Document ID: EPA-HQ-OPPT-2006-0499-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-18T04:00Z

ATTACHMENT
1
TSCA
Health
&
Safety
Study
Cover
Sheet
and
Instructions
Approved
Under
OMB
Control
#
2070­
0156
Expiration
Date:
xx/
xx/
xxxx
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
Use
of
this
form
is
voluntary,
but
recommended
by
EPA
as
a
cover
sheet
for
TSCA
section
4,
8(
d),
and
8(
e)
submssions
to
expedite
and
improve
the
management,
processing,
quality,
review,
and
public
availability
of
data
in
TSCATS
TSCA
CBI
STATUS:

9
CHECK
IF
THIS
PAGE
CONTAINS
CONFIDENTIAL
BUSINESS
INFORMATION
(
CBI)
Clearly
mark
the
confidential
information
with
bracketing
and
check
the
box
in
the
appropriate
section
(
9
Contains
CBI).
Submit
a
sanitized
cover
sheet
with
CBI
deleted.
Mark
the
sanitized
copy,
"
Public
Display
Copy"
in
the
heading.

1.0
SUBMISSION
TYPE
9
Contains
CBI
9
8(
d)
9
8(
e)
9
FYI
9
4
9
OTHER:
Specify____________________

9
Initial
Submission
9
Follow­
up
Submission
9
Final
Report
Submission
Previous
EPA
Submission
Number
or
Title
if
update
or
follow­
up:
Docket
Number,
if
any:
#
ITC
Submission
9
Yes
9
No
9
continuation
sheet
attached
2.1
SUMMARY/
ABSTRACT
ATTACHED
(
may
be
required
for
8(
e):
optional
for
'
4,
8(
d)
&
FYI)
9
YES
9
NO
2.2
SUBMITTER
TRACKING
NUMBER
OR
INTERNAL
ID
2.3
FOR
EPA
USE
ONLY
2.4
Study
___
of
____

3.0
CHEMICAL/
TEST
SUBSTANCE
IDENTITY
9
Contains
CBI
Reported
Chemical
Name
(
specify
nomenclature
if
other
than
CAS
name):
CAS#__________­_____­___
Purity
_______%

9
Single
Ingredient
9
Commercial/
Tech
Grade
9
Mixture
Trade
Name:
________________________
Common
Name:
__________________________
CAS
Number
NAME
%
WEIGHT
Other
chemical(
s)
present
in
tested
mixture
9
continuation
sheet
attached
4.0
REPORT/
STUDY
TITLE
9
Contains
CBI
9
continuation
sheet
attached
5.1
STUDY/
TSCATS
INDEXING
TERMS
[
CHECK
ONE]
HEALTH
EFFECTS
(
HE):
ENVIRONMENTAL
EFFECTS
(
EE):
ENVIRONMENTAL
FATE
(
EF):_____
5.2
STUDY/
TSCATS
INDEXING
TERMS
(
see
instructions
for
4
digit
codes)
STUDY
SUBJECT
ROUTE
OF
VEHICLE
OF
TYPE:
___________
ORGANISM
(
HE,
EE
only):
EXPOSURE
(
HE
only):
EXPOSURE
(
HE
only)_____
Other:____________
Other:_________________________
Other:
____________________
Other:__________________
6.0
REPORT/
STUDY
INFORMATION
9
Contains
CBI
9
Study
is
GLP
Laboratory
Report/
Study
Date_______
Source
of
Data/
Study
Sponsor
(
if
different
than
submitter)
Number
of
pages
_________

9
continuation
sheet
attached
7.0
SUBMITTER
INFORMATION
9
Contains
CBI
Submitter:
_____________________________________
Title:
________________________
Phone:
(
)______________
Company
Name:
_________________________________
Company
Address:_____________________________________
_____________________________________________
________________________________________
_______________________________________________
Submitter
Address
(
if
different):
_____________________________________
Technical
Contact:
________________
______________
Phone:
(
)______________

9
continuation
sheet
attached
e­
mail
address__________________________________________________________
8.0
ADDITIONAL
COMMENTS
9
Contains
CBI
9
continuation
sheet
attached
Submitter
Signature:
Date:
EPA
Form
No.
7710­
58
(
Revised
6/
25/
96)
Page____
of____
Approved
Under
OMB
Control
#
2070­
0156
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
9.0
CONTINUATION
SHEET
TSCA
CBI
STATUS:

9
CHECK
IF
THIS
PAGE
CONTAINS
CONFIDENTIAL
BUSINESS
INFORMATION
(
CBI)
Clearly
mark
the
confidential
information
with
bracketing
and
check
the
box
in
the
appropriate
section
(
9
Contains
CBI).
Submit
a
sanitized
cover
sheet
with
CBI
deleted.
Mark
the
sanitized
copy,
"
Public
Display
Copy"
in
the
heading.

