UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
February
1,
2006
Subj:
Propiconazole:
Revised
Occupational
and
Residential
Exposure
Assessment
of
the
Antimicrobial
Uses
to
Support
the
Reregistration
Eligibility
Decision
(
RED)
Document.
PC
Code:
122101.
Reregistration
Case
No.
3125.
DP
Barcode
324052.

From:
Tim
Leighton,
Environmental
Scientist
Antimicrobials
Division/
Regulatory
Management
Branch
2
(
7510C)

Through:
Mark
Hartman,
Branch
Chief
Antimicrobials
Division/
Regulatory
Management
Branch
2
(
7510C)

To:
Stacey
Grigsby,
Chemical
Review
Manager
Antimicrobials
Division/
Regulatory
Management
Branch
2
(
7510C)

And,

Yan
Donovan,
Risk
Assessor
Health
Effects
Division/
Registration
Action
Branch
4
(
7509C)

The
attached
assessment
is
the
revised
draft
occupational
and
non­
occupational
(
residential)
exposure
and
risk
estimates
for
the
antimicrobial
uses
of
propiconazole
to
support
HED's
Reregistration
Eligibility
Decision
(
RED)
document.
The
revisions
are
based
on
the
"
erroronly
comments
submitted
by
Janssen
Pharmaceutica
Inc.
1
TABLE
OF
CONTENTS
EXECUTIVE
SUMMARY...................................................................................................
2
1.0
INTRODUCTION....................................................................................................
6
1.1
Purpose
.................................................................................................................
6
1.2
Criteria
for
Conducting
Exposure
Assessments
......................................................
6
1.3
Chemical
Identification
..........................................................................................
7
1.4
Physical/
Chemical
Properties..................................................................................
8
2.0
USE
INFORMATION..............................................................................................
8
2.1
Formulation
Types
and
Percent
Active
Ingredient
.................................................
8
2.2
Summary
of
Use
Pattern
and
Formulations............................................................
8
3.0
SUMMARY
OF
TOXICITY
DATA
........................................................................
10
3.1
Acute
Toxicity......................................................................................................
10
3.2
Summary
of
Toxicity
Endpoints
............................................................................
10
3.3
FQPA
Considerations
...........................................................................................
12
4.0
RESIDENTIAL
EXPOSURE
ASSESSMENT.........................................................
12
4.1
Summary
of
Registered
Uses
................................................................................
12
4.2
Residential
Exposure.............................................................................................
12
4.2.1
Residential
Handler
Exposures
......................................................................
13
4.2.2
Residential
Post­
application
Exposures..........................................................
14
4.2.3
Data
Limitations/
Uncertainties
......................................................................
15
5.0
RESIDENTIAL
AGGREGATE
RISK
ASSESSMENT
AND
CHARACTERIZATION..........................................................................................
15
6.0
OCCUPATIONAL
EXPOSURE
ASSESSMENT
....................................................
15
6.1
Occupational
Handler
Exposures
..........................................................................
18
6.2
Occupational
Post­
application
Exposures..............................................................
23
6.3
Metalworking
Fluids:
Machinist
...........................................................................
23
6.4
Wood
Preservation
...............................................................................................
25
6.4.1
Non­
Pressure
Treatment
Scenarios
(
Handler
and
Post­
application)................
25
6.4.1.1
Scenarios
Assessed
by
Worker
Function...................................................
25
6.4.1.2
Scenarios
Assessed
for
High
Pressure/
High
Volume
Spray
Application
Methods....................................................................................................
31
6.4.2
Pressure
Treatment
Scenarios
(
Handler
and
Post­
Application).......................
34
6.5
Data
Limitations/
Uncertainties
..............................................................................
36
7.0
REFERENCES.........................................................................................................
38
APPENDIX
A
(
Summary
of
CMA
and
PHED
Data)
:..........................................................
40
APPENDIX
B
(
Calculation
of
DDAC
Unit
Exposure
Values)
..............................................
43
2
EXECUTIVE
SUMMARY
This
document
is
the
Occupational
and
Residential
Exposure
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)
for
propiconazole.
It
addresses
the
potential
risks
to
humans
that
result
from
the
use
of
this
chemical
in
occupational
and
residential
settings.

At
this
time,
propiconazole
is
the
active
ingredient
in
material
preservative
products
(
Use
Site
Category
VII)
and
in
wood
preservation
products
(
Use
Site
Category
X).
As
a
materials
preservative,
the
products
are
used
in
items
such
as
metalworking
fluids,
adhesives,
caulks,
coatings,
stains,
paints,
inks,
paper,
textiles1,
canvas,
cordage,
leather,
and
leather
finishing
pastes,
fat
liquors,
or
finishes.
As
a
wood
preservative,
the
products
can
be
used
on
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
manufactured
wood
products
such
as
logs
(
including
for
log
home
construction),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
dry
lumber;
and
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
The
majority
of
the
products
are
intended
for
use
at
wood
treatment
facilities;
however,
propiconazole
is
also
formulated
for
use
in
mushroom
houses
to
protect
timber
trays
and
benches
and
for
use
on
cooling
tower
wood.
The
wood
and
wood
products
can
be
treated
through
non­
pressure
treatment
methods
and
pressure
treatment
methods.
The
percentage
of
propiconazole
in
various
products
can
range
from
0.1%
to
50%.
Products
containing
propiconazole
are
formulated
as
liquid
ready­
to­
use,
soluble
concentrates,
emulsifiable
concentrates,
and
flowable
concentrates.

The
durations
and
routes
of
exposure
evaluated
in
this
assessment
include
short­
term
(
ST),
intermediate­
term
(
IT),
and
in
some
instances
long­
term
(
LT)
dermal
and
inhalation
exposures
as
well
as
ST
incidental
oral
exposures.
Short­
term
dermal,
inhalation,
and
incidental
oral
endpoints
are
based
on
an
acute
neurotoxicity
(
oral)
study
in
rats.
The
shortterm
endpoint
(
NOAEL)
is
30
mg/
kg/
day
for
dermal,
inhalation,
and
incidental
oral
exposures.
The
adverse
effects
for
these
endpoints
are
based
on
observations
of
clinical
signs
consisting
piloerection,
diarrhea,
and
tip
toe.
The
intermediate­
and
long­
term
dermal,
inhalation,
and
incidental
oral
toxicological
endpoints
are
the
same
at
10
mg/
kg/
day.
These
endpoints
are
based
on
a
24
month
oncogenicity
(
oral)
study
in
mice
where
adverse
effects
included
increased
liver
weight
and
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)
in
males.
A
dermal
absorption
factor
of
40%
was
used
based
the
results
of
a
dermal
absorption
study.
For
inhalation
assessments,
an
absorption
factor
of
100%
was
used.

The
Agency's
level
of
concern
for
non­
cancer
risks
(
i.
e.,
target
level
for
MOEs
or
Margins
of
Exposure)
is
defined
by
the
uncertainty
factors
that
are
applied
to
the
assessment.
The
Agency
applies
a
10X
factor
to
account
for
inter­
species
extrapolation
and
a
10X
factor
to
account
for
intra­
species
variation.
The
total
uncertainty
factors
that
have
been
applied
to
non­
cancer
risk
assessments
are
100
for
occupational
and
residential
short­
and
intermediateterm
scenarios.
Propiconazole
is
listed
as
a
Group
C,
Possible
Human
Carcinogen.
A
cancer
slope
factor
was
not
identified
for
propiconazole,
therefore
a
quantitative
cancer
risk
assessment
is
not
provided
at
this
time.
Since
the
toxicity
effects
were
the
same
for
dermal,
inhalation
and
incidental
oral
exposures,
these
exposures
were
combined
for
a
total
MOE
for
1
It
should
be
noted
that
Syngenta
and
Janssen
agree
to
withdraw
the
use
of
propiconazole
for
the
treating
of
carpet
fibers,
apparel,
and
furnishings.
The
primary
textile
use
includes
"
canvas"
(
i.
e.,
awnings,
boat
covers,
carpet
backing,
cordage,
tents,
tarpaulins,
and
wall
coverings).
3
both
occupational
and
residential
assessments.

Based
on
examination
of
product
labels
describing
uses
for
the
product,
it
has
been
determined
that
exposure
to
handlers
can
occur
in
a
variety
of
occupational
and
residential
environments.
Additionally,
postapplication
exposures
are
likely
to
occur
only
in
the
occupational
setting.
The
representative
scenarios
selected
by
the
Antimicrobials
Division
(
AD)
for
assessment
were
evaluated
using
maximum
application
rates
as
stated
on
the
product
labels.

To
assess
the
handler
risks,
AD
used
surrogate
unit
exposure
data
from
the
following
proprietary
resources:
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study,
the
Pesticide
Handlers
Exposure
Database
(
PHED),
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)
(
Bestari
et
al.,
1999,
MRID
455243­
04
which
is
a
Sapstain
Industry
Task
Force
Study,
#
73154),
and
"
Assessment
of
Potential
Inhalation
and
Dermal
Exposure
Associated
with
Pressure
Treatment
of
Wood
with
Arsenical
Wood
Products"
(
ACC,
2002).
Additionally,
EPA's
Health
Effects
Division's
(
HED)
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
was
used
to
estimate
postapplication/
bystander
exposures.

Residential
Handler
Risk
Summary
For
the
residential
handler
dermal
and
inhalation
risk
assessment,
all
dermal,
inhalation
and
total
MOEs
were
above
the
target
MOE
of
100.

Occupational
Handler
Risk
Summary
For
the
occupational
handler
dermal
and
inhalation
risk
assessment,
the
MOEs
were
above
the
target
MOE
of
100
at
either
baseline
PPE/
open
pouring
or
through
the
use
of
mitigation
(
e.
g.,
metering
pumps)
for
all
scenarios
except
for
the
following
scenarios
listed
below.
The
reader
is
referred
to
Tables
6.2
through
6.10
to
review
the
various
needs
for
PPE
and/
or
metering
pumps
to
mitigate
risks
for
each
scenario.
It
should
be
noted
that
the
baseline
(
ungloved)
dermal
MOEs
for
material
preservation
of
paints,
textiles,
adhesives,
and
metalworking
fluid
were
calculated
using
unit
exposure
values
from
the
cooling
tower
CMA
data
set
because
baseline
dermal
unit
exposures
are
not
available
for
preservative
or
metal
fluid
categories.

Wood
Preservation:
 
Wood
Preservation,
spray
in
wood
treatment
facility:
IT/
LT
dermal
MOE
(
gloves)
at
50
gallons
=
96,
IT/
LT
total
MOE
at
50
gallons
=
86
 
Wood
Preservation,
spray
in
mushroom
house:
IT
dermal
MOE
(
gloves)
at
1,000
gallons
=
56,
IT
total
MOE
at
1,000
gallons
=
50.
 
Wood
Preservation,
treatment
operator
(
pressure
treatment):
IT
dermal
MOE
=
86
and
IT
total
MOE
=
86
Material
Preservation:
4
 
Painting,
airless
sprayer:
IT
baseline
dermal
MOE
=
26
and
IT
gloved
dermal
MOE
=
71.
IT
baseline
total
MOE
=
25
and
IT
gloved
total
MOE
=
62.

Occupational
Post­
application/
Bystander
Risk
Summary
For
the
occupational
postapplication
risk
assessment,
the
MOEs
were
above
target
MOE
of
100,
and
therefore
not
of
concern
for
all
scenarios
except
the
following:

Wood
Preservation:
 
Wood
Preservation,
clean­
up
worker
(
non­
pressure
treatment):
IT/
LT
dermal
MOE
=
51
and
IT/
LT
total
MOE
=
49.

Data
Limitations
and
Uncertainties:

There
are
a
number
of
uncertainties
associated
with
this
assessment
and
these
have
been
reiterated
from
Sections
4.4.3
(
residential)
and
6.5
(
occupational)
respectively.

The
data
limitations
and
uncertainties
associated
with
the
residential
handler
and
postapplication
exposure
assessments
include
the
following:

 
Surrogate
dermal
and
inhalation
unit
exposure
values
were
taken
from
the
Pesticide
Handler
Exposure
Database
(
USEPA,
1998)
(
See
Appendix
A
for
summary
of
this
database).
 
The
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
HED's
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000,
and
2001)
and
AD
standard
assumptions.
In
certain
cases,
no
standard
values
were
available
for
some
scenarios.
Assumptions
for
these
scenarios
were
based
on
AD
estimates
and
could
be
further
refined
from
input
from
registrants.
 
Propiconazole
is
used
on
many
different
types
of
wood.
AD
needs
additional
information
on
the
"
dry
lumber"
uses.
The
other
wood
treatments
would
result
in
minimal
dermal
and/
or
incidental
oral
exposure.
Inhalation
exposure
(
e.
g.,
in
log
homes
treated
with
propiconazole)
is
also
expected
to
be
negligible
based
on
the
low
vapor
pressure.
The
"
dry
lumber"
uses
need
to
be
defined
by
the
registrant
to
determine
if
propiconazole­
treated
lumber
is
used
to
build
residential
decks
and/
or
play
sets.
There
is
the
potential
for
dermal
exposure
to
treated
lumber
for
uses
in
decks
and
or
play
sets.
To
complete
an
assessment,
dislodgeable
residues
from
treated
wood
need
to
be
generated
(
i.
e.,
wipe
studies).

The
data
limitations
and
uncertainties
associated
with
the
occupational
handler
and
postapplication
exposure
assessments
include:

 
Surrogate
dermal
and
inhalation
unit
exposure
values
were
taken
from
the
proprietary
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study
(
USEPA,
1999:
DP
Barcode
D247642)
or
from
the
Pesticide
Handler
Exposure
Database
(
USEPA,
1998)
(
See
Appendix
A
for
summaries
of
these
data
sources).
Since
the
CMA
data
are
of
poor
quality,
the
Agency
requests
that
confirmatory
data
be
submitted
to
support
the
occupational
scenarios
assessed
in
this
document.
5
 
The
baseline
(
ungloved)
dermal
exposures
and
risks
for
material
preservation
of
paints,
textiles,
adhesives,
and
metalworking
fluid
were
calculated
using
unit
exposure
values
from
the
cooling
tower
CMA
data
set
because
baseline
dermal
unit
exposures
are
not
available
for
preservative
or
metal
fluid
CMA
unit
exposure
categories.
 
For
the
wood
preservative
pressure
treatment
scenarios,
proprietary
CCA
exposure
data
were
used
for
lack
of
propiconazole­
specific
exposure
data
and
for
the
wood
preservative
non­
pressure
treatment
scenarios,
proprietary
DDAC
exposure
data
were
used
for
the
lack
of
propiconazole­
specific
exposure
data.
Limitations
and
uncertainties
associated
with
the
use
of
these
data
include:
o
The
assumption
was
made
that
exposure
patterns
for
workers
at
treatment
facilities
using
CCA
and
DDAC
would
be
similar
to
exposure
patterns
for
workers
at
treatment
facilities
using
propiconazole,
and
therefore
the
exposures
could
be
used
as
surrogate
data
for
workers
that
treat
wood
with
propiconazole.
o
For
environmental
modeling,
it
was
assumed
that
the
leaching
process
from
the
propiconazole
treated
wood
would
be
similar
to
that
of
CCA
and
DDAC.
However,
due
to
the
lack
of
real
data
for
propiconazole
­
treated
wood,
it
is
not
possible
to
verify
this
assumption.

 
The
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
HED's
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000,
and
2001)
and
AD
standard
assumptions.
In
certain
cases,
no
standard
values
were
available
for
some
scenarios.
Assumptions
for
these
scenarios
were
based
on
AD
estimates
and
could
be
further
refined
from
input
from
registrants.
In
particular,
the
quantities
handled/
treated
for
the
application
of
propiconazole
to
wood
in
mushroom
houses
through
high
pressure/
high
volume
spray
methods
could
be
further
refined.
6
1.0
INTRODUCTION
1.1
Purpose
In
this
document,
the
Antimicrobials
Division
(
AD)
presents
the
results
of
its
review
of
the
potential
human
health
effects
of
occupational
and
residential
exposure
to
propiconazole.
This
information
is
for
use
in
EPA's
development
of
the
propiconazole
Reregistration
Eligibility
Decision
Document
(
RED).

1.2
Criteria
for
Conducting
Exposure
Assessments
An
occupational
and/
or
residential
exposure
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
propiconazole,
both
criteria
are
met.

