Document ID: EPA-HQ-OPPT-2003-0026-0006
Agency: epa
Document Type: Notice
Title: Forty-Second Report of the TSCA Interagency Testing Committee to the Administrator; Receipt of Report and Request for Comments
Posted Date: 2003-06-09T04:00Z

federalregister
42553
Friday
August
7,
1998
Part
V
Environmental
Protection
Agency
Forty­
Second
Report
of
the
TSCA
Interagency
Testing
Committee;
Notice
RECEIVED
OPPT
NCIC
2003
JUN­
9
2:
29PM
OPPT­
2003­
0026­
0006
42554
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPTS
 
41050;
FRL
 
5797
 
8]

Forty­
Second
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
TSCA
Interagency
Testing
Committee
(
ITC),
established
under
section
4(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA),
transmitted
its
Forty­
Second
Report
to
the
Administrator
of
the
EPA
on
May
29,
1998.
In
the
Forty­
Second
Report,
which
is
included
with
this
notice,
the
ITC
revised
the
TSCA
section
4(
e)
Priority
Testing
List
by
recommending
four
chemicals:
3­
Amino­
5­
mercapto­
1,2,4­
triazole,
ethyl
silicate,
glycoluril,
and
methylal.
There
are
no
``
designated''
or
``
recommended
with
intent­
to­
designate''
chemicals
or
chemical
groups
in
the
Forty­
Second
Report.
EPA
invites
interested
persons
to
submit
written
comments
on
the
Report.
DATES:
Written
comments
on
the
Forty­
Second
ITC
Report
should
be
received
by
September
8,
1998.
ADDRESSES:
Comments
on
the
Forty­
Second
Report
should
be
submitted
to
both
the
ITC
and
the
TSCA
Docket.
Send
one
copy
of
written
comments
to:
John
D.
Walker,
ITC
Executive
Director
(
7401),
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
Send
six
copies
of
written
comments
to:
Document
Control
Office,
Rm.
G
 
099,
Office
of
Pollution
Prevention
and
Toxics
(
7407),
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460.
All
submissions
should
bear
the
docket
control
number
OPPTS
 
41050.
Comments
may
also
be
submitted
electronically
by
sending
electronic
mail
(
e­
mail)
to
the
ITC
(
walker.
johnd@
epa.
gov)
or
the
TSCA
Docket
(
ncic@
epa.
gov).
Electronic
comments
are
preferred
by
the
ITC.
Electronic
comments
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.
Comments
will
be
accepted
on
disks
in
WordPerfect
5.1/
6.1
file
format
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
the
docket
control
number
OPPTS
 
41050.
No
Confidential
Business
Information
(
CBI)
should
be
submitted
through
e­
mail.
Electronic
comments
on
the
Forty­
Second
Report
may
be
filed
online
at
many
Federal
Depository
Libraries.
Additional
information
on
electronic
submissions
can
be
found
in
Unit
IV
of
this
preamble.

FOR
FURTHER
INFORMATION
CONTACT:
Susan
B.
Hazen,
Director,
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460,
(
202)
554
 
1404,
TDD
(
202)
554
 
0551.

SUPPLEMENTARY
INFORMATION:
EPA
has
received
the
TSCA
Interagency
Testing
Committee's
Forty­
Second
Report
to
the
Administrator.

I.
Background
TSCA
(
Pub.
L.
94
 
469,
90
Stat.
2003
et
seq.
(
15
U.
S.
C.
260l
et
seq.))
authorizes
the
Administrator
of
the
EPA
to
promulgate
regulations
under
section
4(
a)
requiring
testing
of
chemicals
and
chemical
groups
in
order
to
develop
data
relevant
to
determining
the
risks
that
these
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.

II.
The
ITC
Forty­
Second
Report
The
most
recent
revisions
to
the
Priority
Testing
List
are
included
in
the
ITC's
Forty­
Second
Report.
The
Report
was
received
by
the
Administrator
of
the
EPA
on
May
29,
1998,
and
is
included
in
this
notice.
Four
chemicals:
3­
Amino­
5­
mercapto­
1,2,4­
triazole,
ethyl
silicate,
glycoluril,
and
methylal
are
being
recommended
because:
1.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
is
being
considered
for
health
effects
testing
based
on
concerns
related
to
effects
on
thyroid
hormone
activity.
2.
Ethyl
silicate
is
under
review
for
mutagenicity
and
subchronic
or
chronic
toxicity
testing
based
on
potential
human
exposures
and
suspicions
of
genotoxicity
or
carcinogenicity.
3.
Glycoluril
is
under
review
for
carcinogenicity
testing
based
on
a
potential
for
human
exposure
and
a
suspicion
of
carcinogenicity.
4.
Methylal
is
under
review
for
carcinogenicity
testing
based
on
its
potential
for
human
exposure
and
a
suspicion
of
carcinogenicity.

