Document gDEwr0JdN77g2v4QyaYeZBjDQ

Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 1 of 68 Appendix E: Histopathological Findings Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 2 of 68 Table 1: Summary of histopathological findings (all animals) FRAUNHOFER ITA 01G0002 Summary of histopathological fi ndi ngs (all animals) Page: 1 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T ! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 ! ! !!7341 ! ! !T!7342 !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Ulcerative inflammation ! Epidermal erosion(s) ! Dermal inflammatory cell infiltration ! Subcutaneous inflammatory cell infi1trati on ! SKIN (UNTREATED SITE) ! No abnormality detected ! (Ulcerative) inflammation ! Epidermal hyperplasia ! Hyperkeratosis ! Dermal fibrosis ! HEART ! No abnormality detected ! Myocardial degeneration ! Myocardial mononuclear cell infiltration !11 !! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! 2! 1! 2! 1! 4! 2! 2! 3! 3! ! (25%) ! (13%)! (25%) ! (13%) ! (50%) ! (25%)! (25%) ! (38%) ! (38%)! ! 6! 7! 6! 7! 4! 6! 6! 5! 5! ! (75%) ! (88%)! (75%) ! (88%) ! (50%) ! (75%)! (75%) ! (63%) ! (63%)! ! 0! 1! 1! 1! 1! 1! 0! 0! 2! ! (0%) ! (13%)! (13%) ! (13%) ! (13%) ! (13%)! (0%) ! (0%) ! (25%)! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! ! 0! 3! 1! 2! 1! 1! 0! 0! 1! ! (0%) ! (38%)! (13%) ! (25%) ! (13%) ! (13%)! (0%) ! (0%) ! (13%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! ! (8) ! (8) ! (8) ! (8) ! ((( ! (8) ! ((( ! (O( ! (8) ! ! ! 8! 8! 7! 8! 8! 8! 7! 8! 8! !(100%) !(100%)! (88%) !(100%) !(100%) !(100%)! (88%) !(100%) !(100%)! ! 0! 0! 1! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! ((88(! (0%( ! (OO( ! (0%) ! (OO( ! (OO ! (0%) ! ! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! 7! 7! 6! 7! 7! 8! 6! 8! 6! ! (88%) ! (88%)! (75%) ! (88%) ! (88%) !(100%)! (75%) !(100%) ! (75%)! ! 1! 1! 1! 0! 1! 0! 1! 0! 0! ! (13%) ! (13%)! (13%) ! (0%) ! (13%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 1! 1! 2! 1! 1! 0! 2! 0! 2! ! (13%) ! (13%)! (888) ! (OOO( ! (OOO( ! (0%) ! (OOO( ! (OO ! (25%)! !!! !! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 3 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 2 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mai es ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Hepatocellular necrosis ! Granulation tissue ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Cortical scar(s) ! Tubular-cell degeneration ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! Interstitial mononuclear cell infiltration ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! !! !! ! (8) ! (8) ! (o ! (8) ! (O ! (O ! (8) ! (8) ! ((( ! ! !! ! 6! 7! 7! 7! 6! 8! 7! 6! 8! ! (75%) ! (88%) ! (88%) ! (88%)! (75%) !(100%) ! (88%) ! (75%) !(100%)! ! 0! 1! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 2! 0! 1! 0! 2! 0! 0! 2! 0! ! (25%) ! (88) ! ((m ! (0%) ! (((((! (M 0 ! (0%) ! (25%) ! (M 0 ! ! !! ! (8) ! (8) ! (o ! (8) ! (O ! (O ! (8) ! (8) ! (O ! ! !! ! 8! 8! 8! 8! 8! 8! 8! 8! 8! !(100%) !((00%( !(((H (!(100%)! (((H (!(((H (!(100%) !(100%) !(((m ! ! !! ! (8) ! (O ! (O ! (8) ! (O ! (O ! (8) ! (8) ! (o ! ! !! ! 6! 8! 4! 7! 4! 7! 6! 5! 6! ! (75%) !(100%) ! (50%) ! (88%)! (50%) ! (88%) ! (75%) ! (63%) ! (75%)! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 2! 0! 1! 1! 4! 0! 0! 1! 1! ! (25%) ! (0%) ! (13%) ! (13%)! (50%) ! (0%) ! (0%) ! (13%) ! (13%)! ! 0! 0! 1! 0! 1! 1! 2! 2! 1! ! (0%) ! (0%) ! (13%) ! (0%) ! (13%) ! (13%) ! (25%) ! (25%) ! (13%)! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (M 0 ! (M 0 ! (0%) ! (M 0 ! (M 0 ! (0%) ! (13%) ! (M 0 ! ! !! ! (8) ! (o ! (O ! (8) ! (O ! (O ! (8) ! (8) ! (O ! ! !! ! 7! 7! 5! 6! 7! 8! 8! 8! 7! ! (88%) ! (88%) ! (63%) ! (75%)! (88%) !(100%) !(100%) !(100%) ! (88%)! ! 1! 1! 3! 0! 1! 0! 0! 0! 0! ! (13%) ! (1( O ! (m ! ! (0%) ! (((((! (M 0 ! (0%) ! (0%) ! (M 0 ! ! !! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 4 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 3 21-Aug-00 ! LESIONS ! ADRENALS ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected ! INCIDENCE OF LESIONS (PERCENT) l ! Mal es ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 ! ! !!7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! !!!! !!!!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! Oo oo oo Oo Oo Oo ! 2! 0! ! (25%)! (0%) ! ! 1! ! (13%)! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! COoo COoo COoo COoo COoo COoo COoo COoo COoo ! CEREBRUM ! No abnormality detected ! THYMUS ! Haemorrhage ! (l) ! ! ! ! 1! ! ! !(100%)! !! !!!! !!!! !!!! !!!! !!!!! !! !!!!! !!!!! !! ! ! ! (l) ! (l) ! !! ! ! ! 1! 1! ! ! !(100%) !(100%)! !!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 5 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: H 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !! !! ! - !T!7090.2!7339 ! ! !T- !7340 ! ! !T!7341 !T- !7342 ! ! !T!7343 SKIN (TREATED SITE) No abnormality detected Epi dermal hypertrophy/hyperpl as ia Hyperkeratosis Epidermal erosion(s) Dermal inflammatory cell infiltration SKIN (UNTREATED SITE) No abnormality detected (Ulcerative) inflammation Epidermal erosion(s) Dermal inflammatory cell infiltration Subcutaneous inflammatory cell infiltration Epidermal hyperplasia Hyperkeratosis Haemorrhage HEART No abnormality detected Myocardial mononuclear cell infiltration ! 11 ! ! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! !! ! 0! 0! 2! 1! 1! 0! 0! 1! 2 ! (0%) ! (0%) ! (25%)! (13%) ! (13%) ! (0%) ! (0%) ! (13%) ! (25%) ! 8! 8! 6! 7! 7! 8! 8! 7! 6 !(100%) !(100%) ! (75%)! (88%) ! (88%) !(100%) !(100%) ! (88%) ! (75%) ! 2! 1! 2! 2! 1! 3! 1! 2! 1 ! (25%) ! (13%) ! (25%)! (25%) ! (13%) ! (38%) ! (13%) ! (25%) ! (13%) ! 0! 0! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! 2! 1! 1! 2! 1! 2! 0! 2! 0 ! (25%) ! (13%) ! (13%)! (25%) ! (13%) ! (25%) ! (0%) ! (25%) ! (0%) ! !! ! (8) ! (8) ! (8) ! (8) ! (%( ! (8) ! (O ! (8) ! (O ! !! ! 6! 8! 7! 6! 8! 6! 8! 7! 5 ! (75%) !(100%) ! (88%)! (75%) !(100%) ! (75%) !(100%) ! (88%) ! (63%) ! 1! 0! 1! 2! 0! 1! 0! 0! 3 ! (13%) ! (0%) ! (13%)! (25%) ! (0%) ! (13%) ! (0%) ! (0%) ! (38%) ! 1! 0! 0! 0! 0! 0! 0! 0! 0 ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 0! 0! 0! 0! 0! 0! 0 ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0! 1! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (13%) ! (0%) ! 2! 0! 1! 2! 0! 1! 0! 0! 3 ! (25%) ! (0%) ! (13%)! (25%) ! (0%) ! (13%) ! (0%) ! (0%) ! (38%) ! 0! 0! 0! 1! 0! 1! 0! 0! 3 ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (13%) ! (0%) ! (0%) ! (38%) ! 1! 0! 0! 0! 0! 0! 0! 0! 0 ! (13%) ! (88) ! (0%) ! (0%) ! (O ! (0%) ! (O ! (0%) ! (O ! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! !! ! 7! 8! 8! 7! 8! 8! 7! 8! 8 ! (88%) !(100%) !(100%)! (88%) !(100%) !(100%) ! (88%) !(100%) !(100%) ! 1! 0! 0! 1! 0! 0! 1! 0! 0 ! (13%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 6 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 5 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T- !7343 ! ! ! ! ! ! ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Cortical scar(s) ! Tubular-cell degeneration ! Tubular mineralisation ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! Interstitial mononuclear cell infiltration ! ADRENALS ! No abnormality detected ! Accessory cortical nodule (rest) !!!! ! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8( ! (8) ! (8( ! (8) ! !!!! ! ! 8 ! 8 ! 7 ! 8 ! 7 ! 8 ! 4* ! 7 ! 7 ! !(100%) !(100%) ! (88%) !(100%) ! (88%) !(100%) ! (50%) ! (88%) ! (88%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (13%)! ! 0! 0! 1! 0! 1! 0! 3! 1! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! ((88) ! (88( ! (38%) ! (888( ! (0%) ! !!!! ! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8( ! (8) ! (8( ! (8) ! !!!! ! ! 8! 8! 8! 8! 8! 8! 8! 8! 8! !(100%) !(100%) !(100%) !(100%) !(8888( !(1888( !(100%) !(8888( !(100%)! !!!! ! ! (8) ! (8) ! (8) ! (8) ! (8( ! (8( ! (8) ! (8( ! (8) ! !!!! ! ! 7! 8! 7! 6! 5! 7! 6! 8! 4! ! (88%) !(100%) ! (88%) ! (75%) ! (63%) ! (88%) ! (75%) !(100%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 2! 1! 0! 0! 1! ! (0%) ! (0%) ! (13%) ! (0%) ! (25%) ! (13%) ! (0%) ! (0%) ! (13%)! ! 0! 0! 0! 1! 1! 0! 0! 0! 3! ! (0%) ! (0%) ! (0%) ! (13%) ! (13%) ! (0%) ! (0%) ! (0%) ! (38%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (88( ! (88( ! (13%) ! (88( ! (13%)! !!!! ! ! (8) ! (8) ! (8) ! (8) ! (8( ! (8( ! (8) ! (8( ! (8) ! !!!! ! ! 8! 8! 8! 8! 8! 8! 8! 8! 7! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (88%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (88( ! (88( ! (0%) ! (88( ! (13%)! !!!! ! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 7 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 6 21-Aug-00 LESIONS OVARIES No abnormality detected Cyst(s) PITUITARY Cyst(s) THYMUS No abnormality detected UTERUS Di 1atati on ABDOMINAL CAVITY Fat necrosis INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! T7343 ! ! (8) !!!!!! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ((( COo o oo COo o oo COo o oo COo o oo COo o oo COoo o o COo o oo COo o oo 7 (88%) 1 ((3( ( ! ((( ! ! ! ! ! ! ! !! ! 1! ! ! ! ! ! ! ()888( ! ! ! ! ! ! ! !! ! !!!!!! ((( ! !! ! !!!!!! 1 ! !!!!!! (((M ( ! !! ! ! ! ! ! ! (l) ! ! !! ! ! ! ! ! ! 1! ! ! ! ! ! !(100%) ! ! !! ! ! (l) ! ! ! ! ! ! !! ! ! 1! ! ! ! ! ! !(100%) ! ! ! ! ! ! !!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 8 of 68 Table 2: aSlul manmimaraylso)f histopathological findings (with scores, FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 1 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Mal es LESIONS SKIN (TREATED SITE) ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 ! ! !T!7341 ! ! !T- !7342 ! ! !!7343 ! ! ii!!!!!!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) No abnormality detected Epi dermal hypertrophy/hyperplas ia very siight siight Score Expanded Totals Hyperkeratosis siight Score Expanded Totals Ulcerative inflammation siight Score Expanded Totals Epidermal erosion(s) siight Score Expanded Totals Dermal inflammatory cell infiltration very siight siight Score Expanded Totals Subcutaneous inflammatory cell infiltration moderate Score Expanded Totals ! 2! 1! 2! 1! 4! 2! 2! 3! 3 ! (25%)! (13%)! (25%)! (13%)! (50%)! (25%)! (25%)! (38%)! (38%) !!!!!!!!! ! 6! 6! 5! 4! 4! 5! 5! 5! 3 ! (75%)! (75%)! (63%)! (50%)! (50%)! (63%)! (63%)! (63%)! (38%) ! 0! 1! 1! 3! 0! 1! 1! 0! 2 ! (0%) ! (13%)! (13%)! (38%)! (0%) ! (13%)! (13%)! (0%) ! (25%) ! 6! 7! 6! 7! 4! 6! 6! 5! 5 ! (75%)! (88%)! (75%)! (88%)! (50%)! (75%)! (75%)! (63%)! (63%) !!!!!!!!! ! 0! 1! 1! 1! 1! 1! 0! 0! 2 ! (0%) ! (13%)! (13%)! (13%)! (13%)! (13%)! (0%) ! (0%) ! (25%) ! 0! 1! 1! 1! 1! 1! 0! 0! 2 ! (0%) ! (13%)! (13%)! (13%)! (13%)! (13%)! (0%) ! (0%) ! (25%) !!!!!!!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 1! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (%%( !!!!!!!!! ! 0! 0! 0! 0! 0! 1! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0! 1! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (6%) !!!!!!!!! ! 0! 2! 1! 0! 0! 0! 0! 0! 0 ! (0%) ! (25%)! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 1! 0! 2! 1! 1! 0! 0! 1 ! (0%) ! (13%)! (0%) ! (25%)! (13%)! (13%)! (0%) ! (0%) ! (13%) ! 0! 3! 1! 2! 1! 1! 0! 0! 1 ! (0%) ! (38%)! (13%)! (25%)! (13%)! (13%)! (0%) ! (0%) ! (33%( !!!!!!!!! ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 9 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores , all animals) Page: 2 21-Aug-00 LESIONS SKIN (UNTREATED SITE) No abnormality detected (Ulcerative) inflammation siight moderate Score Expanded Totals Epidermal hyperplasia moderate severe Score Expanded Totals Hyperkeratosis moderate Score Expanded Totals Dermal fibrosis moderate Score Expanded Totals HEART No abnormality detected Myocardial degeneration siight Score Expanded Totals ! TREATMENT ! ! ! ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! ------ ! ! ------ ! !saline!T- !T !T- !T- !T- ! - !T- !T- ! ! !7088-2 !7338 !7090.2!7339 !7340 !7341 !7342 !7343 ! !!!!!!! !! !!!!!!! !! !11 !!! ------ ! 11 ! (8) ! (8) ! (8) ! 888 ! (8) ! (8) ! 888 ! 888 ! (8) ! !! ! 8! 8! 7! 8! 8! 8! 7! 8! 8! !(100%) !(100%)! (888) !888888 !(100%) !(100%)! 88888 !888888 !(100%)! !!! !!! !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! ((38(! 888 ! (0%) ! (0%) ! 88888! 8888 ! (0%) ! !!! !!! !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! 88888! 8888 ! (0%) ! (0%) ! 88888! 8888 ! (0%) ! !!! !!! !! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! 88888! 8888 ! (0%) ! (0%) ! 8888 ! 8888 ! (0%) ! !!! !!! !! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! 88888! 8888 ! (0%) ! (0%) ! 8888 ! 8888 ! (0%) ! !! ! (8) ! (8) ! 888 ! 888 ! (8) ! (8) ! 888 ! 888 ! (8) ! !! ! 7! 7! 6! 7! 7! 8! 6! 8! 6! ! (88%) ! (88%)! 88888! 88888 ! (88%) !(100%)! 888%8!888888 ! (75%)! !!! !!! !! ! 1! 1! 1! 0! 1! 0! 1! 0! 0! ! (13%) ! (13%)! (13%) ! (0%) ! (13%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 1! 1! 1! 0! 1! 0! 1! 0! 0! ! (13%) ! (13%)! 88888! 8888 ! (13%) ! (0%) ! 88888! 8888 ! (0%) ! !!! !!! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 10 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 3 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! HEART ! Myocardial mononuclear cell infiltration ! very siight ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Hepatocellular necrosis ! moderate ! Score Expanded Totals ! Granulation tissue ! moderate ! Score Expanded Totals ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected !! !!!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! !! !! !!!! ! 0! 0! 1! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 1! 1! 0! 1! 0! 2! 0! 2! ! (13%) ! (13%) ! (13%) ! (0%) ! (13%) ! (0%) ! (25%) ! (0%) ! (25%)! ! 1! 1! 2! 1! 1! 0! 2! 0! 2! ! (13%) ! ((88) ! (25%) ! (888) ! (888) ! (8%) ! (25%) ! (0%) ! (25%)! ! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! !! ! 6! 7! 7! 7! 6! 8! 7! 6! 8! ! (75%) ! (88%) ! (88%) ! (88%) ! (75%) !(100%) ! (88%) ! (75%) !(100%)! ! 0! 1! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (888) ! (0%) ! (88) ! (88) ! (8%) ! (13%) ! (0%) ! (0%) ! !! !!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (88) ! (0%) ! (888) ! (88) ! (8%) ! (0%) ! (0%) ! (0%) ! !! !!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (88) ! (0%) ! (888) ! (88) ! (8%) ! (0%) ! (0%) ! (0%) ! !! !!!! ! 2! 0! 1! 0! 2! 0! 0! 2! 0! ! (25%) ! (0%) ! (13%) ! (0%) ! (25%) ! (0%) ! (0%) ! (25%) ! (0%) ! ! 2! 0! 1! 0! 2! 0! 0! 2! 0! ! (25%) ! (88) ! (13%) ! (88) ! (8!%) ! (8%) ! (0%) ! (25%) ! (0%) ! ! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! !! ! 8! 8! 8! 8! 8! 8! 8! 8! 8! !(100%) !(1888( !(100%) !(8888( !(8888( !(888%( !(100%) !(100%) !(100%)! !! !!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 11 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 4 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! KIDNEYS ! No abnormality detected ! Cortical scar(s) ! slight ! Score Expanded Totals ! Tubular-cell degeneration ! slight ! Score Expanded Totals ! Tubular basophilia ! very siight ! slight ! Score Expanded Totals ! ! Tubular dilatation with luminal hyaline substances ! slight ! Score Expanded Totals ! ! Interstitial mononuclear cell infiltration ! slight ! Score Expanded Totals ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! slight !!!!!!!11 ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! 888 ! ! ! 6! 8! 4! 7! 4! 7! 6! 5! 6! ! (75%) !(100%)! (50%)! (88%)! (50%)! (888) ! (75%) ! (63%)! 88888 ! !!!!!!!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (08) ! (0%) ! (0%) ! 8o 8 ! !!!!!!!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! 8o ! (0%) ! (0%) ! 8o 8 ! !!!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 1! 1! 4! 0! 0! 1! 1! ! (13%) ! (0%) ! (13%)! (13%)! (50%)! (0%) ! (0%) ! (13%)! (13%)! ! 2! 0! 1! 1! 4! 0! 0! 1! 1! ! (25%) ! (0%) ! (13%)! (13%)! (50%)! 8o ! (0%) ! (13%)! 88888 ! !!!!!!!!! ! 0! 0! 1! 0! 1! 1! 2! 2! 1! ! (0%) ! (0%) ! (13%)! (0%) ! (13%)! (13%) ! (25%) ! (25%)! (13%)! ! 0! 0! 1! 0! 1! 1! 2! 2! 1! ! (0%) ! (0%) ! (13%)! (0%) ! (13%)! 88888! (25%) ! (25%)! 88888 ! !!!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 8888 ! (0%) ! (13%)! 8o 8 ! ! ! (8) ! (8) ! (8) ! (8) ! (8) ! 888 ! (8) ! (8) ! 888 ! ! ! 7! 7! 5! 6! 7! 8! 8! 8! 7! ! (88%) ! (88%)! (63%)! (75%)! (88%)! 8888 8 8!(100%) !(100%)! 88888 ! !!!!!!!!! ! 1! 1! 3! 0! 1! 0! 0! 0! 0! ! (13%) ! (13%)! (38%)! (0%) ! (13%)! 8888 ! (0%) ! (0%) ! 8o 8 ! !!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 12 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 5 21-Aug-00 ! i______ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! T- !T- 7090.2!7339 ! ! !- !7340 ! ! T7341 !T!7342 !T- !7343 ! ! ! ! ! ! ! ADRENALS ! Cortical fatty cytoplasmic vacuolation ! Score Expanded Totals ! Accessory cortical nodule (rest) ii !! ! (8) ! (8) (O (K ! (8) ! (( !! ! 1! 1 ! (13%)! (13%) ! 0! 0 ! (0%) ! (88) 3 (38%) 0 (M O !! 0! 1! 0 (0%) ! (13%)! (0%) 2! 0! 0 ((m ! (0%) ! (M 0 !! (O ! (o ! (8) ! !! 0! 0! 0! (0%) ! (0%) ! (0%) ! 0! 0! 1! (M 0 ! (M 0 ! (13%)! ! TESTES ! (8) ! (8) (O (O ! (8) ! (O (O ! (O ! (8) ! ! No abnormality detected ! 8! 8 8 8! 8! 8 8! 8! 8! !(100%)! ((00%( (1(H ( (!(H (!(100%)! (((H ( (((H (!(((H (!(100%)! ! CEREBRUM ! No abnormality detected ! (l) ! ! 1! !(100%)! !! !! !! !! !! !! ! THYMUS ! Haemorrhage ! slight ! Score Expanded Totals !! !! !! !! !! !! !! !! !! !! !! !! !! !! oo oo oo oo ! ((( ! (l) ! !! ! 1! 1! ! 1! 1! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 13 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 6 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ! TREATMENT ! ! ! 'saline!T- !T! !7088-2 !7338 !! !! ! - !T!7090.2!7339 ! ! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !- !7343 ! ! SKIN (TREATED SITE) !!!! !!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) No abnormality detected Epi dermal hypertrophy/hyperplas ia very siight siight Score Expanded Totals Hyperkeratosis siight Score Expanded Totals Epidermal erosion(s) siight Score Expanded Totals Dermal inflammatory cell infiltration very siight siight Score Expanded Totals ! 0! 0! 2! 1! 1! 0! 0! 1! 2 ! (0%) ! (0%) ! (25%)! (13%) ! (13%) ! (0%) ! (0%) ! (13%)! (25%) !!!! !!! ! 4! 6! 4! 6! 6! 5! 7! 5! 5 ! (50%) ! (75%)! (50%)! (75%) ! (75%) ! (63%) ! (88%)! (63%)! (63%) ! 4! 2! 2! 1! 1! 3! 1! 2! 1 ! (50%) ! (25%)! (25%)! (13%) ! (13%) ! (38%) ! (13%)! (25%)! (13%) ! 8! 8! 6! 7! 7! 8! 8! 7! 6 !(100%) !(100%)! (75%)! (88%) ! ( W O !((((O(!(100%)! (88%)! (7((( !!!! !!! ! 2! 1! 2! 2! 1! 3! 1! 2! 1 ! (25%) ! (13%)! (25%)! (25%) ! (13%) ! (38%) ! (13%)! (25%)! (13%) ! 2! 1! 2! 2! 1! 3! 1! 2! 1 ! (25%) ! (13%)! (25%)! (%%%( ! ((( O ! (W O ! (13%)! (25%)! ((((( !!!! !!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! 0! 0! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) !!!! !!! ! 2! 0! 0! 0! 0! 0! 0! 0! 0 ! (25%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 1! 1! 2! 1! 2! 0! 2! 0 ! (0%) ! (13%)! (13%)! (25%) ! (13%) ! (25%) ! (0%) ! (25%)! (0%) ! 2! 1! 1! 2! 1! 2! 0! 2! 0 ! (25%) ! (13%)! (13%)! (%%%( ! ((( O ! ((( O ! (0%) ! (25%)! (T%( SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) No abnormality detected (Ulcerative) inflammation siight moderate ! 6! 8! 7! 6! 8! 6! 8! 7! 5 ! (75%) !(100%)! (88%)! (75%) !(100%) ! (75%) !(100%)! (88%)! (63%) !!!! !!! ! 0! 0! 0! 0! 0! 1! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (13%) ! 0! 0! 1! 2! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (13%)! (25%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 14 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological fi ndi ngs (wi th scores , all animals) Page: 7 21-Aug-00 LESIONS ! TREATMENT ! ! ! SKIN (UNTREATED SITE) (Ulcerative) inflammation severe Score Expanded Totals Epidermal erosion(s) siight Score Expanded Totals Dermal inflammatory cell infiltration siight Score Expanded Totals Subcutaneous inflammatory cell infiltration siight moderate Score Expanded Totals Epidermal hyperplasia siight moderate Score Expanded Totals Hyperkeratosis siight moderate Score Expanded Totals ! 1_______ ! INCIDENCE OF LESIONS (PERCENT) Females !saline!T !T ! 17088.217338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 ! ! !!7341 ! ! !!!11!! ! (8) ! (8) ! ((( ! (8) ! (8) ! (8) ! (K !!! !!!!!!! ! 1! 0! 0! 0! 0! 0! 0 ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 1! 2! 0! 1! 0 ! (13%)! (88) ! (1(((! (25%)! (0%) ! (13%)! (m o !!!!!!! ! 1! 0! 0! 0! 0! 0! 0 ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 0! 0! 0! 0! 0 ! (13%)! (0%) ! (M 0 ! (0%) ! (0%) ! (0%) ! (m o !!!!!!! ! 1! 0! 0! 0! 0! 0! 0 ! (13%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 0! 0! 0! 0! 0 ! (13%)! (0%) ! (m o ! (0%) ! (0%) ! (0%) ! (m o !!!!!!! ! 0! 0! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (m o ! (0%) ! (0%) ! (13%)! (m o !!!!!!! ! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! 2! 0! 1! 2! 0! 0! 0 ! (25%)! (0%) ! (13%) ! (25%)! (0%) ! (0%) ! (0%) ! 2! 0! 1! 2! 0! 1! 0 ! (25%)! (M 0 ! ()(((! (25%)! (0%) ! (13%)! (m o !!!!!!! ! 0! 0! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! 0! 0! 0! 1! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (13%)! (0%) ! (0%) ! (0%) ! 0! 0! 0! 1! 0! 1! 0 ! (0%) ! (M 0 ! (m o ! (13%)! (0%) ! (13%)! (m o !!!!!!! ! ----- ! ! !!7342 ! ! ----- ! T- ! 7343 ! !! !! ----- ! !!! ! (K ! (8) ! !! !!! ! 0! 1! ! (0%) ! (13%)! ! 0! 3! ! (m o ! (38%)! !!! ! 0! 0! ! (0%) ! (0%) ! ! 0! 0! ! (m o ! (0%) ! !!! ! 0! 0! ! (0%) ! (0%) ! ! 0! 0! ! (m o ! (0%) ! !!! ! 1! 0! ! (13%) ! (0%) ! ! 0! 0! ! (0%) ! (0%) ! ! 1! 0! ! ()(((! (0%) ! !!! ! 0! 1! ! (0%) ! (13%)! ! 0! 2! ! (0%) ! (25%)! ! 0! 3! ! (m o ! (38%)! !!! ! 0! 1! ! (0%) ! (13%)! ! 0! 2! ! (0%) ! (25%)! ! 0! 3! ! (m o ! (38%)! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 15 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 8 21-Aug-00 ! LESIONS ! !----! INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! 'saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T!7342 !T- !7343 ! ! ! ! ! ! ! SKIN (UNTREATED SITE) ! Haemorrhage ! slight ! Score Expanded Totals ! HEART ! No abnormality detected ! Myocardial mononuclear cell infiltration ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! !! !! !! ! (8) ! (8) ! (8) ! (8) ! ((( ! (8) ! (8) ! ((( ! (8) ! !! !! ! !! !! !! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (88) ! (0%) ! (0%) ! (M 0 ! (0%) ! (0%) ! (M 0 ! (0%) ! !! !! ! (8) ! (8) ! (8) ! (8) ! (O ! (8) ! (8) ! (O ! (8) ! !! !! ! 7! 8! 8! 7! 8! 8! 7! 8! 8! ! (88%) !((00%( !(100%) ! (88%) !(((H (!(100%) ! (88%) !(((H (!(100%)! ! !! !! !! ! 1! 0! 0! 1! 0! 0! 1! 0! 0! ! (13%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 1! 0! 0! 1! 0! 0! 1! 0! 0! ! (13%) ! (M 0 ! (0%) ! (13%) ! (M 0 ! (0%) ! (13%) ! (M 0 ! (0%) ! !! !! ! (8) ! (O ! (8) ! (8) ! (O ! (8) ! (8) ! (O ! (8) ! !! !! ! 8 ! 8 ! 7 ! 8 ! 7 ! 8 ! 4* ! 7 ! 7 ! !(100%) !(100%) ! (88%) !(100%) ! (88%) !(100%) ! (50%) ! (88%) ! (88%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! (M 0 ! (0%) ! (0%) ! (M 0 ! (0%) ! (13%) ! (M 0 ! (13%)! ! !! !! !! ! 0! 0! 1! 0! 1! 0! 3! 1! 0! ! (0%) ! (0%) ! (13%) ! (0%) ! (13%) ! (0%) ! (38%) ! (13%) ! (0%) ! ! 0! 0! 1! 0! 1! 0! 3! 1! 0! ! (0%) ! (M 0 ! (13%) ! (0%) ! (((((! (0%) ! (38%) ! (((((! (0%) ! !! !! ! (8) ! (o ! (8) ! (8) ! (O ! (8) ! (8) ! (O ! (8) ! !! !! ! 8! 8! 8! 8! 8! 8! 8! 8! 8! !(100%) !(1(H (!(100%) !(100%) !(((H (!(100%) !(100%) !(((H (!(100%)! !! !! ! (8) ! (o ! (8) ! (8) ! (O ! (8) ! (8) ! (O ! (8) ! !! !! ! 7! 8! 7! 6! 5! 7! 6! 8! 4! ! (88%) !(!(H (! (88%) ! (75%) ! (((((! (88%) ! (75%) !(((H (! (50%)! ! !! !! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 16 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores , all animals) Page: 9 21-Aug-00 LESIONS ! TREATMENT ! ! ! KIDNEYS Cortical scar(s) moderate Score Expanded Totals Tubular-cell degeneration very siight Score Expanded Totals Tubular mineralisation siight Score Expanded Totals Tubular basophilia siight Score Expanded Totals Tubular dilatation with luminal hyaline substances siight Score Expanded Totals Interstitial mononuclear cell infiltration siight moderate Score Expanded Totals ADRENALS No abnormality detected ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! ----- ! ! !saline!T- !T- ! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 ! ! !!7340 ! ! !T- !7341 ! ! !T- !7342 ! ! ----- ! !T- ! !7343 ! !! !! ----- ! !!!!11!!!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! !!!! !!! !!!!!!!!!! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (888 ! (13%) ! (0%) ! (0%) ! !!!!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !!!!!!!!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !!!!!!!!!! ! 0! 0! 1! 0! 2! 1! 0! 0! 1! ! (0%) ! (0%) ! (13%) ! (0%) ! (25%)! (13%) ! (0%) ! (0%) ! (13%)! ! 0! 0! 1! 0! 2! 1! 0! 0! 1! ! (0%) ! (0%) ! (13%) ! (0%) ! (25%)! (10%(! (0%) ! (0%) ! (13%)! !!!!!!!!!! ! 0! 0! 0! 1! 1! 0! 0! 0! 3! ! (0%) ! (0%) ! (0%) ! (13%) ! (13%)! (0%) ! (0%) ! (0%) ! (38%)! ! 0! 0! 0! 1! 1! 0! 0! 0! 3! ! (0%) ! (0%) ! (0%) ! (13%) ! (13%)! (M 0 ! (0%) ! (0%) ! (38%)! !!!!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (13%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (M 0 ! (13%) ! (0%) ! (13%)! !!!! !!! ! (8) ! (8) ! (8) ! (8) ! (8) ! (K ! (8) ! (8) ! (8) ! !!!! !!! ! 8! 8! 8! 8! 8! 8! 8! 8! 7! !(100%) !(100%) !(100%) !(100%) !(100%)! (!(H (!(100%) !(100%)! (88%)! !!!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 17 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 10 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ADRENALS Accessory cortical nodule (rest) OVARIES No abnormality detected Cyst(s) PITUITARY Cyst(s) THYMUS No abnormality detected UTERUS Di1atati on moderate Score Expanded Totals ABDOMINAL CAVITY Fat necrosis ! TREATMENT ! ! ! IsalinelT- IT! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! T7340 !T- !7341 ! ! !- !7342 ! ! T- ! 7343 ! !!11 ! (8) ! (8) ! (8) ! ! ! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! ! ! (8) ! (8) ! (8) ! Oo oo ! (8) ! (8) ! (8) (8) 11 (8) ! (8) ! (8) 0! 0! 0 (88) ! (0%) ! 80 O (8) ! (8) ! 88 888 ! 1! 8888 8 ! 888 ! COOO O O COoo o o COoo o o COoo o o COoo o o COoo o o COoo o o COoo o o ! ! (l) ! ! ! ! ! ! 1! ! ! ! !(100%) ! ! ! ! !!!!! ! !!!!! !!!!! ! !!!!! ! !!!!! !!!!! !!!!! !!!!! !!!!! ! ! ! ! (l) ! ! ! ! ! ! 1! ! ! ! !(100%)! ! !!!!! !! !! !! !! !! !! ! (l) ! !! ! 1! !(100%)! ! 1! !(100%)! !! !! !! !! 7! (88%)! 1! 88888 ! 