In
this
document,
scenarios
were
assessed
by
using
unit
exposure
data
to
estimate
occupational
and
residential
handlers'
exposures.
Unit
exposures
are
estimates
of
the
amount
of
exposure
to
an
active
ingredient
a
handler
receives
while
performing
various
handler
tasks
and
are
expressed
in
terms
of
micrograms
or
milligrams
(
1
mg
=
1,000
µ
g)
of
active
ingredient
per
pounds
of
active
ingredient
handled.
A
series
of
unit
exposures
have
been
developed
that
are
unique
for
each
scenario
typically
considered
in
assessments
(
i.
e.,
there
are
different
unit
exposures
for
different
types
of
application
equipment,
job
functions,
and
levels
of
protection).
The
unit
exposure
concept
has
been
established
in
the
scientific
literature
and
also
through
various
exposure
monitoring
guidelines
published
by
the
USEPA
and
international
organizations
such
as
Health
Canada
and
OECD
(
Organization
for
Economic
Cooperation
and
Development).

Using
surrogate
unit
exposure
data,
maximum
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposures
and
risks
to
handlers
were
assessed.
The
exposure/
risks
were
calculated
using
the
following
equations:

Daily
Exposure:
Daily
dermal
or
inhalation
handler
exposures
are
estimated
for
each
applicable
handler
task
with
the
application
rate,
quantity
treated/
handled
in
a
day,
and
the
applicable
dermal
or
inhalation
unit
exposure
using
the
following
formula:

Daily
Exposure:
E
=
UE
x
AR
x
AT
(
Eq.
1)

Where:
E
=
Amount
(
mg
ai/
day)
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
inhaled
that
is
available
for
inhalation
absorption;
UE
=
Unit
exposure
value
(
mg
ai/
lb
ai)
derived
from
August
1998
PHED
data
or
from
1992
CMA
data;
AR
=
Maximum
application
rate
based
on
a
logical
unit
treatment,
such
as
acres
(
A),
square
feet
(
sq.
ft.),
gallons
(
gal),
or
cubic
feet
(
cu.
ft).
Maximum
values
are
generally
used
(
lb
ai/
A,
lb
ai/
sq
ft,
lb
ai/
gal,
lb
ai/
cu
ft);
and
AT
=
Normalized
application
area
based
on
a
logical
unit
treatment
such
as
acres
(
A/
day),
square
feet
(
sq
ft/
day),
gallons
(
gal/
day),
or
cubic
feet
(
cu
ft/
day).
7
Daily
Dose:
The
daily
dermal
or
inhalation
dose
is
calculated
by
normalizing
the
daily
exposure
by
body
weight
and
adjusting,
if
necessary,
with
an
appropriate
absorption
factor.
An
absorption
factor
of
40%
was
used
for
dermal
exposures
and
an
absorption
factor
of
100%
was
used
for
inhalation
exposures
since
the
endpoint
was
based
on
an
oral
study.
Daily
dose
was
calculated
using
the
following
formula:

Daily
Dose:
ADD
=
E
x
ABS
(
Eq.
2)
BW
Where:
ADD
=
Average
daily
dose
or
the
absorbed
dose
received
from
exposure
to
a
chemical
in
a
given
scenario
(
mg
active
ingredient/
kg
body
weight/
day);
E
=
Amount
(
mg
ai/
day)
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
inhaled
that
is
available
for
inhalation
absorption;
ABS
=
A
measure
of
the
amount
of
chemical
that
crosses
a
biological
boundary
such
as
lungs
(%
of
the
total
available
absorbed);
and
BW
=
Body
weight
determined
to
represent
the
population
of
interest
in
a
risk
assessment
(
kg).

Margins
of
Exposure:
Non­
cancer
inhalation
and
dermal
risks
for
each
applicable
handler
scenario
are
calculated
using
a
Margin
of
Exposure
(
MOE),
which
is
a
ratio
of
the
daily
dose
to
the
toxicological
endpoint
of
concern.

Margins
of
Exposure:
MOE
=
NOAEL
or
LOAEL
(
Eq.
3)
ADD
Where:
MOE
=
Margin
of
exposure,
value
used
to
represent
risk
or
how
close
a
chemical
exposure
is
to
being
a
concern
(
unitless);
NOAEL
or
LOAEL
=
Dose
level
in
a
toxicity
study,
where
no
observed
adverse
effects
(
NOAEL)
or
where
the
lowest
observed
adverse
effects
(
LOAEL)
occurred
in
the
study
(
mg/
kg/
day);
and
ADD
=
Average
daily
dose
or
the
absorbed
dose
received
from
exposure
to
a
chemical
in
a
given
scenario
(
mg
ai/
kg
body
weight/
day).

In
addition
to
the
target
MOEs
from
Table
3.2
that
were
used
for
the
analysis,
a
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
handler
risk
assessment.
Each
general
assumption
and
factor
for
both
residential
and
occupational
assessments
is
detailed
below.
Assumptions
specific
to
the
use
site
category
are
listed
in
each
separate
section
of
this
document.
The
general
assumptions
and
factors
include:

 
Propiconazole
products
are
widely
used
and
have
a
large
number
of
use
patterns
that
are
difficult
to
completely
capture
in
this
document.
As
such,
AD
has
patterned
this
risk
assessment
on
a
series
of
likely
representative
scenarios
for
each
use
site
that
are
believed
by
AD
to
represent
the
vast
majority
of
propiconazole
uses.
 
The
average
body
weight
of
an
adult
handler
of
70
kg
was
used
to
complete
the
noncancer
risk
assessment.
 
Exposure
factors
used
to
calculate
daily
exposures
to
handlers
were
based
on
applicable
data,
if
available.
When
appropriate
data
were
lacking,
values
from
a
scenario
deemed
similar
were
used.
 
The
maximum
application
rates
allowed
by
labels
were
assumed.
1.3
Chemical
Identification
8
Propiconazole
is
identified
as
follows:

 
Common/
Chemical
Name:
Propiconazole
 
PC
Code:
122101
 
CAS
Number:
60207­
90­
1
1.4
Physical/
Chemical
Properties
Table
1.1
shows
physical/
chemical
characteristics
that
have
been
reported
for
propiconazole.

Table
1.2.
Physical/
Chemical
Properties
of
Propiconazole
Parameter
Propiconazole
Molecular
Weight
342.23
Density
1.27
g/
cm3
Boiling
Point
180
C
at
0.1
mmHg
Water
Solubility
110
ppm
at
20
C
Vapor
Pressure
1.0
x
10
­
6
mmHg
at
20
C
2.0
USE
INFORMATION
2.1
Formulation
Types
and
Percent
Active
Ingredient
The
products
containing
propiconazole
as
the
active
ingredient
(
a.
i)
are
formulated
as
liquid
ready­
to­
use,
soluble
concentrates,
emulsifiable
concentrates,
and
flowable
concentrates.
Concentrations
of
propiconazole
in
these
products
range
from
0.1%
to
50%.

2.2
Summary
of
Use
Pattern
and
Formulations
The
Agency
determines
potential
exposures
to
handlers
of
the
product
by
identifying
exposure
scenarios
from
the
various
application
methods
that
are
plausible,
given
the
label
uses.
These
scenarios
are
identified
in
Table
2.1.
Based
on
a
review
of
product
labels,
propiconazole
is
the
active
ingredient
in
material
preservation
products
(
Use
Site
Category
VII)
and
in
wood
preservation
products
(
Use
Site
Category
X).
As
a
materials
preservative,
the
products
are
used
in
items
such
as
metalworking
fluids,
adhesives,
caulks,
coatings,
stains,
paints,
inks,
paper,
textiles2,
canvas,
cordage,
leather,
and
leather
finishing
pastes,
fat
liquors,
or
finishes.
As
wood
preservative,
the
products
can
be
used
on
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
manufactured
wood
products
such
as
logs
(
including
for
log
home
construction),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
dry
lumber;
and
2
It
should
be
noted
that
Syngenta
and
Janssen
agree
to
withdraw
the
use
of
propiconazole
for
the
treating
of
carpet
fibers,
apparel,
and
furnishings.
The
primary
textile
use
includes
"
canvas"
(
i.
e.,
awnings,
boat
covers,
carpet
backing,
cordage,
tents,
tarpaulins,
and
wall
coverings).
9
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
The
majority
of
the
products
are
intended
for
use
at
wood
treatment
facilities,
however,
propiconazole
is
also
formulated
for
use
in
mushroom
houses
to
protect
timber
trays
and
benches
and
for
use
on
cooling
tower
wood.
The
wood
and
wood
products
can
be
treated
through
non­
pressure
treatment
methods
and
pressure
treatment
methods.

From
Table
2.1,
AD
selected
representative
exposure
scenarios
to
assess
the
labeled
uses
of
propiconazole
in
this
document.
These
scenarios
were
selected
to
be
representative
of
the
vast
majority
of
uses
and
are
believed
to
provide
high­
end
degrees
of
dermal
or
inhalation,
exposure.
The
representative
scenarios
assessed
in
this
document
are
shown
in
Table
4.1
(
residential)
and
Table
6.1
(
occupational).

Table
2.1.
Potential
Use
Scenarios
Based
on
Product
Labels
for
Propiconazole
Registration
Numbers
Example
Use
Sites
Scenarios
Use
Site
Category
VII
­
Material
Preservatives
5383­
114,
1448­
394,
3813­
19,
43813­
37,
43813­
16,
70227­
6,
71406­
1
Used
in
the
production
of
various
household,
institutional
and
industrial
items
 
Adhesives
 
Caulks
 
Coatings
(
including
paper,
roof
and
stucco
and
EIFS
coatings)
 
Inks
 
Joint
cements
 
Leather
 
Leather
finishing
pastes,
fatliquors,
or
finishes
 
Metalworking
fluids
 
Paints
 
Sealants
 
Stains
 
Canvas,
and
cordage
(
through
dye
incorporation,
pad,
exhaust,
or
spray
application)
Use
Site
Category
X
­
Wood
Preservatives
1022­
585,
1448­
394,
1448­
414,
5383­
114a,
43813­
15,
43813­
16b,
43813­
19,
43813­
37c,
57227­
3,
57227­
6,
60061­
102d,
60061­
107,
60061­
109,
60061­
112,
60061­
114,
60061­
115,
62190­
12,
62190­
17,
70227­
4,
70227­
6,
71406­
1,
72616­
1,
74405­
1,
75101­
1
 
Fresh
lumber,
poles,
posts,
timbers
 
Dry
lumber
 
Wood
products
such
as
logs
(
including
log
home
construction,
poles,
timbers),
particle
board,
wafer
board,
wood
chips,
saw
dust,
and
plywood
 
Wood
in
cooling
towers
 
Wood
in
mushroom
houses
 
Non­
pressure
treatment
of
wood
and
wood
products
through
methods
such
as
dipping,
conventional
spray
system,
spray
box,
low
pressure
spray,
high
pressure
spray,
low
volume
spray
machine,
immersion,
brush,
roller
coater,
and
flood.

 
Pressure
treatment
of
wood
and
wood
products
through
methods
such
as
vacuum,
full­
cell,
and
modified
fullcell

 
Spray
and
paint
cooling
tower
wood
 
Pouring
of
product
into
cooling
tower
water
for
protection
of
wood
 
Spray
(
large
droplet
sprayer)
or
dip
wood
trays
and
boards
in
mushroom
house
a.
Label
5383­
114
does
not
provide
an
application
method.
b.
Label
43813­
16
does
not
specifically
indicate
if
the
cooling
tower
wood
is
treated
before
or
after
manufacture
10
of
the
cooling
tower.
c.
Label
43813­
37
indicates
a
maximum
of
1%
ai
solution
for
non­
pressure
treatment
methods
such
as
immersion,
roller
coater,
flood,
spray,
and
brush
d.
Label
60061­
102
indicates
that
the
product
(
Kop­
Coat
Woodtreat­
10)
is
to
be
used
only
in
combination
with
Kop­
Coats
sapstain
control
products.

3.0
SUMMARY
OF
TOXICITY
DATA
3.1
Acute
Toxicity
The
acute
toxicity
data
for
propiconazole
are
summarized
below
in
Table
3.1
(
USEPA,
2003).

Table
3.1.
Acute
Toxicity
Profile
for
Propiconazole
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
81­
1
Acute
Oral
­
rat
00058591
LD50
=
1517
mg/
kg
III
81­
2
Acute
Dermal­
rabbit
00058596
LD50
=
>
4000
mg/
kg
III
81­
3
Acute
Inhalation
­
rat
41594801
LC50
=
>
50.84
mg/
L
IV
81­
4
Primary
Eye
Irritation
00058597
Corneal
opacity
reversed
in
72
hours
III
81­
5
Primary
Skin
Irritation
00058598
No
irritation
IV
81­
6
Dermal
Sensitization
00058600
Non
sensitizer
­

3.2
Summary
of
Toxicity
Endpoints
Table
3.2
summarizes
the
toxicological
endpoints
for
propiconazole
(
USEPA,
2003).

Table
3.2
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
50)
Dev.
NOAEL
=
30
mg
ai/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Developmental
Toxicity
Study
­
Rats.
Increased
incidence
of
rudimentary
ribs,
cleft
palate
malformations
(
0.3%)
unossified
sternebrae,
as
well
as
increased
incidence
of
shortened
and
absent
renal
papillae.

Acute
Dietary
(
General
Population
including
infants
and
children)
NOAEL
=
30
mg
ai/
kg
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
at
100
mg/
kg
11
Table
3.2
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Chronic
Dietary
(
All
populations)
NOAEL
=
10
mg
ai/
kg/
day
UF
=
100
Chronic
RfD
=
0.1
mg/
kg/
day
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.1
mg/
kg/
day
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Short­
Term
(
1­
30
days)
Incidental
Oral
NOAEL=
30
mg
ai/
kg
Residential
MOE
=
100
Occupational
=
NA
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
at
100
mg/
kg
Intermediate­
Term
(
1
­
6
months)
Incidental
Oral
NOAEL=
10
mg
ai/
kg/
day
Residential
MOE
=
100
Occupational
=
NA
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Short­
Term
(
1
­
30
days)
Dermal
(
General
Pop.
including
infants
and
children)
Oral
NOAEL=
30
mg
ai/
kg
(
Dermal
absorption
rate
=
40%)
Residential
MOE
=
100
Occupational
MOE
=
100
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
at
100
mg/
kg
Intermediate­
Term
(
1
­
6
months)
and
Long­
Term
Dermal
(>
6
months)
Oral
NOAEL=
10
mg
ai/
kg/
day
(
Dermal
absorption
rate
=
40%)
Residential
MOE
=
100
Occupational
MOE
=
100
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Short­
Term
(
1
­
30
days)
Inhalation
Oral
NOAEL=
30
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
Acute
Neurotoxicity
Study
­
Rats.
Clinical
toxicity:
piloerection,
diarrhea,
tip
toe
at
100
mg/
kg
Intermediate­
Term
(
1
­
6
months)
and
Long­
Term
Inhalation
(>
6
months)
Oral
NOAEL=
10
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Cancer
(
Oral,
dermal,
inhalation)
Group
C,
possible
human
carcinogen
UF
=
uncertainty
factor,
FQPA
SF
=
special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic),
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
Level
of
concern,
NA
=
Not
Applicable.
12
It
should
be
noted
that
although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.

3.3
FQPA
Considerations
It
has
been
determined
by
the
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
that
no
special
FQPA
safety
factor
is
required
for
propiconazole
because
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity.
For
a
more
thorough
review
of
the
FQPA
safety
factor
the
reader
is
referred
to
the
HIARC
report
(
USEPA
2003a).

4.0
RESIDENTIAL
EXPOSURE
ASSESSMENT
4.1
Summary
of
Registered
Uses
Some
products
containing
propiconazole
can
be
used
as
a
material
preservative
in
a
variety
of
products,
such
as
textiles
and
paints,
which
can
result
in
exposure
to
residential
users
handling
the
treated
products.
Table
2.1
presents
a
summary
of
all
exposure
scenarios,
including
those
scenarios
which
may
occur
in
residential
settings.
Table
4.1
identifies
the
representative
exposure
scenarios
assessed
in
this
document.
It
should
be
noted
that
Syngenta
and
Janssen
agree
to
withdraw
the
use
of
propiconazole
for
the
treating
of
carpet
fibers,
apparel,
and
furnishings.
The
primary
textile
use
includes
"
canvas"
(
i.
e.,
awnings,
boat
covers,
carpet
backing,
cordage,
tents,
tarpaulins,
and
wall
coverings).