III.
Status
of
the
Priority
Testing
List
The
current
TSCA
section
4(
e)
Priority
Testing
List
contains
11
chemical
groups;
of
these,
4
chemical
groups
were
designated
for
testing.

IV.
Public
Record,
Electronic
Comment
Submission,
and
Oral
Comments
The
EPA
invites
interested
persons
to
submit
detailed
comments
on
the
ITC's
Forty­
Second
Report.
An
official
record
has
been
established
for
this
notice,
as
well
as
a
public
version,
under
docket
control
number
OPPTS
 
41050
(
including
comments
and
data
submitted
electronically
as
described
below).
A
public
version
of
this
record,
including
printed
paper
versions
of
electronic
comments
and
data,
which
does
not
contain
any
information
claimed
as
CBI,
is
available
for
inspection
from
12
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
public
record
is
located
in
the
TSCA
Nonconfidential
Information
Center,
Rm.
NE
 
B607,
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC.
Electronic
comments
can
be
sent
directly
to
the
ITC
at
walker.
johnd@
epa.
gov
and
to
the
TSCA
Docket
at
ncic@
epa.
gov.
Electronic
comments
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.
Comments
will
be
accepted
on
disks
in
WordPerfect
5.1/
6.1
file
format
or
ASCII
file
format.
The
official
record
for
the
ITC's
Forty­
Second
Report,
as
well
as
the
public
version
as
described
above,
will
be
kept
in
paper
form.
Accordingly,
EPA
will
transfer
all
comments
received
electronically
into
printed,
paper
form
as
they
are
received
and
will
place
the
paper
copies
in
the
official
record
which
will
also
include
all
comments
submitted
directly
in
writing.
The
official
record
is
the
paper
record
maintained
at
the
EPA
address
in
this
unit.

List
of
Subjects
Environmental
protection,
Chemicals,
Hazardous
substances,
Health
and
safety.

Authority:
15
U.
S.
C.
2603.

Dated:
July
27,
1998.

Charles
M.
Auer,

Director,
Chemical
Control
Division,
Office
of
Pollution
Prevention
and
Toxics.

Forty­
Second
Report
of
the
TSCA
Interagency
Testing
Committee
Administrator,
U.
S.
Environmental
Protection
Agency
Summary
This
is
the
42nd
Report
of
the
TSCA
Interagency
Testing
Committee
(
ITC)
to
the
Administrator
of
the
U.
S.
42555
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
Environmental
Protection
Agency
(
EPA).
In
this
Report,
the
ITC
is
revising
its
TSCA
section
4(
e)
Priority
Testing
List
by
recommending
3­
amino­
5­
mercapto­
1,2,4­
triazole,
ethyl
silicate,
glycoluril,
and
methylal.
The
revised
TSCA
section
4(
e)
Priority
Testing
List
follows
as
Table
1.

Table
1.
 
The
TSCA
Section
4(
e)
Priority
Testing
List
(
May
1998)
1
Report
Date
Chemical/
Group
Action
26
.........................
May
1990
...........................
8
Isocyanates
..................................................
Recommended
with
intent­
to­
designate
27
.........................
November
1990
.................
62
Aldehydes
...................................................
Recommended
with
intent­
to­
designate
28
.........................
May
1991
...........................
Chemicals
with
Low
Confidence
Reference
Dose
(
RfD).
Acetone
Thiophenol
Designated
30
.........................
May
1992
...........................
5
Siloxanes
......................................................
Recommended
31
.........................
January
1993
.....................
24
Chemicals
with
insufficient
dermal
absorption
rate
data.
Designated
32
.........................
May
1993
...........................
32
Chemicals
with
insufficient
dermal
absorption
rate
data.
Designated
35
.........................
November
1994
.................
24
Chemicals
with
insufficient
dermal
absorption
rate
data.
Designated
36
.........................
May
1995
...........................
9
High
production
volume
chemicals
(
HPVCs)
Recommended
37
.........................
November
1995
.................
22
Alkylphenols
and
alkylphenol
ethoxylates2
Recommended
39
.........................
November
1996
.................
23
Nonylphenol
ethoxylates2
..........................
Recommended
41
.........................
November
1997
.................
29
Alkylphenols,
alkylphenol
ethoxylates,
and
polyalkyphenols2.
Recommended
42
.........................
May
1998
...........................
3­
Amino­
5­
mercapto­
1,2,4­
triazole2
................
Recommended
42
.........................
May
1998
...........................
Glycoluril2
........................................................
Recommended
42
.........................
May
1998
...........................
Methylal2
..........................................................
Recommended
42
.........................
May
1998
...........................
Ethyl
silicate2
...................................................
Recommended
1
The
Priority
Testing
List
is
available
from
the
ITC's
web
site
(
http://
www.
epa.
gov/
opptintr/
itc).
2Data
requested
using
the
ITC's
Voluntary
Information
Submissions
Policy
(
VISP),
see
http://
www.
epa.
gov/
opptintr/
itc/
visp.
htm.

