direct
application
to
water
bodies.
To
address
this
use,
the
EFED
Memorandum
described
a
process
which
assumed
that
the
maximum
labeled
application
rate
(
37
lbs/
acre,
the
highest
among
the
three
products)
would
be
applied
directly
to
the
treated
water
body.
In
order
to
develop
EECs
for
the
ecological
risk
assessment,
EFED
assumed
that
the
application
would
occur
to
EFED's
standard
EXAMS
water
body
of
20,000,000
L.
(
See
the
EFED
Memorandum
for
additional
details
of
the
EXAMS
model).
According
to
the
results
of
this
model,
assuming
instantaneous
equilibrium,
the
EEC
for
these
mosquito
larvicide/
pupacide
products,
when
applied
directly
to
the
water
body,
would
be
2.1
mg/
L
(
ppm),
based
on
the
description
from
the
EFED
Memorandum
(
see
Table
12
for
RQs,
based
on
this
EEC).

Due
to
the
characteristics
of
these
mosquito
control
products,
however,
it
is
likely
that
the
oils
would
not
mix
within
the
water
column,
and
that
the
exposures
would
be
restricted
to
a
much
higher
concentration
at
the
film
layer
on
the
surface
of
the
water.
Thus,
there
would
be
a
higher
EEC
exposure
at
the
surface,
but
in
a
smaller
proportion
of
the
entire
water
body,
and
a
lower
EEC
throughout
the
vertical
extent
of
the
water
body.
Thus,
any
possible
adverse
effects
on
the
critical
components
of
the
aquatic
ecosystem
would
be
much
lower
within
the
water
column.

Concerning
these
mosquito
larvicide/
pupacide
uses,
the
Agency
has
solicited
a
benefits
consultation
from
the
Centers
for
Disease
Control
and
Prevention
(
CDC).
In
a
letter
(
dated
June
13,
2006),
Dr.
Michael
A.
McGeehin
described
the
comparative
benefits
of
31
Aliphatic
Oils,
as
follows:

 
"
Surface
film
larvicides
generally
have
a
shorter
environmental
persistence
(
approx.
2­
3
days)
than
most
chemical
larvicide
alternatives."
 
"
They
are
very
quick
acting,
making
them
well
suited
to
situations
where
rapid
control
is
required,
such
as
habitats
in
which
most
of
the
mosquitoes
are
in
late
larval
or
pupil
stages,
or
in
ephemeral
habitats
in
which
the
active
ingredient
need
not
be
present
for
a
long
time."
 
"
Surface
film
larvicides
like
the
oils
kill
all
immature
mosquito
stages
(
all
larval
stages
and
pupae).
Therefore,
timing
of
application
is
not
as
critical
as
with
other
products
that
require
the
active
ingredient
be
consumed
by
feeding
larvae
(
e.
g.,
those
containing
Bacillus
thurinigensis
israelensis,
Bti)
or
during
key
periods
in
larval
development
(
e.
g.,
the
insect
growth
regulators)."
 
"
Surface
films
kill
pupae,
while
most
other
products
do
not.
As
such,
they
often
provide
the
only
alternative
for
control
of
immature
mosquitoes
in
certain
habitats
before
they
become
adults."
 
"
Surface
films
perform
effectively
under
most
field
conditions,
regardless
of
water
quality
(
pH,
turbidity,
and
BOD
don't
impact
performance),
and
on
all
mosquito
species
that
use
the
water
surface
to
breathe
(
e.
g.,
excluding
members
of
the
genera
Mansonia
or
Coquillettidia).
Other
larvicides,
such
as
those
using
BTI,
bacillus
sphaericus,
and
methoprene,
often
don't
perform
well
in
highly
polluted
water
that
can
produce
large
numbers
of
Culex
pipiens
or
Culex
quinquefasciatus
mosquitoes
(
important
West
Nile
virus
vectors).
Bti
doesn't
work
well
with
anophelines,
because
of
their
habit
of
feeding
near
the
water
surface.
As
such,
surface
films
provide
a
valuable
option
to
an
integrated
mosquito
control
program."

The
letter
from
McGeehin
of
CDC
further
went
on
to
describe
the
types
of
areas
where
these
surface
film
mosquito
larvicides/
pupacides
have
advantages.
For
example,
these
surface
film
mosquito
larvicides/
pupacides
are
utilized
in
any
habitat
where
pupae
and
late
4th
instar
larvae
are
found
and/
or
the
organic
content
of
the
water
is
extremely
high.
The
most
common
type
of
this
situation
would
be
where
the
organic
matter
in
the
water
would
reduce
the
efficacy
of
other
types
of
larvicides
(
sites
such
as
storm
sewer
catch
basins,
sewage
treatment
plants,
storm
water
impoundments
collecting
runoff
in
urban
areas,
dairy
lagoons,
or
agricultural
processing
facilities
where
waste
water
accumulates,
such
as
sugar
beet
plants
in
the
Great
Plains
States).
The
surface
film
mosquito
larvicides/
pupacides
are
also
effective
in
areas
known
to
produce
mosquitoes
for
only
a
very
short
time
duration,
sites
which
are
expected
to
be
dry
for
some
time
periods,
or
where
the
use
of
longer
duration
products
would
not
be
warranted,
such
as
swales
along
rivers
and
lakes,
and
certain
types
of
floodwater
habitats.
If
longer
term
control
is
needed,
surface
film
oils
would
not
be
reapplied,
but
instead,
a
product
would
be
used
which
would
provide
a
longer
duration
of
control
(
such
as
Bti,
B.
sphaericus,
or
methoprene).
These
surface
film
oils
would
not
be
routinely
utilized
in
marsh
or
swamp
habitats,
unless
the
mosquitoes
were
found
to
be
in
the
pupil
stage
and
concentrated
within
a
discrete
area,
and
in
these
situations,
the
surface
film
products
would
be
targeted
32
in
that
discrete
area,
rather
than
broadcast
over
a
very
large
area.