4.2
Residential
Exposure
The
exposure
scenarios
assessed
in
this
document
for
the
representative
uses
selected
by
AD
are
shown
in
Table
4.1.
The
table
also
shows
the
maximum
application
rate
associated
with
the
representative
use
and
the
EPA
Registration
number
for
the
corresponding
product
label.
Handler
exposures
were
assessed
for
the
application
of
propiconazole
used
as
a
material
preservative
in
paint
(
paint
brush/
roller
and
airless
sprayer).
Based
on
the
low
vapor
pressure
of
propiconazole,
no
post
application
inhalation
exposure
is
anticipated
to
occur.
Furthermore,
based
on
the
new
use
patterns
(
i.
e.,
no
treated
fibers/
textiles)
in
the
residential
setting,
no
post­
application
exposures
are
expected
to
occur.
13
Table
4.1.
Representative
Uses
Associated
with
Residential
Exposure
to
Propiconazole
Representative
Use
Exposure
Scenario
Application
Method
Registration
#
Application
Rate
Using
treated
paint
ST
Handler:
Adult
dermal
and
inhalation
(
aerosols)
Paint
brush/
rollers,
airless
sprayer
5383­
114
0.35%
a.
i.
by
weight
of
material
to
be
preserved
(
5%
product
by
weight
of
material
treated
x
7%
a.
i.
in
the
product)

ST
=
Short­
term
exposure
4.2.1
Residential
Handler
Exposures
The
residential
handler
scenarios
described
in
Table
4.1
were
assessed
to
determine
dermal
and
inhalation
exposures.
The
scenarios
were
assessed
using
PHED
data
and
Equations
1­
3
in
Section
1.2,
"
Criteria
for
Conducting
Risk
Assessment."
A
summary
of
the
PHED
data
set
is
presented
in
Appendix
A.

Unit
Exposure
Values:
Unit
exposure
values
were
taken
from
the
PHED
data
presented
in
HED's
Residential
SOPs
(
USEPA,
1997).

 
For
the
airless
sprayer
scenario,
PHED
dermal
and
inhalation
unit
exposure
values
for
a
residential
handler
applying
a
pesticide
using
an
airless
sprayer
were
used.
These
unit
ungloved
exposure
values
(
79
mg/
lb
a.
i.
for
dermal
and
0.83
mg/
lb
a.
i.
for
inhalation)
represent
a
handler
wearing
short
pants
and
a
short
sleeve
shirt,
with
no
gloves.
 
For
the
brush/
roller
scenario,
PHED
dermal
and
inhalation
unit
exposure
values
for
a
residential
handler
applying
a
pesticide
in
paint
using
a
paint
brush
to
paint
a
bathroom
were
used.
These
unit
exposure
values
(
230
mg/
lb
a.
i.
for
dermal
and
0.284
mg/
lb
a.
i.
for
inhalation)
represent
a
handler
wearing
short
pants
and
a
short
sleeve
shirt,
with
no
gloves.

Quantity
handled/
treated:
The
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
AD's
standard
assumptions.

 
For
the
airless
sprayer
in
paint
applications,
it
is
assumed
that
15
gallons
(
or
150
lb/
day,
assuming
paint
has
a
density
of
10
lb/
gal)
of
treated
paint
will
be
used
per
day
(
USEPA,
2005b).
 
For
the
brush/
roller
in
paint
applications,
it
is
assumed
that
2
gallons
(
or
20
lb/
day,
assuming
paint
has
a
density
of
10
lb/
gal)
of
treated
paint
will
be
used
per
day
(
USEPA,
2005b).

Duration
of
Exposure:
The
duration
of
exposure
for
most
homeowner
applications
of
paint
is
believed
to
be
best
represented
by
the
short­
term
duration
(
1
to
30
days).
The
reason
that
short
term
duration
was
chosen
to
be
assessed
is
because
the
different
handler
and
postapplication
scenarios
are
assumed
to
be
episodic,
not
daily.
In
addition,
homeowners
are
assumed
to
use
different
products
with
varying
actives,
not
exclusively
propiconazole
treated
products.
14
Results
The
resulting
short­
term
exposures
and
MOEs
for
the
representative
residential
handler
scenarios
are
presented
in
Table
4.2.
The
calculated
dermal
and
total
MOEs
were
above
the
target
MOE
of
100
for
both
scenarios
(
330
for
brush/
roller
and
130
for
airless
spray).
The
inhalation
MOEs
were
also
well
above
the
target
MOE
of
100.

Although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.
All
short­
term
inhalation
MOEs
exceeded
1,000
therefore,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
these
exposure
scenarios.

Table
4.2
Short­
Term
Residential
Handlers
Exposures
and
MOEs
Unit
Exposure
(
mg/
lb
a.
i.)
Absorbed
Daily
Dose
(
mg/
kg/
day)
e
MOE
f
Exposure
Scenario
­­
Application
Method
Application
Ratea
Quantity
Handled/
Treated
per
dayb
Dermalc
Inhalationd
Dermal
Inhalation
Dermal
(
Target
=
100)
Inhalation
(
Target
=
100)
TOTAL
MOE
g
(
Target
=
100)

Painting
­­
Brush/
Roller
0.35%
a.
i.
by
weight
20
lbs
230
0.284
0.092
0.0003
330
110,000
330
Painting 
Airless
Sprayer
0.35%
a.
i.
by
weight
150
lbs
79
0.83
0.24
0.0062
130
4,800
120
a
Application
rates
are
the
maximum
application
rates
determined
from
EPA
registered
labels
for
propiconazole.
b
Amount
handled
per
day
values
are
estimates
based
on
AD's
standard
assumptions.
c
All
dermal
unit
exposures
represent
ungloved,
short­
sleeve
shirt,
and
short
pants
replicates.
d
Baseline
=
No
respirator
e
Absorbed
Daily
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
a.
i.)
*
application
rate
(%
a.
i.
weight)
*
quantity
treated
(
lb/
day)
*
absorption
factor
(
0.4
for
dermal;
1.0
for
inhalation)]/
Body
weight
(
70
kg).
f
MOE
=
NOAEL
/
Absorbed
Daily
Dose.
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation].
Target
MOE
is
100.
g
Total
MOE
=
1/((
1/
Dermal
ST
MOE)
+
(
1/
Inhalation
ST
MOE)).
The
target
MOE
is
100.

4.2.2
Residential
Post­
application
Exposures
As
previously
stated,
post­
application
residential
scenarios
were
not
necessary
to
assess
because
of
propiconazole's
low
vapor
pressure
(
therefore,
no
inhalation
exposure)
and
the
registrants'
deletion
of
the
only
other
residential
use
(
i.
e.,
materials
preservative
in
fabrics,
textiles,
are
carpet
fibers).

Additionally,
propiconazole
is
used
to
treat
various
types
of
wood.
Propiconazole
is
used
on
many
different
types
of
wood
including
1)
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
2)
manufactured
wood
products
such
as
logs
(
including
for
log
home
construction),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
3)
dry
lumber;
and
4)
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
From
these
4
groupings,
AD
needs
additional
information
on
the
"
dry
lumber"
uses.
The
other
3
groupings
would
result
in
minimal
dermal
and/
or
incidental
oral
exposure.
Inhalation
exposure
(
e.
g.,
in
log
homes
treated
with
propiconazole)
is
also
expected
to
be
15
negligible
based
on
the
low
vapor
pressure.
The
"
dry
lumber"
uses
need
to
be
defined
by
the
registrant
to
determine
if
propiconazole­
treated
lumber
is
used
to
build
residential
decks
and/
or
play
sets.
There
is
the
potential
for
dermal
and
incidental
oral
exposures
to
treated
lumber
for
uses
in
decks
and
or
play
sets.
To
complete
an
assessment,
dislodgeable
wood
residues
would
need
to
be
generated
(
i.
e.,
wipe
studies).

4.2.3
Data
Limitations/
Uncertainties
There
are
several
data
limitations
and
uncertainties
associated
with
the
residential
handler
exposure
assessments.
These
include
the
following:

 
Surrogate
dermal
and
inhalation
unit
exposure
values
were
taken
from
the
Pesticide
Handler
Exposure
Database
(
USEPA,
1998)
(
See
Appendix
A
for
summaries
of
these
data
sources).
 
The
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
HED's
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000,
and
2001).
In
certain
cases,
no
standard
values
were
available
for
some
scenarios.
Assumptions
for
these
scenarios
were
based
on
AD
estimates
and
could
be
further
refined
from
input
from
registrants.

5.0
RESIDENTIAL
AGGREGATE
RISK
ASSESSMENT
AND
CHARACTERIZATION
The
aggregate
risk
assessment
for
propiconazole
will
be
conducted
by
the
Health
Effects
Division
(
HED).
However,
there
are
no
antimicrobial
residential
uses
that
are
likely
to
co­
occur.

6.0
OCCUPATIONAL
EXPOSURE
ASSESSMENT
The
exposure
scenarios
assessed
in
this
document
for
the
representative
uses
selected
by
AD
are
shown
in
Table
6.1.
The
table
also
shows
the
maximum
application
rate
associated
with
the
representative
use
and
the
appropriate
EPA
Registration
number
for
the
product
label.
It
should
be
noted
that
for
the
calculation
of
application
rates
in
which
8.34
lb
a.
i./
gal
is
noted,
the
product
is
assumed
to
have
the
density
of
water
because
no
product­
specific
density
is
available.

Occupational
handler
exposure
can
occur
during
the
preservation
of
materials
that
are
used
for
household,
institutional,
and
industrial
uses
(
metalworking
fluid,
paint,
canvas,
etc),
along
with
the
preservation
of
wood.
Additionally,
occupational
post­
application
exposures
can
occur
through
the
use
of
the
treated
products
through
job
functions
such
as
a
painter
and
machinist.
The
"
preservation
of
materials"
refers
to
the
scenario
of
a
worker
adding
the
preservative
to
the
material
being
treated
through
either
liquid
pour
or
liquid
pump
methods.
Liquid
pour
refers
to
transferring
the
antimicrobial
product
from
a
small
container
to
an
open
vat.
Liquid
pump
refers
to
transferring
the
preservative
by
connecting/
disconnecting
a
chemical
metering
pump
from
a
tote
or
by
gravity
flow.
For
the
preservation
of
wood,
the
procedure
for
treatment
can
occur
in
different
ways,
such
that
multiple
worker
functions
were
analyzed.
Due
to
the
complexity
of
the
wood
preservative
analysis,
the
results
for
handler
and
post­
application
exposures
are
presented
in
a
separate
section,
6.4.
16
Table
6.1.
Representative
Exposure
Scenarios
Associated
with
Occupational
Exposures
to
Propiconazole
Representative
Use
Method
of
Application
Exposure
Scenario
Registration
#
Application
Rate
Material
Preservation
(
Use
Site
Category
VII)

Paint
Preservation
of
paint
 
Liquid
pour
 
Liquid
pump
Professional
painter
 
Brush/
Roller
 
Airless
sprayer
IT
and
ST
Handler:
Dermal
and
inhalation
ST
Prof
Painter:
Dermal
and
inhalation
5383­
114
0.35%
a.
i.
by
weight
of
material
to
be
preserved
(
5%
product
by
weight
of
material
treated
x
7%
a.
i.
in
the
product)

Textiles/
Canvas
 
Liquid
pour
 
Liquid
pump
IT
and
ST
Handler:
Dermal
and
inhalation
5383­
114
0.28%
a.
i.
by
weight
of
material
to
be
preserved
(
4%
product
by
weight
of
material
treated
x
7%
a.
i.
in
the
product)

Adhesives,
coatings,
caulks,
sealants,
and
inks
 
Liquid
pour
 
Liquid
pump
IT
and
ST
Handler:
Dermal
and
inhalation
43813­
19
1.213%
a.
i.
by
weight
of
material
to
be
preserved
(
12.5%
based
on
total
weight
of
formulation
x
9.7%
a.
i.
in
product)

Metalworking
fluid
(
worker
pouring
preservative
into
fluid
being
treated)
 
Liquid
pour
 
Liquid
pump
IT/
LT
and
ST
Handler:
Dermal
and
inhalation
ST
and
IT/
LT
Machinist:
dermal
and
inhalation
43813­
16
0.07%
a.
i.
by
weight
of
fluid
(
700
ppm
a.
i.
in
diluted
fluid
x
1%/
10,000
ppm)
17
Wood
Preservation
(
Use
Site
Category
X)

Handler
Worker
Functions
 
Diptank
Operators
 
Blender/
spray
operators
 
Chemical
operators
Post­
Application
Worker
Functions
 
Graders
 
Trim
saw
operators
 
Clean­
up
crews
 
Construction
Workers
IT/
LT
and
ST
Handler
and
Post­
application:
Dermal
and
inhalation
43813­
19
or
43813­
37a
Diptank
operators
and
blender/
spray
operators:

1%
ai
solution
for
sapstain
(
43813­
19)

and
0.5%
ai
solution
for
decay
control
All
other
worker
functions:

50%
ai
in
product
(
43813­
37)
Non­
pressure
treatment
of
wood
and
wood
products
in
wood
treatment
facilities
 
High
pressure/
high
volume
spray
IT
and
ST
Handler:
Dermal
and
inhalation
60061­
112
0.1460
lb
ai
gal
(
1
gal
product/
2
gal
water
*
density
8.34
lb/
gal
*
3.5%
ai)

Mushroom
house
(
Nonpressure
treatment)
 
High
pressure/
high
volume
spray
IT
and
ST
Handler:
Dermal
and
inhalation
43813­
15
0.0125
lb
ai/
gal
(
19.5
oz/
25gal
water*
1gal/
128
oz
*
2.05
lb
ai/
gal)

**
1
gal
solution/
200
ft2
wood
Cooling
towers
(
Non­
pressure
treatment)
 
High
pressure/
high
volume
spray
IT
and
ST
Handler:
Dermal
and
inhalation
43813­
16
0.0216
lb
ai/
gal
(
1.1%
product
solution
*
23.6%
ai
*
8.34
lb/
gal)

**
1
gal
solution/
47
ft2
wood
Pressure
treatment
of
wood
and
wood
products
in
wood
treatment
facilities
Handler
Worker
Functions
 
Treatment
assistant
 
Treatment
operator
Post­
Application
Worker
Functions
 
Tram
setter,
stacker
operator,
loader
operator,
supervisor,
test
borer,
and
tallyman
IT/
LT
and
ST
Handler
and
Post­
application:
Dermal
and
inhalation
Provided
by
Registrant
b
1%
ai
solution
ST=
short­
term
(
1
to
30
days),
IT=
intermediate­
term
(
1
to
6
months),
LT
=
long­
term
(
greater
than
6
months)
a.
Diptank
operators
and
blender/
spray
operators
are
assessed
using
the
maximum
percent
ai
in
solution.
The
maximum
application
for
non­
pressure
treatment
methods
such
as
immersion,
roller
coater,
flood,
spray,
and
brush
is
1%
ai
solution
(
43813­
19).
These
methods
are
for
finished
wood
products.
Label
43813­
37
also
indicates
a
maximum
of
1%
ai
solution
for
these
application
methods;
however,
the
dilution
rate
on
the
label
(
gallons
product
to
gallons
water)
does
not
coincide
with
%
ai
in
solution.
The
Registrant
indicated
that
for
dip
tank,
conventional
spray,
and
electrostatic
spray
methods,
the
maximum
application
rate
is
0.5%
ai
solution
from
Propiconazole
Use
Closure
Memo
Amendment
dated
April
22,
2005
(
USEPA,
2005a).
Therefore,
the
assessment
for
diptank
operators
and
blender/
spray
operators
was
conducted
using
both
application
rates.
It
should
be
noted,
however,
that
the
maximum
application
rates
according
to
the
labels
are
0.65%
ai
solution
(
60061­
115)
for
an
open
dip
tank,
0.8%
ai
solution
(
1448­
394)
for
conventional
spray,
and
50%
ai
(
43813­
37)
for
electrostatic
spray.
For
the
remaining
worker
functions,
the
exposures
are
assessed
using
the
%
active
ingredient
in
the
product.
The
product
with
the
highest
18
percent
active
ingredient
is
43813­
37
(
50%
ai).

b.
Not
all
of
the
labels
provided
the
application
rate
in
terms
of
%
ai
solution,
therefore,
pressure
treatment
was
assessed
using
the
maximum
application
rate
of
1
%
which
was
provided
by
the
Registrant
and
reported
in
the
Propiconazole
Use
Closure
Memo
Amendment
dated
April
22,
2005
(
USEPA,
2005a).
The
application
rate
is
needed
in
terms
of
%
ai
solution
in
order
to
use
the
surrogate
unit
exposure
data.