Submitter
Tracking
Number/
Internal
ID
CONTINUED
FROM
COVER
SHEET
SECTION
#
_______________

9
Contains
CBI
EPA
Form
No.
7710­
58
(
Revised
6/
25/
96)
Page____
of____
Approved
under
OMB
Control
#
2070­
0156
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
­
INSTRUCTIONS
(
Note:
Do
not
mail
these
instructions
with
your
submission)

Paperwork
Reduction
Act
Notice
The
annual
public
burden
for
this
collection
of
information
is
estimated
to
average
30
minutes
per
response,
including
the
time
needed
for
reading
the
instructions
and
completing
the
necessary
information
contained
in
this
form.
Send
comments
regarding
the
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division,
Environmental
Protection
Agency
(
2822T),
1200
Pennsylvania
Avenue,
N.
W.,
Washington,
D.
C.
20460.
Include
OMB
number
2070­
0156
in
any
correspondence.
Do
not
send
the
completed
form
to
this
address.
The
actual
information
or
form
should
be
submitted
in
accordance
with
the
instructions
specified
in
the
corresponding
regulations
General
Instructions
$
This
voluntary
cover
sheet
was
designed
to
serve
as
a
tool
for
industry
and
EPA
in
the
preparation,
processing,
review,
and
availability
of
TSCA
information,
and
as
an
alternative
for
cover
letters
to
TSCA
submissions.

$
As
with
all
EPA
submissions,
follow
applicable
EPA
regulations
and
guidance
in
submitting
the
information.

$
A
check
box
at
the
top
has
been
provided
to
indicate
if
there
is
confidential
business
information
(
CBI).
Check
this
box
if
the
page
contains
information
that
is
confidential.
For
information
what
can
be
claimed
confidential
under
TSCA
refer
to
TSCA
section
14,
40
CFR
Part
2
Sub­
Part
B
and
other
applicable
EPA
and
TSCA
guidance.
If
the
page
contains
CBI,
clearly
mark
the
information
with
bracketing.
Check
the
box
"
Contains
CBI"
in
the
appropriate
section.
Submit
another
cover
sheet
with
the
CBI
deleted
and
mark
"
Public
Display
Copy"
in
the
heading.

$
Under
TSCA
reporting
requirements,
a
submission
may
contain
multiple
studies.
A
cover
sheet
should
be
completed
for
each
study
in
the
submission
and
go
to
box
2.4
and
add
Study
1
of
1
for
a
submission
having
a
single
study,
Study
1
of
x,
Study
2
of
x,
etc.
(
for
a
submission
having
multiple
or
x
number
of
studies).

$
A
cover
sheet
is
unnecessary
for
submissions
containing
no
health
and
safety
data.
Examples
of
submissions
with
no
health
and
safety
data
include:
section
4
related
correspondence
on
issues
of
different
test
protocols;
section
8(
e)
or
FYI
voluntary
actions
of
submitters
to
reduce
exposures;
information
on
chemical
use
or
commercial
status;
substantiation
for
submitting
FYI
vs
8(
e).
If
a
submission
is
related
to
a
previous
submission,
please
reference
the
EPA
assigned
Document
ID
for
PMN,
8(
e)
and
FYI
submissions
(
PMN,
8EHQ
and
FYI
numbers).
For
other
submissions,
please
reference
the
EPA
Document
Control
Number
(
DCN)
or
Study
title
with
submission
date.
The
EPA
will
provide
the
Document
ID
as
well
as
the
DCN
when
acknowledging
PMNs,
8(
e)
s
and
FYIs.

If
additional
space
is
needed
in
any
of
the
sections
of
the
Cover
Sheet,
please
check
the
"
continuation
sheet
attached"
box
in
the
appropriate
section
and
attach
a
Continuation
Sheet
(
a
standardized
continuation
sheet
has
been
provided;
it
is
titled
9.0
Continuation
Sheet).
INSTRUCTIONS
­
continued
page
2
$
It
is
important
to
indicate
if
a
study/
submission
is
initial,
follow­
up
or
final.
An
initial
submission
is
for
a
given
chemical/
case
identified
or
initiated
by
a
company.
A
follow­
up
or
a
supplement
is
a
submission
which
contains
information
specifically
requested
by
EPA
(
Follow­
up)
or
information
related
to
a
previous
submission
but
not
specifically
requested
by
EPA
(
Supplement).

