Document ID: EPA-HQ-OPP-2002-0233-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-13T04:00Z

[
Sporodex
L
/
2001­
0304
/
PLG
]
~
PROTECTED
~
Reporting
of
Hypersensitivity
Incidence
/
1
[
Pseudozyma
flocculosa
/
2000­
0680
/
STF]
DACO
M4.
6
/
USEPA
OPPTS
885.3400
Reviewer:
Esther
Seto
,
Date
February
12,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________

STUDY
TYPE:
Reporting
of
Hypersensitivity
Incidence
PMRA
DATA
CODE
M4.6
/
USEPA
OPPTS
885.3400
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa,
STF
CITATION:
Hale,
J.
(January
24,
2000).
"Sporodex
WP
Reporting
of
Hypersensitivity."
Plant
Products
Co.
Ltd,
Bramptom,
Ontario.
Unpublished.

SPONSOR:
Plant
Products.
Co.
Ltd.
Bramptom,
Ontario
EXECUTIVE
SUMMARY:

No
adverse
effects
have
been
noted
among
researchers
who
have
worked
closely
with
Pseudozyma
flocculosa
for
up
to
10
years.
The
applicant
has
submitted
a
waiver
rationale
from
conducting
a
dermal
sensitization
study
based
on
the
assumption
that
most
microorganisms
contain
substances
that
could
elicit
a
hypersensitivity
response.
Pseudozyma
flocculosa
is
considered
a
potential
sensitizing
agent,
therefore,
the
statement,
"POTENTIAL
SENSITIZER"
is
required
on
the
primary
display
panel
of
the
label.
Also,
if
registration
is
granted,
all
incidents
of
hypersensitivity
occurring
after
registration
must
be
reported.