In
conclusion,
the
CDC
letter
from
McGeehin
summarized
the
findings
by
stating
that
the
"
mineral
oils
and
aliphatic
petroleum
hydrocarbons
used
as
surface
films
provide
a
valuable
option
in
integrated
mosquito
control
programs
that
target
mosquitoes
of
public
health
importance."

XII.
Labeling
for
Aliphatic
Solvents
Products:
A
summary
of
the
various
label
changes
are
included
in
the
Label
Table.
Key
changes,
and
the
important
reasons,
are
as
follows:

 
Due
to
concerns
that
maximum
label
rates
for
citrus
on
some
labels
that
were
as
high
as
4500
gallons
of
spray
mix
per
acre
(
equal
to
477
lbs
a.
i../
Acre),
these
registrants
have
voluntarily
agreed
to
reduce
their
highest
rate
on
citrus,
with
revised
labels
which
will
indicate
that
applications
in
Texas
and
Florida
should
not
exceed
1500
gallons
of
spray
mix,
and
in
California,
should
not
exceed
1800
gallons
of
spray
mix
(
based
on
Thorough
Coverage
Spray,
with
1.5
gallons
of
product
mixed
in
100
gallons
of
water).

 
Due
to
concerns
for
the
potential
for
spray
drift
to
travel
off­
site,
and
deposit
onto
surface
waters,
possibly
resulting
in
toxic
effects
to
aquatic
invertebrates,
the
revised
labels
submitted
in
fulfillment
of
reregistration
activities
should
include
the
following
statement
concerning
the
restrictions
on
the
use
of
airblast
equipment
on
the
outer
edges
of
orchards:
"
For
airblast
applications,
turn
off
outward
pointing
nozzles
at
row
ends
and
when
spraying
the
outer
two
rows.
To
minimize
spray
loss
over
the
top
in
orchard
applications,
spray
must
be
directed
into
the
canopy.
For
aerial
applications
of
agricultural
products,
do
not
release
spray
at
a
height
greater
than
10
feet
above
the
ground,
top
of
crops,
or
above
the
orchard
canopy,
when
spraying
within
1000
feet
of
water
bodies
or
aquatic
habitat."

XIII.
Tolerance
Reassessment:

The
Tolerance
Expression
at
40
CFR
180.149
for
active
ingredient
use
for
Mineral
Oil
(
Table
3),
the
post­
harvest
uses
on
corn
and
sorghum
(
to
combat
storage
insect
infestation)
predates
the
establishment
of
the
Environmental
Protection
Agency,
having
been
first
proposed
in
the
1950s.
A
review
of
the
EFED
spreadsheets
developed
by
BEAD
and
an
extensive
search
of
the
existing
labels
failed
to
detect
any
Mineral
Oil
products
with
a
current
label
for
this
grain
storage
usage.
Thus,
as
part
of
the
reregistration
process,
SRRD
will
publish
a
notice
of
intent
to
revoke
this
tolerance
(
40
CFR
180.149)
in
the
Federal
Register.

Taking
into
consideration
all
available
information
presented
herein
on
the
aliphatic
solvents,
including
the
mineral
oils
and
aliphatic
petroleum
hydrocarbons,
the
Agency
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
these
chemicals
when
considering
33
exposure
through
food
commodities
and
as
well
as
any
occupational
or
non­
occupational
sources
for
which
there
is
reliable
information.
Therefore,
the
current
exemption
from
the
requirement
of
a
tolerance
established
for
"
Petroleum
Oils"
when
applied
to
growing
crops,
in
accordance
with
good
agricultural
practice,
under
40
CFR
180.905,
is
reassessed
as
being
safe
under
section
408(
q)
of
the
FFDCA.

XIV.
References:

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(
2006).
Environmental
Fate
and
Effects
Division.
Memorandum
Describing
the
Environmental
Fate
and
Effects
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Ecological
Risk
Assessment
on
Aliphatic
Oils
(
PC
Codes
063502
and
063503)
in
Support
of
Reregistration
Eligibility
Decision.
Memorandum
from
Brain
Anderson/
Stephen
Carey/
Mark
Corbin
(
ERB
III/
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to
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(
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April
25,
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EPA
Reg.
No.:
10163­
RLU
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Spray
Oil.
Memorandum
from
Mark
Perry
(
Biologist,
Precautionary
Review
Section/
Registration
Support
Branch/
Registration
Division)
to
Dennis
Edwards
(
Insecticide/
Rodenticide
Branch/
Registration
Division).
File:
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EPA
(
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ID#
063503:
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Petroleum
Hydrocarbons
 
