Document ID: EPA-HQ-OPP-2006-0154-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-26T04:00Z

February
22,
2006
MEMORANDUM
SUBJECT:
Inert
Ingredient
Dietary
and
Non­
dietary
Risk
Assessments
for
O­
Phenylphenol
and
Salts
Reregistration
Eligibility
Document
(
RED)

TO:
Rebecca
Miller,
Chemical
Review
Manager,
Reregistration
Team
36
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

FROM:
Talia
Milano,
Chemist,
Team
II
Cassi
Walls,
Ph.
D.,
Chemist,
Team
III
Risk
Assessment
and
Science
Support
Branch
(
RASSB)
Antimicrobials
Division
(
7510C)

THRU:
Norm
Cook,
Branch
Chief
Risk
Assessment
and
Science
Support
Branch
(
RASSB)
Antimicrobials
Division
(
7510C)

Case
No.:
2575
Chemical
Name(
s)
CAS
#
PC
Codes
Ortho­
phenylphenol
90­
43­
7
064103
Sodium
ortho­
phenylphenate
132­
27­
4
064104
Potassium
ortho­
phenylphenol
13707­
65­
8
064108
As
part
of
the
overall
risk
assessment
for
Reregistration
Case
No.
2575:
o­
phenylphenol,
sodium
o­
phenylphenate,
and
potassium
o­
phenylphenate
exposures
resulting
from
the
active
ingredient
uses
are
aggregated
with
exposures
resulting
from
their
uses
as
inert
ingredients.
This
memorandum
includes
an
assessment
of
dietary
(
including
both
food
and
drinking
water)
and
nondietary
exposures
for
these
inert
ingredients.

Background
Information
This
document
is
the
inert
dietary
and
residential
non­
dietary
exposure
chapter
of
the
reregistration
eligibility
decision
document
(
RED)
for
ortho­
phenylphenol
(
OPP)
and
OPP
salts,
which
include
sodium
o­
phenylphenate
(
OPP
Na
salt)
and
potassium
o­
phenylphenate
(
OPP
K
salt).
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
Page
2
of
25
However,
it
is
important
to
recognize
that
sodium
o­
phenylphenate
is
the
only
chemical
in
this
case
that
is
formulated
as
inert
ingredient.
Sodium
o­
phenylphenate
is
formulated
as
inert
ingredient
in
approximately
123
registered
end­
use
products
and
is
used
primarily
as
a
materials
preservative.
The
types
of
products
that
contain
sodium
o­
phenylphenate
as
an
inert
ingredient
include:
turf
insecticides
and
herbicides;
garden
and
ornamental
insecticides
and
herbicides;
insect
repellant
for
pets;
and
indoor/
outdoor
crack
and
crevice
insecticides.
These
products
are
formulated
as
soluble
concentrates,
gels,
flowable
concentrates,
ready
to
use
liquids,
granular,
and
bait
traps.
The
vast
majority
of
these
products
contain
sodium
o­
phenylphenate
as
an
inert
ingredient
in
amounts
less
than
2%
of
the
formulation.

Sodium
ortho­
phenylphenate
also
can
be
used
as
pesticide
inert
ingredient
in
a
number
of
agricultural
insecticides
and
herbicides
products.
In
these
cases,
the
residues
on
food
have
an
exemption
from
the
requirement
of
a
tolerance
under
the
40
CFR
§
180.920
when
used
as
an
inert
ingredient
in
pesticide
formulations
that
are
applied
to
growing
crops
(
see
Table
1).
Based
on
the
inert
ingredient
use
patterns,
it
was
determined
that
dietary
(
food
and
water)
and
residential
nondietary
exposure
assessments
were
necessary
to
conduct.

Table
1
Tolerance
Exemptions
for
Sodium
o­
phenylphenate
as
Inert
Ingredients
Tolerance
Exemption
Expression/
Chemical
Name
CAS
Reg.
No.
40
CFR
§
180.
Limits
Use
Pattern
Sodium
o­
phenylphenate
132­
27­
4
920
Not
more
than
0.1%
of
pesticide
formulation
Preservative
of
formulation
The
toxicological
endpoints
(
Table
2)
used
in
these
assessment
were
selected
by
the
Antimicrobial
Division
Toxicity
Advisory
Committee
(
ADTAC).

Table
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Ortho­
Phenylphenol
and
Salts
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
Dietary
Risk
Assessments
Acute
Dietary
(
all
populations)
No
appropriate
endpoints
were
identified
that
represent
a
single
dose
effect.
Therefore,
this
risk
assessment
is
not
required.

Chronic
Dietary
(
all
populations)
NOAEL
=
39
mg/
kg/
day
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)

Chronic
RfD
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
Page
3
of
25
Table
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Ortho­
Phenylphenol
and
Salts
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
(
cPAD)
=
0.39
mg/
kg/
day
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity.

Non­
Dietary
Risk
Assessments
Incidental
Oral
Short­
Term
(
1
­
30
days)
NOAEL
(
maternal)
=
100
mg/
kg/
day
Target
MOE
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
FQPA
SF
=
1
Developmental
(
gavage)
toxicity
studies
in
rats
(
MRID
00067616,
92154037)
and
rabbits
(
MRID
41925003;
co­
critical
developmental
toxicity
study)

Maternal
LOAEL
of
300
mg/
kg/
day
based
upon
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
in
the
rat
developmental
toxicity
study.

Incidental
Oral
Intermediate­
Term
(
1
­
6
months)
NOAEL
=
39
mg/
kg/
day
Target
MOE
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)

FQPA
SF
=
1
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity.

Dermal
Short­
Term
(
1
­
30
days)

(
residential
and
occupational)
NOAEL
(
dermal)
=
100
mg/
kg/
day
Target
MOE
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
21­
Day
Dermal
toxicity
study
in
rats
(
MRID
42881901)

LOAEL
(
dermal)
of
500
mg/
kg/
day
based
upon
dermal
irritation
(
erythema,
scaling)
at
the
site
of
test
substance
application.

Dermal
Intermediate­
and
Long­
Term
(
1
­
6
months
and
>
6
months)

(
residential
and
occupational)
NOAEL
=
39
mg/
kg/
day
Target
MOE
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
(
effects
observed
as
early
as
13
weeks
in
this
study),
increased
clinical
and
gross
pathological
signs
of
toxicity.