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
41
semi­
annual
(
May
and
November)
Reports
to
the
EPA
Administrator
transmitting
the
Priority
Testing
List
and
its
revisions.
In
1989,
the
ITC
began
recommending
chemical
substances
for
information
reporting,
screening,
and
testing
to
meet
the
data
needs
of
its
member
U.
S.
Government
organizations.
ITC
Reports
are
available
from
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
List
with
administrative
and
technical
support
from
the
ITC
staff
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
Rules
Following
receipt
of
the
ITC's
Report
by
the
EPA
Administrator
and
addition
of
chemicals
to
the
Priority
Testing
List,
the
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
promulgates
TSCA
section
8(
a)
Preliminary
Assessment
Information
Reporting
(
PAIR)
and
TSCA
section
8(
d)
Health
and
Safety
Data
(
HaSD)
rules
for
chemicals
added
to
the
List.
These
rules
require
producers
and
importers
of
chemicals
recommended
by
the
ITC
to
submit
production
and
exposure
reports
under
TSCA
section
8(
a)
and
producers,
importers,
and
processors
of
chemicals
recommended
by
the
ITC
to
submit
unpublished
health
and
safety
studies
under
TSCA
section
8(
d).
These
rules
are
automatically
promulgated
by
OPPT
unless
requested
not
to
do
so
by
the
ITC.

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
studies,
and
``
other
information''
that
becomes
available
after
the
ITC
adds
chemicals
to
the
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,
ITCFYI
voluntary
submissions,
unpublished
data
submitted
to
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
List,
or
if
recommendations
should
be
changed
to
designations.

C.
Policy
Promoting
More
Efficient
Use
of
TSCA
Section
8
Resources
In
its
40th
Report
(
62
FR
30580,
June
4,
1997)
(
FRL
 
5718
 
3),
the
ITC
proposed
the
Voluntary
Information
Submissions
Policy
(
VISP)
to
promote
more
efficient
use
of
TSCA
section
8
resources.
After
the
40th
and
41st
(
63
FR
17658,
April
9,
1998)
(
FRL
 
5773
 
5)
Reports
were
delivered
to
the
EPA
Administrator,
the
VISP
was
revised
and
posted
on
the
ITC's
web
site
(
http:/
/
www.
epa.
gov/
opptintr/
itc/
visp.
htm).
Revisions
to
the
VISP
included
eliminating
the
need
to
submit
a
list
of
studies,
changing
the
milestone
for
notifying
the
ITC
Director
from
30
to
60
days,
and
providing
clearer
guidance
for
submitting
electronic
data.
The
VISP
is
part
of
the
ITC's
Voluntary
Information
Submissions
Innovative
Online
Network
42556
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
1E­
mail
voluntary
information
submissions
to
walker.
johnd@
epa.
gov.
2Provide
voluntary
information
submissions
through
http://
www.
epa.
gov/
opptintr/
itc/
vision.
htm.
(
VISION)
that
is
described
in
the
ITC's
web
site
(
http://
www.
epa.
gov/
opptintr/
itc/
vision.
htm).
The
ITC's
VISION
currently
includes
the
VISP,
the
TSCA
Electronic
HaSD
Reporting
Form
(
http:/
/
cyber22.
dcoirm.
epa.
gov/
oppt/
tsca.
nsf/
HaSDForm?
openform),
and
instructions
for
the
Form
(
http://
www.
epa.
gov/
opptintr/
itc/
tsca­
hlp.
htm).
The
VISP
provides
examples
of
data
needed
by
ITC
member
U.
S.
Government
organizations,
examples
of
studies
that
should
not
be
submitted,
the
60­,
90­
and
120­
day
milestones
for
meeting
the
objectives
of
the
VISP,
guidelines
for
using
the
TSCA
Electronic
HaSD
Reporting
Form,
and
instructions
for
electronically
submitting
full
studies.
The
ITC
implemented
the
VISP
in
its
41st
Report
for
the
alkylphenols,
alkylphenol
ethoxylates,
and
polyalkylphenols
recommended
in
its
37th
(
61
FR
4188,
February
2,
1996)
(
FRL
 
4991
 
6),
39th
(
62
FR
8578,
February
25,
1997)
(
FRL
 
5580
 
9),
and
41st
Reports.