6.1
Occupational
Handler
Exposures
The
occupational
handler
scenarios
included
in
Table
6.1
were
assessed
to
determine
dermal
and
inhalation
exposures.
The
general
assumptions
and
equations
that
were
used
to
calculate
occupational
handler
risks
are
provided
in
Section
1.2,
Criteria
for
Conducting
the
Risk
Assessment.
The
majority
of
the
scenarios
were
assessed
using
CMA
data
and
Equations
1­
3.
However,
for
the
occupational
scenarios
in
which
CMA
data
were
insufficient,
other
data
and
methods
were
applied.

Unit
Exposure
Values
(
UE):
Dermal
unit
exposure
values
were
taken
from
the
proprietary
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study
(
USEPA,
1999:
DP
Barcode
D247642)
or
from
the
Pesticide
Handler
Exposure
Database
(
USEPA,
1998).

 
For
the
liquid
pour
scenarios
for
materials
preservatives,
the
unit
exposure
depends
on
the
material
being
treated.
The
following
CMA
unit
exposures
were
available
and
used
for
the
assessment
of
the
risk
associated
with
the
treatment
of
the
specified
materials.
o
Metalworking
fluid:
CMA
metal
fluid
gloved
data.
The
dermal
UE
is
0.184
mg/
lb
a.
i.
and
the
inhalation
UE
is
0.00854
mg/
lb
a.
i..
The
values
are
based
on
8
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
clothing
and
chemical
resistant
gloves.
Since
no
baseline
dermal
(
ungloved)
unit
exposure
data
are
available
for
metalworking
fluid,
the
baseline
dermal
exposures
were
evaluated
using
the
cooling
tower
CMA
data
(
50.3
mg/
lb
ai).
o
Adhesives,
Paint
and
Textiles:
CMA
preservative
gloved
data.
The
dermal
UE
is
0.135
mg/
lb
a.
i.
and
the
inhalation
UE
is
0.00346
mg/
lb
a.
i..
The
values
are
based
on
2
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
clothing
and
chemical
resistant
gloves.
Since
no
baseline
dermal
(
ungloved)
unit
exposure
data
are
available
for
preservative
uses
in
adhesives,
paint,
or
textiles,
the
baseline
dermal
exposures
were
evaluated
using
the
cooling
tower
CMA
data
(
50.3
mg/
lb
ai).
 
For
the
liquid
pump
scenarios,
the
unit
exposure
depends
on
the
material
being
treated.
The
following
CMA
unit
exposures
were
available
and
used
for
the
assessment
of
the
risk
associated
with
the
treatment
of
the
specified
materials.
o
Metalworking
fluid:
CMA
metal
fluid
gloved
data.
The
dermal
UE
is
0.312
mg/
lb
a.
i.
and
the
inhalation
UE
is
0.00348
mg/
lb
a.
i.
The
values
are
based
on
2
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
clothing
and
chemical
resistant
gloves.
Since
no
baseline
dermal
(
ungloved)
unit
exposure
data
are
available
for
metalworking
fluid,
the
baseline
dermal
exposures
were
evaluated
using
the
cooling
tower
CMA
data
(
0.454
mg/
lb
ai).
o
Adhesives,
Paint
and
Textiles:
CMA
preservative
gloved
data.
The
dermal
UE
is
0.00629
mg/
lb
a.
i.
and
the
inhalation
UE
is
0.000403
mg/
lb
a.
i.
The
values
are
based
on
two
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
19
clothing
and
chemical
resistant
gloves.
Since
no
baseline
dermal
(
ungloved)
unit
exposure
data
are
available
for
preservative
uses
in
adhesives,
paint,
or
textiles,
the
baseline
dermal
exposures
were
evaluated
using
the
cooling
tower
CMA
data
(
0.454
mg/
lb
ai).
 
For
roller/
brush
scenarios,
the
occupational
PHED
dermal
and
inhalation
unit
exposure
values
for
paintbrush
applications
(
PHED
scenario
22)
were
used
(
single
layer
of
clothing).
The
inhalation
exposure
value
is
0.28
mg/
lb
a.
i.
The
dermal
unit
exposures
are
180
mg/
lb
a.
i.
for
ungloved
replicates
and
24
mg/
lb
a.
i.
for
gloved
replicates.
 
For
airless
sprayer
scenarios,
the
occupational
PHED
dermal
and
inhalation
unit
exposure
values
for
airless
sprayer
application
(
PHED
scenario
23)
were
used
(
single
layer
of
clothing).
The
inhalation
exposure
value
is
0.83
mg/
lb
a.
i.
The
dermal
unit
exposures
are
38
mg/
lb
a.
i.
for
ungloved
replicates
and
14
mg/
lb
a.
i.
for
gloved
replicates.

Quantity
handled/
treated:
The
quantity
handled/
treated
values
were
estimated
based
on
information
from
various
sources.
The
following
assumptions
were
made:

 
For
the
liquid
pour
scenarios,
the
quantity
of
the
chemical
that
is
handled
depends
on
the
material
that
is
being
treated.
The
following
values
were
used
for
the
different
materials:
o
Metalworking
fluid:
2,502
lbs
(
approximately
300
gallons,
based
on
the
density
of
of
water,
8.34
lb
a.
i./
gal)
(
Dang,
1997)
o
Paint:
2,000
lbs
(
approximately
200
gallons,
weight
based
on
a
density
10
lb
a.
i./
gal)
(
standard
AD
assumption).
o
Adhesives
and
Textiles:
10,000
lbs
(
standard
AD
assumption).
 
For
the
liquid
pump
scenarios
the
quantity
that
is
handled
depends
on
the
material
that
is
being
treated.
The
following
values
were
used
for
the
different
materials:
o
Metalworking
fluid:
2,502
lbs
(
approximately
300
gallons,
based
on
the
density
of
of
water,
8.34
lb
a.
i./
gal)
(
Dang,
1997)
o
Paint:
10,000
lbs
(
approximately
1,000
gallons,
weight
based
on
a
density
of
10
lb
a.
i./
gal)
(
standard
AD
assumption).
o
Adhesives
and
Textiles:
10,000
lbs
(
standard
AD
assumption).
 
For
the
roller/
brush
painting
scenario,
it
was
assumed
that
50
lbs
(
approximately
5
gallons
of
paint
with
a
density
of
10
lb/
gal)
of
treated
paint
are
used
(
standard
AD
assumption).
 
For
the
airless
sprayer
in
the
painting
scenario,
it
was
assumed
that
500
lbs
(
approximately
50
gallons
of
paint
with
a
density
of
10
lb/
gal)
of
treated
paint
are
used.
(
standard
AD
assumption).

Duration
of
Exposure:
The
MOEs
were
calculated
for
the
short­
and
intermediate­
term
durations
for
occupational
handlers
using
the
appropriate
endpoints
in
Table
3.2.

Exposure
Calculations
and
Results
The
resulting
exposures
and
MOEs
for
the
representative
occupational
handler
scenarios
are
presented
in
Table
6.2
(
short­
term)
and
in
Table
6.3
(
intermediate­
term).
The
calculated
MOEs
were
above
the
target
MOE
of
100
for
all
scenarios,
except
those
listed
below.
It
should
be
noted
that
the
baseline
(
ungloved)
dermal
MOEs
for
the
material
preservation
of
paints,
textiles,
adhesives,
and
metalworking
fluid
were
calculated
using
unit
exposure
values
from
the
cooling
tower
CMA
data
set
because
baseline
dermal
unit
exposures
are
not
available
for
preservative
or
metal
fluid
categories.
20
 
Adhesives,
liquid
pour:
IT
baseline
dermal
MOE
and
IT
baseline
total
MOE
=
<
1.
ST
baseline
dermal
MOE
and
ST
baseline
total
MOE
=
<
1.
 
Adhesives,
liquid
pump:
ST
baseline
dermal
MOE
and
ST
baseline
total
MOE
=
95.
IT
baseline
dermal
MOE
and
IT
baseline
total
MOE
=
32.
 
Metalworking
fluid,
liquid
pour:
ST
baseline
dermal
MOE
and
ST
baseline
total
MOE
=
60.
IT/
LT
baseline
dermal
MOE
and
IT/
LT
baseline
total
MOE
=
20.
 
Paint,
liquid
pour:
ST
baseline
dermal
MOE
and
ST
baseline
total
MOE
=
15.
IT
baseline
dermal
MOE
and
IT
baseline
total
MOE
=
5.
 
Textiles,
liquid
pour:
ST
baseline
dermal
MOE
and
ST
baseline
total
MOE
=
4.
IT
baseline
dermal
MOE
and
IT
baseline
total
MOE
=
1.
 
Painting
(
professional),
brush/
roller:
IT
baseline
dermal
MOE
=
56
and
IT
baseline
total
MOE
=
55.
 
Painting
(
professional),
airless
sprayer:
IT
baseline
dermal
MOE
=
26
and
IT
gloved
dermal
MOE
=
71.
IT
baseline
total
MOE
=
25
and
IT
gloved
total
MOE
=
62.
ST
baseline
dermal
MOE
=
79
and
ST
baseline
total
MOE
=
75.

It
should
be
noted
that
although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.
All
of
the
occupational
inhalation
MOEs
were
above
1,000,
except
for
the
following
scenarios:

 
Painting
(
professional),
airless
sprayer:
IT
inhalation
MOE
=
480.
21
Table
6.2
Short­
Term
Risks
Associated
with
Occupational
Handlers
Unit
Exposure
(
mg/
lb
a.
i.)
Absorbed
Daily
Dose
(
mg/
kg/
day)
c
MOEd
Baseline
Dermal
(
Target
MOE
=

100)
a
PPE­
Gloves
Dermal
(
Target
MOE
=

100)
b
Inhalation
(
Target
MOE
=

100)
Total
ST
MOEe
(
Target
MOE
=
100)

Exposure
Scenario
Method
of
Application
Baseline
Dermala
PPEGloves
Dermalb
Inhalation
Application
Rate
(%
a.
i.

by
weight)
Quantity
Handled/

Treated
per
day
Baseline
Dermala
PPEGloves
Dermalb
Inhalation
ST
ST
ST
Baseline
PPE
Material
Preservatives
(
Use
Site
Category
VII)

Liquid
Pour
50.3
0.135
0.00346
1.213
10,000
lbs
35
0.094
0.006
<
1
320
4,300
<
1
300
Preservation
of
Adhesives
Liquid
Pump
0.454
0.00629
0.000403
1.213
10,000
lbs
0.31
0.0044
0.0007
95
6,900
37,000
95
5,900
Liquid
Pour
50.3
0.184
(
f)
0.00854
0.07
2,502
lbs
0.50
0.0018
0.00021
60
16,000
(
f)
120,000
60
15,000
(
f)

Preservation
of
Metalworking
Fluid
Liquid
Pump
0.454
0.312
(
f)
0.00348
0.07
2,502
lbs
0.0045
0.0031
0.000087
6,600
9,600
(
f)
3,00,000
6,500
9,300
(
f)

Liquid
Pour
50.3
0.135
0.00346
0.35
2,000
lbs
2.0
0.0054
0.00035
15
5,600
74,000
15
5,200
Preservation
of
Paint
Liquid
Pump
0.454
0.00629
0.000403
0.35
10,000
lbs
0.091
0.0013
0.00020
330
24,000
130,000
330
21,000
Liquid
Pour
50.3
0.135
0.00346
0.28
10,000
lbs
8.0
0.022
0.0014
4
1,400
19,000
4
1,300
Preservation
of
Textiles
Liquid
Pump
0.454
0.00629
0.000403
0.28
10,000
lbs
0.073
0.0010
0.00016
410
30,000
160,000
410
26,000
Brush/
Roller
180
24
0.28
0.35
50
lbs
0.18
0.024
0.0007
170
1,300
37,000
170
1,200
Application
of
Paint
by
professionals
Airless
Sprayer
38
14
0.83
0.35
500
lbs
0.38
0.14
0.021
79
210
1,200
75
190
ST
=
short­
term,
N/
A=
No
data
available
a
Baseline
Dermal:
Long­
sleeve
shirt,
long
pants,
no
gloves.
It
should
be
noted
that
the
baseline
dermal
unit
exposures
for
the
preservation
of
adhesives,
metalworking
fluid,
paint,
and
textiles
were
from
the
cooling
tower
CMA
data
set
because
baseline
(
ungloved)
dermal
unit
exposures
are
not
available
for
the
preservation
CMA
data
set.

b
PPE
Dermal
with
gloves:
baseline
dermal
plus
chemical­
resistant
gloves.

c
Absorbed
Daily
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
a.
i.)
*
absorption
factor
(
0.4
for
dermal;
1.0
for
inhalation)
*
application
rate
*
quantity
treated
/
Body
weight
(
70
kg).

d
MOE
=
NOAEL
(
mg/
kg/
day)
/
Absorbed
Daily
Dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation].

e
Total
ST
MOE
=
1/((
1/
Dermal
ST
MOE)
+
(
1/
Inhalation
ST
MOE))

f
The
dermal
exposures
for
the
MWF
use
for
liquid
pour
vs.
pump
appear
to
be
illogical/
inconsistent
with
the
protection
afforded
by
closed
systems.
The
liquid
pour
value
is
based
on
8
replicates
while
the
pump
is
based
on
2
replicates.
22
Table
6.3
Intermediate­
Term
Risks
Associated
with
Occupational
Handlers
Unit
Exposure
(
mg/
lb
a.
i.)
Absorbed
Daily
Dose
(
mg/
kg/
day)
c
MOEd
Baseline
Dermal
(
Target
MOE
=

100)
a
PPE­
Gloves
Dermal
(
Target
MOE
=

100)
b
Inhalation
(
Target
MOE
=

100)
Total
IT
MOEe
(
Target
MOE
=
100)

Exposure
Scenario
Method
of
Application
Baseline
Dermala
PPEGloves
Dermalb
Inhalation
Application
Rate
(%
a.
i.

by
weight)
Quantity
Handled/

Treated
per
day
Baseline
Dermala
PPEGloves
Dermalb
Inhalation
IT
IT
IT
Baseline
PPE
Material
Preservatives
(
Use
Site
Category
VII)

Liquid
Pour
50.3
0.135
0.00346
1.213
10,000
lbs
35
0.094
0.006
<
1
110
1,700
<
1
100
Preservation
of
Adhesives
Liquid
Pump
0.454
0.00629
0.000403
1.213
10,000
lbs
0.31
0.0044
0.0007
32
2,200
14,000
32
2,000
Liquid
Pour
50.3
0.184
0.00854
0.07
2,502
lbs
0.50
0.0018
0.00021
20
5,400
47,000
20
4,900
Preservation
of
Metalworking
Fluid
Liquid
Pump
0.454
0.312
0.00348
0.07
2,502
lbs
0.0045
0.0031
0.000087
2,200
3,200
110,000
2,200
3,100
Liquid
Pour
50.3
0.135
0.00346
0.35
2,000
lbs
2.0
0.0054
0.00035
5
1,900
29,000
5
1,700
Preservation
of
Paint
Liquid
Pump
0.454
0.00629
0.000403
0.35
10,000
lbs
0.091
0.0013
0.00020
110
7,900
50,000
110
6,900
Liquid
Pour
50.3
0.135
0.00346
0.28
10,000
lbs
8.0
0.022
0.0014
1
460
7,200
1
440
Preservation
of
Textiles
Liquid
Pump
0.454
0.00629
0.000403
0.28
10,000
lbs
0.073
0.0010
0.00016
140
9,900
62,000
140
8,600
Brush/
Roller
180
24
0.28
0.35
50
lbs
0.18
0.024
0.0007
56
420
14,000
55
400
Application
of
Paint
by
professionals
Airless
Sprayer
38
14
0.83
0.35
500
lbs
0.38
0.14
0.021
26
71
480
25
62
IT
=
intermediate­
term,
N/
A=
No
data
available
a
Baseline
Dermal:
Long­
sleeve
shirt,
long
pants,
no
gloves.
It
should
be
noted
that
the
baseline
dermal
unit
exposures
for
the
preservation
of
adhesives,
metalworking
fluid,
paint,
and
textiles
were
from
the
cooling
tower
CMA
data
set
because
baseline
(
ungloved)
dermal
unit
exposures
are
not
available
for
the
preservation
CMA
data
set.

b
PPE
Dermal
with
gloves:
baseline
dermal
plus
chemical­
resistant
gloves.

c
Absorbed
Daily
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
mg/
lb
a.
i.)
*
absorption
factor
(
0.4
for
dermal;
1.0
for
inhalation)
*
application
rate
*
quantity
treated
/
Body
weight
(
70
kg).

d
MOE
=
NOAEL
(
mg/
kg/
day)
/
Absorbed
Daily
Dose
[
Where
intermediate­
and
long­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].
Note
MWF
is
considered
to
be
long­
term.

e
Total
IT
MOE
=
1/((
1/
Dermal
IT
MOE)
+
(
1/
Inhalation
IT
MOE))
23
6.2
Occupational
Post­
application
Exposures
Except
for
the
post­
application
scenarios
assessed
for
wood
preservatives
in
Section
6.4,
occupational
post­
application
exposures
are
assumed
to
be
negligible.