Inhalation
Short­
Term
NOAEL
(
maternal)
=
100
mg/
kg/
day
Target
MOE
=
100
Developmental
(
gavage)
toxicity
studies
in
rats
(
MRID
00067616,
92154037)
and
Page
4
of
25
Table
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Ortho­
Phenylphenol
and
Salts
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
(
1
­
30
days)

(
residential
and
occupational)
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).

An
additional
10x
factor
for
route­
toroute
extrapolation
is
used
to
determine
the
need
for
an
inhalation
toxicity
study
rabbits
(
MRID
41925003;
co­
critical
developmental
toxicity
study)

Maternal
LOAEL
of
300
mg/
kg/
day
based
upon
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
in
the
rat
developmental
toxicity
study.

Inhalation
Intermediate­
and
Long­
Term
(
1
­
6
months
and
>
6
months)

(
residential
and
occupational)
NOAEL
=
39
mg/
kg/
day
Target
MOE
=
100
(
10x
interspecies
extrapolation,
10x
intra­
species
variation)

An
additional
10x
factor
for
route­
toroute
extrapolation
is
used
to
determine
the
need
for
an
inhalation
toxicity
study.
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
(
effects
observed
as
early
as
13
weeks
in
this
study),
increased
clinical
and
gross
pathological
signs
of
toxicity.

Cancer
Classification:
ortho­
Phenylphenol
is
classified
as
ANot
likely
to
be
carcinogenic
below
a
specific
dose
range."
Quantitation
of
cancer
risk
is
not
required.

Dietary
Exposure
and
Risk
Assessments
A
dietary
exposure
analysis
was
conducted
for
the
inert
ingredient
of
sodium
ophenylphenate
used
in
agricultural
pesticide
products.
This
dietary
assessment
was
conducted
using
the
generic
dietary
screening
model
for
estimating
inert
ingredients.
The
generic
model's
output
was
adjusted
to
reflect
the
tolerance
exemption
limitation
given
in
40
CFR
§
180.920
(
i.
e.,
no
more
than
0.1%
of
the
pesticide
formulation)
and
maximum
application
rates.
Based
on
a
review
of
the
agricultural
labels
that
contain
sodium
o­
phenylphenate
as
an
inert
ingredient,
it
appears
that
the
maximum
application
rate
(
in
terms
of
the
inert
ingredient)
is
less
than
0.05
lb/
acre.
The
generic
screening
model
does
not
specifically
include
an
application
rate
input;
rather
it
is
based
on
tolerances
for
pesticide
active
ingredients
with
application
rates
generally
ranging
from
1
to
5
lb
ai/
acre.
Therefore,
to
more
accurately
estimate
residues
resulting
from
the
lower
application
rate
of
0.05
lbs
sodium
o­
phenylphenate
/
acre,
the
results
from
the
generic
model
were
adjusted
by
a
factor
of
20
(
using
the
ratio
of
1
lb.
per
acre
÷
0.05
lbs
per
acre)
and
100
(
using
the
ratio
of
5
lbs.
per
acre
÷
0.05
lbs/
acre).
Page
5
of
25
It
should
be
noted
that
the
generic
model
output
is
unrefined
and
extremely
conservative
since
it
assumes
that
the
inert
ingredient
is
used
on
all
commodities
and
that
100
percent
of
crops
are
treated
with
the
inert
ingredient.
Further,
the
model
assumes
finite
residues
for
every
consumed
commodity
(
including
meat,
milk,
poultry
and
eggs)
that
is
included
in
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
.
A
complete
explanation
of
the
assumptions
used
in
the
generic
screening
model
for
estimating
inert
ingredient
dietary
exposure
is
given
in
Appendix
A.

The
dietary
risks
were
estimated
using
the
toxicity
endpoints
selected
by
the
ADTAC.
The
ADTAC
did
not
select
an
endpoint
for
acute
dietary
exposures
as
no
effects
are
attributable
to
a
single
dose,
therefore
acute
dietary
(
food)
risk
estimate
for
the
inert
ingredient
use
was
not
performed.
The
ADTAC
selected
an
endpoint
for
chronic
dietary
exposure
to
OPP
and
salts
of
0.39
mg/
kg/
day.
The
table
below
(
Table
3)
provides
a
summary
of
the
results
of
chronic
dietary
risk
estimates
for
the
inert
ingredient
use
of
sodium
o­
phenylphenate.

Table
3.
Estimated
Chronic
Dietary
Exposure
for
Inert
Ingredients
:
Sodium
o­
phenylphenate
Population
Subgroup2
Generic
Estimated
Exposure1
(
mg/
kg/
day)
OPP/
salts
Estimated
Exposure3
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
total)
0.120
0.0012
­
0.006
0.31%
­
1.5%
All
infants
(<
1
year)
0.245
0.0025
­
0.012
0.63%
­
3.1%
Children
(
1­
2
years)
0.422
0.0042
­
0.021
1.1%
­
5.4%
Children
(
3­
5
years)
0.310
0.0031
­
0.016
0.79%
­
4.0%
Children
(
6­
12
years)
0.174
0.0017
­
0.009
0.45%
­
2.2%
Youth
(
13­
19
years)
0.100
0.0010
­
0.005
0.26%
­
1.3%
Adults
(
20­
49
years)
0.087
0.00087
­
0.004
0.22%
­
1.1%
Adults
(
50+
years)
0.086
0.00086
­
0.004
0.22%
­
1.1%
Females
(
13­
49
years)
0.087
0.00087
­
0.004
0.22%
­
1.1%
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs
2
Only
representative
population
subgroups
are
shown
3
Generic
exposures
based
on
application
rates
of
1
­
5
lb
ai/
acre
were
adjusted
for
the
tolerance
exemption
limitation
of
0.1%
maximum
formulation
and
maximum
application
rates
(
0.05
lb
inert/
acre);
the
generic
exposures
were
divided
by
a
factor
of
20
(
1/
0.05)
and
100
(
5/
0.05)
cPAD
=
0.39
mg/
kg/
day
Based
on
the
results
of
the
screening
level
inert
ingredient
dietary
exposure
model,
there
are
no
concerns
for
risks
associated
with
dietary
(
food)
exposures
since
the
estimated
dietary
exposures
for
the
U.
S.
population
and
all
population
subgroups
are
well
below
100%
of
the
cPAD.

