Document NpqV77Gy56dL6r91j1rxee5y
Katherine E Reed, Ph.D. Staff Vice President
3M Environmental Technology and Safety Services
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December 4, 2002
Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) Office of Pollution Prevention and Toxics
US EPA 1200 Pennsylvania Ave., NW Washington, DC 20460-0001
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TSCA 8(E) SUBSTANTIAL RISK SUPPLEMENTAL NOTICE ON: Perfluorooctane sulfonate (PFOS), perfluorohexanesulfonate (PFHS), N-methyl-N-acetylperfluorooctanesulfonamide (M570) Reference 8EHQ -1180-373, 374
Dear Sir:
3M has received the draft report for a repeated dermal contact absorption/toxicology study in rats conducted with four mill-applied and aftermarket carpet/fabric/upholstery protector products that 3M ceased manufacturing as part of its perfluorooctanyl chemistries phase-out. The attachment hereto provides the composition for each of these products. The results indicate that repeated daily dermal contact over a 28-day period with these formulations, in the liquid state or after application and drying on gauze, resulted in increases above background controls in the concentration of perfluorooctanesulfonate (PFOS) in liver and serum (all but one product), and of perfluorohexanesulfonate (PFHS) and N-methyl-N-acetyl-perfluorooctanesulfonamide (M570) in serum (not measured in liver) for certain products. M570 is an intermediary metabolite of a manufacturing residual (N-methyl-perfluorooctanesulfonamido ethanol (N-MeFOSE)) present in certain products, which can be further metabolized to PFOS No toxicity attributable to any sample was evident in this study, either on the skin, or
systemically.
The study was conducted by the Fraunhofer Institute of Toxicology, Hannover, Germany. Cotton gauze patches (~1 square inch) to which the liquid test material had previously been applied and allowed to dry, or liquid samples (0.1 ml) applied to gauze without drying, were applied to the shaved dorsal skin of male and female rats in a semi-occluded fashion for six hours each day for up to 28 days. The preparation of the samples dried on cotton gauze involved saturating the gauze with liquid product, wringing the saturated gauze through a roller press at 100 pounds pressure and allowing the wrung gauze to air dry at room temperature. As such, the application of product to gauze did not precisely
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mimic normal application on carpet, fabrics and upholstery btifwas expected to represent the higher end of,norfnal product application. The liquid samples were adjusted to provide approximately the same amount of product solids'as prbsent in the dried samples applied to fresh g&uzeina volume of 0.1. Fresh treated patches were applied each day. Pairs of rats, 2/sex, were sacrificed on days 4, 14, 28 and 42 for pathology and determination of PFOS level in liver ahcFPFOS, PFHS, and M57D levels in serum (selected time points). Rats sacrificed on day 42 were treated for the first 28'days ; followed by a 14-day period without treatment.
Repeated dermal contact under semi-occlusive conditions with all but one of the test samples resulted.^ consistently quantifiable serum and liver conqentrations;of PFOS that exceeded levels jo control-rats exposed to gauze patches.moistened only with saline. >The exception was a,mill-applied, carpet protector. With that product, only,onpmale exposed to the liquid product for 28 days, and one female exposed to previously treated and driqd gauze patches for 28 days showed.liver PFOS levels at close to the level of quantitation (LOQ) of 10 ppb. jAll other samples were'below the LOQ. M570 was detected at consistently quantifiable levels in serum from exposure tq ojily one of the product samples. This sample also yielded trace levels (about 1 ppb) of PFHS in serum of rats, exposed daily for 28days. PtFHS was.also detected at higher levels (up to about 1 ppm) in the serum of ^niyhals exposed to the product that also yielded the highest liver (up to 710 ppm) and serum (up to 1 ppm) levels of PFOS.
3M will submit the final report to EPA when available., Et'ecause o f differences in the nature of the treated fabric (cotton gauze v. carpet or upholstery) and conditions of dermal contact, these data can not be used quantitatively to determine human exposures to PFOS, PFHS and N-MeFOSE from contact with treated materials. These data do, however, indicate that dermal absorption of PFOS, PFHS nd N-MeFOSE from contact with these materials is possible. As indicated above, 3M discontinued the manufacture of these products for commercial sale as part of 3M's phase out of its perfluorooctanyl chemistries.
Please contact Dr. John L. Butenhoff (651-733-1962) if you have any questions or if we can provide additional information.