6.3
Metalworking
Fluids:
Machinist
There
is
a
potential
for
dermal
and
inhalation
exposure
when
a
worker
handles
treated
metalworking
fluids.
This
route
of
exposure
occurs
after
the
chemical
has
been
incorporated
into
the
metalworking
fluid
and
a
machinist
is
using/
handling
this
treated
endproduct

Dermal
Exposures
Exposure
Calculations
A
short­
term
and
an
intermediate­
and
long­
term
exposure
estimate
were
derived
using
the
2­
hand
immersion
model
from
ChemSTEER.
The
model
is
available
at
www.
epa.
gov/
opptintr/
exposure/
docs/
chemsteer.
htm.
The
2­
hand
immersion
equation
is
as
follows:

PDR
=
SA
x
%
a.
i.
x
FT
x
FQ
BW
where:

PDR
=
Potential
dose
rate
(
mg/
kg/
day);
SA
=
Surface
area
of
both
hands
(
cm2);
%
a.
i.
=
Fraction
active
ingredient
in
treated
metalworking
fluid
(
unitless)
FT
=
Film
thickness
of
metal
fluid
on
hands
(
mg/
cm2)
FQ
=
Frequency
of
events
(
event/
day);
BW
=
Body
weight
(
kg)

Assumptions
 
The
surface
of
area
of
both
hands
is
840
cm2
(
USEPA
1997)
 
The
body
weight
of
an
adult
is
70
kg
(
USEPA
1997)
 
The
percent
active
ingredient
in
treated
metalworking
fluid
is
0.07
%
(
EPA
Registration
No.
43813­
16).
 
For
short­,
intermediate­
and
long­
term
durations,
the
film
thickness
on
the
hands
is
1.75
mg/
cm2,
which
was
extracted
from
the
document
entitled,
"
A
Laboratory
Method
to
Determine
the
Retention
of
Liquids
on
the
Surface
of
Hands"
(
Cinalli,
1992).
The
film
thickness
is
based
on
a
machinist
immersing
both
hands
in
metalworking
fluid
and
then
partially
cleaning
hands
with
a
rag.
The
film
thickness
was
chosen
because
the
dermal
endpoint
for
short­,
intermediate­
and
long­
term
durations
is
based
on
systemic
effects.
24
Inhalation
Exposures
Exposure
Calculations
A
screening­
level
intermediate
and
long
term
inhalation
exposure
estimate
for
treated
metalworking
fluids
has
been
developed
using
the
OSHA
PEL
for
oil
mist.
The
equation
used
for
calculating
the
inhalation
dose
is:

PDR
=
PEL
x
IR
x
%
a.
i.
x
ED
BW
where:
PDR
=
Potential
dose
rate
(
mg/
kg/
day);
PEL
=
OSHA
PEL
(
mg/
m3);
IR
=
Inhalation
rate
(
m3
/
hr)
%
a.
i.
=
Fraction
active
ingredient
in
treated
metalworking
fluid
(
unitless)
ED
=
Exposure
duration
(
hrs/
day);
BW
=
Body
weight
(
kg)

Assumptions
 
The
high­
end
oil
mist
concentration
is
based
on
OSHA's
Permissible
Exposure
Limit
(
PEL)
of
5
mg/
m3
(
NIOSH,
1998).
 
The
percent
active
ingredient
in
treated
metalworking
fluid
is
0.07
%
(
EPA
Registration
No.
43813­
16).
 
The
inhalation
rate
for
a
machinist
is
1.0
m3
/
hr.
 
A
machinist
is
exposed
to
the
metalworking
fluid
8
hours
a
day,
for
5
days
a
week.
 
The
body
weight
of
an
adult
is
70
kg
(
USEPA
1997).

Dermal
and
Inhalation
Results
Table
6.4
shows
the
calculation
of
the
absorbed
daily
dose
and
MOE
for
a
machinist
working
with
metalworking
fluids.
The
dermal
and
inhalation
MOE
values
are
above
the
target
MOE
of
100
for
all
durations.
Total
MOEs
are
also
above
the
target
MOE
of
100
for
short­
and
intermediate/
long­
term
exposures
(
ST
Total
MOE
=
4,800
and
IT/
LT
Total
MOE
=
1,600).

Although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.
Since
the
inhalation
MOEs
are
above
1,000,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
this
scenario.
25
Table
6.4.
Short­,
Intermediate­,
and
Long­
Term
Risks
Associated
with
Postapplication
Exposure
to
Metalworking
Fluids
treated
with
Propiconazole
(
Machinist)

Dermal
Inputs
Inhalation
Inputs
Absorbed
Daily
Dose
(
mg/
kg/
day)
MOE
Dermal
MOE
(
Target
MOE
=
100)
c
Inhalation
MOE
(
Target
MOE
=
100)
d
Total
MOE
(
Target
MOE
=
100)
e
%
a.
i.
Hand
Surface
Area
(
cm2)
Film
thickness
(
mg/
cm2)
Frequency
(
event/
day)
OSHA
PEL
(
mg/
m3)
Inhal.
rate
(
m3/
hr)
Exposure
Duration
(
hrs/
day)
Dermal
a
Inhal.
b
ST
IT/
LT
ST
IT/
LT
ST
IT/
LT
0.07
840
1.75
1
5
1.0
8
0.0059
0.00040
5,10
0
1,700
75,00
0
25,000
4,80
0
1,600
a
Absorbed
Dermal
Daily
Dose
(
mg/
kg/
day)
=
[(%
active
ingredient
*
hand
surface
area*
dermal
absorption
factor
(
40%
for
all
durations)*
film
thickness
(
mg/
cm2)*
Frequency
(
event/
day)]
/
Body
weight
(
60
kg).
b
Absorbed
Inhalation
Daily
Dose
(
mg/
kg/
day)
=
%
active
ingredient
*
OSHA
PEL
(
mg/
m3)
*
Inhalation
rate
(
m3/
hr)
*
exposure
duration
(
hr/
day)
*
inhalation
absorption
factor
(
100%
for
all
durations)/
body
weight
(
70
kg)
c
Dermal
MOE
=
NOAEL
(
mg/
kg/
day)
/
Absorbed
Daily
Dose
(
mg/
kg/
day)
[
Where:
short­
term
NOAEL
=
30
mg/
kg/
day
and
intermediate
 
and
long­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
exposures,
Table
3.2
].
d
Inhalation
MOE
=
NOAEL
(
mg/
kg/
day)
/
Absorbed
Daily
Dose
(
mg/
kg/
day)
[
Where:
short­
term
NOAEL
=
30
mg/
kg/
day
and
intermediate­
and
long­
term
NOAEL
=
10
mg/
kg/
day
for
inhalation
exposures,
Table
3.2].
e
Total
MOE
=
1/((
1/
Dermal
MOE)
+
(
1/
Inhalation
MOE))

6.4
Wood
Preservation
Propiconazole
is
used
in
products
that
are
intended
to
preserve
wood
through
both
non­
pressure
treatment
methods
and
pressure
treatment
methods.
The
products
can
be
used
on
many
different
types
of
wood
including
1)
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
2)
manufactured
wood
products
such
as
logs
(
including
for
log
home
construction),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
3)
dry
lumber;
and
4)
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
The
majority
of
the
products
are
intended
for
use
at
wood
treatment
facilities,
however,
propiconazole
is
also
formulated
for
use
in
mushroom
houses
to
protect
timber
trays
and
benches.
Propiconazole
is
also
formulated
for
use
on
cooling
tower
wood,
however,
the
label
does
not
specifically
indicate
if
the
wood
is
treated
prior
to
or
after
manufacture
of
the
cooling
tower.

The
exposure
scenarios
assessed
in
this
document
for
the
representative
wood
preservation
uses
selected
by
AD
are
shown
in
Table
6.1.
Section
6.4.1
presents
the
exposure
analysis
for
the
handler
and
post­
application
scenarios
for
non­
pressure
treatment
scenarios
and
Section
6.4.2
presents
the
exposure
analysis
for
the
handler
and
post­
application
scenarios
for
pressure
treatment
scenarios.

6.4.1
Non­
Pressure
Treatment
Scenarios
(
Handler
and
Post­
application)

6.4.1.1
Scenarios
Assessed
by
Worker
Function
The
proprietary
study,
"
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)"
(
Bestari
et
al.,
1999,
MRID
455243­
04
which
is
a
Sapstain
Industry
Task
Force
Study,
#
73154)
identified
various
worker
functions/
positions
for
individuals
that
26
handle
DDAC­
containing
wood
preservatives
for
non­
pressure
treatment
application
methods
and
for
individuals
that
could
then
come
into
contact
with
the
preserved
wood.
The
worker
functions/
positions
identified
in
the
DDAC
study
are
presented
below.
It
was
assumed
that
similar
tasks
are
performed
when
handling
propiconazole
products
and
propiconazole
treatedwood
therefore,
these
same
functions
were
assessed
for
propiconazole.

Handler:
 
Blender/
spray
operators
are
workers
that
add
the
wood
preservative
into
a
blender/
sprayer
system
for
composite
wood
via
closed­
liquid
pumping.
 
Diptank
Operators
can
be
in
reference
to
wood
being
lowered
into
the
treating
solution
through
an
automated
process
(
i.
e.,
elevator
diptank,
forklift
diptank).
This
scenario
can
also
occur
in
a
smaller
scale
treatment
facility
in
which
the
worker
can
manually
dip
the
wood
into
the
treatment
solution.
 
Chemical
operators
for
a
spray
box
system
consist
of
chemical
operators,
chemical
assistants,
chemical
supervisors,
and
chemical
captains.
These
individuals
maintain
a
chemical
supply
balance
along
with
flushing
and
cleaning
spray
nozzles.

Post­
application:
 
Graders,
positioned
right
after
the
spray
box,
grade
dry
lumber
by
hand
(
i.
e.
detect
faults).
In
the
DDAC
study,
graders
graded
wet
lumber;
therefore,
the
exposures
to
graders
using
propiconazole
are
worst­
case
scenarios.
 
Millwrights
repair
all
conveyer
chains
and
general
up­
keep
of
the
mill.
 
Clean­
up
crews
perform
general
cleaning
duties
at
the
mill.
 
Trim
saw
operators
operate
the
hula
trim
saw
and
consist
of
operators
and
strappers.
In
the
DDAC
study,
hula
trim
saw
operators
handled
dry
lumber.
 
Construction
workers
install
treated
plywood,
oriented
strand
board,
medium
density
fiberboard,
and
others.

As
very
little
chemical
specific
data
were
available
regarding
typical
exposures
to
propiconazole
as
a
wood
preservative,
surrogate
data
were
used
to
estimate
exposure
risks.
The
blender/
spray
operator
position
was
assessed
using
CMA
unit
exposure
data
and
the
remaining
handler
and
post­
application
positions
were
assessed
using
data
from
the
DDAC
study
(
Bestari
et
al.,
1999,
Task
Force
#
73154).
This
study
is
proprietary;
therefore,
data
compensation
needs
to
be
addressed
for
use
of
these
data
in
this
exposure
assessment.

Blender/
Spray
Operators
Exposures
and
risks
to
the
composite
wood
blender/
spray
operators
were
assessed
using
Equations
1
through
3
in
Section
1.2.
The
surrogate
unit
exposures
were
taken
from
the
CMA
study
(
USEPA
1999).
Specifically,
the
liquid
pump
preservative
unit
exposures
for
gloved
workers
were
used
in
this
assessment.
The
dermal
unit
exposure
was
0.00629
mg/
lb
ai
and
the
inhalation
unit
exposure
was
0.000403
mg/
lb
ai.
These
values
are
based
on
two
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
clothing
and
chemical
resistant
gloves.
The
quantity
of
the
wood
being
treated
was
derived
from
other
wood
preservative
estimates
(
USEPA,
2004)
for
the
amount
of
wood
slurry
treated
because
no
chemical
specific
data
were
available
for
propiconazole.
It
was
assumed
that
batches
of
wood
slurry
are
treated
in
10,000
gallon
tanks,
and
that
eight
batches
of
wood
slurry
are
treated
per
day
(
one
per
hour
for
an
8­
hr
work
shift).
Additionally,
it
was
assumed
that
each
batch
requires
3,000
gallons
of
27
preservatives
and
the
remainder
volume
of
the
tank
consists
of
wood
slurry
(
7,000
gallons
of
wood
slurry
per
batch).
Wood
chips
have
a
density
of
approximately
380
kg/
m3
(
SIMetric,
2005),
therefore,
the
total
amount
of
wood
slurry
treated
per
day
would
be
178,000
lbs
(
8
batches/
day
*
7,000
gallons/
batch
*
0.003785
m3/
gallon
*
380
kg/
m3
*
2.2
lb/
kg).
The
assumptions
used
for
batch
sizes
and
the
quantity
of
preservative
needed
are
consistent
with
an
assessment
performed
previously
by
the
EPA.
The
propiconazole
assessment
was
conducted
for
both
the
1%
ai
solution
and
0.5%
ai
solution
application
rates.
The
higher
maximum
application
rate
represents
the
labels
which
indicate
the
product
can
be
used
on
finished
wood
products
through
immersion,
roller
coater,
flood,
spray,
and
brush
application
methods.
The
lower
application
rate
used
in
this
assessment
represents
the
maximum
application
rate
presented
by
the
registrant
in
the
Propiconazole
Use
Closure
Memo
Amendment
dated
April
22,
2005
(
USEPA,
2005a)
for
dip
tank,
conventional
spray,
and
electrostatic
spray
methods
on
seasoned
and
unseasoned
forest
products.
It
should
be
noted,
however,
that
the
maximum
application
rates
according
to
the
label
review
are
0.65%
ai
solution
(
60061­
115)
for
an
open
dip
tank,
0.8%
ai
solution
(
1448­
394)
for
conventional
spray,
and
50%
ai
solution
(
43813­
37)
for
electrostatic
spray.

Table
6.5
provides
the
short­
and
intermediate­
term
doses
and
MOEs
for
the
workers
adding
the
preservative
to
the
wood
slurry.
All
MOEs
are
above
the
target
MOE
of
100
for
short­,
intermediate­,
and
long­
term
dermal,
inhalation,
and
total
exposures.

It
should
be
noted
that
although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.
All
of
the
occupational
inhalation
MOEs
were
above
1,000,
except
for
the
following
scenarios:

$
Blender/
spray
operator:
IT/
LT
inhalation
MOE
at
the
1%
application
rate
=
980.