Drinking
Water
Exposure
and
Risk
Assessments
A
September
20,
2005,
memorandum
from
Najm
Shamim
to
Ben
Chambliss
and
Killian
Swift
entitled
"
Science
Chapter
on:
Environmental
Fate
Studies
and
Environmental
Fate
Assessment
of
Orthophenylphenol"
provided
information
on
environmental
fate
data.
These
environmental
fate
data
are
also
used
to
characterize
the
environmental
fate
of
sodium
o­
phenylphenate.
Based
on
the
environmental
fate
data
presented
in
that
assessment,
these
chemicals
are
stable
and
persistent
in
abiotic
aqueous
medium
at
pHs
5,
7
and
9.
It
degrades
completely
in
14
days
when
exposed
to
Page
6
of
25
sunlight
and
is
therefore
photolytically
unstable
in
neutral
aqueous
medium.
It
degrades
when
exposed
to
UV
light
(
253.7
nm).
Its
half
life
(
measured
against
hydroxyl
radical)
is
14
hours,
and
it
is
unstable
in
the
atmosphere.
It
has
a
high
KOC
value
of
10,000,
and
is
immobile
in
soils.
Its
major
degradation
pathway
appears
to
be
through
biodegradation
under
aerobic
and
anaerobic
conditions.
Even
though
it
is
likely
to
stay
on
soil
surfaces,
it
biodegrades
under
aerobic
and
anaerobic
soil
conditions
and
is
not
likely
to
contaminate
surface
water
(
drinking
water)
or
migrate
into
ground
water.

Considering
o­
phenylphenol
and
its
salts'
tendency
to
degrade
under
environmental
conditions
and
the
small
amount
(
0.05
lbs.
per
acre)
that
may
be
applied
to
crops
via
the
inert
use,
sodium
o­
phenylphenate
is
not
likely
to
be
present
in
drinking
water
sources
at
substantial
concentrations.
Therefore
a
quantitative
drinking
water
assessment
was
not
necessary
to
conduct
and
drinking
water
risks
are
not
of
concern.

Residential
Non­
dietary
Exposure
and
Risk
Assessments
Based
on
the
inert
ingredient
use
patterns
of
sodium
o­
phenylphenate,
it
was
determined
residential
non­
dietary
exposure
assessments
were
necessary
to
conduct.
An
inert
non­
dietary
exposure
assessment
was
conducted
for
several
high­
end,
representative
residential
products
such
as
various
formulations
of
turf
and
garden
products
as
well
as,
insect
repellant
pet
spray
products.
It
should
be
noted
that
the
non­
dietary
inert
assessment
did
not
specifically
evaluate
indoor/
outdoor
crack
and
crevice
uses
since
it
was
anticipated
the
applicator
exposures
resulting
from
the
outdoor
lawn
products
would
result
in
higher
exposures
based
on
the
amount
used
per
day.
Additionally,
it
was
also
anticipated
the
post­
application
exposures
resulting
from
the
use
of
turf
products
would
result
in
higher
exposures
than
from
indoor/
outdoor
crack
and
crevice
residues
when
considering
the
fact
that
exposure
to
residues
on
a
lawn
are
much
more
accessible
than
residues
applied
in
cracks/
crevices
and
along
baseboards.

U.
S.
EPA's
Pesticide
Inert
Risk
Assessment
Tool
(
PiRat)
was
used
to
estimate
applicator
and
post­
application
exposure
and
risk
from
the
use
of
sodium
o­
phenylphenate
as
an
inert
ingredient
in
representative
residential
products.
Background
information
and
the
downloadable
executable
file
for
PiRat
can
be
found
at
http://
www.
epa.
gov/
opptintr/
exposure/
docs/
pirat.
htm.
All
of
PiRat's
default
values
were
used
in
each
run.
Based
on
a
review
of
the
confidential
statements
of
formulas
(
CSFs)
for
various
types
of
sodium
o­
phenylphenate
inert
products,
2%
was
selected
as
a
high­
end
representative
value
and
was
used
in
all
of
the
model
simulations.
As
previously
discussed,
since
sodium
o­
phenylphenate
is
used
in
numerous
types
of
products,
only
exposures
from
representative
high­
end
scenarios
were
estimated
using
PiRat.
These
scenarios
include
applicator
dermal
and
inhalation
exposures
to
liquid
turf
and
garden
products
and
toddler
post­
application
dermal
and
incidental
ingestion
exposures
to
liquid
turf
products.
It
should
be
noted
that
the
post­
application
inhalation
exposure
scenario
was
not
assessed
because
sodium
o­
phenylphenate
has
a
low
vapor
pressure
(
1.8
x
10­
9
mm
Hg
@
25
E
C).
Again,
it
is
expected
that
the
crack
and
crevice
applicator
and
post­
applicator
exposure
scenarios
would
result
in
lower
exposures
and
higher
MOEs.
The
applicator
exposures
and
risks
are
presented
in
Table
4
while
the
post­
application
exposures
and
risks
are
presented
in
Table
5.
All
of
the
MOEs
were
greater
than
or
equal
to
the
target
MOE
of
100.
Page
7
of
25
Table
4:
Applicator
Short­
term
Dermal
and
Inhalation
Exposures
and
MOEs
for
sodium
ophenylphenate
when
used
as
an
inert
ingredientd
Product
Use
Application
Method
Dermal
Exposure
(
mg/
kg/
day)
a
Inhalation
Exposure
(
mg/
kg/
day)
a
Dermal
MOE
(
Target
MOE
=
100)
b
Inhalation
MOE
(
Target
MOE
=
100)
b
low
pressure
handwand;
MLAP
1.84E­
03
9.86E­
07
5.4
E+
04
1.0
E+
08
backpack;
MLAP
9.40E­
05
1.29E­
06
1.1
E+
06
7.8
E+
07
sprinkling
can,
MLAP
5.53E­
04
4.07E­
07
1.8
E+
05
2.5
E+
08
Garden
(
concentrate)
c
hose
end
sprayer;
MLAP
5.53E­
04
4.07E­
07
1.8
E+
05
2.5
E+
08
low
pressure
handwand;
MLAP
1.84E­
03
1.29E­
06
5.4
E+
04
7.8
E+
07
backpack;
MLAP
9.40E­
05
1.29E­
06
1.1
E+
06
7.8
E+
07
sprinkling
can;
MLAP
5.53E­
04
4.07E­
07
1.8
E+
05
2.5
E+
08
Turf
(
concentrate)
c
hose
end
sprayer;
MLAP
1.11E­
02
8.14E­
06
9,000
1.2
E+
07
a:
an
application
rate
of
0.00015
lb
product/
ft2
was
assumed
for
all
of
the
scenarios;
body
weight
of
an
adult
=
70
kg;
dermal
absorption
factor
=
43%
b:
MOE
=
NOAEL
/
exposure
where
dermal
and
inhalation
NOAELs
=
100
mg/
kg/
day
and
the
target
MOEs
=
100
c:
For
the
handler
assessment,
it
is
assumed
that
the
uses
of
a
concentrate
on
either
a
garden
or
a
turf
are
the
high
end
representative
scenarios.
d:
Standard
PiRat
model
input
parameters
were
used,
for
complete
model
output
see
Appendix
B
and
C.