III.
ITC's
Dialogue
Group
Activities
During
this
Reporting
Period
(
November
1997
to
May
1998)

Alkylphenols
and
Ethoxylates
(
AP&
E)

The
Chemical
Manufacturers
Association
(
CMA)­
ITC
AP&
E
Dialogue
Group
was
formed
by
the
CMA's
AP&
E
Panel
and
the
ITC's
AP&
E
Subcommittee
in
March
1996
following
the
submission
of
the
ITC's
37th
Report
to
the
EPA
Administrator
in
November
1995.
The
Group
was
created
to
facilitate
the
ITC's
retrieval
of
information
on
uses,
exposures
and
health,
and
ecological
effects
of
alkylphenols
and
alkylphenol
ethoxylates,
and
the
Panel's
understanding
of
data
needed
by
the
U.
S.
Government
organizations
represented
on
the
Subcommittee.
Since
the
creation
of
this
Dialogue
Group,
numerous
activities
have
occurred:
see
the
ITC's
38th
(
61
FR
39832,
July
30,
1996)
(
FRL
 
5379
 
2),
39th,
40th,
and
41st
Reports.
As
a
result
of
the
Dialogue
Group
activities,
the
Panel
voluntarily
provided
the
ITC
with
a
database
of
255
studies
for
the
alkylphenols
and
alkylphenol
ethoxylates
recommended
in
the
37th
Report
and
the
nonylphenol
ethoxylates
recommended
in
the
39th
Report.
In
addition,
at
least
25
non­
Panel
member
companies
provided
240
submissions
on
alkylphenols
and
alkylphenol
ethoxylates
(
each
submission
contains
one
or
more
studies)
in
response
to
the
TSCA
section
8(
d)
rule
for
the
alkylphenols
and
alkylphenol
ethoxylates
recommended
in
the
37th
Report.
The
AP&
E
Dialogue
Group
met
twice
during
this
reporting
period.
On
February
11
and
April
22,
1998,
the
Dialogue
Group
met
to
discuss:
1.
Use
and
exposure
data
for
certain
alkylphenols
and
alkylphenol
ethoxylates.
2.
Progress
and
results
of
ongoing
environmental
and
toxicological
studies
being
conducted
or
sponsored
by
chemical
manufacturers
on
the
Panel,
(
e.
g.,
mammalian
in
vitro
and
in
vivo
toxicology,
mammalian
pharmacokinetic,
biodegradation,
aquatic
toxicity,
and
avian
acute
toxicity
studies).
3.
The
ITC's
VISION.
4.
Information
being
generated
by
the
Society
of
the
Plastics
Industry
(
e.
g.,
dialogue
with
the
Food
and
Drug
Administration
(
FDA)
to
estimate
dietary
exposure
to
tris­
nonylphenyl
phosphite,
nonylphenyl
ethoxylates,
and
nonylphenols).
5.
Historic
AP&
E
monitoring
and
research
conducted
by
the
U.
S.
Geological
Survey.
6.
Recent
AP&
E
monitoring
conducted
by
the
Silent
Spring
Institute
(
published
in
Environmental
Science
and
Technology
32:
861
 
869;
1998).
7.
EPA's
ambient
water
quality
criteria
document
for
nonylphenol.
8.
OPPT's
Risk
Management
 
1
(
RM
 
1)
document
on
p­
nonylphenol.
9.
Organization
for
Economic
Cooperation
and
Development
(
OECD)
Screening
Information
Data
Set
(
SIDS)
dossiers
on
nonylphenol
and
nonylphenol
ethoxylates.
10.
European
nonylphenol
ethoxylates
risk
reduction
activities.

IV.
Revisions
to
the
TSCA
Section
4(
e)
Priority
Testing
List
Revisions
to
the
TSCA
section
4(
e)
Priority
Testing
List
are
summarized
in
Table
2.

Table
2.
 
Revisions
to
the
TSCA
Section
4(
e)
Priority
Testing
List
CAS
No.
Chemical
name
Action
Date
16691
 
43
 
3
....................
3­
Amino­
5­
mercapto­
1,2,4­
triazole
.......................................................
Recommended
................
May
1998
496
 
46
 
8
........................
Glycoluril
...............................................................................................
Recommended
................
May
1998
109
 
87
 
5
........................
Methylal
................................................................................................
Recommended
................
May
1998
78
 