Table
6.5.
Short­,
Intermediate­,
and
Long­
term
Exposures
and
MOEs
for
Wood
Preservative
Blender/
Spray
Operators
Absorbed
Daily
Dosee
(
mg/
kg/
day)
MOEsf
Dermal
Inhalation
Totalg
Exposure
Scenario
Dermal
Unit
Exposurea
(
mg/
lb
ai)
Inhalation
Unit
Exposureb
(
mg/
lb
ai)
Application
Ratec
(%
ai
in
solution/

day)
Wood
Slurry
Treatedd
(
lb/
day)
Dermal
Inhalation
ST
IT/
LT
ST
IT/
LT
ST
IT/
L
T
Occupational
Handler
CMA
Liquid
Pump
0.00629
0.000403
0.50
178,000
0.032
0.051
940
310
5,900
2,000
810
270
CMA
Liquid
Pump
0.00629
0.000403
1.0
178,000
0.064
0.010
470
160
2,900
980
400
130
ST
=
Short­
term
duration;
IT
=
Intermediate­
term
duration;
and
LT
=
long­
term.
a.
Dermal
unit
exposure:
Single
layer
clothing
with
chemical
resistant
gloves.
b.
Inhalation
unit
exposure:
Baseline.
c.
The
assessment
was
conducted
using
both
the
0.5%
and
1%
ai
solution
application
rates
where
0.5%
is
for
sapstain
treatment
and
1%
is
for
decay
control.
d.
Wood
slurry
treated
=
(
8
batches/
day
*
7,000
gallons/
batch
*
0.003785
m3/
gallon
*
380
kg/
m3
*
2.2
lb/
kg)
e.
Absorbed
Daily
Dose
=
unit
exposure
(
mg/
lb
ai)
x
App
Rate
(%
ai/
day)
x
Quantity
treated
(
lb/
day)
x
absorption
factor
(
40%
dermal
and
100%
for
inhalation)
/
BW
(
70
kg)
f.
MOE
=
NOAEL
(
mg/
kg/
day)/
Daily
dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation
and
IT/
LT
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].
Target
MOE
is
100
for
dermal
and
inhalation
exposures.
g.
Total
MOE
=
1/
((
1/
MOEdermal)
+
(
1/
MOEinhalation)).
Target
MOE
is
100.
28
Chemical
Operators,
Graders,
Millwrights,
Clean­
up
Crews,
and
Trim
Saw
Operators
Exposures
to
chemical
operators,
graders,
millwrights,
trim
saw
operators,
and
cleanup
crews
were
assessed
using
surrogate
data
from
the
DDAC
study
(
Bestari
et
al.,
1999,
Task
Force
#
73154).
The
DDAC
study
examined
individuals=
exposure
to
DDAC
while
working
with
antisapstains
and
performing
routine
tasks
at
11
sawmills/
planar
mills
in
Canada.
Dermal
and
inhalation
exposure
monitoring
data
were
gathered
for
each
job
function
of
interest
using
dosimeters
and
personal
sampling
tubes.
Dosimeters
and
personal
air
sampling
tubes
were
analyzed
for
DDAC.
Exposure
data
for
individuals
performing
the
same
job
functions
were
averaged
together
to
determine
job
specific
averages.
Monitoring
was
conducted
using
2
trim
saw
workers,
13
grader
workers,
11
chemical
operators,
3
millwrights,
and
6
clean­
up
staff.

The
individual
dermal
and
inhalation
exposures
from
the
DDAC
study
are
presented
in
Table
B­
1
in
Appendix
B.
To
determine
propiconazole
exposures,
the
average
DDAC
exposures
measured
on
individuals
(
in
terms
of
total
mg
DDAC)
were
multiplied
by
a
modification
factor
of
0.625
to
account
for
the
difference
in
percent
active
ingredient
between
propiconazole
and
DDAC
(
50%
propiconizole
in
the
wood
preservative
product
versus
80%
DDAC
in
the
comparative
wood
preservative
product).
The
lb
ai
handled
by
each
person
or
the
%
ai
in
the
treatment
solution
were
not
provided
for
these
worker
functions.

The
following
equation
was
used
to
calculate
daily
dose
for
propiconazole:

Daily
Dose
=
DDAC
UE
x
CR
x
AB
BW
Where
DDAC
UE
=
DDAC
dermal
or
inhalation
unit
exposure
(
mg/
day);
CR
=
Conversion
ratio
(
50%
propiconazole
/
80%
DDAC)
;
AB
=
Absorption
factor
(
40%
for
dermal,
100%
for
inhalation);
and
BW
=
Body
weight
(
70
kg).

In
using
this
methodology,
the
following
assumptions
were
made:

 
DDAC
and
propiconazole
end­
use
products
will
be
used
in
similar
quantities.

 
The
procedures
for
applying
both
chemicals
are
similar.

 
The
limits
of
detections
(
LOD)
for
inhalation
residues
from
chemical
operators,
graders,
mill
wrights,
and
clean­
up
staff
replicates
were
not
provided
in
the
DDAC
report.
For
lack
of
better
data,
it
was
assumed
that
the
inhalation
LODs
for
these
worker
positions
are
equal
to
the
LOD
of
the
diptank
operator
replicates
(
5.6
Fg).
For
all
measurements
below
the
air
concentration
associated
with
this
detection
limit,
half
the
detection
limit
was
used.
The
dermal
LOD
for
all
operators
is
also
5.6
Fg.

 
In
the
DDAC
study,
dermal
exposures
to
hands
were
measured
separately
from
the
rest
of
the
body.
For
each
replicate,
the
body
dose
measurements
and
hand
dose
measurements
were
summed
for
a
total
dermal
dose.
29
 
Air
concentrations
were
reported
in
the
DDAC
study.
To
convert
air
concentrations
(
Fg/
m3)
into
terms
of
inhalation
unit
exposure
(
mg/
day),
the
air
concentrations
were
multiplied
by
an
inhalation
rate
of
1.0
m3/
hr
for
light
activity
(
EPA
1997),
an
exposure
duration
of
8
hrs/
day,
and
a
conversion
factor
of
1
mg/
1000
mg.
Table
B­
1
in
Appendix
B
presents
the
inhalation
and
dermal
DDAC
exposures.

 
Average
DDAC
dermal
and
inhalation
exposures
were
multiplied
by
a
conversion
ratio
of
0.625
to
account
for
the
differences
in
propiconazole
and
DDAC
concentrations
[(
50%
propiconazole
/
80%
DDAC)].

Table
6.6
provides
the
short­,
intermediate­,
and
long­
term
doses
and
MOEs
for
chemical
operators,
graders,
millwrights,
clean­
up
crews,
and
trim
saw
operators.
For
all
worker
functions,
the
inhalation
MOEs
are
above
the
target
MOE
of
100
for
ST/
IT/
LT
durations,
and
therefore
are
not
of
concern.
For
all
worker
functions,
except
the
clean­
up
worker,
the
dermal
and
total
MOEs
are
above
the
target
MOE
of
100
for
ST/
IT/
LT
durations.
For
the
clean­
up
worker,
the
intermediate­
and
long­
term
dermal
and
total
MOEs
are
below
the
target
MOE
of
100
(
MOE
of
51
and
49,
respectively).

All
inhalation
MOEs
exceeded
1,000,
therefore,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
these
exposure
scenarios.

Table
6.6.
Short­,
Intermediate­
and
Long­
Term
Exposures
and
MOEs
for
Wood
Preservative
Chemical
Operators,
Graders,
Trim
Saw
Operators,
and
Clean­
Up
Crews
Absorbed
Daily
Dosesd
(
mg/
kg/
day)
MOEse
Dermal
Inhalation
Totalf
Exposure
Scenarioa
(
number
of
volunteers)
Dermal
UEb
(
mg/
day)
Inhalation
UEb
(
mg/
day)
Conversion
Ratioc
Dermal
Inhalation
ST
IT/
LT
ST
IT/
LT
ST
IT/
LT
Occupational
Handler
Chemical
Operator
(
n=
11)
9.81
0.0281
0.625
0.035
0.00025
860
290
120,000
40,000
850
280
Occupational
Post­
application
Grader
(
n=
13)
3.13
0.0295
0.625
0.011
0.00026
2,700
890
110,000
38,000
2,600
870
Trim
Saw
(
n=
2)
1.38
0.061
0.625
0.0049
0.00054
6,100
2,000
56,000
19,000
5,500
1,800
Millwright
(
n=
3)
12.81
0.057
0.625
0.046
0.00051
660
220
59,000
20,000
650
220
Clean­
Up
(
n=
6)
55.3
0.60
0.625
0.20
0.0054
150
51
5,600
1,900
150
49
ST
=
Short­
term
duration;
IT
=
Intermediate­
term
duration;
and
LT
=
long­
term
a.
The
exposure
scenario
represents
a
worker
wearing
short
sleeve
shirts,
cotton
work
trousers,
and
cotton
glove
dosimeter
gloves
under
chemical
resistant
gloves.
Volunteers
were
grouped
according
to
tasks
they
conducted
at
the
mill.
b.
Dermal
and
inhalation
unit
exposures
are
from
Bestari
et
al
(
1999,
Task
Force
#
73154).
Refer
to
Table
B­
1
in
Appendix
B
for
the
calculation
of
the
dermal
and
inhalation
exposures.
Inhalation
exposure
(
mg/
day)
was
calculated
30
using
the
following
equation:
air
concentration
(
Fg/
m3)
x
inhalation
rate
(
1.0
m3/
hr)
x
sample
duration
(
8
hr/
day)
x
unit
conversion
(
1
mg/
1000
Fg).
The
inhalation
rate
is
from
USEPA,
1997.
c.
Conversion
Ratio
=
50%
propiconazole
/
80%
DDAC
d.
Absorbed
Daily
dose
(
mg/
kg/
day)
=
exposure
(
mg/
day)
*
conversion
ratio
(
0.625)
*
absorption
factor
(
40%
for
dermal
and
100%
for
inhalation)/
body
weight
(
70
kg).
e.
MOE
=
NOAEL
(
mg/
kg/
day)/
Daily
dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation
and
intermediate­
and
long­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].
Target
MOE
is
100
for
dermal
and
inhalation
exposures.
f.
Total
MOE
=
1/
((
1/
MOEdermal)
+
(
1/
MOEinhalation)).
Target
MOE
is
100.

Diptank
Operators
Exposures
to
diptank
operators
were
also
assessed
using
surrogate
data
from
the
DDAC
study
(
Bestari
et
al.,
1999).
The
diptank
scenario
assessment
was
conducted
differently
than
for
the
other
job
functions
because
the
concentration
of
DDAC
in
the
diptank
solution
was
provided.
The
exposure
data
for
diptank
operators
wearing
gloves
were
converted
into
A
unit
exposures
@

in
terms
of
mg
a.
i.
for
each
1%
of
concentration
of
the
product.
The
calculation
of
the
dermal
and
inhalation
unit
exposures
(
2.99
and
0.046
mg/
1%
solution,
respectively)
is
presented
in
Table
B­
2
in
Appendix
B.
The
air
concentrations
presented
in
the
DDAC
study
were
converted
to
unit
exposures
using
an
inhalation
rate
of
1.0
m3/
hr
(
light
activity)
and
sample
duration
of
8
hrs/
day.

The
following
equations
are
used
to
estimate
dermal
and
inhalation
handler
exposure:

Daily
Dose
=
DDAC
UE
x
AI
x
AB
BW
Where
DDAC
UE
=
DDAC
dermal
unit
exposure
(
mg/
1%
in
solution);
AI
=
AI
(
1%
ai
and
0.5%
ai
in
solution/
day);
AB
=
Absorption
factor
(
40%
for
dermal,
100%
for
inhalation);
and
BW
=
Body
weight
(
70
kg).

Table
6.7
provides
the
short­
term
and
the
intermediate­
and
long­
term
doses
and
MOEs
for
diptank
operators.
All
MOEs
were
above
the
target
MOE
of
100
for
dermal,
inhalation,
and
total
exposures
and
therefore,
are
not
of
concern.

All
inhalation
MOEs
exceeded
1,000,
therefore,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
these
exposure
scenarios.
31
Table
6.7.
Short­,
Intermediate­,
and
Long­
Term
Exposures
and
MOEs
for
Diptank
Operator
Absorbed
Daily
Dosesc
(
mg/
kg/
day)
MOEsd
Dermal
Inhalation
Totalf
Exposure
Scenarioa
(
number
of
replicates)
Dermal
Unit
Exposureb
(
mg
DDAC/
1%
solution)
Inhalation
Unit
Exposureb
(
mg
DDAC/
1%
solution)
App
Rate
(%
a.
i.
in
solution/
day)
c
Dermal
Inhalation
ST
IT/
LT
ST
IT/
LT
ST
IT/
LT
Occupational
Handler
Dipping,
with
gloves
(
n=
7)
2.99
0.046
0.50
0.0085
0.00033
3,500
1,200
91,000
30,000
3,400
1100
Dipping,
with
gloves
(
n=
7)
2.99
0.046
1.0
0.017
0.00066
1,800
580
46,000
15,000
1,700
560
ST
=
Short­
term
duration;
IT
=
Intermediate­
term
duration;
and
LT
=
long­
term.
a.
The
exposure
scenario
represents
a
worker
wearing
long­
sleeved
shirts,
cotton
work
trousers,
and
gloves.
Gloves
were
worn
only
when
near
chemical,
not
when
operating
diptank
b.
Dermal
and
inhalation
unit
exposures
are
from
DDAC
study
(
MRID
455243­
04,
Task
Force
#
73154).
Refer
to
Table
B­
2
in
Appendix
B
for
the
dermal
and
inhalation
unit
exposure
calculations.
Inhalation
exposure
(
mg)
was
calculated
using
the
following
equation:
Air
concentration
(
mg/
m3)
x
Inhalation
rate
(
1.0
m3/
hr)
x
Sample
Duration
(
8
hr).
The
inhalation
rate
is
from
USEPA,
1997.
c.
The
assessment
was
conducted
using
both
the
0.5%
and
1%
ai
solution
application
rates
where
0.5%
is
used
for
sapstain
treatments
and
1%
is
used
for
decay
control.
d.
Absorbed
Daily
dose
(
mg/
kg/
day)
=
unit
exposure
(
mg/
1%
ai
solution)
*
percent
active
ingredient
in
solution
*
absorption
factor
(
40%
for
dermal
and
100%
for
inhalation)
/
body
weight
(
70
kg).
e.
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation
and
intermediateand
long­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].
Target
MOE
is
100
for
dermal
and
inhalation
exposures.
f.
Total
MOE
=
1/
((
1/
MOEdermal)
+
(
1/
MOEinhalation)).
Target
MOE
is
100.

Construction
workers
Not
enough
data
exists
to
estimate
the
amount
of
exposure
associated
with
construction
workers
who
install
treated
wood.
In
particular,
values
for
the
transfer
coefficient
associated
with
a
construction
worker
handling
the
wood
could
not
be
determined.
However,
it
is
believed
that
the
construction
worker
using
a
trim
saw
will
have
larger
dermal
and
inhalation
exposures
than
the
installer,
due
to
the
amount
of
sawdust
generated
and
the
greater
amount
of
hand
contact
that
would
be
necessary
to
handle
the
wood
when
using
a
saw
compared
to
installing
the
wood.

6.4.1.2
Scenarios
Assessed
for
High
Pressure/
High
Volume
Spray
Application
Methods
Handler
exposures
from
operating
high
pressure/
high
volume
spray
equipment
were
assessed
using
Equations
1
through
3
in
Section
1.2
for
applications
to
wood
in
wood
treatment
facilities,
wood
in
mushroom
houses,
and
cooling
tower
wood.
Dermal
and
inhalation
unit
exposure
values
were
taken
from
PHED
(
liquid/
open
pour/
high
pressure
spray).
These
unit
exposure
data
were
monitored
in
greenhouses
where
the
applications
were
made
to
floors,
benches,
and
overhead
plants.
The
dermal
and
inhalation
unit
exposure
values
are
2.5
mg/
lb
a.
i.
and
0.12
mg/
lb
a.
i.,
respectively
(
single
layer
of
clothing
and
gloves)
(
USEPA
1998).
Only
a
gloved
scenario
was
assessed
because
ungloved
data
are
not
available.
32
Due
to
the
uncertainty
in
the
quantity
of
solution
used
for
these
scenarios,
the
scenarios
were
assessed
using
a
range
of
25
to
1,000
gallons.
For
wood
treatment
facility
non­
pressure
spray
applications,
large
applications
are
assumed
to
be
performed
by
mechanical
dip
operations
while
smaller
treatments
may
be
performed
by
reel­
type
handwand
methods
where
the
quantity
handled
ranges
from
25
to
50
gallons.
During
the
error
comment
period
Janssen
provide
additional
information
on
the
quantities
applied
to
cooling
tower
wood.
An
applicator
of
cooling
tower
wood
preservatives
using
a
high­
pressure/
high
volume
spray
method
could
apply
a
maximum
of
200
gallons
of
diluted
solution
per
day
assuming
a
complete
8­
hr
work
shift
is
dedicated
to
the
application
of
the
preservative.
Typical
quantities
handled
are
less
than
100
gallons
per
day
because
service
crews
handle
many
other
unrelated
maintenance
tasks
at
the
facility.
The
values
could
be
further
refined
from
additional
input
from
registrants.