Table
5:
Toddler
Short­
term
Dermal
and
Oral
Post­
application
Exposures
and
MOEs
for
sodium
o­
phenylphenate
when
used
as
an
inert
ingredientc
Product
Use
Route
of
Exposure
Exposure
(
mg/
kg/
day)
a
MOEb
dermal
contact
with
residues
on
turf
0.15
680
incidental
oral
ingestion
of
turf
residues
(
object
to
mouth)
4.90E­
04
2.0
E+
05
Turf
(
concentrate)

incidental
oral
ingestion
of
turf
residues
hand­
to­
mouth
transfer
1.96E­
03
51,000
a:
an
application
rate
of
0.00015
lb
product/
ft2
was
assumed
for
all
of
the
scenarios
assessed;
body
weight
of
a
toddler
=
15kg;
dermal
absorption
factor
=
43%
b:
MOE
=
NOAEL
/
exposure
where
dermal
and
oral
NOAELs
=
100
mg/
kg/
day
and
the
target
MOEs
=
100
c:
Standard
PiRat
model
input
parameters
were
used,
for
complete
model
output
see
Appendix
D
and
E.

As
previously
indicated,
sodium
o­
phenylphenate
is
also
used
as
an
inert
ingredient
in
pet
insect
repellant
products.
Therefore,
applicator
dermal
and
inhalation
exposures
as
well
as,
toddler
post­
application
dermal
and
incidental
oral
exposures
were
evaluated.
Although
PiRat
has
a
Page
8
of
25
module
that
can
estimate
exposures
to
pet
products,
it
was
not
used
since
HED's
screening
level
methodologies
have
changed
since
the
development
of
PiRat.
Therefore,
the
most
recent
methodologies
were
utilized
to
assess
exposure
to
sodium
o­
phenylphenate
when
used
as
an
inert
ingredient
in
pet
products.
In
addition,
aerosol
application
was
the
methodology
chosen
as
the
representative
worst
case
scenario
for
this
assessment.

The
following
equation
and
assumptions
were
used
to
estimate
dermal
and
inhalation
residential
applicator
exposures
to
pet
product
residues:

Exposure
=
UE
x
AR
x
N
/
BW
where,
AR
=
Application
rate
(
lb
ai/
can)
UE
=
Unit
exposure
(
mg/
lb
ai)
N
=
Number
of
cans
(
cans/
day)
BW
=
Body
weight
(
kg)

All
of
the
input
parameters
are
defaults
provided
in
HEDs
Residential
SOPs
(
US
EPA,
1997
and
2001)
and
AD
standard
assumptions.
The
percent
formulation
of
0.2%
was
used
in
this
assessment
and
was
selected
based
on
the
review
of
the
confidential
statements
of
formulas
(
CSFs)
for
labels
containing
sodium
o­
phenylphenate
as
an
inert
ingredient.
All
of
the
MOEs
were
greater
than
or
equal
to
the
target
MOE
of
100.
Table
6
provides
the
input
parameters
and
resulting
exposures
and
MOEs.

Table
6.
Applicator
Short­
term
Exposures
and
MOEs
for
sodium
o­
phenylphenate
used
as
Inert
Ingredients
in
Aerosol
Pet
Products
Exposure
=
UE
x
AR
x
N
/
BW
Dermal
Inhalation
Unit
Exposure
(
mg
/
lb
ai)
1
UE
220
2.4
Application
Rate
(
lb
ai/
can)
2
AR
0.008
0.008
Number
of
cans/
day
1
N
0.5
0.5
Percent
Absorption
43%
100%

Body
weight
(
kg)
1
BW
70
70
Daily
Dose
(
mg/
kg/
day)
5.28E­
04
1.34E­
05
NOAEL
(
mg/
kg/
day)
100
100
Target
MOE
100
100
MOE4
190,000
7.5E+
06
1
US
EPA,
1997
and
2001
(
HED=
s
Residential
SOPs)
2
6
oz/
can
x
0.2%
ai
x
1gal/
128oz
x
8.34lb/
gal
(
assuming
density
of
water).
3AD
assumption
4
MOEs
=
NOAEL
/
exposure,
where
the
ST
dermal
and
inhalation
NOAELs
=
100
mg/
kg/
day
Page
9
of
25
The
following
equation
and
assumptions
were
used
to
estimate
toddler
post­
application
dermal
exposure
to
pet
product
residues:

Exposure
=
AR
x
(
1­
DR)
t
x
T
x
SA
x
DA
/
BW
where,
AR
=
Application
rate
(
mg/
cm2
animal)
t
=
Time
after
application
(
days)
T
=
Transfer
fraction
from
treated
pet
(%)
DR
=
Daily
dissipation
(%)
SA
=
Surface
area
of
a
child
=

s
hug
(
cm2/
event)
DA
=
Dermal
absorption
(
if
applicable)
BW
=
Body
weight
(
kg)

All
of
the
input
parameters
are
defaults
provided
in
HEDs
Residential
SOPs
(
US
EPA,
1997
and
2001).
The
percent
formulation
of
0.2%
was
used
in
this
assessment.
All
of
the
MOEs
were
greater
than
or
equal
to
the
target
MOE
of
100.
Table
7
provides
the
input
parameters
and
resulting
exposures
and
MOEs.