888 ! 1! 888888 ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 18 of 68 Table 3: Summary of histopathological findings (4-days treatment) FRAUNHOFER ITA 01G0002 Summary of histopathological findings (4-days treatment) Page: 1 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mai es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Epidermal erosion(s) ! Dermal inflammatory cell infiltration ! Subcutaneous inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! No abnormality detected ! HEART ! No abnormality detected ! LIVER ! No abnormality detected ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 0! 0! 1! 0! 1! 0! 0! 1! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 2! 2! 1! 2! 1! 2! 2! 1! 2! !(100%) !(100%) ! (50%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%)! ! 0! 0! 0! 0! 1! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! ! (2) ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! O! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! !(100%) !((222( !(((((( !(((M (!(((M (!(((M (!(((M (!(((M (!(((( ! ! ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! O! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! !(100%) !(((((( !(((((( !(((M (!(((M (!(((M (!(((M (!(((M (!(((( ! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! O O O O! 1 ! 2 ! 1 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! ! (50%) !(((((( ! (((%( !((( (! ((( O ! ((( O !((( (!((( (!(((( ! ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 19 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (4-days treatment) Page: 2 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! KIDNEYS ! Cortical scar(s) ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected !11!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! oo oo ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 1! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (22) ! ! (50%) ! (0%) ! (0%) ! (0%) ! !!! ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !!! ! 1 ! 2 ! 1! 1! 2 ! 2 ! 2 ! 2 ! 2 ! oo oo oo oo oo o oun o oo ! (50%) (50%) ! 1 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (22) ! (50%)! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! !!! ! (2) ! (2) ! ((( ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo ! THYMUS ! Haemorrhage ! ! ! ! ! ! ! ! (l) ! (l) ! ! !!! ! ! ! ! ! ! ! ! 1! 1! !!!!!!! !!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 20 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (4-days treatment) Page: 3 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! SKIN (TREATED SITE) ! TREATMENT ! ! ! IsalinelT- !T- ! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Dermal inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 2! 2! 1! 2! 2! 2! 2! 2! 2! !(100%) !(100%) ! (50%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! 1! 0! 0! 0! 1! 1! 1! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (50%) ! (0%) ! (0%) ! ! 2! 0! 0! 0! 0! 0! 0! 0! 0! !(100%) ! (0%) ! (O%( ! (O%( ! (OO( ! (OO( ! (OO( ! (OO( ! (OO( ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! No abnormality detected ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! HEART ! No abnormality detected ! (2) ! (%( ! ((( ! ((( ! (O( ! (O( ! (O( ! (O( ! (O( ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !()00%( !(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(! ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Mononuclear cell infiltration ! SPLEEN ! (2) ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! ! 2! 2! 2! 2! 2! 2! 1! 1! 1! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) ! (50%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 1! 1! 0! ! (0%) ! (O%( ! (O%( ! (O%( ! (OO( ! (OO( ! (OOO(! (OOO(! (OO( ! ! (2) ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! (O( ! ! No abnormality detected ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(!(OOOO(! ! KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! No abnormality detected ! 1! 2! 2! 1! 2! 2! 1! 2! 1! ! (50%) !(100%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%) ! (50%)! ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 21 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (4-days treatment) Page: 4 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! KIDNEYS ! Cortical scar(s) ! Tubular-cell degeneration ! Tubular mineralisation ! Tubular dilatation with luminal hyaline substances ! ADRENALS ! No abnormality detected !!!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! OVARIES ! No abnormality detected ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! ! THYMUS ! No abnormality detected ! UTERUS ! Dilatation ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! (l) ! ! ! ! ! ! ! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%)! !!!!!!!! ! ! ! ! ! ! ! (l) ! ! ! !!!!!!!! ! ! ! ! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%) ! ! ! !!!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 22 of 68 Table 4: 4S-udmaymsatrryeaotfmheisntto)pathological findings (with scores, FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 4-days treatment) Page: 1 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T!7090.2!7339 !! !! T7340 T- !T- !T- ! 7341 !7342 !7343 ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Epidermal erosion(s) ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! slight ! Score Expanded Totals ! Subcutaneous inflammatory cell infiltration ! moderate ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected !!! ! ! (2) ! (2) ! (2) ! (2) ! (2) !!! ! ! 0! 0! 1! 0! 1 ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) !!! ! ! 2! 2! 1! 1! 1 !(100%) !(100%) ! (50%) ! (50%) ! (50%) ! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! 2! 2! 1! 2! 1 !(100%) !(100%) ! (50%) !(100%) ! (50%) !!! ! ! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) !!! ! ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !!! ! ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !!! ! ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !!! ! ! (2) ! (2) ! (2) ! (%( ! (2) !!! ! ! 2! 2! 2! 2! 2 !(100%) !(100%) !(100%) !(!(H (!(100%) !!! ! (2) 0 (0%) 2 (100%) 0 (0%) 2 (((H ( 0 (0%) 0 (0%) 1 (50%) 1 ((m i (50%) 1 ((m 0 (0%) 0 (0%) ((( 2 (((H ( (2) ! (2) ! (2) ! 0! 1! 0! (0%) ! (50%) ! (0%) ! 1! 1! 1! (50%) ! (50%) ! (50%)! 1! 0! 1! (50%) ! (0%) ! (50%)! 2! 1! 2! (((H (! ((m !(((m ! 0! 0! 1! (0%) ! (0%) ! (50%)! 0! 0! 1! (0%) ! (0%) ! (50%)! 0! 0! 0! (0%) ! (0%) ! (0%) ! 0! 0! 0! (M 0 ! (M 0 ! (M 0 ! 0! 0! 1! (0%) ! (0%) ! (50%)! 0! 0! 1! (M 0 ! (M 0 ! ((m ! 1! 0! 0! (50%) ! (0%) ! (0%) ! 1! 0! 0! (50%) ! (0%) ! (0%) ! ((( ! ((( ! ((( ! 2! 2! 2! (((H (!(((H (!(((m ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 23 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 4-days treatment) Page: 2 21-Aug-00 LESIONS HEART No abnormality detected INCIDENCE OF LESIONS (PERCENT) Mal es ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! !!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo LIVER No abnormality detected ! (2) ! (2( ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 SPLEEN No abnormality detected ! (2) ! (2( ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 KIDNEYS No abnormality detected Cortical scar(s) siight Score Expanded Totals Tubular basophilia very siight siight Score Expanded Totals Tubular dilatation with luminal hyaline substances siight Score Expanded Totals ! (2) ! ((( ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!! ! 1! 2 ! 1! 2 ! 1! 1! 2 ! 2 ! 2 ! (50%) ! ! 0! ! (50%) ! 0 ! 1! ! (50%) ! (50%) !! 0! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! (0%) ! ((%( ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !!!!!!! ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! (50%) ! ((%( ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! !!!!!!! ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 24 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 4-days treatment) Page: 3 21-Aug-00 ! i_____________ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! T- !T- 7090.2!7339 ! ! !T!7340 !T!7341 !T!7342 !T- !7343 ! ! ! ! ! ! ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! slight ! Score Expanded Totals ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected !!! ! (2) ! (2) ! (2) ! 1! 2! 1 ! (50%)!(100%)! (222) !!! ! 1! 0! 1 ! (50%)! (0%) ! (50%) ! 1! 0! 1 ! (50%)! (0%) ! (50%) ! 0! 0! 0 (22) ! (2) ! (2) ! (2( ! 2! 2! 2 ! !! (2( ! (2) ! (2( ! (2( ! (2( ! (2) ! ! 1! (222( ! 2! 2! 2! 2! ! 2! ! 0! 0! 0! 0! 0! 0! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0! 0! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 0! 0! 0! 0! (202( ! (0%) ! (22( ! (22( ! (22 ! (0%) ! ! (2( ! (2) ! (2( ! (2( ! (2( ! (2) ! ! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo Oo oo oo oo o oo o oo ! THYMUS ! Haemorrhage ! slight ! Score Expanded Totals !!! !!! !!! !!! !!! !!! !!! ! ! ! ! ! ! ! ! ! (2( ! (l) ! !! ! 1! 1! ! 1! 1! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 25 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathol ogical findings (with scores, 4-days treatment) Page: 4 21-Aug-00 ! INCIDENCE OF LESIONS (PERCENT) !---------------------------------------------! Females LESIONS ! TREATMENT ! !saline!T- !T! !7088.2!7338 !! !! !T- !T!7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! very siight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! HEART ! No abnormality detected ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule !!! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! 1!! 11 ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !!! !! ! 0! 2! 1! 2! 2! 1! 2! 2! 2! ! (0%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%) !(100%) !(100%)! ! 2! 0! 0! 0! 0! 1! 0! 0! 0! !(100%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 2! 2! 1! 2! 2! 2! 2! 2! 2! !(100%) !(100%) ! (50%) !(000((!(100%) !(000((!(000((!(0000( !(100%)! !!! !! ! 1! 0! 0! 0! 1! 1! 1! 0! 0! ! (50%) ! (0%) ! 1! 0 ! (50%) ! (0%) ! ! (0%) !0 ! (0%) ! ! (0%) !0 ! (0%( ! (50%) ! (50%) ! (50%) ! (0%) ! 1! 1! 1! 0 ! (50%) ! ((m ! ((m ! (0%( ! ! (0%) !0 ! (0%) ! ! ! ! ! ! 2! 0! 0! 0! 0! 0! 0! 0! 0! !(100%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 2! 0! 0! 0! 0! 0! 0! 0! 0! !(100%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1!! 11 ! (2) ! (%( ! (2) ! (0( ! (2) ! (0 ( ! (0 ( ! (0 ( ! (2) ! 1!! 11 ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%( !(100%) !(000((!(100%) !(000((!(0000( !(0000( !(100%)! 1!! 11 ! (2) ! (2( ! (2) ! (0 ( ! (2) ! (0 ( ! (0 ( ! (0 ( ! (2) ! 1!! 11 ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !((00((!(100%) !(000((!(100%) !(0000( !(0000( !(0000( !(100%)! 1!! 11 ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! 1!! 11 ! 2! 2! 2! 2! 2! 2! 1! 1! 1! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) ! (50%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! !!! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 26 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 4-days treatment) Page: 5 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! LIVER Mononuclear cell infiltration siight Score Expanded Totals SPLEEN No abnormality detected KIDNEYS No abnormality detected Cortical scar(s) moderate Score Expanded Totals Tubular-cell degeneration very siight Score Expanded Totals Tubular mineralisation siight Score Expanded Totals Tubular dilatation with luminal hyaline substances siight Score Expanded Totals !!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) !!!!!!!!! !!!!!!!!! ! 0! 0! 0! 0! 0! 0! 1! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) ! 0! 0! 0! 0! 0! 0! 1! 1! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) !!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) !!!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) !!!!!!!!! ! 1! 2! 2! 1! 2! 2! 1! 2! 1 ! (50%) !(100%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%) ! (50%) !!!!!!!!! ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) !!!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0 ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 1! 0! 0! 0! 0! 0! 0! 0! 0 ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !!!!!!!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 1! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !!!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! 0! 0! 0! 0! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 27 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathologi cal fi ndi ngs (with scores, 4-days treatment) Page: 6 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! ADRENALS ! No abnormality detected ! OVARIES ! No abnormality detected ! THYMUS ! No abnormality detected ! UTERUS ! Dilatation ! moderate ! Score Expanded Totals !!!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%)!(100%) !(100%)!(100%) !(100%) !(100%)! ((222( !(100%)! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%)!(100%) !(100%)!(100%) !(100%) !(100%)! (((((( !(100%)! ! ! ! ! ! ! ! ! ! ! (l) ! ! ! ! ! ! ! ! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%)! ! ! ! ! ! ! ! ! (l) ! ! ! ! !!!!!!!!!! ! ! ! ! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%)! !! ! ! ! ! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%)! !! !!!