Friday
October
5,
2001
Part
IV
Environmental
Protection
Agency
Forty­
Eighth
Report
of
the
TSCA
Interagency
Testing
Committee
to
the
Administrator,
Receipt
of
Report
and
Request
for
Comments;
Notice
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OPPT
NCIC
2003
JUN­
9
2:
29PM
OPPT­
2003­
0026­
0003
51276
Federal
Register
/
Vol.
66,
No.
194
/
Friday
October
5,
2001
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPTS
 
41056;
FRL
 
6786
 
7]

Forty­
Eighth
Report
of
the
TSCA
Interagency
Testing
Committee
to
the
Administrator;
Receipt
of
Report
and
Request
for
Comments
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
The
Toxic
Substances
Control
Act
(
TSCA)
Interagency
Testing
Committee
(
ITC)
transmitted
its
Forty­
Eighth
Report
to
the
Administrator
of
the
EPA
on
May
15,
2001.
In
the
48th
ITC
Report,
which
is
included
with
this
notice,
the
ITC
adds
5
``
chlorinated
trihalomethyl
pyridines,''
2
``
trihaloethylidene
bisbenzenes,''
3­
chlorotrifluralin,
and
4
``
trichlorophenyldihydropyrazols''
to
its
Priority
Testing
List
and
solicits
voluntary
information
for
these
chemicals
under
the
ITC's
Voluntary
Information
Submissions
Policy
(
VISP).
This
action
is
part
of
the
ITC's
ongoing
effort
to
evaluate
chemicals
with
potential
to
persist
and
bioconcentrate,
and
with
suspicions
of
toxicity
and
few
data.
In
this
Report,
the
ITC
also
removes
22
alkylphenols
and
ethoxylates,
methylal,
and
ethyl
silicate
from
its
Priority
Testing
List
and
requests
that
EPA
promulgate
TSCA
section
8(
d)
health
and
safety
data
reporting
rules
for
3­
amino­
5­
mercapto­
1,2,4­
triazole
and
glycoluril.
DATES:
Comments,
identified
by
docket
control
number
OPPTS
 
41056,
must
be
received
on
or
before
November
5,
2001.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPPTS
 
41056
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
numbers:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
For
technical
information
contact:
John
D.
Walker,
ITC
Executive
Director
(
7401),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
202)
564
 
7527;
fax:
(
202)
564
 
7528;
e­
mail
address:
walker.
johnd@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
notice
is
directed
to
the
public
in
general.
It
may,
however,
be
of
particular
interest
to
you
if
you
manufacture
(
defined
by
statute
to
include
import)
and/
or
process
TSCAcovered
chemicals
and
you
may
be
identified
by
the
North
American
Industrial
Classification
System
(
NAICS)
codes
325
and
32411.
Because
this
notice
is
directed
to
the
general
public
and
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
interested
in
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
or
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,''
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
may
also
access
additional
information
about
the
ITC
and
the
TSCA
testing
program
through
the
web
site
for
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
at
http://
www.
epa.
gov/
opptsfrs/
home/
opptsim.
htm/,
or
go
directly
to
the
ITC
home
page
at
http://
www.
epa.
gov/
opptintr/
itc/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPPTS
 
41056.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
TSCA
Nonconfidential
Information
Center,
North
East
Mall
Rm.
B
 
607,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC.
The
Center
is
open
from
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Center
is
(
202)
260
 
7099.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPPTS
 
41056
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
OPPT
Document
Control
Office
(
DCO)
in
East
Tower
Rm.
G
 
099,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC.
The
DCO
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
DCO
is
(
202)
260
 
7093.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
oppt.
ncic@
epa.
gov,
or
mail
your
computer
disk
to
the
address
identified
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Electronic
comments
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.
Comments
and
data
will
also
be
accepted
on
standard
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPPTS
 
41056.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
Information
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.

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Federal
Register
/
Vol.
66,
No.
194
/
Friday
October
5,
2001
/
Notices
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

We
invite
you
to
provide
your
views
and
comments
on
the
ITC's
48th
Report.
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
Provide
specific
examples
to
illustrate
your
concerns.
5.
Offer
alternatives
for
improvement.
6.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
Background
TSCA
(
15
U.
S.
C.
2601
et
seq.)
authorizes
the
Administrator
of
the
EPA
to
promulgate
regulations
under
section
4(
a)
of
TSCA
requiring
testing
of
chemicals
and
chemical
groups
in
order
to
develop
data
relevant
to
determining
the
risks
that
such
chemicals
and
chemical
groups
may
present
to
health
or
the
environment.
Section
4(
e)
of
TSCA
established
the
ITC
to
recommend
chemicals
and
chemical
groups
to
the
Administrator
of
the
EPA
for
priority
testing
consideration.
Section
4(
e)
of
TSCA
directs
the
ITC
to
revise
the
TSCA
section
4(
e)
Priority
Testing
List
at
least
every
6
months.
A.
The
48th
ITC
Report
The
48th
ITC
Report
was
transmitted
to
the
EPA's
Administrator
on
May
15,
2001,
and
is
included
in
this
notice.
In
the
48th
ITC
Report,
the
ITC:
1.
Adds
5
``
chlorinated
trihalomethyl
pyridines,''
2
``
trihaloethylidene
bisbenzenes,''
3­
chlorotrifluralin,
and
4
``
trichlorophenyldihydropyrazols''
to
its
Priority
Testing
List
and
solicits
voluntary
information
for
these
chemicals
under
the
ITC's
VISP.
This
action
is
part
of
the
ITC's
ongoing
effort
to
evaluate
chemicals
with
potential
to
persist
and
bioconcentrate,
and
with
suspicions
of
toxicity
and
few
data.
2.
Removes
22
alkylphenols
and
ethoxylates,
methylal,
and
ethyl
silicate
from
its
Priority
Testing
List.
3.
Requests
that
EPA
promulgate
TSCA
section
8(
d)
health
and
safety
data
reporting
rules
for
3­
amino­
5­
mercapto­
1,2,4­
triazole
and
glycoluril.

B.
Status
of
the
Priority
Testing
List
The
current
TSCA
4(
e)
Priority
Testing
List
as
of
May
2001
can
be
found
in
Table
1
of
the
48th
ITC's
Report
which
is
included
in
this
notice.

List
of
Subjects
Environmental
protection,
Chemicals,
Hazardous
substances.

Dated:
September
26,
2001.
Charles
M.
Auer,
Director,
Chemical
Control
Division,
Office
of
Pollution
Prevention
and
Toxics.

Forty­
Eighth
Report
of
the
TSCA
Interagency
Testing
Committee
to
the
Administrator,
U.
S.
Environmental
Protection
Agency
Table
of
Contents
Summary
I.
Background
II.
TSCA
Section
8
Reporting
A.
TSCA
Section
8
Reporting
Rules
B.
ITC's
Use
of
TSCA
Section
8
and
Other
Information
C.
Promoting
More
Efficient
Use
of
Information
Submission
Resources
D.
Coordinating
Information
Requests
E.
Requests
to
Promulgate
TSCA
Section
8(
a)
PAIR
and
Section
8(
d)
HaSD
Reporting
Rules
III.
ITC's
Activities
During
this
Reporting
Period
(
November
2000
to
April
2001)
IV.
Revisions
to
the
TSCA
Section
4(
e)
Priority
Testing
List
A.
Chemicals
Added
to
the
Priority
Testing
List
1.
Chlorinated
trihalomethyl
pyridines
2.
Trihaloethylidene
bisbenzenes
3.
3­
Chlorotrifluralin
4.
Trichlorophenyldihydropyrazols
B.
Chemicals
Removed
From
the
Priority
Testing
List
1.
Alkylphenols
and
alkylphenol
ethoxylates
2.
Methylal
3.
Ethyl
silicate
V.
References
VI.
TSCA
Interagency
Testing
Committee
SUMMARY
This
is
the
48th
Report
of
the
TSCA
Interagency
Testing
Committee
(
ITC)
to
the
Administrator
of
the
U.
S.
Environmental
Protection
Agency
(
USEPA).
In
this
Report,
the
ITC
is
adding
5
chlorinated
trihalomethyl
pyridines,
2
trihaloethylidene
bisbenzenes,
3­
chlorotrifluralin,
and
4
trichlorophenyldihydropyrazols
to
its
Priority
Testing
List
and
soliciting
voluntary
information
for
these
chemicals
under
the
ITC's
Voluntary
Information
Submissions
Policy
(
VISP).
This
action
is
part
of
the
ITC's
ongoing
effort
to
evaluate
chemicals
with
suspicions
of
toxicity
and
few
data
and
potential
to
persist
and
bioconcentrate.
In
this
Report,
the
ITC
is
removing
22
alkylphenols
and
ethoxylates
and
methylal
and
ethyl
silicate
from
its
Priority
Testing
List.
The
ITC
is
removing
22
alkylphenols
and
ethoxylates
from
its
Priority
Testing
List
because
domestic
production
or
importation
volumes
were
not
reported
to
the
USEPA
in
response
to
1986,
1990,
1994,
and
1998
TSCA
section
8(
a)
Information
Update
Rules
(
IURs)
and
in
response
to
the
TSCA
section
8(
a)
Preliminary
Assessment
Information
Reporting
(
PAIR)
rule
published
in
the
Federal
Register
of
July
5,
2000
(
65
FR
41371)
(
FRL
 
