Document ID: EPA-HQ-OPP-2005-0497-0039
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-23T04:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
June
20,
2006
Memorandum
SUBJECT:
Propiconazole:
Amendment
to
the
Propiconazole
Reregistrat
ion
Eligibility
Decision
(
RED)
Document
for
Children's
Postapplicat
ion
Exposure
Treated
Structures.
PC
Code
122101.
Reregistrat
ion
Case#
3125.
DP
Barcode
330159.

FROM:
Tim
Leighton,
Environmental
Scient
ist
Cassi
Walls,
Ph.
D.,
Chemist
Ant
imicrobia
ls
Division
TO:
Mark
Hartman,
Branch
Chief,
RMBII
Ant
imicrobia
ls
Division
And
Christ
ina
Scheltema,
Chemical
Review
Manager
Special
Review
and
Reregistrat
ion
Division
At
tached
is
a
screening­
level
review
of
the
children's
exposure
to
propiconazole­
treated
wood
(
i.
e.,
dimensional
lumber).

EXECUTIVE
SUMMARY
The
draft
propiconazole
Reregistrat
ion
Eligibility
Decision
(
RED)
document
did
not
include
an
assessment
of
the
propiconazole
treatment
of
dimensional
lumber
because
at
the
t
ime
no
surface
residue
data
were
available
to
assess
the
exposure.
During
the
comment
period
the
registrants
clarified
that
although
propiconazole
is
not
current
ly
being
marketed,
they
intended
to
keep
it
on
the
label.
Therefore,
this
memorandum
out
lines
a
screening­
level
assessment
for
the
potent
ial
r
isks
to
children
playing
on
propiconazole­
treated
structures,
if
propiconazole
were
to
be
used
to
treat
dimensional
lumber
in
the
future.
It
is
also
recommended
that
the
labels
clarify
the
intended
uses
by
including
the
Amer
ican
Wood
Preservers'
Associat
ion
(
AWPA)
standard
codes
for
wood
classificat
ion.

A
determinist
ic
exposure
assessment
was
developed
using
the
scenarios
and
modified
equat
ions
from
the
probabilist
ic
Stochast
ic
Human
Exposure
and
Dose
Simulat
ion
(
SHEDS)
model
developed
to
assess
children's
exposure
to
CCA­
treated
structures
(
USEPA
2005a).
Although
2
the
SHEDS
model
was
not
developed
to
provide
a
determinist
ic
assessment
,
EPA
believes
that
a
high
end
screening­
level
est
imate
is
appropr
iate
to
determine
"
reasonable
certainty
o
f
no
harm"
for
a
reregistrat
ion
eligibility
decision.
The
result
s
of
the
determinist
ic
screening­
level
assessment
indicate
that
the
short­
term
dermal,
incidental
oral,
and
aggregate
MOEs
for
propiconazole
are
450,
5300,
and
410,
respect
ively.
The
intermediate­
term
dermal,
incidental
oral,
and
aggregate
MOEs
are
150,
1800,
and
140,
respect
ively.
This
r
isk
assessment
,
based
on
high
end
screening­
level
assumpt
ions,
indicates
no
r
isks
o
f
concern.
Confirmatory
data
for
the
surface
residues
are
needed
to
verify
that
the
wood
surface
concentration
of
propiconazole
is
lower
then
that
assumed
in
this
screening­
level
assessment
.

INTRODUCTION
At
this
t
ime
there
are
no
chemical­
specific
surface
wipe
residue
data
available
to
assess
the
dermal
and
incidental
exposure
for
children
playing
on
treated
structures.
Up
unt
il
this
point
in
t
ime,
wood
surface
residue
data
have
not
been
est
imated
without
a
wood
wipe
study.
EPA
has
decided
to
provide
a
screening­
level
assessment
for
a
reregistrat
ion
decision
using
a
conservat
ive
sur
face
residue
value
of
1
µ
g/
cm2
and
callin
confirmatory
data.
The
1
µ
g/
cm2
value
accounts
for
the
skin
reduction
factor,
or
"
transfer
efficiency"
from
a
cloth
wipe
(
i.
e.,
cloth
wipe
surface
residues
are
higher
than
that
available
to
the
skin).
This
high
end
residue
value
is
higher
than
the
maximum
residue
seen
for
chromium
and
non
chromium­
based
wood
preservat
ives.

