Document ID: EPA-HQ-OPP-2006-0078-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-01T05:00Z

FILE
NAME:
company.
wpt
(
7/
1/
2005)
(
xml)
Template
Number
P25
COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2005)

EPA
Registration
Division
contact:
Dr.
Bipin
Gandhi
703­
305­
0599
BASF
Aktiengesellschaft
67056
Ludwigshafen
Germany
[
Insert
petition
number]

EPA
has
received
a
pesticide
petition
([
6E7026])
from
BASF
AG,
67056
Ludwigshafen,
Germany,
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.

2.
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
in
ethanol
(
CASRN
64­
17­
5)
W/
W
40%
in
or
on
raw
agricultural
commodities.
The
basis
of
this
request
is
that
the
polymer
meets
the
criteria
set
forth
in
the
EPA's
polymer
exemption
rule
[
40
CFR
723.250].
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
NA
2.
Analytical
method.
NA
3.
Magnitude
of
residues.
NA
B.
Toxicological
Profile
1.
Acute
toxicity.
LD50/
oral/
rat5/
male/
female:>
2000
mg/
kg
(
OECD
401)
2
LC50/
by
inhalation/
rat/
male/
female:>
3.58
mg/
l/
4
h
(
OECD
403)
Primary
Skin
Irritation/
rabbit:
Irritant
(
OECD
404)
Primary
irritation
of
the
mucous
membrane/
rabbit;
Risk
of
Serious
damage
to
eyes
(
OECD
405)
Sensitization/
Guinea
pig
maximization
test/
guinea
pig:
Non­
sensitizing
(
OECD
406)

2.
Genotoxicty.
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
in
ethanol
(
CASRN
64­
17­
5)
W/
W
40%
was
tested
for
its
mutagenic
properties
in
the
Ames­
Test
according
to
OECD
471
and
was
not
mutagenic
in
this
test.

3.
Reproductive
and
developmental
toxicity.
NA
4.
Subchronic
toxicity.
NA
5.
Chronic
toxicity.
NA
6.
Animal
metabolism.
NA
7.
Metabolite
toxicology.
NA
8.
Endocrine
disruption.
NA
C.
Aggregate
Exposure
1.
Dietary
exposure.
NA
i.
Food.
NA
ii.
Drinking
water.
NA
2.
Non­
dietary
exposure.
NA
3
D.
Cumulative
Effects
NA
E.
Safety
Determination
1.
U.
S.
population.
NA
2.
Infants
and
children.
NA
F.
International
Tolerances
NA
G.
Supplemental
Information:
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
in
ethanol
(
CASRN
64­
17­
5)
W/
W
40%
is
intended
for
the
use
as
an
inert
ingredient
in
end
use
formulations
used
in
agricultural
applications.

EPA
has
established
a
set
of
criteria
(
40
CFR
723.250)
which
it
uses
to
identify
categories
of
polymers
that
present
no
or
minimal
risk
to
man,
animals,
or
the
environment.
These
criteria
also
serve
to
identify
polymers
that
are
relatively
stable
and
nonreactive
as
well
as
polymers
that
typically
are
not
readily
absorbed
from
the
gastrointestinal
tracts
or
through
the
skin
of
man
or
animals.
According
to
these
criteria,
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
in
ethanol
(
CASRN
64­
17­
5)
W/
W
40%
should
be
characterized
as
a
low
risk
polymer,
as
discussed
below:

­
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
has
a
mean
molecular
mass
(
Mn)
of
4500
g/
mol.
The
molecular
mass
distribution
of
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
was
investigated
by
gel
permeation
chromatography,
the
fraction
<
1005
and
>
104
g/
mol
was
4.2
area
%,
the
fraction
<
501
and
>
140
g/
mol
was
2.1
area
%.

­
is
not
a
cationic
polymer,
nor
is
it
reasonably
expected
to
become
cationic
in
natural
aquatic
environments;

­
does
not
contain
less
than
32%
by
weight
of
the
atomic
element
carbon;

­
as
an
integral
part
of
its
composition,
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
in
ethanol
(
CASRN
64­
17­
5)
W/
W
40%
does
not
contain
any
elements
other
than
those
listed
in
40
CFR
723.250(
d)(
3)(
ii),
except
as
impurities
­
is
not
a
biopolymer,
a
synthetic
equivalent
of
a
biopolymer,
or
a
derivate
or
modification
of
a
biopolymer;
4
­
is
not
manufactured
from
reactants
containing
halogen
atoms
or
cyano
groups,
except
as
impurities;

­
does
not
contain
any
functional
groups
that
are
intended
or
reasonably
anticipated
to
undergo
further
reaction;

­
is
not
designed
to,
nor
is
it
reasonably
anticipated
to
substantially
degrade,
decompose,
or
depolymerize;

­
is
not
manufactured
or
imported
from
monomers
and
/
or
other
reactants
that
are
not
already
included
on
the
TSCA
Chemical
Substance
Inventory.

Supporting
data
required
by
EPA:
According
to
information
which
the
Agency
provided,
the
following
data
are
required
to
support
approval
of
polymers
by
OPP:

1)
The
identity
(
by
chemical
name
and
CAS
Registry
number)
and
the
maximum
percent
by
weight
of
each
chemical
substance
that
is
used
intentionally
in
the
manufacture
of
the
polymer
to
become
part
of
the
polymer.

Vinylcaprolactam
(
CAS­
Number
2235­
00­
9)
Approx.
40%
Ethanol
(
CAS­
Number
64­
17­
5)
Approx.
60%
2,2'­
Azobis(
2­
methylbutyronitrile)
(
CAS­
Number
13472­
08­
7)
0.10%
Di­
tert.­
butylperoxide
(
CAS­
Number
110­
05­
4)
0.21%

2)
The
identity
(
by
chemical
name
and
CAS
registry
number)
and
estimated
maximum
weight
percent
of
each
impurity
anticipated
to
be
present
in
the
polymer.

The
impurities
(
by­
products)
present
in
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
(
CASRN
25189­
83­
7)
include:

Vinylcaprolactam
(
CAS­
Number
2235­
00­
9)
<
20
ppm
Caprolactam
(
CAS
Number
105­
60­
2)
<
1000
ppm
Based
on
the
above
information
and
review
of
its
use,
EPA
has
found
that
,
when
used
in
accordance
with
good
agricultural
practice,
this
ingredient
is
useful
and
a
tolerance
is
not
necessary
to
protect
the
public
health.
Therefore,
EPA
proposes
that
the
exemption
from
the
requirement
of
a
tolerance
be
established
as
set
forth
below.
5
H.
Technical
Contact:

Agent
in
the
USA
Laurie
J.
Pariano
BASF
Corporation
11501
Steele
Creek
Road
Charlotte,
NC
28273
704­
587­
8288
­