$
Please
attach
to
the
cover
sheet
package
an
abstract
or
summary
for
each
study
prepared
by
or
for
the
submitter,
if
available,
and
check
the
box
"
YES"
under
section
2.1.
Otherwise
check
the
box
"
NO".
[
Note:
a
summary/
abstract
is
required
under
8(
e).]

$
Space
is
provided
in
section
8.0
for
the
submitter
to
provide
any
additional
study
interpretation,
comments,
etc
which
could
immediately
assist
in
EPA=
s
screening
and
review
of
the
study/
submission.
A
continuation
sheet
may
be
attached.

$
If
any
information
in
the
cover
sheet
is
unknown,
write
"
unknown."
If
it
is
not
applicable
write
"
N.
A."
Provide
written
explanation
if
appropriate.

Detailed
Instructions
For
Completing
Cover
Sheet
TSCA
CBI
(
Confidential
Business
Information)
Status
­
Check
this
box
if
the
page
contains
information
that
is
confidential.
For
information
what
can
be
claimed
confidential
under
TSCA
refer
to
TSCA
section
14,
40
CFR
Part
2
Sub­
Part
B
and
other
applicable
EPA
and
TSCA
guidance.
If
the
page
contains
CBI,
clearly
mark
the
information
with
bracketing.
Check
the
box
"
Contains
CBI"
in
the
appropriate
section.
Submit
another
cover
sheet
with
the
CBI
deleted
and
mark
"
Public
Display
Copy"
in
the
heading.

1.0
Submission
Type
­
Check
one
of
the
boxes
for
the
TSCA
section
that
the
submission
is
being
made
under­
8(
d),
8(
e),
FYI,
4
or
OTHER.
Check
the
appropriate
box
to
indicate
if
a
study/
submission
is
initial,
follow­
up
or
final.
An
initial
submission
is
for
a
given
chemical/
case
identified
or
initiated
by
a
company.
A
follow­
up
or
a
supplement
is
a
submission
which
contains
information
specifically
requested
by
EPA
(
Follow­
up)
or
information
related
to
a
previous
submission
but
not
specifically
requested
by
EPA
(
Supplement).

2.1
Summary/
Abstract
Attached
­
Please
attach
to
the
cover
sheet
package
an
abstract
or
summary
for
each
study
prepared
by
or
for
the
submitter,
if
available,
and
check
the
box
"
YES"
under
section
2.1.
Otherwise
check
the
box
"
NO".
[
Note:
a
summary/
abstract
may
be
required
under
8(
e).]

2.2
Submitter
Tracking
Number
or
Internal
ID
­
Enter
an
internal
company
id
number;
also,
write
this
ID
on
the
complete
submission
for
easy
linkage
to
and
retrieval
of
the
entire
study/
submission
for
EPA
processing,
review,
and
public
availability.

2.3
For
EPA
Use
Only
­
Please
leave
this
section
blank.
This
is
for
EPA
purposes
such
as
assignment
of
submission
tracking
numbers.

2.4
Study
of
­
INSTRUCTIONS
­
continued
page
3
3.0
Chemical/
Test
Substance
Identity
­
If
additional
space
is
required
for
any
chemical
identity
data
element,
check
the
continuation
box
and
attach
a
continuation
sheet
appropriately
identifying
the
relevant
specific
data
element
and
referencing
the
study/
submission.
Enter
the
CAS#
of
the
chemical
for
the
specific
study
of
the
cover
sheet.
Enter
the
chemical
name;
specify
nomenclature
if
other
than
CAS
name.
Enter
the
%
purity
if
impurities
are
present,
leave
blank
if
unknown.
Check
one
of
three
boxes
indicating
if
the
chemical
is
a
single
ingredient
(
e.
g.,
100%
NaCl),
technical
grade
product
(
e.
g.,
50%
NaOH
solution),
or
mixture
(
e.
g.,
perfume
formula
with
many
ingredients).
Enter
the
trade
names
and
common
names
for
the
material
if
applicable.
If
the
test
substance
contains
more
than
one
chemical,
list
the
components
by
CAS
number,
name,
and
%
weight
in
the
mixture.
Submitters
are
requested
to
provide
informative
generic
chemical
names
for
substances
whose
chemical
identity
has
been
claimed
TSCA
confidential
business
information.

