Document ykB2Jz2ereM7YeR7qp19QkqZr
AR226-0984
has actually been processed
as
8EHQ-0501-0373
but is included here in
FYI-0101-1378
as well as it was received as an attachment to this FYI.
geyg. 050.0373 (MR 4745S
LD Bi SmaiVtRyiiaez lPBoeie vn n IMMedicaloeDepartment
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TSCA 8(E) SUBSTANTIAL RISK SUPPLEMENTAL "NOTICE ON: N-Ethyl `perflucrooctylsulfonamido ethanol,seeDocket 8EHQ 1288-0373
Dear 8() Coordinator:
.
.
3Mhas received adraftstatisticalreportfrom CovanceLaboratoryon a 2-ryate feeadir ng
study ofN-EtFOSE {N-Ethyl Perfluorooctanesulfonamido Ethanol (CAS 1691-99-2)}. The
resultsofthis study are
1288-0373. This study
corroborativeofresults submitted in
was conducted using N-EtFOSE at a
1988 to EPAin docket 8EHQ
purity of approximately 98%,
in
contrast to theearlierstudy whichwas believed to be84-88%.
study. . Groupsofmaleandfemaleratsreceivedthecompoundin theirfeed.`Therewereseven
groups ofrat
ppmindiet,
s - twocontrol groups, a lowdoseof 1 pp in dm iet,alow
ahigh intermediate doseof 30 ppmindiet, ahighdose of
intermediatedo
100 ppmin diet
seof
and a
3
high dose recovery group. The high dose recovery animals received the compoundforthe
firstyear of the studyat 100ppm indietand no compoundduringthe second yearof the
Statistical analyses ofthe tumordatafromthisstudy revealed thatthehighdose female group
showed a statistically significant increasein benign liver tumors. The liver tumor data are
presented below.
`Hepatocellular
Adenoma
MALES
Control 1 Control 2 lppm 3ppm 30ppm
2s5
5/60
4/60 4/50 2/50
100ppm
5/60
100 ppm rec
0/40
Carcinoma
0/55 0/60
0/60 0/50 0/50
0/60
0/40
y
Contain NO CR!
A278
'US EPA OfficeofToxic Substances
December 4, 2000
Page2
`Hepatocellular
`Adenoma
Control 1
0/55
FEMALES
Control2 Ippm 3ppm
30ppm
100ppm
100 ppm rec
260 1/60 1/50 3/50
6/60*
3/40%
Carcinoma
0/55
0/60 0/60 0/50 0/50
1/60
0/40
*significantp< 0.05,paired andtrend,based onControl 1
Control 2and the 1ppmdosegroupwereadded after a 300 ppm dosegroupwas discontinued. Thiswas donetwomonthsintothestudy,when itbecameapparentthatthe 300 ppmdose group would nottoleratethis level asalifetime dose.
`The liver is the target organoftoxicityforN-EtFOSE. Livertoxicitywas preset in the high dose (100 ppm) males and females. The liver toxicitywas manifested histologically `hepatocellular vacuolation and hepatocellular centrilobular hypertrophy. These histologic
liverchangeswerenot manifestedinthehighdose (100 ppm)recoveryanimalsindicatingthat
the liver toxicity was a reversible effect.
`Thecomp is mootgu enon toxd ic, havingbeennegativein multipleinvitroandinvivo `genotoxicity assays.
Thefinal reportwillbe submittedtoEPAupon receipt.
Please contact me, 651-733-5181, for further information.
Regards,
IHZAY #2 LarryR Zobel, MD MPH
StaffVice President & Medical Director
274