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 28 of 68 Table 5: Summary of histopathological findings (14-days treatment) FRAUNHOFER ITA 01G0002 Summary of histopathological findings (14-days treatment) Page: 1 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Dermal inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! No abnormality detected ! Ulcerative inflammation ! Epidermal hyperplasia ! HEART ! No abnormality detected ! Myocardial mononuclear cell infiltration ! LIVER ! No abnormality detected ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 1! 0! 0! 0! 0! 0! 0! 0! 1! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 1! 2! 2! 2! 2! 2! 2! 2! 1! ! (50%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%)! ! 0! 0! 1! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 0! 2! 1! 1! 1! 0! 0! 0! 0! ! (0%) !(100%) ! (50%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! ! (2) ! (2) ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! (100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! ! ! 2! 2! 1! 2! 2! 2! 2! 2! 1! (100%) !(100%) ! (50%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%)! ! 0! 0! 1! 0! 0! 0! 0! 0! 1! ! (0%) ! (22) ! ((!%( ! ((%( ! ((%( ! ((%( ! (0%) ! ((%( ! (50%)! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 1! 2! 1! 2! 1! 2! 2! 1! 2! ! (50%) !(100%) ! (50%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%)! ! 1! 0! 1! 0! 1! 0! 0! 1! 0! ! (50%) ! (22) ! ((m ! ((%( ! ((m ! ((%( ! (0%) ! ((m ! (0%) ! ! ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! ! H H H H H! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! !(100%) !(1(((( !(!( (!((( (!((( (!((( (!(100%) !((( (!(100%)! ! ! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 29 of 68 oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo FRAUNHOFER ITA 01G0002 Summary of histopathological findings (14-days treatment) Page: 2 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mai es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! KIDNEYS ! No abnormality detected ! Tubular-cell degeneration ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! Interstitial mononuclear cell infiltration ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected !!! ! !!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! !!! ! !! ! 2! 2! 1! 2! 1! 2! 2! 0! 2! ! (50%) ! (50%) ! (0%) !(100%)! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 1! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! (0%( ! (0%) ! (50%) ! (0%) ! !!! ! !! ! (2) ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! !!! ! !! ! 2! 1! 1! 1! 2! 2! 2! 2! 2! !(100%) ! (50%) ! (50%) ! (50%) ! 0! 1! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! O! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (222) ! (0%) ! ( ! (0%) ! (0%) ! (0%) ! !!! ! !! ! (2) ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! !!! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 30 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (14-days treatment) Page: 3 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T!7341 !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Dermal inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! No abnormality detected ! Ulcerative inflammation ! Subcutaneous inflammatory cell infiltration ! Epidermal hyperplasia ! Hyperkeratosis ! HEART ! No abnormality detected ! Myocardial mononuclear cell infiltration ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule !! ! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! 1! 1! 2! 1! 0! 2! 0! 0! 1! ! (50%) ! (50%) !(100%) ! (50%) ! (0%) !(100%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 1! 1! 0! 2! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (OOO( ! (OO !(100%) ! (OO ! (0%) ! (0%) ! ! !! ! (2) ! (%( ! (2) ! (O( ! (O( ! (2) ! (O( ! (2) ! (2) ! ! !! ! 2! 2! 2! 1! 2! 1! 2! 1! 1! !(100%) !(100%) !(100%) ! (50%) !(100%) ! (50%) !(100%) ! (50%) ! (50%)! ! 0! 0! 0! 1! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 1! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 1! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! !! ! (2) ! (%( ! (2) ! (O( ! (O( ! (2) ! (O( ! (2) ! (2) ! ! !! ! 1! 2! 2! 1! 2! 2! 2! 2! 2! ! (50%) !(100%) !(100%) ! (50%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! 1! 0! 0! 1! 0! 0! 0! 0! 0! ! (50%) ! (OO( ! (0%) ! (OOO( ! (OO ! (0%) ! (OO ! (0%) ! (0%) ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (OO( ! (0%) ! (OO( ! (OO ! (0%) ! (OOO(! (0%) ! (0%) ! !! ! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 31 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (14-days treatment) Page: 4 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Interstitial mononuclear cell infi1trati on ! ADRENALS ! No abnormality detected ! OVARIES ! No abnormality detected ! ! (2) ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !((222( !(((((( !(((M (!(((M (!(((M (!(((M (!(((M (!(((( O ! ! ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 1! 2! 1! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! ((%( ! ((%( ! ((%( ! ((%( ! ((%( ! ((( O ! ((%( ! ((( O ! ! ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(((((( !(((M (!(((M (!(((M (!(((M (!(((M (!(((M (!(((( O ! ! ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(((((( !(((M (!(((M (!(((M (!(((M (!(((M (!(((M (!(((( O ! ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 32 of 68 Table 6: S14u-mdamyasrtyreoaftmhisetnotp) athological findings (with scores, FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 1 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! very siight ! slight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! Ulcerative inflammation ! slight ! Score Expanded Totals ! Epidermal hyperplasia ! moderate ! Score Expanded Totals !!! ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! ! ! ! 1! 0! 0! 0! 0! 0! 0! 0! 1! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! !!! ! ! !! ! 1! 2! 1! 2! 2! 1! 2! 2! 1! ! (50%) !(100%) ! (50%) !(100%) !(100%) ! (50%) !(100%) !(100%) ! (50%)! ! 0! 0! 1! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 1! 2! 2! 2! 2! 2! 2! 2! 1! ! (50%) !(100%) !(100%) !(100%) !(100%) !000000 !(100%) !000000 ! (50%)! !!! ! ! !! ! 0! 0! 1! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! !!! ! ! !! ! 0! 2! 1! 0! 0! 0! 0! 0! 0! ! (0%) !(100%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 1! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 2! 1! 1! 1! 0! 0! 0! 0! ! (0%) !(100%) ! (50%) ! (00%) ! (50%) ! 0M 0 ! (0%) ! 0M 0 ! (0%) ! !! ! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! ! ! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! !!! ! ! !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0M 0 ! (50%) ! 0M 0 ! (0%) ! !!! ! ! !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! 0M 0 ! (0%) ! 0M 0 ! (50%) ! 0M 0 ! (0%) ! !!! ! ! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 33 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 2 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! HEART ! No abnormality detected ! Myocardial mononuclear cell infiltration ! very siight ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Tubular-cell degeneration ! slight ! Score Expanded Totals ! Tubular basophilia ! slight ! ! ! !!!! ! (2) ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! !! ! 2! 2! 1! 2! 2! 2! 2! 2! 1! !(100%) !((222( ! (50%) !(2222( !(100%) !(2222( !(100%) !(100%) ! (50%)! ! ! ! !!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 1! 0! 0! 0! 0! 0! 1! ! (0%) ! (22) ! (50%) ! (22 ! (0%) ! (22 ! (0%) ! (0%) ! (50%)! ! ! !! ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! !! ! 1! 2! 1! 2! 1! 2! 2! 1! 2! ! (50%) !((222( ! (50%) !(2222( ! (50%) !(2222( !(100%) ! (50%) !(100%)! ! ! ! !!!! ! 1! 0! 1! 0! 1! 0! 0! 1! 0! ! (50%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 1! 0! 1! 0! 1! 0! 0! 1! 0! ! (50%) ! (22 ! (50%) ! (22 ! (50%) ! (22 ! (0%) ! (50%) ! (0%) ! ! ! !! ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(2222( !(100%) !(2222( !(100%) !(2222( !(100%) !(100%) !(100%)! ! ! !! ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! !! ! 2! 2! 1! 2! 1! 2! 2! 0! 2! !(100%) !(2222( ! (50%) !(2222( ! (50%) !(2222( !(100%) ! (0%) !(100%)! ! ! ! !!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (22 ! (50%) ! (22 ! (0%) ! (22 ! (0%) ! (0%) ! (0%) ! ! ! ! !!!! ! 0! 0! 0! 0! 1! 0! 0! 0! 0! ! (0%) ! (22 ! (0%) ! (22 ! (50%) ! (22 ! (0%) ! (0%) ! (0%) ! ! ! ! !!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 34 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 3 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! KIDNEYS ! Tubular basophilia ! Score Expanded Totals ! Tubular dilatation with luminal hyaline substances ! slight ! Score Expanded Totals ! Interstitial mononuclear cell infiltration ! slight ! Score Expanded Totals ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! slight ! Score Expanded Totals ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! !!!!!!!! ! 0! 0! 0! 0! 1! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (22) ! !!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! !!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! !!!!!!!! ! 2! 1! 1! 1! 2! 2! 2! 2! 2! !(100%) ! (50%) ! (50%) ! (50%) !!!!!!!! ! 0! 1! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 1! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (22( ! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 35 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 4 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T!7341 !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! slight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! Ulcerative inflammation ! slight ! moderate ! Score Expanded Totals ! Subcutaneous inflammatory cell infiltration ! slight ! Score Expanded Totals ! Epidermal hyperplasia ! slight ! ! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! ! !!! ! 1! 1! 0! 1! 1! 0! 2! 2! 1! ! (50%) ! (50%) ! (0%) ! (50%) ! (50%) ! (0%) !(100%) !(100%) ! (50%)! ! 1! 1! 2! 1! 1! 2! 0! 0! 1! ! (50%) ! (50%) !(100%) ! (50%) ! (50%) !(100%) ! (0%) ! (0%) ! (50%)! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! ! !!! ! 1! 1! 2! 1! 0! 2! 0! 0! 1! ! (50%) ! (50%) !(100%) ! (50%) ! (0%) !(100%) ! (0%) ! (0%) ! (50%)! ! 1! 1! 2! 1! 0! 2! 0! 0! 1! ! (50%) ! (50%) !(500%( ! (0( O ! (0%( !(100%) ! (0%( ! (0%) ! (50%)! ! ! !!! ! 0! 0! 1! 1! 0! 2! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) !(100%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 1! 0! 2! 0! 0! 0! ! (0%) ! (0%) ! (0( O ! (0( O ! (0%( !(100%) ! (0%( ! (0%) ! (0%) ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 2! 2! 2! 1! 2! 1! 2! 1! 1! !(100%) !(100%) !(100%) ! (50%) !(100%) ! (50%) !(100%) ! (50%) ! (50%)! ! ! !!! ! 0! 0! 0! 0! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%( ! (0( O ! (0%( ! (50%) ! (0%( ! (0%) ! (50%)! ! ! !!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! ! !!! ! 0! 0! 0! 0! 0! 1! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%)! ! ! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 36 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 5 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ! TREATMENT 'saline!T- IT- IT- IT- IT- IT- IT- !T- ! ! !7088,2 !7338 !7090,2 !7339 ! 7340 ! 7341 ! 7342 ! ! ! ! ! !! ! ! ! ! ! ! ! ! !! ! ! ! !7343 SKIN (UNTREATED SITE) Epidermal hyperplasia moderate Score Expanded Totals Hyperkeratosis siight moderate Score Expanded Totals HEART No abnormality detected Myocardial mononuclear cell infiltration siight Score Expanded Totals LIVER No abnormality detected Hepatodiaphragmatic nodule SPLEEN No abnormality detected !!!! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ((( ! (2) ! (2) 1!!! ! !! !!!! ! !! ! 0! 0! 0! 1! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 1! 0! 1! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! (50%) ! ((%( ! (0%) ! (50%) !!!! ! !! !0 ! (0%) !0 ! (0%) !0 ! (0%) ! !0 ! (0%) !0 ! (0%) !0 ! (0%) ! !0 ! (0%) !0 ! (0%) !0 ! (0%) ! ! 0! 0 ! (0%) ! (0%) ! 1! 0 ! (50%) ! (0%) ! 1! 0 ! (50%) ! (22) ! ! 1! 0 ! (50%) ! (0%) ! 0! 0 ! (0%) ! (0%) ! 1! 0 ! (50%) ! ((%( ! !0 ! (0%) !0 ! (0%) !0 ! (0%) ! !1 ! (50%) !0 ! (0%) !1 ! (50%) ! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! ((( ! (2) ! (2) |!!! ! !! ! 1! 2! 2! 1! 2! 2! 2! 2! 2 ! (50%) !(100%) !(100%) ! (50%) !(1(((( !(100%) !(((H (!(100%) !(100%) !!!! ! !! ! 1! 0 ! (50%) ! (0%) ! 1! 0 ! (50%) ! (0%) !! !0 ! (0%) !0 ! (0%) ! ! 1! 0 ! (50%) ! (0%) ! 1! 0 ! (50%) ! (!%( ! !0 ! (0%) !0 ! (0%) ! !0 ! (0%) !0 ! ((%( !0 ! (0%) !0 ! (0%) ! !0 ! (0%) !0 ! (0%) ! ! (2) ! (2) ! (2) ! (2) ! ((( ! (2) ! ((( ! (2) ! (2) i!!! ! !! ! 2! 2! 2! 2! 2! 2! 1! 2! 2 !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%) ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! ((%( ! (0%) ! ((m ! (0%) ! (0%) i!!! ! !! ! (2) ! (2) ! (2) ! (2) ! ((( ! (2) ! ((( ! (2) ! (2) i!!! ! !! H H! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 !(100%) !(100%) !(100%) !(100%) !(!( (!(100%) !((( (!(100%) !(100%) !!!! ! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 37 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 14-days treatment) Page: 6 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T!7342 !T- !7343 ! ! ! ! ! ! ! KIDNEYS ! No abnormality detected ! Interstitial mononuclear cell infi1trati on ! slight ! moderate ! Score Expanded Totals ! ADRENALS ! No abnormality detected !!!!!!! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 1! 2! 1! ! (50%) !!!!!!! ! (50%)! !! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! (50%)! !!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! ! OVARIES ! No abnormality detected ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! !!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 38 of 68 Table 7: Summary of histopathological findings (28-days treatment) FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatment) Page: 1 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Ulcerative inflammation ! Dermal inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! No abnormality detected ! (Ulcerative) inflammation ! Epidermal hyperplasia ! Hyperkeratosis ! Dermal fibrosis ! HEART ! No abnormality detected ! Myocardial degeneration ! Myocardial mononuclear cell infiltration ! LIVER ! No abnormality detected !!! !!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! !! ! 1! 0! 0! 0! 1! 1! 1! 1! 1! ! (50%) ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (50%) ! (50%) ! (50%)! ! 1! 2! 2! 2! 1! 1! 1! 1! 1! ! (50%) !(100%) !(100%) !(100%) ! (50%) ! (50%) ! (50%) ! (50%) ! (50%)! ! 0! 0! 0! 1! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! O O! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (50%) ! (0%) ! (50%) ! ( ! ( ! (0%) ! (0%) ! (0%) ! !! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! !! ! 2! 2! 1! 2! 2! 2! 2! 2! 2! (100%) !(100%) ! (50%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !! !! ! (2) ! (2) ! (2) ! (%( ! ((( ! ((( ! (2) ! (2) ! (2) ! !! !! ! 2! 2! 1! 1! 1! 2! 1! 2! 2! (100%) !(100%) ! (50%) ! (50%) ! (50%) !(100%) ! (50%) !(100%) !(100%)! ! 0! 0! 1! 0! 1! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 1! 1! 0! 1! 0! 0! ! (0%) ! (0%) ! (50%) ! (50%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! !! !! ! (2) ! (2) ! (2) ! (%( ! ((( ! ((( ! (2) ! (2) ! (2) ! !! !! ! 2! 2! 2! 1! 1! 2! 2! 1! 2! !(100%) !(100%) !(100%) ! ((( O ! ((( O !(((O (!(100%) ! (50%) !(100%)! !!! !!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 39 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatment) Page: 2 21-Aug-00 ! LESIONS ! ! ! ! LIVER ! Hepatocellular necrosis ! Granulation tissue ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mai es ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! !!!! !!! ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 1! 0 ! ! (0%) ! (0%) ! (0%) ! (0%) ! (222) ! (0%) ! (0%) ! (50%) ! (( O ! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! !!!! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! ADRENALS ! No abnormality detected ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! !!!! !!! ! 2 ! 2 ! 1! 2 ! 2 ! 2 ! 1! 1! 2 ! ! (50%) ! (50%) ! (50%) ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 1! 0 ! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! 1! 0 ! ! (0%) ! (0%) ! (0%) ! (0%) ! (22( ! (0%) ! (50%) ! (50%) ! (( O ! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! !!!! !!! ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1! ! (50%)! ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%( ! (0%) ! (0%) ! (0%) ! (2( O ! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! !!!! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! CEREBRUM ! No abnormality detected ! (l) ! ! ! !!!! ! 1! ! ! !(100%) ! ! ! !!!! !!! !!! !!! !!! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 40 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatment) Page: 3 21-Aug-00 ! INCIDENCE OF LESIONS (PERCENT) ! !------------------------------------------------------------- ! ! Females ! LESIONS ! TREATMENT ! !saline!T- !T! !7088.2 !7338 !! !! !T- !T!7090.2 !7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! SKIN (TREATED SITE) ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! Epidermal erosion(s) ! Dermal inflammatory cell infiltration ! SKIN (UNTREATED SITE) ! No abnormality detected ! (Ulcerative) inflammation ! Epidermal erosion(s) ! Dermal inflammatory cell infiltration ! Subcutaneous inflammatory cell infiltration ! Epidermal hyperplasia ! Hyperkeratosis ! Haemorrhage ! HEART ! No abnormality detected ! LIVER ! No abnormality detected !! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! 1! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! ! 0! 0! 0! 1! 0! 0! 0! 2! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) !(100%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 1! 0! 1! 1! 0! 0! 2! 0! ! (0%) ! (50%) ! (0%) ! (OOOO ! (OOOO ! (0%) ! (0%) !(100%) ! (O%( ! 1! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! 1! !!! ! 0! 2! 1! 1! 2! 1! 2! 2! 0! ! (0%) !(100%) ! (50%) ! (50%) !(100%) ! (50%) !(100%) !(100%) ! (0%) ! ! 1! 0! 1! 1! 0! 0! 0! 0! 2! ! (50%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%)! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 2! 0! 1! 1! 0! 0! 0! 0! 2! !(100%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 2! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%)! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (O%( ! (O%( ! (0%) ! (0%) ! (0%) ! (OO( ! !! !!! ! (2) ! (%( ! (2) ! (O( ! (O( ! (2) ! (2) ! (2) ! (O( ! 1! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(500%( !(100%) !(OOOO(!(OOOO(!(100%) !(100%) !(100%) !(OOOO(! 1! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! !!! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! !! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 41 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatment) Page: H 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! ! ! ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! LIVER ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! ADRENALS ! No abnormality detected ! OVARIES ! No abnormality detected ! PITUITARY ! Cyst(s) ! ABDOMINAL CAVITY ! Fat necrosis !!!!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! C \J oo o C \J oo o C \J oo o C \J oo o C \J oo o o oo o oo o oo o oo o oo !1 ! (50%) !1 ! (50%) !0 ! (0%) ! o oo C \J oo o ! 0! 1 ! (0%) ! (50%) ! 1! 1 ! (50%) ! (50%) ! 1! 0 ! (50%) ! (0%) !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! !!!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!!!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! !!!!!!!! ! ! (l) ! ! ! ! ! ! ! ! !!!!!!!! ! ! 1! ! ! ! ! ! ! ! ! !(100%) ! ! ! ! ! ! ! ! !!!!!!!! ! ! ! (1) ! ! ! ! ! ! ! !!!!!!!! ! ! ! 1! ! ! ! ! ! ! ! ! !(100%) ! ! ! ! ! ! ! !!!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 42 of 68 Table 8: 2S8u-mdamyasrtyreoaftmhisetnotp) athological findings (with scores, FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 1 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 ! ! !!7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Ulcerative inflammation ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! slight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! (Ulcerative) inflammation ! moderate ! Score Expanded Totals ! Epidermal hyperplasia ! severe !! !!!!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! !! ! 1! 0! 0! 0! 1! 1! 1! 1! 1! ! (50%) ! (0%) ! (0%) ! (0%) ! (50%)! (50%) ! (50%) ! (50%) ! (50%)! !! !!!!!!! ! 1! 1! 2! 0! 1! 1! 1! 1! 0! ! (50%) ! (50%) !(100%) ! (0%) ! (50%)! (50%) ! (50%) ! (50%) ! (0%) ! ! 0! 1! 0! 2! 0! 0! 0! 0! 1! ! (0%) ! (50%) ! (0%) !(100%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 1! 2! 2! 2! 1! 1! 1! 1! 1! ! (50%) !(100%) !(100%) !(100%) ! (50%)! 00m ! (50%) ! (50%) ! (50%)! !! !!!!!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 0! 1! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! !! !!!!!!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! 0n o ! (0%) ! (0%) ! (0%) ! !! !!!!!!! ! 0! 1! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 1! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! 0n o ! (0%) ! (0%) ! (0%) ! !! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! !! ! 2! 2! 1! 2! 2! 2! 2! 2! 2! !(100%) !(100%) ! (50%) !(100%) !(100%)! (100%) !(100%) !(100%) !(100%)! !! !!!!!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (10%) ! (0%) ! (0%) ! 0H O ! (0%) ! (0%) ! (0%) ! !! !!!!!!! ! 0! 0! 1! 0! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! 00m ! (0%) ! (0%) ! 0n o ! (0%) ! (0%) ! (0%) ! !! !!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 43 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 2 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! T- !T- !T- !T- ! 7340 !7341 !7342 !7343 ! ! SKIN (UNTREATED SITE) ! Epidermal hyperplasia ! Score Expanded Totals ! Hyperkeratosis ! moderate ! Score Expanded Totals ! Dermal fibrosis ! moderate ! Score Expanded Totals ! HEART ! No abnormality detected ! Myocardial degeneration ! slight ! Score Expanded Totals ! Myocardial mononuclear cell infi1trati on ! very siight ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected !!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! !!!!! ! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (50%)! (0%) ! (22) !!!!! ! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (50%)! (0%) ! (0%) ! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (50%)! (0%) ! (22) !!!!! ! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (50%)! (0%) ! (0%) ! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (50%)! (0%) ! (22) ! (2( ! (2( ! (2( ! (2( ! 0! 0! 0! 0! (22( ! (22( ! (22( ! (22( ! 0! 0! 0! 0! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! (22( ! (22( ! (22( ! (22( ! 0! 0! 0! 0! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! (22( ! (22( ! (22( ! (22( ! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2( ! (2( ! (2( ! (2( ! ! 2! 2! 1! 1! 1 2! 1! 2! 2! !(100%) !(100%) ! (50%)! (50%)! (222 (2222( ! (222( !(2222( !(2222(! !!!!! ! 0! 0! 1! 0! 1 0! 0! 0! 0! ! (0%) ! (0%) ! (50%)! (0%) ! (50%) ! 0! 0! 1! 0! 1 ! (0%) ! (0%) ! (50%)! (0%) ! (222 !!!!! (0%) ! (0%) ! (0%) ! (0%) ! 0! 0! 0! 0! (22( ! (22( ! (22( ! (22( ! ! 0! 0! 0! 1! 0 ! (0%) ! (0%) ! (0%) ! (50%)! (0%) ! 0! 0! 1! 0! 1 ! (0%) ! (0%) ! (50%)! (0%) ! (50%) ! 0! 0! 1! 1! 1 ! (0%) ! (0%) ! (50%)! (50%)! (522 ! 0! 0! 0! 0! (0%) ! (0%) ! (0%) ! (0%) ! 0! 1! 0! 0! (0%) ! (50%) ! (0%) ! (0%) ! 0! 1! 0! 0! (22( ! (222( ! (22( ! (22( ! ! (2) ! (2) ! (2) ! (2) ! (2( ! (2( ! (2( ! (2( ! (2( ! ! 2! 2! 2! 1! 1 2! 2! 1! 2! !(100%) !(100%) !(100%)! (50%)! (222 (2222( !(2222( ! (222( !(2222(! !!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 44 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 3 21-Aug-00 ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! ! ! ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! LIVER ! Hepatocellular necrosis ! moderate ! Score Expanded Totals ! Granulation tissue ! moderate ! Score Expanded Totals ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! slight ! Score Expanded Totals ! Tubular dilatation with luminal hyaline substances ! slight ! Score Expanded Totals !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! 222 ! !!!! !!! !!!! !!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! (0%) ! (0%) ! (0%) ! 22!0 ! !!!! !!! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (22) ! (0%) ! (0%) ! (0%) ! 22!0 ! !!!! !!! ! 0! 0! 0! 0! 1! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 1! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (222) ! (0%) ! (0%) ! (50%) ! 22!0 ! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! 222 ! (2) ! (2) ! (2) ! 222 ! !!!! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !212222 !(100%) !(100%) !(100%) !22222}! !!!! !!! ! (2) ! (2) ! (2) ! (2) ! 222 ! (2) ! (2) ! (2) ! 222 ! !!!! !!! ! 2! 2! 1! 2! 2! 2! 1! 1! 2! !(100%) !(100%) ! (50%) !(100%) !222222 !(100%) ! (50%) ! (50%) !222m ! !!!! !!! ! 0! 0! 1! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 1! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! 222 ! (0%) ! (0%) ! (50%) ! 2m ! !!!! !!! ! 0! 0! 0! 0! 0! 0! 1! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! 222 ! (0%) ! (50%) ! (50%) ! 2m ! !!!! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 45 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: H 21-Aug-00 ! LESIONS ! ADRENALS ! No abnormality detected ! Accessory cortical nodule (rest) ! TESTES ! No abnormality detected ! i____________ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! TREATMENT ! ! ! IsalinelT- !T- ! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! !!! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! ((( ! ((( ! ((( ! !! oo oo oo Oo oo oo oo o oo o ! 2! 2! 2! 2! 2! 2! 2! 2! 1! ! (50%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 1! ! (0%) ! (22) ! (0%) ! ((%( ! ((%( ! ((%( ! (((%(! !! ! (2) ! (2) ! (2) ! (2( ! (2) ! ((( ! ((( ! ((( ! ((( ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo ! CEREBRUM ! No abnormality detected ! (l) ! ! 1! !(100%)! !! ! ! ! ! ! ! ! ! ! ! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 46 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 5 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! LESIONS ! TREATMENT ! ! ! !saline!T- !T- ! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! SKIN (TREATED SITE) ! Epidermal hypertrophy/hyperplasia ! very siight ! slight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! Epidermal erosion(s) ! slight ! Score Expanded Totals ! Dermal inflammatory cell infiltration ! slight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! (Ulcerative) inflammation ! moderate ! severe ! Score Expanded Totals ! Epidermal erosion(s) ! slight ! ! !!! ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! ! !!! ! ! !!! ! 1! 1! 2! 2! 2! 2! 1! 0! 2! ! (50%) ! (50%) !(100%) !(100%) !(100%) !(100%) ! (50%) ! (0%) !(100%)! ! 1! 1! 0! 0! 0! 0! 1! 2! 0! ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) !(100%) ! (0%) ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !((222( !(1222( !(100%) !(2222( !(100%) !(100%) !(100%) !(2222(! ! ! !!! ! 0! 0! 0! 1! 0! 0! 0! 2! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) !(100%) ! (0%) ! ! 0! 0! 0! 1! 0! 0! 0! 2! 0! ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) !(100%) ! (0%) ! ! ! !!! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 0! 1! 0! ! (0%) ! (22) ! (22 ! (0%) ! (22 ! (0%) ! (0%) ! (50%) ! (22( ! ! ! !!! ! 0! 1! 0! 1! 1! 0! 0! 2! 0! ! (0%) ! (50%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) !(100%) ! (0%) ! ! 0! 1! 0! 1! 1! 0! 0! 2! 0! ! (0%) ! (222) ! (22 ! (50%) ! (222( ! (0%) ! (0%) !(100%) ! (22( ! ! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !!! ! 0! 2! 1! 1! 2! 1! 2! 2! 0! ! (0%) !(100%) ! (50%) ! (50%) !(100%) ! (50%) !(100%) !(100%) ! (0%) ! ! ! !!! ! 0! 0! 1! 1! 0! 0! 0! 0! 1! ! (0%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 1! 0! 0! 0! 0! 0! 0! 0! 1! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 1! 0! 1! 1! 0! 0! 0! 0! 2! ! (50%) ! (22( ! (222( ! (50%) ! (22 ! (0%) ! (0%) ! (0%) !(2222(! ! ! !!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (22( ! (22 ! (0%) ! (22 ! (0%) ! (0%) ! (0%) ! (22( ! ! ! !!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 47 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathol ogical findings (with scores, 28-days treatment) Page: 6 21-Aug-00 LESIONS ! TREATMENT ! ! ! SKIN (UNTREATED SITE) Epidermal erosion(s) Score Expanded Totals Dermal inflammatory cell infiltration siight Score Expanded Totals Subcutaneous inflammatory cell infiltration moderate Score Expanded Totals Epidermal hyperplasia moderate Score Expanded Totals Hyperkeratosis moderate Score Expanded Totals Haemorrhage siight Score Expanded Totals HEART No abnormality detected ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! ------- ! ! ------- ! 'saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 ! ! !!7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T!7343 ! ! ! ! ! ! ------- ! ! !!11!!!! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! !! !!!! ! !!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (22) ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! (0%) ! (0%) ! ! !!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (22) ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! (0%) ! (0%) ! ! !!!!!!!! ! 0! 0! 0! 0! 0! 1! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 1! 0! 0! 0! ! (0%) ! (22) ! (0%) ! (0%) ! (0%) ! (222) ! (0%) ! (0%) ! (0%) ! ! !!!!!!!! ! 2! 0! 1! 1! 0! 0! 0! 0! 2! !(100%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%)! ! 2! 0! 1! 1! 0! 0! 0! 0! 2! !(100%) ! (22) ! (50%) ! (50%) ! (0%) ! (22) ! (0%) ! (0%) !(100%)! ! !!!!!!!! ! 0! 0! 0! 0! 0! 0! 0! 0! 2! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%)! ! 0! 0! 0! 0! 0! 0! 0! 0! 2! ! (0%) ! (22) ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! (0%) !(100%)! ! !!!!!!!! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (22) ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! (0%) ! (0%) ! !! !!!! ! (2) ! (2( ! (2) ! (2) ! (2) ! (2( ! (2) ! (2) ! (2) ! !! !!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo !(100%) !(1222( !(100%) !(100%) !(100%)! (!222( !(100%) ! !!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 48 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 7 21-Aug-00 ! LESIONS ! ! ! ! LIVER ! No abnormality detected ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T!7341 !T!7342 !T- !7343 ! ! ! ! ! ! !!! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! ((( ! ((( ! ((( ! (2) ! !!! ! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! ! ((( O !!! ! !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (22) ! (0%) ! ((%( ! (((O ! ((%( ! (0%) ! !!! ! ! (2) ! (2) ! (2) ! (2( ! (2) ! ((( ! ((( ! ((( ! (2) ! !!! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! slight ! Score Expanded Totals ! Tubular dilatation with luminal hyaline substances ! slight ! Score Expanded Totals ! ADRENALS ! No abnormality detected ! (2) ! (2) ! (2) ! (2( ! (2) ! ((( ! ((( ! ((( ! (2) ! !!! ! ! 2! 2! 1! 2! 0! 1! 2! 2! 2! ! (50%) ! (0%) ! (((O !!! ! !! ! 0 ! 0 ! 1! 0 ! 1! 1 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 1! 1! 0! 0! 0! ! (0%) ! (0%) ! (50%) ! ((%( ! (50%) ! (((O ! ((%( ! ((%( ! (0%) ! !!! ! !! ! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 1! 0! 0! 0! 0! ! (0%) ! (0%) ! (0%) ! ((%( ! (50%) ! ((%( ! ((%( ! ((%( ! (0%) ! !!! ! ! (2) ! (2) ! (2) ! ((( ! (2) ! ((( ! ((( ! ((( ! (2) ! !!! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! ! OVARIES ! No abnormality detected ! (2) ! (2) ! (2) ! ((( ! (2) ! ((( ! ((( ! ((( ! (2) ! !!! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 49 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatment) Page: 8 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS PITUITARY Cyst(s) ABDOMINAL CAVITY Fat necrosis ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090 2 !7339 !! !! !T!7340 ! ! !T!7341 ! ! !T!7342 ! ! !T!7343 ! ! !!!!!!!!! ! ! (i) ! ! ! ! ! ! ! !!!!!! ! ! 1! ! ! ! ! ! ! ! !(100%)! !!!!!! !!!!!! ! ! ! (1) ! ! ! ! ! ! !!!!!! ! ! ! 1! ! ! ! ! ! ! ! !(100%) ! ! ! ! ! ! !!!!!!!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Table 9: S(2u8m-dmayasrytroefahtmisetonpta+th1o4lodgaicyaslrfeincodvinegrys) Page 50 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatm. + 14-days recov.) Page: 1 21-Aug-00 ! !----! INCIDENCE OF LESIONS (PERCENT) Mai es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T!7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! Hyperkeratosis ! SKIN (UNTREATED SITE) ! No abnormality detected ! HEART ! No abnormality detected ! Myocardial degeneration ! Myocardial mononuclear cell infiltration ! LIVER ! No abnormality detected ! Hepatodiaphragmatic nodule ! Mononuclear cell infiltration ! SPLEEN ! No abnormality detected ! ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! ! 0! 1! 1! 1! 2! 1! 1! 1! 1! ! (0%) ! (50%) ! (50%) ! (50%) !(100%) ! (50%) ! (50%) ! (50%) ! (50%)! ! 2! 1! 1! 1! 0! 1! 1! 1! 1! !(100%) ! (50%) ! (50%) ! (50%) ! (0%) ! (50%) ! (50%) ! (50%) ! (50%)! ! 0! 1! 0! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%) !(100%)! !! ! (2) ! (2) ! ((( ! (2) ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! 1! 1! 2! 2! 2! 2! 1! 2! 1! ! (50%) ! (50%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) ! (50%)! ! 1! 1! 0! 0! 0! 0! 1! 0! 0! ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 1! 1! 0! 0! 0! 0! 1! 0! 1! ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (50%)! !! ! (2) ! (2( ! ((( ! (2) ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! 1! 1! 2! 2! 2! 2! 1! 2! 2! ! (50%) ! (50%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! ! 0! 1! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 1! 0! 0! 0! 0! 0! 0! 0! 0! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! !! ! (2) ! (2( ! ((( ! (2) ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(((((( !(((((( !(100%) !(((((( !(((((( !(100%) !(((((( !(100%)! ! ! ! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 51 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatm. + 14-days recov.) Page: 2 21-Aug-00 ! INCIDENCE OF LESIONS (PERCENT) ! !------------------------------------------------------------- ! ! Males ! LESIONS ! TREATMENT ! !saline!T- !T! !7088.2 !7338 !! !! !T- !T!7090.2 !7339 !! !! !T!7340 !T!7341 !T!7342 !T!7343 ! ! ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! Tubular dilatation with luminal hyaline substances ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! TESTES ! No abnormality detected !! ! !! ! (2) ! (2) ! (2) ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! II ! 1! 2! 1! 1! 0! 2! 1! 2! 0! ! (50%) ! (50%) ! (50%) ! (0%) !(100%) ! (50%) ! (0%) ! ! 1! 0! 0! 1! 2! 0! 0! 0! 1! ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 0! 0! 1! 0! 1! 0! 1! 0! 1! ! (0%) ! (22) ! (50%) ! ((%( ! ((( O ! ((%( ! (50%) ! ((%( ! (50%)! !! ! !! ! (2) ! (2( ! (2) ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! !! ! 2! 2! 1! 2! 1! 2! 2! 2! 2! ! (50%) ! (50%) ! 0! 0! 1! 0! 1! 0! 0! 0! 0! ! (0%) ! (22) ! (50%) ! ((%( ! ((( O ! ((%( ! (0%) ! ((%( ! (0%) ! !! ! !! ! (2) ! ((( ! (2) ! ((( ! ((( ! ((( ! (2) ! ((( ! (2) ! !! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 52 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatm. + 14-days recov.) Page: 3 21-Aug-00 LESIONS SKIN (TREATED SITE) No abnormality detected Epi dermal hypertrophy/hyperpl as ia SKIN (UNTREATED SITE) No abnormality detected INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T!7343 !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) !! ! 0! 0! 1! 1! 1! 0! 0! 1! 2 ! (0%) ! (0%) ! (50%) ! (50%) ! (50%) ! (0%) ! (0%) ! 2! 2! 1! 1! 1! 2! 2! 1! 0 ! (50%) ! (50%) ! (50%) ! (0%) ! (2) ! (2) ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 oo oo oo oo oo oun oo oo oo oo oo oo oo oun oun oo oo oo oo oo oo oo oo oun oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo HEART No abnormality detected Myocardial mononuclear cell infiltration LIVER No abnormality detected Mononuclear cell infiltration SPLEEN No abnormality detected oo ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( !! ! 2! 2! 2! 2! 2! 2! 1! 2! 2 ! 0! 0! 0! 0! 0! 0! 1! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) !! ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( !! ! 2! 2! 1! 2! 1! 2! 1! 2! 2 ! 0! 0! 1! 0! 1! 0! 1! 0! 0 ! (0%) ! ((%( ! (((%( ! ((%( ! ((( O ! ((%( ! (50%) ! ((%( ! ((%( !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 oun oo oun oun oo oo KIDNEYS No abnormality detected Tubular basophilia Tubular dilatation with luminal hyaline substances ! (2) ! ((( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( !! ! 2! 2! 2! 1! 1! 2! 2! 2! 0 ! (50%) ! (0%) ! 0! 0! 0! 0! 1! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (50%) ! 0! 0! 0! 1! 0! 0! 0! 0! 2 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 53 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (28-days treatm. + 14-days recov.) Page: 4 21-Aug-00 LESIONS ADRENALS No abnormality detected Accessory cortical nodule (rest) OVARIES No abnormality detected Cyst(s) INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! 'saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! ! !!!! ! (2) ! (2) ! (2( ! (2) ! ((( ! (2) ! (2) ! (2) ! (2) ! !!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 1 ! (50%) ! 0! 0! 0! 0! 0! 0! 0! 0! 1 ! (0%) ! (22) ! ((%( ! (0%) ! ((%( ! (0%) ! (0%) ! (0%) ! (50%) ! !!!! ! (2) ! (2( ! ((( ! (2) ! ((( ! (2) ! (2) ! (2) ! (2) ! !!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 1 ! (50%) ! 0! 0! 0! 0! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 54 of 68 Table 10: 2S8u-mdamyasrtyreoafthmisetnotpa+th1o4lodgaiycsalreficnodvinegrys) (with scores, FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatm. + 14-days recov.) Page: 1 21-Aug-00 ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T!7342 !T- !7343 ! ! ! ! ! ! ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! Score Expanded Totals ! Hyperkeratosis ! slight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! HEART ! No abnormality detected ! Myocardial degeneration ! slight ! Score Expanded Totals ! Myocardial mononuclear cell infiltration ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected ! ! !! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 0! 1! 1! 1! 2! 1! 1! 1! 1! ! (0%) ! (50%) ! (50%) ! (50%) !(100%) ! (50%) ! (50%) ! (50%) ! (50%)! ! ! !! !! ! 2! 1! 1! 1! 0! 1! 1! 1! 1! !(100%) ! (50%) ! (50%) ! (50%) ! (0%) ! (50%) ! (50%) ! (50%) ! (50%)! ! 2! 1! 1! 1! 0! 1! 1! 1! 1! !(100%) ! (50%) ! (50%) ! (50%) ! (0%) ! (50%) ! (50%) ! (50%) ! (50%)! ! ! !! !! ! 0! 1! 0! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0! 1! 0! 0! 0! 0! 0! 0! 0! ! (0%) ! (50%) ! (O%( ! (0%) ! (OO ! (0%) ! (0%) ! (OO ! (0%) ! ! !! ! (2) ! (%( ! (O( ! (2) ! (O( ! (2) ! (2) ! (O( ! (2) ! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! !(100%) !(500%( !(OOOO(!(100%) !(OOOO(!(100%) !(100%) !(OOOO(!(100%)! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 1! 1! 2! 2! 2! 2! 1! 2! 1! ! (50%) ! (50%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) ! (50%)! ! ! !! !! ! 1! 1! 0! 0! 0! 0! 1! 0! 0! ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 1! 1! 0! 0! 0! 0! 1! 0! 0! ! (50%) ! (OOOO ! (O%( ! (0%) ! (OO ! (0%) ! (50%) ! (OO ! (0%) ! ! ! !! !! ! 1! 1! 0! 0! 0! 0! 1! 0! 1! ! (50%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (50%)! ! 1! 1! 0! 0! 0! 0! 1! 0! 1! ! (50%) ! (OOOO ! (O%( ! (0%) ! (OO ! (0%) ! (50%) ! (OO ! (50%)! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! !! ! 