Document ID: EPA-HQ-OPP-2004-0301-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-09-10T04:00Z

Page
1
of
12
Overview
of
the
Phenol/
Sodium
Phenate
Preliminary
Risk
Assessment,
September
13,
2004
Introduction
This
document
summarizes
EPA's
preliminary
human
health
and
ecological
risk
findings
and
conclusions
for
the
antimicrobial
pesticide
phenol/
sodium
phenate,
as
presented
fully
in
the
following
nine
documents:

1.
Incidents
reported
with
Phenol:
Human
Health
Effect
Report,
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
7/
24/
04.,
Jonathan
Chen,
Ph.
D.

2.
Product
Chemistry
Science
Chapter
on
Phenol.
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
8/
4/
04,
A.
Najm
Shamim,
Ph.
D.

3.
Phenol/
Sodium
Phenate:
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
7/
6/
04,
Michelle
M.
Centra,
Pharmacologist
and
Timothy
F.
McMahon,
Ph.
D.

4.
Phenol/
Sodium
Phenate:
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision.
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
5/
18/
04,
A.
Najm
Shamim,
Ph.
D.

5.
Phenols
Occupational/
Residential
Exposure
Assessment.
PC
Code
64001
and
64002,
Case
4074
Antimicrobials
Division,
6/
11/
04,
Timothy
Leighton.

6.
Report
of
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee.
PC
Code
64001
and
64002,
Case
4074
Antimicrobials
Division,
3/
9/
04,
Timothy
F.
McMahon,
Ph.
D.

7.
Science
Chapter
on:
Environmental
Fate
Studies
and
Environmental
Fate
Assessment
of
Phenol.
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
1/
29/
04,
A.
Najm
Shamim,
Ph.
D.

8.
Ecological
Hazard
and
Environmental
Risk
Assessment:
Phenol.
PC
Code
64001
and
64002,
Case
4074,
Antimicrobials
Division,
7/
28/
04,
Kathryn
Montague,
M.
S.

9.
Phenols
Preliminary
Risk
Assessment.
PC
Code
64001
and
64002,
Case
4074,
7/
7/
04,
Tim
McMahon,
Ph.
D.
Page
2
of
12
The
purpose
of
this
overview
summary
is
to
assist
the
reader
by
identifying
the
key
features,
findings,
and
conclusions
of
these
risk
assessments.
This
standard
overview
format
was
developed
in
response
to
comments
and
requests
from
the
public
which
indicated
that
prior
risk
assessments
for
other
chemicals
were
difficult
to
understand
and
too
lengthy,
as
well
as
that
it
was
not
easy
to
compare
the
assessments
for
different
chemicals
due
to
the
use
of
different
formats.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
Phenol/
Sodium
Phenate.
The
Food
Quality
Protection
Act
requires
that
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity".
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
Although
it
is
possible
that
Phenol/
Sodium
Phenate
may
express
toxicity
through
a
common
mechanism
with
other
compounds,
at
this
time,
the
Agency
does
not
have
sufficient
reliable
information
to
make
this
determination.
Consequently,
the
risks
summarized
herein
are
only
for
Phenol/
Sodium
Phenate.
If
EPA
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
Phenol/
Sodium
Phenate,
aggregate
exposure
assessments
will
be
performed
on
each
chemical,
followed
by
a
cumulative
risk
assessment.

Once
the
risk
assessments
are
available
to
the
public,
there
will
be
an
opportunity
for
the
public
to
view
them
and
to
comment
on
them.
Public
comments
may
be
submitted
to
the
OPP
electronic
docket
at:
www.
epa.
gov/
edocket
under
the
docket
number
OPP­
2004­
0305.
Meetings
with
stakeholders
(
e.
g.,
registrants,
distributors,
etc.)
are
planned
to
discuss
the
identified
risks
and
to
solicit
input
on
risk
mitigation
strategies.
This
feedback
will
be
used
to
complete
the
Reregistration
Eligibility
Decision
(
RED)
document,
which
will
include
the
resultant
risk
management
decisions.
The
Agency
plans
to
conduct
a
closure
conference
call
with
interested
stakeholders
to
discuss
the
final
regulatory
decisions
presented
in
the
RED.

PROFILE
ANTIMICROBIAL
Phenol
is
used
as
a
surface
cleaner
in
commercial­
transportation
facilities,
institutions,
industrial
premises,
eating
establishments,
indoor
residential
areas
and
medical
premises.

The
following
information
is
based
on
the
currently
registered
uses
of
Phenol/
Sodium
Phenate.