Table
7.
Toddler
Short­
term
Post­
application
Dermal
Exposure
and
MOE
to
sodium
ophenylphenate
when
used
as
an
Inert
Ingredient
in
Aerosol
Flea
and
Tick
Pet
Products
Exposure
=
AR
x
(
1­
DR)
t
x
T
x
SA
x
DA
/
BW
Application
Rate
(
mg/
cm2
of
animal)
1
AR
0.030
Transferable
Fraction2
T
20%

Time
after
application
(
days)
t
0
Daily
dissipation
(%)
2
DR
5%

Surface
area
of
a
child=
s
hug
(
cm2)
2
SA
1875
Dermal
absorption
DA
43%

Body
weight
(
kg)
2
BW
15
Daily
Dose
(
mg/
kg/
day)
0.32
Oral
NOAEL
(
mg/
kg/
day)
100
Target
MOE
100
MOE4
310
1
3
oz
x
0.2%
ai/
6000cm2
x
1gal/
128oz
x
8.34lb/
gal
x
1kg/
2.2lb
x
1000g/
kg
x
1000mg/
g
where
it
was
assumed
that
2
of
6
oz
spray
container
is
applied
to
a
30
lb
animal
having
a
surface
area
of
6000cm2
2
US
EPA,
1997
and
2001
(
HED=
s
Residential
SOPs)

The
following
equation
and
assumptions
were
used
to
estimate
toddler
incidental
oral
residential
post­
application
exposure
to
pet
product
residues:

Exposure
=
AR
x
T
x
SA
x
SE
x
FQ
/
BW
where,
AR
=
Application
rate
(
mg/
cm2
animal)
T
=
Transfer
fraction
from
treated
pet
(%)
SA
=
Surface
area
of
a
child
=

s
hands
(
cm2/
event)
Page
10
of
25
SE
=
Saliva
extraction
(%)
FQ
=
Frequency
of
contact
(
event/
day)
BW
=
Body
weight
(
kg)

All
of
the
input
parameters
are
defaults
provided
in
HEDs
Residential
SOPs
(
US
EPA,
1997
and
2001).
The
percent
formulation
of
0.2%
was
used
in
this
assessment.
The
MOE
was
greater
than
or
equal
to
the
target
MOE
of
100.
Table
8
provides
the
input
parameters
and
resulting
exposures
and
MOEs.

Table
8.
Toddler
Short­
term
Post­
application
Incidental
Oral
Exposure
and
MOE
to
sodium
o­
phenylphenate
when
used
as
an
Inert
Ingredient
in
Aerosol
Flea
and
Tick
Pet
Products
Exposure
=
AR
x
T
x
SA
x
SE
x
FQ
/
BW
Application
Rate
(
mg/
cm2
of
animal)
1
AR
0.030
Transferable
Fraction2
T
20%

Surface
area
of
a
child=
s
hand
(
cm2)
2
SA
20
Saliva
Extraction2
SE
50%

Frequency
(
events/
day)
3
FQ
1
Body
weight
(
kg)
2
BW
15
Daily
Dose
(
mg/
kg/
day)
0.0039
Oral
NOAEL
(
mg/
kg/
day)
100
Target
MOE
100
MOE4
25,000
1
3
oz
x
0.2%
ai/
6000cm2
x
1gal/
128oz
x
8.34lb/
gal
x
1kg/
2.2lb
x
1000g/
kg
x
1000mg/
g
where
it
was
assumed
that
2
of
6
oz
spray
container
is
applied
to
a
30
lb
animal
having
a
surface
area
of
6000cm2
2
US
EPA,
1997
and
2001
(
HED=
s
Residential
SOPs)
3
frequency
was
modified
to
reflect
transferable
residue
assumptions
which
is
based
on
a
5
minute
heavy
rubbing/
petting
technique
that
would
lead
to
significantly
higher
hand
concentrations
than
would
result
from
a
single
contact
4
MOE
=
NOAEL
/
exposure
Appendix
A:
Dietary
Exposure
Model
for
Inert
Ingredients
Dietary
Exposure
Model
for
Inert
Ingredients
A
screening
level
model
for
predicting
dietary
exposure
to
inert
ingredients
was
developed
and
is
based
on
the
following
assumptions
and
inputs:

Model
Assumptions
 
Actual
crop­
specific
residue
data
for
active
ingredients
can
be
utilized
as
surrogate
data
for
inert
ingredient
residue
levels
(
including
secondary
residues
in
meat,
milk,
poultry
and
eggs).
 
Inert
ingredients
are
used
on
all
crops
and
100%
of
all
crops
are
"
treated"
with
inert
ingredients
 
No
adjustment
made
for
%
of
inert
in
formulation,
application
rate,
or
multiple
applications
of
different
active
ingredient
formulations
 
Considers
only
preharvest
applications
Model
Inputs
A
group
of
57
of
the
most
"
significant"
active
ingredients
were
considered.
These
active
ingredients
included
substances
in
the
insecticide
(
20),
fungicide
(
17),
and
herbicide
class
(
20)
and
were
selected
based
on
an
overall
ranking
scheme
that
included
the
following
components:
 
Overall
Use 
Based
on
1999
data
for
active
ingredient
use
(
in
lbs/
yr).
(
All
herbicides
at
>
5
million
lbs/
yr
and
all
fungicides
and
insecticides
at
>
1
million
lbs/
yr
were
included)
 
Use
on
crops
that
are
significant
contributors
to
diet
(
All
a.
i.
s
which
had
substantial
use
on
crops
that
make
up
the
"
Top
25"
kids
diet
were
included).
 
Use
on
specific
crops
(
crop­
by­
crop
pesticide
use
information
was
evaluated
to
identify
the
most
frequently
used
active
ingredients)
 
Actual
residue
monitoring
studies
(
active
ingredients
with
the
highest
frequency
of
detection)

Model
Construct
A
DEEM
 
­
type
analysis
was
performed
utilizing
the
highest
established
tolerance
level
residue
for
each
commodity.
In
those
cases
where
DEEM
listed
a
commodity
for
which
a
published
tolerance
did
not
exist,
the
input
value
was
selected
based
on
representative
crops
or
other
"
default"
values
(
e.
g,
use
of
standard
processing
factors).
A
DEEM­
FCID
 
,
Version
1.3
analyses
were
performed
for
both
acute
and
chronic
dietary
exposure
scenarios
and
the
results
for
each
are
given
in
Table
1
and
2.

DEEM­
FCID
 
Program
and
Consumption
Information
Generic
inert
ingredient
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96
and
998
CSFII
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
EPA­
defined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.

