Document ID: EPA-HQ-OPPT-2002-0051-0024
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-07T05:00Z

6
I
:
Larry
R.
Zobel,
MD,
MPH
Staff
Vice
President
3M
Medical
Department
3M
Center,
Building
220­
2E­
02
`.,
a*
PO
Box
33220
,
61
4~
ndMedica1
Director
@"
Oq00m3
r3
St.
Paul,
MN
55133­
3220
­
6.51
651
733
733
5181
5157
I
Fxsimile
Office
'

April
20,
2000
Attn:
Section
g(
e)
Coordinator
Document
Processing
Center
(7407)
Office
Of
Pollution
Prevention
And
Toxics
United
States
Environmental
Protection
Agency
401
M
Street,
S.
W.
Washington,
DC
20460
Re:
SUPPLEMENT
TO
TSCA
SECTION
S(
e)
NOTICE
ON:
N­
Ethyl
Perfluorooctyl
Sulfonamido
Ethanol
(N­
EtFOSE)
and
Perfluorooctane
Sulfonate
(PFOS)
Docket
Numbers:
SEHQ­
0998,373,374,394
Dear
Sir
or
Madam:

On
February
15,
2000,
3M
submitted
final
reports
for
two­
generation
rat
reproduction
studies
on
the
above
referenced
compounds.
3M
had
originally
submitted
a
TSCA
Section
S(
e)
notice
dated
September
14,
1998
based
on
preliminary
data
from
these
studies.

With
this
letter,
3M
is
supplementing
these
earlier
submissions
as
follows:

=D
3M
is
submitting
an
amended
final
report
for
the
two­
generation
rat
reproduction
study
on
PFOS
(Sponsor's
Study
number
T­
6295.9).
This
amended
final
report
supercedes
our
earlier
submission.
It
contains
several
clarifications,
including
that
there
were
no
toxicologically
important
effects
on
pup
survival
or
growth
at
the
0.4
.g/
kg/
day
dose
level.
The
amended
report
also
includes
all
data
tables
­
both
individual
and
summary.

3
3M
is
submitting
additional
studies
and
documents
which
relate
to
the
PFOS
two­
generation
rat
reproduction
study
(Sponsor's
Study
number
6295.9)
These
additional
studies
and
documents
are
listed
in
Attachment
A
to
this
letter.
P
Section
8(
e)
Coordinator
April
20,
2000
Page
2
Please
do
not
hesitate
to
contact
the
undersigned
at
(65
1)
733­
S
18
1
or
Dr.
John
Butenhoff,
3M
Toxicology,
at
(65
1)
733­
1962
for
further
information.

Sincerely.

L&
y
R.
Zobel,
MD
MPH
Staff!
Vice
President
&
Medical
Director
Enclosures
cc:
Dr.
Charles
Auer,
Director
Chemical
Control
Division
Attachment
A
Protocol
4
18­
008
Combined
oral
(gavage)
fertility,
developmental
and
perinataVpostnata1
reproduction
toxicity
study
of
PFOS
in
rats
(Sponsor's
study
number:
6295.9)
Table
E20,
l­
3.

Harb,
R.
V.,
Hartman,
H.
A.,
and
Cox,
R.
H.
(1994),
Prevention
of
fluvastatin
induced
toxicity,
mortality,
and
cardiac
myopathy
in
pregnant
rats
by
mevalonic
acid
supplementation.
Teratology,
50,
19­
26
Haughom,
B.
and
Spydevold,
0.
(1992),
The
mechanism
underlying
the
hyperlipemic
effect
of
perfluorooctanoic
acid
(PFOA),
perfluorooctane
sulphonic
acid
(PFOS)
and
clofibric
acid.
Biochimica
et
Biophysics
Acta,
1128,
65­
72.

Levin,
M.
S.,
Pitt,
A.
J.
A.,
Schwartz,
A.
L.,
Edwards,
P.
A.
and
Gordon,
J.
I.
(1989),
Developmental
changes
in
the
expression
of
genes
involved
in
cholesterol
biosynthesis
and
lipid
transport
in
human
and
rat
fetal
and
neonatal
livers.
Biochimica
et
Biophysics
Acta,
1003,
293­
300.

Final
Report
Protocol
418­
013
Oral
(Gavage)
Pharmacokinetic
Study
of
PFOS
in
Rats
(Sponsor's
study
number:
T­
6295.12)
June
24,
1999
Protocol
FACT­
TOX­
110
Oral
(Gavage)
Pharmacokinetic
Study
of
PFOS
in
Rats,
Protocol,
June
8,
1999
Final
Report
Protocol
4
18­
015
Oral
(Gavage)
Pharmacokinetic
Recovery
Study
of
PFOS
in
Rats
(Sponsor's
study
number:
T­
6295,14),
July
23,
1999
Protocol
FACT­
TOX­
111
Oral
(Gavage)
Pharmacokinetic
Recovery
Study
of
PFOS
in
Rats,
Protocol,
June
8,
1999
Summary
PFOS
Rat
Two­
Generation
Reproduction
Study
(Study
numbers:
3M
T­
6295.9,
Argus
418­
008
[in­
life],
FACT­
TOX­
012
[analytical])

Report
Amendment
I,
13
April
2000,
Protocol
418­
008
(Sponsor's
study
number:
6295.9)
Combined
Oral
(Gavage)
Fertility,
Developmental
and
Perinatal/
Postnatal
Reproduction
Toxicity
Study
of
PFOS
in
Rats,
Final
Report
Analytical
Laboratory
Report
on
the
Determination
of
the
Presence
and
Concentration
of
Potassium
Perfluorooctanesulfonate
(CAS
Number:
2759­
39­
3)
in
the
Serum
and
Liver
of
Sprague­
Dawley@
Rats
Exposed
to
PFOS
via
Gavage,
Laboratory
Report
No.
<U2006>,
Requestor
Project
No.
<3M
TOX
6295.93,
October
27,
1999
Interoffice
Memo
from
Tom
Kestner
to
Leo
Gehlhoff,
"Fluorochemical
Isomer
Distribution
by
"F­
NMR
Spectroscopy,
December
1,
1997
Final
Report
Protocol
4
1
S­
008
Combined
Oral
(Gavage)
Fertility,
Developmental
and
PerinataVPostnatal
Reproduction
Toxicity
Study
of
PFOS
in
Rats
(Sponsor's
study
number
6295.9,
June
10,
1999
Summary
PFOS
Rat
Cross­
Fostering
(Study
numbers:
3M
T­
6295.13,
Argus
4
18­
014)

Final
Report
Protocol
4
18­
O
14,
Oral
(Gavage)
Cross­
Fostering
Study
of
PFOS
in
Rats
(Sponsor's
study
number:
T­
6295.13),
July
23,
1999
Analytical
Laboratory
Report
on
the
Determination
of
the
Presence
and
Concentration
of
Perfluorooctanesulfonate
(PFOS)
(CAS
Number:
2759­
39­
3)
in
the
Serum
of
Sprague­
Dawley@
Rats
Exposed
to
Potassium
Perfluorooctanesulfonate
via
Gavage,
Laboratory
Report
No.
U2779,
Requestor
Project
No.
3M
Tox
6295.13,
June
10,
1999
­"...
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I_."
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.._