6589
 
1).
The
ITC
is
removing
methylal
and
ethyl
silicate
from
its
Priority
Testing
List
because
data
are
being
developed
under
the
USEPA's
High
Production
Volume
(
HPV)
Challenge
Program.
The
revised
TSCA
section
4(
e)
Priority
Testing
List
follows
as
Table
1.

TABLE
1.
 
THE
TSCA
SECTION
4(
E)
PRIORITY
TESTING
LIST
(
MAY
2001)

Report
Date
Chemical/
group
Action
28
................
May
1991
................
Chemicals
with
Low
Confidence
Reference
Dose
(
RfD)
............................................
Designated
Acetone
Thiophenol
30
................
May
1992
................
5
Siloxanes
..................................................................................................................
Recommended
31
................
January
1993
..........
13
Chemicals
with
insufficient
dermal
absorption
rate
data
.......................................
Designated
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Federal
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/
Vol.
66,
No.
194
/
Friday
October
5,
2001
/
Notices
TABLE
1.
 
THE
TSCA
SECTION
4(
E)
PRIORITY
TESTING
LIST
(
MAY
2001)
 
Continued
Report
Date
Chemical/
group
Action
32
................
May
1993
................
16
Chemicals
with
insufficient
dermal
absorption
rate
data
.......................................
Designated
35
................
November
1994
......
4
Chemicals
with
insufficient
dermal
absorption
rate
data
.........................................
Designated
37
................
November
1995
......
12
Alkylphenols
and
alkylphenol
ethoxylates
.............................................................
Recommended
39
................
November
1996
......
8
Nonylphenol
ethoxylates
..........................................................................................
Recommended
41
................
November
1997
......
7
Alkylphenols
and
alkylphenol
ethoxylates
...............................................................
Recommended
42
................
May
1998
................
3­
Amino­
5­
mercapto­
1,2,4­
triazole
..............................................................................
Recommended
42
................
May
1998
................
Glycoluril
......................................................................................................................
Recommended
46
................
May
2000
................
8
Nonylphenol
polyethoxylate
degradation
products
..................................................
Recommended
47
................
November
2000
......
37
Indium
chemicals
...................................................................................................
Recommended
47
................
November
2000
......
Pentachlorothiophenol
.................................................................................................
Recommended
47
................
November
2000
......
Tetrachloropyrocatechol
..............................................................................................
Recommended
47
................
November
2000
......
p­
Toluidine,
5­
chloro­.
alpha.,.
alpha.,.
alpha.­
trifluoro­
2­
nitro­
N­
phenyl
........................
Recommended
47
................
November
2000
......
Benzoic
acid,
3­[
2­
chloro­
4­
(
trifluoromethyl)
phenoxy]­,
2­
ethoxy­
1­
methyl­
2­
oxoethyl
ester.
Recommended
47
................
November
2000
......
3
Chloroalkenes
..........................................................................................................
Recommended
48
................
May
2001
................
5
Chlorinated
trihalomethyl
pyridines
..........................................................................
Recommended
48
................
May
2001
................
2
Trihaloethylidene
bisbenzenes
.................................................................................
Recommended
48
................
May
2001
................
3­
Chlorotrifluralin
.........................................................................................................
Recommended
48
................
May
2001
................
4
Trichlorophenyldihydropyrazols
................................................................................
Recommended
I.
Background
The
ITC
was
established
by
section
4(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA)
``
to
make
recommendations
to
the
Administrator
respecting
the
chemical
substances
and
mixtures
to
which
the
Administrator
should
give
priority
consideration
for
the
promulgation
of
a
rule
for
testing
under
section
4(
a)....
At
least
every
six
months...,
the
Committee
shall
make
such
revisions
to
the
Priority
Testing
List
as
it
determines
to
be
necessary
and
transmit
them
to
the
Administrator
together
with
the
Committee's
reasons
for
the
revisions''
(
Public
Law
94
 
469,
90
Stat.
2003
et
seq.,
15
U.
S.
C.
2601
et
seq.).
Since
its
creation
in
1976,
the
ITC
has
submitted
47
semi­
annual
(
May
and
November)
Reports
to
the
EPA
Administrator
transmitting
the
Priority
Testing
List
and
its
revisions.
ITC
Reports
are
available
from
the
ITC's
web
site
(
http://
www.
epa.
gov/
opptintr/
itc)
within
a
few
days
of
submission
to
the
Administrator
and
from
http://
www.
epa.
gov/
fedrgstr
after
publication
in
the
Federal
Register.
The
ITC
meets
monthly
and
produces
its
revisions
to
the
Priority
Testing
List
with
administrative
and
technical
support
from
the
ITC
Staff,
ITC
Members,
and
their
U.
S.
Government
organizations
and
contract
support
provided
by
EPA.
ITC
Members
and
Staff
are
listed
at
the
end
of
this
Report.

II.
TSCA
Section
8
Reporting
A.
TSCA
Section
8
Reporting
Rules
Following
receipt
of
the
ITC's
Report
(
and
the
revised
Priority
Testing
List)
by
the
USEPA
Administrator,
the
USEPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
promulgates
TSCA
section
8(
a)
PAIR
and
TSCA
section
8(
d)
Health
and
Safety
Data
(
HaSD)
reporting
rules
for
chemicals
added
to
the
Priority
Testing
List.
The
PAIR
rule
requires
producers
and
importers
of
CASnumbered
chemicals
added
to
the
Priority
Testing
List
to
submit
production
and
exposure
reports
under
TSCA
section
8(
a).
The
HaSD
reporting
rule
requires
producers,
importers,
and
processors
of
all
chemicals
(
including
those
with
no
CAS
numbers)
added
to
the
Priority
Testing
List
to
submit
unpublished
health
and
safety
studies
under
TSCA
section
8(
d)
that
must
be
in
compliance
with
the
revised
HaSD
reporting
rule
published
in
the
Federal
Register
of
April
1,
1998
(
63
FR
15765)
(
FRL
 
5750
 
4).
All
submissions
must
be
received
by
the
USEPA
within
90
days
of
the
reporting
rules'
Federal
Register
publication
date.
The
reporting
rules
are
automatically
promulgated
by
OPPT
unless
otherwise
requested
by
the
ITC.
It
is
an
ITC
policy,
for
most
chemicals
that
are
added
to
the
Priority
Testing
List,
to
delay
automatic
promulgation
of
HaSD
reporting
rules
to
allow
voluntary
submission
of
studies
of
specific
interest
(
see
Unit
II.
C.
of
this
Report
for
further
details).