A
determinist
ic
screening­
level
assessment
has
been
developed
by
EPA
to
assess
children's
exposure
using
the
1
µ
g/
cm2
wood
residue
value
along
with
exposure
algor
ithms
and
parameters
from
the
probabilist
ic
Stochast
ic
Human
Exposure
and
Dose
Simulat
ion
(
SHEDS)
model
(
USEPA
2005a).
SHEDS
was
developed
by
EPA
to
assess
exposure
to
children
contact
ing
CCA­
treated
structures
(
i.
e.,
decks
and
play
sets).
The
SHEDS
report
along
with
EPA's
response
to
the
Science
Advisory
Panel's
(
SAP)
review
comment
s
is
located
at
ht
tp://
www.
epa.
gov/
heasd/
sheds/
cca_
treated.
htm.

The
SHEDS
model
includes
the
following
exposure
scenarios
for
children
playing
on
treated
structures:

 
Dermal
exposure
to
wood
residues;
 
Incidental
ingest
ion
from
hand­
to­
mouth
act
ivit
ies
(
wood
residues);
 
Incidental
ingest
ion
from
soil;
and
 
Dermal
exposure
to
soil.
3
Based
on
the
result
s
of
the
CCA
assessment
and
preliminary
calculat
ions
for
propiconazole,
direct
contact
with
the
treated
wood
exhibit
s
the
highest
potent
ial
for
exposure.
The
leaching
of
wood
preservat
ive
into
the
so
il
and
subsequent
exposure
is
less
then
that
attributed
to
direct
contact
with
the
treated
wood
itself.
Therefore,
for
screening­
level
assessment
purposes,
only
the
contact
with
the
treated
wood
is
quant
ified.
I
f
the
r
isks
are
not
of
concern
for
contacting
the
treated
wood
direct
ly,
then
the
so
il
exposure
and
aggregate
of
the
so
il
exposure
with
the
direct
wood
exposure
is
expected
to
be
of
minimal
addit
ional
contribut
ion.

Toxicological
Endpoints
of
Concern
Table1
summar
izes
the
toxicological
endpoint
s
for
propiconazole
(
USEPA
2003
and
2005b).
Table
1.
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenar
io
Dose
Used
in
Risk
Assessment
,
UF
Special
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Shor
t­
Term
(
1­
30
days)
Incidental
Or
al
NOAEL=
30
mg
ai
/
kg
Residential
MOE
=
100
Acute
Neurotoxici
ty
Study
­
Rats.
Cl
inical
toxicity:
piloerect
ion,
diarrhea,
tip
toe
at
100
mg/
kg
Intermediate­
Term
(
1
­
6
months)
Incidental
Or
al
NOAEL=
10
mg
ai
/
kg/
day
Residential
MOE
=
100
24
Month
Oncogenici
ty
Study
­
Mice.
Liver
toxicity
(
increased
l
iver
weight
in
males
and
increase
in
l
iver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Shor
t­
Term
(
1
­
30
days)
Dermal
(
General
Pop.
including
infants
and
children)
Oral
NOAEL=
30
mg
ai
/
kg
(
Dermal
absorption
rate
=
40%)
Residential
MOE
=
100
Acute
Neurotoxici
ty
Study
­
Rats.
Cl
inical
toxicity:
piloerect
ion,
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
24
Month
Oncogenici
ty
Study
­
Mice.
Liver
toxicity
(
increased
l
iver
weight
in
males
and
increase
in
l
iver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Cancer
Group
C,
possible
human
carcinogen
4
UF
=
uncer
tainty
factor
,
FQPA
SF
=
special
FQPA
safety
factor
,
NOAEL
=
no
observed
adver
se
effect
level
,
LOAEL
=
lowest
observed
adver
se
effect
level
,
PAD
=
populat
ion
adjusted
dose
(
a
=
acute,
c
=
chronic),
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
Level
of
concern,
NA
=
Not
Applicable.