For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
foodform
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day.
This
procedure
is
performed
for
each
population
subgroup.

For
acute
exposure
assessments,
individual
one­
day
food
consumption
data
are
used
on
an
individual­
by­
individual
basis.
The
reported
consumption
amounts
of
each
food
item
can
be
multiplied
by
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
deterministic
(
Tier
1
or
Tier
2)
exposure
assessment,
or
"
matched"
in
multiple
random
pairings
with
residue
values
and
then
summed
in
a
probabilistic
(
Tier
3/
4)
assessment.
For
this
screeninglevel
assessment,
only
a
Tier
1
analysis
was
performed.

Use
of
Model
in
Inert
Risk
Assessment
The
results
of
this
model
would
likely
represent
an
upper­
bound
estimate
of
likely
potential
dietary
exposure
to
an
inert
ingredient
resulting
from
preharvest
use.
These
values
could
be
compared
to
the
expected
toxicity
in
a
qualitative
(
Tier
1
substance)
assessment,
or,
in
those
cases
where
a
bounding
level
risk
assessment
is
necessary,
these
exposure
values
could
be
compared
to
the
selected
toxicity
endpoints
in
a
%
PAD
or
MOE
type
approach
(
see
Figure
1).
In
cases
where
this
model
would
yield
dietary
risk
values
below
the
level
of
concern,
no
further
refinements
would
be
necessary,
and
the
potential
dietary
exposure
and
risk
could
be
considered
adequately
characterized.
If
this
model
results
in
dietary
risk,
above
the
level
of
concern,
then
additional
data,
use
limitations,
and/
or
/
further
refinements
would
be
necessary.
Additionally,
the
use
of
this
model
could
allow
apportionment
of
the
amount
of
remaining
`
acceptable'
risk
to
other
routes
of
exposure.

Figure
1.
Fictional
Example
of
Use
of
Dietary
Exposure
Model
in
%
PAD
Approach
Dose
selected=
500
mg/
kg­
bw/
day
Uncertainty
factor=
1000
cPAD=
0.5
mg/
kg­
bw/
day
Dietary
exposure=
0.12
mg/
kg/
day
%
cPAD=
0.12
mg/
kg/
day/
0.5
mg/
kg­
bw/
day
x100
=
24
Model
Limitations
and
Areas
for
Further
Consideration
 
Actual
inert
ingredient
residue
levels­­
While
the
selected
group
of
active
ingredients
possesses
some
chemical
structural
diversity,
could
inert
ingredients
(
by
virtue
of
their
uptake
into
plants
and
environmental
persistence)
differ
greatly
from
active
ingredients
in
terms
of
the
nature
and
magnitude
of
their
plant
and
animal
residues?
What
about
degradates 
would
they
be
of
concern
or
need
to
be
separately
assessed?
 
Concentration
of
inert
in
formulation­­
Initial
analysis
of
"
benchmark"
products
for
many
of
the
57
most
"
significant"
active
ingredients
indicates
that
the
concentration
of
the
a.
i
 
any
single
inert
ingredient.
If
this
can
be
further
confirmed,
it
may
allow
for
a
"
maximum
%
inert"
adjustment
to
be
used
in
the
model.
 
Differences
in
product
use
rate
and
impacts
on
residue
level.­­
While
there
are
a
few
outliers,
most
of
these
a.
i.'
s
are
used
in
the
1­
5
lb
(
AI
basis)
per
season
use
rate.
 
"
Generic"
inert 
The
model
makes
no
distinction
as
to
formulation
type
or
timing
of
application.
It
may
be
possible
to
develop
other
models
for
more
specific
inert
use
(
e.
g.,
preemergent
use
only,
soil
incorporation
only).
 
Residues
in
meat,
milk,
poultry
and
eggs 
This
model
used
the
highest
tolerance
level
residues
for
input
into
DEEM
 
,
but
it
may
be
possible
to
utilize
residues
in
livestock
feed
items
and
chemical
specific
information
related
to
uptake
or
accumulation
of
secondary
residues
develop
a
different
set
of
values
on
a
per
inert
basis
for
meat,
milk,
poultry
and
eggs.

Table
1.
Estimated
Chronic
Dietary
Exposure1
for
a
Generic
Inert.
Population
Subgroup2
Estimated
Exposure,
mg/
kg/
day
U.
S.
Population
(
total)
0.120
All
infants
(<
1
year)
0.245
Children
(
1­
2
years)
0.422
Children
(
3­
5
years)
0.310
Children
(
6_
12
years)
0.174
Youth
(
13­
19
years)
0.100
Adults
(
20­
49
years)
0.087
Adults
(
50+
years)
0.086
Females
(
13_
49
years)
0.087
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs.
2Only
representative
population
subgroups
are
shown.

Table
2.
Estimated
Acute
Dietary
Exposure1
for
a
Generic
Inert.
Population
Subgroup2
Estimated
Exposure,
mg/
kg/
day
95th
Percentile
99th
Percentile
99.9th
Percentile
U.
S.
Population
(
total)
0.336
0.643
1.164
All
infants
(<
1
year)
0.701
1.060
2.056
Children
(
1­
2
years)
0.939
1.382
2.106
Children
(
3­
5
years)
0.683
1.010
1.476
Children
(
6_
12
years)
0.395
0.563
0.827
Youth
(
13­
19
years)
0.239
0.357
0.815
Adults
(
20­
49
years)
0.199
0.295
0.468
Adults
(
50+
years)
0.191
0.263
0.357
Females
(
13_
49
years)
0.198
0.287
0.415
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs.
2Only
representative
population
subgroups
are
shown.
Appendix
B:
PiRat
Output
Handler
Dermal
Exposures
PiRat
Handler
Report
for
Formulation
Type
Soluble
Concentrate
(
GARDEN)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
70.0
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
43
%