TYPE
OF
PESTICIDE
Sanitizer,
bacteriostat,
fungicide/
fungistat,
Tuberculocide,
disinfectant,
and
Virucide
SUMMARY
OF
USE
SITES
Page
3
of
12
Indoor
Food:
For
use
in
Eating
Establishments
Equipment/
Utensils
(
Food
Contact)

Indoor
Non­
Food
Residential:
For
use
on
Bathroom
Premises,
Hard
Surfaces,
Diaper
Pails,
Dogs/
Canines,
Household/
Domestic
Dwellings,
Indoor
Premises,
Solid
Waste
Containers
(
Garbage
Cans),
Rugs,
Carpets,
Swimming
Pool
Related
Surfaces,

Indoor
Non­
Food,
Commercial
&
Industrial:
For
use
in
Animal
Cages,
Commercial­
Transportation
Facilities,
Buses,
Boats,
Trains,
Airplanes,
Automobiles,
Ambulances
Institutional/
Industrial
Floors,
Industrial
Premises/
Equipment,
Laundry
Equipment,
Veterinary
Hospital
Premises,
Athletic
Facilities.

Indoor
non­
food
materials
preservative:
For
use
in
the
preservation
of
Paints,
Latex,
Specialty
Industrial
Products,
Metal
Working
Cutting
Fluids,
Coatings,
Plastics,
Polymers,
Polyurethane,
Synthetic
Yarns,
Polishes,
Emulsions,
Wax,
Air
Ducts.
.
Indoor
Medical:
For
Use
in
Hospital­
Critical
Items
(
Surgical
Instruments/
Pacemakers),
Hospital­
Non
Critical
Items
(
Bedpans/
Furniture,
Hospital­
Semi
Critical
Items(
Catheters/
Inhalation
Equipment),
Hospital/
Medical
Institutions­
Non
conductive
Floors,
Critical
Premises
(
Burn
Wards),
Noncritical
Premises,
Patient
Premises,
Institutions
Premises
(
Human/
Veterinary),
Hemodialysis
Machines.

TARGET
PESTS:
Animal
Pathogenic
Bacteria
(
G­
And
G+
Vegetative),
Pseudomonas
SPP.,
Mycobacterium
SPP.
(
Tubercle
Bacilli),
Animal
Pathogenic
Fungi,
Hydrophilic
Viruses,
Polio
virus
Type
1,
Parvo
virus,
Lipophilic
Viruses,
Vaccinia
Virus,
Influenza
A2
(
Hong
Kong,
Japan,
Japan
305/
57
Asian
Strain),
HIV­
I
(
human
Immunodeficiency
Virus),
Mold/
Mildew
FORMULATION
TYPES
REGISTERED
Phenol/
Sodium
Phenate
is
formulated
as
a
pressurized
liquid
(
aerosol
spray),
as
a
liquid
concentrate,
as
a
ready­
to­
use
liquid,
and
as
an
impregnated
towelette.

METHOD
AND
RATES
OF
APPLICATION
Page
4
of
12
Concentrations
of
phenol/
sodium
phenate
in
products
range
from
1.6%
to
8.2%,
1.6%
(
being
the
most
common
concentration)

Sanitize
Non­
food
Contact
Surfaces:
Before
Treatment,
clean
surface
of
loose
dirt.
Spray
4
to
6
inches
from
surface
for
3­
4
seconds
until
covered
with
mist.
Allow
to
air
dry
and
remain
undisturbed
for
15
minutes.

Food
Handling
areas:
Spray
for
use
at
start
of
day/
End
of
Day
anti­
microbial
treatment
on
precleaned
surfaces.

Hospital
Use:
Spray
for
use
to
precleaned
or
decontaminate
critical
or
semi
critical
medical
devices
prior
to
sterilization
or
high
level
disinfection.

Disinfectant
towelette
contact
times:
HIV­
1
(
AIDS
virus)
on
hard
nonporous
surfaces:
Kills
in
one
minute
Staphylococcus
aureus,
Salmonella
colorists.
Pseudomonas
aerogenes,
Trichophylon
mentagrophytes
(
Athlete's
Foot
fungus)
on
hard
nonporous
surfaces
in
3
minutes.

Vegetative
organisms
including
Streptococcus
progenies,
streptococcus
solitarius,
Escherichia
coli,
"
Herpes
Simplexs
types
1/
F
and
2/
G
(
oral,
ocular
and
genital)
Influenza
A,
Canine
pavovirus,
Cylomegalovirus,
Coronavirus
and
Polio
type
1
viruses
on
hard
inanimate
surfaces
and
Mycobacterium
tuberculosis
at
20
degrees
Celsius/
68
Degrees
Fereignhieht,
or
above
10
minutes.

Dialysis
Machines:
Single
Patient
Delivery
Systems.
Place
150cc
(
5.04oz)
into
the
hemdialysate
system.
Multipatinet
Selivery
Systems
Place
3.0
liters
(
33.87
oz)
into
the
hemdialysate
system.
Maintain
product
in
system
for
minimum
of
10
minutes.