Review
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Paul
Chin,
Ph.
D.
(
Section
2/
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Branch
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EPA
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Mineral
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Review
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Ph.
D.
(
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13000
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light
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97­
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88­
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Chemical
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inchem.
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htm
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petroleum,
solvent­
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heavy
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88­
4).
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petroleum,
solvent­
refined
light
naphthenic
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97­
5).
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1430
MSDS
(
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Material
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Data
Sheet:
Pennzar
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light
paraffinic
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64742­
55­
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gov/
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ULV_
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msds.
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#
100
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solvent­
refined
heavy
paraffinic
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CAS#
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4).
http://
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com/
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openelement
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(
2002b).
Material
Safety
Data
Sheet:
Ergon­
West
Virginia,
Inc.
Hyprene
P70N.
(
CAS#
64742­
56­
9).
http://
www.
adapcoinc.
com/
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ulvm.
pdf
MSDS
(
2003a).
Material
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Data
Sheet:
BVA
Spray
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(
CAS#
72623­
87­
1).
http://
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com/
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BVA13m.
pdf
MSDS
(
2003b).
Material
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Data
Sheet:
Lamp
Fuel
used
in
Hollowick
HD8
and
HD
12
Disposable
Cells.
(
CAS#
8042­
47­
5).
http://
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com/
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b.
pdf
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(
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Material
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Sheet:
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84­
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com/
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htm
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(
2006).
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13,
15,
22.
(
CAS#:
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The
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mixture
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following
CAS#
s:
8042­
47­
5,
64742­
46­
7,
64742­
52­
5,
64742­
54­
7,
72623­
84­
8,
72623­
85­
9,
72623­
86­
0,
72623­
87­
1,
178603­
64­
0,
178603­
65­
1,
178603­
66­
2,
445411­
73­
4")
http://
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ca/
datasheets/
en_
us/
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pdf
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Mineral
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petroleum
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(
mild)
heavy
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(
CAS#
64742­
54­
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RTECS#:
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petroleum
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55­
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RTECS#:
PY8036501.

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(
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(
CAS#
8012­
95­
1).
RTECS#:
PY8030000.

Ulrich,
Charles
(
1999).
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MRID
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(
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of
Certain
Food
Additives
and
Contaminants
in
Food,"
WHO
Food
Additives
Series
35,
"
Mineral
Oils
(
Food­
Grade),
Paraffin
Waxes
and
Microcrystalline
Waxes."
http://
www.
inchem.
org/
documents/
jecfa/
jecmono/
v35je10.
htm
WHO
(
2003).
World
Health
Organization,
International
Programme
on
Chemical
Safety,
"
Safety
Evaluation
of
Certain
Food
Additives,"
WHO
Food
Additives
Series
50,
"
Mineral
Oils
(
Medium­
and
Low­
Viscosity)
and
Paraffin
Waxes."
http://
www.
inchem.
org/
documents/
jecfa/
jecmono/
v50je04.
htm
36
Appendix
A.
SLUA
37
Paraffin
Oil
(
063503)
Screening­
level
Usage
Analysis
(
SLUA)

Date:
12/
13/
05
What
is
a
Screening
Level
Usage
Analysis
(
SLUA)?

 
Available
estimates
of
pesticide
usage
data
for
a
particular
active
ingredient
that
is
used
on
agricultural
crops
in
the
United
States.
What
does
it
contain?

 
Pesticide
usage
data
for
a
single
active
ingredient
only.
 
Agricultural
use
sites
(
crops)
that
the
pesticide
is
reported
to
be
used
on.
 
Available
pesticide
usage
information
(
i.
e.,
does
not
include
all
of
the
United
States).
 
Annual
percent
of
crop
treated
(
average
&
maximum)
for
each
agricultural
crop.
 
Average
annual
pounds
of
the
pesticide
applied
for
each
agricultural
crop
(
i.
e.,
for
the
states
surveyed,
not
for
the
entire
United
States).
What
assumptions
can
I
make
about
the
reported
data?

 
Average
pounds
of
active
ingredient
applied
­
Values
are
calculated
by
merging
pesticide
usage
data
sources
together;
averaging
by
year,
averaging
across
all
years,
&
then
rounding.
Note:
If
the
estimated
value
is
less
than
500,
then
that
value
is
labeled
<
500.
Estimated
values
between
500
&
<
1,000,000
are
rounded
to
1
significant
digit.
Estimated
values
of
1,000,000
or
greater
are
rounded
to
2
significant
digits.)

 
Average
percent
of
crop
treated
­
Values
are
calculated
by
merging
data
sources
together;
averaging
by
year,
averaging
across
all
years,
&
rounding
to
the
nearest
multiple
of
5.
Note:
If
the
estimated
value
is
less
than
1,
then
the
value
is
labeled
<
1.

 
Maximum
percent
of
crop
treated
­
Value
is
the
single
maximum
value
reported
across
all
data
sources,
across
all
years,
&
rounded
up
to
the
nearest
multiple
of
5.
Note:
If
the
estimated
value
is
less
than
2.5,
then
the
value
is
labeled
<
2.5.

What
are
the
data
sources
used?

 
USDA­
NASS
(
United
States
Department
of
Agriculture's
National
Agricultural
Statistics
Service)
 
pesticide
usage
data
from
1999
to
2004.
 
