Document ID: EPA-HQ-OPP-2004-0305-0038
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

HEALTH
EFFECTS
OF
PHMB
IN
HUMANS
PC
CODE
111801
CASE
3122
August
4,
2004
Jonathan
Chen,
Ph.
D.
Office
of
Pesticide
Programs
Antimicrobials
Division
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
TABLE
OF
CONTENTS
0.0
INTRODUCTION
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1
1.0
INCIDENT
REPORT
DATA
ASSOCIATED
WITH
HEALTH
EFFECTS
OF
PHMB
EXPOSURE
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1.1
OPP's
Incident
Data
System
(
IDS)
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2
1.2
Poison
Control
Center
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3
1.3
California
Data
­
1982
through
1996
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3
1.4
National
Pesticide
Telecommunications
Network
(
NPTN)
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3
1.5
Incident
Reports
Associated
with
Acute
Toxic
Effects
of
PHMB
Published
in
Scientific
Literature.
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3
2.0
EPIDEMIOLOGIC
STUDIES
ASSOCIATED
WITH
HEALTH
EFFECTS
OF
PHMB
IN
HUMANS
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3
3.0
SUMMARY
AND
CONCLUSION
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3
1
0.0
INTRODUCTION
Poly(
hexamethylenebiguanide)
hydrochloride,
also
known
as
PHMB,
is
a
group
of
polymers
been
used
as
an
antimicrobial
agent
in
a
wide
variety
of
applications
including
oil­
in­
water
and
water­
in­
oil
emulsions,
industrial
reagents,
silicone
systems,
cellulose
solutions
and
oil
recovery
systems.
Now,
PHMB
is
primarily
used
as
a
non­
chlorinated
antimicrobial
agent
used
in
swimming
pool
and
spa
facilities.
The
purpose
of
this
chapter
is
to
review
the
evidence
of
health
effects
in
humans
resulting
from
exposure
to
PHMB.
In
particular,
the
acute
and
chronic
toxicity,
teratogenic/
reproductive
effects,
and
carcinogenicity
are
discussed.

Two
approaches
are
used
in
this
section:

°
The
potential
health
effects
of
PHMB
in
humans,
reported
as
incident
reports
from
different
sources,
are
summarized.

°
A
literature
search
of
chronic
health
effects
associated
with
PHMB
exposure,
including
results
of
epidemiological
studies,
is
summarized.

This
reports
summarized
the
potential
health
effects
of
PHMB
in
humans,
reported
as
incident
reports
from
different
sources.

1.0
INCIDENT
REPORT
DATA
ASSOCIATED
WITH
HEALTH
EFFECTS
OF
PHMB
EXPOSURE
The
following
databases
have
been
consulted
for
the
poisoning
incident
data
on
the
active
ingredient
PHMB
(
PC
Code:
11180)

a.
OPP
Incident
Data
System
(
IDS)
­
The
Incident
Data
System
of
The
Office
of
Pesticide
Programs
(
OPP)
of
the
Environmental
Protection
Agency
(
EPA)
contains
reports
of
incidents
from
various
sources,
including
registrants,
other
federal
and
state
health
and
environmental
agencies
and
individual
consumers,
submitted
to
OPP
since
1992.
Reports
submitted
to
the
Incident
Data
System
represent
anecdotal
reports
or
allegations
only,
unless
otherwise
stated.
Typically
no
conclusions
can
be
drawn
implicating
the
pesticide
as
a
cause
of
any
of
the
reported
health
effects.
Nevertheless,
sometimes
with
enough
cases
and/
or
enough
documentation
risk
mitigation
measures
may
be
suggested.

b.
Poison
Control
Centers
­
As
the
result
of
a
data
purchase
by
EPA,
OPP
received
Poison
Control
Center
data
covering
the
years
1993
through
1996
for
all
pesticides.
Most
of
the
national
Poison
Control
Centers
(
PCCs)
participate
in
a
national
data
collection
system,
the
Toxic
Exposure
Surveillance
System,
which
obtains
data
from
about
65­
70
centers
at
hospitals
and
universities.
PCCs
provide
telephone
consultation
for
individuals
and
health
care
providers
on
suspected
poisonings,
involving
drugs,
household
products,
pesticides,
etc.
2
c.
California
Department
of
Pesticide
Regulation
­
California
has
collected
uniform
data
on
suspected
pesticide
poisonings
since
1982.
Physicians
are
required,
by
statute,
to
report
to
their
local
health
officer
all
occurrences
of
illness
suspected
of
being
related
to
exposure
to
pesticides.
The
majority
of
the
incidents
involve
workers.
Information
on
exposure
(
worker
activity),
type
of
illness
(
systemic,
eye,
skin,
eye/
skin
and
respiratory),
likelihood
of
a
causal
relationship,
and
number
of
days
off
work
and
in
the
hospital
is
provided.

d.
National
Pesticide
Telecommunications
Network
(
NPTN)
­
NPTN
is
a
toll­
free
information
service
supported
by
OPP.
A
ranking
of
the
top
200
active
ingredients
for
which
telephone
calls
were
received
during
calendar
years
1984­
1991,
inclusive,
has
been
prepared.
The
total
number
of
calls
was
tabulated
for
the
categories
human
incidents,
animal
incidents,
calls
for
information,
and
others.

e.
Published
Incident
Reports
­
Some
incident
reports
associated
with
PHMB
related
human
health
hazard
are
published
in
the
scientific
literature.