Industrial
Additive:
Add
2­
5%
by
weight
of
active
ingredients.

TECHNICAL
REGISTRANTS
(
There
is
no
technical
grade
product
registered
with
the
EPA)
The
following
companies
have
phenol
products
registered:
Alphamed
Pharmaceutical
Corp.,
Pro­
Clean
Products,
Ristex
Biochemicals,
Sporicidin
International
CHEMICAL
FORMULA
AND
MOLECULAR
WEIGHT
C
6
H
6
O
MW
=
94.144
Page
5
of
12
HAZARD:

Phenol/
Sodium
Phenate
has
a
moderate
order
of
acute
toxicity
via
the
oral
and
dermal
routes
of
exposure
(
Toxicity
Category
II
or
III)
and
produces
severe
and
marked
irritation
to
the
eyes
and
skin
(
Toxicity
Category
I
or
II).
Phenol
concentrations
used
in
acute
inhalation
studies
failed
to
induce
mortality
in
the
study
animals.
Therefore,
toxicity
endpoints
and
a
toxicity
category
could
not
be
established.

Phenol/
Sodium
Phenate
was
administered
in
two
developmental
guideline
studies
in
the
rat
and
mouse
at
concentrations
of
30,
60,
or
120
mg/
kg/
day
and
70,
140,
or
280
mg/
kg/
day,
respectively.
There
was
no
evidence
of
toxicity
in
these
animals
at
concentrations
below
the
high
dose.
Fetal
body
weight
was
significantly
reduced
at
120
and
280
mg/
kg/
day
in
both
rat
and
mouse
studies.
Additionally,
female
mice
experienced
increased
mortality
and
clinical
signs
of
central
nervous
system
toxicity
(
tremors,
ataxia,
lethargy)
at
the
high­
dose
(
280
mg/
kg/
day).
In
a
non­
guideline
developmental
study
(
Kavlock,
1990),
there
were
decreases
in
rat
maternal
body
weight
gain
in
maternal
and
offspring.

In
a
2­
generational
reproductive
study
in
rats
exposed
to
200,
1000,
or
5000
ppm
phenol
in
drinking
water
for
10
weeks/
generation,
there
were
decreases
in
water
and
food
consumption,
body
weight
and
body
weight
gain
at
the
high­
dose
(
potential
reduced
palatability).
Offspring
toxic
effects
including
decreases
in
body
weight
and
litter
survival
were
observed
at
5000.
This
occurred
concurrently
with
maternal
toxicity
(
decreased
maternal
body
weight);
believed
to
be
secondary
to
the
animals'
aversion
to
the
flavor
of
phenol­
treated
water
and
resulted
in
decreased
maternal
as
well
as
offspring
body
weight.
In
a
non­
guideline
reproductive
study
(
Bishop,
et
al.
1997)
phenol
was
administered
to
mice
at
a
concentration
of
350
mg/
kg.
There
were
no
treatment­
related
clinical
signs
or
mortality
observed
in
maternal,
reproductive,
and
developmental
parameters
sand
the
LOAEL
was
not
established
(
highest
dose
tested,
350
mg/
kg).

Two
carcinogenicity
studies
performed
by
the
National
Cancer
Institute
did
not
exhibit
an
incidence
of
neoplasms
in
male
and
female
mice
or
rats
following
administration
of
phenol,
with
the
exception
of
a
statistically
significant
increase
in
the
occurrence
of
leukemia,
lymphoma,
or
interstitial­
cell
tumors
in
low­
dose
male
rats.
Due
to
the
lack
of
significant
tumors
in
high­
dose
males
and
the
absence
of
significant
neoplasms
in
mice
and
female
rats,
phenol
was
found
to
be
non­
carcinogenic
in
the
2­
year
drinking
water
studies.
Although
phenol­
treated
rats
and
mice
experienced
a
decrease
in
mean
body
weight
and
body
weight
gain,
the
reduction
was
not
significantly
different
from
the
respective
controls
and
chronic
toxicity
was
not
observed
at
phenol
concentrations
up
to
5000
ppm.
A
20­
week
dermal
study
exhibited
effects
of
chronic
irritation
and
hair
growth
inhibition
with
administration
of
3
mg
phenol
(
in
200
uL
acetone).
A
single
papilloma
was
found
7
weeks
into
the
study,
but
there
was
no
evidence
that
it
was
significantly
increased
or
treatment­
related.
In
a
special,
mechanistic
study
there
was
no
evidence
of
tumor
initiation
or
hepatocyte
GSH
depletion
following
administration
of
100
mg/
kg/
day
phenol.