NCFAP
(
National
Center
for
Food
and
Agricultural
Policy)
 
pesticide
usage
data
from
1997
and
used
only
if
data
are
not
available
from
the
other
sources.
 
Private
Pesticide
Market
Research
 
pesticide
usage
data
from
1999
to
2004.
 
California
DPR
data
can
be
requested
separately.
What
are
the
data
limitations?

 
Additional
registered
uses
may
exist
but
are
not
included
because
the
available
surveys
do
not
report
usage
(
e.
g.,
small
acreage
crops).
 
Lack
of
reported
usage
data
for
the
pesticide
on
a
crop
does
not
imply
zero
usage.
 
Usage
data
on
a
particular
site
may
be
noted
in
data
sources,
but
not
quantified.
In
these
instances,
the
site
would
not
be
reported
in
the
SLUA.
38
 
Non­
agricultural
use
sites
(
e.
g.,
turf,
post­
harvest,
mosquito
control,
etc.)
are
not
reported
in
the
SLUA.
A
separate
request
must
be
made
to
receive
these
estimates.
 
Some
sites
show
some
use,
even
though
they
are
not
on
the
label.
This
usage
could
be
due
to
Section
18
requests,
existing
stocks
of
the
chemical,
data
collection
errors,
experimental
use
permit
(
EUP),
and/
or
because
of
an
illegal
use.

Who
do
I
contact
for
further
information
and/
or
questions
on
this
SLUA?

 
Jenna
Carter
(
703
308­
8370)
 
Art
Grube
(
703
308­
8095)
39
Thursday,
December
8,
2005
10:
28
Screening
Level
Estimates
of
Agricultural
Uses
of
Paraffin
Oil
(
063503)
Sorted
Alphabetically
Crop
Lbs
A.
I.
Percent
Crop
Treated
Avg.
Max.
1
Almonds
8,300,000
25
60
2
Apples
6,600,000
30
65
3
Apricots
400,000
35
65
4
Avocados
600,000
20
35
5
Beans,
Green
6,000
<
1
5
6
Blackberries
3,000
5
10
7
Blueberries
6,000
5
5
8
Broccoli
30,000
<
1
<
2.5
9
Cabbage
5,000
<
1
<
2.5
10
Cantaloupes
2,000
<
1
<
2.5
11
Carrots
5,000
<
1
<
2.5
12
Cauliflower
90,000
5
5
13
Celery
20,000
5
5
14
Cherries
1,300,000
15
30
15
Corn
60,000
16
Cotton
30,000
17
Cucumbers
10,000
<
1
5
18
Grapefruit
4,900,000
40
80
19
Grapes
1,200,000
5
10
20
Hazelnuts
(
Filberts)
90,000
5
10
21
Lemons
2,100,000
30
45
22
Limes
100,000
80
80
23
Nectarines
1,200,000
60
75
24
Olives
90,000
5
10
25
Onions
5,000
<
1
<
2.5
26
Oranges
35,700,000
40
75
27
Peaches
2,100,000
25
45
28
Pears
3,700,000
45
85
29
Peas,
Green
<
500
<
1
<
2.5
30
Pecans
200,000
<
1
<
2.5
31
Peppers
7,000
<
1
<
2.5
32
Pistachios
1,100,000
15
40
33
Prunes
&
Plums
2,000,000
30
50
34
Pumpkins
7,000
<
1
<
2.5
35
Raspberries
10,000
5
10
36
Squash
50,000
5
10
37
Strawberries
7,000
<
1
5
38
Sweet
Corn
20,000
<
1
<
2.5
39
Tangelos
600,000
80
95
40
Tangerines
1,400,000
60
70
41
Tomatoes
100,000
<
1
<
2.5
42
Walnuts
200,000
5
10
43
Watermelons
20,000
<
1
<
2.5
______________________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
40
Appendix
B.
Mammalian
Toxicity
Data
for
Aliphatic
Solvents
41
ACUTE
TOXICITY
Table
B­
1.
Summary
of
Acute
Toxicity
for
the
Aliphatic
Solvents
(
Mineral
Oil
and
Petroleum
Hydrocarbons)

Study
Type
Test
species:
Result
Reference
PC
Code:
063502
Test
Material:

Mineral
Oil
CAS#:
8012­
95­
1
Gowan
Spray
Oil
(
EPA
Reg.
10163­
RLU)
MRD­
87­
984;
mineral
oil
90
Neutral
Oil
;
mineral
oil
(
100%
purity)

Acute
oral
Mouse:
LD50
=
22
g/
kg
(
NIOSH,
2003
[
document
cited
is
in
German;
translation
indicates
that
mineral
oil
was
not
tested
alone,
only
in
combination
with
other
chemicals])

Rat:
LD50
=
>
25
mL/
kg
(>
28
g/
kg)
no
deaths
observed
(
Hine
and
Zuidema
(
1970)
also
cited
in
INCHEM
(
WHO),

1982)
Rat:
LD50
>
5
g/
kg
(
EPA,
1992)
Rat:
LD50
>
5
g/
kg
for
males
and
females
(
EPA,
1994c)
NFa
Acute
dermal
NFa
Rabbit:
LD50
>
2
g/
kg
(
EPA,
1992)
Rat:
LD50
>
2
g/
kg
for
males
and
females
(
EPA,
1994c)
Rat:
LD50
>
2
g/
kg
for
males
and
females
(
EPA,
1994b)