The
calculated
dermal,
inhalation,
and
total
MOEs
are
shown
in
Table
6.8
for
short­,
intermediate­,
and
long­
term
durations
of
exposure.
All
MOEs
for
high
pressure/
high
volume
wood
preservative
uses
were
above
the
target
MOE
of
100
for
all
scenarios
except
for
the
following:

 
Wood
Preservation,
high
pressure/
high
volume
spray
in
wood
treatment
facility:
IT/
LT
dermal
MOE
(
gloves)
at
50
gallons
=
96,
IT/
LT
total
MOE
at
50
gallons
=
86.

 
Wood
Preservation,
high
pressure/
high
volume
spray
in
mushroom
house:
IT
dermal
MOE
(
gloves)
at
1,000
gallons
=
56,
IT
total
MOE
at
1,000
gallons
=
50.

It
should
be
noted
that
although
the
target
inhalation
MOE
is
100,
if
the
MOE
is
below
1,000
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study
because
the
current
inhalation
endpoint
is
based
on
an
oral
NOAEL.
All
of
the
occupational
inhalation
MOEs
are
above
1,000,
except
for
the
following
scenarios:

 
Wood
Preservation,
high
pressure/
high
volume
spray
in
wood
treatment
facility:
IT/
LT
inhalation
MOE
at
50
gallons
=
800
 
Wood
Preservation,
high
pressure/
high
volume
spray
in
mushroom
house:
IT
inhalation
MOE
at
1,000
gallons
=
470.
33
Table
6.8.
Short­
and
Intermediate­
Term
Exposures
and
MOEs
for
High
Pressure/
High
Volume
Spray
Scenarios
(
Wood
Treatment
Facility,
Mushroom
House,
and
Cooling
Tower
Wood)

Absorbed
Daily
Dosesc
(
mg/
kg/
day)
MOEsd
Baseline
Inhalation
Dermal
(
gloves)
Totale
Exposure
Site
Surrogate
Exposure
Data
App.

Rate
(
lb
ai/
dilute
gallon)
Quantity
Handled/

Treated
per
daya
(
gallons)
Baseline
Inhalation
Unit
Exposure
(
mg/
lb
ai)
Dermal
(
gloves)

Unit
Exposureb
(
mg/
lb
ai)
Baseline
Inhalation
Dermal
(
gloves)
ST
IT
ST
IT
ST
IT
25
0.12
2.5
0.0063
0.052
4,800
1600
580
190
510
170
Wood
Treatment
Facility
0.146
50
0.12
2.5
0.013
0.10
2,400
800
290
96
260
86
100
0.12
2.5
0.0021
0.018
14,000
4,700
1,700
560
1,500
500
Mushroom
House
0.0125
1,000
0.12
2.5
0.021
0.18
1,400
470
170
56
150
50
100
0.12
2.5
0.0037
0.031
8,100
2,700
970
520
870
290
Cooling
Tower
PHED
M/
L/
A
high
pressure
spray
0.0216
200
0.12
2.5
0.0074
0.062
4,100
1,400
490
160
430
140
a.
Due
to
the
uncertainty
of
the
use
amounts,
the
scenarios
were
assessed
for
both
100
and
1,000
gallons.

b.
No
ungloved
data
available
such
that
only
a
gloved
scenario
was
assessed.

c.
Absorbed
Daily
dose
(
mg/
kg/
day)
=
unit
exposure
(
mg/
1%
ai
solution)
*
percent
active
ingredient
in
solution
*
absorption
factor
(
40%
for
dermal
and
100%
for
inhalation)
/
body
weight
(
70
kg).

d.
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation
and
intermediate­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].

Target
MOE
is
100
for
dermal
and
inhalation
exposures.
The
mushroom
house
applications
are
expected
to
be
an
intermittent
exposure,
at
most
once
a
week,
and
therefore
the
mushroom
house
duration
is
believed
to
be
short­
term
only.

e.
Total
MOE
=
1/
((
1/
MOEdermal)
+
(
1/
MOEinhalation)).
Target
MOE
is
100.
34
6.4.2
Pressure
Treatment
Scenarios
(
Handler
and
Post­
Application)

Propiconazole
may
be
used
to
treat
wood
and
wood
products
using
pressurized
application
methods
such
as
vacuum,
double
vacuum,
full­
cell,
and
modified
full­
cell.
The
maximum
rate
of
application
used
in
this
assessment
is
1%
ai
solution
for
decay
control
(
USEPA,
2005a).
Propiconazole­
specific
exposure
data
are
not
available
for
assessment
of
pressure
treatment
exposure.
Therefore,
the
assessment
relies
on
surrogate
chromated
copper
arsenate
(
CCA)
data
(
ACC,
2002)
and
was
based
on
the
approach
used
in
a
previous
exposure
assessment
(
USEPA,
2003).

Surrogate
Unit
Exposure
Data
Dermal
and
inhalation
exposures
for
pressure
treatment
uses
are
derived
from
information
in
the
exposure
study
by
the
American
Chemistry
Council
(
2002)
entitled
"
Assessment
of
Potential
Inhalation
and
Dermal
Exposure
Associated
with
Pressure
Treatment
of
Wood
with
Arsenical
Wood
Products"
(
ACC,
2002).
In
this
study,
a
treatment
solution
of
CCA
was
approximately
0.5
percent.
The
CCA
study
is
the
best
pressure
treatment
data
available
for
a
water
based
solution
to
estimate
exposure
to
propiconazole.

The
CCA
study
measured
both
handlers
and
post­
application
activities.
Although
there
is
overlap
in
job
functions,
the
handlers
are
defined
as
being
either
treating
operators
(
TOs)
or
treating
assistants
(
TAs).
The
TOs
were
monitored
at
three
sites
(
A,
B,
and
C)
using
5
replicates
at
each
site.
The
TAs
were
monitored
at
two
sites
(
Sites
A
and
C)
using
5
replicates
at
each
site.
The
post­
application
activities
included:
tram
setter
(
TS)
at
Site
A
(
n=
5);
stacker
operator
(
SO)
at
Site
A
(
n=
4);
loader
operator
(
LO)
at
Sites
A,
B,
C
(
n=
15);
supervisor
(
S)
at
Site
B
(
n=
5);
test
borer
(
TB)
at
Site
C
(
n=
5);
and
the
tallyman
(
TM)
at
Site
C
(
n=
5).
According
to
the
CCA
study,
workers
wore
cotton
long­
sleeved
shirts
and
cotton
trousers
(
or
one­
piece
cotton
coveralls)
over
the
whole­
body
dosimeters
("
plus
additional
shirts
or
jackets
per
typical
practice
at
Site
B")
and
chemical­
resistant
or
work
gloves,
when
appropriate.
Therefore,
the
CCA
study
provides
exposure
data
associated
with
maximum
PPE
(
excluding
respirators).
In
using
the
CCA
study
for
this
propiconazole
assessment,
the
TO
and
TA
handlers
are
assessed
separately.
The
post­
application
job
functions,
however,
have
been
combined
into
one
data
set
to
represent
post­
application
activities
because
for
most
activities
the
sample
size
is
small
(
5
 
n
 
15).

The
measured
CCA
dermal
and
inhalation
exposure
values
were
normalized
by
the
treatment
solution
concentration
used
at
each
of
the
3
facilities
(
i.
e.,
unit
exposure
reported
as
µ
g
arsenic/
ppm
treatment
solution).
The
normalization
by
treatment
solution
concentration
was
performed
to
extrapolate
the
measured
exposures
in
the
CCA
study
(
monitored
at
~
0.5%
ai
solution)
to
the
maximum
propiconazole
treatment
solution
concentration
(
1%
ai
solution).
Table
6.9
presents
the
dermal
and
inhalation
unit
exposure
values
normalized
to
the
treatment
solution
concentration
in
ppm
for
(
1)
all
sites,
(
2)
treatment
operator
(
TA
handler),
(
3)
treatment
assistant
(
TA
handler),
and
(
4)
all
post­
application
job
functions
(
TS,
SO,
LO,
S,
TB,
TM).

Note:
The
U.
S.
and
Canadian
sites
indicate
a
7x
difference
in
the
mean
dermal
exposures
(
US
site
mean
is
0.40
µ
g
As/
ppm
compared
to
the
Canadian
site
mean
of
2.84
µ
g
As/
ppm).
It
is
recommended
that
additional
analysis
be
performed
to
determine
if
the
35
increased
exposure
levels
at
the
Canadian
site
can
be
attributed
to
differences
in
site­
specific
engineering
controls
or
facility
design.

Exposure
Calculations
The
following
equation
was
used
to
estimate
dermal
and
inhalation
handler
exposure:

Daily
Dose
=
UE
x
AI
x
AB
BW
Where
UE
=
Unit
exposure
(
mg
As/
ppm);
AI
=
AI
(
1%
ai
and
0.5%
ai
in
solution);
AB
=
Absorption
factor
(
40%
for
dermal,
100%
for
inhalation);
and
BW
=
Body
weight
(
70
kg).

Results
The
estimated
dermal
and
inhalation
exposures
and
risks
for
propiconazole
are
presented
in
Table
6.10.
The
calculated
dermal,
inhalation,
and
total
MOEs
for
short­,
intermediate­,
and
long­
term
durations
are
above
the
target
MOE
of
100
for
all
scenarios
except
for
the
intermediate­
and
long­
term
dermal
and
total
MOE
for
the
treatment
operator
(
both
MOEs
are
86).

All
inhalation
MOEs
exceeded
1,000,
therefore,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
these
exposure
scenarios.

Table
6.9.
Dermal
and
Inhalation
Exposure
Values
from
a
CCA
Pressure
Treatment
Study
(
Exposure
Data
used
as
Surrogate
Unit
Exposures
for
Propiconazole
Assessment)

Treatment
Solution
Site
%
ppma
Statistic
Dermal
Unit
Exposure
(
Fg
As/
ppm)
Air
Concentrationb
(
Fg
As/
m3/
ppm)
Inhalation
Unit
Exposurec
(
Fg
As/
ppm)

Average
±
std
0.97
±
Unknown
0.00013
±
0.00023
0.00104
Median
0.36
0.00013
0.00104
90th
percentile
2.07
0.00077
0.00617
All
sites
­
All
Data
(
n
=
64)
0.438
to
0.595
4,380
to
5,950
Maximum
7.74
0.0011
0.00882
Average
±
std
2.04
±
2.68
0.00032
±
0.00038
0.00257
Median
0.37
0.00013
0.00104
90th
percentile
5.39
0.00092
0.00737
All
sites
­
Handler
Treatment
Operator
(
n
=
15)
0.438
to
0.595
4,380
to
5,950
Maximum
7.74
0.0011
0.00882
Average
±
std
0.24
±
0.14
0.0001
±
0.00004
0.000802
Median
0.23
0.00013
0.00104
90th
percentile
0.40
0.00013
0.00104
All
sites
­
Handler
Treatment
Assistant
(
n
=
10)
0.438
to
0.595
4,380
to
5,950
Maximum
0.52
0.00014
0.00112
Average
±
std
0.74
±
0.73
0.00020
±
0.00025
0.00160
All
sites
 
Postapplication
All
job
functions
­­
­­

Median
0.42
0.00013
0.00104
36
Table
6.9.
Dermal
and
Inhalation
Exposure
Values
from
a
CCA
Pressure
Treatment
Study
(
Exposure
Data
used
as
Surrogate
Unit
Exposures
for
Propiconazole
Assessment)

Treatment
Solution
Site
%
ppma
Statistic
Dermal
Unit
Exposure
(
Fg
As/
ppm)
Air
Concentrationb
(
Fg
As/
m3/
ppm)
Inhalation
Unit
Exposurec
(
Fg
As/
ppm)

90th
percentile
1.81
0.00050
0.00401
(
TS,
SO,
LO,
S,
TB,
TM)
(
n
=
39)
Maximum
3.11
0.0011
0.00882
a.
ppm
=
(%
treatment
solution)
*
(
10,000).
b.
Air
concentration
was
calculated
as
Fg
collected
per
sample
per
ppm
/
(
480
min
per
day
x
2
L/
min).
c.
Inhalation
unit
exposure
=
air
concentration
(
Fg
As/
m3/
ppm)
*
breathing
rate
for
light
activities
(
0.0167
m3/
min)
*
sample
duration
(
480
min).

Table
6.10.
Short­,
Intermediate­,
and
Long­
Term
Exposures
and
MOEs
for
Pressure
Treatment
Handler
and
Post­
application
Scenarios
Unit
Exposurea
(
Fg
As/
ppm)
Absorbed
Daily
Dosesb
(
mg/
kg/
day)
MOEsc
Dermal
Inhalation
Totald
Exposure
Scenarioa
Dermal
Inhalation
Application
Rate
(%
ai
solution)
Dermal
Inhalation
ST
IT/
L
T
ST
IT/
LT
ST
IT/
LT
Occupational
Handler
Treatment
Operator
(
TO)
2.04
0.00257
1
0.12
0.00037
260
86
82,000
27,000
260
86
Treatment
Assistant
(
TA)
0.24
0.000802
1
0.014
0.00012
2,200
730
260,000
87,000
2,200
730
Occupational
Post­
application
All
(
Tram
setter,
stacker
operator,
loader
operator,
supervisor,
test
borer,
and
tallyman)
0.74
0.00160
1
0.042
0.00023
710
240
130,000
44,000
710
240
ST
=
Short­
term
duration;
IT
=
Intermediate­
term
duration;
and
LT
=
long­
term.
a.
Unit
exposure
values
taken
from
CCA
study
and
are
shown
in
Table
6.10.
b.
Absorbed
Daily
Dose
(
mg/
kg/
day)
=
Unit
Exposure
(
µ
g
As/
ppm)
*
[%
propiconazole
in
solution
(
1)
*
10,000
(
parts
per
million
conversion)]
*
(
0.001
mg/
µ
g)
*
absorption
factor
(
40%
for
dermal
and
100%
for
inhalation)
/
Body
weight
(
70
kg).
c.
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
dose
[
Where
short­
term
NOAEL
=
30
mg/
kg/
day
for
dermal
and
inhalation
and
intermediate­
term
NOAEL
=
10
mg/
kg/
day
for
dermal
and
inhalation].
Target
MOE
is
100
for
dermal
and
inhalation
exposures.
d.
Total
MOE
=
1/
((
1/
MOEdermal)
+
(
1/
MOEinhalation)).
Target
MOE
is
100.

6.5
Data
Limitations/
Uncertainties
37
There
are
several
data
limitations
and
uncertainties
associated
with
the
occupational
handler
and
postapplication
exposure
assessments.
These
include:

 
Surrogate
dermal
and
inhalation
unit
exposure
values
were
taken
from
the
proprietary
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study
(
USEPA,
1999:
DP
Barcode
D247642)
or
from
the
Pesticide
Handler
Exposure
Database
(
USEPA,
1998)
(
See
Appendix
A
for
summaries
of
these
data
sources).
Since
the
CMA
data
are
of
poor
quality,
the
Agency
requests
that
confirmatory
data
be
submitted
to
support
the
occupational
scenarios
assessed
in
this
document.
 
The
baseline
(
ungloved)
dermal
exposures
and
risks
for
material
preservation
of
paints,
textiles,
adhesives,
and
metalworking
fluid
were
calculated
using
unit
exposure
values
from
the
cooling
tower
CMA
data
set
because
baseline
dermal
unit
exposures
are
not
available
for
preservative
or
metal
fluid
CMA
unit
exposure
categories.
 
For
the
wood
preservative
pressure
treatment
scenarios,
CCA
exposure
data
were
used
for
lack
of
propiconazole­
specific
exposure
data
and
for
the
wood
preservative
non­
pressure
treatment
scenarios,
DDAC
exposure
data
were
used
for
the
lack
of
propiconazolespecific
exposure
data.
Limitations
and
uncertainties
associated
with
the
use
of
these
data
include:
o
The
assumption
was
made
that
exposure
patterns
for
workers
at
treatment
facilities
using
CCA
and
DDAC
would
be
similar
to
exposure
patterns
for
workers
at
treatment
facilities
using
propiconazole,
and
therefore
the
exposures
could
be
used
as
surrogate
data
for
workers
that
treat
wood
with
propiconazole.
o
For
environmental
modeling,
it
was
assumed
that
the
leaching
process
from
the
propiconazole
treated
wood
would
be
similar
to
that
of
CCA
and
DDAC.
However,
due
to
the
lack
of
real
data
for
propiconazole
­
treated
wood,
it
is
not
possible
to
verify
this
assumption.
 