TOXICITY
ENDPOINTS
Page
6
of
12
The
toxicity
endpoints
used
in
this
document
to
assess
potential
risks
include
the
chronic
dietary
reference
dose
(
RfD),
and
short­,
intermediate­
and/
or
long­
term
incidental
oral,
dermal,
and
inhalation
doses.
The
endpoints
selected
were
reviewed
by
the
ADTC
in
2004.

Dietary
Endpoints:
The
chronic
RfD
value
was
calculated
to
be
0.6
mg/
kg/
day,
based
on
a
developmental
No
Observable
Adverse
Effects
Level
(
NOAEL)
value
of
60
mg/
kg/
day
and
an
uncertainty
factor
of
100
(
10x
interspecies
extrapolation,
10x
intraspecies
variation).

Dermal
Endpoints:
The
Developmental
Toxicity
NOAEL
of
60
mg/
kg/
day
was
selected
for
short­
and
intermediate­
term
dermal
risk
assessments
from
a
developmental
toxicity
study
in
rats
(
Jones­
Price,
Ledoux,
Reel,
et
al.
1983)
based
on
a
significant
reduction
from
the
control
in
mean
fetal
body
weight/
litter
at
the
LOAEL
of
120
mg/
kg/
day.
A
dermal
absorption
factor
of
50%
is
used
since
an
oral
endpoint
was
selected.
A
target
margin
of
exposure
(
MOE)
of
100
was
selected
for
the
dermal
risk
assessment,
based
on
10x
for
differences
among
humans
(
intra
species
variability)
and
10x
for
differences
between
the
test
animals
and
humans
(
inter
species
extrapolation).

Inhalation
Endpoints:
The
endpoint
used
for
inhalation
risk
assessment
is
a
LOAEL
of
0.1
mg/
L
from
a
published
inhalation
toxicity
study
(
Dalin
and
Kristoffersson
(
1974)
)
based
on
alterations
in
sliding
angle
from
tilting
plane
test,
and
significant
increases
in
liver
enzymes.
An
uncertainty
factor
of
300
is
applied
to
this
risk
assessment
for
short­
and
intermediate­
term
risk
assessments
(
10x
interspecies
extrapolation,
10x
intraspecies
variation,
3x
for
use
of
a
LOAEL).
For
long­
term
risk
assessments,
an
uncertainty
factor
of
1,000
is
applied
to
the
risk
assessment
(
10x
interspecies
extrapolation,
10x
intraspecies
variation,
3x
for
use
of
a
LOAEL,
3x
for
lack
of
a
long­
term
study).

FQPA
SAFETY
FACTOR
On
March
9,
2004,
the
ADTC
reviewed
the
available
toxicology
data
for
phenol
and
discussed
endpoint
selection
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
The
ATDC
determined
that
for
acute
dietary
risk,
there
was
no
appropriate
endpoint
for
assessment.
The
conclusion
was
based
upon
examination
of
the
hazard
data
which
might
be
used
in
support
of
such
an
endpoint.
Body
weight
effects
observed
are
not
believed
to
be
the
result
of
a
single
exposure,
and
there
were
no
other
effects
from
the
data
that
were
considered
reflective
of
an
adverse
effect
from
a
single
exposure.
An
acute
RfD
value
was
not
selected.

For
chronic
dietary
risk,
the
ATDC
cited
the
published
chronic
RfD
value
in
EPA's
Integrated
Risk
Information
System
(
IRIS)
database.
This
RFD
value
is
based
upon
an
unpublished
developmental
toxicity
study
conducted
according
to
GLP
guidelines
(
Argus
Research
Laboratories,
1977).
The
chronic
RfD
value
was
determined
to
be
0.6
mg/
kg/
day.
The
ATDC
determined
that
a
special
hazard­
based
safety
factor
was
not
required
for
phenol
and
could
be
reduced
to
1x.
Page
7
of
12
Based
on
Agency
policy,
a
RfD
modified
by
a
FQPA
safety
factor
is
a
population
adjusted
dose
(
PAD).
The
Agency
calculated
a
chronic
PAD,
and
used
this
value
to
estimate
chronic
dietary
risk.
The
chronic
PAD
(
cPAD)
is
the
chronic
RfD
divided
by
the
FQPA
safety
factor.

HUMAN
HEALTH
RISK
ASSESSMENT
DIETARY
(
FOOD)
RISK
ASSESSMENTS
Dietary
Exposure:
The
Agency
has
conducted
a
dietary
exposure
and
risk
assessment
for
use
of
phenol
in
a
ready­
to­
use
solution
and
in
a
wettable
disposable
cloth
impregnated
with
phenol
and
sodium
phenate.
A
counter
top
that
is
treated
with
either
of
these
products
may
come
into
contact
with
food,
which
in
turn
may
be
ingested.
An
acute
RfD
value
was
not
selected,
thus
the
acute
dietary
risk
was
not
evaluated.
For
chronic
dietary
exposure,
children
had
the
highest
percentage
of
the
chronic
PAD,
at
363%,
which
exceeds
the
Agency's
level
of
concern
(
100%
cPAD).
For
adult
males
and
females,
the
dietary
exposure
is
90.7%
and
77.8%,
respectively,
which
is
below
the
Agency's
level
of
concern
(
100%
of
aPAD
or
cPAD).