Acute
inhalation
NFa
Rat:
LC50
>
4.6
mg/
L
(
EPA,
1992)
Rat:
LC50
>
4.7
mg/
L
(
EPA,
1994c)
Rat:
LC50
>
3.5
mg/
L
(
EPA,
1994b)

Acute
eye
irritation
Rabbit:
Moderate
effect
at
500
mg
(
NIOSH,
2003)
NFa
Rat:
Slight
eye
irritation;
did
not
clear
at
day
14
(
last
day
of
observation)
(
EPA,

1994c)
NFa
42
Table
B­
1.
Summary
of
Acute
Toxicity
for
the
Aliphatic
Solvents
(
Mineral
Oil
and
Petroleum
Hydrocarbons)

Study
Type
Test
species:
Result
Reference
PC
Code:
063502
Test
Material:

Mineral
Oil
CAS#:
8012­
95­
1
Gowan
Spray
Oil
(
EPA
Reg.
10163­
RLU)
MRD­
87­
984;
mineral
oil
90
Neutral
Oil
;
mineral
oil
(
100%
purity)

Guinea
pig:
Mild
effect
at
100
mg/
24
hour
(
NIOSH,
2003)

Acute
dermal
irritation
Rabbit:
Mild
effect
at
100
mg/
24
hour
(
NIOSH,
2003)
NFa
NFa
NFa
Skin
sensitization
NFa
NFa
NFa
43
Table
B­
1.
Summary
of
Acute
Toxicity
for
the
Aliphatic
Solvents
(
Mineral
Oil
and
Petroleum
Hydrocarbons)

Study
Type
Test
species:
Result
Reference
PC
Code:
063502
Test
Material:

Mineral
Oil
CAS#:
8012­
95­
1
Gowan
Spray
Oil
(
EPA
Reg.
10163­
RLU)
MRD­
87­
984;
mineral
oil
90
Neutral
Oil
;
mineral
oil
(
100%
purity)

PC
Code:
063503
Test
Material:

Petroleum
hydrocarbons
Hydrotreated
light
paraffinic
petroleum
distillates
(
64742­
55­
8)
Hydrotreated
heavy
paraffinic
petroleum
distillates
(
64742­
54­
7)
Paraffinic
oil
(
API
78­
9/
64742­
56­
9*)

*
CAS
number
found
in
HPV
Robust
Summary
Acute
oral
NFa
Rat:
LD50
=
>
15
g/
kg
(
NIOSH,
1997a)
Rat:
LD50
>
5
g/
kg
for
males
and
females
(
EPA,
1994a)

Acute
dermal
NFa
Rabbit:
LD50
=
>
5
g/
kg
(
NIOSH,
1997a)
Rat:
LD50
>
5
g/
kg
for
males
and
females
(
EPA,
1994a)

Acute
inhalation
Rat:
LD50
=
3,900
mg/
m3
(
3.9
mg/
L)
for
4
hr
(
NIOSH,
2000
[
from
an
OTS
document,
published
in
01/
06/
83,
submitted
by
BP
Oil,
conducted
by
Gulf
Life
Sciences
Center
1983;
original
document
not
seen])
NFa
NFa
Acute
eye
irritation
NFa
NFa
Rabbit:
Not
an
eye
irritant
(
EPA,
1994a)

Acute
dermal
irritation
NFa
NFa
Rabbit:
Slight
skin
irritant
(
EPA,
1994a)

Skin
sensitization
NFa
NFa
Guinea
pig:
Not
a
dermal
sensitizer
(
EPA,
1994a)

a
NF
=
Not
found
44
45
Description
of
Specific
Acute
Toxicity
References
from
Table
B­
1:

Hine
CH,
Zuidema
HH.
(
1970)
The
toxicological
properties
of
hydrocarbon
solvents.
Industrial
Medicine.
39(
5):
39­
44.

NIOSH
(
1997a).
National
Institute
for
Occupational
Safety
and
Health:
The
Registry
of
Toxic
Effects
of
Chemical
Substances.
Mineral
oil,
petroleum
distillates,
hydrotreated
(
mild)
heavy
paraffinic
(
CAS#
64742­
54­
7).
RTECS#:
PY8035500.

NIOSH
(
2000).
National
Institute
for
Occupational
Safety
and
Health:
The
Registry
of
Toxic
Effects
of
Chemical
Substances.
Mineral
oil,
petroleum
distillate,
hydrotreated
(
severe)
light
paraffinic
(
CAS#
64742­
55­
8).
RTECS#:
PY8036501.

NIOSH
(
2003).
National
Institute
for
Occupational
Safety
and
Health:
The
Registry
of
Toxic
Effects
of
Chemical
Substances.
Mineral
Oil
(
CAS#
8012­
95­
1).
RTECS#:
PY8030000.

INCHEM
(
1982)
WHO.
Environmental
Health
Criteria
20.
Selected
Petroleum
Products.
IPCS
(
International
Programme
on
Chemical
Safety)

EPA
(
1992).
EPA
File
Symbol/
EPA
Reg.
No.:
10163­
RLU
Gowan
Spray
Oil.
Memorandum
dated
9/
1/
92
from
Mark
Perry
(
Precautionary
Review
Section,
Registration
Support
Branch,
Registration
Division)
to
Dennis
Edwards
(
Insecticide­
Rodenticide
Branch,
Registration
Division).
(
HED
Doc#
009979)

Summary:
Acute
toxicity
tests
on
product:
Gowan
Spray
Oil
(
EPA
Reg.
10163­
RLU
 
not
found
in
PPIS
nor
in
HED
label
spreadsheet),
which
contains
99%
mineral
oil
(
no
CAS
number
provided)
by
weight.