Scenario
#
1
Scenario
#
2
Scenario
#
3
Scenario
#
4
Product
Use:
garden
garden
garden
garden
Application
Method:
low
pressure
handwand;
MLAP
backpack;
MLAP
sprinkling
can,
MLAP
hose
end
sprayer;
MLAP
Dermal
PDR
(
mg/
kg/
day):
1.84E­
03
9.40E­
05
5.53E­
04
5.53E­
04
Inhalation
PDR
(
mg/
kg/
day)
N/
A
N/
A
N/
A
N/
A
Dermal
Unit
Exposure
(
mg/
lb):
100.00
Low
9­
80
reps
5.10
Low
9­
11
reps
30.00
Low
8
reps
30.00
Low
8
reps
Inhalation
Unit
Exposure
(
mg/
lb):
N/
A
N/
A
N/
A
N/
A
Application
Rate:
1.50E­
04*
lb/
ft2
1.50E­
04*
lb/
ft2
1.50E­
04*
mg/
kg/
day
1.50E­
04*
lb/
ft2
Fraction
Exposed:
N/
A
N/
A
N/
A
N/
A
Amount
used:
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
1000.00
ft2/
day
Density
(
lb/
gal):
N/
A
N/
A
N/
A
N/
A
MOE:
54000
1100000
180000
180000
Exposure
Frequency
(
yrs)
N/
A
N/
A
N/
A
N/
A
Exposure
Duration
(
yrs)
N/
A
N/
A
N/
A
N/
A
Averaging
Time
(
yrs)
N/
A
N/
A
N/
A
N/
A
LADD
N/
A
N/
A
N/
A
N/
A
Cancer
Risk
N/
A
N/
A
N/
A
N/
A
Dose
Calculation:
Scenario
#
1­
4
PDR=(
UE*
AR*
WF*
A)/
BW
Assumptions:
Scenario
#
1,
2
1,000
ft2/
day
assumed
to
be
equivalent
to
5
gal/
day;
SAC
Policy
11
Scenario
#
3
assumed
based
on
hose­
end;
SOPs
Scenario
#
4
SAC
Policy
11
*
Modified
by
user
PiRat
Handler
Report
for
Formulation
Type
Soluble
Concentrate
(
TURF)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
70
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
43
%

Scenario
#
1
Scenario
#
2
Scenario
#
3
Scenario
#
4
Product
Use:
turf
turf
turf
turf
Application
Method:
low
pressure
handwand;
MLAP
backpack;
MLAP
sprinkling
can;
MLAP
hose
end
sprayer;
MLAP
Dermal
PDR
(
mg/
kg/
day):
1.84E­
03
9.40E­
05
5.53E­
04
1.11E­
02
Inhalation
PDR
(
mg/
kg/
day)
N/
A
N/
A
N/
A
N/
A
Dermal
Unit
Exposure
(
mg/
lb):
100.00
Low
9­
80
reps
5.10
Low
9­
11
reps
30.00
Low
8
reps
30.00
Low
8
reps
Inhalation
Unit
Exposure
(
mg/
lb):
N/
A
N/
A
N/
A
N/
A
Application
Rate:
1.50E­
04*
lb/
ft2
1.50E­
04*
lb/
ft2
1.50E­
04*
mg/
kg/
day
1.50E­
04*
lb/
ft2
Fraction
Exposed:
N/
A
N/
A
N/
A
N/
A
Amount
used:
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
2.00E+
04
ft2/
day
(
full
broadcast)

Density
(
lb/
gal):
N/
A
N/
A
N/
A
N/
A
MOE:
54000
1100000
180000
9000
Exposure
Frequency
(
yrs)
N/
A
N/
A
N/
A
N/
A
Exposure
Duration
(
yrs)
N/
A
N/
A
N/
A
N/
A
Averaging
Time
(
yrs)
N/
A
N/
A
N/
A
N/
A
LADD
N/
A
N/
A
N/
A
N/
A
Cancer
Risk
N/
A
N/
A
N/
A
N/
A
Dose
Calculation:
Scenario
#
1­
4
PDR=(
UE*
AR*
WF*
A)/
BW
Assumptions:
Scenario
#
1,2
1,000
ft2/
day
assumed
to
be
equivalent
to
5
gal/
day;
SAC
Policy
11
Scenario
#
3
assumed
based
on
hose­
end;
SOPs
Scenario
#
4
upper
percentile
lawn
size
(
SAC
Policy
11)

*
Modified
by
user
Appendix
C:
PiRat
Output
Handler
Inhalation
Exposures
PiRat
Handler
Report
for
Formulation
Type
Soluble
Concentrate
(
GARDEN)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
70.0
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
100
%

Scenario
#
1
Scenario
#
2
Scenario
#
3
Scenario
#
4
Product
Use:
garden
garden
garden
garden
Application
Method:
low
pressure
handwand;
MLAP
backpack;
MLAP
sprinkling
can,
MLAP
hose
end
sprayer;
MLAP
Dermal
PDR
(
mg/
kg/
day):
N/
A
N/
A
N/
A
N/
A
Inhalation
PDR
(
mg/
kg/
day)
9.86E­
07
1.29E­
06
4.07E­
07
4.07E­
07
Dermal
Unit
Exposure
(
mg/
lb):
N/
A
N/
A
N/
A
N/
A
Inhalation
Unit
Exposure
(
mg/
lb):
3.00E­
02
Medium
80
reps
3.00E­
02
Low
11
reps
9.50E­
03
Low
8
reps
9.50E­
03
Low
8
reps
Application
Rate:
1.15E­
04*
lb/
ft2
1.50E­
04*
lb/
ft2
1.50E­
04*
mg/
kg/
day
1.50E­
04*
lb/
ft2
Fraction
Exposed:
N/
A
N/
A
N/
A
N/
A
Amount
used:
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
1000.00
ft2/
day
Density
(
lb/
gal):
N/
A
N/
A
N/
A
N/
A
MOE:
100000000
78000000
250000000
250000000
Exposure
Frequency
(
yrs)
N/
A
N/
A
N/
A
N/
A
Exposure
Duration
(
yrs)
N/
A
N/
A
N/
A
N/
A
Averaging
Time
(
yrs)
N/
A
N/
A
N/
A
N/
A
LADD
N/
A
N/
A
N/
A
N/
A
Cancer
Risk
N/
A
N/
A
N/
A
N/
A
Dose
Calculation:
Scenario
#
1­
4
PDR=(
UE*
AR*
WF*
A)/
BW
Assumptions:
Scenario
#
1,2
1,000
ft2/
day
assumed
to
be
equivalent
to
5
gal/
day;
SAC
Policy
11
Scenario
#
3
assumed
based
on
hose­
end;
SOPs
Scenario
#
4
SAC
Policy
11
*
Modified
by
user
PiRat
Handler
Report
for
Formulation
Type
Soluble
Concentrate
(
TURF)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
70
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
100
%