4.0
Report/
Study
Title
­
Provide
the
title
of
the
entire
submission,
not
the
title
of
any
specific
study
subsection;
if
insufficient
space,
check
the
continuation
box
and
attach
a
continuation
sheet
with
the
complete
title.

5.1
Study/
TSCATS
Indexing
Terms
­
Check
either
Health
Effects,
Environmental
Effects,
or
Environmental
Fate
­
check
only
one.

5.2
Study/
TSCATS
Indexing
Terms
­
See
the
attached
Study
Indexing
Terms
Sheet.
Find
appropriate
(
checked)
Study
Type
and
select
relevant,
detailed
Study
Type
(
for
HE,
EE,
EF),
Subject
Organism
(
HE,
EE
only),
Route
of
Exposure
(
HE
only),
and
Vehicle
(
HE
only,
if
applicable);
transfer
the
4­
letter
TSCATS
code
to
the
cover
sheet.
If
an
appropriate
indexing
term
is
not
available,
check
other
box
and
clearly
print
description.

6.0
Report/
Study
Information
­
If
additional
space
is
required
for
any
study
information
data,
check
the
continuation
box
and
attach
a
continuation
sheet
identifying
the
relevant
specific
data
element
and
referencing
the
study/
submission.
Enter
the
complete
name
of
the
contractor
or
laboratory
which
conducted
the
study.
Include
the
source
of
data
or
study
sponsor,
if
different
than
the
submitter.
Enter
the
actual
completion
date
of
the
study/
submission
as
dd/
mm/
yy.
Check
GLP
box
if
existing
Good
Laboratory
Practices
were
used
in
the
conduct
of
the
study.

7.0
Submitter
Information
­
If
additional
space
is
required
for
any
submitter
information,
check
the
continuation
box
and
attach
a
continuation
sheet
identifying
this
data
element
and
referencing
the
study/
submission
(
e.
g.
submitter
tracking
number).
Enter
submitter
name,
title,
and
phone.
Enter
company
name
and
address.
Enter
the
address
of
the
submitter
if
the
submitters
address
is
different
than
the
company
address.
Please
provide
a
key
technical
contact
name
and
telephone
number
of
an
individual
who
can
discuss
the
content/
substance
of
the
study/
submission
during
the
EPA
scientific
review
process.

8.0
Additional
Comments
­
This
space
is
provided
for
the
submitter
to
provide
any
additional
study
interpretation,
comments,
etc.,
which
could
immediately
assist
in
EPA=
s
screening
and
review
of
the
study/
submission.
A
continuation
sheet
may
be
attached.
For
TSCA
section
8(
e)
and
FYI
submissions
state
rationale
for
submitting
information
as
8(
e)
versus
FYI
and
voluntary
actions
taken
by
the
submitter
in
response
to
the
new
information.

Submitter
Signature/
Date
­
TSCA
section
8(
e)
submissions
must
be
signed
by
the
submitter
and
dated.
All
submissions
should
be
submitted
by
certified
mail
with
return
receipt
to
demonstrate
submission
receipt
by
the
EPA.