Sincerely,
Katherine E. Reed Staff Vice President, Environmental Technology and Safety Services
Enclosure
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Composition of Tssted Products, Dermal Contact
Abeonrtion/Toidcploflv Study (PFOS, PFHS, M570> -
T-7068.2(Kquki), Component Name T-73$8(dHed)
WATER IS0 6 UTAWE J i ^ 8lltf0 XYPROPOXY)-2PROPANOL
1*METHOXY-2*PROPANOL E1WYLA8GQNOL
CAS#
7732-18*5 75-28-5
29911-28-2
...i...
64-17-5
&,>. Deosmber 4,2002 v.
_______
tMut!hi %w
85.33 7,0 252
tax IM S %w *MPRaew 85.33
7.0 2.52
_ . . .. -......... -. . YE 0.86 0.88 0.837 0.837
if e iM S iJ
SCX)IUMNITRITf
! .7632*^10-0
MORPHOLINE
110-91-8
AMMONIUMHYDROXIDE
1388-21-6
METHYLALCOHOL
S7-56-1
2-IMIDAZOLINE*1-ETHANOL, 2- IWTRTfc
UNDfiCYL-
2-methoxy-t -propanol
1589-47-5
SOLVENT NAPHTHA
64742*89-8
(PETROLEUM). UGHT !>
ALIPHATIC
HEPTANE tr
142*88-5
ETHYLACETATE
141-78-8
Fluorochemicai Alcohol
24448-09-7
RESIDUALORGANIC
FLUOROCHEMICALS
METHYL ISOBUTYL KETONE
108-10-1
0.18 0.186 0.0384 0.0326 0.015
0.014 0.0088
0.0 0.0 0.0 0.0
0.0
'1
0.188] 0.186 0.0384 0.0326 0.015
0.014 0.0086
0.0093 0.0837 0.0375 0.625
0.0093
eST copy AVAtLA8i 3
T-T940(NC|uld), T-7341(drtod)
WATER
UMMI
$*m ! m
HV8 T i*fc
A!TftOer'Wal
7732-1*51 74.0 74.0
!ai|(aigp^j:iei(BjiafeiMiiiB:aasig^i;awmMifaMfeigfe:S 35601-65-7
m xM Q W W fc
N-M^THVL, PERFLUOftOOCTANESULFONA
3-'15>0t.6-32-8
WIDE
UNEAR N^ETHYL
! 4151-50-2
FeriCuorooctanesul.fona I
Mice .';.... . ............. i "'
Fluorochemlcai.Alcohol
24448-09-7
MEmVL ISOS/lTJUfcTONE i 108-10-1 RESIDUAL ORGANICFLUOROCHEMfCXtS
.siKiaijaiwYIR* ... 0.05 0.05 0.0 0.03
0.0 002
0.0 0.2 Q.O 1,0 b.o - L M
T - 7 0 ^ ^ q y i) , i^QPRDRYL A U ^ H ^ T "
pr o pa KM" 7 T ; : . ^H VrtSO Q DTYL KETONE Dt-N-OCTYL ADIPATE
67-63-0
106-97-8
74-08-6 106-10-1
123-79-5
57.25
35.31
5.05 146
57.25
35.31
5.05 1.46
.
0.5
.
S frS r C o p y
A V A ll~ A B i
H
T-73420ktuk!), T-7343(dded)
Comportent Name
CAS#
Mln Max Trade
Secret
WATER
7732-18-5 79.0 79.0
BORIC ACID
- V* 10043-35-3 0.62 0.62
TRISODIUM N-
138-89-9 0.5
0.5
(HYDROXYETHYL)ETHYLENEDI
AMINETRIACETATE
SODIUM MONO-C10-16-ALKYL 68585-47-7 0.32 0.32
SULFATES
RESIDUAL ORGANIC FLUOROCHEMICALS
0.2 0.2
FRAGRANCE
[ 0.07 0.07
OISODIUM
62099-15-4 0.026 0.026
HYDROXYETHYLETHYLENEDIA
MINE DIACETATE
SODIUM GLYCOLATE Alcohols, C10-16
2836-32-0 0.026 0.026L . 67762-41-8 0.014 0.014!
TRISODIUM
5064-31-3 0.013 0.013
NITRILOTRIACETATE
SODIUM HYDROXIDE SODIUM SULFATE
1310-73-2 0.013 0.013 . 7757-82-6 0.011 0.011
SODIUM CHLORIDE
7647-14-5 0.0055 0.0055
2-BUTOXYETHANOL
l~"~ 111-76-2 11.64 13.55
ISOPROPYL ALCOHOL
67-63-0^ 1.71 2.62
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