Scenario
#
1
Scenario
#
2
Scenario
#
3
Scenario
#
4
Product
Use:
turf
turf
turf
turf
Application
Method:
low
pressure
handwand;
MLAP
backpack;
MLAP
sprinkling
can;
MLAP
hose
end
sprayer;
MLAP
Dermal
PDR
(
mg/
kg/
day):
N/
A
N/
A
N/
A
N/
A
Inhalation
PDR
(
mg/
kg/
day)
1.29E­
06
1.29E­
06
4.07E­
07
8.14E­
06
Dermal
Unit
Exposure
(
mg/
lb):
N/
A
N/
A
N/
A
N/
A
Inhalation
Unit
Exposure
(
mg/
lb):
3.00E­
02
Medium
80
reps
3.00E­
02
Low
11
reps
9.50E­
03
Low
8
reps
9.50E­
03
Low
8
reps
Application
Rate:
1.50E­
04*
lb/
ft2
1.50E­
04*
lb/
ft2
1.50E­
04*
mg/
kg/
day
1.50E­
04*
lb/
ft2
Fraction
Exposed:
N/
A
N/
A
N/
A
N/
A
Amount
used:
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
(
spot)
1000.00
ft2/
day
2.00E+
04
ft2/
day
(
full
broadcast)

Density
(
lb/
gal):
N/
A
N/
A
N/
A
N/
A
MOE:
78000000
78000000
250000000
12000000
Exposure
Frequency
(
yrs)
N/
A
N/
A
N/
A
N/
A
Exposure
Duration
(
yrs)
N/
A
N/
A
N/
A
N/
A
Averaging
Time
(
yrs)
N/
A
N/
A
N/
A
N/
A
LADD
N/
A
N/
A
N/
A
N/
A
Cancer
Risk
N/
A
N/
A
N/
A
N/
A
Dose
Calculation:
Scenario
#
1­
4
PDR=(
UE*
AR*
WF*
A)/
BW
Assumptions:
Scenario
#
1,2
1,000
ft2/
day
assumed
to
be
equivalent
to
5
gal/
day;
SAC
Policy
11
Scenario
#
3
assumed
based
on
hose­
end;
SOPs
Scenario
#
4
upper
percentile
lawn
size
(
SAC
Policy
11)

*
Modified
by
user
Appendix
D:
PiRat
Output
Dermal
Post­
application
Exposures
Scenario
#
1
Product
Use:
turf
Activity:
dermal
contact
with
residues
on
turf
Population:
toddlers
(
3
years)

PDR
(
mg/
kg/
day)
0.15
Ingestion
Rate:
N/
A
T
(
or
Tc)
8700.00
cm2/
hr
Application
Rate:
1.50E­
04*
lb/
ft2
Weight
Fraction:
2.00E­
02
Fraction
Exposed:
0.20
Surface
Area
(
cm2/
event):
N/
A
Exposure
Time
(
hrs/
day):
2.00
Frequency
(
ev/
hr)
N/
A
Kp
(
cm/
hr)
N/
A
Vp
(
torr)
N/
A
Molecular
Weight
(
g/
mole)
N/
A
Room
Volume
(
m3)
N/
A
MOE:
680
Exposure
Frequency
(
days/
yr)
0.00
Exposure
Duration
(
yrs)
0.00
Averaging
Time
(
yrs)
70.00
LADD
(
mg/
kg/
day)
N/
A
Cancer
Risk
N/
A
Density
(
lbs/
gal)
N/
A
Body
Wt
(
postapp)
(
kg)
15.00
Treated
area
N/
A
Dose
Calculation:
PDR=(
AR*
WF*
F*
4.54e5
mg/
lb*
1.08e­
3
ft2/
cm2*
Tc*
ET)/
BW*
ABS
*
Modified
by
user
PIRAT
Post
Application
Report
for
Formulation
Type
Soluble
Concentrate
(
TURF)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
15
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
43
%
Appendix
E:
PiRat
Output
Oral
Post­
application
Exposures
PIRAT
Post
Application
Report
for
Formulation
Type
Soluble
Concentrate
(
TURF)

Functional
Use:
Antimicrobial
/
Preservatives
(
antimicrobial
agent,
bacteriacide,
preservative)
Toxicity
Value:
100
Body
Weight:
15
kg
Weight
Fraction:
2.00E­
02
Duration:
Short
Term
Absorption
Value:
100
%

Scenario
#
1
Scenario
#
2
Product
Use:
turf
turf
Activity:
ingestion
of
turf
residues
(
object
to
mouth)
hand­
to­
mouth
transfer
Population:
toddlers
(
3
years)
toddlers
(
3
years)

PDR
(
mg/
kg/
day)
4.90E­
04
1.96E­
03
Ingestion
Rate:
25.00
cm2/
day
0.50
(
saliva
extraction
factor)

T
(
or
Tc)
N/
A
N/
A
Application
Rate:
1.50E­
04*
lb/
ft2
1.50E­
04*
lb/
ft2
Weight
Fraction:
2.00E­
02
2.00E­
02
Fraction
Exposed:
0.20
5.00E­
02
Surface
Area
(
cm2/
event):
N/
A
20.00
Exposure
Time
(
hrs/
day):
N/
A
2.00
Frequency
(
ev/
hr)
N/
A
20.00
Kp
(
cm/
hr)
N/
A
N/
A
Vp
(
torr)
N/
A
N/
A
Molecular
Weight
(
g/
mole)
N/
A
N/
A
Room
Volume
(
m3)
N/
A
N/
A
MOE:
200000
51000
Exposure
Frequency
(
days/
yr)
0.00
0.00
Exposure
Duration
(
yrs)
0.00
0.00
Averaging
Time
(
yrs)
70.00
70.00
LADD
(
mg/
kg/
day)
N/
A
N/
A
Cancer
Risk
N/
A
N/
A
Density
(
lbs/
gal)
N/
A
N/
A
Body
Wt
(
postapp)
(
kg)
15.00
15.00
Treated
area
N/
A
N/
A
Dose
Calculation:
PDR=(
IgR*
AR*
WF*
F*
4.54E5
mg/
lb*
1.08e­
3
ft2/
cm2)/
BW*
ABS
PDR=(
AR*
WF*
F*
4.54e5
mg/
lb*
1.08E­
3
ft2/
cm2*
SA*
IgR*
FQ*
ET)/
BW*
ABS
*
Modified
by
user