10
 
4
..........................
Ethyl
silicate
..........................................................................................
Recommended
................
May
1998
A.
Chemicals
Added
to
the
Priority
Testing
List
At
this
time,
the
ITC
is
requesting
that
the
EPA
not
promulgate
a
TSCA
section
8(
d)
rule
for
any
of
the
recommended
chemicals.
The
ITC
is
encouraging
producers,
importers,
processors,
and
users
of
the
recommended
chemicals
to
use
its
VISION
(
http://
www.
epa.
gov/
opptintr/
itc/
vision.
htm)
to
provide
voluntary
electronic
information
submissions
and
establish
a
dialogue
with
the
ITC
to
discuss
needed
data.
1.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
i.
Recommendation.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
is
being
recommended
to
obtain
annual
production/
importation
volumes
and
trends,
use,
exposure,
and
health
effects
data
needed
by
U.
S.
Government
organizations
represented
on
the
ITC.
ii.
Rationale
for
recommendation.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
is
being
considered
for
health
effects
testing
based
on
concerns
related
to
effects
on
thyroid
hormone
activity.
Before
designating
3­
amino­
5­
mercapto­
1,2,4­
triazole
for
priority
testing
consideration
by
the
EPA
Administrator,
the
ITC
wants
to
review
the
PAIR
data
and
the
needed
data
listed
below:
iii.
Data
needed
a.
Recent
non­
Confidential
Business
Information
(
CBI)
estimates
of
annual
production
or
importation
volume
data
and
trends.
1
b.
Use
information,
including
percentages
of
production
or
importation
that
are
associated
with
different
uses.
1
c.
Estimates
of
the
number
of
humans
and
concentrations
of
3­
amino­
5­
mercapto­
1,2,4­
triazole
to
which
humans
may
be
exposed
from
use,
manufacturing,
or
processing.
1
d.
Health
effects.
2
iv.
Supporting
information.
There
is
a
need
to
determine
potential
toxicity
of
42557
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
3­
amino­
5­
mercapto­
1,2,4­
triazole
based
on
concerns
related
to
effects
on
thyroid
hormone
activity
(
Ref.
3,
Takaoka
et
al.,
1994).
Non­
CBI
data
reported
to
the
EPA
indicated
that
about
250,000
pounds
of
3­
amino­
5­
mercapto­
1,2,4­
triazole
were
imported
into
the
United
States
in
1993.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
is
reportedly
used
in
organic
synthesis,
processing
of
silver
halide
photographic
materials,
as
an
antioxidant
for
aluminum
and
as
a
viscosity
index
improver,
dispersant,
and
antioxidant
for
lubricating
oils.
No
published
data
were
found
on:
a.
Environmental
releases.
b.
Environmental
fate.
c.
Occupational
exposures.
d.
Concentrations
of
3­
amino­
5­
mercapto­
1,2,4­
triazole
to
which
humans
may
be
exposed.
A
few
data
related
to
potential
effects
were
found.
3­
Amino­
5­
mercapto­
1,2,4­
triazole
was
not
included
in
the
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH)
National
Occupational
Exposure
Survey
(
NOES),
and
guidelines
for
occupational
exposures
have
not
been
established
by
NIOSH
or
Occupational
Safety
and
Health
Administration
(
OSHA).
Schafer
et
al.
(
Ref.
2,
1982)
reported
that
3­
amino­
5­
mercapto­
1,2,4­
triazole
has
an
LD50
>
316
mg/
kg
body
weight
of
quails
(
Coturnix
coturnix).
3­
Amino­
5­
mercapto­
1,2,4­
triazole
was
reported
to
be
one
of
five
chemicals
structurally
related
to
3­
amino­
1,2,4­
triazole
(
Amitrol
Ò
)
,
a
herbicide
that
affected
thyroid
hormone
activity
(
Ref.
3,
Takaoka
et
al.,
1994).
In
studies
with
rats,
3­
amino­
5­
mercapto­
1,2,4­
triazole
was
also
reported
to
be
a
metabolite
of
Amitrol
Ò
(
Ref.
1,
Grunow
et
al.,
1975).
2.
Glycoluril
i.
Recommendation.
Glycoluril
is
being
recommended
to
obtain
annual
production/
importation
volumes
and
trends,
use,
exposure
and
health
effects
data
needed
by
U.
S.
Government
organizations
represented
on
the
ITC.
ii.
Rationale
for
recommendation.
Glycoluril
is
under
review
for
carcinogenicity
testing
based
on
a