Water
Exposure
and
Risk:
Phenol's
use
in
the
production
of
resins
and
other
manufacturing
industries,
pulp
mills,
wood
treatment
facilities,
and
as
a
general
disinfectant
allows
for
the
possibility
of
ground
and
surface
water
contamination.
Despite
phenol's
high
water
solubility
and
poor
sorption
to
soil,
biodegradation
of
phenol
is
sufficiently
rapid
so
that
the
probability
of
groundwater
contamination
will
be
low.
Because
phenol
absorbs
light
in
the
region
of
290­
330
nm,
phenol
might
photo
degrade
directly
in
surface
water.
Phenol
is
not
expected
to
absorb
to
sediment
in
the
water
column.

Cumulative
Chronic
Dietary
Risk
­
Cumulative
chronic
dietary
risk
estimates
from
indirect
food
uses
(
i.
e.,
exposure
to
disinfectant
solutions
and
room
deodorizers)
were
calculated
to
be
36%
for
children,
9.0%
for
adult
females,
and
7.5%
for
adult
males,
indicating
no
risk
of
concern
from
dietary
exposure
RESIDENTIAL
EXPOSURE
Phenols
and
salts
are
formulated
as
a
soluble
concentrate,
towelette,
ready­
to­
use
solution
an
aerosol
spray.
Based
on
product
labels,
all
formulations
are
liquid.
The
following
scenarios
were
considered
for
residential
handlers
of
phenol­
containing
products:
(
1)
application
of
paint
treated
with
a
material
preservative
using
paintbrush/
roller,
(
2)
use
of
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces,
and
(
3)
use
of
disinfectant
towelette
on
hard
non­
porous
surfaces.
Inhalation
and
dermal
exposures
were
addressed
for
residential
populations
using
surrogate
data
from
the
Chemical
Manufacturers
Association
(
CMA,
1992),
and
several
studies
which
relate
to
the
use
patterns
of
PHMB.
Using
surrogate
unit
exposure
data,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
and
risks
to
handlers
and
postapplication
workers
were
assessed.
At
this
time,
EPA
does
not
have
available
chemical­
specific
handler
or
post­
application
exposure
studies
that
meet
Agency
guidelines.

The
calculated
inhalation
MOE's
for
all
three
scenarios
are
above
the
target
MOEs
of
1,000.
Page
8
of
12
The
calculated
dermal
MOEs
for
the
following
scenarios
were
below
the
target
MOE
of
100,
and
are
therefore
of
concern:
painting
using
a
paintbrush/
roller
(
MOE
=
18.3)
and
wiping
hard
surfaces
using
a
towelette
(
MOE
=
41.0).

Residential
post­
application
exposures
(
adults
and
children)
are
expected
to
be
minimal
because
the
majority
of
exposure
is
expected
occur
through
contact
with
dry
surfaces
(
e.
g.
paints)
and
the
end
use
products
are
expected
to
be
diluted.
The
residential
post­
application
scenario
considered
in
this
assessment
is
exposure
to
residue
from
carpets
that
have
been
machine­
cleaned
with
a
product
containing
phenol
(
and
phenol
salts).
While
the
label
also
indicates
that
the
product
may
be
sprayed
directly
onto
carpet,
this
scenario
was
not
evaluated
due
to
lack
of
data
regarding
application
rates.
In
general,
dermal
exposure
to
residues
in
treated
carpet
should
be
limited
to
contact
on
bare
feet.
However,
there
is
also
potential
exposure
to
undressed
toddlers.
The
dermal
MOEs
calculated
is
below
the
target
MOE
of
100.
However,
the
potential
daily
dose
calculated
is
extremely
conservative,
due
to
a
lack
of
supporting
data.
The
dose
should
not
be
considered
indicative
of
the
true
values
associated
with
this
type
of
exposure.
.