B.
ITC's
Use
of
TSCA
Section
8
and
Other
Information
The
ITC
reviews
the
TSCA
section
8(
a)
PAIR
reports,
TSCA
section
8(
d)
HaSD
reporting
studies
and
``
other
information''
that
becomes
available
after
the
ITC
adds
chemicals
to
the
Priority
Testing
List.
``
Other
information''
includes
TSCA
section
4(
a)
and
4(
d)
studies,
TSCA
section
8(
c)
submissions,
TSCA
section
8(
e)
``
substantial
risk''
notices,
``
For
Your
Information''
(
FYI)
submissions,
ITC
voluntary
submissions,
unpublished
data
submitted
to
and
from
U.
S.
Government
organizations
represented
on
the
ITC,
published
papers,
as
well
as
use,
exposure,
effects,
and
persistence
data
that
are
voluntarily
submitted
to
the
ITC
by
manufacturers,
importers,
processors,
and
users
of
chemicals
recommended
by
the
ITC.
The
ITC
reviews
this
information
and
determines
if
data
needs
should
be
revised,
if
chemicals
should
be
removed
from
the
Priority
Testing
List,
or
if
recommendations
should
be
changed
to
designations.

C.
Promoting
More
Efficient
Use
of
Information
Submission
Resources
To
promote
more
efficient
use
of
information
submission
resources,
the
ITC
developed
VISP.
VISP
provides
examples
of
data
needed
by
ITC
Member
U.
S.
Government
organizations,
examples
of
studies
that
should
not
be
submitted,
the
milestones
for
submitting
information,
guidelines
for
using
the
TSCA
Electronic
HaSD
Reporting
Form,
and
instructions
for
electronically
submitting
full
studies.
The
TSCA
Electronic
HaSD
Reporting
Form
can
be
used
to
provide
information
electronically
on
ITC
voluntary
submissions,
TSCA
section
8(
d)
studies,
FYI
submissions,
and
TSCA
section
8(
e)
studies.
VISP
is
described
in
the
ITC's
41st
Report
published
in
the
Federal
Register
of
April
9,
1998
(
63
FR
17658)
(
FRL
 
5773
 
5)
and
is
accessible
through
the
world
wide
web
(
http://
www.
epa.
gov/
opptintr/
itc/
visp.
htm
).
To
facilitate
the
implementation
of
VISP,
the
ITC
developed
the
Voluntary
Information
Submissions
Innovative
Online
Network
(
VISION).
VISION
is
described
in
the
ITC's
42nd
Report
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/
Notices
published
in
the
Federal
Register
of
August
7,
1998
(
63
FR
42554)
(
FRL
 
5797
 
8)
and
is
accessible
through
the
world
wide
web
(
http://
www.
epa.
gov/
opptintr/
itc/
vision.
htm).
VISION
includes
the
VISP
and
links
to
the
TSCA
Electronic
HaSD
Reporting
Form
(
http:/
/
www.
epa.
gov/
opptintr/.
er/
hasd.
htm)
including
revised
section
3.2
of
the
TSCA
Electronic
HaSD
Reporting
Form
to
provide
more
use
and
exposure
information
(
see
the
ITC's
46th
Report
published
in
the
Federal
Register
of
December
1,
2000
(
65
FR
75552)
(
FRL
 
6594
 
7)
for
details.
The
ITC
requests
that
chemical
producers,
importers,
processors,
and
users
provide
information
electronically
via
VISION
on
chemicals
for
which
the
ITC
is
soliciting
voluntary
information.
To
enhance
visibility,
the
ITC
will
be
adding
all
chemicals
to
the
Priority
Testing
List
for
which
it
is
soliciting
voluntary
information.
If
the
ITC
does
not
receive
voluntary
information
submissions
to
meet
its
data
needs
according
to
the
procedures
in
VISP,
the
ITC
may
then
request
that
EPA
promulgate
the
appropriate
TSCA
sections
8(
a)
and
8(
d)
reporting
rules
to
determine
if
there
are
unpublished
data
to
meet
those
needs.
The
ITC
requests
that
those
companies
responding
to
a
TSCA
section
8(
d)
HaSD
reporting
rule
provide
data
by
using
the
TSCA
Electronic
HaSD
Reporting
Form.

D.
Coordinating
Information
Requests
To
avoid
duplicate
reporting,
the
ITC
carefully
coordinates
its
information
solicitations
and
reporting
requirements
with
other
national
and
international
testing
programs,
e.
g.,
the
National
Toxicology
Program,
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
Screening
Information
Data
Set
(
SIDS)
Program,
and
the
USEPA's
HPV
Challenge
Program.
The
ITC
is
currently
focusing
its
efforts
on
persistent
non­
HPV
chemicals
that
have
exposure
potential,
but
few,
if
any,
publicly
available
ecological
or
health
effects
data.
The
ITC
is
working
with
the
USEPA's
workgroups,
such
as
the
Persistent
Bioaccumulative
Toxics
(
PBT),
Endocrine
Disruption,
and
perfluoroctylsulfonate
chemicals
workgroups
to
develop
data
that
will
complement
the
objectives
of
those
programs.

E.
Requests
to
Promulgate
TSCA
Section
8(
a)
PAIR
and
Section
8(
d)
HaSD
Reporting
Rules
The
ITC
has
not
received
any
submissions
on
the
chloroalkenes,
chlorinated
trihalomethyl
pyridines,
trihaloethylidene
bisbenzenes,
trifluralins
and
trichlorophenyldihydropyrazols
in
response
to
its
solicitation
for
use
and
exposure
information
in
the
ITC's
45th
Report.
Therefore,
the
ITC
is
asking
the
EPA
to
promulgate
a
TSCA
section
8(
a)
PAIR
rule
for
the
3
chloroalkenes
added
to
the
Priority
Testing
List
in
the
ITC's
47th
Report
published
in
the
Federal
Register
of
April
3,
2001
(
66
FR
17768)
(
FRL
 
6763
 
6)
and
5
chlorinated
trihalomethyl
pyridines,
2
trihaloethylidene
bisbenzenes,
3­
chlorotrifluralin,
and
4
trichlorophenyldihydropyrazols
added
to
the
Priority
Testing
List
in
this
48th
ITC
Report.
The
PAIR
data
will
provide
production
and
exposure
information
and
aid
in
the
selection
of
chemicals
for
potential
TSCA
section
8(
d)
HaSD
reporting
rules.
The
ITC
is
asking
the
USEPA
not
to
promulgate
TSCA
section
8(
d)
HaSD
reporting
rules
for
the
alkylphenols
and
alkylphenol
ethoxylates
that
were
added
to
the
Priority
Testing
List
in
the
ITC's
39th
Report
published
in
the
Federal
Register
of
February
25,
1997
(
62
FR
8578)
(
FRL
 
5580
 
9)
and
in
the
ITC's
41st
Report
because
of
a
need
to
further
review
the
data.
The
TSCA
section
8(
d)
HaSD
reporting
rule
for
methylal
that
was
added
to
the
Priority
Testing
List
in
the
ITC's
42nd
Report
is
no
longer
needed
since
this
chemical
is
being
removed
from
the
Priority
Testing
List
in
this
Report
(
see
Unit
IV.
B.
2.
of
this
Report).
At
this
time,
the
ITC
is
requesting
that
EPA
not
promulgate
TSCA
section
8(
d)
HaSD
reporting
rules
for
the
5
chlorinated
trihalomethyl
pyridines,
2
trihaloethylidene
bisbenzenes,
3­
chlorotrifluralin,
and
4
trichlorophenyldihydropyrazols
added
to
the
Priority
Testing
List
in
this
ITC
Report,
to
allow
producers,
importers,
processors,
and
users
an
opportunity
to
voluntarily
provide
the
requested
information
(
see
Unit
IV.
of
this
Report).
After
review
of
the
information
provided
in
the
TSCA
section
8(
a)
PAIR
rule
published
in
the
Federal
Register
of
July
24,
2000
(
65
FR
45535)
(
FRL
 
6589
 
1),
the
ITC
is
requesting
that
the
USEPA
promulgate
TSCA
section
8(
d)
HaSD
reporting
rules
for
3­
amino­
5­
mercapto­
1,2,4­
triazole
(
CAS
No.
16691
 