1! 1! 2! 2! 2! 2! 1! 2! 2! ! (50%) ! (50%) !(100%) !(100%) !(100%) !(100%) ! (50%) !(100%) !(100%)! ! ! !! !! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 55 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatm. + 14-days recov.) Page: 2 21-Aug-00 ! LESIONS ! ! ! ! LIVER ! Hepatodiaphragmatic nodule ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! i_____ ! INCIDENCE OF LESIONS (PERCENT) Mal es ! TREATMENT ! ! ! IsalinelT- !T! 17088.217338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! ! ! ! ! ! !!!! ! (2) ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! ! !! ! 0 ! 1! 0 ! 0 ! 0 ! 0 ! 1! 0 ! 0 ! ! (0%) ! (222) ! (0%) ! (22 ! (0%) ! (O2( ! (50%) ! (0%) ! (0%) ! ! ! ! !!!! ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 1! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! (50%) ! (22) ! (0%) ! (22 ! (0%) ! (O2( ! (0%) ! (0%) ! (0%) ! ! ! ! !! ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! ! !! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo oo oo oo oo oo oo oo oo ! KIDNEYS ! No abnormality detected ! Tubular basophilia ! slight ! Score Expanded Totals ! Tubular dilatation with luminal hyaline substances ! slight ! Score Expanded Totals ! ADRENALS ! No abnormality detected ! Cortical fatty cytoplasmic vacuolation ! slight ! Score Expanded Totals ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! ! !! ! 1! 2 ! 1! 1! 0 ! 2 ! 1! 2 ! 0 ! ! (50%) ! ! 1! ! (50%) ! (222( ! (0%) !(2222( ! (50%) ! ! !! 0 ! 0 ! 1! 2 ! 0 ! 0 ! ! (0%) ! !! 0 ! 1! ! (50%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (50%)! ! 1! 0 ! 0 ! 1! 2 ! 0 ! 0 ! 0 ! 1! ! (50%) ! (22( ! (0%) ! (222( !!! ! 0 ! 0 ! 1! 0 ! ! (O2( ! (0%) ! (0%) ! (50%)! !!!! 1! 0 ! 1! 0 ! 1! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (50%)! ! 0 ! 0 ! 1! 0 ! 1! 0 ! 1! 0 ! 1! ! (0%) ! (02 ! (50%) ! (22 ! (50%) ! (O2( ! (50%) ! (0%) ! (50%)! ! ! ! !! ! (2) ! (2( ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! ! ! ! !! ! 2 ! 2 ! 1! 2 ! 1! 2 ! 2 ! 2 ! 2 ! oo oo oo oo oo oo oo ! (50%) ! (50%) ! ! ! !!!! ! 0 ! 0 ! 1! 0 ! 1! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) ! ! 0 ! 0 ! 1! 0 ! 1! 0 ! 0 ! 0 ! 0 ! ! (0%) ! (22 ! (50%) ! (O2( ! (50%) ! (O2( ! (0%) ! (0%) ! (0%) ! ! ! ! !!!! Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 56 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatm. + 14-days recov.) Page: 3 21-Aug-00 LESIONS TESTES No abnormality detected INCIDENCE OF LESIONS (PERCENT) Mai es ! TREATMENT ! ! ! Isaline !T- !T! !7088.2 !7338 !!! !!! !T- !T- !7090 -2 !7339 !! !! !T- !7340 ! ! !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! ! ! !!!! ! (2) ! (2) ! (2( ! (2) ! (2( ! (2) ! (2) ! (2) ! (2) ! !!!! ! 2! 2! 2! 2! 2! 2! 2! 2! 2 oo oo oo oo oo oo oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 57 of 68 oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatm. + 14-days recov.) Page: 4 21-Aug-00 ! LESIONS ! SKIN (TREATED SITE) ! No abnormality detected ! Epidermal hypertrophy/hyperplasia ! very siight ! Score Expanded Totals ! SKIN (UNTREATED SITE) ! No abnormality detected ! 1_____ ! INCIDENCE OF LESIONS (PERCENT) Females ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T!7342 !T!7343 ! ! !! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 0! 0! 1! 1! 1! 0! 0! 1! ! (0%) ! (0%) ! (50%) ! (50%) ! (50%) ! (0%) ! (0%) ! (50%) !! 2! ! 2! 2! 1! 1! 1! 2! 2! 1! 0! oo oo ! (50%) ! (50%) ! (50%) ! (50%) ! (0%) ! ! 2! 2! 1! 1! 1! 2! 2! 1! 0! ! (50%) ! (50%) ! (50%) ! (50%) ! (0%) ! ! (2) ! (2) ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo oo oo ! HEART ! No abnormality detected ! Myocardial mononuclear cell infiltration ! slight ! Score Expanded Totals ! LIVER ! No abnormality detected ! Mononuclear cell infiltration ! slight ! Score Expanded Totals ! SPLEEN ! No abnormality detected ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( ! ! ! 2! 2! 2! 2! 2! 2! 1! 2! 2! ! (50%) !! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 0! 0! 0! 0! 1! 0! 0! ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! ! (2) ! (2( ! ((( ! ((( ! ((( ! ((( ! (2) ! ((( ! ((( ! ! ! 2! 2! 1! 2! 1! 2! 1! 2! 2! ! (((%( ! (((O ! (50%) !! ! 0! 0! 1! 0! 1! 0! 1! 0! 0! ! (0%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (50%) ! (0%) ! (0%) ! ! 0! 0! 1! 0! 1! 0! 1! 0! 0! ! (0%) ! ((%( ! (((O ! ((%( ! (((O ! ((%( ! (50%) ! ((%( ! ((%( ! ! ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! 2! 2! 2! 2! 2! 2! 2! 2! 2! oo oo oo Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Conti nued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 58 of 68 FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, 28-days treatm. + 14-days recov.) Page: 5 21-Aug-00 INCIDENCE OF LESIONS (PERCENT) Females LESIONS ! TREATMENT ! ! ! !saline!T- !T! !7088-2 !7338 !!! !!! !T- !T- !7090.2!7339 !! !! !T!7340 !T- !7341 ! ! !T- !7342 ! ! !T- !7343 ! ! KIDNEYS No abnormality detected Tubular basophilia siight Score Expanded Totals Tubular dilatation with luminal hyaline substances siight Score Expanded Totals ADRENALS No abnormality detected Accessory cortical nodule (rest) OVARIES No abnormality detected Cyst(s) !!!! !!! ! (2) ! (2) ! (2) ! (2) ! (2) ! 222 ! (2) ! (2) ! (2) !!!! !!! ! 2! 2! 2! 1! 1! 2! 2! 2! 0 ! (50%) ! (222) !!!! ! (0%) !!! oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo oo ! 0! 0! 0! 0! 1! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (50%) ! 0! 0! 0! 0! 1! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (222) ! 222 ! (0%) ! (0%) ! (50%) !!!! !!! ! 0! 0! 0! 1! 0! 0! 0! 0! 2 ! (0%) ! (0%) ! (0%) ! (50%) ! (0%) ! (0%) ! (0%) ! (0%) !(100%) ! 0! 0! 0! 1! 0! 0! 0! 0! 2 ! (0%) ! (0%) ! (0%) ! (50%) ! 2222 ! 222 ! (0%) ! (0%) !(100%) !!!! !!! ! (2) ! (2) ! (2) ! (2) ! 222 ! 222 ! (2) ! (2) ! (2) !!!! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 1 ! 0! 0! 0! 0! 0! 0 ! (0%) ! (0%) ! (0%) ! (0%) ! 2022 ! 222 !!!! ! (50%) ! 0! 0! 1 ! (0%) ! (0%) ! (50%) !!! ! (2) ! (2) ! (2) ! (2) ! 222 ! 222 ! (2) ! (2) ! (2) !!!! !!! ! 2! 2! 2! 2! 2! 2! 2! 2! 1 ! (50%) ! 0! 0! 0! 0! 0! 0! 0! 0! 1 ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (0%) ! (50%) Significance of difference in a pairwise Fisher's test between control and treatment groups: *P<0.05,**P<0.01,***P<0.001 Figures in brackets represent the number of animals from which this tissue was examined microscopically Listing Complete Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Table 11: Histopathological findings of Individual Animals Page 59 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 1 21-Aug-00 LESIONS 1 SKIN (TREATED SITE) No abnormality detected 1 TREATMENT 1 1 1 Epi dermal hypertrophy/hyperplas ia very siight siight Multifocal hyperkeratosis siight Focal hyperkeratosis siight Focal ulcerative inflammation siight Focal epidermal erosion(s) siight Multifocal dermal inflammatory cel 1 infi1trati on very siight siight Focal dermal inflammatory cell infi1trati on siight Focal subcutaneous inflammatory cel 1 infi1trati on moderate SKIN (UNTREATED SITE) No abnormality detected 1 INCIDENCE OF LESIONS (ANIMAL REFERENCES) 1 1----1 Mal es ------ 1 1 ------ 1 IsalinelT- 1T- 1T- 1T- 1T- 1T- 1T- 1T- 1 1 17088.217338 17090.217339 17340 17341 17342 17343 1 11111 11 11111 11 111 ------ 1 11 1 (8) 1 (8) 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 1 1010004 10300081050001 1070007 1090002 1110006 1130006 1150001 11700041 1010006 1 11 11 11 1050007 1 1 1 1090006 1110007 1130007 1150005 11700051 1090007 1090008 1150008 11700071 11 11 1010001 10300011050002 1070002 1090001 1110001 1130002 1150002 11700021 1010002 10300021050003 1070003 1090003 1110002 1130003 1150003 11700031 1010003 10300031050005 1070004 1090004 1110004 1130004 1150004 11700081 1010005 10300041050006 1070008 1090005 1110005 1130005 1150006 1 1 1010007 10300061050008 1110008 1130008 1150007 1 1 1010008 10300071 11 1 10300051050004 1070001 1110003 1130001 11700011 1 1 1 1070005 11700061 1 1 1 1070006 11 111 11 1 10300071050004 1070005 1090001 1110003 111 11700061 11 111 111 1 1 1 1070005 111 111 111 1 10300031050003 1 10300041 1110002 11700011 11 11 11 11 11 11 11 1 10300051 1070006 111 1 1 1 1070004 1090004 1110002 111 111 1130001 11 11 11700011 11 11 1 1 (8) 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 1 1010001 10300011050001 1070001 1090001 1110001 1130001 1150001 11700011 1010002 10300021050002 1070002 1090002 1110002 1130002 1150002 11700021 1010003 10300031050003 1070003 1090003 1110003 1130003 1150003 11700031 1010004 10300041050004 1070004 1090004 1110004 1130005 1150004 11700041 1010005 10300051050006 1070005 1090005 1110005 1130006 1150005 11700051 111 11 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 60 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 2 21-Aug-00 LESIONS ! TREATMENT ! ! ! SKIN (UNTREATED SITE) No abnormality detected Focal ulcerative inflammation : due to mechanical irritation siight Focal inflammation : due to mechanical irritation moderate Focal epidermal hyperplasia : due to mechanical irri tati on moderate severe Focal hyperkeratosis : due to mechani cal irri tati on moderate Focal dermal fibrosis : due to mechanical irri tati on moderate ! !----! INCIDENCE OF LESIONS (ANIMAL REFERENCES) Mal es ! i ! ------------ ! !saline!T- !T- !T- !T- !T- !T- !T- !T- ! ! !7088-2 !7338 !7090.2!7339 !7340 !7341 !7342 !7343 ! !!!! ! !! !!!! ! !! ------------ ! ! !! ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! !010006 !030006 !050007 !070006 !090006 !110006 !130007 !150006!170006! !010007 !030007 !050008 !070007 !090007 !110007 !130008! 150007 !170007 ! !010008 !030008 !070008 !090008! 110008 150008!170008! ! !! ! !! ! !130004! !! ! !! ! !050005 !! ! !! ! !! ! !130004! !! ! !050005 !! ! !! ! !! ! !050005 !! ! !! ! !! ! !050005 !! CEREBRUM No abnormality detected HEART No abnormality detected Focal myocardial degeneration siight Focal myocardial mononuclear cell infiltration very siight siight ! (i) ! !010006 !! !! ! ! (8) ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! (8) ! (8) ! ! !010001 !030001 !050001 !070001 !090001 !110001 !130001 !150001 !170001 ! !010002 !030002 !050002 !070002 !090002 !110002 !130002 !150002 !170002 ! !010003 !030003 !050003 !070003 !090003 !110003 !130003 !150003 !170004! !010004 !030004 !050005 !070004 !090004! 110004 !130004! 150004!170005 ! !010005 !030005 !050007 !070005 !090005 !110005 !130006! 150005 !170006! !010006 !030006 !050008 !070007 !090007 !110006 !130007 !150006!170008! !010008 !030007 !070008 !090008! 110007 150007! ! ! 110008 150008! !! !010007 !030008 !050006 !090006 ! !130008! ! !! ! !050004 !070006 ! ! ! ! ! ! !010007 !030008 !050006 !090006 ! !130005 ! !170003 ! ! !130008! !170007 ! ! !! Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 61 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 3 21-Aug-00 LESIONS LIVER No abnormality detected ! TREATMENT ! ! ! Hepatodiaphragmatic nodule Focal hepatocellular necrosis moderate Focal granulation tissue moderate Multifocal mononuclear cell infiltration siight Focal mononuclear cell infiltration siight KIDNEYS No abnormality detected Multifocal tubular dilatation with luminal hyali ne substances siight Uni-lateral multifocal tubular di 1atati on wi th luminal hyaline substances siight ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! !----! Mal es ------ ! ! ------ ! !saline!T- !T- !T- !T- !T- !T- !T- !T- ! ! !7088-2 !7338 !7090.2!7339 !7340 !7341 !7342 !7343 ! !!!!! !! !!!!! !! !!! ------ ! !! ! (8) ! (8) ! (8) ! (8) ! ((( ! ((( ! ((( ! ((( ! (8) ! ! O o o un un un o oo o o o CO CO CO o oo !010001 !070001 !090001 !110001 !130001 !150001 !170001 ! !010002 !030002!050002 !070002 !090002 !110002 !130002 !150002 !170002 ! !010003 !030003!050003 !070003 !090003 !110003 !130003 !150003 !170003 ! ooou n uoooo ooo ooou n !010005 !070004 !090006 !110004 !130004 !150006 !170004! !010006 !070006 !090007 !110005 !130005 !150007 !170005 ! oo OoooJ"~1OooooJr cooooCnOcoooo"in~ !010007 !070007 !090008 !110006 !130006 !150008 !170006! ! !070008 !110007 !130007 !170007 ! !!! !110008 !170008! ! !030008! !130008 !! !!! !! ! ! ! !070005 !! !!! !! ! ! ! !070005 !! !!! !! !010004 ! ! !150005 ! ! !010008 ! ! !! !!! !! ! ! !050004 !090004 !150004 ! ! !!! !090005 !! ! ! (8) ! (8) ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! (8) ! ! Ooo ooou n CoooO uon uon uon ooo CoooO ooo CoO CoO CoO !010002 !070001 !090002 !110002 !130001 !150001 !170001 ! !010003 !030002!050003 !070002 !090004 !110003 !130002 !150002 !170002 ! !010004 !070003 !090005 !110004 !130003 !150006 !170003 ! !010005 !070004 !090006 !110005 !130004 !150007 !170004! !010006 !030005 ! !070005 !110006 !130006 !150008 !170005 ! !010007 !030006 ! ! !030007 ! ! !030008! !!! !!! !070006 !070007 !110007 !130008 !110008 !170006! !! !! !! !! ! ! !050007 !!! !!! !!! !!! !090008 !110001 !170007 ! !! !! !130005 !150003 ! ! ! ! Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 62 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 4 21-Aug-00 LESIONS INCIDENCE OF LESIONS (ANIMAL REFERENCES) Mal es ! TREATMENT !saline!T- !T- !T- !T- !T- !T- !T- !T- ! ! !7088.2 !7338 !7090.2 !7339 ! 7340 ! 7341 ! 