Document NGX4znd9Z25aVB4w4BxaKEQ1w
AR226 - 0TH yrmse
Contain NO CBI
EH _12R 00_ 3773
December 4, 2000
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Document Processing Center (7407)
(Attn: Section 8(e) Coordinator)
Office of Toxic Substances
US EPA 401 M Street, SW. Washington, DC 20460
CERTIFIED MAIL
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"TSCA 8(E) SUBSTANTIAL RISK SUPPLEMENTAL NOTICE ON: perfluorooctylsulfonamido ethanol, see Docket SEHQ1288-0373
N-Ethyl
Dear 8() Coordinator:
3M has received a draft statistical report from Covance Laboratory on a 2-year rat feeding
study of N-EtFOSE {N-Ethyl Perfluorooctanesulfonamido Ethanol (CAS 1691-99-2)}. The e of results submitted in 1988 to EPA in docket S8EHQ
results ofthis study are 1288-0373. This study
corroborativ was conducted
using
'N-EtFOSE
at
a
purity of approximately
98%,
in
contrast to the earlier study which was believed to be 84-88%.
Ggrroouuppssooffrmaatsle-
and
two
fceomnatlroelragtrsourpesc,eiaveldowthdeocsoemopfo|unpdpmin
itnhediiretf,eead.lowThienrteerwmeedrieatseevdeonse
of3
ppm
High first
in diet, a high
dose recovery
intermediate
group. The
dose
high
doofs3e0repcpomveirnydaienti,maalhsirgehcdeoisveedotfhe10c0opmppomuinnddifeotr
and
the
yearof the study at 100 ppm in diet and no compound during the second yearofthe
a
study.
S<thaotiwsetidcaal satnaatlisytsiecsaollfytshiegnitfuimcaonrt diantcarefarsoeminthbiesnsitgundlyivreervetaulmoerdst.hatThtheelhiivegrh tduomsoerfdeamtaaleargeroup
presented below.
Hepatocellular Adenoma Carcinoma
Control 1
ss 0/55
MALES
Control 2 lpm 3ppm
S60 460 4/50 0/60 0/60 0/0
30ppm
2s0 0/50
100ppm
5/60 0/60
Ferpa-0 20--T37CS
iii EPA-OTS
soos13s1
100 ppmrec
0/40 0/40
os
g 3 ox
EE = oR
= 58
8= 5c
US EPA OfficeofToxic Substances December 4, 2000 Page 2
FEMALES
Control 1 Control 2 1ppm 3ppm 30pm 100ppm 100 ppm rec
Hepatocellular Adenoma
oss
260 160 1/0 3/50 660% 3/40
Carcinoma ~~ 0/55. 00 0/60 0/50 0/50 1/60 0/40
* significant p< 0.05, paired and trend, based on Control 1
Control 2 and discontinued.
the 1 This
ppm dose group were was done two months
added after a 300 ppm into the study, when it
dose group was became apparent
that
the
300 ppm dose group would not tolerate this level as a lifetime dose.
Tdohseel(iv1e0r0isptphme)tamragleetsoarngdanfoemfatloexsi.ciTtyheforliNve-rEtXoFxiOcSiEty.waLsivmearntiofxeisctietyd whiasstoplroegsiceanltlyinatshe high hJeivpeartocchealnlguelsarwvearceuonloattimoanniafnedstheedpaitnotcheellhuilgahr dcoensteri(l1o0b0ulparpmhy)perretcroovpehryy.anTihmeasles hiinsdtioclaotgiincg that the liver toxicity was a reversible effect.
The compound is not genotoxic, having been negative in multiple in vitro and in vivo genotoxicity assays.
The final report will be submitted to EPA upon receipt Please contact me, 651-733-5181, for further information.
Regards,
IZA r= SLtaarfrfyViRceZoPbreels,idMenDt &MPMeHdical Director
2