Acute
oral,
acute
dermal
and
eye
irritation
studies
accepted
as
core
guideline
data.


Acute
inhalation
and
dermal
irritation
studies
acceptable
as
core
minimum
data.
o
Acute
inhalation
study:
particle
size
distribution
only
determined
once
during
exposure
period
o
Dermal
irritation:
study
failed
to
include
a
48
hour
evaluation
period

Eye
and
dermal
irritation
studies
do
not
support
product
registration
because
of
the
presence
of
an
inert.

Acute
Toxicity
data
for
Gowan
Spray
Oil
(
99%
mineral
oil)
(
EPA,
1992)
Study
Type
Results
Toxicity
Category
Acute
oral
 
rat
LD50
>
5
g/
kg
IV
Acute
dermal
 
rabbit
LD50
>
2
g/
kg
III
Acute
inhalation
 
rat
LC50
>
4.6
mg/
L
III
46
EPA
(
1994a).
EPA
ID#
063503:
Aliphatic
petroleum
hydrocarbons
 
Review
of
10
Acute
Toxicity
Studies.
Memorandum
dated
3/
3/
94
from
Paul
Chin,
Ph.
D.
(
Section
2,
Toxicology
Branch
I,
HED)
to
Kathryn
Davis/
Bonnie
Adler
(
PM52,
Reregistration
Division).
(
HED
Doc#
010813;
PC
Code:
063503)

**
CAS
numbers
were
found
in
the
HPV
Robust
Summaries.
API
78­
10
is
not
included
in
the
list
of
CAS
numbers
provided
by
EPA
for
the
aliphatic
solvents
RED.

Summary
of
Acute
Toxicity
data
for
Aliphatic
Petroleum
Hydrocarbons
from
EPA
(
1994)

Study
Type
Test
material
(
API
78­
9/
64742­
56­
9
&
API
78­
10/
64742­
56­
0)
MRID
Results
Toxicity
Category
063503
Paraffinic
oil
(
API
78­
10)
416853­
13
Acute
oral:
rat
Paraffinic
oil
(
API
78­
9)
416853­
14
LD50
>
5
g/
kg
for
males
and
females
IV
Paraffinic
oil
(
API
78­
9)
416853­
15
Acute
dermal:
rat
Paraffinic
oil
(
API
78­
10)
416853­
16
LD50
>
5
g/
kg
for
males
and
females
IV
Paraffinic
oil
(
API
78­
9)
416853­
17
Primary
eye
irritation:
rabbit
Paraffinic
oil
(
API
78­
10)
416853­
18
Not
an
eye
irritant
IV
Paraffinic
oil
(
API
78­
9)
416853­
19
Primary
dermal
irritation:
rabbit
Paraffinic
oil
(
API
78­
10)
416853­
20
Slight
skin
irritant
IV
Paraffinic
oil
(
API
78­
10)
416853­
21
Dermal
sensitization:
guinea
pig
Paraffinic
oil
(
API
78­
9)
416853­
22
Not
a
dermal
sensitizer
NA
EPA
(
1994b).
EPA
ID#
063502:
Mineral
Oil
 
Review
of
Acute
Toxicity
Studies.
Memorandum
from
Paul
Chin,
Ph.
D.
(
Section
2,
Toxicology
Branch
I,
HED)
to
Kathryn
Davis/
Bonnie
Adler
(
PM52,
Reregistration
Division).
(
HED
Doc#
010809;
PC
Code:
063502,
No
CAS
numbers
provided)

EPA
(
1994c).
EPA
ID#
063502:
Mineral
Oil
 
Review
of
Acute
Toxicity
Studies.
Memorandum
from
Paul
Chin,
Ph.
D.
(
Section
2,
Toxicology
Branch
I,
HED)
to
Kathryn
47
Davis/
Bonnie
Adler
(
PM52,
Reregistration
Division).
(
HED
Doc#
010810;
PC
Code:
063502,
No
CAS
numbers
provided.)

Summary
of
Acute
Toxicity
data
for
Mineral
Oil
(
EPA,
1994b
and
1994c)

Study
Type
Test
materials
MRID
Results
Toxicity
Category
Acute
oral
 
rat
MRD­
87­
984;
mineral
oil
416853­
07
LD50
>
5
g/
kg
for
males
and
females
IV
90
Neutral
Oil
;
mineral
oil
(
100%
purity)
416853­
11
LD50
>
2
g/
kg
for
males
and
females
III
Acute
dermal
­
rat
MRD­
87­
984;
mineral
oil
416853­
08
LD50
>
2
g/
kg
for
males
and
females
III
90
Neutral
Oil
;
mineral
oil
(
100%
purity)
416853­
12
LC50
>
3.5
mg/
L
IV
Acute
inhalation
­
rat
MRD­
87­
984;
mineral
oil
416853­
09
LC50
>
4.7
mg/
L
IV
Primary
eye
irritation
­
rat
MRD­
87­
984;
mineral
oil
416853­
10
Slight
eye
irritation;
did
not
clear
at
day
14
(
last
day
of
observation)
III
48
SUB­
CHRONIC
TOXICITY
Description
of
Data
from
Sub­
chronic
Toxicity
Studies
and
Referenced
DERs:

EPA
(
1996).
Petroleum
Oils.
Review
of
Toxicology
Data.
Memorandum
from
Raymond
Locke
(
Section
2,
Toxicology
Branch
I,
HED)
to
Kathryn
Davis/
Bonnie
Adler
(
PM52,
Reregistration
Division).
(
HED
Doc
#
012030)

Petroleum
oils
 
Review
of
toxicology
data
(
PC
Code
063503;
no
CAS
numbers
provided)

Summary
of
Subchronic
toxicity
tests
for
Petroleum
Hydrocarbons
(
EPA,
1996)

Study
Test
material
Test
animal
Doses
Results
Study
classification
NOTE:
Memo
indicates
that
for
MRIDs
413688­
06,
413688­
29,
413688­
21,
413688­
22,
413688­
07,
413688­
23,
and
413688­
24:
Since
petroleum
oils
tests
for
inhalation
toxicity
elicited
adverse
lung
effects
in
rats,
all
of
the
available
dermal
and
inhalation
toxicity
data
must
be
reviewed
by
the
HED's
TES
Committee
28­
day
dermal
MRID
413688­
22
Light
neutral
oil,
Gulf
(
purity
not
provided)
C3H/
HeNCrlBR
mice
(
15/
sex/
dose)
Undiluted
test
material
or
42.5%
(
w/
v)
solution
in
heavy
mineral
oil
once
daily,
3x/
week
for
4
weeks
LOEL
>
2000
mg/
kg/
day
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Based
on
lack
of
toxicity,
a
repetition
of
the
study
was
not
required
14­
day
dermal
MRID
413688­
29
100
Paraffine
Oil,
Gulf
(
purity
not
provided)
New
Zealand
white
rabbits
(
3/
sex/
dose)
0,
1
or
2
g/
kg/
day
for
5
days/
week
for
2
week
period
Systemic
LOEL
>
2000
mg/
kg/
day
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Based
on
lack
of
toxicity,
a
repetition
of
the
study
was
not
required
49
Summary
of
Subchronic
toxicity
tests
for
Petroleum
Hydrocarbons
(
EPA,
1996)

Study
Test
material
Test
animal
Doses
Results
Study
classification
14­
day
dermal
MRID
413688­
06
Gulf
Orchard
Spray
70
(
purity
not
provided)
New
Zealand
white
rabbits
(
3/
sex/
dose)
0,
1,
or
2
g/
kg/
day
for
5
days/
week
for
2­
week
period
Systemic
LOEL
>
2000
mg/
kg/
day
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Based
on
lack
of
toxicity,
a
repetition
of
the
study
was
not
required
5­
day
dermal
MRID
413688­
21
Light
Neutral
Oil,
Gulf
(
purity
not
provided)
Fischer
344
rats
(
5/
sex/
dose)
0,
0.85,
1.0,
or
2.0
g/
kg/
day
for
5
days/
week
for
1­
week
period
Systemic
and
dermal
LOEL
>
2000
mg/
kg/
day
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Based
on
lack
of
toxicity,
a
repetition
of
the
study
was
not
required
28­
day
inhalation
MRID
413688­
24
Light
Neutral
Oil,
Gulf
(
purity
not
provided)
Fischer
344
rats
(
10/
sex/
dose)
0,
0.52,
0.76,
or
1.53
g/
m3
or
g/
mL
for
6­
hours/
day.
Five
days/
week,
for
total
of
28
days
LOEL
=
520
mg/
m3
or
mg/
mL
(
146,640
mg/
kg/
day)
a
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.
50
Summary
of
Subchronic
toxicity
tests
for
Petroleum
Hydrocarbons
(
EPA,
1996)

Study
Test
material
Test
animal
Doses
Results
Study
classification
9­
day
inhalation
MRID
413688­
07
70
Orchard
Spray
(
purity
not
provided)
Fischer
344
rats
(
5/
sex/
dose)
0,
0.70,
1.60
g/
m3
or
g/
mL
for
6­
hours/
day
for
total
of
9
exposures
LOEL
 
700
mg/
m3
or
mg/
mL
(
197,400
mg/
kg/
day)
a
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Does
not
satisfy
the
guideline
requirement
for
subchronic
inhalation
study,
but
is
satisfactory
for
use
as
a
range­
finding
study
5­
day
inhalation
MRID
413688­
23
Light
Neutral
Oil,
Gulf
(
purity
not
provided)
Fischer
344
rats
(
5/
sex/
dose)
0,
0.54,
1.70
or
2.79
g/
m3
or
g/
mL
for
6­
hours/
day
for
total
of
5
exposures
LOEL
=
1700
mg/
m3
or
mg/
mL
(
479,400
mg/
kg/
day)
a
NOEL
=
540
mg/
m3
or
mg/
mL
(
152,280
mg/
kg/
day)
a
Unacceptable,
but
upgradable
due
to
lack
of
purity
and
stability
data
on
test
material.