potential
for
human
exposure
and
a
suspicion
of
carcinogenicity.
The
suspicion
of
carcinogenicity
is
based
on
a
potential
for
the
formation
of
a
nitrosamide.
A
document
prepared
for
the
U.
S.
Government
organization
nominating
glycoluril
to
the
ITC
is
available
on
the
ITC's
web
site
(
glycoluril
document)
and
in
the
TSCA
Docket
for
the
ITC's
42nd
Report
(
Ref.
5,
TRI,
1997b).
Before
designating
glycoluril
for
priority
testing
consideration
by
the
EPA
Administrator,
the
ITC
wants
to
retrieve
and
review
the
most
current
data
on
exposures
and
health
effects.
Data
already
included
in
the
glycoluril
document
should
not
be
submitted
to
the
ITC.
Data
needed
are
listed
below.
iii.
Data
needed
a.
Recent
non­
CBI
estimates
of
annual
production
or
importation
volume
data
and
trends.
1
b.
Use
information,
including
percentages
of
production
or
importation
that
are
associated
with
different
uses.
1
c.
Estimates
of
the
number
of
humans
and
concentrations
of
glycoluril
to
which
humans
may
be
exposed
from
use,
manufacturing
or
processing.
1
d.
Health
effects.
2
iv.
Supporting
Information.
Data
reported
to
the
EPA
in
1986,
1990
and
1994
indicated
that
the
non­
CBI
annual
production/
importation
volumes
for
glycoluril
ranged
from
10,000
to
1,000,000
pounds.
Available
use
information
suggested
that
glycoluril
may
be
used
as
a
slow­
release
nitrogen
fertilizer,
but
its
use
may
be
limited
because
of
the
chemical's
cost.
It
has
also
been
reported
that
glycoluril
resins
have
been
used
in
paint
and
coating
formulations.
No
published
data
were
found
on:
a.
Environmental
releases.
b.
Environmental
fate.
c.
Ecological
effects.
d.
Health
effects.
e.
Occupational
exposures.
f.
Concentrations
of
glycoluril
to
which
humans
may
be
exposed.
Glycoluril
was
not
listed
in
the
Registry
of
Toxic
Effects
of
Chemical
Substances
(
RTECS)
or
in
NIOSH's
NOES
and
guidelines
for
occupational
exposures
have
not
been
established
by
NIOSH
or
OSHA.
3.
Methylal
i.
Recommendation.
Methylal
is
being
recommended
to
obtain
production/
importation
volume
data
and
trends,
use,
exposure,
health
effects,
especially
in
vivo
mammalian
metabolism
and
chronic
effects
data
needed
by
U.
S.
Government
organizations
represented
on
the
ITC.
ii.
Rationale
for
recommendation.
Methylal
is
under
review
for
carcinogenicity
testing
based
on
its
potential
for
human
exposure
and
a
suspicion
of
carcinogenicity.
The
suspicion
of
carcinogenicity
is
based
on
mutagenicity
data
from
a
number
of
bacterial
and
mammalian
systems
and
the
potential
for
methylal
to
be
metabolized
to
formaldehyde,
a
rodent
carcinogen.
A
document
prepared
for
the
U.
S.
Government
organization
nominating
methylal
to
the
ITC
is
available
on
the
ITC's
web
site
(
methylal
document)
and
in
the
TSCA
Docket
for
the
ITC's
42nd
Report
(
Ref.
6,
TRI,
1997c).
Before
designating
methylal
for
priority
testing
consideration
by
the
EPA
Administrator,
ITC
wants
to
retrieve
and
review
the
most
current
data
on
exposures
and
health
effects.
Data
already
included
in
the
methylal
document
should
not
be
submitted.
Data
needed
are
listed
below.
iii.
Data
needed
a.
Recent
non­
CBI
estimates
of
annual
production
or
importation
volume
data
and
trends.
1
b.
Use
information,
including
percentages
of
production
or
importation
that
are
associated
with
different
uses.
1
c.
Estimates
of
the
number
of
humans
and
concentrations
of
methylal
to
which
humans
may
be
exposed
from
use,
manufacturing,
or
processing.
1
d.
Health
effects,
especially,
in
vivo
mammalian
metabolism
and
chronic
effects.
2
iv.
Supporting
information.
Data
reported
to
the
EPA
in
1990
indicated
that
the
non­
CBI
annual
production/
importation
volume
for
methylal
was
in
the
range
of
1.2
to
6.4
million
pounds.
Methylal
is
reportedly
used
in
perfumery,
as
a
chemical
intermediate
in
the
manufacture
of
artificial
resins
and
in
organic
synthesis,
a
solvent,
and
a
special
fuel.
NOES
human
exposure
data
from
1981
 