43
 
3)
and
glycoluril
(
CAS
No.
496
 
46
 
8).
These
TSCA
section
8(
d)
HaSD
reporting
rules
will
require
the
submission
of
pharmacokinetics,
subchronic
toxicity,
immunotoxicity,
genotoxicity,
carcinogenicity,
reproductive
and
developmental
effects,
and
ecological
effects
studies.
The
chemical
purity
of
3­
amino­
5­
mercapto­
1,2,4­
triazole
and
glycoluril
in
these
studies
should
exceed
90%.
III.
ITC's
Activities
During
this
Reporting
Period
(
November
2000
to
April
2001)
In
its
45th
and
46th
ITC
Reports,
the
ITC
discussed
its
strategies
to
screen
and
evaluate
chemicals
for
persistence
and
bioconcentration
potential.
These
strategies
are
referred
to
as
Degradation
Effects
Bioconcentration
Information
Testing
Strategies
(
DEBITS).
DEBITS
provides
a
means
to
prioritize
chemicals
based
on
degradation,
ecological
or
human
health
effects,
and
bioconcentration
information.
In
its
45th
ITC
Report,
the
ITC
added
several
chemicals
to
its
web
site
to
solicit
measured
bioconcentration
data
and
use
and
exposure
information.
To
avoid
duplicate
reporting
requirements,
the
ITC
is
removing
the
USEPA's
HPV
Challenge
Program
chemicals
(
http://
www.
epa.
gov/
opptintr/
chemrtk/
hpvchmlt.
htm)
and
European
Union's
HPVCs
(
http://
ecb.
ei.
jrc.
it/
existingchemicals
from
its
web
site.
In
its
46th
ITC
Report,
the
ITC
initiated
efforts
to
implement
DEBITS
by
focusing
its
efforts
on
structural
classes
of
chemicals
from
a
subset
of
42
moderate
production
volume
(
MPV)
chemicals
(
production/
importation
volumes
between
100,000
and
1,000,000
pounds)
with
estimated
or
measured
bioconcentration
factors
(
BCFs)
>
250
and
about
70
structurally
related
non­
MPV
chemicals
(
also
with
BCFs
>
250).
In
its
47th
ITC
Report,
the
ITC
added
more
of
these
chemicals
from
its
DEBITS
prioritization
to
its
Priority
Testing
List.
Other
chemical
groups
such
as
nitro
musks,
polycyclic
musks,
and
tertiary
butyl
peroxyl
chemicals
were
reviewed
but
not
added
to
the
Priority
Testing
List.
During
this
reporting
period,
the
ITC
continued
to
focus
its
efforts
on
structural
classes
of
MPV
chemicals
by
adding
5
chlorinated
trihalomethyl
pyridines,
2
trihaloethylidene
bisbenzenes,
4
trichlorophenyldihydropyrazols,
and
3­
chlorotrifluralin
to
its
Priority
Testing
List
and
soliciting
voluntary
health
and
ecological
effects
information
for
these
chemicals
under
the
ITC's
VISP.
The
ITC
evaluated
several
chlorinated
pyridines,
and
azo
bis
(
alpha
nitriles)
and
decided
not
to
add
them
to
the
Priority
Testing
List
at
this
time.

IV.
Revisions
to
the
TSCA
Section
4(
e)
Priority
Testing
List
A.
Chemicals
Added
to
the
Priority
Testing
List
1.
Chlorinated
trihalomethyl
pyridines
 
i.
Recommendation.
Five
non­
HPV
chlorinated
trihalomethyl
pyridines
are
being
added
to
the
Priority
Testing
List
to
obtain
information
on
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2001
/
Notices
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects
as
well
as
the
percent
by
weight
of
any
of
the
5
unreacted
chlorinated
trihalomethyl
pyridines
in
formulated
products.
The
5
non­
HPV
chlorinated
trihalomethyl
pyridines
are
3,5­
dichloro­
2­
(
trichloromethyl)
pyridine
(
CAS
No.
1128
 
16
 
1),
2,3,4,5­
tetrachloro­
6­
(
trichloromethyl)
pyridine
(
CAS
No.
1134
 
04
 
9),
3,4,5­
trichloro­
2­
(
trichloromethyl)
pyridine
(
CAS
No.
1201
 
30
 
5),
2,6­
dichloro­
3­
(
trichloromethyl)
pyridine
(
CAS
No.
55366
 
30
 
8),
and
2,3­
dichloro­
5­
(
trichloromethyl)
pyridine
(
CAS
No.
69045
 
84
 
7).
See
Table
2
below.

TABLE
2.
 
CHLORINATED
TRIHALOMETHYL
PYRIDINES
IDENTIFIED
BY
DEBITS
CAS
No.
Chlorinated
trihalomethyl
pyridine
HPV
BCF
Fish
LC50
001128
 
16
 
1
.....
3,5­
Dichloro­
2­(
trichloromethyl)
pyridine
.............................................
No
.....................
238
....................
3.5
001134
 
04
 
9
.....
2,3,4,5­
Tetrachloro­
6­(
trichloromethyl)
pyridine
..................................
No
.....................
2343
..................
0.1
001201
 
30
 
5
.....
3,4,5­
Trichloro­
2­(
trichloromethyl)
pyridine
.........................................
No
.....................
747
....................
2.7
001817
 
13
 
6
.....
3,6­
Dichloro­
2­(
trichloromethyl)
pyridine
.............................................
Yes
...................
238
....................
3.5
001929
 
82
 
4
.....
2­
Chloro­
6­(
trichloromethyl)
pyridine
...................................................
Yes
...................
84
......................
9.3
055366
 
30
 
8
.....
2,6­
Dichloro­
3­(
trichloromethyl)
pyridine
.............................................
No
.....................
238
....................
3.1
069045
 
78
 
9
.....
2­
Chloro­
5­(
trichloromethyl)
pyridine
...................................................
Yes
...................
76
......................
7.6
069045
 
83
 
6
.....
2,3­
Dichloro­
5­(
trichloromethyl)
pyridine
.............................................
Yes
...................
238
....................
3.2
069045
 
84
 
7
.....
2,3­
Dichloro­
5­(
trifluoromethyl)
pyridine
..............................................
No
.....................
45
......................
12.2
ii.
Rationale
for
recommendation.
The
5
non­
HPV
chlorinated
trihalomethyl
pyridines
are
predicted
to
persist
in
the
environment.
They
present
suspicions
of
toxicity
based
on
fish
LC50
values
and
mutagenicity
based
on
data
from
structurally
related
compounds.
Several
of
these
non­
HPV
chlorinated
trihalomethyl
pyridines
are
produced/
imported
in
substantial
amounts
(>
100,000
pounds)
and
have
potential
to
bioconcentrate.
iii.
Supporting
information.
The
ITC
used
DEBITS
to
identify
9
chlorinated
trihalomethyl
pyridines
(
Table
2
of
this
unit).
Four
of
these
chlorinated
trihalomethyl
pyridines
are
in
the
USEPA's
HPV
Challenge
Program,
including
the
registered
pesticide,
nitrapyrin
(
CAS
No.
1929
 
82
 
4).
The
ITC
is
not
soliciting
information
on
the
HPV
chemicals
but
did
review
the
available
toxicity
and
ecological
effects
information
on
these
compounds
to
better
evaluate
the
data
needs
for
the
non­
HPV
chlorinated
trihalomethyl
pyridines.
The
trichloro­
and
tetrachloro
trichloromethyl
pyridines
have
estimated
bioconcentration
factors
(
BCFs)
>
250
while
2
of
3
dichloro
trichloromethyl
pyridines
have
estimated
BCFs
very
close
to
this
threshold
(
i.
e.,
BCFs
of
238).
All
five
chloro
trihalomethyl
pyridines
have
fish
LC50
values
about
10
milligram/
Liter
(
mg/
L)
or
less,
indicating
that
they
have
potential
to
cause
acute
effects
in
fish.
The
fish
LC50
values
are
based
on
measured
or
estimated
values
for
fathead
minnows.
The
predicted
mode
of
toxic
action
(
based
on
fathead
minnow
models
described
by
Russom
et
al.,
1997)
for
4
of
5
chlorinated
trihalomethyl
pyridines
is
narcosis.
The
tetrachloro
trichloromethyl
pyridine
(
CAS
No.
1134
 