Dermal
Exposure
I
f
propiconazole
were
to
be
so
ld
in
the
future
to
treat
dimensional
lumber,
potent
ial
dermal
exposure
to
children
can
result
from
playing
on
propiconazole­
treated
structures
such
as
decks
and/
or
play
sets.
The
dermal
toxicological
endpoints
o
f
concern
for
propiconazole
are
non
cancer.
Therefore,
the
amort
izat
ion
o
f
exposure
over
t
ime
that
is
provided
in
the
SHEDS
model
for
CCA
is
not
appropriate
for
propiconazole.
The
frequency
o
f
exposure
is
believed
to
be
best
represented
by
the
short­
term
durat
ion
(
i.
e.,
1
to
30
days
o
f
cont
inuous
exposure).
However,
the
intermediate­
term
durat
ion
is
also
presented
to
provide
r
isk
est
imates
for
that
port
ion
o
f
the
populat
ion
that
plays
cont
inuously
on
treated
structures
up
to
6
months
at
a
t
ime
(
Note:
For
propiconazole,
the
intermediate­
and
long­
term
endpoints
are
ident
ical).

The
potent
ial
daily
dose
(
PDD)
from
the
dermal
route
of
exposure
is
est
imated
using
the
following
modified
equat
ion
from
the
SHEDS
report
(
i.
e.,
SHEDS
Appendix
2
page
A2­
5):

PDD
=
SR
x
SA
x
DA
x
CF1
BW
where:
PDD
=
Potent
ial
daily
dose
(
mg/
kg/
day)
;
SR
=
Wood
surface
residue
adjusted
for
dermal
transfer
or
"
transfer
efficiency"
(
EPA
high
end
assumpt
ion
o
f
1
µ
g/
cm2)
;
SA
=
Sur
face
area
of
unclothed
body
areas
assuming
100%
contacts
the
treated
area
(
2,530
cm2
warm
weather);
DA
=
Dermal
absorpt
ion
(
40%);
CF1
=
Unit
conversion
factor
(
0.001
mg/
µ
g);
and
BW
=
Body
weight
(
15
kg)
(
USEPA,
2000
and
2001).

Note:
The
wood
surface
residue
of
1
µ
g/
cm2
represents
a
bounding
est
imate
o
f
the
steady
state
amount
of
residue
on
a
hand
wiping
the
surface
of
treated
wood.
A
confirmatory
study
to
determine
the
surface
residues
o
f
propiconazole
over
t
ime
is
needed
to
ver
ify
the
bounding
est
imate
and
refine
the
r
isk
assessment
.

The
result
s
of
dermal
exposure
assessment
indicate
an
absorbed
dose
of
0.0675
mg/
kg/
day.
The
short­
and
intermediate­
term
margin
of
exposures
(
MOEs)
are
450
and
150,
respect
ively,
with
a
target
MOE
of
5
100.
Therefore,
the
screening­
level
assessment
indicates
no
r
isk
o
f
concern
for
the
dermal
route
of
exposure.