AGGREGATE
EXPOSURE
AND
RISK
In
order
for
a
pesticide
registration
to
continue,
it
must
be
shown
that
the
use
does
not
result
in
"
unreasonable
adverse
effects
on
the
environment".
Section
2
(
bb)
of
FIFRA
defines
this
term
to
include
"
a
human
dietary
risk
from
residues
that
result
from
a
use
of
a
pesticide
in
or
on
any
food
inconsistent
with
standard
under
section
408..."
of
FFDCA.
Consequently,
even
though
no
pesticide
tolerances
have
been
established
for
phenol,
the
standards
of
FQPA
must
still
be
met,
including
"
that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
is
the
total
exposure
to
a
single
chemical
(
or
its
residues)
that
may
occur
from
dietary
(
i.
e.,
food
and
drinking
water),
residential,
and
other
non­
occupational
sources,
and
from
all
known
or
plausible
exposure
routes
(
oral,
dermal,
and
inhalation).
Aggregate
risk
assessments
were
conducted
for
acute
(
1
day),
short­
term
(
1­
30
days),
intermediate­
term
(
1­
6
months)
and
chronic
(
several
months
to
lifetime)
exposures.

Dermal
Aggregate
Exposure:
Aggregate
risk
assessments
were
considered
for
three
short­,
intermediate
and
long­
term
exposure
scenarios
for
adults
exposed
to
phenol
and
phenol
salts
as
a
result
of
residential
handling,
including:
(
1)
application
of
paint
treated
with
a
material
preservative
using
paintbrush/
roller,
(
2)
use
of
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces,
and
(
3)
Use
of
disinfectant
towelette
on
hard
non­
porous
surfaces.

The
dermal
MOE
calculated
for
the
paintbrush/
roller
application
is
18.3.
The
dermal
MOE
calculated
for
the
disinfectant/
deodorizing
spray
is
41.0.
Because
these
dermal
MOEs
are
below
the
target
MOE
of
100,
the
application
of
treated
paints
with
a
material
preservative
using
a
paintbrush/
roller
by
adults
and
the
use
of
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces
by
adults,
are
risks
of
concern.
As
a
result,
an
aggregate
risk
assessment
of
the
application
of
paint
or
the
use
of
the
disinfectant/
deodorizing
spray
in
conjunction
with
another
activity
(
i.
e.
the
use
of
a
disinfectant
towelette
on
hard
non­
porous
surfaces)
would
not
be
required
to
show
that
a
composite
of
activities
is
also
below
the
target
MOE
of
100.

The
dermal
MOEs
calculated
for
the
disinfectant
towelettes
on
hard
non­
porous
surfaces
is
871,000.
Because
the
dermal
MOE
is
above
the
target
MOE
of
100,
the
use
of
Page
9
of
12
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces
by
adults,
in
itself,
is
not
a
significant
risk.
However,
for
other
possible
applications
of
phenol
and
phenol
salts,
the
dermal
MOE
is
below
the
target
MOE
of
100.
As
a
result,
an
aggregate
risk
assessment,
including
the
use
of
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces
in
conjunction
with
another
activity
(
i.
e.
application
of
paint
treated
with
a
material
preservative
using
paintbrush/
roller
or
the
use
of
a
disinfectant
towelette
on
hard
non­
porous
surfaces)
is
not
needed
to
demonstrate
that
a
combination
of
two
activities
would
be
below
the
target
MOE
of
100.

Inhalation
Aggregate
Exposure:
In
two
of
the
three
adult
exposure
scenarios
considered,
the
dermal
MOEs
were
below
the
target
MOE
of
100
and
demonstrate
a
concern
of
risk
for
these
scenarios.
The
calculated
inhalation
MOEs
for
these
same
scenarios
exceed
the
target
MOE
of
1,000.
However,
because
the
dermal
MOEs
already
demonstrate
a
concern
of
risk
for
these
scenarios,
an
aggregate
of
inhalation
exposure
to
restate
a
concern
of
risk
for
these
scenarios
is
not
required.

OCCUPATIONAL
EXPOSURE
A
detailed
human
exposure
risk
assessment
for
phenol
and
phenol
salts
is
provided
in
the
Appendix.
The
summary
of
the
occupational
exposures
are
presented
below.

Inhalation
and
dermal
exposures
were
addressed
for
occupational
populations
using
surrogate
dat
from
the
chemical
Manufacturers
Association
(
CMA,
1992)
and
PHED.
Using
surrogate
unit
exposure
data,
application
rates
from
labels,
and
EPA
estimates
of
daily
amount
handled,
exposure
and
risks
to
handlers
and
post­
application
workers
were
addressed.
At
this
time,
EPA
has
not
identified
post­
application
scenarios
for
commercial
uses
that
are
not
addressed
by
the
residential
post­
application
exposure
assessment
(
e.
g.,
contacting
treated
surfaces
are
represented
by
children's
incidental
oral
and
dermal
exposures
while
crawling
on
treated
surfaces
such
as
carpets).

