Document ID: EPA-HQ-OPP-2002-0233-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-13T04:00Z

[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
1
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M5
Reviewer:
Esther
Seto
,
Date
February
11,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________

STUDY
TYPE:
Exposure
Assessment
PMRA
DATA
CODE
M5
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa
REVIEWER'S
COMMENTS
AND
CONCLUSION:

Proposed
Use
Pattern
The
proposed
use
of
Sporodex
L
is
as
a
foliar
spray
on
roses
and
cucumbers
grown
in
greenhouse
environments
(use
site
categories
#5
and
#6).
According
to
the
draft
label,
up
to
7.
5
L
of
Sporodex
L
(diluted
with
water
up
to
1500
L)
will
be
applied
to
one
hectare
of
cut
roses
or
cucumbers
and
up
to
5.
0
L
of
Sporodex
L
(diluted
with
water
up
to
1000
L)
will
be
applied
to
one
hecatre
of
potted
plants.
Application
of
Sporodex
L
is
recommended
to
begin
when
environmental
conditions
favour
development
of
powdery
mildew,
or
at
the
first
sign
of
disease,
followed
by
weekly
treatments
thereafter.
When
handled
according
to
the
label
instructions,
the
oral,
pulmonary,
dermal
and
ocular
routes
are
potential
routes
of
applicator
and
bystander
exposure.
Occupational
exposure
is
of
particular
concern
as
the
product
will
be
used
in
an
enclosed
environment.

Toxicological
and
Pathogenicity
Profile
An
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
Pseudozyma
flocculosa
(see
Part
M2
review).
The
fungitoxic
unsaturated
C­
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.

According
to
the
toxicological
information
submitted
under
Part
M4
Human
Health
and
Safety
Testing,
Sporothrix
flocculosa
(now
termed
Pseudozyma
flocculosa)
was
not
toxic
or
pathogenic
to
Fisher
344
rats
following
oral
gavage
of
Sporodex
WP
(an
alternative
end­
use
formulation)
at
a
dose
of
5.
8
x
10
8
CFU/
animal.
Exposure
via
intraperitoneal
injection
of
3.
5
x
10
7
CFU/
animal
indicated
that
S.
flocculosa
was
of
slight
toxicity
(due
to
decreased
body
weight
gain
coupled
with
increased
food
consumption
of
treated
male
rats)
but
was
not
pathogenic.
No
signs
of
dermal
irritation
or
dermal
toxicity
were
noted
in
rabbits
after
dermal
exposure
to
Sporodex
WP.
Slight
ocular
irritation
was
observed
up
to
24
hours
after
exposure
to
Sporodex
WP,
but
all
signs
of
irritation
subsided
by
the
48­
hour
scoring
interval.
Sporodex
L
is
expected
to
be
less
irritating,
than
Sporodex
WP,
to
the
skin
and
eyes
due
to
the
reduction
of
an
irritating
[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
2
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M5
component
of
the
final
formulation.

The
acute
pulmonary
toxicity/
infectivity
study
was
not
acceptable
due
to
a
large
number
of
deaths
in
the
treatment
and
control
groups,
likely
due
to
improper
dosing
technique.
A
subsequent
range­
finding
study
indicated
that
S.
flocculosa
was
not
toxic
at
doses
of
up
to
4.
2
x
10
7
CFU/
animal.
This
study,
however,
was
considered
supplemental
because
the
highest
dose
administered
was
below
the
minimum
dose
required
of
10
8
CFU/
animal
and
because
infectivity/
pathogenicity
was
not
addressed.

Occupational
Exposure
and
Risk
Characterization
The
Agency
does
not
expect
that
occupational
exposures
will
pose
an
undue
risk
on
the
basis
of
the
low
toxicity/
pathogenicity
profile.
While
submitted
acute
pulmonary
toxicity/
infectivity
studies
were
found
to
be
lacking,
inhalation
exposure
is
not
of
concern
if
the
required
respirator
is
also
worn
by
workers.
To
mitigate
dermal
and
inhalation
exposure
and
risk
to
workers,
use
of
appropriate
Personal
Protective
Equipment
(PPE)
will
be
required
as
described
under
the
Labelling
Statements
section,
below.

Assuming
that
most
microorganisms
contain
substances
that
would
elicit
positive
hypersensitivity
reactions,
P.
flocculosa
is
considered
a
potential
sensitizing
agent,
and
a
"POTENTIAL
SENSITIZER"
statement
will
be
required
on
the
principal
display
panel
of
the
TGAI
and
end­
use
formulation
labels.

Non­
Occupational
Exposure
and
Risk
Characterization
The
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
infants
and
children
in
school,
residential
and
daycare
facilities
is
likely
to
be
minimal
to
non­
existent.
Consequently,
the
health
risk
to
infants
and
children
is
expected
to
be
negligible
to
nonexistent.

Labelling
Statements
Given
the
potential
for
sensitization
and
for
worker
inhalation
and
dermal
exposure
it
is
recommended
that
the
Sporodex
L
label
include
the
following
signal
words
and
precaution
and
first
aid
statements:

Principal
Display
Panel:

"POTENTIAL
SENSITIZER"

Secondary
Display
Panel:

"PRECAUTIONS
May
cause
sensitization.
Avoid
contact
with
skin
and
eyes
or
clothing.
Avoid
breathing
mist.
Workers
and
handlers
(includes
mixer/
loader,
applicators,
and
early­
entry
workers)
must
wear
a
long
sleeved
shirt,
long
pants,
shoes
plus
socks,
waterproof
gloves
and
a
NIOSH
approved
respirator
with
any
N­
95,
R­
95,
P­
95
or
HE
filter
for
biological
products
when
mixing/
loading
or
applying
the
product
and
during
all
clean­
up/
repair
activities.
Workers
wearing
appropriate
PPE
can
enter
treated
areas
during
the
restricted
entry
interval
(REI)
of
4
hours.
Wash
thoroughly
with
soap
and
water
after
handling.
Remove
contaminated
clothing
and
follow
manufacturers
directions
[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
3
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M5
for
cleaning/
maintaining
personal
protective
equipment
(PPE)
before
reuse.
If
no
such
instructions
are
available
use
clothing
detergent
and
hot
water
for
cleaning
all
washable
PPE.
Keep
and
wash
PPE
separately
from
other
laundry.

FIRST
AID
IF
ON
SKIN/
CLOTHING
Take
off
contaminated
clothing.
Rinse
skin
immediately
with
plenty
of
water.
IF
IN
EYES
Hold
eye
open
and
rinse
slowly
and
gently
with
water.
Remove
contact
lenses,
if
present,
then
continue
rinsing
eye.
GENERAL
Seek
medical
attention
immediately
if
irritation
occurs
and
persists
or
is
severe.
Take
container,
label
or
product
name
and
Pest
Control
Product
Registration
Number
with
you
when
seeking
medical
attention."