Document ID: EPA-HQ-OPP-2003-0217-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-06-04T04:00Z

Summary
of
Imazalil
RED
Worker
and
Ecological
Risk
Assessment
June
1,
2003
Uses
°
Fungicide
for
post­
harvest
treatment
of
citrus
fruits,
seed
treatment
of
barley
and
wheat
prior
to
planting,
and
used
as
a
disinfectant
in
chicken
hatcheries.

Health
Effects
°
Placed
in
an
acute
Category
II,
III
and
IV
for
oral,
dermal,
and
inhalation
toxicity,
respectively.
Imazalil
is
highly
irritating
to
eyes
(
Category
I),
but
is
not
a
skin
irritant
(
Category
IV)
or
a
dermal
sensitizer.

°
The
primary
target
organ
for
imazalil
toxicity
in
animals
is
the
liver.

°
Carcinogenicity
studies
in
rodents
find
that
imazalil
is
carcinogenic
to
male
mice
and
rats,
based
on
significant
increases
in
liver
adenomas
and
combined
adenomas/
carcinomas.
Imazalil
has
been
classified
as
"
likely
to
be
carcinogenic
in
humans."

Health
Risk
°
The
registrant
conducted
a
study
and
submitted
new
data
to
address
whether
a
linear
low
dose
(
Q*)
or
a
threshold
cancer
model
should
be
used
to
characterize
the
cancer
risk
for
imazalil.
The
Agency
reviewed
the
study
and
concluded
the
Q*
model
was
most
appropriate.
The
registrant
indicated
they
will
provide
additional
analysis
and
data
on
this
issue
during
the
Phase
5
comment
period.
There
is
the
possibility
that
additional
data
may
result
in
a
determination
that
the
threshold
cancer
model
is
more
appropriate.
The
Agency
will
consider
their
comments,
and
adjust
the
cancer
model
if
appropriate.

Worker
Risk
°
For
handlers,
the
results
of
the
non­
cancer
short,
intermediate
and
long
term
dermal
and
inhalation
risk
assessments
show
that
risks
are
not
of
concern
all
scenarios
at
baseline
attire
(
i.
e.,
long
pants,
and
long
sleeved
shirts),
or
with
the
addition
of
PPE,
(
protective
gloves).

°
There
were
14
scenarios
evaluated
for
cancer
risk;
one
scenario
was
1.50
x
10­
4,
when
PPE
is
employed,
two
scenarios
were
in
the
10­
5
range,
and
the
remaining
scenarios
were
in
the
10­
6
to
10­
7
range,
when
PPE
is
employed.
Most
imazalil
labels
currently
prescribe
the
following
PPE
for
all
handlers:
long
sleeved
shirt
and
­
2­
long
pants,
gloves,
shoes,
socks,
and
protective
eye­
wear.
°
The
estimated
lifetime
cancer
risk
for
post
application
citrus
workers
was
estimated
to
be
6.68
x
10­
4
assuming
a
baseline
exposure
scenario.
Exposure
estimates
were
derived
from
residue
chemistry
data,
surface
area
calculations,
and
a
reentry
study
for
citrus
found
in
the
scientific
literature,
and
are
considered
very
conservative.
With
the
addition
of
protective
gloves,
risk
are
in
the
range
of
10­
5
to
10­
7.

Ecological
Risk
Risk
to
Terrestrial
Organisms

On
the
basis
of
risk
quotients,
imazalil
does
not
result
in
an
acute
or
chronic
risk
to
either
avian
or
mammalian
species.
No
levels
of
concern
(
LOCs)
are
exceeded
due
to
the
low
application
rate
and
minimal
exposure.

Risk
to
Aquatic
Organisms

On
the
basis
of
risk
quotients,
imazalil
does
not
exceed
levels
of
concern
for
freshwater
organisms.
No
acute
LOC
for
freshwater
organisms
are
exceeded
due
to
the
extremely
low
exposure,
which
is
attributable
to
the
low
application
rate
(
0.01
lb
ai/
A)
and
the
seed
treatment
end­
use
(
only
1%
residue
left
on
soil
surface).
Because
of
the
extremely
low
exposure
and
relatively
low
acute
toxicity
to
freshwater
organisms,
acute
toxicity
testing
for
estuarine
aquatic
organisms
and
all
chronic
testing
have
been
waived.

Endangered
Species

None
of
imazalil
RQ
values
for
endangered
species
exceed
Levels
of
Concern
for
either
terrestrial
or
aquatic
non­
target
organisms.
The
risk
quotients
for
freshwater
fish
and
invertebrate
values
are
0.00005
and
0.00002,
respectively.
This
is
well
below
the
L0C
(
Level
of
Concern)
value
of
0.05.
The
RQ
values
for
avian
and
mammal
species
are
both
<
0.01
and
also
well
below
the
LOC
of
0.05.