Six
commercial/
institutional
scenarios
have
been
considered
in
this
assessment:

1.
Use
of
disinfectant
solutions
in
hemodialysis
machines,

2.
Application
of
paint
treated
with
a
material
preservative
using
airless
sprayer,

3.
Application
of
paint
treated
with
a
material
preservative
using
paintbrush/
roller.

4.
Use
of
disinfectant/
deodorizing
spray
on
hard
non­
porous
surfaces.

5.
Use
of
disinfectant
towelette
on
hard
non­
porous
surfaces.

6.
Use
as
a
material
preservativeas
a
liquid
pour.

For
hemodialysis
machines,
the
label
indicates
that
the
product
can
be
used
in
single­
patient
and
multiple­
patient
delivery
systems.
The
use
of
this
product
in
multi­
patient
delivery
systems
was
chosen
for
evaluation
since
it
involves
a
greater
volume
of
product
(
1.0
L
vs.
0.150mL)
than
the
single­
patient
delivery
system.
It
was
assumed
that
the
machines
are
disinfected
daily
and
on
average,
a
worker
handles
3
machines
per
day.

One
phenol
product
is
listed
for
use
as
an
industrial
additive,
and
lists
paint
as
a
possible
use.
The
label
recommends
2%­
5%
by
active
ingredients
be
added.
As
a
conservative
measure,
it
is
assumed
that
the
treated
paint
is
comprised
of
5%
active
ingredient,
by
weight.
Assuming
that
paint
Page
10
of
12
has
a
density
of
10
lbs
per
gallon,
the
concentration
of
phenols
in
paint
is
0.5
lbs
a.
i./
gallon.
For
the
material
preservative
use
of
phenol,
primary
handlers
adding
the
product
during
the
manufacturing
of
paint
has
been
selected
to
represent
the
high
end
of
exposure
for
the
primary
handlers.
It
is
assumed
that
paint
is
produced
in
1,000
gallon
batches
(
i.
e.,
10,000
lbs.).
In
addition,
paint
also
has
been
selected
to
represent
the
high
end
of
the
exposures
for
the
secondary
handlers.
Two
painting
scenarios
were
considered
in
this
assessment:
use
of
an
airless
sprayer
(
50
gallons
per
day)
and
use
of
a
paintbrush/
roller
(
5
gallons
per
day)
to
paint
the
exterior
of
a
house.

The
sprays
and
the
solution
used
to
treat
the
towelette
contain
1.62%
phenol/
sodium
phenate.
It
was
assumed
that
the
density
of
this
solution
is
the
same
as
the
density
of
water.
The
label
for
the
towelette
product
did
not
describe
the
quantity
of
product
to
be
used,
rather,
the
directions
state
that
towelette
to
be
used
to
wipe
the
surface,
and
then
the
surface
should
be
wiped
dry.
In
the
absence
of
more
specific
use
information,
it
was
assumed
that
1
liter
of
the
solution
used
to
wet
the
towelette
is
used
by
the
exposed
individual
per
day.
Similarly,
the
aerosol
spray
directions
state
that
the
product
can
be
sprayed
2­
4
seconds
to
deodorize
a
room,
but
no
data
were
available
describing
the
quantity
that
is
emitted
by
spraying
for
this
time.
Therefore,
1
liter
of
solution
also
was
assumed
for
use
of
the
aerosol
spray.

The
estimated
short­
and
intermediate­
term
dermal
MOEs
for
the
following
scenarios
were
below
the
target
MOE
of
100,
and
are
therefore
of
concern.

6.
Painting
using
an
airless
sprayer,
with
chemical
resistant
gloves
(
MOE=
21);
and
7.
Wiping
hard
surfaces
using
a
towelette
(
MOE
=
70)

The
estimated
short­
and
intermediate­
term
inhalation
MOEs
for
the
following
scenarios
were
below
the
target
MOE
of
300,
and
are
therefore
of
concern:

8.
Painting
using
an
airless
sprayer
(
MOE
=
88).

INCIDENT
REPORT
ASSESSMENT
A
total
of
10
individual
human
incident
cases
submitted
to
the
EPA
Office
of
Pesticide
Programs
are
associated
with
exposed
to
phenol
and/
or
sodium
phenate
containing
products.
Dermal
and
inhalation
are
the
two
primary
route
of
exposure.

The
most
common
symptoms
reported
for
cases
of
dermal
exposure
were
skin
irritation/
burning
,
rash
,
itching
,
skin
discoloration/
redness.