04
 
9)
with
the
lowest
fish
LC50
value
and
highest
BCF
is
predicted
to
have
a
mode
of
toxic
action
based
on
uncoupling
of
oxidative
phosphorylation.
There
were
no
health
effects
data
available
for
the
5
chlorinated
trihalomethyl
pyridines
being
added
to
the
Priority
Testing
List.
However,
there
were
some
available
health
effects
data
for
the
two
HPV
monochloro
substituted
trichloromethyl
pyridines
(
CAS
Nos.
1929
 
82
 
4
and
69045
 
78
 
9)
and
a
HPV
dichloro
trichloromethyl
pyridine
(
CAS
No.
69045
 
83
 
6).
Subchronic
and
mutagenicity
data
were
available
for
2­
chloro­
5­
(
trichloromethyl)
pyridine
(
CAS
No.
69045
 
78
 
9).
Mice
exposed
to
10
parts
per
million
(
ppm)
of
2­
chloro­
5­
(
trichloromethyl)
pyridine
died
after
4
days.
Histologic
examination
of
these
animals
revealed
hepatic
necrosis
and
vacuolization.
No
treatment
related
effects
were
observed
at
0,
0.1,
or
1.0
ppm
exposure
levels
(
Dow
Chemical
Co.,
1991).
In
a
dermal
irritation
study
with
rats,
a
dose
of
500
mg/(
kilogram)
kg/
day
[
for
21
days
(
18
hours
per
day)]
2­
chloro­
5­(
trichloromethyl)
pyridine
produced
a
well­
defined
systemic
toxic
response
characterized
by
hepatic
necrosis
and
a
disturbance
of
lipid
metabolism.
As
a
result
of
topical
irritation
among
the
rats
in
the
100
mg/
kg/
day
group,
the
no­
observed­
adverseeffect
level
(
NOAEL)
was
20
mg/
kg/
day
(
Hazelton
Laboratories,
1992).
In
a
number
of
mutagenicity
test
systems,
2­
chloro­
5­
(
trichloromethyl)
pyridine
was
found
to
be
mutagenic
(
Confidential,
1984a;
Confidential
1984b;
and
Confidential
1984c).
Subchronic
data
were
available
for
2,3­
dichloro­
5­(
trichloromethyl)
pyridine
(
CAS
No.
69045
 
83
 
6).
Degenerative
lesions
occurred
in
the
nasal
turbinates
of
rats
and
mice
exposed
to
0.5
ppm
2,3­
dichloro­
5­(
trichloromethyl)
pyridine
for
2
weeks
(
Confidential,
1986).
Numerous
health
effects
data
were
available
for
2­
chloro­
6­
(
trichloromethyl)
pyridine
or
nitrapyrin
(
CAS
No.
1929
 
82
 
4).
Nitrapyrin
was
well
absorbed
by
dogs
when
administered
using
the
oral
route
(
Redemann
et
al.,
1966).
Oral
administration
of
nitrapyrin
at
doses
of
30
to
50
mg/
kg/
day
and
greater
in
pregnant
rats
and
rabbits
caused
maternal
and
fetal
toxicity
(
Berdasco
et
al.,
1988).
Nitrapyrin
is
also
reported
to
be
mutagenic
in
the
reverse
mutation
assay
in
Salmonella
typhimurium
under
most
conditions
(
Zeiger
et
al.,
1988).
Hepatotoxicity
occurred
in
rats
dermally
exposed
to
500
mg/
kg/
day
of
2­
chloro­
5­
(
trichloromethyl)­
pyridine
for
3
weeks
(
Hazelton
Laboratory,
1992).
iv.
Information
needs.
For
the
5
non­
HPV
chlorinated
trihalomethyl
pyridines
in
Table
2
of
this
unit,
the
ITC
needs:
a.
Use
information,
including
percentages
of
production
or
importation
that
are
associated
with
different
uses;
b.
Identification
of
the
chlorinated
trihalomethyl
pyridines
that
are
intermediates
and
the
final
products
in
which
they
are
contained;
c.
Weight
percent
of
chlorinated
trihalomethyl
pyridines
in
commercial
formulated
products;
and
d.
Pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects
data.
2.
Trihaloethylidene
bisbenzenes
 
i.
Recommendation.
Two
non­
HPV
trihaloethylidene
bisbenzenes
are
being
added
to
the
Priority
Testing
List
to
obtain
information
on
uses,
exposures,

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5,
2001
/
Notices
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects.
The
2
non­
HPV
trihaloethylidene
bisbenzenes
are
hexafluoroisopropylidenebis
(
4­
hydroxybenzene)
and
benzene,
1,1'­
(
2,2,2­
trichloroethylidene)
bis­.
See
Table
3
below.

TABLE
3.
 
TRIHALOETHYLIDENE
BISBENZENES
IDENTIFIED
BY
DEBITS
CAS
No.
Trihaloethylidene
bisbenzene
BCF
000072
 
43
 
5
.......................
Methoxychlor
(
2,2­
bis(
p­
methoxyphenyl)­
1,1,1­
trichloroethane)
.................................................
8128
001478
 
61
 
1
.......................
Hexafluoroisopropylidenebis
(
4­
hydroxybenzene)
......................................................................
556
002971
 
22
 
4
.......................
Benzene,
1,1'­(
2,2,2­
trichloroethylidene)
bis­
...............................................................................
1122
ii.
Rationale
for
recommendation.
The
2
non­
HPV
trihaloethylidene
bisbenzenes
have
been
produced/
imported
in
substantial
amounts
(>
100,000
pounds)
and
are
predicted
to
persist
and
bioconcentrate
in
the
environment.
Benzene,
1,1'­(
2,2,2­
trichloroethylidene)
bis­
(
CAS
No.
2971
 
22
 
4)
is
structurally
related
to
the
insecticide
methoxychlor,
which
has
estrogenic
activity
and
has
been
shown
to
alter
hormone
levels,
decrease
fertility,
damage
reproductive
organs,
and
retard
reproductive
development
in
experimental
animals.
iii.
Supporting
information.
The
ITC
used
DEBITS
to
identify
3
trihaloethylidene
bisbenzenes
(
Table
3
of
this
unit).
All
are
MPV
chemicals
that
have
estimated
BCFs
well
over
250
(
Table
3
of
this
unit).
One
of
the
trihaloethylidene
bisbenzenes
is
the
well
studied
insecticide,
methoxychlor
(
CAS
No.
72
 
43
 
5),
that
is
not
being
added
to
the
Priority
Testing
List
but
which
is
currently
regulated
by
a
number
of
international,
Federal,
and
State
agencies
because
of
its
potential
to
cause
adverse
effects
in
humans.
Methoxychlor
is
included
in
the
USEPA's
Toxics
Release
Inventory
(
TRI)
PBT
rule
published
in
the
Federal
Register
of
November
4,
1999
(
64
FR
60194)
(
FRL
 