7342 ! ! ! ! ! !! ! ! ! ! ! ! ! ! !! ! ! ! !7343 KIDNEYS Uni-lateral focal tubular dilatation with luminal hyaline substances siight Uni-lateral focal interstitial mononuclear cell infi1trati on siight Uni-lateral focal cortical scar(s) siight Uni-lateral focal tubular-cell degeneration siight Multifocal tubular basophilia siight Uni-lateral multifocal tubular basophilia siight Uni-lateral focal tubular basophilia very siight siight ADRENALS No abnormality detected Uni-lateral accessory cortical nodule (rest) Diffuse cortical fatty cytoplasmic vacuolation siight Multifocal cortical fatty cytoplasmic vacuolation siight ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) 130007 150005 150004 050002 050004 090008 170008 010001 010008 050006 070008 090001 090003 090007 150005 (8) (8) (8) (8) (8) (8) (8) (8) (8) 010001 010003 030001 030002 050001 050003 070002 070004 090001 090002 111100000012 130001 130002 150001 150002 170001 170002 010004 030004 050005 070005 090003 110003 130003 150003 170003 010005 030005 050006 070006 090004 110004 130004 150004 170004 010006 030006 050008 070007 090005 110005 130005 150005 170006 010007 030007 070008 090006 110006 130006 150006 170007 010008 030008 090007 110007 130007 150007 170008 110008 130008 150008 070001 170005 070003 010002 050002 050004 090008 050007 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 63 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 5 21-Aug-00 LESIONS ! TREATMENT ! ! ! ADRENALS Uni-lateral focal cortical fatty cytoplasmic vacuolati on siight TESTES No abnormality detected THYMUS Multifocal haemorrhage siight Focal haemorrhage siight SPLEEN No abnormality detected ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ((((((! !----- ! Mal es ----- ! !saline!T- !T- !T- !T- !T- !T- !T- !T- ! ! !7088-2 !7338 !7090.2!7339 !7340 !7341 !7342 !7343 ! !!!!! ! !!!!! ! ----- ! !! ! (8) ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! (8) ! ! !! !! ! !030003 ! ! ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! (8) ! ! !010001 !030001 !050001 !070001 !090001 !110001 !130001 !150001 !170001! !010002 !030002 !050002 !070002 !090002 !110002 !130002 !150002 !170002! !010003 !030003 !050003 !070003 !090003 !110003 !130003 !150003 !170003! !010004 !030004 !050004 !070004 !090004 !110004 !130004 !150004 !170004! !010005 !030005 !050005 !070005 !090005 !110005 !130005 !150005 !170005! !010006 !030006 !050006 !070006 !090006 !110006 !130006 !150006! 170006! !010007 !030007 !050007 !070007 !090007 !110007 !130007 !150007 !170007! !010008 !030008 !050008 !070008 !090008 !110008 !130008 !150008! 170008! ! ! ! (i( ! (1) ! ! !! ! !150002 ! ! !! ! 170001! ! ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! ((( ! (n ! (8) ! ! !010001 !030001 !050001 !070001 !090001 !110001 !130001 !150001 !170001! !010002 !030002 !050002 !070002 !090002 !110002 !130002 !150002 !170002! !010003 !030003 !050003 !070003 !090003 !110003 !130003 !150003 !170003! !010004 !030004 !050004 !070004 !090004 !110004 !130004 !150004 !170004! !010005 !030005 !050005 !070005 !090005 !110005 !130005 !150005 !170005! !010006 !030006 !050006 !070006 !090006 !110006 !130006 !150006! 170006! !010007 !030007 !050007 !070007 !090007 !110007 !130007 !150007 !170007! !010008 !030008 !050008 !070008 !090008 !110008 !130008 !150008! 170008! !! Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 64 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 6 21-Aug-00 LESIONS 1 SKIN (TREATED SITE) No abnormality detected Epi dermal hypertrophy/hyperplas ia very siight 1 TREATMENT 1 1 1 siight Multifocal hyperkeratosis siight Focal epidermal erosion(s) siight Multifocal dermal inflammatory cel 1 infi1trati on very siight siight Focal dermal inflammatory cell infi1trati on siight 1 1----1 INCIDENCE OF LESIONS (ANIMAL REFERENCES) Females IsalinelT- 1T1 17088.217338 111 111 1T- 1T- 17090.217339 11 11 1T17340 1T17341 1T17342 1 1 ------ 1 1 ------ 1 1T- 1 17343 1 11 11 ------ 1 11 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 1 1 1060001 1080007 1100008 1 1060007 1 1160008 11800071 11800081 11 1020003 1040001 1060002 1080001 1100001 1120002 1140001 1160001 11800011 1020006 1040002 1060005 1080002 1100002 1120005 1140002 1160002 11800021 1020007 1040004 1060006 1080004 1100003 1120006 1140003 1160003 11800031 1020008 1040006 1060008 1080005 1100005 1120007 1140004 1160004 11800051 1 1040007 1080006 1100006 1120008 1140005 1160007 11800061 1 1040008 1080008 1100007 1140007 11 1 1140008 11 1020001 1040003 1060003 1080003 1100004 1120001 1140006 1160005 11800041 1020002 1040005 1060004 1120003 1160006 1 1 1020004 1120004 11 1020005 11 1 11 1020001 1040003 1060003 1080003 1100002 1120001 1140002 1160005 11800041 1020004 1060004 1080006 1120003 1160006 1 1 1 1120004 11 1 11 1 1160005 1 1 1 11 1020001 1020002 1 1 1 1 1160005 1 1 1 1 1 1 1 1040005 1060003 1080003 1100005 1120003 1 1080006 1120004 1160006 1 1 1 1 SKIN (UNTREATED SITE) No abnormality detected 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 1 1020001 1040001 1060001 1080001 1100001 1120001 1140001 1160001 11800011 1020002 1040002 1060002 1080002 1100002 1120002 1140002 1160002 11800021 1020003 1040003 1060003 1080004 1100003 1120004 1140003 1160003 11800031 1020004 1040004 1060004 1080006 1100004 1120006 1140004 1160005 11800071 1020007 1040005 1060006 1080007 1100005 1120007 1140005 1160006 11800081 1020008 1040006 1060007 1080008 1100006 1120008 1140006 1160007 1 1 1 1040007 1060008 1100007 1140007 1160008 1 1 1 1040008 1100008 1140008 11 1 11 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 65 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 7 21-Aug-00 LESIONS INCIDENCE OF LESIONS (ANIMAL REFERENCES) Females TREATMENT salinelT- IT17088.217338 !I I! T- IT- 7090.217339 I I T7340 T7341 T7342 T7343 SKIN (UNTREATED SITE) Focal ulcerative inflammation : due to mechanical irritation siight moderate severe Focal epidermal erosion(s) : due to mechanical im i tati on siight Focal dermal inflammatory cell infiltration : due to mechanical irritation siight Focal epidermal hyperplasia : due to mechanical im i tati on siight moderate Focal hyperkeratosis : due to mechanical im i tati on siight moderate Focal haemorrhage : due to mechanical irritation siight Focal subcutaneous inflammatory cell infiltration siight moderate PITUITARY Cyst(s) HEART No abnormality detected ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) ( 8) 020006 060005 080003 080005 120003 1800041 1800051 1800061 020005 020005 020005 020006 060005 080003 080005 120003 1800041 1800051 1800061 080003 120003 1800041 1800051 1800061 020005 120005 160004 ((( 040006 (8) (8) (8) ((( ((( ((( ((( ((( ((( 020001 020002 040001 040002 060001 060002 080001 080002 100001 100002 120001 120002 140001 140002 160001 160002 1800011 1800021 020004 040003 060003 080003 100003 120003 140003 160003 1800031 020005 040004 060004 080005 100004 120004 140004 160004 1800041 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 66 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 8 21-Aug-00 LESIONS 1 HEART No abnormality detected 1 TREATMENT 1 1 1 Focal myocardial mononuclear cell infiltration siight 1 INCIDENCE OF LESIONS (ANIMAL REFERENCES) 1 1----1 Females ------ 1 1 ------ 1 IsalinelT- 1T- 1T- 1T- 1T- 1T- 1T- 1T- 1 1 17088.217338 17090.217339 17340 17341 17342 17343 1 11111 11 11111 11 ------ 1 1 11 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 (8) 1 1020006 1040005 1060005 1080006 1100005 1120005 1140005 1160005 11800051 1020007 1040006 1060006 1080007 1100006 1120006 1140006 1160006 11800061 1020008 1040007 1060007 1080008 1100007 1120007 1140008 1160007 11800071 1 1040008 1060008 1100008 1120008 1160008 11800081 1 11 1020003 1080004 1140007 11 ABDOMINAL CAVITY Focal fat necrosis 1 1 ((( 1 1060006 11 11 LIVER 1 (8) 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 No abnormality detected Hepatodiaphragmatic nodule Multifocal mononuclear cell infiltration siight Focal mononuclear cell infiltration siight KIDNEYS No abnormality detected 1020001 1040001 1060001 1080001 1100001 1120001 1140001 1160001 11800011 1020002 1040002 1060002 1080002 1100002 1120002 1140003 1160003 11800031 1020003 1040003 1060003 1080003 1100003 1120003 1140006 1160004 11800041 1020004 1040004 1060004 1080004 1100004 1120004 1140007 1160005 11800051 1020005 1040005 1060005 1080005 1100005 1120005 1160006 11800061 1020006 1040006 1060006 1080006 1100006 1120006 1160007 11800071 1020007 1040007 1060007 1080007 1100008 1120007 1020008 1040008 1080008 1120008 1160008 11800081 11 1 1140004 11800021 1 11 1 1160002 1 1 1 11 1 1060008 1100007 1140002 11 1 1140005 11 1 1140008 11 1 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 1 1020001 1040001 1060001 1080001 1100001 1120001 1140001 1160001 11800021 1020003 1040002 1060002 1080003 1100002 1120002 1140003 1160002 11800031 1020004 1040003 1060003 1080004 1100003 1120003 1140005 1160003 11800051 1020005 1040004 1060004 1080005 1100004 1120004 1140006 1160004 11800061 1020006 1040005 1060006 1080006 1100008 1120005 1140007 1160005 1 1 1020007 1040006 1060007 1080007 1120007 1140008 1160006 1 1 1020008 1040007 1060008 1120008 1160007 1 1 1 1040008 1160008 1 1 1 11 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 67 of 68 FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 9 21-Aug-00 LESIONS 1 KIDNEYS 1 TREATMENT 1 1 1 1 INCIDENCE OF LESIONS (ANIMAL REFERENCES) 1 1------------------1 Females ------ 1 1 ------ 1 IsalinelT- 1T- 1T- 1T- 1T- 1T- 1T- 1T- 1 1 17088.217338 17090.217339 17340 17341 17342 17343 1 11111 11 11111 11 111 ------ 1 11 1 (8) 1 (8) 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 Multifocal tubular dilatation with luminal hyali ne substances siight Uni-lateral focal tubular dilatation with luminal hyaline substances siight Uni-lateral focal interstitial mononuclear cell infi1trati on siight moderate Uni-lateral focal cortical scar(s) moderate Uni-lateral focal tubular mineralisation siight Uni-lateral focal tubular-cell degenerati on very siight Multifocal tubular basophilia siight Uni-lateral multifocal tubular basophi1ia siight Uni-lateral focal tubular basophilia siight 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 10200021 11 11 11 11 11 11 11 1 1 1 1 1 1 1080008 1100006 1 1 1 1 1 1140004 1 1 1140002 1 1 1080002 1 1 1 1060005 1 1 1 1 1100005 1120006 1 1100007 11 11 11800011 11 11 11800071 11800081 11 11 11800041 11 11 11 11 11 11 11 11 11 11 11800081 11 11 11 ADRENALS 1 (8) 1 (8) 1 (8) 1 ((( 1 ((( 1 ((( 1 ((( 1 ((( 1 (8) 1 No abnormality detected Uni-lateral accessory cortical nodule (rest) OOoCoOCoooCoXOI ooo CoooXI oo ooo oooXI XoI XoI 1080001 1100001 1120001 1140001 1160001 11800011 1080002 1100002 1120002 1140002 1160002 11800021 102000310400031060003 1080003 1100003 1120003 1140003 1160003 11800031 oooCo=OToooCou On CoooCoOO ooo ooou n CoooO ooo ooo ooou n CoooO XoI XoI XoI 1080004 1100004 1120004 1140004 1160004 11800041 1080005 1100005 1120005 1140005 1160005 11800051 1080006 1100006 1120006 1140006 1160006 11800061 102000710400071060007 1080007 1100007 1120007 1140007 1160007 11800071 coooCoOo CoooO o CoooO o X I 1080008 1100008 1120008 1140008 11600081 1 111 111 11800081 11 Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats Page 68 of 68 FRAUNHOFER ITA 01G0002 Unmerged nistopathological findings (all animals) Page: 10 21 -Aug-00 LESIONS OVARIES ! TREATMENT ! ! ! ! !----! INCIDENCE OF LESIONS (ANIMAL REFERENCES) Females 'saline!T- !T! !7088-2 !7338 !!! !!! !T- !T!7090.2!7339 ! ! !T!7340 ! ! !T!7341 !T!7342 ! ! (8) ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! m ! ----- ! ! ----- ! !T- ! !7343 ! ! ! ----- ! ! ! (8) ! No abnormality detected Uni-lateral cyst(s) Macroscopic finding: see abdominal cavity UTERUS Di 1atati on moderate THYMUS No abnormality detected 020001 !040001 !060001 !080001 !100001 !120001 !140001 !160001 !180001! 020002 !040002 !060002 !080002 !100002 !120002 !140002 !160002 !180002! 020003 !040003 !060003 !080003 !100003 !120003 !140003 !160003 !180003! !020004 !040004 !060004 !080004 !100004! 120004 !140004 !160004! 180004! 020005 !040005 !060005 !080005 !100005 !120005 !140005 !160005 !180005! 020006 !040006 !060006 !080006 !100006! 120006 !140006 !160006! 180006! 020007 !040007 !060007 !080007 !100007 !120007 !140007 !160007 !180008! !020008 !040008 !060008 !080008 !100008! 120008 !140008 !160008! ! ! 180007! ! !060006 ! ! ! (i( ! !! ! !140001 ! ! (i) ! ! 180001! SPLEEN ! (8) ! ((( ! ((( ! ((( ! ((( ! ((( ! (K ! m ! (8) ! No abnormality detected 020001 !040001 !060001 !080001 !100001 !120001 !140001 !160001 !180001! 020002 !040002 !060002 !080002 !100002 !120002 !140002 !160002 !180002! 020003 !040003 !060003 !080003 !100003 !120003 !140003 !160003 !180003! !020004 !040004 !060004 !080004 !100004! 120004 !140004 !160004! 180004! 020005 !040005 !060005 !080005 !100005 !120005 !140005 !160005 !180005! 020006 !040006 !060006 !080006 !100006! 120006 !140006 !160006! 180006! 020007 !040007 !060007 !080007 !100007 !120007 !140007 !160007 !180007! !020008 !040008 !060008 !080008 !100008! 120008 !140008 !160008! 180008! !! Figures in brackets represent the number of animals from which this tissue was examined microscopically The absence of a numeral indicates that the lesion specified was not identified *** Listing Complete ***