Incidental
Oral
Exposure
I
f
propiconazole
were
to
be
so
ld
to
treat
dimensional
lumber,
potent
ial
oral
exposure
to
children
can
result
from
hand­
to­
mouth
act
ivit
ies
while
playing
on
propiconazole­
treated
structures
such
as
decks
and/
or
play
sets.
The
incidental
oral
toxicological
endpoints
o
f
concern
for
propiconazole
are
non
cancer.
Therefore,
the
amort
izat
ion
of
exposure
over
t
ime
that
is
provided
in
the
SHEDS
model
for
CCA
is
not
appropriate
for
propiconazole.
The
frequency
o
f
exposure
is
believed
to
be
best
represented
by
the
short­
term
durat
ion
(
i.
e.,
1
to
30
days
o
f
cont
inuous
exposure).
However,
the
intermediate­
term
durat
ion
is
also
presented
to
provide
r
isk
est
imates
for
that
port
ion
o
f
the
populat
ion
that
plays
cont
inuously
on
treated
structures
up
to
6
months
at
a
t
ime.

The
potent
ial
daily
dose
(
PDD)
from
the
dermal
route
of
exposure
is
est
imated
using
the
following
modified
equat
ion
from
the
SHEDS
report
(
i.
e.,
SHEDS
Appendix
2
page
A2­
8):

PDD
=
SR
x
SA
x
FQ
x
ET
x
SE
x
CF1
BW
where:
PDD
=
Potent
ial
daily
dose
(
mg/
kg/
day)
;
SR
=
Wood
surface
residue
adjusted
for
dermal
transfer
or
"
transfer
efficiency"
(
EPA
high
end
assumpt
ion
o
f
1
µ
g/
cm2)
;
SA
=
Sur
face
area
of
the
hands
that
contact
both
the
treated
area,
and
the
individuals
mouth
(
20
cm2
/
event)
(
USEPA,
2000
and
2001);
FQ
=
Frequency
o
f
hand­
to­
mouth
events
(
mean
8.45
events/
hr)
(
Table
10,
page
62,
USEPA
2005a);
SE
=
Saliva
extract
ion
efficiency
(
50%
unit
less
fract
ion)
(
USEPA,
2000
and
2001);
ET
=
Exposure
Time
(
mean
1
hr/
day)
(
Table
49
page
165
USEPA
2005a);
CF1
=
Unit
conversion
factor
(
0.001
mg/
µ
g);
and
BW
=
Body
weight
(
15
kg)
(
USEPA,
2000
and
2001).

Note:
The
wood
surface
residue
of
1
µ
g/
cm2
represents
a
bounding
est
imate
o
f
the
steady
state
amount
of
residue
on
a
hand
wiping
the
surface
of
treated
wood.
A
confirmatory
study
to
determine
the
surface
residues
o
f
propiconazole
over
t
ime
is
needed
to
ver
ify
the
bounding
est
imate
and
refine
the
r
isk
assessment
.
6
The
result
s
of
incidental
oral
exposure
result
ing
from
hand­
tomouth
act
ivity
indicate
a
dose
of
0.0437
mg/
kg/
day.
The
short­
and
intermediate­
term
MOEs
are
5,300
and
1,800,
respect
ively,
with
a
target
MOE
of
100.
Therefore,
the
screening­
level
assessment
indicates
no
risk
of
concern
for
the
oral
route
of
exposure.

Aggregate
Exposure
The
dermal
and
oral
endpoints
used
to
assess
the
potent
ial
exposures
are
from
the
same
studies,
and
therefore,
same
toxicological
effects.
The
dermal
and
oral
exposures
may
occur
simultaneously,
and
therefore,
are
aggregated
to
determine
the
total
MOE.
Table
2
presents
the
aggregate
r
isk
assessment
.
The
aggregate
or
total
MOEs
are
410
and
140
for
the
short­
and
intermediate­
term,
respect
ively.
The
aggregate
MOEs
are
not
of
concern.
Incremental
increase
to
the
aggregate
exposure
from
contact
ing
the
soil
around
treated
structures
is
expected
to
be
minimal
as
a
screening­
level
assessment
using
high
end
inputs
has
been
used
to
est
imate
the
potent
ial
r
isks.