6097
 
7)
and
is
a
candidate
for
regulatory
action
under
the
USEPA's
PBT
Initiative.
The
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR)
has
recently
completed
a
Toxicological
Profile
for
methoxychlor
which
summarizes
available
health
effects
data
(
ATSDR,
2000).
Among
the
effects
that
are
relevant
to
predicting
the
effects
of
hexafluoroisopropylidenebis
(
4­
hydroxybenzene)
and
benzene,
1,1'­
(
2,2,2­
trichloroethylidene)
bis­
are
those
related
to
alteration
of
hormone
levels,
including
increasing
levels
of
prolactin,
follicle
stimulating
hormone
(
FSH),
and
thyroid
stimulating
hormone
(
TSH)
in
the
pituitary
of
male
rats
(
Goldman
et
al.
1986;
Gray
et
al.
1989).
In
addition
to
the
ATSDR
Toxicological
Profile
that
summarizes
the
health
effects
of
methoxychlor,
a
Pesticide
Information
Profile
that
summarizes
the
ecological
effects
of
methoxychlor
is
available
on
the
web
(
http://
ace.
orst.
edu/
cgi­
bin/
mfs/
01/
pips/
methoxyc.
htm).
Methoxychlor
is
slightly
toxic
to
bird
species,
with
reported
acute
oral
LD50
values
of
greater
than
2,000
mg/
kg
in
the
mallard
duck,
sharp­
tailed
grouse,
and
California
quail
(
Hudson
et
al.,
1984).
In
contrast,
methoxychlor
is
highly
toxic
to
fish;
96­
hour
LD50
values
for
the
technical
grade
90%
pure
chemical
are
less
than
20
ug/
L
for
cutthroat
trout,
atlantic
salmon,
brook
trout,
lake
trout,
northern
pike,
and
large
mouth
bass
(
Johnson
and
Finley,
1980).
There
are
some
health
effects
data
for
hexafluoroisopropylidenebis(
4­
hydroxybenzene)
and
benzene,
1,1'­
(
2,2,2­
trichloroethylidene)
bis­.
In
an
in
vitro
study
evaluating
endocrine
disruption,
hexafluoroisopropylidenebis(
4­
hydroxybenzene)
was
found
to
be
estrogenic
in
MCF­
7
cells,
promoting
cell
proliferation
and
increasing
protein
synthesis
(
Olea­
Serrano,
1998;
Perez
et
al.,
1998).
Benzene,
1,1'­(
2,2,2­
trichloroethylidene)
bis­
had
estrogenic
activity
at
doses
as
low
as
1
mg/
rat
(
Bitman
and
Cecil,
1970).
No
other
health
or
ecological
effect
studies
were
available
for
these
two
trihaloethylidene
bisbenzenes.
iv.
Information
needs.
The
ITC
needs
information
on
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects.
3.
3­
Chlorotrifluralin
 
i.
Recommendation.
3­
Chlorotrifluralin
(
CAS
No.
29091
 
20
 
1)
is
being
added
to
the
Priority
Testing
List
to
obtain
information
on
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects.
ii.
Rationale
for
Recommendation.
3­
Chlorotrifluralin
is
a
non­
HPV
chemical
that
has
been
produced/
imported
in
substantial
amounts
(>
100,000
pounds)
and
is
predicted
to
persist
and
bioconcentrate
in
the
environment.
It
is
a
chlorinated
analog
of
the
herbicide,
trifluralin
(
CAS
No.
1582
 
09
 
8).
Trifluralin
causes
adverse
effects
in
experimental
animals
and
is
considered
to
be
a
possible
human
carcinogen
by
the
USEPA.
3­
Chlorotrifluralin
has
limited
toxicity
data
even
though
its
potential
to
persist
and
bioconcentrate
in
the
environment
may
be
greater
than
trifluralin.
iii.
Supporting
Information.
3­
Chlorotrifluralin
meets
the
DEBITS
criteria
and
has
an
estimated
BCF
of
7,700.
There
are
no
available
subchronic
toxicity
studies
or
ecological
effects
data
on
this
compound.
The
LD50
in
mice
was
determined
to
be
2,744
mg/
kg
(
Industrial
Bio­
Test
Laboratories,
1992).
The
structurally
related
trifluralin
caused
adverse
liver
and
kidney
effects
in
rodents
and
dogs
as
a
result
of
subchronic
and
chronic
feeding
studies.
Trifluralin
induced
urinary
tract
tumors
(
renal
pelvis
carcinomas
and
urinary
bladder
papillomas)
and
thyroid
tumors
(
adenomas/
carcinomas
combined)
in
one
animal
species
(
Fisher
344
rats)
in
one
study
(
USEPA,
2000).
Trifluralin
is
included
in
the
USEPA's
TRI
PBT
rule
and
is
a
candidate
for
regulatory
action
under
the
USEPA's
PBT
Program.
iv.
Information
Needs.
The
ITC
needs
information
on
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects.

4.
Trichlorophenyldihydropyrazols
 
i.
Recommendation.
Four
trichlorophenyldihydropyrazols
are
being
added
to
the
Priority
Testing
List
to
obtain
information
on
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects
(
Table
4
of
this
unit).

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/
Vol.
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No.
194
/
Friday
October
5,
2001
/
Notices
TABLE
4.
 
TRICHLOROPHENYLDIHYDROPYRAZOLS
IDENTIFIED
BY
DEBITS
CAS
No.
Trichlorophenyldihydropyrazol
BCF
030707
 
68
 
7
......................
3H­
Pyrazol­
3­
one,
5­[(
2­
chloro­
5­
nitrophenyl)
amino]­
2,4­
dihydro­
2­(
2,4,6­
trichlorophenyl)­
.......
2230
040567
 
18
 
8
......................
Benzamide,
3­
amino­
N­[
4,5­
dihydro­
5­
oxo­
1­(
2,4,6­
trichlorophenyl)­
1H­
pyrazol­
3­
yl]­
...............
92
053411
 
33
 
9
......................
3H­
Pyrazol­
3­
one,
5­[(
5­
amino­
2­
chlorophenyl)
amino]­
2,4­
dihydro­
2­(
2,4,6­
trichlorophenyl)­
.....
44
063134
 
25
 
8
......................
Benzamide,
N­[
4,5­
dihydro­
5­
oxo­
1­(
2,4,6­
trichlorophenyl)­
1H­
pyrazol­
3­
yl]­
3­
nitro­
..................
338
ii.
Rationale
for
recommendation.
The
4
trichlorophenyldihydropyrazols
are
predicted
to
persist
in
the
environment.
Two
of
these
trichlorophenyldihydropyrazols
(
CAS
Nos.
30707
 
68
 
7
and
63134
 
25
 
8)
are
produced/
imported
in
substantial
amounts
(>
100,000
pounds)
and
have
potential
to
bioconcentrate.
iii.
Supporting
information.
Two
of
the
four
trichlorophenyldihydropyrazols
have
estimated
BCFs
>
250
(
Table
4
of
this
unit).
The
other
two
chemicals
are
structurally
related
but
are
predicted
to
have
lower
bioconcentration
potential.
There
are
no
available
health
or
ecological
effects
studies
for
any
of
the
trichlorophenyldihydropyrazols.
iv.
Information
needs.
The
ITC
needs
information
on
uses,
exposures,
environmental
releases,
pharmacokinetics,
subchronic
toxicity,
mutagenicity,
reproductive
and
developmental
effects,
carcinogenicity,
and
ecological
effects.

B.
Chemicals
Removed
From
the
Priority
Testing
List
1.
Alkylphenols
and
alkylphenol
ethoxylates.
In
this
Report,
the
ITC
is
removing
22
alkylphenols
and
alkylphenol
ethoxylates
that
were
added
to
the
Priority
Testing
List
in
the
ITC's
41st
Report
published
in
the
Federal
Register
of
April
9,
1998
(
63
FR
17658)
(
FRL
 
5773
 
5).
The
22
alkylphenols
and
alkylphenol
ethoxylates
are
being
removed
from
the
Priority
Testing
List
because:
i.
No
domestic
production
or
importation
volumes
were
reported
to
the
USEPA
in
response
to
1986,
1990,
1994,
and
1998
IURs
(
indicating
that
volumes
were
less
than
10,000
pounds
per
site
in
1985,
1989,
1993,
and
1997)
and
ii.
No
domestic
production
or
importation
volumes
were
reported
to
the
USEPA
in
response
to
the
PAIR
rule
published
in
the
Federal
Register
of
July
5,
2000
(
65
FR
41371)
(
FRL
 
6589
 
1)
(
indicating
that
volumes
were
less
than
1,000
pounds
per
site
in
1999).
The
22
alkylphenols
and
alkylphenol
ethoxylates
being
removed
from
the
Priority
Testing
List
are
listed
in
Table
5
of
this
unit.