The
most
common
symptoms
reported
for
cases
of
inhalation
exposure
were
respiratory
irritation/
burning,
asthma/
difficult
breathing,
throat
/
chest
congestion
and
sore
throat.
Headache,
drowsiness,
night
sweats
and
heart
palpitation
have
also
been
reported
when
expose
to
the
chemical
through
both
dermal
and
inhalation
exposure
routes.
Page
11
of
12
ECOLOGICAL
RISK
ASSESSMENT
III.
ENVIRONMENTAL
FATE
ASSESSMENT
Phenol
appears
to
have
degradation
pathways
in
air
(
calculated
half
life
less
than
a
day)
water
(
measured
half
life
less
than
a
day),
aerobic
and
anaerobic
soils
(
degradation
half
lives
less
than
5
days).
It
is
not
likely
to
bio­
accumulate
in
aquatic
organisms.
(
Measured
BCF
in
goldfish
is
0.28
and
1.3
in
golden
orfe).
Data
on
plants
show
that
due
to
a
high
respiratory
decomposition
of
phenol
into
carbon
dioxide
(
mineralization),
it
is
also
not
likely
to
accumulate
in
plants.
Due
to
multi
media
degradation
pathways,
phenol
is
not
likely
to
be
an
environmental
concern.

IV.
ECOLOGICAL/
ENVIRONMENTAL
RISK
ASSESSMENT
Phenol/
Sodium
Phenate
is
registered
with
EPA
as
an
active
product
and
is
used
as
an
intermediate
in
the
production
of
epoxy
resins,
the
production
of
various
other
products,
as
a
general
disinfectant
and
in
medicinal
preparations.
For
the
reregistration
eligibility
decision
(
RED)
process
the
Agency
has
relied
on
open
literature
and
fate
properties
of
Phenol
from
open
literature.

Phenol
and
sodium
phenate
also
are
used
as
sanitizers,
primarily
for
hard
surfaces
and
as
materials
preservatives.
Outdoor
uses,
such
as
swimming
pool
waters
and
intermittently
flooded
areas,
were
once
registered
uses
for
phenol
and
sodium
phenate,
but
are
no
longer
supported
by
any
registrants.

Terrestrial
Animals
­
For
indoor
uses,
an
acute
oral
toxicity
study
using
the
technical
grade
of
the
active
ingredient
(
TGAI)
is
required
to
establish
the
toxicity
of
phenol
to
birds.
The
preferred
test
species
is
either
mallard
duck
(
a
waterfowl)
or
northern
bobwhite
quail
(
an
upland
game
bird).
No
avian
acute
toxicity
studies
were
identified
in
the
reviewed
literature
for
phenol
and
its
salts.
Avian
acute
oral
toxicity
testing
(
850.2100/
71­
1)
is
required
to
support
the
currently
registered
uses
of
phenol/
sodium
phenate.
Avian
dietary
toxicity
studies
using
the
TGAI
of
phenol
and
sodium
phenate
are
not
required
for
the
indoor
uses
of
phenol/
sodium
phenate.

Freshwater
Fish
­
Freshwater
fish
toxicity
studies
using
the
TGAI
to
establish
the
toxicity
of
phenol
to
fish.
Data
generally
are
required
for
only
one
species.
Testing
in
two
fish
species
is
required
for
stable
chemicals
with
high
volume
effluents
(
e.
g.,
including,
but
not
limited
to,
egg
washing,
fruit
and
vegetable
rinses,
swimming
pools
or
materials
preservatives)
and
if
the
LC
50
in
the
first
species
is
greater
than(>
1
ppm.
The
preferred
test
species
are
rainbow
trout
(
a
coldwater
fish)
and
bluegill
sunfish
(
a
warmwater
fish),
although
other
test
species
identified
in
OPPTS
Guideline
(
i.
e.,
850.1075
(
e)(
4)(
i)(
A))
also
may
be
used.
Many
freshwater
fish
acute
toxicity
studies
were
identified
from
peerreviewed
literature,
but
no
studies
have
been
submitted
to
support
registration
of
phenol/
sodium
phenate.
Freshwater
fish
acute
toxicity
testing
(
850.1075/
72­
1)
on
one
species
is
required
to
support
the
currently
registered
uses
of
phenol/
sodium
phenate.

Acute
toxicity
for
freshwater
fish
ranged
from
5
mg/
L
(
rainbow
trout)
to
23.9
mg/
L
(
bluegill),
with
average
values
of
9.1
mg/
L
for
rainbow
trout
and
17.1
mg/
L
for
bluegill.
These
data
indicate
the
phenol
is
moderately
toxic
to
coldwater
species,
such
as
the
rainbow
trout,
and
slightly
toxic
to
warmwater
species,
such
as
the
bluegill.
Page
12
of
12
RISK
TO
ENDANGERED
SPECIES
The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
risk
assessments
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticide
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.

Based
on
the
low
likelihood
of
environmental
exposure
from
the
registered
indoor
uses,
coupled
with
phenol's
rapid
degradation
in
air,
water,
and
soil,
as
well
as
the
low
toxicity
of
phenol
to
fish,
aquatic
invertebrates,
and
aquatic
plants,
adverse
impacts
to
endangered
species
are
not
expected
from
the
registered
uses
of
phenol/
sodium
phenate.