The
quantities
handled/
treated
were
estimated
based
on
information
from
various
sources,
including
HED's
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000,
and
2001)
and
AD's
standard
assumptions.
In
certain
cases,
no
standard
values
were
available
for
some
scenarios.
Assumptions
for
these
scenarios
were
based
on
AD
estimates
and
could
be
further
refined
from
input
from
registrants.
In
particular,
the
quantities
handled/
treated
for
the
application
of
propiconazole
to
wood
in
mushroom
houses
through
high
pressure/
high
volume
spray
methods
could
be
refined.
 
Inhalation
exposures
are
expected
to
occur
to
bystanders
as
a
result
of
material
preservative
applications
in
industrial
settings.
Currently,
no
data
are
available
to
assess
these
bystander
exposures
and
therefore,
monitoring
data
are
needed.
38
7.0
REFERENCES
American
Chemistry
Council
(
ACC).
2002.
Assessment
of
Potential
Inhalation
and
Dermal
Exposure
Associated
With
Pressure
Treatment
of
Wood
with
Arsenical
Wood
Products.
MRID
4550211­
01.

Bestari
KT,
Macey
K,
Soloman
KR,
Tower
N.
1999.
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III).
MRID
455243­
04.

Cinalli,
Christina,
et
al.
A
Laboratory
Method
to
Determine
the
Retention
of
Liquids
on
the
Surface
of
Hands.
Exposure
Evaluation
Division.
September
1992.

NIOSH
(
1998)
What
You
Need
to
Know
About
Occupational
Exposure
to
Metalworking
Fluids.
U.
S.
Department
of
Health
and
Human
Services.
National
Institute
for
Occupational
Safety
and
Health.

SIMetric.
2005.
http://
www.
simetric.
co.
uk/
si_
materials.
htm
Last
viewed
November
9,
2005.

USEPA.
1998.
PHED
Surrogate
Exposure
Guide.
Estimates
of
Worker
Exposure
from
the
Pesticide
Handler
Exposure
Database
Version
1.1.
Washington,
DC:
U.
S.
Environmental
Protection
Agency.

USEPA.
1999.
Evaluation
of
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study
(
Amended
on
8
December
1992).
Memorandum
from
Siroos
Mostaghimi,
PH.
D.,
USEPA
to
Julie
Fairfax,
USEPA.
Dated
November,
4
1999.
DP
Barcode
D247642.

USEPA.
1997.
Exposure
Factors
Handbook.
Volume
I­
II.
Office
of
Research
and
Development.
Washington,
D.
C.
EPA/
600/
P­
95/
002Fa.
August
1997.

USEPA.
2000.
Residential
SOPs.
EPA
Office
of
Pesticide
ProgramsBHuman
Health
Effects
Division.
Dated
April
5,
2000.

USEPA.
2001.
HED
Science
Advisory
Council
for
Exposure.
Policy
Update,
November
12.
Recommended
Revisions
to
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessment,
February
22,
2001.

USEPA.
2003a.
Propiconazole
 
3rd
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
Dated
December
17,
2003.
TXR
No.
0052277.

USEPA.
2003b.
Assessment
of
the
Proposed
Bardac
Wood
Preservative
Pressure
Treatment
Use.
Memorandum
from
Tim
Leighton
and
Siroos
Mostaghimi.
February
11,
2003.

USEPA.
2004.
Occupational
and
Residential
Exposure
Assessment
for
Carboquat
WP­
50.
Memorandum
from
Siroos
Mostaghimi,
USEPA
to
Welma
Noble,
USEPA.
Dated
November
4,
2004.
DP
Barcodes
D303714
and
D303938.
39
USEPA
2005a.
Propiconazole
Use­
Closure
Memo
Amendment.
Memorandom
from
Jaqueline
Guerry,
USEPA
to
Propiconazole
RED
Team
Member,
USEPA.
Dated
April
22,
2005.
40
APPENDIX
A:
Summary
of
CMA
and
PHED
Data
41
Chemical
Manufacturers
Association
(
CMA)
Data:
In
response
to
an
EPA
Data
Call­
In
Notice,
a
study
was
undertaken
by
the
Institute
of
Agricultural
Medicine
and
Occupational
Health
of
The
University
of
Iowa
under
contract
to
the
Chemical
Manufacturers
Association.
In
order
to
meet
the
requirements
of
Subdivision
U
of
the
Pesticide
Assessment
Guidelines
(
superseded
by
Series
875.1000­
875.1600
of
the
Pesticide
Assessment
Guidelines),
handler
exposure
data
are
required
from
the
chemical
manufacturer
specifically
registering
the
antimicrobial
pesticide.
The
applicator
exposure
study
must
comply
with
the
assessment
guidelines
for
AApplicator
Exposure
Monitoring@
in
Subdivision
U
and
the
AOccupational
and
Residential
Exposure
Test
Guidelines@
in
Series
875.
For
this
purpose,
CMA
submitted
a
study
on
28
February,
1990,
entitled
"
Antimicrobial
Exposure
Assessment
Study
(
amended
on
December
8,
1992)"
which
was
conducted
by
William
Popendorf,
et
al.
It
was
evaluated
and
accepted
by
Occupational
and
Residential
Exposure
Branch
(
OREB)
of
Health
Effect
Division
(
HED),
Office
of
Pesticides
Program
(
OPP)
of
EPA
in
1990.
The
purpose
of
this
CMA
study
was
to
characterize
exposure
to
antimicrobial
chemicals
in
order
to
support
pesticide
reregistrations
(
CMA,
1992).
The
unit
exposures
presented
in
the
most
recent
EPA
evaluation
of
the
CMA
database
(
USEPA,
1999)
were
used
in
this
assessment.

The
Agency
determined
that
the
CMA
study
had
fulfilled
the
basic
requirements
of
Subdivision
U
­
Applicator
Exposure
Monitoring.
The
advantages
of
CMA
data
over
other
Asurrogate
data
sets@
is
that
the
chemicals
and
the
job
functions
of
mixer/
loader/
applicator
were
defined
based
on
common
application
methods
used
for
antimicrobial
pesticides.
A
few
of
the
deficiencies
in
the
CMA
data
are
noted
below:

 
The
inhalation
concentrations
were
typically
below
the
detection
limits,
so
the
unit
exposures
for
the
inhalation
exposure
route
could
not
be
accurately
calculated.
 
QA/
QC
problems
including
lack
of
either/
or
field
fortification,
laboratory
recoveries,
and
storage
stability
information.
 
Data
have
an
insufficient
amount
of
replicates.

The
Pesticide
Handlers
Exposure
Database
(
PHED):
The
Pesticide
Handlers
Exposure
Database
(
PHED)
has
been
developed
by
a
Task
Force
consisting
of
representatives
from
Health
Canada,
the
U.
S.
Environmental
Protection
Agency
(
EPA),
and
the
American
Crop
Protection
Association
(
ACPA).
PHED
provides
generic
pesticide
worker
(
i.
e.,
mixer/
loader
and
applicator)
exposure
estimates.
The
dermal
and
inhalation
exposure
estimates
generated
by
PHED
are
based
on
actual
field
monitoring
data,
which
are
reported
generically
(
i.
e.,
chemical
specific
names
not
reported)
in
PHED.
It
has
been
the
Agency=
s
policy
to
use
Asurrogate@
or
Ageneric@
exposure
data
for
pesticide
applicators
in
certain
circumstances
because
it
is
believed
that
the
physical
parameters
(
e.
g.,
packaging
type)
or
application
technique
(
e.
g.,
aerosol
can),
not
the
chemical
properties
of
the
pesticide,
attribute
to
exposure
levels.
[
Note:
Vapor
pressures
for
the
chemicals
in
PHED
are
in
the
range
of
E­
5
to
E­
7
mm
Hg.]
Chemical
specific
properties
are
accounted
for
by
correcting
the
exposure
data
for
study
specific
field
and
laboratory
recovery
values
as
specified
by
the
PHED
grading
criteria.

PHED
handler
exposure
data
are
generally
provided
on
a
normalized
basis
for
use
in
exposure
assessments.
The
most
common
method
for
normalizing
exposure
is
by
pounds
of
active
42
ingredient
(
ai)
handled
per
replicate
(
i.
e.,
exposure
in
mg
per
replicate
is
divided
by
the
amount
of
ai
handled
in
that
particular
replicate).
These
unit
exposures
are
expressed
as
mg/
lb
ai
handled.
This
normalization
method
presumes
that
dermal
and
inhalation
exposures
are
linear
based
on
the
amount
of
active
ingredient
handled.
43
APPENDIX
B:

Calculation
of
DDAC
Unit
Exposure
Values
(
MRID
455243­
04)
44
Table
B­
1:
DDAC
Dermal
and
Inhalation
Exposure
Values
for
Chemical
Operators,
Graders,
Millwrights,
Clean­
up
Crews,
and
Trim
Saw
Operatorsa
Chemical
Operator
Grader
Trim
Saw
Operator
Millwright
Cleanup
Crew
Dermal
Inhalation
Dermal
Inhalation
Dermal
Inhalation
Dermal
Inhalation
Dermal
Inhalation
Replicate
Number
Potential
exposure
(
mg)
Air
Concentrationb,

c
(:
g/
m
3
)
Potential
exposured
(
mg)
Potential
exposure
(
mg)
Air
Concentration
b,
c
(:
g/
m
3
)
Potential
exposure
d
(
mg)
Potential
exposure
(
mg)
Air
Concentration
b,
c
(:
g/
m
3
)
Potential
exposure
d
(
mg)
Potential
exposure
(
mg)
Air
Concentration
b,
c
(:
g/
m
3
)
Potential
exposure
d
(
mg)
Potential
exposure
(
mg)
Air
Concentration
b,
c
(:
g/
m
3
)
Potential
exposure
d
(
mg)

1
3.5
10.1
0.0808
3.05
2.90
0.0232
0.78
2.83
0.0227
1.31
2.92
0.0233
68.3
2.99145
0.0239
2
6.11
2.80
0.0224
7.47
2.93
0.0234
1.98
12.3
0.0984
29.08
2.83
0.0226
0.720
2.78840
0.0223
3
6.07
2.79
0.0223
1.09
2.91
0.0233
8.03
15.6
0.1248
166
30.3
0.2424
4
46.37
2.82
0.0226
10.51
3.00
0.0240
95.2
412
3.2960
5
0.94
2.93
0.0235
0.61
2.82
0.0226
1.20
2.83585
0.0227
6
22.15
2.83
0.0227
0.98
2.85
0.0228
0.260
2.80989
0.0225
7
21.45
2.77
0.0222
2.63
2.91
0.0233
8
0.22
2.73
0.0218
5.23
2.85
0.0228
9
0.44
2.77
0.0222
0.19
13.20
0.1056
10
0.33
3.14
0.0251
1.47
2.89
0.0231
11
0.29
2.88
0.0230
2.38
2.85
0.0228
12
4.09
2.81
0.0225
13
1.03
2.94
0.0235
Arithmetic
Mean
9.81
3.51
0.0281
3.13
3.68
0.0295
1.38
7.57
0.061
12.8
7.12
0.057
55.3
75.6
0.60
Minimum
0.22
2.73
0.0218
0.19
2.81
0.0225
0.78
2.83
0.0227
1.31
2.83
0.0226
0.260
2.79
0.0223
Maximum
46.4
10.1
0.081
10.51
13.2
0.106
1.98
12.3
0.098
29.1
15.6
0.125
166
412
3.30
a.
"
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)"
is
the
study
that
values
were
obtained
from
for
this
table
(
Bestari
et
al.,
1999,
MRID
455243­
04).

b.
The
inhalation
LOD
was
not
provided
for
chemical
operators,
graders,
trim
saw
operators,
millwrights,
or
the
clean­
up
crew.
Therefore,
the
LOD
provided
for
the
diptank
operator
(
5.6
:
g)

was
used
for
these
positions.
Residues
less
than
the
LOD
were
adjusted
to
1/
2
LOD.

c.
The
inhalation
limit
of
detection
was
converted
to
:
g/
m3
using
the
following
equation:
air
concentration
(:
g/
m3)
=
5.6
:
g/
[
average
flow
rate
(
L/
min)
*
sampling
duration
(
480
min)
*
1000
L/
m3.
Data
was
obtained
from
Bestari
et
al
(
1999).

d.
DDAC
air
concentrations
were
converted
to
inhalation
exposure
using
the
following
equation:
Air
concentration
(:
g/
m3)
x
inhalation
rate
(
1.0
m3/
hr)
x
Conversion
factor
(
1
mg/
1000
:
g)
x
sample
duration
(
8
hours/
day
45
Table
B­
2:
Normalization
of
DDAC
Dermal
and
Inhalation
Exposure
Values
for
Diptank
Operatorsa
Worker
ID
Mill
number
Sample
Time
(
min)
DDAC
Conc.
in
Diptank
(%)
Gloves
Dermal
Body
Exposureb
(
mg)
Hand
Exposureb
(
mg)
Total
Dermal
Exposure
(
mg)
Normalized
Total
Dermal
Unit
Exposurec
(
mg/
1
%
solution)
Air
Conc.
d
(
mg/
m3)
Inhalation
Exposuree
(
mg)
Normalized
Inhalation
Unit
Exposurec
(
mg
/
1%
solution)

M7P1A
7
480
0.64
Rubber
0.5
3.44
3.94
6.16
0.003
0.024
0.0375
M7P1B
7
480
0.64
Rubber
0.32
2.02
2.34
3.66
0.003
0.024
0.0375
M8P4A
8
408
0.42
Rubber
0.04
f
1.34
1.38
3.29
0.003
0.024
0.057
M8P4B
8
480
0.42
Rubber
0.04f
0.5
0.54
1.29
0.003
0.024
0.057
M8P7
8
480
0.42
Cotton
0.03
0.04
0.07
0.17
0.003
0.024
0.057
M11P9A
11
395
0.63
Leather
0.15
3.33
3.48
5.52
0.003
0.024
0.0381
M11P9B
11
480
0.63
Leather
0.1
0.45
0.55
0.87
0.003
0.024
0.0381
Arithmetic
Mean
0.17
1.59
1.76
2.99
0.0030
0.0240
0.046
Standard
Deviation
0.18
1.39
1.53
2.32
0.0000
0.0000
0.0103
Median
0.10
1.34
1.38
3.29
0.0030
0.0240
0.0381
Geometric
Mean
0.10
0.83
0.99
1.86
0.0030
0.0240
0.045
90%
tile
0.39
3.37
3.66
5.78
0.0030
0.0240
0.057
Maximum
0.50
3.44
3.94
6.16
0.0030
0.0240
0.057
a.
"
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)"
is
the
study
that
values
were
obtained
from
for
this
table
(
Bestari
et
al.,
1999,
MRID
455243­
04,
Task
Force
#
73154).

b.
DDAC
concentration
that
was
detected
in
the
monitoring
study
(
MRID
#
455243­
04).

c.
Normalization
of
DDAC
data
for
percent
ai
treatment.
Normalized
Unit
Exposure
(
mg/
1%
ai
solution)
=
Exposure
(
mg
DDAC)
/
concentration
in
diptank
solution
(%
DDAC)

d.
All
inhalation
residues
were
<
LOD
(
5.6
Fg
or
0.0056
mg/
m3).
1/
2
LOD
was
used
in
all
calculations
(
0.003
mg/
m3).
Air
Concentration
(
mg/
m3)
=
5.6
Fg
/
(~
2
L/
min
flow
rate
x
~
480
min)

x
1000
L/
m3
conversion
x
0.001
Fg/
mg
=
0.003
mg/
m3
e.
Inhalation
exposure
(
mg)
=
air
concentration
(
mg/
m3)
x
inhalation
rate
(
1.0
m3/
hr)
x
sample
duration
(
8
hours/
day).

f.
Residues
were
<
LOD
for
dermal
samples
M8P4A,
M8P4B.
Sample
size
of
~
11,231
cm2
x
<
0.007
ug/
cm2
=
LOD
of
0.079
mg.
1/
2
LOD
reported
(
i.
e.,
0.04
mg)