Table
2.
Propiconazole
Assessment
of
Children
Playing
on
Treated
Structures.
MOEs
(
Target
=
100)
b
Exposure
Dose
(
mg/
kg/
day)
a
Short­
term
Intermediate
Dermal
Contact
0.0675
450
150
Incidental
Oral
0.00563
5,300
1,800
Aggregate
0.0731
410
140
a
Dose
(
mg/
kg/
day)
=
See
above
equat
ions
for
dermal
and
oral
exposure.
Aggregate
dose
=
dermal
dose
+
oral
dose.
b
MOEs
=
ST
and
IT
NOAELs
(
mg/
kg/
day)
/
Dose
(
mg/
kg/
day).
Where
ST
NOAEL
=
30
mg/
kg/
day
and
IT
NOAEL
=
10
mg/
kg/
day.
Target
MOE
=
100.

Data
Limitations
and
Uncertainties
It
is
important
to
highlight
some
o
f
the
limitat
ions
and
uncertaint
ies
in
this
exposure/
r
isk
assessment
for
children
playing
on
treated
structures
because
this
assessment
is
very
different
than
that
of
the
SHEDS
probabilist
ic
assessment
for
CCA.
The
following
issues
should
be
considered:

 
The
SHEDS
CCA
assessment
amort
izes
exposures
over
a
year
for
a
cancer
r
isk
assessment
.
Conversely,
the
propiconazole
assessment
provided
in
this
memorandum
is
based
on
non
cancer
endpoints.
Therefor
e,
input
parameters
as
well
as
algorithms
have
been
modified
from
those
presented
in
the
SHEDS
documents.

 
The
durat
ion
of
exposure
for
children
playing
on
propiconazoletreated
wood
is
best
represented
by
the
short­
term
durat
ion;
however,
the
intermediate­
term
durat
ion
is
also
included
to
indicate
7
what
the
r
isks
are
for
that
populat
ion
o
f
children
which
play
on
treated
structures
cont
inuously
for
6
months
at
a
t
ime.

 
The
surface
concentrat
ion
o
f
1
µ
g/
cm2
represents
the
high
end
for
data
available
to
the
EPA
at
this
t
ime.
The
retent
ion
for
propiconazole
is
approximately
one
order
of
magnitude
lower
than
for
this
high
end
observat
ion.
In
addit
ion,
the
1
µ
g/
cm2
represents
the
surface
residue
after
init
ial
treatment
.
The
surface
concentrat
ion
is
believed
to
reduce
to
a
lower
steady
state
over
t
ime.
Therefore,
the
surface
residue
concentration
is
assumed
to
be
a
very
conservat
ive
est
imate,
perhaps
by
an
order
of
magnitude
or
more.

REFERENCES
USEPA.
2000.
Resident
ial
SOPs.
EPA
Office
of
Pest
icide
Programs
B
Human
Health
Effects
Division.
Dated
Apr
il
5,
2000.

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

USEPA.
2003.
Propiconazole
 
3r
d
Report
of
the
Hazard
Ident
ificat
ion
Assessment
Review
Commit
tee.
Dated
December
17,
2003.
TXR
No.
0052277.

USEPA.
2005a.
Propiconazole
 
3x
database
uncertainty
factor
used
in
risk
assessment
.
Memorandum
from
Abdallah
Khasawinah
(
USEPA)
to
Chr
ist
ina
Scheltema
(
USEPA).
PC
Code
122101.
Reregistrat
ion
Case#:
3125.
Dated
December
29,
2005.

USEPA.
2005b.
A
Probabilist
ic
Exposure
Assessment
for
Children
Who
Contact
CCA­
Treated
Playsets
and
Decks;
Using
the
Stochast
ic
Human
Exposure
and
Dose
Simulat
ion
Model
for
the
Wood
Preservat
ive
Exposure
Scenario
(
SHEDS­
Wood).
Final
Report.
February,
2005.