TABLE
5.
 
ALKYLPHENOLS
AND
ALKYLPHENOL
ETHOXYLATES
BEING
REMOVED
FROM
THE
PRIORITY
TESTING
LIST
CAS
No.
Chemical
000136
 
81
 
2
.......................
Phenol,
2­
pentyl­
002446
 
69
 
7
.......................
Phenol,
4­
hexyl­
002589
 
78
 
8
.......................
Phenol,
4­
hexadecyl­
003279
 
27
 
4
.......................
Phenol,
2­(
1,1­
dimethylpropyl)­
009004
 
87
 
9
.......................
Poly(
oxy­
1,2­
ethanediyl),
 ­(
iso
octylphenyl)­
 ­
hydroxy­
009063
 
89
 
2
.......................
Poly(
oxy­
1,2­
ethanediyl),
 ­
(
octylphenyl)­
 ­
hydroxy­
025401
 
86
 
9
.......................
Phenol,
2­
hexadecyl­
025735
 
67
 
5
.......................
Phenol,
4­
sec­
pentyl­
026401
 
47
 
8
.......................
Poly(
oxy­
1,2­
ethanediyl),
 ­(
4­
dodecylphenyl)­
 ­
hydroxy­
026401
 
74
 
1
.......................
Phenol,
2­
sec­
pentyl­
027157
 
66
 
0
.......................
Phenol,
decyl­
059911
 
95
 
4
.......................
Poly(
oxy­
1,2­
ethanediyl),
 ­(
4­
hexadecylphenyl)­
 ­
hydroxy­
061723
 
87
 
3
.......................
Poly(
oxy­
1,2­
ethanediyl),
 ­(
tridecylphenyl)­
 ­
hydroxy­
068081
 
86
 
7
.......................
Phenol,
nonyl
derivs.
068784
 
24
 
7
.......................
Phenol,
C18
 
30­
alkyl
derivs.
068891
 
67
 
8
.......................
Phenol,
polypropene
derivs.
068954
 
70
 
1
.......................
Phenol,
polyethylene
derivs.
070682
 
80
 
3
.......................
Phenol,
tetradecyl­
071902
 
25
 
5
.......................
Phenol,
octenylated
084605
 
25
 
4
.......................
Phenol,
1­
methylhexyl
derivs.
091672
 
41
 
2
.......................
Phenol,
2­
nonyl­,
branched
112375
 
89
 
0
.......................
Phenol,
poly(
2,4,4­
trimethylpentene)
derivs.

2.
Methylal.
Methylal
(
CAS
No.
109
 
87
 
5)
was
added
to
the
Priority
Testing
List
in
the
ITC's
42nd
Report
and
recommended
for
information
reporting
to
meet
U.
S.
Government
data
needs.
In
response
to
that
recommendation,
the
USEPA
added
methylal
to
the
PAIR
rule
published
in
the
Federal
Register
of
July
24,
2000
(
65
FR
45535)
(
FRL
 
6589
 
1).
The
ITC
reviewed
the
data
submitted
in
response
to
the
PAIR
rule.
These
data
indicated
that
in
1999,
10,000
to
500,000
pounds
of
methylal
were
produced
under
controlled
release
and
enclosed
conditions,
involving
<
10
and
10
 
100
workers,
respectively.
Methylal's
manufacture
was
associated
with
industrial
products.
The
ITC
is
removing
methylal
from
the
Priority
Testing
List
because
it
is
being
sponsored
for
testing
under
the
USEPA's
HPV
Challenge
Program.
Test
plans
and
data
developed
under
the
challenge
program
may
be
reviewed
to
determine
if
they
meet
the
needs
of
the
U.
S.
Government.
3.
Ethyl
silicate.
Ethyl
silicate
(
CAS
No.
78
 
10
 
4)
was
also
added
to
the
Priority
Testing
List
in
the
ITC's
42nd
Report
and
recommended
for
information
reporting
to
meet
U.
S.
Government
data
needs.
In
response
to
that
recommendation,
the
USEPA
added
ethyl
silicate
to
the
PAIR
rule
published
in
the
Federal
Register
of
July
24,
2000
(
65
FR
45535)
(
FRL
 
6589
 
1)
and
the
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Register
/
Vol.
66,
No.
194
/
Friday
October
5,
2001
/
Notices
ITC
received
voluntary
use
and
toxicity
data
from
the
Silicones
Environmental
Health
and
Safety
Council
(
SEHSC).
Data
submitted
in
response
to
the
PAIR
rule
indicated
that
in
1999,
10,000
to
500,000
pounds
of
ethyl
silicate
were
produced
under
enclosed
conditions,
that
10
 
100
workers
were
involved
in
the
production
of
ethyl
silicate
under
those
conditions
and
that
ethyl
silicate's
manufacture
and
customer
uses
were
associated
with
industrial
products.
SEHSC's
voluntary
submissions
confirmed
that
ethyl
silicate
is
used
as
an
industrial,
not
consumer
chemical.
Toxicity
data
voluntarily
submitted
by
SEHSC
indicated
that:
i.
Ethyl
silicate's
rat
oral
LD50
was
5,920
mg/
kg
(
Smyth
et
al.,
1949);
ii.
No
deaths
occurred
when
rats,
mice,
guinea
pigs,
and
rabbits
were
exposed
to
50
and
88
ppm
ethyl
silicate
for
90
days
and
the
only
significant
observation
was
a
depression
in
kidney
weights
in
the
mice
exposed
to
88
ppm
ethyl
silicate
(
Pozzani
and
Carpenter,
1951);
iii.
The
mutagenic
potential
of
ethyl
silicate
was
evaluated
using
the
Chinese
Hamster
Ovary
(
CHO),
Sister
Chromatid
Exchange
(
SCE),
and
Unscheduled
DNA
Synthesis
(
UDS)
assays;
the
only
significant
mutagenic
effect
was
seen
in
the
UDS
assay
(
Slesinski
et
al.,
1981).
The
ITC
is
removing
ethyl
silicate
from
the
Priority
Testing
List
because
it
is
being
sponsored
for
testing
under
the
USEPA's
HPV
Challenge
Program.
Test
plans
and
data
developed
under
the
challenge
program
may
be
reviewed
to
determine
if
they
meet
the
needs
of
the
U.
S.
Government.

V.
References
1.
ATSDR.
2000.
Toxicological
Profile
for
Methoxychlor.
Update
 
DRAFT
FOR
PUBLIC
COMMENT
edition.
Agency
for
Toxic
Substances
and
Disease
Registry,
Atlanta,
GA.
2.
Berdasco,
N.,
Lomax,
L.,
Zimmer,
M.,
and
Hanley,
T.
1988.
Teratologic
evaluation
of
orally
administered
nitrapyrin
in
rats
and
rabbits.
Fundamentals
of
Applied
Toxicology.
11(
3):
464
 
471.
3.
Bitman,
J.
and
Cecil,
H.
C.
1970.
Estrogenic
activity
of
DDT
analogs
and
polychlorinated
biphenyls.
Journal
of
Agricultural
Food
Chemistry.
18:
1108
 
12.
4.
Confidential.
1984a.
Summary
of
results
from
several
genotoxicity
studies
with
2­
chloro­
5­
trichloromethyl
pyridine;
EPA
Document
No.
88
 
8500683;
Fiche
No.
OTS0509740.
5.
Confidential.
1984b.
The
mutagenicity
evaluation
of
2­
chloro­
5­
trichloromethyl
pyridine
in
the
Ames
test
with
cover
letter
dated
121284;
EPA
Document
No.
88
 
85704;
Fiche
No.
OTS0509740.
6.
Confidential.
1984c.
Substance
H.
109345:
a
cytogenetic
study
in
human
lymphocytes
(
in
vitro)
and
an
evaluation
in
the
Salmonella
mutagenicity
assay
with
cover
letter
dated
122684;
EPA
Document
No.
88
 