9.0
Continuation
Sheet
­
If
additional
space
is
needed
in
any
of
the
sections
of
the
cover
sheet,
please
check
the
"
continuation
sheet
attached"
box
in
the
appropriate
section
and
attach
a
Continuation
Sheet,
Section
9.0.
INSTRUCTIONS
­
continued
page
4
STUDY
INDEXING
TERMS
FOR
HEALTH
EFFECT
(
HE)
STUDIES
ONLY
Study
Type
___
Acute
Toxicity
(
ATOX)
___
Subchronic
Toxicity
(
STOX)
___
Chronic
Toxicity
(
CTOX)
___
Carcinogenicity
(
CARC)
___
Combined
Chronic
Toxicity/
Carcinogenicity
(
CTCA)
___
Cell
Transformation
(
TRFM)
___
Biochemical
Interactions
and/
or
Mechanism
of
Toxic
Effects
(
BCHM)
___
Absorption,
Distribution,
Metabolism
Excretion
(
ADME)
___
Primary
Dermal
Sensitization
(
DSEN)
___
Primary
Dermal
irritation
(
DIRR)
___
Primary
Eye
irritation
(
EIRR)
___
Reproduction/
Fertility
Effects
(
RTOX)
Teratology
(
TERA)
___
Combined
Teratology/
Reproductive
Effects
(
TERE)
___
Epidemiology
Study
(
EPID)
___
Case
Report
(
CASE)
___
Genotoxicity
(
GTOX)
___
Gene
Mutation
(
MUTA)
___
Chromosomal
Effects
(
CHRM)
___
DNA
Effects
(
DNAF)
___
Tissue
Determination
Concentration
(
TCON)
___
Industrial
Hygiene
(
HYGN)
___
Neurotoxicity
(
NEUR)
___
Immunotoxicity
(
ITOX)
___
Target
Organ
Toxicity:
specify____
___
Other:
specify_________________
Subject
Organism/
Test
System
___
Mammals
(
MAMM)
___
Rats
(
RATS)
___
Mice
(
MICE)
___
Hamsters
(
HAMS)
___
Guinea
Pigs
(
GUIN)
___
Rabbits
(
RABB)
___
Dogs
(
DOGS)
___
Cats
(
CATS)
___
Monkeys
(
MNKY)
___
Pigs
(
PIGS)
___
Cattle
(
COWS)
___
Sheep
(
SHEP)
___
Goats
(
GOAT)
___
Humans
(
HUMN)
___
Other
Mammals
(
OTMA)
___
Bacteria
(
BACT)
___
Algae
(
ALGA)
___
Fungi
(
FUNG)
___
Yeast
(
YEST)
___
Plant
(
PLNT)
___
Insect
(
INSE)
___
Bird
(
BIRD)
Route
of
Exposure
___
Oral
(
ORAL)
___
Gavage
(
GAVG)
___
Dermal
(
DERM)
___
Inhalation
(
INHL)
___
Intratracheal
Instillation
(
INTR)
___
Parenteral
(
PARN)
___
Intravenous
(
INTV)
___
Intraperitoneal
(
INTP)
___
Intramuscular
(
INTM)
___
Subcutaneous
(
SUBC)
___
Implant
(
IMPL)
___
Transplacental
(
TRPL)
___
In
Vitro
(
INVR)

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Vehicle
of
Exposure
(
check
only
if
applicable)

___
Water
___
Corn
Oil
___
Food
___
Other:
specify________________

FOR
ENVIRONMENTAL
EFFECT
(
EE)
STUDIES
ONLY
FOR
ENVIRONMENTAL
FATE
(
EF)
STUDIES
ONLY
Study
Type
___
Acute
Toxicity
(
ATOX)
___
Subchronic
Toxicity
(
STOX)
___
Chronic
Toxicity
(
CTOX)
___
Critical
Life
Stage
Test
(
CLIF)
___
Seed
Germination
Test
(
SEED)
___
Plant
Growth
or
Damage
Test
(
PGRD)
___
Microbiological
Function
Test
(
MICR)
___
Ecosystem
Modeling
(
ECOS)
___
Reproduction/
Fertilization
Test
(
RTOX)
___
Absorption,
Distribution,
Metabolism
Excretion
(
ADME)
___
Tissue
Concentration
(
TCON)
___
Other
Environmental
Effects
(
OTEE)
specify
__________________________
Subject
Organism
___
Bacteria
(
BACT)
___
Algae
(
ALGA)
___
Fungi
(
FUNG)
___
Yeast
(
YEST)
___
Plant
(
PLNT)
___
Amphibians
(
AMPH)
___
Mollusks
(
MOLL)
___
Fish
­
Freshwater
(
FFRE)
___
Fish
­
Marine
(
FMAR)
___
Reptiles
(
REPT)
___
Bird
(
BIRD)
___
Insect
(
INSE)
___
Invertebrates
(
INVE)
___
Other
Wildlife
(
WILD)
specify
________________________
Study
Type
___
Physical
/
Chemical
Properties
(
PCHE)
___
Water
Solubility
(
WSOL)
___
Vapor
Pressure
(
VPRE)
___
Partition
Coefficient
(
PART)
___
Dissociation
Constant
(
DISS)
___
Henry's
Law
Constant
(
HLAW)
___
Transport
Processes
(
TSPT)
___
Biodegradation
(
BDEG)
___
Bioconcentration
/
Bioaccumulation
(
BIOC)
___
Photolysis
(
PHOT)
___
Hydrolysis
(
HYDR)
___
Monitoring
Information
(
MONT)
___
Production
and
Process
Info
(
PROD)
___
Other
Studies
(
OTHR)
specify
____________________________