1983
were
found,
as
well
as
threshold
limit
values
for
human
exposures.
According
to
the
NOES,
156,795
workers,
including
21,092
female
employees,
were
potentially
exposed
to
methylal.
No
published
data
were
found
on
the
ecological
effects
of
methylal,
in
vivo
mammalian
metabolism,
chronic
effects
or
concentrations
of
methylal
to
which
humans
were
exposed.
Published
acute,
subchronic,
mutagenic
effects,
environmental
releases,
and
environmental
fate
data
were
located
as
well
as
some
metabolism
data.
4.
Ethyl
silicate
i.
Recommendation.
Ethyl
silicate
is
being
recommended
to
obtain
production/
importation
volume
data
and
trends,
use,
exposure
and
health
effects,
especially
in
vivo
mammalian
mutagenicity
and
subchronic
or
chronic
effects
data
needed
by
U.
S.
Government
organizations
represented
on
the
ITC.
ii.
Rationale
for
recommendation.
Ethyl
silicate
is
under
review
for
mutagenicity
and
subchronic
or
chronic
toxicity
testing
based
on
potential
human
exposures
and
suspicions
of
genotoxicity
or
carcinogenicity.
These
suspicions
are
based
on
in
vitro
mammalian
mutagenicity
data.
A
document
prepared
for
the
U.
S.
Government
organization
nominating
ethyl
silicate
to
the
ITC
is
available
on
the
ITC's
web
site
(
ethyl
silicate
42558
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
document)
and
in
the
TSCA
Docket
for
the
ITC's
42nd
Report
(
Ref.
4,
TRI,
1997a).
Before
designating
ethyl
silicate
for
priority
testing
consideration
by
the
EPA
Administrator,
the
ITC
wants
to
retrieve
and
review
the
most
current
data
on
exposures
and
health
effects.
Data
already
included
in
the
ethyl
silicate
document
should
not
be
submitted
to
the
ITC.
The
ITC
has
an
ongoing
dialogue
with
the
Silicones
Environmental
Health
and
Safety
Council
(
SEHSC)
related
to
previouslyrecommended
siloxanes
and
anticipates
that
SEHSC
will
establish
a
dialogue
with
the
ITC
to
discuss
data
needed
for
ethyl
silicate.
Data
needed
are
listed
below.
iii.
Data
needed
a.
Recent
non­
CBI
estimates
of
annual
production
or
importation
volume
data
and
trends.
1
b.
Use
information,
including
percentages
of
production
or
importation
that
are
associated
with
different
uses.
1
c.
Estimates
of
the
number
of
humans
and
concentrations
of
ethyl
silicate
to
which
humans
may
be
exposed
from
use,
manufacturing
or
processing.
1
d.
Health
effects,
especially
in
vivo
mammalian
mutagenicity
and
subchronic
or
chronic
effects.
2
iv.
Supporting
information.
In
the
ITC's
28th
Report
(
56
FR
41212,
August
19,
1991),
ethyl
silicate
and
36
other
alkoxysilanes
were
recommended
for
ecological
effects
testing.
In
its
32nd
Report
(
58
FR
38490,
July
16,
1993),
at
EPA's
request,
all
37
alkoxysilanes
were
removed
from
the
Priority
Testing
List,
before
TSCA
section
8(
a)
PAIR
or
section
8(
d)
HaSD
rules
were
promulgated
(
58
FR
38490,
July
16,
1993).
At
the
time
alkoxysilanes
were
removed
from
the
List,
the
EPA
indicated
that
other
chemicals
had
a
higher
priority
than
the
alkoxysilanes.
The
ITC
acknowledged
that
there
were
no
existing
U.
S.
Government
data
needs,
but
agreed
to
reconsider
any
of
these
chemicals
if
data
were
needed
in
the
future.
Data
reported
to
the
EPA
indicated
that
the
non­
CBI
annual
production/
importation
volume
for
ethyl
silicate
was
in
the
range
of
7
to
20
million
pounds
in
1989
and
1
to
100
million
pounds
in
1993.
Ethyl
silicate
is
reportedly
used
in
weatherproofing
and
hardening
stone;
in
the
manufacture
of
weatherproof
and
acid­
proof
mortars,
cements,
refractory
bricks,
other
molded
objects;
in
heatand
chemical­
resistant
paints,
protective
coatings
for
industrial
buildings
and
castings;
in
lacquers,
as
abonding
agent;
and
as
a
chemical
intermediate.
NOES
data
from
1981
 