8500713;
Fiche
No.
OTS0509740.
7.
Confidential.
1986.
Two­
week
inhalation
toxicity
study
in
Fischer
344
rats
and
B6C3F1
mice
(
company
sanitized)
with
cover
letter
dated
101686;
EPA
Document
No.
FYI­
OTS­
1086­
0473;
Fiche
No.
OTS0000473_
1.
8.
Dow
Chemical
Co.
1991.
Initial
submission:
2­
chloro­
5­
trichloromethyl
pyridine:
two­
week
inhalation
toxicity
study
in
b6c3f1
mice
(
final
report)
with
attachment
and
cover
letter
(
sanitized).
EPA
Document
No.
88
 
920000186S;
Fiche
No.
OTS0534636.
9.
Goldman,
J.
M.,
Cooper,
R.
L.,
and
Rehnberg,
G.
L.,
et
al.
1986.
Effects
of
low
subchronic
doses
of
methoxychlor
on
the
rat
hypothalamic­
pituitary
reproductive
axis.
Toxicology
and
Applied
Pharmacology.
86:
474
 
483.
10.
Gray,
L.
E.,
Otsby,
J.
S.,
and
Ferrell,
J.
M.,
et
al.
1989.
A
dose­
response
analysis
of
methoxychlor­
induced
alterations
of
reproductive
development
and
function
in
the
rat.
Fundamentals
of
Applied
Toxicology.
12:
92­
108.
11.
Hazelton
Laboratories.
1992.
Initial
submission:
three­
week
dermal
toxicity
study
in
the
rat
with
cover
letter.
EPA
Document
No.
88
 
920007444;
Fiche
No.
OTS0545698.
12.
Hudson,
R.
H.,
Tucker,
R.
K.,
and
Haegele,
M.
A.
1984.
Handbook
of
Acute
Toxicity
of
Pesticides
to
Wildlife,
Resource
Publication
153.
U.
S.
Department
of
Interior,
Fish
and
Wildlife
Service,
Washington,
DC.
pp.
6
 
54.
13.
Johnson,
W.
W.
and
Finley,
M.
T.
1980.
Handbook
of
Acute
Toxicity
of
Chemicals
to
Fish
and
Aquatic
Invertebrates,
Resource
Publication
137.
U.
S.
Department
of
Interior,
Fish
and
Wildlife
Service,
Washington,
DC.
pp.
6
 
56.
14.
Olea­
Serrano,
M.
F.,
Pulgar,
R.,
Perez,
P.,
Metzler,
M.,
Pedraza,
V.,
and
Olea,
N.
1998.
Bisphenols:
in
vitro
effects.
Hormonal
Active
Agents
Food,
Symposium.
1998:
161
 
180.
15.
Perez,
P.,
Pulgar,
R.,
Olea­
Serrano,
F.,
Villalobos,
M.,
Rivas,
A.,
Metzler,
M.,
Pedraza,
V.,
and
Olea,
N.
1998.
The
estrogenicity
of
bisphenol
A­
related
diphenylalkanes
with
various
substituents
at
the
central
carbon
and
the
hydroxy
groups.
Environmental
Health
Perspectives.
106(
3):
167
 
174.
16.
Pozzani,
U.
C.
and
Carpenter,
C.
P.
1951.
Response
of
Rodents
to
Repeated
Inhalation
of
Vapors
of
Tetraethyl
Orthosilicate.
Archives
of
Industrial
Hygiene
and
Occupational
Medicine.
4:
465
 
468.
17.
Redemann,
C.,
Williams,
E.,
Clark,
H.,
and
Kaku,
J.
1966.
The
excretion
of
n­
6­
chloropicolinoyl
glycine
by
the
dog
fed
2­
chloro­
6­
(
trichloromethyl)
pyridine.
Journal
of
Agricultural
Food
Chemistry.
14(
5):
530
 
532.
18.
Russom,
C.
L.,
Bradbury
S.
P.,
Braiders
S.
J.,
Hammermeister
D.
E.,
and
Drummond
R.
A.
1997.
Predicting
modes
of
toxic
action
from
chemical
structure:
Acute
toxicity
in
the
fathead
minnow
(
Pimephales
Promelas).
Environmental
Toxicology
and
Chemistry.
16(
5):
948
 
967.
19.
Slesinski,
R.
S.,
Guzzie,
P.
J.,
Hengler,
W.
C.,
and
Wagner,
K.
J.
1981.
TetraethylOrthosilicate­
In
Vitro
Mutagenesis
Studies­
3­
Test
Battery.
Export,
PA:
Bushy
Run
Research
Center,
Project
Report
44
 
68,
June
1981.
20.
Smyth,
H.
F.,
Jr.,
Carpenter,
C.
P.,
and
Weil,
C.
S.
1949.
Range­
Finding
Toxicity
Data,
List
III.
Journal
of
Industrial
Hygiene
and
Toxicology.
31:
60
 
62.
21.
USEPA.
2000.
Integrated
Risk
Information
System
(
IRIS):
Trifluralin,
oral
RfD
last
revised
7/
89,
cancer
assessment
updated
10/
93.
Online
chemical
toxicity
database,
available
at
www.
epa.
gov/
iris,
accessed
12/
00.
22.
Zeiger,
E.,
Anderson,
B.,
Haworth,
S.,
Lawlor,
T.,
and
Mortelmans,
K.
1988.
Salmonella
mutagenicity
tests:
IV.
Results
from
the
testing
of
300
chemical.
Environmental
Molecular
Mutagenesis.
11(
s12):
1
 
158.

VI.
TSCA
Interagency
Testing
Committee
Statutory
Organizations
and
Their
Representatives
Council
on
Environmental
Quality
Vacant
Department
of
Commerce
National
Institute
of
Standards
and
Technology
Robert
Huie,
Member
Barbara
C.
Levin,
Alternate
National
Oceanographic
and
Atmospheric
Administration
Vacant
Environmental
Protection
Agency
Paul
Campanella,
Member
David
R.
Williams,
Alternate
National
Cancer
Institute
Alan
Poland,
Member
National
Institute
of
Environmental
Health
Sciences
Scott
Masten,
Member,
Chair
William
Eastin,
Alternate
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Register
/
Vol.
66,
No.
194
/
Friday
October
5,
2001
/
Notices
National
Institute
for
Occupational
Safety
and
Health
Albert
E.
Munson,
Member
Mark
Toraason,
Alternate
National
Science
Foundation
A.
Frederick
Thompson,
Member
Marge
Cavanaugh,
Alternate
Occupational
Safety
and
Health
Administration
Val
H.
Schaeffer,
Member,
Vice
Chair
Lyn
Penniman,
Alternate
Liaison
Organizations
and
Their
Representatives
Agency
for
Toxic
Substances
and
Disease
Registry
William
Cibulas,
Member
Stephanie
Miles­
Richardson,
Alternate
Consumer
Product
Safety
Commission
Jacqueline
Ferrante,
Member
Treye
Thomas,
Alternate
Department
of
Agriculture
Clifford
P.
Rice,
Member
Laurau
L.
McConnell,
Alternate
Department
of
Defense
Barbara
Larcom,
Member
Kenneth
Still,
Alternate
Jose
´
Centeno,
Alternate
Department
of
the
Interior
Barnett
A.
Rattner,
Member
Food
and
Drug
Administration
David
Hatten,
Alternate
National
Library
of
Medicine
Vera
W.
Hudson,
Member
National
Toxicology
Program
NIEHS,
FDA,
and
NIOSH
Members
Counsel
Scott
Sherlock,
OPPT,
EPA
Technical
Support
Contractor
Syracuse
Research
Corporation
ITC
Staff
John
D.
Walker,
Executive
Director
Norma
S.
L.
Williams,
Executive
Assistant
TSCA
Interagency
Testing
Committee,
Office
of
Pollution
Prevention
and
Toxics
(
7401),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone:
(
202)
564
 
7527;
fax:
(
202)
564
 
7528;
e­
mail
address:
williams.
norma@
epa.
gov;
url:
http://
www.
epa.
gov/
opptintr/
itc.

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