Does
not
satisfy
the
guideline
requirement
for
subchronic
inhalation
study,
but
is
satisfactory
for
use
as
a
range­
finding
study
a
Conversion
of
g/
mL
to
g/
kg/
day
performed
using
route­
to­
route
extrapolation
method.
Assumed
default
values
for
respiratory
volume
and
body
weight
based
on
test
species.

Equation:
mg/
kg/
day
=
mg/
L
*
A
*
CF
*
D
*
AF
Where:
mg/
L
=
NOEL/
LOEL
in
mg/
L;
A
=
absorption
or
ration
of
deposition
and
absorption
in
the
respiratory
tract
compared
to
another
route;
assumed
to
be
100%
;
CF
=
Conversion
factor
based
on
default
respiratory
volume
and
body
weight
(
L/
hr/
kg);
D
=
Duration
of
exposure
(
hr/
day);
AF
=
Activity
factor
 
default
for
animals
=
1.
51
Ulrich,
Charles.
(
1999)
"
A
90­
day
(
with
recovery)
nose­
only
inhalation
toxicity
study
of
GB­
1111
Technical
in
Albino
Rats".
WIL
Research
Laboratories,
Inc.,
Ashland,
OH.
Project
Number
WIL­
357008.
December
2,
1999.
MRID
450029­
01.

Test
Material:
GB­
1111;
EPA
Reg.
#
8239­
72,
lists
active
ingredient
as
CAS#
8002­
05­
9:
petroleum
distillates,
naptha)
EPA
Reg.
#
8239­
72
is
listed
as
GB­
1313
in
HED
label
spreadsheet
Summary
of
Subchronic
toxicity
test
(
Ulrich,
1999)

Study
Test
material
Test
animal
Doses
Results
90­
day
inhalation
GB­
1111
Crl:
CD
®
(
SD)
IGS
BR
rats
Target
concentrations:
0.01,
0.1,
and
1.0
mg/
L
Actual
concentrations:
0.012,
0.10,
and
0.9
mg/
L
NOEL
=
0.1
mg/
L
(
26.1
mg/
kg/
day)
a
a
Conversion
performed
using
assumption
of
body
weight
and
respiratory
volume
since
exact
conversion
factor
is
not
known
for
this
species
of
rat.
Used
minimum
default
conversion
factor
provided
for
all
species
of
rats.

API
(
2004).
High
Production
Volume:
Robust
Summary
of
Information
on
Lubricating
Oil
Basestocks.
Prepared
by
American
Petroleum
Institute
(
API).

Summary:
Provides
acute
as
well
as
repeat
dose
testing.
Not
all
identify
NOELs
and
LOELs,
or
assess
the
CAS
numbers
listed
for
the
aliphatic
solvents
RED.

Summary
of
Robust
Summary
Sub­
chronic
Information
from
the
HPV
Submission
Study
Test
material
Test
animal
Doses
Results
Study
classification
28­
day
inhalation
from
HPV
Robust
Summary
WTO
(
white
oil,
CAS#
8042­
47­
5)
&
HBO
(
hydrotreated
base
oil,
CAS#
64742­
54­
7)
Male/
female
Sprague­
Dawley
rats
(
10/
sex/
dose)
0,
50,
220,
and
1000
g/
m3
for
6
hr/
day,
5
days/
week,
4
weeks
LOAEL:
210
mg/
m3
(
54,810
mg/
kg/
day)

NOAEL:
50
mg/
m3
(
13,050
mg/
kg/
day)
?
52
Miscellaneous
Toxicity
Information
provided:

EPA
(
1995a).
OPP
Official
Record,
Health
Effects
Division,
Scientific
Data
Reviews,
EPA
Series
361.
CBRS
Transmittal
Sheet
for
Phase
4
Reviews,
Case
No.
3004;
Chemical
No(
s):
63502/
63503,
.

Summary:
Residue
data
for
mineral
oil
(
PC
code:
063502;
no
CAS
number
provided):
Based
on
CBRS
Transmittal
Sheet
for
Phase
4
Reviews
dated
9/
7/
95,
CBRS
will
not
require
residue
data
for
mineral
oil
is
the
Toxicology
Branch
I,
HED,
concludes
that
there
are
no
toxicological
concerns.
In
addition,
a
recommendation
will
be
made
for
the
exemption
of
mineral
oil
from
tolerance
requirements
for
food/
feed
uses.

EPA
(
1995b).
OPP
Official
Record,
Health
Effects
Division,
Scientific
Data
Reviews,
EPA
Series
361.
OREB
Transmittal
Sheet
for
Phase
4
Reviews,
Case
No.
3004;
Chemical
No(
s):
63502/
63503.

Summary:
Aliphatic
petroleum
hydrocarbons
(#
63503;
no
CAS
numbers
provided)
information
specific
to
postapplication
exposure
monitoring
test
guidelines
subdivision
K:


Indicated
that
dermal
exposure
does
not
warrant
an
exposure
study
since
mineral
oil
is
applied
by
either
low
volume
spray
or
high
volume
ground
spraying
and
because
toxicity
is
low
(
FDA
recommended
it
for
GRAS
status).


Indicated
that
OREB
does
not
require
inhalation
exposure
study
for
same
reasons.
53
Appendix
C.
Detailed
Information
on
the
Use
Rates
for
Aliphatic
Solvents