1983
were
found
as
well
as
threshold
limit
values
for
human
exposures,
and
data
on
concentrations
of
ethyl
silicate
to
which
humans
may
be
exposed.
According
to
the
NOES,
10,422
workers,
including
2,566
female
employees,
were
potentially
exposed
to
ethyl
silicate.
No
published
available
data
were
found
on:
1.
Environmental
releases.
2.
Ecological
effects.
3.
Chronic
health
effects.
4.
Mutagenicity
from
in
vivo
mammalian
test
systems.
Published
data
included
those
related
to:
1.
Acute
and
subchronic
effects.
2.
Metabolism.
3.
Mutagenicity
from
in
vitro
mammalian
test
systems.

V.
References
All
references
are
available
in
the
TSCA
Docket
for
the
ITC's
42nd
Report.
The
TSCA
Docket
is
located
in
the
TSCA
Nonconfidential
Information
Center,
Rm.
NE
 
B607,
401
M
St.,
SW.,
Washington,
DC.
1.
Grunow,
W.,
H.
J
Altman,
and
C.
Boehme.
Uber
den
Staffwechsel
von
3­
Amino­
1,2,4­
triazol
in
Ratten
[
On
the
Metabolism
of
3­
Amino­
1,2,4­
triazole
in
Rats].
Archives
of
Toxicology.
34(
4):
315
 
324.
1975.
2.
Schafer,
Jr.,
E.
W.,
R.
B.
Brunton,
E.
C.
Schafer,
and
G.
Chavez.
Effects
of
77
Chemicals
on
Reproduction
in
Male
and
Female
Coturnix
Quail.
Ecotoxicology
and
Environmental
Safety.
6:
149
 
156.
1982.
3.
Takaoka,
M.,
M.
Teranishi,
and
S.
Manabe.
Structure­
Activity
Relationships
in
5­
Substituted
3­
Amino­
1,2,4­
Triazoles­
Induced
Goiters
in
Rats.
Journal
of
Toxicology
and
Pathology.
7:
429
 
434.
1994.
4.
TRI.
1997a.
Ethyl
Silicate
 
summary
of
data
for
chemical
selection
by
the
National
Cancer
Institute
(
NCI)
Chemical
Selection
Working
Group.
Prepared
by
Technical
Resources
International,
Inc.
under
NCI
Contract
No.
NO2
 
CB
 
50511
(
1/
96;
rev.
9/
96,
rev.
8/
97).
5.
TRI.
1997b.
Glycoluril
 
summary
of
data
for
chemical
selection
by
the
National
Cancer
Institute
(
NCI)
Chemical
Selection
Working
Group.
Prepared
by
Technical
Resources
International,
Inc.
under
NCI
Contract
No.
NO2
 
CB
 
50511
(
6/
97;
rev.
9/
97).
6.
TRI.
1997c.
Methylal
 
summary
of
data
for
chemical
selection
by
the
National
Cancer
Institute
(
NCI)
Chemical
Selection
Working
Group.
Prepared
by
Technical
Resources
International,
Inc.
under
NCI
Contract
No.
NO2
 
CB
 
50511
(
7/
96;
rev.
8/
97).
VI.
TSCA
Interagency
Testing
Committee
Statutory
Organizations
and
Their
Representatives
Council
on
Environmental
Quality
Brad
Campbell,
Member
Juliet
Healey,
Alternate
Department
of
Commerce
National
Institute
of
Standards
and
Technology
Malcolm
W.
Chase,
Member
Barbara
C.
Levin,
Alternate
National
Oceanographic
and
Atmospheric
Administration
Nancy
Foster,
Member
Teri
Rowles,
Alternate
Richard
S.
Artz,
Alternate
Environmental
Protection
Agency
Paul
Campanella,
Member
David
R.
Williams,
Alternate
National
Cancer
Institute
Victor
Fung,
Member,
Chair
Harry
Seifried,
Alternate
National
Institute
of
Environmental
Health
Sciences
William
Eastin,
Member,
Vice
Chair
H.
B.
Matthews,
Alternate
National
Institute
for
Occupational
Safety
and
Health
Albert
E.
Munson,
Member
Christine
Sofge,
Alternate
National
Science
Foundation
A.
Frederick
Thompson,
Member
Joseph
Reed,
Alternate
Occupational
Safety
and
Health
Administration
Lyn
Penniman,
Member
Val
H.
Schaeffer,
Alternate
Liaison
Organizations
and
Their
Representatives
Agency
for
Toxic
Substances
and
Disease
Registry
William
Cibulas,
Member
Consumer
Product
Safety
Commission
Jacqueline
Ferrante,
Member
Department
of
Agriculture
Clifford
P.
Rice,
Member
Department
of
Defense
Colonel
Richard
Drawbaugh,
Member
Captain
Kenneth
Still,
Alternate
Department
of
the
Interior
Barnett
A.
Rattner,
Member
Food
and
Drug
Administration
Edwin
J.
Matthews,
Member
Raju
Kammula,
Alternate
National
Library
of
Medicine
Vera
Hudson,
Member
National
Toxicology
Program
NIEHS,
FDA,
and
NIOSH
Members
Counsel
Scott
Sherlock,
OPPT,
EPA
Technical
Support
Contractor
42559
Federal
Register
/
Vol.
63,
No.
152
/
Friday,
August
7,
1998
/
Notices
Syracuse
Research
Corporation
ITC
Staff
John
D.
Walker,
Executive
Director
Norma
S.
L.
Williams,
Executive
Assistant
TSCA
Interagency
Testing
Committee,
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics
(
MC/
7401),
401
M
St.,
SW.,
Washington,
DC
20460,
telephone:
202
 
260
 
1825,
fax:
202
 
260
 
7895,
e­
mail:
walker.
johnd@
epa.
gov,
url:
http://
www.
epa.
gov/
opptintr/
itc.

[
FR
Doc.
98
 
21206
Filed
8
 
6
 
98;
8:
45
am]

BILLING
CODE
6560
 
50
 
F