1.1
OPP's
Incident
Data
System
(
IDS)

A
total
of
118
individual
incident
cases
submitted
to
the
EPA
Office
of
Pesticide
Programs
involving
use
of
PHMB­
containing
swimming
pool
products
were
reviewed
to
determine
the
effects
of
exposure
to
PHMB
(
CAS
No.
27083­
27­
8).
All
of
the
incident
reports
reviewed
were
for
residential
use
of
the
products
by
consumers.
In
17
(
i.
e.,
14%)
out
of
the
118
individual
incident
cases
reviewed,
it
was
determined
that
the
exposure
effects
were
the
result
of
not
using
the
product
as
intended
by
the
manufacturer.
They
included
not
following
the
instructions
on
the
label,
accidental
ingestion
of
the
product,
or
splashing
the
concentrated
product
onto
the
skin
or
into
the
eyes.

The
reported
routes
for
exposure
of
the
118
incident
cases
were
dermal
(
58%),
ocular
(
30%),
ingestion
(
9%),
inhalation
(
7%)
and
unknown
(<
1%).
In
some
cases
more
than
one
route
of
exposure
applied
for
a
individual
incident
case
(
e.
g.,
both
dermal
and
ocular
exposure).
The
most
common
symptoms
reported
for
each
exposure
route
are
as
follows:

°
The
most
common
symptoms
reported
for
cases
of
dermal
exposure
were
skin
irritation/
burning
(
80%),
rash
(
50%),
hives/
welts
(
19%),
itching
(
16%),
skin
discoloration/
redness
(
9%),
allergic
reaction
(
7%),
and
blistering
(
7%).

°
The
most
common
symptoms
reported
for
cases
of
ocular
exposure
were
eye
irritation/
burning
(
100%),
eye
pain
(
69%),
loss
of
vision
(
17%),
swelling
of
eyes
(
6%),
and
allergic
reactions
(
6%).
°
The
most
common
symptoms
reported
for
cases
of
exposure
via
ingestion
were
vomiting/
nausea/
abdominal
pain
(
46%),
irritation
to
the
mouth/
throat
(
46%),
respiratory
irritation
including
coughing/
choking
(
18%)
and
diarrhea
(
9%).
3
°
The
most
common
symptoms
for
cases
of
exposure
via
inhalation
were
respiratory
irritation
(
75%)
and
coughing/
choking
(
38%).

1.2
Poison
Control
Center
All
the
incidences
reported
in
the
Poison
Control
Center
database
were
included
in
the
OPP's
IDS.
No
additional
data
were
reported
in
the
Poison
Control
Center
database
covering
the
years
1993
through
1996.

1.3
California
Data
­
1982
through
1996
There
is
no
incidences
report
submitted
to
the
California
Pesticide
Illness
Surveillance
Program
(
1982­
1996)
database
related
to
PHMB
exposure.

1.4
National
Pesticide
Telecommunications
Network
(
NPTN)

There
is
no
incidences
reported
in
the
NPTN
database
related
to
PHMB
exposure.

1.5
Incident
Reports
Associated
with
Acute
Toxic
Effects
of
PHMB
Published
in
Scientific
Literature.

There
is
no
incident
report
associated
with
acute
toxic
effects
of
PHMB
published
in
scientific
literature.

2.0
EPIDEMIOLOGIC
STUDIES
ASSOCIATED
WITH
HEALTH
EFFECTS
OF
PHMB
IN
HUMANS
There
are
no
chronic
health
effects
associated
with
PHMB
exposure,
including
results
of
epidemiological
study
are
reported
in
scientific
literature.

3.0
SUMMARY
AND
CONCLUSION
There
are
incidences
been
reported
associated
with
exposure
to
end­
use
products
containing
PHMB.
Dermal
and
ocular
are
the
primary
routes
of
exposure.
Most
of
the
incidences
are
related
to
irritation
and/
or
allergic
type
reaction.
There
are
no
chronic
health
effects
associated
with
PHMB
exposure,
including
results
of
epidemiological
study
are
reported
in
scientific
literature.